Awareness and knowledge of doctors, pharmacists and nurses on adverse drug reaction reporting systems in Namibia.

Masters Degree. University of KwaZulu-Natal, Durban.Objective Reporting of adverse drug reactions (ADRs) in Namibian public health facilities is routinely done through safety yellow forms which are forwarded to the Therapeutics Information and Pharmacovigilance Centre (TIPC) for further assessment and possible interventions. This study investigated the awareness and knowledge of healthcare practitioners (HCPs) regarding the ADR reporting system in the country. Methods A cross-sectional study was conducted via a self-administered questionnaire at two state hospitals in Namibia; one located in the Khomas region and the other located in the Hardap region. The questionnaire was distributed to HCPs in current practice dealing directly with medication and it included a combination of open-ended, closed-ended and multiple-choice questions. Questionnaires were distributed in hard copy form during the period of 1 October 2019 up until 15 December 2019. Data was coded and transcribed into Microsoft® Excel® 2016 and analysed with SPSS® for IOS version 24. Results One-hundred and three completed questionnaires were received. Sixty-eight percent of the respondents were nurses, 24.3% were medical doctors and 7.8% were pharmacists. The majority of HCPs (73.8% and 56.3% respectively) were able to define the terms “adverse drug reaction” and “pharmacovigilance” correctly while only 41.7% correctly defined “spontaneous reporting”. The majority of HCPs (60.2%) have identified an ADR in practice; however only 36.9% reported this following the approved process. Only 48.5% of HCPs were aware of the safety yellow form for ADRs and 63.1% of HCPs did not know where to obtain the form. Furthermore only 37.9% of HCPs knew the name of the drug regulatory authority in Namibia. Conclusion Awareness and knowledge of ADR reporting systems by HCPs in Namibia is insufficient. While HCPs deem it necessary to report ADRs, reporting is unacceptably low leading to serious concerns regarding continuous monitoring of drug safety. Pharmacists showed better awareness compared to other HCPs and can, therefore, be best utilised as focal points in pharmacovigilance protraction. Mass awareness programs by the TIPC and other stakeholders need to be established to expand pharmacovigilance among HCPs

Comparative analysis of the functionalities of the ADR reporting systems in Bulgaria and other countries in Europe

The aim of the current study is to compare the system of ADRs reporting in Bulgaria, in the context of good European practices.Material and methods: In order to perform an analysis of the European systems for ADRs reporting, two types of documentary sources of information were used. The content was analyzed in comparative terms:- Scientific publications in refereed scientific medical journals;- Websites of national centers for pharmacovigilance.Information about ADR reporting forms by patients and medical professionals was extracted from the studied sources. The organization of the systems was also studied, including the engagement of additional structures and institutions.Results and conclusions: The pharmacovigilance system in Bulgaria functions in accordance with European legislation, and despite the common principles of work of individual EU member states, there are different approaches in the organization at the national level.At least 3 different channels are available for patients and healthcare professionals to report ADRs in all analyzed countries. Online forms for reporting ADRs are readily available on the Internet. Despite the existence of different forms for patients and for health professionals, the basic volume of patient information is guaranteed through both forms.An important aspect of the activities of the agencies is the promotion of the importance of reporting ADR through various organized information campaigns

Nursing and adverse drug reactions: a dawning role

Trabajo fin de grado en EnfermeríaObjetivo: El presente trabajo pretende explorar y definir el rol de la enfermera en la detección y notificación de las reacciones adversas a medicamentos. Metodología: Se realizó una revisión narrativa mediante la búsqueda bibliográfica en las bases de datos PubMed, Cinahl y Scielo; en el repositorio Cochrane Library, y en el metabuscador Google Académico. Resultados: Se seleccionaron 29 artículos que se organizaron en tres subapartados: la notificación de RAM en los profesionales sanitarios, herramientas e instrumentos utilizados por enfermeras, y características y otros datos relacionados. Se examinaron resultados como el porcentaje de notificación de las enfermeras, la calidad de dichas notificaciones y el conocimiento de las enfermeras en cuanto a los sistemas de farmacovigilancia en distintos países. Asimismo, se recogieron otros datos como las herramientas desarrolladas para el uso por enfermeras, su validez y los resultados derivados de su uso; los sentimientos reportados por enfermeras en cuanto al desarrollo de su rol como notificadoras; sus conductas y las barreras referidas por ellas mismas para cumplir sus nuevas responsabilidades, y estudios con una intervención educativa con distintos fines. Discusión: Las enfermeras ostentan una posición privilegiada para la detección y notificación de RAM. No obstante, existen déficits de conocimiento relacionados con el ámbito de la farmacovigilancia y la farmacología general, que deben solventarse si las enfermeras quieren afianzar su rol en los equipos clínicos de farmacovigilancia en el ámbito hospitalario. Los estudios parecen apoyar la idea de que la formación continua es clave para ello.Aim: Explore and define the nurses’ role in detection and reporting of adverse drug reactions (ADR). Method: A narrative review was carried out through a bibliographic research in the following databases: PubMed, Cinahl and Scielo; in the Cochrane Library repository, and in the metasearcher Google Scholar. Outcomes: 29 articles were selected, which were divided into three subparts: ADR reporting by healthcare professionals, tools and instruments used by nurses, and characteristics and other data related to the aim of the study. Results were examined, such as nurses’ reporting percentage, the quality of these reports and the nurses’ self-reported knowledge on the pharmacovigilance system in different countries. In addition, other data were collected, such as the tools developed for nurses’ usage, their validity and the outcomes of their implementation; the feelings reported by nurses related to the development of their role as reporters; their conducts and self-reported barriers to accomplish their new responsibilities, and studies with educational interventions involved. Discussion: Nurses are a in a privileged position to detect and report ADR. Nevertheless, there is a lack of knowledge on pharmacovigilance and general pharmacology that must be dealt with if nurses are to secure their role in the pharmacovigilance clinical team at hospitals. Studies seem to support the idea that continuous training is the key to do so

An Ethical Enquiry that Questions Whether Psychiatrists Truly are Mental Health/Disability Experts? Reasons to Doubt!

The observation that a crisis of confidence regarding Psychiatry exists is a notion shared even among psychiatrists themselves. Psychiatry has a checkered history and its alliance with the pharmaceutical industry, aka Big-Pharma, continues to reinforce a need for healthy skepticism. Why? Mainly, an over-reliance on the questionable expertise and authority afforded psychiatry as the specialists of mental health. I contend that the authority of psychiatry is misplaced and too often harmful. Since the criteria required to justify and satisfy psychiatric expertise is not fully established as can be substantiated by compelling reasons to rethink its authority as a reliable profession in its current form. Psychiatric expertise is not particularly scientific and this is especially dangerous in a sector that prescribes mind-altering drugs. There are a number of identified criteria that would otherwise substantiate psychiatric expertise and whilst partially existent, are nonetheless deficient. These major yet deficient aspects of psychiatric practice concern diagnostic problems – reliability and verification of diagnoses and accurate testable validity of diagnoses - mainly due to an absence of identifiable underlying biomarkers ordinarily related to disease or biological conditions. Psychiatrists often fail to distinguish between reactive-depression (reaction to external event or circumstance) and endogenous-depression (biological) resulting, in part, from incorrectly distinguishing between conditions constitutive of ‘trait’ (endogenous) and of those of ‘state’ (e.g. reactive depression; adverse effects from medication, etc.)

Impacto da pandemia COVID-19 nas notificações de eventos adversos de medicamentos às autoridades de saúde: protocolo de revisão sistemática

The aim was to outline the protocol for carrying out the systematic review, which will have the objective of evaluating the impact of the COVID-19 pandemic on notifications of adverse drug events to health authorities worldwide. This is a systematic review protocol consistent with PRISMA 2020 regulations and checklist, will be conducted in accordance with the recommendations of the Cochrane Manual, will include original observational studies, letters to editors and editorials containing summary information on adverse drug events before and during the COVID-19 pandemic. The search strategy was developed for the MEDLINE, Embase, CINALH, SciELO and gray literature databases, using the Health Sciences Descriptors (DECs) and the Medical Subject Heading (MeSH). Two independent reviewers will investigate the eligibility of the articles, extract the data and assess the risk of bias. The results of this review will contribute to identifying the impact of COVID-19 on adverse drug event reporting, this will be a significant step in informing and preventing such events and will provide an essential evidence base for the development of strategies and improvements that will contribute to patient safety worldwide.Objetivou-se delinear o protocolo da realização da revisão sistemática que terá o objetivo de avaliar o impacto da pandemia COVID-19 nas notificações de eventos adversos a medicamentos às autoridades sanitárias em todo o mundo.  Trata-se de um protocolo de revisão sistemática consistente com as normativas e checklist PRISMA 2020, será conduzido de acordo com as recomendações do Manual Cochrane, incluirá estudos observacionais originais, cartas aos editores e editoriais contendo informações resumidas sobre os eventos adversos a medicamentos antes e durante a pandemia COVID-19. A estratégia de busca foi desenvolvida para as bases de dados MEDLINE, Embase, CINALH, SciELO e literatura cinzenta, utilizando os Descritores em Ciências da Saúde (DECs) e no Medical Subject Heading (MeSH). Dois revisores independentes investigarão a elegibilidade dos artigos, extrairão os dados e avaliarão o risco de viés. Os resultados desta revisão contribuirão para identificar o impacto da COVID-19 nas notificações de eventos adversos a medicamentos, este será um passo significativo para informar e prevenir tais eventos e fornecerá uma base de evidências essenciais para o desenvolvimento de estratégias e melhorias que contribuirão para a segurança do paciente em nível mundial

Impacto da pandemia COVID-19 nas notificações de eventos adversos de medicamentos às autoridades de saúde: protocolo de revisão sistemática

The aim was to outline the protocol for carrying out the systematic review, which will have the objective of evaluating the impact of the COVID-19 pandemic on notifications of adverse drug events to health authorities worldwide. This is a systematic review protocol consistent with PRISMA 2020 regulations and checklist, will be conducted in accordance with the recommendations of the Cochrane Manual, will include original observational studies, letters to editors and editorials containing summary information on adverse drug events before and during the COVID-19 pandemic. The search strategy was developed for the MEDLINE, Embase, CINALH, SciELO and gray literature databases, using the Health Sciences Descriptors (DECs) and the Medical Subject Heading (MeSH). Two independent reviewers will investigate the eligibility of the articles, extract the data and assess the risk of bias. The results of this review will contribute to identifying the impact of COVID-19 on adverse drug event reporting, this will be a significant step in informing and preventing such events and will provide an essential evidence base for the development of strategies and improvements that will contribute to patient safety worldwide.Objetivou-se delinear o protocolo da realização da revisão sistemática que terá o objetivo de avaliar o impacto da pandemia COVID-19 nas notificações de eventos adversos a medicamentos às autoridades sanitárias em todo o mundo.  Trata-se de um protocolo de revisão sistemática consistente com as normativas e checklist PRISMA 2020, será conduzido de acordo com as recomendações do Manual Cochrane, incluirá estudos observacionais originais, cartas aos editores e editoriais contendo informações resumidas sobre os eventos adversos a medicamentos antes e durante a pandemia COVID-19. A estratégia de busca foi desenvolvida para as bases de dados MEDLINE, Embase, CINALH, SciELO e literatura cinzenta, utilizando os Descritores em Ciências da Saúde (DECs) e no Medical Subject Heading (MeSH). Dois revisores independentes investigarão a elegibilidade dos artigos, extrairão os dados e avaliarão o risco de viés. Os resultados desta revisão contribuirão para identificar o impacto da COVID-19 nas notificações de eventos adversos a medicamentos, este será um passo significativo para informar e prevenir tais eventos e fornecerá uma base de evidências essenciais para o desenvolvimento de estratégias e melhorias que contribuirão para a segurança do paciente em nível mundial

Retired Professor Continues to Impact School of Pharmacy

Tom Brown still mentoring students, advancing hospital practic

An educational intervention’s effect on healthcare professionals’ attitudes towards pharmacovigilance

BackgroundPharmacovigilance concerns the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. Consumer pharmacovigilance is the involvement of consumers in adverse drug reaction (ADR) reporting. Assessing healthcare professionals’ (HCPs) knowledge of and attitude towards pharmacovigilance and consumer pharmacovigilance is integral to strengthening adverse drug reaction reporting systems. AimsTo study knowledge of and attitude towards pharmacovigilance and consumer pharmacovigilance among HCPs from KIST Medical College, Lalitpur, Nepal, and to plan an appropriate educational intervention to address deficiencies noted.Methods The study was conducted from February 2013 to December 2013 at KIST Medical College using a self-administered, pretested, structured questionnaire. The maximum possible scores for knowledge, attitude, and total were 100, 95, and 195, respectively. Baseline knowledge and attitude were studied. Two months after the questionnaire, an intervention that used a combination of methods about pharmacovigilance and consumer pharmacovigilance was undertaken. Knowledge and attitudes were studied immediately after the intervention. Scores before and after the intervention were compared using Wilcoxon signed-rank test.Results A total of 105 HCPs participated. The median (interquartile range) knowledge, attitude, and total scores before the intervention were 56 (7), 72 (9), and 127 (16), respectively. After the intervention the scores increased significantly to 72 (8), 75 (11.5), and 146 (16.5) (