The safety of medicines in Zambia - why health workers need to take action | Produced by the National Pharmacovigilance Unit (NPVU)
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
3 February 2021
Vaccine- and vaccination-related crises require a communication response that is different from the communication strategies used to promote the benefits and importance of vaccines in general. This document presents the technical guidance needed to develop a communication plan that ...is appropriate for managing crises related to vaccine safety. This guidance will be useful for managers in the areas of immunization and vaccine and vaccination safety. They will also help preparedness and response teams working in safety crises to optimize their communication plans in order to regain, maintain, or strengthen trust in vaccines, vaccination, and immunization programs in general.
more
This document builds on the Background document prepared for the September 4-5, 2014 Consultation. It includes proposed elements to consider during the development of a framework to assist decision-making at global and national level.
The aim of the document is to assist Member States and releva...nt partners in their discussions to identify the best approaches to ensure the accelerated evaluation and use of available or near-term therapies and vaccines for the treatment and prevention of EVD. The document calls for a coordinated effort by the international community to remove unnecessary obstacles towards this goal.
more
Weekly Epidemiological Record No 9, 2022, 97, 61–80
This position paper supersedes the 2016 publication, “Malaria vaccine: WHO position paper-2016.”1 It includes the updated WHO recommendations on the wider use of the RTS,S/AS01 vaccine for the reduction of malaria morbidity and mortality in ...children living in areas of moderate to high malaria transmission. It also incorporates findings from the evaluation of the WHO-coordinated Malaria Vaccine Implementation Programme (MVIP), recommended by SAGE and MPAG in 2015, and from additional studies since 2015.
This paper does not include findings on vaccine efficacy in infants first vaccinated at 6–12 weeks of age. Because of the lower vaccine efficacy observed in this age category, WHO did not recommend pilot implementation or RTS,S/AS01 vaccine introduction for these young infants. Recommendations2 on the use of RTS,S/AS01 vaccine were discussed by SAGE and MPAG during a joint session in October 2021; evidence presented at the meeting can be accessed at https://terrance.who.int/mediacentre/data/ sage/SAGE_eYB_Oct2021.pdf
more
The Pharmacovigilance team in WHO aims to assure the safety of medicines and vaccines by ensuring reliable and timely exchange of information on safety issues, promoting pharmacovigilance activities throughout the Organization and encouraging participation in the WHO Programme for International Drug... Monitoring. This text was developed in consultation with the WHO Collaborating Centre for International Drug Monitoring and the national pharmacovigilance centres participating in the WHO Programme for International Drug Monitoring.
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
In many countries neonatal tetanus is responsible for half of all neonatal deaths due to vaccine-preventable diseases and for almost 14% of al¡ infant deaths. It is estimated that in the 1970s more than 10,000 newborns died annually from neonatal tetanus in the Americas. Neonatal tetanus is prevent...ed by immunization and/or assuring clean delivery and post-delivery practices.
more
Arsenical monotherapies were previously very successful for treating human African trypanosomiasis (HAT).
Melarsoprol resistance emerged as early as the 1970s and was widespread by the late 1990s.
Melarsoprol resistance represents the only example of widespread drug resistance in HAT patients wher...e the genetic mechanism has been established.
The current goal of elimination of HAT as a public health problem by 2020 may be undermined by the emergence and spread of resistance to current or new drugs.
Insights into potential resistance mechanisms for current and new drugs will facilitate predictions of the likelihood of resistance and will also facilitate rational approaches to minimizing, monitoring, and tackling the future emergence of resistance.
more
There is an urgent need for safer, simpler, more efficacious and accessible treatment regimens for all forms of TB. The development of Target Product Profiles for TB treatment regimens (referred to as Target Regimen Profiles or TRPs) seeks to guide the drug development process towards important regi...men characteristics corresponding to the needs of end-users.
more
The WHO South-East Asia (SEA) Region bears a high burden of tuberculosis (TB) and MDR-TB. In 2015, the Region accounted for nearly 200 000 or 35% of the global estimated new RR/MDR-TB cases eligible for treatment. Extensively drug-resistant TB (XDRTB) has also been reported from s...ix countries of the SEA Region. MDR-TB could potentially replace drug-susceptible TB, and constitutes a threat to global public health security. The South- East Asia Regional Response Framework for DR-TB 2017–2021 complements the Ending TB in the South-East Asia Region: Regional Strategic Plan 2016–2020” and outlines key strategies for reducing morbidity, mortality and transmission of DR-TB.
more