Who qualifies for medical marijuana
Medical cannabis: the main changes
With the entry into force of the law on the “Amendment of Narcotics Law and Other Regulations” on March 1st, medical cannabis can be prescribed for the first time in Germany. Questions and Answers for Prescribers.
From March 1st, doctors of all specialties can prescribe cannabis flowers and extracts from cannabis using a narcotic (BtM) prescription. No special qualification is required for this. The previous procedure is no longer applicable when patients at the Federal Opium Agency of the Federal Institute for Drugs and Medical Devices (BfArM) obtain an exemption under Section 3 (2) Narcotics Act (BtMG) to purchase a standardized cannabis extract preparation or medicinal cannabis flowers for use as part of medically supervised self-therapy need to apply.
- What will change with regard to the prescription of other cannabis-based drugs?
All other cannabis-based drugs that are already prescribable in Germany can continue to be prescribed unchanged. However, only the Nabiximols oral spray (Sativex®) a drug approval for the therapy of moderate to severe spasticity in adults with multiple sclerosis (MS). The cannabis extract Nabiximols (consisting of a combination of tetrahydrocannabinol [THC] and cannabidiol [CBD]) can be prescribed off-label in other indications, as can the THC active ingredients dronabinol and nabilone. Before an off-label prescription (by health insurance prescription), you should always apply to the health insurance company to cover the costs. The law expressly states that “even finished medicinal products approved in Germany (for example Sativex®) ... fall under this regulation "and that insured persons" in the same limited exceptional cases ... are entitled to drugs with the active ingredients dronabinol or nabilone ". The new law can therefore be expected to improve the prescription options for all cannabis-based drugs.
- Which patients can cannabis be prescribed to?
The law expressly refrained from listing individual indications. Cannabis flowers and extracts can therefore be prescribed for every indication if "a generally recognized service corresponding to the medical standard is not available in an individual case" or if this service is "in individual cases based on the justified assessment of the treating contract doctor, weighing the expected side effects and taking into account the state of illness of the insured person cannot be applied ”. This means that treatment with cannabis can also be initiated if, in theory, other treatments that have not yet been used (approved) are available and the patient has not yet been “exhausted”.
- In which indications is cannabis effective?
The fact that the legislature has refrained from listing individual indications in the law makes it clear that it is still unknown today for which diseases or symptoms cannabis is indicated. There is currently no approval for cannabis for any single indication. In the years 2007 to 2016, however, patients with more than 50 different illnesses / symptoms received an exemption from the BfArM for medically supervised self-therapy with medicinal cannabis. It is therefore widely believed that cannabis has a very broad therapeutic spectrum.
The established indications for cannabis-based drugs are chronic - especially neuropathic - pain, spasticity in MS, loss of appetite, nausea and vomiting. Indications for positive effects range from neurological (spasticity and pain of various causes, hyperkinetic movement disorders), through dermatological (neurodermatitis, psoriasis, acne inversa, hyperhidrosis), ophthalmological (glaucoma) and internal (arthritis, ulcerative colitis, Crohn's disease) to psychiatric Diseases / symptoms (depression, anxiety disorders, post-traumatic stress disorder, attention deficit hyperactivity disorder [ADHD], sleep disorders).
- When does the statutory health insurance fund the treatment?
Prior to the start of treatment, approval must be given by the health insurance company if the treatment is to be carried out at their expense. However, the law states that this application may be rejected by the health insurance company “only in justified exceptional cases”. A decision should be made on the applications within 3–5 weeks, even if the medical services of the health insurance companies are involved. If the prescription is made within the framework of specialized outpatient palliative care according to Section 37 b, the approval period is reduced to three days. A prescription using a private prescription can be made at any time and for any indication, regardless of approval by the health insurance company.
- How exactly is cannabis prescribed?
The maximum prescription dose for cannabis is 100,000 mg (100 g) in 30 days. In order to make it easier to handle, the maximum amount was set independently of the content of individual cannabinoids in the respective cannabis variety. Cannabis flowers with a THC content - the most psychotropically effective - cannabinoid of around one to around 22% can currently be prescribed. With a prescription of 100 g of cannabis, the prescribed amount of THC can therefore vary between 100 and 22,000 mg. In addition to the quantity, the cannabis variety must also be stated on the recipe. Different varieties with different THC contents can also be prescribed on one prescription at the same time. As is the case with the prescription of substances subject to BtM, in justified individual cases it is possible to deviate from the specified maximum amount by labeling them with the letter "A". Since cannabis flowers are usually dispensed in doses of 5 or 10 g, a prescription in these steps is recommended. A regulation could for example read like this: "Cannabis flower variety Bedrocan, 15 g, dosage according to written instructions".
- Which cannabis strains can be prescribed?
Currently, only cannabis varieties imported from abroad (Netherlands, Canada) can be prescribed. All 13 currently available varieties are standardized for the content of the cannabinoids THC and CBD, but also contain a large number of other (not identified) cannabis active ingredients and terpenes in low concentrations that can influence the overall effect (Table 1). In order to ensure a sufficient supply of cannabis medicinal products of standardized quality in the long term, the BfArM was given the task of setting up a cannabis agency so that state-monitored cannabis cultivation will soon be permitted in Germany. However, the availability of cannabis flowers from Germany is only expected in 2–3 years.
- Which cannabis strain is most effective for which indication?
This question cannot be answered at the moment. The majority of patients prefer cannabis strains with a higher THC content (> 10%). In individual indications (such as rare childhood epilepsy), pure CBD (without THC) also proved to be effective.
- How are cannabis flowers dosed?
All cannabis-based drugs, including cannabis flowers and extracts, should be dosed gradually. Depending on the THC content, the starting dose should be 25–50 mg of cannabis flowers (for varieties with a higher THC content> 10%) and a maximum of 100 mg of cannabis flowers with a low THC content per day. Depending on the effectiveness and tolerance, the dose should be increased by around 2.5–5 mg THC (depending on the variety, around 25–100 mg of cannabis) every 1–3 days. According to previous experience, daily doses of THC-rich cannabis varieties are often between 0.2 and 3 g, with fluctuations of 0.05–10 g. The maximum prescription amount of 100 g cannabis per 30 days stipulated in the law was based on the experience of the BfArM in recent years in the context of granting permits for self-therapy with medicinal cannabis. As far as we know today, the required dosages of cannabis-based drugs vary greatly from one individual to the next and - at least at present - cannot be given with sufficient accuracy for individual indications. How often it should be taken per day depends on the type of intake, indication and duration of action and must be determined individually in consultation between doctor and patient.
- What types of income are possible?
Basically, cannabis can be inhaled or ingested. Inhalation is possible through smoking and vaporizing (using a vaporiser). The great advantage of vaporizing is that no potentially damaging burnt plant materials (like smoking) are inhaled. The pharmacokinetics of THC and other cannabinoids with inhalation are very different from those with oral intake in terms of onset, strength and duration of action (Table 2). Which type of intake is more favorable depends on the patient's wishes, the indication and, if applicable, concomitant diseases. In individual cases, a combined oral and inhalative intake can also be useful.
- What side effects can occur?
Acute side effects primarily affect the psyche and psychomotor (euphoria, fear, fatigue, reduced psychomotor performance) as well as the heart and circulation (tachycardia, drop in blood pressure, dizziness, syncope). With regular use, you get used to it, so that cannabis-based drugs are generally considered to be well tolerated.
- What are the contraindications?
Cannabis should not be prescribed in the presence of a severe personality disorder, psychosis and severe cardiovascular diseases, as well as pregnant women and nursing mothers. In the absence of data, treatment in children and adolescents (before puberty) should be carefully considered. Greater central nervous and cardiovascular side effects can occur, particularly in older patients.
- Can a dependency occur?
So far, no case of cannabis addiction as a result of medically supervised therapy has been published if treatment with cannabis or a cannabis-based drug was carried out for a medical indication and none of the above-mentioned contraindications existed. With abrupt termination of therapy, in particular, mild to moderate withdrawal symptoms can occur.
- What else do contract doctors have to consider?
According to the law, the prescribing doctor must take part in a non-interventional, exclusively scientific survey. If the doctor is not willing to do this, the health insurance company will not be able to reimburse the costs. The patient must be informed about the data collection before the first prescription by the doctor. The accompanying survey is planned for a period of 5 years after the law has come into force. For each individual patient who is treated with cannabis, the doctor must provide the BfArM with anonymized data on age, gender, diagnosis, previous and current treatments as well as the reason for the prescription for treatment with cannabis, including dose, efficacy, tolerability and quality of life.
- How this article is cited:
Dtsch Arztebl 2017; 114 (8): A 352-6
Address for the authors:
Prof. Dr. med. Kirsten Müller-Vahl, Clinic for Psychiatry, Social Psychiatry and Psychotherapy, Hannover Medical School
Carl-Neuberg-Str. 1, 30625 Hanover
Email: [email protected]
The Internationale Arbeitsgemeinschaft für Cannabinoidmedikamente e. V. (IACM) and the BfArM on their websites (www.cannabis-med.org, http://d.aerzteblatt.de/FZ11).
Frankfurt am Main, May 13, 2017
Cannabis and cannabinoids in medicine
Training event of the working group Cannabis as Medicine e. V. in cooperation with the State Medical Association of Hesse and the City of Frankfurt.
Cologne, 29–30. September 2017
IACM 9th Conference on Cannabinoids in Medicine
Grotenhermen F, Häußermann K: Cannabis: Regulation aid for doctors. Scientific publishing company Stuttgart. 60 pages, 19.80 euros, date of publication: end of March 2017.
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