The Supreme Audit Institution's report for 2019-2023 indicates irregularities in the process of granting OTC categories, supervision of drug quality and distribution, and handling of reports of adverse drug reactions.
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 Medi...
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