Package leaflets of the most consumed medicines in Portugal: safety and regulatory compliance issues. A descriptive study / Bulas dos medicamentos mais consumidos em Portugal: aspectos de segurança e de adequação regulamentar. Um estudo descritivo

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. .

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 ser revistas e otimizadas de forma a assegurar um mínimo de informação essencial para a utilização segura dos medicamentos. .

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

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.

Options, challenges and potentials of poultry meat: an empirical investigation on european consumers

Agricultural market developments have attracted considerable attention recently, due to increasing consumer food prices and sharp short term price fluctuations of agricultural commodity prices. This medium term outlook provides a projection for major EU agricultural commodity markets and agricultural income until the year 2022, based on a set of coherent assumptions. Under these assumptions, agricultural commodity prices are expected to stay firm over the medium term, supported by factors such as the growth in global food demand, the development of the biofuel sector and a prolongation of the long-term decline in food crop productivity growth. EU commodity markets are projected to remain balanced on average over the outlook period, without the need for market intervention. Prospects for agricultural income grow at EU level during the outlook period, resulting from continuing decline in labor input rather than from income increases at sector level (European Commission, 2012). The article concentrates on the prospects for European meat market trends and on results of the primary quantitative research which was carried out in four countries EU member state.(AU)

Options, challenges and potentials of poultry meat: an empirical investigation on european consumers

Agricultural market developments have attracted considerable attention recently, due to increasing consumer food prices and sharp short term price fluctuations of agricultural commodity prices. This medium term outlook provides a projection for major EU agricultural commodity markets and agricultural income until the year 2022, based on a set of coherent assumptions. Under these assumptions, agricultural commodity prices are expected to stay firm over the medium term, supported by factors such as the growth in global food demand, the development of the biofuel sector and a prolongation of the long-term decline in food crop productivity growth. EU commodity markets are projected to remain balanced on average over the outlook period, without the need for market intervention. Prospects for agricultural income grow at EU level during the outlook period, resulting from continuing decline in labor input rather than from income increases at sector level (European Commission, 2012). The article concentrates on the prospects for European meat market trends and on results of the primary quantitative research which was carried out in four countries EU member state.