Initial justification for the classification system for the legal status of supply of anti-inflammatories (NSAIDs) and acetylsalicylic acid
In its meeting of 2 July 2009, the MEB determined a classification system for the legal status of supply of OTC anti-inflammatories. This covers ibuprofen, diclofenac potassium, naproxen sodium, ketoprofen and acetylsalicylic acid (aspirin).
The classification system is based on the latest scientific insights. Relevant recommendations from the ‘HARM-Wrestling’ report published in the spring of 2008 by Dutch medication safety experts have also been taken into consideration.
Three points determine the classification of NSAIDs: the active substance, the dosage and the package size. Of the anti-inflammatories studied, the MEB notes that the dosage, both each time and per day, is the key factor in reducing the risks of side effects and interactions with other medicinal products. Additionally, the MEB aims to minimize possible health risks by limiting the package size.
Given their overall safety profile, the MEB believes that naproxen and diclofenac should remain available as OTC medicinal products, even though the profiles of these medicinal products are less favourable than those of other medicinal products, especially at higher doses. That is why naproxen 550 mg and diclofenac 25 mg now have the pharmacy-only (PH) status. The MEB also concluded that ibuprofen is the only type eligible for the general sale (GS) status, as long as the package size has no more than 12 dosage units and the amount of active substance is limited to 200 mg per unit. Ibuprofen in packages with more dosage units and the other NSAIDs will get the pharmacy and drugstore only (PDO) or PH status, depending on the package size.
The MEB has looked into whether or not the PDO legal status of supply for non-prescription anti-inflammatories (so-called NSAIDs) and acetylsalicylic acid should be retained. The Medicines Act that came into effect on 1 July 2007 introduced a new classification of medicinal products according to the legal status of supply. In accordance with that act, non-prescription / OTC medicinal products can be classified into three categories: pharmacy-only (PH), the aforementioned pharmacy and drugstore only category (PDO), or general sale (GS). Pending a definitive classification, non-prescription NSAIDs and acetylsalicylic acid have for the time being been classified in the PDO category as of the moment of the enactment. Medicinal products that require a prescription are in the prescription-only (PO) category.