Current approaches to the use of generic antiepileptic drugs

• Published in: Epilepsy & behavior Vol. 11; no. 1; pp. 46 - 52
• Main Authors: Krämer, G, Biraben, A, Carreno, M, Guekht, A, de Haan, G.J, Jędrzejczak, J, Josephs, D, van Rijckevorsel, K, Zaccara, G
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.08.2007
• Subjects: Adherence; Anticonvulsants - pharmacokinetics; Anticonvulsants - therapeutic use; Bioequivalence; Cost; Drug Prescriptions; Drugs, Generic - standards; Drugs, Generic - therapeutic use; Epilepsy; Epilepsy - drug therapy; Generic drugs; Health Policy; Humans; Neurology; Patient Education as Topic; Seizure control; Therapeutic Equivalency; United States; United States; Adherence; Generic drugs; Seizure control; Bioequivalence; Cost; Epilepsy
• ISSN: 1525-5050; 1525-5069
• DOI: 10.1016/j.yebeh.2007.03.014

Abstract Generic substitution is encouraged as a cost containment strategy for the management of health care resources. However, in epilepsy, the consequences of loss of symptom control are important, and antiepileptic drugs have narrow therapeutic indices. For this reason, generic substitution may be problematic, and certain health authorities have excluded antiepileptic drugs from overall policy recommendations on generic prescribing. The absence of bioequivalence data among generic forms and the relatively broad criteria for bioequivalence with the branded drug allow differences in drug exposure to arise that may be clinically relevant and necessitate monitoring of plasma levels when switching formulations to avoid loss of seizure control or emergence of side effects. Management of these issues carries a significant cost, which should be weighed carefully against the cost savings acquired when purchasing the drug. Both physicians and patients have a right to be informed and approve before pharmacists make a generic substitution or switch between generics.