Medicine regulation in NZ Flashcards
What are the two regulatory bodies of medicines in NZ?
Pharmac and medsafe
What are the roles of medsafe? (5)
MAAC- to determine whether the drug should become available by looking at the pre market
MCC- classification of medicines
MARC- regulation and safety
education and information; quality and safety of manufacturing
What does medsafe regulate and what does it not?
Does:Anything that pharmacologically or physically causes therapeutic effect
Does not: complementary and alternative medicines, dietary supplements, supplemented foods, cosmetics
What new legislation is currently being sorted about supplements?
Will check that these are safe to use, do what they say they do and contain what they say they do.
People who make their own and give to people in a consultation are exempt unless selling over the counter
What is pharmacovigilance?
Monitoring the safety of marketed medicines
and taking action to reduce risk and promote safe
use, thereby protecting public health.
Done by MARC
if you notice an adverse reaction to a drug who do you go to?
CARM. Do not have to have evidence, just suspicion.
Medsafe will then analyse to determine if the signal is real and will undergo a risk benefit assessment.
What do pharmac do?
Fund medicines. Essentially to provide the best health outcomes from pharmaceutics within the funding available.
Manages the pharmaceutical schedule; manages the subsidy of medicines in public hospitals.
What are the roles within pharmac?
PTAC: Funding proposals can be initiated by anyone, an these go through the pharmaceutical and therapeutics advisory committee who provide medical advice.
Economic assessment, best value per dollar spent
Pharmac board or delegate makes decision following wide consultation
CAC
