ArticleJournal of clinical pharmacy and therapeutics2021
Adverse Drug Reactions Spontaneously Reported at a Tertiary Care Hospital and Preventable Measures Implemented.
Article in Journal of clinical pharmacy and therapeutics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers.
What it found
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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
18 citing papers in PubMed, 23 citations in OpenAlex.
- Article
- Strengthening pharmacovigilance in emergency care: knowledge, attitudes and barriers to adverse drug reaction reporting among nurses in Ghana.BMC nursing · 2026Article
- Metabolic and Endocrine ADRs of Atypical Antipsychotics (AAPs) in Paediatric Patients with Autism Spectrum Disorder (ASD): A Review of Prevalence, Risk Factors, and Implications for Clinical Monitoring.Journal of clinical medicine · 2025Review
- Characteristics of Drug-RElated Hospitalizations for Nursing HOme Residents: Cross-Sectional RENHO Study.Drug safety · 2025Article
- Labeled NSAID hypersensitivity and the risk of opioid prescribing; an observational study.Frontiers in allergy · 2025Article
- Assessment of public awareness and perspectives towards adverse drug reaction reporting system in Karachi, Pakistan.PloS one · 2025Article
- Preventing Overrides of Severe Drug Allergy Alerts Initiative: an Implemented System Upgrade.Journal of medical systems · 2024Article
- Pharmacovigilance Strategies to Address Resistance to Antibiotics and Inappropriate Use-A Narrative Review.Antibiotics (Basel, Switzerland) · 2024Review
- A Formulary Management Group Consensus.Global journal on quality and safety in healthcare · 2024Article
- Spontaneous adverse drug reactions reported in a thirteen-year pharmacovigilance program in a tertiary university hospital.Frontiers in pharmacology · 2024Article
- Misoprostol-Induced Fever and Unnecessary Antibiotic Prescribing: A Retrospective Study.Infectious diseases and therapy · 2023Article
- Evaluation of the Safety Profile of Direct-Acting Antivirals on Patients with Hepatitis C Virus: A Pharmacovigilance Study.Therapeutic innovation & regulatory science · 2023Review
- Review
- Linezolid vs Vancomycin in Induced Thrombocytopenia.Infectious diseases and therapy · 2022Article
- Perceptions and barriers of adverse drug reaction reporting within inpatient state psychiatric facilities.The mental health clinician · 2022Article
- Drug-Related Problems in Pulmonary Hypertension with Valvular Heart Disease.Therapeutics and clinical risk management · 2022Article
- Spontaneous Reporting of Adverse Drug Reactions in a Pediatric Population in a Tertiary Hospital.Journal of clinical medicine · 2021Article
- Adverse Drug Reactions Spontaneously Reported at a Tertiary Care Hospital and Preventable Measures Implemented.Journal of clinical pharmacy and therapeutics · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
what is knownLimitations of clinical trials in determining all safety concerns related to a drug are well recognized. Monitoring spontaneous adverse drug reaction (ADR) reports remains an easy and relatively inexpensive method for overseeing that a drug remains a safe and effective option for patients.
objectiveTo characterize and describe ADR reports at one of the largest healthcare institutions in the region and share the measures implemented by the team.
methodsWe conducted a retrospective analysis of all ADRs submitted by healthcare providers in a tertiary healthcare system in Saudi Arabia between January 2016 and December 2019. The main outcome measures included reporting rate, patient characteristics, suspected drugs involved, seriousness and reporting specialities. RESULTS AND DISCUSSION: Throughout this study, 1156 ADR reports were submitted. The top reported ADR was immune system disorders (87.8%). The most represented class were antimicrobials (56.8%), followed by analgesics (11.4%) and diagnostic agents (5.1%). The ADRs were deemed definitely avoidable in 11.4% (132/1156) of the cases, and 24.2% (280/1156) were deemed possibly avoidable. Reporting ADRs has steadily increased over the years at our institution, but there continues to be a lack of reporting by physicians. Almost one-third of the reported ADRs were considered to be avoidable or possibly avoidable, which is a driver to continue pharmacovigilance activates on an institutional level and provide specific and tailored preventative measures guided by the specific types of ADRs reported. WHAT IS NEW AND
conclusionThis is the first study to report trends of ADRs spontaneously reported at one of the largest healthcare institutions in the Middle East. It shows similar trends to what has been reported by other institutions, with mainly immediate immunological ADRs being the top reported ADRs, which could be explained by the immediate onset which simplifies the temporal association. Every institution should support and maintain an active ADR team, with responsibilities of evaluating incidents, monitoring trends and most importantly identifying opportunities to improve medication and patient safety. We share here our workflow and hope it serves as a guide for other institutions.
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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.