Diversion of Pharmaceutical Drugs
(Diversion of Licit Drugs) "'Drug diversion' is best defined as the diversion of licit drugs for illicit purposes. It involves the diversion of drugs from legal and medically necessary uses towards uses that are illegal and typically not medically authorized or necessary."Source:"Drug Diversion in the Medicaid Program: State Strategies for Reducing Prescription Drug Diversion in Medicaid," Centers for Medicare & Medicaid Services (Baltimore, MD: January 2012), p. 1.
(Nonmedical Users of Prescription Drugs in the US, 2012)
" The percentage of persons aged 12 or older who were current nonmedical users of psychotherapeutic drugs in 2012 (2.6 percent) was similar to the percentage in 2011 (2.4 percent) and all years from 2002 through 2010 (ranging from 2.5 to 2.9 percent) (Figure 2.2). The number of persons aged 12 or older who were current nonmedical users of psychotherapeutic drugs in 2012 (6.8 million) was higher than the number in 2011 (6.1 million), but it was similar to the numbers in 2005 to 2010.
" The number and percentage of persons aged 12 or older who were current nonmedical users of pain relievers in 2012 (4.9 million or 1.9 percent) were similar to those in 2011 (4.5 million or 1.7 percent) and in 2007 to 2010 (ranging from 4.7 million to 5.3 million and from 1.9 to 2.1 percent) (Figure 2.3).
" The number of persons aged 12 or older who were current nonmedical users of the pain reliever OxyContin® declined from 566,000 in 2010 to 358,000 in 2012.
" The number and percentage of persons aged 12 or older who were current nonmedical users of stimulants in 2012 (1.2 million or 0.5 percent) were similar to those in 2011 (970,000 or 0.4 percent), 2010 (1.1 million or 0.4 percent), and 2009 (1.3 million or 0.5 percent)."Source:Substance Abuse and Mental Health Services Administration, Results from the 2012 National Survey on Drug Use and Health: Summary of National Findings, NSDUH Series H-46, HHS Publication No. (SMA) 13-4795. Rockville, MD: Substance Abuse and Mental Health Services Administration, 2013, pp. 14-15.
(Majority of Pain Patients Use Prescription Drugs Properly) "The research findings noted above need to be set against the testimony of people with pain, many of whom derive substantial relief from opioid drugs. This tension perhaps reflects the complex nature of pain as a lived experience, as well as the need for biopsychosocial assessments and treatment strategies that can maximize patients’ comfort and minimize risks to them and society. Regardless, the majority of people with pain use their prescription drugs properly, are not a source of misuse, and should not be stigmatized or denied access because of the misdeeds or carelessness of others."Source:Institute of Medicine, "Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research" (Washington, DC: National Academy of Sciences, 2011), p. 145.
(Prosecutions and Administrative Reviews for Prescribing Opiates)
"We identified a total of 986 cases over the 1998–2006 study time frame in which physicians had been criminally charged and/or administratively reviewed with offenses involving the prescribing of opioid analgesics. 335 were criminal cases (178 state, 157 federal) and 651 were administrative cases (525 state medical board cases, 126 DEA administrative actions regarding CS registrations).
"Numbers and Specialties of Study Physicians
"The 725 individual physicians involved in these cases over the study time period represent 0.1% of the total 691,873 patient-care physicians active in 2003, or one out of 954 physicians.
"As shown in Table 1, General Practice/Family Medicine physicians comprised the largest proportion of physicians involved in the criminal and administrative cases (39.3%). Pain Medicine specialists, both self-identified and board certified, comprised 3.5% of the physicians involved in these cases."Source:Goldenbaum, Donald M.; Christopher, Myra; Gallagher, Rollin M.; Fishman, Scott; Payne, Richard; Joranson, David; Edmondson, Drew; McKee, Judith; Thexton, Arthur, "Physicians Charged with Opioid Analgesic-Prescribing Offenses" Pain Medicine (Glenview, IL: American Academy of Pain Medicine, September 2008) Volume 9, Issue 6, pp. 741.
(Influence of Drug Control Policy on Pain Medicine) "Opioid medications also have a potential for abuse (a discussion of this important issue is in the Evaluation Guide 2012). Consequently, opioids and the healthcare professionals who prescribe, administer, or dispense them are regulated pursuant to federal and state controlled substances policies, as well as under state laws and regulations that govern professional practice.64;65 Such policies are intended to prevent illicit trafficking, drug abuse, and substandard practice related to prescribing and patient care. However, in some states these policies go well beyond the usual framework of controlled substances and professional practice policy, and can negatively affect legitimate healthcare practices and create undue burdens for practitioners and patients,66‐70 resulting in interference with appropriate pain management."Source:Pain & Policy Studies Group, "Achieving Balance in State Pain Policy: A Progress Report Card (CY 2012)" (Madison, WI: University of Wisconsin Carbone Cancer Center, 2013).
(Community Epidemiology Working Group Assessment of Non-Prescription Use of Prescription Analgestic in the US, 2012) "Mixed results were noted for prescription opioids, with increases in indicators for prescription opioids as a key finding reported by representatives in two areas—New York City and San Francisco—based on treatment admissions data (primary treatment admissions for opioids/opiates other than heroin increased in 2012 from 2011 in New York City), numbers of prescriptions (the Prescription Drug Monitoring Programs in both New York City and San Francisco showed increases in numbers of prescriptions in 2012), death data (unintentional opioid analgesic poisoning deaths increased in New York City by 65 percent from 2005 to 2011), and ED visit data (visits involving prescription opioids/other opiates increased in New York City from 2010 to 2011 and in San Francisco from 2004 to 2011). A decline in indicators for prescription opioids/opiates other than heroin was reported as a key finding in three other CEWG areas—Maine, Seattle, and South Florida/Miami-Dade and Broward Counties. Deaths related to prescription opioids/opiates other than heroin declined from 2011 to 2012 in Seattle and both Miami-Dade and Broward Counties in South Florida. Treatment admissions and drug reports among drug items seized and analyzed in NFLIS laboratories declined in 2012 from 2011 in the two South Florida counties. Arrests showed decreases in Maine from 2011 to 2012, and reported use of prescription-type opiates in the last month to 'get high' among high school students decreased significantly from 2010 to 2012 in the Seattle area."Source:"Epidemiologic Trends in Drug Abuse: Proceedings of the Community Epidemiology Work Group, Advance Report, June 2013" (Bethesda, MD: National Institute on Drug Abuse, December 2013), p. 4.
(Sources of Psychotherapeutic Drugs Used Nonmedically in the US, 2012)
" Past year nonmedical users of psychotherapeutic drugs are asked how they obtained the drugs they most recently used nonmedically. Rates averaged across 2011 and 2012 show that more than one half of the nonmedical users of pain relievers, tranquilizers, stimulants, and sedatives aged 12 or older got the prescription drugs they most recently used 'from a friend or relative for free.' About 4 in 5 of these nonmedical users who obtained prescription drugs from a friend or relative for free indicated that their friend or relative had obtained the drugs from one doctor."Source:Substance Abuse and Mental Health Services Administration, Results from the 2012 National Survey on Drug Use and Health: Summary of National Findings, NSDUH Series H-46, HHS Publication No. (SMA) 13-4795. Rockville, MD: Substance Abuse and Mental Health Services Administration, 2013, p. 29.
(Sources of Pain Relievers Used Nonmedically in the US, 2012)
" Among persons aged 12 or older in 2011-2012 who used pain relievers nonmedically in the past year, 54.0 percent got the pain relievers they most recently used from a friend or relative for free (Figure 2.16). Nearly 1 in 5 (19.7 percent) received them through a prescription from one doctor (which was higher than the 17.3 percent in 2009-2010). Another 10.9 percent bought them from a friend or relative. In addition, 4.0 percent of these nonmedical users in 2011-2012 took pain relievers from a friend or relative without asking. An annual average of 4.3 percent got pain relievers from a drug dealer or other stranger; 1.8 percent got pain relievers from more than one doctor; 0.8 percent stole pain relievers from a doctor's office, clinic, hospital, or pharmacy (which was higher than the 0.2 percent in 2009-2010); and 0.2 percent bought the pain relievers on the Internet.
" Among persons aged 12 or older in 2011-2012 who used pain relievers nonmedically in the past year and indicated that they most recently obtained the drugs from a friend or relative for free, 82.2 percent of the friends or relatives obtained the drugs from just one doctor (Figure 2.16). About 1 in 20 of these past year nonmedical users of pain relievers (5.4 percent) reported that the friend or relative got the pain relievers from another friend or relative for free, 4.1 percent reported that the friend or relative bought the pain relievers from a friend or relative, 1.4 percent reported that the friend or relative bought the pain relievers from a drug dealer or other stranger (which was lower than the 2.3 percent in 2009-2010), 1.3 percent reported that the friend or relative took the pain relievers from another friend or relative without asking, and 0.2 percent reported that the friend or relative bought the pain relievers on the Internet."Source:Substance Abuse and Mental Health Services Administration, Results from the 2012 National Survey on Drug Use and Health: Summary of National Findings, NSDUH Series H-46, HHS Publication No. (SMA) 13-4795. Rockville, MD: Substance Abuse and Mental Health Services Administration, 2013, pp. 29-30.
(Estimated Prevalence of Opioid Diversion by "Doctor Shoppers" in the US) "We applied our composite probability distribution to each patient to calculate the probability that the patient was a member of the 'extreme' group. That is, we multiplied the size of each stratum of patients by its posterior probability of population 3 membership to estimate the total number of probable shoppers in the United States. Summing these probabilities, we estimated that of the 19 million patients in the US who purchased opioids in the first 60 days of 2008, 135,000 (0.7%) were members of this extreme population (Table 2).
"Although only a small fraction of active patients, members of this extreme population obtained an estimated 1.9% (4.3 million) of all 223 million opioid prescriptions dispensed during 2008, and 2.8% of all oxycodone prescriptions (Table 3). They purchased an average of 32 opioid prescriptions that year. When we accounted for the quantity of drugs prescribed, their share of the market was even larger: an estimated 4.0% of the total amounts of these drugs dispensed that year, or about 11.1 million grams. This was equivalent to approximately 5.4 million grams of morphine. This would have provided an average of 109 morphine equivalent milligrams per patient in this extreme group for every day in 2008."Source:Douglas C. McDonald and Kenneth E. Carlson, "Estimating the Prevalence of Opioid Diversion by 'Doctor Shoppers' in the United States," PLoS One, 2013; 8(7): e69241. Published online 2013 July 17. doi: 10.1371/journal.pone.0069241.
(Societal Impact of Diversion) "The societal impact of CPD [controlled prescription drugs] diversion and abuse is considerable. Violent and property crime associated with CPD diversion and abuse has increased in all regions of the United States over the past 5 years, according to the National Drug Intelligence Center (NDIC) National Drug Threat Survey (NDTS). However, the association between crime and CPD diversion is reported much less frequently than the association between crime and illicit drugs. Increases in crime rates often result in higher budgetary expenditures for additional law enforcement resources. Moreover, the estimated cost of CPD diversion and abuse to public and private medical insurers is $72.5 billion a year,3 much of which is passed to consumers through higher health insurance premiums. Additionally, the abuse of prescription opioids is burdening the budgets of substance abuse treatment providers, particularly as prescription opioid abuse might be fueling heroin abuse rates in some areas of the United States."Source:National Drug Intelligence Center, Drug Enforcement Administration, "National Prescription Drug Threat Assessment," (Washington DC, April 2009), p. IV.
(Pain Relief and Non-Prescription Use of Prescription Opioids by US High School Seniors) "The lifetime medical use of prescription opioids was reported by approximately 14.0% of those who did not engage in past-year nonmedical use of prescription opioids, 76.1% of nonmedical users of prescription opioids motivated only by pain relief, 71.4% of those motivated by pain relief and other motives, and 46.7% of those who reported non-pain relief motives only (p < 0.001). Among past-year nonmedical users of prescription opioids, approximately 56.5% of those motivated only by pain relief as compared to 23.1% of those who reported pain relief and other motives, and 14.2% of those who reported only non-pain relief motives had initiated medical use of prescription opioids before nonmedical use of prescription opioids. In contrast, approximately 19.6% of those motivated only by pain relief as compared to 48.3% of those who reported pain relief and other motives, and 32.5% of those who reported only non-pain relief motives initiated nonmedical use of prescription opioids before medical use of prescription opioids."Source:Sean Esteban McCabe, Phd, et al., "Motives for Nonmedical Use of Prescription Opioids among High School Seniors in the United States: Self-Treatment and Beyond," Archives of Pediatric and Adolescent Medicine, 2009 August; 163(8): 739-744. doi:10.1001/archpediatrics.2009.120.
(Initiation of Nonmedical Use of Prescription Psychotherapeutics in the US, 2012)
" Nonmedical use of psychotherapeutics includes nonmedical use of any prescription-type pain relievers, tranquilizers, stimulants, or sedatives. Over-the-counter substances are not included. In 2012, there were approximately 2.4 million persons aged 12 or older who used psychotherapeutics nonmedically for the first time within the past year, which averages to about 6,700 initiates per day. The number of new nonmedical users of psychotherapeutics in 2012 was similar to estimates for 2002, 2003, and 2005 through 2011 (ranging from 2.3 million to 2.6 million), but was lower than the 2004 estimate (2.8 million).
" The number of new nonmedical users of pain relievers in 2012 (1.9 million) was similar to the estimates in 2007, 2010, and 2011, but was lower than the numbers in 2002 through 2006 and in 2008 and 2009 (ranging from 2.2 million to 2.5 million). In 2012, the numbers of initiates were 1.4 million for tranquilizers, 676,000 for stimulants, and 166,000 for sedatives.
" In 2012, the average age at first nonmedical use of any psychotherapeutics among recent initiates aged 12 to 49 was 22.9 years. Average ages at first nonmedical use were 22.1 years for stimulants, 22.3 years for pain relievers, 23.6 years for tranquilizers, and 26.2 years for sedatives. All of these 2012 estimates were similar to the corresponding estimates in 2011.
" In 2012, the number of new nonmedical users of OxyContin® aged 12 or older was 372,000, which was similar to the 2011 estimate of 483,000, but was lower than the 2010 estimate (600,000). The average age at first use of OxyContin® among past year initiates aged 12 to 49 was similar in 2011 and 2012 (22.8 and 22.0 years, respectively)."Source:Substance Abuse and Mental Health Services Administration, Results from the 2012 National Survey on Drug Use and Health: Summary of National Findings, NSDUH Series H-46, HHS Publication No. (SMA) 13-4795. Rockville, MD: Substance Abuse and Mental Health Services Administration, 2013, p. 58.
(Nonmedical Prescription Drug Use by Young People in the US, 2012)
" In 2012, the rate of current nonmedical use of psychotherapeutic drugs among young adults aged 18 to 25 was 5.3 percent, which was similar to the rates in 2010 and 2011, but it was lower than the rates in 2003 to 2007 (Figure 2.9). The rate of current nonmedical use of pain relievers among young adults in 2012 (3.8 percent) was similar to the 2011 rate (3.6 percent), but it was lower than the rates between 2003 (4.7 percent) and 2010 (4.4 percent)."Source:Substance Abuse and Mental Health Services Administration, Results from the 2012 National Survey on Drug Use and Health: Summary of National Findings, NSDUH Series H-46, HHS Publication No. (SMA) 13-4795. Rockville, MD: Substance Abuse and Mental Health Services Administration, 2013, p. 20.
(Nonmedical Use of Psychotherapeutic Drugs by Type, 2004) "In 2004, 6.0 million persons were current users of psychotherapeutic drugs taken nonmedically (2.5 percent). These include 4.4 million who used pain relievers, 1.6 million who used tranquilizers, 1.2 million who used stimulants, and 0.3 million who used sedatives. These estimates are all similar to the corresponding estimates for 2003.
"There were significant increases in the lifetime prevalence of use from 2003 to 2004 in several categories of pain relievers among those aged 18 to 25. Specific pain relievers with statistically significant increases in lifetime use were Vicodin®, Lortab®, or Lorcet® (from 15.0 to 16.5 percent); Percocet®, Percodan®, or Tylox® (from 7.8 to 8.7 percent); hydrocodone products (from 16.3 to 17.4 percent); OxyContin® (from 3.6 to 4.3 percent); and oxycodone products (from 8.9 to 10.1 percent)."Source:Substance Abuse and Mental Health Services Administration, Results from the 2004 National Survey on Drug Use and Health: National Findings (Rockville, MD: US Dept. of Health and Human Services, Office of Applied Studies, 2005), p. 1.
(OxyContin Availability) "The large amount of OxyContin available in the marketplace may have increased opportunities for abuse and diversion. Both DEA and Purdue have stated that an increase in a drug's availability in the marketplace may be a factor that attracts interest by those who abuse and divert drugs."Source:General Accounting Office, "Prescription Drugs: Oxycontin Abuse and Diversion and Efforts to Address the Problem," GAO-04-110 (Washington, DC: Government Printing Office, December 2003), p. 30.
(Oxycontin) "There are several factors that may have contributed to the abuse and diversion of OxyContin. OxyContin's formulation as a controlled- release opioid that is twice as potent as morphine may have made it an attractive target for abuse and diversion. In addition, the original label’s safety warning advising patients not to crush the tablets because of the possible rapid release of a potentially toxic amount of oxycodone may have inadvertently alerted abusers to possible methods for misuse. Further, the rapid growth in OxyContin sales increased the drug's availability in the marketplace and may have contributed to opportunities to obtain the drug illicitly. The history of abuse and diversion of prescription drugs in some geographic areas, such as those within the Appalachian region, may have predisposed some states to problems with OxyContin. However, we could not assess the relationship between the growth in OxyContin prescriptions or increased availability with the drug's abuse and diversion because the data on abuse and diversion are not reliable, comprehensive, or timely."Source:General Accounting Office, "Prescription Drugs: Oxycontin Abuse and Diversion and Efforts to Address the Problem," GAO-04-110 (Washington, DC: Government Printing Office, December 2003), p. 29.
(Cost of Controlled Prescription Drug (CPD) Diversion) "Moreover, the estimated cost of CPD diversion and abuse to public and private medical insurers is $72.5 billion a year,3 much of which is passed to consumers through higher health insurance premiums. Additionally, the abuse of prescription opioids is burdening the budgets of substance abuse treatment providers, particularly as prescription opioid abuse might be fueling heroin abuse rates in some areas of the United States."Source:National Drug Intelligence Center, Drug Enforcement Administration, "National Prescription Drug Threat Assessment," (Washington DC, April 2009), p. V.
(Insurance Fraud and Diversion) "Insurance fraud is the main financier and enabler of drug diversion. Even so, few health insurers understand the pivotal role insurance fraud plays in a diversion epidemic that costs insurers up to $72.5 billion a year.
" Swindlers and drug abusers obtain the bulk of their illicit prescription narcotics through fraudulent insurance claims for bogus prescriptions, treating phantom injuries and other illegal deceptions;
" Drug diversion drains health insurers of up to $72.5 billion a year, including up to $24.9 billion annually for private insurers. The losses include insurance schemes, plus the larger hidden costs of treating patients who develop serious medical problems from abusing the addictive narcotics they obtained through the swindles;
" Insurers are potentially vulnerable to enormous liability lawsuits for failing to reasonably prevent fraud schemes that kill and injure people addicted by diversion schemes. Drug manufacturers and pharmacists already face such lawsuits."Source:The Mahon Consulting Group LLC for the Coalition Against Insurance Fraud, "Prescription for Peril: How Insurance Fraud Finances Theft and Abuse of Addictive Prescription Drugs," (Washington, DC: December, 2007), p. 4.
(Prescriptions for OxyContin and Other Opioids) "According to IMS Health data, the annual number of OxyContin prescriptions for noncancer pain increased nearly tenfold, from about 670,000 in 1997 to about 6.2 million in 2002. In contrast, during the same 6 years, the annual number of OxyContin prescriptions for cancer pain increased about fourfold, from about 250,000 in 1997 to just over 1 million in 2002. The noncancer prescriptions therefore increased from about 73 percent of total OxyContin prescriptions to about 85 percent during that period, while the cancer prescriptions decreased from about 27 percent of the total to about 15 percent. IMS Health data indicated that prescriptions for other schedule II opioid drugs, such as Duragesic and morphine products, for noncancer pain also increased during this period. Duragesic prescriptions for noncancer pain were about 46 percent of its total prescriptions in 1997, and increased to about 72 percent of its total in 2002. Morphine products, including, for example, Purdue's MSContin, also experienced an increase in their noncancer prescriptions during the same period. Their noncancer prescriptions were about 42 percent of total prescriptions in 1997, and increased to about 65 percent in 2002."Source:General Accounting Office, "Prescription Drugs: Oxycontin Abuse and Diversion and Efforts to Address the Problem," GAO-04-110 (Washington, DC: Government Printing Office, December 2003), p. 18.
(Theft of Pharmaceuticals) The Journal of Pain and Symptom Management published a research letter by scientists from the Pain & Policy Studies Group at the University of Wisconsin-Madison on drug crime as a source of diverted pharmaceuticals. The researchers examined data maintained by the US Drug Enforcement Administration on thefts and other incidents of loss of controlled substances by DEA registrants including pharmacists, manufacturers, and distributors. The data was complete for the years 2000-2003 for 22 Eastern states representing 53% of the US population. According to the researchers:
"A total of 12,894 theft/loss incidents were reported in these states between 2000 and 2003. Theft/losses were primarily from pharmacies (89.3%), with smaller portions from medical practitioners, manufacturers, distributors, and some addiction treatment programs that reported theft/losses of methadone.
"Over the 4-year period, almost 28 million dosage units of all controlled substances were diverted. The total number of dosage units for the six opioids is as follows: 4,434,731 for oxycodone; 1,026,184 for morphine; 454,503 for methadone; 325,921 for hydromorphone; 132,950 for meperidine; 81,371 for fentanyl."Source:Joranson, David E. MSSW & Aaron M. Gilson, PhD, Pain & Policy Studies Group, University of Wisconsin-Madison, "Drug Crime is a Source of Abuse Pain Medication in the United States," Letters, Journal of Pain & Symptom Management, Vol. 30, No. 4, Oct. 2005, p. 299.
(OxyContin Investigations, Arrests, and Seizures, 1996-2002) "From fiscal year 1996 through fiscal year 2002, DEA initiated 313 investigations involving OxyContin, resulting in 401 arrests. Most of the investigations and arrests occurred after the initiation of the action plan. Since the plan was enacted, DEA initiated 257 investigations and made 302 arrests in fiscal years 2001 and 2002. Among those arrested were several physicians and pharmacists. Fifteen health care professionals either voluntarily surrendered their controlled substance registrations or were immediately suspended from registration by DEA. In addition, DEA reported that $1,077,500 in fines was assessed and $742,678 in cash was seized by law enforcement agencies in OxyContin-related cases in 2001 and 2002."Source:General Accounting Office, "Prescription Drugs: Oxycontin Abuse and Diversion and Efforts to Address the Problem," GAO-04-110 (Washington, DC: Government Printing Office, December 2003), p. 37.
(Illicit Sales of OxyContin, 2001) "According to a 2001 HIDTA [High Intensity Drug Trafficking Area] report, the Appalachian region, which encompasses parts of Kentucky, Tennessee, Virginia, and West Virginia, has been severely affected 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 such as Percocet, Percodan, and Tylox, was among the most diverted prescription drugs in Appalachia. According to the report, OxyContin has become the drug of choice of abusers in several areas within the region. The report indicates that many areas of the Appalachian region are rural and poverty-stricken, and the profit potential resulting from the illicit sale of OxyContin may have contributed to its diversion and abuse. In some parts of Kentucky, a 20-milligram OxyContin tablet, which can be purchased by legitimate patients for about $2, can be sold illicitly for as much as $25. The potential to supplement their incomes can lure legitimate patients into selling some of their OxyContin to street dealers, according to the HIDTA report."Source:General Accounting Office, "Prescription Drugs: Oxycontin Abuse and Diversion and Efforts to Address the Problem," GAO-04-110 (Washington, DC: Government Printing Office, December 2003), pp. 31-32.
(Growth in Overdose Deaths and Treatment Admissions, 2001-2006) "According to the Centers for Disease Control and Prevention (CDC) National Center for Health Statistics, unintentional overdose deaths involving prescription opioids increased 114 percent from 2001 (3,994) to 2005 (8,541), the most recent nationwide data available. Further, the number of treatment admissions for prescription opioids as the primary drug of abuse increased 74 percent from 46,115 in 2002 to 80,131 in 2006, the most recent data available, according to the SAMHSA Treatment Episode Data Set (TEDS)."Source:National Drug Intelligence Center, Drug Enforcement Administration, "National Prescription Drug Threat Assessment," (Washington DC, April 2009), p. III.
(Diversion and Fraud) "According to law enforcement reporting, some individuals and criminal groups divert CPDs [controlled prescription drugs] through doctor-shopping and use insurance fraud to fund their schemes. In fact, Aetna, Inc. reports that nearly half of its 1,065 member fraud cases in 2006 (the latest year for which data are available) involved prescription benefits, and most were related to doctor-shopping, according to the Coalition Against Insurance Fraud (CAIF). CAIF further reports that diversion of CPDs collectively costs insurance companies up to $72.5 billion annually, nearly two-thirds of which is paid by public insurers. Individual insurance plans lose an estimated $9 million to $850 million annually, depending on each plan’s size; much of that cost is passed on to consumers through higher annual premiums."Source:National Drug Intelligence Center, Drug Enforcement Administration, "National Prescription Drug Threat Assessment," (Washington DC, April 2009), p. 20.
(Pharmaceutical Drug Distribution in the US) "Drugs in the United States generally do not travel straight from the line of production to the dispensing pharmacy. Rather, a serpentine maze provides a ripe environment for the infiltration of counterfeit, adulterated, and diverted drugs.15
"The distribution system is primarily tiered among manufacturers, the “Big 3” distributors/drug wholesalers, secondary wholesalers,16 and repackagers. The FDA has identified three primary routes for drug sales in the United States, and each involves drugs passing through multiple hands, demonstrating the vulnerability of the distribution system to counterfeit, adulterated, and diverted products.17 The “Big 3” wholesalers—Cardinal Health,18 McKesson19 and Amerisource Bergen,20 which collectively account for nearly 90% of the primary wholesale arket21—sell drugs into a distribution web containing large governmental agencies, secondary wholesalers, and criminal actors.22 “Repackagers” of drugs further obscure the origin of a particular drug when they break wholesale drugs in bulk containers into smaller units for sale to pharmacies or, conversely, re-aggregate smaller units purchased as overstock from pharmacies into larger bundles for resale to wholesalers.23 Because of the multiple distributors and the repackaging, the true origin of drugs in this net remains obscure.24"Source:Aleong, Stephanie Feldman, "Green Medicine: Using Lessons From Tort Law and Environmental Law to Hold Pharmaceutical Manufacturers and Authorized Distributors Liable for Injuries Caused by Counterfeit Drugs," University of Pittsburgh Law Review (Pittsburgh, PA: Winter 2007) Volume 69, Issue 2, p. 248-250.
(Progress In Achieving Balance In Pain Policy) "Overall, the positive progress in the adoption of balanced state pain policy has continued into the new decade. Such momentum apparently is in response to increasing national and state‐level recognition that improving or removing provisions that can influence professional practice and patient care is a necessary step in improving pain management for patients with cancer, HIV/AIDS, and other diseases or conditions. It is apparent that state professionals or groups have used policy evaluation resources and/or model policies to guide positive policy change efforts.
"This trend even has occurred throughout a period of increase in the abuse and diversion of opioid pain medications.101‐109 It is important to understand that the policy improvement represented in this report does not undermine the basic prohibitions against drug trafficking and diversion established in controlled substances or healthcare regulatory policies; states that improve their grades do not weaken their ability to prevent drug abuse and diversion or to deal with unprofessional conduct. Nevertheless, there must be continued efforts by governments and healthcare professionals to address drug abuse while not interfering with legitimate healthcare practices and patient access to appropriate pain care."Source:Pain & Policy Studies Group, "Achieving Balance in State Pain Policy: A Progress Report Card (CY 2012)" (Madison, WI: University of Wisconsin Carbone Cancer Center, 2013).
Prescription Drug Monitoring Programs
(State Prescription Drug Monitoring Programs, 2012) "Prescription drug monitoring programs (PDMPs) are now authorized in 48 states and only two states (Missouri and New Hampshire) and the District of Columbia lack legislation authorizing a PDMP. States such as Maryland, Georgia, and Arkansas recently passed legislation to establish PDMPs. In addition, states are beginning to share data across state lines. Ohio and Kentucky successfully shared data in a test pilot and many other states are expected to increase their data sharing capabilities over the next several months."Source:Office of National Drug Control Policy, "National Drug Control Strategy," (Washington, DC: Executive Office of the President, April 2012), p. 48.
(PDMPs and Limits on Access to Pain Medication) "In this survey of a random sample of Kentucky Medicaid beneficiaries, nearly 90% of respondents report they are unaffected by the KASPER [Kentucky All Schedule Prescription Electronic Reporting] program. Of the small group affected, Hispanic respondents are more likely to report discussing KASPER with a health care provider. Respondents with non-cancer chronic pain conditions are also more apt to report discussing KASPER with a health care provider as well as difficulty obtaining controlled substance prescriptions due to KASPER when confounding factors are controlled for in multivariate analyses. Respondents living in rural counties report less difficulty obtaining and filling controlled substance prescriptions due to KASPER. This result is not surprising, given that data reported by the KASPER program consistently shows higher usage of controlled substances (per 1,000 patients) in Kentucky’s rural counties compared with urban counties (16)."Source:Amie Goodin, MPP, Karen Blumenschein, PharmD, Patricia Rippetoe Freeman, PhD, and Jeffrey Talbert, PhD, "Consumer/Patient Encounters with Prescription Drug Monitoring Programs: Evidence from a Medicaid Population," Pain Physician 2012; 15:ES169-ES175.
(Effect of Implementation of PDMP) "Our analysis showed that the implementation of a province-wide centralized prescription network was associated with large, immediate and sustained reductions in filled prescriptions for opioid analgesics and benzodiazepines deemed inappropriate by our definition. These findings provide empirical evidence that centralized prescription networks can reduce inappropriate prescribing and dispensing of prescriptions by offering health care professionals real-time access to prescription data. Physicians did not have access to PharmaNet when it was first introduced; consequently, the reductions observed in our study likely reflect the availability of real-time prescription information to front-line pharmacists."Source:Dormuth, Colin R., et al., "Effect of a centralized prescription network on inappropriate prescriptions for opioid analgesics and benzodiazepines," Canadian Medical Association Journal, November 6, 2012, vol. 184, no. 16, DOI:10.1503/cmaj.120465, p. 854.
(Physician Concerns Over PDMPs) "Physicians are concerned that their prescribing decisions and patterns may be questioned and that they could be investigated without sufficient cause. Some physicians contend that patients may suffer because physicians will be reluctant to prescribe appropriate controlled substances to manage a patient's pain or treat their condition. Patients are concerned that their personal information may be used inappropriately by those with authorized access or shared with unauthorized entities. Pharmacists have also expressed concerns."Source:General Accounting Office, "Prescription Drugs: State Monitoring Programs Provide Useful Tool to Reduce Diversion" (Washington, DC: Government Printing Office, May 2002), GAO-PO-634, p. 18.
(PDMPs and Reduction of Diversion) "States with PDMPs have realized benefits in their efforts to reduce drug diversion. These include improving the timeliness of law enforcement and regulatory investigations. For example, Kentucky's state drug control investigators took an average of 156 days to complete the investigation of an alleged doctor shopper prior to the implementation of the state's PDMP. The average investigation time dropped to 16 days after the program was established. In addition, law enforcement officials in Kentucky and other states view the programs as a deterrent to doctor shopping, because potential diverters are aware that any physician from whom they seek a prescription may first examine their prescription drug utilization history based on PDMP data."Source:General Accounting Office, "Prescription Drugs: State Monitoring Programs Provide Useful Tool to Reduce Diversion" (Washington, DC: Government Printing Office, May 2002), GAO-PO-634, p. 3.
(Effects of PDMPs) "Although several studies found implementation of prescription monitoring programs for Schedule II opioids associated with a decrease in prescription rates for Schedule II opioids and a shift towards increased rates of Schedule III, non-monitored opioid prescribing, the studies were not designed to determine whether the changes were due to a decrease in inappropriate or unnecessary Schedule II opioid use, or if these changes resulted in subsequent undertreatment of pain.317, 318 No study has evaluated patient outcomes such as pain relief, functional status, ability to work, and abuse/addiction associated with implementation of a prescription monitoring program, formulary restriction, or other policies related to opioids prescribing. Claims of positive effects of prescription monitoring programs on reducing diversion are primarily based on anecdotal reports of impressions of efficacy from policymakers and law enforcement officials.316"Source:"Use of Chronic Opioid Therapy in Chronic Noncancer Pain: Evidence Review," The American Pain Society in Conjunction with The American Academy of Pain Medicine (Glenview, IL: American Pain Society, February 2009), pp. 98-99.
(PDMP start-ups) "Officials from DEA, the Alliance [National Alliance for Model State Drug Laws], and state PDMPs told us that states considering establishing a PDMP, or expanding an existing one, face several challenges. These include educating the public and policymakers about the extent of prescription drug diversion and abuse in their state and the benefits of a PDMP, responding to the concerns of physicians, patients, and pharmacists regarding the confidentiality of prescription information, and funding the cost of program development and operations. Given a state's particular funding availability and budget priorities, program costs can be a major hurdle. The start-up costs for the three most recent PDMPs were $415,000 for Kentucky, $134,000 for Nevada, and $50,000 for Utah. Estimated annual operating costs for these PDMPs varied from a high of about $500,000 in Kentucky, to $150,000 in Utah and $112,000 in Nevada. Costs in these three states vary because of differences in the PDMP systems implemented, the number of pharmacies reporting drug dispensing data, and the number of practitioners and law enforcement agencies seeking information from the systems."Source:General Accounting Office, "Prescription Drugs: State Monitoring Programs Provide Useful Tool to Reduce Diversion" (Washington, DC: Government Printing Office, May 2002), GAO-PO-634, pp. 3-4.
(PDMPs and Neighboring States) "The existence of a PDMP [prescription drug monitoring program] within a state, however, appears to increase drug diversion activities in contiguous non-PDMP states. When states begin to monitor drugs, drug diversion activities tend to spill across boundaries to non-PDMP states. One example is provided by Kentucky, which shares a boundary with seven states, only two of which have PDMPs—Indiana and Illinois. As drug diverters became aware of the Kentucky PDMP’s ability to trace their drug histories, they tended to move their diversion activities to nearby nonmonitored states. OxyContin diversion problems have worsened in Tennessee, West Virginia, and Virginia—all contiguous non-PDMP states—because of the presence of Kentucky’s PDMP, according to a joint federal, state, and local drug diversion report."Source:General Accounting Office, "Prescription Drugs: State Monitoring Programs Provide Useful Tool to Reduce Diversion" (Washington, DC: Government Printing Office, May 2002), GAO-PO-634, pp. 16-17.