Changes to pharmacy regulations after NIK audit

In 2017, NIK conducted an audit on hospital pharmacies and hospital pharmacy departments. The audit results showed that neither the management of medications nor the functioning of  pharmacies and pharmacy departments in hospitals guaranteed safe hospital treatment. Moreover, some of the identified irregularities posed a threat to patient health and life.

In part of the audited hospitals, it happened that pharmacists were not present in pharmacies/ pharmacy departments and pharmaceutical services were provided by unauthorised persons. That was a crucial factor lowering the safety level of hospital pharmacotherapy. That practice, usually resulting from staff shortages, was a breach of the Pharmaceutical Law Act.

To eliminate that negative phenomenon, NIK has recommended that the law should define how many pharmacists need to work in hospital pharmacies and pharmacy departments. As a result of the legislative process initiated by the Council of Ministers, the amendment proposed by NIK has been made to the Pharmacy Law. Now the required number of pharmacists in hospital pharmacies and pharmacy departments is determined by the number of beds and dialysis machines in a given hospital.

In the majority of the audited hospitals, their directors did not obtain required training information from pharmacists hired in pharmacies and pharmacy departments. Therefore, the hospital management lacked knowledge if the pharmaceutical services in hospitals were provided by qualified persons. The main reason was the absence of an adequate regulation in the applicable law. That is why, NIK has recommended that the Minister of Health should take legislative measures to oblige hospital directors under the Pharmacy Law to monitor the required training coverage by pharmacists.

A form of implementing NIK’s de lege ferenda proposal in this area has been an amendment to the Pharmacy Law made by implementing the Act on the Pharmacist Profession. According to the new law, pharmacists are now obliged to immediately present a professional development certificate to their employer.

Both the hospital directors’ obligation to ensure the minimum headcount of pharmacists and the pharmacists’ obligation to provide required training information to hospital directors came into force on 16 April 2021.


Article informations

Date of creation:
23 April 2021 00:02
Date of publication:
23 April 2021 00:02
Published by:
Marta Połczyńska
Date of last change:
23 April 2021 12:38
Last modified by:
Marta Połczyńska
A pharmacy with two pharmacists inside

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