National Association of Pharmacy Regulatory Authorities (NAPRA) Guidelines
The National Association of Pharmacy Regulatory Authorities (NAPRA) is a voluntary association of provincial and territorial pharmacy regulatory bodies, as well as the Canadian Forces Pharmacy Services.
Their members regulate the practice of pharmacy and the operation of pharmacies in their respective jurisdictions in Canada. Their primary mandate is to protect the public. The association provides a platform for its members to discuss issues and to take a national approach in addressing common issues in the practice of pharmacy in Canada.
The NAPRA Guidelines outlined the minimum requirements for information management systems used by pharmacy professionals in the delivery of quality care and services. There are 38 requirements, which have been reviewed to ensure their applicability to both community-based pharmacies and hospital pharmacies. The following requirements below outline how GS1 standards are included within the NAPRA guidelines.
Requirement 36: Traceability and Bulk Preparation Record-Keeping
Every PPMS must provide authorized users with the capability to create, access and update records of drugs that have been compounded or repackaged in bulk by pharmacy professionals, including:
- Global Trade Item Number (GTIN), batch number, batch preparation date and beyond use date (this combination is unique to bulk preparation)
- Lot number and expiry date of all components
- Used to prepare the product and, where applicable, lot numbers of dosing devices
- The identity of the pharmacy professionals who prepared the batch
Requirement 37: Traceability and Bulk Preparation Labelling
Every PPMS must provide authorized users with the capability to print a preparation label for primary packaging, such that:
- The bulk preparation is identified by brand-name, non-proprietary name or both – as appropriate – and printed in human-readable format
- The bulk preparation is also identified by a combination of Global Trade Item Number (GTIN), lot number and beyond use date printed in machine-readable and human-readable format
- A list of active ingredients is printed in human-readable format showing the amount of each ingredient present and the net contents (such as dosage units, mass or volume)
- Where applicable, the notation “sterile” is printed in human-readable format
- In the case of injectable preparations:
- For single dose use only, “use for single dose only” is printed in human-readable format along with the total dose
- For multiple dose use, “use for multiple doses” is printed in human-readable format along with total dose, total volume and concentration
Requirement 38: Automated Data Input from Barcode Labels
Every PPMS must provide authorized users with the capability to read GS1 barcodes on the products, dispensing or preparation labels on primary packaging and automatically input data fields into relevant records, including machine-readable ones, including:
- Global Trade Item Number (GTIN) to identify the product
- Lot or batch number
- Beyond use date
Where available, also include the following:
- Product serial number
- Machine-readable patient identifiers
The Supplemental Requirements reflect the minimum requirements for PPMS for record keeping and label printing for the routine preparation of drugs compounded and repackaged in bulk. The requirements also apply to dispensing environments and include information in both human-readable and machine-readable formats.
To review the NAPRA Pharmacy Practice Management Systems Supplemental Requirements, click here (External link opens in new tab.).
To review the NAPRA Pharmacy Practice Management Systems Supplemental Requirements on Traceability and Bulk Preparation Labelling, click here (Document link opens in new tab.).
For access to the NAPRA Guidelines Webinar, click here (External link opens in new tab.).