What’s the difference between Indica and Sativa?
Botany distinguishes between three subspecies of Cannabis sativa L. (hemp plant).
1. cannabis sativa var. sativa
2. cannabis sativa var. indica
3. cannabis sativa var. ruderalis
The two subspecies sativa and indica are suitable for use as medicine. The sativa-dominant varieties are said to have stimulating and energizing properties. The indica-dominant varieties, on the other hand, have a more calming and relaxing effect.
For which patients may cannabis-containing drugs be prescribed?
Since March 10, 2017, physicians have been able to prescribe cannabis-containing drugs for patients with a severe disease. Thus, there is a statutory right for SHI-insured persons.
As prerequisites for this, § 31 subesection 6 SGB V stipulates that
1. a generally approved service in accordance with the medical standard
(a) is not available; or
(b) cannot be applied in individual cases after the justified assessment of the treating panel physician, taking into account the expected side effects and the state of illness of the insured person,
2. there is a not entirely obvious prospect of a noticeable positive impact on the course of the disease or on serious symptoms.
Which diseases are considered ” severe diseases ” is neither explained in the legislation nor in the explanatory memorandum. According to SGB V, a disease is considered severe in other circumstances if it is life-threatening or if it permanently impairs the quality of life due to the severity of the health disorders it causes.
The law in § 31 subsection 6 SGB V does not contain a delimitation of the indication areas.
What are the requirements for a prescription of cannabis-containing medicinal products?
Approval by the health insurance
For the first prescription, approval must first be obtained from the respective health insurance of the insured person. The approval must be granted by the respective health insurance before the treatment begins.
The health insurance companies provide information on the exact procedure of the approval procedure. In principle, the prerequisites listed in the legislation should be addressed, in which
1. it must be documented that it is a severe disease for which
2. it is demonstrated that a generally approved service that meets medical standards is not available; or
3. it is demonstrated, on the basis of a reasoned assessment, that in individual cases, taking into account the side effects to be expected and the state of the patient’s illness, a generally approved service in accordance with the medical standard cannot be applied,
4. it is demonstrated that the prescription of cannabis blossoms or extracts or medicinal products containing cannabis has a not entirely distant prospect of a noticeable positive effect on the course of the disease or on severe symptoms.
Prior authorisation is only required for the prescription of finished medicinal products containing cannabinoids which are already prescribable if they are to be used off-label. If the request is made as part of a specialized outpatient palliative care according to § 37b SGB V, this should be noted separately in the request in order to shorten the approval period.
The health insurance company must have decided about the application no later than three weeks after receiving the application. In cases where the health insurance company considers an expert evaluation, e.g. by the MDK (Medical Service of the Health Insurance), to be necessary, the deadline is extended up to five weeks. The deadline starts after the health insurance company has received the application.
In case of patients who are in specialised outpatient palliative care in accordance with § 37b SGB V, the period for approval by the health insurance is shortened to three days (§ 31 Subsection 6 Sentence 3 SGB V).
Reasons for refusal
A refusal by the health insurance company is legally possible “only in justified exceptional cases” (§ 31 Subsection 6 Sentence 2 SGB V).
Participation in a substitution register
§ 31 Subsection 6 Sentences 4 and 5 SGB V stipulates that the insured person must participate in a non-interventional substitution register. This results in particular obligations for the treating physician.
Is the approval by the health insurance company a prerequisite for the cannabis therapy?
No, it is not. In case the expenses for the cannabis therapy are not covered by the health insurance, the prescription can be issued by the treating physician on a private prescription. The costs for cannabis therapy are then covered by the patient.
The decision on a cannabis therapy is therefore made exclusively by the attending physician, irrespective of whether the costs are covered by the health insurance.
Which doctors are allowed to prescribe cannabis-containing drugs?
Doctors of all specialties (except dentists and veterinary doctors) may prescribe drugs containing cannabis.
For which indications can cannabis-containing drugs be prescribed?
The law does not specify the indications for which a prescription may be given.
Development of a Federal Joint Committee (G-BA) guideline on the basis of the results of the substitution register by the Federal Institute for Drugs and Medical Devices (BfArM)
As for many clinical pictures there is still no sufficient research results for the benefit and for the effect of a treatment with cannabis-containing drugs are available, the Federal Institute for Drugs and Medical Devices (BfArM) conducts a non-interventional scientific substiution register of the treatments approved by the health insurance funds over a period of 60 months (§ 36 Subsection 6 Sentence 4 SGB V). The Federal Institute for Drugs and Medical Devices (BfArM) will prepare a study report on the basis of the data obtained from the substitution register, on the basis of which the Joint Federal Committee (G-BA) will then regulate the details of the granting of benefits in a guideline within six months (§ 36 Subsection 6 Sentence 8 SGB V). This will therefore only be the case in 2022.
The previous exemptions for treatment with cannabis according to § 3 Subsection 2 Narcotics Act (BtMG) were granted by the Federal Institute for Drugs and Medical Devices (BfArM) primarily for the following indications:
– Pain (approx. 57 %)
– ADHD (approx. 14 %)
– Spasticity (different genesis) (approx. 10 %)
– Depression (approx. 7 %)
– Inappetence/Cachexia (approx. 5 %)
– Tourette’s syndrome (approx. 4 %)
– Intestinal diseases (approx. 3 %)
– Epilepsy (approx. 2 %)
– Other psychiatric disorders (approx. 2 %)
What effects can be expected from a prescription of cannabis-containing drugs?
The effect of drugs containing cannabis mainly depends on the composition of the cannabinoids they contain. A total of more than 100 different cannabinoids, some of which have very different activity spectra, are already known. The main cannabinoids found in the hemp plant are:
– Tetrahydro-Cannabinol (THC) with antiemetic, relaxing, sedative effect
– Cannabidiol (CBD) with anti-psychotic, anxiolytic, anti-inflammatory, antiemetic, spasmolytic action
– The effect of the ?9-THC can be modified by other cannabinoids such as cannabinol (CBN) or cannabidiol (CBD)
What types of administration are possible for cannabis-containing drugs?
Cannabis can generally be inhaled or taken orally. The type of administration should be taken into account for the dosage. The most appropriate route of administration depends on a number of factors: Preference of the patient, indication, possible concomitant diseases. In individual cases, combined oral and inhaled administration may also be appropriate.
The ingredients of the cannabis blossoms can be inhaled via special vaporizers. The preparation of tea has proved to be less efficient. Baking in pastries is possible according to Federal Institute for Drugs and Medical Devices (BfArM), but therapy with the products is difficult to control because the dose per application cannot be reproduced during baking. In this respect, this application cannot be recommended for reasons of drug therapy safety. Inhalation after burning as a joint can also not be recommended due to possible health damage.
What possible side effects must be considered when prescribing cannabis-containing drugs?
A meta-analysis of 79 studies conducted by Whiting et al. on the use of cannabinoids in medicine showed an increased risk of short-term adverse effects such as dizziness, dry mouth, nausea, fatigue, sleep disturbances, euphoria, vomiting, disorientation, drowsiness, confusion, balance disorders and hallucinations.
Müller-Vahl and Grotenhermen (2017) point out that acute side effects can primarily affect the mind and psychomotor functions (euphoria, anxiety, fatigue, reduced psychomotor performance) as well as the heart and circulatory system (tachycardia, hypotension, dizziness, syncope).
Which information needs to be explained to the patient by the doctor?
In addition to the usual information before the start of treatment, the patient should be informed by the doctor about the following aspects:
· Education about possible effects and side effects of prescribed cannabis-containing drugs
· vPossible interactions of cannabis drugs with other drugs
· Education about possible effects on the ability to drive
· Information on dosage and application method
· Information on appropriate and child safe storage
How can a patient prove that his cannabis is medically used?
Difficulties during a police check or a comparable situation can be avoided by patients carrying a copy of the current narcotic prescription. This is sufficient proof.
How are cannabis-containing drugs stored?
Cannabis blossoms should be stored childproof, hermetically sealed and protected from light at room temperature up to 25°C. Cannabis blossoms do not have to be stored in the refrigerator.
How do patients measure the exact dose for the inhalation of cannabinoids?
The patient usually receives a dosage spoon (1ml) from his pharmacy. If this is loose, not completely filled, this corresponds to approx. 100mg (0.1g) of blossoms.
How does an overdose of medicinal cannabis manifest itself?
Especially patients without experience with medical cannabis products can experience an unpleasant feeling of intoxication. In addition, side effects such as dizziness or nausea can occur.
What should patients do in case of overdose with medicinal cannabis?
First of all, the patient should remain calm. The unpleasant side effects described above do not lead to medical emergencies. The duration of effect by inhaled administration is 2 to 3 hours, with oral administration the duration of effect is 4 to 8 hours. A medically critical dose would be more than 500g medical cannabis. The dose for the next administration of medicinal cannabis should be reduced by approx. 50mg. It is also recommended to discuss the further procedure with the treating doctor.
When should cannabis-containing drugs not be taken?
· During pregnancy
· During breastfeeding
· With simultaneous intake of alcohol
· Heart rhythm disturbances (arrhythmias)
Prescriptions should be examined individually for patients with a tendency to addiction.
Is it allowed to carry the medical cannabis abroad?
There are standardized rules for carrying narcotics with you on your travels, but these differ depending on the destination. Travelling with medical cannabis is basically possible as with other narcotics. Patients can import and export an appropriate quantity of their prescribed narcotics for the duration of their journey. For citizens who come from the member states of the Schengen Agreement, it is relatively easy to take the medicine with them when travelling. For this purpose, the patient must carry the certificate completed by the doctor in accordance with Article 75 of the Convention Implementing the Schengen Agreement.
The Schengen countries include:
Austria, Belgium, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and Iceland
The following European countries do not belong to the Schengen area, so the Implementing Agreement does not apply here:
Romania, Croatia, Bulgaria, Great Britain, Ireland and Cyprus
The required certificate is available at the Federial Institute for Drugs and Medical Devices (BfArM):