Amendments to the Pharmacy and Drug Act (PDA) and the Pharmacy and Drug Regulation (PDR) come into effect today, June 1, 2022. Efforts to amend the PDA and PDR began in 2018. This marks the first step in ACP’s pursuit of modernized legislation that governs the practice of pharmacy professionals and the operation of pharmacies.
Most of these amendments were introduced in the Health Statutes Amendment Act (Bill 65-2021). Collectively, they provide more flexibility to establish licensing requirements for licensed pharmacies, enable new authorities to ensure proprietors understand their responsibilities under the Act, and provide harmonization with the Health Professions Act (HPA). Through these amendments
- proprietors must meet requirements established in the regulations;
- agreements entered by the Minister or the council with organizations in other jurisdictions responsible for governing pharmacy practice will include pharmacy technicians;
- more flexibility in establishing requirements about the structure of pharmacies, the storage of drugs, and the maintenance of records exists, as these will now be addressed in standards;
- authority for setting pharmacy fees is harmonized with that under the HPA for pharmacists and pharmacy technicians; and
- authority for identifying field officers shifted from the regulations to the bylaws.
Many of the amendments to the PDR are a result of amendments to the PDA. Some of the more significant amendments follow:
- The definition of “proprietor’s representative” has been amended to clarify the responsibility of this individual to represent the proprietor and to be responsible for ensuring that the proprietor complies with the proprietor’s obligations under the Act.
- Clinical pharmacists applying for a pharmacy licence must meet requirements with respect to experience, training, and evaluation required by Council.
- An electronic copy of a pharmacy’s operating procedures and quality assurance procedures must be submitted to the registrar at the time of application for a licence.
- New information about pharmacy owners and proprietors’ representatives is required at the time of applying for a pharmacy licence. **
- An application for renovation is required 30 days before the intended change.
- Sections 12-16 respecting physical facilities, hours of operation, records, types of records, pharmacy area, dispensary, patient services area, distinguishing areas of the pharmacy; and section 21 respecting products storage, dispensary, and patient services area have been rescinded and authority for these transferred to the Standards for the Operation of Licensed Pharmacies (SOLP).
- Advertising restrictions have been expanded requiring that a licensee or a proprietor must not
- claim to offer or imply that it offers specialized pharmacy services or that it is a specialist unless that specialized pharmacy service or specialty is authorized by the registrar pursuant to an approval by the Council, and,
- solicit the transfer of prescriptions or the transfer of care of patients.**
- A licensee must ensure that a pharmacy employs an appropriate number and combination of pharmacists, pharmacy technicians, other regulated health professionals and non-regulated staff for the safe and effective provision of pharmacy services.**
- A licensee must ensure that a criminal records check is conducted of all unregulated individuals engaged by the pharmacy to support or provide assistance in the provision of a restricted activity or the delivery of a drug to a patient.**
** – will be addressed in further detail in a future edition of The Link