|1. Reductions in Opioid Prescribing for People with Severe Pain
"According to the Medical Expenditure Panel Survey, the annual share of US adults who were prescribed opioids decreased from 12.9 percent in 2014 to 10.3 percent in 2016, and the decrease was concentrated among adults with shorter-term rather than longer-term prescriptions. The decrease was also larger for adults who reported moderate or more severe pain (from 32.8 percent to 25.5 percent) than for those who reported lessthan-moderate pain (from 8.0 percent to 6.6 percent). In the same period opioids were prescribed to 3.75 million fewer adults reporting moderate or more severe pain and 2.20 million fewer adults reporting less-thanmoderate pain. Because the decline in prescribing primarily involved adults who reported moderate or more severe pain, these trends raise questions about whether efforts to decrease opioid prescribing have successfully focused on adults who report less severe pain."
Mark Olfson, Shuai Wang, Melanie M. Wall, and Carlos Blanco. Trends In Opioid Prescribing And Self-Reported Pain Among US Adults. Health Affairs 2020 39:1, 146-154.
|2. Prevalence Of Illegal Use of Prescription Drugs In The US
"The 2020 NSDUH assessed the use and misuse of psychotherapeutic drugs currently or recently available by prescription in the United States, including prescription stimulants, tranquilizers or sedatives (e.g., benzodiazepines), and pain relievers. In NSDUH, misuse of prescription drugs was defined as use in any way not directed by a doctor, including use without a prescription of one’s own; use in greater amounts, more often, or longer than told to take a drug; or use in any other way not directed by a doctor. Misuse of over-the-counter (OTC) drugs was not included.
"Among people aged 12 or older in 2020, 5.8 percent (or 16.1 million people) misused prescription psychotherapeutic drugs in the past year (Table A.12B). The percentage was highest among young adults aged 18 to 25 (9.5 percent or 3.2 million people), followed by adults aged 26 or older (5.6 percent or 12.2 million people), then by adolescents aged 12 to 17 (2.8 percent or 688,000 people) (Tables A.13B to A.15B).
"Of the prescription drugs presented in this report, prescription pain relievers were the most commonly misused by people aged 12 or older. The 16.1 million people in 2020 who misused prescription psychotherapeutic drugs in the past year included 9.3 million people who misused prescription pain relievers, 6.2 million people who misused prescription tranquilizers or sedatives (including 4.8 million past year misusers of benzodiazepines), and 5.1 million people who misused prescription stimulants (Figure 9)."
Substance Abuse and Mental Health Services Administration. (2021). Key substance use and mental health indicators in the United States: Results from the 2020 National Survey on Drug Use and Health (HHS Publication No. PEP21-07-01-003, NSDUH Series H-56). Rockville, MD: Center for Behavioral Health Statistics and Quality, Substance Abuse and Mental Health Services Administration.
|3. Tighter Prescribing Regulations Drive Illegal Sales
"The US Drug Enforcement Administration introduced a schedule change for hydrocodone combination products in October 2014. During the period of our study, October 2013 to July 2016, the percentage of total drug sales represented by prescription opioids in the US doubled from 6.7% to 13.7%, which corresponds to a yearly increase of 4 percentage points in market share. It is not possible to determine the location of buyers from cryptomarket data. We cannot know, for example, if a drug shipped from a vendor in Europe was purchased by a US customer. Nevertheless, cryptomarket users often prefer buying and selling from vendors in the same country; international shipments carry risks of loss, interception by officials, and increased delivery times. A study of cryptomarkets in Australia found that local vendors were often preferred over international counterparts, despite substantially higher prices.24 Another study36 also noted the downward trends of international sales and therefore an increase in domestic sales, and yet another study47 found that drug trading through cryptomarket is heavily constrained by offline geography. This preference for domestic trading, combined with the relatively large numbers of US drug vendors trading in cryptomarkets, leads us to presume that most sales of prescription drugs by US vendors will be sold to customers based in the US. Conversely, most transactions generated by non-US vendors will not be sold to US customers.
"The results of our interrupted time series suggest the possibility of a causal relation between the schedule change and the percentage of sales represented by prescription opioids on cryptomarkets. Our analysis cannot rule out other possible causal explanatory factors, but our results are consistent with the possibility that the schedule change might have directly contributed to the changes we observed in the supply of illicit opioids. This possibility is reinforced by the fact that the increased availability and sales of prescription opioids on cryptomarkets in the US after the schedule change was not replicated for cryptomarkets elsewhere.
"Our results are consistent with the possibility of demand led increases. The first increase observed for prescription opioids was for actual sales (fig 1); with increases for active listings, and then all listings, following. One explanation is that cryptomarket vendors perceived an increase in demand and responded by placing more listings for prescription opioids and thereby increasing supply. Our results are also consistent with the iron law of prohibition34 insofar as we identified the largest sales increases for more potent prescription opioids—specifically, oxycodone and fentanyl. Cryptomarkets may function as a supply gateway48: customers who initially sought out illicit hydrocodone on cryptomarkets after the schedule change might then have favoured more potent opioids available on the marketplace."
Martin James, Cunliffe Jack, Décary-Hétu David, Aldridge Judith. Effect of restricting the legal supply of prescription opioids on buying through online illicit marketplaces: interrupted time series analysis. British Medical Journal. 2018; 361:k2270.
|4. Impact of Drug Control Policy on Medical Treatment of Pain
"Opioid medications also have a potential for abuse (a discussion of this important issue is in the Executive Summary and Section III of the Evaluation Guide 2013). Consequently, opioid analgesics and the healthcare professionals who prescribe, administer, or dispense them are regulated pursuant to federal and state controlled substances laws, as well as under state laws and regulations that govern professional practice.70;71 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,72-76 resulting in interference with appropriate pain management.
"Examples of such policy language include:
Pain & Policy Studies Group, "Achieving Balance in State Pain Policy: A Progress Report Card (CY 2013)," Madison, WI: University of Wisconsin Carbone Cancer Center, July 2014.
|5. Prosecutions and Administrative Reviews Of Physicians For Offenses Involving The Prescribing Of 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).
Goldenbaum, D. M., Christopher, M., Gallagher, R. M., Fishman, S., Payne, R., Joranson, D., Edmondson, D., McKee, J., & Thexton, A. (2008). Physicians charged with opioid analgesic-prescribing offenses. Pain medicine (Malden, Mass.), 9(6), 737–747. doi.org/10.1111/j.1526-4637.2008.00482.x
|6. Definition of Diversion of Licit, Legally Prescribed 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."
"Drug Diversion in the Medicaid Program: State Strategies for Reducing Prescription Drug Diversion in Medicaid," Centers for Medicare & Medicaid Services, Baltimore, MD: January 2012.
|7. Number Of Painkiller Prescriptions Written Annually In The US
"Prescribers wrote 82.5 OPR [Opioid Pain Reliever] prescriptions and 37.6 benzodiazepine prescriptions per 100 persons in the United States in 2012 (Table). LA/ER [Long-Acting or Extended Release] OPR accounted for 12.5%, and high-dose OPR accounted for 5.1% of the estimated 258.9 million OPR prescriptions written nationwide. Prescribing rates varied widely by state for all drug types. For all OPR combined, the prescribing rate in Alabama was 2.7 times the rate in Hawaii."
Leonard J. Paulozzi, MD1, Karin A. Mack, PhD2, Jason M. Hockenberry, PhD, "Vital Signs: Variation Among States in Prescribing of Opioid Pain Relievers and Benzodiazepines — United States, 2012," Morbidity and Mortality Weekly Report, July 4, 2014, US Centers for Disease Control, p. 564.
|8. 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."
"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.
|9. Tightened Restrictions on Legal Prescription Hydrocodone Led to Increase in Illegal Sales
"Objective: To examine the effect on the trade in opioids through online illicit markets (“cryptomarkets”) of the US Drug Enforcement Administration’s ruling in 2014 to reschedule hydrocodone combination products.
"Design: Interrupted time series analysis.
"Setting: 31 of the world’s largest cryptomarkets operating from October 2013 to July 2016.
"Main outcome measures: The proportion of total transactions, advertised and active listings for prescription opioids, prescription sedatives, prescription steroids, prescription stimulants, and illicit opioids, and the composition of the prescription opioid market between the US and elsewhere.
"Results: The sale of prescription opioids through US cryptomarkets increased after the schedule change, with no statistically significant changes in sales of prescription sedatives, prescription steroids, prescription stimulants, or illicit opioids. In July 2016 sales of opioids through US cryptomarkets represented 13.7% of all drug sales (95% confidence interval 11.5% to 16.0%) compared with a modelled estimate of 6.7% of all sales (3.7% to 9.6%) had the new schedule not been introduced. This corresponds to a 4 percentage point yearly increase in the amount of trade that prescription opioids represent in the US market, set against no corresponding changes for comparable products or for prescription opioids sold outside the US. This change was first observed for sales, and later observed for product availability. There was also a change in the composition of the prescription opioid market: fentanyl was the least purchased product during July to September 2014, then the second most frequently purchased by July 2016.
"Conclusions: The scheduling change in hydrocodone combination products coincided with a statistically significant, sustained increase in illicit trading of opioids through online US cryptomarkets. These changes were not observed for other drug groups or in other countries. A subsequent move was observed towards the purchase of more potent forms of prescription opioids, particularly oxycodone and fentanyl."
Martin James, Cunliffe Jack, Décary-Hétu David, Aldridge Judith. Effect of restricting the legal supply of prescription opioids on buying through online illicit marketplaces: interrupted time series analysis. British Medical Journal. 2018; 361:k2270.
|10. 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."
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.
|11. 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.
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.
|12. 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).
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.
|13. 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."
National Drug Intelligence Center, Drug Enforcement Administration, "National Prescription Drug Threat Assessment," (Washington DC, April 2009), p. IV.
|14. 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."
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.
|15. Estimated Prevalence of Current Nonmedical Use of Psychotherapeutics in the US, 2014
"In 2014, the estimate of 6.5 million Americans aged 12 or older who were current nonmedical users of psychotherapeutic drugs represents 2.5 percent of the population aged 12 or older (Figures 1 and 4). The 2014 estimate for current nonmedical use of psychotherapeutic drugs among people aged 12 or older was slightly lower than the estimates in 2006, 2007, 2009, and 2010 (ranging from 2.7 to 2.9 percent), and it was similar to the estimates in the other years between 2002 and 2013.19"
Center for Behavioral Health Statistics and Quality. (2015). Behavioral health trends in the United States: Results from the 2014 National Survey on Drug Use and Health (HHS Publication No. SMA 15-4927, NSDUH Series H-50), p. 6.
|16. Initiation of Nonmedical Use of Prescription Psychotherapeutics in the US, 2013
" 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 2013, there were approximately 2.0 million persons aged 12 or older who used psychotherapeutics nonmedically for the first time within the past year, which averages to about 5,500 initiates per day. The number of new nonmedical users of psychotherapeutics in 2013 was lower than the estimates for prior years from 2002 through 2012 (ranging from 2.3 million to 2.8 million).
Substance Abuse and Mental Health Services Administration, Results from the 2013 National Survey on Drug Use and Health: Summary of National Findings, NSDUH Series H-48, HHS Publication No. (SMA) 14-4863. Rockville, MD: Substance Abuse and Mental Health Services Administration, 2014, pp. 64-66.
|17. Nonmedical Prescription Drug Use by Young Adults Aged 18-25 in the US, 2013
" Among young adults aged 18 to 25, the rate of current nonmedical use of psychotherapeutic drugs in 2013 (4.8 percent) was similar to the rates in 2011 (5.0 percent) and 2012 (5.3 percent), but it was lower than the rates in 2002 to 2010 (ranging from 5.5 to 6.5 percent) (Figure 2.9). The rate of current nonmedical use of pain relievers among young adults in 2013 (3.3 percent) was lower than the rates in 2012 (3.8 percent) and in 2002 to 2010 (ranging from 4.1 to 5.0 percent), but it was similar to the rate in 2011 (3.6 percent)."
Substance Abuse and Mental Health Services Administration, Results from the 2013 National Survey on Drug Use and Health: Summary of National Findings, NSDUH Series H-48, HHS Publication No. (SMA) 14-4863. Rockville, MD: Substance Abuse and Mental Health Services Administration, 2014, p. 23.
|18. 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.
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.
|19. 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."
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.
"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."
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.
|21. Estimated Prevalence of Non-Medical Use of Pain Relievers in the US, 2014
"Overall estimates of current nonmedical use of prescription psychotherapeutic drugs among the population aged 12 or older that were described previously have largely been driven by the nonmedical use of prescription pain relievers. In 2014, about two thirds of the current nonmedical users of psychotherapeutic drugs who were aged 12 or older reported current nonmedical use of pain relievers (Figure 5).
Center for Behavioral Health Statistics and Quality. (2015). Behavioral health trends in the United States: Results from the 2014 National Survey on Drug Use and Health (HHS Publication No. SMA 15-4927, NSDUH Series H-50), p. 7.
|22. 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."
National Drug Intelligence Center, Drug Enforcement Administration, "National Prescription Drug Threat Assessment," (Washington DC, April 2009), p. V.
|23. 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.
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.
|24. 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:
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.
|25. 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."
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.
|26. 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."
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.
|27. 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."
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.
|28. 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)."
National Drug Intelligence Center, Drug Enforcement Administration, "National Prescription Drug Threat Assessment," (Washington DC, April 2009), p. III.
|29. Annual Cost of Prescription Drug Diversion
"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."
National Drug Intelligence Center, Drug Enforcement Administration, "National Prescription Drug Threat Assessment," (Washington DC, April 2009), p. 20.
|30. 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"
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.
|31. Progress In Achieving Balance In Pain Management Policy In The US
"Alabama and Idaho now join Georgia, Iowa, Kansas, Maine, Massachusetts, Michigan, Montana, Oregon, Rhode Island, Vermont, Virginia, Washington, and Wisconsin as having the most balanced policies in the country related to pain management, including with the appropriate use of pain medications for legitimate medical purposes. Over time, these 15 states took advantage of available policy templates and resources, and repealed all excessively restrictive and ambiguous policy. This achievement does not mean that their work is finished, because policy needs to be properly implemented (see next section). Importantly, there is no ceiling on policy quality, so states with high grades should continue to explore how additional policy can help to improve access to pain management while avoiding the adoption of restrictive requirements or limitations. In fact, 25 states that achieved an A for positive language in the past have continued to adopt policy language promoting appropriate pain management during this evaluation timeframe.h"
Pain & Policy Studies Group, "Achieving Balance in State Pain Policy: A Progress Report Card (CY 2013)" (Madison, WI: University of Wisconsin Carbone Cancer Center, July 2014), p. 23.
|32. State Prescription Drug Monitoring Programs
"There have been significant advances in implementing PDMPs, 49 states and Washington, D.C. now have operational PDMPs. PDMPs help providers understand their patients’ medication histories, as well as problematic behaviors that signal a need for more in-depth conversations about pain and substance use. The Bureau of Justice Assistance (BJA) supported PDMP expansion grants in 11 states in 2015. ONC, SAMHSA, and CDC all have funded research and standards development for PDMP improvements. The IHS, DoD, and VA have piloted the integration of PDMP systems within their electronic health records systems. In July 2016, both VA and IHS announced new policies that require prescribers to check the PDMP prior to making a decision to prescribe controlled medications.
"Historically, the ability of states to share data has been limited, but agencies are currently involved in efforts to enhance the interoperability of state PDMPs. At the time of this writing, two electronic data sharing hubs are operational, enabling 43 states to work through one or both to share PDMP data with at least one other state. Funding from BJA and DoD has been used to enhance this interstate data sharing.
"PDMPs are only one approach to monitoring. The DoD, VA, and CMS all have initiated drug utilization review programs for some of their patient populations to better coordinate care for individuals who are prescribed opioid medications. Many hospitals administer patient surveys to determine whether their pain was managed adequately. CMS has proposed new questions for these surveys that avoid the perception that performance is linked to prescribing opioid medications for pain control.14"
Office of National Drug Control Policy, "National Drug Control Strategy 2016," (Washington, DC: Executive Office of the President, January 2017), p. 67.
|33. Prescription Drug Monitoring Programs and Heroin Use
"Even well-intentioned policies have exacerbated the link between opioid use and infectious disease. For instance, prescription drug monitoring programs and other measures to limit access to prescription opioids triggered a transition to heroin and, eventually, injection use among people who had become dependent on prescription pain relievers. At the same time, primary care clinics have not adequately screened, treated, and retained patients in treatment for substance use disorders. The resulting increase in the number of people who inject drugs has also increased the overall risk of infectious disease outbreaks. Other policies have similarly exacerbated the link between opioid use disorder and infectious diseases. For instance, policies that limit access to sterile syringes tend to increase infectious disease risk among people who inject drugs, as do the broad array of “war on drugs” policies that incarcerate individuals rather than connect them to treatment and harm-reduction programs. A number of studies have demonstrated that such programs—especially syringe services—lead to a net reduction in substance use through active referral, engagement, and retention in substance use disorder treatment."
National Academies of Sciences, Engineering, and Medicine 2020. Opportunities to Improve Opioid Use Disorder and Infectious Disease Services: Integrating Responses to a Dual Epidemic. Washington, DC: The National Academies Press. https://doi.org/10.17226/25626
|34. 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)."
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.
|35. 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."
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.
|36. 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."
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.
|37. 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"
"Clinical Guideline for the 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.
|38. 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."
General Accounting Office, Prescription Drugs: State Monitoring Programs Provide Useful Tool to Reduce Diversion (Washington, DC: Government Printing Office, May 2002), GAO-PO-634.