Lecture 11 - Regulation of Medicines

Question 1

Definition of medicine?

Answer 1

something with pharmalogical effects primarily for a therapeutic purpose

Question 2

Definition of medical device?

Answer 2

products exerting therapeutic benefit via physical rather than pharmacological means

Question 3

Matter of dosage - Folic acid?

Answer 3

less than 300mcg is supplement, more han 500mcg is medicine, between is regulated supplement

Question 4

Pre-market approval?

Answer 4

new medicines need consent of Minister of Health, changed medicines need consent of Director-General of Health

Question 5

Use of unapproved medicines?

Answer 5

Director-General of Health must be notified, detailed records must be kept, patient must be fully informed

Question 6

Pharmacovigilance definition?

Answer 6

monitoring safety of marketed medicines and taking actions to reduce risk and promote safe use, protecting public health

Question 7

Medsafe response if adverse effect safety is concerned?

Answer 7

information to healthcare professionals, changes to warnings, restrictions of viable conditions

Question 8

Process of medicine evaluation - consider evidence?

Answer 8

receipt of proposals, medicine advice - PTAC

Question 9

Process of medicine evaluation - Assess relative value?

Answer 9

economic assessment, prioritisation of funding, negotiation

Question 10

Process of medicine evaluation - Outcome?

Answer 10

consultation, decision, implementation

Question 11

Special authority medicines?

Answer 11

prescriber requests government subsidy

Question 12

Specialist only medicines?

Answer 12

subsidised if prescribed by appropriate specialist