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Dominic Farronato
Summary Points:
A pill mill is a medical practice that inappropriately prescribes large amounts of opioid drugs without sufficient medical reasoning.
From 1998-2019, a total of 372 U.S. physicians have been named in opioid related criminal cases with 86.3% of these cases occurring between 2010-2019.
PDMPs were created to monitor opioid prescription patterns and their increase in use has helped decrease the opioid prescription dispensing rate from 81.3 per 100 people in 2012 to 46.7 in 2019.
Florida and Pennsylvania have the most cases brought against physicians for negligent opioid-prescribing.
What is a “Pill Mill”?
“Pill mills” are physician offices that inappropriately prescribe large quantities of opioids to patients without a sufficient medical history, physical examination, diagnosis or documentation. These clinics have been a contributor to the opioid epidemic and are the subject of many legislative initiatives to combat the ongoing opioid crisis. The difference between pill mills and legitimate pain management practices is the volume of patients seen, the number of prescriptions written and the amounts prescribed, and the limited medical exams performed in order to receive an opioid prescription. Most also only accept cash payments in order to limit a paper trail.
Often times, the site of these pill mills can be found in smaller communities that are seeing a disproportionate volume of prescription drugs. For example, in 2017 the House Committee on Energy and Commerce discovered that in the small community of Kermit, WV (population 392), a single pharmacy dispensed 9 million hydrocodone pills over a two years. They also found that over a ten-year period, manufacturers shipped 20.8 million opioid pills to two pharmacies only four blocks apart in Williamson, WV (population of approximately 3,000).1 In both of these scenarios it was found that drug wholesalers were over supplying prescription drugs in areas that did not have the population to support the amount supplied. In 2018, new laws were implemented to require drug wholesalers who ship opioids to take greater responsibility for reporting suspicious quantities to the Drug Enforcement Agency (DEA) in order to help prevent pills mills from forming.
Prescriber Scrutiny
From 1998 to 2019, a total of 372 physicians have been accused of criminal action (excluding reports on 12 physicians involved in civil lawsuits) for negligent opioid prescribing behaviors.2 Of note, 231 (86.3%) of these cases occurred between January, 2010 and December, 2019 (Fig. 1).
Figure 1. Annual Frequency of Criminal Cases against Physicians Charged with Opioid-Related Offenses Reported in the US News Media, 1995–20192
Looking at the number of cases on a state-by-state level, nearly a quarter (23.4%) occurred in Florida, followed by Pennsylvania (12.1%), Georgia (6.5%), West Virginia (5.6%), Ohio (5.4%), New York (5.4%) and Tennessee (5.1%).2
When breaking down the demographics of physicians who have been accused of criminal opioid-prescribing, the vast majority (90.1%) were male with a mean age of 58.6 ± 10.7 years, with 27.4% being 65 years and older.2 The three clinical speacalties that saw the highest number of criminal cases were family medicine (25.7%), internal medicine (24.9%), and pain management (17.9%).2
In addition to criminal cases, there have also been many physicians placed under review for overprescribing. From 1998– 2006, 986 cases have been identified in which 752 physicians had been criminally charged and/or facing administrative review for wrongdoings involving the prescribing of opioids. In total, 335 were criminal cases (178 state, 157 federal) and 651 were administrative cases (525 state medical board cases, 126 DEA administrative actions regarding controlled substance registrations).3
The Rise of Prescription Drug Monitoring Programs (PDMPs)
Prescription drug monitoring programs (PDMPs) are designed to facilitate the collection, analysis, and reporting of information on the prescribing, dispensing, and use of prescription drugs within a state. The origin can be traced back to 1918 when New York State passed legislation requiring a serial number for pain killers over a certain quantity to track prescriptions.4 Three years later these laws were rescinded; however, they were the blueprint for what would later become PDMPs.
In 1939, the newly created Bureau of Narcotic Enforcement created in California what is now the oldest continuously operated PDMP program in the nation. By 2000 a total of 17 PDMPs were operational (including Guam). That number would drastically increase to 44 programs by 2010 and by 2015 the only state without enacted PDMP legislation was Missouri, which ultimately enacted its own PDMP in 2021. In the interim, St. Louis County had implemented a local PDMP and made the program available to any other county or city in Missouri wanting to join.4 The St. Louis County PDMP ultimately served more than half the population of Missouri. On June 8th the Missouri governor signed a bill that will finally allow Missouri to implement a state wide PDMP in August 2021.5
Are PDMPs Working?
The dispensing rate of opioids experienced a steady increase from 2006 until it peaked in 2012 at more than 255 million with a dispensing rate of 81.3 prescriptions per 100 persons. The national opioid dispensing rate then declined from 2012 to 2019, with the dispensing rate dropping to 46.7 prescriptions per 100 persons by 2019 (Table 1).6 Paradoxically, with the decreasing opioid prescription rate, there has been an increase in the number of physicians criminally charged (Fig. 1), which has been attributed to increased policing and the ability of law enforcement to identify high volume prescribers through PDMPs. Overall, the decline in opioid prescribing rates since 2012, and concomitant decrease in high-dose prescribing rates (≥90 MME) since 2008, suggest that healthcare providers have become more cautious in their opioid prescribing practices.7
Fortunately, the issue of over-prescribing and pill mills appear to be concentrated problems with a small number of offenders relative to the large physician population. Chang et al. showed that in the country’s largest opioid prescription state, Florida, 1526 (4%) of prescribers accounted for 67% of total opioid volume and 40% of total opioid prescriptions. Relative to the overall prescriber population, these high volume prescribers wrote 16x more monthly opioid prescriptions (79 vs. 5, p < 0.01), and had more prescription-filling patients receiving opioids (47% vs. 19%, p < 0.01).8
Interestingly, these prescribers were generally not pain management specialists. Following new policy implementation, Florida's high-volume prescribers experienced large relative reductions in opioid patients, opioid prescriptions per MME dose and total opioid pill volume. In contrast, low-volume prescribers did not experience statistically significantly relative reductions indicating that these policies are intended to target the outlying prescribers, and they appear to be working.8
Future Directions?
The PDMP continues to be an excellent tool to combat the opioid crisis by targeting Pill Mills and high volume opioid-prescribers. However, great variability in data collection, registration, enforcement, as well as communication across state lines persist limiting its ability to achieve maximum efficacy. PDMPs need to be continually evaluated, studied, and upgraded. Moreover, maximizing communication between states and with national agencies such as the CDC and FDA should be promoted.
Resources:
Combating the Opioid Crisis: Investigation. Energy and Commerce Committee. (n.d.). https://republicans-energycommerce.house.gov/opioids-pilldumping/.
Berman, J.B., Li, G. Characteristics of criminal cases against physicians charged with opioid-related offenses reported in the US news media, 1995–2019. Inj. Epidemiol. 7, 50 (2020). https://doi.org/10.1186/s40621-020-00277-8
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, 9(6), 737–747. https://doi.org/10.1111/j.1526-4637.2008.00482.x
Brandeis University. (2018, March). History of Prescription Drug Monitoring Programs. Prescription Drug Monitoring Program Training and Technical Assist Center . https://www.pdmpassist.org/pdf/PDMP_admin/TAG_History_PDMPs_final_20180314.pdf.
SB63 - Modifies provisions relating to the monitoring of certain controlled substances. (n.d.). https://www.senate.mo.gov/21info/BTS_Web/Bill.aspx?SessionType=R&BillID=54228843.
Centers for Disease Control and Prevention. (2020, December 7). U.S. Opioid Dispensing Rate Maps. Centers for Disease Control and Prevention. https://www.cdc.gov/drugoverdose/maps/rxrate-maps.html.
Centers for Disease Control and Prevention. (2019, August 13). Prescribing Practices. Centers for Disease Control and Prevention. https://www.cdc.gov/drugoverdose/data/prescribing/prescribing-practices.html.
Chang, H. Y., Lyapustina, T., Rutkow, L., Daubresse, M., Richey, M., Faul, M., Stuart, E. A., & Alexander, G. C. (2016). Impact of prescription drug monitoring programs and pill mill laws on high-risk opioid prescribers: A comparative interrupted time series analysis. Drug and alcohol dependence, 165, 1–8. https://doi.org/10.1016/j.drugalcdep.2016.04.033
Corey S. Davis & Derek H. Carr (2017) Self-regulating profession? Administrative discipline of “pill mill” physicians in Florida, Substance Abuse, 38:3, 265-268, DOI: 10.1080/08897077.2017.1316812