Adverse drug reaction reporting in institutions across six Chinese provinces: a cross-sectional study

Zhang, Xuemei; Niu, Rui; Feng, Bianling; Guo, Jiaying; Ying, Liu; Liu, Xinyu

doi:10.1080/14740338.2018.1486820

Cited by 8 publications

(13 citation statements)

References 22 publications

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“…Jiangsu and Hubei provinces have more developed economies and also more complete regulatory systems for ADR monitoring, which other studies have noted. 22,23) Shaanxi province is a typical representative of the poorer western China provinces, and has worse supervision and policies on ADRs. It therefore seems likely that economic differences and mismatches in regional policy may be the main reasons for the geographical differences in report quality.…”

Section: Discussionmentioning

confidence: 99%

The Quality of Spontaneous Adverse Drug Reaction Reports in China: A Descriptive Study

Chen

Niu

Xiang

et al. 2019

Biological & Pharmaceutical Bulletin

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Pharmacovigilance is important to monitor the safety of drugs. There are, however, problems with the quality of adverse drug reaction reports in China. This study aimed to analyze the quality of adverse drug reaction reports in China, identify the factors affecting it, and propose measures to improve it. In our study, the western province of Shaanxi, the central province of Hubei and the eastern province of Jiangsu were chosen as typical, and adverse drug reaction reports from these three provinces from 2015 to 2017 were systematically sampled. The sampling reports were scored and graded to assess their quality. The results showed that only 10.18% were considered high quality in a total of 3429 reports. There were statistically significant differences in quality by year, province, report type, report source, and occupation of the reporter (p < 0.001). Reports from Shaanxi were slightly poorer quality, and "new" and "serious" reports and those from pharmacists were higher quality. Five indicators were particularly poor quality: patient information, adverse drug reaction, reporter information, drug information and vigilance. In conclusion, the quality of adverse drug reaction reports in China still needs improvement. Factors affecting quality included timing, location, report type, report source, and reporter's occupation. It may be helpful to publicize the importance of monitoring adverse drug reactions and improve the knowledge of reporters.

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Section: Discussionmentioning

confidence: 99%

The Quality of Spontaneous Adverse Drug Reaction Reports in China: A Descriptive Study

Chen

Niu

Xiang

et al. 2019

Biological & Pharmaceutical Bulletin

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“…The survey was only developed in English. Potential for reporting bias 31 Rorig and de Oliveira [ 57 ] To evaluate the implementation and operation of the pharmacovigilance programme in the pharmaceutical industry Not reported Brazil Pharmaceutical companies 50 companies Self-administered questionnaire by pharmaceutical companies' PV sector, regulatory affairs sector, or customer support service Not reported 1—Company identification, its origin and the characterisation or absence of a PV programme; 2—Information relating to factors required for PV programme implementation; 3—Pharmacovigilance programme results, and information about notifications reception and how this was treated Not reported 25 Shin et al [ 55 ] To survey the collection and management of adverse effect reports in 21 Asia–Pacific Economic Cooperation (APEC) countries, compare the PV status and systems by country, and finally, to harmonise PV regulation in the APEC region Not reported Asia‐Pacific Economic Cooperation (APEC) region countries National Pharmacovigilance Centre 15 countries: Australia (AU), Brunei (BN), Chile (CL), Indonesia (ID), Malaysia (MY), Mexico (MX), Papua New Guinea (PG), Peru (PE), Philippines (PH), Singapore (SG), Taiwan (TW), Thailand (TH), Japan (JP), South Korea (SK), and the USA Self-administered questionnaires by heads of PV teams from PV agencies Modified WHO Pharmacovigilance Indicators Three domains: Structure, process, and outcome of pharmacovigilance system Not all countries in the region responded to the survey. Did not include all questions and answers from WHO's PV indicators.…”

Section: Resultsmentioning

confidence: 99%

“…Ten studies employed self-completion questionnaires for data collection [ 45 , 48 – 53 , 55 – 57 ], and nine employed mixed-methods [ 37 – 41 , 43 , 44 , 46 , 47 ] including interviewer-administered questionnaires alongside a documentary review. Two studies [ 42 , 54 ] employed only qualitative methods including interviews and literature or documentary review.…”

Section: Resultsmentioning

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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“…The 2019 Chinese national monitoring report on ADEs recommends that attention be paid to risks of anti‐infective medications, cardiovascular system medications, oncology medications, and medications predominantly used in the elderly 9,10 . Studies have shown that the most frequent manifestations of ADEs are gastrointestinal disorders, skin and subcutaneous tissue disorders, general disorders, and nervous system disorders as reported by pharmaceutical manufacturers, operating companies, and medical institutions 11,12 .…”

Section: Introductionmentioning

confidence: 99%

Emergency hospitalizations for adverse drug events in China: Clinical pharmacists' approach to assessment and categorization

Zhang

et al. 2021

Pharmacoepidemiology and Drug

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Purpose Little is known about emergency hospitalizations owing to adverse drug events (ADEs) in Chinese populations. The aim of this study was to identify the types and characteristics of ADEs as well as estimate the length of hospital stay and ADE‐related costs in a hospital emergency setting in China. Methods This prospective study was conducted in the emergency department of our hospital from April 1, 2017 to December 31, 2019. ADEs of patients admitted to the emergency department were collected by a clinical pharmacist during daily pharmacy rounds. Results Of 4020 cases admitted to the emergency department, 198 emergency ADE‐related hospitalizations (4.93%) were noted, which were classified into certain (n = 0, 0%), probable (n = 122, 61.6%), and possible (n = 76, 38.4%). The ADE was serious in 93.9% of the 198 cases. Ten cases were fatal, and two cases were life‐threatening. More than 80% of the emergency ADE‐related hospitalization cases were of patients over 60 years. The pharmacological agents implicated in the hospitalizations were oral antiplatelet agents (20.7%), oral hypoglycemic agents (16.7%), insulin (11.1%), and antihypertensive agents (9.1%). The average length of ADE‐related hospital stay was 10 (7.0–14.0) days. ADE‐related costs ranged from $1684.68 to $4531.35 for each hospitalization. The length of ADE‐related hospital stay and associated costs were statistically significant. Most ADEs (n = 146, 73.7%) were preventable. Conclusions Most emergency ADE‐related hospitalizations in older adults resulted from lack of medication monitoring or inappropriate medication. Improved management of medicines by clinical pharmacists has the potential to reduce ADE‐related hospitalizations in older adults in China.

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Adverse drug reaction reporting in institutions across six Chinese provinces: a cross-sectional study

Abstract: The institutions surveyed have established ADR monitoring systems. However, these systems have flaws. Urgent improvements are needed in funding, basic resources, reporting processes, and other pharmacovigilance activities.

Cited by 8 publications

References 22 publications

The Quality of Spontaneous Adverse Drug Reaction Reports in China: A Descriptive Study

The Quality of Spontaneous Adverse Drug Reaction Reports in China: A Descriptive Study

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

Emergency hospitalizations for adverse drug events in China: Clinical pharmacists' approach to assessment and categorization

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