STAMFORD, Conn., Jan. 22 /PRNewswire/ -- The General Accounting Office (GAO) has released a report entitled "PRESCRIPTION DRUGS: OxyContin Abuse and Diversion and Efforts to Address the Problem." This report is the culmination of a two-year study by the GAO to determine how OxyContin(R) (oxycodone HCl controlled-release) Tablets were marketed and promoted, what factors contributed to the abuse and illegal trafficking of the product, and what actions Purdue Pharma and others have taken to address the problem.
The GAO, which was specifically asked to investigate the issue, did not establish a correlation between Purdue Pharma's marketing strategies for OxyContin and its abuse. The GAO stated " ... we could not assess the relationship between the growth in OxyContin prescriptions or increased availability with the drug's abuse and diversion ... " (p.29). The report states that " ... the Appalachian region, which encompasses parts of Kentucky, Tennessee, Virginia, and West Virginia has been severely impacted by prescription drug abuse, particularly pain relievers, including oxycodone, for many years. Three of the four states -- Kentucky, Virginia and West Virginia -- were among the initial states to report OxyContin abuse and diversion. Historically, oxycodone, manufactured under brand names Percocet, Percodan and Tylox, was among the most diverted prescription drugs in Appalachia"(p.31). Since these are all generic drugs, they are not heavily marketed by their manufacturers. The GAO report also states that, according to the Drug Enforcement Administration, " ... OxyContin has not been and is not now considered the most highly abused and diverted prescription drug on a national basis"(p.33).
The GAO's recommendation to the FDA for executive action is "To improve efforts to prevent or identify the abuse and diversion of schedule II controlled substances, ... the Commissioner of Food and Drugs should ensure that FDA's risk management plan guidance encourages pharmaceutical manufacturers that submit new drug applications for these substances to include plans that contain strategy for monitoring the use of these drugs and identifying potential abuse and diversion problems"(p.42).
"We agree with the GAO's recommendation and believe that all schedule II products of this kind should be required to have comprehensive risk management plans," said Howard R. Udell, Executive Vice President and Chief Legal Officer. "We are firmly committed to combating the abuse of our product, and we appreciate the GAO's acknowledgment of our efforts in this regard. We also are committed to ensuring that patients have access to the pain medicines they need to relieve their suffering."
The GAO notes that as the problem began to surface in 2000, the Food and Drug Administration and Purdue collaborated in developing a risk management plan to help detect and prevent abuse and illegal trafficking of OxyContin. "Purdue's risk management plan includes actions such as strengthening the safety warnings on OxyContin's label for professionals and patients, training Purdue's sales force on the revised label, conducting comprehensive education programs for health care professionals, and developing a database for identifying and monitoring abuse and diversion of OxyContin"(p.39). The GAO conclusions recognize the risks of not having programs in place to detect abuse and diversion, or the infrastructure for detecting and preventing abuse and diversion of schedule II controlled substances (p.42). The report states that FDA plans to complete its guidance to the pharmaceutical industry on risk management plans by September 2004. (p.42)
Further information about Purdue's 10 Point Program to combat prescription drug abuse can be found at http://www.purduepharma.com/.
OxyContin(R) Tablets are a controlled-release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe pain when a continuous, around-the-clock analgesic is needed for an extended period of time. OxyContin has been clinically studied in patients suffering from pain caused by cancer and non-malignant conditions, such as osteoarthritis and chronic back pain. OxyContin is a Schedule II opioid analgesic with an abuse liability similar to morphine.
The professional product labeling for OxyContina Tablets contains the following boxed warning:
WARNING:
OxyContin is an opioid agonist and a Schedule II controlled substance with an abuse liability similar to morphine.
Oxycodone can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing OxyContin in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion.
OxyContin Tablets are a controlled-release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe pain when a continuous, around-the-clock analgesic is needed for an extended period of time.
OxyContin Tablets are NOT intended for use as a prn analgesic.
OxyContin 80 mg and 160 mg Tablets ARE FOR USE IN OPIOID-TOLERANT PATIENTS ONLY. These tablet strengths may cause fatal respiratory depression when administered to patients not previously exposed to opioids. OxyContin TABLETS ARE TO BE SWALLOWED WHOLE AND ARE NOT TO BE BROKEN, CHEWED, OR CRUSHED. TAKING BROKEN, CHEWED, OR CRUSHED OxyContin TABLETS LEADS TO RAPID RELEASE AND ABSORPTION OF A POTENTIALLY FATAL DOSE OF OXYCODONE.
Full prescribing information for OxyContin is available at http://www.purduepharma.com/PRESSROOM/PI/OXYCONTIN_PI.PDF.
Purdue Pharma L.P.CONTACT: James Heins of Purdue Pharma L.P., +1-203-588-8069
Web site: http://www.purduepharma.com/