ABSTRACT
Since 10 March 2017, physicians have been allowed to prescribe cannabis to patients with serious illnesses and in the absence of alternative therapies. Patients can obtain it as dried flowers or extracts in standardised pharmaceutical quality by prescription (narcotic prescription, except for cannabidiol) in pharmacies. When prescribing, physicians have to take a few things into account. The first step is to decide which therapeutic effects are to be achieved and which is the most suitable cannabis product.Cannabis for medical use must meet the requirements for pharmaceutical quality. An identity check must be carried out in the pharmacy on the basis of the monographs of the German Pharmacopoeia (DAB) or the German Pharmaceutical Codex/New Prescription Form (DAC/NRF). For the production of prescription drugs, e.g. capsules, drops or inhalates, there are also corresponding monographs for the preparation of prescription drugs. These standardised, quality-assured prescription formulas should be given preference in the case of a medical prescription.When prescribing an oral or inhalative form of application, it should be noted that the onset and duration of action are very different. Also, due to the complex pharmacology of cannabinoids, interindividual genetic differences in the metabolisation of ∆9-tetrahydrocannabinol (THC), the individual structure and function of the cannabinoid receptors, as well as differences in receptor density and distribution, the dosage and frequency of application must be individually determined. Last but not least, the dosage also depends on the type of disease and individual susceptibility to side effects. When prescribed for the first time, a creeping dosage with a very low initial dose is recommended.
Subject(s)
Cannabis , Medical Marijuana/therapeutic use , Cannabidiol , Dronabinol , Drug Prescriptions , Germany , Humans , Plant ExtractsABSTRACT
Diese Leitlinie richtet sich an Assistenz- und Fachärzte der Dermatologie sowie an Kostenträger und politische Entscheidungsgremien. Die Leitlinie wurde im formellen Konsensusverfahren (S2k) von Dermatologen unter Einbindung von Apothekern erstellt. Die Leitlinie stellt allgemeine Aspekte der Pharmakokinetik sowie der regulatorischen Begrifflichkeiten dar. Es werden Empfehlungen zur Indikation von Magistralrezepturen sowie deren Qualitätssicherung gegeben. Die Bedeutung der galenischen Grundlagen und die Problematik bei einer Substitution gegeneinander verschiedener Grundlagen werden dargestellt. Die Leitlinie umfasst Kriterien zur Auswahl einer adäquaten Grundlage sowie spezifische Aspekte zur Therapieplanung. Die Leitlinie gibt Empfehlungen zum Management bei Unverträglichkeiten gegenüber Bestandteilen der Grundlagen oder Hilfsstoffe.
ABSTRACT
The present guidelines are aimed at dermatology residents and board-certified dermatologists as well as policymakers and insurance companies. Developed by dermatologists in collaboration with pharmacists using a formal consensus process (S2k), they include general aspects with respect to pharmacokinetics and regulatory terminology. Recommendations are provided on the various indications for extemporaneous preparations and their quality assurance. The importance of pharmaceutical vehicles and problems associated with substituting one vehicle for another are discussed. The guidelines include criteria for choosing a suitable pharmaceutical vehicle and for specific aspects in terms of treatment planning. In addition, recommendations are given for managing allergic reactions to vehicles or additives.
Subject(s)
Dermatologic Agents/administration & dosage , Skin Diseases/drug therapy , Consensus , Dermatologic Agents/adverse effects , Dermatologic Agents/classification , Dermatologic Agents/pharmacokinetics , Dermatology/education , Drug Compounding , Drug Eruptions/etiology , Drug Eruptions/therapy , Germany , Humans , Internship and Residency , Pharmaceutical Vehicles/adverse effects , Quality Assurance, Health Care , Risk Factors , Terminology as TopicABSTRACT
BACKGROUND/AIMS: According to current guidelines, the emergency kit for patients with severe urticaria and/or angioedema should include a corticosteroid with a prednisolone-equivalent of 50-100 mg. Since severe dysphagia may occur in anaphylaxis, liquid corticosteroids are advantageous. Presently, only liquid preparations with less than 100 mg prednisolone equivalent are available worldwide. METHODS: We prepared a highly concentrated liquid prednisolone formula for oral administration (1 or 5 mg prednisolone per ml). We observed efficacy and safety of 100 mg or >250 mg liquid oral prednisolone in comparison to intravenous administration (250 mg prednisolone) in 53 patients with urticaria and/or angioedema. RESULTS: The symptom control achieved with oral administration was comparable to that obtained with intravenous therapy, with remission of at least 50% of the symptoms in less than 30 min. No side effects occurred during the treatment period. CONCLUSION: The liquid prednisolone formula is an additional therapeutic rescue medication in dermatological emergency medicine, filling a therapeutic niche for patients who need high-concentration liquid prednisolone. It is suitable for self-administration emergency kits in children and adults, in accordance with current guidelines.