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

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.

Pharmacovigilance and Adverse Drug Reactions Reporting: Healthcare Providers’ Experiences from Southern Highland Tanzania

“…The underreporting of ADR may also be due to the limited engagement of pharmacists in clinical patient care. Therefore, to reduce ADRs and address the underreporting of ADRs, the focus should also be placed on clinical pharmacy services [ 30 ].…”

Severity and Management of Adverse Drug Reactions Reported by Patients and Healthcare Professionals: A Cross-Sectional Survey

“…Since 2010, patients have been allowed to notify the ADRs to the HPVC. The HPVC has emphasized the importance of ADR monitoring and reporting as a standard drug surveillance method for hospital pharmacists, and hospital pharmacists play an especially important role in the detection, identification, management, and prevention of serious ADRs [ 23 ]. The study hospitals mainly used SRS for ADR monitoring, which are regulated by the HPVC as standard drug surveillance methods for hospital pharmacists nationwide.…”

Development of service standards and manpower calculation criteria for hospital clinical pharmacies in South Korea: a survey-based study

“…In addition, the role of clinical pharmacists was demonstrated in terms of the reduction of potential prescribing errors, improvement of treatment effects [3][4][5][6], and economic evaluation [4,5]. Clinical pharmacy services are recognized not only in Korea but also worldwide by hospital pharmacists as an essential part of their work, and many are interested in strategies to promote their implementation based on country-speci c analyses [7][8][9][10][11][12][13][14][15][16] .…”