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Many NPs Unable to Prescribe Meds to Treat Opioid Addiction

TUESDAY, April 9, 2019 (Pharmacist's Briefing) -- Greater practice restrictions are associated with a lower percentage of nurse practitioners (NPs) with waivers to prescribe buprenorphine, but no association is seen for physician assistants (PAs), according to a study published in the April 9 issue of the Journal of the American Medical Association.

Joanne Spetz, Ph.D., from the University of California in San Francisco, and colleagues examined the proportions of NPs and PAs with waivers in 2018 and the correlation with state regulations restricting their scope of practice. The scope of practice was measured as a binary variable.

The researchers found less restrictive regulations in 27 and 23 states for NPs and PAs, respectively. Overall, 5.57 percent of all physicians, 3.17 percent of NPs, and 1.66 percent of PAs had waivers to prescribe buprenorphine. Correlations between the state-level percentages of physician and NP waivers and between physician and PA waivers were 0.80 and 0.63, respectively. The mean percentage of NPs with waivers was 5.58 and 2.44 percent in less and more restrictive states, respectively. After multivariable adjustment controlling for the percentage of physicians with waivers, the adjusted percentage of NPs with waivers was 4.73 and 2.03 percent in less and more restrictive states, respectively. There was no significant correlation between PA scope of practice and percentages of PAs and physicians with waivers in unadjusted or adjusted analyses.

"The results of this study suggest that states in which NP practice is restricted may be less able to expand the opioid treatment workforce," the authors write.

Abstract/Full Text (subscription or payment may be required)

 

FDA Advances Regulation to Ensure Sunscreen Safety, Efficacy

THURSDAY, Feb. 21, 2019 (Pharmacist's Briefing) -- The U.S. Food and Drug Administration took steps Thursday to tighten regulation of over-the-counter sunscreen products.

Included in the proposed rule are updates on sunscreen safety, sun protection factor (SPF) requirements, and the effectiveness of insect repellent/sunscreen combinations. Under the proposed rule, two of the 16 active ingredients in sunscreens -- zinc oxide and titanium dioxide -- are now considered safe and effective, while two others (para-aminobenzoic acid [PABA] and trolamine salicylate) are not. No sunscreens sold in the United States contain PABA or trolamine salicylate. Safety data for 12 other sunscreen ingredients are not sufficient to determine if they are safe and effective, the agency added.

The Environmental Working Group (EWG), a watchdog organization for consumer health, called the new initiative way overdue. "After more than 40 years, the FDA is at last taking serious steps to finalize rules that would require sunscreen companies to make products that are both safe and effective," David Andrews, Ph.D., senior scientist at EWG, said in a news release. He pointed to one ingredient, oxybenzone, in particular. "For a decade, EWG has worked to raise concerns about sunscreens with oxybenzone, which is found in nearly all Americans, detected in breast milk and potentially causing endocrine disruption," Andrews said. "Today the FDA recognized those concerns."

According to the FDA, products that combine sunscreens with insect repellents are not generally considered safe and effective. Under the rule, the maximum sun protection factor on sunscreen labels would be raised from SPF 50+ to SPF 60+. Sunscreens with SPF values of 15 and higher will be required to be broad-spectrum, and broad-spectrum protection against ultraviolet A radiation must also increase as SPF increases. New sunscreen label requirements will include listing of active ingredients on the front of the bottle and other requirements for the front of sunscreen bottles -- all meant to help consumers better understand what the sunscreens they are buying can actually do.

More Information: FDA
More Information: EWG

ALABAMA

Alabama State Regulatory Update April 2019

Farm Bill and CBD/THC Sales by Pharmacies

The Agriculture Improvement Act of 2018, or Farm Bill changes certain federal oversight relating to hemp production, sale, and possession. These changes remove hemp (and therefore, hemp-related products) from the federal Controlled Substances Act, which means that hemp is no longer an illegal substance under federal law. The farm bill allows for the sale, production, and possession of cannabidiol (CBD) derived from industrial hemp, with a tetrahydrocannabinol (THC) concentration not more than 0.3% (dry weight).

But, the Alabama Uniform Controlled Substances Act (AUCSA) lists any product containing THC to be a Schedule I controlled substance (CS).

Until the Alabama Department of Public Health (ADPH) removes hemp and hemp-derived products from the list of Schedule I CS, Alabama pharmacies and pharmacists must abide by the strictest rule. In this situation, the strictest rule is that CBD products containing any THC are a Schedule I CS under Alabama law. Because of this, pharmacies do NOT have the ability to sell CBD products.

Medicaid limits on Short Acting Opiates

Effective November 1,2018, the Alabama Medicaid Agency will begin implementing limits on short acting opiate for opioid naive recipients. The Agency defines 'opioid naive' as a recipient with no opioid claim in the past 180 days.

Limits now include:

  • A 7 day supply limit for adults age 19 and older.
  • A 5 day supply limit for children age 18 and younger.
  • A maximum of 50 morphine milligram equivalents (MME) per day allowed on a claim for an opioid naive recipient.

Any claim for a short acting opioid for an opioid naive recipient exceeding the maximum days' supply limit or MME limit will be denied. Claims prescribed by oncologists will bypass the edit. Long term care and hospice recipients are excluded.

Refills of remaining quantities and/or new prescriptions filled within 180 days of the initial opioid naive claim will require an override.

Refills of remaining quantities of prescriptions that are partially-filled will be allowed per State and federal law' but will require an override through Medicaid.

For adults, the refill of the quantity remaining on the partial fill will not count towards the prescription limit if filled within 30 days of the original prescription. Monthly maximum unit quantities still apply.

Overrides for quantities exceeding the maximum days' supply limit or MME limit may be submitted to Health lnformation Designs (HID).

IMPORTANT: A recipient may not pay cash for the remaining amount over 7 days for the same prescription of a Medicaid-paid opioid claim (i.e. a single fill/dispense/claim may not be 'split billed' to both Medicaid and cash). lf the prescription to be paid by Medicaid exceeds the drug's limit allowed, an override may be requested. Only if the override is denied, then the excess quantity above the maximum unit limit is deemed a non-covered service, and the recipient can be charged as a cash recipient for that amount.

What does this mean for pharmacists practicing in the state of Alabama?

  • Pharmacists can not sell any type of CBD or THC containing products to customers.
  • If you have a patient that is an opiate naive user, and has questions around restrictions on prescription quantities, be prepared to provide accurate counseling on the new regulation. Also ensure that pharmacy staff understands how to properly bill for allowed quantities of opioids for these patients and understand split billing/cash billing restrictions.

Alabama BOP Regulations Update November 2018

Important Statement on CBD oils:

Pharmacies cannot store or sell CBD oils. CBD oils contain a substance listed in the Alabama Uniform Controlled Substances Act as unlawful.

Notwithstanding the above, a pharmacy can dispense Epidiolex only if pursuant to an FDA approved use and record keeping consistent with its schedule as a controlled substance.

Please refer to the Alabama Board of Pharmacy's Practice of Pharmacy Act 205(Title 20-Controlled Substances Act) for further information.

Alabama State Regulatory Summary- February 2018

The partial filling of a prescription for a controlled substance listed in Schedule II is permissible if:
  • The pharmacist is unable to supply the full quantity called for in a written or emergency oral prescription and he makes a notation of the quantity supplied on the face of the prescription.
  • The remaining portion of the prescription may be filled within 72 hours of the first partial filling.
  • If the remaining portion is not or cannot be filled within the 72-hour period, the pharmacist shall notify the prescribing individual practitioner.
  • No further quantity may be supplied beyond 72 hours without a new prescription.
A pharmacist to partially fill a prescription for a schedule II-controlled substance (such as an opioid) if:
  • such partial fills are not prohibited by state law;
  • a partial fill is requested by the patient or prescribing practitioner, and
  • the total quantity dispensed in partial fillings does not exceed the quantity prescribed.
  • All partial fills for phoned-in emergency prescriptions must be filled within 72 hours.

What does this mean for pharmacists practicing within the state of Alabama?

  • The Alabama Board of Pharmacy provides several means of taking care of your patient if the entire Schedule II prescription cannot be filled at initial dispensing. Proper documentation and physician notification must occur.
  • Know your employer's specific rules around the dispensing of Schedule II medications; their policies may supersede this state guidance with more strict procedures in place.

For more information, visit the

Alabama Division of Professional Licensing

Alaska BOP Regulations Update November 2018

HB 240Drug Pricing; Pharmacy Benefits ManagersEffective August/September 2018 Section 08.80.297

AS 08.80.297 Cost Effective Alternatives for prescription drugs

No contract or agreement may prohibit a pharmacist from informing a patient of a less costly alternative for a prescription drug or medical device or supply, which may include the amount the patient would pay without the use of a health care plan.

AS 21.27.910 - Pharmacy audit procedural requirements.

When a pharmacy benefits manager conducts an audit of the records of a pharmacy, the period covered by the audit of a claim may not exceed two years from the date that the claim was submitted to or adjudicated by the pharmacy benefits manager, whichever is earlier.

A PBM conducting an on-site audit shall give the pharmacy written notice of at least 10 business days before conducting an initial audit. This section also provides details around audit allowances, responses, and recoupment measures.

HB240

SB32Prescriptions for Biological ProductsEffective July 13, 2018

AS 08.80.030: The board shall post and maintain a link to the United States Food and Drug Administration's list of all currently approved interchangeable biological products on the board's Internet website.

AS 08.80.294: A pharmacist, when dispensing a brand-name prescription drug order that is not a biological product, shall include the generic drug name that is an equivalent drug product for the drug dispensed, the dispensed product's proprietary name, if available; or proper name. The generic drug name or proprietary or proper biological product name shall be placed directly on the container's label near the brand name.

Sec. 08.80.295: Unless the prescription indicates that it is to be dispensed only as written, the pharmacist may, with the consent of the patient, substitute an equivalent drug product or interchangeable biological product. If an interchangeable biological product exists for a biological product prescribed to a patient, the dispensing pharmacist or the pharmacist's designee shall communicate to the prescribing practitioner information regarding the biological product provided to the patient, within three business days after dispensing.

SB32

What does this mean for pharmacists practicing within the state of Alaska?

  • Pharmacists can now provide information to patients around cost savings alternatives to their prescription medications, without penalty from the pharmacy benefit manager. This will help to cultivate a strong pharmacist- patient relationship and allow the pharmacist to provide options to promote positive outcomes through medication adherence for their patient.
  • Pharmacists can also offer cost savings options through interchangeable biologic product availability to their patients, provided the patient is agreeable, the pharmacist notifies the prescriber of that substitution or interchange and maintain proper recordkeeping. This allows the pharmacist to promote important therapy initiation and maintenance by the patient, resulting in positive health outcomes.

Alaska State Regulatory Update 2018

The below pharmacy practice laws, summarized here, were enacted by the Alaska legislature during the 2018 session:

HB 159

Sec. 08.64.363. Maximum dosage for opioid prescriptions.

A prescriber may not issue an initial prescription for an opioid that exceeds a seven-day supply to an adult patient or to a minor; the prescriber must discuss with the parent or guardian of the minor why the prescription is necessary, and the risks associated with opioid use.

A licensee may issue a prescription for an opioid that exceeds a seven-day supply if more than a seven-day supply of an opioid is necessary for the patient's medical condition or if the patient is unable to access a practitioner within the time necessary for a refill of the seven-day supply because of a logistical or travel barrier.

Sec. 08.80.345. Prescription for an opioid; voluntary request for lesser quantity.

A pharmacist filling a prescription for an opioid that is a schedule II or III controlled substance may, at the request of the individual for whom it is written, dispense the prescribed opioid in a lesser quantity than prescribed.

Substitution of an equivalent drug is allowed.

What does this new regulation mean to pharmacists practicing in the state of Alaska?

Pharmacists may fill prescriptions for patients that are written that exceeds a 7 days supply; it is up to the physician to ensure that the requirements for that extended supply are met and appropriately documented in the patient's medical file.

Pharmacists can provide an approved, substitutable product to improve patient therapy and treatment outcomes.

For more details, refer to the Alaska Pharmacists Association and the Alaska Board of Pharmacy

Arizona State Regulatory Update April 2019

HB 2075: E-Prescribing CS and Physician Assistant Prescriptive Authority

Covers e-prescribing, exceptions, and deadlines. It is an emergency measure made retroactive to December 31, 2018. HB 2075 delays e-prescribing requirements for all counties until January 1, 2020.

Additionally, the bill immediately reinstates a Board-certified physician assistant's ability to issue a 30-day prescription for Schedule II, III, IV, and V controlled substances (CS) that are opioids and benzodiazepines.

Pharmacy Technician Trainee Licenses: Extensions

Pharmacy technician trainees with licenses that have expiration dates on or before July 31, 2019, are eligible to reapply for a two-year extension of their licenses, up to 60 days before their licenses expire. Note: No applications that reapply for extensions will be accepted after July 31, 2019. Pharmacy technician trainees with licenses expiring after July 31, 2019, are not eligible to reapply for extensions. Reapplying for an extension is not available for a technician trainee whose license has already expired or has already been extended. An extension is only allowed one time. Technician trainees who are granted reapply extensions will receive a one-time, two-year extension of their licenses. If the technician trainee license expires, the technician trainee may not work until he or she receives a technician license.

What does this mean for pharmacists practicing in the state of Arizona?

  • Mandatory e-prescribing has been delayed; pharmacists may still accept written and called in prescriptions for controlled substances through January 1, 2020 (current CS laws still apply). Pharmacies must use this time to prepare and train their staff on the proper use of e-prescribing for controlled substance prescriptions to prepare for the upcoming requirement.
  • Pharmacy managers must educate their technician staff on the new licensure requirements for work, and routinely inspect that all technicians on staff are appropriately licensed to work.

Arizona State Regulatory Summary- July 2018

The following is a summary of recent pharmacy practice bills passed in the state of Arizona:

Senate Bill (SB) 1001: Controlled substance; regulation; appropriation.

  • Prohibits some healthcare from dispensing Schedule II controlled substances (CS) that are opioids.
  • Limits an initial prescription for a Schedule II CS that is an opioid to a five-day supply and permits a 14-day supply for initial prescriptions following a surgical procedure.
  • Prohibits a health professional who is authorized to prescribe CS from issuing a new prescription order for a Schedule II CS that is an opioid and that exceeds 90 morphine milligram equivalents (MMEs) unless the prescription meets specific exemption criteria.
  • Requires that a health professional additionally prescribe naloxone or another opioid antagonist to a patient who is prescribed more than 90 MMEs per day.
  • Requires that a nonemergency prescription order for a Schedule II opioid dispensed directly by a pharmacist must have a red cap and warning label.
  • Requires an electronic prescription to a pharmacy for a Schedule II drug that is an opioid.

SB 2149: Remote dispensing pharmacies.

Allows for a certified licensed technician to operate a pharmacy that is supervised by a pharmacist remotely.

House Bill (HB) 2633: Pharmacist; controlled substances.

Pharmacist is not required to verify with the prescriber whether the initial prescription meets exemption requirements.

HB 2107: Pharmacies; practices; pharmacy benefits managers.

Prohibits pharmacy benefits managers (PBMs) from prohibiting a pharmacy or pharmacist from providing information regarding the amount of the patient's cost share for a prescription drug and discussing alternative treatment.

HB 2548: Health professionals; continuing education; opioids.

A prescriber or dispenser shall complete a minimum of three hours of opioid-related continuing medical education each license renewal cycle.

HB 2040: Pharmacy board; definitions; reporting.

Defines satellite pharmacy and remote pharmacy kiosks into regulation.

HB 2041: Pharmacy board; licenses; permits.

Aligns the language on renewal processes.

HB 2549: Controlled substance; dosage limit.

Exempts opioid prescriptions that are issued following surgical procedures and that are limited to a 14-day supply from the 90 MME limitation.

Permits a health professional to issue a prescription that exceeds the 90 MME limitations under certain parameters.

What do these new regulations mean for pharmacists practicing within the state of Arizona?

  • Pharmacists must be aware of who can prescribe opioid prescriptions by law, and the limitations of opioid prescribing, to help educate health care providers. Pharmacists are not required to verify all prescriptions that are written outside of required limitations and can assume that the patient meets one of the allowable exemptions but must also use their professional judgement during all opioid dispensing.
  • Pharmacists must be prepared to accept electronic prescription for all opioids by the set deadlines; begin to create awareness with your pain management patients, and local physicians to avoid delays in treatment later.
  • All healthcare providers must plan to include pain management or opioid continuing education beginning with their next license renewal, per new requirements.
  • Pharmacists can now provide information to their patients around cost effective alternatives, including generic options and therapeutic interchanges, to promote adherence and improved health outcomes of their patients. Include this discussion as part of your patient counseling discussions.

For more information, visit the Arizona Division of Professional Licensing

Arkansas State Regulatory Update April 2019

SB 174: To Require Mandatory Electronic Prescribing for Controlled Substances

A practitioner shall not issue a prescription for a controlled substance included in Schedule II through Schedule VI unless the prescription is made by electronic prescription from the practitioner issuing the prescription to a pharmacy.

A practitioner may issue a prescription for a controlled substance included in Schedule II through Schedule VI by written, oral, or faxed method only if issued by:

  • A veterinarian;
  • a practitioner to be dispensed by a pharmacy located outside of the state;
  • For a controlled substance which requires the prescription to contain certain elements that are not captured through electronic prescribing methods;
  • for the dispensing of a nonpatient specific prescription under a standing order, approved protocol for drug therapy, collaborative drug management or comprehensive medication management, or in response to a public health emergency or other circumstances in which the practitioner may issue a nonpatient specific prescription; for a controlled substance under a research protocol;
  • who has received a waiver;
  • other exceptional circumstances demonstrated by the practitioner.

This act is effective on and after the later of: January 1, 2021; or the certification by the Attorney General that the United States Department of Health and Human Services requires mandatory electronic prescribing.

Regulation 5 Nursing Home Consulting Changes that became effective on August 1, 2018.

  • Updated language regarding the destruction of unused drugs for long-term care facilities to remove outdated language.

Regulation 7 General Regulations Regarding Prescriptions Changes that became effective on January 1, 2019.

  • Reduced regulatory burdens when transferring prescriptions between pharmacies by allowing for transfers to be "communicated directly between two licensed or registered individuals where one of the two must be a pharmacist," meaning that interns and technicians can take part in the transfer of prescriptions under supervision.
  • This change also states, "Pharmacies transferring prescriptions may utilize facsimile or other electronic means to communicate information for transfers," which will be a useful tool for non-controlled substances (CS). Drug Enforcement Administration (DEA) regulations state that the transfer of CS refills, "must be communicated directly between two licensed pharmacists."
  • Added language to specify that a pharmacist cannot dispense more of a Schedule II narcotic medication than a prescriber can prescribe as required by Act 820 of 2017.
  • Also clarified partial filling of Schedule II prescriptions.

Regulation 8 Wholesale Distribution Changes that became effective on August 1, 2018.

  • Allowed an outsourcing facility to operate under a single permit if it does not provide medications directly to patients.

Regulation 9 Pharmaceutical Care/Patient Counseling Changes that became effective on December 1, 2017.

  • Matched updated statutes to delete language for the Medications Administration Advisory Committee.
  • Matched updated statutes to remove the limitations on the list of medications that can be administered by pharmacists.
  • Deleted a reference that CPR courses must be accredited by the American Heart Association, which does not accredit such courses.

What does this mean to pharmacists practicing in the state of Arkansas?

  • Pharmacists must ensure that their pharmacy is equipped to receive prescription orders for controlled substances by the effective date and begin to educate their pharmacy staff on the requirement and allowed exceptions. Now is a good time to also educate their pain management patients on these new requirements to avoid delays or interruptions in therapy.
  • Train your staff on the clarification of transfer prescription regulations; use these clarifications to provide improved service and operational efficiency to the pharmacist's day. Check with your employer to ensure that operational policies and SOP's allow for this activity.

Arkansas State Regulatory Updates 2017 Session

Administration changes:

  • Influenza vaccines may be administered to a person seven (7) years of age and older under a general written protocol.
  • Immunizations other than influenza vaccines and influenza immunizations may be administered to a person from seven (7) years of age to eighteen (18) years of age under a patient-specific order or prescription and subject to reporting of the administration to the prescribing physician together with any other reporting.
  • Vaccines and immunizations other than influenza vaccines and influenza immunizations may be administered to a person eighteen (18) years of age or older under a general written protocol. Prescriptions must be written by a physician licensed by the Arkansas State Medical Board and practicing in Arkansas or within fifty (50) miles of the Arkansas border.
  • Pursuant to a statewide protocol, a pharmacist may initiate therapy and administer or dispense, or both, naloxone.

Requirements for administering and dispensing under a statewide protocol. When initiating therapy and administering or dispensing, or both, under a statewide protocol, a pharmacist shall:

  • Notify the primary care provider of any drug or device furnished to the patient.
  • Provide the patient with a written record of the drugs or devices furnished and advise the patient to consult a physician of the patient's choice, if the patient does not have a primary care provider; and
  • Make a standardized fact sheet available to the recipient of the drug or device.

What do these new regulations mean for pharmacists practicing within the state of Arkansas?

The amended Pharmacy Practice Act regulation marks many positive steps in the way the state views the pharmacist's contributions to healthcare, including:

  • Recognition of the pharmacist as an individual healthcare provider,
  • Allows pharmacists to administer expanded immunizations other than influenza, to patients 18 years and older pursuant to an approved general written protocol,
  • Allows pharmacists to provide naloxone to patients pursuant to a statewide protocol.
  • Pharmacists can now provide these services to the community. Establish proper training and standard operational procedures for pharmacy teams to ensure that these new services are in accordance to state law, including the use of approved protocols for each service.

For more information, visit the Arkansas Board of Pharmacy

California State Regulatory Update April 2019

AB 149- Controlled substances: prescriptions.

Existing law classifies certain controlled substances into designated schedules. Existing law requires prescription forms for controlled substance prescriptions to be obtained from security printers approved by the department, as specified. Existing law requires those prescription forms to be printed with specified features, including a uniquely serialized number.

This bill delays the requirement for those prescription forms to include a uniquely serialized number until a date determined by the Department of Justice that is no later than January 1, 2020. The bill would require, among other things, the serialized number to be utilizable as a barcode that may be scanned by dispensers.

The bill would additionally make any prescription written on a prescription form that was otherwise valid prior to January 1, 2019, but that does not include a uniquely serialized number, or any prescription written on a form approved by the Department of Justice as of January 1, 2019, a valid prescription that may be filled, compounded, or dispensed until January 1, 2021. The bill would authorize the Department of Justice to extend this time for a period no longer than an additional 6 months, if there is an inadequate availability of compliant prescription forms.

This bill would declare that it is to take effect immediately as an urgency statute.

What does this mean for pharmacists practicing in the state of California?

  • Pharmacists will be allowed to accept controlled substance prescriptions are not written on forms that include a serial number until January 1, 2020. Pharmacies must prepare for the upcoming date by training their staff on the new requirement and begin to educate local physician office staff and patients of the upcoming requirement, to avoid an interruption of therapy.

California BOP Regulations Update November 2018

AB-2037 Pharmacy: automated patient dispensing systems

Section 4119.11 Pharmacy Business and Professions Code

Authorizes a pharmacy to provide services through an automated patient dispensing system (APDS) to covered entity patients participating in federal drug discount programs and establishes minimum safety and security standards that must be met by pharmacies that utilize this program.

AB 2256: Law enforcement agencies: opioid antagonist. Section 4119.9 Pharmacy Business and Professions Code

Authorizes a pharmacy or wholesaler to furnish naloxone hydrochloride (naloxone) or another opioid antagonist to law enforcement agencies, under specified conditions.

AB 2783: Controlled substances: schedules. Section 4021 Pharmacy Business and Professions Code

Reschedules hydrocodone combination products (HCP) from a Schedule III drug to a Schedule II drug.

AB 2789: Health care practitioners: prescriptions: electronic transmission. Section 688 Pharmacy Business and Professions Code

Requires that all health care practitioners authorized to issue prescriptions to be capable of electronically prescribing and requires that all prescriptions for controlled substances be transmitted electronically, with exceptions, by January 1, 2022.

AB 2859: Pharmacy: safe storage products. Section 4106.5 Pharmacy Business and Professions Code

Requires a chain community pharmacy or an independent community pharmacy that dispenses Schedule II, III, or IV controlled substances to display safe storage products within 50 feet of the counter from which those controlled substances are furnished and would require the pharmacy to make customers aware of the availability of the safe storage products by displaying a sign on or near the pharmacy counter that complies with specified requirements. Provides an exemption for independent pharmacies.

SB 1254: Hospital pharmacies: Medication Profiles Section 4118.5 Pharmacy Business and Professions Code

Requires a pharmacist at a hospital pharmacy to obtain an accurate medication profile for each high-risk patient upon admission and discharge of the patient. Authorizes an intern pharmacist or a pharmacy technician to perform that function if the intern pharmacist or pharmacy technician has successfully completed training and proctoring by a pharmacist and where a quality assurance program is used to monitor competency.

SB 1442: Pharmacies: staffing. Section 4118.5 Pharmacy Business and Professions Code

Prohibits a community pharmacy from requiring a pharmacist employee to engage in the practice of pharmacy at any time the pharmacy is open to the public, unless another employee is made available to assist the pharmacist at all times. Exempts intendent pharmacies.

SB 1447: Pharmacy: automated drug delivery systems: licensing. Sections 4008 (A), 4017.3(N), 4068 (A), 4105.5(R), 4119.1 (R), 4186 (R), 4400 (A) Pharmacy Business and Professions Code

Revises the requirements for the operation and licensing of an automated drug delivery system (ADDS) after July 1, 2019.

What do these changes mean for pharmacists practicing within the state of California?

  • Pharmacists and pharmacies will need to make changes to their policies to reflect new scheduling of opioid combination products and the storage of controlled substances within their pharmacy, including new signing. Ensure that your pharmacy is compliant and that all employees are properly trained on these new requirements.
  • If a pharmacy's internal policy allows, naloxone can now be provided to law enforcement agencies. Pharmacists should review their corporate policy and if allowed, educate staff on the proper operational and recordkeeping procedures around this task.
  • Ensure that your pharmacy is prepared to accept controlled substance prescriptions only by electronic prescribing by January 2022.
  • Pharmacies practicing in a hospital setting must have a procedure set that collects complete medication profiles from all high-risk patients upon admission and discharge. If a pharmacist delegates this task to a qualified technician or intern, ensure that they are properly trained in profile collection criteria.

California State Business and Professional Code Update Summary 2018 Session

Section 4044.3 - Remote Dispensing Site Pharmacy Revised Definition

Section 4044.7 -Telepharmacy Revised Definition

Section 4052.10 Partial Fill of Schedule II Controlled Substances

  • A pharmacist may dispense a Schedule II controlled substance as a partial fill if requested by the patient or the prescriber, but must retain the original prescription, with a notation of how much of the prescription has been filled, until the prescription has been fully dispensed. The total quantity dispensed shall not exceed the total quantity prescribed. Subsequent fills, until the original prescription is completely dispensed, shall occur at the pharmacy where the original prescription was partially filled, and must not be more than 30 days after the date on which the prescription was written.

Section 4059.5 Ordering and Delivery of Drugs and Devices to Remote Dispensing Pharmacy

  • Dangerous drugs and devices and controlled substances may be ordered by signed for by a registered pharmacy technician at the remote site.

Section 4081 Dispensing of Nonprescription Diabetes Test Devices

  • Pharmacies that dispense nonprescription diabetes test devices pursuant to prescriptions shall retain records of acquisition and sale of those nonprescription diabetes test devices for at least three years.

Section 4119.0 Stocking and Maintenance of EMSADDS

Section 4127.15 Hospital Satellite Compounding Pharmacy

  • A hospital satellite compounding pharmacy must satisfy the ratio of not less than one pharmacist on duty for a total of two pharmacy technicians on duty; sterile compounds tasks require immediate supervision.

Article 8: Telepharmacy Systems and Remote Dispensing Site Pharmacies

Section 4130 Telepharmacy

A remote dispensing site pharmacy shall only be in a medically underserved area; must not have a pharmacy that serves the public within 10 road miles of the remote dispensing site.

Section 4131 Telepharmacy Staffing

A supervising pharmacy shall provide telepharmacy services for only one remote dispensing site pharmacy and must be within 150 road miles from that site; and must be staffed by at least one registered pharmacy technician (unless staffed by a pharmacist).

Section 4132 Pharmacy Technicians and Remote Dispensing Site Pharmacy

A registered pharmacy technician may perform nondiscretionary tasks at a remote dispensing site pharmacy under the supervision of a pharmacist.

A pharmacist may supervise up to two pharmacy technicians at each remote dispensing site pharmacy.

Section 4133 Telepharmacy; Systems and Communication

A telepharmacy system shall maintain a video and audio communication system between the supervising pharmacy and the site pharmacy's personnel and patients.

All dispensing records shall be maintained at the remote dispensing site pharmacy for three years.

Section 4134 - Remote Dispensing Site Pharmacy; Supervision and inventory control

A pharmacist from the supervising pharmacy shall complete a monthly in-person, self-inspection of each remote dispensing site pharmacy.

A perpetual inventory shall be kept for all controlled substances stored securely at a remote dispensing site pharmacy.

A pharmacist from the supervising pharmacy shall compile an inventory reconciliation report of all Schedule II controlled substances at a remote dispensing site pharmacy at least once every three months.

Section 4135 Remote Dispensing Site Pharmacy Security and Access

Section 4169.1 Wholesalers Responsibility to Report Suspicious Control Substance Orders

Section 11165.1 Access to Online Controlled Substance Patient History

A pharmacist must apply to obtain approval to electronically access information online on the CURES PDMP regarding the controlled substance history of a patient.

What do these new regulations mean for pharmacists practicing within the state of California?

  • When operating a remote dispensing or satellite pharmacy, ensure that the proper requirements are met around location, security and operational access.
  • The state regulation allows for a schedule II prescription to be filled for a partial quantity, upon prescriber or patient request. All partial fills must be documented, must not exceed the total amount indicated on the original prescription, and expires 30 days after the date of the original prescription. Ensure that your pharmacy is educated on the requirements around partial fill processes, and that dispensing processes and documentation meet those needs. Refer to your company's policies and procedures, as they may be stricter and supersede state regulations regarding partial controlled substance dispensing.
  • If operating a remote dispensing pharmacy, telepharmacy must be available as a viable communication platform to provide required patient counseling and other discussions between the patient, filling technician, and licensed pharmacist. If a telecommunication cannot occur, prescriptions may not be dispensed to the patient.
  • When dispensing a nonprescription diabetes testing device via a patient order, all record of the dispensing must be maintained for three years. Ensure that your documentation policy includes these products.
  • All pharmacists, prior to dispensing a schedule II, III, or IV medication, must first review the patient history within the CURES PDMP database. This database requires an application to be submitted and approved for the pharmacist prior to first access. Have a process for completion for all current pharmacists at your location, and future new hires, to avoid disruption or delay of patient care.

For more infomormation, visit the California Board of Pharmacy

Colorado State Regulatory Update April 2019

SECTION 3: 12-42.5-122.5. Pharmacists' authority to dispense chronic maintenance drugs

On or after January 1, 2020, a pharmacist may dispense an emergency supply of a chronic maintenance drug to a patient without a current, valid prescription if:

  • The pharmacist makes every reasonable attempt but is unable to obtain authorization to refill the prescription from the prescribing health care provider or another health care provider responsible for the patient's care;
  • The pharmacist has a record of a prescription at the pharmacy or has been presented proof of a recent prescription for the chronic maintenance drug in the name of the patient who is requesting the emergency supply; or in the pharmacist's professional judgement, the refusal to dispense an emergency supply of the chronic maintenance drug will endanger the patient's health or disrupt essential drug therapy for a chronic condition of the patient;
  • The amount of the chronic maintenance drug dispensed does not exceed the amount of the most recent prescription or the standard quantity or unit of use package of the drug;
  • The pharmacist has not dispensed an emergency supply of the chronic maintenance drug to the same patient in the previous twelve-month period;
  • The prescriber of the drug has not indicated that no emergency refills are authorized.

What does this mean for pharmacists practicing in the state of Colorado?

  • Pharmacists may help a patient avoid an interruption in therapy with chronic maintenance drug by using their professional and clinical judgement in providing an emergency supply until their physician can be reached.

Colorado State Update Summary- July 2018

The following is a summary of newly passed pharmacy practice laws:

HB 1284 -Concerning the cost of prescription drugs purchased at a pharmacy.

Consumers have the right to know about options to reduce their pharmacy costs for prescription drugs, and pharmacists can provide such information to their patients.

HB 1313-The Allowance of a pharmacist to serve as a practitioner under certain circumstances.

A pharmacist may act as a "Practitioner", or a person authorized by law to prescribe any drug or device, acting within the scope of such authority, IF THEY ARE PARTICIPATING WITHIN THE PARAMETERS OF A STATEWIDE DRUG THERAPY PROTOCOL PURSUANT TO A COLLABORATIVE PHARMACY PRACTICE AGREEMENT AS DEFINED IN SECTION 12-42.5-601 (1)(b), OR PRESCRIBING OVER-THE-COUNTER MEDICATIONS PURSUANT TO SECTION 25.5-5-322.

HB 1187 -Concerning the lawful use of a prescription drug that contains Cannabidiol that is approved by the United States Food and drug Administration.

If the United States food and drug administration approves a prescription medicine that contains cannabidiol that is derived from marijuana, thereafter prescribing, dispensing, transporting, or possessing that prescription drug is legal in Colorado.

SB 129 -Concerning the nonsubstantive reorganization of the law exempting certain drugs and medical therapeutic devices.

The following goods are exempt from taxation:

  • Prescription medications;
  • Insulin per a prescription order;
  • Glucose products used for treatment of insulin reactions;
  • All urine and blood testing kits and materials;
  • All insulin measuring and injecting devices, including syringes;
  • Prosthetic devices;
  • Oxygen delivery devices and supplies dispensed via prescription order;
  • All medical, feeding, incontinence, infusion, enteral nutrition, ostomy, urology, diabetic, and wound care disposable supplies, dispensed per a prescription order;
  • All sleep, inhalation, and electrotherapy supplies pursuant to a prescription order;
  • All sales of corrective eyeglasses contact lenses, and hearing aids.

What do these new regulations mean for pharmacists practicing within the state of Colorado?

  • Pharmacists can now provide information to their patients around cost effective alternatives, including generic options and therapeutic interchanges, to promote adherence and improved health outcomes of their patients. Include this discussion as part of your patient counseling discussions.
  • CBD oil can be sold if it has been approved by the Food and Drug Administration (FDA).
  • Know what supplies and over the counter items are exempt from taxation in the state of Colorado and be sure that your POS systems are set up appropriately. Prescription orders are required for most to be considered non-taxable products. Educate pharmacy staff and patients about these requirements.

For more information, visit the Colorado Division of Public Licensing, or refer to the Colorado Opioid Guidelines.

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Connecticut State Regulatory Update April 2019

Sec. 4. Subsection (h) of section 21a-254 of the 2018 supplement to the general statutes is repealed and the following is substituted in lieu thereof (Effective January 1, 2019):

  • A complete and accurate record of all stocks of controlled substances on hand shall, on and after July 1, 1981, be prepared annually within four days of the first day of May of the calendar year, except that a registrant may change this date provided the general physical inventory date of such registrant is not more than six months from the annual inventory date, and kept on file for three years; and shall be made available to the commissioner or his authorized agents.

Sec. 6. Subsection (c) of section 20-633b of the 2018 supplement to the general statutes is repealed and the following is substituted in lieu thereof (Effective January 1, 2019):

  • A sterile compounding pharmacy shall comply with the most recent version of the United States Pharmacopeia, Pharmaceutical Compounding - Sterile Preparations, as amended from time to time. A sterile compounding pharmacy shall also comply with all applicable federal and state statutes and regulations.

What does this mean for pharmacists practicing in the state of Connecticut?

  • All pharmacy management must ensure that their policies include the new controlled substance inventory requirements.
  • All pharmacy management must ensure that they understand and that their standard operating procedures follow the updated USP guidelines for sterile compounding, as well as all federal and state regulations. Ensure that all staff are properly trained in these guidelines.

Connecticut State Regulatory Summary- 2018

The below laws were enacted to effect pharmacy practice by the Connecticut legislature during the 2018 session:

SB 195 - An Act Concerning Changes to Pharmacy and Drug Control Statutes. Effective January 1, 2019.

Provides guidance for drug manufacturers on recordkeeping and reporting of suspicious drug order activity from pharmacies.

SB 197 - An Act Concerning Biological Products. Effective October 1, 2018.

Unless the purchaser or prescriber instructs otherwise, the pharmacist may substitute a biological product for a prescribed biological product.

The pharmacist shall inform the prescribing practitioner within 72 hours of dispensing.

Each pharmacy shall post a sign in block letter, not less than one inch in height, stating that, "THIS PHARMACY MAY BE ABLE TO SUBSTITUTE A LESS EXPENSIVE DRUG PRODUCT OR INTERCHANGEABLE BIOLOGICAL PRODUCT WHICH IS THERAPEUTICALLY EQUIVALENT TO THE ONE PRESCRIBED BY YOUR DOCTOR UNLESS YOU DO NOT APPROVE."

A pharmacist may substitute a drug product or interchangeable biological product only when there will be a savings in cost passed on to the purchaser.

The provisions here shall not apply a pharmacy operated by a hospital.

HB 5384 - An Act Concerning Prescription Drug Costs. Effective January 1, 2020.

Establishes rules for insurance carriers and manufacturers to provide detailed information to the consumer and the state regarding pricing, rebates, premiums, and formulary lists.

SB 246 -An Act Limiting Auto Refills of Prescription Drugs Covered Under the Medicaid Program. Effective June 1, 2018.

A pharmacy provider may be prohibited from automatically refilling certain prescription drugs for a medical assistance recipient.

SB 302 - An Act Concerning Telehealth Services. Effective July 1, 2018.

At the time of the telehealth provider's first interaction with a patient, they must inform the patient of treatment methods and limitations using a telehealth platform and obtain the patient's consent to provide telehealth services.

No telehealth provider shall prescribe any schedule I, II or III controlled substances using telehealth, unless the treatment condition is exempt by law.

What does this new regulation mean for pharmacists practicing within the state of Connecticut?

  • Pharmacists can apply the above cost saving discussions to biologics and interchangeable drugs, again helping to promote medication adherence for their patients. Within 48 hours of dispensing the interchangeable product, the pharmacist must report that information to the prescribing physician, ensure that all staff are trained to do so, and that software systems are equipped to retain and report the required data per law. Required signage informing the consumer of interchangeable drug substitution practices must be present in the pharmacy.
  • Controlled substance inventories have been amended to reflect an annual completion, from the previous biannual completion requirement. Also, manufacturers and distributors are required to report any suspicious ordering practices. Ensure that proper inventory policies are in place at your location.
  • Ensure that all auto-refill software account for the recent changes to prescriptions billed to Medical Assistance patients, who may not be eligible for this service.
  • Pharmacists can participate in telemedicine services.

For full regulatory language visit the Connecticut Division of Pharmacy Regulation.

Delaware State Regulatory Update April 2019

HB 441-Prior Authorizations:

To reduce the delays and hardships of the waiting process from waiting on prior authorizations by pharmacy benefits managers (PBMs), this bill puts into place specified time tables to fill emergency prescriptions and make subsequent prior authorizations for chronic and long-term conditions filled more readily. This bill was signed into law on August 28, 2018.

HB 425-Transparency of prescription costs and alternatives:

This act establishes that a contract between a PBM and a pharmacy may not prohibit a pharmacy or pharmacist from doing any of the following because of a "gag clause":

  • Providing to, or discussing with an insured person with information regarding the retail price of a prescription drug or the amount of the cost share for which the insured person is responsible for paying for a prescription drug;
  • If a more affordable, therapeutically equivalent prescription drug is available, selling the more affordable, therapeutically equivalent prescription drug to the insured person. This includes if a prescription drug could be purchased at a lower cost if consumers paid out of pocket rather than through their health insurance plan.

This bill was signed into law on August 28, 2018.

HB 331-Benzodiazepine dispensing:

This bill requires practitioners to obtain consent from a minor's parent or guardian prior to prescribing these drugs and requires the pharmacist to include a cautionary statement explaining the risks associated with the long-term use of these drugs. This bill was signed into law on September 4, 2018.

SB 157-Expedited Partner Therapy for STDs:

Expedited partner therapy (EPT) is the clinical practice of treating the sex partners of patients diagnosed with a sexually transmitted disease without clinical assessment of the partners. In August 2006, the Centers for Disease Control and Prevention recommended EPT as an evidence based option to manage chlamydial infections and gonorrhea by treating index patients' sex partners to prevent reinfection and curtail further transmission. This act makes EPT clearly permissible in Delaware and requires health care professionals to provide information developed by the Delaware Department of Health and Social Services when providing EPT. It also provides immunity to health care practitioners and pharmacists acting in compliance with the statute and provides immunity to health care practitioners who do not provide EPT and pharmacists who do not fill a prescription written under this statute if doing so would violate any of the laws that govern pharmacies and pharmacists. This bill was signed into law on August 29, 2018.

What does this mean to pharmacists practicing in the state of Delaware?

  • PBMs now have more stringent requirements to provide prior authorization results to patients and prescribers, avoiding potentially dangerous interruption in critical therapy.
  • Pharmacists can now provide information and guidance to patients about the cost of their medication, and potential solutions. This will result in more positive health outcomes and improved adherence to prescribed therapy.
  • Pharmacists must include cautionary guidance about the risks of long term benzodiazepine use during patient counseling.
  • Pharmacists participating in the prescribing and dispensing of prescriptions for STDs must understand the new guidelines and the potential immunity, as it pertains to the treatment and reporting of extended partners in these cases.

Delaware BOP Regulations Update November 2018

HB441: Prior Authorization of Emergency Prescriptions and Prescriptions for Chronic and Long Term Conditions (Section 3333A)

  • A prior authorization form for a prescription medication shall include a question regarding whether the prescription medication is for a chronic or long-term condition for which the prescription medication may be necessary for the life of the patient.
  • If a prescriber indicates on a prior authorization form that the prescription medication is for a chronic or long-term condition for which the prescription medication may be necessary for the life of the patient, the pharmacy benefit manager may not request a reauthorization for the same prescription medication more frequently than every 12 months.
  • A pharmacy benefit manager or the pharmacy benefit manager's agent shall provide alternative medications for therapeutically equivalent medications to the pharmacy that require prior authorization on the National Council for Prescription Drug Programs response transaction to a denied claim for prior authorization.

HB 425: Permitted disclosures related to prescription drugs (section 3332A)

A contract between a pharmacy benefits manager and a pharmacy may not prohibit a pharmacy or pharmacist from doing any of the following:

  • Providing and discussion with an insured information regarding the retail price of a prescription drug or the amount of the cost share for which the insured is responsible for a prescription drug.
  • If a more affordable substitute is available, selling the more affordable substitute to the insured.

SB157: Expedited Partner Therapy for Sexually Transmitted Diseases (Section 703A)

  • Expedited partner therapy is limited to a sexual partner who may have been exposed to a sexually transmitted disease within the previous 60 days and who is able to be contacted by the patient.
  • Notwithstanding any other provision of law or regulation to the contrary, a pharmacist licensed to practice pharmacy in this State may recognize a prescription authorized by this section as valid.
  • A pharmacist or pharmacy is not subject to civil or professional liability for filling a prescription ordered under this section unless it is established that the pharmacist or pharmacy acted with unreasonable care, willfully, wantonly, or by gross negligence.
  • The label of any drug prescribed, or records created under this section are not required to contain the name of the patient's sexual partner.

HB331: The Use, Distribution and Education of Benzodiazepines and Non-benzodiazepine Hypnotics (Section 4740B).

The Secretary shall produce and distribute either in written or electronic form to pharmacies, not including institutional pharmacies, pamphlets for consumers relative to benzodiazepines and non-benzodiazepine hypnotics that includes educational information about: (i) misuse and abuse by adults and children; (ii) risk of dependency and addiction; (iii) proper storage and disposal; (iv) addiction support and treatment resources; and (v) a telephone helpline. A pharmacist shall distribute the pamphlet when dispensing a benzodiazepines or a non-benzodiazepine hypnotic.

SB225: Registration requirements. (Section 4732)

  • Any pharmacy, distributor, manufacturer, practitioner, researcher or other controlled substance registrant who has or proposes to engage in activities accordingly within this State must obtain biennially a registration issued by the Secretary in accordance with the Secretary's rules.
  • As a condition of biennial renewal of registration, an applicant shall complete continuing professional education relating to all the following:
  • The prescribing, distributing, dispensing or delivery of controlled substances.
  • The detection and recognition of symptoms, patterns of behavior, or other characteristics of impairment and dependency resulting from the abusive or illegal use of controlled substances.
  • The risks of using opioids and effective alternatives to the use of opioids.

What does this mean for pharmacists practicing within the state of Delaware?

  • Prescription drug orders for qualified therapies that require a prior authorization from the prescriber and/or pharmacy will receive notification of alternative therapies that are covered by the insurer; as well as allowing that medication to be refilled for a 12-month period without the need of reauthorization. This allows for improved therapy initiation and adherence and reduce a potential interruption of therapy for these patients; all result in an improved level of patient care.
  • Pharmacists must complete continuing education on controlled substance prior to license renewal; ensure that all CE completion reflects this new requirement, to prevent potential loss of professional license.
  • Pharmacists can now provide information to patients around cost savings alternatives to their prescription medications, without penalty from the pharmacy benefit manager. This will help to cultivate a strong pharmacist- patient relationship and allow the pharmacist to provide options to promote positive outcomes through medication adherence for their patient.
  • Pharmacists may see new prescriptions for STD partner treatment within their daily practice. Ensure that all staff understands the new regulatory allowances and ensures that proper and prompt dispensing occurs with these products, while meeting privacy guidelines for that patient.
  • New and expanded information must be provided to patients receiving benzodiazepines. Ensure that your practice includes this new information during patent counseling.

Delaware State Regulatory Summary- 2017

The following regulations were enacted or updated on June 11, 2017:

24 Del. C., Section 2506(a)(1):

Subsection 1.4.1

All Delaware licensees must now complete two hours of continuing education in 1) the distribution, dispensing, or delivery of controlled substances, or 2) the detection and recognition of symptoms, patterns of behavior, or other characteristics of impairment and dependency resulting from the abusive or illegal use of controlled substances as part of their continuing education requirement for licensure or renewal.

Subsection 5.1.7

The regulation addressing compounded medications for office use has been revised to delineate standards for both human use and animal use. The proposed changes allow veterinarians to administer and dispense compounded preparations for animal patients subject to certain specified requirements.

What do these new regulations mean for pharmacists practicing within the state of Delaware?

  • All pharmacists licensed to practice in the state of Delaware must complete all continuing education requirements prior to renewal; this includes all topic-specific requirements to maintain competency standards with current practice needs outlined by the state. Ensure that all pharmacists understand these requirements and complete all required CE prior to license renewal biannually. Proper documentation of all completed activities must be retained as proof, if audited.
  • If your practice includes the care of veterinary patients, communicate the new changes to your staff as it pertains to compounded preparations for animal patients; different standards may apply.

For full regulatory language, refer to Delaware Division of Professional Regulations.

Florida State Regulatory Summary- May 2018

The following regulations were enacted and schedule to take effect July 1, 2018:

HB 21 - Controlled Substances

Section 456.0301 added to limit opioid prescriptions for the treatment of acute pain to a specified period and requires health care practitioners to check the prescription drug monitoring program (PDMP) database prior to prescribing or dispensing a controlled substance.

HB 351 - Prescription Drug Pricing Transparency

Section 465.0244 was amended to provide requirements for pharmacists to inform patients of generically equivalent drug product availability and if the cost sharing obligations for these patients exceed the retail price of a prescription.

Full Bill Language

What do these new regulations mean for pharmacists practicing within the state of Florida?

  • Pharmacists must register for access to the state PDMP prior to dispensing controlled substances within the state of Florida. Ensure that you understand how to navigate the site to allow for minimal disruption in patient care. Maintain competency in opioid standards of care in order to hold impactful conversations with the healthcare team and the patient.
  • Pharmacists must have a standard operating procedure and policies in place to provide patients with all pricing information, including potential cash price, if the cost sharing option exceeds that cash price. Ensure that all support staff that routinely is involved in pricing conversations are also trained on this new regulation.

For full regulatory language, refer to the Florida Board of Pharmacy

Georgia State Regulatory Summary- 2018

The following regulations were enacted during the 2018 Legislative Session:

SB 422 Pharmacist Point of Care Testing

Full Regulation

Chapter 22 of Title 31 of the Official Code of Georgia Annotated, relating to clinical laboratories, is amended in Code Section 31-22-9, by revising subsection (b) as follows:

"(b) This chapter shall not apply to pharmacists, who shall be considered practicing within their scope of practice, when they are performing capillary blood tests and interpreting the results as a means to screen for or monitor disease risk factors or drug use and facilitate patient education, so long as such capillary blood tests are available to and for use by the public without licensure of the user of the test such tests. Pharmacists performing such tests shall make reasonable efforts to report the results obtained from such tests to the patient's physician of choice."

HB 769 Remote Pharmacy Operation in Rural Areas

Full Regulation

To amend Chapter 4 of Title 26 and Title 31 of the Official Code of Georgia Annotated

Authorizes hospital pharmacies to use remote order entry when:

  • The licensed pharmacist is not physically present in the hospital, the hospital pharmacy is closed, and a licensed pharmacist will be physically present in the hospital pharmacy within 24 hours or the next business day;
  • At least one licensed pharmacist is physically present in the hospital pharmacy and at least one other licensed pharmacist is practicing pharmacy in the hospital but not physically present in the hospital pharmacy; or
  • At least one licensed pharmacist is physically present in a another hospital within this state which remotely serves only on weekends not more than four other hospitals under the same ownership or management which have an average daily census of less than 12 acute patients.

What do these new regulations mean for pharmacists practicing within the state of Georgia?

  • Pharmacists are now recognized as providing point of care testing to the public as part of their normal scope of duties but must have a process in place for providing results and follow-up patient education.
  • The pharmacy must inform the patient's primary care provider of all results, ensure that all participating pharmacists are properly trained on performing testing and the interpreting of results.
  • The pharmacy must have standard operating procedures in place to capture testing requirements, results, and appropriate patient and prescriber notification of those results.
  • Remote pharmacy order entry is now approved for hospitals and clinics, if a pharmacist is not present in the hospital or is in another section of the hospital. This new regulation is to assist with the more rural locations, to allow for more timely and accessible pharmacy services, or "micro-hospitals".
  • A licensed pharmacist must be scheduled to be physically present at that pharmacy location within the next 24 hours after the remote service is provided.
  • The remote pharmacy must comply with all ASHP requirements before operating the remote order procedures, including processes for accuracy, event reporting, and recordkeeping.

For full regulatory language, refer to George Board of Pharmacy

Hawaii State Regulatory Summary- 2018

The below laws were enacted to effect pharmacy practice by the Hawaii legislature during the 2018 session.

SB 2298 - Relating To Healthcare Preceptor Tax Credits. Effective December 31, 2018.,

  • There shall be allowed to each taxpayer subject to the tax imposed by this chapter, a healthcare preceptor tax credit that shall be deductible from the taxpayer's net income tax liability, if any, imposed by this chapter for the taxable year in which the credit is properly claimed.
  • The amount of the credit shall be equal to $1,000 for each volunteer-based supervised clinical training rotation supervised by the taxpayer, up to a maximum of $5,000 per taxable year, regardless of the number of volunteer-based supervised clinical training rotations supervised by the taxpayer.

What does this new regulation mean for pharmacists practicing within the state of Hawaii?

  • Hawaii pharmacists that participate in pharmacy school preceptor activities can now receive tax credits for their time.
  • The school for which the pharmacist is providing preceptor duties for will provide a tax credit form for tax purposes.

For full regulatory language, refer to the Hawaii Board of Pharmacy

Idaho State Regulatory Update April 2019

HB0058: Addition of the provision for the transfer of legend drugs for donation to medically indigent patients.

54-1761. DEFINITIONS. As used in sections 54-1760 through 54-1765, Idaho Code:

Redefines "Donation repository", "legend drug", and "medically indigent patient", "patient assistance program", and "qualified charitable clinic/donor" in the state.

37 54-1762. LEGEND DRUG DONATION.

Legend drugs may be transferred from a qualified donor to a donation repository for donation to medically indigent patients.

Qualified donors may distribute legend drugs in accordance with the following requirements:

Drugs donated by an individual member of the public must be in the manufacturer's original sealed packaging, including those packaged in single unit doses when the outside packaging is open, and the single unit dose packaging is intact; and

Drugs donated by an entity that is a qualified donor must meet either of the following conditions:

  • The drugs are in the manufacturer's original sealed packaging, including those packaged in single unit doses when the outside packaging is open and the single unit dose packaging is intact; or
  • The drugs are opened or unsealed but have remained under the control and storage of the qualified donor.

Donation repositories may accept drugs in accordance with the following specifications:

  • Only drugs that bear a clear and verifiable lot number and expiration date may be accepted and dispensed. Drugs bearing an expiration date fewer than three (3) months from the date the drug is donated shall not be accepted and shall not be dispensed;
  • Drugs and other substances provided in schedules II through V of article II, chapter 27, title 37, Idaho Code, shall not be accepted and shall not be dispensed; and
  • A drug shall not be accepted or dispensed if the person accepting or dispensing the drug has reason to believe that the drug has been adulterated.

Any donation repository dispensing legend drugs shall:

  • Comply with all applicable federal and state laws related to the storage and distribution of drugs;
  • Inspect all drugs prior to dispensing to determine that such drugs have not been adulterated;
  • Dispense drugs pursuant only to a valid prescription; and
  • Separate donated drugs from the donation repository's normal drug stock. Donated drugs may not be resold.

HB 182: Amends existing law to add products that may be prescribed by a pharmacist

Law now includes:

  • Tobacco cessation products pursuant to section 54-1733E, Idaho Code;
  • Tuberculin purified protein derivative products pursuant to section 54-1733F, Idaho Code

2019 Pharmacy Administrative Rule Changes that become effective in early April 2019:

Rule Chapter 1: General Provisions

Limited service outlet has been expanded to include mobile pharmacies. Standard of care now encompasses acts or omissions within the practice of pharmacy, "which fail to meet the standard provided by other qualified licensees or registrants in the same or similar setting."

Rule Chapter 2: Rules Governing Licensing and Registration.

Chapter 2 is updated so that the Idaho-based Multistate Pharmacy Jurisprudence Examination is no longer a requirement for licensure. This change is consistent with nearly every other Idaho health profession.

Rule Chapter 3: Rules Governing Pharmacy Practice.

For in-state drug outlets, the requirement by the Board to designate a pharmacist-in-charge has been removed from Chapter 3.

Prescription Drug Order: Validity.

There is no longer a specified expiration date for prescription orders on non-controlled substances. Digital image prescriptions may now be accepted, but not for a controlled substance (CS) or if the patient intends to pay cash for the drug in whole.

Prescription Drug Order: Minimum Requirements.

For a non-controlled substance, a prescriber may omit the required drug information and directions if the prescriber makes a clear indication that the pharmacist is to finalize the patient's drug therapy plan.

Filling Prescription Drug Orders: Drug Product Substitution.

Any institutional facility may participate in drug product substitution using a formulary created by its quality assessment and assurance committee. Prescriber-authorized substitution is added under this section. A prescriber must clearly indicate that substitution is allowed by indicating "therapeutic substitution allowed" or a similar designation. The substitution must benefit the patient and is made to either comply with the patient's insurance formulary or to reduce the patient's cost. The patient must opt-in and be informed of the substitution. Notification to the patient's prescriber of the substitution must be given within five business days of dispensing the prescription. Drugs exempt to substitution are biological products, narrow therapeutic index drugs, and psychotropic drugs.

Filling Prescription Drug Orders.

Adaptation Updates have been made under changes in quantity pertaining to non-controlled substances. Biological products and compounded drugs are also excluded. The change is intended to dispense up to the total amount authorized by the prescriber including refills. The change extends a maintenance drug for the limited quantity necessary to coordinate a patient's refills in a medication synchronization program.

Rule Chapter 4: Rules Governing Pharmacist Prescriptive Authority Pharmacist Prescribing for Minor Conditions.

There are new minor ailments listed that pharmacists can independently prescribe for when following the parameters indicated in Chapter 4. Allergic rhinitis: Prescribing is limited to intranasal drugs only. Mild acne: Prescribing is limited to topical drugs only. Mild cough: Only benzonatate may be prescribed for cough suppression.

Prescribing for these conditions must be in accordance with the general requirements specified in Rule 020 Pharmacist Prescribing: General Requirements. The Board has published template protocols for pharmacists to use as a starting point for allergic rhinitis and mild acne. Some changes were also made to the urinary tract infection (UTI) template, such as removing post-menopause as an exclusion criterion. Pharmacist Prescribing for Clinical Gaps in Care Pharmacist statin prescribing is clarified to include only those who have been diagnosed with diabetes, removing the previous requirement for a current prescription for a drug for diabetes. Pharmacist Prescribing to Supplement an Infusion Order Items have been added to include: Agents for catheter occlusion. Additional supplemental drugs: methylprednisolone, hydrocortisone, diphenhydramine, epinephrine, and normal saline.

Rule Chapter 5: Rules Governing Drug Compounding.

Changes were made to Chapter 5 under Rule 101.02 Dosage Forms Requiring Sterility. Previously, sprays intended to treat bronchial mucosa were exempt from sterile compounding. This has been changed to exempt only sprays and irrigations intended to treat nasal mucosa. The requirement for gloved fingertip sampling has been updated to reflect United States Pharmacopeia Chapter (797). It is required every six months for personnel who compound high-risk sterile preparations and annually for those who compound only low- and medium-risk sterile preparations.

Updated CPE Requirements.

Per Rule 27.01.02.033: Each pharmacist applicant for license renewal must complete fifteen (15) CPE hours each calendar year between January 1 and December 31. 01. ACPE credits must be reported to and documented in CPE Monitor in order to be accepted. No longer must a pharmacist complete a minimum number of live, law, immunization, or sterile compounding credits as a matter of law. No longer will attendance sheet-based documentation be accepted. The link between license renewal and CPE completion is severed, and 15 CPE hours must be obtained each calendar year between January 1 and December 31.

Birth Month Renewal.

The Board is going to birth month renewal. Those pharmacists who renewed on or before June 30, 2018, will renew one more time on or before June 30, 2019.

What does this mean for pharmacists practicing in the state of Idaho?

  • If your pharmacy takes part in a drug donation program, be aware of the new regulations surrounding this practice, and ensure that your policy matches those new rules.
  • If your pharmacy offers a pharmacist prescriptive authority program, be aware of the many changes that have occurred and be sure that you are using the most up to date prescribing template or protocol.
  • Several new rules involve how prescriptions can be dispensed regarding generic substitution and partial filling of non-controlled substance prescriptions. Also included are requirements around non-sterile compounding of nasal sprays. Ensure that your SOP's reflect these changes, and that all staff are trained on these changes.
  • Many changes have taken effect around licensure requirements and administrative or supervisory functions of pharmacists. All pharmacists must be aware of these changes and renewal requirements to avoid a lapse in licensure.

Idaho Regulatory Update November 2018

Rule 27-0104-1701: Rules Governing Pharmacist Prescriptive Authority

Requires that for each drug or drug category the pharmacist intends to prescribe, that the pharmacist must maintain a patient assessment protocol based on current clinical guidelines, when available, or evidence-based research findings that specifies patient inclusion and exclusion criteria and explicit medical referral criteria.

Rule 27.01.03.303.03: Rules governing refills when a physician is not available for authorization.

A pharmacist may refill a prescription for a noncontrolled drug one (1) time in a six (6)-month period when the prescriber is not available for authorization. In such cases, a pharmacist may dispense a refill up to the quantity on the most recent fill or a thirty (30)-day supply, whichever is less.

What does this mean for pharmacists practicing within the state of the District of Columbia?

  • If the pharmacist or pharmacy initiates participation in services utilizing prescriptive authority, they must ensure that they have a protocol in place that provides up to date clinical guidance for practice. Ensure that your pharmacy's standard operating procedures includes the training on and proper use of a standard protocol that meets the state requirements.
  • A pharmacist can provide one refill of a non-controlled medication to a patient in the event that the prescriber cannot be contacted for authorization, avoiding an interruption in critical therapy.

Idaho State Regulatory Summary- 2018

The following regulations were enacted during the 2018 Legislative Session, and can be found in detail at theIdaho Board of Pharmacy or in the Idaho March Board of Pharmacy Newsletter.

Rule 021.03 Pharmacy License Renewal Periods

The Board of Pharmacy will transition from a June 30 license renewal deadline to a birth month renewal model: individuals would renew their license by the last day of their birth month beginning with 2019 renewals.

Rule 030.03 - Controlled Substance Registration Exemption for Pharmacists

Pharmacists are exempt from obtaining a controlled substance registration in addition to their pharmacist license. Pharmacists are still required to maintain compliance with the Idaho Uniform Controlled Substances Act.

Rule 033 Pharmacists Continuing Education Completion Requirement

Pharmacists must complete 15 hours of continuing education annually between January 1 and December 31. Specific category requirements have been removed.

Rule 036 Pharmacy Extern and Intern Licensure Consolidation

Pharmacy "externs" and "interns" are now placed into a single category named "pharmacist interns."

Rule 041 Pharmacy Technician and Training Registration

Technician-in-training registration category is now a one-time registration with a two-year duration. The employer requirement is eliminated. Current technicians in-training will not be required to renew.

Rule 042 New Student Technician Category

This rule creates a "student technician" registration category for individuals who are enrolled in a school-supervised program and who do not otherwise meet the requirements for registration as a technician-in-training or certified technician.

Rule 101 Pharmacist Delegation of Duties to Technicians or Interns

Pharmacists retain full discretion over what tasks to delegate and to which individuals under their supervision, but they must first consider whether the task is commensurate with the education, skill, and experience and whether the unique professional judgment of the pharmacist is necessary for the task.

Rule 202 Required Steps to Prescription Dispensing

The rule specifies the five steps that must occur, unless exempted, when dispensing a prescription drug:

  • obtain a valid prescription drug order;
  • perform prospective drug review;
  • affix label meeting specific requirements;
  • verify dispensing accuracy; and
  • counsel the patient.

Rule 203 Off Site Dispensing Requirements

Rule 203 allows each of the activities in Rule 202 to be performed off site if specific parameters are met.

Rule 303 - Emergency Refill Authority

A pharmacist may refill a prescription for a non-controlled drug one time in a six-month period for the quantity on the most recent fill or a 30-day supply, whichever is less.

Rules Governing Pharmacist Prescriptive Authority

Rule 020.03 Patient Assessment Protocols

The rule requires a pharmacist to use a patient assessment protocol for each drug he or she intends to prescribe. The protocol must be based on current clinical guidelines or evidence-based research findings and must specify patient inclusion and exclusion criteria, as well as explicit medical referral criteria.

Rule 020.06 PCP Notification of Prescribing

Requires the pharmacist to notify the patient's primary care provider of any drug prescribed within five business days.

Rules 021-026 - Drugs, drug categories, and devices that pharmacists may independently prescribe

Conditions for which pharmacists can prescribe within certain parameters. Refer to the full regulation for a complete list of covered conditions.

What do these new regulations mean for pharmacists practicing within the state of Idaho?

  • Many changes take effect concerning pharmacist and technician registration. Ensure that all are aware of these changes and that employees maintain proper licensure through this transition and avoid potential non-compliance risks.
  • All pharmacists must understand the allowances and limitations with all new technician and intern designations, and assign tasks as allowed.
  • Practicing pharmacists must become familiar with all new rules of practice, including emergency refill rules and record-keeping, along with all new prescriptive authority allowances.
  • With greater ability comes a great responsibility; ensure that all pharmacy team members fully understand the new requirements, complete all competency training, and have operating procedures in place to provide patient care in compliance with the Idaho Board of Pharmacy.
  • All pharmacists must also review their corporate policies, as those policies may be stricter than the above policies and take precedence.

For full regulatory language, refer to the Idaho Board of Pharmacy

Illinois State Regulatory Updates- 2018

The below pharmacy practice laws, excerpted here, were enacted by the Illinois legislature during the 2018 session.

SB 1790 Refill Authorization for medications when a physician cannot be reached for approval. Effective immediately.

A pharmacist may exercise professional judgment to dispense an emergency supply of medication for a chronic disease or condition if the pharmacist is unable to obtain refill authorization from the prescriber when:

  • in the pharmacist's professional judgment, interruption of therapy might reasonably produce undesirable consequences or cause patient suffering;
  • the pharmacy previously dispensed or refilled a prescription from the prescriber for the same patient and medication;
  • the prescription is not for a controlled substance;
  • the pharmacist informs the patient or the patient's agent at the time of dispensing that prescriber authorization is required for future refills; notification may be made verbally, electronically, or in writing; and
  • the emergency dispensing is documented in the patient's prescription record and the pharmacist informs the prescriber of the emergency refill.

The emergency supply must be limited to the amount needed for the emergency period as determined by the pharmacist within his or her professional judgment. However, the total amount dispensed shall not exceed a 30-day supply.

What does this new regulation mean for pharmacists practicing within the state of Illinois?

  • Pharmacists can provide medication to patients if the prescriber cannot be reached for approval, given the continuation of therapy in critical for patient care.
  • Ensure that proper documentation and follow-up with the physician occurs after the provision of the emergency refill of medication.

For full regulatory language, refer to the Illinois Board of Pharmacy

Indiana State Regulatory Updates- 2018

The following regulations were enacted during the 2018 Legislative Session, and can be found in detail at the Indiana Pharmacists Association.

House Bill 1317 Medication Cost Discussions-EFFECTIVE JULY1, 2018

A pharmacist has the right to provide a covered individual with information concerning the amount of the covered individual's cost share for a prescription drug, including more affordable alternatives if available.

A pharmacy benefits manager may not include a provision that requires a covered individual to make payment for a prescription drug at the point of sale in an amount that exceeds the lesser of the contracted copayment amount; or the amount of total approved charges by the pharmacy benefits manager at the point of sale.

Senate Bill 221 INSPECT Program

Sec. 11.3. Beginning January 1, 2019, a practitioner who is permitted to distribute, dispense, prescribe, or administer ephedrine, pseudoephedrine, or a controlled substance during the practitioner's professional practice or research must be certified to receive information from the INSPECT program.

House Bill 1175 Diabetes Reporting

Chapter 16. Strategic Plan to Reduce Diabetes Sec. 1.

The state department shall develop a strategic plan to identify and significantly reduce the prevalence of diabetes and prediabetes in Indiana by utilizing a cross-collaborative effort of health care providers specializing in diabetes prevention, screening, treatment, research, or education, who provide direct patient care, health instructors, and public advocates. The state department shall update the strategic plan every two (2) years.

What do these new regulations mean for pharmacists practicing within the state of Indiana?

  • Pharmacists now can discuss medication costs more freely with patients covered by insurance, and provide their patients with more affordable options, if available. This allows pharmacists to play more active roles in improved patient health outcomes.
  • If a practitioner (including pharmacists) dispense controlled dangerous substances, including pseudoephedrine and ephedrine products, they must first be certified to access the information contained in the INSPECT platform, including entering all dispensing activities in which they participate.
  • The state of Indiana recognizes the growing prevalence of diabetes within their borders and is moving to build a program to examine the disease and deter its progression. As a health care professional, we can play a large role in this, through our routine contact with the community. This includes patient counseling, preventive education, screening events, and medication therapy management activities.

For full regulatory language, refer to the Indiana Board of Pharmacy.

Iowa State Regulatory Update April 2019

Technician Product Verification

During the 2018 legislative session, the Iowa Administrative Code (IAC) Chapter 40 was amended to allow technician product verification (TPV) programs in community pharmacies. TPV programs essentially replace programs currently known as tech-check-tech programs but will be expanded to the community setting for redirecting pharmacists' time to patient clinical activities.

Statewide Protocol Updates

The IAC was also amended to allow pharmacists to order and administer certain medications based on a statewide protocol developed by the Board in collaboration with the Iowa Department of Public Health (IDPH). The pharmacy services allowed to be handled by a pharmacist under such protocols include naloxone, nicotine replacement tobacco cessation therapy, and immunizations. Only once the protocols are approved by the Board and the final rules are adopted and effective will pharmacists be authorized to practice pursuant to the protocols. This rule is effective April 5, 2019.

Naloxone-Pharmacists may continue to practice under the currently provided protocol order in accordance with Board rules. The Board's statewide protocol will be a second option for pharmacists to dispense naloxone to interested individuals who are not able to get a patient-specific prescription from a practitioner.

Nicotine replacement tobacco cessation therapy This protocol is being drafted, and updates will be on the Board's website as they are available.

Immunizations The IAC section authorizing pharmacists to administer immunizations under a physician-signed protocol was repealed, effective July 1, 2019. Pharmacists may continue, only until July 1, 2019, to practice under a physician-signed protocol. Once the Board's statewide protocol is approved and rules are adopted and effective, pharmacists will be able to practice under the Board's protocol.

What does this mean for pharmacists practicing in the state of Iowa?

  • Technicians can now perform technician product verification duties in the state, once they meet the state-mandated requirements. This will allow pharmacists to better utilize their support staff, which will allow them to provide more enhanced patient care.
  • All pharmacists must ensure that they are using the appropriate state-provided protocols for the above outlined clinical services. Pharmacists administering immunizations must update all records, procedures, and training to include the new statewide protocol after July 1st, 2019.

The following regulations were enacted during the 2018 Legislative Session and can be found in detail on the Iowa Board of Pharmacy (Press Releases) website at https://pharmacy.iowa.gov/.

65737.3(124) Requirements for the PMP (Effective May 16, 2018)

37.3(3) Reporting periods. A record of each reportable prescription dispensed shall be submitted by each dispenser no later than the next business day following dispensing. Records may be submitted with greater frequency than required by this sub-rule.

What do these new regulations mean for pharmacists practicing within the state of Iowa?

  • Pharmacists are required to report all opioid dispensing activity (other than the approved exempt activities, including hospital, long term care, and inpatient hospice dispensing) within 24 hours of the medication being dispensed to the patient. Ensure that all pharmacists are registered with the state PMP program and have appropriate access. Have appropriate policies in place to report all dispensing activity in a timely manner, according to law.
  • Beginning in 2020, all controlled substance prescriptions must be submitted electronically to the pharmacy by the prescriber, unless they meet one of the exceptions outlined by the law. The pharmacist is NOT required to verify or document if a prescription received outside of the electronic platform meets one of the exceptions BUT does that the professional responsibility to report any suspected violations of this regulation to the appropriate licensing board for investigation.
  • If a pharmacist participates in providing or administering opioid antagonist medication to a patient, that interaction is considered protected health information is protected by the Good Samaritan laws.

For more information on the above changes, visit the Iowa Board of Pharmacy at https://pharmacy.iowa.gov/ or the Iowa State Pharmacists’ Association at https://www.iarx.org/.

Kansas State Regulatory Update April 2019

Pharmacy Technician Certification

Before the October 2019 renewal period for pharmacy technicians, each pharmacy technician initially registered on or after July 1, 2017, whose registration expires on October 31, 2019, will be required to pass a national pharmacy technician certification examination (K.A.R. 68-5-17). The Board has approved the Pharmacy Technician Certification Board and the National Healthcareer Association's Examination for the Certification of Pharmacy Technicians, also known as ExCPT. Any technician who is unable to take or pass an approved exam may request a six-month extension at least 30 days before the pharmacy technician's registration expiration date.

New Board Regulations and Guidance - Effective January 4, 2019.

Kansas Administrative Regulations (K.A.R.) 68-7-10, 68-9-2, and 68-9-3 align definitions with statutory changes and allow nurses and other healing arts professionals to access automated drug delivery systems in long-term care facilities, pharmacies, and other facilities to administer medications to patients consistent with their respective practice acts. This should eliminate the perceived need for nurses to also be registered as pharmacy technicians.

K.A.R. 68-2-23 requires each owner of a Kansas-registered pharmacy to notify the Board within 30 days of any denial, limitation, suspension, revocation, voluntary surrender, or other disciplinary action taken by the state of Kansas or another jurisdiction against the pharmacy, the pharmacy owner, or any application, license, registration, or permit held by the pharmacy owner.

K.A.R. 68-20-15b requires either the PIC or the pharmacy owner to notify the Board in writing within one day of any suspected diversion, theft, or loss of any controlled substance (CS) and provide a copy of Drug Enforcement Administration (DEA) Form 106 upon completion.

K.A.R. 68-7-25 requires each pharmacist, pharmacy technician, and pharmacy student to notify the Board within 30 days of any criminal arrest, charge, or conviction rationally related to drugs or the practice of pharmacy, or any denial, limitation, suspension, revocation, voluntary surrender, or other disciplinary action taken by the state of Kansas or another jurisdiction against any professional or occupational application, license, registration, or permit held by the individual.

Intern Immunization Authority

The Board recently adopted guidance to provide clarification regarding whether pharmacy students or interns who administer vaccines are required to have a signed vaccination protocol with licensed physicians. Interns are authorized to administer vaccines under Kansas Statutes Annotated 65-1635a only under the direct supervision and control of a pharmacist. Each intern is required to complete a CPR course and an immunization training course approved by Accreditation Council for Pharmacy Education (ACPE) or the Board and have a current CPR certificate. The supervising pharmacist is also required to complete a CPR course and an immunization training course approved by ACPE or the Board and have a current CPR certificate. The supervising pharmacist is responsible for ensuring that he or she has a current, signed protocol with a licensed physician to administer vaccinations and that all requirements are met for administering, recording, and reporting all vaccinations administered by the intern under the pharmacist's supervision in accordance with the Kansas Pharmacy Act. Interns are not required to have a signed protocol or be party to a protocol between their supervising pharmacist and a licensed physician.

What does this mean for pharmacists practicing in the state of Kansas?

  • All pharmacy managers must ensure that their technician staff is aware of the changes for technician licensure, and that two exams are approved for national certification. All technicians on staff must adhere to the registration policies outlined above for continued employment. All hiring practices for pharmacy technicians must include a validation of state registration and adherence to these new requirements.
  • Several administrative changes involve reporting, recordkeeping for the Board of Pharmacy for the pharmacy and pharmacist permit holder. Ensure that all processes include these new notifications and that all staff are trained.
  • Pharmacists can allow interns to administer immunizations if both the pharmacist and intern meet the above requirements. Review all current intern and immunizing pharmacist credentials to ensure that the requirements are met in your pharmacy. All hiring processes must include a method of reviewing candidate credentials prior to immunizing.

Kansas State Regulatory Summary- 2018

The following regulations were enacted or amended during the 2018 legislative session and can be found in detail at the Kansas Board of Pharmacy.

KAR 68-13-2: Definitions update; Compounding

KAR 68 13-3: Compounding of Non-Sterile Products

KAR 68-13-4: Compounding of Sterile Products

KAR 68-21-7: Drugs of Concern

KAR 68-5-17: Pharmacy Technicians; Certification Exams; Request for Extension

What do these new regulations mean for pharmacists practicing within the state of Kansas?

  • Term definitions have been updated to reflect updated FDA and USP compounding requirements and language. If you work in a pharmacy location that participates in non-sterile or sterile compounding, review all terms to ensure that new regulations are understood.
  • Additional guidance for non-sterile compounding is present in the regulations to include what can be compounded, compounding, storage, and labeling conditions, and record-keeping. Review and audit that all aspects of the law is being met in your current practice of non-sterile compounding.
  • Additional guidance has also been included for sterile compounding (as in above), but also including quality and sterility testing, appropriate device inspection and certification, and employee technique testing. Ensure that there is a complete understanding of all regulations and that proper technique assessment is completed and proper documentation and record-keeping is in place.
  • Provide consistent educational opportunities to maintain professional competency in current techniques and processes.
  • Gabapentin has been added as a "drug of concern" based on increased incidences of abuse. Execute due diligence and professional judgement when dispensing this medication to patients.
  • Pharmacy technicians must pass either the PTCE or ExCPT exam before their first renewal date. If the candidate fails to pass either exam, they may file for an extension to the Board of Pharmacy 30 days prior to their registration expiration.
  • All technicians must provide proof to the Board of Pharmacy within 30 days of passing, or prior to their first renewal date, whichever is less. Communicate these changes to your technician employees and ensure that they are prepared for their national exam through proper training and education.

For full regulatory language, refer to the Kansas Board of Pharmacy

Kentucky State Regulatory Update April 2019

HB470 - Amend KRS 217.186 to allow a pharmacist to dispense naloxone to a person or agency who provides training on the use of naloxone as a part of a harm reduction program.

SB54 - Create a new section of subtitle 17A of KRS Chapter 304 to require an insurer develop processes for electronic prior authorizations; to establish an extended length of authorization under certain circumstances; amend KRS 304.17A-607 to require that decisions relating to utilization reviews are conducted by physicians of the same specialty as the ordering provider; to establish a time frame for providing utilization decisions; to allow for electronic format of certain required notices; to establish that an insurer's failure to respond within set time frames shall be deemed a prior authorization; EFFECTIVE January 1, 2020.

HB342 - Create a new section of KRS Chapter 218A to require that all prescriptions for controlled substances be submitted electronically except for certain conditions; EFFECTIVE January 1, 2021.

HB64 - Amend KRS 217.215 to permit pharmacists to dispense a prescription refill in an amount equal to the standard unit of dispensing for the drug without authorization by the prescribing practitioner in emergency situations in which such authorization may not be readily or easily obtained; require the Board of Pharmacy to promulgate administrative regulations to carry out these provisions.

What does this mean for pharmacists practicing in the state of Kentucky?

  • Pharmacists now have a broader allowance for the dispensing of naloxone, to include outside agencies. Ensure that recordkeeping procedures reflect this new allowance and that staff are appropriately trained.
  • New electronic requirements have been established around electronic prior authorizations and electronic prescribing; train all staff on these new rules and include in all SOPs.
  • Pharmacists can now provide patients with an emergency supply of medication in emergency circumstances to avoid an interruption of a patient's therapy. Use professional judgement and ensure that proper recordkeeping is completed.

Kentucky State Regulatory Summary- 2018

The following bills were passed during the 2018 legislative session and can be found in detail at theKentucky Pharmacy Association .

SB 6: Safe disposal of controlled substances.

A pharmacist or a pharmacist's designee shall inform persons who receive a prescription for a controlled substance that contains an opioid, benzodiazepine, a barbiturate, codeine, or an amphetamine, about the importance of proper and safe disposal of unused, unwanted, or expired prescription drugs either verbally, in writing, or posted signage.

Upon dispensing of any prescription that contains any opioid, benzodiazepine, a barbiturate, codeine, or an amphetamine, a pharmacist or a pharmacist's designee may:

  • Make available for purchase, or at no charge distribute, a nontoxic composition for the sequestration, deactivation, destruction, and disposal of any unused, unwanted, or expired prescription; or,
  • Provide an on-site, safe, and secure medicine disposal receptacle or kiosk for the safe disposal of any unused, unwanted, or expired prescription.

HB 463: Pharmacy Benefits

A pharmacy benefit manager shall not:

  • Require an insured purchasing a prescription drug to pay a cost-sharing amount greater than the amount the insured would pay for the drug if he or she were to purchase the drug without coverage under a health benefit plan;
  • Prohibit a pharmacy from discussing any pricing information, and
  • Impose a penalty on a pharmacy for complying.
  • A pharmacist shall have the right to provide an insured information regarding the applicable limitations on his or her cost-sharing pursuant to this section for a prescription drug.

What do these new regulations mean for pharmacists practicing within the state of Kentucky?

  • Pharmacists must ensure that the dispensing and counseling processes include informing the patient or patient's representative of proper disposal of qualifying medications.
  • Pharmacists are urged to consider providing a nontoxic product that the patient can use for safe medication disposal or provide a kiosk in their pharmacy as a safe disposal option.
  • Pharmacists can now provide pricing information and cost-effective alternatives to patients without potential retaliation from payer groups. This provides pharmacists with another opportunity to improve patient adherence and ensure that patients take their medication according to schedule, resulting in more improved patient outcomes.

For full regulatory language, refer to the Kentucky Board of Pharmacy.

Louisiana State Regulatory Update April 2019

Guidance Document for CBD Oil Revised (19-04-602)

During its November 2018 meeting, the Board issued a guidance document related to the sale of cannabidiol (CBD) oil. That document referenced pertinent federal and state controlled substance (CS) laws. The relevant federal law changed in December 2018; however, the state law has not yet changed. In the interim, state law is more stringent than federal law. The ultimate guidance remains the same: the sale of CBD oil would violate the state CS law and place the licensee at risk for criminal and/or administrative sanctions. The Board distributed a notice of the revised guidance document to all licensees on February 23, 2019, and the document was also posted to the Board's website.

Advisory Opinions and Guidance Documents (19-01-595)

During its November 14, 2018 meeting, the Board issued advisory opinions and guidance documents on multiple topics, including the following:

  • Joint Accreditation for Interprofessional Continuing Education this opinion recognizes continuing education (CE) activities with the Joint Accreditation credit mark as valid to substantiate compliance with CE requirements for pharmacists and technicians.
  • Recordkeeping Requirements for Written Prescription Forms Received in Pharmacies by Facsimile or Electronic Images this opinion clarifies the Board's intent for such forms that they may be stored electronically and are not required to be printed and maintained in hard copy form merely for record keeping purposes.
  • Compounding of Drugs by Nurses this opinion addresses the emergent preparation of medication for immediate use, where waiting for a pharmacist to compound such medication might not be in the patient's best interest.
  • Guidance Information re Cannabidiol (CBD) Oil this guidance document was issued in response to the many requests for the legal status of CBD oil products and the retail sale of such products.

What does this mean for pharmacists practicing in the state of Louisiana?

  • CBD Oil cannot be sold in pharmacies in the state. Ensure that these products are not present in the pharmacy.
  • Several practice initiatives are being watched by the Board, and the Board has provided opinions on said practices. Ensure that all Standard Operating Procedures keep in mind the BOP stance.

Louisiana State Regulatory Summary- 2018

The following bills were passed during the 2018 legislative session and can be found in detail at the Louisiana Pharmacy Association.

SB: 131 Pharmacist licensure

Updates certain terminology regarding the education, professional experience, criminal background check, and application forms required for licensure.

Provides for issuance of a license in 14 working days once the applicant successfully complies with the licensing requirements.

Updates certain terminology regarding the pharmacist's license in another state being in active status, passing all exams required by the board, and investigations of the applicant's original and subsequently acquired licenses in other states.

Effective August 1, 2018.

SB: 134 Partial Dispensing of Schedule II CDS

Provides that a patient may request that the pharmacist dispense less of a Schedule II drug than the amount indicated in the prescription.

This bill mirrors the federal law requirements outlined in 21 U.S.C. 829.

Effective August 1, 2018.

What do these new regulations mean for pharmacists practicing within the state of Louisiana?

  • Pharmacists that are working to gain licensure in Louisiana should have a shorter wait for their official licensure to practice once all required documentation is submitted to the board for approval. This will streamline not only a pharmacist's ability to practice within the state, but also for employers to meet pharmacy needs sooner, allowing for better patient care.
  • Pharmacists may now dispense a prescription written for a controlled substance (CDS) for less than the prescribed quantity, upon the request of the patient. All federal guidelines must be met as well. This regulation brings the state guidelines in alignment with federal controlled substance partial fill regulation.
  • By allowing partial fill requests, this provides a way to limit unwanted or unnecessary controlled substances from the community; reducing abuse and diversion opportunities.

For full regulatory language, refer to the Louisiana Board of Pharmacy.

Maine State Regulatory Update April 2019

LB659 - An Act Regarding the Use of Interchangeable Biological Products

Within 5 business days after a pharmacist dispenses a biological product, the dispensing pharmacist or the pharmacist's designee shall enter in an electronic records system that is electronically accessible to the practitioner who prescribed the biological product the specific biological product dispensed, including the name of the biological product and the manufacturer. Entry into an electronic records system as described in this paragraph is presumed to provide notice to the practitioner. If a pharmacist cannot make an entry in an electronic records system, the pharmacist shall notify the practitioner of the specific biological product dispensed by facsimile, telephone, electronic transmission or other similar means. The board shall maintain a link on the board's publicly accessible website to the current list of all biological products determined by the federal Food and Drug Administration to be an interchangeable biological product.

What does this mean for pharmacists practicing in the state of Maine?

  • Pharmacists can now provide information to patients about potential interchangeable biological products. This will result in more positive health outcomes and improved adherence to prescribed therapy. If an interchange is made, then the pharmacist must provide notification to the prescriber. Ensure that proper documentation of the interchange occurs in the pharmacy system and that SOPs include this notification.

Maine State Regulatory Summary- 2018

The following laws, summarized below, were enacted by the Maine legislature during the 2018 session. All take effect August 1, 2018, unless otherwise noted.

LD 565 Public Law Chapter 364 Prescribing and Dispensing of Naloxone Hydrochloride by Pharmacists

LD 1892 Public Law Chapter 417 Emergency Prescribing and Dispensing of Naloxone Hydrochloride by Pharmacists

Chapter 40 Authorization Training and Procedures for Prescribing and Dispensing Naloxone Hydrochloride (Effective May 23, 2018)

Taken from the Maine Board of Pharmacy.

What do these new regulations mean for pharmacists practicing within the state of Maine?

  • Pharmacists can now prescribe, as well as dispense, naloxone for use to patients. Naloxone can be provided to a patient of any age, or to an immediate family member, friend, or any person in position to assist that individual in the event of an opioid related drug overdose.
  • Proper treatment and prescribing protocols must be established if the pharmacist is dispensing without a standing order or collaborative practice agreement under another qualified healthcare professional.
  • All prescribing activities must be within the guidelines outlined in Title 32, section 13815 of the Maine Regulatory code.

For full regulatory language, refer to the Maine Division of Professional Licensing.

Maryland State Regulatory Summary- 2018

The following laws, summarized below, were enacted by the Maryland legislature during the 2018 session.

HB 736/SB 576 - Gag Rule Prohibition. Effective October 2018

Pharmacists may now voluntarily share if a patient's cash price may be less than their co-pay or if there is an affordable alternative.

HB 1349 /SB 1079- MAC Reform and MIA Enforcement. Effective June 2018

PBMs may not reimburse a pharmacy or pharmacist less than it reimburses itself or affiliate for the same product or service, with some restrictions.

Clarifies definition of MAC list.

Updates pharmacy appeal procedures.

HB 1558 - Single Dispensing; 30 90 Day Conversions. Effective October 2018.

Pharmacist may dispense in a single dispensing a 30-day prescription with two refills (90-day fill) without physician authorization.

Does not apply to first prescriptions or a change in a script.

Some restrictions for contraceptives dispensed after January 2020.

Does not apply if prescriber indicates "dispense only as prescribed."

HB 1452 - Required Opioid-CE for Healthcare Providers. Effective October 2018.

Prior to initial registration or first renewal of CDS registration after October 1, 2018. one-time commitment.

Required completion of 2 CE on prescribing or dispensing of CDS.

CE program must be recognized by Board of Pharmacy.

What do these new regulations mean for pharmacists practicing within the state of Maryland?

  • Pharmacists can play a larger role in patient adherence to their medication regimen though cost savings solutions, ensuring the most affordable therapy for their patients.
  • Pharmacists can also positively affect adherence through 90-day dispensing conversions, allowing the patient to save time and money, and ensuring that they have needed medication on hand.
  • Positive moves are being made regarding pharmacy reimbursement for dispensed medications by PBMs, enforcing fair payment and more guidelines with the appeals process. It also allows for more fair competition, allowing patients the option to choose their pharmacy.
  • Finally, pharmacists must plan to include a one-time opioid education, board approved CE in their controlled substance registration renewal completion requirements.

For full regulatory language, refer to the Maryland Board of Pharmacy

Massachusetts State Regulatory Update April 2019

Reporting the Loss of CS Update

On December 6, 2018, the policy detailing the requirements for reporting a theft or loss of CS to the Board was updated, and a new electronic fillable loss reporting form was instituted. The updated policy requires pharmacies to email the Board within seven business days of the discovery of a possible significant loss. Within the next 21 days, or upon completion of investigation, whichever comes first, the pharmacy must then report to the Board the findings of its investigation. Regardless of the outcome of the investigation, the pharmacy must submit the outcome of its investigation in accordance with the requirements defined in Board Policy 2018-05. If it is determined that a significant loss did not occur, the pharmacy must report back to the Board with a detailed description of the investigatory process that concluded no reportable loss occurred. If the investigation confirms a significant loss, the report must be submitted within seven business days of confirming a significant loss. The policy includes updated descriptions for types of losses, including those that are considered "not reportable." Non-reportable losses include insignificant losses and losses resulting from confirmed dispensing errors.

What does this mean for pharmacists practicing in the state of Massachusetts?

  • Pharmacists and pharmacy supervisors must have a process in place for the reporting, investigation, and remedy of controlled substance losses in their pharmacy. Ensure that all policies reflect the state board's requirements, and that all staff is trained on that policy.

Massachusetts State Regulatory Summary- 2018

The following laws, summarized below, were enacted by the Massachusetts legislature during the 2018 session.

SB 1240 - Recognizing Pharmacists as Healthcare Providers

  • Recognize registered pharmacists as healthcare providers.
  • Allow pharmacists to negotiate with health plans to provide medication therapy management (MTM) services.
  • Amend the current CDTM law to eliminate the list of disease states eligible for a CDTM agreement in a retail setting to allow pharmacists and physicians to team up on any disease that the physician requests; Authorize pharmacists to administer medications ordered by a prescriber; permits pharmacists to dispense nicotine replacement therapies and hormonal contraceptives by protocols established jointly by the Boards of Medicine and Pharmacy.

SB 583 - Access to generic medications

  • This legislation provides very reasonable standards to ensure independent and small chain pharmacies are treated fairly by the large PBMs.

SB 523 - Access to specialty medications

  • This legislation amends the "Any Willing Provider" law to allow community pharmacies to fill prescriptions for "specialty medications" if they can provide the required administrative, handling, and monitoring services required by the drug.

HB 3582 Prohibition of certain pharmacy claims fees

  • This legislation defines certain fees imposed on pharmacists or pharmacies by health insurance companies (i.e. DIR fees) or pharmacy benefit managers as unfair and deceptive trade practices, including any fees that are not apparent, that are not reported on remittance advice or which are imposed after claim adjudication.
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What do these new regulations mean for pharmacists practicing within the state of Massachusetts?

  • Pharmacists can now have a greater impact on patient outcomes, through medication administration, chronic disease state management services, and expanded dispensing services pursuant to protocols.
  • Pharmacists will also have greater access to approved generic reimbursement rates from PBMs, allowing them to make professional decisions on inventory and dispensing practices. They will also have greater access and ability to provide their patients with needed specialty medications, rather than be forced to use specialty pharmacies; this will be dependent on the complexity of the medication.
  • Finally, there will be more visibility to all charges to a pharmacy from a pharmacy benefit manager, removing potential "hidden" costs to the dispensing agent. This allows a pharmacy to make informed business decisions and provide more continuity of care to their patients.

For full regulatory language, refer to httMassachusetts Board of Pharmacy

Michigan State Regulatory Summary- 2018

The following laws, summarized below, were enacted by the Michigan legislature during the 2018 session:

HB 4472 (Public Act 41) Interchangeable Biologic Substitution

  • When a pharmacist receives a prescription for a brand name drug product or biological drug product, the pharmacist may, upon patient request or approval, dispense a lower cost but not higher cost generically equivalent drug product or interchangeable biological drug product if available in the pharmacy.
  • The pharmacist shall not dispense a generically equivalent drug product or interchangeable biological drug product if the prescriber indicates DAW on the prescription, or otherwise communicates no substitution.
  • A pharmacist may not dispense a drug product with a total charge that exceeds the total charge of the drug product originally prescribed, unless agreed to by the purchaser.
  • Within 5 days after dispensing an interchangeable biological drug product, the prescriber must be notified, either by electronic notification or otherwise.

The complete regulation can be found at Michigan Board of Pharmacy.

What do these new regulations mean for pharmacists practicing within the state of Michigan?

  • The new regulation allows Michigan pharmacists greater flexibility to take care of their patients when dispensing biologicals, by providing the most cost-effective option either through generic substitution or via interchangeability evaluations.
  • If a substitution occurs based on patient request and prescription allowance, the provider must be notified and proper documentation must occur.
  • Flexibility is allowed as this notification can occur electronically or via phone and is not required to occur at the time of dispensing.

For full regulatory language, refer to the Michigan Board of Pharmacy

Minnesota State Regulatory Update April 2019

CBD products derived from industrial hemp and intended for human consumption are drugs, as defined in Minnesota Statute 151.01, Subdivision 5.

Under Minnesota law, drugs are misbranded and adulterated if: they are not approved for medical use by FDA; their labeling has not been approved by FDA; they are not manufactured at a facility registered by FDA and licensed by the Board; or they are not manufactured using cGMPs. From the labeling of some CBD products, they are intended to affect the structure or function of the bodies of humans and animals.

Any products, other than a food product, that make such claims fall under the legal definition of the word "drug". And if the products are drugs, their sales are illegal under Minnesota Statute 151.34.

The sale of most products that contain CBD extracted from any type of cannabis plant and intended to be used to treat medical conditions or to alter the structure and function of human or animal bodies, remains illegal under both federal and state law. The exceptions would be FDA-approved drugs, such as the recently approved Epidiolex, and the products allowed to be sold under state law by the manufacturers that are regulated by the Minnesota Department of Health, Office of Medical Cannabis.

What does this mean to pharmacists practicing in the state of Minnesota?

  • Pharmacists cannot sell any products containing CBD, hemp, or any derivative that are classified as a drug by the Board of Pharmacy. The only exemptions are those products approved by the FDA or regulated by the state of Minnesota DOH. Ensure that none of these products are represented for sale in your pharmacy.

Minnesota State Regulatory Summary- 2018

The following laws, summarized below, were enacted by the Minnesota legislature during the 2018 session:

SF3480 Disclosure for Payment of Healthcare Services Effective July 1, 2019

A healthcare provider is obligated to provide a good-faith estimate to a consumer of the anticipated costs for services, including total cost and patient responsibility. No healthcare plan contract can prohibit a provider (defined as a primary care provider) from providing this information to the consumer.

HF 3196 Step Therapy Protocol and Establishment of Overrides for Prescription Drug Coverage Established - Effective July 1, 2019

A health plan shall consider available recognized evidence-based and peer-reviewed clinical practice guidelines when establishing a step therapy protocol.

What do these new regulations mean for pharmacists practicing within the state of Minnesota?

  • While the regulations do not directly affect or require additional work on the part of the pharmacist, these can help the pharmacist assist the patient in gaining resolution for rejected prescriptions when associated with an approved step therapy protocol.

For full regulatory language, refer to the Minnesota Board of Pharmacy.

Mississippi State Regulatory Update April 2019

SB 2365

An Act To Amend Section 73-21-73, Mississippi Code Of 1972, To Define The Terms "biological Product" And "interchangeable Biological Product" And Revise The Definition Of The Term "product Selection" For The Purposes Of The Pharmacy Practice Act; To Amend Section 73-21-117, Mississippi Code Of 1972, To Allow Product Selection Of Interchangeable Biological Products By Pharmacists In The Same Manner As Product Selection Of Generic Drug Equivalents; To Require Pharmacists To Make Certain Electronically Accessible Records Of Biological Products Dispensed By Them And Convey That Information To The Prescribers Of Those Products; To Amend Section 73-21-119, Mississippi Code Of 1972, To Require That The Labels For Biological Products And Interchangeable Biological Products Contain Certain Information; To Amend Section 73-21-127, Mississippi Code Of 1972, To Conform To The Preceding Provisions; And For Related Purposes.

What does this mean for pharmacists practicing in the state of Mississippi?

  • Allows pharmacists to provide patients with interchangeable biologic products, just as they currently do with generic alternatives. Pharmacists must provide information to patients around the cost benefit of the interchange, properly document that interchange, and share that information to the prescribing physician in a timely manner. This will allow pharmacists to provide guidance to patients that can results in timely initiation and continued therapy of such products.

Mississippi Regulatory Update November 2018

The Mississippi Medical Licensure Board (MSMLB) has revised its rules on prescribing opioids in Mississippi. While the Mississippi Board of Pharmacy does not enforce the MSMLB regulations, it is important for pharmacists to be aware of the recommendations.

MS Medical Licensure Quick Reference Guide

What does this mean for pharmacists practicing within the state of Mississippi?

  • While the board of pharmacy is not enforcing the opioid prescribing recommendations, pharmacists should be aware of them in an effort to support them as part of their role in the care of their patients.

Mississippi State Regulatory Summary- 2018

The following law was enacted by the Mississippi legislature during the 2018 session:

HB709 Prescription Drug Consumer Affordable Payment Options Act Effective July 1, 2018

Mississippi State Legislature Bill Activity

  • Pharmacists may provide additional information to a patient to allow them an opportunity to consider affordable alternative payment options when acquiring their prescription medication.
  • Neither the board, any pharmacy benefit manager nor any third party shall penalize a pharmacist for acting or failing to act under this section, nor shall a pharmacist or his agents or employees be liable for any act or failure to act.

What do these new regulations mean for pharmacists practicing within the state of Mississippi?

  • This regulation prohibits all pharmacy benefit managers from including "gag orders" as part of enrollment contracts.
  • Pharmacists can now provide additional information around alternative payment options when dispensing medications to patients, allowing for potentially better adherence and continuity to their therapy regimens.

For full regulatory language, refer to the Mississippi Board of Pharmacy.

Missouri State Regulatory Update April 2019

The Board recently revised 20 CSR 2220-6.050 (Immunization by Protocol) to streamline Missouri's immunization requirements:

  • Mileage Limits Protocol physician - No mileage restrictions.
  • Minimum Patient Age- The minimum age authorized by law which is currently seven (7) years old or the age recommended by the Centers for Disease Control and Prevention, whichever is higher (unless otherwise restricted by protocol).
  • Authorized Immunization Locations -Only nonpharmacy sites must be listed in the protocol.
  • Notifications of Intent Annual renewal required Must be renewed every two (2) years with your Missouri pharmacist license.
  • Vaccine Notifications- Protocol physician must be notified as designated in the governing protocol; No minimum time limit set by rule. *Notification of adverse events still required within 24 hours.
  • Continuing Education- Two (2) hours of CE required each biennial renewal period (11/1 of even numbered years to 10/31 of even numbered years).
  • Licensees should review 20 CSR 2220-6.050 for a complete listing of the updated requirements.
  • The Pharmacist Administration/ Immunization Checklist brochure has also been updated and is available on the Board's website.

What does this mean to pharmacists practicing in the state of Missouri?

  • Immunizing pharmacies will have more options in obtaining physicians for their immunization protocols, reporting vaccine administration to the protocol physician, and lowered the minimum age for vaccine administration per a protocol. Pharmacists should check and update their protocols to make sure the protocol includes/allows the rule changes such as the lower immunization age. Compliance with your protocol is mandatory even though the rule has changed.
  • All pharmacies must also ensure that the most current Immunization Checklist brochure is being used.

Missouri Regulatory Update November 2018

20 CSR 2220-2.200 Sterile Compounding.

Clarifies the requirements for in-use times/beyond-use dating and remedial investigations as the result of environmental monitoring.

  • Aseptic Technique and Preparation.

    Single-dose vials/containers and pharmacy bulk vial/containers exposed to ISO Class 5 or cleaner air may be used in compounding until the assigned in-use time which shall not exceed six hours after initial needle puncture, unless otherwise specified by the manufacturer. Opened single-dose ampules shall not be stored for any time period. The in-use time must be placed on the vial/container. For multiple-dose vials/containers with no antimicrobial preservative used in the preparation of radiopharmaceuticals whose beyond-use dates are twenty-four hours or less, the in-use time shall not exceed twenty-four hours.

    Remedial Investigations.

    A remedial investigation shall be required if any environmental monitoring sample demonstrates a colony forming unit (CFU) count that exceeds USP Chapter 797 recommended action levels for the type of sampling. The amendment also provides guidance on when a pharmacy must cease compounding until the investigation is complete and board notification requirements.

    Sterile Compounding

SB826 Practice of Pharmacy

Section 195.080: Opioid Prescribing and Dispensing Restrictions

  • A practitioner, other than a veterinarian, shall not issue an initial prescription for more than a seven-day supply of any opioid controlled substance upon the initial consultation and treatment of a patient for acute pain.
  • If, in the professional medical judgment of the practitioner, more than a seven-day supply is required to treat the patient's acute pain, the practitioner may issue a prescription for the quantity needed to treat the patient; provided, that the practitioner shall document in the patient's medical record the condition triggering the necessity for more than a seven-day supply and that a nonopioid alternative was not appropriate to address the patient's condition.
  • The provisions of this subsection shall not apply to prescriptions for opioid controlled substances for a patient who is currently undergoing treatment for cancer, is receiving hospice care from a hospice certified in palliative care, is a resident of a long-term care facility, or is receiving treatment for substance abuse or opioid dependence. A pharmacist or pharmacy shall not be subject to disciplinary action or other civil or criminal liability for dispensing or refusing to dispense medication in good faith pursuant to an otherwise valid prescription that exceeds the prescribing limits established. The quantity of Schedule II controlled substances prescribed or dispensed at any one time shall be limited to a thirty-day supply.
  • The supply limitations provided in this subsection may be increased up to three months if the physician describes on the prescription form or indicates via telephone, fax, or electronic communication to the pharmacy to be entered on or attached to the prescription form the medical reason for requiring the larger supply.

Section195.265: Controlled Substance Disposal

  • Unused controlled substances may be accepted from ultimate users, from hospice or home health care providers on behalf of ultimate users to the extent federal law allows, or from any person lawfully entitled to dispose of a decedent's property if the decedent was an ultimate user who died while in lawful possession of a controlled substance, even if the authorized collector did not originally dispense the drug.

Section 338.010: Administration of Immunizations

  • The administration of viral influenza, pneumonia, shingles, hepatitis A, hepatitis B, diphtheria, tetanus, pertussis, and meningitis vaccines by written protocol authorized by a physician for persons at least seven years of age or the age recommended by the Centers for Disease Control and Prevention, whichever is higher, or the administration of pneumonia, shingles, hepatitis A, hepatitis B, diphtheria, tetanus, pertussis, meningitis, and viral influenza vaccines authorized by a physician for a specific patient as authorized.
  • A pharmacist shall inform the patient that the administration of the vaccine will be entered into the ShowMeVax system. The patient shall attest to the inclusion of such information in the system by signing a form provided by the pharmacist. If the patient indicates that he or she does not want such information entered, the pharmacist shall provide a written report within fourteen days of administration of a vaccine to the patient's primary health care provider, if provided by the patient.

Section 338.056: Substitutable and interchangeable products

  • A pharmacist filling prescription orders for drug products prescribed by trade or brand name may select another drug product with the same active chemical ingredients of the same strength, quantity and dosage form, and of the same generic drug or interchangeable biological product type, as determined by the United States Adopted Names and accepted by the Federal Food and Drug Administration. The pharmacist shall assume the same responsibility for that selection. The pharmacist shall not select a drug or interchangeable biological product pursuant to this section unless the product selected costs the patient less than the prescribed product. The pharmacist shall note the instructions on the file copy of the prescription.
  • A pharmacist may, unless the prescriber has specified on the prescription that dispensing a prescription for a maintenance medication in an initial amount followed by periodic refills is medically necessary, a pharmacist may exercise his or her professional judgment to dispense varying quantities of maintenance medication per fill, up to the total number of dosage units as authorized by the prescriber on the original prescription, including any refills, but shall be limited to no more than a ninety-day supply of the medication, and the maintenance medication shall have been previously prescribed to the patient for at least a three-month period.

Section 376.387: Cost saving discussions on medications

  • No pharmacy benefits manager shall include a provision in a contract entered into or modified on or after August 28, 2018, with a pharmacy or pharmacist that requires a covered person to make a payment for a prescription drug at the point of sale in an amount that exceeds the lesser of the copayment amount as required under the health benefit plan or the amount an individual would pay for a prescription if that individual paid with cash.
  • A pharmacy or pharmacist shall have the right to provide to a covered person information regarding the amount of the covered person's cost share for a prescription drug, the covered person's cost of an alternative drug, and the covered person's cost of the drug without adjudicating the claim through the pharmacy benefits manager.
  • Neither a pharmacy nor a pharmacist shall be proscribed by a pharmacy benefits manager from discussing any such information or from selling a more affordable alternative to the covered person.
  • No pharmacy benefits manager shall, directly or indirectly, charge or hold a pharmacist or pharmacy responsible for any fee amount related to a claim that is not known at the time of the claim's adjudication, unless the amount is a result of improperly paid claims or charges for administering a health benefit plan.

For more information, refer to SB826 Complete Ruling

HB 1719

Section 337.718: New CE requirement for pharmacists for licensure

Any licensee that provides health services must complete 2 hours of suicide assessment, referral, treatment, and management training.

Section 338.315: Purchase of legend drugs by a pharmacy

Except as otherwise provided by the board by rule, it shall be unlawful for any pharmacist, pharmacy owner or person employed by a pharmacy to knowingly purchase or receive any legend drugs under 21 U.S.C. Section 353 from other than a licensed or registered drug distributor, drug outsourcer, third-party logistics provider, or licensed pharmacy.

Pharmacies shall establish and maintain inventories and records of all transactions regarding the receipt and distribution or other disposition of legend drugs. Such records shall be maintained for two years and be readily available upon request by the board or its representatives.

For full regulation details, refer to HB1719.

What does this mean for pharmacists practicing within the state of Missouri?

  • Any pharmacist that performs aseptic compounding must ensure that their standard operation and quality procedures incorporate direction for beyond-use dating and investigations.
  • Pharmacists must understand the new requirements for controlled substance and opioid prescribing and dispensing; be prepared to discuss these new requirements with patients receiving prescriptions for pain control.
  • The state regulation now allows for immunizations to be administered via a protocol or patient specific prescription, by a certified pharmacist, to patients 7 or older. Ensure that current protocols are updated to reflect this new age limit, and that all staff are aware and duly trained.
  • Pharmacists can now provide information concerning prescribed medications, including cost saving alternative substitutions and cost options, without penalty from pharmacy benefit managers. This can allow pharmacists to play a larger part in promoting medication adherence and reducing interruption of therapy due to cost concerns by the patient.
  • Pharmacists must complete two hours of suicide assessment and management training prior to license renewal. Ensure that your CE profile reflects this new requirement.

Missouri State Regulatory Summary- 2018

No new pharmacy legislation was passed during the 2018 General Assembly Sessions

*Full legislature documents can be found at the Missouri legislative site at Missouri Legislature.

What do these new regulations mean for pharmacists practicing within the state of Missouri?

For full regulatory language, refer to the Missouri Board of Pharmacy.

Montana State Regulatory Update April 2019

SB 83 Establishment of allowable and prohibited practices for pharmacy benefit managers. Establishes rules for allowable fees, copay limitations, and the rights of pharmacies. Effective 1/1/2020.

HB 86 General Revisions of Pharmacy Drug Laws Establishes rule that every pharmacist, at initial licensure or license renewal, must register to use the Prescription Drug Registry.

What does this mean for pharmacists practicing in the state of Montana?

  • All pharmacists must register to use the Prescription Drug Registry and refer to this registry before dispensing controlled substances. All pharmacy supervisors must ensure that all pharmacists at their site are compliant.

Montana State Regulatory Summary- 2018

The following laws, summarized below, were enacted by the Montana legislature during the 2017 session (the legislative session meets every two years on odd numbered years):

HB 177 Revision of Immunization Allowance for Pharmacist Administration effective immediately

Amended the current immunization law to allow pharmacists to administer all pneumococcal vaccines pursuant to a valid collaborative practice agreement.

HB 233 Montana Drug Product Selection Act

Amended to include the provision to provide a generic or interchangeable biologic product if a less expensive one is available to the patient.

If an interchangeable product is dispensed, the pharmacist must provide notification to the prescribing physician within 5 days of dispensing, either by electronic or other means.

All recordkeeping must be maintained for a period of 2 years.

HB 276 Revision of Reimbursement for Pharmacies

Amended to update terminology to include health insurance issuer, for inclusiveness, and adds the revision that all insurers must provide pharmacy with up to date pricing lists to show accurate MAC and reimbursement rates of dispensed products.

HB 333 Adoption of Help Save Lives Overdose Act

Enacts policy around opioid-antagonist prescribing and dispensing, patient designation and instruction on use of opioid antagonist products, professional immunity, good Samaritan laws around administering, and protection from criminal liability.

*Full legislature documents can be found at the Montana legislative site at the Montana Legislature website.

What do these new regulations mean for pharmacists practicing within the state of Montana?

  • Pharmacists can now provide all forms of pneumococcal vaccine recommended by the CDC/ACIP guidelines.
  • Pharmacists can use professional judgment to provide approved, interchangeable biological products if that interchange provides a cost saving to the patient and the patient requests it. If an interchangeable product is provided, the prescriber must be notified, and proper documentation must occur.
  • Pharmacists will now be provided more up-to-date information by insurers around drug pricing, allowing them to make better decisions to improved and patient care and business sustainability.
  • Montana has adopted a comprehensive act to help combat the state and national opioid crisis, including allowances for pharmacists and caregivers to provide methods to reverse overdose events without fear of liability.

For full regulatory language, refer to the Montana Board of Pharmacy.

Nebraska State Regulatory Update April 2019

LB 74 Pharmacy technicians

Pharmacy Practice Act; amends section 38-2845 and sections 38-2801 and 38-2802 to define and redefine terms; to provide for validation of acts, tasks, and functions by certified pharmacy technicians as prescribed;

Adds guidance for the allowance of certified pharmacy technicians to check the accuracy and completeness of tasks completed by another certified pharmacy technician in specific settings.

LB 442 - Require insurance coverage for synchronizing prescription medications

A plan provider shall not deny coverage for the dispensing of a medication that is dispensed by a network pharmacy on the basis that the dispensing is for a partial supply if the prescribing practitioner or pharmacist determines the fill or refill to be in the best interest of the patient and the patient requests or agrees to a partial supply for synchronizing the patient's medications. The plan shall allow a pharmacy to override any denial codes indicating that a prescription is being refilled too soon for purposes of medication synchronization.

To be eligible for coverage under this section, the medication:

  • Must be covered by the enrollee's health benefit plan or have been approved by a formulary exception process;
  • Must meet the prior authorization or utilization management criteria specifically applicable to the medication under the health benefit plan on the date the request for synchronization is made;
  • Must be used for treatment and management of a chronic illness;
  • Must be a formulation that can be safely split into short-fill periods to achieve medication synchronization; and
  • Must not be a controlled substance.

What does this mean for pharmacists practicing in the state of Nebraska?

  • Pharmacists can now assist patients in planning medication refills without gaps in plan coverage or denials. This will lead to decreased visits to the pharmacy and timely refill pickup, resulting in improved patient adherence to medication schedules.

Nebraska State Regulatory Summary- November 2018

The following laws, summarized below, were enacted by the Nebraska legislature during the 2018 session:

LB 731 Remote Dispensing Pharmacies

Allows remote dispensing to occur in Nebraska. The purpose of the legislation is to provide access to pharmacies/pharmacists in rural and underserved areas of Nebraska. The remote pharmacy will be staffed by a certified pharmacy technician and owned by a supervising pharmacy (licensed and located in Nebraska - and no less than 10 driving miles from a pharmacy already in operation) to dispense medications. Remote dispensing shall occur under remote supervision via a real-time audiovisual communication system by a licensed pharmacist employed by a supervising pharmacy.

LB 931 Opioid and other controlled substance prescribing

Prohibits medical practitioners from prescribing more than a seven-day supply of opioid pain relievers for a patient younger than 19. The bill includes an exception from the seven-day supply limitation for patients suffering from chronic pain, a cancer diagnosis, or palliative care. The bill does not apply to controlled substances prescribed to a narcotic-dependent person. Legislative findings are provided. The portions of the bill relating to the "seven-day supply" terminates on January 1, 2029. Unless the individual taking receipt of dispensed opiates is personally and positively known to the pharmacist, the individual is required to provide photographic identification (i.e. driver's license, state identification card). An exception is provided for patients who are residents of a health care facility.

LB 1034 Prescription drug monitoring program

Changes language relating to the Prescription Drug Monitoring Program (PDMP). This bill clarifies the definition of dispenser and dispensing to a nonhuman patient.

What do these new regulations mean for pharmacists practicing within the state of Nebraska?

  • Pharmacists that provide new remote dispensing pharmacies must ensure that their policies and procedures meet all board requirements.
  • Pharmacists must also be aware of, and ensure that all staff is duly trained on, all new regulations around the prescribing and dispensing of controlled substances, including opioids

Nebraska State Regulatory Summary- 2018

The following laws, summarized below, were enacted by the Nebraska legislature during the 2018 session:

LB 931 - Provide requirements for opiate and controlled substance prescriptions

Legislation requires health care providers to provide education to the patient on proper opioid use, reasoning for use, and risks of addiction when prescribing Schedule II and opioid medications.

Healthcare providers may only prescribe a 7 days supply for an opioid medication; if the condition requires therapy exceeding 7 days, the condition must be noted on the patient's medical record.

Patient must provide positive identification to the pharmacy or dispensing practitioner upon presentation of an opioid prescription, unless the patient is positively known to the dispensing agent.

What do these new regulations mean for pharmacists practicing within the state of Nebraska?

  • Pharmacies must have an operations policy in place that includes the verification of a valid form of identification when a patient that is not positively known to the pharmacist is presenting a prescription for a Schedule II controlled substance or opioid.

For full regulatory language, refer to the Nebraska Board of Pharmacy.

Nevada State Regulatory Update April 2019

Collaborative Practice Agreements

Through collaborative practice agreements, the Nevada Legislature expanded the scope of services that Nevada registered pharmacists can provide to patients, including as part of an interdisciplinary team. The requirements of a valid collaborative practice agreement are found in Nevada Revised Statutes (NRS) 639.2623 and NRS 639.2627, which allow pharmacists to engage in the collaborative practice of pharmacy and in collaborative drug therapy management, pursuant to a collaborative practice agreement.

Through a collaborative practice agreement, a pharmacist may engage in the collaborative practice of pharmacy, or in collaborative drug therapy management, where a pharmacist may initiate, monitor, modify, or discontinue patients' drug therapies. To enter into a valid collaborative practice agreement, a practitioner must be licensed and in good standing in the state of Nevada.

The practitioner must also maintain an ongoing relationship with the patient, who must give informed, written consent before the pharmacist may provide services to that patient pursuant to the collaborative practice agreement.

Additionally, the collaborative practice agreement must specify the disease state(s) a pharmacist may help treat, the types of decisions a pharmacist may make, and the procedure(s) a pharmacist may carry out, pursuant to the collaborative practice agreement. The agreement must also include a description as to how a practitioner will communicate any necessary medical information and diagnosis to the pharmacist and monitor clinical outcomes. Further, the agreement must state that the practitioner is authorized to override the agreement to protect the patient and accomplish treatment goals. The pharmacist must also comply with the requirements documented in the collaborative practice agreement concerning how a pharmacist must document, maintain records, and communicate with the practitioner and patients regarding patient care, treatment, and adverse effects. Collaborative practice agreements are only effective for up to one year after the effective date. These agreements must be submitted to the Nevada State Board of Pharmacy for approval in both a written and electronic form before they are effective.

Sample Collection by a Pharmacist

A registered pharmacist may use a fingerstick or an oral or nasal swab to perform Clinical Laboratory Improvement Amendments-waived tests per NRS 639.0747 and NRS 652.210. For example, a registered pharmacist can now perform tests for blood glucose levels, the international normalized ratio, influenza, and strep throat. Registered pharmacists are still not allowed to collect urine or stool specimens.

What does this mean to pharmacists practicing in the state of Nevada?

  • Pharmacists can function as an integral part of the healthcare team and have limited prescriptive authority as part of a collaborative practice agreement with a physician. Pharmacists practicing under a CPA must meet all protocol requirements as stated above, including proper patient condition assessment, analysis and monitoring.
  • Pharmacists can also collect patient specimens by either fingerstick, oral or nasal swab. Ensure that proper technique for collection is used, and that all documentation is completed.

Nevada State Regulatory Summary- 2018

The following laws, summarized below, were enacted by the Nevada legislature during the 2018 session:

AB 249 and SB 233 Revision to Contraceptive Prescription Guidance Effective January 1, 2018

A pharmacist to dispense up to a 12-month supply of drugs for contraception if:

  • The patient has previously received a three-month supply of the same drug;
  • The patient has previously received a nine-month supply of the same drug or a supply of the same drug for the balance of the plan year in which the three-month supply was prescribed, whichever was less;
  • The patient is insured by the same health insurance plan;
  • A provider of health care has not specified in the prescription that a different supply of the drug is necessary.

SB 131 Provision of Prescription Readers Upon Patient Request

A retail pharmacy must provide a prescription reader at the request of a patient or directions or advice on obtaining a prescription reader.

AB 474 Controlled Substance (CS) Prescription Requirements Revision Effective January 1, 2018

Each prescription for a CS must now also include:

  • the practitioner's Drug Enforcement Administration (DEA) number,
  • the patient's date of birth,
  • the days' supply of the CS. The prescriber may choose to assign a day's supply that is of longer duration than what is calculated.
  • the International Classification of Diseases, Tenth Revision (ICD-10) code that corresponds to the diagnosis for which the CS is prescribed.

Prescribing limits on an initial prescription for a CS:

  • Must be intended to be used for no more than 14 days, and
  • Must not exceed 90 morphine milligram equivalents (MMEs) daily for opiate naive (never received an opioid prescription or most recent course was completed more than 19 days prior to initial prescription).

What do these new regulations mean for pharmacists practicing within the state of Nevada?

  • Pharmacists can now play a larger role in patient care and adherence through the provision of long-term refill supplies of oral contraception to their qualifying patients. As a result, pharmacists will play a larger role in the communication and follow-up with those patients to identify potential issues, such as side effects, promoting long term patient care.
  • Pharmacists must be aware of prescription reader offerings, if a patient requests a device, including device types, and how to obtain.
  • Policies must be implemented to include the new requirements on controlled substance prescriptions, what the pharmacist can change during dispensing, and new prescribing limits for opioid prescriptions. Please refer to the CDC's conversion chart for MMEs, which can be found at CDC Opioid Conversion Chart.

For full regulatory language, refer to the Nevada Board of Pharmacy.

New Hampshire State Regulatory Update April 2019

New Hampshire Requirements to Upgrade from a Registered Pharmacy Technician to a Certified Pharmacy Technician

The New Hampshire Board of Pharmacy would like to remind pharmacy technicians and their pharmacists-in-charge (PICs) of the requirements for upgrading from a registered pharmacy technician to a certified pharmacy technician in New Hampshire.

Responsibilities of a PIC regarding Registered Pharmacy Technicians

A registered pharmacy technician who wishes to continue to practice as a registered pharmacy technician can continue to do so under current Board regulations. There is no requirement or administrative rule requiring a technician to move from a registered pharmacy technician to a certified pharmacy technician.

If you have a registered pharmacy technician who is currently studying and working toward becoming a certified pharmacy technician, the timeline to complete this process is one year from January 15, 2019, so it should be completed no later than January 15, 2020.

If you, as a PIC, wish for this person to practice as a certified pharmacy technician in New Hampshire under your supervision in your pharmacy/practice setting, then you and the technician need to complete the required steps to register then as a certified technician with the Board of Pharmacy.

As a PIC, please be certain that the correct designation is on each permit when the technician presents it to you. All permits should be presented to the PIC within 15 days of the technician receiving the permit.

A registered pharmacy technician cannot perform the duties of a certified pharmacy technician in New Hampshire without the correct designation (CPhT) after his or her name on the permit. The permit is required to be in hand before beginning to practice as a New Hampshire certified pharmacy technician.

The PIC is required to sign the application affirming that he or she will supervise the certified pharmacy technician in New Hampshire. If your PIC does not wish to have the technician practice in this capacity, then no action is needed.

Permits must always be posted or on file at the pharmacy.

Hormonal Contraceptives by Pharmacists

In 2018, RSA 318:47-1 was passed, which allows a prescriber to delegate limited prescriptive authority via a standing order so that a licensed pharmacist may dispense oral contraception. Any such prescription shall be regarded as being issued for a legitimate medical purpose in the usual course of professional practice. A standing order shall specify a mechanism for documenting the screening used by the pharmacist, placing the document in the patient's medical record, and including any plans for evaluating and treating adverse events.

Prior to prescribing and dispensing hormonal contraception under the law, a pharmacist shall complete an Accreditation Council for Pharmacy Education (ACPE)- accredited educational training program related to hormonal contraceptives. In addition to the educational requirement, a pharmacist shall comply with the most current United States Medical Eligibility Criteria for contraceptive use as adopted by the Centers for Disease Control and Prevention (CDC). A patient receiving oral hormonal contraception from a pharmacist shall be provided with a standardized information sheet written in plain language, which shall include, but is not limited to, the indication for usage, the importance of follow-up care, and health care referral information.

A statewide protocol has been developed and approved by the New Hampshire boards of medicine and nursing and by DHHS. Rules have been drafted and are expected to be reviewed by the Board at its April 2019 meeting. The goal is to have this program operational by fall 2019.

What does this mean for pharmacists practicing in the state of New Hampshire?

  • Pharmacists must ensure that all technicians that are considering national certification meet all requirements outlined by the state Board of Pharmacy. Pharmacists must also be aware of the tasks that certified and non-certified technicians can perform, and all technician registration designations reflect the capacity in which the pharmacy is using their technicians.
  • Pharmacists also now have hormonal contraception prescriptive authority. If a pharmacist chooses to provide this clinical service, they must meet all training and practice requirements outlined by the state BOP. Ensure that all SOPs and policies reflect these requirements.

New Hampshire State Regulatory Summary- November 2018

New NH Controlled Drug Loss Reporting Form

CDS Loss Reporting Form

The completed forms can be either mailed, faxed to 271-2856, or emailed to Pharmacy Compliance BOP NH

In order to ensure consistency in the reporting of all controlled drug losses and allow the Board to properly track them, this is now the only acceptable form for submitting controlled drug losses to the Board they will no longer accept the old paper DEA 106 forms or any other chain-specific reporting forms. Please note that this change in no way affects the reporting of controlled substance losses to the Federal Drug Enforcement Administration (DEA), which has its own reporting requirements.

Required PSE electronic tracking

In compliance with SB 376, this bill requires all pharmacies in New Hampshire that sell over the counter pseudoephedrine (PSE)/ephedrine (EPH) products to participate in NPLEx, which provides real time PSE electronic tracking in accordance with the Combat Methamphetamine Epidemic Act (CMEA). NPLEx is provided FREE of charge. Register your pharmacy by these steps:

  • Go to Apriss Website
  • If your pharmacy is not found, you can manually register
  • You will receive a confirmation email with instructions for account set up
  • Optional Scanner: Pharmacies interested in further enhancing their workflow have the option of purchasing scanners that will scan 2D Driver's License, product UPC, and capture signature. The State of Wisconsin does NOT require scanners.
  • Point-of-Sale Integration:
  • By integrating with the POS software, transactions can be submitted directly to NPLEx from your existing POS system instead of using the NPLEx retail web portal.
  • Please contact your POS vendor to see if this is an option for your pharmacy.
  • Don't Sell OTC PSE? If your store does NOT sell over the counter PSE products, please send an email to NHNPLEx@appriss.com stating your pharmacy name, DEA #, your name, and that you do not sell PSE over the counter.
  • All pharmacies must be fully compliant with the law by January 1, 2019.

What do these new regulations mean for pharmacists practicing within the state of New Hampshire?

  • All pharmacies must ensure that they discard all old controlled substance loss forms and include the new form into their standard operating procedure. All individuals responsible for reporting these losses must be properly trained on the new procedure/form. This is also a great opportunity to review the requirements for reporting CS losses.
  • All locations that sell PSE products must ensure compliance with the new reporting through NPLEx before January 1, 2019. Ensure that all standard operation procedures and training include this new process.

New Hampshire State Regulatory Summary- 2018

The following laws, summarized below, were enacted by the New Hampshire legislature during the 2018 session:

HB 1791 Disclosure of information pertaining to lower cost medications regarding biologics Effective January 1, 2019

  • A pharmacist may substitute a biological product only if it has been licensed by the federal Food and Drug Administration as an interchangeable biological product.
  • When a pharmacist dispenses an interchangeable biological product the pharmacist or his or her designee shall inform the patient.
  • A pharmacist shall not substitute an interchangeable biological product if the prescriber indicates that substitution is not authorized by specifying "medically necessary" on a paper prescription, or uses electronic indications, or gives instructions when transmitted orally.
  • Within 3 business days following dispensing, the dispensing pharmacist or the pharmacist's designee shall make an entry of the specific product provided to the patient, including the name of the product and the manufacturer.
  • Entry into an electronic records system as described in this paragraph is presumed to provide notice to the prescriber. Otherwise, the pharmacist shall communicate the biological product dispensed to the prescriber using facsimile, telephone, electronic transmission, or other prevailing means.

HB 1822 Pharmacist Dispensing of Oral Contraception Pursuant to Standing Order - Effective August 7, 2018

  • Licensed pharmacists following standing orders may dispense hormonal contraceptives to persons in this state without a prior prescription.
  • Prior to dispensing hormonal contraceptives under this section, a pharmacist shall complete an Accreditation Council for Pharmacy Education (ACPE) accredited educational training program related to hormonal contraceptives.
  • The pharmacist shall provide each recipient of hormonal contraceptives pursuant to this section with a standardized information sheet written in plain language, which shall include, but is not limited to;
  • the indication for the use of the hormonal contraceptive,
  • the importance of follow-up care,
  • health care referral information.

What do these new regulations mean for pharmacists practicing within the state of New Hampshire?

  • Pharmacists may, using the board of pharmacy FDA list of interchangeable biological products and their professional judgement, may provide an alternate product to a patient upon their request to provide cost effective alternatives that assists the patient in adherence and therapy outcomes.
  • The prescriber must allow for interchangeable products through the prescription. No DAW or non-substitution indicators must be present. The pharmacist must notify the prescribing physician of the change within three days of dispensing. This can be done electronically or by other means.
  • Pharmacists can also provide oral contraceptives to patients via a standing order after they have completed approved training outlined by the board of pharmacy; ensure that training is completed by all pharmacists and proof of training can be provided, and also be sure that standard operations procedures are in place to ensure that all required information is provided to the patient at time of dispensing and counseling.

For full regulatory language, refer to the New Hampshire Board of Pharmacy.

New Jersey State Regulatory Update April 2019

SB724 Vaccine Administration by Pharmacy Interns

Allows pharmacy interns and pharmacy externs to administer certain vaccines under direct supervision of pharmacist and requires reporting of certain vaccine administrations.

Adds allowance of a pharmacy intern or extern to administer vaccinations to a patient aged 7 and older, provided that they act under the direct supervision of a pharmacist who has been approved to administer vaccinations by the state of NJ, and that the supervising pharmacist reports all vaccinations administered by the intern/extern to the NJ immunization information system to be added to that patient's registry profile.

What does this mean to pharmacists practicing in the state of New Jersey?

  • Pharmacists can delegate the administration of immunizations to interns, as long as they directly supervise the administration, and that the pharmacist is certified and approved to provide immunizations in the stat of New Jersey.
  • The supervising pharmacist assumes the responsibility of all administration, and all recordkeeping of those immunizations given.

New Jersey State Regulatory Summary- 2018

No new laws were enacted to effect pharmacy practice by the New Jersey legislature during the 2018 session.

What do these new regulations mean for pharmacists practicing within the state of New Jersey?

For full regulatory language, refer to theNew Jersey Board of Pharmacy.

New Mexico State Regulatory Update April 2019

SB 415 / SB 394 Amends current regulations regarding Pharmacy Benefit Managers. Adds additional language around audits and recoupment allowances resulting from pharmacy audits.

SB188 Health Insurance Prior Authorization Act. Provides amended language around the expectations of insurers to provide reasonable turnaround for prior authorization requests from healthcare providers.

SB 221 Requires healthcare providers to provide adequate counseling to patients receiving prescriptions for opioid medications. Also requires those who prescribe more than 5 days of opioid medications to also prescribe an opioid antagonist.

What does this mean to pharmacists practicing in the state of New Mexico?

  • PBMs now have requirements around pharmacy audits, prior authorizations, and recoupments. Pharmacies should become familiar with this should an audit occur.
  • Any patient should receive counseling regarding the risk of opioid medications , and any patient receiving a prescription for more than 5 days of an opioid, an opioid antagonist must also be provided for that patient.

New Mexico State Regulatory Summary- 2017-18

The following laws, summarized below, were enacted by the New Mexico legislature during the 2017 session:

Amendments:

16.19.6 NMAC

Wording added to require Non-Resident Sterile Compounding Pharmacies, initially registering within New Mexico, to show compliance with USP within the past 12 months.

16.19.26 NMAC

Pharmacist Prescriptive Authority; Addition of Hormonal Contraception Drug Therapy to Pharmacist Prescriptive Authority.

16.19.33 NMAC

Tele-Pharmacy and Remote Dispensing- expansion, revision, clarification of the NMBOP Tele-Pharmacy Regulation. The remote telepharmacy must be greater than 20 miles from an existing retail pharmacy.

New Statutes:

House Bill (HB) 370 Opioid Overdose Education

Increase access to naloxone and provide opioid overdose education.

This will be done in three ways:

  • Opioid treatment centers that provide methadone or other narcotic treatment to patients will be required to also provide naloxone to patients and provide education on opioid overdose.
  • State and local law enforcement will be required to possess naloxone.
  • Inmates with a diagnosed substance abuse disorder will receive naloxone and opioid overdose education upon their release.

HB 260/Senate Bill 180 Regulation of Biosimilar Products

Allows pharmacists to substitute a "biosimilar" medicine for a "biological" medicine. The requirements are similar to when a generic drug is substituted for a brand name drug. This can only be done with biosimilar drugs approved by the Food and Drug Administration as interchangeable.

What do these new regulations mean for pharmacists practicing within the state of New Mexico?

  • All pharmacies performing sterile compounding as part of their services must show proof of conformation of USP requirements for the past 12 months before initially registering with the BOP, and ensure that recordkeeping accurately reflects this requirement.
  • Pharmacists can now provide oral contraceptives to patients as part of their prescriptive authority; ensure that standard operating procedures include proper training, patient assessment, and recordkeeping to provide safe conduct of this new service, in accordance to the regulation.
  • Telepharmacy services can only be provided if the location is more than 20 miles from an existing retail pharmacy; ensure that all investigation is completed, including this new mileage requirement, before launching telepharmacy services.
  • Pharmacists may, using the board of pharmacy FDA list of interchangeable biological products and their professional judgement, may provide an alternate product to a patient upon their request to provide cost effective alternatives that assists the patient in adherence and therapy outcomes. The prescriber must allow for interchangeable products through the prescription (no DAW or non-substitution indicators), and the pharmacist must notify the prescribing physician of the change within three days of dispensing. This can be done electronically or by other means.

For full regulatory language, refer to the New Mexico Board of Pharmacy.

New York State Regulatory Summary- 2018

The following laws, summarized below, were enacted by the New York legislature during the 2018 session, as reported by the Pharmacist Society of the State of New York:

PBM On-Site Audits - effective April 1, 2018

  • Pharmacies must be provided 15 days written notice, and audits cannot occur on the first three days of the month.
  • Invoice Audits can be requested for:
  • Prescription drugs
  • Other (e.g. DME, wound care, etc.)

PBM Contracts:

  • Gag clauses and clawbacks are prohibited.
  • Pharmacists can discuss price options with patients
  • Less expensive therapeutic equivalents can be offered
  • Alternatives to copays can be offered
  • Copay adjudicated cannot be higher than usual and customary price

Immunization Rule Changes - effective April 1, 2018

Pediatric Immunizations Influenza

  • Pharmacists may now immunize children aged 2-18 for flu.
  • Need standing order specifically for pediatric vaccination and treatment. This must be issued by a physician or nurse practitioner in your county or an adjacent county.
  • MUST report within 14 days of administration for 19 years old and younger.
  • No consent or opt out for reporting.
  • New York City report to Citywide Immunization Registry (CIR).
  • All others report to New York State Immunization Information System (NYSIIS).
  • Pharmacists are required to post informational materials provided by the Commissioners of Health and Education.

Adult Immunizations

  • Need non-patient specific standing order from a physician or nurse practitioner in your county or an adjacent county for each type of vaccine.
  • Requirement to report vaccination to patient's primary care provider.
  • Report to CIR or NYSISS for patients aged 19+ with patient consent.
  • Discuss patient cost of receiving the vaccine at the pharmacy, but also option to receive vaccine from PCP, and to have a PCP.
  • Post the most current ACIP recommended adult immunization schedule.
  • All vaccines administered via non-patient specific order must follow ACIP guidelines.
  • All non-patient specific standing orders must include orders for medications required for emergency treatment of anaphylaxis.
  • Pharmacy interns are not permitted to vaccinate.

What do these new regulations mean for pharmacists practicing within the state of New York?

  • PBMs now have clear guidelines on how invoice audits shall be conducted, minimizing patient care impact and provides clear timelines to audit process.
  • Pharmacists can now explain how 90-day cash price might be cost effective to the patient.
  • Pharmacist MUST get a new prescription to change the quantity dispensed on an Rx. Section 6816 of article 137 of NY State Education Law prohibits filling the prescription for "a greater or lesser quantity of any ingredient specified in any such prescription."
  • Pharmacists can now immunize pediatric patients for influenza, and ensure that all standard operating procedures include non-patient specific standing orders for pediatric influenza and emergency treatment options. All pharmacists' training must include pediatric CPR. Proper reporting to PCP and state registry applies.

For full regulatory language, refer to the New York Board of Pharmacy.

North Carolina State Regulatory Update April 2019

Item 2386 New Board Rules Effective March 1, 2019. Pharmacist-managers for multi-locations

Amendment to Rule 21 NCAC 46.2502 adds a new exception to the general rule that a pharmacist may only serve as pharmacist-manager at one pharmacy. A pharmacist may serve simultaneously as pharmacist-manager at two full-service pharmacies if one of the two is a newly permitted pharmacy that has not yet begun providing pharmacy services to patients. The pharmacist-manager may serve in this dual capacity until the newly permitted pharmacy begins providing pharmacy services to patients or six months from the issuance of the new pharmacy permit, whichever comes first. At that point, the pharmacist must relinquish the earlier pharmacist-manager position and may only serve as pharmacist-manager at the newly permitted pharmacy.

What does this mean for pharmacists practicing in the state of North Carolina?

  • Pharmacists can only be the pharmacist in charge at two locations if one location has not begun providing services to patients. All pharmacy leaders must ensure that they are not listing a pharmacist as the PIC at multiple active locations; all pharmacists must be aware of what locations they are listed as PIC and ensure that they are within the law to be listed as such.

North Carolina State Regulatory Summary- 2018

The following laws, summarized below, were enacted by the North Carolina legislature during the 2018 session:

Rule 21 NCAC 46.2201-Continuing education requirements for pharmacist license renewal effective January 1, 2018

  • Fifteen (15) total hours required for renewal of pharmacy license.
  • Five (5) "live" CE hours required.
  • CE must fall into one of the following categories: (1) ACPE-accredited courses; (2) North Carolina Association of Pharmacists (NCAP)-accredited courses; (3) Precepting students enrolled in an approved college of pharmacy for at least 160 hours.
  • Course titles and accreditation numbers are not required. The new rule specifies that if an approved accreditor keeps an electronic database of all pharmacists granted CE, the pharmacist's recordkeeping requirement is met.
  • The five-hour carry-over option ends effective January 1, 2018. For 2019 renewals and going forward, all 15 hours must be completed within that calendar year only.

What do these new regulations mean for pharmacists practicing within the state of North Carolina?

  • All pharmacists must be aware of the new CE requirements and ensure that their CE meets them to apply for their license renewals beginning in 2018. Failure to do so could result in an inability to practice pharmacy within the state of North Carolina.

For full regulatory language, refer to the North Carolina Board of Pharmacy.

North Dakota State Regulatory Update April 2019

ND223 Pharmacists Limited Prescriptive Practices

Amends language to current regulation to include Collaborative Practice Agreement guidance and removes the four year update requirement for established protocols and CPAs.

What does this mean for pharmacists practicing in the state of North Dakota?

  • Pharmacists engaged in CPA activity may remove the update verbiage from their established protocol and CPA, given that the collaborating physician agrees. All pharmacists should still complete a regular review process to ensure that the most current clinical recommendations are used.

North Dakota State Regulatory Summary- 2017

The following laws were enacted to effect pharmacy practice by the North Dakota legislature during the 2017 session:

SB 2258 - PBM Prohibition of Gag Orders and Billing Practices

  • A pharmacy benefits manager or third-party payer may not charge or hold a pharmacy responsible for a fee related to a claim that is not apparent at the time of claim processing.
  • A pharmacy or pharmacist may provide relevant information to a patient, including the cost and clinical efficacy of a more affordable alternative drug if one is available. Gag orders placed on a pharmacy or pharmacist are prohibited.
  • A pharmacy may mail or deliver drugs to a patient as an ancillary service of a pharmacy.
  • A pharmacy benefits manager or third-party payer may not prohibit a pharmacy from charging a shipping and handling fee to a patient requesting a prescription be mailed or delivered.

SB 2301 - Specialty pharmacy services and patient access to pharmaceuticals

"Specialty drug" means a prescription drug that:

  • Is not available for order or purchase by a retail community pharmacy and long-term care pharmacy, regardless of whether the drug is meant to be self-administered; and
  • Requires special storage and has distribution or inventory limitations not available at a retail community pharmacy or long-term care pharmacy.

A pharmacy benefits manager or third-party payer may not require pharmacy accreditation standards or recertification requirements to participate in a network which are inconsistent with, more stringent than, or in addition to the federal and state requirements for licensure as a pharmacy in this state.

A licensed pharmacy or pharmacist may dispense all drugs allowed under that license.

Update to ND 1099 Addition of Gabapentin to list of controlled substances.

What do these new regulations mean for pharmacists practicing within the state of North Dakota?

  • Pharmacists will have more visibility to billing of medications for patients and cannot be held liable for after-dispensing charges; pharmacists can also provide additional services, such as delivery or mailing services and charge for those services.
  • Pharmacies can be charged fees from the PBM based on nationally recognized quality measures, but those measures must be outlined in the contract, must only be added to the dispensing fee to the pharmacy, and not the COGS.
  • A pharmacist can provide information to the patient regarding cost-effective alternatives, such as lower cost generics, cash costs, or 90-day supply options, without penalty from the PBM. This can provide potential adherence and health outcomes improvement and standard of care for the patient.
  • Pharmacy PBMs must provide visibility to reimbursement for specialty drugs and allow pharmacy establishments to dispense all drugs that are allowed under that pharmacy license, including specialty drugs. Access may not be limited for patients.
  • Pharmacists must revise standard operating procedures and treat Gabapentin the same as all other controlled substances in their pharmacy regarding dispensing, recordkeeping and inventory requirements. Train all employees accordingly.

For full regulatory language, refer to the North Dakota Board of Pharmacy.

Ohio State Regulatory Update April 2019

Continuing Education Requirements

Effective September 16, 2018, OAC 4729:1-5-02 updates the required minimum continuing education units (CEUs) pharmacists are required to obtain and aligns the reporting period to the biennial renewal cycle. Specifically, pharmacists are required to obtain a minimum of 4 CEUs (40 hours) every two years prior to license renewal.

Reporting Suspected Elder Abuse

Effective September 29, 2018, Ohio Revised Code (ORC) 5101.63 will significantly expand the list of individuals mandated to report suspected elder abuse in Ohio. The new individuals mandated to report suspected elder abuse in Ohio will now include pharmacists. To support these individuals in their new responsibilities, the Ohio Department of Job and Family Services developed training materials specifically for medical professionals on identifying and reporting elder abuse, and a general guide for Ohioans.

Operation of the Ohio Automated Rx Reporting System (OARRS)

4729:8-2-02: Specifies that naltrexone must only be reported by dispensing pharmacies.

4729:8-1-01 Ohio Automated Rx Reporting System - Definitions. 3/15/2019

4729:8-2-01 List of drugs to be reported. 3/15/2019

4729:8-2-02 Additional drugs to be reported. 3/15/2019

4729:8-3-01 Entities required to submit information. 3/15/2019

Rules Update Drug Distributors - Spring 2019

4729:6-1-01 Definitions. 3/1/2019

4729:6-2-01 Responsible person - drug distributor. 3/1/2019

4729:6-2-02 Distributor of dangerous drugs licensing and renewal. 3/1/2019

4729:6-2-03 Criminal records checks. 3/1/2019

4729:6-2-04 Drug distributor applications. 3/1/2019

4729:6-2-05 Change in description of a distributor of dangerous drugs. 3/1/2019

4729:6-2-06 Procedure for discontinuing business as a distributor of dangerous drugs. 3/1/2019

Rules Update Terminal Distributors Spring 2019

4729:5-1-01 Definitions. 3/1/2019

4729:5-2-01 Responsible person - terminal distributor. 3/1/2019

4729:5-2-02 Terminal distributor of dangerous drugs licensing and renewal. 4/1/2018

4729:5-2-03 Change in description of a terminal distributor of dangerous drugs. 3/1/2019

4729:5-2-04 Procedure for discontinuing business as a terminal distributor of dangerous drugs. 3/1/2019

4729:5-3-01 Disposal of controlled substances. 3/1/2019

4729:5-3-04 Verification of licensure prior to sale or purchase. 3/1/2019

4729:5-3-06 Storage of adulterated drugs. 3/1/2019

4729:5-3-07 Controlled substances inventory requirements. 3/1/2019

4729:5-3-08 Sales of dangerous drugs on-line. 3/1/2019

4729:5-3-09 Occasional sale and drug transfers. 3/1/2019

4729:5-3-10 Employment of individuals with felony convictions. 3/1/2019

4729:5-4-01 Disciplinary actions. 3/1/2019

4729:5-8-01 Definitions - Nonresident terminal distributors. 3/1/2019

4729:5-8-02 Licensure - Nonresident terminal distributors. 3/1/2019

4729:5-8-03 Compliance - Nonresident terminal distributors. 3/1/2019

What does this mean to pharmacists practicing in the state of Ohio?

  • Pharmacists must ensure that they meet the new continuing education requirements for license renewals.
  • Pharmacists must report any cases of suspected elder abuse to the proper authorities. Ensure that all pharmacists on staff are aware of this new requirement and how to report suspected elder abuse.
  • Several rules have been updated regarding OARRS reporting, drug distributers, and terminal distributers. All pharmacists engaged in these areas of pharmacy practice must ensure that their SOPs and policies reflect these changes, and all staff is properly trained in these new regulations.

Ohio State Regulatory Summary- 2018

The following laws, summarized below, were enacted by the Ohio legislature during the 2018 session:

4729-5-30.1 Diagnosis or Procedure Code effective March 1, 2018

All pharmacy computer systems receiving electronic controlled substance prescriptions shall have the capability to receive an ICD-10-CM medical diagnosis code.

4729-11-02 Schedule I controlled substances effective February 19, 2018

Etizolam is now a schedule I controlled substance depressant.

4729-17-11 Hospital self-service employee prescription kiosks effective June 1, 2018

"Self-service employee prescription kiosk" or "kiosk" means a self-service kiosk for the pickup of new or refill prescriptions only for hospital employees and their family members.

A self-service employee prescription kiosk shall meet all security requirements.

A kiosk shall not provide any refrigerated or hazardous drugs.

All kiosks shall be continuously monitored.

What do these new regulations mean for pharmacists practicing within the state of Ohio?

  • Pharmacists must be able to identify and record an ICD-10-CM diagnosis code for any prescription written for a controlled substance transmitted by electronic prescription. Ensure that software and procedures include this task.
  • Understand the procedures and regulations around prescription dispensing kiosks if your pharmacy uses or plans to use one as part of offered services.
  • Ensure that proper placement and security is maintained, as well as proper inventory control and recordkeeping of dispensed and non-dispensed products per state regulatory requirements; all staff is trained in these rules.

For full regulatory language, refer to the Ohio Board of Pharmacy.

Ohio State Regulatory Update April 2019

Senate Bill 1446: Immediate Release Opioids

SB 1446 applies only to immediate release opioids prescribed for acute pain and includes tramadol and codeine products. Buprenorphine is not included in this law. Diagnosis for "acute vs chronic" pain is not required on the prescription; however, insurance policies or company policies may require it. Pharmacists may ask the patient, check the prescription monitoring program, check the patient profile, or contact the prescriber to verify if the prescription is for "acute vs chronic" pain. Pharmacists are not required to verify acute pain diagnosis and will need to utilize their professional judgment.

The initial prescription for an acute pain event can be issued for a seven-day supply to be determined by the prescriber.

If a second prescription is needed, then the prescriber, after consultation with the patient, can issue another prescription for a seven-day supply.

If a third prescription is needed, there must be a written agreement, pain management agreement, or pain management contract in place between the prescriber and the patient. Pharmacists are not required to make sure this contract is in place. However, this information may be requested during the counseling and verification process.

If the patient is on chronic pain medication and has an acute event, then the pharmacist will carefully evaluate the impact of adding an immediate release opioid to the patient's therapy.

475:30-1-4. Manner of issuance of prescriptions

A practitioner must state on a written prescription for any controlled dangerous substance the name, address and DEA registration number of the practitioner; the date of delivery of the prescription; the name, dosage and strength per dosage unit of the controlled dangerous substance;

the name and address of the patient, or if it is a veterinary prescription, the species of the animal and the name and address of the owner;

the directions for use and any cautionary statements required; and

if allowable, the number of times to be refilled.

The face of a prescription must not be materially altered; if an error is made in filling out the prescription, a new prescription must be written by the prescribing practitioner. A pharmacist may add to the prescription the patient's address or age, the prescribing practitioner's federal DEA number, or the generic drug name if used.

After confirming with the prescribing practitioner, the pharmacist may add information indicating the strength, whether tablet or capsule form, and whether it is compounded if such additions would not materially alter the prescription.

If omitted, the directions (Sig) or the quantity, may be added by the pharmacist after confirming with the prescribing practitioner.

Documentation of contacting the prescribing practitioner will be noted on the back of the prescription regarding the items above.

A written prescription for a controlled dangerous substance in Schedule II becomes invalid thirty (30) days after the date of issuance, with day one (1) of the thirty (30) day period being the first day after the date of issuance.

After issuing an initial prescription pursuant to Section 2-309I of Title 63, an individual practitioner may issue one (1) subsequent prescription for an immediate-release opioid drug in Schedule II in a quantity not to exceed seven (7) days if the subsequent prescription is due to a major surgical procedure and/or "confined to home" status as; the practitioner provides the subsequent prescription on the same day as the initial prescription; the practitioner provides written instruction on the subsequent prescription indicating the earliest date on which the prescription may be filled (i.e. "do not fill until" date); and the subsequent prescription is dispensed no more than five (5) days after the "do not fill until" date indicated on the prescription.

Each scheduled drug shall be written on a single prescription form, and no other prescriptions (controlled or non-controlled) shall be written on the same prescription form.

19.03 Out-of-State Mid-Level Practitioners

Pharmacies can now fill non-controlled dangerous substance (CDS) prescriptions from out-of-state optometrists, physician assistants, and advanced practice registered nurses. For pharmacies to fill CDS prescriptions from out-of-state optometrists, the optometrist needs to be licensed in Oklahoma. For pharmacies to fill CDS prescriptions from out-of-state physician assistants and advanced practice registered nurses, they need to be licensed in Oklahoma and supervised by an Oklahoma licensed physician.

This law became effective on November 1, 2018

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What does this mean for pharmacists practicing in the state of Oklahoma?

  • Pharmacists must be aware of all requirements around the prescribing and dispensing of controlled substance/opioid medications and ensure that all staff are also trained in these requirements. Proper documentation of all changes and additions allowed by regulation must follow the above guidance. While pharmacists are not required by law to regulate prescriber requirements, strong professional judgement is required to ensure patient safety in all circumstances.
  • Pharmacists must also be aware of the regulations for out of state prescribers. Proper validation of out of state prescriber registration is required for proper and legal dispensing of mediations. Ensure that all staff are properly trained to avoid potential delays in patient therapy.

Oklahoma State Regulatory Summary- November 2018

SB 1446: Regulation of opioid drugs; providing limitations on quantities of certain prescriptions.

475:30-1-4. Manner of issuance of prescriptions

  • A written prescription for a controlled dangerous substance in Schedule II becomes invalid thirty (30) days after the date of issuance, with day one (1) of the thirty (30) day period being the first day after the date of issuance.
  • After issuing an initial prescription pursuant to Section 2-309I of Title 63, an individual practitioner may issue one (1) subsequent prescription for an immediate-release opioid drug in Schedule II in a quantity not to exceed seven (7) days if:
  • The subsequent prescription is due to a major surgical procedure and/or "confined to home" status as defined in 42 U.S.C. 1395n(a);
  • The practitioner provides the subsequent prescription on the same day as the initial prescription;
  • The practitioner provides written instruction on the subsequent prescription indicating the earliest date on which the prescription may be filled (i.e. "do not fill until" date); and,
  • The subsequent prescription is dispensed no more than five (5) days after the "do not fill until" date indicated on the prescription.

What do these new regulations mean for pharmacists practicing within the state of Oklahoma?

Pharmacists must be informed of these new dispensing requirements on schedule II-controlled substances containing opioids. They must also ensure that all staff are aware, to maintain compliance with the law and also provide education to their patients.

Oklahoma State Regulatory Summary- 2017

The below laws, summarized below, were enacted by the Oklahoma legislature during the 2017 session. All were effective September 11, 2017.

Chapter 1:Administrative Operations

Changes related to hearings made to current regulation.

Chapter 15:Pharmacies

  • Amended responsibilities to include pharmacist in charge duties, automated dispensing systems, and identification badge requirements for staff.
  • Hospital pharmacy duties amended to include remote order processing rules, emergency dispensing, and pre-packing of medication.
  • Non-sterile compounding rules amended to include guidance for bulk compounding and OTC products; compounding for physicians' offices has been revoked.
  • Amendments made to provide additional guidance provided around supportive personnel duties.
  • New and updated guidance provided for nuclear pharmacy.

Chapter 20:Manufacturers, Repackagers, Outsourcing Facilities, Wholesalers, Third-Party Logistics Providers, and Medical Gas Suppliers and Distributors

  • Establishes guidance regarding personnel criteria at outsourcing facilities

Chapter 25:Rules Affecting Various Registrants

  • Defines an incorrect medication fill as a violation of registrant conduct.

What do these new regulations mean for pharmacists practicing within the state of Oklahoma?

  • Pharmacists must have a good understanding of how these new rules and amendments affect their area of practice, if applicable.
  • Special attention must be made to support staff limitations of duties and review current policies and standard operating procedures to ensure that they align with the most current rules.

For full regulatory language, refer to the Oklahoma Board of Pharmacy.

Oregon State Regulatory Summary- Nov 2018

HB 2397-Pharmacist Authority to Prescribe via Formulary and Protocol Compendia

ORS 689.025 General Responsibilities of a Pharmacist

General responsibilities of a pharmacist now include statutory authority to prescribe certain drugs and devices.

ORS 689.005. Prescribing Practices

These rules describe the Board's compliance expectations for prescribing from the formulary. These rules establish a pharmacist's authority to prescribe drugs and devices, and via protocols recommended by the Committee and adopted to the Board's Compendia. They contemplate this authority for an Oregon licensed pharmacist, practicing in Oregon and the patient assessment must be performed via a face-to-face, in-person interaction. Recognize that participation in prescribing authorities is voluntary, and only a pharmacist is entitled to practice pharmacy, pursuant to ORS 689.005.

ORS 689.205 Prescribing Prohibited Practices

This rule describes the Board's compliance expectations for prescribing from the Compendia.

ORS 689.205 Formulary Compendium

These rules establish a pharmacist's authority to prescribe drugs and devices via protocols recommended by the Formulary Advisory Committee. These rules create the Formulary Compendia, per recommendations of the Committee.

ORS 689.205 Protocol Compendium

These rules establish a pharmacist's authority to prescribe drugs and devices via protocols recommended by the Formulary Advisory Committee. These rules create the Protocol Compendia, per recommendations of the Committee.

ORS 689.205 Drug Outlet Procedures

This amendment adds the policy and procedure documentation requirements for a pharmacy drug outlet offering prescribing services.

What do these new regulations mean for pharmacists practicing within the state of Oregon?

The new regulations allow pharmacists an expanded ability to prescribe medication and DME for therapy and treatment, using a protocol or formulary. Ensure that all current standard operating procedures and training include these new duties.

Oregon State Regulatory Summary- 2018

No new legislation was passed directly effecting pharmacy practice in 2018

What do these new regulations mean for pharmacists practicing within the state of Oregon?

For full regulatory language, refer to the Oregon Board of Pharmacy.

Pennsylvania State Regulatory Updates- 2018

The pharmacy practice law excerpted below was enacted by the Pennsylvania legislature during the 2018 session.

Section 515.1 Medication synchronization.

The program shall permit and apply a prorated daily cost-sharing rate fee to prescription drugs that are dispensed by a pharmacy for less than a 30 days' supply if the pharmacist or prescriber determines the fill or refill to be in the best interest of the program participant and the program participant requests or agrees to less than a 30 days' supply for medication synchronization. The program must not incorporate prorated dispensing fees.

Full Payment. The dispensing fees for a partial supply or refilled prescription shall be paid in full for each maintenance medication dispensed, regardless of any prorated copay for the patient.

Partial Supply. The program may not deny coverage for the dispensing of a maintenance medication by a network pharmacy on the basis that the dispensing is for a partial supply of the prescriber or pharmacist determines the fill or refills is in the best interest of the patient and the patient requests or agrees to a partial supply for medication synchronization.

Annual Limitation. The fill or refill under this section shall be limited to three times a year for each maintenance medication for a covered individual. For each clinically necessary synchronization thereafter, approval may be required at the discretion of the program.

Override of denial codes. The program shall allow a pharmacy to override any denial codes indicating that a prescription drug is being refilled too soon for the purposes of medication synchronization.

Exemption. This section does not apply to prescription drugs that are either: unit of use packaging for which medication synchronization is not possible; or for controlled substances classified in schedule II under the Controlled Substance, Drug, Device, and Cosmetic Act.

HB 353 Further providing for definitions and for professional prescription, administration, and dispensing.

Amends terminology in the Controlled Substance, Drug, Device and Cosmetic Act to include electronic prescribing requirements, electronic medical records and other new technology advancements.

SB542 Further defining unlawful acts concerning emergency prescriptions.

Section 8. Unlawful Acts. It shall be unlawful for any pharmacist to dispense an emergency prescription, unless:

  • The pharmacist first attempts to obtain an authorization from the authorized prescriber and cannot obtain the authorization.
  • The drug which is the subject of the refill is not a controlled dangerous substance.
  • The drug which is the subject of the refill is essential to the maintenance of life.
  • The drug which is the subject of the refill is essential to the continuation of therapy in chronic conditions, and, in the pharmacist's professional judgment, the interruption of the therapy reasonably might produce an undesirable health consequence, be detrimental to the patient's welfare or cause physical or mental discomfort.

The pharmacist enters on the back of the prescription or on another appropriate, uniformly maintained and readily retrievable record, the date and quantity of the refill, and, in addition, the pharmacist signs the refill.

The pharmacist provides only one refill of the prescription and the quantity of that refill is in conformity with the prescribed directions for use but limited to a seventy-two-hour emergency supply. IF THE PRESCRIPTION IS NOT DISPENSED OR SOLD IN A SEVENTY-TWO HOUR SUPPLY, AN AMOUNT NOT TO EXCEED A THIRTY-DAY EMERGENCY SUPPLY MAY BE DISPENSED OR SOLD.

Within seventy-two hours of dispensing the refill, the pharmacist notifies the prescriber that an emergency prescription has been dispensed.

What do these new regulations mean for pharmacists practicing within the state of Pennsylvania?

  • Pharmacists can offer medication synchronization to patients without risking dispensing fees or penalties from payers, allowing for improved medication adherence and better patient health outcomes.
  • Pharmacists can also provide emergency prescriptions to patients on qualifying medications, avoiding therapy interruption in their patients.

The following regulations were enacted by the Pennsylvania legislature during the 2018 session.

Regulation Summary

Pharmacists can provide one emergency refill of a medication, not to exceed a 72 hour supply, in the event that the prescriber cannot be reached for authorization of additional refills. If the medication is only provided in a unit of use container (such as inhalers), an amount not to exceed a 30-days supply can be dispensed.

What do these new regulations mean for pharmacists practicing within the state of Pennsylvania?

Pharmacists may provide an emergency supply of medication based on professional judgement but is only allowed to provide up to a 72-hour supply, unless that medication can only be dispensed in a full 30 day supply unit. This amendment allows pharmacists to ensure that interruptions of critical therapy does not occur for their patients.

More information

For more details, refer to the Pennsylvania Pharmacists Association and the Pennsylvania Board of Pharmacy.

>> Read Full Summary

Rhode Island State Regulatory Summary- Nov 2018

SB 2534/HB 7723 Amendment to Uniform Controlled Substances Act

Prescriptions in schedule III cannot be written for more than one hundred (100) dosage units and not more than one hundred (100) dosage units may be dispensed at one time. Provided, however, manufacturer prepackaged steroids and hormones in Schedule III shall be exempt from this subsection.

HB 7416

5-19.1-33. Partial fill of Schedule II controlled substance.

  • A pharmacist may dispense a Schedule II controlled substance as a partial fill if requested by the patient or the prescriber.
  • If a pharmacist dispenses a partial fill on a prescription pursuant to this section, the pharmacy shall retain the original prescription, with a notation of how much of the prescription has been filled, until the prescription has been fully dispensed. The total quantity dispensed shall not exceed the total quantity prescribed.
  • Subsequent fills, until the original prescription is completely dispensed, shall occur at the pharmacy where the original prescription was partially filled.
  • The full prescription shall be dispensed not more than thirty (30) days after the date on which the prescription was written.
  • Thirty-one (31) days after the date on which the prescription was written, the prescription shall expire and no more of the drug shall be dispensed without a subsequent prescription. The pharmacist shall record in the prescription-drug-monitoring-program only the actual amounts of the drug dispensed.

What do these new regulations mean for pharmacists practicing within the state of Rhode Island?

  • Pharmacists may provide steroids per a written prescription that exceed 100 days supply, if the medication comes in a manufacturer prepackaged form that does not allow them to break the package. This will allow pharmacists to provide improved patient care without a delay in therapy.
  • Pharmacists can now provide partial fills on a prescription, which may provide better patient care and therapy adherence.

Rhode Island State Regulatory Summary- 2018

The following law, summarized below, was enacted by the Rhode Island legislature during the 2018 session.

SB 2534/HB 7723 Amendment to Uniform Controlled Substances Act

Prescriptions in schedule III cannot be written for more than one hundred (100) dosage units and not more than one hundred (100) dosage units may be dispensed at one time. Provided, however, manufacturer prepackaged steroids and hormones in Schedule III shall be exempt from this subsection.

What do these new regulations mean for pharmacists practicing within the state of Rhode Island?

  • Pharmacists may provide steroids per a written prescription that exceed 100 days supply, if the medication comes in a manufacturer prepackaged form that does not allow them to break the package. This will allow pharmacists to provide improved patient care without a delay in therapy.

For full regulatory language, refer to the Rhode Island Board of Pharmacy.

South Carolina State Regulatory Summary- 2018

The following laws, summarized below, were enacted by the South Carolina legislature during the 2018 session.

HB 5038 To Amend Duties of a Pharmacy Benefit Manager, so as to establish prohibited acts for a Pharmacy Benefit -Effective immediately

A pharmacy benefit manager may not:

  • prohibit a pharmacist or pharmacy from providing an insured information on the amount of the insured's cost share for a prescription drug. A pharmacist or pharmacy may not be penalized by a pharmacy benefit manager for discussing such information to an insured or for selling a more affordable alternative to the insured if one is available;
  • prohibit a pharmacist or pharmacy from offering and providing direct and limited delivery services to an insured as an ancillary service of the pharmacy.

HB 3438 -To Amend SECTION 39-24 of the Drug Product Selection Act, to include interchangable biological - Effective immediately

  • Upon receiving a prescription for a specific biological product, a registered pharmacist may substitute an interchangeable biological product.
  • Substitution may not occur unless the pharmacist advises the patient that the practitioner has authorized substitution and the patient consents.
  • Within five business days following the dispensing of a biological product, the dispensing pharmacist or the pharmacist's designee shall make an entry into an electronic records system, which is presumed to provide notice to the prescriber. Otherwise, the pharmacist shall communicate the biological product dispensed to the prescriber using facsimile, telephone, electronic transmission, or other prevailing means.

HB 3926 TO AMEND SECTION 40-43-30 Relating to compounding pharmacies effective immediately

  • Provides a pharmacist with a final check on preparations compounded by a pharmacy technician,
  • Refines the requirements for an area used for compounding in a pharmacy, and
  • Establishes a means for determining the maximum beyond-use date for an excess amount of a specific compound in certain circumstances.

What do these new regulations mean for pharmacists practicing within the state of South Carolina?

  • Pharmacists can play a larger role in patient adherence to their medication regimen through cost savings solutions, ensuring the most affordable therapy for their patients.
  • Pharmacists can also positively affect adherence through 90-day dispensing conversions, allowing the patient to save time and money, and ensuring that they have needed medication on hand.
  • Pharmacists may, using the board of pharmacy's FDA list of interchangeable biological products and their professional judgment, may provide an alternate product to a patient upon their request to provide cost effective alternatives that assists the patient in adherence and therapy outcomes.
  • The prescriber must allow for interchangeable products through the prescription (no DAW or non-substitution indicators), and the pharmacist must notify the prescribing physician of the change within five days of dispensing.
  • This can be done electronically or other means.
  • Pharmacists can now feel more confident in providing compounding services as a result of more clarity in regulatory guidance.
  • All pharmacists participating in sterile and non-sterile compounding must review the new regulations and ensure that all policies and standard operating procedures include the new guidance; all staff must be re-trained.

For full regulatory language, refer to the South Carolina Board of Pharmacy.

South Dakota State Regulatory Update April 2019

ARSD 20:51:32, 20:51:33, 20:51:34, 20:67 changes were approved by the Board and by the Interim Legislative Research Council on November 20, 2018. Effective on December 20, 2018.

These rules provide clarification regarding prescription drug monitoring program (PDMP) reporting and wholesale and other drug distributors licensing.

ARSD 20:51:33 and 20:51:34 provide a mechanism for managing complaints and discipline for licensees or registrants.

House Bill 1137 was signed into law on March 7, 2019.

Section 1. Prevents pharmacy benefit manager (PBM) claw backs.

No pharmacy benefit manager shall contractually require a pharmacy to charge or collect from an insured a cost share for a prescription or pharmacy service that exceeds the amount retained by the pharmacist or pharmacy from all payment sources for the filling of the prescription or providing the pharmacy service.

Section 2 and 3. Preventing retroactive direct and indirect remuneration (DIR) fees

No pharmacy benefit manager shall retroactively adjust a claim for reimbursement submitted by a pharmacy for a prescription drug unless the adjustment is a result of either a pharmacy audit or technical billing error.

Section 4. Establishes 340B Drug Discount Program protections.

No pharmacy benefit manager may discriminate against a pharmacy participating in a health plan as an entity authorized to participate under section 340B of the Public Health Service Act, as amended to January 1, 2019, or any pharmacy under contract with such an entity to provide prescriptions.

What does this mean for pharmacists practicing in the state of South Dakota?

  • Pharmacists must be familiar with reporting requirements to the state PDMP and ensure that they are practicing within the guidance of this regulation.
  • Pharmacists must be aware of their rights regarding insurer billing for claims; clawbacks are not allowed, but PBMs can retroactively adjust a claim for reimbursement if it's a result of a pharmacy audit or technical billing error. Ensure that recordkeeping and billing procedures are accurate, and staff are properly trained in prescription billing activities.
  • If a pharmacist or pharmacy participates in a 340B program, they should be familiar with the protections provided to them.

South Dakota State Regulatory Summary- 2018

The following laws, summarized below, were enacted by the South Dakota legislature during the 2018 session.

SB 32 - Places certain substances on the controlled substances schedule and to declare an emergency; effective immediately.

SB 62 - Provide for the notification related to a breach of certain data and to provide a penalty; effective immediately.

SB 63 - Revises certain prohibitions regarding methamphetamines and to create a mandatory penalty; effective immediately.

SB 75 - Establishes certain provisions regarding the dispensing of biological products; effective immediately.

  • No pharmacy may dispense an equivalent drug product or an interchangeable biological product if a brand name has been prescribed without informing the patient of the selection and the right to refuse the product selected either by telephone or in writing.
  • A practitioner may prohibit a pharmacist from selecting an equivalent drug product or interchangeable biological product by handwriting on the prescription drug order the words brand necessary, or words of similar meaning.
  • A pharmacist dispensing a prescription drug order for a biological product prescribed by its brand or proper name may select an interchangeable biological product of the prescribed product.
  • Within five business days following the dispensing of a biological product, the dispensing pharmacist or the pharmacist's designee shall make an entry of the specific product provided to the patient, including the name of the product and the manufacturer.
  • Any entry into an electronic records system is presumed to provide notice to the practitioner.

SB 141 - Establishes certain provisions regarding pharmacy benefits management; effective immediately.

The following acts or practices by a pharmacy benefits manager are declared to be false, misleading, deceptive, or unfair:

  • Penalizing a pharmacist or pharmacy for providing cost-sharing information on the amount that a covered individual may pay for a prescription drug by a pharmacist or pharmacy.

What do these new regulations mean for pharmacists practicing within the state of South Dakota?

  • Pharmacists should make themselves aware of the methamphetamine guidelines for dispensing; specifically, the maximum limits for methamphetamine precursors.
  • Pharmacists should review the regulations around the security and accidental sharing of protected information, specifically that information collected as part of the routine pharmacy business.
  • Ensure that all employees are protecting this information and that policies are in place to reflect these new requirements.
  • Pharmacists may, using the board of pharmacy FDA list of interchangeable biological products and their professional judgment, may provide an alternate product to a patient upon their request to provide cost effective alternatives that assists the patient in adherence and therapy outcomes.
  • The prescriber must allow for interchangeable products through the prescription (no DAW or non-substitution indicators), and the pharmacist must notify the prescribing physician of the change within five days of dispensing. This can be done electronically or other means.
  • Pharmacists can play a larger role in patient adherence to their medication regimen through cost savings solutions, ensuring the most affordable therapy for their patients.
  • Pharmacists can also positively affect adherence through 90-day dispensing conversions, allowing the patient to save time and money, and ensuring that they have needed medication on hand.

For full regulatory language, refer to the South Dakota Board of Pharmacy.

Tennessee State Regulatory Update April 2019

SB870 Concerning Scheduled Controlled Substances

SECTION 3. Tennessee Code Annotated, Section 63-1-160. By January 1, 2020, all pharmacy dispensing software vendors operating in this state shall update their dispensing software systems to allow for partial filling of controlled substances pursuant to this section and submit documentation of compliance to the board of pharmacy. The board of pharmacy is authorized to act against pharmacy dispensing software vendors for non-compliance with this section. Any pharmacist acting in good faith and with reasonable care in the partial filling of controlled substances is immune from disciplinary or other adverse administrative actions if the pharmacy dispensing software system at the pharmacy at which they dispense is not compliant with this section. Nothing in this section conflicts with or supersedes federal law or drug enforcement administration rules authorizing partial dispensing or partial filling of Schedule II prescriptions for terminally ill or long-term care facility patients, or for partial fill of Schedules III-V controlled substances.

SECTION 10. Tennessee Code Annotated, 63-1-164(b). Except as provided in this section, a healthcare practitioner shall not treat a patient with more than a three-day supply of an opioid and shall not treat a patient with an opioid dosage that exceeds a total of one hundred eighty (180) morphine milligram equivalent dose. A healthcare practitioner shall not be required to include an ICD-10 code on any prescription for an opioid of a three-day supply or less and an opioid dosage of less than one hundred eighty (180) morphine milligram equivalent.

SECTION 11. Tennessee Code Annotated, Section 63-1-164(c). A healthcare practitioner may authorize the prescription to be dispensed by partial fill by placing "partial fill" or "PF" on the prescription.

SECTION 15. Tennessee Code Annotated, Section 63-1-164. This section does not apply to opioids approved by the food and drug administration to treat upper respiratory symptoms or cough.

SECTION 17. SECTION 8 of this act shall take effect July 1, 2019, the public welfare requiring it. All other provisions of this act shall take effect upon becoming a law, the public welfare requiring it.

Public Chapter 675 Requires TDH to Accept Opioid Abuse or Diversion Allegations

Effective January 1, 2019, Public Chapter 675 requires registrants to either provide documentation individually to employees or post a sign concerning the reporting of opioid abuse or diversion to TDH. This sign is required to be posted in a conspicuous but non-public location. The Board is communicating this information to ensure compliance with the law and to improve the reporting of abuse and misuse of opioids to the proper authorities.

The information may be provided to each employee individually in writing, documented by the employing entity, or by posting, in a conspicuous location in a non-public area regularly used by employees, a sign at least eleven inches (11") in height and seventeen inches (17") in width stating:

NOTICE: PLEASE REPORT ANY SUSPECTED ABUSE OR DIVERSION OF OPIOIDS, OR ANY OTHER IMPROPER BEHAVIOR WITH RESPECT TO OPIOIDS, TO THE DEPARTMENT OF HEALTH'S COMPLAINT INTAKE LINE: (NUMBER OF INTAKE LINE)

No employee of an entity that prescribes, dispenses, or handles opioids shall be discharged or terminated solely for reporting information in good faith to the department of health.

No person licensed under this title shall suffer an adverse licensure action solely for reporting information in good faith to the department of health.

A person who reports information in good faith to the department of health is immune from civil liability related to the report.

This act became effective January 1,2019.

What does this mean for pharmacists practicing in the state of Tennessee?

  • Pharmacists must be aware of the rules and changes effecting the dispensing of opioid prescriptions and the limitation applied, so that physicians and patients can be provided with information around their pain therapy, and pharmacists can ensure they are practicing within the limits of state law.
  • All pharmacies must provide guidance to their employees for reporting opioid abuse or diversion to the department of Health. Staff must be trained how to report, and that protection is provided for those who report.

Tennessee State Regulatory Summary- Nov 2018

Senate Bill 2362 / House Bill 2219 PBM Anti Gag Clause

  • Establishes that a pharmacy or pharmacist shall have the right to provide an insured information regarding the amount of the insured's cost share for a prescription drug.

Senate Bill 2257 / House Bill 1831 Controlled Substance Dispensing

Required Dispenser CSMD Checks:

  • Requires all dispensers (or their delegates) to check the Controlled Substance Monitoring Database (CSMD) prior to dispensing an opioid or a benzodiazepine the first time that human patient is dispensed a controlled substance at that practice site.
  • Requires all dispensers (or their delegates) to check the CSMD again at least once every six (6) months for that human patient after the initial dispensing, for the duration of time the controlled substance is dispensed to that patient.

Opioid Prescriptions Written for 3-Day Supply or Less:

  • No required CSMD checks for prescribers or dispensers
  • No additional documentation requirements or partial fill restrictions
  • ICD-10 Codes are not required to be written on prescriptions
  • Maximum of 180 cumulative morphine milligram equivalents (MME)

Non-Exempt Opioid Prescriptions:

  • Must be partially filled with no more than a 5-day supply (for a 10-day prescription), or partially filled with no more than half the prescribed day supply limit (for prescriptions written for more than 10 days)
  • ICD-10 Codes (and "medical necessity" or "surgery", if applicable) must be written on all non-exempt opioid prescriptions

General script limits: No more than a 10-day supply and a maximum of 500 cumulative MME

Surgery: No more than a 20-day supply and a maximum of 850 cumulative MME

Medical necessity: No more than a 30-day supply and a maximum of 1,200 cumulative MME

Exempt Opioid Prescriptions:

  • Partial fill requirements do not apply
  • MME limits do not apply
  • ICD-10 Codes and "Exempt" must be written on all Exempt Opioid Prescriptions
  • Exempt conditions: active or palliative cancer treatment, hospice care, diagnosis of Sickle Cell Disease, inpatients of a licensed healthcare facility, patients seen by pain management specialists, patients treated with opioids for 90 days or more in the last year OR who are subsequently treated for 90 days or more, patients on methadone, buprenorphine, or naltrexone, or patients with severe burns or major physical trauma

Senate Bill 2258 / House Bill 1832

Adds Gabapentin as a Schedule V Controlled Substance

Senate Bill 2025 / House Bill 2440 Partial Filling of Controlled Substances

(January 1, 2019 for Opioids; July 1, 2019 for all others)

  • Authorizes the partial filling of a controlled substance if the partial fill is requested by the patient or the practitioner who wrote the prescription and the total quantity dispensed through partial fills does not exceed the total quantity prescribed for the original prescription.
  • Requires the pharmacist to retain the original prescription at the pharmacy where the prescription was first presented and the partial fill dispensed, and any subsequent fill shall occur at the pharmacy that initially dispensed the partial fill within thirty (30) days from issuance of the original prescription.
  • Requires the pharmacist to notify the prescriber of the partial fill and of the amount actually dispensed.
  • Requires any person who presents a prescription for a partial fill to pay the prorated portion of cost sharing and copayments.
  • Authorizes a pharmacist or pharmacy to charge a dispensing fee to cover the actual supply and labor costs associated with the dispensing of the original prescription for a controlled substance and each partial fill associated with the original prescription.

Senate Bill 1670 / House Bill 1695 Dispensing by Pharmacists in Emergency Situations

  • Authorizes a pharmacist in this state, in good faith, to dispense to a patient without proper authorization or a valid prescription, the number of dosages of a prescription drug necessary to allow the patient to secure proper authorization or a valid prescription from the patient's prescriber.
  • Prohibits the amount of the prescription drug being dispensed from exceeding a 20-day supply.
  • Allows prescription information to be obtained from a prescription label, verbal medical order, verbal prescription order, or any other means determined to be legitimate in the professional judgment of the pharmacist.

Senate Bill 2191 / House Bill 1993 Electronic Prescribing of Controlled Substances (effective January 1, 2020)

  • Requires certain prescriptions for a Schedule II controlled substance to be made as an electronic prescription from the person issuing the prescription to a pharmacy.
  • Requires the name, address, and telephone number of the collaborating physician of an advanced practice registered nurse or physician assistant to be included on the electronic prescription.

What do these new regulations mean for pharmacists practicing within the state of Tennessee?

  • Pharmacists can provide a partial fill for a controlled substance upon a patient or practitioner's request, ensure that all rules are followed, and that standard operating procedure reflect proper documenting and dispensing procedures.
  • Ensure that all software and dispensing systems can accept electronic prescriptions for controlled substances by 7/1/2020.
  • All pharmacists must review the revisions to the controlled substance list and regulations and ensure that all medications that are now included in the above rule are handled per state and federal CDS guidelines regarding dispensing, recordkeeping.
  • Pharmacists can provide emergency prescriptions for certain medications to avoid an interruption in critical therapy for the patient, in the event that the prescriber cannot be contacted for authorization.
  • Pharmacists can discuss price savings options with patients, including cash options, without penalty from the PBM. This can help with patient expenditure, and promote therapy initiation and adherence.

Tennessee State Regulatory Summary- 2018

The following laws, summarized below, were enacted by the Tennessee legislature during the 2018 session.

HB 2440 / SB 2025

  • Authorizes a partial fill of a prescription of a controlled substance. Effective July 1, 2019.
  • A prescription for a controlled substance may be partially filled if:
  • The partial fill is requested by the patient or the practitioner who wrote the prescription; and
  • The total quantity dispensed through partial fills does not exceed the total quantity prescribed for the original prescription.
  • If a partial fill is made, the pharmacist shall retain the original prescription at the pharmacy where the prescription was first presented and the partial fill dispensed.
  • Any subsequent fill shall occur at the pharmacy that initially dispensed the partial fill. Any subsequent fill shall be filled within thirty (30) days from issuance of the original prescription.

SB 2191 / HB 1993

  • Requires health care prescribers to issue prescriptions for Schedule II controlled substances electronically by July 1, 2020.

HB 1832 Controlled Substance law revisions

  • Revises various provisions of law regarding the scheduling of controlled substances and their analogues and derivatives, including updated identifications of drugs categorized in Schedules IV.

What do these new regulations mean for pharmacists practicing within the state of Tennessee?

  • Pharmacists can provide a partial fill for a controlled substance upon a patient or practitioner's request, ensure that all rules are followed, and that standard operating procedure reflect proper documenting and dispensing procedures.
  • Ensure that all software and dispensing systems can accept electronic prescriptions for controlled substances by 7/1/2020.
  • All pharmacists must review the revisions to the controlled substance regulations and ensure that all medications that are now included in the above rule are handled per state and federal CDS guidelines regarding dispensing, recordkeeping.

For full regulatory language, refer to the Tennessee Board of Pharmacy.

Texas State Regulatory Update April 2019

The following amendments were adopted on March 8, 2019, to take effect on March 12, 2019.

283.12 concerning Licenses for Military Service Members, Military Veterans, and Military Spouses

Allows a military service member, military veteran, or military spouse to place his or her pharmacist license on inactive status while not practicing pharmacy in Texas without paying a fee.

291.31 Concerning Definitions

Updates the definitions of an automated counting device and automated pharmacy dispensing systems.

291.33 Concerning Operational Standards

Clarifies the pharmacist's patient counseling duties by expressly prohibiting a pharmacy's computer system from asking questions of the patient intended to screen and/or limit interaction with the pharmacist.

291.35 Concerning Official Prescription Requirements

Regarding the requirement for the use of official prescriptions for Schedule II controlled substances in Class A pharmacies.

291.75 Concerning Records

Updates citation references regarding outpatient records, outpatient prescription forms, and official prescriptions for Schedule II controlled substances, remove references to nalbuphine (e.g., Nubain) from the electronic recordkeeping requirements for distribution and return of controlled substances.

291.121 Concerning Remote Pharmacy Services

Provides standards and requirements for the provision of remote pharmacy services using automated storage and delivery systems, including definitions, general requirements, operational standards, and records requirements.

What does this mean for pharmacists practicing in the state of Texas?

  • Pharmacists must be familiar with the changes that effect the prescription document requirement for controlled substances in both Class A and outpatient pharmacies. Ensure that all requirements are met by the pharmacy's policies and training.
  • Pharmacies that participate in remote pharmacy services and automated storage and delivery system must ensure that their equipment and policies meet the new requirements established by the state; review all current policies and compare with new regulation.

Texas State Regulatory Summary- November 2018

22 TAC 291.32

The amendments allow pharmacy technicians and pharmacy technician trainees to load prepackaged containers previously verified by a pharmacist or manufacturer's unit of use packages into an automated dispensing system.

22 TAC 291.133

The amendments update the media fill and aseptic procedures test requirements for all sterile compounding personnel in Class A-S, Class B, Class C-S and Class E-S pharmacies; clarify the testing requirements for supervisory pharmacists working in multiple pharmacies under common ownership; clarify the environmental testing certification procedures; and correct grammatical and punctuation errors.

22 TAC 295.9

The amendments add a requirement of one hour of continuing education on opioid abuse for pharmacist license reactivation.

22 TAC 291.3

The amendments add inspection requirements for sterile compounding pharmacies (Class A-S, C-S and E-S) and nuclear pharmacies (Class B) when the pharmacy changes location.

What do these new regulations mean for pharmacists practicing within the state of Texas?

  • Pharmacy technicians can now load prepackaged containers into automated dispensing systems; ensure that standard operating procedures and training includes the proper verification methods prior to initiation of this new procedure.
  • If a pharmacy participates in sterile compounding, ensure that all new regulations are understood and followed by all staff members.

Texas State Regulatory Summary- 2017

The below pharmacy practice laws, summarized here, were enacted by the Texas legislature during the 2017 session.

SB 1633 Telepharmacy services; remote dispensing sites. Effective September 1, 2017.

  • A pharmacy technician and pharmacy technician trainee shall be responsible to and must be directly supervised by a pharmacist.
  • A pharmacy may provide pharmacy services, through a telepharmacy system and remote dispensing sites at locations separate from the Class A or Class C pharmacy.

A telepharmacy system may be located only at:

  • a clinic designated as a rural health clinic,
  • locations eligible to be licensed as remote dispensing sites, which must include locations in medically underserved areas, areas with a medically underserved population, and health professional shortage areas.

licensing and operating requirements for remote dispensing sites, including, but not limited to:

  • a requirement that a remote dispensing site be staffed by an on-site pharmacy technician who is under the continuous supervision of a pharmacist;
  • a requirement that all pharmacy technicians at a remote dispensing site be counted for the purpose of establishing the pharmacist-pharmacy technician ratio of the provider pharmacy, which may not exceed three pharmacy technicians for each pharmacist providing supervision;
  • a requirement that, before working at a remote dispensing site, a pharmacy technician must:
  • have worked at least one year at a retail pharmacy;
  • have completed a board-approved training program on the proper use of a telepharmacy system;
  • a requirement that pharmacy technicians at a remote dispensing site may not perform sterile or nonsterile compounding but may prepare commercially available medications for dispensing, including the reconstitution of orally administered powder antibiotics;
  • A telepharmacy system located at a remote dispensing site may not dispense a controlled substance listed in Schedule II.

What do these new regulations mean for pharmacists practicing within the state of Texas?

  • Pharmacists must actively supervise all pharmacy staff completing tasks regarding patient care, including those actions of technicians and interns.
  • Pharmacists operating telepharmacy and remote pharmacy sites are responsible for the location of operations, and all applicable rules and regulations governing that special area of operation, including technician training, location of the pharmacy, and tasks association with those pharmacy operations (including compounding and the dispensing of CDS).

For full regulatory language, refer to the Texas State Board of Pharmacy.

Utah State Regulatory Update April 2019

Senate Bill (SB) 184. passed during the 2018 Utah Legislative General Session, amended the Pharmacy Practice Act to permit a pharmacist to dispense a self-administered hormonal contraceptive under a standing prescription order.

Section R156-17b-102. The following definitions are added:

The term "self-administered hormonal contraceptive" is defined by referring to Section 26-62-102(9).

The new "Utah Hormonal Contraceptive Self Screening Risk Assessment Questionnaire" is defined as the self-screening risk assessment questionnaire that is approved by the Division of Occupational and Professional Licensing pursuant to Section 26-62-106.

Section R156-17b-309. These proposed amendments make the following clarifications and updates to CE requirements by:

  • for pharmacists, updating CE standards and topics by deleting the old topics of "drug therapy or patient management," and substituting the current topics of "disease state management/drug therapy," "AIDS/ HIV therapy," or "patient safety";
  • for pharmacy technicians, reducing the eight-hour "live or technology-enabled participation" requirement to six hours;
  • for pharmacists, clarifying the existing CE requirements regarding individual licensee practices (such as requiring two CE hours in topics related to long acting injectables if the licensee will be providing administration of long-acting injectable drug therapy, and requiring two hours in topics related to hormonal contraceptive therapy if the licensee will be prescribing and dispensing a self-administered hormonal contraceptive);
  • adding additional options for fulfilling CE requirements, including allowing one "live" CE hour for attending one Board meeting, for a maximum of two CE hours during each two-year period, and allowing two CE hours for each hour of lecturing or instructing a CE course or teaching in the licensee's profession, for a maximum of ten CE hours during each two-year period; and
  • requiring licensees to prove compliance with their CE requirements through registration with the CPE Monitor service, accessible through the National Association of Boards of Pharmacy website. Either of the two CPE Monitor plans, the standard or the plus, meet this requirement. Licensees using the free CPE Monitor standard plan are also required to maintain a certificate of completion or other adequate documentation for CE that cannot be tracked through this plan.

Section R156-17b-610. These proposed amendments provide guidelines for patient counseling by a pharmacist or pharmacy intern who dispenses a self-administered hormonal contraceptive. The guidelines require the pharmacist or pharmacy intern to obtain a completed Utah Hormonal Contraceptive Self-Screening Risk Assessment Questionnaire, and provide the written information and counseling described in Section 26-62-106.

Section R156-17b-621b. This proposed rule establishes the operating standards for pharmacists and pharmacy interns dispensing a self-administered hormonal contraceptive. These standards require special initial training, CE, and the use of the new Utah Hormonal Contraceptive Self-Screening Risk Assessment Questionnaire, which was adopted by the Division of Occupational and Professional Licensing in collaboration with the Board.

Pharmacy Technician Training Programs. "On-the-job" pharmacy technician training pharmacies will no longer meet the education requirement for pharmacy technician trainee applications submitted after December 31, 2018. Pharmacy technician trainees must attend a program that is American Society of Health-System Pharmacists (ASHP)-accredited; in ASHP candidate status; or conducted by the National Pharmacy Technician Association, Pharmacy Technicians University, or a branch of the United States Armed Forces. Please refer to the following excerpt of the rule for further clarification. R156-17b-303a.

Qualifications for Licensure.

Education Requirements. (3) In accordance with Subsection 58-17b-305(1)(f), a pharmacy technician shall complete a training program that is: accredited by ASHP; or conducted by the National Pharmacy Technician Association; Pharmacy Technicians University; or a branch of the Armed Forces of the United States, and meets the following standards:

  • Completion of at least 180 hours of directly supervised practical training in a licensed pharmacy as determined appropriate by a licensed pharmacist in good standing; and
  • Written protocols and guidelines for the teaching pharmacist outlining the utilization and supervision of pharmacy technician trainees that address: (A) the specific way supervision will be completed; and (B) an evaluative procedure to verify the accuracy and completeness of all acts, tasks and functions performed by the pharmacy technician trainee. An individual shall complete a pharmacy technician training program and successfully pass the required examination within two years after obtaining a pharmacy technician trainee license. Unless otherwise approved, an individual who fails to apply for and obtain a pharmacy technician license within the two-year time frame shall repeat a pharmacy technician training program in its entirety if the individual pursues licensure as a pharmacy technician.
  • Pharmacy technician training programs that received Division approval on or before April 30, 2014 are exempt from satisfying standards for students enrolled on or before December 31, 2018. A student in such program shall comply with the program completion deadline and testing requirements, except that the license application shall be submitted to the Division no later than December 31, 2021. A program in ASHP candidate status shall notify a student prior to enrollment that if the program is denied accreditation status while the student is enrolled in the program, the student will be required to complete education in another program with no assurance of how many credits will transfer to the new program. A program in ASHP candidate status that is denied accreditation shall immediately notify the Division, enrolled students and student practice sites, of the denial. The notice shall instruct each student and practice site that: (i) the program no longer satisfies the pharmacy technician license education requirement in Utah; and (ii) enrollment in a different program meeting requirement established is necessary for the student to complete training and to satisfy the pharmacy technician license education requirement in Utah. An applicant from another jurisdiction seeking licensure as a pharmacy technician in Utah is deemed to have met the qualifications for licensure if the applicant: (a) has engaged in the practice of a pharmacy technician for a minimum of 1,000 hours in that jurisdiction within the past two years or has equivalent experience as approved by the Division in collaboration with the Board; and (b) has passed and maintained current PTCB or ExCPT certification.

What does this mean for pharmacists practicing in the state of Utah?

  • Pharmacists are now allowed limited prescriptive authority of hormonal contraception by protocol, if they meet all requirements for training, assessment, and monitoring as part of their program and protocol.
  • Pharmacists must be aware of all changes to CE requirements and tracking for all renewals going forward. Proper documentation and completion of CE is required for continued practice within the state.
  • There have been some major changes regarding technician training programs, and what is accepted within the state. Review your pharmacy's technician training program and requirement and ensure that it either satisfied all requirements for the state or provide a suitable alternative for your technicians going forward. Educate your technician candidates on the changes to the state's requirements.

Utah State Regulatory Summary- 2018

The following laws, summarized here, were enacted by the Utah legislature during the 2018 session:

58-17b-622. Pharmacy benefit management services - Auditing of pharmacy records - Appeals. Effective May 8, 2018.

If an audit is conducted on site at a pharmacy, the entity conducting the audit:

  • shall give the pharmacy 10 days advanced written notice of the audit; and the range of prescription numbers or a date range included in the audit;
  • may not audit a pharmacy during the first five business days of the month, unless the pharmacy agrees to the timing of the audit.

58-37-7. Labeling and packaging-controlled substance -- Informational pamphlet for opiates Effective May 8, 2018.

A pharmacist shall affix a warning to the container or the lid for the container in which the substance is sold or dispensed that contains the following text:

  • "Caution: Opioid. Risk of overdose and addiction"; or
  • any other language that is approved by the Department of Health.

A pharmacist shall prominently display the informational pamphlet developed by the Department of Health and use this pamphlet as part of their patient counseling session.

Chapter 37f- Controlled Substance Database Act Updates Effective May 8, 2018

  • If the dispenser's access and review of the database suggest that the individual seeking an opioid may be obtaining opioids in quantities or frequencies inconsistent with generally recognized standards, the dispenser shall reasonably attempt to contact the prescriber to obtain the prescriber's informed, current, and professional decision regarding whether the prescribed opioid is medically justified.
  • Failure by pharmacist to submit information Penalties added
  • A pharmacist must submit information to the PMP real time, or 24-hour daily or next business day, whichever is later, batch submission of the information.

What do these new regulations mean for pharmacists practicing within the state of Utah?

  • The new law now places limits and guidelines on when and how a PBM can initiate an audit, allowing pharmacists to comply with those audits with minimal disruption of patient care, and ensure that the pharmacist in charge is aware of these new audit policies.
  • When a pharmacist dispenses a prescription for an opioid, they must ensure that all required information, including a new addiction warning label is affixed to the vial.
  • The pharmacist must make available an educational brochure approved by the Department of Health; they should also use this for counseling on the new opioid medication
  • Ensure that both steps are included in any standard operating procedures and that all pharmacists are aware and trained on these new required actions.
  • The controlled substance reporting regulation has been updated to include penalties for not using the state reporting site, new requirements for when a dispensing must be recorded into the site and outlining the state's plan to monitor usage of the site by both practitioners and pharmacists. Finally, language was updated to exempt veterinarian activities from reporting requirements, as well as ensure that all pharmacists are registered to access and are using the reporting site as part of their standard dispensing duties.

For full regulatory language, refer to the Utah Board of Pharmacy.

Vermont State Regulatory Update April 2019

The statutes were updated in November 2018 and contain all actions of the 2018 legislative session.

Title 26: Professions and Occupations. Chapter 36: Pharmacy; Subchapter 1: General Provisions

  • 2021 Statement of purpose
  • 2022 Definitions
  • 2023 Clinical pharmacy

Subchapter 3: Licensing

  • 2041 Unlawful practice
  • 2042 Qualifications for licensure
  • 2042a Pharmacy technicians; qualifications for registration
  • 2042b Pharmacy technicians; nondiscretionary tasks; supervision
  • 2046 Fees

Subchapter 5: Registration Of Facilities

  • 2061 Registration and licensure
  • 2062 Application
  • 2063 Notifications
  • 2064 Violations and penalties

Subchapter 6: Wholesale Distributors

  • 2067 Wholesale distributor; licensure required
  • 2068 Requirements; applicants; licenses
  • 2069 Denials based on public interest
  • 2071 Application of federal guidelines
  • 2073 Rules
  • 2076 Inspection powers; access to wholesale distributor records

Subchapter 8: Naloxone Hydrochloride

  • 2080 Naloxone hydrochloride; dispensing or furnishing

What does this mean for pharmacists practicing in the state of Vermont?

  • Pharmacists must become familiar with changes regarding the definition and allowances around clinical pharmacy practice, licensing requirements for pharmacists, technicians, facilities, and wholesale distributers; ensure that their staff is aware and meets all requirements.
  • If your facility dispenses or provides Naloxone to first responders, review the changes to the dispensing or furnishing of Naloxone products.

Vermont State Regulatory Summary- 2018

The following law, summarized below, was enacted by the Vermont legislature during the 2018 session. All are effective July 1, 2018.

SB 92 - An act relating to prescription drug price transparency and cost containment

  • When a pharmacist receives a prescription for a drug which that is listed either by generic name or brand name the pharmacist shall select the lowest priced drug from the list which is equivalent as defined by the "Orange Book," unless otherwise instructed by the prescriber, or by the purchaser.
  • Within five business days following the dispensing of a biological product, the dispensing pharmacist or designee shall submit the information in a format that is accessible to the prescriber electronically.
  • If a pharmacy does not have access to an electronic system, the pharmacist or designee shall communicate to the prescriber the information regarding the biological product dispensed using telephone, facsimile, electronic transmission, or other prevailing means.
  • Every pharmacy in the state shall have posted a sign in a prominent place that is in clear unobstructed view which shall read: "Vermont law requires pharmacists in some cases to select a less expensive generic equivalent drug or interchangeable biological product for the drug or biological product prescribed unless you or your physician direct otherwise. Ask your pharmacist."

What do these new regulations mean for pharmacists practicing within the state of Vermont?

  • Pharmacists are no longer prohibited by PBMs of providing counseling on less expensive avenues for medication therapies, including 90-day supply, cash pay, and generic alternative options. This can help pharmacists promote medication adherence and decrease therapy interruption.
  • Pharmacists can also apply the above cost-saving discussions to biologics and interchangeable drugs, again helping to promote medication adherence for their patients.
  • All pharmacies must have a sign posted that indicates that less expensive alternatives may be recommended by your doctor or pharmacist.

For full regulatory language, refer to the Vermont Board of Pharmacy.

Virginia State Regulatory Summary- 2018

The following pharmacy practice laws, summarized below, were enacted by the Virginia legislature during the 2018 session. All are effective July 1, 2018.

HB 234 - Health insurance; synchronization of medications.

  • Any health plan shall permit and apply a prorated daily cost-sharing rate to prescriptions that are dispensed by a network pharmacy for a partial supply if the prescribing provider or the pharmacist determines the fill or refill to be in the best interest of the enrollee and the enrollee requests or agrees to a partial supply for synchronizing the enrollee's medications, provided that such a proration for any prescription shall not occur more frequently than annually.
  • The health plan shall allow a pharmacy to override any denial codes indicating that a prescription is being refilled too soon for the purposes of synchronizing the enrollee's medications.

HB 313 Prescription Monitoring Program; prescriber and dispenser patterns, annual review, reporting

HB 1556 - Prescription Monitoring Program; adds controlled substances included in Schedule V and naloxone.

  • "Covered substance" means all controlled substances included in Schedules II, III, and IV; controlled substances included in Schedule V for which a prescription is required; naloxone; and all drugs of concern that are required to be reported to the Prescription Monitoring Program.

SB 632 - Controlled substances; limits on prescriptions containing opioids.

  • A prescriber shall not be required to meet the provisions of prescribing limits if: Removes the exemption: The opioid is prescribed to a patient as part of treatment for a surgical or invasive procedure and such prescription is for no more than 14 consecutive days.

SB 933 - Health insurance; contracts with pharmacies and pharmacists

Provider contracts must allow a pharmacy to:

  • Disclose information relating to the availability of a more affordable therapeutically equivalent prescription drug;
  • Sell a more affordable therapeutically equivalent prescription drug if one is available; and
  • Offer and provide delivery services as an ancillary service.

SB 226 - Prescription Monitoring Program; veterinarians.

  • In cases where the ultimate user is an animal, the dispenser shall report the relevant information required for the owner of the animal.

What do these new regulations mean for pharmacists practicing within the state of Virginia?

  • Pharmacists can now offer medication synchronization services, and the insurance payor must allow for the proper billing and prorated costs of the synchronization services. This is a huge win for the pharmacist to help improve patient care and promote medication adherence opportunities for their patients.
  • The state will now be monitoring the PMP annually for proper usage by both prescribers and dispensers; pharmacists must ensure that the are using the PMP for controlled substance dispensing activities.
  • Pharmacists are no longer prohibited by PBMs of providing counseling on less expensive avenues for medication therapies, including 90-day supply, cash pay, and generic alternative options. This can help pharmacists promote medication adherence and decrease therapy interruption.
  • Pharmacists must be aware of the newest changes to the controlled substance regulations, including the addition of naloxone to the controlled substances listing, making it now required to be entered the PMP site; post-surgical pain management is no longer an approved exemption for the limitation on opioid dispensing.
  • Veterinarian prescriptions must now be entered into the PMP under the owner's name.

For full regulatory language, refer to the Virginia Board of Pharmacy.

Washington State Regulatory Update April 2019

No. 1317 Chapter 246-887 WAC Updated

The amendments incorporate changes proposed by rulemaking petitions from the Washington State Office of the Attorney General Consumer Protection Division and Greenwich Biosciences by adding substances to Schedule I and Epidiolex to Schedule V.

No. 1318 Defining Emergency Medical Reasons

The Commission filed an interpretive statement to advise and clarify to pharmacists and to the public its current definition of emergency medical reasons as it is used in WAC 246-879-010(10)(e). The Commission does not interpret the meaning in the same way as Food and Drug Administration, in that the borrowing, lending, selling, purchasing, or transferring of medications between pharmacies to a practitioner to alleviate a temporary shortage or for another emergency medical reason does not constitute wholesaling. The Emergency Medical Reasons Interpretive Statement was filed with the Washington State Legislature Office of the Code Reviser under WSR 19-07-062 on March 19, 2019. It is on the Commission's "Policies, Procedures and Guidelines" web page.

What does this mean to pharmacists practicing in the state of Washington?

  • Pharmacists must be aware of, and educate their staff, on the proper dispensing documentation and storage of Epidiolex as a Schedule V medication.
  • Pharmacists must review the regulatory language that dictate the practice of transferring medication from one pharmacy to another for emergency reasons. Review your current polices and ensure that they meet the state's definition of emergency needs.

Washington State Regulatory Summary- 2018

The following law, excerpted here, was enacted to effect pharmacy practice by the Washington legislature during the 2018 session.

HB 1047 - Protecting the public's health by creating a system for safe and secure collection and disposal of unwanted medications. Effective June 7, 2018.

Pharmacies and other entities that sell medication in the state are encouraged to promote secure disposal of covered drugs by one or more approved drug take-back programs. Upon request, a pharmacy must provide materials explaining the use of approved drug take-back programs to its customers. The program operator must provide pharmacies with these materials upon request and at no cost to the pharmacy.

What does this new regulation mean for pharmacists practicing within the state of Washington?

  • Pharmacists are encouraged to promote options for safe disposal of unused medications, especially controlled substances and opioids, to remove them from potential abuse within the community.
  • Pharmacists should have information that can be provided to their patients if asked about proper disposal of unwanted medications, if asked.

For full regulatory language, refer to the Washington State Board of Pharmacy.

Washington, District of Columbia Regulatory Update November 2018

Department of Health Regulation Title 17 DCMR, BUSINESS, OCCUPATIONS, AND PROFESSIONALS, is amended by adding a new Chapter 100 to read as follows: Chapter 100 Collaborative Practice Agreements Between Physicians and Pharmacists

This new chapter outlines the provision of collaborative practice agreements between physicians and pharmacists for the advancement of patient care.

What does this mean for pharmacists practicing within the state of the District of Columbia?

  • Pharmacists can now partner with physicians through a written, collaborative practice agreement to provide advanced care to their patients.

District of Columbia State Regulatory Summary- 2018

The below laws were enacted to effect pharmacy practice by the District of Columbia legislature during the 2018 session.

DC B22-0106 - Defending Access to Women's Health Care Services Amendment Act Of 2017. Effective March 28, 2018.

A pharmacist may prescribe and dispense up to a 12-month supply of self-administered hormonal contraceptives pursuant to a written protocol established by the Board of Medicine. The protocols shall include the following requirements:

  • The pharmacist must complete a training program approved by the Board and the Board of Medicine for prescribing and dispensing self-administered hormonal contraceptives;
  • The patient will use a self-screening tool that will identify patient risk factors for the use of self-administered hormonal contraceptives;
  • A pharmacist may determine, based on the results of the self-screening tool described above, when it is safe to dispense a 12-month supply of self-administered hormonal contraceptives;
  • When a self-administered hormonal contraceptive is prescribed and dispensed, the patient shall be provided, in a manner that ensures patient confidentiality, appropriate counseling and information on the product furnished, including dosage, effectiveness, potential side effects, safety, the importance of receiving recommended preventive health screenings, and that a self-administered hormonal contraceptive does not protect against sexually transmitted infections;
  • The pharmacist will refer the patient to the patient's primary care provider or reproductive health provider or to a nearby clinic, upon prescribing and dispensing a self-administered hormonal contraceptive or if it is determined that the use of a self-administered hormonal contraceptive is not recommended.
  • The pharmacist must provide the patient with written material, developed by the Board and the Department of Health.
  • A pharmacy shall display in stores and online a list of the times during which a pharmacist certified to prescribe and dispense contraception is available.

What does this new regulation mean for pharmacists practicing within the District of Columbia?

  • Pharmacists can, after completing a board-approved training program on oral contraceptive prescribing, provide a 12-month supply on oral contraceptives to eligible patients.
  • Appropriate pre-screening must occur in accordance to the rule, a roster of approved dispensers by location must be provided to the board of pharmacy and required signage must be conspicuously posted at the pharmacy location providing this service.
  • Ensure that all participating pharmacists hold the required credentials and training prior to initiating this service, and that all standard operating procedures reflect the details of this rule.

For full regulatory language, refer to the District of Columbia Department of Health.

The following laws, summarized below, were enacted by the West Virginia legislature during the 2018 session.

SB 46 - Permitting pharmacists to inform customers of lower-cost alternative drugs. Effective June 10, 2018.

A pharmacy shall have the right to provide an individual with information related to lower cost alternatives and cost share to assist health care consumers in making informed decisions. A pharmacy shall be penalized by a pharmacy benefit manager for discussing information or for selling a lower cost alternative to a covered individual, if one is available, without using a health insurance policy.

HB 4524 - Establishing guidelines for the substitution of certain biological pharmaceuticals. Effective June 10, 2018.

  • Except as limited by law and unless instructed otherwise by the patient, a pharmacist who receives a prescription for a specific biological product shall select a less expensive interchangeable biological product unless in the exercise of his or her professional judgment the pharmacist believes that the less expensive drug is not suitable for the patient.
  • Within five business days following the dispensing, the dispensing pharmacist shall communicate the specific product provided to the prescriber using an electric records system.
  • Communication through an electronic records system is presumed to provide notice to the prescriber.
  • If the pharmacist is unable to communicate pursuant to an electronic records system the pharmacist shall communicate using facsimile, telephone, electronic transmission, or other prevailing means.

HB 4025 - Permitting reciprocity for licensure as a pharmacy technician. Effective June 6, 2018.

To be eligible for registration as a pharmacy technician to assist in the practice of pharmacist care, the applicant shall register with the board.

SB 273 - Reducing use of certain prescription drugs (opiates). Effective June 9, 2018.

  • No medication listed as a Schedule II controlled substance, may be prescribed by a practitioner for greater than a 30-day supply.
  • A veterinarian may not issue more than an initial opioid prescription for more than a seven-day supply. The prescription shall be for the lowest effective dose which in the medical judgment of the veterinarian would be the best course of treatment for this patient and his or her condition.

What does this new regulation mean for pharmacists practicing within the state of West Virginia?

  • Pharmacists are no longer prohibited by PBMs of providing counseling on less expensive avenues for medication therapies, including 90-day supply, cash pay, and generic alternative options. This can help pharmacists promote medication adherence and decrease therapy interruption.
  • Pharmacists can also apply the above cost-saving discussions to biologics and interchangeable drugs, again helping to promote medication adherence for their patients. Within five days of dispensing the interchangeable product, the pharmacist must report that information to the prescribing physician. Ensure that all staff are trained to do so, and that software systems are equipped to retain and report the required data per law.
  • All pharmacists must be aware of the changes in technician registration requirements and hire appropriately, especially when hiring an out of state technician.
  • There are updates to prescribing regulations regarding opioids; ensure that all staff are familiar with the updates and handle those prescriptions lawfully, including identification verification when required and reporting to the PMP.

For full regulatory language, refer to:

https://www.wvbop.com/public/verify/lawlinks.asp.

The following laws, summarized below, were enacted by the Wisconsin legislature during the 2018 session.

SB 172 - Administration of vaccines by pharmacy students.

A person engaged in the practice of pharmacy may not administer a vaccine unless he or she acts under the direct supervision of a pharmacist and he or she and the supervising pharmacist have successfully completed 12 hours in a course of study and training, approved by the Accreditation Council for Pharmacy Education or the board, and the supervising pharmacist has also satisfied these requirements. A person engaged in the practice of pharmacy may not administer a vaccine under this subsection to a person who is under the age of 6.

SB 575 The treatment of biological products for various purposes under the pharmacy practice law.

A pharmacist shall dispense every prescription using either the drug product prescribed or its drug product equivalent, if its drug product equivalent is lower in price to the consumer than the drug product prescribed and shall inform the consumer of the options available in dispensing the prescription.

Within 5 business days after the dispensing of a biological product, the dispensing pharmacist or the pharmacist's designee shall do one of the following:

  • Make an entry of the specific product provided to the patient into an electronic records system, providing notice to the prescribing practitioner.
  • If a pharmacist is unable to make an entry, communicate the biological product dispensed to the prescribing practitioner using facsimile, telephone, electronic transmission, or another prevailing means.

What does this new regulation mean for pharmacists practicing within the state of Wisconsin?

  • Pharmacists can authorize pharmacy student interns to administer immunizations as part of their study if they have completed an ACPE approved program. Ensure that there is a process in place to verify completion of training prior to allowing students to immunize and provide direct supervision during the immunization process.
  • Pharmacists can also apply the above cost-saving discussions to biologics and interchangeable drugs, again helping to promote medication adherence for their patients. Within five days of dispensing the interchangeable product, the pharmacist must report that information to the prescribing physician. Ensure that all staff are trained to do so, and that software systems are equipped to retain and report the required data per law.

For full regulatory language, refer to:

https://dsps.wi.gov/Pages/RulesStatutes/Pharmacy.aspx

Wyoming State Regulatory Update April 2019

HB 0063 - relating to regulation of pharmacy benefit managers under the insurance code; providing that a pharmacy benefit manager shall not prohibit or penalize disclosure of prescription cost information or affordable alternatives; and providing for an effective date.

A pharmacy benefit manager may not, by contract or otherwise, prohibit or penalize a pharmacy or pharmacist for:

  • Disclosing information to a covered individual regarding any cost differential that the covered individual must pay for a prescription under the individual's prescription drug benefit or outside of the individual's prescription drug benefit;
  • Offering to a covered individual a more affordable alternative if one is available.

SF 0047 - AN ACT relating to controlled substances; providing for specified boards regulating health care practitioners to require continuing education related to controlled substances; requiring electronic prescriptions for controlled substances; requiring practitioners to search the controlled substance prescription tracking program; exempting veterinarians from required use of the program; authorizing exceptions; requiring the state board of pharmacy to provide specified information from the prescription tracking program to providers and dispensers; and providing for an effective date.

33-26-202. Board; duties; general powers.

The board shall require licensees who are registered with the board of pharmacy to dispense a controlled substance in this state to complete one (1) hour of continuing education related to the responsible prescribing of controlled substances or the treatment of substance abuse disorders every two (2) years.

On and after January 1, 2021, except when dispensed directly by a practitioner other than a pharmacy to an ultimate user, no controlled substance included in any schedule shall be dispensed without the electronic prescription of a practitioner. The prescription for a controlled substance included in Schedule III or IV shall not be filled or refilled more than six (6) months after the date of the prescription or be refilled more than five (5) times unless renewed by the practitioner. The board may by rule and regulation provide exemptions from the requirements of this subsection including exemptions for emergencies and technical failures.

35-7-1060. Controlled substance prescription tracking program. Except as otherwise provided in this subsection, when a practitioner, other than a veterinarian, prescribes a schedule II, III, IV or V controlled substance, the practitioner or his delegate shall search the prescription tracking program for prior prescriptions issued to the patient before first issuing the prescription and shall repeat the search every three (3) months thereafter for as long as the controlled substance remains a part of the patient's treatment. A practitioner who prescribes a schedule V controlled substance shall only be required to search the program as otherwise provided in this subsection if the substance is an opioid. A dispenser, other than a veterinarian, shall electronically file with the board information regarding any prescription for a schedule II, III, IV or V controlled substance dispensed by the dispenser no later than the close of business on the business day immediately following the day the controlled substance was dispensed. The board may grant a reasonable time extension to a dispenser or practitioner who is unable to electronically file or search information as required under this subsection. The board may require the filing of other prescriptions and may specify the way the prescriptions are filed.

What does this mean for pharmacists practicing in the state of Wyoming?

  • Pharmacists can now provide information to patients about potential affordable alternative products. This will result in more positive health outcomes and improved adherence to prescribed therapy. Ensure that proper documentation of the change occurs in the pharmacy system and that SOPs include this notification.
  • Pharmacists must be aware of the many changes made to the dispensing of controlled substances and proper PDMP use, including the implementation of a mandatory electronic prescribing regulation. Ensure that policies reflect these changes and that all staff are adequately trained on the new requirements.

The following bills were passed by the Wyoming State Legislature in the 2018 General Session:

SF 75 - Biosimilar Pharmaceutical Product Substitution

This bill allows biosimilar products to be substituted by pharmacists if the product is considered "interchangeable" by the FDA. There is a specific process a pharmacist must do in this instance, notably giving the practitioner notice of the product used within 5 business days. If a product is considered biosimilar, but not interchangeable, then the prescriber must be notified and agreeable to any change in product prior to the prescription being dispensed.

What does this mean for pharmacists practicing within the state of Wyoming?

This law provides pharmacists with the ability to provide patients with more options for biosimilar products. Pharmacists must be educated on biosimilar products and their FDA "interchangeability" rating for those products. Practices must be in place for notification of the prescribing physician of any product changes. State product substitution regulations still apply.

For full regulatory language, refer to:

http://pharmacyboard.wyo.gov/laws.