5 Things to Know about Centralized Prescription Processing (Central Fill)

The term central fill pharmacy is defined solely for the purpose of the Policy – Centralized Prescription Processing (Central Fill) and is not a separate class of accreditation. The policy permits an accredited community pharmacy in Ontario to provide “central fill” services by entering into an agreement to prepare prescription orders for another accredited community pharmacy (defined as the originating pharmacy).

All pharmacies, regardless of the services provided, must meet the standards for accreditation and operation as defined in the Drug and Pharmacies Regulation Act (DPRA) and as established by the College.

Similarly, registrants must meet the Standards of Practice on all prescriptions regardless of the services provided. For example, pharmacists at the originating pharmacy must perform the patient assessment, review the prescription for therapeutic appropriateness, and provide counselling when the prescription is dispensed; registrants at the central fill pharmacy must ensure the prescription is technically accurate and record keeping is in accordance with the DPRA.

The originating pharmacy has the responsibility for disclosing patient information in compliance with the Personal Health Information Protection Act (PHIPA), and posting a notice or making a written statement readily available to inform patients about:

• The assumption of implied consent (i.e., within the circle of care) for the transfer of personal health information (PHI) to the Central Fill pharmacy for prescription processing. 
• How to expressly (verbally or in writing) change, withhold or withdraw their consent at the originating pharmacy. 
  

For transparency and to ensure record keeping requirements are met, the prescription or auxiliary label must clearly show when a prescription was prepared by the central fill pharmacy, including the date of preparation and the transaction/prescription number assigned.

The Policy – Centralized Prescription Processing (Central Fill) permits a central fill pharmacy to act as an agent of the originating pharmacy to prepare and package prescription orders. Legislation, such as the federal Food And Drug Regulations, C.01.001 and the provincial Drug and Pharmacies Regulation Act, s1(1), clearly indicates that a prescription is patient-specific. There must be an auditable and traceable method to identify which prescriptions were transmitted to the central fill pharmacy for processing.

If central fill is being used for compounded preparations, Health Canada’s Policy on Manufacturing and Compounding Drug Products in Canada (POL-0051) does not permit a preparation to be compounded in bulk, or in anticipation of a prescription, for the originating pharmacy.

There must be an agreement in place between the Designated Managers of the pharmacies that fulfills the criteria outlined in the Policy – Centralized Prescription Processing (Central Fill).

The College must be notified of the agreement, or of changes to an existing agreement, within seven days using the Central Fill Notification Form. A copy of the agreement does not need to be sent, however should be readily available upon request.

A central fill arrangement adds complexity to the overall dispensing process which introduces incremental risk for an incident to occur. As such, the Policy – Centralized Prescription Processing (Central Fill) requires Designated Managers to establish sufficiently detailed policies and procedures to mitigate these risks, ensure the entire process is auditable and traceable, and to maintain a quality assurance program.

When central fill is used for compounded preparations, the degree of potential risk is even greater, and it is difficult – if not impossible – to visually inspect the final preparation for accuracy prior to dispensing. The Designated Manager of the originating pharmacy has an obligation to ensure the prescription – even though prepared by another accredited pharmacy – is of acceptable quality and safe for dispensing to the patient. Due diligence is necessary to ensure the central fill pharmacy meets all applicable NAPRA compounding standards by conducting a comprehensive review of their operations, both prior to utilization of this service, and on an ongoing basis.

Should a formal complaint arise, the dispensing process as a whole, and the conduct of all registrants involved, may be subject to the subsequent investigation.