NIK report: Are over-the-counter drugs too easily available?
Published Nov. 25, 2024 09:07

Problematic decisions on drug availability
The Chamber considered it illegal for the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products to grant the OTC category to three drugs:
- Dezamigren (almotriptan) - used in migraines
- Dorminox (doxylamine) - antihistamine drug with sleeping effects
- Vemonis Max (metamizole, caffeine, drotaverin) - a drug with analgesic effects.
Self-diagnostic tests bundled with drugs to justify their availability without a prescription are also questionable. The NIK assessed that their effectiveness and reliability do not guarantee patient safety.
Side effects
Between 2019 and 2023 (through April 30), a total of nearly 74,500 reports of Adverse Drug Reactions (ADRs) have been filed with the Office for Registration of Medicinal Products, of which about 1,600 (nearly 2%) were related to OTC drugs, including, for example, those used for erectile dysfunction.
The Chamber's auditors examined documentation on the change of the availability category of six such drugs from prescription to OTC. They found that Adverse Drug Reaction Reports prepared at URPL based on data generated from the European Medicines Agency's database showed cases of death after taking drugs used for erectile dysfunction or the active substances included in them.
A significant number of NDPL reports have been reported for erectile dysfunction drugs containing sildenafil:
- Princex - 276 reported deaths,
- Maxigra Max - 218 deaths,
- Doppelsil Max - 138 deaths.
While the data did not prejudge a direct link to the drugs, they do point to the need for a detailed safety analysis.
Sales outside of pharmacies - more risk
OTC drugs account for nearly half of pharmacy turnover, but their sale in supermarkets, drugstores or online raises serious concerns:
- Risk of misdiagnosis of self-diagnosis - lack of professional advice can result in poor choice of drugs.
- Poly-pragmasy - taking multiple drugs at the same time, especially by seniors, increases the risk of interactions and overdose.
- Minors - have easy access to drugs that can be abused, such as for intoxicating purposes.
In the case of OTC drugs, another very important aspect is that granting an OTC availability category to a drug containing a specific active substance means that the President of URPL cannot refuse to register further OTC drugs having the same active substance in their composition, for the same medical indication. An example is the aforementioned Dezamigren. After it was approved as an OTC drug, two more drugs containing the active substance Almotriptani malas were approved in the same category, for the same medical indication . And in the case of the drug Dorminox, another 14 drugs containing the active substance Doxylamini hydrogenosuccinas were registered.
Delays and errors in reporting
URPL significantly delayed submitting NDPL notifications to the European Medicines Agency, which could affect the safety assessment of drugs. In one case, a severe case notification did not reach the EMA until 988 days later, instead of in the required 15.
What's next for OTC drugs?
The NIK report reveals that Poland's legal regulations on the sale of OTC drugs are inadequate to ensure health security. Proposals for changes, such as the registration of outlets conducting non-pharmacy sales, are stuck at the stage of legislative drafts.
In connection with the results of the audit, the NIK made requests to the Minister of Health to:
- Take action to develop and introduce legal solutions regulating the principles of non-pharmacy trade in OTC drugs, enabling the State Pharmaceutical Inspectorate to exercise effective supervision over this trade;
- To re-examine the legitimacy of limiting the number of substances and their content in OTC medicinal products authorized for sale in non-pharmacy trade, in order to reduce the risk of drug addiction and abuse of these drugs for non-medical purposes, as well as the effects they may have on the health of citizens and the health care system in Poland;
- Take action to ensure effective implementation by the Chief Pharmaceutical Inspector of the duty to exercise proper supervision over compliance with the provisions of the Pharmaceutical Law on advertising of OTC drugs.
In its post-audit speeches, the NIK also formulated conclusions resulting from the audit findings to the President of URPL and the Chief Pharmaceutical Inspector.
Source: NIK