FDA approvals of generic drugs: impact on the diversion of opioid analgesics with a potential for abuse.
Generic drugs account for half of all prescription drug purchases in the United States. Although they are bioequivalent to their branded counterparts, they are typically sold at substantial discounts from the branded price. Given this, the purpose of this analysis is to examine the impact of the introduction of generic forms of selected opioids on their diversion to the illicit marketplace. The analgesics in this analysis include oxycodone ER (extended release), and the fentanyl transdermal patch. The data were collected through a post-marketing surveillance initiative supported by the Researched Abuse Diversion and Addiction-Related Surveillance (RADARS) System risk management program, gathered on a quarterly basis from a national sample of police and regulatory agencies. The results indicate that with oxycodone ER and the fentanyl transdermal patch, the diversion of their generic formulations occurs less often than that of the branded products, and that the introduction of the generic formulations did not significantly increase the overall levels of diversion during the period covered by this analysis. Although diversion did not increase in the short-term, the need for longer term monitoring appears warranted.
Inciardi
James A
JA
University of Delaware, Coral Gables, Florida, USA.
Surratt
Hilary L
HL
Stivers
Yamilka
Y
Cicero
Theodore J
TJ
D000279:Administration, Cutaneous; D000701:Analgesics, Opioid / Q000008:administration & dosage / Q000009:adverse effects*; D003692:Delayed-Action Preparations; D017277:Drug Approval; D016568:Drugs, Generic / Q000008:administration & dosage / Q000009:adverse effects*; D005283:Fentanyl / Q000008:administration & dosage / Q000009:adverse effects*; D006801:Humans; D009293:Opioid-Related Disorders / Q000453:epidemiology*; D010098:Oxycodone / Q000008:administration & dosage / Q000009:adverse effects*; D055553:Prescription Drugs / Q000008:administration & dosage / Q000009:adverse effects*; D011358:Product Surveillance, Postmarketing; D013997:Time Factors; D014481:United States / Q000453:epidemiology; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence*
D000701:Analgesics, Opioid; D003692:Delayed-Action Preparations; D016568:Drugs, Generic; D055553:Prescription Drugs; D010098:Oxycodone; D005283:Fentanyl