National Kidney Foundation Releases Findings of Consensus Conference on Drug Substitution in Transplantation

New York, NY
February 1, 1999

The National Kidney Foundation (NKF) has announced the adoption of new recommendations for the safe and effective use of generic immunosuppresant medications in solid organ transplant recipients. The recommendations, which are published in the February issue of NKF's American Journal of Kidney Disease,were developed at a recent NKF conference on drug substitution in transplantation by more than 40 experts in organ transplantation, managed care and pharmacology, as well as patients and representatives of government agencies.

Drug substitution may involve the substitution of one generation of a drug for another, the use of a different agent within the same class of drugs or the use of a generic formulation for a brand name product. Possible advantages involve lower cost and better compliance. Possible dangers include overdose, underdose and unexpected side effects.

"Drug substitution has become a common practice in medicine today," says Joel Kopple, MD, president of the National Kidney Foundation.

"As the cost-saving potential and efficacy of generic drugs have become more widely recognized, substitution has become standard for many managed care providers. Some substitution may also be inadvertent, because of confusion arising from the array of medications available for certain indications and inadequate communication among physicians, patients and pharmacists."

"The introduction of new generic immunosuppressives could lead to substitution without the knowledge of patients or even their doctors. Our goal is to ensure that patients are fully aware of their unique drug regimens and involved in the decision-making process when changes or substitutions occur," Dr. Kopple continues.

Key conference recommendations include:

  • The immunosuppressive agents cyclosporine and tacrolimus should be included in lists of critical-dose drugs. In the future, new immunosuppressive agents should be evaluated to determine whether they also meet these criteria.

  • For critical-dose drugs, replicate design studies to determine subject-by-formulation interactions should be required as part of the FDA approval process for both innovator drugs and their generic equivalents.

  • Health care providers should educate the patient about generic drugs and include him or her in the decision of whether to switch drugs. The pharmacist should inform the prescribing physician and patient whenever a prescribed immunosuppressive drug for a transplant patient is to be switched.

"The well-being of all transplant recipients is a major part of the National Kidney Foundation's mission," says Dr. Kopple. "We anticipate widespread dissemination of our recommendations and implementation suggestions through our paper in the American Journal of Kidney Diseases."

The National Kidney Foundation is dedicated to preventing kidney and urinary tract diseases, improving the health and well-being of individuals and families affected by these diseases and increasing the availability of all organs for transplantation. To receive an executive summary of the drug substitution recommendations call the foundation at (800) 622-9010.