ArticlePerspectives in clinical research
An analysis of completeness and quality of adverse drug reaction reports at an adverse drug reaction monitoring centre in Western India.
Article in Perspectives in clinical research. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 1 of them a synthesis that pooled 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.
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.
Who cites it
10 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Factors that influence patient and public adverse drug reaction reporting: a systematic review using the theoretical domains framework.International journal of clinical pharmacy · 2023Pooled it
- EudraScore: Modification of the Vigi4Eudra-score for the Assessment of the Completeness of Adverse Drug Reaction Reports in EudraVigilance.Drug safety · 2026Article
- "Measurement or Judgment?" Reconsidering Data Quality and Inference in EudraVigilance.Therapeutic innovation & regulatory science · 2026Article
- Quality of adverse drug reaction reports submitted to the national pharmacovigilance center of Nepal: a pre- and post-training evaluation.BMC medical education · 2026Article
- Understanding causes of incomplete reports of adverse drug reactions associated with dolutegravir-based HIV treatment in uganda: a qualitative study.BMC infectious diseases · 2025Article
- Disponibilité de l'information médicale requise pour la déclaration d'une réaction indésirable médicamenteuse à Santé Canada: une étude exploratoire.The Canadian journal of hospital pharmacy · 2024Article
- The completeness of adverse drug reaction reports in South Africa: An analysis in VigiBase®.African journal of primary health care & family medicine · 2023Article
- Adverse drug reactions reporting: Five years analysis from a teaching hospital.Journal of family medicine and primary care · 2022Article
- Adverse drug reaction management in hospital settings: review on practice variations, quality indicators and education focus.European journal of clinical pharmacology · 2022Review
- ADR in Journals: Are They Translated into Regulatory Frameworks?Current drug safety · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
PURPOSE/
aimThe Adverse Drug Reaction [ADR] form is the source document for the Pharmacovigilance Programme of India [PvPI] and captures information first hand from the patient. The raw data from it then gets converted into an individual case safety report [ICSR] after entry into Vigiflow. The National Coordinating Centre [NCC] uses an instrument to assess quality of these ICSRs. We carried out the present study to assess whether the same instrument with minor modifications could be used to check the quality of ADR forms at our centre. MATERIALS AND
methodsADR reports of three months from three consecutive years were selected randomly. The ADR form [18 fields] was matched with the NCC instrument [14 fields] as the latter is made from the former. A perfect ICSR would score 1. Three fields in the NCC instrument - case narrative, compliance with standard operating procedures [SOPs] and free text [5 components] were modified, while the rest were retained. Zero was given to the first two fields. In the third field, we retained only 3/5 components and changed the last two components [sender and reporter comments] to dechallenge and rechallenge while keeping the total score the same.
resultsA total of 1008 ADR reports were analyzed. We found an overall completeness score of approximately 80% with the lowest completeness score being for the year 2015. The mandatory fields had close to 100% scores.
conclusionThe NCC instrument was found well suited to evaluate quality and completeness of ADR forms.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
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.