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LIFE207 > Drug Safety > Flashcards

Drug Safety Flashcards

1
Q

What is pre-clinical testing?

A

Where pharmaceutical companies trial drugs for toxicity in a number of tissue in vitro or in vivo

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2
Q

What does drug licensing require?

A

Requires 2 rodent species and 1 non-rodent species through intra-venous, intra-peritoneal or oral dosing

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3
Q

What are Phase 1 trials?

A

20-100 healthy volunteers are given the drug to assess the pharmacokinetics and to determine dosing regiments and safety

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4
Q

What are Phase 2 trials?

A

100-500 patients with the disease/condition given the drug

Looks at efficacy and side-effects

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5
Q

What are Phase 3 trials?

A

1000-5000 patients given the drug

Assesses long-term use and its efficacy - better than best current treatment?

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6
Q

How much does it cost to fully develop a drug?

A

≈1Bn pounds

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7
Q

How long does it take to develop a drug?

A

12-15 years

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8
Q

What are adverse drug reactions?

A

It is a response to a medicinal product which is noxious and unintended

This event has at least reasonable probability

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9
Q

What are type A adverse drug reactions?

A

Exaggeration of a drugs normal pharmacological actions when given the usual recommended dose

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10
Q

What’s an example of a type A adverse drug response?

A

Respiratory depression with codeine in CYP2D6 ultra-rapid metabolisers

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11
Q

What are type B adverse drug reactions?

A

Move, responses that are unexpected/unpredictable from the known pharmacological actions of the drug. May only be discovered after the drug has already been made available for general use

These are rare; 1:100,000 patients

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12
Q

Give 2 examples of type B ADRs.

A

Anaphylaxis with penicillin

Skin rashes with antibiotics

Typically immune mediated

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13
Q

What are type C ADRs?

A

Persist for a relatively long time after drug withdrawal

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14
Q

What are type D ADRs?

A

Become apparent some time after use. Timing may make them more difficult to detect

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15
Q

What are type E ADRs?

A

Associated with the withdrawal of the medicine

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16
Q

What are idiosynchratic ADRs?

A

Type B adverse drug reactions - off target

17
Q

What was thalidomide originally - then laterally - marketed as?

A

A sedative/hypnotic

Later marketed to alleviate morning sickness

18
Q

What did thalidomide cause?

A

Teratogen

Inflammation of fat cells under the skin

19
Q

How long is the exclusivity license after a drug is marketed for general use?

A

15 years

20
Q

What % of drugs have been withdrawn over safety concerns over past 20 year?

A

4% of all licensed drugs

21
Q

What effects does ADRs have on pharmaceutical companies?

A

Risk of ADRs make them more cautious and hence less inventive for new ideas

Prevent potentially good drugs from getting to the market and helping patients who could benefit

22
Q

What is cervastatin?

A

A lipid lowering drug

23
Q

Why was cervastatin removed from the market?

A

52 deaths reported from kidney failure - rhabdomyolysis - post marketing

24
Q

How many hospital admissions are because of ADR?

A

6-7%

25
Q

How many patients develop ADR prolonging it?

A

10-20%

26
Q

How many deaths per annum in the USA due to ADRs?

A

100,000 deaths per annum

27
Q

How much do ADRs cost the NHS every year?

A

£2.2Bn per year

28
Q

Why can’t idiosynchratic ADRs be predicted?

A

Preclinical animal and cell toxicity screens are not representative of human mechanism

ADRs are rare and not observed until wider use of drug - 10k-100k patients

29
Q

How can ADRs be predicted better?

A

Better “humanized” animal models

Pre-treatment predictive bio-markers

30
Q

Why did 5/15 healthy volunteers die in trials for Fialuridine?

A

Because animal model of liver toxicity was not representative of human

31
Q

What models are out there currently that give a better picture for detecting potential ADRs?

A

‘Humanized’ mouse liver

3D models

Tissue culture models

Tissue-organ models

32
Q

What is abacavir? What were it’s ADRs?

A

A reverse transcriptase inhibitor used in HIV treatment

Hypersensitivity syndrome
~9% of patients showed this after first 6 weeks

Symptoms include:
Fever
Fatigue
GI and respiratory problems

33
Q

What is hypersensitivity caused by abacavir strongly associated with? What did this cause?

A

Strongly associated with genetic variant HLA-B* 57:01

Patients screened beforehand reduced incidence of hypersensitivity to 0%

Screening is now mandatory before receiving abacavir

PPHARMACOGENOMICS

LIFE207 (9 decks)

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