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. Its 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.
Unregulated Herbs a Problem
Ms. Vincler noted that the FDAs ineffective regulation of herbs
and nutritional products creates problems. Its 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.
Its 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 todays 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
patients 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 patients 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.
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 patients
medical condition, and the scope of the physicians knowledge
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 patients 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 isnt bliss: What healthcare
practitioners and facilities should know about complementary and
alternative medicine. Journal of Health and Hospital Law
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. Thats why you shouldnt take on more risk
for a patients 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 carewhen harmonized with
traditional treatment. Physicians shouldnt 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.