Package leaflets of the most consumed medicines in Portugal: safety and regulatory compliance issues. A descriptive study

Abstract

CONTEXT AND OBJECTIVES: Package leaflets are necessary for safe use of medicines. The aims of the present study were: 1) to assess the compliance between the content of the package leaflets and the specifications of the pharmaceutical regulations; and 2) to identify potential safety issues for patients. DESIGN AND SETTING: Qualitative descriptive study, involving all the package leaflets of branded medicines from the three most consumed therapeutic groups in Portugal, analyzed in the Department of Pharmacoepidemiology, School of Pharmacy, University of Lisbon. METHODS: A checklist validated through an expert consensus process was used to gather the data. The content of each package leaflet in the sample was classified as compliant or non-compliant with compulsory regulatory issues (i.e. stated dosage and descriptions of adverse reactions) and optional regulatory issues (i.e. adverse reaction frequency, symptoms and procedures in cases of overdose). RESULTS: A total of 651 package leaflets were identified. Overall, the package leaflets were found to be compliant with the compulsory regulatory issues. However, the optional regulatory issues were only addressed in around half of the sample of package leaflets, which made it possible to identify some situations of potentially compromised drug safety. CONCLUSION: Ideally, the methodologies for package leaflet approval should be reviewed and optimized as a way of ensuring the inclusion of the minimum essential information for safe use of medicines. RESUMO CONTEXTO E OBJETIVO:As bulas dos medicamentos são necessárias para a sua utilização segura. Os objetivos do presente estudo foram: 1) avaliar a adequação entre o conteúdo das bulas e as especificações da regulação farmacêutica e 2) identificar os aspectos que potencialmente possam comprometer a utilização segura dos medicamentos pelos doentes. TIPO DE ESTUDO E LOCAL:Estudo descritivo qualitativo com a inclusão de todas as bulas dos medicamentos de marca dos três grupos terapêuticos mais consumidos em Portugal, analisados no Departamento de Farmacoepidemiologia da Faculdade de Farmácia da Universidade de Lisboa. MÉTODOS: Utilização de uma checklist para recolher os dados. A checklist foi validada por um processo de consenso entre peritos. O conteúdo de cada uma das bulas da amostra foi classificado em relação à adequação aos aspectos regulatórios obrigatórios, como a descrição das reações adversas, dose e frequência de administração, e à adequação dos aspectos regulatórios facultativos, como a frequência das reações adversas e sintomas e procedimentos em caso de sobredosagem. RESULTADOS: Foram identificadas 651 bulas. Em termos gerais, todas as bulas foram consideradas conformes em relação aos aspectos regulatórios obrigatórios. No entanto, os aspectos regulatórios opcionais foram descritos em apenas cerca de metade da amostra de bulas, o que permite a identificação de situações susceptíveis de comprometer a utilização segura dos medicamentos. CONCLUSÃO: Idealmente as metodologias de aprovação das bulas devem ...

Validation of a new tool for evaluating subjects’ satisfaction with medicine package leaflets: a cross-sectional descriptive study

“…The package leaflets that were tested were randomized using the MS Excel software function from a large database used in a previous study (with approximately 500 Portuguese package leaflets). 14 A total of 12 randomized package leaflets were tested: six package leaflets from over-the-counter medicines (three package leaflets comprising more than 1500 words and another three with less than 1500 words) and six package leaflets from prescription medicines (also with either more than or less than 1500 words). The cutoff of 1500 words was defined because previous studies had concluded that package leaflets with fewer than 1500 words tended to be easily read and understood.…”

Using an Automatic Tool to Identify Potential Readability Issues in a Large Sample of Medicinal Package Inserts

“…PIs of medicinal products are very important in transmitting information on the effective and safe use of medicines [1][2][3][4]. Currently, there is a wide range of regulations worldwide concerning the adequate development and approval of PIs by marketing authorization holders and medicine agencies [5][6][7].…”