Wednesday 28 September 2011
Special Edition 3
“Euthanasia campaigner Dr Philip Nitschke appears to have misled a reporter about his TGA approval to import the barbiturate Nembutal,” FamilyVoice Australia research officer Ros Phillips said today. (http://m.news.com.au/VIC/fi843966.htm ) Dr Nitschke says he plans to prescribe the drug as a sleeping pill to a Victor Harbor patient who wants to die.
Mrs Phillips said a TGA spokeswoman has given a different version of the situation.
“She said in an email today that:
• The TGA has not approved the use of Nembutal by Dr Nitschke.
• Dr Nitschke has notified the TGA that he intends to use Nembutal for a patient under Category A of the Special Access Scheme (SAS).
• Category A of the SAS is intended to allow doctors to treat life-threatening diseases with medicines that may not yet have gone through formal clinical trials.
• Use of unregistered medicines under Category A of the SAS requires the use to be in accordance with good medical practice, but does not involve any approval process by the TGA.
• The TGA has written to Dr Nitschke advising him of these requirements and of the need for him to ensure his prescribing is in accordance with good medical practice.
• There is a clear process for doctors to follow in order to import and prescribe unapproved drugs and if Dr Nitschke does not follow appropriate clinical practice, he could face a range of serious sanctions from professional bodies.
• There are strong safeguards in place to ensure that practitioners act in accordance with good medical practice and professional bodies have very high standards in place so that this occurs.”
Ros Phillips said that Nembutal was banned in Australia some decades ago because of widespread addiction and abuse problems. It was used as a drug to help people sleep, but other medications are available which are equally effective and without Nembutal’s side effects.
Retired NSW palliative care specialist Dr Brian Pollard has said: “The only use of Nembutal for human beings in the world today is to end life. To prescribe Nembutal as a sleeping pill is not in accord with good medical practice. In my view, Dr Nitschke cannot fulfil the conditions set down by the Therapeutic Goods Administration by using Nembutal in this way.”
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