Pharmacovigilence In A Nutshell

1.) Adverse Drug Reactions

ADR

• Type A: Augmented pharmacologic effects that are dose dependent and predictable (these are 80% of all ADRs)
• Type B: Idiosyncratic

2.) Medication Errors

medication error

Why is Pharmacovigilance Important?

Out in the “real world”, drugs may not have same results as in clinical trials (different/more diverse patients, different doses due to compliance issues, different durations, more patients, more flexible conditions/less controlled, etc.). Pharmacovigilance helps us track any adverse events, look for associations between them and drugs, and record medication errors. This way we can track potentially hazardous drugs and minimize the risk of any harm to patients.

• 82 percent of American adults take at least one medication and 29 percent take five or more;
• ADEs cause more than 1 million emergency department visits and 280,000 hospitalizations each year;
• $3.5 billion is spent on excess medical costs of ADEs annually;

stated that

Reporting Adverse Events

Reporting to the FDA

FDA Medwatch Form 3500A

FDA Adverse Event Reporting System (FAERS)

• an identifiable patient
• an identifiable reporter
• a suspect drug
• an adverse event

serious adverse event

• Death
• Life-threatening
• Hospitalization (initial or prolonged)
• Disability or Permanent Damage
• Congenital Anomaly/Birth Defect
• Required Intervention to Prevent Permanent Impairment or Damage (Devices)
• Other Serious (Important Medical Events)
• Healthcare professionals or patients (or other intermediaries)
• Clinical or post-marketing studies
• Drug regulatory authorities
• Patient support programs
• Literature sources
• Media

HL7 Version 3 Standard: Individual Case Safety Report

Signal Detection

signal detection

Practice Question

good case report

More Practice Questions

book

Reading & References:

Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment.  

Casualty Assessment

Patterns of medication use in the United States, 2006.

National Action Plan for Adverse Drug Event Prevention