Pharmacy teams are required to maintain their own written or electronic records of narcotic, controlled, and targeted drugs received. The Regulatory Operations and Enforcement Branch of Health Canada has confirmed that relying solely on digitally signed invoices stored electronically in their pharmaceutical wholesaler’s order management system as their narcotic/controlled drug record does not meet legislative requirements.
As per section 30 of the Narcotic Control Regulations, pharmacists must create a record when they receive narcotics from a licensed dealer. Similar record requirements may be found for controlled drugs under section G.03.001(1) of the Food and Drug Regulations, and for targeted substances under section 50 of the Benzodiazepines and Other Targeted Substances Regulations. The narcotic/controlled drug record must contain
- drug name;
- quantity received;
- date received; and
- name and address of the licensed dealer, pharmacist, or hospital.
The narcotic/controlled drug record must be retained onsite in the pharmacy for at least two years and be kept in a manner that permits auditing. As indicated in the Standards for the Operation of Licensed Pharmacies, the pharmacy must have an effective system for the creation, maintenance, secure storage, and retrieval of all records. All required records must be stored securely to ensure that only persons authorized by the licensee have access to the records. Electronic records stored offsite in a wholesaler’s order management system may become unavailable should the pharmacy change suppliers or should the supplier’s data integrity be compromised.
A pharmacy’s narcotic/controlled drug record may take several forms, such as a file of invoices organized by receipt date or a separately created register or log. When creating your pharmacy’s record, remember the following:
- The record may be paper-based or electronic, although it must be stored in the dispensary. To store these records outside of the dispensary, the licensee must apply to the ACP registrar for authorization to do so.
- The record must clearly indicate the pharmacist who received the order, including the pharmacist’s signature and printed name.
- The record must clearly indicate the date the narcotic was received (not the shipping date).
Licensees are encouraged to review and revise the pharmacy’s policies and procedures regarding record keeping of narcotic, controlled, and targeted drugs received and ensure that all pharmacy staff members understand and comply with these requirements.