Policy Statement 2006-01: joint guidelines regarding pharmacist dispensing of Emergency Contraception
Table of Contents
Pharmacist dispensing of Emergency Contraception
The Department of Public Health (Department), specifically the Board of Registration in Pharmacy (Pharmacy Board), the Board of Registration in Medicine and the Drug Control Program under authority of M.G.L. c. 94C, have adopted Guidelines (Pharmacy Board Policy No. 2006-1) that describe the requirements for pharmacists to dispense Emergency Contraception (EC) pursuant to M.G.L. c. 94C, § 19A in accordance with a written standardized procedure or protocol (i.e., Standing Order) developed by an actively practicing physician registered with the Commissioner to distribute or dispense a controlled substance in the course of professional practice pursuant to M.G.L. c. 94C, § 7. Pursuant to the statute, the Standing Order must be maintained on file at the participating pharmacy and a copy filed with the Pharmacy Board. In addition to requirements for dispensing, these Guidelines set forth requirements for training and reporting.
Physician orders are required to dispense EC
Prior to the enactment of Chapter 91 of the Acts of 2005, a prescription from an authorized prescriber in compliance with Department regulations was required to dispense EC (e.g., Plan B).
In accordance with M.G.L. c. 94C, § 19A, a pharmacist may now alternatively dispense EC pursuant to a Standing Order developed by an actively practicing registered physician (see the Guidelines below). Standing Orders must include written, standardized procedures and protocols, the printed name and signature of the physician and the entity(ies) authorized by the Physician.
A physician may issue a Standing Order for a pharmacist, pharmacy or group of pharmacies under common ownership or control of one entity.
Guidelines for dispensing EC pursuant to a Standing Order
A pharmacist may dispense EC pursuant to a Standing Order of an actively practicing physician who is registered with the Commissioner provided that:
- The pharmacist is currently licensed by the Pharmacy Board
- The pharmacist has completed training accredited by the Accreditation Council on Pharmacy Education (ACPE) or offered by an "Approved College or School of Pharmacy" (247 CMR 2.00), which training shall include instruction on:
- Referring patient for additional service and follow-up
- Quality assurance
- Proper documentation
- The Standing Order is maintained on file (readily retrievable) at the pharmacy
- A copy of the Standing Order has been filed with the Pharmacy Board
Proof of training must be on file (readily retrievable) at the pharmacy.
A copy of the Standing Order must be maintained on file (readily retrievable) at each participating pharmacy site.
One copy of the Standing Order must be filed with the Board. Where a Standing Order provided to the participating pharmacy includes a certification that the Order has been filed with the Board, it is not necessary to make duplicate filings with the Board.
Offer to Provide Medication Counseling
As currently required by M.G.L. c. 94C and Pharmacy Board regulations 247 CMR.
In accordance with M.G.L. c. 94C, § 19A(d), annual reporting of dispensings is required. Where possible, reports shall aggregate the total number of units of use dispensed pursuant to a Standing Order (not including units of use dispensed pursuant to a prescription). Reports are not public records and shall not include any patient names or identifiers.
Annual reports must be electronically submitted to the Department not later than August 1st for the period from July 1 through June 30 of the prior year.
An authorized representative for a group of pharmacies under common ownership or control of one entity may report on behalf of all pharmacies, provided subtotals are submitted for each location by permit number (and zip code).
A reporting format is provided below and will be available on the Department's website.
Reports shall be submitted electronically to the Department. Instructions will be provided on the Department's website.