December 31, 2016

Prescription Drug Monitoring Programs and Their Role in Combatting the Opioid Epidemic

Geoffrey Mospan, Wingate University School of Pharmacy, Wingate, NC

Introduction

The abuse, misuse, and diversion of prescription drugs continues to increase in the United States to epidemic levels. In 2014, over 25,000 overdose deaths occurred from prescription drugs, an amount that has more than tripled from 1999 rates.1 Opioids, a class of medication used to treat pain, were implicated in nearly three out of every four overdoses due to prescription drugs in 2014.2 As a result of this public health emergency, many strategies have been implemented by states to decrease deaths from opioid and prescription medications.3 Examples of these strategies include prescription drug take back programs, limiting quantities of opioid prescriptions, prescribing naloxone for patients at risk of opioid overdose, and prescription drug monitoring programs (PDMPs). This article will discuss PDMPs, including information on their functionality, benefits, limitations, and opportunities for improvement.

Overview of PDMPs

PDMPs, also known as prescription monitoring programs, are databases that collect information on patients who receive controlled substances dispensed by a pharmacy (or other dispenser), including opioids.4 PDMP databases and their corresponding laws are developed by each individual state. Currently, 49 states and the District of Columbia utilize a PDMP.5 Missouri is the only state which does not have a PDMP currently, although the Mayor of St. Louis has recently signed a bill to institute a PDMP for the city and the county that it’s in.6

While the requirements of PDMPs vary from state to state, many generalizations can be made.7 Within a certain time after dispensing a prescription to a patient, the pharmacy (or dispenser) is required to upload information to the database. Generally, prescriptions for Controlled Substances in Schedules II, III, IV, and V are reported, although states may require reporting of certain non-controlled substances they deem dangerous.8 Information uploaded into the database includes information about the pharmacy (name, location), the patient (name, address, date of birth, method of payment), and the prescription (medication name, strength, quantity, prescriber).

Benefits of PDMPs

Compiling all of this information into a statewide database has many potential benefits, including detecting diversion and “doctor shopping,” as well as identifying fraudulent, forged, or deceitful prescriptions for controlled substances.9 Prescribers and pharmacists play an equally important role in preventing these untoward activities from occurring.10 Physicians in all practice settings can utilize the database at the time of prescribing to review their patients’ controlled substance history and ensure that patients are not traveling to several different physician offices (“doctor shopping”). Pharmacists, according to the Drug Enforcement Administration (DEA), have a corresponding responsibility to make certain that controlled substance prescriptions are prescribed for a legitimate purpose.11 PDMPs are a very useful tool for pharmacists to determine the legitimacy of prescriptions at the time of dispensation, and can thereby prevent diversion and overdose.

Although considered confidential information, persons other than prescribers and pharmacists may be able to request or access reports from PDMPs.12 Depending on state law, patients, law enforcement officials, licensing/regulatory boards, state health insurance programs, and parents/guardians of minor children may obtain PDMP reports. Data from a PDMP obtained by a regulatory agency may be used to analyze trends in the state or send unsolicited reports or alerts to prescribers, pharmacists, and law enforcement.13

Studies have been performed to determine the effectiveness of PDMPs on several different outcomes. One noted study, in an adjusted analysis, determined that in the year after a PDMP was implemented, an average decrease of 1.12 opioid-related deaths occurred per 100,000 persons.14 Furthermore, states which monitored more schedules of controlled substances and dispensers who uploaded data sooner into the database had an additional decrease in opioid-related deaths compared to states with less stringent criteria.15

Additionally, states with PDMPs have been associated with a decrease in the number of prescriptions for Schedule II opioids,16 smaller increases in drug abuse and misuse over time,17 and fewer shipments of oxycodone.18

Although it may seem that preventing diversion of controlled substances is the sole use for PDMPs, there are other beneficial purposes for the database. For example, an elderly patient may see several different physicians and/or have his/her medications filled at multiple pharmacies. If the physicians and/or pharmacies do not share a common electronic medical record system, a patient may receive duplicative therapy, interacting medications, or excessive dosages leading to adverse events. By reviewing the patient’s controlled substance history, a prescriber or pharmacist would be able to prevent this from occurring. Finally, analyzing a patient’s PDMP report can identify red flags of diversion, which can be a sign of addiction. Recognizing patients who potentially have addiction issues offers the provider a chance to consider this diagnosis and refer the patient to a treatment and recovery center. Furthermore, for patients actively or previously treated for opioid addiction, pharmacists and physicians would be able to reasonably deduce this from a PDMP report and could prevent a relapse from occurring by avoiding the prescription of opioids.19

Limitations of PDMPs

Although the benefits of PDMPs are widely known, there are several limitations to these databases. First, while dispensers, such as pharmacies, are required to upload the information into the database after dispensing a prescription, usage of the program by prescribers and/or pharmacists is only required in 29 states.20 For example, a state may outline only certain situations that require a physician or pharmacist to obtain a PDMP report, such as prior to a patient’s initial opioid prescription. An even fewer number of states, 26, require all prescribers and/or dispensers to even register for PDMP access.21 The voluntary nature of the PDMPs may greatly limit their effectiveness.

Second, up until recent years, many states did not share their PDMP data across states lines. This became especially problematic in areas near the border of neighboring states. To date, 34 states are actively participating in the National Association of Boards of Pharmacy PMP InterConnect® which transmits data to each contributing state.22 Several other states will be added to the InterConnect® program in the near future.23

Third, PDMPs are only as effective as the information uploaded into the system. PDMPs will not be effective for patients using false identities or controlled substances obtained from illegal diversionary markets. For instance, researchers analyzed data in Maine in 2014 and found that only 24 percent of people arrested for drug trafficking had a matching PDMP report for the controlled substance documented in their criminal record.24

Efforts to improve PDMPs

The opioid epidemic in the United States is a multifactorial problem with many components affecting the amount of deaths due to overdose. Despite efforts currently in place, deaths from prescription drugs, opioids, benzodiazepines, and heroin are all trending up in the United States.25 The use of PDMPs is one important tool in the fight; however, improvements in the uptake, utilization, awareness, and connectivity of the databases across state lines needs to be a top priority to improve their effectiveness. A recent survey of primary care physicians determined the that majority of them knew about their state’s PDMP; however, only approximately half of physicians accessed the database.26 Similarly, only 71 percent of Indiana pharmacists reportedly used PDMPs in response to a survey.27

As lack of training, time constraints, and general unfamiliarity of PDMPs have been shown to be barriers of use,28 education to physicians and pharmacists is imperative, especially in states where accessing the database is not mandatory. Thirty-eight states permit a PDMP registrant to authorize a delegate at the registrant’s practice site to query the database.29 In states where this is lawful, delegating the task of generating a PDMP report can save the prescriber or dispenser a significant amount of time. Moreover, states should investigate the possibility of interfacing PDMPs with electronic medical records used by prescribers and pharmacists to streamline and integrate this information routinely into clinical practice, as noted in the Comprehensive Addiction and Recovery Act of 2016.30 As the improvements, utilization, and awareness to PDMPs increase, their effectiveness should continue to be formally evaluated. For example, efforts should be made to analyze data from states that require prescriber and pharmacist utilization of PDMPs compared to states without this requirement.31 Measuring the effectiveness of different laws and regulations will help identify and implement the most optimal characteristics of PDMPs.32

Conclusion

As the battle to stop the opioid epidemic rages on, members of the healthcare team such as prescribers and pharmacists play an important role in their respective arenas. PDMPs alone will not end the epidemic, but usage will better identify persons diverting controlled substances, decrease the supply of opioids in the community, and importantly, allow more patients to receive substance abuse treatment.

1 Includes the most recent available statistics. See “Overdose Death Rates Revised December 2015,” available at https://www.drugabuse.gov/related-topics/trends-statistics/overdose-death-rates.

2 Id.

3 See Paulozzi L, Baldwin G, Franklin G, et al, “CDC grand rounds: prescription drug overdoses - a U.S. epidemic,” MMWR Morb Mortal Wkly Rep 61:1 (January 2012): 10-3.

4 If authorized by state law to dispense medications to patients, examples of dispensers other than pharmacies may include physicians, nurse practitioners, or physician assistants. See “State Prescription Drug Monitoring Programs,” available at http://www.deadiversion.usdoj.gov/faq/rx_monitor.htm#7.

5 Although New York is credited with operating the first PDMP in the United States in 1918, only a few other states established PDMPs in the 20th century. In the year 2000, 16 states utilized a PDMP and by 2008, the number of states with a functioning PDMP increased to 32. See National Alliance for Model State Drug Laws, 2015 Annual Review of Prescription Monitoring Programs, available at http://www.namsdl.org/prescription-monitoring-programs.cfm.

6 See Brian Kelly, “St. Louis Prescription Drug Database Signed Into Law,” CBS St. Louis, May 31, 2016 (http://stlouis.cbslocal.com/2016/05/31/st-louis-prescription-drug-database-signed-into-law/).

7 See National Alliance for Model State Drug Laws, 2015 Annual Review of Prescription Monitoring Programs, available at http://www.namsdl.org/prescription-monitoring-programs.cfm.

8 Id.

The Controlled Substances Act created five schedules in which drugs are placed based on their currently accepted medical use, abuse potential, and degree to which the drug may cause physical or psychological dependence. Drugs in Schedule I have no accepted medical use and are used for research purposes only according to federal law. Pharmacies regularly dispense medications in Schedules II, III, IV, and V.
Many states require prescriptions dispensed for gabapentin (a non-controlled substance) to be reported to the PDMP due to the increased abuse of this medication.

9 See DEA, Pharmacist’s Manual: An Informational Outline of the Controlled Substances Act, Revised 2010, available at http://www.deadiversion.usdoj.gov/pubs/manuals/pharm2/index.html.

10 The term ‘prescriber’ includes a person who is licensed to issue prescriptions for controlled substances. Select examples include: doctors, nurse practitioners, physician assistants, dentists, podiatrists, optometrists, and pharmacists (in some states).

11 See DEA, Pharmacist’s Manual: An Informational Outline of the Controlled Substances Act, Revised 2010, available at http://www.deadiversion.usdoj.gov/pubs/manuals/pharm2/index.html.

12 See National Alliance for Model State Drug Laws, 2015 Annual Review of Prescription Monitoring Programs, available at http://www.namsdl.org/prescription-monitoring-programs.cfm.

13 Id.

14 See Patrick SW, Fry CE, Jones TF, Buntin MB, “Implementation Of Prescription Drug Monitoring Programs Associated With Reductions In Opioid-Related Death Rates,” Health Aff 35:7 (July 2016): 1324-32.

15 Id.

16 See Bao Y, Pan Y, Taylor A, Radakrishnan S, Luo F, et al, “Prescription Drug Monitoring Programs Are Associated With Sustained Reductions In Opioid Prescribing By Physicians,” Health Aff 36:6 (June 2016): 1045-51. See also Rutkow L, Chang HY, Daubresse M, Webster DW, Stuart EA, et al, “Effect of Florida's Prescription Drug Monitoring Program and Pill Mill Laws on Opioid Prescribing and Use,” JAMA Intern Med 175:10 (October 2015): 1642-9.

17 See Reifler LM, Droz D, Bailey JE, Schnoll SH, Fant R, et al, “Do prescription monitoring programs impact state trends in opioid abuse/misuse?” Pain Med 13:3 (March 2012): 434-42.

18 There are several potential explanations for the benefits seen from these studies. As the medical community gained an awareness of the overprescribing of opioids and the benefits of PDMPs, physicians likely changed their prescribing habits. Additionally, the period of time during which many of these studies were performed mirrored the increase in implementation of PDMPs and requirements by select states for prescribers and pharmacists to access the database.

See Reisman RM, Shenoy PJ, Atherly AJ, Flowers CR, “Prescription opioid usage and abuse relationships: an evaluation of state prescription drug monitoring program efficacy,” Subst Abuse 3 (May 2009): 41-51.

19 It is important to note that PDMPs, based on the state, will remove information from the database after a certain amount of years have passed.

20 See National Alliance for Model State Drug Laws, 2015 Annual Review of Prescription Monitoring Programs, available at http://www.namsdl.org/prescription-monitoring-programs.cfm.

21 Id.

22 See NABP, PMP InterConnect, http://www.nabp.net/programs/pmp-interconnect/nabp-pmp-interconnect.

23 Alabama, Georgia, Maine, Massachusetts, Montana, New Hampshire, North Carolina, Pennsylvania, and Wyoming have all signed memorandums of understanding to participate in the InterConnect program. California, Florida, Hawaii, Nebraska, Oregon, and Washington are the remaining states not currently involved in the InterConnect program.

24 See McCall K, Nichols SD, Holt C, Ochs L, Cattabriga G, et al, “Prescription Monitoring Program Trends Among Individuals Arrested in Maine for Trafficking Prescription Drugs in 2014,” Pharmacotherapy 36:6 (June 2016): 585-9.

25 See “Overdose Death Rates Revised December 2015,” available at https://www.drugabuse.gov/related-topics/trends-statistics/overdose-death-rates.

26 See Rutkow L, Turner L, Lucas E, Hwang C, Alexander GC, “Most primary care physicians are aware of prescription drug monitoring programs, but many find the data difficult to access,” Health Aff 34:3 (March 2015): 484-92.

27 See Norwood CW, Wright ER, “Promoting consistent use of prescription drug monitoring programs (PDMP) in outpatient pharmacies: removing administrative barriers and increasing awareness of Rx drug abuse,” Research in Social & Administrative Pharmacy 12:3 (2016): 509-514.

28 See Devo RA, Irvine JM, Hallvik SE, et al, “Leading a horse to water: facilitating registration and use of a prescription drug monitoring program,” Clin J Pain 31:9 (2015): 782-787.

29 See National Alliance for Model State Drug Laws, 2015 Annual Review of Prescription Monitoring Programs, available at http://www.namsdl.org/prescription-monitoring-programs.cfm.

30 The Comprehensive Addiction and Recovery Act of 2016 was signed into law in July 2016 and focuses on prevention, treatment, and recovery of opioid abuse. In addition, the law improves access to opioid overdose treatment (naloxone), raises awareness to the opioid epidemic, and expands prescription drug take back.

See Comprehensive Addiction and Recovery Act of 2016. Pub. L. 114-198. 130 Stat. 695; 85 pages. 22 July 2016.

31 Mandating use of PDMPs by physicians or pharmacists has received considerable pushback. Many are concerned with time constraints or added liability due to mandates establishing a new duty of care.

32 The National Alliance for Model State Drug Laws has published the “Model Prescription Monitoring Program (PMP) Act” which provides recommendations to states when developing PDMP laws and regulations. Available at: http://www.namsdl.org/namsdl-model-laws.cfm.

Geoffrey Mospan

Wingate University School of Pharmacy, Wingate, NC

Geoffrey Mospan is an Assistant Professor of Pharmacy at Wingate University School of Pharmacy in Wingate, NC where he is the course leader for Pharmacy Law and Ethics and also teaches in the Pain Pharmacotherapy course. Dr. Mospan is Board Certified in Pharmacotherapy, practices in the hospital setting as an Internal Medicine pharmacist, and is licensed in North Carolina and Ohio. He may be reached at g.mospan@wingate.edu.