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 ...hlight medbox">quality medicines for the population. To fulfill its mandate, DPMED aims to strengthen 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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This guidance should be followed if an unlicensed medicine is prepared in
a registered pharmacy. The preparation of an unlicensed medicine (for
example unlicensed methadone, or menthol in aqueou...s cream) in a pharmacy is called ‘extemporaneous preparation’.
The guidance should be read alongside the standards for registered pharmacies. These aim to create and maintain the right
environment, both organizational and physical, for the safe and effective practice of pharmacy.
By following this guidance, the pharmacy will:
• demonstrate that it meets our standards, and
• provide assurances that the health, safetyand wellbeing of patients and the public are safeguarded
Responsibility for making sure this guidance is followed lies with the pharmacy owner. If the registered pharmacy is owned by a ‘body
corporate’, the directors have responsibility.
Those responsible for the overall safe running of the pharmacy need to take into account the nature of the pharmacy and the range of services
already provided and, most importantly, the needs of patients and members of the public.
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WHO Technical Report Series, No. 961, 2011, Annex 8 - These guidelines are intended to provide a description of ways in which pharmacists can improve access to health care, health promotion and the use of medicines on behalf of the patients they ser...ve. The role of FIP is to provide leadership for national pharmacy professional organizations, which in turn provide the impetus for setting national standards. The vital element is the commitment of the pharmacy profession worldwide to promoting excellence in practice for the benefi t of those served. The public and other professions will judge the pharmacy profession on how its members translate that commitment into practice in all settings, especially community and hospital pharmacy settings.
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Procurement and supply management activities are fundamental to consistent and reliable access to essential medicines and health products. To reduce the impact of CVD, action needs to be taken to improve prevention, diagnosis, care and management of... CVD diseases. Affordable essential medicines and technologies to manage CVD disease must be available where and when they are required. Medicines and technologies need to be managed appropriately to ensure that the correct medicines are selected, procured in the right quantities, distributed to facilities in a timely manner, and handled and stored in a way that maintains their quality. This needs to be backed up by policies that enable sufficient quantities to be procured in order to reduce cost inefficiencies, ensure the reliability and security of the distribution system, and encourage the appropriate use of these health products. In order to avoid stock-outs and the disruption of treatment, all related activities need to be conducted in a timely manner, with performance continually monitored, and prompt action taken in response to problems that may arise. Additionally, medication must be dispensed correctly and used rationally by the healthcare provider and patient alike. The purpose of this guide is to explain the necessary steps.
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This standard Operating procedure (SOP) for JDWNRH is intended to describe and
address various important areas like admission procedure, on call process of the
doctors, interdepartmental consultation, patient discharge process and verity of
other areas which was so far solely based on verbal i...nstruction in the workplace by
the seniors which very often led to mishaps and other associate problems. This SOP,
though not comprehensive, would serve as a guidebook for newly recruited health
staff as well as a reference book for existing health professionals in JDWNRH while
delivering health care services
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Cardiovascular diseases, principally ischemic heart disease (IHD), are the most important cause of death and disability in the majority of low- and lower-middle-income countries (LLMICs). In these countries, IHD mortality rates are significantly greater in individuals of a low socioeconomic status (...SES).
Three important focus areas for decreasing IHD mortality among those of low SES in LLMICs are (1) acute coronary care; (2) cardiac rehabilitation and secondary prevention; and (3) primary prevention. Greater mortality in low SES patients with acute coronary syndrome is due to lack of awareness of symptoms in patients and primary care physicians, delay in reaching healthcare facilities, non-availability of thrombolysis and coronary revascularization, and the non-affordability of expensive medicines (statins, dual anti-platelets, renin-angiotensin system blockers). Facilities for rapid diagnosis and accessible and affordable long-term care at secondary and tertiary care hospitals for IHD care are needed. A strong focus on the social determinants of health (low education, poverty, working and living conditions), greater healthcare financing, and efficient primary care is required. The quality of primary prevention needs to be improved with initiatives to eliminate tobacco and trans-fats and to reduce the consumption of alcohol, refined carbohydrates, and salt along with the promotion of healthy foods and physical activity. Efficient primary care with a focus on management of blood pressure, lipids and diabetes is needed. Task sharing with community health workers, electronic decision support systems, and use of fixed-dose combinations of blood pressure-lowering drugs and statins can substantially reduce risk factors and potentially lead to large reductions in IHD. Finally, training of physicians, nurses, and health workers in IHD prevention should be strengthened.
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The objective of the evaluation is to understand whether the CHW program has achieved its intended objectives, thus contributing to the overarching objectives defined in the HSSP III of improving the health status of the population by “Ensuring universal accessibility of ...highlight medbox">quality health services for all Rwandans”.
This evaluation has focused on CHWs, who are selected, trained and deployed by the MoH to deliver a defined set of tasks at community level. CHWs are the central element of the Community Health Policy and of the community health strategy plan (CHSP) of the MoH.
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SOP- Quality Assurance of Malaria Diagnostic Tests
Good Manufacturing Practice (GMP) describes a set of principles and procedures that, when followed, ensure that medicines and related substances are of high quality, safety and efficacy. SAHPRA is a...
participating authority of the Pharmaceutical Inspection Cooperation Scheme (jointly known as PIC/S). PIC/S aims to develop international standards between countries and pharmaceutical inspection
authorities, to provide harmonised and constructive co-operation in the field of GMP. PIC/S affiliation is subject to initial and periodic assessment of the participating authority to ensure that it has equivalent legislation, regulatory and enforcement procedures and inspection capacity.
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This guidance addresses rationale, risk-based scenarios, practical considerations prior to adoption of the self-testing products, quality assurance, safety and ethical considerations, and data manag...ement considerations for COVID-19 self-testing. The Africa CDC recommends the use of rapid antigen self-testing within two key scenarios. The first includes testing for case identification within scenarios with a high risk of infection, including symptomatic cases and contacts of a confirmed case. The second scenario involves general screening within scenarios of low or unknown risk exposure allowing for self-care such as before gatherings with at-risk individuals and prior to participation in events involving members of different households. Within these scenarios, a positive test result indicates likelihood of current infection, while a negative test result indicates a lower risk of active infection, though it does not rule out infection altogether. All positive cases should be managed following the national COVID-19 management protocol of Member States.ssur
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The Federal Ministry of Health (FMOH) has been coordinating sector wide reforms that aim to improve equity and quality of maternal and child health services. As part of these efforts, the ministry is also exerting concerted effor...ts to improve availability and use of quality RMNCH pharmaceuticals. Management of RMNCH pharmaceuticals has had significant challenges such as poor availability of essential pharmaceuticals and wastages of valuable resources as pharmacy professionals were not demonstrating the required knowledge, skill and attitude towards availing the pharmaceuticals and ensuring their rational medicine use.
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Malar J (2017) 16:174 DOI 10.1186/s12936-017-1808-x
Background: Since 2004, artemisinin-based combination therapy (ACT) has been the first-line treatment for uncomplicated malaria in Benin. In 2016, a medicine outlet survey was implemented to inves...tigate the availability, price, and market share of anti-malarial treatment and malaria diagnostics. Results provide a timely and important benchmark to measure future interventions aimed at increasing access to quality malaria case management services.
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Types of radiotherapy equipment covered by the guide include external beam radiotherapy machines (both Cobalt-60 and linear accelerators), brachytherapy devices that apply radiation sources directly to tumours and complementary imaging devices such as conventional or computed tomography (CT) simulat...ors, as well as other tools essential for safe operation and quality control. Depending on the type of radiotherapy machine, the need for specialized professionals and infrastructure, as well as quality assurance and maintenance, may vary.
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The document, "Sustainable Management of Radiotherapy Facilities and Equipment," by WHO and IAEA, provides guidelines for managing radiotherapy equipment and facilities to ensure effective and safe cancer treatment. It covers essential aspects like preventive and corrective maintenance, funding, inf...rastructure, and staffing requirements for sustainable operation. The document aims to support radiotherapy departments, especially in low-resource settings, by outlining strategies for equipment procurement, maintenance, and replacement, emphasizing safety, quality assurance, and optimal patient care.
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Thesis presented in partial fulfilment of the requirements for the degree of Master of Nursing Science in the Faculty of Health Sciences at Stellenbosch University.
The mobile clinic health care services fulfil an essential role in delivering primary health care to the dwellers in the rural commun...ities of the Western Cape. However, occupational health and safety, as well as quality assurance are issues that need to be addressed urgently. It is thus recommended that policy makers take cognizance of the specific needs of every individual mobile clinic team.
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What are the FP and CAC competencies?
Through the clear articulation of the family planning and comprehensive abortion care (FP and CAC) competencies for the primary health care workforce, the aim is to advance improvements in FP and CAC service delivery by aligning health worker education approach...es with population health needs and health system demands.
This document, which describes these competencies in detail, is intended to:
be a foundational tool to be adopted and adapted by educators and regulators for FP and CAC providers (students) with a pre-service training pathway of at least 12 months;
describe competencies that are relevant to current and future health practice;
enable widespread use of the competencies not only for curriculum development for pre-service education, but also for in-service education, regulation, qualifications, quality assurance, personal development, performance evaluation, recruitment, management and career progression;
focus on the core functions of FP and CAC providers within broader efforts towards achieving universal health coverage
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The Practical manual on laboratory strengthening, 2022 update provides practical guidance on implementation of WHO recommendations and best practices for TB laboratory strengthening. It is an updated version of the GLI Practical Guide to Laboratory Strengthening published in 2017 and provides the la...test practical guidance on use of newly recommended diagnostics as well as guidance in key technical areas, including quality assurance and quality management systems, specimen collection and registration, procurement and supply-chain management, diagnostic connectivity, biosafety, data management, human resources, strategic planning, and model algorithms. The key changes are:
inclusion of recent or updated WHO recommendations for tests to diagnose TB and detect drug resistance;
alignment with the latest WHO critical concentrations for phenotypic drug-susceptibility testing (DST) and the new definitions of pre-XDR-TB and XDR-TB;
updated information on building quality-assured TB testing and management capacity using the Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) approach (Score-TB package1);
updated information on assessing, analysing and optimising TB diagnostic networks; and
updated information on the use of next-generation sequencing (NGS) to detect mutations associated with drug resistance for surveillance purposes.
The document also provides references to resources and tools relevant for work on laboratory strengthening.
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A technical guide for sputum smear microscopy, initiated by the International Union against Tuberculosis, is designed to be an easy to use reference standard for the collection, storage and transport of sputum specimens and for the examination of sputum smears by direct microscopy. This edition incl...udes updates addressing bio-safety and quality assurance aspects of sputum smear microscopy.
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The meeting was held from 26 to 27 March 2018 to review and discuss the following topics:
Advances and challenges in the use of fTLC, and new approaches to detecting mycolactone using monoclonal antibodies (mAbs).
The status of development of rapid diagnostic tests (RDTs) targeting the MUL..._3720 protein.
The role of PCR as a reference test, and hurdles in providing a confirmatory diagnosis and in establishing a quality assurance programme.
New molecular tools with potential for implementation at a level lower than in the national or regional reference laboratory, such as loop-mediated isothermal amplification (LAMP) and recombinase polymerase amplification (RPA).
The need to harmonize and standardize methods for collection and preparation of specimens, so samples can be referred for diagnosis and stored for evaluation of new diagnostic tests in optimal conditions.
Barriers to accessing early diagnosis and treatment, including coordination at the programme level, and lack of adequate diagnostic tools.
Defining target product profiles (TPPs) to guide the development of new diagnostic tools that can be applied at different levels of the health system. Participants agreed that two TPPs would be developed to address the current gaps: (i) a rapid test for BU diagnosis at the primary health-care level; and (ii) a test for diagnosis of BU that can also assist in treatment monitoring and differential diagnosis at the district hospital or reference centre.
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HIV testing programmes need to ensure that all clients who test for HIV are provided with correct diagnoses. The accuracy of HIV testing is critical to prevent misdiagnosis, as the consequences of giving an incorrect test result can be serious for clients, HIV testing services, HIV programmes and pu...blic health.
With the evolution of global HIV epidemiology, HIV testing approaches must also evolve to maintain accuracy and efficiency in population-level diagnosis. Reports suggest that misdiagnosis of HIV status may occur when suboptimal testing algorithms and out-of-date testing strategies are used. As a result of changing epidemiology and declining HIV positivity in testing, WHO recommends all countries use a standard three-test strategy to ensure a PPV of at least 99%, minimizing false-positive misdiagnosis. The WHO-recommended HIV testing strategy, along with quality assurance measures such as retesting to verify a positive diagnosis prior to initiation of HIV treatment, is cost-effective as it prevents misdiagnosis and unnecessary initiation of costly lifelong treatment.
This implementation guide provides practical advice on switching to a three-test strategy and instituting other measures that can help national HIV programmes deliver high-quality, accurate HIV testing services and ensure that misdiagnosis is minimized.
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