The safety of medicines in Zambia - why health workers need to take action | Produced by the National Pharmacovigilance Unit (NPVU)
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 medicines, medical devices and IVDs.
Over the last three or four decades, there has been an enorm...ous 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.
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These guidelines have been developed for scientific purpose with the main aim to guide the regulatory authority for evaluating probiotic products in our country.
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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August 2020.
In December 2018, the President launched the UHC pilot covering four strategically selected counties-Isiolo, Kisumu, Machakos and Nyeri. It isplanned that by the year 2022, all persons in Kenya will be able to use the essential services they need for their health... and wellbeing through a single unified benefit package, without the risk of financial catastrophe. Essential health products are considered an integral part of UHC andare an indispensable element for delivery ofservices andare also a requirement for qualitycare. Despite this realization, a review of the UHC pilot in September 2019 established that whereas the Kenya Medical Supplies Authority (KEMSA) was able to fill up to 80% of pharmaceutical items, the order fill rate for medical supplies was less than 50%for level 2 and 3 facilities and as low as 30%for level 4 and 5 facilities.
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This new edition and fully updated publication replaces the 2012 UCG and is being circulated free of charge to all public and private sector prescribers, pharmacists, and regulatory authorities in the country
Overcoming barriers in low- and middle-income countries
For the first time, this year’s report includes information on hepatitis C diagnostics. With a focus on selected countries with diverse HCV epidemics, the report provides updates on the various dimensions of access to HCV diagnostics and pha...rmaceutical products, including product pricing, the regulatory environment and patent status, which together shape the national hepatitis response in different settings. It highlights key areas for action by ministries of health and other government decision-makers, pharmaceutical manufacturers and technical partners.
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August 2020.
Essential diagnostic products areconsidered an integral part of UHC, they are an indispensable element for delivery ofservices andare also a requirement for qualitycare. Despite this realization, a review of the UHC pilot in September 2019 es...tablished that whereas the Kenya Medical Supplies Authority (KEMSA) was able to fill up to 80% of pharmaceutical items, the order fill rate for diagnostic products was less than 50 percent for level 2 and 3 facilities and as low as 30 percent for level 4 and 5 facilities.
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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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Updated with information on Ebola virus disease and Middle East respiratory syndrome coronavirus
A wide variety of health events ranging in severity may occur related to air transport, requiring different responses or, perhaps, no response at all. The target audience for this guidance document incl...udes the national focal points (NFP) for the IHR and public health authorities at PoE, as well as national aviation regulatory authorities, airport operators and personnel, aircraft operators, air crew and other stakeholders involved in air transport and emergency preparedness and response to public health events
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Manual for step-by-step risk management for safely managed sanitation systems. 2nd edition.
This Sanitation safety planning (SSP) manual provides practical, step-by-step guidance to assist in the implementation of the 2018 World Health Organization (WHO) Guidelines on sanitation and health and the ...2006 WHO Guidelines for safe use of wastewater, excreta and greywater in agriculture and aquaculture. The approach and tools should be applied to all sanitary systems to ensure that they are managed to meet health objectives.
The SSP manual is targeted at a variety of users at different levels including; health authorities and regulators, local authorities, sanitation utility managers, sanitation enterprises and farmers, community-based organizations, farmers associations and nongovernmental organizations.
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In order to streamline and effectively control compounding of medicinal products in hospitals and pharmacies, these Guidelines for Production of Extemporaneous and Hospital Based Sterile Preparations has been crafted. The purpose of these guidelines therefore is to assist pharmacists in ...discharging their legal and professional obligations to patients in the area of extemporaneous dispensing. This guidance will help to assure the safe and appropriate preparation and supply of extemporaneously prepared medicinal products to patients, where
the supply of such products is necessary.
Extemporaneous and hospital based sterile preparations are critical for patients whose clinical needs cannot be met by registered medicinal products. The guidelines outline the principles and application of the concepts of Good Manufacturing Practice (GMP) requirements for premises, equipment, personnel, storage, quality management system, quality control, compounding processes as well as documentation.
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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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2014-2020, Draft March 2014