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Table 1 Position statements of various professional societies regarding the use of generic immunosuppressive drugs (ISDs)

From: Is it ethical to prescribe generic immunosuppressive drugs to renal transplant patients?

Canadian Society of Transplantation (2012) [ [1] ] • Insufficient literature regarding efficacy and safety.
• Close monitoring with any change.
• Not recommended in pediatric patients.
• The intended drug formulation must be explicitly stated on all prescriptions to avoid substitutions.
• Educate patients about formulations and substitutions.
• Prescriber and patient should be involved in any decision to change formulation. Mandatory notification of the prescriber should be a legal requirement.
• Licensing requirements for critical dose drugs must be re-assessed. Bioequivalence in solid organ transplant recipients (SOTR). Requirement for generic manufacturers to provide clinical outcome data in SOTR.
• Transplant centres should be funded according to the increased costs associated with managing SOTR arising from the introduction of generic immunosuppression.
American Society of Transplantation (2003) [ [16] ] • Supports the availability of efficacious, less expensive immunosuppressive medications and endorses efforts to introduce generic alternatives. Medication costs may contribute to non-compliance with prescribed medical regimens.
• FDA-approved generic immunosuppressive agents appear to provide adequate immunosuppression to low-risk patients.
• Insufficient data to make recommendations for at-risk populations (African-Americans or pediatric).
European Society for Organ Transplantation (2011) [ [18] ] • Generic formulations that do not meet the stricter criteria should not be used.
• Substitution should only be initiated by the transplant physician; pharmacists or insurance providers should refrain from forcing substitution.
• Repetitive substitution should be avoided.
• Patients should be informed about substitution and taught how to identify different formulations of the same drug so they can alert their physician if an uncontrolled substitution is made.
• The simultaneous use of different formulations in the same patients should be avoided.