Off-label use in Germany - a current appraisal of gynaecologic university departments.
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OBJECTIVE: The off-label use, referring to the applicability of pharmaceutical drugs beyond the submitted and from the Federal Institute for Drugs and Medical Devices (BfArM, Bundesamt fur Arzneimittel und Medizinprodukte) certified and approved administration, is the subject of controversial discussions. The application can be considered in case of severe illness - if no therapeutic alternatives are available - or it exists as a founded perspective for achieving therapeutic success. METHODS: A latitudinal study for evaluating the application of off-label use supplements was performed at 43 German university and academic teaching hospitals. Five doctors at each hospital applied off-label pharmaceutical drugs and were called upon to share their personal experience to the application of those medications. RESULTS: 75 (35%) questionnaires were returned out of 22 (51%) medical centres with 215 contacted physicians. Off-label use was common for 65 (91%) of the physicians. Only 9% of them obviate the application of off-label drugs. About a half of the medication is related to application in obstetrics (54%) and in most cases on an every day basis. Uterotonics were the most commonly used off-label medications (34%). The main part of information about off-label use is obtained from personal information of colleagues (66%) and personal experience (58%). 34% of physicians think that off label use is risky. Interestingly, the view about off label use of medication varies considerably among physicians from various hospitals. CONCLUSIONS: The application of off-label pharmaceutical drugs in Germany seems to be a well established practice. More than 90% of participators of our trial use at least one medication outside the administration. This includes particularly prostaglandins, anti-hypertonic therapeutics and chemotherapeutics. (+info)
Novel oral anticoagulants: focus on stroke prevention and treatment of venous thrombo-embolism.
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Rates and determinants of antimicrobial use, including extra-label, on Ontario sheep farms.
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Few antimicrobials are licensed for use in sheep in Canada, and the range of indications is narrow. Treatment in an "extra-label" manner may be ineffective. In addition, potentially harmful drug residues in food-animal products and antimicrobial resistance in bacteria may be associated with extra-label drug use (ELDU). No data had been documented on drug use, specifically antimicrobial use (AMU), in Ontario sheep, although it was thought that much use was extra-label. This study investigated AMU and ELDU on 49 lamb-producing Ontario sheep farms. Data were prospectively collected over 12 months from the participating farms, and farm-level practices were ascertained with a questionnaire. Treatment-level and farm-level variables were investigated for associations with rates of AMU by means of Poisson rate regression models fit with a generalized estimating equation to control for clustering at the farm level. Antimicrobials with high mean exposure rates included chlortetracycline (in feed), penicillins, and oxytetracycline. The exposure rate in lambs was significantly lower (P < 0.01) with antimicrobial treatment of systemic signs, respiratory disease, or wound or injury than with treatment of other reported diseases or conditions; it was also significantly lower with 3 or more lambing periods per year (alpha = 0.05). The exposure rate in adult sheep was significantly lower with treatment of 5 of the 6 most prevalent diseases or conditions (alpha = 0.05) and significantly higher with producer decision to treat and producer experience of 20 y or greater. Rates of using antimicrobials not licensed for use in sheep were high, as was extra-label use of licensed antimicrobials. Diseases reportedly treated most often with antimicrobials (e.g., systemic signs, mastitis) were significantly associated with lower rates of ELDU (alpha = 0.05). Compared with the rates in adult sheep, the mean rate of use of nonlicensed antimicrobials was similar in the lambs, whereas the mean rate of extra-label use of licensed antimicrobials was lower among the lambs. The results are useful in determining if public health concerns about antimicrobial use in Ontario sheep are warranted and in creating drug use and licensure strategies for the Canadian sheep industry. (+info)