In-house production of pharmaceuticals
When pharmaceuticals are manufactured in-house in pharmacies , pharmaceuticals are individually prepared by pharmacists according to a prescription by a doctor or at the request of a patient according to a recipe . In Austria this is called magistral preparation , in Switzerland formula magistralis . Defectiveness drugs are drugs that are produced in quantities of up to a hundred ready-to-sell packs per day in pharmacies without the need for a manufacturing license or drug approval under the German Medicines Act . The official preparation in Austria and the formula officinalis in Switzerland designate the pharmacy production according to a monograph of the pharmacopoeia for direct distribution to the patients who are customers of this pharmacy; this essentially corresponds to the defect.
In contrast to prescription and non-prescription drugs, there are finished drugs that are manufactured in quantities of over 100 per day or require a manufacturing permit and approval for other reasons. These are mostly produced and packaged industrially by pharmaceutical companies in standardized dosages and quantities. But there are also pharmacy operations that have a manufacturing license for certain products.
Methodological and legal basis
There are recognized formulation regulations for the in-house production of pharmaceuticals, such as the New Formulation Form (NRF) or the standard formulations (SR) used in the German Democratic Republic (GDR) until 1990 and still frequently used in the new federal states , as well as their predecessors , the German Reich Formulas (DRF). Such ad hoc preparations according to standardized and tested regulations are also known as magistral recipes. With regard to the analytical tests, the regulations of the pharmacopoeia apply , in Germany for example the German Pharmacopoeia (DAB) and the European Pharmacopoeia (Ph. Eur.). The legal basis for the in-house production of pharmaceuticals in pharmacies is the pharmacy operating regulations in Germany . According to the German Medicines Act, prescription and non-prescription drugs are not subject to authorization. The prohibition of the dispensing of questionable drugs, which also results from the drug law, also applies to drugs from in-house production. According to Section 11 Paragraph 3 of the German Patent Act , the protective effect of patents does not extend to the immediate individual preparation of a drug by a pharmacist based on a doctor's prescription.
In Austria the terms official preparation and mainline preparation are defined in the Austrian Medicines Act , the definition of Formula magistralis and Formula officinalis can be found in the Swiss Medicines Act . The European Directive 2001/83 / EC also uses the terms Formula magistralis and Formula officinalis.
Dosage forms and areas of application
The most common dosage forms for prescription and defective drugs are ointments and creams , suppositories and capsules, as well as tinctures and other liquid preparations. The most important areas of application for these drugs include dermatological preparations for the treatment of skin diseases and cytostatics for cancer therapy . The main advantages of in-house production of drugs are the possibility of individual dosing and, if necessary, combination with other active ingredients , as well as the avoidance of allergic reactions to certain ingredients in finished drugs. The main disadvantages are the higher costs due to manual production and the limited shelf life. For this reason, prescription drugs are only prepared when there is a specific need and in quantities that are intended for immediate consumption. As a rule, there is no provision for the patient to be stored. Defect medicines are also usually not stored for a long period of time.
United States
In the US, in-house manufacturing of drugs is regulated differently, for example, hospitals can outsource the in-house manufacturing of drugs . There are also special compounding pharmacies . In these, inexpensive pharmaceuticals are mass-produced by bypassing the regular drug approval and good manufacturing practice regulations. Outsourcing has become increasingly popular in recent years. In 2002, only 21% of US hospitals outsourced parts of their in-house production of pharmaceuticals, compared with 71% in 2011. This also increased the associated risks.
In October 2012, an outbreak of meningitis from fungal infections was reported in the United States. The outbreak has been traced to three contaminated drug batches for injection into the spinal cord . The drugs were bottled and sold by the New England Compounding Center (NECC), a compounding pharmacy in Framingham . Doses of these three batches were administered to approximately 14,000 patients between May 2012 and September 2012 in 75 different medical facilities. The first symptoms were reported in late August, but it wasn't until late September that it became clear that the cases had a common cause. As of March 2013, 48 people had died and 720 had been treated for existing fungal infections.
literature
- ABDA - Federal Association of German Pharmacists' Associations (Hrsg.): New recipe form (NRF). Govi-Verlag, Eschborn and Deutscher Apotheker-Verlag, Stuttgart, regularly updated loose-leaf collection
- Institute for Drugs of the GDR (ed.): Standard recipes 1990 (SR 90). Edition intended for pharmacy. 15th edition. VEB Verlag Volk und Gesundheit, Berlin 1990
Web links
- NRF - New Formulation Form Formulation information from the Pharmaceutical Laboratory of the NRF
Individual evidence
- ^ Roland Niedner, Max Gloor: Magistrale recipe. In: The dermatologist . 51/2000. Springer-Verlag, pp. 278-295, ISSN 0017-8470
- ↑ Denise Grady, Andrew Pollack, Sabrina Tavernise: Overview of Manufacturers in Meningitis Outbreak . New York Times, October 7, 2012.
- ^ The gold sheet "A Lesson on Outsourcing: The NECC Fungal Meningitis Outbreak" November 2012, Vol. 46, No.11, p. 3.
- ↑ http://www.cbsnews.com/8301-18560_162-57573470/lethal-medicine-linked-to-meningitis-outbreak/
- ^ Persons with Meningitis Linked to Epidural Steroid Injections, by State . Centers for Disease Control and Prevention (CDC). Archived from the original on November 22, 2013. Info: The archive link was automatically inserted and not yet checked. Please check the original and archive link according to the instructions and then remove this notice. Retrieved November 7, 2013.
