Ethical dilemma associated with the off‐label use of antipsychotic drugs for the treatment of behavioral and psychological symptoms of dementia

Abstract

The term 'off-label use' is generally taken to mean the prescription of a drug without approved official authorization. The present article deals with ethical problems associated with the off-label use of antipsychotic drugs for the treatment of behavioral and psychological symptoms of dementia (BPSD) in Japan. Before the introduction of the Law of Protection of Private Information, the off-label use of antipsychotics was an almost open secret in Japan. Indeed, users of mental health care make strong requests that they receive the best and newest treatment available. Here, a huge gap exists between what psychiatrists consider 'best' and what the health service authority approves. For the sake of patients' interest, psychiatrists cannot help prescribing a drug for an unapproved indication or in a dose outside the usual range, otherwise they are unable to effect a therapeutic outcome. Although thioridazine and vegetamin are officially approved for the treatment of geriatric psychosis in Japan, they are not used commonly compared with atypical neuroleptics. Clinicians' preference for atypical agents over conventional neuroleptics is based on ethical motivation regarding the safe use of the drug rather than profitability. The failure to follow the information on the drug label should not necessarily preclude a psychiatrist from making a good clinical judgment in the interest of the patient. Even so, the psychiatrist should be aware that the patient retains the right to redress for possible medical malpractice. Japanese psychiatrists should take into account the evidence concerning the effectiveness of the drug for any unlicensed indication when they prescribe it off-label. They should also inform patients of the fact that the prescription is off-label and of any risks and benefits involved in the prescription of that particular drug. Whenever there is evidence of benefit, a trial of the drug should always be performed under careful clinical monitoring.

Adverse effects of anticholinergic activity on cognitive functions in Alzheimer's disease

“…Moreover, a warning on prescription of antipsychotic agents to demented elderly patients is issued to increase mortality of the patients. 19 The impairments of cognitive functions were principally reversible, 20 however, it took a lot of time to recover and partially reverse these impairments, even though the prescribed medications were discontinued. 21 In the present study, the stage of dementia in the SAA (+) group was more severe than in the SAA (-) group, although there were no significant differences in age at onset of dementia and age at the time of the test between these two groups.…”

Behavioral and psychological symptoms of dementia and medical treatment

“…Presently, the situation is also the same in Japan. It is essential to inform patients and their families of the status of this drug therapy and obtain their consent to proceed, to use the drugs at as low a dose as possible and for a short period of time, and to always pay attention to any adverse physical effects 10 …”

Management of behavioral and psychological symptoms of dementia in long‐term care facilities in Japan

“…We must recognize that the use of psychotropic drugs is ‘off‐label use’, meaning the prescription of a drug without approved official authorization. Ihara and Arai pointed out that a trial of these drugs should always be performed under careful clinical monitoring 37 . Physical restraint never appeared in the active rules, suggesting that this technique does not reduce the difficulty of managing BPSD.…”