OTC medicinal products

People are confronted with risks in all kinds of situations. For example, road use is associated with risks, as is dealing with pesticides or cleaning agents; event cosmetics and foods have health risks, albeit minor ones. The same is true for categorization of over-the-counter medicines: on principle, there is always some risk involved. A safety guarantee excluding any risk, however small, cannot be provided. After all, the substance must have the desired effect, so the risk of undesirable effects at an effective dose of a medicinal product is inevitable, particularly in (very) sensitive individuals. This risk is (significantly) controlled by using the medicinal product as indicated (normal use), based on the information in the patient information leaflet. For example, the leaflet contains warnings for the user, such as situations in which the medicinal product should not be used as it would entail an elevated risk. Furthermore, the leaflet contains recommendations on responsible use, for example that a doctor should be consulted in the event complaints fail to disappear following use of the over-the-counter medicinal product in question.

Categories of legal status of supply

Since the enactment of the Medicines Act of 2007, OTC medicinal products have been categorised into three categories of legal status of supply. The aim of the legislator was to ensure a good balance between availability and risks. These categories are:

• Pharmacy only (PH): Medicines with a relatively mild potential risk
• Pharmacy and Drugstore only (PDO): Medicines with a relatively low potential risk
• General Sales (GS): Medicines with a relatively very low potential risk

Medicinal products in the PH category can only be obtained from a pharmacy, medicinal products in the PDO category can be obtained only from a pharmacy or chemist, while medicinal products in the GS category can be obtained from other outlets as well. The last category means these medicinal products are available not only from pharmacists and chemists, but also via sales channels such as super markets or service stations.

Medicinal product factors and user factors

There are two aspects important for good categorisation:

• based on medicinal product properties, or medicinal product factors
• characteristics of (individual) users or patients, also referred to as user or patient factors.

These two aspects are closely related and cannot always be distinguished clearly.

Medicinal product factors are inherent risks of the medicinal product's active substance. Patient factors relate to the risks caused or affected by use of a medicinal product (as well as patient behaviour).

In determining legal status of supply, medicinal product factors are weighed more heavily. The number of units per pack and dosage will contribute to the MEB decision on which category the medicinal product in question will fall under. Medicinal products in the PH category may be dosed relatively higher and be available in larger units per pack, while medicine in the GS category will be relatively lower dosed and contain fewer doses per pack.

In determining legal status of supply, user factors are also considered. The packaging and information leaflet for medicinal products in the PDO category and in particular the GS category will have to, insofar as applicable, contain warnings for certain high-risk situations, including warnings for specific groups of users, in order to promote good and safe use of the medicinal product.

Potential risks relating to use by the patient (user or patient factors) are:

• Off-label use
• Addiction/dependence
• Development of resistance to the medicinal product
• Interactions
• Relatively serious undesirable effects

If relevant, medicinal products with GS or PDO legal status of supply will list potentially high-risk situations in which users are advised to seek guidance from a doctor or pharmacist first. Potential high-risk situations may develop in case of:

• Serious organ dysfunction (kidney/liver)
• Having other disease "co-morbidity" (e.g. diabetes, cardiovascular disease, depressive disorders)
• The use of other medicines "co-medication" (e.g. coumarins or other medicinal products with a narrow therapeutic range, such as digoxin)
• Masking conditions that require other treatment, e.g. the use of analgesics while antibiotic or surgical treatment is required.
• Specific patient groups:
  • Children up to a certain age
  • Pregnant women (or women who wish to become pregnant)
  • Lactation (breastfeeding)
  • Elderly over a certain age
• An elevated risk of certain (serious) undesirable effects due to the patient's abnormal genetic predisposition (e.g. deficiency in a specific protein or enzyme)
• Long-term treatment, as over-the-counter medicines are generally intended for short-term treatment.