Refrigerators to jail, patient will not get medicine. The regulation will paralyze pharmacies?
- The Ministry of Health proposes introducing a procedure for monitoring the conditions of storing medicines in pharmacies and proceeding in the event of a violation of these conditions
- It also plans a new obligation to conduct and document a risk analysis in the event of such a violation, in particular a significant exceedance of the permissible temperature range.
- The new procedure is to allow pharmacies to manage quality more effectively without automatic product recalls in incidental situations.
- Marek Tomków, president of the Supreme Pharmaceutical Council, comments: - The proposed regulation will not change the level of drug safety in any way, on the contrary, the health or lives of patients who do not receive these drugs will be at risk.
- - If the temperature is exceeded on Friday afternoon, it will be necessary to wait for the pharmacy manager to be present so that he can conduct a documented risk analysis and decide whether the violation was significant or not. Until then, the refrigerator will remain out of order - he explains
- The NRA will be seeking to have these provisions removed.
The Ministry of Health has presented a draft amendment to the regulation on the basic conditions for running a pharmacy . It proposes removing the requirement to monitor temperature and humidity in pharmacy premises and humidity in refrigeration equipment 24 hours a day. This requirement has been deemed excessive, disproportionate and of no significant value from the perspective of assessing the quality and safety of medicinal products.
At the same time, the Ministry proposes a procedure for monitoring the storage conditions of medicines and proceeding in the event of a breach of these conditions, as well as a new obligation to conduct and document a risk analysis in the event of such a breach, in particular a significant exceedance of the permissible temperature range .
- The head of the Supreme Pharmaceutical Council, Dr. Marek Tomków, speaks about this idea briefly: it will paralyze pharmacies.
Because if we read the project literally, it would mean that new obligations are imposed in the event of any violation of the conditions of storing medicines. These conditions include, among others, protection from sunlight, dust, dirt and destruction, away from walls, floors and heating installations, with clear separation from dietary supplements, etc.
- According to the Ministry, each violation of storage conditions, which also concerns the arrangement of medicines on shelves or their proper storage in cabinets, should end with a documented analysis conducted by the pharmacy manager - assesses President Tomków.
Even if the legislator’s intention was to impose new obligations only in the case of medicines stored in refrigerated equipment, implementation may be problematic.
- The proposed form of the regulation means in practice that in a moment pharmacies will stop dispensing thermolabile drugs, including insulins, products used in the in vitro procedure and many others. Often the value of such products in a pharmacy is several dozen thousand zlotys - comments the president of the NRA.
He points out that the introduction of the procedure itself is not a problem. The situation becomes problematic when it is found that storage conditions have been violated, especially significant deviations, when there is no definition of what significant deviations are.
- This means that every time the storage conditions are breached, for example when the refrigerator is left open for a little longer and the temperature is exceeded by even one degree, such a procedure should be started and a documented, i.e. written risk analysis should be carried out. Even one degree is a temperature exceedance of a dozen or so percent. Therefore, in each such case, the pharmacy should be shut down and the manager must independently assess whether the deviation is significant - he explains.
Risk analysis should be carried out, among others, on the basis of available documents regarding the storage conditions of medicines in the refrigerator, including the Summary of Product Characteristics.
- Since drug tests indicate that they can be stored at much higher temperatures, for much longer, common sense speaks of even a dozen or so degrees . At the same time, the SPC clearly states a specific temperature. So why should the manager decide what these important assumptions are? - he asks:
- Very often, I will have to contact the manufacturer to check whether such an excess can be dangerous. Only after performing all these activities will I be able to "release the fridge from custody". There is no guarantee that the situation will not repeat itself in a few hours.
For his own safety, he should actually contact the manufacturer. - And manufacturers are able to answer such a question, but for tens of thousands of euros. It's a bit like every time I exceed the speed limit by one kilometer, I have to stop the car, check the tire pressure, oil, and then call the police and the municipal guard, asking if I can continue driving and whether my exceedance was significant.
In Dr. Tomkow’s opinion, another problem is related to the provision that, based on the results of the risk analysis, the pharmacy manager decides whether to continue storing and dispensing the medicinal product or to dispose of it.
- In practice, no manager would take the risk of determining that a product stored at 1 degree for 10 minutes is or is not intended for disposal, but would refer these issues to the manufacturer . It is hard to imagine a manager making a decision on his own to withhold or transfer a drug for disposal, to reintroduce it to circulation or to withdraw it, taking full responsibility for it.
- It's not just bureaucracy, but also a situation where managers are being forced to implement absurd requirements that no normal pharmacy will be able to meet. In addition, they can charge pharmacies for the costs of procedures and risk analyses.
It also raises the issue of inequality between entities. New obligations would be imposed only on pharmacies. They are not being introduced on primary healthcare facilities, which store vaccines, for example. There is no obligation to monitor temperatures and humidity at petrol stations and stores, where medicines are displayed in places that are not entirely appropriate for this purpose.
The proposed regulation will not change the level of safety of medicines in any way, on the contrary, the health or lives of patients who do not receive these medicines will be at risk . If the temperature is exceeded on Friday afternoon, it will be necessary to wait for the presence of the manager in the pharmacy so that he can conduct a documented risk analysis and decide whether the violation was significant or not. Until then, the refrigerator will remain out of order. It is, in short, arrested.
As the head of local government adds, the currently existing regulations guarantee safe conditions for storing medicines in pharmacies. If any change were to occur, it would be to introduce an obligation for validated thermometers. Therefore, NIA will apply during the consultations to delete this regulation:
- Millions of vaccines are dispensed from pharmacies every year. If these regulations were to enter into force in their proposed form, the only thing we can do is to strictly comply with them. But this could result in paralysis and the inability to dispense medicines from pharmacies. Not because these medicines will be stored in unsafe conditions, but because pharmacies will be blocked by the procedures introduced - says Marek Tomków.
It also notes that the Ministry of Health has shortened the consultation period to 21 days and the time when pharmacies should provide the necessary monitoring equipment, deciding that the regulation will enter into force 30 days after publication.
This applies to temperature monitoring equipment with a calibration certificate issued by an accredited calibration laboratory and a system enabling temperature recording and notification of exceedances of temperature parameters.
The Ministry of Health argues that the proposed solution is systemic in nature, based on good practices in force in pharmaceutical wholesalers and other entities responsible for the safety of medicines in the supply chain.
The new procedure is to allow pharmacies to manage quality more effectively without automatic product recalls in incidents . It states that the most common causes of incidents include, among others, failures of refrigeration equipment, power outages, errors in the operation of monitoring systems or external factors beyond the control of pharmacy staff.
In such cases, having established procedures allows for quick and responsible management of the situation, which can lead to significant savings and reduced material losses. As a result, the risk of drug shortages due to unjustified disposal of products is also reduced.
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