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
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This field study to measure access to and use of medicines was undertaken in GHANA in May-June 2008. The study assessed information on the socio-economic level of households, and access to and use of medicines for acute and chronic conditions as well as opinions and perceptio...ns about medicines. The survey was conducted in six regions. In each region, six reference public heath care facilities were selected among those participating in the Level II Facility Survey that was carried out in parallel. Within defined distances from each reference public health care facility, households were selected by purposive cluster sampling. A total of 1065 household respondents were interviewed by means of a structured paper questionnaire
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The survey aimed at evaluating the quality of selected antimalarials in six countries of sub-Saharan Africa (Cameroon, Ethiopia, Ghana, Kenya, Nigeria and the United Republic of Tanzania). These countries have been supported by WHO to strengthen their regulatory controls o...ver antimalarial products. The survey was organized independently of manufacturers of antimalarial medicines.
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The new guidelines provide public health guidance on pharmacological agents for managing hyperglycaemia in type 1 and type 2 diabetes for use in primary health-care in low-resource settings. These guidelines update the recommendations for managing hyperglycaemia in the WHO Package of Essential NCD I...nterventions (WHO PEN) for primary care in low-resources settings, reviewing several newer oral agents as second- and third-line treatment: dipeptidyl peptidase-4 inhibitors, sodium-glucose co-transporter 2 inhibitors and thiazolidinediones. The guidelines also present recommendations on the selection of type of insulin (analogue versus human insulin) for adults with type 1 and type 2 diabetes.
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Research Article
PLOS ONE | DOI:10.1371/journal.pone.0164619 October 13, 2016
The primary role of Benin’s Department of Pharmacy and Medicines (DPMED) is to develop and apply the national pharmaceutical policy. The main objective of this policy is to ensure the availability and accessibility of quality medicines for the population. To fulfill its mandate, DPMED aims to stre...ngthen its regulatory capacity, including the issuance of licenses to pharmaceutical establishments and the registration of pharmaceutical products. Benin’s current registration system shares core concerns that are common to most developing countries, notably the capacity to evaluate and monitor the security, efficacy, and quality of medicines and other health products. It is currently characterized by 1) poor or inadequate traceability of records or regulations (example: a product’s marketing authorization [MA] is often hard to find); 2) lack of evidence used in the regulatory decision-making process (reasons behind special import authorization, i.e., products without valid MAs); 3) inconsistent and unsecured archiving system; 4) limited human resources; and 5) an inefficient information management system
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Document No. : FDA/SMC/CTD/GL-CCT/2013/01
5th revised edition.
This document provides a ranking of medically important antimicrobials for risk management of antimicrobial resistance due to non-human use. The current revision took place at the seventh meeting of the AGISAR held in Raleigh, United States of America in 2016.
Made under Section 5 (c) of the Tanzania Food, Drugs and Cosmetics Act, 2003 | Second Edition
Direct acting antivirals (DAAs) have revolutionized treatment for hepatitis C. Combi-
nations of DAAs can cure infection with HCV in 12 weeks, are highly effective and
have limited side-effects. Affordability of DAAs has improved significantly, but access remains lim-
i...ted. Initially, due to their high prices, affordability of DAAs was limited in high-, middle- and low-
income countries alike. Now there is a divide between those countries where, because of intellectual
property barriers, prices have remained (very) high and other countries where generics are, or can be,
available at much lower prices. The result is a dual market
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The product of all this work is the Standard Treatment Guideline and Essential Medicines List of Common Medical Conditions in the Kingdom of Swaziland. These systematically developed statements are designed to assist practitioners in making decisions about appropriate treatment for specific clinical... conditions. They are meant to reflect expert consensus based on a review of current and published scientific evidence of acceptable approaches to diagnosis, man-agement, or prevention of specific conditions.It is enlightening to note that section A of the document contains the STG, and effort has been made to have the conditions commonly encountered in Swaziland classified according to systems. Written in simple, clear language, each section consists of a short definition followed by common symptoms and signs of the disease or condition and then management (pharmacological and nonpharmacological)
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This technical note summarizes the consolidated guidelines and adapts them to the context of Latin America and the Caribbean, in order to adequately monitor the number of people on ART. For this purpose, guidance is presented on the indicators and the methodology to know more precisely the number of... people who are in ART.
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This report reviews and analyses the Affordable Medicines Programme, which was introduced in Ukraine in April 2017 to provide patients with improved access to 23 outpatient medicines for the treatment of chronic noncommunicable diseases. The evaluation combines both quantitative and qualitative anal...ysis. The findings confirm that the Programme has contributed to a significant increase in access to needed outpatient medicines in Ukraine. Further, while implementation was successful overall, uptake across regions was uneven. The report concludes by listing a number of policy options to support the sustainability and expansion of the Affordable Medicines Programme.
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This series of supportive tools are based on the WHO Therapeutics and COVID-19: living guideline. They are intended to provide supportive information for healthcare workers who are prescribing, administering and monitoring patients receiving nirmatrelvir-ritonavir for non-severe COVID-19.