Maintaining proper storage conditions for health commodities is vital to ensuring their quality. Product expiration dates are based on ideal storage conditions and protecting product quality until their expiration date is important for serving customers and conserving resources. Guidelines for the S...torage of Essential Medicines and Other Health Commodities is a practical reference for those managing or involved in setting up a storeroom or warehouse. The guide contains written directions and clear illustrations on receiving and arranging commodities; special storage conditions; tracking commodities; maintaining the quality of the products; constructing and designing a medical store; waste management; and resources. It was written to meet the needs of district-level facilities; however, the guidelines and information it contains apply to any storage facility, of any size, in any type of environment.
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In September, 2018, the first international Medicine Quality and Public Health Conference was held at Oxford University, UK, to discuss opportunities and solutions to ensure that all people have access to affordable and quality-assured medical products. Delegates developed the short Oxford Statement..., calling for investment, policy change, and action to eliminate substandard and falsified medical products. The statement was born out of discussion between governments, national and international agencies, non-governmental organisations, professional associations, and academic institutions who together examined the latest evidence on the epidemiology and public health implications of substandard and falsified medical products.
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Document No. : FDA/SMC/SMD/GL-SMP/2015/05 |
These guidelines are for information, guidance and strict compliance by Marketing Authorization Holders and Local Representatives of regulated products to help in the continuous safety monitoring of products granted marketing authorization in Ghana.
First edition, November 1997 | Revised July 2002
Doc. No.: INS/GDL/001-(Annexes)
Public Report
PQMC 0001-001-04 WHO PQMC Public Report November/2016, version 8.0
Public Report
PQMC 0003-003-00 WHO PQMC PR June/2015, version 2.0
The Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008, presents evidence-
based recommendations on the preferred methods for cleaning, disinfection and sterilization of patient-
care medical devices and for cleaning and disinfecting the healthcare environment. This docume...nt
supercedes the relevant sections contained in the 1985 Centers for Disease Control (CDC) Guideline for
Handwashing and Environmental Control. 1 Because maximum effectiveness from disinfection and
sterilization results from first cleaning and removing organic and inorganic materials, this document also
reviews cleaning methods. The chemical disinfectants discussed for patient-care equipment include
alcohols, glutaraldehyde, formaldehyde, hydrogen peroxide, iodophors, ortho-phthalaldehyde, peracetic
acid, phenolics, quaternary ammonium compounds, and chlorine. The choice of disinfectant,
concentration, and exposure time is based on the risk for infection associated with use of the equipment
and other factors discussed in this guideline. The sterilization methods discussed include steam
sterilization, ethylene oxide (ETO), hydrogen peroxide gas plasma, and liquid peracetic acid. When
properly used, these cleaning, disinfection, and sterilization processes can reduce the risk for infection
associated with use of invasive and noninvasive medical and surgical devices. However, for these
processes to be effective, health-care workers should adhere strictly to the cleaning, disinfection, and
sterilization recommendations in this document and to instructions on product labels.
LAST UPDATE 2019
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This chronology of facts has challenged public health systems worldwide and regulatory bodies are no exception. Regulatory authorities with mechanisms in place to authorize the use of investigational products had to development guidelines and procedures, create task forces and alliances to maximize ...the efficiency of assessment, review and authorizations of medical products. Vaccines are undoubtedly the most complex medical products to develop, from concept to a stage where sufficient evidence of quality, safety and efficacy are collected to provide an assurance that their use will provide more benefits than risks when used in the context of a public health emergency.
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Maintaining proper storage conditions for health commodities is vital to ensuring their quality. Product expiration dates are based on ideal storage conditions and protecting product quality until their expiration date is important for serving customers and conserving resources. Guidelines for the S...torage of Essential Medicines and Other Health Commodities is a practical reference for those managing or involved in setting up a storeroom or warehouse. The guide contains written directions and clear illustrations on receiving and arranging commodities; special storage conditions; tracking commodities; maintaining the quality of the products; constructing and designing a medical store; waste management; and resources. It was written to meet the needs of district-level facilities; however, the guidelines and information it contains apply to any storage facility, of any size, in any type of environment.
Available in English, French, Spanish and Russian
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The purpose of this document is to provide relevant information and guidelines on
coronavirus outbreaks – and in particular the novel coronavirus SARS-CoV-2 and the
diseases it produces, COVID-19 – for pharmacists and the pharmacy workforce, both in a
primary care context (i.e. community phar...macies and primary healthcare facilities) and in
hospital settings, as well as for pharmacists working as clinical biologists in medical
analysis laboratories, for example, as clinical biologists, and offer a set of references that
may be consulted for more informationstor
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Communication to Healthcare Professionals Mar-2020
This guideline is intended to assist healthcare professionals in the participation of very important process of continuous surveillance of safety and efficacy of the health products which are used in their clinical practice. Continuous evaluation o...f medicines’ benefit and harm help to achieve the ultimate goal of safe and effective treatments available to patients.
The guideline is intended to assist healthcare professionals in the reporting of suspected adverse drug reactions (ADRs) associated with the use of all registered health products, including medicines, old medicines, medical devices and in-vitro diagnostics (IVDs).
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Resource platform.
The Global Atlas of medical devices (GAMD) provides global, regional and country data on availability of:
national policy on health technology
regulation of medical devices
health technology assessment national unit
health technology management
use of med...ical devices nomenclature system
national lists of priority medical devices
high cost medical equipment.
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The twentieth century ended with human African trypanosomiasis (HAT) epidemics raging across many parts of Africa. Resistance to existing drugs was emerging, and many programs aiming to contain the disease had ground to a halt, given previous success against HAT and the competing priorities associat...ed with other medical crises ravaging the continent. A series of dedicated interventions and the introduction of innovative routes to develop drugs, involving Product Development Partnerships, has led to a dramatic turnaround in the fight against HAT caused by Trypanosoma brucei gambiense. The World Health Organization have been able to optimize the use of existing tools to monitor and intervene in the disease. A promising new oral medication for stage 1 HAT, pafuramidine maleate, ultimately failed due to unforeseen toxicity issues. However, the clinical trials for this compound demonstrated the possibility of conducting such trials in the resource-poor settings of rural Africa.
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Many vaccines and drugs hold the promise of reducing mortality and morbidity among pregnant women and infants living in low- and middle-income countries (LMICs). However, sufficient information on the safety of drugs and vaccines in pregnant women is rarely available at the time of product licensure... or approval. To account for this, active safety surveillance efforts are needed during the post-licensure and post-approval
phase to assess the safety of drugs and vaccines in pregnant women and their offspring. Pregnancy exposure registries (PER) are used to monitor the safety of vaccines and drugs. PERs are observational studies that systematically collect health information on exposure to medical products such as drugs and vaccines during pregnancy. This review demonstrates that a number of resources presently exist in LMICs that perform active safety surveillance in pregnant populations. These results indicate such systems employ a wide variety of approaches, each with their own set of strengths and challenges, as summarized in the final section of the report.
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Over one third of all deaths in Kenya in 2019 were attributed to NCDs (Vos et al., 2020). The four major NCDs – CVDs, cancer,
diabetes and chronic respiratory diseases – accounted for 57% of these deaths. Furthermore, the direct and indirect economic
impact of NCDs is significant- Kenya is sai...d to have lost Ksh 230 billion or 3.4% of its gross domestic product in 2016 from rising
NCD-related medical costs and indirect productivity losses. At the household level, an estimated decrease of 28.6% in income
due to NCDs was reported in 2007 (Mwai & Muriithi, 2016; Mensah et al., 2020). Therefore, preventing and managing NCDs are
significant public health and economic priorities.
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This study investigated occupational risk factors and exposure–response relationships for airway disease among health workers (HWs) exposed to cleaning agents in two tertiary hospitals in South Africa and Tanzania.
Previous studies have demonstrated an association between asthma or respiratory... symptoms and exposure to broad categories of cleaning-related exposures in healthcare settings. However, few studies have identified the specific cleaning agents responsible for asthma and other health outcomes. Products used for medical instrument cleaning and disinfection such as glutaraldehyde, orthophthalaldehyde (OPA) and quaternary ammonium compounds (QACs) have been implicated in the causation and exacerbation of work-related asthma (WRA) and upper airway outcomes such as rhinitis.
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