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What Is the Future of Generics in Transplantation?
- Source :
-
Transplantation [Transplantation] 2015 Nov; Vol. 99 (11), pp. 2269-73. - Publication Year :
- 2015
-
Abstract
- Generic immunosuppressive drugs are available in Europe, Canada, and the United States. Between countries, there are large differences in the market penetration of generic drugs in general, and for immunosuppressive drugs in particular. The registration criteria for generic immunosuppressive drugs are often criticized. However, it is unlikely that the criteria for registration of narrow therapeutic index drugs are going to change, and bioequivalence studies, performed in healthy volunteers, will remain the backbone of the registration process. It would be good if the registration authorities would demand that all generic variants of an innovator drug have the same pill appearance to reduce errors and promote drug adherence.To allow for safe substitution, a number of criteria need to be fulfilled. Generic substitution should not be taken out of the hands of the treating physicians. Generic substitution can only be done safely if initiated by the prescriber, and in well-informed and prepared patients. Payers should refrain from forcing pharmacists to dispense generic drugs in patients on maintenance treatment with innovator drug. Instead, together with transplant societies, they should design guidelines on how to implement generic immunosuppressive drugs into clinical practice. Substitutions must be followed by control visits to check if the patient is taking the medication correctly and if drug exposure remains stable. Inadvertent, uncontrolled substitutions from 1 generic to another, initiated outside the scope of the prescriber, must be avoided as they are unsafe. Repetitive subsequent generic substitutions result in minimal additional cost savings and have an inherent risk of medication errors.
- Subjects :
- Cost Savings
Cost-Benefit Analysis
Drug Costs
Drug Substitution economics
Drugs, Generic adverse effects
Drugs, Generic economics
Forecasting
Graft Rejection economics
Graft Rejection immunology
Humans
Immunosuppression Therapy adverse effects
Immunosuppression Therapy economics
Immunosuppressive Agents adverse effects
Immunosuppressive Agents economics
Medication Adherence
Medication Errors prevention & control
Organ Transplantation adverse effects
Organ Transplantation economics
Patient Safety
Practice Patterns, Physicians'
Risk Factors
Time Factors
Treatment Outcome
Drug Substitution trends
Drugs, Generic therapeutic use
Graft Rejection prevention & control
Graft Survival drug effects
Immunosuppression Therapy trends
Immunosuppressive Agents therapeutic use
Organ Transplantation trends
Subjects
Details
- Language :
- English
- ISSN :
- 1534-6080
- Volume :
- 99
- Issue :
- 11
- Database :
- MEDLINE
- Journal :
- Transplantation
- Publication Type :
- Academic Journal
- Accession number :
- 26050017
- Full Text :
- https://doi.org/10.1097/TP.0000000000000782