AMA: Switching Patients' Medication without Their Consent Is Unethical
Has your HMO switched one of your medications
without telling you? When arriving at the pharmacy, have you suddenly found
that you are suddenly taking something new? Without prior warning or consent?
If so, you've been treated unethically.
In response to an inquiry I sent to the American
Medical Association, its Council on Ethics and Judicial Affairs determined
that patients do have an ethical right of informed consent when healthcare
plans seek to switch them to similar drugs (1).
I'm not referring to switching from a brand name to a generic, or from one
generic to another, of the very same drug. I'm speaking of switching patients
from one drug to an entirely different one, done without patients' consent,
which has become a common practice of HMOs and other healthcare agencies seeking
to reduce costs.
I've always believed that this practice is unethical,
and the AMA now agrees. You are paying the bill and taking the risk, so you
have a fundamental right to have a say in the treatment.
Debate on this issue began after the publication
in September 2000 of an analysis by Nelson et al. about the experience within
one health plan after patients were switched from Prilosec (omeprazole), a
drug for upper gastrointestinal disorders such as ulcers and gastritis, to
therapeutically equivalent doses of Prevacid (lansoprazole), a similar drug
(2). The reason was that Prevacid was less
expensive, and the rationale was that Prevacid is equally effective -- "therapeutically
equivalent" -- to Prilosec. Yet in this study, 52% of patients, whose
heartburn or gastroesophageal reflux disease had been stable after being treated
with Prilosec, developed a worsening of their symptoms when switched to Prevacid.
I've always believed that this practice is unethical, and the AMA agrees. You are paying the bill and taking the risk, so you have a fundamental right to have a say in your own treatment."
From my own clinical experience, I knew that
switching patients from one drug to another, even if they are supposedly equal
therapeutically, can be fraught with difficulties. So I wrote a letter in
response to the Nelson article (3). I stated
that even though the averaged effectiveness of two drugs may be statistically
similar in studies, this doesn't mean that the drugs will have equal benefit
for each patient.
Moreover, similar drugs often have very dissimilar
side effect tendencies, and people frequently react quite differently to supposedly
similar medications. Both of these problems are readily seen when patients
are switched between, for example, cholesterol-lowering statins such as Zocor
and Lipitor and Pravachol, and anti-inflammatory drugs such as Voltaren and
Celebrex and Vioxx.
And with SSRI antidepressants such as Prozac,
Paxil, and Zoloft. Indeed, a recent article in the Journal of the American
Medical Association underscored this: "The fact that SSRI drugs
are equally effective on average does not mean that they are equally effective
for individual patients (4)."
In my letter, I pointed out that "one of
the more challenging aspects of clinical medicine is to find the right drug
at the right dosage for each patient (3)."
Sometimes you have to try several drugs until you find the right fit, even
though all of the drugs you try are "therapeutically equivalent"
For many people, there's a big difference between
Prozac and Zoloft, Claritin and Allegra, Norvasc and Zestril, etc. Individual
variation -- the differences in how people respond to drugs -- is a basic
principle of medical science. Individual variation isn't the exception --
it's the rule, and an everyday reality of working with patients.
"You have a right of informed consent with all types of treatment -- including medication therapy.Healthcare systems need policies to keep costs down so that we can afford our insurance premiums, but not at the cost of losing our basic rights."
Most important of all, you have a fundamental
right of informed consent with all types of treatment -- including medication
therapy. Just as you are provided informed consent before surgery, you have
the same right with medication therapy. This right extends to knowing what
medication you'll be taking before -- and if you agree to -- being switched
to it. Even if the switching is done with the doctors' approval, this isn't
an acceptable alternative to informing and obtaining approval from patients
I submitted my letter to the Archives of
Internal Medicine, in which the article by Nelson had been published.
The Archives published my letter on September 24, 2001, and at the same time
also published a response by Dr. Nelson and other authors of the original
Although Nelson et al. agreed that healthcare
systems should take steps "to ensure that patients who experience significant
outcome deficits are treated appropriately," this didn't mean patients
had a right of consent before their medications were switched. Citing the
AMA's statements on switching medications, Nelson et al. concluded that "informed
consent of the patient is not a requirement for routine medical practice,
which (based on the AMA position) currently includes the process of therapeutic
The AMA's policy statements were indeed contradictory,
so I wrote to the AMA for clarification. In a letter dated December 7, 2001,
the Chairman of the AMA Council on Ethics and Judicial Affairs replied:
"The Code of Medical Ethics' Opinion 8.135, `Managed Care Cost Containment Involving Prescription Drugs,' speaks most directly to your question and states: `Prescriptions should not be changed without physicians having a chance to discuss the change with patients.' In addition, the Code of Medical Ethics includes several Opinions that stress the importance of informed consent. Opinion 8.08, `Informed Consent,' states: `The patient should make his or her own determination on treatment' and Opinion 10.01, `Fundamental Elements of the Patient-Physician Relationship,' states: `The patient has the right to make decisions regarding the health care that is recommended by his or her physicians (2).’"
Based on these principles of medical ethics,
the AMA council concluded:
"Considered jointly, these Opinions make clear that the patient's informed consent is ethically required when substituting therapeutically equivalent prescription drugs [my italics] (2)."
In other words, switching patients without
their consent is unethical! However, I certainly understand the need
of healthcare programs to implement policies to keep costs down so that we
can afford our insurance premiums, but not at the cost of losing our basic
Rather than curtailing our rights, the problem
should be addressed at the source. The need to disrupt people's treatment
by switching them to entirely new drugs isn't necessitated by medical considerations,
but by economic ones: the exorbitant costs of prescription drugs that, for
more than a decade, have allowed the pharmaceutical industry to reap profits
far beyond those of any other major industry.
Unlike Canada and most of Europe, the U.S. government
has no policy for controlling drug costs so that people's treatment isn't
threatened. Perhaps our government, which was established of, by, and for
the people, needs to find a better balance between protecting the pharmaceutical
industry's ability to fund their important research and ensuring that patients
and their healthcare programs are not burdened unreasonably for vital medication
If drug costs are so high that patients' treatment must be disrupted (and millions of others cannot afford essential drugs), while drug companies continue to reap enormous profits, then the system is terribly out of balance. Switching patients to new drugs without their consent is not the solution.
1. Riddick, Frank A., Jr., M.D., Council on Ethical and Judicial Affairs, American Medical Association. Letter to Jay S. Cohen, M.D., December 7, 2001.
2. Nelson, WW, Vermeulen, LC, Geurkink, EA, et al. Clinical and humanistic outcomes in patients with gastroesophageal reflux disease converted from omeprazole to lansoprazole. Archives of Internal Medicine, 2000 Sep 11, 160(16):24916.
3. Cohen, JS. Clinical and Ethical Concerns about Switching Patient Treatment to "Therapeutically Interchangeable" Medications. Archives of Internal Medicine, Sept. 24, 2001;161:2153-54.
4. Simon, G. Choosing a First-Line Antidepressant: Equal on Average Does Not Mean Equal for Everyone. JAMA, Dec. 19, 2001;286(23):3003-04.
5. Nelson, WW, et al. In Reply. Archives of Internal Medicine, Sept. 24, 2001;161:2154.
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