This 3rd edition of Guidelines for medicine donations has been developed by the World Health Organization (WHO) in cooperation with major international agencies active in humanitarian relief and development assistance. The guidelines are intended to improve the quality of medicine donations in inter...national development assistance and emergency aid. Good medicine donation practice is of interest to both donors and recipients...
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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.
Situational Analysis: 13-23 October 2014
Report prepared using the WHO/SEARO workbook tool for undertaking a situational analysis of medicines in health care delivery in low and middle income countries
The right to the enjoyment of the highest attainable standard of physical and mental health is enshrined in many international human rights treaties. However, studies have shown that people with mental disabilities are often marginalized and discriminated against in the fulfillment of their right to... health. The aim of this study is to identify and reach a broader understanding of barriers to the right to mental health in the Eastern Cape Province in South Africa. Eleven semi-structured interviews were carried out with health professionals and administrators.
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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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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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Medicines and Allied Substances [No. 3 of 2013 47 | An Act to continue the existence of the Pharmaceutical Regulatory Authority and re-name it as the Zambia Medicines Regulatory Authority; provide for the functions and powers of the Authority; provide for the registration and regulation of pharmacie...s, health shops and agro-veterinary shops; provide for the registration and regulation of medicines and allied substances; provide for the regulation of the manufacture, importation, exportation, possession, storage, distribution, supply, promotion, advertising, sale and use of medicines and allied substances; provide for the regulation and control of clinical trials; repeal and replace the Pharmaceutical Act, 2004; and provide for matters connected with, or incidental to, the foregoing.
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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...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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The prevalence, availability, and use of antimalarial medicines (AMLs) were studied in six Cambodian provinces along the Thai-Cambodian border. The study was divided into two parts: the first looked at the quality of AMLs available in Pursat, Pailin, Battambang, Bantey Meanchey, Oddar Meanchey, and ...Preah Vihear and the second obtained information about the availability and use of AMLs.
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The Kenya Essential Medicines List 2019 is an indispensable guide to the medicines recommended for the management of common conditions in Kenya. It is primarily directed at health care providers and medicines supply managers in the public and non-public health sectors. It should be used together wit...h the current versions of updated national clinical guidelines for those conditions for which such guidelines exist
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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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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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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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