Therapy emergency
There is a therapeutic emergency when a patient's health is seriously endangered, but no effective drug is approved or no recognized form of treatment has been established.
The term is mainly used in veterinary medicine , where, in particular for rare or economically less important animal species, there are no approved effective drugs available due to the high requirements for drug approval. In Germany, it is regulated by Section 56a (2) of the Medicines Act (AMG). Medicines may be used in animals, even if they are not approved for the respective species or indication, provided that there is no risk of endangering human or animal health. In the case of food-producing animals, it is also mandatory that the active ingredient is listed in Table 1 of EU Regulation No. 37/2010 (of December 22, 2009 “ Maximum Residue Quantity Regulation ”) or is one of the so-called “out of scope” substances. In the case of horses, this restriction can be circumvented by means of an equine passport , which excludes use as an animal for slaughter.
For rededication , i.e. the use of a drug for a different animal species or indication, veterinary medicine law prescribes a "rededication cascade":
- First of all, another drug must be used that is approved for the respective animal species, but not for the area of application if this also promises a therapeutic effect. The corresponding waiting time must be observed for food-producing animals .
- If such a drug is not available, one approved for another species can be used. The withdrawal period is set at a minimum of 28 days for edible tissues, 7 days for eggs and 7 days for milk. A waiting period of 6 months applies to horses if they are treated with drugs from the so-called "positive list".
- If a drug according to (2) is not available, a human drug approved in Germany or a veterinary drug approved in another EU country or EEA country may be used. The waiting period is regulated as under point 2. Since the 14th amendment to the AMG of October 29, 2005, the import of human pharmaceuticals from abroad for use in animals is no longer permitted.
- If no medication is available according to point 3 either, a medication manufactured by the vet himself or by a pharmacy may be used.
The term is rather uncommon in human medicine. It could be transferred to the doctor's sole approach in individual medical cases, for example with the help of off-label use .
literature
- Wolfgang Löscher et al .: Medical regulations . In: Wolfgang Löscher et al. (Ed.): Pharmacotherapy in pets and farm animals . 7th edition. Paul Parey, 2006, ISBN 3-8304-4160-6 , pp. 8-22 .
- FR Ungemach, K. Kluge: Therapy gaps and therapy emergency in the medical care of animals and special regulations for horses . In: Wolfgang Löscher et al. (Ed.): Pharmacotherapy in pets and farm animals . 7th edition. Paul Parey, 2006, ISBN 3-8304-4160-6 , pp. 601-610 .
