Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2010 Sep;88(3):347-53.
doi: 10.1038/clpt.2010.90. Epub 2010 Jul 14.

Refilling and switching of antiepileptic drugs and seizure-related events

Affiliations

Refilling and switching of antiepileptic drugs and seizure-related events

J J Gagne et al. Clin Pharmacol Ther. 2010 Sep.

Abstract

We sought to estimate the risk of seizure-related events associated with refilling prescriptions for antiepileptic drugs (AEDs) and to estimate the effect of switching between brand-name and generic drugs or between two generic versions of the same drug. We conducted a case-crossover study using health-care databases from British Columbia, Canada, among AED users who had an emergency room visit or hospitalization for seizure (index seizure-related event), defined using International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9) codes 345.xx (epilepsy and recurrent seizures) and 780.3x (convulsions), between 1997 and 2005. AED prescription refilling itself was associated with 2.3-fold elevated odds of seizure-related events when the refill occurred within 21 days before the index event (odds ratio (OR) 2.31; 95% confidence interval (CI) 1.56-3.44). The OR was 2.75 (95% CI 0.88-8.64) for refills that involved switching, yielding a refill-adjusted OR for switching of 1.19 (95% CI 0.35-3.99). Refilling the same AED prescription was associated with an elevated risk of seizure-related events whether or not the refill involved switching from a brand-name to a generic product.

PubMed Disclaimer

Figures

Figure 1
Figure 1
Case-crossover design to study the association between seizure-related outcomes and refilling and switching of antiepileptic medications. Note: In primary analyses, the induction period was defined as 1 day (i.e. day t-1) and 21 days were used for the case- (i.e. days t-22 to t-2) and the control-period (i.e. days t-43 to t-23).
Figure 2
Figure 2
Distributions of exposures (refills and switches) in the 8 weeks preceding the index event dates.
Figure 3
Figure 3
Results of sensitivity analyses (odds ratios and 95% confidence intervals) for the association between refilling or switching antiepileptic medications and seizure-related outcomes, along with difference in differences results, varying the case- and control-periods, the induction period, and the grace period.

Comment in

Similar articles

Cited by

References

    1. Guidance for industry: Conduct and analysis of bioavailability and bioequivalence studies: Part A: Oral dosage formulations used for systemic effects. Health Canada; 1997. [Accessed on October 10, 2009]. Available at http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/bio/bi....
    1. Guidance for industry: Bioavailability and bioequivalence studies for orally administered drug products – general considerations. US Food and Drug Administration; 2003. [Accessed on May 20, 2008]. Available at http://www.fda.gov/cder/guidance/5356fnl.htm.
    1. Guideline on the investigation of bioequivalence. European Medicines Agency; 2008. [Accessed on October 10, 2009]. Available at http://www.emea.europa.eu/pdfs/human/qwp/140198enrev1.pdf. - PubMed
    1. Andermann F, Duh MS, Gosselin A, Paradis PE. Compulsory generic switching of antiepileptic drugs: high switchback rates to branded compounds compared with other drug classes. Epilepsia. 2007;48:464–469. - PubMed
    1. Berg MJ. What’s the problem with generic antiepileptic drugs?: A call to action. Neurology. 2007;68:1245–1246. - PubMed

Publication types

MeSH terms