Evidence map›Paper›PMID 26318468›Full record

ArticleSaudi medical journal2015

A qualitative exploration of the major challenges facing pharmacovigilance in Saudi Arabia.

Hisham Aljadhey, Mansour A Mahmoud, Thamir M Alshammari, Mohammed Al-Dhaeefi, Herve Le Louet, Susana Perez-Gutthann, Peter J Pitts

Abstract read
In one paragraph

Article in Saudi medical journal, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

14 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Localizing pharmaceuticals manufacturing and its impact on drug security in Saudi Arabia.Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society · 2022
    Review
  5. Covid-19 Vaccine Surveillance in Saudi Arabia: Opportunities for Real-time Assessment.Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society · 2021
    Article
  6. Article
  7. Article
  8. Article
  9. Article
  10. Article
  11. Article
  12. Current status, and future prospects of pharmaco-epidemiology and post-marketing surveillance in Saudi Arabia: A review of literature.Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society · 2018
    Review
  13. Public awareness and perception toward Adverse Drug Reactions reporting in Riyadh, Saudi Arabia.Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society · 2017
    Article
  14. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors.

Hisham AljadheyMedication Safety Research Chair, College of Pharmacy, King Saud University, Riyadh, Kingdom of Saudi Arabia. E-mail. haljadhey@ksu.edu.sa.
Mansour A Mahmoud
Thamir M Alshammari
Mohammed Al-Dhaeefi
Herve Le Louet
Susana Perez-Gutthann
Peter J Pitts

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo explore the challenges facing pharmacovigilance in Saudi Arabia and formulate recommendations to improve it from the perspective of healthcare professionals in Saudi Arabia.

methodsThis was a qualitative study of 4 focus group discussions with pharmacists, physicians, and academicians held under the auspices of the King Saud University School of Pharmacy and the Center for Medicine in the Public Interest, Riyadh, Saudi Arabia. A total of 29 eligible healthcare professionals were invited to participate in the discussion. The predefined themes of the study were the current practice and major challenges facing pharmacovigilance in regulatory bodies, hospitals, the community, and academia, as well as recommendations to improve pharmacovigilance practice.

resultOf the 29 participants invited, 27 attended the discussion. Challenges facing regulatory bodies included complicated adverse drug reactions (ADR) reporting forms, lack of feedback on ADRs submitted to the Saudi Food and Drug Authority, lack of decisions from the local authority to withdraw medications, and lack of data on pharmacovigilance. The challenges to pharmacovigilance in hospitals included the lack of knowledge of the significance of ADR reporting, workload, blaming culture, and lack of collaboration between regulatory bodies and hospitals. However, challenges facing pharmaceutical industries included the lack of drug manufacturers in Saudi Arabia and lack of interest in pharmacovigilance. Recommendations to improve pharmacovigilance included the need for communication, stronger regulatory requirements, the need for research, the need for unified ADRs reporting, and continuous education and training.

conclusionThe study has identified the challenges facing pharmacovigilance in Saudi Arabia and made certain recommendations to overcome them. These recommendations might be helpful for regulatory bodies to enhance spontaneous reporting and promote pharmacovigilance.

Indexed as

PharmacovigilanceDrug-Related Side Effects and Adverse ReactionsFocus GroupsHumansQualitative ResearchSaudi Arabia

Identifiers

PMID26318468
PMCPMC4613635

What OpenQuestion holds

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LicenceCC BY-NC-SA
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.