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Table 4 Guidelines for generic prescription of AEDs (Krämer et al. 2007; Connock et al. 2006; Perucca et al. 2006; Network 2003; Liow et al. 2007; American Academy of Neurology 1990; Duh et al. 2009a; Bialer and Midha 2010)

From: Potential problems and recommendations regarding substitution of generic antiepileptic drugs: a systematic review of literature

Country Organization Principal recommendations
United States AAN The AAN argues the generic substitution of AEDs and advises to seek consent of attending physician
Epilepsy Foundation Both physician and patient should give consent and to be notified upon substitution of AEDs
FDA According to the FDA, a therapeutically equivalent product (either generic or brand) may be expected to have equivalent clinical effects
American Epilepsy Society The physicians involved in epilepsy treatment are trained for selection of appropriate AEDs and their dosages to minimize or eradicate seizures and to avoid adverse events
It is done by utilizing the best available scientific evidences and clinical expertise
Also, the society contradicts the formulation substitution of AEDs without obtaining approval from the physician as well as the patient
England NICE Be precautious while generic substitution of AEDs having complex pharmacokinetics that may cause larger differences in therapeutic effects upon minor changes in drug absorption
Germany German chapter of ILAE A switch must be avoided for patients having well-controlled seizures
Consider a generic switch towards a lower cost AED only for the patients having poorly controlled seizures. It is better to initiate the treatment with a low-cost AED
The serum drug levels should be monitored closely while switching and the patient should be informed about the potential risks
Italy Italian chapter of ILAE For patients exhibiting partial controlled seizures upon treatment with a brand AED, it might be appropriate to switch to a generic product
The patient should be informed about the properties and nature of these products
A switch is not recommended for the patients having well-controlled seizures
France LFCE AEDs belong to a class that may cause problems when substituted. It is recommended to avoid generic substitution of AEDs
Poland Polish Society of Epileptology Because of an increased risk of deterioration in epilepsy patients switching of formulations is contraindicated
Pharmacists should not make substitution without informing the physicians and the physicians are responsible to make aware the patients of all the potential and possible risks
Scotland Scottish Intercollegiate Guidelines Network Generic substitution of AEDs should not be made as different available formulations of AEDs are not switchable
Sweden Swedish Medicinal Products Agency Switching between formulations may cause a poor control of seizures
Netherland Netherlands Society of Child Neurology The substitution of AEDs is not recommended
  1. AAN American Academy of Neurology, FDA Food and Drug Administration, NICE National Institute for Health and Care Excellence, ILAE International League Against Epilepsy, LFCE Ligue Francaise Contre L’Epilepsie