Undergraduate and postgraduate pharmacovigilance education: A proposal for appropriate curriculum content

Comoglio, Raquel Herrera

doi:10.1111/bcp.14179

Cited by 22 publications

(16 citation statements)

References 54 publications

(93 reference statements)

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“…Therefore, we would recommend that other healthcare curricula (medicine, pharmacy, or nursing) incorporate this simple reallife, problem-and context-based pharmacovigilance educational intervention as it fits perfectly into the proposed curriculum. [21] Further research is needed to analyze whether a shorter version of the reporting assignment will further encourage ADR reporting. Although our findings are encouraging, reporting rates were limited by "Excuses made by professionals", an aspect not adequately addressed in our educational intervention.…”

Section: Discussionmentioning

confidence: 99%

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The potential of training specialist oncology nurses in real-life reporting of adverse drug reactions

Reumerman

Tichelaar

Eekeren

et al. 2021

Eur J Clin Pharmacol

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Specialist oncology nurses (SONs) have the potential to play a major role in monitoring and reporting adverse drug reactions (ADRs); and reduce the level of underreporting by current healthcare professionals. The aim of this study was to investigate the long term clinical and educational effects of real-life pharmacovigilance education intervention for SONs on ADR reporting. This prospective cohort study, with a 2-year follow-up, was carried out in the three postgraduate schools in the Netherlands. In one of the schools, the prescribing qualification course was expanded to include a lecture on pharmacovigilance, an ADR reporting assignment, and group discussion of self-reported ADRs (intervention). The clinical value of the intervention was assessed by analyzing the quantity and quality of ADR-reports sent to the Netherlands Pharmacovigilance Center Lareb, up to 2 years after the course and by evaluating the competences regarding pharmacovigilance of SONs annually. Eighty-eight SONs (78% of all SONs with a prescribing qualification in the Netherlands) were included. During the study, 82 ADRs were reported by the intervention group and 0 by the control group. This made the intervention group 105 times more likely to report an ADR after the course than an average nurse in the Netherlands. This is the first study to show a significant and relevant increase in the number of well-documented ADR reports after a single educational intervention. The real-life pharmacovigilance educational intervention also resulted in a long-term increase in pharmacovigilance competence. We recommend implementing real-life, context- and problem-based pharmacovigilance learning assignments in all healthcare curricula.

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Section: Discussionmentioning

confidence: 99%

“…Our recent literature review showed an urgent need for more innovative learning initiatives in pharmacovigilance training [20] and a recent study stressed the use of clinical and real-life continuing learning initiatives. [21] It also advised studying the long-term effects and clinical value of educational initiatives. [20].…”

Section: Introductionmentioning

confidence: 99%

The potential of training specialist oncology nurses in real-life reporting of adverse drug reactions

Reumerman

Tichelaar

Eekeren

et al. 2021

Eur J Clin Pharmacol

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“…Complementing these WHO curricular recommendations, Herrera-Comoglio further proposed basic and advanced ADR education contents to be taught in both undergraduate and postgraduate settings (Table 3) [59].…”

Section: Adr Education Curriculummentioning

confidence: 99%

“…Topics and content of adverse drug reaction education curriculum[59] ADR adverse drug reaction, ALDEN Algorithm for Assessment of Drug Causality in Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis, Regi-SCAR Registry of Severe Cutaneous Adverse Reaction, WHO World Health Organization…”

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confidence: 99%

Adverse drug reaction management in hospital settings: review on practice variations, quality indicators and education focus

Aung

Walker

Khu

et al. 2022

Eur J Clin Pharmacol

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Purpose Adverse drug reactions (ADRs) contribute significantly to healthcare burden. However, they are largely preventable through appropriate management processes. This narrative review aims to identify the quality indicators that should be considered for routine monitoring of processes within hospital ADR management systems. It also examines the potential reasons behind variation in ADR management practices amongst HCPs, and explores possible solutions, focusing on targeted education programmes, to improve both the quality and quantity indicators of ADR management processes. Methods A comprehensive literature review was conducted to explore relevant themes and topics concerning ADR management, quality indicators and educational interventions. Results Substantial variability exists in ADR management amongst healthcare professionals (HCPs) with regard to reporting rates, characteristics of ADRs reported, quality of assessment, completeness of reports and, most importantly, risk communication practices. These variable practices not only threaten patient safety but also undermine pharmacovigilance processes. To date, quality indicators to monitor ADR management practices within hospital settings remain ill-defined. Furthermore, evidence behind effective interventions, especially in the form of targeted education strategies, to improve the quality of ADR management remains limited. Conclusions The focus of ADR management in hospitals should be to promote patient safety through comprehensive assessment, risk communication and safe prescribing. There is a need to develop a system to define, measure and monitor the quality of ADR management. Educational strategies may help improve the quality of ADR management processes.

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“…After a drug reaches the drug market, it is necessary to regularly evaluate its safety profile (post-marketing surveillance) and assess the ADRs associated with it because only the most prevalent ADRs are found during pre-marketing trials. 6 As a result, developing strategies for quickly recognizing and monitor ADR and other post-marketing post-marketing surveillance activities is critical. 7 The purpose of this study was to determine the prevalence of ADRs and associated factors among patients on psychotropic medications at Mizan Tepi University Teaching Hospital (MTUTH).…”

Section: Introductionmentioning

confidence: 99%

Adverse Drug Reaction and Its Predictors Among Psychiatric Patients Taking Psychotropic Medications at the Mizan-Tepi University Teaching Hospital

Ejeta¹,

Aferu²,

Feyisa³

et al. 2021

NDT

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Introduction Psychotropic medications are crucial in the treatment of a variety of psychiatric disorders. Use of second-generation antipsychotics (SGA) has been associated with many adverse events. Assessment and monitoring of ADRs is required to develop appropriate interventional strategies to manage, prevent and minimize the risks of undesirable effects and thus improve quality of life and adherence, avoid relapse, and reduce treatment costs. Objective The objectives of this study were to assess adverse drug reactions and its predictors in psychiatric patients taking psychotropic medications from the outpatient pharmacy of MTUTH. Methods A cross-sectional study design was conducted using a structured questionnaire interviewing a psychiatric patient. One way ANOVA and bivariate logistic regression was computed for all independent variables to identify variables that fit for multivariate logistic regression. A p-value less than 0.05 was considered significant. Results and Discussions A total of 101 patients (91.8%) experienced one or more types of ADR in the current study. There was a statistically significant relationship between ADRs management and age, marital status, educational status, occupation, and monthly income of the study participants. The odds of having experienced autonomic adverse drug reactions experience among respondents aged 30 years and older higher than those under 30 years. Participants taking multiple medications were more likely to face psychiatric adverse drug reactions compared to those taking a single medication. Patients taking multiple psychotropic medications were ten times more likely to develop autonomic adverse drug reactions compared to those taking a single drug. Conclusion The study revealed a moderate incidence of ADR in patients attending the psychiatric OPD. Age and number of antipsychotics were predictors of ADR (autonomic and psychiatric). This study revealed that there is a gap in the role of clinicians in the monitoring and reporting of ADRs.

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Undergraduate and postgraduate pharmacovigilance education: A proposal for appropriate curriculum content

Cited by 22 publications

References 54 publications

The potential of training specialist oncology nurses in real-life reporting of adverse drug reactions

The potential of training specialist oncology nurses in real-life reporting of adverse drug reactions

Adverse drug reaction management in hospital settings: review on practice variations, quality indicators and education focus

Adverse Drug Reaction and Its Predictors Among Psychiatric Patients Taking Psychotropic Medications at the Mizan-Tepi University Teaching Hospital

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