Policy for the Use of Central Fill in Ontario
Council, September 2005
Principles:
1. The patient accesses and receives prescription and other pharmacy services from the “originating pharmacy”
2. The prescription must be received, dispensed and filled from a pharmacy accredited in Ontario.
3. Pharmacists involved in the central fill process must maintain all Standards of Practice.
4. Written consent from the patient is required for any personal health information data transfer.
5. The designated manager and owner of both the originating pharmacy and the central fill pharmacy are responsible for the security of all data transmission.
6. The prescription authority and all documentation relating to the prescription and the patient remains in the originating pharmacy.
7. The designated manager and owner of both the originating pharmacy and the central fill pharmacy must report to the Ontario College of Pharmacists in writing that they participate in a central fill arrangement.
8. The designated manager and owner of both pharmacies are responsible for accurate record keeping, labeling and all legislative requirements.
Definitions
“Originating pharmacy” is defined as a pharmacy accredited by the Ontario College of Pharmacists that uses a central fill pharmacy to fill or process prescription orders for the purposes of dispensing by the originating pharmacy.
“Central Fill pharmacy” is defined as a pharmacy accredited by the Ontario College of Pharmacists acting as an agent of the originating pharmacy to fill or process prescription orders on the originating pharmacy’s direction.
Ownership Requirements
1. Central fill may only take place between pharmacies accredited in the Province of Ontario.
2. The Ontario College of Pharmacists must be provided with 30 days written advance notice of the intent to operate or utilize the services of a central fill pharmacy, in order to ensure compliance with all requirements and legislation.
3. The Central fill pharmacy must have the same ownership as the originating pharmacy or a legally binding contract with the originating pharmacy outlining the services and responsibilities ensuring that all legislative requirements are met.
3.1 The agreement will be signed by the owner and Designated Manager of the Central Fill pharmacy and the Originating pharmacy.
3.2 A new agreement will be signed upon change of ownership or designated manager within 7 days of any changes.
3.3 The agreement will be available to the Ontario College of Pharmacists upon request.
Patient Consent
4. The originating pharmacy may only transmit a request to a central fill pharmacy where a patient has been advised of their rights and written consent by the patient has been provided.
5. Written patient consent is valid for 2 years and maintained on site at the originating pharmacy.
Responsibility of the Originating Pharmacy
6. The overall processing of prescriptions as required by the Drug and Pharmacies Regulation Act (DPRA) and claims adjudication is the responsibility of the originating pharmacy.
7. The originating pharmacy remains responsible for meeting the Standards of Practice for pharmacists on all prescriptions which includes reviewing all prescriptions and identifying and resolving drug related problems. All interactions with the patient, their agent and health care professionals are the responsibility of the originating pharmacy.
Responsibility of the Central Fill Pharmacy
8. The Central Fill pharmacy is responsible for meeting the legislative requirements, Standards of Practice and the terms of an agreement including but not limited to the accuracy of labeling, packaging, processing and record keeping of the drug product preparation. All records will be maintained on the premises for a minimum of 2 years at the Central Fill pharmacy.
9. The Central Fill pharmacy is responsible for the safety and integrity of the drug product until received by the originating pharmacy.
Quality Control
10. A continuous quality control program must be in place and maintained with participation by both pharmacies involved in the central fill process. At a minimum the program must monitor the quality and integrity of the process to ensure patient safety and confidentiality. Records or supporting documentation will be made available forthwith to the Ontario College of Pharmacists. (i.e. Discrepancy reports / Security Breaches)
Policy and Procedures
11. A policy and procedures manual of the central fill process will be maintained by both the Central Fill and Originating pharmacies.
11.1 The manual will outline how patient confidentiality and privacy of patient health information will be maintained and meet the requirements of any Provincial or Federal Privacy legislation.
11.2 The manual will outline how the parties will comply with federal and provincial legislation.
11.3 The manual will describe an audit procedure for the processes involved. It will include the roles and responsibilities of all individuals involved in the processing of each prescription from the originating pharmacy to the central fill pharmacy and the return to the originating pharmacy for dispensing.
11.4 The manual will outline the procedures for ensuring that all prescription labels meet the requirements of the DPRA. In addition, the label or auxiliary label will identify the name of the central fill pharmacy, indicate that the prescription was filled using central fill, the date filled and the transaction / prescription number used for cross referencing at the central fill pharmacy.
11.5 The manual will outline 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 on the premises for a minimum of 2 years at the Central Fill pharmacy.
