lecture 11 - medicine regulations Flashcards
1
Q
role of Medsafe
A
- responsible for administering Medicines Act 1981 and Regulations 1984
- Medicines assessment advisory committee (MAAC) = content to market drugs
- Medicines classification committee (MCC) = classification of medicines
- Medicines adverse reaction committee (MARC) = regulation and safety
- education, information
- quality and safety of manufacturing
2
Q
products that Medsafe regulates
A
• medicines (products that have a pharmacological effect and used in humans for primarily
therapeutic purpose)
• medical devices (exert therapeutic effects by physical means)
3
Q
products that Medsafe doesn’t regulate
A
- complementary and alternative medicines
- dietary supplements
- supplemented foods
- cosmetics
4
Q
pre-marketing approval
A
- new medicines need consent from Minister of Health
- changed medicines need consent of Director-General of Health
- MAAC provides advice to Minister of Health on benefits/risks of new medicines
5
Q
medicine classification
A
MCC recommends as:
- prescription medicines
- restricted medicines
- pharmacy-only medicines
6
Q
considerations when classifying medicines
A
- policy
- convenience
- therapeutic index
- toxicity and abuse potential
- risks of inappropriate use
- risk of communal harm
7
Q
define pharmacovigilance and its goals
A
- monitoring of medicines after they are in the market — monitoring safety
- by MARC
goals
- identify previously unrecognized hazards
- evaluate changes in risks and benefits
- take action to promote safer use
- provide info to health professionals
8
Q
reporting of suspected adverse reactions
A
- reported to Centre for Adverse Reactions Monitoring (CARM)
- anyone can report when reaction suspected
- determine if previously unknown adverse reaction, change in frequency or severity of known side-effect
- Medsafe committee analyses data to determine if action is required (changes to warnings, restricts conditions medicine can be used for, change in legal status of medicine, ask pharmaceutical company to commission a study, removal of medicine from market
9
Q
role of Pharmac
A
- manages pharmaceutical schedule
- manage the subsidy of medicine in public hospitals
- manage special access programmes
- promotes best use of medicines
10
Q
restrictions on the availability for some medicines
A
- special authority medicines = prescriber requires government subsidy for particular individual
- specialist only medicines = only subsidised if prescribed by appropriate specialist
11
Q
pharmac doesn’t fund….
A
- drugs outside schedule
- unregistered medicines
- partly subsidised medicines
- exceptions to these if requested
12
Q
process for evaluation of medicines
A
- receipt of proposals
- medical advice -PTAC
- economic assessment
- prioritisation for funding
- negotiation
- consultation
- decision
- implementation
13
Q
special authority medicines
A
prescriber requests government subsidy for a particular individual
14
Q
specialist only medicines
A
only subsidised if prescribed by the appropriate specialist
