- CONDITION CENTERS
Coping with the issue of discontinued medications is perplexing. Even the word "discontinued" has different meanings based upon the context within which it is used. Clinically, discontinuing a medication usually means a change in medication therapy. From a logistics point of view, it could mean that the product is no longer commercially available. Each situation has ramifications that impact patients and pharmacy practice. This article addresses the issue of medications discontinued by their commercial source.
Many in the health care industry have an interest in discontinued medications. Health care practitioners are interested because the availability of medications affects decisions concerning patient care. Manufacturers and distributors are interested because of the impact upon their business. Government agencies are interested because of regulatory, economic, and public health issues. Insurance and pharmacy benefit providers are interested primarily because of the formulary issues involved.
The number of discontinued items in recent history in the United States alone is considerable. Tracking and identifying discontinued medications is challenging, expensive, and time-consuming. Compounding pharmacists in particular need to have a fundamental understanding of the enigma of discontinued medications and sources of information concerning them.
The reasons for discontinuing medications are complex and varied. Probably the most important reason involves safety and toxicity issues. Most of the other reasons are economic, concerning patent expirations, bankruptcies, reorganizations, raw material availability, obsolescence, contract changes, mergers, acquisitions, and marketing agreements. Often when a manufacturer or distributor discontinues a product, the tendency is to believe that it is no longer commercially available, when in fact the medication may still be marketed by others. An interesting observation is that pharmaceutical manufacturers appear to spend fortunes advertising product introductions, but virtually no money announcing discontinuations.
To help identify the scope of the problem, note that between October 2004 and March 2005, the FDA's Orange Book listed 143 medications as having been discontinued. Complicating use of the Orange Book is that entries are linked to the original application which must also be taken into consideration. Examples of medications listed as having been discontinued within the above time period include benzyl penicilloyl-polylysine (Pre-pen); cefaclor (Ceclor); conjugated estrogens, synthetic b (Enjuvia); somatrem (Protropin); clotrimazole cream, topical (Lotrimin and Mycelex); norethindrone/ethinyl estradiol tablet, oral-28 (Ortho-Novum 7/14-28); fomivirsen sodium (Vitravene Preservative Free); furosemide injectable (Lasix); kanamycin sulfate (Kantrex); phendimetrazine tartrate (Cam-metrazine); trichlormethiazide (Naqua); acetic acid glacial solution/drops, otic (VoSol); estradiol film, extended release, transdermal (Esclim); and many other branded and generic medications.
The medications listed above are simply examples, may include only specific strengths, and do not imply that their entire product lines have been discontinued. Entire product lines are often discontinued, however, and sold to another company. For detailed information, there are several Web sites where information can be found. The FDA Orange Book link is found at www.fda.gov/cder. The American Society of Health-System Pharmacists shortages site is also helpful (www.ashp.com/shortage). One of the more comprehensive databases can be found at the Compounding Today Web site (compoundingtoday.com). This site is available by subscription and contains a wealth of practice resources, including information on many discontinued medications.
Dr. Vance is a writer for the International Journal of Pharmaceutical Compounding and content editor of compoundingtoday.com.