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)
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 |