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 serve. The role of FIP is to provide leadership for na...tional 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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SOP- Quality Assurance of Malaria Diagnostic Tests
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 quality health services fo...r 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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Last revised 2015.
Original Word document on: http://www.epnetwork.org/Resources/Standard%20Operating%20Procedure/Temperature%20chart_Form.doc
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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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 investigate 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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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 efforts 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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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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Licensed pharmaceutical products (marketing authorization) should be manufactured only by licensed manufacturers (holders of a manufacturing authorization) whose activities are regularly inspected by competent national authorities. This guide to GMP shall be used as a standard to justify GMP status,... which constitutes one of the elements of the WHO Certification Scheme on the quality of pharmaceutical products moving in international commerce, through the assessment of applications for manufacturing authorizations and as a basis for the inspection of manufacturing facilities. It may also be used as training material for government medicines inspectors, as well as for production, QC and QA personnel in the industry
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Pharmaceutical regulators are at the forefront of ensuring that only safe and effective medicines are authorized and available in the market. This document builds on the recommendations in the above publication and has been prepared to specifically assist national medicines regulatory authorities to... understand the nature and extent of oxytocin quality issues and to provide key technical information and quality requirements for oxytocin products in dossier assessments. Furthermore, this document also presents recommendations on other regulatory actions needed to ensure that only quality-assured oxytocin products are authorized and made available to women.
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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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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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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 management considerations for COVID-19 self-testing. The Africa CDC recommends the use of rapid antigen sel...f-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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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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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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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 M...UL_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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Ces deux dernières années, les infirmières et les autres professionnels de santé ont été fortement exposés à la COVID-19,
le manque de protection, de vaccination en temps opportun et de soutien requis pour travailler dans un cadre sûr et sain étant des facteurs aggravants. En outre, les i...nfirmières et les médecins sont 16 fois plus susceptibles de subir des violences sur leur lieu de travail que les autres acteurs du secteur des services. Les conditions de travail des infirmières et des autres professionnels
de santé se répercutent non seulement sur leurs propres droits, mais également sur ceux des personnes devant avoir accès à des
soins de santé de qualité et abordables.
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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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