Lecture 12; Medicine regulations in NZ Flashcards
What are the categories of classified medicines?
Three classification
- Prescription medicine
- Restricted medicine (pharmacist only medicine)
- Pharmacy-only medicine
- General sale medicine
How are medicines classified?
- Classified according to their active ingredient
- If more than one active ingredient the most restricted one determines the classification
- Classification changes occur approximately every six months
What is a prescription medicine?
A medicine administered only in accordance with:
- A prescription given by an authorised prescriber, delegated prescriber or a standing order
What is a restricted medicine?
Restricted medicine means a medicine that is declared by regulations made under this act:
- Sold by retail only by a pharmacist in a pharmacy or hospital
- Standing order
What is a pharmacy only medicine?
Pharmacy only medicine may be:
- Sold by retail only in a pharmacy, hospital or on a specifically licensed premise
What is a general sale medicine?
Medicines not listed in the classification schedules are referred to as a general sale medicines.
These medicines may be sold from any outlet.
What factors should be considered for a medicine?
- Harm
- Therepeutic index
- Harmful misuse
- Consumption method
- Benefits / Risks
Why regulate medicines?
Manage the risk of avoidable harm associated with the use of medicines by ensuring that:
- > Medicines meet acceptable standards of safety, quality and efficacy
- > Ensure a standard of persons issuing and manufacturing
What is post marketing surveillance?
Pharmacovigilance
Describe pharmacovigilance?
Monitoring of the safety of marketed medicines and taking action to reduce risk and promote safe use, thereby protecting public health
What are the key activities when it comes to the regulation of medicines?
Key activities:
- Control of the manufacturing chain
- Control of the distribution chain
- Pre-market evaluation and approval
- Post-market surveillance
- Control of access to medicines
What does pharmac do?
- Manages the pharmaceutical schedule
- Manages the subsidy of medicines in public hospitals
- Manages special access programmes
- Promotes best use of medicines
Review the last slide of the lecture
Review the last slide of the lecture
