Off-label prescription of psychiatric drugs by non-psychiatrist physicians in three general hospitals in Germany

Abstract

BackgroundOff-label prescribing of psychoactive drugs is a common practice in psychiatry. Here, we sought to investigate the frequency of off-label prescribing in a population of hospitalized patients with a somatic illness who were also suffering from a psychiatric pathology.MethodsUsing a prospective, observational design, we collected data from 982 hospitalized patients with a somatic illness for whom a psychiatric consultation was requested because of the presence of additional psychiatric symptoms. Data were collected at three hospitals in Germany. Demographic and clinical data, including the previous psychoactive medications and an assessment of the suitability of the previous medications, were recorded and analyzed.ResultsData on the previous psychiatric medications were available for 972 patients. In 16.6% of patients, at least one psychoactive drug had been prescribed off-label, 20.2% had received on-label medication, and 63.2% had not received any psychiatric medication. Among all patients receiving psychiatric medication, 45.1% had received off-label medication. The logistic regression analysis showed a significant influence of age on the likelihood of receiving off-label medication (p = 0.018). Benzodiazepines were the most frequent off-label prescription (25.8% of off-label prescriptions), followed by atypical antipsychotics (18.2%) and low-potency antipsychotics (17.2%). Notably, 57.1% of off-label prescriptions were judged to be ‘not indicated’ by experienced psychiatrists.ConclusionsOur data show a high frequency of the off-label prescription of psychoactive drugs by physicians treating patients with somatic illnesses in general hospitals. Because more than half of these cases were judged to be “not indicated”, these prescriptions indicate a potential risk to patients. Furthermore, the classes of drugs that were most frequently prescribed off-label, benzodiazepines and antipsychotics, both show a substantial risk profile, particularly for elderly patients.

Off-label Drug Prescribing: Deciphering the Ambiguity

“…It has been observed that 45.1% patients receiving psychiatric medications in general hospitals were off label and that most frequently prescribed medications were Benzodiazepines (25.8%) followed by atypical antipsychotics (18.2%) and typical antipsychotics (17.2%). 4 A similar trend of prescribing was also observed in India. Majority of patients attending the psychiatric OPD were prescribed the off label drugs (39.5%) and the most frequently used drugs in off-label manner were clonazepam (12.4%), lorazepam 30 (12%), and trihexyphenidyl HCL (10%).…”

The necessary paradigm shift in the study of addiction: Inconsistencies and fallacies of the brain disease model of addiction

“…On the other hand, off-label prescription is subject in most countries to legal limits, most commonly including the absence of an equally safe and effective licensed alternative, the existence of sufficient scientific evidence to support the use of the drug for the intended indication and having the patient's fully informed consent to be treated outside the indication (in Spain there is Royal Decree 1015/2009, in BOE n. • 174 of July 20, 2009, regulating the availability of medicines in special situations); however, these rules are usually breached: the patient is not informed, consent is not sought, scientific evidence regarding side effects is underestimated, and side effects are not reported, as required by law (Lücke et al, 2018). Consequently, this is a regulated but uncontrolled practice, encouraged by the pharmaceutical industry, in which legal limits are breached, scientific evidence is omitted, and risks are increased for many patients.…”

Off-Label Medication: From a Simple Concept to Complex Practical Aspects

“…In these populations, safety issues arise. Other important reasons that generate controversy are indicated by studies in the literature: the difficulty of measuring of the off-label phenomenon which can be over- or underestimated [ 84 , 85 ], the unjustified off-label prescribing with no evidence of superiority when compared with on-label medication (for example, antidepressants prescribed for sleeping show no evidence of superior efficacy compared with benzodiazepines [ 86 ]), or unjustified off-label prescribing by physicians of other medical specialties than psychiatry [ 87 ].…”