Adverse Drug reactions

Question 1

Define an ADR

Answer 1

an unwanted or harmful reaction experienced following the administration of a drug or combination of dugs, and is suspected to be related to the drug

Question 2

what are the 2 types of ADR?

Answer 2

type A - most common - predictable, dose dependent, manage by reducing dose

type B - unpredictable, not dose dependent, manage by stopping the drug

Question 3

What is the pharmacists role in managing ADRs?

Answer 3

• identify patients at risk of them
• identify common drugs that are known to cause ADRs and monitor
• avoid using drugs that cause ADRs if an equally effective and safer alternative exists
• review medicines, stop unnecessary ones, check interactions.
• report ADRs

Question 4

what patients are at risk of ADRs? identifying them.

Answer 4

• age - young <6 months have a weak immune system and can’t fully metabolise drugs increasing the risk. Also elderly- organs failing, harder to process
• polypharmacy - if patient is on 5 or more drugs - increased risk
• incurrent diseases e.g renal or liver failure
• females
• history of intolerance or hypersensitivity - some are more prone to side effects and if have an ADR for one drug,more likely to get for another too.

Question 5

why is it important to identify and report ADRs?

Answer 5

• clinical trials are not really enough to pick up on serious side effects and represent every person, they are also always based on healthy people who would not necessarily need the drug
• In animal testing- they don’t pick up on mental health reactions
• It is important for post marketing surveillance, in order to identify drug safety information, long term Side effects

Question 6

What is reported ADR information used for?

Answer 6

providing early earnings of unrecognised ADRs
identify predisposing factors
compare drugs in the same therapeutic class
monitor drug safety

Question 7

What is yellow card scheme?

Answer 7

Form of reporting ADRs- anyone can report including the public, pooling HCP and patient experiences to improve patient safety
- online, BNF, app

Question 8

How can ADRs be identified? (3)

Answer 8

• a patient reports a symptom that appears soon after a new drug started
• after dosage increase
• stops when drug is stopped and appears again when it s started again

Question 9

what is required to be reported?

Answer 9

serious ADRs that are: fatal, life threatening, result in hospitalisation, disability, abnormalities, and black triangle drugs

Question 10

What are black triangle drugs?

Answer 10

ALWAYS report ADRs associated with these - these are

• New drug or combination
• new route or delivery system of administration
• new indication