ADR - Retrospective

Question 1

What is a retrospective enquiry?

Answer 1

Suspected ADR has already occurred.

Question 2

Summary of ADR

Answer 2

• Has the patient had any previous history of ADR?
• When did the ADR start?
• Symptoms and management
• Tests undertaken to monitor ADR?
• Legality and reporting of the ADR

Question 3

When did the ADR start?

Answer 3

• Time of reaction in relation to:
  starting
  or dose increase of the suspected drug?

Question 4

Symptoms and management

Answer 4

• Obtain a full description of the signs and symptoms of the reaction; clarify reactions such as ‘rash’, ‘abnormal liver function tests (LFTs)’, ‘aching all over’.
• How has the patient been managed so far?
• Has the suspected drug been stopped?
• Did the suspected ADR resolve when the suspect drug was stopped?

Question 5

Tests undertaken to monitor ADR?

Answer 5

• What are the results of any relevant biochemical tests e.g. renal function tests, liver function tests, full blood count, biopsies, relevant ultrasound or screening tests.

Question 6

Legality and reporting of the ADR

Answer 6

• Is the enquirer involved in a legal case?
• Has the manufacturer been informed or a yellow card completed?

Question 7

Has the patient had any previous history of ADR?

Answer 7

• What is the current and previous medical history if relevant, including risk factors for the ADR?
• Is there a history of adverse drug reactions or allergies?