Is It Ethical To Prescribe Generic Drugs To CKD and Diabetics, Especially After Kidney Transplant?

Program To Offset Kidney Donor Expenses Should Boost Chronic Kidney Disease Patients' TransplantsA generic drug is one that is typically cheaper and chemically identical to its brand name equivalent. Still, Université de Montréal researchers Julie Allard and Marie-Chantal Fortin (Nephrology and Transplantation Division) posed the question, "Is it ethical to prescribe generic immunosuppressive drugs to renal transplant patients?" Their findings were then published in the Canadian Journal of Kidney Health and Disease on Tuesday, September 9th, 2014. 

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Although the researchers question is a good one, the Chronic Kidney Disease and Diabetes communities are filled with people who have received a transplant, those waiting on a transplant, as well as individuals who due to ineligibility or lack of desire - do not want or cannot receive a Kidney Transplant. Still, most patients with either disease take generic drugs, right? Hence, KidneyBuzz.com chose to extend the focus and include all members of this diverse community, "Is it ethical to prescribe generic drugs to Chronic Kidney Disease and Diabetics, especially after a Kidney Transplant?" The answer may be surprising.

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The Food and Drug Administration (FDA) suggests that generics must contain the same active ingredients in the same amounts as its brand name counterpart, and must pass a series of tests to prove that it is the same in "dosage, safety, strength, quality, the way it works, the way it is taken, and the way it should be used." However, there is a consensus among Physicians as well as Transplant Societies that clinical data is lacking and that caution should be exercised. 

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The reluctance to use generics in organ transplantation is partly related to the fact that most are "critical dose drugs" which require a narrow dose range to achieve and maintain their intended effects. Similar concerns extend to the larger Chronic Kidney Disease and Diabetic communities which also require critical dose drugs for necessary treatments such as Dialysis and to combat common complications such as  Hypothyroidism (low thyroid condition). 

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If the critical dosage is either too low or high it could have serious adverse life- and kidney-threatening consequences for patients. Despite the fact that the active ingredient in a generic medication must be the same as in the brand name, a generic does NOT necessarily contain the same INACTIVE ingredients as its brand name drug equivalent. These small differences could affect how the generic medication works in your body. 

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This may be due to how the generic medication is produced or the type and amount of inactive materials present in the medication. For some people, these slight differences may cause the drug to be less effective or lead to side effects. What's more is if you suffer a serious side effect from a generic drug you cannot sue. "If you take a brand-name drug, you still have your rights to go to court and hold them accountable," said attorney Larry Jones. "If you take a generic drug, you have no rights. And most people don't realize that."

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You may be thinking, "What!? Why would that be? It seems like I am taking more risk with the generic than the name brand." Well, under current FDA rules, only name-brand drugmakers are responsible for safety warnings. Generics are required to copy the label from the name brand and have no control over what’s on it, so as a result they can’t be held liable.

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Although the FDA is attempting to correct this major liability gap, Ralph G. Neas (President, Generic Pharmaceutical Association) suggested that closing this loophole "would be nothing short of catastrophic," and cause prices to soar. The FDA also admits, "Research shows that generics work just as well as brand name drugs." Also, according to the FDA, many of these reactions are actually known risks of the active drug ingredients.

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Hence, this is what you should know, the mass production of any medication—whether generic or brand name—can result in small variations in purity, strength, absorption and other characteristics. The FDA sets limits on these disparities and determines how much variation is acceptable for generics. However, is it acceptable for you!? Well, now that you know the issue, be proactive by printing this article out, taking it to your Primary Physician, and sharing your concerns. They can likely provide you with the most informed answer based upon your budget and the known risks of your given medication.

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For Daily News & Real-Time Information about how YOU as a Chronic Kidney Disease and/or Diabetic patient can better manage and improve your life, visit KidneyBuzz.com every day. 

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References:

"Is It Ethical to Prescribe Generic Immunosuppressive Drugs to Renal Transplant Patients?" Http://www.cjkhd.org/. Canadian Journal of Kidney Health and Disease.

"Generic vs. Brand Name Drugs." Http://www.healthcommunities.com/. Remedy Health Media, LLC.

"Generic Drugs - Are They as Safe and Effective as Brand-Name Drugs?" Http://healthinsurance.about.com. About Health.

"Drugs: Facts about Generic." Http://www.fda.gov. U.S. Food and Drug Administration.

"FDA Moves to Make Generic Drugmakers More Accountable." Http://www.today.com/. NBC News.

Savage, David G. "Generic Drug Makers Fight Rule on Health Risk Warnings." Http://articles.latimes.com. Los Angeles Times.

"Ingredient Differences in Generic Drugs Pose Allergy Risk." Http://www.kidswithfoodallergies.org. Food Allergy Resources.

"Generic Drugs Facts from Drugs.com." Http://www.drugs.com/. Drugs.com.