In an important move for quality and safety, the Alberta College of Pharmacy (ACP) has introduced a complete set of standards and guidance governing non-sterile compounding in pharmacies. Working from the Model Standards for Pharmacy Compounding of Non-Sterile Preparations developed by the National Association of Pharmacy Regulatory Authorities (NAPRA), in addition to consultation with regulated members, ACP built standards specifically for pharmacies in our province.
ACP deputy registrar Jeff Whissell helped to lead the development of the new documents, and believes that they are essential to ensure both patient safety and the safety of personnel involved in compounding non-sterile drugs.
“The genesis was really recognizing that pharmacists needed a greater level of support out there. They were asking questions, and the public’s expectations for drug safety are extremely high.”
Pharmacists will now be expected to begin with an assessment that examines the types of preparations that they are compounding and determines the risks involved for the patients and the employees performing the tasks. A quality assurance program for compounding will also be required, and certain alterations in training, equipment, and/or physical renovations may be necessary.
The rules will apply to new pharmacies effective immediately, but existing pharmacies have time to comply via the phased implementation plan. All pharmacies performing non-sterile compounding must achieve the standards involving human factors (risk assessment, PPE, additional training, etc.) by January 1, 2020. Other areas that may require renovations or additional equipment have a deadline of July 1, 2020.
“Colleges across Canada are putting rules in place based on the NAPRA model,” said Jeff. “These standards will ensure that Alberta is at the forefront of safe and effective compounding.
Standards for Pharmacy Compounding of Non-sterile Preparations
Guidance Document for Pharmacy Compounding of Non-sterile Preparations
