Pediatrics

Children are not simply small adults. Pediatric recipients of solid organ transplants have unique and specific medical needs. The optimal use of immunosuppressive medications in pediatric transplant recipients requires strategies and tactics that are different than those in adult recipients.

In addition, children have a longer life expectancy and hence a longer period of exposure to the side effects of our immunosuppressive medications. Specifically, children have greater risks from the long term use of the most effective anti-rejection medications currently available. These may often cause kidney damage (either in the transplanted kidney or in the patients' own kidneys after heart, lung, liver, pancreas or intestine transplantation). Further, children have the most to gain from novel immunosuppressive minimization and tolerance induction regimens. Children also metabolize many immunosuppressant medications differently than adults.

Adolescents also have special needs and challenges, especially because of issues of medication non-compliance. This group of pediatric patients requires a higher degree of psychosocial support and/or may benefit from novel long-acting immunosuppressive agents.

Finally, the transition of pediatric patients from pediatric transplant centers to the adult center poses significant challenges to patients and their families. Gaps in insurance coverage, and access to medical care and essential medications, continue to be a significant problem as children with organ transplants transition to adulthood.

These issues and several others (including the prevention of growth retardation following transplantation, prevention of neuro-developmental delay, special needs related to their chronic illness, etc.) require special study. Increased support for both basic sciences and clinical research is needed to allow children to maximally benefit from organ transplantation. Pediatric patients have much to gain from a successful transplant, including the optimization of growth, neurological and psychological development, the ability to attend school, learn and enter college, and ultimately to become productive citizens as they enter the workplace as adults.

The American Society of Transplantation (AST) has strongly supported past legislative efforts to improve the field of pediatric transplantation, including medical research provisions included in the Children’s Health Act of 2000, 106th Congress, P.L. 106-310, Title XXI, Special Needs of Children Regarding Organ Transplantation. The AST supports reauthorization of this bill. The AST is also supportive of the Food and Drug Administration’s (FDA) pediatric rule for drug manufacturers. The FDA published its pediatric rule in the December 2, 1998, Federal Register (63 Fed Reg 66631). Under the rule, which became effective April 1, 1999, sponsors must include pediatric assessments in all new drug applications, biologic license applications, and certain abbreviated new drug application (ANDAs) submitted after Dec. 2, 2000. This rule will ensure all medications will be tested for safety and efficacy in pediatric patients.

In summary, the AST supports the following initiatives:

• Support for research that specifically addresses the special needs of children who have undergone organ transplantation, and promoting studies that provide for the successful transition of care into adulthood,
• Reauthorization of the Children’s Health Act of 2000,
• Guaranteed insurance coverage for all pediatric organ transplant recipients.

Approved by the AST Board of Directors on February 15, 2006
Revised and approved by the AST Board of Directors on April 13, 2009
Revised and approved by the AST Board of Directors on September 6, 2011