The package insert that comes with a medication is more important than many prescribers give it credit for, according to Sheldon H. Preskorn, MD, and professor at the University of Kansas School of Medicine.  Prescribers who dismiss a package insert as needless legal information written to protect drug manufacturers are making a grave mistake, said Preskorn.Inserts are actually jointly written by a team of clinical experts from the pharmaceutical manufacturer and the U.S. Food and Drug Administration (FDA).  The 1966 Fair Packaging and Labeling Act requires all consumer products in interstate commerce to be honestly and informatively labeled and has tasked the FDA with enforcing this and providing important information to prescribers.

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“It is one of the few places you will find where your federal government, the agency of the FDA, and the manufacturer have come together to write up what they think you should know about the prescription of a drug,” he said.  Preskorn has served as a medical malpractice lawsuit expert witness multiple times and warned that inserts can play a significant role in such cases.  “When a patient does suffer injury from a drug treatment, the prescriber’s actions must be measured against the standard of care; that is, practice considered to be acceptable for professionals in the same field. One tool used by the courts as evidence of standard of care has been the PI,” or package insert, according to Joseph P. Nathan, MS, PharmD.During a session Preskorn lead in pharmacology and malpractice at Psych Congress 2018, he used several examples to illustrate this point.  One such example was the case of Tommy.“Tommy was a 55-pound, 6-year-old diagnosed with attention-deficit/hyperactivity disorder (ADHD). When he failed to adequately improve with amphetamine and methylphenidate, the prescriber began imipramine at 50 mg/day, which was gradually titrated to 200 mg/day based on an assessment of response.  One day at school, Tommy collapsed.  Later, in the hospital, he experienced a bout of ventricular fibrillation and cardiac arrest and died.The package insert for imipramine warned against exceeding 2.5 mg/kg in a child, the presenter explained.  At the time of his collapse, Tommy was taking 8 kg/mg—an amount nearly 3 times higher than the recommended dose.  The insert also recommended an electrocardiogram before starting the drug in a child and after each dose increase.  None was ever done.”The case “ended poorly for the prescriber,” Dr. Preskorn said. “The failure to follow the package insert was a direct cause of the child’s death.”Unfortunately, this happens often enough to cause concern and the need to reiterate how important it is to review the information placed on the insert when prescribing to patients.  “Even when courts do not accept the PI as prima facie evidence of the established standard of care, the PI may be used to establish malpractice by reason of a failure to obtain informed consent from the patient.  In these cases, malpractice may be established on the basis of the prescriber’s failure to make the patient aware of pertinent safety information described in the PI, so that an informed decision could have been made while knowing all risks that pertained to taking the medication.  If the prescriber fails to convey the appropriate information contained in the PI, he or she may be held responsible for any harm that befalls the patient,” according to Nathan.Prescribers should be beware of the dangers of not properly educating themselves or those taking the medication.  Part of this is reviewing the information on the insert.

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Package Inserts Can Play a Role in Malpractice ClaimsThe Package Insert