Adverse Drug Reactions Spontaneously Reported at a Tertiary Care Hospital and Preventable Measures Implemented

Abstract

What is known Limitations of clinical trials in determining all safety concerns related to a drug are well recognized. Monitoring spontaneous adverse drug reaction (ADR) reports remains an easy and relatively inexpensive method for overseeing that a drug remains a safe and effective option for patients. Objective To characterize and describe ADR reports at one of the largest healthcare institutions in the region and share the measures implemented by the team. Methods We conducted a retrospective analysis of all ADRs submitted by healthcare providers in a tertiary healthcare system in Saudi Arabia between January 2016 and December 2019. The main outcome measures included reporting rate, patient characteristics, suspected drugs involved, seriousness and reporting specialities. Results and discussion Throughout this study, 1156 ADR reports were submitted. The top reported ADR was immune system disorders (87.8%). The most represented class were antimicrobials (56.8%), followed by analgesics (11.4%) and diagnostic agents (5.1%). The ADRs were deemed definitely avoidable in 11.4% (132/1156) of the cases, and 24.2% (280/1156) were deemed possibly avoidable. Reporting ADRs has steadily increased over the years at our institution, but there continues to be a lack of reporting by physicians. Almost one‐third of the reported ADRs were considered to be avoidable or possibly avoidable, which is a driver to continue pharmacovigilance activates on an institutional level and provide specific and tailored preventative measures guided by the specific types of ADRs reported. What is new and conclusion This is the first study to report trends of ADRs spontaneously reported at one of the largest healthcare institutions in the Middle East. It shows similar trends to what has been reported by other institutions, with mainly immediate immunological ADRs being the top reported ADRs, which could be explained by the immediate onset which simplifies the temporal association. Every institution should support and maintain an active ADR team, with responsibilities of evaluating incidents, monitoring trends and most importantly identifying opportunities to improve medication and patient safety. We share here our workflow and hope it serves as a guide for other institutions.

Drug-Related Problems in Pulmonary Hypertension with Valvular Heart Disease

“…Abu Ebsa (2021) reported ADRs caused 1.6% resulted in hospital admission, 1.4% required intensive medical care and 0.3% of the reported ADRs caused permanent harm. 27 The occurrence of ADRs required early cessation of the causal drug, which worsened the disease condition. Factors such as dose-related and drug-related ADR are usually predictable but sometimes unavoidable.…”

Spontaneous Reporting of Adverse Drug Reactions in a Pediatric Population in a Tertiary Hospital

“…The ultimate goal of a hospital pharmacovigilance program is to improve medication safety and prevent harm. Despite the limitations of the spontaneous ADR reporting system, it is useful for monitoring internal trends and providing signals on drug safety that could be addressed through internal policies [ 46 ]. Some actions that could help improve drug safety in hospitals are aimed at promoting consultation with clinical pharmacologists for the evaluation and diagnosis of the causality of ADRs, monitoring of drug doses, safe prescription tools such as electronic prescriptions to assist in avoiding errors and drug interactions to prevent ADRs, double-checking the administration of risky medications, and having nurses with experience in working with hospitalized pediatric patients.…”

Perceptions and barriers of adverse drug reaction reporting within inpatient state psychiatric facilities

“… 19 Clinical trials identify adverse reactions of medications, but often, not all ADRs are known until medications are on the market, making ADR reporting crucial to improving patient care. 9 , 20 …”

“…Abu Esba et al 20 credit an increase in ADR reporting to more education and awareness surrounding the importance of reporting. This study finds that a third of the ADRs reported could have been avoidable, showing the importance of prevention efforts after an ADR is discovered.…”

“…This study finds that a third of the ADRs reported could have been avoidable, showing the importance of prevention efforts after an ADR is discovered. 20 A Norwegian study 21 identifies that, prior to an educational intervention, 93% of pharmacists in the intervention group and 91.5% of pharmacists in the control group had not reported an ADR to one of the national reporting centers. After an educational session, 51.4% of pharmacists in the intervention group had reported an ADR in the following 3 months and had a statistically significant improvement in their confidence and knowledge in ADR reporting.…”