Electronic Health Records and Drugs Prescribed for Off-label Indications/In Reply

To the Editor: In a previous issue of Mayo Clinic Proceedings, Mackey and Liang delivered an insightful summary of the Amarin v FDA decision and attendant events that have reduced the ability of the US Food and Drug Administration (FDA) to limit promotion by pharmaceutical companies of off-label uses of drugs owned by those companies.1 From a population health perspective, they cite the increased risk of adverse events associated with drugs prescribed for off-label indications. Among the 16 indications presented in the prescribing module by the contractor, chronic heart failure stands out as an indication not sufficiently supported by evidence to merit FDA approval or for metoprolol tartrate to be included in the American Heart Association/American College of Cardiology guidelines for use in patients with heart failure.2 Other off-label indications for metoprolol tartrate that appear comingled with the 3 FDA-approved indications (included in the EHR prescribing module) are the treatment of mitral valve prolapse and the prevention of ventricular arrhythmias in congenital long QT syndrome. The increased risk of adverse drug events has now been well documented with populations at enhanced risk now identified as women, patients receiving 5 or more drugs, and patients receiving either cardiovascular drugs or anti-infectives.3 The question of whether the electronic health care industry is a better steward of drug prescribing information than the pharmaceutical industry seems now to have been answered. EgualeT, Buckeridge DL,VermaA,etal.Association of off-label drug use and adverse drug events in an adult population.JAMA intern Med. 201 6;176(1):55-63. http://dx.doi.Org/10.1016/j.mayocp.2017.02.001 In Reply-Electronic Health...