Lecture 15 Flashcards
What is a Medicine?
- for human beings for a therapeutic purpose
- pharmacological, immunological means
Meaning of therapeutic purpose?
- preventing, diagnosing, monitoring, alleviating, treating, curing, or compensating for, a disease, ailment, defect, or injury
- influencing, controlling, or preventing conception
- testing for pregnancy
Classification of Medicines
- prescription medicine
- restricted medicine
- pharmacy-only medicince
- general sale medicines
How are medicines classified?
- according to their active ingredients
Prescription Medicines
sold only under a prescription
Restricted Medicine
sold by a pharmacist in a pharmacy or hospital
Pharmacy only Medicine
sold in a pharmacy or hosptial
Factors to consider when considering classification
- Indications and dose
- Presentation
- Consumer benefits
- Contraindications and precautions
- Undesirable effects
- Overdose
- Medication errors and abuse/ misuse potential
- Communal harm
- Benefit/risk
- Risk mitigating strategies
Why does medicines needs to be regulated?
manages the risk of avoidable harm associated with the use of medicines by ensuring that medicine meets the acceptable standards of safety, quality and efficacy
What is Medsafe?
Organisation responsible for administering most aspects of the Medicine Act 1981 and its associated regulations in New Zealand
What is post-marketing surveillance?
monitoring the safety of medicines and medical devices in use and removing unsafe products from use
Key activities of regulations of medicines
- control of the manufacturing chain
- control of the distribution chain
- Pre-market evolution and approval
- Post-market surveillance
- Control of access to medicines
