Brainscape's Knowledge GenomeTM

Browse over 1 million classes created by top students, professors, publishers, and experts.


See full index

a PR3145 > LEC 7 Pharmacovigilance l > Flashcards

LEC 7 Pharmacovigilance l Flashcards

1
Q

Range of therapeutic products regulated by HSA (7)

A
  1. Investigational drugs / Clinical trials drugs
  2. Therapeutic products
  3. Medical devices
  4. CPM
  5. Cosmetics
  6. Advanced therapy products (CTGT)
  7. Tobacco products
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
2
Q

Health product regulation (pre-market) (3)

A
  1. Clinical trials
  2. Product registration/listing
  3. Dealers licensing
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
3
Q

Health product regulation (post-marketing) (4)

A
  1. Vigilance
  2. Surveillance
  3. Compliance monitoring
    - to GDP/GMP
  4. Enforcement
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
4
Q

Health product regulation (placing on market) (3)

A
  1. Storage and distribution
  2. Advertising
  3. Supply and sale
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
5
Q

How are the levels of risks assessed? (2)

A

Titrate risk based on :

  1. Types of health product & its inherent risks (CPM vs Therapeutic products)
    - therapeutic products have higher risks
  2. Treatment for diseases
    - treatment for more serious diseases means higher risk tolerance
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
6
Q

Controls on products (high risk vs low risk)

A

More stringent control for high risks products

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
7
Q

HSA approval of drug use into the market

A

Benefits outweigh the risks for the intended population and use

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
8
Q

Are all product risk-free?

A

No

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
9
Q

Efficacy vs Effectiveness

A

Efficacy

  • under controlled conditions
  • shown in clinical trials

Effectiveness
- under clinical conditions

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
10
Q

Adverse Drug Reaction (WHO definition)

A

A reaction that is

  • noxious/harmful
  • unintended
  • occurs at doses normally used in man for prophylaxis, diagnosis or treatment of disease of the modification of physiological function (normal therapeutic doses)
  • excludes overdosage, drug abuse and medication errors
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
11
Q

Side effects

A

Any unintended effect occurring at doses normally used in humans that is related to the pharmacological properties of the drug
- can be positive or negative side effects
eg discovery of new SE can lead to the off-label use of the drug

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
12
Q

ADR vs SE (2)

A

ADR

  • negative reactions
  • may or may not be related to pharmacological properties

SE

  • can be positive or negative reactions
  • related to pharmacological properties
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
13
Q

Adverse Events vs Adverse Reactions

A

Adverse Events
- causality not implied

Adverse Reactions
- causality assumed

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
14
Q

Rule of Three

A
  • 95% confidence
  • point estimate for the frequency of that ADR is not higher than 3 in the size of the investigated population

eg clinical trial sample size = 1,800 (no ADR)
- there is 95% confidence that the true frequency of the ADR is less than 1/600

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
15
Q

Limitations of clinical trials (5)

A
  1. Mainly test efficacy only
  2. Detect common ADR only (1/100 to 1/1,000)
  3. Detect short term ADR
  4. Small number of exposed patients (1,500-3,000)
  5. Short duration (1-3y)
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
16
Q

Pharmacovigilance

A
  • is the science of collecting, monitoring, researching, assessing and evaluating information
  • from healthcare providers and patients
  • on the adverse effects
  • of health products
  • with a view to :
    1. Identifying new information about hazards
    2. Preventing harm to patients
17
Q

Pharmacovigilance framework (4)

A
  1. Signal/Risk detection
  2. Risk assessment
    - assess benefit/risk profile
  3. Risk minimisation
    - implement appropriate regulatory actions
    - maintain product in market > remove product in market
  4. Risk communication
18
Q

What are ‘signals’ (3)

- what does it provide?

A
  • an early indicator or warning of a potential new problem with a drug or class of drug
  • more than 1 report to generate a signal
  • new ADR or additional info about known ADR
19
Q

Source of a signal (4)

A
  1. International Data
  2. Local Data
  3. Pre-market Data
  4. Post-market Data
20
Q

Can liver toxicity be a signal of paracetamol?

A

No because it is not a new problem with paracetamol.

It is already known that paracetamol can cause liver toxicity

21
Q

International data (3)

A
  1. WHO International Drug Monitoring Programme
  2. Environmental Scanning
    - literature
    - media reports
    - information from other regulatory agencies
  3. International Regulatory Exchanges
22
Q

Local data (4)

A
  1. Healthcare Professionals
  2. Autopsy Reports & Toxicology Lab
  3. Active Surveillance Initiatives
    - CMIS
    - Sentinel Sites (vaccines)
    - Registries for selected drugs
  4. Mandatory Reporting (Drug companies)
    - serious reports within 15 days
23
Q

Advantages of ADR reporting (5)

A
  1. Operates for all drugs given to patients
  2. Operates throughout the whole lifespan of the drug
  3. Relatively inexpensive to operate
  4. Accessible to all healthcare providers
  5. Can provide rapid identification of newly identified adverse drug reactions
24
Q

Disadvantages of ADR reporting (4)

A
  1. Low level of reporting
    - 2-4% of all ADR
    - <10% of serious ADR are reported
  2. Schemes requires HCPs to recognise ADR
    - recognition is complicated by many ADR mimic naturally-occurring illnesses
  3. Data collected relate to suspected association only
    - not confirmed causality
  4. Unable to provide incidence rate
    - only the frequency / prevalence
    - due to the lack of denominator
25
Q

Given the limitations of ADR reporting, is ADR reporting still important?

A

Yes.

It is the only way of monitoring the safety of a drug throughout its marketed life

26
Q

Is ADR reporting confidential?

A

Yes.

Any information related to the identities of the reporter and the patient will be kept confidential

27
Q

Channels of ADR reporting (6)

A
  1. Phone
  2. Fax
  3. Mail
  4. Email
  5. Online reporting
  6. E-reporting linked to medical records
    - Critical Medical Information Store (CMIS)
28
Q

Methods of assessing Signal detection (2)

A
  1. Qualitative methods

2. Quantitative methods

29
Q

Qualitative methods of signal detection (5)

A

Case by case basis

  1. Frequency
  2. Nature/Type of event
  3. Time of onset
  4. Duration
  5. Rechallenge/Dechallenge
30
Q

Quantitative methods of signal detection

A
  1. Frequentist method

2. Bayesian approaches

31
Q

Follow up on signal detection (2)

To confirm causality

A
  1. Hypothesis testing

2. Epidemiological study

32
Q

Steps for conducting Risk/Benefit assessment (2)

A
  1. Review safety signals and further confirmatory studies/data
  2. Determine the benefit vs risk profile
    - efficacy data
    - safety data
    - therapeutic alternatives
    - type of disease
    - impact on population
    - ability to mitigate risks
33
Q

Risk minimisation & management classes (2)

A
  1. Retention of product in market (favourable)

2. Removal of product in market (unfavourable)

34
Q

(( favourable ))

Risk minimisation & management if product is retained in market

  • more common (4)
  • less common (3)
A

More common :

  • enhancement of warnings in package insert
  • change of indications to mitigate new risk
  • new contraindications to use
  • postmarket studies and registries

Less common :
- restriction of use to certain medical disciplines
- restriction of access to certain patients only
eg when treatment resistant
- black box warning (sternest warning)

35
Q

Risk minimisation & management if product is removed from market (3)

A
  • suspension of sales
  • recall of product
  • withdrawal of product (or voluntary withdrawal)
36
Q

Risk communication aim (1)

A
  • to minimise risk and enhance safe use of drugs by updating and informing intended audience of safety issues in a timely, transparent and unbiased manner
37
Q

Risk communication methods

A
  • Dear Healthcare Professionals Letters
  • Public advisories
  • Posters
38
Q

Impact of ADR (3)

A
  1. Increase length of hospital stays
  2. Increase costs
  3. Risks of mortality
39
Q

Relevance / Importance of pharmacovigilance (4)

A
  1. Clinical trials limitations
  2. Genetic & environmental influence
  3. Ageing population (polypharmacy, comorbidities)
  4. Rising use of Complementary Proprietary Medicines (CPM)

a PR3145 (14 decks)

Brainscape helps you reach your goals faster, through stronger study habits.
© 2024 Bold Learning Solutions. Terms and Conditions