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Policy

Position Statements

Epilepsy & Driving

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1. POSITION STATEMENTS

  • 'Medical Marijuana' in the treatment of epilepsy
  • Epilepsy and Driving  

"Medical Marijuana" in the treatment of epilepsy

Executive Summary

  • The supply or possession of cannabis, in any form, is illegal in all states of Australia.
  • While pharmaceutical cannabis is available in the treatment of pain and wasting associated with HIV and chemotherapy, and in the treatment of spasticity in multiple sclerosis, its efficacy in the treatment of severe refractory epilepsy or catastrophic epilepsy syndromes compared to approved therapies is currently unknown.
  • The Joint Epilepsy Council of Australia understands the medical complexity of epilepsy and the difficult decisions facing people with epilepsy and their families.
  • Trials are underway in the US investigating efficacy and safety of medical marijuana in Dravet and Lennox-Gastaut syndromes with results to date giving cautious optimism.
  • It is anticipated that these trials will provide rigorous scientific evidence and if medical marijuana is found to be beneficial then best practice guidelines can be developed in the treatment of severe epilepsy.
  • Until the Therapeutic Goods Administration approves medical marijuana as an adjunct treatment for severe epilepsy, the Joint Epilepsy Council of Australia cannot endorse its use.

Patients, families, carers and doctors recognise the need for additional and more effective therapies for severe epilepsy syndromes. There have been several reports in the media of dramatically positive responses to derivatives of cannabis, medical marijuana in children with severe forms of epilepsy, that have not responded to available therapies. While these reports give reason for hope, we must be mindful that these are anecdotal reports only. However such reports have brought attention to the potential for cannabis to provide a new anti-epileptic therapy and help us understand how epilepsy occurs.1

Currently, the use of medical marijuana in all Australian states is illegal.

In this context it is important to distinguish between medical marijuana (crude cannabis) and pharmaceutical (synthetic) cannabis. The term medical marijuana refers to the unique compounds of the plant Cannabis sativa, called cannabinoids, which may be effective in preventing or reducing seizures. Components that have attracted considerable attention are cannabidiol (CBD), the major nonpsychotropic compound, and tetrahydrocannabinol (THC) the compound that gives cannabis its psychotropic effect, and combinations of these compounds. Medical marijuana or crude cannabis is unregulated, and the potency and safety is unknown and variable. It is illegal to supply or be in possession of medical marijuana in Australia.

Pharmaceutical or synthetic cannabis is the product of a controlled manufacturing process that mimics or produces similar effects to cannabis and is approved for the treatment of various medical conditions. The pharmaceutical drugs Cesamet and Marinol (synthetic cannabinoids usually used to treat pain and wasting associated with HIV or chemotherapy) are not marketed in Australia but are included on schedule 8 to enable particular patients to access them through the Special Access Scheme (SAS), while Sativex, an oromucosal spray containing cannabinoids, was registered in Australia for use in treating spasticity related to multiple sclerosis, in 2012. 2

Research data on the use of medicinal marijuana for the treatment of epilepsy is limited.

Basic research studies have provided strong evidence for safety and anticonvulsant properties of CBD. However, the lack of pure, pharmacologically active compounds and legal restrictions have prevented clinical research and confined data on efficacy and safety to anecdotal reports. 3

A Cochrane Review published in 2014 on Cannabinoids for Epilepsy reviewed published literature to assess the efficacy and safety of cannabinoids when used as monotherapy or add-on treatment for people with epilepsy found that no reliable conclusions could be drawn at present regarding the efficacy of cannabinoids as a treatment for epilepsy. Only four studies from 1978 to 1990 met the selection criteria of randomized control trials (RCTs) whether blinded or not. Patient numbers were small, 48 in total, with varying reports on reduction in seizure frequency and/or seizure freedom (2 of 4 patients at 3 months, Mechoulam, 1978), and as the studies ran for short periods of time, (4 weeks 18mths) the safety of long term cannabidiol treatment cannot be reliably assessed. 4

The American Academy of Neurology conducted a systematic review of the efficacy and safety of medical marijuana in selected neurological disorders, found that the use of oral cannabinoids are of unknown efficacy in epilepsy, that the risks and benefits of medical marijuana should be weighed carefully, and that the comparative effectiveness of medical marijuana vs other therapies is unknown for epilepsy. 5

In the United States, the Food and Drug Agency has given Orphan Drug Status[a] to Epidiolex (cannabidiol) as an investigational drug therapy of Dravet and Lennox-Gastaut syndromes. There is an ongoing open label study, i.e. a clinical research study in which the participant, health care professional, and others know the drug and dose being given, that has recently released data for 27 patients treated for more than 12 weeks. (6) Four patients were seizure free and approximately half the patients had a 50% reduction in seizures. Somnolence, fatigue, diarrhoea and altered appetite were each seen in more than 10% of these patients. These interim results look positive and we wait for further results to be published.

How can we improve the current situation? We need to be able to use information from well-conducted clinical trials of these treatments, just the same as any other new treatment. Trials are currently in progress. These will provide good quality evidence and if 'medical marijuana' is found to be beneficial, allow best practice guidelines to be developed in the treatment of severe epilepsy. At the moment that information just isn't available. We need to recognise there is uncertainty around the efficacy and safety of using medical marijuana in children and the potential impact it can have on the developing brain in regard to memory, cognition, and the potential for psychosis in later years. Patients and families need to give careful consideration to such issues. If this alternative treatment is commenced, it is advisable to inform the treating doctor so that if a significant change in the patient's health occurs this can be more completely assessed.

It also important to understand that if this alternative therapy is commenced and the person requires future hospitalization, the therapy will be discontinued during this time.

There is a lot of excitement about these therapies, but at the moment we need to be cautious and look carefully at the new information coming out of trials before we can give these treatments unqualified endorsement. Patients and families need to keep in mind that Epilepsy Associations, hospitals and doctors cant legally provide or recommend these treatments at the current time.

The Joint Epilepsy Council of Australia understands the medical complexity of epilepsy and the difficult decisions facing people with epilepsy and their families. The Council urges all people living with epilepsy to consult with an epilepsy specialist and explore the many existing treatment options, so that they can make informed decisions with their specialist that weighs the risks and benefits of the different treatment options.
Until such time medical marijuana is approved by the Therapeutic Goods Administration as an adjunct treatment in the management of severe refractory seizures or catastrophic epilepsy syndromes with clear guidelines and indications for its use and recommended doses, the Joint Epilepsy Council of Australia cannot endorse the illegal use of this substance.

Joint Epilepsy Council of Australia, 
October 2014
Endorsed by Epilepsy Australia, October 2014

References

1. The case for medical marijuana in epilepsy Maa E, Figi P. Epilepsia, 2014, 55:783-6
2. The case for assessing cannabidiol in epilepsy. Cilio MR, Thiele EA, Devinsky O. Epilepsia. 2014 55:787-90.
3. Australian National Council on Drugs. Medicinal use of cannabis: Background and information paper. August 2014
4. Cannabinoids for epilepsy (Review). Gloss D, Vickrey B. The Cochrane Collaboration. 2014. John Wiley & Sons, Ltd.
5. Systematic review: efficacy and safety of medical marijuana in selected neurologic disorders: report of the Guideline Development Subcommittee of the American Academy of Neurology. Koppel BS, Brust JC, Fife T, Bronstein J, Youssof S, Gronseth G, Gloss D. Neurology, 2014 Apr 29;82(17): 1556-63
6. GW Pharmaceuticals announces physician reports of Epidiolex treatment effect in children and young adults with treatment-resistant epilepsy from physician-led expanded access treatment program. http://www.gwpharm.com/GW%20Pharmaceuticals%20Announces%20Physician-Led%20Expanded%20Access%20Treatment%20Program.aspx accessed 21 June 2014

[a] Orphan drug status is given to drugs which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the US, or that affect more than 200,000 persons but are not expected to recover the costs of developing and marketing a treatment drug.

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Epilepsy and Driving

13 July 2010

Epilepsy and driving is a serious and sensitive community issue. Epilepsy affects 1-2% of the population and those with well-controlled epilepsy are legally able to drive.

The Joint Epilepsy Council of Australia acknowledges that for many adults, the sudden loss or suspension of a driving licence for a significant period of time can adversely affect employment, education, and social participation. Driving restrictions impact on quality of life and independence.

The challenge for the Australian Transport Council was to develop driving regulations and guidelines that balance the interests of public health and safety, and the promotion of the optimal quality of life for people living with epilepsy.

It is well understood that driving carries the risk of accident. The level of risk tolerated by the community is reflected in our regulations and legislation, and population variables.

In comparison, the relative accident risk of drivers with epilepsy compared with other drivers is estimated to be between 1.0 and 1.95, (far below the accident rate of young males), while the contribution of seizures to accident statistics is only 0.025-0.053%.1

For example, risks that the community finds acceptable or unavoidable are:

a) driving within the legal alcohol limit of .05 - an accepted increased accident rate of 2.0;


b) young males under 25 - an unavoidable increased accident rate of 7.0;


c) drivers 75 years and over - an unavoidable increased accident rate of 3.2. 2

Based on these statistics, Austroads and the National Transport Commission, with the contribution of the Epilepsy Society of Australia, developed management guidelines and medical standards for licensing drivers with epilepsy. The Joint Epilepsy Council of Australia supports these guidelines and their consistent application across all jurisdictions.

The Joint Epilepsy Council of Australia supports the position taken by the Epilepsy Society of Australia that:

  • determining fitness to drive and the subsequent granting of a driver licence lies ultimately with the Driver Licensing Authority (DLA);
  • that decisions are based on a full consideration of relevant factors relating to health and driving performance, including medical reports provided by a treating practitioner; and
  • such a system should be supported by a review process consisting of an expert panel of neurologists indemnified by the driver licensing authority. 3.

The Joint Epilepsy Council of Australia acknowledges that drivers with epilepsy who are assessed fit to drive are personally accountable for management of their condition in conjunction with support of their medical practitioner.

It is a legal requirement in all Australian states and territories for the driver to notify the DLA of the onset of epilepsy or recurrence of seizures.

The Joint Epilepsy Council of Australia is firmly opposed to mandatory reporting to the DLA by the treating doctor as it will encourage non-reporting of seizures to the treating doctor. The withholding of information interferes with treatment and has the potential for possible fatal consequences. Mandatory reporting breaches doctor-patient confidentiality, has the potential to erode the doctor-patient relationship, and serves neither patient nor public safety.

The Joint Epilepsy Council of Australia advocates self-reporting with the individual taking responsibility for the condition and the limitations it presents. Consequences, for example, may be the inability to get to work, loss of employment resulting in financial hardship, or difficulties in meeting family commitments. The Joint Epilepsy Council of Australia strongly advocates for government transport assistance to support the person with epilepsy during the suspension period until driving rights are restored.

Joint Epilepsy Council of Australia, May 2010
Endorsed by Epilepsy Australia, May 2010

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2. SUBMISSIONS

Senate Inquiry into Consumer Access to Pharmaceutical Benefits. March 2010

Senate Inquiry into Suicide in Australia. November 2009

The Parliamentary Friends of Epilepsy:
Inquiry into the Impact of Epilepsy in Australia today. October 2009.

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