SAN FRANCISCO —As alternative (or complementary) medicine becomes more popular, physicians are starting to face troubling questions about their liability for patients’ use of these therapies. But unfortunately, physicians may not be informed about the potential efficacy of these therapies or their safety, Lisa A. Vincler, JD, Assistant Attorney General at the University of Washington Health Sciences and Medical Center, said at the Society of Gynecologic Oncologists annual meeting in February 1999.
For doctors, one of the main questions is whether they may be liable for authorizing or refusing patients’ requests for complementary medicine referrals. Another concern is whether physicians can legally prevent patient access to these therapies.
A Wide-Ranging Field
Some medical literature defines complementary medicine as fitting into four categories: spiritual or psychological, nutritional, drugs or biologics, and physical forces or devices. “But there are actually more types of complementary medicine than can fit into these categories. It’s a very wide-ranging field,” Ms. Vincler said.
Many patients are using alternative therapies without the knowledge of their physicians. Thus, there is the potential for interaction with conventional therapies. Furthermore, the field of alternative medicine is changing so rapidly that it is difficult for physicians or other medical professionals to keep up with the newest trends. “Communication with patients about these therapies is complicated by their extent and variety as well as potential inherent conflicts between alternative and traditional medicine,” Ms. Vincler said.
Unregulated Herbs a Problem
Ms. Vincler noted that the FDA’s ineffective regulation of herbs and nutritional products creates problems. “It’s very frustrating because ‘nutritional supplement’ products are not well regulated. Studies have shown variations in potencies between brands and even among bottles of herbs from the same company. There also may be dangerous impurities contained in these substances,” Ms. Vincler said.
A good resource for information about herbs, she said, is the Complete German Commission E Monographs by Blumenthal, edited by the American Botanical Council. The herbs and their effects described in this book were studied for years in the German medical system. “It’s considered an unbiased source and the most complete source currently available,” Ms. Vincler said.
Family doctors should know that their gatekeeper role may carry with it a special obligation to stay up to date on alternative therapies and inform patients of their risks and benefits.
Under today’s managed care systems, most doctors may be allowed to refer patients to alternative medicine practi-tioners only when a condition is incurable or chronic and conventional therapy is not successful, Ms. Vincler said. “Some examples of these types of conditions would be chronic pain and chronic fatigue,” she added.
With high-risk patients and terminally ill patients, however, the choices about alternative therapies may be particularly problematic. With some high-risk patients, the physician may question whether a patient’s compromised immune system may permit alternative therapy. Terminally ill patients, who may be especially vulnerable to the claims of alternative practitioners, may need to be protected from ineffective and useless therapies. On the other hand, the physician should consider the patient’s needs, including hope. “You should ask yourself, does this alternative therapy give the patient a feeling of control or a better quality of life?” Ms. Vincler said.
Protecting Against Liability
To protect against potential liability, Ms. Vincler suggests that physicians should follow institutional informed consent protocols when alternative medicine is part of the recommended therapy. “The doctor should have a dialogue with the patient and clearly state what he or she thinks about the therapy,” Ms. Vincler said. “Good documentation of the conversation, the patient’s medical condition, and the scope of the physician’s knowledge also help.”
In cases where the physician is not knowledgeable about the alternative therapy, he or she should do a basic risk-to-benefit assessment of the patient’s request for complementary medicine using available resources. If there is a significant risk, Ms. Vincler suggests that the physician should not authorize the therapy. But if there is no known significant risk, the physician could allow the therapy. To clearly document alternative medicine authorizations, the physician should consider asking the patient to sign a Consent to Assume Risks form. [A sample of this form is included as an appendix in the article upon which Ms. Vincler based her talk: Vincler LA, Nichol MF: When ignorance isn’t bliss: What healthcare practitioners and facilities should know about complementary and alternative medicine. Journal of Health and Hospital Law 30(3):160-178, 1997.]
The legal concept of “Assumption of Risks” simply allows patients to accept responsibility for their acts and decisions and the potential consequences of these choices. It requires that the patient understand the risk of the treatment, as well as voluntarily choose to assume the risk.
“Having the patient assume risk for the alternative therapy is not saying that the doctor is off the hook for negligence,” Ms. Vincler added. “The doctor still has to deliver medical treatment meeting the standard of care.” Physicians should remember that ‘standard of care’ is dynamic, she added, and they should stay current in their practices.
The more a physician actively participates in coordinating and supervising alternative therapy, the more potential liability is created. “That’s why you shouldn’t take on more risk for a patient’s complementary therapy than you feel comfortable with,” Ms. Vincler said.
She noted that it is difficult to effectively manage liability exposure for use of alternative medicine because there are so many unknowns about these therapies. In addition, very few cases have tested the liability of conventional physicians who work with patients to help provide complementary therapies.
“Physicians should consider the benefits to supporting patients’ use of complementary care—when harmonized with traditional treatment. Physicians shouldn’t automatically reject patient requests for complementary medicine based just on unreasonable fears of liability,” Ms. Vincler said. The potential benefits and risks should be considered for each patient request and documented.
