1. Medicines Regulation

2. Warning !! This lecture may prove to be BORING.

3. The Thalidomide Disaster

4. Regulatory Agencies • Food and Drug Administration (USA) • EMEA • Therapeutic Goods Administration (Australia) • Medsafe (NZ)

5. Regulatory Agencies • In the future there will be a single trans Tasman agency responsible for registration of medicines in Australia and New Zealand.

6. Drug Development • Pre-Clinical • Clinical

7. Preclinical Development • Medicinal Chemistry • In Vitro Screening • Animal Studies • Pharmacology • Pharmacokinetics (ADME) • Toxicology

8. Clinical Studies • Phase I Safety and Tolerability (10-20 subjects) • Phase II Proof of Efficacy (100-200 subjects) • Phase III Large Randomised Controlled Trials (May involve several thousand subjects)

10. MAAC • MAAC – Medicines Assessment Advisory Committee. • Considers efficacy and safety. • Makes recommendation to Minister of Health on whether consent should be granted to market the medicine (registration).

11. Off License Prescribing • Pharmaceutical companies need to seek separate approval for each new indication for a medicine. • Companies can only promote approved indications for a medicine. • OFF LICENSE PRESCRIBING When doctors prescribe a medicine for an indication that is not approved. .

12. Medicines Classification • Prescription Medicines • Over the Counter Medicines

13. Over The Counter Medicines • General Sale • Pharmacy Only Medicines • Restricted Medicines

14. Herbal Medicines • They do not have to go through the same regulatory process of medicines. • No therapeutic claims can be made for them. • Medsafe can remove them from the market if there are concerns about safety

15. Herbal Medicines • Natural does not necessary mean safe e.g. comfrey - veno-occlusive disease royal jelly - anaphylaxis aristolochic acid - renal failure • Also be aware of interactions e.g. St John’s Wort

16. Pharmaceutical Schedule • PHARMAC Pharmaceutical Management Agency. • PTAC Pharmacology and Therapeutics Advisory Committee.

17. Pharmaceutical Schedule • Not all of the medicines that are marketed in New Zealand are funded through the Pharmaceutical Schedule. e.g. Bupropion - smoking cessation Finasteride - baldness Sildenafil - erectile dysfunction

18. PHARMAC Successful but Controversial.

19. PHARMAC • Most developed countries have seen expenditure on pharmaceuticals increase by 10-20% year • PHARMAC has restricted increase in expenditure to rate of inflation (2-3% per year) • Current expenditure by PHARMAC on medicines is $505 million per year. They estimate that without measures institutes by PHARMAC since 2004 that expenditure would now be $930 million per year.

20. Pricing Strategies • Reference Pricing • Sole Supply • Special Authority • Specialist Recommendation • Part Charge

21. If a medicine is not on the pharmaceutical schedule….. • Use of Medicines in Hospital • Exceptional Circumstances Scheme • Discretionary Community Supply

22. Unregistered Medicines • Section 29 • Clinical trials (SCOTT)

23. Hospital Formulary • Most hospitals have a formulary listing the medicines that can be prescribed in the hospital. • The aim of a formulary is to improve prescribing in hospital.

24. Hospital Formulary A formulary allows: • A reduction of the number of medicines in each therapeutic class used in hospital. • Avoidance of medicines of limited efficacy. • Establishment of guidelines for the use of medicines (particularly where there are concerns about safety or cost).