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Compliance CA2 Revision > PV, S&S > Flashcards

PV, S&S Flashcards

1
Q

Range of Health Products Regulated by HSA

A

Nearly all medication stuff:

  1. Investigational drugs
  2. Medical devices
  3. Therapeutic products
  4. Complementary Health Products
  5. Cosmetics
  6. Advanced Therapy products
  7. Tobacco
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2
Q

Health products regulation consist of pre-market and post-market stage. Which stage does PV stand and what are some components of PV in that stage?

A

Post-market stage

  1. Vigilance
  2. Surveillance
  3. Compliance monitoring
  4. Enforcement
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3
Q

What products are considered high risk?

A

Therapeutic products. (Usually the potent ones but with serious AE/SE)

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4
Q

The thalidomide tragedy led to the 1962 Kefauver-Harris amendment to the FD and C. What did the amendment include?

A
  1. All drugs to demonstrate substantial evidence of efficacy and safety for its indication
  2. Strengthened control on experimentation on humans
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5
Q

Name some major events in PV

A
  1. Sulfanilamide tragedy caused by DEG in product
  2. Thalidomide tragedy due to racemic mixture
  3. Practolol (1975): caused occulomucocutaneous reaction
  4. Biologicals from bovine materials due to BSE
  5. Rofecoxib (Vioxx) which increased risk of MI
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6
Q

In which year was PV established in HSA

A

2000

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7
Q

Medicines are licensed today on the basis of ______, ________ and _______.

A

Efficacy, safety, quality

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8
Q

How is efficacy shown?

A 
Randomised trials 
(note: randomised trials are NOT sufficient for safety testing)
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9
Q

What are some tests and ways to ensure safety of a medicine before and after licensing?

A
  1. Animal testing
  2. Phase I CT (human volunteers)
  3. Phase II CT (early clinical trials)
  4. Phase III CT (large scale trials)
  5. Postmarketing surveillance/pharmacovigilance
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10
Q

Describe the rule of three. What is it used for?

A
  • Rule of three is used to determine the sample size required to detect a rare ADR
  • If ADR is not detected in CT, can only rule out with 95% confidence that the point estimate for the frequency of that ADR is not higher than 3 in the size of the investigated population
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11
Q

What are some limitations of clinical trials (CTs) in the detection of ADRs?

A
  1. Designed to test efficacy. Only can detect common ADRs (1/100 to 1/1000)
  2. By the time drug is approved and marketed, many patients are already exposed
  3. Duration of CTs is too short (1-3yrs)
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12
Q

ICH guideline number on Clinical trials

A

E1

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13
Q

Goals of Pharmacovigilance (PV) according to its definition from HSA

A
  1. Identify new info about hazards

2. Prevent harm to patients

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14
Q

The 4 steps in the process of PV

A
  1. Signal/risk detection: indicator/warning of potential new problem with drug/class of drug
  2. Risk assessment: review safety signals for drugs and do risk-benefit analysis (R/B analysis)
  3. Risk minimisation and management: make changes according to favourable or unfavourable R/B analysis
  4. Risk communication: Update stakeholders of safety issues in timely, transparent and unbiased manner
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15
Q

In signal and risk detection of the PV frameworks, what are some possible sources of signals?

A
  • ADR reports
  • Literature report
  • New epidemiological study
  • Randomised trial

Data from international organisations or local

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16
Q

In signal and risk detection of the PV frameworks, what are some advantages of ADR reporting?

A
  1. Operates for all drugs given to patient
  2. Operates throughout drug’s life
  3. Inexpensive to do so
  4. Accessible to all HCP
  5. Rapid identification of new ADR
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17
Q

In signal and risk detection of the PV frameworks, what are some disadvantages of ADR reporting?

A
  1. Low level of reporting
  2. ADR recognition complicated by mimicking naturally-occuring illness
  3. Data collected related to suspected associations only
  4. Cannot provide incidence rates (no denominator data)
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18
Q

In signal and risk detection of the PV frameworks, what are some channels of reporting ADRs?

A
  1. Mail/fax/telephone
  2. Email to HSA drug safety
  3. Online reporting
  4. E-reporting linked to medical records: Critical Medical Info Store (CMIS)
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19
Q

Qualitative methods of signal detection in the PV framework

A
  1. Freq
  2. Nature/Type of Event
  3. Time to Onset
  4. Duration
  5. Rechallenge/Dechallenge
20
Q

Must action be taken immediately to a signal detection? How are follow-up on Signal Detection carried out?

A

No. Action taken usually when there are more similar reports. After signals are confirmed, then follow-up on signal detection should be carried out via:

  • Hypothesis testing
  • Epidemiological Study
21
Q

In R/B assessment of the PV framework, what are some data used to assess R/B?

A
  1. Safety & Efficacy data
  2. Therapeutic alternatives
  3. Type of disease
  4. Impact on population
  5. Ability to mitigate risks
22
Q

In risk minimisation and management of the PV framework, what are some actions taken in the case of favourable R/B analysis?

A
  1. Enhance warnings in package inserts (E.g. black box warning)
  2. Change indication to mitigate risk
  3. New C/I
  4. Postmarket studies/ registries
  5. Restrict use to certain medical disciplines
  6. Restrict of access to certain patients only
23
Q

In risk minimisation and management of the PV framework, what are some actions taken in the case of unfavourable R/B analysis?

A
  1. Suspend sales
  2. Recall pdt
  3. Withdraw pdt (“voluntary” if initiated by company)
24
Q

Name some ways of risk communication in the PV framework.

A
  1. Professional letters to HCP

2. Public advisories on websites/press/TV (E.g. Posters, bulletin inserts)

25
Q

Distinguish between Adverse Event (AE), Adverse Reaction (AR) and Side effect (SE).

A

AE: Occurrence associated with use of medicinal product, but not causally related

AR: Noxious and unintended response to a drug occurring at doses normally given

SE: Unintended effect at normal dose related to pharmacological properties of a drug (nature of the effect does not matter)

26
Q

Distinguish between Spontaneous Reporting and mandatory Reporting of ADRs

A

Spontaneous: Voluntary submission of reports of AE/ADR by HCP to authority

Mandatory: legal obligation to report suspected ADRs

27
Q

What are the minimum information required in an Individual Case Safety Report (ICSR)

A
  1. Identifiable reporter
  2. Identifiable patient (e.g. age, gender, initials, no need IC)
  3. At least one identifiable drug
  4. At least one identifiable suspected ADR
28
Q

Terms by CIOMS used to describe the frequency of ADR

A
  1. Very common: ≥10%
  2. Common/Frequent: ≥1%, <10%
  3. Uncommon (infrequent): ≥0.1%, <1%
  4. Rare: ≥0.01%, <0.1%
  5. very rare: <0.01%

(steps of tenths)

29
Q

What is required to determine whether an AE is and ADR?

A

Suspicion of causal relation

30
Q

What are the 5 things to consider in causality assessments?

A
  1. Pharmacological (e.g. principle of Bayes, chemical nature)
  2. Chronology: Temporal relation, dechallenge and rechallenge
  3. Synergistic PK (due to DDI)
  4. Synergistic (broad factors)
  5. Alternatives (e.g. allergy)
31
Q

The five categories of causality assessments

A
  1. Certain
  2. Probable
  3. Possible (causality pharmacologically not excludable, >1 drug, etc.)
  4. Unlikely (chrono sequence hardly fitting, can be explained via alternative causes
  5. Unclassified/Unassessable (due to incomplete info)
32
Q

What does the CIOMS/RUCAM scale measure and what parameters is it based on?

A
  • Measures causal relationship with drug and DILI (drug induced liver injury)

Params:

  • Hx of drug ingestion (incl. CAM) within 12 months of onset
  • Time of onset of reaction in association with intake of product and discontinuation of product
33
Q

The scoring system for CIOMS/RUCAM Scale in diagnosing DILI

A
  • <0: Not related
  • 1-2: Unlikely
  • 3-5: Possible
  • 6-8: Probable
  • > 8: Highly Probable
34
Q

What are the criteria before the diagnosis of DILI is confirmed?

A
  1. Exclude viral infection via serology
  2. Exclude autoimmune disorders/ acute liver injuries
  3. Daily alcohol <20g
  4. Absence of biliary/focal liver pathology on ultrasound/CT scan of abdomen
35
Q

What are the local legislation on PV requirements for therapeutic products (TP)?

A
  1. Maintain records of defects and AE (at least 2 yrs after expiry)
  2. Report serious AE within 15 days
  3. Report defects (within 48h for serious threats, 15d for others)
  4. Notify authority of recall (1d prior to start of recall)
  5. Risk management plan to ensure favourable R/B of TP
  6. Submit R/B evaluation report per 6 months for 2 yrs, then annually for 3 more years
36
Q

Purpose of Risk Management by industry

A

Ensure benefits of product exceeds its risks throughout the product’s life cycle

37
Q

In Singapore, when is submission of existing RMPs mandatory?

A
  1. New Drug Applications
  2. Biosimilars
  3. Anything else if requested (e.g. generic products where existing local RMP already in place for innovators)
38
Q

In Singapore, what are some components of Risk Management Plans by Industry?

A
  1. Letter at launch of product (E.g. special monitoring, serious potential SE to be aware)
  2. Educational materials (E.g. package inserts for both HCP and patient)
  3. PBRER/PSUR
  4. Provision of sales data
  5. Restricted use/access schemes (pdt with serious potential risk, but important role in therapy)
  6. Drug registries (difficult)
  7. Post market clinical studies (difficult)
39
Q

In RMPs by industry, what are some key features of Restricted Access Scheme?

A
  1. Patients: selected group, informed consent
  2. Physician: Undertaking, supply to only Registered personnel
  3. Pharmacists: Undertaking
  4. Company: provide regular sales data and updated physician’s list to HSA
40
Q

List of restricted use/access programs in Singapore

A
  1. Restriction on use:
    - Tegaserod (discontinued?)
    - Aprotinin (discontinued 2015)
    - Rosiglitazone (discontinued 2019)
  2. Pregnancy Prevention Program:
    - Pomalidomide
    - Lenalidomide
    - Isotretinoin (teratogenicity concern)
41
Q

In US, describe the program that controls the use of Thalidomide

A

Program: Thalomid Risk Evaluation and Mitigation Strategy (REMS)

Includes:

  • Pregnancy test
  • Proper counselling
  • Double protection against pregnancy when taking drug
  • Limited qnty dispensed per visit to prevent abuse
  • Close monitoring by HCP
42
Q

Describe the program that controls the use of Thalidomide analogues in Singapore

A

i-access Program (under pregnancy prevention program)

Before Rx/Dispensing:

  • Prescriber to register manually. or via i-access
  • Pharmacy or dispensing clinic to register as well
  • One-time registration with Celgene required before Rx/dispensing thalidomide analogues
43
Q

The overview of i-access program in Singapore for

  1. Women of child bearing potential
  2. Men/Women of Non-childbearing Potential
A
  1. Women of child bearing potential:
    - Patient agreement form (1st Rx) + negative pregnancy test
    - Prescribing drugs: submit preg test results and Rx form
    - Refer patient to i-access registered pharmacy (dispesngin allowed only after Celgene authorise it)
    - Max 1 box (21 caps)
  2. Men/Women of non-child bearing potential:
    - Same as above, w/o preg test results
    - Max 2 boxes (42 caps) dispensed at a time
44
Q

Briefly describe how are CAR-T cells prepared

A
  1. Extract WBC, filter T-cells, cryopreserve
  2. Reprogram T cells with inactive virus
  3. Expansion
  4. Quality check
  5. Lymphodepleting chemotherapy to help patient’s body accept reprogrammed CAR-T
  6. Infuse CAR-T
45
Q

Potential SE of CAR-T Cells

A
  1. Neurotoxic
  2. Attack own cells (On target, off tumour toxicity)
  3. Allergy/Anaphylaxis
  4. Cytokine Release Syndrome
  5. insertional Oncogenesis

Compliance CA2 Revision (5 decks)

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