PH legal status of supply

Based on section 4.1 of the Medicines Act Regulation, the MEB will categorize a medicinal product as PH if:

• Supervision of use of the medicinal product by a pharmacist is required due to the risk of significant interactions with other medicinal products or important undesirable effects
• Education and supervision is required upon provision, consisting of giving information about the medicinal product and giving advice on the correct choice and safe use of the medicinal product, or
• Supervision of use of the medicinal product is required in order to prevent off-label use.

Classification as PH only occurs if the MEB feels additional supervision or information provision is required upon delivery from a Pharmacovigilance perspective. PH status of supply for a medicinal product requires the pharmacist to speak with the patients and determine whether the patient meets the criteria for using said medicinal product. Furthermore, the pharmacist will check whether a PH medicinal product will lead to interactions with other medicinal products or whether it is contraindicated in the patients; this means it would be wise to purchase a PH medicinal product from one's own pharmacy, as that is where information on a patient's medicinal product use is available. This limits the health risks. A relatively small number of over-the-counter medicines fall into this category.

If during evaluation, it is determined that a substance in a particular dose, dosage form (tablet, drink, powder, etc.) and/or pack size meets the criteria for PH legal status of supply, the MEB will decide to impose PH status for all products with that active substance for that strength, pharmaceutical and/or pack size.

Examples of OTC medicinal products with PH legal status of supply

Below are a number of examples of over-the-counter medicinal products that have been reclassified as PH since the Medicines Act came into force in July 2007. The reason for assigning PH legal status of supply may have a number of reasons/angles. The reason for this change may be that the MEB is of the opinion that the initial legal status of supply of PDO no longer provides sufficient safeguards. This may be due to signals and data collected prior to the changes to the Medicines Act. Prior to the changes to the Medicines Act, it was only possible to change to prescription only status, which the board may have seen as too great a limitation. With PH legal status of supply becoming an option, these medicinal products (currently over-the-counter but only available from pharmacies) were categorized properly. Examples are domperidon and dextromethorfan.

The MEB believes that long-term use, often at too high doses, of certain medicinal products should be limited without affecting the availability of a certain active substance and pharmaceutical form in the PDO channel. Certain pack sizes and/or doses have remained available in the PDO sales channel, while larger packs and higher doses have been limited to the PH channel, as Pharmacovigilance and supervision by pharmacists is considered necessary. The measures taken for NSAIDs are a good example of this. Finally, there is the example of medicinal products for which the MEB is of the opinion that for certain indications, an active substance may become available over-the-counter, no longer requiring intervention by a doctor.

Dextromethorfan
In 2008, the legal status of supply for Dextromethorfan-containing medicinal products was changed from Pharmacy and Drugstore Only (PDO) to Pharmacy Only (PH). Dextromethorfan is an antitussive substance. The primary reason for reclassifying dextromethorfan was the series of worrying signals that young people were purposefully overdosing on dextromethorfan, using it as a party drug, with a risk of neuropsychiatric undesirable effects.

NSAIDs and aspirin
The legal status of supply for NSAIDs and aspiring was also changed in 2009. The MEB determined that these OTC medicinal products were being used in increasingly large doses and for longer periods of time, resulting in gastrointestinal and cardiovascular health risks. The MEB felt intervening was necessary. The reclassification rested on three main pillars: the active substance (diclofenac has a different cardiovascular risk profile than ibuprofen, for instance), dosage and pack size. The MEB determined that the dosage, both twice and once daily, is an important instrument for limiting risks.