Introduction Pharmacovigilance (PV) systems to monitor drug and vaccine safety are often inadequate in sub-Saharan
Africa. In Malawi, a PV enhancement initiative was introduced to address major barriers to PV.
Objective The objective of this initiative was to improve reporting of adverse events (A...Es) by strengthening passive safety
surveillance via PV training and mentoring of local PV stakeholders and healthcare providers (HCPs) at their own healthcare
facilities (HCFs).
Methods An 18-month PV training and mentoring programme was implemented in collaboration with national stakeholders,
and in partnership with the Ministry of Health, GSK and PATH. Two-day training was provided to Expanded Programme on
Immunisation coordinators, identified as responsible for AE reporting, and four National Regulatory Authority representa-
tives. Abridged PV training and mentoring were provided regularly to HCPs. Support was given in upgrading the national
PV system. Key performance indicators included the number of AEs reported, transmission of AE forms, completeness of
reports, serious AEs reported and timeliness of recording into VigiFlow.
Results In 18 months, 443 HCPs at 61 HCFs were trained. The number of reported AEs increased from 22 (January 2000 to
October 2016) to 228 (November 2016 to May 2018), enabling Malawi to become a member of the World Health Organization
Programme for International Drug Monitoring. Most (98%) AE report forms contained mandatory information on reporter,
event, patient and product, but under 1% were transmitted to the national PV office within 48 h.
Conclusion Regular PV training and mentoring of HCPs were effective in enhancing passive safety surveillance in Malawi,
but the transmission of reports to the national PV centre requires further improvement.
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Many vaccines and drugs hold the promise of reducing mortality and morbidity among pregnant women and infants living in low- and middle-income countries (LMICs). However, sufficient information on the safety of drugs and vaccines in pregnant women is rarely available at the time of product licensure... or approval. To account for this, active safety surveillance efforts are needed during the post-licensure and post-approval
phase to assess the safety of drugs and vaccines in pregnant women and their offspring. Pregnancy exposure registries (PER) are used to monitor the safety of vaccines and drugs. PERs are observational studies that systematically collect health information on exposure to medical products such as drugs and vaccines during pregnancy. This review demonstrates that a number of resources presently exist in LMICs that perform active safety surveillance in pregnant populations. These results indicate such systems employ a wide variety of approaches, each with their own set of strengths and challenges, as summarized in the final section of the report.
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Medication errors are a leading cause of patient harm globally. WHO launched the Global Patient Safety Challenge: Medication Without Harm, with the objective of preventing severe medication related patient harm globally. This publication is one of the documents in the WHO Technical Series on “Medi...cation Safety Solutions” that the WHO is publishing, to address important aspects pertaining to medication safety.
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Accessed on 15.08.2022
La farmacovigilancia es una herramienta que permite la detección, evaluación, conocimiento y prevención de efectos adversos y/o inesperados de los medicamentos que se prescriben. También facilita la detección de fallas de respuesta terapéutica por deficiencias de calid...ad.
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The purpose of this manual is to define a limited number of indicators that will objectively describe the management and use of antimicrobials in hospitals and to provide tools and step-by-step instructions for designing and carrying out an assessment of antibiotic use and management in hospitals. T...he indicators in this manual will complement the existing WHO (1993) indicators of outpatient antimicrobial use suggested in How to Investigate Drug Use in Health Facilities (including percentage of encounters in which an antibiotic was prescribed and percentage of medicine costs spent on antibiotics) and will address the need for antimicrobial indicators for inpatient conditions.
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The ICAT is a simple and practical approach for assessing the adequacy of existing infection prevention and control practices and provides specific recommendations for improving practices and monitoring their effectiveness over time
Millennium Development Goal 8E aims for affordable access to essential medicines. Essential medicines, as defined by WHO, are those that “satisfy the health-care needs of the majority of the population” and that should therefore “be available at all times in adequate amounts”. However, there... is a category of medicines that faces a unique challenge in terms of availability. These are the medicines governed by the international conventions on narcotic and psychotropic substances. “Controlled medicines” is the common definition for pharmaceuticals whose active principles are listed under the 1961 United Nations Single Convention on Narcotic Drugs as amended by the 1972 Protocol, such as morphine and methadone; the 1971 United Nations Convention on Psychotropic Substances, such as diazepam and buprenorphine; and the 1988 United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances, such as ergometrine and ephedrine. The conventions list substances in “Schedules” according to their different levels of potential for abuse and harm, and the commensurate severity of control measures to be applied by countries.
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Its main objectives are: to explain the educational approach underlying the Guide; to explain how to teach pharmacotherapy with the Guide; to give practical advice on how to assess the students, the teachers and the course; and to assist in mobilizing support for problem-based pharmacotherapy teachi...ng.
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Guide pratique d’utilisation à l'usage des médecins, pharmaciens, infirmiers et auxiliaires de santé.
Practical guide intended for physicians, pharmacists, nurses and medical auxiliaries. This guide is not a dictionary of pharmacological agents. It is a practical manual intended for health professionals, physicians, pharmacists, nurses and health auxiliaries invoved in curative care and drug managem...ent. We have tried to provide simple, practical solutions to the questions and problems faced by field medical staff, using the accumulated field experience of Médecins Sans Frontières, the recommendations of reference organizations such as the World Health Organization (WHO) and specialized documentation in each field. Also available in French, Spanish and Arabic
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This Knowledge and Skills reference guide to support professional desvelopment in diabetes is intendet to help pharmacists with the increasingly necessary competencies they may have to acquire in managing patients with diabetes. There roles range from prevention and acreening to clinical management.... Some barriers and regulations may prevent pharmacists in some countries from performing certain services as outlined in the diabetes handbookor listed in this guide, but the incorporation of pharmacists into multidisciplinary diabetes care teams shouldalways be strongly considered by clinicians and health policymakers. By expanding the full potential of pharmacists in the delivery of diabetes care and associated services, weg et closer to offering optimal health services to patients making sure that no one is left behind.
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This course introduces participants to the foundations of vaccine pharmacovigilance. The aim of this course is to provide healthcare professionals whose work involve vaccine safety issues, with essential knowledge about vaccines and their safety aspects. These professionals can include nurses, midwi...ves, community health workers, as well as pharmacists, medical doctors and immunization programme or vaccine safety communication officers.
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This course is based on the Manual on Safety in Administering Medicines for Neglected Tropical Diseases which provides practical tools, training modules and jobs aids to further improve the planning, preparation, and monitoring of safe administration of NTD medicines.
A toolkit for pharmacists.
Emerging data show that medication errors and adverse events cause significant harm to patients’ health and
well-being. It is estimated that the burden of adverse events due to medicines is now comparable to that of
widespread diseases, such as malaria or tuberculosis....1 The impacts of medication errors also represent a
burden for health systems, with the annual cost associated with medication errors estimated at USD 42 billion
worldwideharm
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This manual summarizes key issues related to the safety of NTD medicines and their administration, with a focus on essential medicines used in mass drug administration (MDA), also called preventive chemotherapy. It can be used as a standalone reference manual, but is intended to be used in conjuncti...on with the accompanying training modules, which provide practical instruction, and the aide-mémoires. Versions of the aide-mémoires and training modules are available respectively for both (i) programme managers and district-level health officials and (ii) community drug distributors and community health workers
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Antimicrobial resistance (AMR) surveillance plays an important role in the early detection of resistant strains of public health importance and prompt response to outbreaks in hospitals and the community. Surveillance findings are needed to inform medical practice, antibiotic stewardship, and policy... and interventions to combat AMR. Appropriate use of antimicrobials, informed by surveillance, improves patients’ treatment outcomes and reduces the emergence and spread of AMR. This protocol describes the steps and procedures to establish/enhance AMR surveillance in Latin America and the Caribbean.
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La vigilancia de la resistencia a los antimicrobianos (RAM) desempeña un papel importante en la detección temprana de cepas resistentes que revisten gran importancia para la salud pública, así como en la respuesta rápida a los brotes en los hospitales y en la comunidad. Los resultados de la vig...ilancia son necesarios para fundamentar la práctica médica, la administración de antibióticos, y las políticas e intervenciones para combatir la RAM. El uso apropiado de antimicrobianos, fundamentado en la vigilancia, mejora los resultados del tratamiento de los pacientes y reduce la aparición y propagación de la RAM.
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