Piecing together new Board of Pharmacy legislative changes

Piecing together new Board of Pharmacy legislative changes

Monika Tawfik, PharmD, Hennepin Healthcare

The Minnesota Board of Pharmacy recently enacted several changes effective July 1st, 2019. These changes affect both community pharmacies and primary care practitioners. Pharmacists must be ready to answer questions received by both patients and practitioners regarding these changes. 

Controlled Substance Prescriptions: According to the new rules, no prescription for an opiate or narcotic pain reliever listed in Schedule II-IV can be dispensed more than 30 days after the date on which the prescription was issued. Additionally, opiate prescriptions for acute pain can only be issued for a seven-day supply for an adult, a five-day supply for a minor under 18 years of age, and four days for acute dental pain. These limits do not apply to pain related to cancer care, palliative care, hospice, or other end-of-life care. However, pharmacists must continue to act with professional judgment if a prescription is written for acute pain and exceeds these quantity limits, but has been deemed appropriate.

Prescriptions for Schedule III-V medications can still have up to five refills within six months; however, each refill must be dispensed no more than 30 days after the last fill was dispensed. Although prescribers can no longer issue multiple opiate prescriptions at a time, prescriptions for stimulant medications are not affected by this rule.

Emergency Refills: Although many pharmacies have had their own rules regarding emergency prescription refills, the new rules specify certain requirements that must be met and various restrictions. The requirements include: patient compliance (determined by the pharmacist’s professional judgement); pharmacy must have a record of the prescription drug order; the pharmacist must try to contact the prescriber to obtain authorization of a refill; the drug is necessary to sustain life or continue therapy for a chronic condition; failure to dispense the medication would result in harm to the patient; and the drug is not a controlled substance, except for controlled substances used to treat seizure disorders, in which a 72-hour supply can be dispensed. If these requirements are met, the pharmacist can dispense up to a 30-day supply of the medication, but must notify the practitioner no later than 72 hours. The pharmacist cannot dispense or sell the same drug to the same patient as an emergency refill more than once per year.

Therapeutic Substitution: There are no changes to this practice as pharmacists have been engaging in therapeutic substitution for several years. However, the new rules provide clarity and guidance. Therapeutic substitutions are allowed if the pharmacist has a written protocol with each prescriber that outlines the class of medication and is designed for the same indication. The pharmacist must communicate the change to both the patient and the practitioner. When communicating to the practitioner, the pharmacist is required to include the name and manufacturer of the substituted drug and the reason for substitution.

Pharmacist Administration of Medications: Pharmacists can now administer drugs by intramuscular (IM) and subcutaneous (SQ) routes when used for treatment of alcohol or opioid dependence or mental illness. A collaborative practice agreement or protocol is required for drugs administered by IM or SQ routes when used for the treatment of mental illness. However, it is acceptable for a prescription to indicate the pharmacist to administer the medication. The prescriber should be notified after the administration is complete. In other cases (first dosages and medical emergencies, vaccines, and for the treatment of alcohol or opioid dependence), a protocol or collaborative practice agreement need not be in place, but the administration should follow a prescription or drug order from a practitioner. The board will exercise discretion to protect a pharmacist who acts in good faith to administer a medication needed to treat an emergency.

Although the new rules reflect overall clarity to various pharmacy practices, the rules repeatedly affirm that pharmacists must rely on professional judgment. Thus, despite the rules, pharmacists are likely to encounter situations that may not perfectly fit the mold, and will still have to use clinical knowledge and judgment to make the best decision for the patient.

Reference:

  1. 2019 Legislation Affecting MN Board of Pharmacy Licensees and Registrants. Minnesota Board of Pharmacy.https://mn.gov/boards/assets/2019MinnesotaLegislationAffectingBoardofPharmacy LicenseesandRegistrants06142019_tcm21-388725.pdf. Updated June 14, 2019. Accessed July 22, 2019.