STUTTGART – 09.03.2017, 6:00 PM
On March 9, 2017, the Cannabis Act was published in the Federal Gazette. This means that cannabis blossoms and preparations in Germany are available from 10 March onwards and can be prescribed by any physician regardless of their specialist field. (Photo: Michael / Fotolia)
The “Cannabis Act” entered into force on 10 March. Now it can be that a patient with a prescription over cannabis blossoms comes to you in the pharmacy. You still have not found time to get closer to the subject? No panic! Here is the first aid in the fast run.
Previously the patient for a cannabis-based therapy had a permit from the Federal Institute for Drugs and Medical Devices (BfArM) seek, as the supplying pharmacy. With the entry into force of the new Act on 10 March 2017, the medical use of cannabis in Germany is no longer a derogation. Cannabis blossoms and preparations are now available in Germany and can be prescribed by any physician independently of their specialist field, but not by dentists and veterinarians. The substances dronabinol and nabilone as well as the finished medicinal products approved in Germany were already listed in Annex III of the Narcotic Drugs Act (BtMG).
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MONOGRAPHS PUBLISHED IN THE DAC / NRF
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Another important innovation concerns the reimbursement: the statutory health insurance funds must pay the costs for the therapy with medicinal hemp as a rule. The prerequisite is that in the case of a serious illness, no other generally accepted medical performance standard is available or is associated with intolerable disadvantages. In the case of the first regulation, the health insurance fund must be approved before the start of the service. This is why the patient has to take care of himself (with the help of the doctor).
There is no compulsory medical check-up for the supplying pharmacy, but it is recommended to insure with the health insurance company that the costs are taken over. A decision on the costs must be taken within three weeks after the application, within the framework of an outpatient palliative care even within three days. If the medical service is consulted, a period of five weeks applies. An immediate start of therapy is only possible with the issuance of a private recipe.
Where can I get binding information?
Admittedly, not all questions regarding the medical use of cannabis have been clarified at the present time. On some sources, however, is definitely left.
When BfArM one is in the course of the new law “cannabis agency” established which ensures that sufficient medicinal purposes from state-controlled cultivation is in the required quality. Until all plants are produced in Germany, the supply of cannabis flowers is covered by imports, mainly from the Netherlands and Canada. The BfArM provides information on which cannabis varieties are currently available for an appropriate therapy, but does not answer any questions regarding their application.
The German drug-Codex (DAC) includes the monographs “Cannabis flowers, cannabis flos (C-053)”, “Adjusted, refined cannabis oil resin (C-054)”, “cannabidiol (C-052)” and “Dronabinol (D-100 ) “In which data on testing, storage, labeling, application areas, counter-indications, side effects and interactions are made.
The New Rezepturformularium (NRF) already contains the formulation instructions “dronabinol capsules 2.5 mg / 5 mg / 10 mg (NRF 22.7.)” And “Oily dronabinol drops 25 mg / ml (NRF 22.8.)” In addition, the ” Oily cannabidiol solution 50 mg / ml (NRF 22.10.) “, Which however does not fall under the BtMG. “Cannabis Blossoms for inhalation after evaporation (NRF 22.12.)”, “Cannabis Blossoms in single doses for inhalation after evaporation (NRF 22.13.)”, “Cannabis Blossoms.” The new recipe regulations “Oily cannabis oil resin solution 25 mg / ml Dronabinol (NRF 22.11 (NRF 22.15.) “And” Ethanolic dronabinol solution 10 mg / ml for inhalation (NRF 22.16.) “,” Cannabis flowers in single doses for tea preparation (NRF 22.15.
Reliable information can also be found in the technical information of the registered in Germany finished drug Sativex ® and Canemes ® .
What can be prescribed?
All THC-containing starting materials, preparations and finished medicinal products are subject to the Narcotics Act (BtMG); The applicable rules for the delivery of a BtM recipe as well as the resulting documentation obligations must be observed.
The maximum quantity for cannabis blossoms, which may be prescribed for a patient within 30 days, is limited to 100 g. At the moment, the demand for starting material is covered by the Netherlands (from the company Bedrocan BV) and Canada (MedCann GmbH and Peace Naturals) (see table).
The Dutch varieties can be obtained from Fagron GmbH & Co. KG and Pedanios GmbH, the Canadian flowers from Peace Naturals by Pedanios.
Due to the content of tetrahydrocannabinol (THC) and cannabidiol (CBD) in the cannabis blossoms, the therapy can be controlled. Thus, it is possible for the patient to prescribe different cannabis varieties in parallel. On the BtM-recipe must therefore also be explicitly noted by the doctor in addition to the indication “Cannabis-Blüten” the concerned varieties. For example, 100 g of the sorgcan variety as well as 50 g of each of the varieties sorgcan and bedica could be prescribed. If the regulation exceeds the maximum permitted level, the recipe must be marked with the exception “A”.
THC / CBD content of the varieties of cannabis blossoms offered
|variety||THC content||Salary CBD|
|Varieties offered by Bedrocan BV|
|Bedica granulated *||Approximately 14%||<1%|
|Bediol granulated *||Approximately 6.3%||Approx. 8%|
|Bedrolite granulated *||<1%||Approx. 9%|
|Offered by MedCann GmbH|
|Princeton (MCTK007)||About 16.5%||Up to 0.05%|
|Houndstooth (MCTK001)||Approximately 13.5%||Up to 0.05%|
|Penelope (MCTK002)||Approximately 6.7%||Up to 10.2%|
|Argyle (MCTK005)||Approx. 5.4%||Approx. 7%|
|Offered by Peace Naturals|
|Pedanios 22/1||Approx. 22%||Up to 1%|
|Pedanios 18/1||Approx. 18%||Up to 1%|
|Pedanios 16/1||Approximately 16%||Up to 1%|
|Pedanios 14/1||Approximately 14%||Up to 1%|
|Pedanios 8/8||Approx. 8%||Approx. 8%|
* Granulated means that the dried flowers in max. 5 mm in size were crushed
For the purpose of the identity check, please refer to the DAC monograph “Cannabis Blossoms, Cannabis Flos” (C-053) and the alternative methods of the DAC.
The recipe regulations NRF 22.12. To 22.15. Contain instructions for delivering cannabis blossoms to the patient. To prepare, cannabis flowers are coarsely ground in a closed herbs mill and then sieved (2000 μm). Usually 5-g doses are prescribed. Dosing by the patient is then carried out by means of a dosing spoon. However, it may also happen that individual doses are desired by the doctor, for example, 10 times 1 g. In this case, the pharmacy must weigh the portions, portion them and fill them in suitable containers (see NRF 22.13.).
Well, a doctor is not obligated to prescribe NRF recipes so that recipes can also be made via unbrewned cannabis blossoms.
The first order of cannabis blossoms is presumably “application according to written instructions”. However, the operating instructions with individual and daily doses must be available in writing to the supplying pharmacy, as this must be recorded on the primary packaging. In follow-on doses, the dosage on the prescription is usually indicated.
Cannabis blossoms can be inhaled or orally taken. For inhalation, the use of an electric evaporator is recommended, in which a certain quantity of cannabis blossoms is heated to a temperature of 180 to 210 ° C. Currently, two certified medical products are registered in Germany (Volcano Medic, Vaporisator Mighty Medic). For the oral application of cannabis blossoms in the form of a tea, the NRF recipe regulations 22.14. And 22.15. he is working.
The issue of settlement of cannabis flowers answers the Federal Chamber of Pharmacists on its website (the protected area) as follows: “If the cannabis flowers transferred to the natural state, bottled, packaged or labeled delivered to the patient, the price to be § 4 AMPreisV form . If cannabis flowers according to NRF rules, that is under crushing and sieving of the drug and, if necessary, processed packaging in single doses to a recipe medicine products applies, § 5 AMPreisV . Plus pharmacies can calculate 7 AMPreisV amounting to EUR 0.26 including Umsetzsteuer narcotics fee under § “. (Editor’s note: The latter narcotics charge is, with the entry into force of the Drug Supply Support Act 2 91 Euro rise) . The special Pharmazentralennummer 06460665 has been established for the settlement of prescriptions for cannabis-containing and cannabis-containing preparations (prescription medicines).
Prescriptions with dronabinol
If Dronabinol (= THC) is prescribed as a pure substance, the doctors normally refer to the two NRF formulations that can be made in the pharmacy: “Olyige Dronabinol capsules 2.5 mg, 5 mg and 10 mg (NRF 22.7 ) “And” oily dronabinol drops 25 mg / ml (NRF 22.8) “. The formulation substance can be ordered from THC Pharm GmbH, Bionorica Ethics GmbH and Fagron GmbH. The DAC monograph “Dronabinol” (D-100) contains rules for the identity test.
For the taxation of dronabinol drops, a 90% surcharge is added to the cost of the recipe substance amounts used or the recipe set. Five Euros are calculated for making solutions using heat up to 300 grams. The total amount is 19 percent VAT plus the BtM prescription fee of 0,26 Euro. In the case of Dronabinol capsules, the prescription surcharge amounts to five euros for the filling of capsules up to the basic amount of twelve pieces seven euros.
Finished medicinal products
Currently, the finished drug Sativex in Germany ® and Canemes ® approved. On the BtM recipe, the preparation must be mentioned by name and clearly determine the amount per separate form.
The oral spray Sativex ® contains the standardized extract nabiximols and is approved for symptom improvement in adults with moderate to severe spasticity due to multiple sclerosis (MS). The patient takes 2.7 mg of THC and 2.5 mg of CBD per dose as a single dose.
Canemes ® contains the active substance nabilone as a fully synthetically manufactured derivative of delta-9-tetrahydrocannabinol and is indicated for treatment of nausea and vomiting associated with chemotherapy in adults who do not respond adequately to other anti-emetic treatments.
It is also possible that recipes on foreign-registered preparations are issued, which may be introduced as a single imports into Germany, for example, approved in the US Marinol ® . The special code 06460671 has been established for the settlement of prescriptions for cannabis-containing finished medicinal products without a pharmaceutical central number (imports pursuant to section 73 (3) of the German Medicinal Products Act).
Extract of cannabis flowers
A cannabis-full extract is to become an official component of the Bionorica Ethics range from June 2017 onwards. This is a flower extract for oral use which is adjusted to a content of 5% THC and is delivered among other things in 10 g bottles. The DAC contains the monograph “Adjusted refined cannabis oil (C-054)”. There is a prescription of 1000 mg extract within 30 days. To adjust the physically prescribed concentration, the starting extract is diluted with Miglyol, a mixture of medium-chain triglycerides. Further information is contained in NRF 22.11.
The prorated amount of flower extract and the price of the prescription set plus 90% surcharge as well as a prescription surcharge of 2.50 euros for the preparation of a solution without application of heat are given. The VAT and the BTM fee of 0,26 Euro are charged to the total amount.
What should be addressed in the consultation?
The new law explicitly failed to list individual indications for the medical use of cannabis. Theoretically, cannabis blossoms and extracts as well as prescription drugs with dronabinol could therefore be prescribed for every indication. Irrespective of the area of application, the patient should be given some words when they are handed over.
For the dosage of cannabis as a medicine, there are no general rules, but recommendations. Regardless of whether they are blossoms, extracts, formulations or finished medicinal products, it is essential to titrate the correct dose slowly for a long-term therapy. This may take several weeks. During this time the patient should not drive a vehicle. The application should always be carried out under the same conditions, ie before, at or after meals and at the same time.
For cannabis blossoms, an initial dose of 25 to 50 mg cannabis blossoms is recommended depending on the THC content and a maximum of 100 mg cannabis blossoms with a low THC content per day. The dose can be increased by approximately 25 to 100 mg cannabis blossoms every one to three days. For inhalation, a vaporiser is recommended (see NRF 22.12 and 22.13.). It is also possible to use as a tea, but with a lower yield (see NRF 22.14 and 22.15.).
Concerning formulations with dronabinol, 2.5 mg dronabinol should be started with once or twice daily and the dosage carefully adjusted within four weeks every one or two days by one unit (2.5 mg dronabinol) until the desired effect or effect is achieved Occurrence of side effects. Oar drops of dronabinol should not be diluted with water for oral administration, but should be taken either directly on a spoon or on a piece of bread, a biscuit or a diced sugar.
The adverse effects of Sativex ® is started with a puff in the evening. The patient can gradually increase the dose by one spray per day to a maximum of twelve spray shocks daily. Spray gaps should be at least 15 minutes apart.
When finished medicinal Canemes ® , a dosage of one to two capsules (1.0 or 2.0 mg nabilone) per day is common.
The extract from cannabis blossoms usually starts with a single dose of 2.5 mg dronabinol daily. It is sensible to drop the drops directly into a spoon. Alternatively, they can be taken on a piece of bread, a butter biscuit or on a piece of sugar. Do not inhale the drops.
Especially at the beginning of therapy, dizziness and fatigue often occur. Side effects such as tachycardia, blood pressure drop, mouth dryness, muscle relaxation, increased appetite and psychotropic effects are also possible. When taken regularly, however, usually a habituation occurs.
Personality disorders, psychotic disorders, severe cardiovascular diseases, pregnancy and lactation are important contraindications.
Interactions with substrates of the cytochrome P450 system (CYP450) are possible, including CYP inhibitors such as itraconazole, ritonavir or clarithromycin and CYP inducers such as rifampicin, carbamazepine and phenytoin. Pharmacodynamically, the sedative effects of benzodiazepines and hypnotics and the muscle-relaxing effect of spasmolytics can be enhanced.
In case of overdose of the finished product Sativex ® acute intoxikationsartige reactions including dizziness, hallucinations, delusions, paranoia, tachycardia or bradycardia were observed with hypotension.
ISBN 978-3-7692-6819-5. German pharmacist publishing house 2017
Klaus Häußermann, Franjo Grotenhermen, Eva Milz
The song “Legalize it!” Was awarded the title of “Cannabis” as a medicine in 1976 – and landed on the index in 2016. Father Beimer in Lindenstraße alleviates his parkinsons symptoms with grass and has the nation on his side. A long way – but now is the time: Cannabis on prescription from the pharmacy! This scenario is brand new and raises unusual questions:
- What varieties and dosage forms of cannabis are available?
- Who is prescribed what legal basis?
- What are the indications for cannabis?
- What are the effects, effects and side effects for the patient?
- How is procurement, storage and testing performed at the pharmacy?
The authors, proven experts for BtM and cannabis-based drugs, provide you with a compact work aid for the pharmacy. Take advantage of this knowledge!
Rika noise , pharmacist
redaktion @ German-pharmacist-newspaper