Medicines

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Medicines

• Regulation

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

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The Thalidomide Disaster
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Regulatory Agencies

• Food and Drug Administration (USA)
• EMEA
• Therapeutic Goods Administration (Australia)
• Medsafe (NZ)

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Regulatory Agencies

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

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Drug Development

• Pre-Clinical
• Clinical

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Preclinical Development

• Medicinal Chemistry
• In Vitro Screening
• Animal Studies
• Pharmacology
• Pharmacokinetics (ADME)
• Toxicology

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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)

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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).

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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.
• .

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Medicines Classification

• Prescription Medicines
• Over the Counter Medicines

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Over The Counter Medicines

• General Sale
• Pharmacy Only Medicines
• Restricted Medicines

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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

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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 Johns Wort

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Pharmaceutical Schedule

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

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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

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PHARMAC

• Successful
• but
• Controversial.

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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.

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Pricing Strategies

• Reference Pricing
• Sole Supply
• Special Authority
• Specialist Recommendation
• Part Charge

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If a medicine is not on the pharmaceutical
schedule..

• Use of Medicines in Hospital
• Exceptional Circumstances Scheme
• Discretionary Community Supply

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Unregistered Medicines

• Section 29
• Clinical trials (SCOTT)

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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.

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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).