Adverse drug reactions

Question 1

What are the current drug regulation systems?

Answer 1

minister or europe
commission on human medicines
- advice on applications for national and eu marketing authorisations
- promotes reporting through the yellow card scheme
- advice on new safety issues
- expert advisory groups
all supported by MHRA

Question 2

How are drugs licensed in the UK?

Answer 2

drug licensing = marketing authorisation

• required before medicine can be used in UK
• relates to manufacture, distribution and supply

3 hurdles to jump through:

1) quality
2) safety
3) efficacy

Question 3

What is NOT a drug licensing issue?

Answer 3

cost effectiveness

Question 4

How are drugs licensed in Europe?

Answer 4

approval overseen by european medicines agency
evaluate applications for marketing authorisation
- biological drugs; gene therapy
- new active substances for AID, cancer, diabetes, ND, autoimmune disorders
- orphan medicinal products

Question 5

What does it mean by unlicensed drugs?

Answer 5

not licensed for use in the UK

• if the clinical need cannot be met by a licensed medicine
• use could be supported by evidence and experience for its safety and efficacy

Question 6

What does off-label use mean?

Answer 6

prescribing a medicine for use outside the terms of its license

• use of a different dose or prescribed for a different indication
• up to 1/5 medicines use is probably off label - especially in paeds, psychiatry and palliative care

Question 7

What is the WHO definition of adverse drug reaction?

Answer 7

response to a drug which is noxious and unintended and which occurs at doses normally used in man for the prophylaxis, diagnosis or therapy of a disease or for the modification of physiological function

Question 8

What are some examples of important ADRs?

Answer 8

erythema multiforme
drug induced lupus
torsades de pointes

Question 9

What are the 2 traditional types of ADRs?

Answer 9

1) type A = sometimes referred to as augmented reactions - dose-dependent and predictable on the basis of the pharmacology of the drug
2) Type B = bizarre reactions- which are idiosyncratic and not predictable on the basis of the pharmacology

Question 10

What is the DoTS classification?

Answer 10

classifies reactions dependent on the…

• dose of the drug
• time course of the reaction and
• relevant susceptibility factors (genetics, pathological, other biological differences)

it is useful in helping to determine diagnosis and prevention of ADRs in practice

Question 11

How can you determine if the ADR was due to the drug?

Answer 11

“challenge” = . at or after the treatment was started

“de-challenge” = stopped when treatment stopped

“re-challenge” - began again on re-starting

Question 12

How should you deal with ADRs?

Answer 12

stop the suspect drug(s) OR
pause the suspect drug(s) OR
reduce the dose of the suspected drug

and treat the symptoms and also important to consider why the drug was being given

Question 13

What is icatibant used to counteract?

Answer 13

ACE inhibitor causing ADR

- tx for life threatening angiooedema affecting airway/ head and neck

Question 14

What is idarucizumab used to counteract?

Answer 14

dabigatran causing ADR

- antidote for the reversal of direct oral thrombin inhibitor

Question 15

What is IV lipid emulsion used to counteract?

Answer 15

local anaesthetics

- treatment for local toxicity for example severe cardiotoxic effects

Question 16

What is pharmacovigilance?

Answer 16

science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug related problem

important for public health programmes for providing reliable, balanced info for effective assessment of risk-benefit of medicine over product lifetime

Question 17

What should suspected adverse drug reactions be reported to?

Answer 17

yellow card scheme - includes suspected ADRs due to misuse, overdose, medication errors or from use of unlicened and off label medicines

Question 18

What other important approaches to pharmacovigilance are there?

Answer 18

case reports in scientific literature 
cohort studies 
case control studies 
disease registers 
record linkage schemes