Patch-For-Patch Fentanyl Return Program: Fact Sheet

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In an effort to combat the abuse, misuse, and diversion of prescription fentanyl, the provincial government has passed new legislation1 which requires patients who receive a prescription for fentanyl to return their used patches to a pharmacy before receiving new ones.

The College of Physicians and Surgeons of Ontario (CPSO) and Ontario College of Pharmacists (OCP) strongly support this new legislation, as well as the government’s approach to delineate specific roles and responsibilities for physicians and pharmacists when prescribing and dispensing fentanyl.

Requirements of the legislation:

When prescribing fentanyl patches:

  1. Prescribers must record on every prescription for fentanyl the name and address of the pharmacy where the prescription will be filled.
  2. Prescribers must notify the pharmacy in advance that each prescription has been written, either by faxing a copy of the prescription to the pharmacy or by telephone.
  3. When writing a patient’s first prescription for fentanyl, prescribers must note “first prescription” on the prescription itself.2 A prescription is considered a “first prescription” when:
    i. The prescriber has not previously prescribed a fentanyl patch for that patient; and
    ii. The prescriber is reasonably satisfied that the patient has not previously obtained a prescription for fentanyl from another prescriber.3

When dispensing fentanyl patches:

  1. Dispensers must confirm that the name and location of the pharmacy is recorded on the prescription by the prescriber, and the pharmacy has been notified by the prescriber of the prescription before any patches are dispensed.
  2. Unless a first time prescription, dispensers must only dispense fentanyl in exchange for used patches provided by the patient or his or her authorized representative.
  3. Dispensers must examine and document returned patches, and store them in a secure location prior to proper destruction as outlined in the College’s Fact sheet — Destruction of Narcotics, Controlled Drugs, and Targeted Substances.
  4. Where a dispenser receives a prescription for fentanyl patches but does not collect all of the patient’s used patches, or collects fewer patches than the quantity to be dispensed under the prescription, he or she must:
    i. Use his or her professional judgment to dispense an appropriate number of patches based on an assessment of the patient, including an assessment of the patient’s circumstances and the patient’s medical condition; and
    ii. Notify the prescribing physician of the number of used patches that were collected as well as the number of new patches that were dispensed, if any.
  5. Dispensers apply exceptions in the following circumstances:
    i. A prescription has been authorized by a prescriber from outside Ontario, and the prescription is verified by the dispenser; or
    ii. Another pharmacy is listed on the prescription, and the authenticity of the prescription is verified by the dispenser, and no fentanyl patches were dispensed by the other pharmacy.
  6. Dispensers apply exceptions when dispensing to a resident of a long-term care home, a person who is confined in a correctional facility, or a patient of a hospital, in the following circumstances:
    i. The facility has a written policy establishing a medication management system for the collection and administration of fentanyl patches; and
    ii. The dispenser has a copy of the policy.
Supplementary guidance for physicians:

Where applicable, the above requirements regarding fentanyl patches have been incorporated into the CPSO’s Prescribing Drugs policy. The following guidance is intended to assist physicians in addressing anticipated practical issues that arise under the legislation:

  1. Clearly communicate with patients: Physicians who prescribe fentanyl patches must ensure that patients understand the importance of keeping track of every patch that is dispensed, whether it is used or unused, as failing to do so may result in lost or stolen patches. Failing to return all used patches to the pharmacy may result in the pharmacist withholding new patches.
  2. Respect patient choice of pharmacy: Patients are entitled to choose the pharmacy that will fill the prescription.
  3. Collaborate professionally with pharmacists: A patch-for-patch program requires physicians and pharmacists to work in close partnership to ensure that patches are safely prescribed, dispensed, stored, and returned to the pharmacy.Physicians who prescribe fentanyl patches must respond in a timely and professional manner when contacted by a pharmacist to confirm the validity of a prescription, to raise questions or concerns regarding the patches that have been returned, or, where used patches have not been returned, to seek advice with respect to dispensing new patches based on the patient’s specific circumstances.
  4. Where patients fail to return used patches: Where a patient fails to return all of their used patches, and it is a not the patient’s first prescription, the regulations permit the pharmacist to use his or her professional judgment to dispense an appropriate number of new patches based on the specific circumstances of the patient. In all cases, pharmacists must notify the prescribing physician that used patches were not returned, and the number of new patches that were dispensed, if any.
Supplementary guidance for pharmacists:
  1. Dispense: In the event that the patch-for-patch aspect of the program has not been met, the pharmacist will dispense fentanyl patches based on professional judgement, and in accordance with the patient’s circumstances, history and the prescriber’s instructions.
  2. Communicate effectively with patients: The pharmacist will advise the patient on the requirement to store used patches securely, given the potential harm associated with the residual medication in the used patch.
  3. Notify the police: The act of notification is balanced against the obligation to protect patient privacy. Notification should only be undertaken where the pharmacist has concerns that counterfeit/misuse/tampering has occurred or that a pattern of returning zero patches, or fewer than were prescribed, indicates potential diversion activities. Suggestions on notification are listed in the “if you identify a forgery” section in the College Fact Sheet: Forgery: Tips for Identifying Fraudulent Prescriptions.
  4. Evaluate additional circumstances requiring contingency dispensing: In the event that a patient reports the theft of one or more fentanyl patches, prior to use, the pharmacist will require a police report. In the event that the patient reports that his or her fentanyl patches are lost, the pharmacist will evaluate the circumstances and the history with the patient and whether there is a demonstrated pattern of theft or loss.
    Where a patient requires more than the usual number of fentanyl
    patches due to planned travel, the patient should provide evidence of
    the dates of travel.
  5. Document: Document according to the requirements established under the Drug and Pharmacies Regulation Act and OCP Guidelines: Documentation Guidelines and Record Retention, Disclosure, and Disposal.

 


1 Safeguarding our Communities Act (Patch for Patch Return Policy), 2015, and O.Reg. 305/16: General
2 This notation will confirm for the dispensing pharmacist that the patient is not required to return previously used patches in order for the prescription to be filled.

3 Prescribers can be “reasonably satisfied” based on a discussion with the patient and any other information available to the prescriber.