Intro to pharmacovigilance

  • Phase IV required by regulator to follow up drug once released to market so identify ADR and long term harm.

    Spontaneous reports:

  • Yellow card

  • Methodology for monitoring the safety of all marketed medicines

  • It’s primary function is to provide early warning of unknown ADR of medicines.

Types of ADR:

  • Type A- drug effect- rare but easy to know if occur

  • Type B- patient reaction (anaphylaxis, Steven-Johnson syndrome)

  • Type C- where drug increases the frequency of spontaneous disease

  • ways spontaneous report signals are looked at:

Strength of spontaneous reports:

Large scale – potentially cover entire population

Relatively inexpensive to operate

Surveillance can start immediately

No time limit

Generation of hypotheses and signals

Stronger the drug-event relationship and rarity of event = fewer reports needed

Healthcare professionals can help to improve public health

Weaknesses of spontaneous reports:

Adverse event recognition

False signals

Underreporting

Biases

Estimated population exposure?

Report quality

Comparing drugs (piroxicam, GI ulcers?): confounding?

Bias from new drugs

  • Pharmacovigilance- the detection ,assessment and prevention of ADR in humans (WHO)

  • Pharmacoepidemiology- the principles of chronic disease epidemiology applied to the clinical area of pharmacology