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ABDA: The fact sheet formulation drugs with cannabis has been updated and is available for download.

ABDA:  The fact sheet formulation drugs with cannabis has been updated and is available for download.

RECIPROCAL MEDICINES WITH CANNABIS

Updated: June 21, 2018 What is cannabis?

»Cannabis is the scientific name of the genus hemp and is colloquially used for plant parts and products, in particular for marijuana (flowers of the female plant) and hashish (resin). Medicinal use of cannabis

»The data on the medicinal use of cannabis in various indications is inconsistent.1 There is good evidence for the therapeutic benefits of cannabis and cannabinoids in chronic neuropathic or cancer-related pain and spasticity due to multiple sclerosis. There are moderate evidences of efficacy against nausea and vomiting as a result of chemotherapy. In contrast, little or no evidence has been found that cannabis and cannabinoids help with chronic rheumatic pain, improve the appetite of patients with HIV and slow their weight loss, relieve symptoms of Tourette’s and anxiety disorders, psychosis or post-traumatic stress syndrome.

»On March 10, 2017, a law on the medical use of cannabis came into force. (“Act amending narcotics and other regulations”) 2> Physicians may prescribe cannabis to their patients upon prior approval by the health insurer, and pharmacies may manufacture appropriate prescription medicines. For medical use, cannabis flowers can be inhaled after being heated in special evaporators or drunk as an aqueous decoction (“tea”). > These prescription medicines containing cannabis are reimbursed by health insurances. The current Pharmaceuticals Price Regulation (AMPreisV) is applicable to the pricing of medicinal products manufactured from cannabis. Patients are required to make a co-payment of 10 percent of the drug price, but no more than 10 euros per drug.3 1 http://jama.jamanetwork.com/article.aspx?ar 2 »In 2017, pharmacies will have to pay the statutory health insurance companies around 44,000 units of cannabis prescription drugs delivered4. Statements about the number of patients or the amount are not possible. »Availability: The Federal Government had no information available in June 2018 that the delivery difficulties for cannabis flowers that occurred in the summer of 2017 persisted5. If in individual cases in a pharmacy a certain sort of cannabis flowers are not in stock, this could be the case in another pharmacy. There is also a potential for physicians to prescribe alternative cannabis-based prescription or finished medicinal products. Pharmaceutical Evaluation of Cannabis

»In total, more than 400 different ingredients have been detected in cannabis. Main ingredients are the so-called cannabinoids. Important ingredients for medical use are delta-9-tetrahydrocannabinol (Δ9-THC, also called dronabinol) and cannabidiol (CBD) in the form of largely pharmacologically inactive precursors (“THC-A” or “CBD-A”). considered. »In cannabis plants and their extracts – as with all natural products – the concentration of the various ingredients varies. There are several varieties of cannabis flowers available that contain different concentrations of the precursors of the main ingredients Δ9-THC and CBD. DAC / NRF Monographs and Formulation Regulations »The German Medicines Codex (DAC) and the New Formulation Form (NRF) are the responsibility of the DAC / NRF Commission. The publisher is the ABDA – Bundesvereinigung Deutscher Apothekerverband e. V. It appoints the independent expert DAC / NRF Commission. > DAC monographs contain information that aggregates the pharmaceutical knowledge of the active substance described. In DAC monographs u. a. Test method for identity, purity and content as well as storage and application instructions described. > NRF recipe prescriptions contain information on the preparation but also on the use of prescription drugs.

»For Dronabinol, there has been a DAC monograph since 2001 as well as the standardized NRF 4 ABDA press release dated 8 March 2018, https://tinyurl.com/y7tonsqe 5 Federal Government Response to Small Request, June 14, 2018 http: / /dip21.bundestag.de/dip21/btd/19/027/1902753.pdf 3 Formulation instructions for capsules and drops for oral use. In addition, in March 2017, the NRF formulation requirement for a solution for inhalation was pre-published.

»In 2015, a DAC monograph and an NRF prescription protocol were published for cannabidiol as the starting material and for cannabidiol solution as an oral preparation. Cannabidiol is not an anesthetic, but since 2016 de

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Cannabis Law – reveals legal uncertainty one year after its entry into force. A top-class group of experts debated the 22nd Eppendorfer Dialog on April 11, 2018 in Hamburg

http://www.eppendorferdialog.de/veranstaltungen/medizinischer-cannabis-zwischen-hoher-nachfrage-und-regulatorischen-huerden.html

Well meant, but from the perspective of many not concretized to the end. § 31 para. 6 SGB V, the “Law on the Amendment of Narcotic and Other Regulations” – in short: the Cannabis Law – reveals legal uncertainty one year after its entry into force. A top-class group of experts debated the 22nd Eppendorfer Dialog on April 11, 2018 in Hamburg in front of a large and dedicated participatory auditorium the experiences made so far. With increasing expectations of the patients, numerous construction sites reveal themselves: Disconcerting doctors due to missing indication formulations, high numbers of application rejections by the health insurance funds, supply bottlenecks in the medical cannabis and questions regarding the pricing. But there are also noteworthy achievements: Estimated 14.

speakers

The Eppendorfer Dialogue on Health Policy this time asked the question “Medical cannabis between high demand and regulatory hurdles: where do we stand?” Chairman Prof. Dr. med. med. Achim Jockwig had succeeded in inviting a group of experts to cover the entire range of questions surrounding the cannabis law.

Therapy benefit for patients outweighs evidence deficit

It all started with the representative of the Federal Ministry of Health, which is responsible for the realization of the law. The spokeswoman for health policy of the CDU / CSU parliamentary group Karin Maag explained the background to a legal adoption of a therapy in which the usually required evidence standards could not be applied. Maag: “There are many patients with serious illnesses, for whom there is no alternative recognized by medicine, if the standard therapy does not help.” It has been shown – according to Maag – that cannabis is a good treatment option in diseases such as multiple Sclerosis, AIDS, epilepsy or chronic pain can be. These people should be helped. Another impetus was given by the new legal situation and the critical question of self-cultivation. Politics had to act and, in March 2017, passed a law of high political significance and relevance for the everyday care routine. Since then, the use of cannabis for medical purposes is possible – but only to these. The Cannabis Law controls and controls the manufacture and distribution of medicinal hemp. All parties involved must comply with the narcotic and drug legislation. The Cannabis Law controls and controls the manufacture and distribution of medicinal hemp. All parties involved must comply with the narcotic and drug legislation. The Cannabis Law controls and controls the manufacture and distribution of medicinal hemp. All parties involved must comply with the narcotic and drug legislation.

“Once again, we make it clear that a patient does not have to endure serious side effects for many years before he can get approved for the therapeutic alternative of a cannabis drug, and we have strengthened the therapy sovereignty of the doctors. In the future, they will prescribe on the basis of their own examination that any exemption will be waived. “(Karin Maag)

Health policy has found a viable solution in their view by setting very definite standards for the supply of medicinal cannabis. Furthermore, the law is open to rework, says Maag.

Health insurance companies feel overwhelmed by the law

In addition to standardization requirements for cultivation, processing, active substance content and delivery, the standards stipulated in the law include the description of the parameters under which patients are reimbursed for a cannabis therapeutic. And here lies the crux, because the formulations are too concretely many doctors as well as the health insurance companies. This leads to uncertainty at the regulation level and substantiates a large number of the application rejections by the health insurance companies. Dr. Detlev Parow (Business Unit Product and Payroll Management at DAK-Health) describes the decision-making process at the health insurance fund, which according to the law may only refuse a pension application in justified exceptional cases. But what does exceptional case mean? “As the disease is very vague and the indications are completely open, With the exception of palliative care, we see ourselves in the situation of having to obtain nearly 100 percent of the MDK’s assessment. Due to the assessments, which also take time to annoy all beyond the defined deadlines, currently about 30 percent of the applications are rejected, “said Dr. med. Parow. Like other insurers, the DAK sees itself, to a certain extent, in the protective position of the solidary community of insured persons. Dr. Parow puts the treatment costs per patient per year at up to 30,000 euros and at the same time alludes to the lack of treatment evidence. He demands a time limit for the approval with subsequent verification. However, this statement was objected to in the discussion

“The health insurance companies are not the dark side of power when it comes to obstructions. The path from application to approval is too many pitfalls. “(Dr. Detlev Parow)

Cannabis therapy in practice: Pain patients benefit in the first place

The renowned palliative physician and Federal Cross of Merit Professor Winfried Hardinghaus, chief physician of the Clinic for Palliative Medicine Franziskus Hospital at the Charité Berlin and Chairman of the German Hospice and PalliativeVerband, emphasizes at the beginning of his presentation on the therapeutic benefits of cannabis medication that he neither the thin Evidence still the unconcrete indication description holds bad. Finally, one has the meta-analysis and the results of the CaPRis study. In addition, Prof. Hardinghaus considers the side effect potential of medicinal cannabis to be low – especially in comparison to many classic medicines. Prof. Hardinghaus describes the influence of cannabis drugs on the cannabis receptors and points out It is precisely the combination of THC and CBD that has a positive effect on chronic pain, the improvement of nausea and vomiting, as well as an increase in appetite. However, interactions with, for example, amphetamines, antihistamines, barbiturates and, in particular, psychotropic drugs and dronabinol must be taken into account at low organic side effects and low addictive potential in medical applications. As the effect of medicinal cannabis is known, Prof. Hardinghaus welcomes the fact that the legislator does not specifically specify the indications and thus does not further regulate the therapeutic use. This opens up opportunities, especially for oncological concomitant therapy. “If we get 30 percent pain improvement, that’s a lot and relevant,” said the palliative care physician. Many colleagues would shy away from the regulation because they would not be able to handle cannabis therapy. He advises him to use the offered prescription aids for doctors. Doctors in the auditorium ask why, given the high level of side effects associated with the treatment of pain, it is justifiable that these should be prescribed if medical cannabis is the alternative.

“I do not want to give up cannabis on my palliative care ward.” (Prof. Winfried Hardinghaus)

Regulatory conflicts fuel legal uncertainty in the handling of cannabis medication

He is surprised that one wonders that in Germany so far no one has researched cannabis therapy, said the medical lawyer and board member of the German Society for Palliative Medicine. Oliver Tolmein. Given the current legal situation of cannabis in our country, it is in no way surprising that there is no evidence. Which claim should you have invested in research? Dr. Tolmein explains the regulatory situation of prescribers, pharmacists, manufacturers, and patients with the entry into force of the cannabis law. This is characterized by a high degree of legal uncertainty. The conflicts are primarily related to a crisis in evidence-based medicine. In the case of the complex herbal medicine, this leads to cannabis, Regulatory restrictions and unconcrete formulations have to be carried out on the shoulders of all stakeholders. Tolmein: “To deal with this conflict, we have to ask ourselves whether we want to have evidence as the only criterion, or whether there are other criteria for patient benefit, which ultimately lead to legal certainty.” At this point, the in Auditorium present protection police and reports on the uncertainty, for example, in traffic. The requirement: Medicinal cannabis regulations should be treated in the traffic regulations as a normal drug. So far, people who take medical cannabis regularly, the driving license must be withdrawn. “To cope with this conflict, we need to ask ourselves if we want evidence as the only criterion, or if there are other criteria for patient benefit that ultimately lead to legal certainty.” This is where the audience present at the auditorium announces Protective police to word and reports on the uncertainty, for example, in traffic. The requirement: Medicinal cannabis regulations should be treated in the traffic regulations as a normal drug. So far, people who take medical cannabis regularly, the driving license must be withdrawn. “To cope with this conflict, we need to ask ourselves if we want evidence as the only criterion, or if there are other criteria for patient benefit that ultimately lead to legal certainty.” This is where the audience present at the auditorium announces Protective police to word and reports on the uncertainty, for example, in traffic. The requirement: Medicinal cannabis regulations should be treated in the traffic regulations as a normal drug. So far, people who take medical cannabis regularly, the driving license must be withdrawn. “At this point, the protection police present in the auditorium speaks up and reports on the uncertainty, for example in traffic. The requirement: Medicinal cannabis regulations should be treated in the traffic regulations as a normal drug. So far, people who take medical cannabis regularly, the driving license must be withdrawn. “At this point, the protection police present in the auditorium speaks up and reports on the uncertainty, for example in traffic. The requirement: Medicinal cannabis regulations should be treated in the traffic regulations as a normal drug. So far, people who take medical cannabis regularly, the driving license must be withdrawn.

“It has been contested by the patients up to the Federal Administrative Court that today we can talk about the regulation of cannabis.” (Dr. Oliver Tolmein)

It has become clear that the cannabis law has set in motion medical advances accompanied by a great wave of questions and uncertainties. There is still much to be done for medical cannabis therapy to do what it can do: to relieve people of their suffering.

Presentation of the speakers

Dr. med. Detlev Parow on cannabis as a medicine

Prof. Dr. med. Winfried Hardinghaus on cannabis as a therapy

Dr. Oliver Tolmein on the subject of cannabis as medicine

Flyer to the event


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‘A puff a day’ can keep Alzheimer’s away, says cannabis researcher at The Ohio State University.

https://420intel.com/articles/2018/05/29/puff-day-can-keep-alzheimers-away-says-cannabis-researcher-0?utm_source=420+Intel+-+Marijuana+Industry+News&utm_campaign=28e2059f64-420+Intel&utm_medium=email&utm_term=0_3210cbef52-28e2059f64-278148489

Cannabis may be an effective treatment for Alzheimer’s disease, says Dr. Gary Wenk of Ohio State University. That’s because Alzheimer’s is linked to brain inflammation and cannabis has known anti-inflammatory properties, writes Calvin Hughes.

Wenk’s research has found that early detection of brain inflammation can determine whether someone will develop Alzheimer’s disease nearly 40 years before it sets in. He says that while brain inflammation happens naturally as people age, it can also be induced by injury or trauma.

So athletes and anyone else who has suffered a blow to the head might want to look into medical marijuana now to offset the lingering effects of their injuries later.

Even at very low dosages – as little as “a puff a day” – brain inflammation was noticeably reduced, Dr. Wenk found after experimenting on lab rats.

Those results have inspired Wenk to tell his students, “that if their patients were in a car accident and had a severe head injury, the first thing they should tell their patient to do is start smoking marijuana heavily for the next few weeks because it would protect the brain.”

 

 

 


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Strain Chart

Figuring out which strain(s) will work for individuals can be a very difficult journey for many people. What most people do not realize, is the application or method of consumption varies from person to person. Meaning, what works for you might not be as therapeutic for me. All to often people go off their medications, in hopes that cannabis can manage it all and often feel defeated if nothing changes. It really comes down to learningstrain ailment chart the various ways to use cannabis. This detailed chart is a great start for better understanding.


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German cultivation tender for medical marijuana stopped in its tracks…..and information on the GERMAN PATIENT ROUNDTABLE www.germanpatientroundtable.de

https://www.cannabisindustryjournal.com/news_article/german-court-stops-pending-cannabis-cultivation-bid-on-technical-fault/

German Patients are Going to be on the Front Lines of This Discussion

The difficulties that German patients have already faced in obtaining a drug that is now legal in their own country for medical use (and even for recreational purposes across an open border in Holland) are legion. While to a certain extent, German patients are in the same boat as patients elsewhere and their problems, in fact, there are still huge access issues that remain. For starters, the drug is much more expensive here, so those without health insurance approval face bills of about $3,000 per month. Why the eye-watering price? All medical grade cannabis is still imported, although increasingly this is now just via other EU countries, not just from Canada.

“One of the reasons we organized the national German Patient Roundtable is to give patients a voice in all of this supply and demand discussion and to help BfArM and others formulate workable solutions for all,” responded Philip Cenedella IV when reached for a response by CIJ. Cenedella, an American expat and the organizer of the Roundtable, a nationally focussed, umbrella group that is kicking off its campaign this year, spoke for many who are far from court and boardrooms where the decisions are being made.

Philip Cenedella
Philip Cenedella, pictured left, at the Deutsche Hanfverband (DHV) conference in Berlin last November.
Photo: @MedPayRx, Instagram

“While there are very talented firms who will now take up this discussion with the government and reissue a response for the tender, what we continue to see on the ground is that patients simply do not have the access granted them in the law which was passed over a year ago,” Cenedella says, with more than a note of frustration. “We again are calling on all government officials, industry executives and patient advocates to band together to immediately establish workable protocols that directly help the patients.”

Indeed, despite the frustration and delay, if not new costs and opportunities that this decision creates, one thing is very clear on the ground here. The current status quo is unacceptable. That alone should also put pressure on the powers that be to remedy the situation as quickly as possible. And via several routes, including widening import quotas or even issuing new licenses as a new solution to domestic cultivation is implemented.

“Patients are not being served and do not have access to a medicine that has been proven to improve lives,” says Cenedella. “Our simple request is for BfArM to finally invite patients into their discussions, to work with patients to formulate workable cultivation and distribution solutions, and we humbly request that this happen now before they go down another dead-end road, ending in another court defeat, and resulting in even more delays to the patients that are still lacking the care afforded them by the German Federal Court’s decision of 2017.”

 

For more info:

http://www.germanpatientroundtable.de