Keeping Up With
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FDA Advisory Panels: Prescribe Naloxone With Opioid Painkillers

WEDNESDAY, Dec. 19, 2018 (Pharmacist's Briefing) -- The labels of prescription opioid painkillers should advise doctors to consider simultaneously prescribing the opioid overdose antidote naloxone, two U.S. Food and Drug Administration advisory panels recommend.

The 12-to-11 vote during a joint meeting of the committees was described by several members as a message to the federal government to make naloxone more widely available, easier to obtain, and cheaper, the Washington Post reported. Although not required to do so, the FDA often follows the recommendations of its advisory committees.

Earlier this year, U.S. Surgeon General Jerome Adams, M.D., M.P.H., issued an advisory urging opioid users, their families, and their friends to keep naloxone nearby, the Post reported.

In 2017, there were a record 70,000 drug overdose deaths, including a record 47,600 opioid overdose deaths in the United States, according to the U.S. Centers for Disease Control and Prevention.

Washington Post Article

FDA Announces 2019 Plans to promote increased access to biological therapy

MONDAY, Dec. 17, 2018 (Pharmacist's Briefing) --The U.S. Food and Drug Administration (FDA) announced today that they will focus on more efficient access to biologics and biosimilar products in 2019. The FDA's mission has been to protect the public through patient safety, while advancing patient care through fair competition; this results in lower costs and broadening patient access to critical medications and devices. Recent innovation has resulted in a cutting edge biological and biosimilar market, yet the current approval process, along with several activities by drug manufacturers and pharmacy benefit managers make it unaffordable for some patients to take advantage of treatment options.

The FDA will introduce new actions to promote the mission of the FDA and the Public Health Service Act (PHSA), including the new Biosimilars Action Plan, and the close monitoring of the actions of drug manufactures around the use of limited distribution pathways, and REMS requirements. The FDA will not allow manufacturers to misuse these patient safety mechanisms to limit the access for patient care and treatment of these new and innovative products.

The Biosimilars Action Plan will allow for an approval process like the Abbreviated New Drug Application (ANDA) process now used for generic products, to be launched for the approval of biosimilar and interchangeable biologic products. This will allow for cost saving options to be available to the patient, resulting in improved patient access and care. Recent insulin product cost and production activities have brought the need for this renewed focus to the FDA.

For the complete press release by the FDA, refer to FDA Newsroom.

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 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 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 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 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 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 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 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.

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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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.

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 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 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 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 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 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 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

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.