Quality responsible pharmacist

Competency and experience

By law, the quality responsible pharmacist must have sufficient experience and competency to be able to carry out their tasks. According to the Swedish MPA regulations, the quality responsible pharmacist must have the following:

• At least 2 years experience as a pharmacist for a dispensing pharmacy;
• At least one year of experience of quality‍-‍related self‍-‍monitoring work tasks, either at a pharmacy, in the pharmaceutical industry or an equivalent;
• A good knowledge of the current regulatory framework for pharmacy practice;
• A good knowledge of the responsibilities that a quality responsible pharmacist has at a pharmacy.

Responsibilities

The quality responsible pharmacist

• is responsible for ensuring that the dispensing pharmacy meets the requirements for sales and handling of medicinal products in general;
• has overall responsibility for monitoring quality in the practice;
• must ensure that the pharmacy meets self‍-‍monitoring requirements;
• must ensure that there is an up‍-‍to‍-‍date and implemented self‍-‍monitoring program in place
• must ensure that regular internal inspections are conducted;
• is responsible for ensuring that deviations and incidents that emerge are assessed and suitable measures for rectification are implemented.

If serious deviations emerge, if a risk of such is posed or if there are serious incidents in the practice, the quality responsible pharmacist has a duty to report this to the Swedish MPA as soon as possible after the issue has been identified.

Participating in inspections

The quality responsible pharmacist is expected to be present at Swedish MPA inspections. The licence holder will be notified of the results of the inspection.

The licence holder’s responsibilities

The pharmacy licence holder:

• appoints a quality responsible pharmacist;
• registers this person with the Swedish MPA;conducts an assessment of the person’s experience and competency;
• verifies that the requirements are met.

One pharmacist may be quality responsible pharmacist for up to three pharmacies. The Swedish MPA may, whenever there are special reasons to do so, decide that a pharmacist can be quality responsible pharmacist for more pharmacies.

If the quality responsible pharmacist is absent for a longer period, the licence holder may temporarily replace them with a different pharmacist for a period of up to 6 months. After this period of time a new quality responsible pharmacist must be appointed and registered with the Swedish MPA.

It is the licence holder’s responsibility to ensure that the quality responsible pharmacist is allocated the time and resources and has the influence necessary to carry out their tasks.