Related Experiment Video
Updated: Jul 15, 2026
07:50
A Metadata Extraction Approach for Clinical Case Reports to Enable Advanced Understanding of Biomedical Concepts
Published on: September 20, 2018
Guidelines for submitting adverse event reports for publication
William N Kelly1, Felix M Arellano, Joanne Barnes
1William N. Kelly Consulting, Inc., Oldsmar, Florida 34677, USA. wnkelly@earthlink.net
Pharmacoepidemiology and Drug Safety
|May 2, 2007
Summary
Publishing drug adverse event case reports is crucial for safety surveillance. However, many reports lack vital details, limiting their usefulness. New guidelines aim to improve the quality and impact of these essential safety publications.
Area of Science:
- Pharmacovigilance and Drug Safety
- Medical Device Surveillance
- Herbal and Complementary Medicine Safety
Background:
- Publication of adverse event case reports is vital for postmarketing surveillance of drugs, vaccines, biologicals, devices, and complementary medicines.
- Deficiencies in published case report details often hinder differential diagnosis, cause-effect assessment, and biological plausibility, limiting their value.
- Many major journals have inadequate or nonexistent requirements for publishing adverse event reports.
Purpose of the Study:
- To propose essential information that should always be included in published adverse event case reports.
- To enhance the quality and utility of case reports for postmarketing surveillance and risk assessment.
- To provide guidelines endorsed by the International Society for Pharmacoepidemiology (ISPE) and the International Society of Pharmacovigilance (ISoP).
Main Methods:
- Literature review of existing requirements for publishing adverse event reports.
- Analysis of collective experience in reviewing case reports within regulatory, academic, and industry settings.
- Development of proposed guidelines for essential information in case report publications.
Main Results:
- Identification of critical information gaps in many published adverse event case reports.
- Formulation of a comprehensive list of recommended inclusions for case report publications.
- Endorsement of the proposed guidelines by ISPE and ISoP.
Conclusions:
- Adoption of these guidelines by biomedical journals will improve the quality of published adverse event reports.
- Enhanced case reports will provide more reliable signals for drug and medical product risk assessment.
- Incorporation of these guidelines into healthcare education curricula is encouraged to improve reporting standards.
Related Concept Videos
01:21Types of Reports II: Incident or Occurrence Report
An Incident or Occurrence Report in a healthcare setting is a crucial document used to record any unexpected occurrence that may or may not have affected a patient, employee, or visitor. Such reports are critical to improving patient safety and include all details leading up to and including the event.
Purposes:
In the healthcare industry, reports play a crucial role in documenting incidents within an agency. The primary objective of these reports is to ensure patient safety, uphold the...
Purposes:
In the healthcare industry, reports play a crucial role in documenting incidents within an agency. The primary objective of these reports is to ensure patient safety, uphold the...
01:19Pharmacovigilance
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.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
01:06Legal Guidelines for Documentation
The legal guidelines for nursing documentation are essential for ensuring accurate, professional, and ethical recording of patient care. The guidelines are discussed here:
01:26Types of Reports III: Telephone and Verbal Reports
Telephone and Verbal Reports in healthcare settings are two communication methods for conveying therapeutic instructions from healthcare providers to nurses or other healthcare staff.
Here's an overview of each type:
Telephone Orders
Here's an overview of each type:
Telephone Orders
01:26Guidelines for Nursing Documentation II
Effective documentation is an integral part of nursing practice. Here are some essential guidelines to follow when documenting patient care:
Timely documentation is crucial to ensure continuity of care for patients. Any delays in recording or reporting medical information can result in medical errors and even adverse patient outcomes. From medication administration to diagnostic test results, every detail must be accurately and promptly documented to provide the best possible care for patients.
Timely documentation is crucial to ensure continuity of care for patients. Any delays in recording or reporting medical information can result in medical errors and even adverse patient outcomes. From medication administration to diagnostic test results, every detail must be accurately and promptly documented to provide the best possible care for patients.
01:24Data Reporting and Recording
Reporting and recording are crucial in data documentation. The timely, thorough, and accurate documentation of facts is essential when recording patient data. Failure to record findings during an assessment or interpretation of a problem will result in loss of information and make the patient document unreliable. The reader is left with general impressions if the information is not specific. A recording is documenting data of the individual's health information in a traceable, secure, and...