Strengthening of causality assessment of adverse events following immunization in the WHO South East Asia and Western Pacific regions: Lessons from the 2014 SEAR inter-country workshop

MacDonald, Noni E.; Guichard, Stephane; Amarasinghe, Ananda; Balakrishnan, Madhava Ram

doi:10.1016/j.vaccine.2015.01.033

Cited by 8 publications

(5 citation statements)

References 1 publication

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“…Primarily provided by health institutions, these interventions were not reported as part of a broader PV strengthening scheme. The format, content and duration varied, with duration ranging from 45 min16 to several days 17. For a majority of these interventions, the content was information on ADR reporting and raising awareness on PV.…”

Section: Resultsmentioning

confidence: 99%

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Strategies and interventions to strengthen pharmacovigilance systems in low-income and middle-income countries: a scoping review

Menang,

Kuemmerle,

Maigetter

et al. 2023

BMJ Open

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ObjectivesThe slow progress of pharmacovigilance (PV) in low-income and middle-income countries (LMIC) raises questions about core challenges on the growth of PV, and the appropriateness of strategies used so far to develop PV. Therefore, this scoping review aims to describe strategies and interventions to strengthen PV in LMIC and to propose recommendations for future investments in PV capacity building.Inclusion criteriaPublications included were primary studies, articles, policy and guideline papers, describing interventions to strengthen PV in LMIC.MethodsThe review was conducted following the Joanna Briggs Institute (JBI) guidelines on conducting scoping reviews. Literature searches were performed in MEDLINE, EMBASE, Web of Science, PDQ-evidence, CINAHL and other relevant websites from January 1990 to January 2021. Two reviewers independently screened titles, abstracts and full texts. One reviewer performed data extraction and descriptive analysis, which were reviewed by two other reviewers.Results10 922 unique titles were screened and 152 were eligible for full text review. Of these, 57 and an additional 13 reports from grey literature fulfilled eligibility criteria for inclusion in the review. These were grouped into two categories: (1) Interventions aimed at increasing PV knowledge and adverse drug reactions (ADR) reporting (45 papers), primarily education of healthcare professionals (HCP), alone or in combination with other interventions such as mobile and electronic reporting and (2) Interventions aimed at strengthening various components of the national PV system (25 papers), describing strategies or mixed interventions implemented at the national level, targeting different components of the national PV system.ConclusionsResults of this review suggest that educating HCP on ADR reporting is the most common approach to build PV capacity in LMIC. Though important, education alone is insufficient and should ideally be organised within the holistic framework of strengthening national PV systems, with a focus on also building capacity for advanced activities such as signal detection.

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Section: Resultsmentioning

confidence: 99%

“…The format, content and duration varied, with duration ranging from 45 min 16 to several days. 17 For a majority of these interventions, the content was information on ADR reporting and raising awareness on PV.…”

Section: Educational Interventionsmentioning

confidence: 99%

Strategies and interventions to strengthen pharmacovigilance systems in low-income and middle-income countries: a scoping review

Menang,

Kuemmerle,

Maigetter

et al. 2023

BMJ Open

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“…As result of a WHO and Bill and Melinda Gates Foundation project on the development of a global network for vaccine safety monitoring, GACVS also endorsed the revision of the AEFI causality assessment algorithms [31], vaccine specific safety information documents [32], and facilitated the development of on-line vaccine safety learning modules [33]. The causality assessment algorithm was further revised following input from low and middle income country users [34,35]. These revised tools are available to all countries and are disseminated by WHO through regional workshops and in country meetings.…”

Section: Resultsmentioning

confidence: 99%

Contributions and challenges for worldwide vaccine safety: The Global Advisory Committee on Vaccine Safety at 15 years

Asturias

Wharton

Pless

et al. 2016

Vaccine

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In 1999, the Global Advisory Committee on Vaccine Safety (GACVS) was established by the World Health Organization (WHO) to provide independent scientific advice on issues relating to the safety of vaccines and immunization. Fifteen years onward, we conducted a multi-faceted review to evaluate the impact, reach and challenges facing GACVS, including the role GACVS plays in informing global, regional and WHO member state vaccine policy. The methods included measures of organizational structure, citation impact, themes approached, and a discussion by previous and current members to evaluate past, present and future challenges. Given the increasing range of data sources and the deployment of many new vaccines, the Committee is facing the complex task of identifying the best available evidence for recommendations on vaccine safety. To help meet the increased demand for public transparency in decision making, GACVS-structured methodology for evidence-based decisions is evolving. GACVS also promotes best practices and capacity building for timely and accurate risk assessment; risk communications; outreach to help countries maintain and, if needed, rebuild public trust in vaccines; and advocacy for bridging the major gaps in vaccine safety capacity globally.

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“…Primarily provided by health institutions, these interventions were not reported as part of a broader PV strengthening scheme. The format, content, and duration varied, with duration ranging from 45 minutes ( 16) to several days (17).…”

Section: Educational Interventionsmentioning

confidence: 99%

Strategies and interventions to strengthen pharmacovigilance systems in low- and middle-income countries: a scoping review

Menang

Soyres-Kuemmerle

Maigetter

et al. 2022

Preprint

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Introduction In the past decades, numerous strategies have been proposed to strengthen pharmacovigilance (PV) systems in low-and-middle-income countries (LMIC). Though there has been progress, many PV systems in LMIC are still not performing adequately. The objectives of this scoping review are to describe strategies to strengthen PV in LMIC and to propose recommendations for future investments in capacity building. Methods The review was conducted following the Joanna Briggs Institute (JBI) guidelines on conducting scoping reviews. Literature searches were performed in MEDLINE, EMBASE, Web of Science, PDQ-evidence, CINAHL and relevant websites from 1990 to January 2021. Publications included were primary studies, articles, and policy and guideline papers, describing interventions to strengthen PV in LMIC. Two reviewers independently screened titles, abstracts and full-texts, and one reviewer performed data extraction and carried out a descriptive data analysis. Results 10,903 unique titles were screened and 152 were eligible for full text review. Of these, 57 and an additional 13 reports from grey literature fulfilled eligibility criteria for inclusion in the review. Forty-five papers (64%) described interventions aimed at increasing PV knowledge and reporting of adverse drug reactions (ADR), primarily education of healthcare professionals (HCP), alone or in combination with other interventions such as mobile and electronic reporting, enhanced passive and active surveillance. Twenty-five papers (36%) discussed interventions or strategies implemented at the national targeting different components of the national PV system, such as legal basis and guidelines for PV, PV organisation and infrastructure and PV procedures. Conclusions Results of this review suggest that educating HCP on ADR reporting is the most common approach to build PV capacity in LMIC. Though important, education alone is insufficient and should ideally be organised within the holistic framework of strengthening national PV systems, with a focus on building capacity for advanced activities such as signal detection.

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Strengthening of causality assessment of adverse events following immunization in the WHO South East Asia and Western Pacific regions: Lessons from the 2014 SEAR inter-country workshop

Cited by 8 publications

References 1 publication

Strategies and interventions to strengthen pharmacovigilance systems in low-income and middle-income countries: a scoping review

Strategies and interventions to strengthen pharmacovigilance systems in low-income and middle-income countries: a scoping review

Contributions and challenges for worldwide vaccine safety: The Global Advisory Committee on Vaccine Safety at 15 years

Strategies and interventions to strengthen pharmacovigilance systems in low- and middle-income countries: a scoping review

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