Analysis of a pharmacist-led adverse drug event management model for pharmacovigilance in an academic medical center hospital in China

He, Wei; Yao, Difei; Hu, Yangmin; Dai, Haibin

doi:10.2147/tcrm.s178297

Cited by 13 publications

(14 citation statements)

References 11 publications

(14 reference statements)

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“…Twenty‐six studies examined the impact of IMS by different methods in both developed and developing countries. The positive effect of IMS on ADR reporting varied widely, from 1.02 to 83.9‐fold . As shown in Table , the range of effect of IMS was nearly similar to the effect of educational interventions and computerized registration.…”

Section: Resultsmentioning

confidence: 77%

“…Out of the 90 studies, 16 were from France; eight from Italy; seven from the United States and Spain; six from the United Kingdom and Portugal; four from Iran and India; three from China, Sweden, and Mexico; two from Brazil, Denmark, Israel, Korea, the Netherlands, Switzerland, and the United Arab Emirates; and one each from Chile, Germany, Morocco, Nigeria, Saudi Arabia, South Africa, and Thailand. The interventions were designed as before‐after in 50 of the studies, non‐comparative in 17 studies, randomized controlled trial (RCT) and cluster RCT in nine studies, and other in 14 studies. In addition, most of the studies had been developed on HCPs, particularly physicians.…”

Section: Resultsmentioning

confidence: 99%

“…As shown in Table , the range of effect of IMS was nearly similar to the effect of educational interventions and computerized registration. In most of the studies, a clinical research assistant (CRA), pharmacists and/or clinical pharmacists were present in settings for intensive monitoring. ADRs were identified and collected both prospectively and retrospectively.…”

Section: Resultsmentioning

confidence: 99%

“…In addition, He et al used a pharmacist‐led ADR management model that increased the quantity and quality of ADR reporting significantly. The sources of the ADRs reported by the clinical pharmacists included mainly pharmacy rounds, ADR‐related pharmacist consultations, centralized monitoring, ADR warning signal analysis, newly introduced drug evaluations, and drug safety research . Only one study was conducted outside the hospital setting on a CRA's regular visits to general practitioner (GP) offices and showed a twofold increase in ADR reporting…”

Section: Resultsmentioning

confidence: 99%

See 3 more Smart Citations

Interventions to improve adverse drug reaction reporting: A scoping review

Khalili

Mesgarpour²,

Sharifi

et al. 2020

Pharmacoepidemiology and Drug

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Purpose Underreporting is the major limitation of a voluntary adverse drug reaction (ADR) reporting system. Many studies have assessed the effectiveness of different interventions designed to improve ADR reporting. The aim of this study was to systematically map interventions and strategies to improve ADR reporting among health care professionals. Methods The six‐stage methodological framework of Arksey and O'Malley was used to conduct this scoping review. Ovid MEDLINE, EMBASE, All EBM, and Web of Science were systematically searched from 1999 to February 2019, and the reference lists of the included papers were also searched for gray literature to identify any interventions and strategies that aimed to increase ADR reporting. Two reviewers screened the papers for eligibility based on the inclusion criteria and extracted their key data and analyzed them descriptively. Results Ninety out of 14 501 papers met the selection criteria. Using computerized registration and active surveillance can increase ADR reporting significantly. Educational interventions performed individually or combined with sending reminders and/or feedback, awards, and providing easier reporting channels can improve ADR reporting over a short to medium term. Multiple interventions may have more impact than single‐component interventions. Conclusion Multiple interventions could cause a greater increase in ADR reporting rates than single interventions. Although educational interventions appear to be effective, few studies have reviewed their long‐term effects to ascertain whether the improvements are sustained over time. Studies with a better methodological quality are required on this subject.

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Section: Resultsmentioning

confidence: 77%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

See 2 more Smart Citations

Interventions to improve adverse drug reaction reporting: A scoping review

Khalili

Mesgarpour²,

Sharifi

et al. 2020

Pharmacoepidemiology and Drug

View full text Add to dashboard Cite

show abstract

“…This is similar to a study in France that found that only 12.7% of ADR reports from GPs were "well-documented." 19) However, it seems likely that the quality of ADR reports could be improved in China.…”

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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Enhancing Pediatric Adverse Drug Reaction Documentation in the Electronic Medical Record

Tillman

Suppes

Feldman

et al. 2020

The Journal of Clinical Pharma

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Adverse drug reactions (ADRs) often go unreported or are inaccurately documented in the electronic medical recorded (EMR), even when they are severe and life‐threatening. Incomplete reporting can lead to future prescribing challenges and ADR reoccurrence. The aim of this study was to evaluate the documentation of ADRs within the EMR and determine specific factors associated with appropriate and timely ADR documentation. Retrospective data were collected from a pediatric hospital system ADR reports from October 2010 to November 2018. Data included implicated medication, type, and severity of reaction, treatment location, the presence or absence of ADR documentation in the EMR alert profile within 24 hours of the ADR hospital or clinic encounter discharge, ADR identification method, and the presence or absence of pharmacovigilance oversight at the facility where the ADR was treated. A linear regression model was applied to identify factors contributing to optimal ADR documentation. A total of 3065 ADRs requiring medical care were identified. Of these, 961 ADRs (31%) did not have appropriate documentation added to the EMR alert profile prior to discharge. ADRs were documented in the EMR 87% of the time with the presence of pharmacovigilance oversight and only 61% without prospective pharmacovigilance (P < .01). Severity of ADR was not a predictor of ADR documentation in the EMR, yet the implicated medication and location of treatment did impact reporting. An active pharmacovigilance service significantly improved pediatric ADR documentation. Further work is needed to assure timely, accurate ADR documentation.

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Analysis of a pharmacist-led adverse drug event management model for pharmacovigilance in an academic medical center hospital in China

Cited by 13 publications

References 11 publications

Interventions to improve adverse drug reaction reporting: A scoping review

Interventions to improve adverse drug reaction reporting: A scoping review

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

Enhancing Pediatric Adverse Drug Reaction Documentation in the Electronic Medical Record

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