Approved and off-label use of prescribed psychotropic medications among federal offenders

Research Highlights: 36% of prescriptions for psychotropic drugs in CSC are off-label, a rate comparable to those cited in community surveys.

The term “off label” refers to the legitimate and common practice use of a wide variety of prescription psychotropic medications by health and mental health professionals for purposes other than for which they were originally designed and officially approved. With this in mind, research indicates that the prevalence of prescribed psychotropic medication use is two to six times greater among incarcerated offenders compared to the general population – and is highest among women offenders. A study in Correctional Service of Canada (CSC) found rates of 30% compared to estimates of 8% in the general public (Farrell Macdonald et al., 2015). Anecdotal reports of off label medication use to somehow control inmates’ behaviour has been raised as a concern by the Office of the Correctional Investigator. The aim of this study was to investigate the issue of off-label use of prescribed medications by examining prescribing practices in a sample of CSC institutions.

In this study, a purposive sample of thirteen Canadian federal institutions representing each of the five regions, different security levels, and men’s and women’s designated facilities was drawn. From a sample of 468 offender files, information on the names of all psychotropic medications prescribed, indications for use, dosage, frequency, and route of administration was retrieved and coded as approved or off-label, that is for an indication or at a dosage or method of administration for which it has not been approved, and which is not described by the drug label. Designation of approved or off-label use of medications was determined via three sources: (1) the Health Canada (2016) Drug Product Database, (2) the Canadian Compendium of Pharmaceuticals and Specialties 2016, and (3) the American Hospital Formulary Service Drug Information 2016.

Inter-rater reliability was good at 63%. Results indicated that 36.2% of prescriptions for psychotropic medication were coded as off-label. Of these, most (98.6%) are medications commonly prescribed for similar use by clinicians in community settings.

There were no differences in the prevalence of approved versus off-label prescriptions based on Indigenous ancestry (Indigenous = 34.1%; non-Indigenous 37.2%) or gender (women = 37.7%; men = 35.2%). Drugs to treat insomnia were most commonly used for off-label purposes.

There was no evidence that off-label prescription practices are being used to manage offenders involved in institutional misconducts or who were serving a current sentence for the most serious violent offences. Further analysis showed that just under 50% of offenders in the sample were prescribed at least one off-label psychotropic medication - a rate similar to those cited in a review of published research on adult psychiatric patients (Royal College of Psychiatrists, 2007).

The rate of 36.2% of off-label prescriptions for psychoactive medications found in the current study is comparable to a Québec study that found that psychotropic medications were prescribed off-label by physicians in the community between 26% and 67% of the time. The rate of off-label prescriptions of psychotropic drugs in CSC, therefore, is not higher, and may be somewhat lower, than rates in many communities.

Brown, G., Rabinowitz, T., Boudreau, H., & Wright, A. (2017). Approved and off-label use of prescribed psychotropic medications among federal inmates.(Research Report R-387).Ottawa, Ontario: Correctional Service of Canada.

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