11 - Medicine regulation in NZ Flashcards
Thalidomide and
congenital abnormalities
EG of why we need monitoring and safety practices
What are the 2 main regulatory authorities
Medsafe - regulates medicines and keeps an eye on safety to maximise safety and benefit. Determines what is available to the public
Pharmac - determines what is funded
What is funded and what is available may not be the SAME but there is overlap
Why is there conflicting domands
Medico-legal consumer + drug company + fixed budget
Roles of Medsafe
- classification of medicines
- consent to market (approval); registered and available in NZ
- regulation and safety via monitoring and surveillance
- education, information, safety and quality of manufacturing
What does medsafe define as a medicine
A product that has a pharmacological effect and is used in humans primarily for a THERAPEUTIC PURPOSE
Medical device?
Products that exert their therapeutic effect by PHYSICAL rather than pharmacological means
What is a therapeutic purpose
Includes the treatment , diagnosis and prevention of disease or the modification of a physiological function
What does Medsafe NOT regulate
- complementary and alternative medicines
- dietary supplements
- supplemented foods
- cosmetics (acne i.e.)
Whether a product is a medicine, dietary supplement, food or cosmetic is determined by:
- ingredients
- INTENDED use
- how it is marketed
- ingredients
- INTENDED use
- how it is marketed
often a matter of dosing i.e. folic acid
Special provisions relating to natural/complementary therapists?
- can manufacture, pack, label, sell, supply certain general sale medicines i.e. what are at supermarkets
- this is providing that they are supplied to an individual following a consultation with the practitioner
- CANNOT include prescription, restriced or pharmacy only medicines
(are bioactive but NOT regulated for safety)
What is the natural health and supplementary products bill?
- new regulatory regime to control low risk natural health products and supplementary products
- intended to ensure they are:
safe to use
that the health claims are true
that they are made and contain what they say they contain
> however products that are by a practitioner for a specific individual patient are EXEMPT from this legislation unless they are subsequently over the counter
What is the pre-market approval?
- new medicines need the consent of the MoH
- CHANGED medicines need consent of the Director-general of health
MAAC?
Medicines Assessment Advisory Committee provides advice to the MoH on the benefits and risks of the new medicines and whether the drug should be registered
Where does medsafe get involved in the drug development process?
End of phase 3 trials and introduction to the market
MCC?
Medicines Classification Committee
Recommends the classification of the medicine i.e. prescription, restricted, pharmacy only.
Some may need a consultation but not a prescription
