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Regulatory and Compliance > Pharmacovigilance (PV) Systems and Standards Part 1 > Flashcards

Pharmacovigilance (PV) Systems and Standards Part 1 Flashcards

1
Q

Organisations involved in setting pharmacovigilance systems and standards:

A
  1. WHO
  2. CIOMS
  3. ICH
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2
Q

What is:

  1. Adverse event
  2. Adverse reaction
  3. Spontaneous reporting
  4. Mandatory reporting of adverse drug reactions
A
  1. Medical occurrence temporally associated with the use of a medicinal product, but not necessarily causally related.
  2. Response directly caused by a drug that is noxious and unintended, and that occurs at normal doses.
  3. Voluntary submission of reports on AEs or ADRs by healthcare professionals to the national regulatory authority outside of a study.
  4. Legal obligation to report suspected ADRs
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3
Q

Minimum information of an Individual Case Safety Report:

A
  1. An identifiable reporter
  2. An identifiable patient (e.g. age, gender, initials)
  3. At least one identifiable drug
  4. At least one identifiable suspected ADR
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4
Q

What is the difference between expected and unexpected ADR?

A

Expected ADR:

  • listed, labelled
  • ADR that is already adequately described, usually can find on package insert of the product, or summary of product characteristics.

Unexpected ADR:
- not consistent with applicable product information or characteristics of drug.

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5
Q

Frequency of Adverse Drug Reactions (CIOMS)

A 
Very common    >/ 1/10
Common            >/ 1/100 and <1/10 
Uncommon        >/ 1/1000 and <1/100
Rare                   >/ 1/10,000 and < 1/1,000 
Very rare            > 1/10,000
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6
Q

What is the relationship between adverse event and adverse drug reaction?

A

An adverse event becomes an adverse drug reaction upon suspicion of causal relation

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7
Q

What are the different elements of causality assessment?

A
  1. Pharmacological plausability
    - Chemical nature of molecule / class
    - Assumable intrinsic activity
    - Dosage and duration of therapy fitting
    - Pharmacokinetics fitting
    - Phenomenoloogical plausability because of previous cases (principle of Bayes)
  2. Chronology
    - temporal relationship
    - dechallenge (stop giving the drug after an adverse event or at the end of a planned treatment), possible rechallenge (restarting of the same drug after having stopped it)
  3. Synergistic - Pharmacokinetic:
    - other drugs or factors which alone could not cause the AE but could raise the concentration of the drug under consideration and elicit ADR.
  4. Synergistic (in a broad sense):
    - drugs that can cause the same AE combine together to elicit a larger ADR effect.
  5. Alternative
    - other drugs alone which alone and may have specifically caused the AE and thus could completely exonerate the drug under conideration.
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8
Q

What are the several criteria for causality causes?

A
  1. WHO - UMC causality assessment
  2. Naranjo causality assessment
  3. CIOMS/RUCAM scale (for Drug Induced Liver Injury)
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9
Q

What are the different categories for causality classes?

A

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

B. Probable

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

C. 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

D. Unlikely

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

E. Unclassified / unassessable

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10
Q

Diagnosis of Drug Induced Liver injury (DILI)

A

Based on the following parameters

  • history of ingestion of drugs, including complementary medicines, within 12 months onset of illness
  • exclusion of viral serology
  • negative metabolic screen
  • daily alcohol intake < 20g
  • absence of biliary or focal liver pathology on ultrasound or CT scan of abdomen
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11
Q

Pharmacovigilance guidelines

A

ICH:

  • E2B: clinical safety data management
  • E2C: periodic benefit risk evaluation report
  • E2D: post-approval safety data: definition and standards for expedited reporting
  • E2E: PV planning

EU Good Pharmacovigilance Practice Modules
REMS Guidance from the US FDA
CIOMS Working Group Reports

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12
Q

Scoring system of DILI

A 
0 or lower: relationship with the drug excluded 
1-2: unlikely 
3-5: possible 
6-8: probable 
>8: highly probable
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13
Q

Steps for local legislation on PV requirements for therapeutic products.

A
  1. Duty to maintain records of defects and adverse effects
  2. Duty to report adverse effects
  3. Duty to report defects
  4. Duty to notify authority regarding recall
  5. Duty to carry out risk management plan
  6. Submission of benefit-risk evaluation report
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14
Q

Duty to maintain records of defects and adverse effects

A
  • records to be retained by manufacturers, importers and registrants
  • standard format required for records
  • to be retained for at least 2 years after expiry of TP
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15
Q

Duty to report adverse effects

A
  • mandatory reporting for serious adverse reactions (SAR) by manufacturers, importers, suppliers, registrants
  • definition of SAR included in legislation
  • non-serious adverse events exempted
  • all SAR to be reported no later than 15 calendar days, aligned with ICH E2D guidance
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16
Q

Duty to report defects

A
  • duty to report by manufacturers, importers, suppliers or registrants
  • to report within 48 hours for defects that represent serious threats to persons or public health
  • to report within 15 days for all other cases.
17
Q

Duty to notify authority regarding recall

A
  • Notification to HSA to be 1 calendar day prior to start of intended recall
  • Class of recall: timelines (depending on health consequence the product issue may cause)
  • Level of recall: extent of recall (i.e. wholesale, retail, consumer)
18
Q

Duty to carry out risk management plan

A
  • aim: to ensure favourable benefit-risk profile of TPs
  • may be requested upon identification of safety issues pre/post-market
  • describes risk management measures
  • applicable to new drug applications (NDA-1), biosimilar applications, others on case-by-case basis
19
Q

Submission of benefit-risk evaluation report

A
  • in alignment with ICH E2C (R2) guidance on Periodic Benefit Risk Evaluation Reports
  • Only for selected therapeutic products with identified safety concerns.
  • Submitted at 6-monthly intervals for first 2 years, then annually for another 3 years
20
Q

Risk management (by industry)

A

A continuous process throughout the lifecycle of a product to optimise benefit-risk balance:

  • proactive risk assessment: pre- and post-market
  • develop and implement tools to minimise risks
  • continual reassessment of benefit-risk balance

Aim: to ensure benefits of the product exceeds its risks throughout the product life cycle

21
Q

Singapore risk management plans by industry:

A
  • discussed with HSA pre-approval and post-market
  • adapt plans from reference agencies that are relevant to local context
  • may contain one or more of the following:
    » letter at launch of product
    » educational materials
    » periodic benefit risk-evaluation report, of periodic safety update report
    » provision of sales data
    » restricted use / access schemes
    » drug registries
    » poor market clinical studies
22
Q

Risk management plans by industry

A
  • mandatory submission of existing RMPs for the following:
    » new drug applications
    » biosimilars
    » on request from HSA (e.g. generic products where existing local RMP are already in place for innovators)
23
Q

When do you design educational materials as part of RMP, and what are they used for?

A
  • 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
24
Q

Letters to Healthcare Professionals

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

Regulatory and Compliance (4 decks)

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