Centralized Prescription Processing (Central Fill)

POLICY

Approved: September 2005; Revised September 2014

Legislative references:

  • Drug and Pharmacies Regulation Act
  • The Controlled Drugs and Substances Act
  • Benzodiazepines and Other Targeted Substances Regulations
  • Narcotic Control Regulations

Additional references:

  • Model Standards of Practice for Pharmacists
  • Model Standards of Practice for Pharmacy Technicians
  • Documentation Guidelines
  • Record Retention, Disclosure, and Disposal Guidelines

College Contact: Pharmacy Practice


Introduction

Centralized prescription processing (central fill) refers to a service one pharmacy provides to another where the central fill pharmacy processes a request from an originating pharmacy to prepare a drug order. Medications packaged by a central fill pharmacy are dispensed by the originating pharmacy pursuant to a prescription. Each participating pharmacy is required to be accredited by the Ontario College of Pharmacists.


Definitions

Originating pharmacy

The originating pharmacy is defined as the patient contact pharmacy accredited by the Ontario College of Pharmacists that uses a central fill pharmacy to prepare and package prescription orders for the purposes of dispensing and provision of patient care by the originating pharmacy.

Central fill pharmacy

The central fill pharmacy is defined as a pharmacy accredited by the Ontario College of Pharmacists acting as an agent of the originating pharmacy to prepare and package prescription orders on the originating pharmacy’s direction.


Policy

Members are obligated to protect the health, safety and well-being of patients. There must be transparent and auditable policies and procedures when using a central fill process to support patient safety.

Responsibilities of Both Pharmacies

  1. Pharmacists, pharmacy technicians, pharmacy managers and owners are required to:
    • Maintain the Standards of Practice and comply with the Code of Ethics and all federal and provincial legislative requirements.
    • Ensure the security of all data transmission to protect the privacy, confidentiality and integrity of patient information.
    • Ensure accurate labelling that is compliant with legislative requirements.
    • Ensure accurate record keeping that is compliant with legislative requirements and the Record Retention, Disclosure, and Disposal Guideline.
    • Maintain a mechanism for tracking the prescription drug order through the stages of the drug preparation and patient care process, including documentation of the member responsible.
    • Maintain a continuous quality assurance program with the participation of both pharmacies. At a minimum the program must monitor the quality and integrity of the process to ensure patient safety and confidentiality, maintain and support patient care, and resolve identified problems.
  2. The prescription or auxiliary label must clearly show that the medication was prepared and packaged by a central fill pharmacy and not by the originating pharmacy including the date of preparation and packaging and the transaction/prescription number used for cross referencing at the central fill pharmacy.
  3. The central fill pharmacy must have the same ownership as the originating pharmacy or a legally binding contract with the originating pharmacy. Documentation will include the services to be provided and the roles, responsibilities and accountabilities of each party in fulfilling the terms of the contract.
    • If the two pharmacies have common ownership, this agreement may take the form of a corporate policy.
    • The agreement will be signed by the owner and designated manager of both the central fill and originating pharmacy.
    • A new agreement will be signed within 7 days upon change of ownership or designated manager.
    • The agreement will be available to the Ontario College of Pharmacists upon request.
  4. The owner/designated manager must provide notice of the provision or utilization of central fill services to the Ontario College of Pharmacists within 7 days upon entering into an agreement.
  5. Drugs listed in the Controlled Drugs and Substances Act (CDSA) and regulations (i.e. narcotics, controlled drugs, and benzodiazepines and other targeted substances) cannot be processed by centralized prescription processing. (1)
  6. It is important for both the central fill and originating pharmacy to document policies and procedures. Items to consider may include the following:
    • How patient confidentiality and the privacy of personal health information will be maintained according to the requirements of provincial and/or federal privacy legislation;
    • The mechanism for auditing each step in the drug preparation and patient care process, including how the individual responsible for each step in the process is identified;
    • The procedures to ensure that all pharmacies involved in dispensing the prescription order will be identified on the prescription or auxiliary label;
    • How the central fill pharmacy will process the records of requests received from the originating pharmacy and maintain them for the purposes of filing and record keeping. All records will be maintained for a minimum of ten years at the central fill pharmacy;
    • The process to establish effective two-way communication between pharmacies on pertinent patient or prescription information.

Responsibility of the Originating Pharmacy

  1. Receiving the prescription from the patient or the patient’s agent and providing the medication and other pharmacy services to the patient or the patient’s agent.
  2. Providing patient care and ensuring the best patient outcomes.
  3. Maintaining all documentation relating to the prescription and patient and accountability for the prescription authority.
  4. Ensuring the overall processing of prescriptions as required by the DPRA and meeting the terms of the agreement with the central fill pharmacy including but not limited to prescription order entry and filing and storing of all documentation relating to the prescription and the patient for a minimum of ten years as per record keeping requirements.
  5. Ensuring there is a method of identifying which prescriptions were transmitted to the central fill pharmacy for processing.
  6. Meeting the Standards of Practice for members on all prescriptions including but not limited to collecting and documenting all relevant patient information, performing the patient assessment, reviewing all prescriptions for appropriateness, identifying and resolving drug therapy problems, providing all patient education and information and performing monitoring and follow-up. All interactions with the patient, the patient’s agent and health care professionals are the responsibility of the originating pharmacy.
  7. Ensuring that the patient or the patient’s agent has provided informed consent to the fact that the prescription will be processed by a central fill pharmacy and that there will be transfer of personal health information. This consent is documented and current and maintained by the originating pharmacy.

Responsibility of the Central Fill Pharmacy

  1. Ensuring the preparation of prescriptions as required by the DPRA and meeting the terms of the agreement with the originating pharmacy including but not limited to the accuracy of labelling, packaging, processing and record keeping of the drug product preparation.
  2. Maintaining all records associated with the processing of prescriptions for a minimum of ten years as per record keeping requirements.
  3. Ensuring the safety and integrity of the drug product until received by the originating pharmacy. There must be an established process in place that gives assurance to the originating pharmacy of this integrity.

References

1. Health Canada has stated that pursuant to subsection 45(1)(b) of the Narcotic Control Regulations and subsection G.03.014(b) of Part G of the Food and Drug Regulations the sale/provision of narcotics or controlled substances from one pharmacy to another is allowed only in emergency situations. Section 55(1)(b)(ii) of the Benzodiazepines and Other Targeted Substances Regulations also states that one pharmacist can sell/provide to another pharmacist if it is required because of a delay or shortfall in an order for the targeted substance placed with a licensed dealer. Pursuant to paragraph 24(2)(b) of the Narcotic Control Regulations, paragraph G.02.024(1)(b) of the Part G of the Food and Drug Regulations and subparagraph 15(2)(c)(ii) of the Benzodiazepines and Other Targeted Substances a licensed dealer may sell or provide a narcotic, a controlled drug or a targeted substance to a pharmacist (please note that a licensed dealer is referring to a controlled substance license). Should a pharmacy become a licensed dealer, the pharmacy as a licensed dealer will be able to sell or provide narcotics, controlled drugs and targeted substances to another pharmacist on the reception of a written order and provided all the requirements of the relevant regulations are met. Please note that depending on the activities the pharmacy wishes to perform, an establishment license may also be required.