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Practice What We Publish

Some time ago, a new pharmacy resident attending my tutorial on child and adolescent psychopharmacology brought up the issue of offlabel prescribing. The comment was related to the delay we were experiencing in recruiting subjects for a clinical trial evaluating aripiprazole and risperidone for autistic disorder. The inclusion criteria were specifically designed to reflect the United States Food and Drug Administration (FDA)-approved labeling for use of these two antipsychotic drugs for treatment of irritability in patients with autism. A lower age limit of 6 years and an upper age limit of 17 years apply to this indication. As this was a pharmacogenetic study to evaluate potential biomarkers of drug-induced weight gain, the exclusion criteria eliminated children who had significant previous exposure to either of the study drugs from participation in the study. This qualification was based on an assumption that a subject with significant prior drug exposure might already have experienced the weight gain associated with the use of these drugs. Such subjects would be less likely to demonstrate an association between a genetic biomarker and weight gain. The problem we encountered in screening potential study subjects was that a substantial proportion of children had received prohibited pharmacotherapy with aripiprazole or risperidone before age 6. Some children had even been treated from age 3 at the time of their diagnosis. The student asked about my experience with off-label prescribing. We discussed the various types of prescribing that could fall under this definition. The prevailing opinion among the group’s participants was that off-label prescribing meant use of a drug for a different indication other than what was officially approved by the FDA. What was not widely appreciated was that off-label prescribing may take many other forms (Table 1). The student referred to discussions held during clinical rotations during which the medical care team would move from one patient care area to another for a patient visit. During these sessions, a neophyte professional would present the essential patient details at the bedside, including a list of initial problems. The team, led by a seasoned professional, would discuss either impromptu or later in conference the alternatives for drug therapy. Most often, the issues of off-label prescribing, economic costs, identification of target symptoms, delayed adverse events, or other variables important in drug selection and dosage regimen design received scant attention or were not covered. Hearing this experience and remembering similar situations in my clinical experience led me to consider how we present case reports to other professionals and how we might improve their presentation in Pharmacotherapy. The case reports published in Pharmacotherapy are mostly abbreviated descriptions of patient experiences to present novel findings encountered during drug therapy or describe innovative approaches to the use of drugs. A large proportion of published cases describe unusual pharmacodynamic responses. This issue of Pharmacotherapy contains a therapeutic review of the treatment of heart failure with preserved ejection fraction. What differs from our (Pharmacotherapy 2015;35(4):349--350) doi: 10.1002/phar.1583