L12. Medicine regulation in NZ Flashcards
What are the 5 key areas of regulation of medicines
Control of manufacturing chain, control of distribution chain, pre-market evaluation, post market surveillance and control of access to medicines
What is the key purpose of legislation in regulating medicines
Medicines Act 1981 defines medicines and classifications, regulates approval, manufacture, sale, distribution, advertising, prescribing and dispensing.
It also has licensing requirements for distribution chains and requirements for approval of related products. Post market controls on medicines too
Misuse of Drugs Act 1975- for some substances (eg. morphine)
How are medicines classified?
Where do you find the classifications
According to the active ingredient with the most restrictive classification. Same ingredient can differ in classification based on indication, pack size, where it is sold.
Classifications are based on risks - abuse, delivery, overdose, communal harm, contraindications, consumer benefits, indications and dose.
Classifications on the medsafe database.
Define medicine
Any substance/article that is manufactured, imported, sold, or supplied wholly for administering to 1 or more human beings for a therapeutic purpose
- achieves its principle intended action on/in the human body by pharmacological, immunological or metabolic means
What is a standing order
A protocol of specific circumstances that another healthcare provider can provide prescription or restricted medicine without needing a prescription from doctor or for it to be sold in a pharmacy/hospital.
this is done under the doctors authority
What is the difference between prescription, restricted, pharmacy only medicine and general sale medicine
-Prescripted med: sold by retail only under a prescription from prescriber
-Restricted med: sold only by a pharmacist in a pharmacy/hospital
-Pharmacy only med: sold by retail same as restricted med or in any shop in accordance w a license.
All can be supplied in circumstances corresponding to retail sale only in accordance w a standing order
- General sale medicine: sold by any outlet
What is the role of medsafe
Responsible for administering most aspects of the Medicines Act 1981 and its associated regulations in NZ.
eg. pharmacovigilance, audit and licensing of manufacturers, medicine recalls,
med classification, border control
What is post marketing surveillance
PMS: Monitors the safety of medicines and medical devices in use so that unsafe products are removed from use and prescribers are advised about it.
This is achieved through
-monitoring adverse reactions- CARM reporting, testing meds for quality, handlings complaints, auditing and licensing manufacturers
What is Pharmacovigilance
Monitoring of the safety of marketed medicines and taking action to reduce risk and promote safe use, thereby protecting public health.
- identify unrecognised hazards, evaluate changes in risk and benefits.
Why are medicines regulated
Medicines are regulated to manage the risk of avoidable harm.
- Assures acceptable standards of quality, safety, efficacy (supported by rct),
- Assures pre market evaluation and approval, continued pharmacovigilance
- Standards for manufacture, storage, delivery, distribution
- Info provided for selection and safe use provided to customers and health pro
What does Pharmac do exactly and why
To secure for eligible people in need of pharmaceuticals the best health outcomes that are reasonably achievable from pharmaceutical treatment within the funding available.
Through: managing the pharmaceutical schedule, subsidy of medicines in public hospitals, special access programmes, best use of medicines.
Balances needs of patients, suitability, health benefits to responsibility to taxpayers in a Utilitarian way
