Abstract
Introduction: In 2002 and 2003, Ortho Biotech Products, L.P. issued “Dear Health Professional” letters describing two distinct episodes with distribution of counterfeit epoetin (ProcritÒ). The first episode in 2002 occurred when counterfeit labels marked as “40,000 Unit” vials were switched onto 2,000 Unit Procrit vials (5% potency). An estimated 97,000 vials of this product were not recovered, as many as 25,000 patients may have been exposed. A second episode occurred in 2003 when bacteria-contaminated tap water was added to vials that were labeled as containing “40,000 Units” of Procrit®. The “Dear Doctor” letters describe the subtle labeling and other product packaging features that distinguish the products from authentic. In addition, specific lot numbers are identified. We reviewed all MedWatch reports from the United States’ Food and Drug Administration (FDA) for confirmed or possible cases of counterfeit epoetin.
Methods: For the years 1998 to 2004, the FDA’s adverse event reporting system (AERS) was searched, using key words: “suspected product tampering,” “decreased drug effect” and related terms, and all epoetin product names. We summarized the demographic variables for the cases and identified the lot numbers reported within the cases.
Results: Seven cases of “medication tampering” were identified in the FDA’s Adverse Event Reporting System (AERS) database - all 7 included Procrit® lot numbers identified in the “Dear Health Professional” Warning Letters from OrthoBiotech. The cases had been reported to the FDA by pharmacists (n=5), a consumer (n=1), and a nurse (n=1). In six of these case reports, among cancer patients, death also listed on the report, although counterfeit product was not listed as the proximate cause of death. There were no case reports identified by the diagnostic term of “pharmaceutical product counterfeit”, which was added to the FDA’s AERS in 2004. We identified an additional 643 cases of MedWatch cases that were coded with the diagnostic labels of “drug ineffective”, “therapeutic response decreased”, “drug effect decreased”, “condition aggravated”, and similar terms. The mean age equal to 59.7± 17.7 years, range 5–95 years. There were 269 females (42%) and 358 males (55%), gender not reported for 3%. All epoietin products were included. Finally, one case was found with a reported lot number corresponding to one listed in the warning letters. Death occurred in this 89 year-old patient.
Conclusion: Health professionals should be alert for potential counterfeit drugs whenever drug effects are less than expected and the pharmaceutical is costly. Whenever suspected, the occurrences should be reported to the FDA and the manufacturer as possible “pharmaceutical product counterfeit.” The use of radio frequency identification (RFID), planned to be implemented in 2007 may help prevent the domestic distribution of counterfeit drugs, but increases in direct importation of drugs from international sources will potentially increase the likelihood of distribution of counterfeit drugs domestically.
Use of case reports and the Adverse Event Reporting System in systematic reviews: overcoming barriers to assess the link between Crohn’s disease medications and hepatosplenic T-cell lymphoma
