Medicine Management

Question 1

Pre-clinical testing procedures of a new drug

Answer 1

Mechanism of action
Efficacy
Toxicity studies (LD50)
Carcinogenicity (if drug can cause cancer or damages DNA)
Teratogenicity (testing abnormalities in the foetus) - normally tested to lab animals such as fruit flies and rodents

Question 2

Phase 1 and 2 of clinical trials

Answer 2

1. Human safety test by healthy volunteers (few pts) - last days or weeks
2. Expanded safety test by healthy volunteers (hundreds) - last weeks or months

Question 3

Phase 3 of clinical trials

Answer 3

3. Efficacy and safety (thousands of volunteers) - last several years
   Gold standard - randomised, double blind, comparison with placebo and not industry sponsored (publication bias)
   Trial cessation - if evidence of harm was observed and no evidence of benefit

Question 4

A drug with no active agents used for clinical trials

Answer 4

Placebo

Question 5

Phase 4 of clinical trials

Answer 5

4. studies side effects caused over time by a new treatment after it has been approved and is on the market.

Question 6

Who can prescribe medicine according to NZ legislation in Medicines Act

Answer 6

Authorised prescriber (nurse practitioner, optometrist, registered midwife)
Practitioner (medical practitioners)
Designated prescriber (registered health professionals)
Standing orders (written instruction from health services)

Question 7

List the schedules in the Medicines Regulations of NZ legislation

Answer 7

Prescription
Restricted or pharmacist only
Pharmacy only meds
General sale meds

Question 8

Classification of drugs according to NZ legislation in Misuse of Drugs Act (Classification of drugs section 3a)

Answer 8

Class A - drugs that pose a very high risk of harm (cocaine)
Class B - drugs that pose a high risk of harm (oxycodone) - opioids
Class C - drugs that pose a moderate risk of harm (benzodiazepines, codeine)

Question 9

the use of multiple medicines which is common for older population with multi morbidity

Answer 9

Polypharmacy