Off-label prescribing, the use of drugs for indications that have not received regulatory approval, occurs with up to 21 percent of prescribed drugs among office-based physicians (Arch Intern Med 2006;166(9):1021-1026). Yet, the problem isn't unique to the ambulatory setting. While individual providers are investigating the problem internally, comprehensive inpatient data aren't available. Off-label usage of prescription drugs is not illegal, but it has the potential to lead to wasteful or even harmful care in some instances, yet can be advantageous in others. Regardless, most experts agree in the value of tracking and properly assessing this practice.
Many administrators and physicians are starting to recognize the value of various health IT systems, such as EHRs, e-prescribing, computerized physician order entry (CPOE) and clinical decision support (CDS) as a means to track, collate data on and potentially, prevent widespread use of the more harmful practices.
First is data collection. Evaluating the MOXXI primary care EHR network in Canada between January 2005 and December 2009, Tewodros Eguale, MD, MSc, of McGill University in Montreal, et al found that 113 primary care physicians wrote 253,347 e-prescriptions for 50,823 patients. They classified each drug indication as on-label or off-label based on the Health Canada drug database, and identified off-label uses lacking "strong" scientific evidence (Arch Intern Med 2012;172(10):781-788).
"Our overall objective was to see how computerization helps the day-to-day activities of primary care physicians by giving them drug information and patient information," Eguale says. "Instead of relying on somewhat unreliable survey data, we implemented a treatment indication chapter within the EHR system, enabling us to capture very fine details of treatment indications."
In the study, the prevalence of off-label use was 11 percent, with 79 percent of the off-label prescriptions lacking strong scientific evidence. Off-label usage was highest for central nervous system drugs (26.3 percent), including anticonvulsants (66.6 percent), antipsychotics (43.8 percent) and antidepressants (33.4 percent). Sicker patients were less likely to receive off-label drugs, which "may be the result of their poor health creating less room to 'experiment' with a drug." This trend also has been observed in children.
The bigger question may lie in understanding why and how physicians make their clinical decisions. "Traditionally, when physicians have written prescriptions, they do not have to write down an indication," explains Surrey Walton, PhD, of the University of Illinois at Chicago. "Indications are typically coded for billing purposes with ICD-9 codes tending to be broad, and therefore, they aren't very helpful for assessing clinical diagnostics or when trying to ascertain why a physician used one drug over another."
For improved prescribing, Eguale says that physicians need to be made aware of three things at the time of decision-making: whether the drug is approved; whether there is strong evidence to use a particular drug for a particular indication; whether there is any report of adverse drug reactions and the severity of that reaction.
The solution may be as simple as color coding on-label and off-label status in the CDS, or another technological or visual method of informing the physician of a potential error, suggests Eguale.
"Linking a prescribed drug with an indication could be a meaningful use objective, and vendors could easily incorporate this feature into EHR systems," the study authors wrote. "EHRs can be used to document treatment indication at the time of prescribing."
Recognizing that off-label use might not be unique to the outpatient environment, a team at the University of Illinois at Chicago launched a pilot project to develop an electronic-based intervention for gathering data regarding off-label drug use in the inpatient setting. The project is seeking to identify and focus on specific drugs in an inpatient setting where there are particular clinical and economic concerns regarding off-label use. Also, the researchers are collecting data on the accuracy of physicians' answers when prompted about why they prescribed a particular medication.
Their single-center, inpatient study assessed a CDS system that was designed to obtain indications and document during CPOE ordering of drugs, which are frequently used off-label, namely the proton pump