Note: This article has been partially outdated due to legislative changes. Below is a link to the entry describing the changes introduced in July 2023: Fitting rooms in pharmacies – is it necessary or even possible? Discussion of the proposed requirements for the premises of entities supplying medical products.
On November 18, 2022, the implementing regulation of the Minister of Health on the basic conditions for running a pharmacy was announced, setting out in detail more important issues. It will repeal the regulation that has been in force in our legal system since 2002. What do pharmacy operators need to prepare for now?
We explain this in the article below.
The regulation itself will enter into force 14 days after its announcement, i.e. on December 3, 2022, but it is worth familiarizing yourself with the obligatory changes on some issues. The regulation specifies, among others, the conditions for storing medicinal products, the conditions for preparing prescription and pharmacy medicines, and many others. Each element will be discussed separately.
Storage of medicinal products, foodstuffs for particular nutritional uses, pharmaceutical raw materials and medical devices
The regulation adopts stricter requirements than its previous version - among other things, medicinal products are stored at the place of business covered by the pharmacy permit – it means that de facto such a place must be organized at the place where the pharmacy is run, and no other place. The method of storing medicines is intended to ensure compliance with the standards set for individual preparations quality requirements and storage security. Specific requirements include, for example, the requirement to equip rooms for storing medicinal products and rooms for preparing prescription, pharmacy and homeopathic medicines in devices enabling 24/7 monitoring of temperature and humidity, and as for the refrigeration devices themselves used to store medicines, they should be equipped with devices for temperature monitoring. Moreover, such equipment (device) must be provided calibration certificate issued by an accredited calibration laboratory and a system enabling the recording of temperature or humidity, as appropriate, and notification about exceedances of temperature or humidity parameters.
In the case of rooms used for: preparation prescription drugs, pharmacy and homeopathic medicinal products should also use devices, equipment and systems that were discussed in the point above, but they are additionally subject to periodic inspections, maintenance and calibrations in accordance with the requirements specified by the manufacturer or in, among others, the Polish or European Pharmacopoeia or other pharmacopoeias recognized in the Member States of the European Union and on the basis of a risk analysis.
Rooms intended for storage medicinal products, as well as to production prescription drugs, pharmacy drugs and homeopathic medicinal products should be kept clean and equipped in such a way as to limit excessive exposure to sunlight and ensure that special storage conditions are met (such as appropriate temperature or air humidity) - here this issue has not changed compared to the previous legal status. The issue of storage, among others narcotic drugs has also not changed - the regulation refers to the Act on Counteracting Drug Addiction.
Very strong substances, specified in list A of the Polish Pharmacopoeia, are defined as a special category for storage - they should be stored here in lockable cabinets or drawers, in order to protect them against theft, substitution and destruction. As for substances that are actually very potent, this is of course justified, but it is quite pointless to secure "under lock and key" methanol or nicotine, which are also on list A.
Medicines should be stored carefully – so how? The regulation requires them to be stored here away from walls, floors and heating installationsto ensure constant ventilation. All products, products, agents and raw materials should also be protected against dust, dirt and destruction. The regulation also specifies which products must be stored separately in pharmacies, including drugs ready for internal and external use, the already mentioned very potent substances, as well as medicinal products withheld or withdrawn, and several others. This catalog is much more extensive than the one specified in the previous legal status.
The issue of storing pharmaceutical raw materials intended for the preparation of medicines in pharmacies has also remained relatively unchanged - they should be stored in factory packaging or vessels that correspond to their properties, with a legible and durable inscription, in a way that protects them against the harmful effects of light, moisture and dust, as well as against foreign odors penetrating them – but they must be located in pharmacy rooms previously equipped with appropriate devices and systems, described in the earlier part of the article. As for the inscription on packaging, another mandatory element has been introduced, i.e date of opening the original packaging, when the raw material is stored there. Additionally, pharmaceutical raw materials are to be stored in accordance with the division in the lists of very potent substances (A), highly potent substances (B) and narcotic drugs (N), separately from raw materials for the preparation of homeopathic products, which also expands the storage method in relation to the previous regulation.
Preparation of prescription and pharmacy medicines - including under aseptic conditions and homeopathic medicinal products
The regulation sets out strict conditions for the preparation of prescription or pharmacy medicines - the previous regulation did not provide for such requirements, although this does not mean that they were not used in practice due to the requirement of sterile work. Prescription, pharmacy or homeopathic medicines themselves are prepared in accordance with the requirements or procedures specified in the Polish, European or other Pharmacopoeia recognized in the EU, on the basis of applicable pharmaceutical standards, on the basis of a prescription, and in the case of a homeopathic medicinal product - on the basis of a prescription or a homeopathic procedure described in the above-mentioned Pharmacopoeias.
Preparation of medicinal products requires at least disinfecting the surface with a disinfectant and appropriately preparing utensils, sterilizing them, using raw materials of a quality that meets the requirements specified by the manufacturer or in the Polish or European Pharmacopoeia, using water of confirmed quality and its appropriate marking, preparing a chamber with laminar air flow in the case of preparing a sterile medicine , as well as the use of protective clothing in this case. The very statement "in particular" means that the calculation is not closed and comprehensive, and pharmacies may adopt more requirements regarding the entire procedure of preparing medicines. Moreover, these medicines are prepared in a prescription chamber or a chamber for the preparation of homeopathic medicinal products by a pharmacist or pharmaceutical technician within the limits of their professional qualifications. Additionally, the regulation imposes on pharmacies new duty – subjecting prescription drugs and pharmacy drugs to quality testing, at least once every 3 years. This study is being carried out at the expense of the pharmacy that prepared the medicines in question.
The packaging of prepared medicines, in addition to the information already required by the previous regulation, also obliges to include on pharmacy labels storage method and expiration date of the medicine. As for homeopathic products, it is also necessary to include on the pharmacy label the age of the person for whom the medicine or product is intended, if he is a minor. Interestingly, the provision authorizing not to include a description of the composition of the prepared medicine was not reproduced - this means the obligation to pay the ingredients of each medicine prepared in a pharmacy. If a pharmacy dispenses a ready-made medicine in the pharmacy's own packaging, it must contain a copy of the leaflet and the information specified in the regulation. This is intended to somehow increase the safety of people using these drugs.
Maintaining documentation, in particular of purchased, sold, prepared, suspended and withdrawn from the market medicinal products or medical devices
Each pharmacy must keep records of prescription drugs, pharmacy drugs and homeopathic medicinal products prepared in the pharmacy - nothing changes in this matter. However, changes have been made to its content - additional changes must be made to it record the expiry date of the prescription drug or a product prepared on the basis of a prescription. The issue of identifying the person preparing the medicine has also been clarified. It is no longer enough to simply provide the person's name and surname and signature, but... you need to add your name and surname in the form of a print or stamp. The same issue applies to records kept in electronic form - it is not sufficient to keep them in this form. It is also necessary to provide the pharmacy with devices that will enable it submitting a qualified electronic signature of the person making the entry – this is supposed to enable the identification of such a person not only based on entering the name and surname using the keyboard, but also on the basis of a handwritten signature. This can also be seen as a desire to ensure greater transparency and to prevent entries from being made by a person other than the person making the entry claims to be.
The documentation regarding, among others, medicinal products, foodstuffs for particular nutritional uses and packaging for prepared medicines has also been expanded. Currently, documents must be prepared regarding, among others, confirmation of control over the conditions of preparation of medicines, medicines sent for disposal of expired, destroyed or unsuitable for use for other reasons, surpluses and losses of medicinal products, and a few other examples. Moreover, the law requires keeping this documentation on an ongoing basis and in a reliable manner.
Electronic documentation of medicines in pharmacies – armored zone?
Extraordinary requirements have been specified for pharmacies to keep the above-mentioned documentation in an electronic system. If the pharmacy decides to use this form, it must meet the following elements:
- access to the system should be individually defined for each user,
- the identity of the system user should be clearly defined and checked before starting work in the system through authentication,
- IT security will be required, i.e. blocking against access to a given user's account during his or her absence,
- data is protected against accidental or unauthorized changes,
- the availability of stored data is checked periodically,
- periodically, however at least once a year, backup copies of stored data are made,
- these copies are kept for 5 years counted from the first day of the calendar year following the year of their creation, in a separate, secured place - this recipe de facto will oblige us to store such copies for up to less than 6 years,
- periodically, at least once a year, procedures are checked that include how to recover data in the event of an error or system failure.
This record is also intended to determine the current inventory status of the pharmacy.
Such an extensive catalog of requirements may actually result in the pharmacy employing a pharmacist who is responsible, perhaps not exclusively, but mainly for working with this system and taking some care of it. Often, especially large pharmacies, they produce countless amounts of self-prepared medicines or sell a lot of ready-made products - so even entering the current pharmacy inventory into such documentation and updating it may take a lot of time. However, developing a system to ensure compliance with these conditions can take a lot of time, as can training pharmacy staff to use processes such as authentication.
Appointing a deputy pharmacy manager for a specified period of time and notifying the provincial pharmaceutical inspector
The regulation introduces a change here in that if a person is appointed to replace the manager during his or her absence, the data of that person is provided in writing. only to the provincial pharmaceutical inspector. The obligation to notify the relevant district pharmacy chamber has also been removed from the text of the Act. The same applies to reporting the absence of the pharmacy manager for more than 30 days - this fact must be reported in writing to the provincial pharmaceutical inspector. It is worth emphasizing that these are two separate reports.
As for other issues included in the new regulation, no major changes have been noted other than broader terminological expansion or extension of the catalog, e.g. data needed to check, for example, the information contained in the transport document along with the actual status of the delivered products.
Until when do pharmacies have to adapt to the new requirements?
The Act explicitly states that pharmacies are to adapt to the requirements specified in the regulation within the deadline 6 months from the date of entry into force of the regulation, i.e. until June 6, 2023. The longer term, i.e. twelve months, applies to obligations regarding the use of devices and equipment, among others, in rooms for storing medicines or preparing them. Extending the deadline in this case seems absolutely justified - in some cases, adapting to the above-mentioned legal requirements may result in huge expenses on the part of pharmacies, while time is needed to collect appropriate funds.
If you have any questions or doubts related to this area of law, we cordially invite pharmacists and pharmacy owners to contact our Pharmaceutical Law Office.