ADR's - case reports/series

ADE’s, ADR’s, and Medication errors

Medication misadventures include

Adverse drug event

Injury caused by a medication - Also encompasses all ADR’s

ADR (Adverse drug reaction)

Undesired response to a drug

Medication error

Any preventable error that may lead to inappropriate med use or patient harm

• Any unexpected, unintended, undesired, or excessive response to a drug that:

  • Requires D/C or changing of drug

  • Requires modifying dose 

  • Necessitates hospital admission or prolongs stay

  • Necessitates supportive treatment

  • Complicates diagnosis

  • negatively affects prognosis

  • Permanent harm/injury/ death

ASHP ADR defintion + criteria

• account for 4%-30% of hospital admission in USA and Canada

• 2-5% of ADR’s in children lead to hospitalization

• 11-35% of ED visits in older adults are due to medications

• May cost 30.1 billion dollars I US annually

• Increases total cost of an inpatient stay by approximately $2262 per ADR

• 32-69% of ADRs are preventable

Impact of ADR’s

• Wrong diagnosis

• Incorrect dosing/selection of prescription meds

• Interactions with other concomitant drugs

Causes for preventable ADR’s

30 different published methods to assess causality!

• Some include:

  • Expert/Global introspection

  • Algorithm

  • Probabilistic

How do we know if a drug caused an ADR?

• Dechallenging

• Rechallenging

• Temporal relationship between drug and event

What tools can help determine probability of ADRs from medications? (not necessarily causality)

Side effects (Typically dose related), Withdrawal, Abuse, Accidental poisoning, complications from overdoses

What are things NOT classified as an ADR?

• Terribly underreported

• A “trend cannot be found” unless enough reactions are reported

• Site specific systems employed 

• Lots of information to collect for report (Location. patients, general description, etc.)

• 36 mins to complete 

Adverse event reporting

1. MedWatch

   1. Safety reports worldwide, sentinel system that looks for trends, interested in serious ADR’s, consumers and professionals can report

   2. Vaccines, tobacco, Investigational drugs, industry drugs (biologics, devices, vet meds, supplements) are NOT reported to MedWatch

2. VAERS

Examples of ADR reporting