Brainscape's Knowledge GenomeTM

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


See full index

PR3145 > Pharmacovigilance > Flashcards

Pharmacovigilance Flashcards

1
Q

Objective of Health Product Regulation Group

A

1) Safeguard public health
- ensure appropriate technical standards are met
- facilitate recalls, pdct withdrawals

2) Facilitate
- support development of high quality healthcare system
- access to safe, gd quality & efficacious health products

3) Assure
- instil trust, confidence & credibility of pdcts

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

Range of HPs regulated by HSA

A
  • investigational drugs
  • therapeutic pdcts
  • complementary HPs
  • medical devices
  • cosmetics
  • advanced therapy pdcts (ie CTGT products)
  • tobacco pdcts
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
3
Q

Overview of HP Regulation

A

1) Pre-market stage
- Clinical trials
- Pdct registration/listing
- Dealers licensing

2) Placing on-market
- storage & distribution (ie. GDP)
- advertising
- supply & sale

3) Post-market stage
- vigilance, surveillance, compliance monitoring, enforcement

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

HSA’s role in Risk Management

A
  • Risk based approach titrated according to inherent risks
  • > stringent controls for high risk products
  • Balance of B/R
  • -> reg, action taken when B/R changes
  • -> HSA approves a drug when benefit > risk for intended population (professional judgement - may be given off-label)
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
5
Q

How is safety regulated?

A

Animal testing, human volunteer studies, early clinical trials in pts, large scale trials, post-marketing surveillance/pharmacovigilance

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
6
Q

What is an Adverse Drug Rxn

A
  • Noxious/harmful, unintended, occurs at doses normally used for treatment/prophlaxis/diagnosis
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
7
Q

What is a side effect

A
  • Unintended effect @ normal doses
  • Related to pharmacological actions of drug

Note: +ve/-ve

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

Required sample size for detecting rare ADR

A

Rule of Three

Eg. 1800 pts
- Only 95% confidence that the true frequency of this ADR is less than 1/600

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

Limitations of Clinical Trials

A
  • Clinical trials are designed to test for efficacy & detect common ADRs
  • by the time drug is marketed only small no. of pts are exposed
  • short duration: 1-3yrs
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
10
Q

Impact on ADRs

A

Economic social & health impact!

  • ADRs 2x the mean length of stay, $ & risk of mortality for pts vs controls
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
11
Q

What is Pharmacovigilance

A
  • Science of collecting, monitoring, assessing, evaluating info from healthcare providers & pts about the ADVERSE EFFECTS of meds/biological pdcts/herbal & traditional meds…
  • Identify new info about hazards
  • Prevent harm to pts
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
12
Q

Relevance of Pharmacovigilance

A
  • biomedical sciences: 4th pillar of economic engine
  • limitations of clinical trials
  • genetic/envt influences
  • ageing population
  • Increase use of complementary medicines
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
13
Q

Pharmacovigilance framework process

A

1) Signal/Risk detection
2) Risk assessment
3) Risk minimisation
4) Risk communication

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

Signal/Risk detection

A

Signals: Indicators/warning of a potential new problem with a drug, or class of drug

  • Repeated info on possible casual r/s btwn an adverse effect & a drug
  • Signal is a hypothesis with data & arguments that support it

Sources: *ADR reports, literature report, new epidemiological study, randomised trial

Qualitative method - case by case evaluation
Quantitative method -
i) frequentist methods (ability to detect disproportionate no. on databases)
ii) bayesian approaches

Follow up by:

  • Hypothesis testing
  • Epidemiological study
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
15
Q

Advantages of ADR Reporting

A
  • Operates for all drugs given to pts
  • Operates throughout whole of drug’s life
  • relatively inexpensive to operate
  • accessible to all physicians. dentists/ pharmacists
  • rapid identification of newly identified ADR
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
16
Q

Disadvantages of ADR Reporting

A
  • low level of reporting
  • scheme requires HCPs to recognise ADRs (complicated by many ADRs mimicking naturally-occurring illnesses)
  • data collected relate to suspected associations only
  • unable to provide incidence rates bc of lack of denominator
17
Q

Risk/Benefit Assessment

A
  • Review safety signals & further confirmatory studies/data
  • Determine B/R profile
  • Taking into consideration overall info from clinical studies, post-marketing experience & balancing pros & cons of…
  • -> efficacy & safety data, therapeutic alternatives, type of disease, impact on population, ability to mitigate risk
18
Q

Risk minimisation & management

A

i) Favourable R/B Analysis
- enhancement of warnings in package inserts
- change indications to mitigate new risks
- new contraindication
- post-market studies; registries

ii) Unfavourable R/B Analysis
- suspend sales, recall pdct, withdraw pdct

19
Q

Risk communication

A
  • Minimise risk & enhance safe use of drugs

- Update & inform audience of safety issues in a timely, transparent & unbiased manner

20
Q

Organisations involved in Pharmacovigilance

A

WHO & UMC (Uppsala Monitoring Centre) - looks at ADR globally
CIOMS - non-profit organisation, reviews laws & methods of regulatory science
ICH

21
Q

Min information needed for an Individual Case Safety Report

A
  • identifiable report
  • identifiable patient
  • at least one identifiable drug
  • at least one identifiable suspected ADR
22
Q

Casuality Assessment

A

1) Pharmacological plausibility
2) Chronology
- temporal r/s
3) Synergistic Pharmacokinetic (eg. serotonin syndrome)
4) Synergistic (in a broad sense)
- Cause whole quantitative degree of the effect when in combination
5) Alternative

23
Q

Criteria for causality classes

A 
A) Certain 
- AE pharmacologically clear & plausible
B) Probable
- AE pharmacologically plausible
C) Possible
- > 1 drug
- casuality pharmacologically not excludable
D) Unlikely
E) Unclassified/Unassessable
24
Q

What is the CIOMS/RUCAM Scale

A

Diagnosis of Drug-Induced Liver Injury (DILI)

Based on the:

  • hx of ingestion of drugs (incl complementary medications) within 12mths of onset of illness
  • -> exclusion of viral serology
  • -> -ve metabolic screen
  • -> daily alcoholic intake < 20g
  • -> absence of biliary or focal liver pathology on ultrasound or CT scan of abdomen
25
Q

Local legislation on PV requirements for Therapeutic Products

A

1) Duty to maintain records of defects & adverse events
- retain for >= 2yrs

2) Duty to report adverse effects
- non serious AE exempted
- no later than 15days

3) Duty to report defects
- no later than 15days
- report within 48hrs for serious threats

4) Duty to notify authority concerning recall

5) Duty to carry out risk management plan
- to ensure favourable B/R profile

6) Submission of benefit- risk evaluation report

26
Q

What is Risk Management (by industry)

A

A continuous process throughout the life cycle of a product to optimise benefit-risk profile
- to ensure benefits of product exceeds its risks throughout the product life cycle

SG’s Risk Management plan by industry:

  • discussed with HSA pre-approval & post-market
  • adapt plans frm reference agencies that is relevant to local context

Mandatory for:

  • new drug applications
  • biosimilars
  • on request from HSA

Note:
- educational materials provided when thr are important safety issues

27
Q

Restricted use/access scheme

A

Implemented for products with serious potential risks but whr the product still has an impt role to play in therapy:
- eg. restricted for use in specified groups of pts/ by certain medical specialties

Key features of the scheme:

  • for selected group of pts
  • physician & pharmacist’s undertaking
  • pt’s informed consent
  • supply of product only to physicians who have “registered”
  • provide regular sales data & updated physician list to HSA
28
Q

Eg. of CAR-T cell therapy

A

What: T cells genetically engineered to produce receptors on surface called Chimeric Antigen Receptors (CARs)

Relevance to PV: Need to keep updated with the rapid evolution of scientific development to unds PV issues

Need to be at forefront of science to ensure quality & safety by having strong fundamentals in:

  • Science, immunology, study designs
  • Product & manufacturing science
  • Pharmacovigilance

Potential SEs of CAR-T cell
- neurological toxicity, insertional oncogenesis, CRS, anaphylaxis/allergy, “on-target, off-tumour toxicity”

29
Q

Causes of ADR

A
  • Inherent drug characteristics (AI, excipients, formulation)
  • quality problems (contamination with toxic heavy metals, counterfeits)
  • adulteration (with potent medicinal ingredients)
  • -> Eg. virtility products (eg. sildenafil & its analogues), anti-inflmm products (eg. dexamethasone, NSAIDs), slimming products (eg. sibutramine)
  • substitution of ingredients
  • DDI, drug-food interactions
  • long-term exposure; high doses
  • indv susceptibility (eg. HLA-B*1502 allele predisposes to severe skin reactions with carbamazepine)
  • in-use issues

Note: Diagnosis of ADR is arrived after excluding all possible causes

30
Q

Toxic metal limits for CMs

A

Arsenic - 5ppm
Cadmium - 0.3ppm
Lead - 10ppm
Mercury - 0.5ppm

31
Q

Future challenges of Pharmacovigilance

A
  • Opportunities in genomic era
  • Emergence of Complementary meds
  • Registries for biological products & gene therapy
  • Forging closer ties with international counterparts
  • Maximising IT tools for signal detection & communication

PR3145 (10 decks)

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