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FAQ.

Here you will find short answers to frequently asked questions about medical cannabis, cannabinoids, therapy with cannabinoids as well as background information about the market and research.

Basic

There are over 180 cannabinoids and related substances such as terpenes in a hemp plant. Most of them are present in very low concentrations and hardly researched. The best known cannabinoids are THC and CBD. THC ((-)-Δ9-trans-tetrahydrocannabinol) is called dronabinol in pharmacy, CBD stands for (-)-trans-cannabidiol.

The use of cannabis dates back around 12,000 years. In China, cannabis was first proven to be used medicinally in 2700
BC.

The reason for this prohibition were decisions of the industrialized countries in 1924 at the Opium Conference.
In Germany, the Reichstag decided in December 1929 that the possession of cannabis was punishable.
Initially, this prohibition did not apply to medicine or to its use as a source of raw materials, such as textiles
or oils. For pharmaceutical use, cannabis was only banned in 1961 by the Single Convention on
Narcotic Drugs 1961.

THC, also called dronabinol, is the main active ingredient of the cannabis plant and the lead substance of the
cannabinoids. THC has a strong effect on the psyche and the body. Among other things, it has analgesic, mood-lifting, antiemetic and appetite-stimulating effects
.

CBD (cannabidiol), unlike THC, is only slightly psychotropic and has no intoxicating effect.
Rather, it has anti-inflammatory, anticonvulsant, antioxidant and also has a calming
to antipsychotic effect.

Cannabis in evidence-based medicine

The human body has its own receptor system for cannabinoids and produces messenger substances that act through it. The complex regulatory system controls a multitude of functions throughout the body, which also explains the diverse effects of cannabis. The sphere of influence of the endogenous cannabinoid system includes: brain development and memory, motor function, regulation of food intake and body temperature, blood circulation, the immune system, pain perception, and cell growth. When pharmaceutical cannabis is ingested, cannabinoids bind to endocannabinoid receptors in the central nervous system (CNS) as well as the rest of the body. This interaction affects those endogenous processes in which the ECS is involved. These effects can be used to positively influence the symptoms of a disease or to compensate for a malfunction of the ECS.

Most often, in this country in an estimated 50 percent of cases, pharmaceutical cannabis is prescribed to chronic pain patients. Other uses for cannabinoids include: Spasms, glaucoma, migraines and cluster headaches, or as an add-on in the treatment of cancer and HIV. In cancer therapies, Tourette's syndrome or even ADHD, the use of cannabis flowers has proven to be advantageous over pure dronabinol (THC). Cannabidiol (CBD) has proven itself in the therapy of epilepsy, among other things. It also attenuates side effects of dronabinol (THC). The need for clinical trials is immense if one wants to unlock the full potential of the use of cannabinoids. The best evidence for efficacy is currently available for the treatment of multiple sclerosis and certain forms of epilepsy.

Yes, except veterinarians and dentists. However, prescribing physicians or their patients must participate in an accompanying survey. In this way, further anonymised data on indication, dosage and efficacy are to be collected. For the assumption of costs by the health insurance company, elaborate and detailed reports or statements are usually necessary, which is why many doctors shy away from prescribing.

Patients either inhale vaporized cannabinoids or take them orally in the form of drops or capsules. Smoking is unsuitable for pharmaceutical purposes, as uncontrolled burning produces potentially harmful substances. It is not advisable to take drops diluted in drinks, as the active ingredients do not dissolve in water and can stick to the cup. The oily, cannabinoid-containing formulations are to be taken perorally, for example on a spoon or a piece of bread, and must not be vaporized or inhaled. The cannabinoids dissolve only in fat or alcohol. Therefore, fatty foods may affect the absorption of the active ingredients. When cannabinoids are inhaled, the effect occurs after 5 to 15 minutes and lasts approximately one to three hours. When used orally, the effect occurs after one to two hours, but lasts up to six hours. These values can vary depending on dosage and individual factors. Those taking cannabinoids orally should first find their optimal dose by gradually increasing drops (titration phase) and can then switch to appropriately dosed capsules if needed.

There are important differences between the mode of action of orally administered dronabinol (THC) and inhaled administration. For example, oral dosage forms are more reliable in delivering the amount of active ingredient, which improves reproducibility. In addition, due to the slow onset and longer duration of action, consistent blood plasma levels are achieved. With inhaled application, the effect occurs without a long time delay, which is relevant for patients with pain peaks, such as migraine or tumor-related pain.

Yes, side effects can occur when taking pharmaceutical cannabis products, especially at the beginning of the therapy. Experience has shown that these will subside within the first few weeks. With cannabidiol (CBD) there are hardly any known side effects, patients report fatigue, especially at high doses. Interactions may occur, for example, if certain psychotropic drugs are taken at the same time.

Background on market and research

The cannabis plant contains over 180 different cannabinoids and related substances such as terpenes. Most of these are only found in small amounts in cannabis. It is extremely costly and time-consuming to isolate these individually from the plant. Therefore, there are still gaps in our knowledge about the effects of these different cannabinoids. Currently, scientists are researching the effects of cannabinoids on over 100 different diseases. The possibility of producing the various cannabinoids efficiently and cheaply using the biosynthetic process developed by Farmako opens up new perspectives for evidence-based empirical research in medicine and science. Researchers and doctors can thus specifically find out which cannabinoids work how and in which combination.

Until May 2019, pharmaceutical cannabis was imported either from the Netherlands or Canada. In the meantime, in addition to Germany, countries such as Macedonia or Malta have also created legal frameworks for the legal cultivation and export of pharmaceutical cannabis.

In 2017, the Cannabis Agency opened a tender procedure for the cultivation of pharmaceutical cannabis. The Cannabis Agency is located at the Federal Institute for Drugs and Medical Devices (BfArM) and manages and controls the cultivation of cannabis for pharmaceutical purposes in Germany. In March 2018, the Düsseldorf Higher Regional Court decided to annul the first cannabis tender. As a result, the BfArM published a new tender in July 2018. In April and May 2019, the three companies were announced, receiving a total of 13 lots. In total, they are expected to harvest 10.4 tonnes of cannabis over four years.

Yes, a few patients had special permission from the Federal Opium Agency.

In Canada, medical cannabis has been legal since 2001. However, patients were only allowed to grow and consume plants for their own use in a strictly regulated manner. It wasn't until 2013 that Canada licensed some companies to produce pharmaceutical cannabis. Since October 2018, the cultivation and consumption of medical cannabis has been fully legalized in Canada. Since then, demand has been so high that Canadian companies can no longer adequately guarantee exports to countries like Germany. In addition, the demand for pharmaceutical cannabis is simultaneously increasing worldwide, which also exacerbates the supply situation.

Farmako GmbH makes no claim to the completeness of the contents and assumes no responsibility, guarantees or liability that the information provided is correct, complete or up-to-date. Moreover, it does not release the doctor, pharmacist, pharmacist from the obligation to inform himself in detail regarding the medical advantages and disadvantages of a cannabinoid therapy considered for the patient. In particular, the information contained herein does not constitute an offer or recommendation for purchase or therapy for specific medical fields of application.

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