Deregulation of nonprescription medicines in Sweden-a look at the control system.

BACKGROUND

Sales of nonprescription medicines (NPMs) in retail outlets in Sweden have been permitted since 2009. The conditions are that sales are reported to the Medicine Product Agency (MPA) and that the owners of the retail outlets fulfill legal requirements. The MPA has an overall supervisory function, whereas municipalities are responsible for the actual control. This is mainly executed through inspections.

OBJECTIVE

The aim of the study was to explore some aspects of control performed by Swedish authorities of NPM sales in retail outlets.

METHODS

Telephonic interviews were conducted with inspectors from a heterogenic sample of municipalities in Sweden during autumn of 2010. A semistructured interview guide was designed, which included questions on inspections and deviations found in inspections. Interviews were documented in writing, and a deductive content analysis was performed.

RESULTS

Inspectors in 15 municipalities participated. In 8 of the municipalities, at least 1 inspection had been conducted. Seven inspectors had used a checklist designed by the MPA, although a majority found it difficult to use. Deviations found were mainly minor; they included lack of signs regarding age limits and prohibition of illegal sales, unlocked/open drug cabinet doors, nonexistent self-inspection programs, erroneous display of NPMs, and broken drug packages. Two serious deviations were found and reported to the MPA; these were negligence in reporting of sales statistics of NPM and 1 case where the inspector had not been allowed to conduct any inspection.

CONCLUSION

The restructuring of the sale of NPMs in Sweden, permitting sale outside pharmacies, has not been accompanied by satisfactory control procedures from authorities according to our findings. Work is still needed to make sure that optimal drug use and patient safety issues are kept in focus.