Snakebites are well-known medical emergencies in many parts of the world, especially in rural areas. Agricultural workers and children are the most affected. The incidence of snakebite mortality is particularly high in South-East Asia. Rational use of snake anti-venom can substantially reduce mortal...ity and morbidity due to snakebites. These guidelines are a revised and updated version of Regional Guidelines for the Management of snakebites published by the WHO Regional Office in South-East Asia in 2011. These guidelines aim to promote the rational management of snakebite cases in various health facilities where trained health functionaries and quality snake antivenom are available.
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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 report is based on comprehensive information collected at representative sample health facilities all over the country by well-organized and trained teams during May and August 2015. This is a continuation of 2014 Assessment activities and findings also reflect comparison between two consecutive... years.
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WHO Package of Essential NCD Interventions (PEN)
Accessed March 18,2019
A cross-sectional descriptive study design covering all states and regions was undertaken to:
1) To assess availability, utilization and supply chain management system for RH commodities at different levels of health facilities,
2) To assess quality of RH services with emphasis on family ...planning in terms of training, supervision, use of guidelines and ICT, and
3) To determine clients’ accessibility to RH services provided at different level of facilities.
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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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Combination file of all the documents related to the national guidelines for accreditation, supervision and regulation of ART clinics in India. Documents included:
National Guidelines for Accreditation, Supervision & Regulation of ART Clinics in India | Preliminary Pages | Corrigendum | Chapter 1 ...- Introduction, Brief history of ART and Requirement of ART Clinics | Chapter 2 - Screening of Patients for ART - Selection Criteria and Possible Complications | Chapter 3 - Code of Practice, Ethical Considerations and Legal Issues | Chapter 4 - Sample Consent Forms | Chapter 5 - Training | Chapter 6 - Future Research Prospects | Chapter 7 - Providing ART Services to the Economically Weaker Sections of the Society | Chapter 8 - Establishing a National Database for Human Infertility | Chapter 9 - Composition of the National Accreditation Committee | Bibliography
| Members of the Expert Group for Formulating the National Guidelines for Accredation, Supervision and Regulation of ART Clinics
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An Act to provide for the efficient and comprehensive regulation and control of food, drugs, medical devices, cosmetics, herbal drugs and poisons and to repeal the Food
(Control of Quality) Act, 1978, the Pharmaceuticals and Poisons Act, 1978 and to provide for related matters.
A Global Analysis of Antimicrobial Resistance and Its Drivers.
Since the first State of the World’s Antibiotics report in 2015, antimicrobial resistance has leveled off in some high-income countries but continues to rise in many low- and middle-income countries (LMICs), where access to antibiotic...s has risen with increases in gross domestic product per capita. Per capita antibiotic consumption in LMICs is lower than in high-income countries, despite a higher infectious disease burden; however, consumption rates are rapidly converging. These trends reflect both better access to antibiotics for those who need them and increases in inappropriate antibiotic use.
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In resource restriced countries
The portable diagnostic imaging technology covered by this document will serve not only the pressing demands for tuberculosis screening and triage but also other diseases. Therefore, the requirements, accessories, hardware and software packages listed in the following specifications are described in... detail in order to serve also other pathologies and conditions, like trauma and pneumonia.
Through the definition of "minimum technical requirements", this document is recommended to support decision-making regarding the selection, incorporation, allocation and use of portable X-ray systems and is intended for health care providers, managers of imaging departments, procurement and regulatory agencies, policymakers and planning officers in ministries of health, as well as biomedical engineering professionals, medical physicists, the private health sector, medical device industry and intergovernmental and international agencies.
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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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Community pharmacists are the health professionals most accessible to the public and are a cornerstone of primary health care. The role of community pharmacists is expanding globally. This report provides an overview of existing components and provisions of the legal and regulatory framework for com...munity pharmacies and their activities in Europe. It presents the diverse approaches to community pharmacy licenses and to establishment of new pharmacies and their ownership. It also details the framework for community pharmacy operating requirements (including opening hours, workforce, premises and equipment, services provided and identification of a community pharmacy) and the types of activity undertaken. Provisions associated with possible alternative forms of dispensing medicines (over-the-counter medicines, prescription-only medicines, dispensing by medical doctors and online medicine sales) are also described
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Drug registration in Kenya started in 1982; the process mainly involves an evaluation committee at the Kenya Pharmacy and Poisons Board (PPB) that aims to approve products based on quality, safety and efficacy.
WHO recently conducted a survey to assess the availability and cost of a national tracer list of essential medicines in the outpatient sector in Ukraine using a new collection tool – the WHO Essential Medicines and Health Products Price and Availability Monitoring Mobile Application. This tool fac...ilitates rapid and inexpensive data collection at the facility level.
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WHO recently conducted a survey to assess the availability and cost of a national tracer list of essential medicines in the outpatient sector in Ukraine using a new collection tool – the WHO Essential Medicines and Health Products Price and Availability Monitoring Mobile Application. This tool fac...ilitates rapid and inexpensive data collection at the facility level.
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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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