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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 t
...
he documents in the WHO Technical Series on “Medication Safety Solutions” that the WHO is publishing, to address important aspects pertaining to medication safety.
more
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.
more
Therapeutics Information and Pharmacovigilance Centre | TIPC
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 conjunction 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
more
Made under Section 5 (c) of the Tanzania Food, Drugs and Cosmetics Act, 2003 | Second Edition
WHO guideline on balanced national controlled medicines policies to ensure medical access and safety
Access to medicines is essential for attainment of universal health coverage, which is central to achievement of the health-related Sustainable Development Goals. Controlled medicines include those
...
such as opioids, benzodiazepines, barbiturates, amphetamines and others with identified or emergent clinical indications. WHO recognizes that these medicines are necessary for pre- and post-operative care, for sedation, for the management of both acute and chronic pain, for palliative care, as anticonvulsants (anti-epileptics), for the management of anxiety disorders and for the management of substance use disorders, including as opioid agonist therapy (OAT).
more
This is a detailed manual giving a step by step approach to undertaking the pharmacovigilance of antiretrovirals. It is intended to be a source of practical advice for Pharmacovigilance Centres and health professionals involved in HIV/AIDS prevention and treatment programmes. A number of WHO publica
...
tions are available that provide a background to pharmacovigilance and, as far as possible, that material will not be repeated here. Health officials, planners, the staff of Pharmacovigilance Centres, public health teams and all health workers should become familiar with these publications, which are: • Safety of Medicines: A guide to detecting and reporting adverse drug reactions
more
This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration of medicines. It represents the Medicines Control Council’s current thinking
...
on the safety, quality and efficacy of medicines.
more
Reporting system for the general public - This document aims to provide practical guidelines on how to set up national systems for consumers to report adverse reactions to medicines. The purpose is to help countries set up a well-organized and effec
...
tive consumer reporting system within their pharmacovigilance centre. Throughout this document, the phrase “consumer reporting” is used to refer to reporting of adverse drug reactions (ADRs) by the general public.
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Essential Medicines are those that satisfy the priority health care needs of the population. They are selected with due regard to public health relevance, evidence on efficacy, safety and comparativ
...
e cost-effectiveness. This edition of the Essential Medicines List (EML) 2017 for Ghana has been derived from its companion Standard Treatment Guidelines 2017 to ensure harmony in treatment, procurement and re-imbursements. The medicines listed have been coded according to the Health Commodity
Codes Catalogue of the Ministry of Health (2008) and their levels of use, based on the type of health facility, including midwifery practice, have been indicated.
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Essential medicines are those that satisfy the priority health care needs of a population. They are selected with due regard to disease prevalence and public health relevance, evidence of efficacy and safe
...
ty and comparative cost-effectiveness. They are intended to be available in functioning health systems at all times, in appropriate dosage forms, of assured quality, and at prices individuals and health systems can afford.
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Malaria in pregnancy is a significant health problem in malaria-endemic areas. It not only causes substantial childhood morbidity and mortality but also increases the risks of adverse events for pregnant women and their developing fetuses. Most of the burden in these areas is due to infection with P
...
lasmodium falciparum. Artemisinin-based combination therapy (ACT) has been recommended as first-line treatment for uncomplicated P. falciparum malaria in all populations, including pregnant women in their second and third trimesters, since 2006. However, for women in their first trimester of pregnancy, WHO recommended as first-line treatment a combination of quinine and clindamycin.
Based on a review of the evidence conducted in 2022, WHO now recommends artemether–lumefantrine, the ACT with the most human safety data available, as the preferred treatment for uncomplicated P. falciparum malaria in the first trimester of pregnancy. This document presents all relevant evidence on the effects and safety in early pregnancy of artemisinins and partner medicines used in ACTs from both studies in experimental animals and observational studies in humans.
more
PQM conducted an assessment of the medicine quality assurance and quality control systems in Rwanda during November 9-13, 2009. Medicine quality assurance remains to be developed in Rwanda: the country has neither a medicine regulatory authority (MRA) nor a national medicine quality control laborato
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ry – the two key institutions to ensure the quality, safety, and efficacy of medicines. The MOH Pharmacy Taskforce (PTF) is to be commended however for successfully controlling the pharmaceutical market to the extent that there is no informal medicines market in Rwanda. Based on its findings, the assessment team expects Rwanda to be able to make great strides in evidence-based medicines quality assurance in the short to medium term, provided it receives adequate technical assistance and financial support.
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Long Acting Muscarinic Antagonists (LAMA) such as tiotropium and glycopyrronium are used in the management of COPD1. They have been shown to improve lung function, quality of life and exercise tolerance. They have also been associated with reduced COPD-related exacerbations, associated hospitalisati
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ons and duration of hospital stay. Both the South African Thoracic Society (SATS) and Global Initiative for Chronic Obstructive Lung Disease (GOLD), guidelines recommend the use of long acting anticholinergic drugs (or long acting beta agonists) in moderate to very severe disease as defined by lung function (FEV1). The most up to date guideline, utilizing the GRADE methodology (European Respiratory Society guidelines of 2017), confirms their superiority over long acting β agonists (LABA) as monotherapy for COPD in that LAMA's have demonstrated greater efficacy in terms of exacerbation reduction, with similar safety profile.2 These recommnedations are supported by published peer-reviewed
evidence including individual papers and Cochrane reviews.
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Selection and Use of Essential Medicines 2021
recommended
The 23rd meeting of the WHO Expert Committee on Selection and Use of Essential Medicines was coordinated from Geneva, Switzerland, and held virtually from 21 June to 2 July 2021. The Committee considered 88 applications proposing additions, changes
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and deletions of medicines, medicine classes and formulations on the Model Lists of Essential Medicines. The Committee evaluated the scientific evidence for comparative effectiveness, safety and cost-effectiveness of the medicines in question. The Committee also considered a review of the therapeutic alternatives for medicines on the Model Lists, and update to the AWaRe classification of antibiotics, and reviews and reports relevant to the selection and use of essential medicines.
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WHO Regional Publications, Western Pacific Series No. 23
Reports the findings and recommendations of a working group convened to prepare guidelines for the use of herbal medicines in Western Pacific countries. Addressed to national health autho ... rities, the report responds to the widespread use of herbal medicine in this part of the world and the corresponding need for mechanisms to ensure that these products are safe and effective, yet remain broadly accessible. With this need in mind, the report sets out a comprehensive framework for developing national policies designed to control the safety, efficacy, and quality of herbal medicines, manufacturing practices, product registration, and labelling, marketing, and trade. more
Reports the findings and recommendations of a working group convened to prepare guidelines for the use of herbal medicines in Western Pacific countries. Addressed to national health autho ... rities, the report responds to the widespread use of herbal medicine in this part of the world and the corresponding need for mechanisms to ensure that these products are safe and effective, yet remain broadly accessible. With this need in mind, the report sets out a comprehensive framework for developing national policies designed to control the safety, efficacy, and quality of herbal medicines, manufacturing practices, product registration, and labelling, marketing, and trade. more
Report of the 23rd WHO Expert Committee on the selection and use of essential medicines
This executive summary reports the recommendations made by the Expert Committee for the 2021 update of the WHO Model List of Essential
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Medicines (EML) and the Model List of Essential Medicine for Children (EMLc).
The 23rd meeting of the WHO Expert Committee on Selection and Use of Essential Medicines was coordinated from Geneva, Switzerland, and held virtually from 21 June to 2 July 2021. The Committee considered 88 applications proposing additions, changes and deletions of medicines, medicine classes and formulation on the Model Lists of Essential Medicines. The Committee evaluated the scientific evidence for comparative effectiveness, safety and cost-effectiveness of the medicines in question. The Committee also considered a review of the therapeutic alternatives for medicines on the Model Lists, and update to the AWaRe classification of antibiotics, and reviews and reports relevant to the selection and use of essential medicines.
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The second ECDC/EFSA/EMA joint report on the integrated analysis of antimicrobial consumption (AMC) and antimicrobial resistance (AMR) in bacteria from humans and food-producing animals addressed data obtained by the Agencies’ EU-wide surveillance networks for 2013–2015. AMC in both sectors, exp
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ressed in mg/kg of estimated biomass, were compared at country and European level. Substantial variations between countries were observed in both sectors. Estimated data on AMC for pigs and poultry were used for the first time. Univariate and multivariate analyses were applied to study associations between AMC and AMR. In 2014, the average AMC was higher in animals (152 mg/kg) than in humans (124 mg/kg), but the opposite applied to the median AMC (67 and 118 mg/kg, respectively). In 18 of 28 countries, AMC was lower in animals than in humans. Univariate analysis showed statistically-significant (p < 0.05) associations between AMC and AMR for fluoroquinolones and Escherichia coli in both sectors, for 3rd- and 4th-generation cephalosporins and E. coli in humans, and tetracyclines and polymyxins and E. coli in animals. In humans, there was a statistically-significant association between AMC and AMR for carbapenems and polymyxins in Klebsiella pneumoniae. Consumption of macrolides in animals was significantly associated with macrolide resistance in Campylobacter coli in animals and humans. Multivariate analyses provided a unique approach to assess the contributions of AMC in humans and animals and AMR in bacteria from animals to AMR in bacteria from humans. Multivariate analyses demonstrated that 3rd- and 4th-generation cephalosporin and fluoroquinolone resistance in E. coli from humans was associated with corresponding AMC in humans, whereas resistance to fluoroquinolones in Salmonella spp. and Campylobacter spp. from humans was related to consumption of fluoroquinolones in animals. These results suggest that from a ‘One-health’ perspective, there is potential in both sectors to further develop prudent use of antimicrobials and thereby reduce AMR.
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The safety of medicines in Zambia - why health workers need to take action | Produced by the National Pharmacovigilance Unit (NPVU)
