O objetivo deste trabalho foi analisar uma proposta de Qualificação de Fornecedores passível de aplicação no âmbito dos Laboratórios Oficiais, e de alguma forma contribuir para a produção nacional, agregando qualidade aos insumos adquiridos e por conseqüência aos medicamentos produzidos pela Rede Pública, enriquecendo e qualificando o Parque Industrial Nacional e o Patrimônio Público. A pesquisa foi desenvolvida no Laboratório Oficial da Fundação Ezequiel Dias em Belo Horizonte (FUNED), MG, tendo sido reunidas informações dos Setores de Compras, Almoxarifado de Recebimento de Insumos, Planejamento de Produção, Garantia da Qualidade, Controle de Qualidade e Produção de Medicamentos. A pesquisa foi delineada através da Análise Documental dos registros que remeteram ao histórico de aquisição de insumos no ano de 2007. Foram analisadas AF (Autorizações de Fornecimento), AR (Autorizações de Recebimento), Check List de Recebimento de Insumos, Boletins da Divisão de Controle de Qualidade com registros de Análise Físico-Química de Matérias Primas, Relatórios de Não conformidade de Produto Acabado e de Matéria Prima. Houve revisão e adaptação do Método de Petrus para Qualificação de Fornecedores, especificamente para o Setor Farmacêutico. Os resultados alcançados demonstraram de forma positiva que a utilização da adaptação do Método de Petrus pode auxiliar na qualificação de insumos farmacêuticos, mas também demonstrou algumas dificuldades que remeteram a pesquisa à importância da Pré-Qualificação de Fornecedores na busca da Certificação e da Garantia da Qualidade dos medicamentos produzidos pelos Laboratórios Oficiais. / The aim of this study was to analyse a proposal of qualification of suppliers which could be applied in official laboratories, and somehow contribute for the national production, adding quality to purchased inputs and thus the drugs produced by the Brazilian governmental industry. These would enrich and qualify the national industry and public patrimony. This research was developed at Fundaçao Ezequiel Dias – FUNED’s Official Laboratory, in Belo Horizonte, MG. It was used information by Purchase, Warehouses, Production Planning, Quality Guaranties, Quality Control and Drug’s Production Departments. This study was designed by documentary analysis of records which recalled the historic acquisition in 2007. SA (supply authorizations), RA (receipt authorization), receipt of supply checklist, bulletins from the division of quality control with records of physic-chemical analysis of raw material, reports non-conformity of finished products and of raw materials were analysed. The Petrus’ Method for supplier’s qualification was revised and adapted, specifically for the pharmaceutical sector. The results showed that the use of the adaptation of Petrus’ Method can help qualify the pharmaceutical supplies but it also demonstrated some difficulties which pointed out the importance of pre-qualification of suppliers when aiming for the certification and quality guarantee for the produced drugs by official laboratories

O objetivo deste trabalho foi analisar uma proposta de Qualificação de Fornecedores passível de aplicação no âmbito dos Laboratórios Oficiais, e de alguma forma contribuir para a produção nacional, agregando qualidade aos insumos adquiridos e por conseqüência aos medicamentos produzidos pela Rede Pública, enriquecendo e qualificando o Parque Industrial Nacional e o Patrimônio Público. A pesquisa foi desenvolvida no Laboratório Oficial da Fundação Ezequiel Dias em Belo Horizonte (FUNED), MG, tendo sido reunidas informações dos Setores de Compras, Almoxarifado de Recebimento de Insumos, Planejamento de Produção, Garantia da Qualidade, Controle de Qualidade e Produção de Medicamentos. A pesquisa foi delineada através da Análise Documental dos registros que remeteram ao histórico de aquisição de insumos no ano de 2007. Foram analisadas AF (Autorizações de Fornecimento), AR (Autorizações de Recebimento), Check List de Recebimento de Insumos, Boletins da Divisão de Controle de Qualidade com registros de Análise Físico-Química de Matérias Primas, Relatórios de Não conformidade de Produto Acabado e de Matéria Prima. Houve revisão e adaptação do Método de Petrus para Qualificação de Fornecedores, especificamente para o Setor Farmacêutico. Os resultados alcançados demonstraram de forma positiva que a utilização da adaptação do Método de Petrus pode auxiliar na qualificação de insumos farmacêuticos, mas também demonstrou algumas dificuldades que remeteram a pesquisa à importância da Pré-Qualificação de Fornecedores na busca da Certificação e da Garantia da Qualidade dos medicamentos produzidos pelos Laboratórios Oficiais. / The aim of this study was to analyse a proposal of qualification of suppliers which could be applied in official laboratories, and somehow contribute for the national production, adding quality to purchased inputs and thus the drugs produced by the Brazilian governmental industry. These would enrich and qualify the national industry and public patrimony. This research was developed at Fundaçao Ezequiel Dias – FUNED’s Official Laboratory, in Belo Horizonte, MG. It was used information by Purchase, Warehouses, Production Planning, Quality Guaranties, Quality Control and Drug’s Production Departments. This study was designed by documentary analysis of records which recalled the historic acquisition in 2007. SA (supply authorizations), RA (receipt authorization), receipt of supply checklist, bulletins from the division of quality control with records of physic-chemical analysis of raw material, reports non-conformity of finished products and of raw materials were analysed. The Petrus’ Method for supplier’s qualification was revised and adapted, specifically for the pharmaceutical sector. The results showed that the use of the adaptation of Petrus’ Method can help qualify the pharmaceutical supplies but it also demonstrated some difficulties which pointed out the importance of pre-qualification of suppliers when aiming for the certification and quality guarantee for the produced drugs by official laboratories

Independent and supplementary prescribing are the two main forms of non-medical prescribing (NMP) that have been practised in the UK since 2006. Most available studies have qualitatively investigated the impact of NMP, especially in primary care. This may be due to the fact that prescriptions are issued mainly by general practitioners in primary care. This PhD thesis aimed at investigating the clinical effectiveness of independent pharmacist and diabetes specialist nurse (DSN) prescribers in the management of patients with type 2 diabetes at outpatient clinics in hospitals. A literature review was firstly conducted to explore the current research on NMP around the world and the UK. A systematic review of the previously published randomised control trials (RCT) and non-RCT studies that focused on prescribing interventions of nurses and pharmacist was also conducted to explore the impact of their prescribing interventions in treating type 2 diabetes using HbA1c level as the primary outcome. A programme of work of three retrospective comparative database analytical studies was then carried out to investigate the impact of independent NMPs in type 2 diabetes care. This programme of work used electronic medical records of patients attending outpatient clinics of diabetes centres in two teaching hospitals in Manchester; one employed an independent pharmacist and the other employed DSN prescribers. A group of subjects seen by an NMP in place of a doctor during the study period were the study group and the control group were those who seen only by doctors. The primary outcome was the average yearly change of HbA1c amongst the two groups. Secondary outcomes were yearly change of total cholesterol, blood pressure and serum creatinine as well as body mass index. Five statistical models, which included multivariable regression, propensity score matching and sensitivity analyses, were utilised to control for confounding effects, and the nature of selection bias in the retrospectively comparative effectiveness research using secondary database resources. A total of 330 patients seen by a team including a pharmacist versus 975 by doctors only between January 2006 and January 2013 at one site; and 656 by a team including DSNs versus 3,746 patients seen by doctors only between January 2007 to December 2013 at the other. The studies found both prescribing pharmacists and DSNs are capable of achieving at least non-inferior improvements in diabetes outcome compared to doctors. The pharmacist achieved a mean 0.01% reduction in HbA1c level versus doctors who achieved slight increase (p<0.4). DSNs also achieved a mean 0.07% reduction compared to doctors. However, after adjustment with multivariate and propensity score as well as with propensity score matching, there were no significant differences between the two groups. These findings were consistent with the findings in the systemic review. Although an RCT is the only method that by definition would produce unbiased treatment effects, the use of propensity score methods here, have reduced the potential for bias that may remain unaccounted for in multivariate models without propensity scores. Adjusting for propensity scores using two different methods also gives more confidence that the results are as unbiased as possible. Nonetheless, caution in generalising the results is necessary because of the retrospective nature of the studies and deficiencies in the database used.

Le pharmacien d’officine, personnage central du système pharmaceutique français, assure la distribution au détail des médicaments et d’autres produits de santé au public. Au cours de ces dernières années, le pharmacien a vu ces obligations professionnelles s’accroître en raison des exigences de la demande sociale à son égard, en termes de contraintes sanitaires mais aussi administratives ou comptables ; des contingences légales et réglementaires nouvelles ont été mises en balance avec le monopole pharmaceutique qui lui est octroyé, depuis la production jusqu’à la mise à disposition du médicament en ville. Dans le cadre de son activité, le pharmacien d’officine encourt ainsi des responsabilités juridiques variées et complexes, qui ont sensiblement évolués ces dernières années. L’engagement juridictionnelle judiciaire (civil et pénal) et/ou administratif (disciplinaire), ou non juridictionnelle, de ces responsabilités vise à apporter une réponse, par une indemnisation et/ou une sanction, lorsqu’un fait dommageable et/ou répréhensible a causé un trouble social et/ou un préjudice à une victime. Si la victime peut naturellement être un client de l’officine, il peut également s’agir d’un autre professionnel de santé, d’un organisme de l’Assurance maladie, d’une institution sanitaire, ou d’un cocontractant fournisseur ou acheteur professionnel de produits de santé. / The evolution of modern society leads each of us to be more exposed to suffer damage or harm as well in privacy that of work relations. The ambulatory pharmacist, central character of the french pharmaceutical system, distributes retail drugs and other products of health to the public. In recent years, the pharmacist saw these professional obligations increase because of the requirements of the social demand for it, in terms of health but also administrative or accounting constraints; regulatory news and legal contingencies were put in balance of pharmaceutical monopoly which it is granted, from production to the availability of the drug in the city. In its activity, the pharmacist is thus liable to legal responsibilities varied and complex, which have significantly advanced in recent years. When a fact injurious or objectionable has caused social disorder or injury to a victim, the responsibilities of the pharmacist may be sought in the courts (civil, criminal or disciplinary). If the victim can naturally be a client of the pharmacy, it may also be other health insurance professional, of a health institution, or a contractor provider or professional buyer product.

Drug-drug interactions (DDI) represent a growing concern for the health units. Therefore, monitoring of pharmaceutical prescriptions in hospitals can rationalize pharmacotherapy. To evaluate the effect of pharmaceutical intervention in identifying and managing drug interactions in an intensive care unit (ICU), in Northeastern of Brazil. Methods: Initially, we performed a systematic review from the search of electronic databases, Jan. 1960 to Aug 2010. After that, we realized a longitudinal study in the ICU, in a private hospital in the city of Aracaju-SE, between 2008 and 2009, which was identified in the prevalence and clinical relevance of the DDI. During the study pharmaceutical interventions were aimed at the management of DDI. The systematic review, only seven articles met all inclusion criteria and the specific sample sizes ranged from 200 to 1785 patients. As for the longitudinal study, 6085 prescriptions were collected, of which 213 contained DDI clinically relevant. Of these 178 were moderate and 35 major severity. The clinical pharmacy interventions consisted in the preparation of reports for physicians, allowing the reduction of 40% of all DDI. The data obtained allow inferring that the participation of clinical pharmacists in the DDIs identification and management may have been essential to promote the safety of ICU patients. / As interações medicamentosas (IM) representam uma crescente preocupação para as unidades de saúde. Por isso, o acompanhamento farmacêutico das prescrições nos hospitais pode racionalizar a farmacoterapia. Avaliar o efeito da intervenção farmacêutica na identificação e manejo de interações medicamentosas em uma unidade de terapia intensiva (UTI), no nordeste do Brasil. Inicialmente, foi realizada uma revisão sistemática sobre a qualidade dos estudos que envolvem o papel do farmacêutico na identificação de IM em hospitais, a partir da busca nos bancos de dados eletrônicos, janeiro de 1960 a agosto de 2010. A revisão utilizou como critérios de inclusão: (i) estudos realizados em hospitais; (ii) identificação de IM com a participação do farmacêutico; (ii) texto em língua inglesa. Em seguida, foi realizado um estudo longitudinal, na UTI, em um hospital privado do município de Aracaju-SE, entre 2008 e 2009, no qual foi identificada a prevalência e relevância clínica das IM do tipo fármaco-fármaco. Durante o estudo foram realizadas intervenções farmacêuticas que visavam o manejo da IM. Na revisão sistemática, apenas seis artigos atenderam a todos os critérios de inclusão específicos e o tamanho das amostras variou de 200 a 1785 pacientes. Quanto ao estudo longitudinal, foram coletadas 6.085 prescrições, sendo que 213 continham IM clinicamente relevantes. Destas 178 apresentaram severidade moderada e 35grave. As intervenções da farmácia clínica consistiram na elaboração de laudos para os médicos, que possibilitaram a redução de 40% de todas as interações. Os dados obtidos permitem inferir que a participação do farmacêutico clínico na identificação e manejo de IM, pode ter sido essencial para promover a segurança de pacientes da UTI.

No description available.

Acknowledgement: "My sincere thanks to my supervisors Julie, Alison and Christina" - Identified Julie and Alison from the Department staff webpages - sm 26/02/2019 / There is little research investigating factors that facilitate or inhibit timely access to palliative care medicines from community pharmacies. Though palliative care is recognised within the UK government’s strategy and community pharmacists are considered to have a role it is uncertain to what extent this aim is incorporated into local practice. This thesis uses mixed methods to investigate the time taken to access palliative care medication from five community pharmacies in one area of England. The effect of prescription errors, stock availability and other factors is examined. Furthermore, semi-structured interviews with five community pharmacists and eleven other healthcare professionals explore medication access and the community pharmacist’s role in palliative care using the Framework method. Stock availability led to delays with one in five customers going to more than one pharmacy to get urgently required palliative care medications. Legal prescription errors were more common on computer generated prescriptions but did not lead to delays. Three subthemes were identified in accessing palliative care medicines: environment and resources; communication and collaboration; skills and knowledge. The community pharmacist’s role in palliative care was limited due to reluctance from other healthcare professionals to share information, poor access to patient records and lack of integration into the primary healthcare team. This study highlights implications for professionals, commissioners and providers to improve services for those trying to access palliative medication. Community pharmacies remain a largely untapped resource for supporting patients, relatives and carers towards the end of life in both cancer and other advanced life-limiting diseases.

Introduction: Trainee pharmacists are required to undertake a work-based pre-registration training placement (PRTP) in order to qualify. Literature exploring how this placement influences the development of students’ professionalism is sparse, however it is acknowledged that placements offer learning that can not be replicated in an academic environment. Following recent recommendations for the PRTP to be split into two six-month placements, the “sandwich” Master of Pharmacy (MPharm) programme at the University of Bradford offers a unique opportunity to study the impact of an early PRTP. This project aimed to understand the experiences of “sandwich” students during their early PRTP and generate a theory explaining how professionalism develops during this time. Methods: A constructivist grounded theory approach was taken. Fourteen students who had recently completed their early PRTP were interviewed using semi-structured, face-to-face interviews. A constant comparative approach to analysis was taken. Findings: The process developing a professional identity emerged as the core category. This consisted of four interlinking stages; reflection, selection of attributes, professional socialisation and perception of role. Developing a professional identity occurred under the conditions of realising the reality of the profession, developing practical knowledge and skills and learning from mentors. The consequence of developing a professional identity was that participants felt they were now a trainee professional. Discussion and conclusion: The theory demonstrates that developing a professional identity was the main process that occurred whilst MPharm students were on their early PRTP. Regulatory, funding and educational organisations should consider this when reviewing pharmacists’ training and students’ approach on return to university.

Background Of the 464 million patients diagnosed with diabetes mellitus globally, type 2 diabetes accounts for 90%. Type 2 diabetes contributes to other conditions such as hypertension, dyslipidaemia and cardiovascular diseases. Glycaemic haemoglobin control is essential in reducing long-term macrovascular and microvascular complications. Pharmacist interventions have been documented to have a positive role in diabetes management. In Kuwait, type 2 diabetes prevalence is increasing and found in a young population. Aims To evaluate the influence of the pharmacist-led intervention on diabetes knowledge, medication adherence and HbA1c, and hypertension. In addition, to estimate the 10-years risk of developing cardiovascular events and assess the cost of diabetes-related complications. Method The study was a randomised controlled trial with control and intervention arms conducted at the military hospital in Kuwait. Participants (n=177) were randomly allocated to the intervention group (n=88) and control group (n=89), using a 4-block randomisation procedure. The intervention group received face-to-face education and counselling from the pharmacist with a monthly follow-up for six months. The primary outcome was glycaemic control, and secondary measures were hypertension, lipid profiles, medication adherence, diabetes knowledge, 10-year estimated cardiovascular events and cost. QRISK3 and UKPDS-OM2 were used to estimate the risk of CVD events and cost comparison analysis. ii Results Compared with baseline, the mean reduction of HbA1c, blood pressure, and lipid profiles showed significant improvement in the intervention group. Additionally, improvement in medication adherence, diabetes knowledge, 10-years estimated cardiovascular events were reported with the intervention group. Also, the pharmacist-led intervention was cost-saving. Conclusion The study highlighted that adult type 2 diabetes patients who received the pharmacist-led intervention experienced a reduction in adverse clinical outcomes, improved non-clinical outcomes, and assisted in lifestyle modification.

There is little research investigating factors that facilitate or inhibit timely access to palliative care medicines from community pharmacies. Though palliative care is recognised within the UK government’s strategy and community pharmacists are considered to have a role it is uncertain to what extent this aim is incorporated into local practice. This thesis uses mixed methods to investigate the time taken to access palliative care medication from five community pharmacies in one area of England. The effect of prescription errors, stock availability and other factors is examined. Furthermore, semi-structured interviews with five community pharmacists and eleven other healthcare professionals explore medication access and the community pharmacist’s role in palliative care using the Framework method. Stock availability led to delays with one in five customers going to more than one pharmacy to get urgently required palliative care medications. Legal prescription errors were more common on computer generated prescriptions but did not lead to delays. Three subthemes were identified in accessing palliative care medicines: environment and resources; communication and collaboration; skills and knowledge. The community pharmacist’s role in palliative care was limited due to reluctance from other healthcare professionals to share information, poor access to patient records and lack of integration into the primary healthcare team. This study highlights implications for professionals, commissioners and providers to improve services for those trying to access palliative medication. Community pharmacies remain a largely untapped resource for supporting patients, relatives and carers towards the end of life in both cancer and other advanced life-limiting diseases.