Drug Intelligence Brief

OXYCONTIN: PHARMACEUTICAL DIVERSION
MARCH 2002

OVERVIEW

Abuse and diversion of the prescription pain reliever OxyContin are serious problems in certain areas of the United States, particularly in the East. In 1996, OxyContin was introduced as a longer lasting dosage of oxycodone, which is prescribed for the treatment of moderate to severe pain. Since 1996, Drug Abuse Warning Network (DAWN) data indicate an increasing number of emergency department mentions and deaths associated with oxycodone. The growing abuse of OxyContin, commonly known as Oxy’s, OC’s, Killers, Poor Man’s Heroin, and Hillbilly Heroin, is leading to an increase in burglaries, thefts, and robberies of residences and pharmacies.

Law enforcement officials have been monitoring oxycodone products for abuse and diversion over the last 30 years. Currently, these officials are taking action to control the illicit distribution of OxyContin nationwide. The Drug Enforcement Administration (DEA), Food and Drug Administration (FDA), U.S. Attorneys, and state and local authorities recognize the problem and are working to limit diversion and abuse of this potentially dangerous drug.

BACKGROUND

OxyContin is a tradename for the narcotic oxycodone hydrochloride (HCl), an opiate agonist. Oxycodone, a semisynthetic opioid derived from the opioid alkaloid thebaine, is similar to codeine, methadone, and morphine in producing opiate-like effects. Oxycodone is a Schedule II drug under the Controlled Substances Act because of its high propensity to cause dependence and abuse.

Oxycodone is the active ingredient in a number of other commonly prescribed pain relief medications such as Percocet, Percodan, and Tylox. These medications contain oxycodone in smaller doses and are combined with other active ingredients like aspirin or acetaminophen. OxyContin contains oxycodone in various dosage strengths as the only active ingredient. These formulations are designed for a controlled release of the drug to minimize the total number of tablets a patient must take for around-the-clock pain relief. OxyContin’s intended application is the relief of moderate to severe pain of long duration, such as pain caused by rheumatoid arthritis and cancer.

OxyContin, marketed in 1996 by Purdue Pharma L.P., was the first product capable of giving 12 hours of pain relief, making it the longest lasting oxycodone product on the market. OxyContin was initially available in 10-, 20-, and 40-milligram (mg) strengths. In 1997, an 80-mg tablet was introduced and later followed by a 160-mg tablet in 2000.¹ Purdue Pharma L.P. also produces OxyFast, an immediate release liquid formulation containing 20-mg of oxycodone. Other pain medications such as Percocet, Percodan, and Percodan-Demi, which contain 5, 4.5, and 2.25 mg of oxycodone respectively, only provide short periods of pain relief (4 to 6 hours) and have to be taken at repeated intervals.

Beginning in 1996, the first full year it was marketed, the number of OxyContin prescriptions rose to approximately 5.8 million prescriptions in 2000. This makes OxyContin the number-one prescribed Schedule II narcotic in the United States. Prescriptions dispensed for all other common opiod analgesics such as codeine, hydrocodone, morphine, and hydromorphone have risen 23 percent during this same period.

EFFECTS

OxyContin is prescribed for the management of moderate to severe pain. Normal side effects include nausea, drowsiness, constipation, and, to a lesser extent, dizziness, headache, vomiting, and sweating. An acute overdose of oxycodone may cause drowsiness, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, bradycardia (slow heartbeat), hypotension, respiratory depression, coma, and death.

ABUSE

Geographic Areas of Abuse

Abuse of OxyContin in rural Maine, Kentucky, Virginia, and West Virginia brought national attention to this problem. Law enforcement personnel, pharmacists, and drug abuse treatment centers report the abuse of OxyContin primarily in the eastern portion of the United States; however, the problem is spreading throughout the United States. The areas most currently affected by OxyContin abuse are eastern Kentucky; New Orleans, Louisiana; southern Maine; Philadelphia and southwestern Pennsylvania; southwestern Virginia; Cincinnati, Ohio; and Phoenix, Arizona.

At the request of the DEA, the American Methadone Treatment Association asked its members and all state methadone authorities to provide any available information regarding the number of patients seeking treatment for OxyContin abuse, as compared to those admitted for abuse of other licit and illicit drugs for the first half of 2001.

• Kentucky – Representatives from the Cumberland River Comprehensive Care reported that 120 of its 295 admissions (40 percent) were related to OxyContin. The Mountain Comprehensive Care Center reported 204 of its 237 emergency room admissions (86 percent) were also related to OxyContin. In Frankfort County, 453 of 608 admissions (74.5 percent) were attributed to the abuse of OxyContin.
  
  
• Louisiana – The Center for Behavioral Health in Louisiana reported that 40 percent of new treatment admissions throughout the state were for the abuse of OxyContin.
  
  
• Maine – The Discovery House Clinic in Winslow reported that 37 of its 75 new drug treatment admissions (49 percent) were OxyContin related. The Discovery House Clinic in South Portland reported that 45 of its 150 new drug treatment admissions (30 percent) were also OxyContin related.
  
  
• Pennsylvania – Two narcotic treatment programs in southwestern Pennsylvania reported that 90 percent of all new admissions were OxyContin abusers.
  
  
• South Carolina – The Center for Behavioral Health in South Carolina reported that 30 percent of new treatment admissions throughout the state resulted from OxyContin abuse.
  
  
• Virginia – One narcotic treatment program in southwestern Virginia reported that 80 to 85 percent of its patient admissions were the result of OxyContin abuse.

According to the DEA Office of Diversion Control, as of November 1, 2001, medical examiners in 31 states have reported 1,096 overdose deaths involving oxycodone. Medical examiner reporting verified that 117 of these deaths were OxyContin related.

ILLICIT USE

OxyContin is designed to be administered orally in tablet form; however, many abusers chew the tablets or crush them and snort the powder to defeat the intended time-release action. However, most deaths appear to be the result of oral ingestion of the intact tablet. Injection also is possible, but it requires a preparation regimen similar to that of heroin. Such a regimen requires the removal of the tablet coating by either sucking on it or scraping it with the teeth or a razor blade, followed by melting the remainder on a spoon, adding water, and then injecting the solution. Snorting or injecting hastens the body’s absorption of OxyContin.

Individuals abuse oxycodone to gain a euphoric high and to avoid the withdrawal symptoms associated with heroin. Because OxyContin contains large doses of oxycodone and produces opiate-like effects, it acts as a reasonable substitute for heroin; however, individuals do not necessarily need to be heroin addicts to become oxycodone abusers.

DAWN reports an increase in the number of oxycodone-related deaths and emergency room visits since 1996. The number of emergency room episodes more than tripled from 1996 to 2000, with approximately 10,825 episodes in 2000 compared to 3,190 in 1996.

From 1996 to 1999, the number of drug abuse deaths reported to DAWN that involved oxycodone more than quadrupled, with 268 deaths in 1999 compared to 51 in 1996.

DIVERSION AND DISTRIBUTION

Since pharmaceuticals containing oxycodone are controlled substances requiring a prescription, a variety of illegal techniques are used to obtain the drug. Pharmacy diversion, dishonest physicians, “doctor shopping,” fraudulent prescriptions, and robbery all contribute to the presence of diverted pharmaceuticals on the illicit market.

Physicians and Pharmacists – The Major Sources

Illegal acts by physicians and pharmacists are the primary sources of diverted pharmaceuticals available on the illicit market. In many cases, they create fraudulent prescriptions to obtain the drug for personal use or to provide associates with a supply of the drug for distribution purposes. To date, many physicians, pharmacists, and pharmacy technicians who have been illegally prescribing or diverting the narcotic OxyContin have been identified or arrested throughout the United States.

• Illinois – A physician in Herrin was arrested in February 2001 for obtaining OxyContin via fraudulent prescriptions. The physician would write a 30-tablet OxyContin prescription for a patient and subsequently meet at the individual’s residence. The physician would then show the individual how to administer the drug for the first time. During the visit, the doctor would mix a solution of two crushed tablets, inject the patient with the mixture, and leave the remaining tablets with the individual. The physician obtained OxyContin by picking up prescriptions under false names.
  
  
• Nevada – In February 2000, a registered pharmacist in Nevada was arrested after attempting to order Schedule II narcotics from various pharmacies and drug distributors. The pharmacist admitted to using forged prescriptions to illegally obtain approximately 18,000 dosage units of Schedule II narcotics, including OxyContin, from pharmacies in the Las Vegas area.

Doctor Shopping

One of the most popular ways to obtain prescription narcotics is through “doctor shopping.” Individuals with real or fabricated ailments visit numerous doctors in an attempt to obtain prescription narcotics like OxyContin, Percocet, and Percodan. In many cases, certain physicians have earned reputations among abusers for easily dispensing prescriptions. An individual may obtain many prescriptions in a short period of time and get them filled at various pharmacies for personal use and/or distribution.

• Arizona – A DEA diversion investigation in Tucson recently arrested an individual who took advantage of a severe medical condition to obtain legitimate prescriptions for OxyContin and other oxycodone products from physicians in Arizona and California. The prescriptions were filled at different retail pharmacies to bypass dispensing regulations. The tablets, approximately 8,000 to 9,000 over the course of a year, were sent via FedEx to another individual in Maryland for distribution.

Robberies, Burglaries, and Thefts

With the abuse of OxyContin on the rise, law enforcement authorities throughout the United States are reporting an increase in the number of burglaries, thefts, and robberies of pharmacies and residences. According to authorities, homes are being robbed and individuals are being targeted for their supplies of OxyContin. In some pharmacy thefts, only OxyContin is stolen.

From 2000 to mid-2001, the DEA’s Office of Diversion Control reported that the greatest number of OxyContin pharmacy thefts occurred in Pennsylvania followed by Florida, Ohio, Kentucky, and Georgia. Employees of the Purdue Pharma L.P. manufacturing section have also been arrested for stealing large amounts of OxyContin.

• Virginia – According to the Virginia State Police, a pharmacy in Fairfax County reported the theft of approximately $12,000 worth of OxyContin early in 2001.
  
  
• Maine – In Portland, two armed men broke into an apartment and stole the tenant’s legitimate supply of OxyContin. In the town of Millinocket, intruders broke into an elderly couple’s home to steal their supply of OxyContin. The intruders fled without the OxyContin after the couple put up a struggle.
  
  
• Massachusetts – On January 7, 2002, the Cliff House Nursing Home in Winthrop was robbed by 2 armed men who held 6 nurses and 40 patients at gunpoint while demanding all of their OxyContin. The armed men took an undisclosed amount of OxyContin without inflicting any injury.
  
  
• New Jersey – On June 28, 2001, two employees of Purdue Pharma L.P. from the Totowa manufacturing section were arrested after stealing over 2,000 dosage units of 10-, 40-, and 80-mg forms of OxyContin.
  
  
• Pennsylvania – In January 2000, over $1,200 worth of OxyContin was stolen from a pharmacy in Geistown. The individual walked into the pharmacy, gestured as if he had a gun, and forced the pharmacist to hand over six bottles of OxyContin before fleeing.

Illicit Internet Distribution

Internet websites are potential sources for the diversion of prescription narcotics and other pharmaceutically controlled substances. Websites designed to facilitate the distribution of illicit drugs and diverted pharmaceuticals, including OxyContin, are becoming increasingly popular with illicit drug dealers. These sites allow dealers or individual users to place orders for drugs and pharmaceuticals, and sometimes use encryption software to thwart law enforcement investigations.

Other Illicit Distribution

Illicit OxyContin distribution is not limited to localized distributors as it also includes polydrug trafficking organizations. In the northeastern United States, a gang operating in southern Maine and New Hampshire obtained controlled substances, primarily OxyContin, using forged, stolen, and altered prescriptions. The drugs were illegally obtained from local pharmacies using cash and insurance cards. Gang members redistributed the drugs throughout areas in the Northeast.

OxyContin Prescriptions Per Capita - Highest and Lowest States for 2000

Legitimate Distribution

In 2000, states with the greatest number of OxyContin prescriptions dispensed per capita were predominantly in the eastern United States. Alaska, which ranked second, was the only state outside the eastern portion of the country with a high dispensing rate.

Foreign Distribution and Diversion

Purdue Pharma L.P. exports OxyContin to wholesale distributors in Mexico. Since 1998, the number of dosage units sent from Purdue Pharma L.P. laboratories in Totowa, New Jersey, to Mexico has dramatically increased. During 2000, approximately 89,000 grams of OxyContin were exported to Mexico compared to 26,500 grams in 1999 and 5,000 grams in 1998. The potential for OxyContin shipped to Mexico to be diverted to illicit markets in the United States, prompted Purdue Pharma L.P. to restrict shipments of certain dosage strengths, and change the indicium on tablets destined for the Mexican market. Now tablets have an “EX” stamped on one side instead of the traditional “OC.” The indicium was changed to help identify tablets seized in the United States that are diverted from Mexico. In December 2001, Purdue Pharma L.P. suspended all shipments of OxyContin to Mexico indefinitely after a large amount was stolen from a Mexican wholesaler.

Purdue Pharma L.P. laboratories in Totowa also shipped OxyContin to Canada with exports reaching approximately 238,000 grams in 2000 compared to 90,000 grams in 1999. In early 2001, Purdue Pharma L.P. stopped exporting OxyContin to Canada from the Totowa facility. Canada now imports OxyContin from a manufacturer located in England. U.S. and Canadian customs officials at border crossings between Maine and New Brunswick report that increasing numbers of Americans are using prescriptions to obtain legitimately large amounts of pharmaceuticals in Canada, especially OxyContin. The drug is also obtained through illicit dealers in Canada who acquire it by doctor shopping or pharmacy theft. Purdue Pharma L.P. has also changed the indicium on tablets distributed in Canada to “CDN.”

INTELLIGENCE ALERT

On December 9, 2001, nine armed individuals wearing masks stole over 30,000 bottles of OxyContin from a pharmaceutical distributor in Mexico City. Each bottle contained 30 tablets of the 20-mg dose. The tablets are round, pink, and have the number 20 on one side and the letters EX on the other. Law enforcement authorities are requested to report seizures matching the above description, including seizures of tablets marked with CDN, to the DEA International Drug Unit at (202) 307-3668.

PRICES

The profit margin associated with the illicit sale of OxyContin is enormous. Legitimate prices for OxyContin generally range from $.09 to $.13 per milligram compared to illicit prices of up to $1 per milligram. For example, an 80-mg tablet that costs approximately $7 to $8 in a pharmacy can sell for between $50 and $80 illicitly. Therefore, a 100-tablet bottle of 80-mg strength OxyContin purchased legally for approximately $750 can sell for $5,000 to $8,000 illicitly. Law enforcement reporting indicates that the most commonly diverted dosages of OxyContin are the 40-mg and 80-mg varieties.

ENFORCEMENT ACTIONS

Many states have taken action against the illegal trafficking and distribution of OxyContin and other related substances. Kentucky, Ohio, Pennsylvania, and Virginia have launched major enforcement actions aimed at stopping the abuse and diversion of OxyContin.

• Kentucky – In February 2001, state and federal authorities concluded a 9-month investigation, Operation OXYFEST 2001, by arresting approximately 200 individuals involved with abuse and/or distribution of OxyContin in the Lexington area. According to the U.S. Attorney, the raids were the largest ever made in Kentucky.
  
  
• Ohio – During 2000, the Cincinnati Police Department’s Pharmaceutical Diversion Squad arrested approximately 30 individuals for illegal possession or trafficking of OxyContin.
  
  
• Pennsylvania – In September 2000, approximately 30 people were charged with selling thousands of dollars worth of OxyContin in Cambria County.
  
  
• Virginia – Since 1999, the Tazewell County prosecutor has charged more than 150 people with OxyContin-related felonies, including burglaries, thefts, and robbery.

DIVERSION PREVENTION EFFORTS

DEA Efforts

In order to combat the serious and growing problems stemming from the diversion and abuse of OxyContin, the DEA has developed an action plan with four major elements.

• Enforcement and Intelligence Tools: Coordinated operations have been initiated in field offices to target individuals and organizations involved in the diversion, illegal sale, and abuse of OxyContin. The DEA is using all available enforcement tools to disrupt these illegal operations, including interagency efforts on the federal, state, and local levels, which extend to both domestic and international arenas.
  
  
• Regulatory and Administrative Powers: The DEA is using the full range of its regulatory and administrative powers, and is pursing action as necessary to make it more difficult for abusers to obtain OxyContin. These changes are not intended to affect the availability of OxyContin for legitimate medical use.
  
  
• Industry Cooperation: The DEA is increasing its cooperative efforts with the pharmaceutical industry in order to stem the abuse and diversion of OxyContin. The agency stresses the importance of voluntary cooperation from industry in adhering to existing regulations.
  
  
• Awareness/Education/Outreach Initiatives: All parties who have studied the situation agree that a key component to solving the problem is an aggressive, national outreach effort to educate the public, children in schools, the healthcare industry, and state and local governments on the dangers related to OxyContin abuse.

FDA Efforts

As a result of a FDA initiative, Purdue Pharma L.P. has strengthened the warnings and precautions on OxyContin labels. The new labeling is primarily intended to increase the prescribing physician’s focus on the potential for abuse, misuse, and diversion of the drug. A “black box warning,” the strongest admonition an FDA-approved drug can carry, is now placed on all OxyContin packaging.

OUTLOOK

OxyContin abuse and diversion will continue to spread throughout the United States. The popularity of OxyContin and oxycodone-related pharmaceuticals, coupled with large profit margins from the illicit market, increases the probability of future abuse and crimes associated with the drug. OxyContin abuse and diversion will continue to pose a significant problem for law enforcement authorities throughout the United States. The DEA, the FDA, U.S. Attorneys, and state and local authorities recognize the problem and are working together to prevent the future diversion and abuse of OxyContin.

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