On 1 January 2018, a new system for self-selection of over-the-counter (OTC) medicines came into force in Denmark. The new system allows for certain OTC medicinal products to be available for self-selection by members of the public, which means that such medicines can be placed on shelves in self-service areas of the pharmacy or retail shop - and not only behind the counter.
The new rules aim at improving the public’s access to medicinal products by providing an opportunity to independently choose which OTC medicines to purchase. The possibility for stores and pharmacies to place certain OTC medicinal products in self-selection areas provides for an alternative to the traditional over- the-counter interaction between costumer and sales personnel.
The new system is voluntary in the sense that it does not impose an obligation on pharmacies and retail shops to set up self-selection areas.
Certain OTC medicinal products are not included
As part of the new system, the Danish Medicines Agency (DMA) has reviewed the OTC medicines currently available on the Danish market and, on the basis of the following criteria, assessed whether some OTC medicinal products should not be available for self-selection:
- Expected improved effect/compliance based on improved accessibility
- Unnecessary increase in consumption
The DMA has decided that all OTC medicines in dispensing groups HA (pharmacy restricted) and HF (non-pharmacy restricted) may be available for self- selection at pharmacies because pharmacists are able to advise the costumers on the use of medicines – also when customers have chosen the medicinal product in question from the self-selection area.
As for retail shops, only certain OTC medicinal products in dispensing group HF will be available for self-selection as retail shops cannot offer customers the same advice as pharmacies on the use of medicines. On its website, the DMA lists all the medicinal products from dispensing group HF that are unavailable for self-selection in retail shops. The list can be retrieved here.
Medicinal products in dispensing groups HA18, HX and HX18 will not be available for self-selection at all. For example, this means that OTC medicines used to treat mild to moderate pain such as paracetamol and ibuprofen are excluded from the new system.
Specific conditions for using the self-selection system
In addition to the existing Danish rules on sales of OTC medicines, the new regulation contains a number of specific conditions that pharmacies and stores must comply with. Hence, OTC medicines made available for self-selection must be:
- Under the supervision of the staff;
- Placed 140 cm above the floor in order to be out of small children’s reach (in so far as special circumstances can imply that the medicines shall be placed even higher or may be placed lower); and
- Placed separately from other products and in connection with signs showing that the products are medicinal products.
Shortly before Christmas, the DMA issued a guidance aimed at pharmacies and stores covered by the new system, which lays out the DMA’s interpretation of the conditions under which OTC medicines may be made available for self-selection. In addition to the points above, the guidance also offers information on the rules on advertising for medicinal products relevant to OTC medicines.
Unwanted consequences may prompt a reassessment
During the consultation period of the legislative proposal, the self-selection system was subject to some criticism. To accommodate this, the DMA will after two years review the self-selection system by reviewing sales figures for all medicinal products available for self-selection to identify any inappropriate increases in the sale and use of certain types of medicinal products. The identification of any unwanted consequences may, thus, prompt the DMA to reassess whether the relevant medicinal product should still be available for self-selection.