When OxyContin was introduced by Purdue Pharma in 1995, doctors welcomed it enthusiastically. When used properly, OxyContin releases timed doses of the synthetic opiate oxycodone. This time-release mechanism meant that OxyContin, unlike earlier narcotic pain relievers, could treat serious pain for up to 12 hours without serious side effects. But addicts soon learned that by crushing the pills and then snorting or injecting the drug, they could circumvent the pill's time-release safeguard to get a powerful high. Although a handful of doctors have been prosecuted in the last few years in connection with OxyContin overdoses, according to Professor Ann Alpers: "Detailed examination of these cases illustrates that fear of criminal liability or investigation should not deter physicians or nurses from aggressively using opioid analgesics to manage terminal pain, provided that pain has been carefully assessed and treated and communication with families and involved professional caregivers is thorough."

"Although heroin and OxyContin have a similar unhappy effect on the lives of people addicted to them, there is a critical and simple difference between the two: heroin is illegal; OxyContin, when used as directed, is legal. More than that: the pill is government-approved.… This fact has meant a major conceptual shift for law-enforcement officials, who are used to combating narcotics produced by international drug lords, not international corporations. Terry Woodworth, the deputy director of the D.E.A.'s office of diversion control, says the spread of OxyContin has posed a challenge to the D.E.A.'s traditional methods: "Instead of using the normal law-enforcement techniques -- like going to the source and attempting to eradicate or destroy the criminal organization producing the drug and immobilize its distribution networks and seize all its assets -- you have a very different situation in a legitimate industry, in that your manufacture and distribution is legal."

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The Double Life of OxyContin:
Miracle Painkiller AND Illicit Street Drug
What Are States Doing?

BACKGROUND

When reports first surfaced of overdoses in Kentucky, Virginia and West Virginia, some officials believed the abuse of the powerful prescription painkiller OxyContin was limited to small areas of the Appalachian mountains. Now, law enforcement agencies, state legislatures and health departments—as well as the drug's manufacturer—are taking steps to prevent the abuse that has been spreading in urban and rural communities across the nation.

Several deaths have resulted specifically from the abuse of OxyContin in Kentucky, Ohio, Virginia and West Virginia, according to the U.S. Department of Justice's National Drug Intelligence Center. And because drug abuse knows no boundaries, officials as far away as Utah appear braced for the potential since one death in that state has already been attributed to the drug.

OxyContin Tablets, the trade name product for an opioid analgesic patented by Purdue Pharma L.P. in 1996, is formulated from the generic narcotic oxycodone hydrochloride. This extemely effective pain management tool allows cancer patients and the terminally ill relief from chronic and intractable pain unmatched by other drugs. Unlike Percocet or other oxycodone products that may require repeat dosages every four to six hours, OxyContin has time-release properties that allow patients up to 12 hours of relief.

Close to 50 million people in the United States are partly or totally disabled by pain, according to the federal Joint Commission on Accreditation of Healthcare Organizations. Those who are prescribed OxyContin are often able to return to normal life functioning with few or no side effects. Unfortunately, it is the very potency and effectiveness of this medication that has attracted illicit drug users to the pills resulting in a range of reported health complications including addiction, miscarriage for pregnant women undergoing withdrawal and death.

Prescription drug abuse and addiction is a growing problem—an estimated 9 million people in the United States reported using sedatives, stimulants, tranquilizers or opiates for non-medical reasons in 1999, according to the National Institute on Drug Abuse. Illegal drug users who obtain OxyContin through theft, fraud, armed robbery or other criminal acts, crush the pill into a powder and then snort it or dissolve it in a liquid and inject the solution into the bloodstream. The effect is said to be immediate and intense and almost as addictive as heroin. One 80 mg tablet can fetch up to $80 on the street.

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LEGISLATION

State officials are launching numerous efforts to curb illegal use of OxyContin. The following chart summarizes enacted legislation from the 2001 legislative session and proposed (including carryover) and enacted legislation from the 2002 session that specifically addresses OxyContin abuse.

State/Bill No.	Author	Date Introduced	Latest Status	Requirements
California SB 1695	Escutia	4/1/02	In Senate Committee on Appropriations: To Suspense File 5/6/02	Declares that according to the Director of the USDEA, overdose deaths from oxycontin totaled at least 117 over the last two years and that in another 179 deaths oxycontin was the likely cause of death. Requires the state emergency medical services authority to adopt regulations that would provide training for treatment of people who have suffered drug overdoses. Requires agency to submit reports on deaths associated with drug overdoses.
Kentucky H 360 (2001) BR 316, HB 26 (2002)	Coleman	6/28/01	Enacted 4/9/02	Amends the state electronic system for monitoring schedules II, III, IV controlled substances. Requests state to apply for federal funds to pilot a real-time electronic system. Declares emergency.
Louisiana SCR 58	Thomas	4/9/01	Adopted 6/4/01	Directs the Department of Health and Hospitals to study the use, abuse, and other problems related to OxyContin and to report to the Senate and House committees on health and welfare on the risks and dangers associated with using this drug in order to protect the health and safety of the citizens of Louisiana.
Maine H 1270	Povich	3/21/01	Enacted 6/15/01	Includes language that addresses penalties for the trafficking and furnishing of illicit prescription pills. Oxycodone, and several other drugs, are singled out for separate treatment based on the aggregate amount of the drug in milligrams due to its availability in very powerful single pill dosage formulations. The law states the specific numbers of pills resulting in the presumption and charge of trafficking and furnishing. The law also prevents the use of altered, forged or counterfeit prescriptions by having the Department of Safety adopt major substantive rules establishing security requirements for written prescriptions for narcotics.
Pennsylvania S 1104	Kasunic	10/9/01	To Senate Committee on Judiciary 10/9/01	Amends the controlled substance act by changing the definition of OxyContin from a Schedule II to a Schedule I drug.
Pennsylvania H 2290	Perzel	1/22/02	To Judiciary 1/23/02	Enhances sentencing offenses involving OxyContin.
Tennessee H 3184 S 3141	Maddox Herron	1/31/02	Enacted 4/24/02 Public Acts, 2002 Chap. No. 657	States that on or before January 15, 2003, the director of the Tennessee bureau of investigation, the board of medical examiners and the board of pharmacy shall report on abuse of the prescription drug, Oxycontin, to the house health and human resources committee and the senate general welfare, health and human resources committee. The reports shall include specific information on the extent of the abuse of Oxycontin in rural areas. The reports shall also make recommendations for any needed legislation to address abuse of Oxycontin.
Virginia HJR 660	Tata	1/10/01	Adopted 2/24/01	Establishes a joint subcommittee to investigate the improper prescription and illegal use and diversion of Ritalin and OxyContin.
West Virginia SB 617	Chafin	2/18/02	To Senate Judiciary Committee	Adds oxycodone to Schedule I of the uniformed controlled substances act.

 

OTHER REGULATORY ACTIVITY

Additional information follows about regulatory changes or other methods states have employed to curtail the abuse and initiatives launched by the pharmaceutical manufacturer.

According to congressional testimony on December 11, 2001 by Asa Hutchinson, administrator of the United States Drug Enforcement Agency, 16 states have prescription monitoring programs. These states are: California, Hawaii, Idaho, Illinois, Indiana, Kentucky, Massachusetts, Michigan, Nevada, New Mexico, New York, Oklahoma, Rhode Island, Texas, Utah and Washington.

Michigan enacted a number of laws in the 2002 session to establish an electronic drug monitoring system, to amend scope of practice laws for pharmacists and to strengthen prescribing and dispensing standards for controlled substances. These standards include requiring pharmacists to make "good faith" judgment about dispensing controlled substances. For example, the lack of consistency in the doctor-patient relationship or requests for unusual dosages should alert pharmacists to the potential for abuse. Michigan also passed legislation to create and distribute an informational book on pain and to develop and conduct educational programs for health professionals who dispense controlled substances. The program must include information on processing allegations of wrongdoing and the disciplinary process. And finally, Michigan passed legislation to establish the Pain Management Education and Controlled Substances Antidiversion Fund in the state treasury.

Kentucky enacted legislation requiring health insurance policies to include a mail order drug option for maintenance drugs for state employees. However, the mail order option does not permit the dispensing of a controlled substance classified in Schedule II, which includes OxyContin.

Several other states are considering legislation in the 2002 session relating to prescription drug monitoring programs including Florida, Ohio, Maryland, New Jersey, Pennsylvania, and Virginia. Indiana introduced legislation (S 228) that would require the state establish a drug monitoring program before single source drugs are placed on prior authorization under Medicaid. Information on model state drug statutes is available through the U.S. Department of Justice.

Maine's Department of Professional and Financial Regulation, which oversees medical and pharmaceutical licensing boards, issued guidelines for pharmacists and physicians prescribing OxyContin. From recommending ample questioning of patients to encouraging the use of tamper-resistant prescription pads, officials hope to stem illegal use.

In an attempt to curtail abuse by Medicaid patients, several states—including Florida, Maine, Ohio, South Carolina and West Virginia—require prior authorization for OxyContin, meaning prescriptions must be individually approved by the state before being dispensed. Maine, for example, requires prior authorization for all patients who do not have cancer. For these patients, doctors must show documented use of two alternative long-acting narcotics, before prescribing OxyContin. Also, some patients on high doses may be required to get a single daily dose under supervision of a doctor. Washington's Medical Assistance Administration, the agency that oversees the state's Medicaid program, requires prior authorization on claims submitted for OxyContin when dosing exceeds two tablets per day.

Vermont placed even tougher restrictions on the drug—it has become the first state to stop paying for it. Vermont's Governor Howard Dean announced that, in order to stop the "growing link to crime and addiction," the state will no longer pay for OxyContin for certain recipients of general assistance through the state's social welfare department. While the action will affect current OxyContin users, the governor is also considering halting coverage for state employees.

Purdue Pharma L.P., the firm that makes the drug, recently developed a model for identifying communities most at-risk for prescription drug abuse. Using the model, the company identified 100 counties, mostly on the Eastern seaboard and in Appalachia, to be targeted for special training programs to help doctors and officials spot abuse. In July 2001, Purdue made changes to the physician prescribing information and package insert for OxyContin as part of its efforts to help reduce abuse and diversion of the medication.

Last year the Connecticut-based company held meetings with attorneys general from several states, U.S. attorneys and the U.S. Drug Enforcement Agency to develop action plans. The plans include, among other initiatives:

• Continuing medical education programs to train health care professionals on proper prescription practices.
• Production and distribution of tamper-resistant prescription pads to West Virginia and seven other states.
• Funding and development of prevention and education programs for teens.
• Underwriting of a major study to develop a model prescription monitoring program.

In three years the drug company plans to bring to market a new abuse-proof version of OxyContin. The new formulation of the drug is currently being tested and uses technology that counteracts the narcotic effects of the drug if the pill is crushed. However, if the pill is taken as directed and swallowed, the drug works normally and the narcotic antagonist is not released.

Information provided by NCSL

Information also provided by FDA