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Medicines

Medicines. Regulation. Warning !! This lecture may prove to be BORING. The Thalidomide Disaster. Regulatory Agencies. Food and Drug Administration (USA) EMEA Therapeutic Goods Administration (Australia) Medsafe (NZ). Regulatory Agencies.

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Medicines

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  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)

  9. 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).

  10. 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. .

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

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

  13. 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

  14. 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

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

  16. 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

  17. PHARMAC Successful but Controversial.

  18. 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.

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

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

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

  22. 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.

  23. 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).

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