L12: Post-marketing surveillance

Question 1

why do we need post-marketing surveillance? [3]

Answer 1

1. to monitor safety of drug by reporting ADRs observed over a large popn + efficacy
2. risk/benefit ratio
3. special indications: do we need to be aware of certain subgroup of patients eg. elderly, diabetics, children

Question 2

is post-marketing surveillance open or closed?

Answer 2

usually open. process ongoing with people knowing what drug they are consuming

Question 3

how do we collect info on ADRs during phase 4?

Answer 3

consumers and HCPs voluntarily report ADRs. once FDA or HSA receive significant no. of ADRs, will evaluate for their seriousness and the likelihood that it is caused by drug

Question 4

why are ADRs not detected during phase 3 trials?

Answer 4

phase 3 done on small, CONTROLLED popn, which may not be able for ADRs to manifest
- since phase 3 is controlled, sub-groups that experience ADR may not be in the trial

Question 5

how do we weight the risk/benefit ratio? [6]
hint: SATTEI

Answer 5

• Type of disease/ADR: how rare the ADR is
• Therapeutic alternatives: are there other alternatives to this drug with similar efficacy?
• Safety data: toxicity levels very high or low
• Efficacy data: is this drug REALLY THAT effective
• Impact on popn
• Ability to mitigate risk: is there a way to lower/prevent risk eg. let public know dont exercise after vaccine

Question 6

for drugs for dementia, how do we measure effectiveness? what outcomes do we measure?

Answer 6

-Activities of daily living
- misery of caregiver
- violent tendencies
- biomarkers: eg. neuro tangles [but not v accurate]

Question 7

state the process of safety vigilance [4]

Answer 7

1. risk detection
2. risk assessment
3. risk minimisation
4. risk communication

Question 8

what is Black box warning?

Answer 8

label on products when drug has very adverse side effects/risk eg. stroke or death
- protects drug company and family of consumer cannot sue company is anything happens

Question 9

when does a drug get withdrawn? [5]

Answer 9

1. rare, unpredictable problems
2. more toxic than expected
3. have other safer options
4. dangerous combinations with other drugs/food
5. improper use/easily abused

Question 10

what is cisapride and why was it withdrawn?

Answer 10

treatment for heartburn, help gut moves forward instead of backwards. has risks of fatal heart rhythm

Question 11

what is phenylpropanolamine? why was it removed?

Answer 11

a decongestant for blocked nose. have risk of stroke

Question 12

what is Vioxx? why was it withdrawn?

Answer 12

a cox2 inhibitor to prevent stomach ulcers. but have risk of stroke and CVS problems

Question 13

what is a class effect?

Answer 13

when a phenomenon eg. ADR is applicable/observed among similar family of drugs eg. COXIBs

Question 14

what is Nefazodone (Serzone)? why was is discontinued?

Answer 14

an antidepressant to prevent depression. found to increase risk of death and liver failure

Question 15

Phase 4 has a fixed duration. T/F?

Answer 15

false. ongoing and open

Question 16

state the general flow of post-marketing surveillance

Answer 16

1. risk detection
2. risk assessment
3. risk minimisation
4. risk communication

Question 17

how can we let the public know about ADR?

Answer 17

1. insert black box warning
2. press releases
3. update on MOH/HSA website
4. manning of hotlines during crisis

Question 18

what are some sources of risk detection? [4]

Answer 18

1. local ADR reports from public/physicians
2. autopsy reports from forensic pathologist
3. product sampling from local markets [HSA go down for spot check]
4. company reports and studies: clinical studies, periodic safety and update reports