Annual report on the inspection of retail sale of OTC medicines 2008-2009

23 July 2009

Efforts to remove expired over-the-counter medicine

In 2008, the Danish Medicines Agency intensified its efforts on removing expired over-the-counter medicine from retail distribution. Previously, the discovery of expired medicine was reported to the police when it involved medicine that had expired by more than 12 months, but in 2008, the Agency started reporting the discovery of medicines expired by only six months.

In 2008, more than one in ten inspections (77 of 665 inspections) caused the Danish Medicines Agency to file police reports with the objective of imposing fines, a tightening which, compared with 2007, doubled the number of incidents reported to the police.

Download the full annual report in the factbox to the right. The report presents the results of the inspections carried out by the Danish Medicines Agency in 2008 in the retail distribution chain.

In the first half of 2009, the most recent inspections show that the retail distributors have become much more aware of removing expired medicines from the shelves, and the number of cases referred to the police has fallen decisively (in the first half of 2009, only 14 incidents out of 235 inspections were recommended for imposition of a fine).

This indicates that the Danish Medicines Agency’s efforts to eliminate medicine that has become too old in retail shops have paid off, and we will maintain focus on the issue to counter medicine that has passed its expiry date.

Consumers can protect themselves from expired medicine by checking the date of the medicine at purchase.

Pharmacies must improve management of their OTC outlets
The pharmacies have the responsibility to supervise their OTC outlets, but the Danish Medicines Agency nevertheless inspects a small section of the pharmacies’ OTC outlets to ensure the adequate supervision of OTC outlets. We have previously criticised the pharmacies for having failed to provide adequate supervision.

In 2008 and the first half of 2009, it has been clear that the role of supervising the OTC outlets still represents a challenge to the pharmacies as revealed by too many deficiencies among the OTC outlets. In 2008, more than one in every four OTC outlet received a poor rating, and the preliminary figures show no signs of improvements (7 out of 15 of the inspected OTC outlets were rated ‘Unsatisfactory’ or ‘Unacceptable’ – see also tables 2a and 2b of the report).

Among other things, the OTC outlets have problems with:

  • the staff’s lack of knowledge about the rules,
  • missing signs informing the customers of the name of the pharmacy responsible for the OTC outlet,
  • medicines that are mixed with other goods,
  • medicines being displayed freely accessible to customers,
  • medicines that have expired.

A number of other deficiencies have been identified (see table 4a through 4c of the report).

Consequently, we have now forwarded the annual report to the Association of Danish Pharmacies and the pharmacies to make the pharmacies aware of their duty to supervise the OTC outlets.

Many more general sales outlets have emerged
In 2008, many more retail shops applied for an authorisation to sell over-the-counter medicine. Previously, some 150 outlets were authorised every year, but 2008 reached a total of 277. As at end-June 2009, 159 new outlets have already been authorised, which suggests that the increase will continue throughout 2009.

Today, there are some 2,000 authorised sales outlets. In addition, there are around 630 OTC outlets dispatching medicine from pharmacies.

Danish Medicines Agency, 23 July 2009

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