Discussions marquées : AEFI

User manual for the revised WHO classification for the causality assessment of an adverse event following immunization (AEFI) – Second edition

The second edition of the user manual for the revised WHO classification for the causality assessment of an adverse event following immunization (AEFI) was developed by the WHO with support from the Global Advisory Committee for Vaccine Safety (GACVS). This was based on the findings of a scientific study, “Indo- Zimbabwe inter-country study to assess the inter-rater reliability of the WHO AEFI causality assessment methodology and the utility of the new WHO AEFI causality assessment software” that was conducted in April 2017. The study determined that there was realistic agreement between assessors in their findings of assessment and identified areas of the methodology that could be made even more robust by the use of more accurate and clearer language, semantics and graphics. In addition recent surveillance systems and research studies have shed new evidence on areas such as, “substandard and falsified vaccines” and “immunization anxiety” that have been incorporated into this edition. The manual is now available: http://www.who.int/vaccine_safety/publications/gvs_aefi/en/

Research proposal guidance: The knowledge & reporting pattern of AEFIs

Goodday colleagues, I am developing a post-graduate research proposal for submission in an academic institution to improve service delivery and continous quality improvement. The topic isTHE KNOWLEDGE (understanding and perception) OF & REPORTING PATTERN OF ADVERSE EVENTS FOLLOWING IMMUNIZATION (AEFIs) AMONG HEALTH-CARE WORKERS. Its a state-wide intiative and drive and may be scaled up to several other states in NIGERIA if further grants are appoved. I write to request the house to provide guidance and direction to sites, journals and relevants lietratures that would aid in simplifying this task. Please time is of the essence and all assistance will be highly appreciated. Useful information could be mailed to me (ejixlawrences@gmail.com or lekeocha@sidhas.org) , also contact(s) of colleagues that have done related works in NIGERIA and outside will be well appreciated.  Kind regards.

Multi-dose vaccine in ampoules

Hello All,
In the website for WHO PQ vaccines BCG and Yellow Fever are the two vaccines which have multi dose preparations packaged in ampoules. As soon as we open a mulit-dose ampoule and administer the first dose, we are leaving the remining doses in the ampoule exposed to environment (very often the not so clean undersurface of the vaccine carrier as the opened ampoule is kept in a slit in the top sponge and the VC closed).
Grateful if someone can enlighten me about the safety of this practice and whether there is any evidence comparing relative incidence of AEFI from multi dose vaccines in an ampoule vs. a vial.
Thanks and regards,
Anindya Bose

SMS-based AEFI reports

Excerpts from a discussion on another forum about adverse events following immunization (AEFI) data collection. Dhruv wrote: A wise option. Why don't we develop a cellphone-based VAERS? Prabir wrote: See http://www.slideshare.net/prabirkc/sms-based-death-reporting which has to do with a similar system. You are quite right. An EPI Surveyor form would be easy or else something costlier -- but more user friendly like CG NetSwara (http://cgnetswara.org/)* I believe that a good VAERS or adverse event reporting system with compensation for likely cases and treatment and rehabilitation for all is a human right in a society that uses vaccines. Here I think both vaccine supporters and doubters will find common ground. Questions of compensating residual paralysis patients, rehabilitation and disability benefits are where physiotherapists, virologists, social workers and activists can agree. Deaths after HPV, after JE and the AFP who are weak need attention. Dr Sunil Kaul wrote: That is a good system you are suggesting. Only worry is who will judge whether the adverse event is attributable to the vaccination or not? But all the same, it may actually increase the adverse events directory and allow research in the long run. theant, Udangshri Dera Rowmari, P O Khagrabari, via Bongaigaon Dist Chirang (BTAD), Assam 783380 INDIA http://www.theant.org sunil@theant.org Ph: 094351 22042 (m) 03664 293803 (r) IDeA 03664 293801 the ant Office: 03664 293802 Padma Prakash wrote: There are a number of commercially available medical alert systems marketed abroad. They use a Global Positioning System (GPS), and are one-button instruments that also are cellphones. I've always wondered at why hospitals haven't thought of offering the service to vulnerable--- older people, or those with particular problems---in their areas. At one time these were thought to be too expensive. But it should not be so with the spread of cellphone services and if a service provider could be drawn into it. But there are some initiatives today ---and several successful ones in Kenya and Nigeria I think-- that are cheap; used if I remember, for pregnancy and delivery related events in far-flung but demographically small communities. There are of course any number of youth-led groups that are using the mobile phone services very effectively for community-related work of all kinds including alerts on help on sexual assaults, police assaults, violence, etc. I don't see why this cannot be developed for adverse drug reaction reporting. A simultaneous website like CG NetSwara would be easy enough. The critical issue is the content. Do you know if it isn't in fact being developed here? * Moderator's note: CGnet Swara is a platform to discuss issues related to Central Gondwana region in India. It is a voice-based portal, freely accessible via mobile phone, that allows anyone to report and listen to stories of local interest. Reported stories are moderated by journalists and become available for playback online as well as over the phone.
Admin

The global network for the post-marketing surveillance of vaccine

Cross-posted from the January 2012 issue of GIN with thanks.
31/01/2012 from Madhav Balakrishnan, WHO HQ

The Global Network for Post-marketing Surveillance (PMS) of Vaccines was established by WHO in early 2008 with a primary objective to monitor the safety of WHO prequalified vaccines supplied through UN agencies. By 2011, twelve countries, Albania, Brazil, China, India, Iran, Kazakhstan, Mexico, Senegal, Sri Lanka, Tunisia, Uganda and Vietnam have been included in the network. These countries were trained in Vaccine Pharmacovigilance, on the methods of causality assessment for vaccine Adverse Event Following Immunization (AEFI) classification and the use of Vigiflow© (a software platform to report and upload AEFI cases to the WHO Programme for International Drug Monitoring, which is maintained by the Uppsala Monitoring Centre (UMC) in Sweden).

As of 31 December 2011, eight of the twelve countries in the Global PMS network were uploading AEFI case reports to the Uppsala Monitoring Centre (UMC) in Sweden, using the Vigiflow system. Reports pertaining to 6,099 AEFI have been uploaded into the WHO UMC database. Of these, 2,770 involved multiple vaccines. DTP vaccines were associated to the largest number (3,745) of adverse events. Most events related to DTP were reported from Iran (3,516) and Sri Lanka (187) both of which have well established AEFI surveillance systems.

With one more year for the project, the PMS Network has improved the reporting of AEFI for vaccines in most participating countries. Systems are being established to ensure harmonization of the surveillance and reporting systems, including case report forms, software systems, and type of AEFI reported. The network countries have identified the need for a more simple data processing tool that could be more specific for vaccines and that could be operated off-line given the internet limitations in many countries. Currently the WHO and UMC are exploring the prospects of creating a simpler tool based on the experience gathered.
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