Estimation of adverse drug reaction reporting in Iran: Correction for underreporting

Khalili, Malahat; Mesgarpour, Bita; Sharifi, Hamid; Golozar, Asieh; Haghdoost, Ali Akbar

doi:10.1002/pds.5235

Cited by 10 publications

(8 citation statements)

References 74 publications

(172 reference statements)

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“…A detailed description of study methodology has been previously reported [23,28]. The following provides a summary with relevant additional detail as needed.…”

Section: Methodsmentioning

confidence: 99%

“…Iran Food and Drug Administration established a national pharmacovigilance center in 1997 to receive spontaneous reports from healthcare professionals. Though, there is a considerable underreporting of ADRs to this spontaneous reporting systems [23].The leading cause of underreporting in Iran is unawareness of the existence of a national pharmacovigilance center [24,25], poor knowledge regarding reporting [26,27], and fear of punishment and criticism [26]. Thus, implementing active ADR detection and reporting in hospitals could be a constructive action in improving the awareness of unintended effects of medicines and patient safety and strengthening the national pharmacovigilance systems.…”

Section: Introductionmentioning

confidence: 99%

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Incidence of Adverse Drug Reactions in Two Tertiary Hospitals: A Prospective Observational Study

Khalili¹,

Sharifi²,

Mesgarpour³

et al. 2021

Preprint

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Background: Monitoring and detecting adverse drug reactions (ADRs) in hospitals is crucial to improving drug safety and healthcare delivery quality. Nevertheless, there was not enough information on ADR incidence and its figure in Iran. Aim: this study aimed to determine the incidence of ADRs in hospitalized patients and investigate their characteristics in Iran.Methods: We conducted a three-month prospective study in two tertiary hospitals in 2019. All admitted patients were intensively monitored for all suspected ADRs through daily visiting hospital wards and soliciting information from physicians, nurses and interviewing suspicious patients. We calculated the incidence of ADRs, and 95% confidence intervals (95% CI). Poisson regression was used to evaluate risk factors for ADR incidence. Results: Among 13,613 admitted patients, we detected 115 ADRs in 114 patients. The incidence of ADR was 8.4 per 1000 admissions (95% CI: 7.0-10.1), and 13.9% of them were ADR-related hospital admissions. The risk of ADRs was significantly predicted by age, length of hospital stay, patients’ diagnostics, number of drug usage, and using respiratory system agents and anti-infectives for systemic use. The most common ADRs were skin and subcutaneous manifestations (52.2%), and 62.6% of ADRs were caused by anti-infectives (commonly vancomycin, ceftriaxone, and ciprofloxacin). Conclusion: This study indicated that ADRs occurrence during the hospital stay or resulting in hospital admissions are considerable. Given that ADR occurrence could be associated with increased morbidity, mortality, and economic burden, constant intensive monitoring is required to address the drug safety issue and promote actions to improve patient safety and reduce the health and economic burden.

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“…A detailed description of study methodology has been previously reported [23,28]. The following provides a summary with relevant additional detail as needed.…”

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Incidence of Adverse Drug Reactions in Two Tertiary Hospitals: A Prospective Observational Study

Khalili¹,

Sharifi²,

Mesgarpour³

et al. 2021

Preprint

Self Cite

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“…This review found that ADR reporting rates were low overall, suggesting underreporting by ADR reporters [ 23 , 79 ], which may be partly due to the passive nature of the reporting systems in these [ 59 ]. Underreporting points to the PV system’s inability to collate data on the safety, quality and effectiveness of marketed drugs that have not been tested outside the confines of clinical trials.…”

Section: Discussionmentioning

confidence: 99%

A Systematic Review of Pharmacovigilance Systems in Developing Countries Using the WHO Pharmacovigilance Indicators

Garashi

Steinke

Schafheutle

2022

Ther Innov Regul Sci

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Background In the context of the growth of pharmacovigilance (PV) among developing countries, this systematic review aims to synthesise current research evaluating developing countries’ PV systems’ performance. Methods EMBASE, MEDLINE, CINAHL Plus and Web of Science were searched for peer-reviewed studies published in English between 2012 and 2021. Reference lists of included studies were screened. Included studies were quality assessed using Hawker et al.'s nine-item checklist; data were extracted using the WHO PV indicators checklist. Scores were assigned to each group of indicators and used to compare countries’ PV performance. Results Twenty-one unique studies from 51 countries were included. Of a total possible quality score of 36, most studies were rated medium (n = 7 studies) or high (n = 14 studies). Studies obtained an average score of 17.2 out of a possible 63 of the WHO PV indicators. PV system performance in all 51 countries was low (14.86/63; range: 0–26). Higher average scores were obtained in the ‘Core’ (9.27/27) compared to ‘Complementary’ (5.59/36) indicators. Overall performance for ‘Process’ and ‘Outcome’ indicators was lower than that of ‘Structural’. Conclusion This first systematic review of studies evaluating PV performance in developing countries provides an in-depth understanding of factors affecting PV system performance.

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“…Underreporting is a concern worldwide because it causes the frequency of ADRs to be underestimated, delaying the detection of safety issues and therefore making it difficult to undertake a timely action [5,11]. Nevertheless, unlike spontaneous reporting, other tools such as active surveillance intentionally and continually search for the presence or absence of ADRs in a defined group of people; it thus allows the real incidence of ADRs to be known.…”

Section: Introductionmentioning

confidence: 99%

Underreporting and Triggering Factors for Ophthalmic Drugs’ ADR Notification; a Comparison between Spontaneous Reporting and Active Pharmacovigilance Databases

Contreras-Salinas¹,

Baiza-Durán²,

Bautista-Castro³

et al. 2022

Preprint

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(1)Aims of the study: calculating the underreporting ratio for two different medications, a fixed combination of 0.5% timolol + 0.2% brimonidine + 2.0% dorzolamide (antiglaucoma) and a fixed combination of sodium hyaluronate 0.1% + chondroitin sulfate 0.18% (artificial tear) and characterizing the features influencing the reporting of adverse drug reactions (ADRs) in spontaneous reporting; (2) Methods: the underreporting ratio was calculated by comparing the adverse drug reactions reported in the spontaneous reporting database for every 10,000 defined daily doses marketed and the adverse drug reactions from an active surveillance study for every 10,000 defined daily doses used for different drugs (antiglaucoma and artificial tear). The factors related to the report in spontaneous reporting through statistical tests were also determined; (3) Results: The underreporting ratio of spontaneous reporting was 0.006029% for antiglaucoma and 0.003552% for artificial tear; additionally, statistically significant differences were found for severity, unexpected adverse drug reactions, and incidence of adverse drug reactions in females; (4) Conclusions: The underreporting ratio of ADRs related to ophthalmic medications indicates worry since the cornerstone of pharmacovigilance focuses on spontaneous reporting. Besides, since underreporting seems to be selective, the role of certain aspects like gender, seriousness, severity, and unexpected ADRs, must be considered in future research.

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Estimation of adverse drug reaction reporting in Iran: Correction for underreporting

Cited by 10 publications

References 74 publications

Incidence of Adverse Drug Reactions in Two Tertiary Hospitals: A Prospective Observational Study

Incidence of Adverse Drug Reactions in Two Tertiary Hospitals: A Prospective Observational Study

A Systematic Review of Pharmacovigilance Systems in Developing Countries Using the WHO Pharmacovigilance Indicators

Underreporting and Triggering Factors for Ophthalmic Drugs’ ADR Notification; a Comparison between Spontaneous Reporting and Active Pharmacovigilance Databases

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