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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Severe Acute Malnutrition (SAM) is one of the greatest child survival challenges in the world today and
reportedly affects more than 16.2 million children each year1. High impact, proven treatment interventions exist
yet sadly approximately only 3.2 million children with SAM have access to treatme...nt each year2. Thus, there
is a need to scale up interventions to improve coverage and access across high burden countries. While efforts
are currently underway to expand services in many countries, obstacles remain.
One critical barrier to expanding SAM treatment services is the acceptance, accessibility and utilisation of
ready-to-use therapeutic food (RUTF). In some countries and contexts, RUTF is still not fully accepted by
community members; while other countries face problems with procurement, storage and supply chain
management which impact on availability and use3. Reports from Ghana and Zambia highlighted that stock-
outs and logistical challenges are often noted as key contributors to high default rates in outpatient treatment
centres4.
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The Malawian government recently introduced cost-covering consultation fees for self-referral patients in tertiary public hospitals. Previously, patients received medicines free of charge in government-owned health facilities, but must pay elsewhere. Before the government implements a payment policy... in other areas of health care, it is important to investigate the prices, affordability and availability of essential medicines in Malawi.
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Les médicaments essentiels sont ceux qui répondent aux besoins de santé prioritaires d'une population. Conformément aux recommandations de l'Organisation mondiale de la Santé (OMS), des listes nationales de médicaments essentiels sont régulièrement révisées, puis mises à la disposition de...s praticiens de la santé et des utilisateurs. La présente liste prend en compte les dernières orientations et directives applicales au Burkina Faso.
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Health-care waste management is a critical aspect of health-care systems, crucial for public health and environmental sustainability. This report provides valuable insights into the existing health-care waste management frameworks across 16 countries in the Western Pacific Region. It provides an ove...rview of essential components of the legal framework and best practices, including adoption of environmental friendly technologies in policies and highlights both strengths and areas in need of improvement. The report provides recommendations to enhance the effectiveness and sustainability of future health-care waste management policies in the Region.
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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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The Africa Centres for Disease Control and Prevention (Africa CDC) Biosafety and Biosecurity Initiative was launched by the Africa CDC in April 2019 with the aim of strengthening the African Union (AU) Member States’ biosafety and biosecurity systems and enabling them to comply with national and i...nternational requirements for biosafety and biosecurity including the International Health Regulations (IHR) (2005), the Biological Weapons Convention (BWC), and United Nations Security Council Resolution (UNSCR) 1540 and the multi-country Global Health Security Agenda (GHSA). The World Health Organization (WHO) Joint External Evaluation (JEE) and the Global Health Security Index report confirmed the known capacity gaps in biosafety and biosecurity among Africa Union Member (AU).
The regional consultations by Africa CDC conducted between 2019-2021 highlighted the deficiency or limited availability of standardized and regionally recognized training programs in the continent, limiting biosafety and biosecurity capacity building efforts in the region. In response, Africa CDC working with AU Member States developed a home grown, implementable and accessible professional training and certification program that is both recognized and endorsed by AU Member States. The Regional Training and Certification Program for Biosafety and Biosecurity Professionals, for African Biosafety and Biosecurity Professionals (RTCP-BBP) has four (4) areas of specialization, namely
Selection, Installation, Maintenance and Certification of Biological Safety Cabinets
Biorisk Management
Design and Maintenance of Facilities Handling High Risk Pathogens (Biocontainment Engineering)
Biological Waste management
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The Africa Centres for Disease Control and Prevention (Africa CDC) Biosafety and Biosecurity Initiative was launched by the Africa CDC in April 2019 with the aim of strengthening the African Union (AU) Member States’ biosafety and biosecurity systems and enabling them to comply with national and i...nternational requirements for biosafety and biosecurity including the International Health Regulations (IHR) (2005), the Biological Weapons Convention (BWC), and United Nations Security Council Resolution (UNSCR) 1540 and the multi-country Global Health Security Agenda (GHSA). The World Health Organization (WHO) Joint External Evaluation (JEE) and the Global Health Security Index report confirmed the known capacity gaps in biosafety and biosecurity among Africa Union Member (AU).
The regional consultations by Africa CDC conducted between 2019-2021 highlighted the deficiency or limited availability of standardized and regionally recognized training programs in the continent, limiting biosafety and biosecurity capacity building efforts in the region. In response, Africa CDC working with AU Member States developed a home grown, implementable and accessible professional training and certification program that is both recognized and endorsed by AU Member States. The Regional Training and Certification Program for Biosafety and Biosecurity Professionals, for African Biosafety and Biosecurity Professionals (RTCP-BBP) has four (4) areas of specialization, namely
- Selection, Installation, Maintenance and Certification of Biological Safety Cabinets
- Biorisk Management
- Design and Maintenance of Facilities Handling High Risk Pathogens (Biocontainment Engineering)
- Biological Waste management
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The document contains a set of indicators that can be used for monitoring traditional and complementary medicine (T&CM) systems in a country.
The core indicator set consists of 16 indicators that were considered essential and collectively able to provide information on T&CM inputs, processes and ou...tputs. A longer list of reference indicators is also available for countries that wish to monitor more indicators or that want to consider alternative metrics that would better suit each country’s T&CM situation, priorities and monitoring capacities.
Each core and reference indicator is accompanied by a set of metadata. This provides information on the indicator rationale, definitions, data elements (numerator, denominator and data disaggregation), frequency of measurement, and data sources. It is a guide towards more standardized data measurement as well as data interpretation.
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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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Ukrainian Title:
УКРАЇНА: Еквівалентність лікарських засобів, зареєстрованих в Україні та інших країнах. Інформація для працівників охорони здоров'я та пацієнтів
To support t...he provision of healthcare and medicines in the host countries, and as part of FIP’s response to the appeals of our member organisation, the All-Ukrainian Pharmaceutical Chamber, FIP has developed the tables of equivalence between medicines registered in Ukraine and those available in other countries, published in this document. This is meant to facilitate the provision of (pharmaceutical) care to refugees and also to support healthcare professionals providing care to them. We are
prioritising medicines for the following chronic non-communicable diseases that require continuation of treatment: asthma & COPD, mental health, cardiovascular diseases and diabetes, but also oral contraceptives. This list may be expanded as necessary.
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Globally each year, millions of people suffer illness or lose their lives because the vaccines, medicines and diagnostic tests that they need are either unavailable or unaffordable – and this lack of access to medicine is acute in low- and middle-in-
come countries (LMICs). While the COVID-19 pan...demic laid this inequity bare, it also saw the pharmaceutical industry develop and bring new vaccines and treat- ments to market at unprecedented speed. As the world emerges from the worst
of this crisis, pharmaceutical companies are now at an important juncture, where lessons learned from the pandemic can prove pivotal in finding solutions to bridge long-standing gaps in access to medicine in LMICs.
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Leishmaniasis is a spectrum of disease caused by the infection of protozoan parasite Leishmania mainly affecting the antigen presenting cell of the host. The disease is although considered as neglected tropical disease still it is not completely eradicated. Majority of the issues related to the ther...apeutic approach is due to increased cytotoxicity of the drugs, less effectiveness, high cost and occurrence of drug resistance. Therefore, recent advancement in the field of parasitology has taken into consideration of the specific arms of immunity which can be triggered with the help of natural products, synthetic molecules or parasite specific ligands which helps in the restoration of host protective immunity and recovery from the infection. Therefore, in this review, we have highlighted the recent advancement in the field of Leishmania research taken into consideration of the therapeutic perspective. We have shown that apart from therapeutic potential of the available drugs and vaccination approach, the immune-therapy are emerging as the modern regime of treatment where the effectiveness of the therapy is significantly increased and making it safer and promising.
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High prevalence of target diseases in rural and developing nations, increased prevalence of malnutrition across the globe, lack of hygiene and poor sanitation facilities, Migratory patterns of population, introduction of new chemical entity in the field of therapeutics, favorable government regulati...ons, and increased R&D investments are key factors contributing to high CAGR of point of care diagnostics market during the forecast period.
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Antibiotics 2022, 11(3), 329; https://doi.org/10.3390/antibiotics11030329.
The authors found that the most-represented antibiotics on the Rwandan market were amoxicillin, co-trimoxazole and cloxacillin. No counterfeit antibiotics were found in this study. However, substandard batches with moderate ...deviations were found, suggesting that regular quality control of antibiotics is needed in Rwanda.
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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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The WHO Pharmaceuticals Newsletter provides you with the latest information on the safety of medicinal products and regulatory actions taken by authorities around the world.
In addition, this edition includes summary and recommendations from the virtual meeting of the members of the WHO Programme f...or International Drug Monitoring (PIDM) and other partners, which was held on 20 October 2022.
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