The opioid epidemic poses a significant threat to the public health, such that, to date, six states have issued emergency declarations in response to opioid misuse (i.e., addiction).1 In an attempt to hinder prescription opioid misuse, regulatory and legislative authorities, as well as the courts, have taken action by tracking prescriptions, controlling the supply of opioids, and policing the marketing of these drugs, among other enforcement activities.
In an attempt to combat prescription drug misuse, states have developed and implemented Prescription Drug Monitoring Programs (PDMPs). A PDMP is a statewide electronic database that collects data on certain drugs dispensed throughout the state and distributes this data to individuals authorized under law to receive this information.2 Data collection and reporting vary across states, but by tracking prescription and patient histories, PDMPs may help to identify patients who may be diverting or abusing opioids and other drugs.3 State reports on the success of PDMPs have indicated that PDMPs have had a positive impact by reducing the number of patients receiving prescriptions from multiple physicians simultaneously, also known as “doctor shopping.”4 Currently, PDMPs are implemented in every state (including Washington, D.C.), with the exception of Missouri.5 In July 2017, Missouri Governor Eric Greitens signed an executive order creating a multi-phase PDMP.6 Although Missouri’s PDMP is not currently in use and has an uncertain launch date, its development is in progress.7 In addition to PDMPs, states are also moving to mandated electronic prescribing of controlled substances (EPCS), in which physicians are prohibited from prescribing opioids in written form.8 This effort may serve to mitigate the risk both of written prescriptions being stolen or altered, and of multiple physicians writing the same prescription for the same patient.9 Currently, three states have passed legislation mandating EPCS, and eight states have introduced such legislation.10 Further, Maine has successfully reduced the prescription of opioids by enacting legislation that restricts physicians from prescribing patients over 100 morphine milligram equivalents (MME) per day.11 This legislation received strong pushback from patients and physicians, but by adding additional exceptions, both patients and physicians has endorsed this legislation.12
On the federal level, the Food and Drug Administration (FDA), Drug Enforcement Administration (DEA), and Department of Justice (DOJ) have taken action to restrict access to opioids and combat the fraudulent diversion or dispensation of opioids. The FDA has implemented a comprehensive action plan that, among other efforts, will require the FDA to assemble an expert advisory committee that will review applications for new opioids that lack abuse-deterrent properties.13 Additionally, on June 8, 2017, the FDA requested that the drug maker Endo Pharmaceuticals halt sales of Opana ER, a powerful opioid, due to public health concerns,14 and the drug maker voluntarily complied.15 This was the first time that the FDA had ever sought the removal of an approved opioid from the market.16 The DEA has also taken regulatory action to fight the opioid epidemic by restricting the manufacture of Schedule II opioids by 25 percent in 2017.17 In addition, some drugs, such as hydrocodone, have been reduced to 66 percent of the 2016 level.18 Further, the DOJ has created an opioid fraud and abuse detection unit that will pursue healthcare fraud claims specifically related to opioids.19 The unit will use data analytics to identify potential opioid-related fraud activities and prosecute the individuals who are believed to be exacerbating the opioid epidemic.20 For example, the unit’s data analytics will be able to identify physicians who are prescribing opioids at a much higher rate than their peers; the unit will then work with other federal and state bodies to determine if fraud or abuse is present, and consequently prosecute the appropriate claim(s).21
Although recent Republican efforts to repeal and replace the 2010 Patient Protection and Affordable Care Act (ACA) were unsuccessful,22 the proposed legislation may indicate future stances on opioid treatment. For example, the revised version of the Better Care Reconciliation Act of 2017 (BCRA), the (ultimately unsuccessful) Republican Senate bill that attempted to repeal and replace the ACA, proposed an allotment of $45 billion per year to states to combat the opioid epidemic, an increase from the initial $2 billion in state allotment proposed in the original version of BCRA.23 Originally refusing advice from both Health and Human Services (HHS) Secretary Tom Price and the Commission on Combating Drug Addiction and Opioid Crisis to declare a national state of emergency on the opioid crisis, President Trump later reversed course and verbally declared a national state of emergency,24 however, no official action has occurred yet.25 Although President Trump has declined to name specific steps that will be taken under the national emergency declaration,26 the declaration will allow the executive branch of the federal government to increase funding for the treatment and prevention of opioid addiction, as well as to supply police with naloxone, a drug used to treat opioid overdoses.27
In addition to state and federal legislative responses to the opioid epidemic, both states and individuals have successfully turned to the court system to regulate the use of prescription drugs, and to seek remedy for the harm suffered due to opioid misuse. In the past, successful malpractice suits have been brought against physicians for the negligent prescription of opioids;28 however, a new wave of lawsuits specifically targeting drug distributors and manufacturers is underway. In December 2016, two pharmaceutical distributors reached a settlement of $36 million with the West Virginia Attorney General representing the West Virginia Boone County Commission.29 In June 2017, the Missouri and Oklahoma Attorneys General filed separate lawsuits against pharmaceutical companies, for “misrepresenting the truth” and falsely downplaying the risk of opioid addiction.30 These two suits follow similar lawsuits filed by the states of Ohio and Mississippi against major drug companies with essentially the same allegations.31
While the future of opioid regulation is still uncertain, the opioid epidemic has drawn the attention of federal and state authorities, prompting them to take steps to combat the crisis and improve public health.
“Emergency Declarations and Opioid Overdose Prevention” By Andy Baker-White, Association of State and Territorial Health Officials, June 8, 2017, http://www.astho.org/StatePublicHealth/Emergency-Declarations-and-Opioid-Overdose-Prevention/6-8-17/ (Accessed 8/9/2017). Note: The six states to declare an emergency in response to the opioid epidemic are: Alaska, Arizona, Florida, Maryland, Massachusetts, and Virginia.
“State Prescribing Drug Monitoring Programs” Drug Enforcement Agency, U.S. Department of Justice, June 2016, https://www.deadiversion.usdoj.gov/faq/rx_monitor.htm (Accessed 7/12/2017).
“Prescription Drug Monitoring Programs: Examining Limitations and Future Approaches” By Christopher Griggs, Scott Weiner, and James Feldman, Western Journal of Emergency Medicine, Vol. 16, No.1 (January 2015), p. 67. See, e.g., “Prescription Drug Monitoring Program Annual Report” Florida Health, Electronic-Florida Online Reporting of Controlled Substances Evaluation, Tallahassee, Florida, 2013, p. 1.
“Status of Prescription Drug Monitoring Programs (PDMPs)” Brandeis University, October 18, 2016, http://www.pdmpassist.org/pdf/PDMPProgramStatus.pdf (Accessed 8/25/2017).
“Missouri Governor Signs Executive Order to Create Statewide Prescription Drug Monitoring Program” By Theo Douglas, Government Technology, July 17, 2017, http://www.govtech.com/policy/Missouri-Governor-Signs-Execurive-Orderto-Create-Statewide-Prescription-Drug-Monitoring-Program.html (Accessed 8/9/2017).
“Maine’s e-prescribing mandate for opioids offers window into similar legislation in other states” By Dr. Sean Kelly, MedCity News, June 22, 2017, http://medcitynews.com/2017/06/e-prescribing-mandate-opioids/ (Accessed 7/5/2017).
Ibid. Note: New York, Maine and Virginia have mandated EPCS and Connecticut, Illinois, Massachusetts, New Jersey, North Carolina, Pennsylvania, Rhode Island, and Texas have introduced EPCS legislation.
“Intent on Reversing its Opioid Epidemic, A State Limits Prescriptions” By Patty Wight, National Public Radio, August 23, 2017, http://www.npr.org/sections/health-shots/2017/08/23/543955887/intent-on-reversing-its-opioid-epidemic-a-state-limits-prescriptions?sc=tw (Accessed 8/25/2017).
“FDA Opioids Action Plan” U.S. Food and Drug Administration, U.S. Department of Health and Human Services, July 11, 2017, https://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm484714.htm (Accessed 7/12/2017).
“FDA Calls on Drugmaker to Pull a Powerful Opioid off the Market” By Rob Stein, National Public Radio, June 8, 2017, http://www.npr.org/sections/health-shots/2017/06/08/532126206/fda-calls-on-drugmaker-to-pull-a-powerful-opioid-off-the-market (Accessed 7/5/2017).
“Opana ER Opioid Pain killer Pulled from the Market at FDA Request” CBS News, July 2017, http://www.cbsnews.com/news/drug-opana-er-opioid-painkiller-pulled-from-the-market-by-fda/ (Accessed 8/9/2017).
“FDA Requests removal of Opana ER for Risks related to Abuse” U.S. Food and Drug Administration, FDA News Release, June 8, 2017, https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm562401.htm (Accessed 7/14/2017).
“DEA Reduces Amount of Opioid Controlled Substances to be Manufactured in 2017” Drug Enforcement Agency, October 4, 2016, https://www.dea.gov/divisions/hq/2016/hq100416.shtml (Accessed 7/5/2017).
“Attorney General Sessions Announces Opioid Fraud and Abuse Detection Unit” Department of Justice, August 2, 2017, https://www.justice.gov/opa/pr/attorney-general-sessions-announces-opioid-fraud-and-abuse-detection-unit (Accessed 8/15/2017).
See HC Topics article “Obamacare Repeal and Replace – In the Heat of the Night” Vol. 10 No. 7, for more information regarding ACA repeal efforts.
“Better Care Reconciliation Act of 2017- Revised” H.R. 1628, 115th Cong. § 202; “Better Care Reconciliation Act – Original” H.R. 1628, 115th Cong. § 202.
“Trump Declares Opioid Crisis National Emergency” By Ali Vitali and Corky Siemaszko, NBC News, August 10, 2017, http://www.nbcnews.com/storyline/americas-heroin-epidemic/trump-declares-opioid-crisis-national-emergency-n791576 (Accessed 8/14/2017); “Trump Vows U.S. Will ‘Win’ Fight Against Opioid Crisis” By Ali Vitali and Corky Siemaszko, NBC News, August 8, 2017, https://www.nbcnews.com/storyline/americas-heroin-epidemic/trump-vows-u-s-will-win-fight-against-opioid-crisis-n790751 (Accessed 8/25/2017).
“Is the Opioid Crisis a National Emergency? No” By Josh Katz, The New York Times, August 24, 2017, https://www.nytimes.com/interactive/2017/08/24/upshot/100000005387020.mobile.html (Accessed 8/25/2017).
“Trump Informally Declares the Opioid Crisis a National Emergency” By Matt Ford, The Atlantic, August 10, 2017, https://www.theatlantic.com/politics/archive/2017/08/president-trump-declares-the-opioid-crisis-a-national-emergency/536514/ (Accessed 8/22/2017).
Vitali and Siemaszko, August 10, 2017.
For example, “Koon v. Walden, M.D.; Saint Louis University” JVR No. 1607060020.
“2 Drug Distributors to Pay $36M to settle WV Painkiller Lawsuit” By Eric Eyre, Charleston Gazette-Mail, January 9, 2017, http://www.wvgazettemail.com/news-cops-and-courts/20170109/2-drug-distributors-to-pay-36m-to-settle-wv-painkiller-lawsuits (Accessed 7/12/2017).
“Missouri AG Files Suit Against 3 Opioid Manufacturers” By Carma Hassan, Cable News Network, June 21, 2017, http://www.cnn.com/2017/06/21/health/opioid-companies-missouri-lawsuit/index.html (Accessed 7/5/2017); “Oklahoma AG Sues Drug Makers over Opioid Epidemic” American Health Lawyers Association, July 7, 2017, https://www.healthlawyers.org/Pages/PageNotFoundError.aspx?requestUrl=https://www.healthlawyers.org/News/Health%20Lawyers%20Weekly/Pages/2017/July%202017/July%2007%202017/Oklahoma-AG-Sues-Drug-Maker%E2%80%A6 (Accessed 7/7/2017). Note: the Missouri Attorney General named three (3) defendant pharmaceutical companies, and the Oklahoma Attorney General named thirteen (13) pharmaceutical companies.
“Ohio Sues 5 Major Drug Companies for ‘Fueling Opioid Epidemic’” National Public Radio, May 31, 2017, http://www.npr.org/sections/thetwo-way/2017/05/31/530929307/ohio-sues-5-major-drug-companies-for-fueling-opioid-epidemic (Accessed 7/5/2017).