Masters of Science / Problem and significance: Off-label use of medicines is not illegal; however, it can be risky and harmful, or beneficial and innovative. The main problem of this practice is the lack of systems for monitoring adverse drug reactions, since the drugs are used in a manner that is not approved by regulatory agencies. For this reason public health protection is not guaranteed. Purpose: To identify the various systems employed in different regions to monitor/manage the risks and benefits of off-label use; and to ascertain their extent of implementation. Method/search strategy: Electronic and manual literature search was done. Articles referring to off-label medicine use were reviewed. The literature included journal articles, national MRA guidelines, international guidelines, etc. The articles were sourced from databases such as Pubmed and Google Scholar. Data was collected from both developed and emerging markets. There was no limit to publication date. Findings: Pharmacovigilance systems for off-label use do exist although the degree of commitment and advancement differs per country. Explicit off-label laws are present in the developed countries but not in the developing ones. Implications of findings: Stakeholder involvement is very important in monitoring off-label use. Reporting of ADRs can be improved by asserting the role of off-label PV in drug repositioning. The regulator is under pressure to maintain public trust through efficient control of off-label use.

Magister Pharmaceuticae - MPharm / Medicines (CMs) are widely available to the South African public. However, CMs have not yet been evaluated by the Medicines Control Council (MCC). The MCC has published new guidelines for the regulation of CMs, with which CM companies are required to comply. OBJECTIVE: Determine to what degree Western Herbal CM labelling complies with the MCC’s requirements. METHODS: Thirteen CM products containing recognised Western Herbal ingredients were selected from pharmacies in the northern suburbs of Johannesburg. Labelling information on the immediate and outer container labels, as well as the package inserts, was investigated. The relevant corresponding European Medicines Agency (EMA) monographs and MCC guidelines were used to assess compliance. RESULTS: None of the products complied with the product dosage section of the monographs. Furthermore, the products contained indications that were not present in the monographs. The products did not fully meet the MCC’s mandatory minimum labelling requirements, and they did not demonstrate total compliance with all of the MCC’s requirements for product labels and package inserts.

Este trabalho avaliou a qualidade dos medicamentos em comercialização no Brasil com base nos bancos de dados dos dois maiores laboratórios oficiais de controle da qualidade de produtos para a saúde: Instituto Nacional de controle de qualidade em saúde - INCQS/RJ e Instituto Adolfo Lutz IAL/SP. Os procedimentos metodológicos deste estudo orientaram-se pelos pressupostos da pesquisa qualitativa, avaliando: modalidades de análises - previstas e não previstas na legislação sanitária; ensaios analíticos executados nas amostras de medicamentos; análise documental; análises física, química e físico-química; análise microbiológica e análise toxicológica/farmacológica; amostras analisadas - quantitativamente em relação ao número de medicamentos em comercialização e qualitativamente em função da avaliação final satisfatória ou insatisfatória. Este estudo demonstrou que o percentual de medicamentos avaliados oficialmente foi insuficiente para definir a qualidade dos medicamentos comercializados no país, apontando para a necessidade de revisão do sistema nacional de controle oficial de medicamentos. / The purpose of this research was to assess the quality of medical drugs on sale in Brazil, using the data banks of the country\'s most important official health products quality control laboratories - the National Institute for Health Quality Control (INCQS/RJ) and the Adolfo Lutz Institute (IAL/SP). The methodological procedures of this research study are based on qualitative research presumptions and evaluate the following: modalities of analysis; laid down or not in health legislation; analytical screening of drug samples; documentary, physical, chemical and physical-chemical; microbiological and toxicological/pharmacological analysis; samples analysed quantitatively in relation to the number of drugs on sale and qualitatively on the basis of final satisfactory or unsatisfactory evaluation. This study demonstrated that the percentage of officially-evaluated drugs is not sufficient to assess the quality of the medicines on sale in the country, and that a requirement therefore exists for a review of the national system of official control of medical drugs.

Magister Pharmaceuticae - Mpharm / The aim of this study was to determine quality control specifications needed for a dossier and an investigator's brochure of A. afra capsules, which can be used to motivate the registration and clinical testing of A. afra capsules in chronic asthma. The specific objectives were: (1) to establish the minimum product quality requirements for registration of A. afra capsules, (2) to prepare and pharmaceutically characterize a capsule product of A. afra freeze dried aqueous extract (FDAE) suitable for registration, and (3) to identify pharmaceutical product quality aspects of an investigator's brochure (IB) that would be appropriate for use in motivating a clinical trial of A. afra capsules in chronic asthma.

Este trabalho avaliou a qualidade dos medicamentos em comercialização no Brasil com base nos bancos de dados dos dois maiores laboratórios oficiais de controle da qualidade de produtos para a saúde: Instituto Nacional de controle de qualidade em saúde - INCQS/RJ e Instituto Adolfo Lutz IAL/SP. Os procedimentos metodológicos deste estudo orientaram-se pelos pressupostos da pesquisa qualitativa, avaliando: modalidades de análises - previstas e não previstas na legislação sanitária; ensaios analíticos executados nas amostras de medicamentos; análise documental; análises física, química e físico-química; análise microbiológica e análise toxicológica/farmacológica; amostras analisadas - quantitativamente em relação ao número de medicamentos em comercialização e qualitativamente em função da avaliação final satisfatória ou insatisfatória. Este estudo demonstrou que o percentual de medicamentos avaliados oficialmente foi insuficiente para definir a qualidade dos medicamentos comercializados no país, apontando para a necessidade de revisão do sistema nacional de controle oficial de medicamentos. / The purpose of this research was to assess the quality of medical drugs on sale in Brazil, using the data banks of the country\'s most important official health products quality control laboratories - the National Institute for Health Quality Control (INCQS/RJ) and the Adolfo Lutz Institute (IAL/SP). The methodological procedures of this research study are based on qualitative research presumptions and evaluate the following: modalities of analysis; laid down or not in health legislation; analytical screening of drug samples; documentary, physical, chemical and physical-chemical; microbiological and toxicological/pharmacological analysis; samples analysed quantitatively in relation to the number of drugs on sale and qualitatively on the basis of final satisfactory or unsatisfactory evaluation. This study demonstrated that the percentage of officially-evaluated drugs is not sufficient to assess the quality of the medicines on sale in the country, and that a requirement therefore exists for a review of the national system of official control of medical drugs.