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a PR3145 > LEC 8 Pharmacovigilance ll > Flashcards

LEC 8 Pharmacovigilance ll Flashcards

1
Q

WHO

A

World Health Organisation

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2
Q

CIOMS

A

Council of International Organisations of Medical Sciences

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3
Q

ICH

A

International Council for Harmonisation

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4
Q

Adverse Drug Event (ADE) vs Adverse Drug Reaction (ADR)

A

ADE
- causality not implied

ADR
- causality implied

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5
Q

Side effects

A

Any unintended effect occurring at doses normally used in humans that is related to the pharmacological properties of the drug

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6
Q

Spontaneous Reporting ADE/ADR

A
  • voluntary submission

- outside of a systemically planned study

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7
Q

Mandatory Reporting of ADR

A
  • legal obligation to report ADR

- srs ADR within 15 calendar days

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8
Q

Minimum information of an Individual Case Safety Report (ICSR) (4)

A
  • identifiable reporter
  • identifiable patient (eg age, gender, initials)
  • at least 1 identifiable drug
  • at least 1 identifiable suspected ADR
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9
Q

ICSR

A

Individual Case Safety Report

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10
Q

Serious ADR (6)

A
  • death
  • threatens one’s life
  • cause or prolong hospitalisation
  • persistent or significant disability or incapacity
  • congenital anomaly / birth defects
  • judged to be medically important
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11
Q

Listed / Labelled / Expected ADR

A
  • ADR alr known

- found in package insert etc

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12
Q

Frequency

A
  • includes both incidence & prevalence
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13
Q

Incidence

A
  • number of new cases during a given period of time
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14
Q

Prevalence

A
  • number of old & new cases during a given period of time
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15
Q

Frequency of ADR (5)

A

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

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16
Q

Pharmacoepidemiology

A
  • studies like cohort studies
17
Q

Predictive value

A
  • diagnostic test to assess suitability of drug for a specific patient
  • positive or negative
18
Q

Causality assessment based on (5)

A
  1. Pharmacological plausability
    - pharmacological properties
  2. Chronology
    - temporal relationship (side effects after taking drug)
    - dechallenge & possibly rechallenge
  3. Synergistic PK
    - enzyme inhibitors & victim drug (increased victim drug conc)
    - >1 factors synergistic interactions
  4. Synergistic (broad sense)
  5. Alternative
    eg genetics for allergy
19
Q

Causality classes (5)

A
  1. Certain
    - dechallenge & rechallenge
  2. Probable
    - recovery upon withdrawal
  3. Possible
    - more than 1 drug
  4. Unlikely
  5. Unclassified / Unassessable
    - not enough information
20
Q

Local legislation on PV requirements for therapeutic products (6)

A
  1. Duty to maintain records of defects & adverse effects
    - at least 2y after expiry
  2. Duty to report adverse effects
    - all serious ADR report within 15 calendar days
    - non-serious ADR exempted
  3. Duty to report defects
    - report within 48h that pose serious threats
    - all others report within 15 calendar days
    - can be therapeutic products
  4. Duty to notify HSA regarding recall
    - at least 1 day prior to recall
    - class (depends on health consequence)
    - level (wholesaler, retailer or consumer)
  5. Duty to carry out risk management
    - new drugs
    - biosimilars
    - upon request from HSA
  6. Submission of benefit-risk evaluation report
    - only for selected therapeutic products
    - 6 monthly intervals for first 2 years then annually for another 3 years
21
Q

Risk management process (3)

A
  • cyclical process
  • to ensure benefits > risks of the product throughout the product life cycle
  1. Proactive risk assessment (pre & post marketing)
  2. Develop & implement tools to minimise risks
  3. Continual reassessment of benefit-risk balance
22
Q

Risk reduction methods (2)

A

Prefer to retain product in market than withdrawal/suspend sales from market

  • educational materials
  • restrict use/access of drugs
23
Q

Restrict use/access of drugs (3)

A
  • 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
24
Q

Example of drug on restriction for use (1)

A

Tegaserod

25
Q

Drugs on pregnancy prevention program (3)

A

PIL

  1. Pomalidomide
  2. Lenolidomide
  3. Isotretinoin
26
Q

Examples of when are educational materials as part of Risk Management Plan used? (4)

A

To communicate

  • groups of patients that are at risk
  • serious safety signals from clinical studies or post-market experience
  • monitoring parameters for HCPs
  • to increase HCPs awareness of potential signs & symptoms of the drug associated ADR (help to identify ADR vs disease
27
Q

i-access program use

A
  • pregnancy prevention program for the use of thialidomide analogues (pomalidomide & lemalidomide)
28
Q

i-access program overview

A

One time registration with Celegene

  • prescriber registration
  • pharmacy/dispensing clinic registration

a PR3145 (14 decks)

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