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Compliance > PV > Flashcards

PV Flashcards

1
Q

Objectives of health products regulation group

A

Safeguard Public Health
► Ensure appropriate technical standards are met
► Facilitate recalls, product withdrawals

• Facilitate
► Access to safe, good quality, and
efficacious health products
► Support development of a high quality healthcare system

• Assure
► Instill trust, confidence & credibility of products at home & abroad

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2
Q

Practolol caused

A

Occulomucocutaneous reaction

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3
Q

Rofecoxib (vioxx) caused

A

MI

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4
Q

Medicines are licensed today on the basis of______

A

Medicines are licensed today on the basis of efficacy, safety & quality

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5
Q

Clinical Trials designed to:

  • Test efficacy
  • Detect common ADRs (1 in 100 to 1 in 1,000)

By the time a drug is marketed:
- Usually 1,500 – 3,000 patients are exposed (ICH E1) (larger numbers for vaccine trials)

Short duration:
- 1-3 years

A

Clinical Trials designed to:

  • Test efficacy
  • Detect common ADRs (1 in 100 to 1 in 1,000)

By the time a drug is marketed:
- Usually 1,500 – 3,000 patients are exposed (ICH E1) (larger numbers for vaccine trials)

Short duration:
- 1-3 years

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6
Q

Required sample size for detecting a rare ADR

A

Incidence
Sample size

1 in 100
300

1 in 200
600

1 in 1,000
3,000

1 in 2,000
6,000

1 in 10,000
30,000

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7
Q

PV frame work

A

1) signal/risk detection
- monitoring ADRs to detect risks and change in R/B profile

2) risk assessment
- assessing risk-benefit profile

3) risk minimization
- minimizing risk by appropriate regulatory actions

4) risk communication
- communicating information to optimize safe and effective use

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8
Q

Source of signal

A

Source of a Signal: **ADR reports, a literature report, a new epidemiological study, a randomised trial

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9
Q

Serious reports within ___ days

A

15days

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10
Q

Advantages of ADR reporting

A

Advantages of ADR Reporting
• Operates for all drugs given to patients
• Operates throughout the whole of the drug’s life
• Relatively inexpensive to operate
• Accessible to all physicians/dentists/pharmacists
• Can provide rapid identification of newly identified adverse drug reactions

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11
Q

Disadvantage of adr reporting

A

• Low level of reporting
- estimated that 2-4% of all ADRs & <10% of
serious ones are reported
• Scheme requires HCPs to recognise ADRs; recognition is complicated by the many ADRs mimick naturally-occurring illnesses
• Data collected relate to suspected associations only
• Unable to provide incidence rates because of lack of denominator data

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12
Q

Risk minimization and management

A

Re-evaluate Approval Decisions

  1. Package Insert Amendments
  2. RestrictedAccess
  3. PostmarketStudies,Registries
  4. Suspension or Withdrawal of a Product (eg Prepulsid®, Lipobay®)
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13
Q

Risk communication aim

A

Aim:
• To minimise risk & enhance safe use of drugs
• Update and inform intended audience of safety issues in a timely, transparent and unbiased manner

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14
Q

National policy on PV

A
  • Responsibility of governments to ensure provision of good quality, safe and effective drugs and their appropriate use
  • Requires establishment of:
  • A national drug regulatory agency; and
  • A special centre for ADR study, and maintenance of their activities

• Multidisciplinary collaboration involving different departments of the Ministry of Health and other stakeholders, such as pharmaceutical industry, universities, non-governmental organizations and professional associations for education on rational use of drugs and pharmacotherapy monitoring is of great importance

Important activities include:
• Establishment of national pharmacovigilance systems, including
national pharmacovigilance centres
• Development of necessary legislation/regulation for drug monitoring
• Development of national policy and plans of action (including costing, budgeting and financing)
• Undergraduate and continuing education of healthcare providers on safe and effective pharmacotherapy
• Continuously providing information on ADR to professionals and consumers
• Monitoring of the impact through process indicators and outcome

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15
Q

Very common =

A

> = 1/10

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16
Q

Common (frequent)

A

> = 1/100 AND <1/10

17
Q

Uncommon (infrequent)

A

> = 1/1000 AND <1/100

18
Q

Rare

A

> = 1/10000 AND <1/1000

19
Q

Very rare

A

<1/10000

20
Q

Criteria for Causality classes

Certain =

A

Certain:
- AE pharmacologically clear and plausible
- Chronologically well fitting challenge/dechallenge, possibly even
rechallenge
- Timing within half hour
- Lab data specifically implicating that drug

21
Q

Criteria for causality classes

Probable

A
  • AE pharmacologically plausible
  • Close temporal or spatial correlation (eg skin)
  • Recovery upon drug withdrawal (no therapy)
  • Uncommon clinical phenomenon and reasonable exclusion of other
    factors
22
Q

Criteria for causality classes

Possible

A

Possible:

  • More than 1 drug
  • Time relationship unclear
  • Causality pharmacologically not excludable
  • Chronically fitting challenge/dechallenge
  • Also explainable through alternative causes
  • Information about the AE incomplete or unclear
23
Q

Criteria for causality classes

Unlikely

A
  • Chronological sequence (challenge, dechallenge) hardly fitting
  • Plausible explanation through alternative causes
24
Q

Criteria for causality classes ranking

A 
Certain 
Probable 
Possible
Unlikely 
Unclassified / unassessable
25
Q

Cioms/Rucam drug induced liver injury (DILI)

Scoring system

A
  • 0 or lower: Relationship with the drug excluded
  • 1-2: Unlikely
  • 3-5: Possible
  • 6-8: Probable
  • > 8: Highly probable

Based on the following parameters:
• History of ingestion of drugs, including complementary medicines, within 12 months of onset of illness
‐ Time of onset of reaction in association with intake of product; and discontinuation of product

26
Q

Diagnosis of DILI
• Exclusion of viral serology e.g. anti-HAV IgM, anti-HCV IgM
• -ve metabolic screen (autoimmune disorders or diseases that causes liver injury) e.g. Antinuclear Antibody Test (ANA), ceruloplasmin, antimitochondrial antibody (AMA)
• Daily alcohol intake < 20 g
• Absence of biliary or focal liver pathology on ultrasound or CT scan of abdomen

A

Diagnosis of DILI
• Exclusion of viral serology e.g. anti-HAV IgM, anti-HCV IgM
• -ve metabolic screen (autoimmune disorders or diseases that causes liver injury) e.g. Antinuclear Antibody Test (ANA), ceruloplasmin, antimitochondrial antibody (AMA)
• Daily alcohol intake < 20 g
• Absence of biliary or focal liver pathology on ultrasound or CT scan of abdomen

27
Q

Clinical safety data management: data elements for transmission of individual case
reports

A

E2B

28
Q

Periodic Benefit Risk Evaluation Report

A

E2C

29
Q

Post-approval safety data: definition and stds for expedited reporting

A

E2D

30
Q

PV planning

A

E2E

31
Q

Mandatory submission of existing RMPs for the following categories of applications:

A

– New Drug Applications
– Biosimilars
– On Request from HSA
o For example, generic products where existing local RMP is already in place for innovators (e.g. Avandia – restricted access)

32
Q

Risk management methods

A

1) Educational Materials
When there are important safety issues to note
– Risks involving identified groups of patients
– Serious safety signals that have arisen from clinical studies or post-market experience
– Important parameters to monitor on regular basis

2) Letters to Healthcare Professionals
• “Letter at Launch” vs Dear Healthcare Professional Letter (DHCPL)
• Serious potential side effects that doctors need to be aware of
• Special monitoring required
• Decoupled from promotional materials
• Letters will need to reach all buyers and potential prescribers

3) Sales Data
Provide Broad Categories of Buyers
- Companies may be required to assist in contacting buyers during investigations or implementing risk mitigation strategies

4) Special Licensing Conditions
• Implemented for products with serious potential risks:
– Identified in specific groups of patients
– Product has important role in therapy
– E.g. of products: Clozapine, Revlimid®

• Product supply is bound by conditions:
– E.g. for patients who have undergone special blood tests, physicians who have undergone special programmes

5) Restricted Access Programme
• Implemented for products with serious potential risks :
– Identified groups of patients with no suitable therapeutic alternatives
– Product still has important role in therapy
– Usually a post-market initiative

6) Letter of acknowledgement/undertaking and/or patient consent form:
• Clozapine – safety concerns with agranulocytoisis
• Natalizumab (Tysabri®, UCB Trading) – safety concern of progressive multifocal leukoencephalopathy (PML)
• Strontium ranelate (Protos, Servier) – physician to acknowledge receipt of letter detailing RMP for Singapore
• Panitumumab (Vectibix®, Amgen) – physician to acknowledge receipt of notification of inferior progression free survival and overall survival observed when Vectibix is used in combination with oxaliplatin based chemotherapy

33
Q

Occurrence most likely signify a drug association:

A

Occurrence most likely signify a drug association:
- SJS
- TEN
- Agranulocytosis
- Acute dystonias
‐ Drug-induced liver injury (if confounders properly excluded)
- Cushing’s syndrome (if endogeneous causes excluded)
A diagnosis of an ADR is arrived after excluding all possible causes

Compliance (6 decks)

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