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<p>Adverse drug reaction (ADR) underreporting remains a critical limitation of pharmacovigilance systems worldwide. In Romania, public awareness of the national ADR reporting system and the factors influencing reporting behaviour have not previously been examined. This study aimed to evaluate public awareness, describe actual reporting behaviour, identify perceived barriers, and determine sociodemographic and behavioural predictors of system knowledge and reporting engagement. A cross-sectional survey was conducted in the first half of 2025 in Romania. Data were collected through a self-administered online questionnaire disseminated via snowball sampling on social media platforms. The analytical sample consisted of 302 respondents (<i>N</i> = 302 for the system-awareness models; <i>N</i> = 278 for lifetime reporting behaviour; <i>N</i> = 141 for the subgroup with ADR experience, of whom 140 entered the replication model). Descriptive statistics, chi-square tests, and multivariable logistic regression were applied. Two main outcomes were examined: knowledge of the national ADR reporting system and lifetime reporting behaviour. Only 16.2% of respondents were aware of the national ADR reporting system, while 62.6% had never heard of it. Pharmaceutical qualification was the strongest independent predictor of system awareness (OR 18.81, 95% CI 7.58–46.72), followed by urban residence (OR 3.09, 95% CI 1.10–8.69). Reporting behaviour was independently predicted by any health-related qualification (OR 2.59), urban residence (OR 2.19), and older age (OR 1.63 per age category). A positive attitude toward reporting was not statistically significantly associated with system awareness; together with the predominance of informational barriers, this pattern suggests that the observed gap reflects informational and structural rather than attitudinal factors. Informational deficits—not knowing how (55.6%) or where (27.8%) to report—were the dominant barriers cited by respondents. ADR underreporting in Romania is primarily attributable to informational deficits rather than attitudinal barriers. Pharmaceutical qualifications and urban residence were the strongest predictors of both system awareness and reporting engagement. Targeted interventions should prioritise structural measures, including simplified digital reporting tools, pharmacist-facilitated reporting, and redesigned medication leaflets incorporating clear reporting pathways.</p>

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Public awareness of pharmacovigilance and adverse drug reaction underreporting in Romania in a cross-sectional online survey

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年7月24日

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  • Marius Călin Cherecheș,
  • Diana Maria Olar,
  • Răzvan Adrian Logigan

摘要

Adverse drug reaction (ADR) underreporting remains a critical limitation of pharmacovigilance systems worldwide. In Romania, public awareness of the national ADR reporting system and the factors influencing reporting behaviour have not previously been examined. This study aimed to evaluate public awareness, describe actual reporting behaviour, identify perceived barriers, and determine sociodemographic and behavioural predictors of system knowledge and reporting engagement. A cross-sectional survey was conducted in the first half of 2025 in Romania. Data were collected through a self-administered online questionnaire disseminated via snowball sampling on social media platforms. The analytical sample consisted of 302 respondents (N = 302 for the system-awareness models; N = 278 for lifetime reporting behaviour; N = 141 for the subgroup with ADR experience, of whom 140 entered the replication model). Descriptive statistics, chi-square tests, and multivariable logistic regression were applied. Two main outcomes were examined: knowledge of the national ADR reporting system and lifetime reporting behaviour. Only 16.2% of respondents were aware of the national ADR reporting system, while 62.6% had never heard of it. Pharmaceutical qualification was the strongest independent predictor of system awareness (OR 18.81, 95% CI 7.58–46.72), followed by urban residence (OR 3.09, 95% CI 1.10–8.69). Reporting behaviour was independently predicted by any health-related qualification (OR 2.59), urban residence (OR 2.19), and older age (OR 1.63 per age category). A positive attitude toward reporting was not statistically significantly associated with system awareness; together with the predominance of informational barriers, this pattern suggests that the observed gap reflects informational and structural rather than attitudinal factors. Informational deficits—not knowing how (55.6%) or where (27.8%) to report—were the dominant barriers cited by respondents. ADR underreporting in Romania is primarily attributable to informational deficits rather than attitudinal barriers. Pharmaceutical qualifications and urban residence were the strongest predictors of both system awareness and reporting engagement. Targeted interventions should prioritise structural measures, including simplified digital reporting tools, pharmacist-facilitated reporting, and redesigned medication leaflets incorporating clear reporting pathways.