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

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.