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This guideline aims to improve the quality of donations and the management thereof and serve as the basis for policies of the State and other organizations in the giving and receiving of donations of medic
...
ines, medical devices and IVDs.
Over the last three or four decades, there has been an enormous increase in scientific knowledge about the mode of action, effects and side effects of medicines, medical devices and IVDs. It is important for all
stakeholders to understand that these products have both benefits and risks, that they have to be used carefully and appropriately and that some can do more harm than good.
There are many different scenarios for the donation of medicines, medical devices and IVDs. Donations may take place in acute emergencies or as part of development aid in non-emergency situations. They may involve donations (i.e. direct or through private voluntary organizations), aid by governments or persons authorized to sell medicines, medical devices and/or IVDs.
more
Interagency Guidelines - This revised Interagency List of Essential Medicines for Reproductive Health presents
the current international consensus on rational selection of essential reproductive health m
...
edicines. The list is intended to support decisions regarding the production, quality assurance, national procurement and reimbursement schemes of these medicines.
more
Antiretroviral medicines in low- and middle-income countries: Forecasts of global and regional demand for 2014-2018
World Health Organization
(2015)
C_WHO
Technical Report
AIDS Medicines and diagnostics service
July 2015
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 f
...
or the functions and powers of the Authority; provide for the registration and regulation of pharmacies, 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.
more
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 popul
...
ation” 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.
more
The essential medicines are those that meet the priority needs of the healthcare of the population. While reviewing the 5th edition of the essential Medicines, special attention focused on the heal
...
th sector policy. Indeed, medicines play an important role in protecting, maintaining and restoring the peoples’ health and credibility of health facilities. Their availability is a fundamental aspect of primary health care as defined in different declarations including Alma-Ata of 1978.
more
Namibia: Medicines and Related Substances Control Act
Government Gazette of the Republic of Namibia
(2003)
C2
GOVERNMENT NOTICE | No. 192 Promulgation of Medicines and Related Substances Control Act, 2003 (Act No. 13 of 2003), of the Parliament
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
Access to controlled medicines. 3rd edition
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
w
...
idespread 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
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
...
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.
more
Survey of the Quality of Selected Antimalarial Medicines Circulating in Six Countries of Sub-Saharan Africa
recommended
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.
more
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
more
Tis first edition describes the standard operating procedures for health products for NTDs amenable to preventive chemotherapy and the medicines donated to treat them. These include albendazole for lymphatic filariasis and soil-transmitted helminthi
...
ases; azithromycin for trachoma and yaws; diethylcarbamazine citrate for lymphatic filariasis; ivermectin for onchocerciasis and lymphatic filariasis; mebendazole for soil-transmitted helminthiases; praziquantel for schistosomiasis; and triclabendazole for foodborne trematodiases. Standard operating procedures for diseases amenable to case management will be covered in subsequent editions, including the application process for requesting medicines (Chapter 1). In the meantime, the procedures described in the rest of the document apply for both case management and preventive chemotherapy NTD health products.
more
Ensuring Access to Simple, Safe and Effective First-Line Medicines for Tuberculosis.
Accessed in November 2017.
CHAPTER 15:03 | Acts 14/1969, 62/1971, 35/1974, 20/1978, 41/1978 (s. 35) 39/1979, 7/1987, 11/1988, 18/1989 (s. 27), 1/1996, 6/2000, 22/2001; R.G.N. 899/1978.
Early-warning indicators to prevent stock-outs and overstocking of antiretroviral, antituberculosis and antimalaria medicines.
