Este trabalho aborda o problema do consumo desenfreado de produtos naturais no Brasil, especificamente de medicamentos fitoterápicos, com suas consequências, discutindo à luz do Direito de Propriedade Industrial e o Direito Sanitário. Procura relacionar o papel e a responsabilidade do INPI e a ANVISA, órgãos diretamente envolvidos na legislação mencionada, para a melhoria da qualidade de produtos fitoterápicos registrados e lançados no mercado brasileiro. Mostra a necessidade de uma reavaliação dos critérios de concessão de patentes para a área analisada por parte do INPI, bem como uma maior aproximação da ANVISA junto à este órgão, de modo que harmonizem estratégias para que a população tenha acesso a medicamentos fitoterápicos seguros e eficazes. Explicita as estratégias d indústria nacional do setor em alavancar suas vendas no mercado, através de projetos de lei que não traduzem com a realidade preconizada pela OMS, para o uso da Medicina Tradicional/Complementar, contrariando a legislação brasileira para o possível registro dos produtos patenteados. Conclui-se que interesses econômicos, ligados à acirrada concorrência no mercado de fitoterápicos e suplementos nutricionais, induzem à concessão de patentes para tais produtos, em detrimento das diretrizes existentes na Lei de Propriedade Industrial brasileira, em critérios de avaliação. / This work approaches the problem of the wild consumption of natural products in Brazil, specifically herbal medicines, with its consequences, discussing to the light of the Right of Industrial Property and the Sanitary Right. It tries to relate the paper and the responsibility of INPI and ANVISA, organs directly involved in the mentioned legislation, for the improvement of the quality of products registered as herbal medicines and thrown in the Brazilian market. It shows the need of a reevaluation of the approaches of concession of patents for the area analyzed on the part of INPI, as well as larger approach of ANVISA close to this organ, so that they harmonize strategies so that the population has access to medications safe and effective herbal medicines. Explicit the strategies of the national industry of the section in it increases its sales in the market, through bills that dont translate with the strategies suggested by Oms, FOR Complementary/Alternative Medicine use, thwarting the Brazilian legislation for the possible registration on the patented products. It is ended that economic interests, linked to the intransigent competition in the herbal medicines market and nutritional supplements, induce to the concession of patents for such products, in detriment of the existent guidelines in the Law of Brazilian Industrial Property, in evaluation approaches.

O aumento do consumo de medicamentos pela população idosa brasileira e mundial no século XXI, somado ao envelhecimento populacional e relevante transição epidemiológica, apontam para a necessidade de mais estudos epidemiológicos por serem úteis ao planejamento de intervenções em saúde no âmbito coletivo. Os Estudos de Utilização de Medicamentos representam uma importante estratégia nesse sentido, por permitir a obtenção de informações sobre padrões de prescrição e uso de medicamentos, representando, desta forma, etapa de grande importância das investigações epidemiológicas. Este estudo visa estimar a prevalência e caracterizar o perfil de utilização de medicamentos na população idosa atendida pelas farmácias básicas do município de Uberaba-MG, bem como identificar os fatores mais implicados no acesso a esses medicamentos. Tratou-se de um estudo transversal, pelo qual uma amostra casual de 384 usuários de medicamentos foi entrevistada após a retirada seus medicamentos nas farmácias básicas municipais, entre março e julho de 2015, sendo utilizado um instrumento de coleta de dados, previamente padronizado e aprovado pelo Comitê de Ética em Pesquisa da Faculdade de Ciências Farmacêuticas de Ribeirão Preto, Universidade de São Paulo (CEP-FCFRP-USP). O pesquisador coletou informações sociodemográficas e relativas à saúde dos indivíduos, fotocopiou as prescrições, perguntou sobre o acesso aos medicamentos, e aplicou os testes de Batalla (TB), Med-Take (MT), Morisky-Green (MG) e o Índice da Complexidade da Farmacoterapia (ICFT). A idade média foi de 68,8 anos, sendo 70,0% do sexo feminino, renda per capita média de R$ 862,7, com predomínio de pardos (44,0%), casados (58%), com ensino fundamental incompleto (43,15%); a morbidade de maior prevalência foi a Hipertensão Arterial Sistêmica (71,95%). Dos 384 participantes, 95 (24,7%) afirmaram não recorrer à farmácia básica mais próxima de sua residência e as principais justificativas foram: fácil acesso devido às linhas de ônibus (40%) e consulta na unidade (31,6%). O perfil farmacoepidemiológico apresentou um intervalo de um a dez fármacos utilizados por paciente, com média de três fármacos/paciente; a maior prevalência foi dos medicamentos do aparelho cardiovascular (40,9%); 55,5% realizam automedicação. Conhecimento satisfatório sobre a farmacoterapia foi observado em 49,7% dos participantes; os resultados dos testes TB e MG foram de 13% e 57% de aderentes à farmacoterapia, respectivamente, não havendo correlação linear entre os resultados destes testes. O valor médio do ICFT foi de 7,3, sendo que 32,8% dos participantes possuíam terapias de alta complexidade; este índice apresentou correlação linear negativa em relação ao teste MT. A polifarmácia (uso de seis ou mais princípios ativos) esteve presente em 25,5% dos idosos, a qual não apresentou associação estatística com as variáveis sexo, estado civil, idade, renda per capita e escolaridade. 570 interações medicamentosas potenciais foram verificadas, estando 47,4% dos participantes sujeitos a pelo menos uma interação; 54,7% utilizam medicamentos considerados inapropriados ao idoso. Tais evidências reforçam a necessidade da adoção de estratégias a fim de melhorar a farmacoterapia e a assistência prestada à saúde do paciente idoso. / The increased consumption of medicines by Brazilian elderly population and world in the twenty-first century, coupled with the aging population and relevant epidemiological transition point to the need for more epidemiological studies to be useful to health interventions planning in a community basis. The Drug Use Studies represent an important strategy accordingly, to allow obtaining information on patterns of prescription and use of drugs, representing thus step of great importance of epidemiological investigations. This study aims to estimate the prevalence and characterize the profile of use of drugs in the elderly population served by basic pharmacies in the city of Uberaba-MG, and identify more factors involved in access to these drugs. It was a cross-sectional study, whereby a random sample of 384 users of drugs was interviewed after that it was withdrawing its medicines on the basic pharmacies in the city, between March and July 2015, using a previously standardized and approved data collection instrument by Ethics Committee in Research of the Faculty of Pharmaceutical Sciences of Ribeirão Preto, University of São Paulo (CEP-FCFRP-USP). The researcher collected socio-demographic and health information from individuals, photocopied the prescriptions, asked about access to medicines, and applied the tests of Batalla (TB), Med-Take (MT), Morisky-Green (MG) and the Complexity Index of the Pharmacotherapy (ICFT). The average age was 68.8 years, 70.0% female, average per capita income of R$ 862.7, with a predominance of browns (44.0%), married (58%), with education incomplete elementary (43.15%); the most prevalent morbidity was Arterial Hypertension (71,95%). Of the 384 participants, 95 (24.7%) said they did not resort to basic pharmacy closest to your residence and the main reasons were: easy access due to bus lines (40%) and in consultation Unit (31.6%). The pharmacoepidemiological profile presented a range of one to ten drugs used per patient with average of three drugs/patient; the highest prevalence was among the drugs of the cardiovascular system (40.9%); 55.5% performed self-medication. Satisfactory knowledge on pharmacotherapy was observed in 49.7% of participants; the results of the TB and MG tests were 13% and 57% adherent to the pharmacotherapy, respectively, and there was no linear correlation between the results of these tests. The mean value of ICFT was 7.3, with 32.8% of participants having high complexity; this index presented a negative linear correlation in relation to the MT test. Polypharmacy (use of six or more active principles) was present in 25.5% of the elderly, which did not present statistic association with the variables gender, marital status, age, per capita income and schooling. 570 potential drug interactions were verified, with 47.4% of participants being subject to at least one interaction; 54.7% use drugs considered inappropriate to the elderly. Such evidences reinforce the need to adopt strategies to improve pharmacotherapy and health care for elderly patients.

FundaÃÃo Cearense de Apoio ao Desenvolvimento Cientifico e TecnolÃgico / Um estudo transversal sobre a utilizaÃÃo de medicamentos fitoterÃpicos nas Unidades BÃsicas de AtenÃÃo à SaÃde da FamÃlia (UBASF) do municÃpio de MaracanaÃ-Ce foi realizado em duas etapas entre agosto de 2002 e janeiro de 2003; Primeiramente, foram entrevistados nas farmÃcias das UBASF, mediante questionÃrio estruturado, 226 usuÃrios maiores de 18 anos, com prescriÃÃo contendo medicamento fitoterÃpico; e posteriormente, utilizando-se metodologia qualitativa, foram selecionados 12 prescritores (6 mÃdicos e 6 enfermeiros) e 12 usuÃrios para um estudo aprofundado sobre a fitoterapia, considerando os aspectos sÃcio-culturais que envolvem tal prÃtica. Esta etapa foi realizada mediante entrevistas semi-estruturadas, gravadas, nos respectivos consultÃrios e residÃncias. Dos 226 usuÃrios entrevistados, 85,4% foram do sexo feminino e 14,6% do masculino, com mÃdia de idade de 38 anos; 94,2% receberam explicaÃÃo do prescritor quanto ao uso do fitoterÃpico; apenas 27,0% relacionaram o fitoterÃpico ao Programa farmÃcias Vivas; 63,1% jà havia utilizando o fitoterÃpico antes, dentre os quais, a maioria relatou sua eficiÃncia terapÃutica. Dos 542 medicamentos prescritos, 58% foram alopÃticos e 41,7% fitoterÃpicos; a mÃdia de medicamentos por prescriÃÃo foi de 2,39 e a mÃdia de fitoterÃpicos foi de 1,01%. Os fitoterÃpicos mais prescritos foram: o Xarope Expectorante (63,8%), o Sabonete de Alecrim (11,4%) e a Tintura de Mororà (11,4%). Dentre os 12 prescritores entrevistados, 91,66% afirmaram que prescrevem medicamentos fitoterÃpicos com freqÃÃncia e reconhecem sua eficiÃncia terapÃutica; o fator econÃmico tambÃm foi constantemente citado. Foi observada a homogeneidade das opiniÃes entre mÃdicos e enfermeiros; 100% dos prescritores reclamaram a quantidade insuficiente dos fitoterÃpicos em relaÃÃo à demanda. Dos 12 usurÃrios entrevistados nas residÃncias, todos demonstraram sua crenÃa na eficiÃncia dos fitoterÃpicos (caseiros ou das UBASF), geralmente relacionada à origem ânaturalâ dos mesmos, conceito legado da cultura empÃrica da comunidade; a referÃncia ao fator econÃmico como justificativa para o uso de produtos fitoterÃpicos foi insignificante. O presente estudo demonstrou que a Fitoterapia em Maracanaà à bastante aceita por usuÃrios e prescritores. Entretanto, o paÃs necessita de uma legislaÃÃo especÃfica para a produÃÃo de fitoterÃpicos na atenÃÃo primaria, que forneÃa subsÃdios aos Programas de Fitoterapia, no que concerne à realizaÃÃo de estudos de eficÃcia e toxicidade dos medicamentos produzidos, e de aÃÃes de FarmacovigilÃncia e controle de qualidade na produÃÃo e uso racional dos mesmos

The chronic and degenerative illnesses are common in elderly and frequently many medicines are used to treat them. The prescription medication and the improper use of medicines may lead to undesirable results causing hospital admissions which may be preventable and raising costs in health system. To evaluate the adequacy of drug therapy prescribed to elderly patients admitted in a teaching hospital of Fortaleza city based on Beers and Canadian criteria; to evaluate the adequacy of medicines prescribed in relation to the four of five swedish quality indicators of pharmacotherapy to older patients and to perceive the frequency of adverse drug reactions (ADR) during the hospital stay. This is an observational, descriptive and transversal study by convenience sample. The study was developed in the clinical patients ward of the University Walter Cantidio Hospital from October 2006 and May 2007. Patients 60 years and older admitted in the hospital were included in the study, particularly those that had signed the informed consent previously. A pharmacotherapeutic follow-up sheet with medical records was used taking into account the profile of medicines usage during the hospital stay and the nature of the ADR if this occurred after the hospital admission. The criteria for evaluating the suspected cases of ADR were defined by causality and severity adopted by World Health Organization (WHO) having as technical support the Pharmacovigilance Center of Cearà (CEFACE). The medicines were classified in accordance with the ATC (anatomic-therapeutic-chemical) up to the principal therapeutic group and also were analyzed according to Beers and Canadian criteria and the four Swedish quality indicators of pharmacotherapy to older patients. The software used to analyze the data was the Microsoft Excel 2002 for Windows. The study was approved by the Research Ethics Committee of the University Federal of Ceara. In the set of the 50% patients admitted in the study 42% were men and 58% were women. Half of the elderly were in the range of 60 to 69 years old. Considering the Beers and Canadian criteria, 84% of the patients received inappropriate prescription medication. The study registered 17 medicines potentially inappropriate to elderly persons. Metoclopramide, mineral oil and diazepam were the most frequently prescribed, in this order. In relation to the adverse drug reactions 30% of the patients showed suspected RAM and 69% of those attempted the female sex. The medication class most often implicated with the emergence of ADR was the antithrombotics and the types of ADR most frequent were the gastrointestinal disturbs. In the universe of followed patients a high percentage received inappropriate prescription medication giving evidence of the necessity of a better attendance of prescribing to older patient. / Nos idosos as doenÃas crÃnicas e degenerativas sÃo comuns e freqÃentemente se utilizam muitos medicamentos para tratÃ-las. A prescriÃÃo e o uso inadequado dos mesmos podem levar a resultados indesejados, acarretando internaÃÃes hospitalares evitÃveis e elevando os custos do sistema de saÃde. Avaliar a adequaÃÃo dos medicamentos prescritos para pacientes idosos internados em um hospital de ensino da cidade de Fortaleza com base nos CritÃrios de Beers e CritÃrios Canadenses; avaliar a adequaÃÃo da prescriÃÃo em relaÃÃo ao uso de quatro dos cinco indicadores suecos de qualidade da farmacoterapia em idosos e conhecer a freqÃÃncia com que reaÃÃes adversas a medicamentos (RAM) aparecem durante o perÃodo de internaÃÃo hospitalar. Estudo observacional, descritivo e transversal por amostra de conveniÃncia. O estudo foi desenvolvido na unidade de pacientes clÃnicos do Hospital UniversitÃrio Walter CantÃdio (HUWC) entre outubro de 2006 e maio de 2007. Foram incluÃdos no estudo pacientes internados com idade igual ou superior a 60 anos, por tempo superior a 24 horas e que tenham assinado o Termo de Consentimento Livre e Esclarecido. Foi utilizada uma Ficha de Acompanhamento FarmacÃutico com dados do prontuÃrio onde foram considerados o perfil de uso de medicamentos durante a internaÃÃo e a natureza da RAM quando esta ocorreu apÃs admissÃo hospitalar. Os critÃrios para avaliaÃÃo dos casos suspeitos de RAM foram estabelecidos pela avaliaÃÃo da causalidade e severidade adotados pela OrganizaÃÃo Mundial de SaÃde (OMS) tendo como suporte tÃcnico o Centro de FarmacovigilÃncia do Cearà (CEFACE). Os medicamentos foram classificados de acordo com o cÃdigo ATC (anatÃmico-terapÃutico-quÃmico) atà o grupo terapÃutico principal e tambÃm foram analisados pelos CritÃrios de Beers; CritÃrios Canadenses e 04 indicadores suecos de qualidade da farmacoterapia em idosos. O programa utilizado para a anÃlise dos dados foi o Microsoft Excel 2002 para Windows. O trabalho foi aprovado pelo Comità de Ãtica em Pesquisa da Universidade Federal do CearÃ. Do total de 50 pacientes idosos admitidos no estudo, 42% eram homens e 58% eram mulheres. Metade dos idosos se encontravam na faixa etÃria dos 60 a 69 anos. Considerando-se os CritÃrios de Beers e Canadenses, 84% dos pacientes tiveram prescriÃÃes de medicamentos a serem evitados. Foram contabilizados 17 medicamentos com potencial de inadequaÃÃo em idosos e o mais freqÃentemente prescrito foi a metoclopramida, seguido do Ãleo mineral e diazepam. Em relaÃÃo Ãs reaÃÃes adversas, 30% dos pacientes apresentaram registros de suspeita de RAM e 69% dessas suspeitas acometeram o sexo feminino. A classe de medicamentos mais envolvida com o aparecimento de RAM foi os agentes antitrombÃticos e os tipos de reaÃÃes mais freqÃentes eram distÃrbios do sistema gastrointestinal. No universo de pacientes acompanhados um percentual elevado recebeu prescriÃÃo de medicamento inadequado demonstrando que hà uma necessidade de um melhor acompanhamento de prescriÃÃes voltadas para o paciente idoso.

O presente trabalho pretende explorar o conceito de circuito superior marginal, proposto por Milton Santos em 1975. Esse conceito faz referência a um subsistema econômico presente nas cidades dos países do Terceiro Mundo. Nesse subsistema, encontramos ações que são, a um só tempo, ligadas às lógicas da modernização e dotadas de menor conteúdo em técnica, ciência e informação. Com isso, formam-se ações híbridas, que expressam tanto as racionalidades globais, instrumentais, como as racionalidades locais, comunicacionais. Para a realização desse estudo, cuidamos da produção de medicamentos no território brasileiro. Embora atentando para as novas condições de hegemonia dos laboratórios multinacionais, enfatizamos a situação dos pequenos laboratórios. Estes se dedicam a produções menos complexas e empregam técnicas e informações menos sofisticadas. Além disso, ficam submetidos ao controle político que os agentes hegemônicos passam a realizar, sobretudo em função dos aparelhos normativos que regulam as ações no território. Nessa medida, os pequenos produtores de medicamentos conformam, para a atividade farmacêutica, um circuito superior marginal. Nosso estudo quer entender as integrações desse circuito com o meio construído em várias situações urbanas brasileiras. / This work aims to explore the concept of marginal superior system, proposed by Milton Santos in 1975. This concept does reference to an economic subsystem that is presented in cities of Third World. In this subsystem we can find actions that are at the same time linked to the rationalities of the modernization and endowed with small contents in terms of technique, science, and information. Thus, hybrid actions emerge, expressing as global and instrumental rationalities as local and communicational rationalities. In order to develop this study, we are concerned about the production of medicines in the Brazilian territory. Though we consider the new conditions of hegemony from the multinational laboratories, we focused the situation of small laboratories. These latter ones develop less complex productions and employ less sophisticated techniques and information. Besides, they are submitted to the political control of the hegemonic actors, especially based on the normative tools that rule the actions in the territory. Thus, the small laboratories constitute, for the pharmaceutical activity, a marginal superior system. Our study aims to understand the linkages between this system and the built environment in several Brazilian urban situations.

Magister Public Health - MPH / Background: The irrational use of medicines, and increasingly antimicrobials, remains a key health problem in many developing countries including Zambia. Inappropriate, ineffective and inefficient use of medicines is common in health facilities at all levels. There are many factors influencing irrational prescribing and dispensing of antimicrobials including patients, prescribers, dispensers, the supply system (including industry influences), government regulations and medicines information and misinformation. Study aim: The aim of the study was to assess the rational use and availability of antimicrobials at primary level health facilities under the Lusaka district community health office, Zambia. Study design: The study was a cross-sectional descriptive study, with prospective and retrospective components. A standardized research methodology, including tools and indicators, adapted from the World Health Organization, was employed. Study population and sampling: The study population included all the 30 government primary level health facilities (health centres) in Lusaka District, from which 20 primary health facilities were sampled using a combination of purposive and random sampling. Using the WHO standard indicators of rational drug use, this study assessed 800 patient encounters, 520 medicines inventory records, and other baseline data, from 20 health facilities at three different levels under the Lusaka district community health office, Zambia. Data collection: The data collection tools were numbered and labeled. Tool 1: Prescribing Indicator Form was used to collect prescribing data; Tool 2: Patient Care (Pharmacy) Form was used to record dispensing data; Tool 3: Antimicrobial Availability Form for recording data for the availability of the key indicator antimicrobials and their substitutes; Tool 4: Facility Indicator Consolidation Reporting Form was used for consolidating the data collected for each health facility under study; and Tool 5: Facility Medicines Use Indicator Consolidation Form was used for the consolidation of the drug use data for the entire study. Third year Pharmacy Technology students were trained for the data collection process. The patients were first observed from outside the prescriber's room and the dispensing area for consultation and dispensing times respectively, and then they were interviewed to collect the prescribing and dispensing data. The tools were pre-tested. Data analysis: After data checking and consolidation, quantitative data were categorized into continuous numerical variables. Calculations were done manually and using computerized analysis (Epi Info package) and presented as simple frequency and means. Ethics: Ethical clearance for the study was obtained from University of the Western Cape Senate Research Committee. Permission was obtained from the Lusaka Provincial and District health offices, being the authorities that are overseeing the health facilities included in the study. Furthermore, permission was obtained from the health centre in-charges. Consent was obtained from healthcare providers and patients. Key results and discussion: The study found that at the primary level facilities there were more Clinical Officers (55%) than Medical Doctors (25%) and Registered Nurses (20%) in charge of prescribing. The main dispensers were Pharmacy Technologists (85%); there were no Pharmacists available in any of the facilities. A third [259 (32.4 %)] of all the 800 patients in the study were children below 12 years of age. Across the clinics, a mean of 2.94 medicines were prescribed per prescription, with an extremely low rate of prescribing drugs by generic name (36.7%). The proportion of prescriptions including an antibiotic was 36.2 % and 3.4 % included an injectable drug. Linking the antimicrobials and injections to patient diagnoses indicated that many were probably irrational, prescribing decisions. Amoxicillin and metronidazole were by far the most commonly prescribed antimicrobials at 32.0 % and 17.2 % of total antimicrobials, respectively. The essential drugs list was available in 80.0% of facilities and a high percentage of medicines were prescribed from the essential medicines list (81.2%). The overall mean percentage of medicines packages correctly labeled was considerably low at 44.8 %. The average consultation time was short at 4.0 (range 1-8.4) minutes, whereas the dispensing times were equally short and averaged at 116.6 (range 15-360) seconds, with the range of 15 to 360 seconds. The average percentage of first line antimicrobials available at health facilities was 79 %; and the average percentage of second line, substitute, antimicrobials available was 15 %. Conclusion: In line with studies from other settings, this medicines use study found considerable overuse and irrational use of antimicrobials in the primary health care clinics in Lusaka District. Irrational medicine prescribing was common and poor dispensing practices were also seen, resulting in poor use of and adherence to medicines and, consequently, poor therapeutic outcomes. Recommendations: Several recommendations have been formulated. They include: Reinforcing the Drug Therapeutic Committees (DTCs) at the national and the local facility level to help manage medicines use; clarification of prescribers and dispensers roles and responsibilities; development, enforcement or adaption of standard operating procedures (SOPS) for prescribing and dispensing; and improvement of prescribing and dispensing practices through introduction of appropriate education, supervision and audit.

The work analyzes trends in medicines used in specialized medical centers from ATC (Anatomical-Therapeutic-Chemical Classification System) L01 in Czech Republic from perspective of the State Institute of Drug Control (SUKL) and of Czech Health Insurance Companies (Vseobecna zdravotni pojistovna Ceske republiky as the biggest one, and rest joined in Svaz zdravotnich pojišťoven Ceske republiky). SUKL perspective considers medicines delivered to healthcare facilities and the other side providing information regarding payments for L01 medicines between years 2012-2015. Conclusions presented show slightly decreasing trend in terms of number of packages delivered (935 ths. in 2012 and 931 ths. in 2015). On the other hand, value of medicines has increased from 5 067 mil. CZK in 2012 to 6 568 mil. CZK in 2015. The increase in value and decrease in volume in the same time (while prices remain stable or decreasing) indicates trend in increasing size of packaging or entry of new strength (with more active ingredient and therefore more expensive) e.g. entry of Herceptin 600 mg in 2014. This paper further identifies the most expensive medicines in ATC L01 group and starts a discussion about possible reasons of discrepancies between different sources of data which are for the most expensive medicines in hundreds of mil. CZK in value and ths. of packages in terms of volume (e.g. Avastin in 2014: difference 104 mil. CZK and 5 598 packages).

Philosophiae Doctor - PhD / Studies on rational medicine use (RMU) have mainly focused on identifying, quantifying, and addressing irrational use without exploring reasons behind this irrational use. In addition, minimal work has been conducted on irrational use of medicines in the context of the growing burden of non-communicable diseases (NCDs). This PhD research examined medicine use in Eswatini, (previously Swaziland) between April 2017 and March 2019, with a focus on prescribing practices linked to specific diagnoses. It further explored factors influencing RMU, which included testing the effects of a short intervention - prescription audit and feedback coupled with small group education - on prescribing practices in health facilities.

Magister Pharmaceuticae - MPharm / Medicines registration decision-making and regulatory best practice involve transparent and consistent rule making and processes with publicly available published assessment decisions and reports (Kaine, 2020). Publication of information relating to evaluation of medicines in the form of Public Assessment Reports (PARs) is one way of ensuring transparency in medicines registration decision making. It is however not clear whether National Medicines Regulatory Authorities (NMRAs) in the Southern African Development Community (SADC) region are in a position to generate or even publish such PARs / summary basis for registration of medicines. Objectives: The study investigated transparency in medicines registration decision-making processes for NMRAs within the SADC region. Specifically, the availability or non-availability of PARs / Summary basis for registration of medicinal products. To establish if all SADC NMRAs have legislative frameworks for regulating medicines and to investigate the sources of funding for SADC NMRAs. Methods: A cross-sectional exploratory descriptive study design with qualitative techniques by questionnaire as a data collection tool was used. Questionnaires were sent via email to senior members / key informants of 11 regulatory authorities belonging to SADC. Trend analysis was conducted based on the emerging themes from questionnaire response. Results The study revealed that currently five (5) NMRAs are operating as semi-autonomous agencies namely: BOMRA, MCAZ, PMRA, SAHPRA and TMDA .While NMRC, DNME of Angola, ACOREP of DRC and DNF of Mozambique are functioning within their respective Ministries of Health Departments. Furthermore, all NMRAs have a legislation framework governing the regulation of medicines in their respective jurisdictions. However, DNME of Angola’s legal framework is not yet officially formalised and as such, they follow a Presidential decree enacted in 2010. Four (4) of nine (9) NMRAs (44 %) reported to have more than 20 internal assessors / evaluators. This indicates a significant milestone for SADC NMRAs in terms of capacity building within the region. The study findings indicated that the SADC NMRAs are receiving funding from multiple sources ranging from a minimum of one to maximum of four funding sources. There were only two NMRAs, MCAZ and PMRA, that were not receiving funding from their governments. The study results further indicates that only TMDA is able to generate and publish PARs amongst SADC NMRAs. Conclusions: The findings in this study suggest that the majority of NMRAs within SADC are not yet matured as compared to countries in the developed world such as the US, Europe, Canada and Australia. It can also be concluded that for SADC NMRAs to be efficient and responsive, they will require massive financial resources. For example, the budget for a matured NMRA such as the US Food and Drug Administration (US FDA) for the 2019 financial year was estimated at US$ 5.7 billion. Literature further indicates that publication of the summary basis of approval or PARs is a norm for mature NMRAs and acts as a tool for regulatory authorities to build and establish confidence in their review processes and provides assurance regarding safety of medicines. The study results indicate that TMDA is publishing PARs or summary of grounds on which approvals are granted. This demonstrates a significant level of transparency in the TMDA medicines registration processes and therefore other SADC NMRAs can benchmark with TMDA to implement this key parameter.

Background Non-adherence to evidence based secondary prevention medicines (SPM) by coronary heart disease (CHD) patients limits their expected benefits and may result in a lack of improvement or significant deterioration in health. This study explored self-reported non-adherence to SPM, barriers to adherence, and the perception that patients in West Yorkshire have about their medicines in order to inform practice and improve adherence. Methods In this cross-sectional study a specially designed postal survey (The Heart Medicines Survey) assessed medicines-taking behaviour using the Morisky Medicines Adherence 8 items Scale (MMAS-8), a modified version of the Single Question Scale (SQ), the Adherence Estimator (AE), Beliefs about Medicines Questionnaire(BMQ) and additional questions to explore practical barriers to adherence. Patients were also asked to make any additional comments about their medicines-taking experience. A purposive sample of 696 patients with long established CHD and who were on SPM for at least 3 months was surveyed. Ethical approval was granted by the local ethics committee. Results 503 (72%) patients participated in the survey. 52%, 34% and 11% of patients were prescribed at least four, three and two SPMs respectively. The level of non-adherence to collective SPM was 44%. The AE predicted that 39% of those had an element of intentional non-adherence. The contribution of aspirin, statins, clopidogrel, beta blockers, angiotensin converting enzyme inhibitors (ACEI) and angiotensin receptor blockers (ARBs) to overall non-adherence as identified by the SQ scale was 62%, 67%, 7%, 30%, 22% and 5%, respectively. A logistic regression model for overall non-adherence revealed that older age and female gender were associated with less non-adherence (OR = 0.96, 95% CI: 0.94, 0.98; OR = 0.56, 95% CI: 0.34, 0.93; respectively). Specific concern about SPM, having issues with repeat prescriptions and aspirin were associated with more non-adherence (OR = 1.12, 95% CI: 1.07, 1.18; OR = 2.48, 95% CI: 1.26, 4.90, OR = 2.22, 95% CI: 1.18, 4.17). Other variables were associated with intentional and non-intentional non-adherence. 221 (44%) patients elaborated on their medicines-taking behaviour by providing additional comments about the need for patient tailored information and better structured medicines reviews. Conclusions The Medicines Heart Survey was successful in revealing the prevalence of self-reported non-adherence and barriers to adherence in our population. Healthcare professionals should examine specific modifiable barriers to adherence in their population before developing interventions to improve adherence. Conducting frequent structured medicines-reviews, which explore and address patients' concerns about their medicines and healthcare services, and enable them to make suggestions, will better inform practice and may improve adherence.