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Records of narcotic, controlled, and targeted drugs received must be kept onsite

November 12, 2020
Digitally signed invoices stored electronically do not meet legislative requirements. 

During recent pharmacy assessments, ACP pharmacy practice consultants have noticed that some pharmacies have been relying solely on digitally signed invoices stored electronically in their pharmaceutical wholesaler’s order management system (e.g., PharmaClik) as their narcotic/controlled drug record. The Regulatory Operations and Enforcement Branch of Health Canada has confirmed that this practice does not meet legislative requirements.

As a reminder, pharmacists are required to keep onsite records of narcotic, controlled, and targeted drugs received.

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.

These requirements are summarized on the ACP Prescription regulations summary chart.

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. 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 on the pharmacy premises. Any requests to store these records outside the pharmacy must apply to the ACP registrar for authorization to do so.
  • The record must clearly indicate the pharmacist who received the order.
  • The record must clearly indicate the date the narcotic was received (not the shipping date).

Moving forward, please review your policies and procedures regarding record keeping of narcotic, controlled, and targeted drugs received at your pharmacy and ensure that all pharmacy staff members understand and comply with these requirements.