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. 2022 Jul 19;22(1):925.
doi: 10.1186/s12913-022-08320-8.

The effect of clinical pharmacists' intervention in adverse drug reaction reporting: a retrospective analysis with a 9-year interrupted time series

Tianwei Lan  1 , Hua Wang  1 , Xin Li  1 , Hang Yin  1 , Dan Shao  1 , Yueyao Jiang  1 , Qian Yu  2
Affiliations

The effect of clinical pharmacists' intervention in adverse drug reaction reporting: a retrospective analysis with a 9-year interrupted time series

Tianwei Lan et al. BMC Health Serv Res. .

Abstract

Background: In China, 85.4% of adverse drug reactions (ADRs) are spontaneously reported by healthcare facilities. As a result, many ADRs are not reported due to lack of mandatory reporting requirements. As healthcare professionals, clinical pharmacists (CPhs) serve as a bridge between clinical work and medication and ensure rational drug use. In China, A team of CPhs implemented an intervention for ADRs reporting, with the goal of improving the number of ADRs reports, the number of unreported ADRs, and the standardized reporting rate.

Methods: On June 01, 2015, a team of CPhs implemented an intervention for ADRs reporting at a Grade A, Class 3 hospital in China. The drug review catalogue (DRC) was used to screen physician orders for having visible symptoms of ADRs across departments, pooled the ADRs, and submitted them to the Center for Advanced Drug Monitoring (CNCAM). We retrospectively analysed the effect of a CPhs ADRs reporting intervention on the number of clinical ADRs reports, the number of unreported ADRs, and the standardized reporting rate over a 9-year period by interrupted time series (ITS). The method was implemented at the hospital on June 1, 2015, and a segmented regression model was used to analyse the data from January 1, 2010, to December 31, 2019.

Results: After the CPhs ADRs reporting intervention, the number of inpatient ADRs reports submitted to the CNCAM immediately increased by approximately 63 (62.658, P < 0.01) and then decreased by approximately 1 (0.701, P = 0.000151 < 0.01) per month afterward; the number of unreported ADRs was immediately reduced by approximately 44 (44.091, P < 0.01) and remained largely unchanged over time (P > 0.05); the standardized ADRs reporting rate per month immediately increased by 63.634% (P < 0.01) and remained largely unchanged over time (P > 0.05).

Conclusion: The CPhs ADRs reporting intervention had an immediate effect on improving ADRs reporting, which highlights the severity of ADRs underreporting in Chinese hospitals. The method is practical and should be used more widely in clinical practice. For example, the method can adjust and establish a DRC catalog that meets the actual situation of the implementing hospital based on the hospital's drug use habits and has the characteristics of good adaptability. However, it does have some limitations; for example, it may be difficult to detect early ADRs without visible symptoms.

Keywords: ADRs reports; Clinical pharmacists; Interrupted time series; Intervention; Standardized reporting rate; Unreported ADRs.

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Conflict of interest statement

Tianwei Lan, Hua Wang, Xin Li, Hang Yin, Dan Shao, Yueyao Jiang and Qian Yu declare that they have no conflict of interest.

Figures

Fig. 1
Fig. 1
The trend in the number of inpatient ADRs reports submitted by our hospital to the CNCAM per month between January 2010 and December 2019. The vertical line represents the start time of the CPhs ADRs reporting intervention
Fig. 2
Fig. 2
The trend in the number of unreported ADRs per month between January 2010 and December 2019. The vertical line represents the start time of the CPhs ADRs reporting intervention
Fig. 3
Fig. 3
The trend in the standardized ADRs reporting rate (%) per month between January 2010 and December 2019. The vertical line represents the start time of the CPhs ADRs reporting intervention
See this image and copyright information in PMC

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