Off-label prescribing? Know evidence base!
Off-label prescribing? Know evidence base!
Physicians must not breach the standard of care
A patient given a medication "off-label" might allege that he or she was harmed by the prescribing physician as a result of negligent prescribing, says Madelyn S. Quattrone, Esq., senior risk management analyst at ECRI Institute in Plymouth Meeting, PA.
In 2008, several lawsuits were brought in numerous states for the off-label use of pain pumps, which were being placed directly in a patient's joint following orthopedic surgery. The plaintiffs argued the off-label use of the pumps destroyed the cartilage in their joints, necessitating joint replacement and causing permanent damage.
The off-label use of corticosteroids to treat brain edema following head trauma was halted after a randomized clinical trial of more than 10,000 adults with head injury revealed that this off-label use significantly increased the risk of patient death in the two weeks following the head injury.1 "Similarly, off-label use of fenfluramine for weight loss was common, until it was shown that heart-valve damage occurred in thousands of patients who took the drug, resulting in lawsuits against providers and in class action litigation," says Quattrone.
Although the Food and Drug Administration (FDA) approves drugs for specific uses based on the data submitted during the approval process, it not only permits but expects off-label use, says Leslie E. Wolf, JD, a professor of law at Georgia State University College of Law's Center for Law, Health, & Society in Atlanta.
Off-label use isn't unlawful, and it doesn't necessarily constitute malpractice, says Quattrone. "The FDA does not regulate the practice of medicine. That function is reserved for state boards of medicine," she says.
Many common uses of FDA-approved drugs, including most pediatric uses, are off-label, says Wolf, but "physicians are at risk of liability if they breach the standard of care in their off-label prescribing."
Develop a policy and procedure for innovative off-label use of medication, with a multidisciplinary task force including medical staff, pharmacists, risk management, and the ethics committee, says Quattrone. "A facility might take several approaches to off-label use," she says. For example, it might not permit off-label prescribing at all, it might restrict off-label use to clinical research approved by an institutional review board, it might permit off-label use only if the use falls within the institution's therapeutic guidelines, or it might approve off-label prescribing based on clinical judgment of the provider that adequate evidence supports its use.
Physicians are less likely to be held liable for off-label prescribing if such use is considered standard of care among physicians in the same specialty and/or if there is evidence supporting the off-label use, says Wolf. (See related stories on the standard of care, below, and obtaining informed consent, below.) "Accordingly, physicians should be familiar with the evidence concerning off-label uses before prescribing," she says.
Physicians are more likely to be held liable for injuries caused by off-label prescribing when the evidence base for the use is weak or non-existent, and when other physicians would not endorse the use, says Wolf.
"This risk can be compounded when physicians ignore FDA or manufacturers' warnings, or when they prescribe off-use without appropriate experience," says Wolf.
Reference
- Dzik W. Off label reports of new biologists: exciting new therapy or dubious research? J Intensive Care Med 2006; 21(1):54-59.
Sources
- Janice M. Ginley, Assistant Claims Manager, MIEC, Oakland, CA. Phone: (510) 596-4936. Fax: (510) 318-6755. Email: [email protected].
- Samantha L. Prokop, Esq., Brennan, Manna & Diamond, Akron, OH. Phone: (330) 253-3766. Fax: (330) 253-3768. Email: [email protected].
- Madelyn S. Quattrone, Esq., Senior Risk Management Analyst, ECRI Institute, Plymouth Meeting, PA. Phone: (610) 825-6000 ext. 5151. Fax: (610) 834-1275. Email: [email protected].
- Leslie E. Wolf, JD, Professor of Law, Georgia State University College of Law, Center for Law, Health & Society, Atlanta. Phone: (404) 413-9164. Fax: (404) 413-9225. Email: [email protected].
Physicians must obtain consent for off-label use Patients can successfully sue if you fail to properly obtain their consent when a drug or device is used in a manner that deviates from the purpose for which it was approved, warns Claudia Dobbs, loss prevention manager at MIEC, an Oakland, CA-based malpractice carrier. When there is a potential for serious side effects due to off-label use of medications, Dobbs recommends considering these practices to reduce legal risks:
"Supplement your oral discussion with written information, video viewing, and Internet resources," recommends Dobbs. "Explain how the off-label drug will work better than the approved drug."
"This will provide insight into your care and treatment of the patient and adherence with the standard of care," Dobbs says.
"Don't make your patients angry by failing to ensure that there is coverage," Dobbs says. "Should the patient experience an unexpected injury from the drug, anger over the uncovered medication will add to the patient's desire to seek the services of an attorney." |
Off-label use might be the standard of care In a 2009 case, the plaintiff developed peripartum cardiomyaopathy pulmonary edema and congestive heart failure, which she claimed was caused by use of turbutaline as a tocolytic to stop contractions during pregnancy.1 She also claimed the physician did not obtain her informed consent before prescribing the drug. "The jury returned a $3.5 million verdict. The defendants appealed, and the court of appeals remanded the case due to procedural issues," says Samantha L. Prokop, Esq., an attorney with Brennan, Manna & Diamond, in Akron, OH. Cases such as this one should not deter clinicians from off-label prescribing, however, cautions Prokop. "In fact, failure to use a drug or product off-label could also be considered malpractice, if the standard of care required off-label use," she says. Off-label prescribing is permitted if it meets the standard of care, explains Prokop, and in some cases, it might constitute the standard of care. Madelyn S. Quattrone, Esq., senior risk management analyst at ECRI Institute in Plymouth Meeting, PA, says, "To succeed in court on a claim of negligence, the plaintiff must prove that the off-label prescribing breached the standard of care, and that the drug, as prescribed, caused harm to the patient, or it was a substantial factor in causing harm to the patient." The use of a drug "off-label" does not imply that the physician has acted below an accepted standard of care, and for some conditions, off-label use has become the standard of care, says Quattrone, "but when there is lack of valid clinical evidence and published peer-reviewed literature to support off-label use of a particular drug, the use of the drug involves some degree of uncertainty and risk about safety and efficacy." Battle of experts If a claim involving off-label use goes to trial, the jury will hear opposing expert opinion on whether the physician's prescribing breached the standard of care and whether the use of the drug was the proximate cause of harm to the patient, says Quattrone. In one claim, a plaintiff alleged that the risk of the off-label use of a YAG laser had not been fully explained to him. "Corrective surgery went well, but the patient claimed impairment to near and intermediate distance vision, clouding in the center of the eye and general reduced vision quality," says Janice M. Ginley, assistant claims manager for MIEC, an Oakland, CA-based malpractice carrier. The physician's documentation of the risks and alternatives to treatment was poor. "Despite review by multiple ophthalmic surgeons, we could not find any support on the standard of care for the use of YAG laser ablation in the treatment of vitreous floaters," adds Ginley. In fact, several ophthalmologic surgery consultants explained that a YAG laser is too dangerous for treatment of vitreous floaters because there is too much risk of injury to the lens in this off-label application of the device, she explains. "Although an independent medical examination demonstrated that the patient had a near-full recovery within months of the incident, because of the intentional acts, personal exposure and lack of expert support, the case was mediated and settled in the mid-six figure range," says Ginley. Reference
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A patient given a medication "off-label" might allege that he or she was harmed by the prescribing physician as a result of negligent prescribing, says Madelyn S. Quattrone, Esq., senior risk management analyst at ECRI Institute in Plymouth Meeting, PA.
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