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Pharmacovigilance

Pharmacovigilance

Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
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A Metadata Extraction Approach for Clinical Case Reports to Enable Advanced Understanding of Biomedical Concepts

A Metadata Extraction Approach for Clinical Case Reports to Enable Advanced Understanding of Biomedical Concepts

Published on: September 20, 2018

Pharmacy student perceptions of adverse event reporting.

Sirisha Kalari¹, Matthew Dormarunno, Oleg Zvenigorodsky

¹Johnson & Johnson Pharmaceutical Research and Development, LLC, Horsham, PA 19044, USA. skalari@its.jnj.com

American Journal of Pharmaceutical Education

|October 5, 2011

Summary

US pharmacy students show gaps in understanding adverse event reporting processes and regulations like HIPAA. Enhanced education is crucial for future practitioners to grasp the importance of reporting drug safety issues.

Keywords:

FDA HIPAA adverse drug reaction adverse event adverse event reporting pharmacists pharmacy students

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Use of Galvanic Skin Responses, Salivary Biomarkers, and Self-reports to Assess Undergraduate Student Performance During a Laboratory Exam Activity

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Published on: February 10, 2016

Area of Science:

Pharmacovigilance
Drug Safety
Healthcare Education

Background:

Adverse event reporting is critical for post-market drug surveillance.
Understanding of reporting mechanisms by future healthcare professionals is essential.

Purpose of the Study:

To evaluate US pharmacy students' knowledge and perceptions of adverse event reporting.
To identify misconceptions regarding regulatory bodies and privacy laws.

Main Methods:

A 10-question survey was distributed to pharmacy students.
The survey assessed perceptions of FDA and pharmaceutical manufacturer reporting procedures.
Understanding of the Health Insurance Portability and Accountability Act (HIPAA) in relation to reporting was evaluated.

Main Results:

228 pharmacy students completed the survey.
Most students believed the FDA is more likely to act on adverse events than manufacturers.
Significant misconceptions exist regarding report handling and HIPAA's impact on reporting.

Conclusions:

Pharmacy students lack a clear understanding of FDA-manufacturer communication on adverse events.
Curriculum updates are needed to ensure pharmacy graduates comprehend adverse event reporting's importance.