Monitoring medication safety

Question 1

Why do all medicines have the potential for adverse events

Answer 1

Mechanism of action (MOA)
Dose taken
Physiological considerations
Individual characteristics
other medications (interactions)

Question 2

Describe type A adverse drug reactions

Answer 2

Augmented
- Predictable
- MOA
- Dose
early in clinical development

Question 3

Describe type B adverse drug reactions

Answer 3

Bizarre
- rare
- individual characteristic
post-licencing

Question 4

Describe type C

Answer 4

Continuing
- temporal relationship
(osteoporosis/steroid)

Question 5

Describe type D

Answer 5

Delayed
- lag time between exposure and outcome

Question 6

Describe type E

Answer 6

End of use
- Withdrawal effects

Question 7

Why are ADRs important

Answer 7

3-6% of hospital admissions
Increased hospital admissions (7.8 days)
12.3% with permanent disability or death

Question 8

What are the phases of clinical development

Answer 8

Phase 1 - first application in humans
Phase 2 - therapeutic trial phase
Phase 3 - therapeutic confirmation
Phase 4 - Long-term observation

Question 9

Who is included/excluded in randomised controlled trials

Answer 9

• Anyone that might be pregnant
• Anyone not healthy
• Old & very young
  provide evidence at ‘usual dose’ in pop.
  treat individuals who vary in their response

Question 10

Describe vigilance regulatory framework

Answer 10

• Duties of importer/manufacturer to report untoward effects
• Control of established medicines
• Designated/authorised prescribers
• Promulgate regulations
• produce guidelines

Question 11

Describe spontaneous reporting

Answer 11

No mandate for clinicians to report
- ADRs that are new/unrecognised, occur due to ‘interaction’, due to physiological changes
- Susceptible patient groups

Question 12

What happens when a report is received

Answer 12

• Assessed and entered into local database - feeds into WHO
• Letter to reporter written
• Possibly medical warning entered, dialogue with Medsafe, referred to MARC (medicines adverse reactions committee)

Question 13

What is the Vioxx story

Answer 13

Reduced GI side effects (COX-2 selective) but increased CV
10% of all NSAID prescriptions
88,000 and 139,000 heart attack or stroke as a result of taking vioxx

Question 14

Describe the COVID vaccine

Answer 14

Rapid development & testing
Global scale use and distribution
‘Real time’ safety monitoring
Rapid process and workflow changes
Lockdown and working from home