Jay S. Cohen M.D.       http://medicationsense.com      1337 Camino Del Mar   Suite C       Del Mar, CA 92014       Phone: 858.345.1760       Fax: 858.509.8944


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" in studies.

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 themselves.

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 paper.

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 interchange (5)."

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 rights.

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 therapy.

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.


References
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.




NOTE TO READERS: The purpose of this E-Letter is solely informational and educational. Theinformation herein should not be considered to be a substitute forthe direct medical advice of your doctor, nor is it meant to encourage the diagnosis or treatment of any illness, disease, or other medical problem by laypersons. If you are under a physician's care for any condition, he or she can advise you whether the information in this E-Letter is suitable for you. Readers should not make any changes in drugs, doses, or any other aspects of their medical treatment unless specifically directed to do so by their own doctors.

If you have questions about your medications or medical care, Dr. Cohen is available for consultation at his office or by telephone.

If you find this article informative, please tell your friends, family members, colleagues, and doctors about www.MedicationSense.com and the free MedicationSense E-Newsletter.