Lecture 13: Medicine Regulations in NZ Flashcards
MOH
Medsafe: MAAC, MCC, MARC (– CARM) and MRC
Pharmac (PTAC, CAC) –> Pharmaceutical schedule
- pharmac has global and general funding
Regulation of medicine
Medsafe:
“Medsafe’s mission is to enhance the health of NZ by REGULATING MEDICINES and MEDICAL DEVICES to maximise safety and benefit”
Medsafe is also responsible for administering the Medicines act of 1981 and Regulations 1984
Roles of Medsafe
- MAAC (assessment advisory com.) –> consent to market (approvals)
- MCC (classification com.) –> classification of medicines and how medicines become available
- MARC (adverse reaction com.) regulation and safety
- Education and information
- Quality and safety of manufacturing
What products does Medsafe regulate?
- Medicines (pharmacologic effect and used in humans primarily for a therapeutic purpose)
- Medical devices ( products which exert their therapeutic effect via physical rather than physiological means)
- Related products (throat lozenges, contact solution, some toothpastes)
Therapeutic purpose of Medsafe medicine and medical devices
includes treatment diagnosis and prevention of disease or the modification of a physiological function
- includes cleaning, soaking or lubricating contact lenses, effecting contraception or inducing anaethesia
- the claim that this product treats a certain conditio
What doesn’t Medsafe regulate
Complementary and alternative medicines (no therapeutic purpose)
Dietary supplements
Supplemented foods
Cosmetics
- these have no legal constraints
- difference b/w supplements and medications can be v. subtle e.g Folic acid (for reducing risk of spinabifida and neural tube defects) 800mg= prescription, but <500g is a supplement
What determines whether a product is a medicine, dietary supplement, food or cosmetic?
- Ingredients
- Intended use
- How it is marketed
Natural therapists Special provisions
Can manufacture, pack, label, sell by retail, or supply certain medicines (“general sale medicines” which arent regulated by med safe)
providing they’re supplied to an individual Following a consultation with a practitioner
Cant include prescription, restricted or pharmacy only medicine
- cannot shelve
- cannot already be a prescription medication (i.e. cannot repackage codeine or thyroxine)
Legislation for supplements
Natural health and supplementary products bill
- new regulatory regime, separate from food and medicines
Ensures that natural health and supplementary products are:
- safe to use
- have true health claims
- are made with and contain substances which the label identified
What supplements are exempt from the Natural health and supplementary products bill?
products which are made by a practitioner for an individual patient
Note: not exempt if sold over the countre
How does Med safe regulate medicine availability?
- PRE-market approval (MAAC)
- safety, quality and efficacy (after phase 3)
- supply chain - Control of access to medicines
- medicines classification: prescription, restricted, pharmacy only, general sales - MCC
- Considerations
Premarketing approval of a drug
New medicines need MOH consent
Changed medicines need consent from Director General of health
MAAC: gives advice to MOH on the benefits and risk of new medicines
MAAC
Medicines Assessment Advisory committee
- advices MOH on risks and benefits of New medicines
MCC
recommends classification of drugs to be - prescription medicines - restricted medication - pharmacy only medications under this act
What are some considerations which are thought about during a drugs pre-marketing approval?
policy convenience therapeutic index toxicity and abuse potential risks of inappropriate use risk of communal harm e.g. paracetamol is classified as relatively easy access as has a wide therapeutic index and doesnt tend to be abused
Unapproved/Unregistered medicines
medicines w/o MOH consent for sale, distribution of marketing
Can you prescribe an unapproved medicine?
- Section 29 of Medicines Act: allows sale or supply of unapproved medicines (have trailed and proved to be effective but arent registered.
- Section 25 of Medicines Act: allows use of unapproved medicines
- but patient cannot bring it in themselves and give it to people
Pharmacovigilance
MARC
medicine safety monitoring
“monitoring of the safety and marketed medicines and taking action to reduce risk and promote safe use, thereby protecting public health”
Note: as some adverse effects of medicines wont be immediately apparent when they come to the market, and only become apparent once tested on a larger group of people
Goals of pharmacovigilance
- Previously unrecognised hazards or signals (are identified)
- Evaluate changes in risk and benefits
- Action taken to promote safer use of medications
- Health professionals to be provided with optimal information
What drugs can often cause allergic reactions?
NSAIDs
CARM reporting
What: Suspecting a ADR, dont have to have evidence (because if receive enough of these signals, begin to realise that this is a real and consistent adverse reaction)
Who: anyone, but ideally Health professions and Pharmaceutical companies
How: Record patient details and event details, yellow ward form, online, email, post, fax.
Spontaneous Adverse Reaction reporting
Early warning of unrecognised possible hazards
- Previously unknown ADRs
- or a Change in the FREQ or SEVERity of a already known side effect
- **Diagram: Health professionals –> Regulatory agency (Medsafe) and Pharmaceutical company
Medsafe response
- Analyse data to determine if safety signal is real
- undertake a risk-benefit assessment –> assess if action is required (MARC)
- Safety concern is confirmed:
- information provided to healthcare professions and consumers
- warning changes
- available to only restricted conditions who receive significant benefit
More significant concern:
- change in medicines legal status
- ask pharmaceutical company to commission a clinical study
- removal of medicine from market
Medsafe monitoring safety issues
watch out for side effects
e.g. highlights safety concerns identified from reports of suspected adverse medicine reactions sent to CARM
Encourages further reports and increase in information gathering re potential safety signals
Medsafe Post Marketing surveliance
- Pharmacovigilence
- medicine safety monitoring
- MARC - Investigation and Enforcement activities
- compliance w. Medicines Act 1981
- illegal import
- adulterated and counterfeit medicines
- unapproved medicines
Medicine Regulations in the future
NZ and AUS collaboration failure: ceased to establish a JTPR Joint Therapeutic Product Regulator
Funding of medicines
PHARMAC has to make dispassionate decisions about How to spend their limited budget
whilst having lots of people advocating for their medicines
Pharmac components
PTAC (Pharmacology and Therapeutics advisory comm.) + CAC (Consumer advisory comm.) –> Pharmac –> Pharmaceutical schedule
** diagram
Roles of Pharmac
- Manages pharmaceutical schedule
- Manages public hospital subsidy of medicines
- Management of Special Access programmes
- Promotes best use of medicines
2000-2010 expenditure of pharmac
Estimated expenditure is higher than actual expenditure
- Pharmac says that it provides equity of medicine availability
- vs america where all meds are available but only accessable if have correct insurance of enough money
NZ public health and disability act 2000
to secure for eligible people in need of pharmaceuticals, the best health outcomes that are reasonably achievable for pharmaceutical treatment within the funding available
New Pharmac criteria
New set of criteria
determines whether or not theyll fund the medicine
Trying to now account for
1. Need
2. Health benefit
3. Cost and savings (treat obesity instead of diabetes long term) (coronary artery medication to save on future stent/bypass surgery)
4. suitability (appropriate in society)
Process of evaluation of medicines
**
How can you see if a pharmacetuical is subsidised?
Look at the pharmaceutical schedule
Note: drug interaction and medicine information also available on NZ formulary
Restrictions on medication’s subsidisation availability
- Specialist only medicines (only subsidised if prescribed by an appropriate specialist)
- Special authority mediication (only subsided by government if individual fulfils criteria)
- e.g IUD funding if anaemic. no funding if for contraceptive use only
Do restrictions apply to inpatients?
DHB hospitals have same funding regime
What medicine resictions are there
- prescriber restrictions
- indication restrictions
- local restrictions
What doesnt pharmac fund?
Drugs outside the schedule: marketed in NZ but not subsidised. or funded for one reason and not another
Unregisterd drugs
Partially subsidised medicines: price depends on difference b/w subsidised price and manufaturer’s price. + markup size
Exception drugs which pharmac will fund
**
Other activities carried out by pharmac
