NIA speaks out about changes to the regulation: they will hinder access to high-quality medicines
- Pharmacists are particularly concerned about the obligation imposed on pharmacies to conduct and document a risk analysis for each violation of the storage conditions of medicinal products.
- - The introduction of additional burdens is disproportionate, especially since similar requirements have not been provided for medical offices - argues the Ministry of Health
The Presidium of the Supreme Pharmaceutical Council presented the Ministry of Health with its detailed comments on the draft amendment to the regulation on the basic conditions for running a pharmacy .
The reservations concern the removal of the obligation to monitor temperature and humidity in pharmacy premises and humidity in refrigeration equipment 24 hours a day , as well as the imposition of the obligation to conduct and document a risk analysis for each violation of the storage conditions of medicinal products.
As we read in the position, the Presidium appreciates the initiative, but expresses concern about the potential consequences of the proposed changes.
- New regulations may make it difficult or impossible for patients to access high-quality medicines, especially in emergency situations - pharmacists fear.
They also emphasize that the current regulations sufficiently ensure the safe storage of medicines under the supervision of pharmacists.
- The introduction of additional, excessive burdens is therefore disproportionate, especially since similar requirements are not provided for doctor's offices, hospital wards or non-pharmacy sales points - argue local government representatives.
The changes proposed by the ministry in the draft, as a reminder, provide for:
- introducing a procedure for monitoring storage conditions and dealing with violations of the storage conditions of medicinal products;
- removing the obligation to monitor temperature and humidity in pharmacy premises and humidity in refrigeration equipment 24 hours a day;
- introducing a new obligation to conduct and document a risk analysis in the event of a breach of the storage conditions of medicinal products, in particular a significant exceedance of the permissible temperature range.
Pharmacists propose to abandon the provision introducing a procedure for monitoring the storage conditions of medicinal products in pharmacies and for dealing with any violations, and to maintain the provision requiring pharmacies to provide refrigeration equipment used for storing medicinal products with "temperature monitoring equipment with a calibration certificate issued by a calibration laboratory and enabling temperature control".
They also propose that paragraph 1 of this Regulation repeal point 2, which concerns the addition of paragraphs 3 and 4 of this Regulation to paragraph 4. These provisions stipulate that in the event of a violation of the storage conditions for medicinal products, especially significant deviations from the permissible temperature range:
- the pharmacy manager will conduct a documented risk analysis based on the pharmacy's monitoring procedures and available documents regarding the storage conditions of the medicinal product,
- and then, based on the analysis results, it will decide whether to continue storing the medicine or dispose of it.
The NRA Presidium also declares its readiness to continue cooperation with the Ministry of Health in order to develop solutions ensuring patient safety and rational working conditions for pharmacists.
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