Framework for Regulating Pharmacy Practice

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On September 27, 2024, the Board of Directors of the College of Pharmacy of Newfoundland and Labrador, with the approval of the Minister of Health and Community Services, filed Regulation 62/24 under the authority of the Pharmacy Act, 2024. This new regulation, effective immediately, provides a comprehensive framework for regulating pharmacy practice in the province, emphasizing standards for registration, licensing, practice, and the administration of drug therapy.

The regulations are officially titled “Pharmacy Regulations, 2024.” They include key definitions to ensure clarity, defining terms such as “ailment,” “preventable disease,” and classifications of drugs (Schedules I, II, and III) to guide practitioners. Essential roles such as “prescriber” and “inspector” are also defined, clarifying authority under the act.

The regulations specify requirements for the registration and renewal of pharmacists and pharmacy technicians. Practical training must be completed by both pharmacists and pharmacy technicians in approved facilities under the supervision of qualified professionals, in addition to any educational prerequisites.

In terms of pharmacy licensing, the regulations detail the processes for licensing new pharmacies, renewing licenses, and procedures for closing a pharmacy. The College issues licenses upon satisfactory application submissions that demonstrate compliance with the Pharmacy Act and relevant standards. Inspections ensure that pharmacies meet operational and safety standards before licensing is granted. When closing a pharmacy, owners must submit closure applications and ensure proper disposal of controlled substances, with prescription records remaining accessible through other pharmacies.

The regulations also establish the role and responsibilities of the pharmacist in charge of a pharmacy. A pharmacist may be designated as the pharmacist in charge if they meet specific criteria set by the College. The pharmacist in charge is responsible for managing the pharmacy, enforcing compliance with legislation and standards, maintaining patient record confidentiality, and ensuring adequate staffing.

The regulations address the practice scope for pharmacists, including the administration of drug therapies and prescribing. There are specific prohibitions and authorizations related to administering drug therapy by inhalation or injection, ensuring adherence to established standards. Pharmacists are granted the authority to prescribe medications under certain conditions, which include adapting prescriptions, therapeutic substitutions, and managing post-exposure prophylaxis for specific diseases.

The regulations aim to improve the quality of care and ensure safe practices by establishing rigorous standards for training, licensing, and operational compliance. This initiative seeks to empower pharmacists while safeguarding public health, adapting to evolving healthcare needs, integrating technology through the pharmacy network, and promoting responsible medication management.

Newfoundland & Labrador (62/24) September 27, 2024