During recent pharmacy inspections, pharmacy practice consultants (PPCs) have received questions from regulated members about the requirement of completing and documenting a final check prior to dispensing compounded and repackaged medications (e.g., compounded preparations, blister packs/compliance packs, or vials).
In addition, PPCs have observed community pharmacy teams receiving blister packs and vials from compounding and repackaging licensed pharmacies and placing the medications directly in the pick-up bin without completing their own final check.
A separate final check must always be completed by the community licensed pharmacy prior to dispensing the compounded or repackaged medication to the patient.
Standard 7 of the Standards of Practice for Pharmacists and Pharmacy Technicians (SPPPT) requires that each time a pharmacist or pharmacy technician dispenses a Schedule 1 drug or blood product pursuant to a prescription, the pharmacist or pharmacy technician must ensure that
- the prescription is filled correctly,
- appropriate dispensing procedures are used,
- the drug or blood product is packaged properly,
- the container is labeled properly, and
- a final check is performed.
As per Standard 7.14 of the SPPPT, a pharmacist or a pharmacy technician who dispenses a drug must perform a final check in order to be satisfied that each step in the dispensing process has been completed properly by verifying that
- the drug dosage form, strength, manufacturer, and quantity dispensed are correct according to the prescription;
- the prescription label is accurate according to the prescription and contains the information required under this standard and under federal and provincial legislation; and
- appropriate auxiliary instruction labels are affixed.
As outlined in Standards 7.16 and 7.17 of the SPPPT, there must be a clear audit trail of the dispensing process, including the final check. A compounding and repackaging licensed pharmacy must perform a final check as per Standard 21 of the SPPPT, and ensure there is sufficient documentation to provide a clear audit trail for the compounded and repackaged medication prior to distribution to the community licensed pharmacy. However, the final check by the compounding and repackaging licensed pharmacy does not replace the final check required by the community licensed pharmacy within Standard 7 of the SPPPT.
As a reminder, regulated members at the community licensed pharmacy from which the patient receives the drug and is provided care must have a professional relationship with the patient. Pharmacists must complete the patient assessment as required by Standard 6 of the SPPPT, and must confirm the appropriateness of the compounded and repackaged medication prior to dispensing. This includes verifying indication, effectiveness, safety, and usage or adherence, and then documenting that this process occurred. The Check up on “checking” tool is a useful resource to support confirming appropriateness.
Regulated members must adhere to the requirements outlined in the SPPPT when dispensing all medications, including those that have been prepared by pharmacies with a compounding and repackaging licence. This is an essential step for regulated members to protect the public’s health and well-being and uphold excellence in pharmacy practice.
Licensees of community pharmacies should review their policies and procedures with their pharmacy teams to ensure that the final check is being completed for all medications, including compounded and repackaged medications received from a compounding and repackaging licensed pharmacy.
