Non-prescription medicinal products dispensed exclusively in the pharmacy: an underused access opportunity in Portugal?

Abstract

In 2013, non-prescription medicinal products dispensed exclusively in the pharmacy (NPMP-Ps), a subcategory of products not subject to a medical prescription, were introduced in Portugal. This category of medicinal products promotes accessibility to treatment, ensuring safety and efficacy, with benefits to public health. This article analyses the medicines classified as NPMP-Ps, or equivalent, in seven European countries: UK, Denmark, Sweden, Norway, Italy, Czech Republic and Portugal. It also suggests a list of medicines, by international non-proprietary name (INN), that meet the requirements for their inclusion in this category in Portugal. The collection and analysis of data were divided into two stages: a wider preliminary selection and a final, more restrictive, selection. For the preliminary selection, approved medicines for each considered country were selected if they met at least one of the following conditions: being classified as a pharmacy-only medicine in any of the countries, or being classified as a prescription-only medicine in Portugal and as a non-prescription medicine in one of the other countries considered. For the final selection, the preliminary list was restricted according to previously established inclusion and exclusion criteria. The preliminary list contained 271 different medicines by INN product. The list was then restricted to 58 INN products for the final selection, by choosing the cases where strong evidence was found regarding the suitability for a new classification. The therapeutic classes that included the highest number of INN products were alimentary tract and metabolism (17 %), respiratory system (17 %), antifungals for dermatological use (16 %) and analgesics (7 %). The INN products suggested to be classified as NPMP-Ps in Portugal already belong to this category (or equivalent) in 81 % of the cases in the UK, 53 % in Sweden, 48 % in Norway, 41 % in Italy and 33 % in Denmark. Although most INN products selected are intended for the management of acute disease (57 %), a considerable number are approved for the treatment of chronic (10 %) and semi-chronic (33 %) diseases. The results allow for reflection on the relevance of extending the range of medicines classified as NPMP-Ps in Portugal, thereby increasing their availability. Given the characteristics and therapeutic indications of these medicines, the public would benefit from access that is not subject to a prescription, but ensures the safety of use through pharmacist mediation. Considering the adoption of this category of products in several European countries, the authors consider that an update to the Directive 2001/83/EC of the European Parliament and of the Council could be relevant, since the classification of medicines regarding dispensing status is not fully reflected in the official guidance.