Medicine's Regulation Flashcards
Why do we regulate medicines?
Safety-drugs post clinical trails
What are the two regulatory bodies in NZ?
Pharmac and Medsafe
What are the three roles of Medsafe?
Medicines assessment advisory committee: consent to market
Medicines Classification Committee: Classification of medicines
Medicines adverse reaction commitee: Regulation and safety
What products does Medsafe regulate?
Medine-has pharmacological effect and is used primarily for a therapeutic purpose and related products (throat lozange)
Medical device- products that exert their therapeutic effect
What does Medsafe not regulate?
Complementary and alternative medicines
Dietary supplements
Supplemented foods
Cosmetics
What are some of the special provisions given to natural therapists?
They can supply certain medicines providing they are supplied following a consultation with a practitioner but these can’t include prescription meds
At what stage does Medsafe first get involved?
Pre market approval for safety quality and efficacy
MAAC
Who decides what is over the counter and what isn’t?
Medsafe
MCC
Can doctors prescribe an unregistered medicine?
Yes but only if detailed records are kept and the patient is fully informed
What is pharmacovigilance and who carries it out?
Monitoring of the safety of marketed medicines and taking action to reduce risk and promote safe use, thereby protecting public health. Done by MARC
What do you do if your patient has an adverse drug reaction?
Report to centre for adverse reactions at medsafe
What are the roles of Pharmac?
Manages the pharmaceutical schedule
Manages the subsidy of medicines in public hospitals
Manages special access programmes
Promotes best use of medicines
Where do you find out which medications are funded?
Pharmaceutical schedule and nz formulary
What are special authority medicines?
Prescriber requests government subsidy
What are specialist only medicines?
Only subsidised if prescribed by appropriate specialist
