S1.1 Safe Prescribing and Medicine Errors

Question 1

Outline the main prescribing problems of drugs

Answer 1

Patient related: drug interactions, sicker/older patients vulnerable to side effects
Pharmaceuticals: side effects only seen later as trials usually on healthy patients
Doctor-related: sleep deprived, bad handwriting on prescriptions

Question 2

What do you need to confirm before writing a prescription?

Answer 2

Drug name, dose, strength, frequency, allergies, adherence

Question 3

What are black triangle drugs?

Answer 3

An intensively monitored drug which may be newly released or have changed formulas.

Question 4

What is a serious reaction?

Answer 4

Something that results in or prolongs hospitalisation but also includes reactions that are fatal, life-threatening or disabling.

Question 5

What is the discovery research stage of medicine development?

Answer 5

4 years
Biological testing
Testing of pharmacology and toxicology

Question 6

Outline the phase 1 stage of medicine development

Answer 6

1 year

Testing 50 healthy volunteers to evaluate pharmaco-kinetics and safety

Question 7

Outline the phase 2 stage of medicine development

Answer 7

2 years

Testing 200-400 patients with the disease to evaluate pharmacology

Question 8

Outline the phase 3 stage of medicine development

Answer 8

4 years

Testing 1000-3000 patients to evaluate efficacy

Question 9

What is the regulatory review of medicine development

Answer 9

1 year

Authority review of efficacy and safety

Question 10

Outline the phase 4 stage of medicine development

Answer 10

Seeks new indications and formulations