LEC 8 Pharmacovigilance ll Flashcards
(28 cards)
WHO
World Health Organisation
CIOMS
Council of International Organisations of Medical Sciences
ICH
International Council for Harmonisation
Adverse Drug Event (ADE) vs Adverse Drug Reaction (ADR)
ADE
- causality not implied
ADR
- causality implied
Side effects
Any unintended effect occurring at doses normally used in humans that is related to the pharmacological properties of the drug
Spontaneous Reporting ADE/ADR
- voluntary submission
- outside of a systemically planned study
Mandatory Reporting of ADR
- legal obligation to report ADR
- srs ADR within 15 calendar days
Minimum information of an Individual Case Safety Report (ICSR) (4)
- identifiable reporter
- identifiable patient (eg age, gender, initials)
- at least 1 identifiable drug
- at least 1 identifiable suspected ADR
ICSR
Individual Case Safety Report
Serious ADR (6)
- death
- threatens one’s life
- cause or prolong hospitalisation
- persistent or significant disability or incapacity
- congenital anomaly / birth defects
- judged to be medically important
Listed / Labelled / Expected ADR
- ADR alr known
- found in package insert etc
Frequency
- includes both incidence & prevalence
Incidence
- number of new cases during a given period of time
Prevalence
- number of old & new cases during a given period of time
Frequency of ADR (5)
Very common : >=1/10
Common : 1/100 to 1/10
Uncommon : 1/1,000 to 1/100
Rare : 1/10,000 to 1/1,000
Very rare : <1/10,000
Pharmacoepidemiology
- studies like cohort studies
Predictive value
- diagnostic test to assess suitability of drug for a specific patient
- positive or negative
Causality assessment based on (5)
- Pharmacological plausability
- pharmacological properties - Chronology
- temporal relationship (side effects after taking drug)
- dechallenge & possibly rechallenge - Synergistic PK
- enzyme inhibitors & victim drug (increased victim drug conc)
- >1 factors synergistic interactions - Synergistic (broad sense)
- Alternative
eg genetics for allergy
Causality classes (5)
- Certain
- dechallenge & rechallenge - Probable
- recovery upon withdrawal - Possible
- more than 1 drug - Unlikely
- Unclassified / Unassessable
- not enough information
Local legislation on PV requirements for therapeutic products (6)
- Duty to maintain records of defects & adverse effects
- at least 2y after expiry - Duty to report adverse effects
- all serious ADR report within 15 calendar days
- non-serious ADR exempted - Duty to report defects
- report within 48h that pose serious threats
- all others report within 15 calendar days
- can be therapeutic products - Duty to notify HSA regarding recall
- at least 1 day prior to recall
- class (depends on health consequence)
- level (wholesaler, retailer or consumer) - Duty to carry out risk management
- new drugs
- biosimilars
- upon request from HSA - Submission of benefit-risk evaluation report
- only for selected therapeutic products
- 6 monthly intervals for first 2 years then annually for another 3 years
Risk management process (3)
- cyclical process
- to ensure benefits > risks of the product throughout the product life cycle
- Proactive risk assessment (pre & post marketing)
- Develop & implement tools to minimise risks
- Continual reassessment of benefit-risk balance
Risk reduction methods (2)
Prefer to retain product in market than withdrawal/suspend sales from market
- educational materials
- restrict use/access of drugs
Restrict use/access of drugs (3)
- when product still has an important role in therapy despite its serious potential risks
- restrict use for specific groups of patients where there is no other suitable alternatives
- restrict access to certain medical disciplines
- diagnostic tests / predictor values to ensure suitability
Example of drug on restriction for use (1)
Tegaserod
