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Clinical Pharmacology > Pharmacovigilance and Pharmacogenetics > Flashcards

Pharmacovigilance and Pharmacogenetics Flashcards

1
Q

What is pharmacovigilance?

A

The identification, assessment and subsequent prevention of adverse drug reactions, whilst optimising the benefits of the drug

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2
Q

Who’s responsibility is it to report and identify ADR’s for pharmacovigilance?

A
  • Prescribers
  • Clinicians
  • Patients
  • Carers
  • Pharmaceutical companies
  • MHRA
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3
Q

How many cases of an ADR would need to be reported before anything was done about it today?

A

10 cases internationally

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4
Q

What ADR’s are classed as serious?

A
  • Fatality
  • Life threatening
  • Prolonged hospitalisation
  • Long term disability
  • Congenital abnormalities
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5
Q

What are adverse drug reactions?

A

Unintended and noxious reactions that attributable to the therapeutic actions when given within normal therapeutic range

(any drug outside of TW can cause ADR)

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6
Q

What are the differences between Type A (augmented) and Type B (bizzare) adverse drug reactions?

A
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7
Q

What are some other classifications of ADRs that have been proposed?

A
  • Chronic
  • Delayed
  • End of use
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8
Q

What is the ADR associated with the drug Diethylstilboestrol? (drug used to prevent premature labour)

A

An increase in vaginal cancer in those exposed to the drug in utero

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9
Q

What are the 4 broad mechanisms of action for ADRs?

A
  • Exaggerated response of drug
  • Desired pharmacological effect at an alternative/ additional site e.g. GTN spray for headache
  • Additional/ secondary pharmacological effect
  • Triggering an immunological response (anaphylaxis)
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10
Q

What are the limitations of pre-marketing clinical studies for identifying ADRs?

A
  • Small number of patients
  • Limited by age and/ or gender (typically male volunteers)
  • Selected participants for precise diagnosis i.e. clinical trials use ‘ideal patients’ not always representative of the entire population
  • Short, well defined duration of study
  • Specialist doctors and continuous follow up
  • Co-comitant therapeutics usually excluded
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11
Q

Why is relative risk of and ADR not always a good indicator of how common ADR’s are?

A

Depends on the baseline risk

A smaller relative risk in a population that has a high baseline risk gives more added cases!

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12
Q

What scheme is in place to report ADRs?

A

Yellow card reporting scheme

Used in both recently introduced (all suspected ADRs even minor ones reported) and well established products (serious and unexpected)

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13
Q

What is the black triangle on drug products?

A

Warning on new drugs or newly repurposed drugs that prompts extra vigillence when prescribing

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14
Q

What are the advantages and disadvantages of the yellow card reporting scheme?

A

Advantages:

  • Simplicity
  • Timely and theoretically inexpensive
  • Detects both common and rare reactions
  • Accessible by all HCPs, patients and carers

Disadvantages:

  • inevitable under reporting
  • Positive bias to serious reactions/ new drugs
  • Duplication
  • Incomplete poor quality data
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15
Q

What is pharmacogenetics?

A

How an individual gene may affect the response to a drug or the drugs effect on the body

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16
Q

What is pharmacogenomics?

A

The whole genome and the effects is has on drugs (epigenetics)

17
Q

Why is it important to consider pharmacogenetics?

A
  • person-person variability in drug response contributes to 7% of serious ADRs
  • Drug reactions leading to hospital deaths may be related to pharmacogenetics
  • Helps understand why a patient may not respond to therapeutics
18
Q

Explain how patient care of patients prescibed Abacavir has changed following identification of pharmacogenetics

A

Abacavir associated with hypersensitivity in patients with HIV with identified split antigen

Screening for split antigen redueced hypersensitivty reactions by 75%

19
Q

Explain how patient care has improved for patients taking carbamazepine based on pharmacogenetics?

A

Carbamazepine reaction causes Steven-Johnson syndrome in patients identified to have a certain split antigen predominantly found in Asian patients

20
Q

Why are ACEi/ ARB not the primary choice of antihypertensives in African Caribbean populations?

A

Afro Caribbeans have low levels of RAAS

Angiodema more prevelent in Afro-Caribbeans (ADR to ACEi)

21
Q

How can pharmacogenetic differences effect drug prescribing?

A
  • May need a different drug
  • May need higher doses of a drug for therapeutic effect
  • May not respond at all
22
Q

What is the effect of 6% of Caucasions carrying 2 null alleles to CYP2D6 at gene locus 19?

A
  • decreased first pass metabolism - metoprolol → bradycardia can result as reduced metabolism
  • Re-routing of metabolism - paracetamol can cause form toxic NAPQI intermediate

Clinical Pharmacology (25 decks)

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