This is a detailed manual giving a step by step approach to undertaking the pharmacovigilance of antiretrovirals. It is intended to be a source of practical advice for Pharmacovigilance Centres and health professionals involved in HIV/AIDS prevention and treatment programmes. A number of WHO publica...tions are available that provide a background to pharmacovigilance and, as far as possible, that material will not be repeated here. Health officials, planners, the staff of Pharmacovigilance Centres, public health teams and all health workers should become familiar with these publications, which are: • Safety of Medicines: A guide to detecting and reporting adverse drug reactions
more
Psychoactive substance use affects the functioning of the brain and leads to impaired driving
"Some of the problems with our current drug policies stem from the fact that these policies have been largely bifurcated between two different and often contradictory approaches. One treats drug use as a crime that cannot be tolerated and should be punished; the other views addiction as a chronic re...lapsing health or behavioral condition requiring ongoing treatment and support. Neither of these views is all encompassing—it should be recognized that there are patterns of drug use that do not result in significant harm or health problems and therefore require no intervention. The public health approach presented here takes the view that our focus should be on the harm caused by drug use and the harm caused by our policy responses to it. We have focused specifically on illicit drugs, not because they are by themselves more harmful (in fact, tobacco causes more morbidity and mortality than any illicit drug), but because it has become increasingly clear that our current policies to manage illicit drugs are failing."
more
Reporting system for the general public - This document aims to provide practical guidelines on how to set up national systems for consumers to report adverse reactions to medicines. The purpose is to help countries set up a well-organized and effective consumer reporting system within their pharmac...ovigilance centre. Throughout this document, the phrase “consumer reporting” is used to refer to reporting of adverse drug reactions (ADRs) by the general public.
more
For the first time in almost 50 years there are two new drugs for the treatment of drug-resistant TB (DR-TB): bedaquiline and delamanid. There has also been increased attention given to the safety and efficacy of “re-purposed” drugs that have been widely used to treat other infections but are al...so showing promise in the treatment of DR-TB, including linezolid and clofazimine. This special supplemental guide has been developed for nurses, because it is essential that nurses be provided with material that maximizes their ability to provide optimal support to patients who are receiving new and re-purposed drugs
more
Framework for implementation.
The END TB Strategy.
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.
The safety of medicines in Zambia - why health workers need to take action | Produced by the National Pharmacovigilance Unit (NPVU)
This manual summarizes key issues related to the safety of NTD medicines and their administration, with a focus on essential medicines used in mass drug administration (MDA), also called preventive chemotherapy. It can be used as a standalone reference manual, but is intended to be used in conjuncti...on with the accompanying training modules, which provide practical instruction, and the aide-mémoires. Versions of the aide-mémoires and training modules are available respectively for both (i) programme managers and district-level health officials and (ii) community drug distributors and community health workers
more
This e-course will guide you through the essentials of latest existing WHO guidelines and policy recommendations on drug-resistant TB. You will also learn more about the rationale behind the WHO recommendations for the management of DR-TB, implementation considerations for different regimens for eli...gible patient groups, adjunctive treatment, the active TB drug safety monitoring and management framework, and the analysis and interpretation of performance indicators.
The main focus of the e-course is programmatic; clinical aspects are only discussed when relevant to specific topics.
more
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.
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).
more
Preventing tuberculosis infection from progressing to tuberculosis disease is a crucial component of the goal to eliminate tuberculosis. When deciding on the use of tuberculosis preventive therapy among household contacts, policy makers regularly ask questions, such as whether tuberculosis preventiv...e therapy is effective, safe, and feasible in a programme setting and what it will cost. For contact management and tuberculosis preventive therapy for multidrug-resistant and rifampicin-resistant tuberculosis, studies from high-income and low-income countries have shown feasibility, safety, and effectiveness.
However, there is scarce information on the cost of tuberculosis preventive therapy for multidrug-resistant and rifampicin-resistant tuberculosis. In The Lancet Global Health, Peter Dodd and colleagues show that household contact management strategies are cost-effective even in low-income and middle-income countries, which has important policy implications for achieving the END TB Strategy goals.
more
The guideline on Drug misuse: opioid detoxification, commissioned by NICE and developed by the National Collaborating Centre for Mental Health, sets out clear, evidence-based recommendations for healthcare staff on how to work with people who misuse opioids to significantly improve their treatment a...nd care, and to deliver detoxification safely and effectively. Of the estimated 4 million people in the UK who use illicit drugs each year, approximately 50,000 misuse opioids (such as heroin, opium, morphine, codeine and methadone). Opioid misuse presents a considerable health risk and can lead to significant social problems. This NICE guideline is an important tool in helping people to overcome their drug problem.
more
The Ethiopian Food and Drug Administration (EFDA) is mandated, in the proclamation 661/2009, to ensure the safety, quality and efficacy of medicines. To achieve this, the authority has been working on different regulatory activities. The medicine market authorization system is one of the top priorit...y areas that have been implemented. In addition to the dedicated assessors, the authority uses a national drug advisory committee for the assessment and registration of medicines.
more
This was a Phase 3, multi-center, randomized, open-label, parallel-group, active control study where 273 male and female patients with first stage Trypanosoma brucei gambiense HAT were treated at six sites: one trypanosomiasis reference center in Angola, one hospital in South Sudan, and four hospita...ls in the Democratic Republic of the Congo between August 2005 and September 2009 to support the registration of pafuramidine for treatment of first stage HAT in collaboration with the United States Food and Drug Administration. Patients were treated with either 100 mg of pafuramidine orally twice a day for 10 days or 4 mg/kg pentamidine intramuscularly once daily for 7 days to assess the efficacy and safety of pafuramidine versus pentamidine. Pregnant and lactating women as well as adolescents were included.
more
Better drug regimens for mass drug administration (MDA) could accelerate the Global Programme to Eliminate Lymphatic Filariasis (LF). This community study was designed to compare the safety and efficacy of MDA with IDA (ivermectin, diethylcarbamazine and albendazole) or DA (diethylcarbamazine and ...albendazole) in India.
more
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.
more