Generic substitution of antiepileptic drugs — A survey of patients' perspectives in Germany and other German-speaking countries

2013 ◽  
Vol 27 (1) ◽  
pp. 135-139 ◽  
Author(s):  
Katrin Hensler ◽  
Carmen Uhlmann ◽  
Thomas Porschen ◽  
Reiner Benecke ◽  
Johannes Rösche
Keyword(s):  
Antiepileptic Drugs ◽  
Generic Substitution ◽  
German Speaking

Pharmacy and Generic Substitution of Antiepileptic Drugs: Missing in Action?

2007 ◽  
Vol 41 (6) ◽  
pp. 1065-1068 ◽  
Author(s):  
Timothy E Welty
Keyword(s):  
Decision Making ◽  
Antiepileptic Drugs ◽  
Generic Substitution ◽  
Careful Consideration ◽  
Professional Organizations ◽  
Missing In Action

Generic substitution of antiepileptic drugs is an issue that is gathering a lot of attention in the neurology community but is not receiving much attention within pharmacy. Several proposals have been drafted that restrict a pharmacist's decision-making in generic substitution. These proposals highlight concerns about the pharmacy community related to generic substitution. Careful consideration needs to be given to these issues by pharmacists and pharmacy professional organizations. Unless pharmacy as a profession takes strong positions in support of a pharmacist's ability to make decisions about pharmacotherapy and addresses many of the pharmacy-related problems of generic substitution, policies that negatively impact pharmacy will be established.

The Economic Consequences of Generic Substitution for Antiepileptic Drugs in a Public Payer Setting: The Case of Lamotrigine

2007 ◽  
Vol 10 (4) ◽  
pp. 216-225 ◽  
Author(s):  
Mei Sheng Duh ◽  
Frederick Andermann ◽  
Pierre Emmanuel Paradis ◽  
Jennifer Weiner ◽  
Ranjani Manjunath ◽  
...  
Keyword(s):  
Antiepileptic Drugs ◽  
Generic Substitution ◽  
Economic Consequences ◽  
Public Payer

The Controversy over Generic Antiepileptic Drugs

2010 ◽  
Vol 15 (2) ◽  
pp. 81-93 ◽  
Author(s):  
Susan J. Shaw ◽  
Adam L. Hartman
Keyword(s):  
Antiepileptic Drugs ◽  
Generic Substitution ◽  
Patent Protection ◽  
Cost Savings ◽  
Pharmacokinetic Profile ◽  
Test Procedures ◽  
Rigorous Study ◽  
Clinically Significant ◽  
Few Data ◽  
Patients With Epilepsy

ABSTRACT As patent protection ends for the next generation of antiepileptic drugs (AEDs), a complex debate continues over generic substitution of AEDs. On one hand, generic drug formulations provide cost savings for patients and society. On the other hand, patients with epilepsy and physicians are wary about the adequacy and efficacy of the Food and Drug Administration's (FDA) standards for generics. This article reviews current and proposed bioequivalence test procedures, summarizes new generic AED formulations and their costs, and discusses potential pitfalls in the current standards. These shortcomings include certain pharmacokinetic factors and clinical pharmacologic factors that may affect bioequivalence of generic AEDs, and statistical limitations of the standards. While the drug concentration differences between the brand name drug and each generic formulation are unlikely to be substantial, the differences with generic-to-generic switches will be greater and potentially clinically significant. Conversely, owing to their more favorable pharmacokinetic profile, newer AEDs may be less prone to problems with generic substitution than older ones. Unfortunately, very few data are available to guide decisions regarding what is best for an individual patient. Based on new prediction methods, generic substitution should be safe for many patients but identifying them ultimately requires more rigorous study.

scholarly journals Are there potential problems with generic substitution of antiepileptic drugs?

Seizure ◽  
2006 ◽  
Vol 15 (3) ◽  
pp. 165-176 ◽  
Author(s):  
P. Crawford ◽  
M. Feely ◽  
A. Guberman ◽  
G. Kramer
Keyword(s):  
Antiepileptic Drugs ◽  
Generic Substitution ◽  
Potential Problems

scholarly journals Brand name to generic substitution of antiepileptic drugs does not lead to seizure-related hospitalization: a population-based case-crossover study

2015 ◽  
Vol 24 (11) ◽  
pp. 1161-1169 ◽  
Author(s):  
Elisabeth Polard ◽  
Emmanuel Nowak ◽  
André Happe ◽  
Arnaud Biraben ◽  
Emmanuel Oger ◽  
...  
Keyword(s):  
Crossover Study ◽  
Antiepileptic Drugs ◽  
Generic Substitution ◽  
Population Based ◽  
Brand Name ◽  
Case Crossover
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