An Indicator-based Approach - This manual presents an indicator-based approach for rapidly assessing pharmaceutical management systems and programs. The manual contains a set of 46 indicators of performance, grouped under eight topics of pharmaceutical management, with each topic being covered by a ...subset of indicators. Thirty-four of the indicators are quantitative, that is, expressed as numbers. Twelve are qualitative, in that they describe the presence or absence of a policy or management system, and in some cases, the degree of implementation.
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Strengthening Parmaceutical Systems. 2nd edition
Submitted to the US Agency for International Development by the Systems for Improved Access to Pharmaceuticals and Services (SIAPS) Program.
Fact Book on WHO Level I and Level II monitoring indicators - To monitor the progress of efforts to improve the global medicines situation, WHO has developed a system of indicators that measure important aspects of a country’s pharmaceutical situation. Level 1 indicators measure the existence and ...performance of key national pharmaceutical structures and processes. Level II indicators measure key outcomes of these structures and processes in the areas of access, product quality and rational use. These indicators can be used to assess progress over time; to compare situations between countries; and to reassess and prioritize efforts based on the results.
This Fact Book gives the results of the assessment of Level I indicators conducted in 2003 and of Level II indicator surveys conducted between 2002 and 2004
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Pharmaceutical system assessments are useful to diagnose problems, plan major projects and interventions, monitor progress, and compare the performance of one system with that of another. Recent years have seen a growth in demand for such assessments because of the global Fund to Fight AIDS, Tubercu...losis and Malaria’s policy to conduct procurement and supply management (PSM) assessments as a grant condition. To produce useful results, all assessments should be structured.
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This field study to assess the pharmaceutical situation was undertaken in Ghana in May-June 2008 using a standardized methodology developed by the World Health Organization. The study assessed medicines availability and affordability, geographical accessibility, quality and r...ational use among other issues. The survey was conducted in six regions. In each region, 6 public health care facilities, 12 private pharmacies and 1 warehouse were surveyed.
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A user-friendly instrument designed to collect and calculate indicators of effective inventory management. The IMAT guides the user through a process of collecting data on the physical and theoretical stock balance and the duration of stockouts for a set of up to 25 frequently-used products, calcula...ting indicators, analyzing the results, and identifying strategies for improving record-keeping and stock management practices. The IMAT comes as a computerized spreadsheet in Excel and includes instructions, a data collection form, analysis guidelines, recommendations, and a graphical display of the indicator results.
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Agodokpessi et al. Journal of Pharmaceutical Policy and Practice (2015) 8:12DOI 10.1186/s40545-015-0033-7
Benin established a revolving drug fund (RDF) for essential asthma medicines in 2008. We evaluated
the operation of the RDF and assessed whether there was interruption of supply of asthma me...dicine from 2008 to
2013.
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This Indicator-Based Pharmacovigilance Assessment Tool (IPAT) was developed as a comprehensive performance metric for pharmacovigilance and medicine safety systems.
The MSF qualification scheme is concerned with the pharmaceutical quality assessment for drugs. This procedure is applicable to products for international supply, i.e. products supplied through the MSF procurement centres. This qualification procedure is not applicable for local purchase, i.e. purch...ase of drugs within the project countries. For quality assurance principles and assessment of drugs for local purchase refer to the guideline for local pharmaceutical market assessment.
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The purpose of this manual is to define a limited number of indicators that will objectively describe the management and use of antimicrobials in hospitals and to provide tools and step-by-step instructions for designing and carrying out an assessment of antibiotic use and management in hospitals. T...he indicators in this manual will complement the existing WHO (1993) indicators of outpatient antimicrobial use suggested in How to Investigate Drug Use in Health Facilities (including percentage of encounters in which an antibiotic was prescribed and percentage of medicine costs spent on antibiotics) and will address the need for antimicrobial indicators for inpatient conditions.
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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.
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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 threat assessment addresses the implications of the ongoing Marburg virus disease (MVD) outbreak in
Rwanda for the European Union/European Economic Area (EU/EEA). MVD is a severe disease in humans and,
although uncommon, it has the potential to cause epidemics with significant case fatality. ...All recorded MVD
outbreaks to date have originated in Africa. MVD is not an airborne disease and is considered not to be
contagious before symptoms appear. Direct contact with the blood and other body fluids of infected people
and animals or indirect contact with contaminated surfaces and materials like clothing, bedding and medical
equipment is required for transmission. The risk of infection is minimised when proper infection prevention and
control precautions are strictly followed. There is no approved treatment or vaccine for MVD; however, several
pharmaceuticals and candidate MVD vaccines are under investigation.
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