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NEUROLOGY 2009;73:213-217
© 2009 American Academy of Neurology

Selegiline shortage

Causes and costs of a generic drug shortage

E. R. Dorsey, MD, MBA, J. P. Thompson, MPH, E. J. Dayoub, BA, B. George, BS, L. A. Saubermann, PharmD, BCPS and R. G. Holloway, MD, MPH

From the Department of Neurology (E.R.D., R.G.H.) and Strong Health Pharmacy (L.A.S.), University of Rochester Medical Center; School of Medicine and Biomedical Sciences (J.P.T.), University at Buffalo, NY; Analysis Group, Inc. (E.J.D.), Boston, MA; and College of Arts and Sciences (B.G.), University of Rochester, NY.

Address correspondence and reprint requests to Dr. E. Ray Dorsey, University of Rochester Medical Center, 1351 Mount Hope Ave., Suite 223, Rochester, NY 14620 ray.dorsey{at}ctcc.rochester.edu

Background: In September 2007, shortages of generic selegiline occurred, forcing patients to either switch to more expensive alternatives or forego treatment. We sought to evaluate prescription trends of generic selegiline and to quantify the economic impact of any resulting drug substitution of more expensive alternatives.

Methods: We analyzed proprietary data from IMS Health on monthly prescriptions in the United States for selegiline and potential substitutes from February 2002 through December 2007. Linear regression was used to predict the number of expected prescriptions after August 2007 had a shortage not occurred. The main outcome measures were the changes in prescriptions filled and the economic impact of drug substitution.

Results: Prior to the shortage, total prescriptions filled for generic selegiline decreased 42%, and supply consolidated into one company, Apotex Inc., Toronto, Canada, whose market share increased from 41% to 83%. During the first 4 months of the shortage, Apotex Inc. filled 10,500 fewer prescriptions than projected and other selegiline manufacturers filled 7,400 more than projected for a net shortage of 3,100 prescriptions. The number of branded selegiline capsules filled during this period increased by 1,800 above projections, and 1,300 prescriptions for generic selegiline were not refilled or substituted. The societal cost of substituting generic selegiline with branded capsules was $75,000 over the first 4 months of the shortage.

Conclusions: Generic drug shortages carry economic and health implications. Given ongoing consolidation in the generics drug industry, these shortages may become more common and may require heightened regulatory scrutiny of the generic drug industry.

Abbreviations: MAO-B = monoamine oxidase type B; PD = Parkinson disease.

Supported by the National Center for Research Resources (http://www.ncrr.nih.gov) of the NIH, and NIH Roadmap for Medical Research (http://nihroadmap.nih.gov/clinicalresearch/overview-translational.asp) (KL2 RR024136 to Dr. Dorsey and 1 UL1 RR024160-01 to Dr. Holloway).

Disclosure: Author disclosures and disclaimer are provided at the end of the article.

Received November 6, 2008. Accepted in final form April 8, 2009.






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