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null Travel restrictions speeded up the adoption of remote inspections of pharmacies

Travel restrictions speeded up the adoption of remote inspections of pharmacies

19.10.2020

The inspection of pharmacies moved late summer to a new era when Fimea carried out the first remote inspections of pharmacies.

The preparation of the new inspection form began over a year ago as part of the reform of the supervision of the retail distribution of medicines with which Fimea is tasked. This development project was part of the Master's thesis of M. Sci. (Pharm.) Päivi Luhtanen.

The adoption of remote inspections was speeded up as the COVID-19 pandemic and travel restrictions caused on-the-spot inspections to be suspended last spring.

Efficient and useful

According to Pirjo Rosenberg, Head of Section, experiences gained from remote inspections have proved excellent.

– Of course, the adoption of the new method always requires a break-in period of some length, but the feedback that we have received from both pharmacists and inspectors has been positive, says Rosenberg.

According to Rosenberg, the feedback received from pharmacists has praised the form of inspection as being effective and useful in particular.

In remote inspections, the pharmacist responds to an enquiry on which the inspection is based and delivers other materials requested from him/her in advance to Fimea. Discussions with the pharmacist take place at agreed times over remote connections.

– Pharmacists have felt that this type of implementation and its preenquiry guide the auditee to consider how things should be implemented in the pharmacy in relation to the requirements laid down in legislation. In addition, pharmacists have stated that the threshold for asking questions is low, says Tiina Kuosa, Senior Pharmaceutical Inspector at Fimea.

According to Kuosa, the fact alone that the actors have felt encouraged to ask questions related to legislation is positive.

– The joint objective of both the operator and the authority is that the activities are in compliance with the regulations and are of the highest quality possible, says Kuosa.

From an audit tool to a self-assessment tool?

The electronic preenquiry, which forms the basis for remote inspection, has attracted interest in the pharmacy field.

– We have been asked if the questionnaire on which the audit was based could be made freely available to all pharmacies to be used, for example, as a self-assessment tool. It will be published on Fimea's website once we have polished up the form a bit and made it easier to use, based on the experiences and feedback, Rosenberg says.

The restrictions caused by the COVID-19 pandemic still prevent almost entirely on-the-spot inspections from being carried out. However, according to Rosenberg, the new inspection form enables pharmacy inspections to be continued at almost normal pace after a start-up phase.

– And, remote inspections are here to stay. With this implementation, we will be able to make better use of our resources, as we do not have to spend time on travelling and, above all, our implementation methods will be more flexible in different situations.

Further information:

Päivi Luhtanen's Master's thesis: Developing the remote inspection of pharmacies as part of pharmacy supervision conducted by the Finnish Medicines Agency

Ask more

  • Pirjo Rosenberg, Head of Section, Drug Distribution Section, tel. + 358 29 522 3246
  • Tiina Kuosa, Senior Pharmaceutical Inspector, Drug Distribution Section, tel. + 358 29 522 326
  • Päivi Luhtanen, Quality Problems Section, tel. +358 29 522 3263 (regarding the Master’s thesis)
  • E-mail address format: firstname.lastname@fimea.fi