Self-monitoring
- Published: December 7, 2020
- Last updated: December 7, 2020
The licence holder must monitor the pharmacy to ensure that medicinal products are being handled and sold in a safe manner.
A self-monitoring program will need to be implemented to ensure that the self-monitoring is effective, that deviations are handled and that regular internal inspections are conducted.
Self-monitoring program
By law, the licence holder must self-monitor their own pharmacy practice and ensure that there is a suitable self-monitoring program in place which has been customised for the specific pharmacy.
A self-monitoring program can be described as a type of quality system that undergoes regular review. It must, among other things, contain instructions for managing the pharmacy’s own practice.
The purpose of the self-monitoring program is to help the licence holder to ensure the quality of the handling and sale of medicinal products in structured way.
The Swedish MPA regulates that certain instructions must be included in the self-monitoring program.
Internal inspection
One part of self-monitoring is conducting internal inspections on a regular basis. During these internal inspections, checks take place to ensure that the practice meets all regulatory framework requirements and to ensure that the pharmacy’s staff are complying to the instructions in the self-monitoring program. If the internal inspections reveal deviations, these will need to be dealt with through assessment and subsequent rectification. Internal inspections may, for example, reveal that something in the self-monitoring program needs to be updated because the requirements have changed, or a different working method may be needed.
Handling of deviations
Handling of deviations is one part of the pharmacy’s self-monitoring. All handling of deviations regarding the pharmacy’s handling and sales of medicinal products, as well as the measures implemented, must be documented, compiled and evaluated. The purpose of the pharmacy’s handling of deviations, apart from rectifying issues that have emerged, is to learn from mistakes and implement preventative measures so that similar situations are avoided in the future.
Serious deviations and incidents must be reported to the Swedish MPA.