Lecture 11: Medicine Regulations in NZ

Question 1

roles of medsafe?

Answer 1

1. classification of medicine
2. consent to market
3. regulation and saftey
4. education and information
5. quality and saftey of manufacturing

Question 2

medicine definition?

medical device definition?

Answer 2

“A product that has a pharmacological effect and is used by humans primarily for therapeutic purpose”

“A product that exerts their therapeutic effect by physical rather than pharmacological means”

NB: Therapeutic purpose includes treatment, diagnosis and prevention of disease or the modification of a physiological function

Question 3

Medsafe considers what when defining a product?

Answer 3

1. ingredients
2. intended use
3. marketing
4. sometimes dose (eg. Folate)

Question 4

Pharmacovigilance?

4 goals?

Answer 4

“monitoring of the safety of marketed medicines and taking action to reduce risk and promote safe use, thereby protecting public health.”

1. identify previously unrecognised hazards
2. evaluate changes in risk and benefit
3. take action to promote safer use
4. provide optimal information to health professionals

Question 5

Where to report adverse reations and what to report?

Answer 5

CARM -(centre for adverse readctions monitoring)

• record any SUSPECTED adverse effect even if there is no strong evidence for it
• record patients details and their conditon and the medicines they are on.

Question 6

Pharmac roles?

Answer 6

1. manages thepharmaceutical schedule
2. manages subsidy of medicines in public hospitals
3. manages the special access programmes
4. promotes the best use of medicines

Question 7

restrictions on subsidy?

Answer 7

special authority medicines

-prescriber requests government subsidy for a particular individual

specialist only medicine

• on subsidised if prescribed by the appropriate specialist

Question 8

Where to look to see if a drug is funded by pharmac?

What drugs are not funded?

restricions on medicines?

Answer 8

Pharmaceutical schedule

1. drugs outside the schedule
2. unregistered medicines
3. prescriber restrictions
4. indication restrictions
5. local restrictions

Question 9

Medsafe components

Answer 9

MAAC

• medicine assessement advisory committee
• advises MOH on risks + benefit of new drug

MCC

• medicine classification committee
• classifies into prescription, restricted and pharmacy only

MARC

- medicine adverse reactions committee - CARM

MRC

• education and info
• quality and saftey of manufacturing

Question 10

Unregestered drug use?

Answer 10

under section 29 of medicines act

• supplier must notify the Director-General of health (via medsafe)
• detailed records must be kept
• the patient muct be fully informed