Like many other medicines, cannabis has the potential for addiction. However, previous scientific studies refer almost exclusively to recreational users. However, when assessing the risk of developing addiction, it must be taken into account that the consumption behavior of recreational users and patients differs significantly. While recreational users are after the “high feeling”, patients want to achieve relief from their symptoms. It is estimated that recreational users have a lifetime risk of developing addiction of around 10%. In comparison, the risk with other substances is significantly higher:

• Nicotine = 32%
• Heroin = 23%
• Alcohol = 15%

If there is the prospect of a positive influence of medical cannabis on the symptoms, the potential for dependency – which is lower in comparison to opioids and benzodiazepines – can under certain circumstances be regarded as less serious than the burden of the disease.< /span>

ACM/IACM

The Working Group Cannabis as Medicine e.V. (ACM) is the regional structure of the International Working Group Cannabis as Medicine (IACM) for the German-speaking area. The aim is to enforce the use of cannabis products for all patients who need such therapy. The ACM provides information about the medical use of various cannabinoid-based therapies, the areas of application, practical information on use, side effects and the legal situation and prescription options. Within the ACM there is the self-help group SCM, in which patients with and without cost coverage and different clinical pictures can exchange information. Furthermore, the AMC operates a patient hotline and, in cases that appear promising, supports complaints against a refusal to assume the costs before the social court.

Add-on therapy

This is the additional administration of a medication to an (initially) unchanged medication/treatment. Cannabinoids are often prescribed as add-on therapy for pain (e.g. in addition to opioids) or for epilepsy (in addition to classic anticonvulsants). This can potentially reduce the dosage of the other drugs and the associated side effects.

Medicines and dressings, authorization to issue prescriptions (§ 31 Paragraph 6 SGB V)

As part of the law amending narcotics law and other regulations of March 10, 2017, Section 6 was added to §31 SGB “Medicines and bandages, prescription authorization”. This states that insured persons with a serious illness are entitled to a supply of cannabis blossoms, cannabis extracts and medicinal products containing the active ingredients dronabinol or nabilone if:

1. a generally recognized medical standard service
   1. is not available or
   2. in individual cases based on the justified assessment of the treating panel doctor, weighing up the side effects to be expected and taking into account the medical condition of the insured person can be used.
2. there is a not entirely distant prospect of a noticeable positive effect on the course of the disease or of serious symptoms.

Application for reimbursement

Cannabis-based medicines can be prescribed at the expense of the patient on a private prescription or an application can be made to the health insurance company to have the costs covered. With private insurance, it is always a case-by-case decision based on the respective tariff of the insured person. When applying to the statutory health insurance companies, a doctor’s questionnaire must be filled out. This statement must state that:

1. the patient has a serious medical condition
2. the Stastandard therapy is not available (e.g. ineffectiveness)
3. there is a prospect of a positive influence on the symptoms/the course of the disease.

The health insurance companies have a decision period of 3 weeks or 5 weeks when the medical service (MDK) is involved. For patients in specialized outpatient palliative care (SAPV) or for follow-up treatment after an inpatient stay, the decision period is 3 days.

Exemption

Until March 2017, in order to purchase a standardized cannabis extract preparation or cannabis blossoms for use as part of medically supervised self-therapy, patients had to apply for a special permit in accordance with Section 3 (2) of the Narcotics Act (BtMG) from the Federal Opium Agency of the Apply for BfArM. From 2007 to 2016, patients received such an exemption for a wide variety of diseases/symptoms. Since the amending law came into force on March 10, 2017, such an exemption is superfluous. However, the previously granted exemptions were still valid for another 3 months.

As part of an observational study, treatment data from cannabis patients (until 2022) will be collected anonymously in order to obtain important information on use, effectiveness and safety. This only affects patients whose treatment costs are covered by the GKV. The data is collected as part of the prescription of flowers and cannabis extracts as well as in the off-label use of the finished medicinal product Sativex® or Canemes®. Patients must be informed by the doctor about the implementation of the accompanying survey (information letter with information for the patients). The latter must transmit the data to the BfArM at least twice (1 year after the start of therapy and after its completion/in the 1st quarter of 2022).

BfArM

The Federal Institute for Drugs and Medical Devices (BfArM) is an independent higher federal authority and is part of the Federal Ministry of Health. The main tasks of the BfArM are the approval of finished medicinal products, the registration of homeopathic and traditional herbal medicinal products, the recording, assessment and defense against medicinal product risks (pharmacovigilance), but also the central recording and assessment of risks in medical devices. The Federal Opium Agency (BOPST), which regulates the trade in narcotics and raw materials, is also part of the BfArM. The Cannabis Agency is also part of the BfArM.

Bedrocan

The Dutch company Bedrocan International B.V. based in Veendam has been producing and exporting standardized medical cannabis since 2003. The company currently produces five different strains of cannabis. Bedrocan is contracted to the Dutch Ministry of Health, Welfare and Sport for the cultivation and production of pharmaceutical grade medicinal cannabis flowers (Cannabis Flos) and holds EMA GMP certification. Bedrocan is currently the largest producer of medicinal cannabis flowers for the German market.

Bioavailability

Bioavailability is a pharmacological measure of the proportion of an active substance that is available unchanged in the systemic circulation (specifically in the bloodstream). The bioavailability of cannabis flowers is around 15-35% when cannabinoids are used by inhalation. With oral application, due to the first-pass effect, among other things, a bioavailability of only approx. 3-12% can be achieved.

In terms of quality, the raw materials used to manufacture medicines must meet strict standards. However, the requirements for identification, purity and content are not included for all substances in the official pharmacopoeia (DAB). In order to close this gap, the Federal Union of German Associations of Pharmacists (ABDA) decided to publish a supplement to the Pharmacopoeia under the title “German Drug Codex” (DAC). The monographs for active ingredients, excipients, herbal drugs and preparations are structured according to the specifications of the official pharmacopoeia.

Decarboxylation

Decarboxylation is the chemical reaction in which heat is applied to convert the cannabinoid acids present in the plant into their pharmacologically active form. In the process, a carbon dioxide molecule is split off from the acid – THCA becomes THC. The optimal temperature for an almost complete decarboxylation of the cannabinoids is around 210°C. Heating at higher temperatures can lead to the loss of active ingredients and thus lower bioavailability, as is the case with smoking, for example. Smoking produces temperatures of up to 700°C.

Measuring spoon

Fine-cut cannabis flower is weighed in either unit doses, citing the NRF regulations: NRF 22.13 (unit-dose cannabis flower for inhalation after vaporization) or NRF 22.15 (unit-dose cannabis flower for tea preparation) or filled into a multi-dose container from which the patient takes the appropriate amount for one application. There are dosing spoons for different amounts for easy and precise dosing. The most common is the 1 mL scoop, which holds a nominal 100 mg of cannabis flowers. For larger quantities, e.g. in the pharmacy, a 1.7 ml spoon that holds approx. 250 mg of cannabis flowers is ideal. Significantly less is sufficient for inhalative use. Dosing spoons with a nominal volume of 0.16 and 0.3 ml (for around 20 or 35 mg of cutting drug) are now available for this purpose.

Dronabinol

AtDronabinol, better known as THC, is the main active ingredient in the cannabis plant. In the US, dronabinol in capsule form (Marinol®) is approved for the treatment of anorexia with weight loss in AIDS patients and as a second-line treatment for nausea and vomiting associated with chemotherapy. Since February 1998, dronabinol has also been available for sale and prescription in Germany. However, in this country it is only available as a prescription drug. Dronabinol preparations are manufactured in pharmacies as drops or capsules according to the relevant NRF regulations.

If required, the finished medicinal product Marinol® can be imported to Germany.

In terms of quality, the raw materials used to manufacture medicines must meet strict standards. However, the requirements for identification, purity and content are not included for all substances in the official pharmacopoeia (DAB). In order to close this gap, the Federal Union of German Associations of Pharmacists (ABDA) decided to publish a supplement to the Pharmacopoeia under the title “German Drug Codex” (DAC). The monographs for active ingredients, excipients, herbal drugs and preparations are structured according to the specifications of the official pharmacopoeia.

Decarboxylation

Decarboxylation is the chemical reaction in which heat is applied to convert the cannabinoid acids present in the plant into their pharmacologically active form. In the process, a carbon dioxide molecule is split off from the acid – THCA becomes THC. The optimal temperature for an almost complete decarboxylation of the cannabinoids is around 210°C. Heating at higher temperatures can lead to the loss of active ingredients and thus lower bioavailability, as is the case with smoking, for example. Smoking produces temperatures of up to 700°C.

Measuring spoon

Fine-cut cannabis flower is weighed in either unit doses, citing the NRF regulations: NRF 22.13 (unit-dose cannabis flower for inhalation after vaporization) or NRF 22.15 (unit-dose cannabis flower for tea preparation) or filled into a multi-dose container from which the patient takes the appropriate amount for one application. There are dosing spoons for different amounts for easy and precise dosing. The most common is the 1 mL scoop, which holds a nominal 100 mg of cannabis flowers. For larger quantities, e.g. in the pharmacy, a 1.7 ml spoon that holds approx. 250 mg of cannabis flowers is ideal. Significantly less is sufficient for inhalative use. Dosing spoons with a nominal volume of 0.16 and 0.3 ml (for around 20 or 35 mg of cutting drug) are now available for this purpose.

Dronabinol

AtDronabinol, better known as THC, is the main active ingredient in the cannabis plant. In the US, dronabinol in capsule form (Marinol®) is approved for the treatment of anorexia with weight loss in AIDS patients and as a second-line treatment for nausea and vomiting associated with chemotherapy. Since February 1998, dronabinol has also been available for sale and prescription in Germany. However, in this country it is only available as a prescription drug. Dronabinol preparations are manufactured in pharmacies as drops or capsules according to the relevant NRF regulations.

If required, the finished medicinal product Marinol® can be imported to Germany.

To this day, the Single Convention forms the basis of worldwide drug control with the aim of restricting the availability of drugs. The core of this agreement is a table in which 4 substance categories with different marketability were defined. Exceptions only apply to the use of these substances for medical and scientific purposes. Cannabis and all its derivatives were grouped together with heroin as substances with particularly dangerous properties and limited therapeutic value. In November 2018, the WHO expert committee recommended a reclassification in Table I.

EMA (European Medicines Agency)

The European Medicines Agency (EMA) is an agency of the European Union that is responsible for the assessment, approval and monitoring of medicines in the EU. Drug manufacturers must comply with the EMA guidelines. The implementation of and compliance with these requirements are regulated by the corresponding laws of the member states.

Endocannabinoid system (ECS)

The endocannabinoid system (also endogenous cannabinoid system) is part of the nervous system and includes the cannabinoid receptors CB₁ and CB₂ with their natural ligands (endocannabinoids) and enzymes for their synthesis and degradation. By modulating the release of various neurotransmitters such as GABA, glutamate or dopamine, the endocannabinoid system is involved in many important bodily functions.

Endogenous cannabinoids (endocannabinoids)

These are endogenous cannabinoids that bind to cannabinoid receptors and act as a retrograde neurotransmitter. The two most well-known endocannabinoids are 2-arachidonylglycerol (2-AG) and anandamide (AEA). The effect of the so-called “runner’s high” is due to the release of anandamide.

Entourage Effect

The “entourage effect” describes the interaction of different substances, which leads to an intensification and expansion of the individual effects. Cannabis strains with almost the same THC and CBD content can differ significantly in their medicinal effects. Among other things, this can be attributed to the fact that the varieties differ in terms of other active ingredients such as terpenes. The synergistic interaction of all the active ingredients in a plant determines the individual therapeutic effect.

Epidiolex

In June 2018, the first finished drug containing cannabidiol (CBD) was approved in the United States for the treatment of seizures associated with two rare and severe forms of childhood epilepsy (Lennox-Gastaut syndrome and Dravet syndrome). In three randomized, double-blind and placebo-controlled clinical studies, a significant reduction in the frequency of seizures (~ 40%) compared to placebo was demonstrated. In 2019, Epidiolex received European approval from the EMA.

Die U. S. Food and Drug Administration (FDA) ist die Lebensmittelüberwachungs- und Arzneimittelbehörde der Vereinigten Staaten. Sämtliche in den USA zugelassenen Medikamente müssen bei Pharmaherstellern gefertigt werden, welche von der FDA inspiziert wurden und deren Herstellungsanlagen den Regularien entsprechen.

Fertigarzneimittel

Ein Fertigarzneimittel ist ein Arzneimittel, das im Voraus hergestellt und in einer zur Abgabe an den Verbraucher bestimmten Packung in den Verkehr gebracht wird. Für das Inverkehrbringen eines Fertigarzneimittels ist eine Zulassung durch die zuständige Aufsichtsbehörde erforderlich. Erhältliche Cannabinoid-Fertigarzneimittel auf dem deutschen Markt (Stand: Mai 2020) sind Sativex (Nabiximols) (Almirall), ein oromukosales, alkoholisches Spray aus THC und CBD und Canemes (AOP Orphan Pharmaceuticals), eine Kapsel mit Nabilon als Wirkstoff und Epidiolex, mit dem Wirkstoff CBD in öliger Lösung .

First-Pass-Effekt

Der First-Pass-effekt bezeichnet die Umwandlung eines Arzneistoffes während dessen erster Passage durch die Leber. THC wird nach oraler Verabreichung in der Leber zu 11-Hydroxy-THC verstoffwechselt. 11-Hydroxy-THC ähnelt in seiner Wirkung stark dem THC.

Good Agricultural and Collection Practice refers to guidelines for quality assurance in the extraction of herbal raw materials that are to be used in the manufacture of herbal medicinal products. The aim of this guideline is to ensure a high and consistent quality of the plant material and the medicinal products made from it. Cannabis is also a plant used to obtain medicines. Therefore, compliance with safety regulations (no contamination/constant concentrations of active ingredients) is particularly important.

GDP (Good Distribution Practice)

Good Distribution Practice means all measures that ensure that the quality and integrity of medicinal products is maintained. Although the guideline is primarily aimed at pharmaceutical wholesalers, pharmaceutical manufacturers and all those involved in logistics (transport companies, warehouses, etc.) must also meet the requirements. These measures are particularly important when dealing with narcotics.

GMP (Good Manufacturing Practice)

Good Manufacturing Practice refers to guidelines for quality assurance of all processes during the production of medicinal products and active ingredients. A GMP-compliant quality management system serves to guarantee product quality and to meet the binding requirements of the health authorities for marketing. In the case of medicinal products such as cannabis blossoms or cannabis extracts, only complete monitoring of all production steps can ensure a consistent composition and concentration of active ingredients and thus a consistent therapeutic effect.

Law amending narcotics law and other regulations 03/10/2017

The draft law was an alternative to self-cultivation by patients (permission by the Federal Constitutional Court 2016). The existing legal regulations were amended or supplemented as follows:

• Dried cannabis blossoms and cannabis blossom extracts were re-classified in Appendix III of the BtMG and are now marketable and prescribable without indication restrictions. This means that these can now also be prescribed without an exemption.
• The prescription can be made by any doctor (except: veterinarians and dentists).
• An extension of the prescription of approved medicinal products. It is now also possible to assume the costs for off-label use.
• Health insurance companies can also cover the costs of cannabis flowers and cannabis flower extracts if the following conditions are met (§ 31 Paragraph 6 SGB V):

1. 1. the patient has a serious medical condition
   2. the standard therapy is not available (side effects/ineffectiveness)
   3. There is a positive prognosis in terms of effectiveness

• Participation in a non-interventional companion survey

(if costs are covered by statutory health insurance)

Act for More Security in the Supply of Drugs (GSAV) 2019

The law for more security in the supply of medicines, passed on June 6th, 2019, makes three major adjustments to the legal provisions for therapy with cannabinoids.

1. After successful approval of the cannabinoid therapy by the GKV, no further application to the health insurance company is necessary at:

– Dose adjustments

– Change of flower type

– Switching between cannabis extracts

1. Following treatment with cannabis medicinal products during an inpatient stay in the hospital, the approval period after discharge should only be three days /li>

Grinders

Before using medicinal cannabis in the form of whole, dried flowers, they must be properly crushed. If this is done by the patient himself, it is advisable to use a grinder (also known as a herb mill). This consists of two round discs that are equipped with blades. Some grinders also have a device for storing or for easier dosing of the ground flowers.

All terms are names for the same plant species – Cannabis sativa L. “Hemp” or “useful hemp” is used in connection with forms that are used purely for industrial purposes (e.g. fiber production) and contain < 0.2% THC. We speak of marijuana or cannabis when the plant contains high concentrations of the cannabinoids THC and/or CBD and is therefore to be used for therapeutic or recreational purposes. In connection with medical use, the term "medicinal cannabis" or "medical cannabis" is usually used. However, this term not only includes cannabis flowers, but also all other cannabinoid-based medicinal products. Hybrid

Hybrid strains are crosses between sativa and indica. They combine the properties of both types and therefore have a balanced effect profile.

The Pharmacy Operating Regulations (ApBetrO) stipulate that medicines manufactured in the pharmacy must be of the quality required by pharmaceutical science. At least two independent checks on the identity of the substance must be carried out to rule out errors in the manufacturer’s labeling, for example. These tests are carried out according to the recognized pharmaceutical rules, which are recorded in the pharmacopoeia (DAB) or in the DAC monographs, among other things. For identity verification, cannabis flowers are examined macroscopically and microscopically. Furthermore, the active ingredients (THC/CBD) are identified using thin-layer chromatography (TLC).

Indica

Indica strains originally come from subtropical regions. The plants grow much more compactly than sativa strains, have broader leaves and are darker in color. A sedating effect is associated with indica strains, making it well suited for evening use.

The Medical Service of Health Insurance (MDK) advises the statutory health insurers on general questions and conducts individual assessments. The MDK works to ensure that the insured receive benefits that correspond to the generally recognized state of medical knowledge and are at the same time economically justifiable. In most cases, applications for reimbursement of costs for cannabis-based therapies are forwarded to the MDK.

Medical Need

In connection with cannabinoid-based therapy, the “medical need” of the patient should always be taken into account. Many patients with chronic diseases or pain have a high level of suffering and an urgent need for suitable therapy.

Mighty Medic

The portable vaporizer MIGHTY MEDIC from Storz & Bickel has a patented combination of hot air convection heating and additional heat conduction as well as an LED display. It is suitable for the inhalative application of dried and crushed cannabis flowers. The two lithium-ion batteries enable a long service life of approx. 8 fillings (60-90 minutes of continuous power).

A non-responder is a person who does not respond or only responds insufficiently to medical treatment such as therapy with a drug. Medical cannabis flowers can be an effective form of therapy, especially for non-responders to cannabinoid therapies with mono-preparations (e.g. Nabiximols).¹

1. Saccá et al., 2016 (https://doi.org/10.1016/j.jns.2016.07. 059)

NRF regulations

The “New Recipe Form” (NRF) is the standard work for drug production in pharmacies and contains information on standardized drug production. It thus fulfills an important function in the pharmaceutical quality assurance of prescription drugs. In the field of medical cannabis, the following NRF regulations are of particular importance:

• Dronabinol capsules 2.5 mg / 5 mg / 10 mg (NRF 22.7.)
• Oily dronabinol drops 25 mg/ml (NRF 22.8.)
• Oily cannabidiol solution 50 mg/ml / 100 mg/ml (NRF 22.10.)
• Oily cannabis oil resin solution 25 mg/ml dronabinol (NRF 22.11.)
• Cannabis flowers for inhalation after vaporization (NRF 22.12.)
• Unidose cannabis flowers for inhalation after vaporization (NRF 22.13.)
• Cannabis flowers for tea preparation (NRF 22.14.)
• Cannabis flowers in single doses 0.25g/0.5g/0.75g/1g for tea preparation
• (NRF 22.15.)
• Dronabinol ethanol solution 10 mg/ml for inhalation (NRF 22.16.)

If the cannabis flowers are to be crushed in the pharmacy, the doctor will indicate the relevant NRF regulation in the prescription.

Off-label use refers to the prescription of a finished medicinal product outside of the indication approved by the medicinal product authorities. The use in the area of application or in the type of application can deviate from the approval. Cannabinoid-based finished medicinal products with restricted indications are:

1. Sativex® (Nabiximols)

Second-line therapy for the treatment of therapy-resistant moderate/severe spasticity in multiple sclerosis.

1. Canemes® (nabilone)

Second-line therapy for the treatment of chemotherapy-related vomiting and nausea in cancer patients.

1. Marinol® as import (dronabinol)

US approval for the treatment of loss of appetite associated with AIDS and nausea associated with chemotherapy. This is to be distinguished from the dronabinol formulation as it is available in Germany.

1. Epidiolex

The first approved finished medicinal product containing the active ingredient cannabidiol (CBD) for the treatment of seizures associated with two rare and severe forms of childhood epilepsy (Lennox-Gastaut Syndrome and Dravet Syndrome).

OMC

Similar to the German Cannabis Agency, the Dutch Office of Medicinal Cannabis (OMC) is a government agency responsible for the production of cannabis for medical and scientific purposes. The OMC is responsible for supplying medicinal cannabis to pharmacies, as well as importing and exporting it. The quality of the medical cannabis is guaranteed by constant monitoring of the cultivation by the manufacturers and distribution by wholesalers.

Pharmacokinetics describes the totality of all processes to which a drug is subject in the body. Depending on the form of administration, cannabinoids are absorbed via the oral mucosa, the lungs or the gastrointestinal tract. It must be taken into account that in the case of oral administration, the active ingredients are first digested. This influences both the bioavailability and the onset and duration of action.

A quality management system is a method of corporate management. It ensures that system quality, process quality and product quality are checked and improved. The aim of a quality management system is a permanent improvement in company performance. A quality management system according to the specifications of Good Manufacturing Practice (GMP) is mandatory for the pharmaceutical industry.

In order to ensure that the statutory health insurance system remains affordable, the health insurance companies are also obliged to carry out cost-effectiveness audits of individual doctors and their prescription behavior. Doctors who prescribe medicines or remedies in excessive quantities can be held liable for this. This means that the health insurers can reclaim the costs for the uneconomically prescribed medicines and remedies. Although many doctors fear recourse when prescribing cannabis, according to health insurance companies, this risk is low. Especially in the case of the complex application for the assumption of costs, the facts (medical necessity/suitable form of therapy/economic viability) are examined in detail before approval is given.

Prescription drug

Prescription medicines are individually prepared by pharmacists after being prescribed by a doctor or at the request of a patient. Prescription drugs are not finished drugs, so they do not fall under the authorization requirement according to § 21 AMG. Cannabis blossoms (cannabis flos) are prescription medicinal products and therefore do not go through the AMNOG procedure for benefit assessment/price determination. Other cannabinoid prescription drugs on the German market (as of May 2020) are isolate-based preparations (dronabinol and/or CBD), which can be produced as an oily solution or capsules, as well as various cannabis extracts (full-spectrum extracts).

Sativa strains originally come from tropical regions. They are tall plants with very narrow, finger-shaped leaves. These cannabis strains are often credited with having a more activating effect.

Sativex

The finished medicinal product Sativex containing nabiximols is an oromucosal spray which contains the two therapeutically effective cannabinoids tetrahydrocannabinol and cannabidiol. It is approved for the add-on treatment of moderate to severe spasticity in patients with multiple sclerosis who have failed other antispastic therapy.

cutting

Cannabis plants are placed as so-called “cuttings”. These are severed branches from a “mother plant” selected and grown for their individual characteristics. The newly created plants all carry the same genetic makeup. This method of propagation ensures that all plants carry the same traits for active ingredient composition and active ingredient concentration. Constant environmental conditions are also created by rearing in controlled climate rooms. These measures are part of standardized cultivation, which aims to ensure product quality that is as consistent as possible.

Storz & Bickel

Currently, STORZ & BICKEL is the only company that manufactures medical cannabis vaporizers that can be prescribed by a doctor as an aid. Currently, however, the vaporizers do not have an official tool number (as of July 2019). The company is certified according to DIN EN ISO 9001 and 13485 and thus fulfills the basic requirements for the manufacture of medical products. For medical use, the Mighty Medic and the Volcano Medic are available in Germany.

Strain/ Cultivar/ Cannabis variety

Medicinal cannabis is a breeding plant. There are many different types of cannabis, also known as “strains” or “cultivars”. Each variety has individual active ingredient compositions and active ingredient concentrations. Together with the genetics of the plant (indica, sativa, hybrid) and the terpene composition, each strain has a unique effect profile.

Terpenes are phytochemicals derived from isoprene. They are widespread in nature and are best known as the main components of the essential oils that give plants their smell and aroma. In pharmacology, terpenes are used as medicinal substances. They are also used in cosmetics and as insecticides and pesticides. Terpenes are formed in the trichomes of cannabis plants and contribute to the pharmacological effects of the plant. In Cannabis sativa L. > 100 terpenes were detected. Their composition differs between the different varieties and depends on various external influences such as climatic conditions, age and maturity of the plant or the time of day. Therefore, the terpene composition and the respective content can also differ in different batches of a variety. Since terpenes not only influence the effect of the cannabinoids, but also have their own therapeutic effects, the respective terpene profile of the product is quite interesting for patients and doctors.

THC

The most well-known cannabinoid is Δ9-tetrahydrocannabinol (THC). This is the psychoactive compound in the cannabis plant. In the plant itself, THC is initially present as THC acid (THCA) and unfolds its effect in the body after decarboxylation. THC is mainly used in the treatment of chronic pain.

Trichomes

Trichomes are so-called glandular hairs that can be found on various other plants besides cannabis. They not only produce the cannabinoids, but also other important substances such as flavanoids and terpenes. In nature, the substances produced serve to protect the plant from predators, fungal infestation, UV radiation and certain weather conditions. The number of trichomes is crucial for the cannabinoid content of the plants. Since trichomes are more common on the flowers of female cannabis plants (protection of the seeds), only these are used in medicine.

Medically certified vaporisers are suitable for the inhalative use of medicinal cannabis flowers. Unlike smoking cannabis, vaping does not produce toxic compounds that can damage body tissues. In addition, the exact temperature setting ensures optimal decarboxylation and thus the best possible release of active ingredients. The only two medical vaporizers are the Mighty Medic and Volcano Medic from Storz&Bickel.

Ability to prescribe / assumption of costs of CBD (§2 benefits SGB V)

CBD supplements have been prescription-only since 2016. Since CBD is not psychoactive, CBD does not fall under the Narcotics Act. The assumption of costs by the health insurance company has not yet been clarified (as of July 2019). In general, however, these are individual case decisions in accordance with §2 Paragraph 1a SGB V.

Insured with a life-threatening or regularly fatal illness or with an illness that is at least comparable in terms of evaluation, for which a generally recognized benefit corresponding to the medical standard is not available can also receive a from Paragraph 1 Clause 3 claim different benefits if there is a not entirely distant prospect of healing or a noticeable positive effect on the course of the disease. The health insurance company issues a cost assumption declaration for services according to sentence 1 before the start of treatment if the insured person or the treating service provider requests this. The billing option for the service according to sentence 1 is determined with the declaration of cost assumption.

Volcano Medic

The VOLCANO MEDIC Vaporizer by Storz&Bickel is a powered cone-shaped desktop vaporizer with hot-air convection heating and a patented, removable valve balloon system, the EASY VALVE, for easy inhalation. The vaporization system allows both the inhalative medical application of liquid cannabinoids dissolved in alcohol (e.g. ethanolic dronabinol solution) and the inhalative use of dried and crushed cannabis flowers.

The spectrum of action of a drug describes the areas in which it shows a pharmacological effect. Via the endocannabinoid system (ECS), the various cannabinoids influence numerous important physiological processes such as:

• Mood
• Sleep
• Appetite
• Metabolism
• Pain sensation
• Reminder
• Immune function
• Inflammatory reactions
• Neuroprotection and development
• digestion
• Reproduction

Principle of economic efficiency (§ 12 SGB V)

Accordingly, services must be sufficient, appropriate and economical and must not exceed what is necessary. The insured persons may not claim services that are not necessary or even uneconomical, the service providers may not carry them out and the health insurance companies may not approve them. Health care providers who violate the principle of cost-effectiveness expose themselves to recourse claims from the health insurance companies and/or risk a reduction in their reimbursement claims. Prerequisites for an economical way of prescribing:

• Sufficient

The service must meet the requirements of the specific individual case and the generally recognized state of medical knowledge. In addition, it should take medical progress into account.

• Useful

The service to be provided must be suitable, appropriate and appropriate with regard to the specific treatment goal. Which dosage form is the most suitable, taking into account the mode of action and the needs of the patient?

• Economic

Therapists have to achieve the greatest possible treatment success with the least resources. If there is a choice between different dosage forms, the cheaper one should be selected.

• Required

The service to be provided must be objectively necessary in order to achieve the desired treatment goal. Cannabis is often used as a last resort.

Source: Bavaria/ Events/ MDK_im_Dialog_Series/ Cannabis_Muenchen/ The_various_dosage_forms_of_cannabis_in_the_performance_of_GKV_Mueller.pdf