Robert Celt
New Member
Legislation on medicinal cannabis is a good move for the management of health conditions where these products can meet a therapeutic need, says Kos Sclavos.
Under the new arrangements, patients with a valid prescription can possess and use a medicinal cannabis product manufactured from cannabis plants legally cultivated in Australia, where the supply is appropriately authorised under the Therapeutic Goods Act 1989 and relevant state and territory legislation.
This is after other treatments have been shown that they were not successful.
"It's the "missing piece" for Australian patients and their doctors to access a safe, legal and reliable supply of medicinal cannabis products for the management heath conditions," Sclavos says.
"It facilitates a process to allow development of novel cannabinoid-based therapies for the treatment of epilepsy; pain; cancer; neurological conditions (e.g, dementia, Parkinson's, or, MS), and mental illness/addictions. The legislation will facilitate access to those products," says Sclavos, who sits on the Queensland Government Steering Committee on Medicinal Cannabis Trials, and says it is an area of interest to him.
However, Sclavos points out that accessibility to medicinal cannabis is going to be a long-term process, given issues about manufacture and production into a final product.
"It will be some time before products will be grown here and turned into pharmaceutical grade product," he told the AJP.
"Because of this, I expect community pharmacies will see many more requests for assistance for this type of medicinal cannabis product from overseas via the Special Access Scheme, administered by the TGA, which allows individual patients to obtain access to drugs not yet registered for marketing in Australia.
"Unmarketed drugs may be otherwise available by importation for personal use, or participation in a clinical trial."
However, the guidelines for the use of medicinal cannabis will be tightly controlled, he says.
For example, it will be a requirement that patients using a drug in the SAS drug and category must have written consent.
Category A patients include: terminally ill patients and seriously ill patients with life-threatening conditions; and people suffering from a serious, but not life-threatening illness.
The treating clinician should be of the opinion that no conventional therapy is likely to cure or adequately control the condition from which the patient is suffering, Sclavos stresses.
Many patients have unrealistic expectations about cannabis, Sclavos says.
"Let me say up front, that cannabis remains an illegal and potentially harmful drug and is not approved as a medicine by the TGA," he says.
"Adults with a terminal illness who choose to use cannabis do so at their own risk. Delta-9-tetrahydrocannabinol is the most abundant cannabinoid in cannabis: it is marijuana's main mind-altering ingredient.
"Other than THC, the marijuana plant contains more than 100 other cannabinoids. Some of these cannabinoids are chemically similar to THC, but some are not, and do not produce the same mind-altering effect as THC, but may potentially produce other beneficial therapeutic effects."
Sclavos cites the example of the UK where the use of pharmaceutical grade medicinal cannabis Sativex, which contains cannabinoids for the treatments of spasticity associated for MS, is being prescribed for patients who have not responded to other treatments, and has worked well.
"There is no clinical evidence to suggest that Sativex produces a 'high'.
"Indeed, evidence suggests that patients are able to obtain symptom relief without experiencing any 'high' This means diversion risk is non-existent.
"In addition, it should also be noted that in both long-term studies and those patients in UK prescribed the medicine up to now (6,000 patients): Sativex has not created addiction. In clinical studies, addiction effects were not observed with treatment."
When asked about the situation overseas, particularly the US, where cannabis has been legalised in some state and jurisdictions, Sclavos points out that the use of medicinal cannabis will be different here, plus, it is a federal policy, unlike the US or the EU.
Also, what's available overseas is not 'medicinal'.
"Most of the cannabinoids products in the US/EU are 'artisanal' or commercial products sold as food (not as medicine) and not prescribed by doctors," Sclavos says.
"This will not happen in Australia with this legislation. As pharmacists, we need access to good manufacturing practice pharmaceutical-grade cannabinoid medication the priority."
While the legislation, in the broad sense, has been passed, Sclavos says there are some practical issues which need to be addressed, which could present some problems for pharmacy, initially.
These need to be ironed out, he says.
"It is a S9 at present but I expect some forms will initially become Controlled Drugs S8 (which must be kept in a safe) and that will create problems.
"For example, Sativex is a refrigerated line and we cannot have fridges in safes. Given the low risk profile for diversion I am working with Governments at present to ensure that are not all classified as controlled drugs S8."
Sclavos says he doubts that the use of medical cannabis is going to be commonplace and immediate.
"As I have a board role with Epilepsy Queensland, this is something I care about but, we have to be realistic.
"The Government funded trials will take three to four years and I do not expect a sudden influx of product into Australia. This will be a slow process and as a board member of Epilepsy Queensland this is the first message I give parents who are desperate for medicinal cannabis to possibly help their child with drug-resistant epilepsy.
"I expect pharmacies will need to be accredited to facilitate supply of medicinal cannabis that will include training for pharmacists and pharmacy assistants. I expect record keeping to the same standard as S8s, initially."
News Moderator: Robert Celt 420 MAGAZINE ®
Full Article: Australia: Medical Cannabis, The Facts
Author: Janet Doyle
Contact: AJP
Photo Credit: None found
Website: AJP
Under the new arrangements, patients with a valid prescription can possess and use a medicinal cannabis product manufactured from cannabis plants legally cultivated in Australia, where the supply is appropriately authorised under the Therapeutic Goods Act 1989 and relevant state and territory legislation.
This is after other treatments have been shown that they were not successful.
"It's the "missing piece" for Australian patients and their doctors to access a safe, legal and reliable supply of medicinal cannabis products for the management heath conditions," Sclavos says.
"It facilitates a process to allow development of novel cannabinoid-based therapies for the treatment of epilepsy; pain; cancer; neurological conditions (e.g, dementia, Parkinson's, or, MS), and mental illness/addictions. The legislation will facilitate access to those products," says Sclavos, who sits on the Queensland Government Steering Committee on Medicinal Cannabis Trials, and says it is an area of interest to him.
However, Sclavos points out that accessibility to medicinal cannabis is going to be a long-term process, given issues about manufacture and production into a final product.
"It will be some time before products will be grown here and turned into pharmaceutical grade product," he told the AJP.
"Because of this, I expect community pharmacies will see many more requests for assistance for this type of medicinal cannabis product from overseas via the Special Access Scheme, administered by the TGA, which allows individual patients to obtain access to drugs not yet registered for marketing in Australia.
"Unmarketed drugs may be otherwise available by importation for personal use, or participation in a clinical trial."
However, the guidelines for the use of medicinal cannabis will be tightly controlled, he says.
For example, it will be a requirement that patients using a drug in the SAS drug and category must have written consent.
Category A patients include: terminally ill patients and seriously ill patients with life-threatening conditions; and people suffering from a serious, but not life-threatening illness.
The treating clinician should be of the opinion that no conventional therapy is likely to cure or adequately control the condition from which the patient is suffering, Sclavos stresses.
Many patients have unrealistic expectations about cannabis, Sclavos says.
"Let me say up front, that cannabis remains an illegal and potentially harmful drug and is not approved as a medicine by the TGA," he says.
"Adults with a terminal illness who choose to use cannabis do so at their own risk. Delta-9-tetrahydrocannabinol is the most abundant cannabinoid in cannabis: it is marijuana's main mind-altering ingredient.
"Other than THC, the marijuana plant contains more than 100 other cannabinoids. Some of these cannabinoids are chemically similar to THC, but some are not, and do not produce the same mind-altering effect as THC, but may potentially produce other beneficial therapeutic effects."
Sclavos cites the example of the UK where the use of pharmaceutical grade medicinal cannabis Sativex, which contains cannabinoids for the treatments of spasticity associated for MS, is being prescribed for patients who have not responded to other treatments, and has worked well.
"There is no clinical evidence to suggest that Sativex produces a 'high'.
"Indeed, evidence suggests that patients are able to obtain symptom relief without experiencing any 'high' This means diversion risk is non-existent.
"In addition, it should also be noted that in both long-term studies and those patients in UK prescribed the medicine up to now (6,000 patients): Sativex has not created addiction. In clinical studies, addiction effects were not observed with treatment."
When asked about the situation overseas, particularly the US, where cannabis has been legalised in some state and jurisdictions, Sclavos points out that the use of medicinal cannabis will be different here, plus, it is a federal policy, unlike the US or the EU.
Also, what's available overseas is not 'medicinal'.
"Most of the cannabinoids products in the US/EU are 'artisanal' or commercial products sold as food (not as medicine) and not prescribed by doctors," Sclavos says.
"This will not happen in Australia with this legislation. As pharmacists, we need access to good manufacturing practice pharmaceutical-grade cannabinoid medication the priority."
While the legislation, in the broad sense, has been passed, Sclavos says there are some practical issues which need to be addressed, which could present some problems for pharmacy, initially.
These need to be ironed out, he says.
"It is a S9 at present but I expect some forms will initially become Controlled Drugs S8 (which must be kept in a safe) and that will create problems.
"For example, Sativex is a refrigerated line and we cannot have fridges in safes. Given the low risk profile for diversion I am working with Governments at present to ensure that are not all classified as controlled drugs S8."
Sclavos says he doubts that the use of medical cannabis is going to be commonplace and immediate.
"As I have a board role with Epilepsy Queensland, this is something I care about but, we have to be realistic.
"The Government funded trials will take three to four years and I do not expect a sudden influx of product into Australia. This will be a slow process and as a board member of Epilepsy Queensland this is the first message I give parents who are desperate for medicinal cannabis to possibly help their child with drug-resistant epilepsy.
"I expect pharmacies will need to be accredited to facilitate supply of medicinal cannabis that will include training for pharmacists and pharmacy assistants. I expect record keeping to the same standard as S8s, initially."
News Moderator: Robert Celt 420 MAGAZINE ®
Full Article: Australia: Medical Cannabis, The Facts
Author: Janet Doyle
Contact: AJP
Photo Credit: None found
Website: AJP
