Lecture 13: Medicine Regulations in NZ

Question 1

MOH

Answer 1

Medsafe: MAAC, MCC, MARC (– CARM) and MRC
Pharmac (PTAC, CAC) –> Pharmaceutical schedule
- pharmac has global and general funding

Question 2

Regulation of medicine

Answer 2

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

Question 3

Roles of Medsafe

Answer 3

1. MAAC (assessment advisory com.) –> consent to market (approvals)
2. MCC (classification com.) –> classification of medicines and how medicines become available
3. MARC (adverse reaction com.) regulation and safety
4. Education and information
5. Quality and safety of manufacturing

Question 4

What products does Medsafe regulate?

Answer 4

1. Medicines (pharmacologic effect and used in humans primarily for a therapeutic purpose)
2. Medical devices ( products which exert their therapeutic effect via physical rather than physiological means)
3. Related products (throat lozenges, contact solution, some toothpastes)

Question 5

Therapeutic purpose of Medsafe medicine and medical devices

Answer 5

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

Question 6

What doesn’t Medsafe regulate

Answer 6

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

Question 7

What determines whether a product is a medicine, dietary supplement, food or cosmetic?

Answer 7

1. Ingredients
2. Intended use
3. How it is marketed

Question 8

Natural therapists Special provisions

Answer 8

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)

Question 9

Legislation for supplements

Answer 9

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

Question 10

What supplements are exempt from the Natural health and supplementary products bill?

Answer 10

products which are made by a practitioner for an individual patient
Note: not exempt if sold over the countre

Question 11

How does Med safe regulate medicine availability?

Answer 11

1. PRE-market approval (MAAC)
   - safety, quality and efficacy (after phase 3)
   - supply chain
2. Control of access to medicines
   - medicines classification: prescription, restricted, pharmacy only, general sales
3. MCC
4. Considerations

Question 12

Premarketing approval of a drug

Answer 12

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

Question 13

MAAC

Answer 13

Medicines Assessment Advisory committee

- advices MOH on risks and benefits of New medicines

Question 14

MCC

Answer 14

recommends classification of drugs to be
- prescription medicines
- restricted medication 
- pharmacy only medications 
under this act

Question 15

What are some considerations which are thought about during a drugs pre-marketing approval?

Answer 15

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

Question 16

Unapproved/Unregistered medicines

Answer 16

medicines w/o MOH consent for sale, distribution of marketing

Question 17

Can you prescribe an unapproved medicine?

Answer 17

1. Section 29 of Medicines Act: allows sale or supply of unapproved medicines (have trailed and proved to be effective but arent registered.
2. Section 25 of Medicines Act: allows use of unapproved medicines
   - but patient cannot bring it in themselves and give it to people

Question 18

Pharmacovigilance

Answer 18

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

Question 19

Goals of pharmacovigilance

Answer 19

1. Previously unrecognised hazards or signals (are identified)
2. Evaluate changes in risk and benefits
3. Action taken to promote safer use of medications
4. Health professionals to be provided with optimal information

Question 20

What drugs can often cause allergic reactions?

Answer 20

NSAIDs

Question 21

CARM reporting

Answer 21

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.

Question 22

Spontaneous Adverse Reaction reporting

Answer 22

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

Question 23

Medsafe response

Answer 23

1. Analyse data to determine if safety signal is real
2. undertake a risk-benefit assessment –> assess if action is required (MARC)
3. 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

Question 24

Medsafe monitoring safety issues

Answer 24

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

Question 25

Medsafe Post Marketing surveliance

Answer 25

1. Pharmacovigilence - medicine safety monitoring - MARC 2. Investigation and Enforcement activities - compliance w. Medicines Act 1981 - illegal import - adulterated and counterfeit medicines - unapproved medicines

Question 26

Medicine Regulations in the future

Answer 26

NZ and AUS collaboration failure: ceased to establish a JTPR Joint Therapeutic Product Regulator

Question 27

Funding of medicines

Answer 27

PHARMAC has to make dispassionate decisions about How to spend their limited budget whilst having lots of people advocating for their medicines

Question 28

Pharmac components

Answer 28

PTAC (Pharmacology and Therapeutics advisory comm.) + CAC (Consumer advisory comm.) --> Pharmac --> Pharmaceutical schedule ** diagram

Question 29

Roles of Pharmac

Answer 29

1. Manages pharmaceutical schedule 2. Manages public hospital subsidy of medicines 3. Management of Special Access programmes 4. Promotes best use of medicines

Question 30

2000-2010 expenditure of pharmac

Answer 30

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

Question 31

NZ public health and disability act 2000

Answer 31

to secure for eligible people in need of pharmaceuticals, the best health outcomes that are reasonably achievable for pharmaceutical treatment within the funding available

Question 32

New Pharmac criteria

Answer 32

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)

Question 33

Process of evaluation of medicines

Answer 33

**

Question 34

How can you see if a pharmacetuical is subsidised?

Answer 34

Look at the pharmaceutical schedule | Note: drug interaction and medicine information also available on NZ formulary

Question 35

Restrictions on medication's subsidisation availability

Answer 35

1. Specialist only medicines (only subsidised if prescribed by an appropriate specialist) 2. Special authority mediication (only subsided by government if individual fulfils criteria) - e.g IUD funding if anaemic. no funding if for contraceptive use only

Question 36

Do restrictions apply to inpatients?

Answer 36

DHB hospitals have same funding regime

Question 37

What medicine resictions are there

Answer 37

1. prescriber restrictions 2. indication restrictions 3. local restrictions

Question 38

What doesnt pharmac fund?

Answer 38

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

Question 39

Exception drugs which pharmac will fund

Answer 39

**

Question 40

Other activities carried out by pharmac

Answer 40

***