B2B predicting variability Flashcards
type A and B ADRS
A - predictable, dose related, high morbidity, respond to dose reduction
B - hypersensitivity (immune) unpredictable, rarely dose dependent, low morbidity, high mortality, respond to drug withdrawal
Phase III trial limitations (FDA 5 “toos”)
- few data points (not enough patients
- simple (complicated medical conditions excluded)
- brief
- median aged (elderly, paed excluded)
- narrow (exclude concurrent med and ethnicity)
Barriers to trial participation
bias, attitude, transportation issues, awareness, perception of race/ethnicity?
gene associated with TENS?
HLA-B*1502 highly prevalent in Asian population
quality of evidence
1 - high
2 - moderate
3 - low
4 - preliminary
Questions to ask to predict ADRs
- Phase I or Phase II processes and are these variable in patient populations
- Is the drug a substrate for specific transporters and if so what are the implications?
- Is the drug to be used in a specific age range - DMPK processes related?
- Any other factors which could influence PK profile (e.g. gender, weight)
- Interactions with additional medications
Post marketing surveillance
Licensing restrictions?
Post authorisation risk management plan? manufacturer responsibility
Who carries out health technology appraisals? (HTA)
1. SMC, NICE Critical appraisal by pharmacist and an economist NDC appraisal SMC final decision Advice on SMC website
Professions involved in SMC HTAs:
doctors pharmacists public partners industry board chief executives economists
Post-marketing surveillance
real world safety data
access, impact stratification/personalisation
Definition of pharmacoepidemiology
study of utilisation and effects of drugs in large numbers of people
QALY
benefits, in terms of length of life, are adjusted to reflect the quality of life. One QALY is equal to 1 year of life in perfect health.
QALYs are calculated by estimating the years of life remaining for a patient following a particular treatment or intervention and weighting each year with a quality-of-life score (on a 0 to 1 scale). It is often measured in terms of the person’s ability to carry out the activities of daily life, and freedom from pain and mental disturbance.
3 roles of the SMC
- New medicines assessment
- Horizons scanning (intelligence on new meds)
- Scottish Antimicrobial Prescribing Group
What do we need in our medicines toolkit (MICPOP)?
Medicine Indication Cost Prescriber Outcome Patient
EFIPPS
Effective Feedback to Imporve Primary care Prescribing Safety
Uses Phase II cluster randomised trial. Design feedback and persuasive communication
