PMID- 37709326
OWN - NLM
STAT- MEDLINE
DCOM- 20230918
LR  - 20230918
IS  - 2044-6055 (Electronic)
IS  - 2044-6055 (Linking)
VI  - 13
IP  - 9
DP  - 2023 Sep 14
TI  - Strategies and interventions to strengthen pharmacovigilance systems in 
      low-income and middle-income countries: a scoping review.
PG  - e071079
LID - 10.1136/bmjopen-2022-071079 [doi]
LID - e071079
AB  - OBJECTIVES: The 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 CRITERIA: Publications included were primary 
      studies, articles, policy and guideline papers, describing interventions to 
      strengthen PV in LMIC. 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 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. RESULTS: 10 922 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. 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 also building capacity for 
      advanced activities such as signal detection.
CI  - (c) Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No 
      commercial re-use. See rights and permissions. Published by BMJ.
FAU - Menang, Olga
AU  - Menang O
AUID- ORCID: 0000-0002-3928-4288
AD  - Swiss Tropical and Public Health Institute, Allschwil, Switzerland 
      olga.menang@swisstph.ch.
AD  - University of Basel, Basel, Switzerland.
FAU - Kuemmerle, Andrea
AU  - Kuemmerle A
AD  - Swiss Tropical and Public Health Institute, Allschwil, Switzerland.
AD  - University of Basel, Basel, Switzerland.
FAU - Maigetter, Karen
AU  - Maigetter K
AD  - Swiss Tropical and Public Health Institute, Allschwil, Switzerland.
AD  - University of Basel, Basel, Switzerland.
FAU - Burri, Christian
AU  - Burri C
AD  - Swiss Tropical and Public Health Institute, Allschwil, Switzerland.
AD  - University of Basel, Basel, Switzerland.
LA  - eng
SI  - Dryad/10.5061/dryad.5hqbzkh9h
PT  - Journal Article
PT  - Review
DEP - 20230914
PL  - England
TA  - BMJ Open
JT  - BMJ open
JID - 101552874
SB  - IM
MH  - Humans
MH  - *Developing Countries
MH  - Pharmacovigilance
MH  - Educational Status
MH  - Academies and Institutes
MH  - Capacity Building
MH  - *Drug-Related Side Effects and Adverse Reactions/prevention & control
PMC - PMC10503375
OTO - NOTNLM
OT  - adverse events
OT  - health policy
OT  - public health
OT  - therapeutics
COIS- Competing interests: None declared.
EDAT- 2023/09/15 00:42
MHDA- 2023/09/18 12:44
PMCR- 2023/09/14
CRDT- 2023/09/14 20:33
PHST- 2023/09/18 12:44 [medline]
PHST- 2023/09/15 00:42 [pubmed]
PHST- 2023/09/14 20:33 [entrez]
PHST- 2023/09/14 00:00 [pmc-release]
AID - bmjopen-2022-071079 [pii]
AID - 10.1136/bmjopen-2022-071079 [doi]
PST - epublish
SO  - BMJ Open. 2023 Sep 14;13(9):e071079. doi: 10.1136/bmjopen-2022-071079.