Published: July 2014 (Revised January 2018)
- Ontario Regulation 264/16 Drug and Pharmacies Regulation Act (s.20-21)
College Contact: Pharmacy Practice
Recordkeeping requirements are established in accordance with Ontario Regulation 264/16 (Drug and Pharmacies Regulation Act), s. 20 and 21. In addition, the Record Retention, Disclosure, and Disposal Guideline specifies that a pharmacy is required to make and maintain a scanned electronic copy of every original prescription pursuant to which a drug is dispensed as well as a copy of the information required by subsection 156 (1) of the Act and retain those electronic copies as part of the patient record.
The Patient Record
A patient record is the complete account of a patient’s care, comprising personal health information collected or generated by the pharmacy in any form or medium. It is comprised of the patient profile, scanned copy of the original prescription, prescription information, dispensing record of all prescriptions (new and refill) with pharmacist/technician authorization and any documentation or information about the patient, including for example:
- MedsCheck documentation
- Pharmacist refill authorization information
- Pharmaceutical Opinion
- Medication Management
- Identified drug related problems
- Consent forms
- Dialogue with patients or
- Any other information essential for continuity of care and
- Any future record keeping requirements under the new expanded scope of practice
Pharmacies shall maintain the records and documents that comprise the patient record in a computer system where possible and, where that is not possible, shall maintain them in a systematic manner that allows for their easy retrieval. While records (paper or electronic) may be stored off site, registrants remain responsible for their easy retrieval in ensuring continuity of care and meeting the standards of practice of the profession. Furthermore, designated managers must consider their responsibility in the safety and security of all off site records, including controlling access to areas where records are stored and taking steps to protect records from fire, flooding, viruses, and other hazards.
Length of Retention
All records and documents relating to the care of a patient, shall be maintained for a period of at least 10 years from the last recorded professional pharmacy service provided to the patient or until 10 years after the day on which the patient reached or would have reached the age of 18 years, whichever is longer. The entire patient record must be retained as a whole. These records and documents may be maintained as scanned originals.* Therefore, the decision to destroy paper based records once scanned is left to the discretion of the designated manager; and should include an evaluation of current software solutions, scanning technology, safeguards and backup processes.
- Example 1: If the patient has been coming to the pharmacy for 4 years and the last recorded professional service was on July 1, 2013 all records and documents relating to the care of that patient (ie; for the last 4 years) would need to be retained by the pharmacy until June 30, 2023 (10 years)
In the event that the patient is under 18 years of age when they receive their last recorded professional pharmacy service all records and documents relating to the care of that patient shall be maintained for the period of time required to reach the age of 18 plus an additional 10 years.
- Example 2: If the patient, used in the example above was only 4 years old on July 1, 2013 (which was their birthday) when they received their last recorded professional pharmacy service, all records and documents relating to the care of that patient (ie; for the last 4 years) would need to be maintained until June 30, 2037 (a total of 24 years; 14 years for the patient to reach the age of 18 and then ten years beyond that).
If the patient continues to use the services of your pharmacy, the patient record would need to be retained on file for an indefinite period of time (i.e. forever).
*Note: Health Canada has clarified that so long as prescriptions are scanned into a secure database and maintained electronically for the required retention period, there is no longer a need to retain original written prescriptions.
All pharmacies shall have equipment capable of generating and storing scanned documents, including electronic copies of every original prescriber generated prescription, as well as a copy of the dispensing record for all prescriptions, both new and refill (hard copy containing pharmacist/technician authorization). Pharmacies should contact their software vendor for direction on scanners and how to integrate them into computer systems.
Safeguards and Backup
A pharmacy shall ensure that appropriate safeguards are installed and maintained to ensure that the records and documents required to be kept by a pharmacy which contain personal health information are collected, recorded, used, stored, handled and destroyed in a manner that protects confidentiality and privacy. Further to this, a pharmacy shall ensure it has adequate backup and recovery systems in place to recover information stored in its computer system. In order to meet these requirements the records may be stored in a fireproof and theft-resistant safe, or off-site in a secure location in a manner that maintains the confidentiality and privacy of the personal health information contained in them, Patient records must be readily retrievable to ensure that they are accessible in the event of a request.
It is understood that there are a variety of ways in which a pharmacy could achieve compliance with the record keeping and scanning requirements established in regulation and the College is not prescribing, nor approving, any specific method. Whether the method involves scanning the original prescription as well as the paper ‘hard’ copy with ‘wet’ signatures or the adoption of a paperless solution which utilizes a secure technology to affix and authenticate electronic signatures, pharmacies have the discretion to choose the process that works best for them.
As with other systems and processes within a pharmacy the designated manager is responsible and accountable for ensuring that the chosen method for record keeping and scanning meets all applicable standards and is compliant with relevant legislation and regulation.