Leveraging precision medicine to mitigate medication-safety challenges

Despite good intentions, health policy decisions sometimes lead to unintended—and potentially harmful—consequences for patient care. The opioid epidemic has prompted many actions to curb analgesic misuse and abuse. One such action is the controversial rescheduling of hydrocodone-containing products (HCPs) in October 2014 by the Drug Enforcement Administration from Schedule III to the more-regulated Schedule II, which bars refills and oral or facsimile prescriptions. This rescheduling of HCPs occurred after years of debate. Some stakeholders argued that the new restrictions would help prevent HCPs from getting into the wrong hands, while others contended that such restrictions may unfairly impede legitimate access for patients in chronic pain, particularly those in medically underserved areas. We are now discovering unintended, medication safety–related consequences of this policy decision. Leveraging precision medicine, specifically pharmacogenetics, may help to address these problems. In this issue of AJHP, Bernhardt et al.1 illustrate the value of real-world data to assess the clinical impact of the rescheduling of HCPs. A significant decrease in HCP prescribing for inpatients and outpatients treated at a children’s hospital and a women’s hospital was observed. However, this decrease in HCP prescribing was coupled with a significant increase in the prescribing of codeine with acetaminophen and tramadol—2 weak opioid analgesics classified as Schedules III and IV, respectively, which are not restricted by the prescribing and dispensing regulations governing Schedule II agents. In the 6 months after HCP rescheduling, the authors noted a twofold increase in codeine and tramadol prescriptions for children. Similarly, women received more than 3 times as many tramadol prescriptions and nearly 7 times the number of prescriptions for codeine-containing agents. The authors correctly indicate that these prescribing trends are concerning among children and breastfeeding women due to risks for harm. Like many pediatric hospitals nationwide, their hospitals’ response was to remove codeine from the formulary. While the authors note the role of pharmacogenetics in codeine and tramadol metabolism as the basis for these risks, there is no mention that pharmacogenetic testing is clinically available and presents a potential solution to these problems.