A cross-sectional study: comparison of public perceptions of adverse drug reaction reporting and monitoring in eastern and western China

Abstract

Background Adverse drug reactions (ADRs) cause a substantial clinical and economic burden. Spontaneous reporting of ADRs by the public is crucial. In some developed countries like the United States, Canada, consumers have been allowed to directly report ADRs, however, convenient channels for direct ADR reporting by the public are lacking in China. Objective We aimed to compare the knowledge, attitudes, and practice(KAP) regarding monitoring and reporting of adverse drug reaction (ADR) among the general public in eastern and western China. Methods A questionnaire-guided cross-sectional study was administered to participants in Nanjing and Xi’an during April–July 2019. A descriptive statistical analysis was used to describe respondents’ demographic information and other results. The t-test and analysis of variance were used to test the differences in knowledge and attitudes among respondents with different demographic characteristics. P < 0.05 was considered statistically significant. Binary logistic regression analysis was used to examine factors associated with knowledge and attitudes. Results A total of 1085 questionnaires were distributed in this survey, 869 valid questionnaires were returned, the recovery rate was 80.09%. Respondents showed poor knowledge of the definition of ADRs and reporting criteria, with a significant difference in average knowledge scores according to education level, gender, and age group. Most respondents had positive attitudes toward ADR monitoring and reporting, with no significant differences in knowledge and attitude scores between the two cities. In total, 68.93% of respondents said they would feedback information to health care professionals, most (84.35%) would take the initiative to report ADRs if there were a convenient method. More than half (58.57%) of respondents were more likely to report ADRs by telephone. Conclusion The findings of our study indicated that health care professionals should encourage patients to actively report ADR. China should also explore ways to facilitate direct public reporting of ADRs by improving relevant laws and regulations.

Factors associated with underreporting of adverse drug reactions by patients: a systematic review

“…Since 9 studies were excluded due to inaccessibility of full-text, a total of 253 articles underwent to full-text analysis. This resulted in thirteen studies [ 37 – 49 ] meeting the inclusion criteria and were included in the review (Fig. 1 ).…”

“…Five studies were conducted in Africa [ 39 , 42 – 44 , 50 ], 3 in Europe [ 38 , 47 , 49 ], 3 in Asia [ 37 , 41 , 46 ], 1 in Australia [ 48 ] and 1 in Canada [ 40 ]. Most of the studies (n = 8, 61.5%) were cross-sectional, with 2 [ 38 , 47 , 49 ] failing to report the study design.…”

“…Six studies were conducted through direct interviews, which were face-to-face [ 42 – 45 ] or telephone calls [ 49 ] or both [ 40 ], 5 studies opted to directly administer the questionnaire on site [ 37 , 43 , 44 , 46 , 47 ] and 4 studies used a web-based survey [ 38 , 39 , 41 , 48 ]. Two studies combined 2 different types of data collection methods [ 43 , 44 ].…”

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“…MeDRA (Medical Dictionary for Regulatory Activities) coding system was utilized for system organ classification of suspected adverse drug reactions 10 . The causal association was done by using Naranjo's causality assessment scale 11 Age is one of the important risk factors for the occurrence of ADR 14 . Previous studies showed that high incidence of ADR reporting in paediatric and old age patients may be due to age-related changes in pharmacokinetics and pharmacodynamics of drugs.…”

Cross-sectional study of pharmacovigilance knowledge, attitudes, and practices based on structural equation modeling and network analysis: a case study of healthcare personnel and the public in Yunnan Province

“…Despite considerable research, there’s a notable gap in literature comparing pharmacovigilance KAP between healthcare professionals and the public within similar demographic settings, particularly in emerging areas like Yunnan ( 11 ). Addressing this gap is crucial, given the increasing ADR events in China and the need for effective pharmacovigilance mechanisms ( 12 ).…”