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


Patients Regain the Right to Control Their Own Medications

Your Consent Is Now Required Before Your Medications Can Be Switched. The Nation's Largest Pharmacy-Benefit Manager Agrees to Settle

You have regained your right to control your own medications. The practice of switching your medications without your consent has taken a big hit.

In the inaugural MedicationSense E-Newsletter (July-Sept 2003), I wrote about the growing practice of pharmacy-benefit managers, working in concert with health insurance companies and HMOs, of switching patients' medications without their awareness or consent. Patients' medications weren't being changed for medical reasons. Instead, pharmacy-benefit managers were switching patients' drugs after signing new deals with different drug companies. Patients weren't notified until discovering new medications when getting refills at their pharmacies or through the mail.

This practice was medically unethical because patients have a right of informed consent before agreeing to any medical treatment. Moreover, it was medically unsupportable because different medications have different effects in people, and switching people from one drug to another, even if the drugs are similar, can lead to side effects or reduced effectiveness.

In fact, back in September 2000, the Archives of Internal Medicine published a study examining the experience of one health plan when patients were switched from Prilosec (omeprazole) to Prevacid (lansoprazole).1 The health care company's excuse was that these drugs are "therapeutically equivalent," meaning that, statistically, they showed similar rates of effectiveness in clinical studies. But statistics don't mean much when it comes to different individuals, whose responses to medications can vary as much as they do with coffee or alcohol. Just because an anti-ulcer and anti-gastritis drug like Prilosec works well for someone is no guarantee that Prevacid will too.

Proving the point, all of the patients in the study had been doing well on Prilosec, yet more than half of them (52%) developed a worsening of symptoms when switched to Prevacid. I wasn't surprised by the high numbers. People frequently react quite differently to supposedly "therapeutically-equivalent" drugs. Such problems are readily seen when patients are switched between cholesterol-lowering statins such as Zocor and Lipitor and Pravachol, or anti-inflammatory drugs such as Voltaren and Celebrex and Vioxx. The same is seen with SSRI antidepressants such as Prozac, Paxil, and Zoloft. Indeed, the conclusion of a study 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."2

Yet, the authors of the Prilosec-Prevacid study supported the practice of switching patients without consent. I wrote a letter to the editor challenging the wisdom and ethics of such methods. I also questioned whether such methods would save insurers any money because side effects are expensive, requiring extra telephone calls to doctors, extra office and emergency room visits, and new prescriptions.3

I also wrote to the American Medical Association and asked for a clarification of their definition of informed consent. 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' [my italics].4


Apparently the attorneys general of twenty states agreed. They launched a 2-year investigation that has now led to a $29 million settlement with the nation's largest pharmacy-benefit manager, Medco Health Solutions Inc., which pioneered the switching-without-consent practice. Medco made "no admission or finding of inappropriate business conduct," but agreed to discontinue the practice of switching your medications without your consent.5

From now on, patients will receive a letter or telephone call from Medco informing them that a switch has been requested. Unless there's a good medical reason or unless your savings will be substantial, it's better to stick with a drug that you know if it is working for you and not causing side effects. Whether they ask you explicitly or not, be sure to state emphatically that you want to stick with your current medication. If unsure, check with your doctor before giving Medco or any other pharmacy-benefit manager your permission.

Getting Medco to agree is a big step. The attorneys general are now focusing on other pharmacy-benefit managers. Hopefully they will rediscover their ethics or at least fear being fined enough to change their unethical ways.

References
1. 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):2491-6.
2. Simon, G. Choosing a First-Line Antidepressant: Equal on Average Does Not Mean Equal for Everyone. JAMA, Dec. 19, 2001;286(23):3003-04.
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. 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.
5. Martinez, B. Settlement Empowers Drug Consumers. Wall Street Journal, Apr. 27, 2004:D1.





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.

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