Martins Ana Paula, Gonçalves Elizabete, Marcelo Ana, Vilão Sergio, Aranda Silva José
Faculdade de Farmácia. Universidade de Lisboa. Lisboa. Portugal.
PharmD. Formifarma, Lda. Lisboa. Portugal.
Acta Med Port. 2016 Sep;29(9):542-548. doi: 10.20344/amp.7465. Epub 2016 Sep 30.
In 2013 medicinal products for human use not subject to medical prescription dispensed exclusively in pharmacy, a subcategory of products not subject to medical prescription was introduced in Portugal. This category of medicinal products promotes the accessibility to treatment, ensuring safety and efficacy, with benefits to public health. This article analyzed the medicines classified as medicinal products for human use not subject to medical prescription dispensed exclusively in pharmacy or equivalent in seven European countries, United Kingdom, Denmark, Sweden, Norway, Italy, Czech Republic and Portugal, and proposes a preliminary list of common international names/ medicines that possess the characteristics that justify their inclusion in Portugal, in this category.
For the selection, common international names /medicines approved in the considered countries were selected if, in at least one of the countries considered, they are classified as medicinal products for human use not subject to medical prescription dispensed exclusively in pharmacy or equivalent, and/ or have the classification of medicinal products subject to medical prescription in Portugal and medicinal products not subject to medical prescription in one of the considered countries.
The preliminary list obtained contains 271 different common international names / presentations. About 19% of the selected common international names do not have a valid marketing authorization in Portugal and the majority (42%) is classified in Portugal as medicinal products not subject to medical prescription, a lower percentage (35%) as medicinal products subject to medical prescription, and only 4% as medicinal products for human use not subject to medical prescription dispensed exclusively in pharmacy.
Safety is one of the main aspects to be considered in the context of the reclassification of medicines regarding their supply to the public. The results obtained promote a reflection on the relevance of extending the availability of medicines with the classification of medicinal products for human use not subject to medical prescription dispensed exclusively in pharmacy in Portugal, which, due to their characteristics and indications, would benefit from an access without a medical prescription, ensuring the safety in its use.
2013年，葡萄牙引入了一类仅在药店配售的非处方人类用药，这是一类非处方产品。这类药品提高了治疗的可及性，确保了安全性和有效性，对公众健康有益。本文分析了在七个欧洲国家（英国、丹麦、瑞典、挪威、意大利、捷克共和国和葡萄牙）被归类为仅在药店或同等机构配售的非处方人类用药或类似药品，并提出了一份具有正当理由可列入葡萄牙此类别的通用国际名称/药品初步清单。
为进行筛选，如果在所考虑的国家中至少有一个国家，通用国际名称/药品被归类为仅在药店或同等机构配售的非处方人类用药，和/或在葡萄牙被归类为处方药品，而在其中一个所考虑的国家被归类为非处方药品，则选择这些通用国际名称/药品。
获得的初步清单包含271个不同的通用国际名称/剂型。约19%的选定通用国际名称在葡萄牙没有有效的市场授权，大多数（42%）在葡萄牙被归类为非处方药品，较低比例（35%）被归类为处方药品，只有4%被归类为仅在药店配售的非处方人类用药。
在药品重新分类以向公众供应的背景下，安全性是要考虑的主要方面之一。所获得的结果促使人们思考在葡萄牙扩大具有仅在药店配售的非处方人类用药分类的药品供应的相关性，由于其特性和适应症，这些药品将受益于无需处方即可获取，同时确保其使用的安全性。
