ADR

Question 1

What is ADR?

Answer 1

A response to a medicinal product which is noxious and unintended

Question 2

How are ADR’s classified?

Answer 2

• Rawlins and Thompson

- DoTS

Question 3

Describe Type A of Rawlins and Thompson ADR?

Answer 3

• Dose related
• Common, predictable
• Related to the pharmacology
• Low mortility

Question 4

Give examples of drugs that cause type A Rawlins and Thompson ADR?

Answer 4

Digoxin toxicity
Constipation from morphine
Sedation from a hypnotic

Question 5

Describe Type B of Rawlins and Thompson ADR?

Answer 5

• Not dose related
• Uncommon, unpredictable
• Not related to pharmacology
• High mortality

Question 6

Give examples of drugs that cause type B Rawlins and Thompson ADR?

Answer 6

• Penicillin hypersensitivity
• Malignant hyperthermia
• Hepatitis

Question 7

Can ACE-inhibitor induce angioedema. TRUE OR FALSE?

Answer 7

TRUE

Question 8

ACE-inhibitor induced angioedema is is life threatning, rare and unlikely to to be picked up in clinical trials. TRUE OR FALSE?

Answer 8

TRUE

Question 9

What are the 4 other types of Rawlins and thompson ADR classifications?

Answer 9

-Type C,D,E AND F

Question 10

Describe type C,D,E and F of Rawlins and thompson ADR classification?

Answer 10

Type C - Long term
Type D - Delayed
Type E - End of use (withdrawal)
Type F -Failure of treatment

Question 11

What does DoTS stand for?

Answer 11

• D - Dose
• T - Time
• S - susceptibility

Question 12

Dose (response), When can ADR occur? and provide an example for each occurance.

Answer 12

• At doses below therapeutic doses e.g anaphylaxis with penicillin
• In the therapeutic dose range e.g Nausea with morphine
• At high doses e.g Liver failure with paracetamol

Question 13

Time (course) can be characteristic; with the first dose, early or after a time or with long term treatment or delayed. TRUE OR FALSE?

Answer 13

TRUE

Question 14

Time is relevant to pharmacovigilance and drug development. TRUE OR FALSE?

Answer 14

TRUE

Question 15

Time can be independent or immediate. TRUE OR FALSE?

Answer 15

TRUE

Question 16

provide an example for time-independent?

Answer 16

eg Increased risk of haemorrhage with change in effective dose of warfarin, should monitor closely throughout

Question 17

provide an example for time-immediate?

Answer 17

This is due to rapid administration e.g red man syndrome from vancomycin, therefore infuse slowly

Question 18

What are the increased risks due to with susceptibility?

Answer 18

• Genetic variation
• Age
• Sex
• Physiological variation
• Exogenous factors
• Disease

Question 19

With susceptibility, more than one fcator can be present. TRUE OR FALSE?

Answer 19

TRUE

Question 20

Provide examples of each:

• Genetic variation
• Age
• Sex
• Exogenous factors
• Disease

Answer 20

• Genetic variation - Malignant hyperthermia
• Age - Elderly - hypnotics
• Sex - Mefloquine (used to treat malaria)
• Exogenous factors - Drug intercations/intercations with food
• Disease - Renal insufficiency e.g lithium

Question 21

Provide an example of DoTS with regards to Osteoporosis due to corticosteriods?

Answer 21

• Osteoporosis due to corticosteriods
  Dose - Collateral effect
  Time - Late
  Susceptibility - older people / women

Question 22

Provide an example of DoTS with regards to Anaphylaxis due to penicillin?

Answer 22

Dose - hypersusceptibility
Time - First dose of a course
Susceptibility - Not understood; needs previous sensitisation

Question 23

Provide an example of DoTS with regards to Hepatoxicity due to isoniazid?

Answer 23

Dose - Collateral effect
Time - Intermediate
Susceptibility - Genetics (drug metabolism), age, exogenous (alcohol), disease (malnutrition)

Question 24

Why are ADRs reported?

Answer 24

-Important for patient safety
-Allow continous monitoring of old and new drugs
-Provide data on ADRs to new drugs
-Provide data in special patients groups
(young and old, pregnant and with co-morbidities or polypharmacy)

Question 25

What does the yellow card scheme collect information on?

Answer 25

Collects reports of suspected problems or incidents involving; - ADRs - Medical device adverse incidents - Defective medicines (those that are not of an acceptable quality) - Counterfeit or fake medicines or medical devices

Question 26

What is a serious reaction?

Answer 26

- includes prolonged hospitalisation - fatal - life-threatning - disabling/incapacitating - Cause congenital abnormalities - medically significant

Question 27

Medical significance can be mild, moderate, severe or lethal. TRUE OR FALSE?

Answer 27

TRUE

Question 28

Describe mild (medical significance)

Answer 28

-No antidote or treament is required

Question 29

Describe moderate (medical significance)

Answer 29

- A change in treatment, but necessarily discontinuation of drug - Hospitalisation may be prolonged - Or specific treatment may be required

Question 30

Describe severe (medical significance)

Answer 30

- An ADR is potentially life threatning and requires discontinuation of drug - Specific treament of ADR

Question 31

Describe lethal (medical significance)

Answer 31

-An ADR directly or indirectly contributes to patients death

Question 32

What is the meaning of a black triangle?

Answer 32

-Means intensive monitoring

Question 33

When are medications given a black triangle?

Answer 33

- When contains new active substance - Is a biological medicine - New indications - Has conditional approval - Company been asked for more data

Question 34

What type of reports are the MHRA keen on?

Answer 34

- Children - Over 65s - Biological medicines and vaccines - Delayed ADRs and interactions - Complimentary and herbal medicines