A completely new regulation from the Minister of Health, setting out the basic conditions for running a pharmacy, came into force in December 2022. It replaced the archaic provisions from 2002. Although in theory the act aims to improve quality, in practice it imposes a number of costly and rigorous technological, record-keeping, and storage obligations on pharmacy owners. What do pharmaceutical businesses have to contend with?
💡 Key takeaways
- Pharmacies are forced to invest in 24-hour monitoring devices temperature and humidity equipped with alarm notifications and accredited calibration certificates.
- Introduced a new, costly obligation subjecting prescription and pharmacy medicines to quality testing, funded from the pharmacy owner's own pocket (no less than once every 3 years).
- Electronic record-keeping in pharmacies now requires employee authentication at the workstation, periodic backups stored for almost 6 years, and submission qualified electronic signatures under the posts.
- The notification of the pharmacy manager's deputy is currently submitted only The WIF Act removed the obligation to notify the pharmaceutical chamber.
The requirements imposed on IT systems in pharmacies are so extensive that they will consume not only time for implementation and regular staff training but will effectively necessitate dedicating one of the pharmacists almost exclusively to record-keeping duties.
New conditions for running a pharmacy. Analysis of changes
Please note: This article has been partially outdated due to legislative changes in July 2023. It is also worth familiarising yourself with the discussion of the latest proposed requirements regarding fitting rooms in pharmacies.
The Minister of Health's Regulation of 18 November 2022 repealed the binding act from 2002. Below we analyse the most important operational changes in the functioning of pharmacies that pose the greatest difficulties for entrepreneurs.
Strict rules for the storage and monitoring of medicines
The regulation radically tightens the policy on monitoring environmental conditions on the premises. The basic changes include:
- 24/7 Mandatory Monitoring Storage rooms and cold stores must have systems for continuous recording and logging of temperature and humidity, and above all, systems for notifying (alerting) personnel of exceeding norms.
- Equipment certification: The equipment (thermometers, hygrometers) must be certified Calibration certificate issued by accredited laboratories, and the equipment itself must undergo periodic, systematic calibrations and inspections.
- Key cabinets Substances of extreme potency (as listed in the Polish Pharmacopoeia, Appendix A) are required to be stored in lockable cabinets (which is causing irritation within the industry, as it applies to, among other things, ordinary nicotine).
- Spatial details: Medicines must be kept strictly away from floors, walls and heating systems to ensure adequate ventilation of the packaging.
Strict conditions for the preparation of prescription medicines
In the field of direct pharmaceutical work, the legislator mandates not only the disinfection of the workstation and sterilisation of utensils on each occasion, but introduces a complete novelty:
Pharmacies are now legally obliged to carry out quality research of compounded and pharmacy medicinal products (at least every 3 years). The total cost of commissioning a test analysis at an external laboratory amounts to 100% per pharmacy.
The labelling rules have also been changed – each time, the packaging of a medicinal product prepared in a pharmacy must contain the full, detailed composition of active substances and storage instructions. The days of dispensing ointments and solutions in packaging without meticulous chemical specification are over.
Bureaucracy anew: traditional record-keeping
In addition to adding the expiry date to the existing prescription drug register, a significant revolution has been introduced regarding the approval of entries: manual signatures have been abolished. From now on, the employee making an entry in the traditional register is obliged to identify themselves using the prepared name stamp (or imprint) next to the signature.
Electronic drug records resemble a banking system
Officials have decided that IT systems for managing pharmacy formulas must meet the highest safety standards:
- The pharmacy position must require individual authentication i to get stuck after an employee leaves.
- To enter a given record into the register, the employee must, each time, use a secure, qualified electronic signature (the implementation of which involves significant logistical difficulties in a busy pharmacy).
- The IT system requires the creation of auditable, annual backups, which must then be deposited and stored for a full 5 years (counted from 1 January of the year following their creation). The pharmacy must also annually demonstrate the implementation and testing of a "disaster data recovery" procedure.
Acting managers and transitional provisions (deadlines)
A small administrative correction benefits entrepreneurs – the notification of the appointment of a substitute or absence of a manager (over 30 days) is currently sent solely to Regional Pharmaceutical Inspectorate (RPI) (articulating this fact to the Chamber of Pharmacists ceased to be mandatory).
Most of the rules set out in the regulation are already in force. However, the legislator has allowed a 12-month grace period (from the date of issue) for the most expensive investments: the provision of cold stores, temperature monitoring modules and warning systems. This ‘grace period’ expired irrevocably on 6 December 2023, and today’s inspections by the National Health Fund (NFZ) and the Pharmaceutical Inspection Authority (WIF) are ruthlessly enforcing the 100% requirements imposed by this legislation on pharmacists.