Abstract
Prescription Drug Monitoring Programs (PDMPSs) permit physicians to determine whether patients obtained addictive substances from multiple physicians or pharmacies. In April 2017, the Saint Louis County Department of Public Health created its own PDMP. This manuscript evaluates evidence regarding the efficacy of PDMPs, in addition to discussing their impact on patient care and a provider’s workflow. It also details how physicians can register to use the St. Louis County PDMP, Missouri’s de-facto PDMP.
Foreword
This article grows from the 1st Annual Larry Lewis Symposium, held at Washington University School of Medicine in St. Louis in August 2017. The Symposium was a scientific forum addressing the current opioid epidemic. The purpose of this article includes:
* Educate Missouri Medicine readership regarding the “pro” and “con” evidence regarding efficacy of Prescription Drug Monitoring Programs (PDMPs).
* Emphasize that when a patient’s PDMP data suggests they have an opioid use disorder (OUD), the next step is NOT to simply stop prescribing opioids.
* Facilitate increased access to and improved utilization of the St. Louis County PDMP, Missouri’s defacto PDMP.
* Instruct residents on how they can gain access to the St. Louis County PDMP.
Prologue/Clinical Vignette
Your first patient arrives with a “chief complaint” of “back pain flare-up.” A brief chart review demonstrates frequent encounters for pain exacerbations. Upon entering the patient’s room, you find a 35-year-old man with hips flexed and knees extended, while crying out in excruciating pain that “only oxycodone can help.”
Upon examination, there are no physical abnormalities, his pain is distractible and inconsistent, and a negative straight leg raise sign is observed. At this point, the patient asks for benzodiazepines and opioids. Recalling a prior issue of Missouri Medicine that focused upon the current opioid epidemic you strongly suspect he has an OUD.1
You would like to know if he recently received opioids from another provider. In a prior issue of Missouri Medicine, you remember reading about PDMPs and are aware of the existence of the St. Louis County PDMP.2 While not wanting to undertreat his pain, you are also unsure whether prescribing opioids is appropriate. You would like to have objective data to support your decision. You suddenly regret not having registered as an authorized user of the PDMP.
Let’s learn how to resolve this dilemma after first reviewing why it is important to do so.
What is the Scope of the Problem?
Opioid1 abuse is a growing epidemic in this country, particularly in the Midwest and Missouri. Between 2002 and 2011, 25 million Americans initiated nonmedical use of pain relievers, the majority of which were opioid analgesics; many developed substance use disorders (SUDs).3 Unfortunately, physicians in training are not adequately taught how to diagnose, treat, or refer patients with SUDs to treatment, causing them to be poorly-prepared to do so.4
The rate of opioid overdose deaths due to prescription and illicit opioids in the United States has exploded, quintupling between 1999 and 2016.5 In 2015 approximately 33,000 Americans died of an opioid-associated drug overdose.6 That number rose to 42,249 in 2016.5 Patients presenting to the emergency department (ED) following an opioid overdose rose 30% between July 2016 and September 2017.7 Of overdose deaths from opioids, almost half are directly due to prescription opioids. The other half of decedents are likely to have utilized prescription opioids during initiation or maintenance of their OUD and subsequently switched to heroin.6
The Midwest was disproportionately affected, with a 70% increase during the same 14 months.7 In Missouri there were 908 opioid-related deaths in 2016, a 35% increase over 2015.8 To put that in perspective, 947 Missourians died in road accidents and 880 Missourians died from breast cancer that year.9,10 The opioid epidemic was estimated to cost Missourians $12.6 billion in 2016, which represents 4.2% of Missouri’s GDP (Figure 1) or nearly $1.4 million per hour.11,12 While opioid-related deaths will never be zero, initiation of proper opioid stewardship programs including utilizing PDMPs and referral for OUD can decrease this number. Conceptually, using a PDMP to screen and intervene to prevent future morbidity draws similarities to physicians discussing mammograms, breast screening exams, or seatbelt and helmet usage with their patients.
Are PDMPs Effective?
The answer to this question may depend on how it is asked and how one judges the results. Sun et al. evaluated the effects of an automated PDMP query, embedded into an electronic health record (EHR), on opioid prescribing by emergency physicians in Washington State.13 The algorithm was not associated with decreased opioid prescribing even in patients with evidence of previous “high-risk” opioid use. However, these results were derived from a database that extracted only selected components of the individual patient encounter records. Based on a single-center study, Hawk et al. concluded that although their state’s PDMP was helpful toward identifying some patients’ aberrant drug-related behavior, it was not able to detect most occurrences.14 A recent systematic review including 17 manuscripts concluded there was insufficient evidence to determine whether PDMPs decreased fatal overdoses. However, low-strength evidence from ten studies did suggest a reduction in fatal overdoses and three studies demonstrated increased overdoses from heroin post-implementation.15
In this journal, Dr. John Lilly argued against enactment of PDMPs. He wrote that PDMPs do not decrease opioid-related unintentional deaths.2 We believe this view derives from an incomplete consideration of the matter, as to decrease opioid-related deaths is not a PDMP’s sole intended purpose. Mortality is a multi-factorial outcome, and in isolation, PDMPs are not expected to significantly impact mortality. However, data from Florida demonstrated decreased opioid-related deaths associated with their PDMP in 2017. According to the CDC, when multiple interventions including a PDMP were implemented, both opioid prescriptions and opioid-related deaths decreased. Further, in Florida, Ohio, and Kentucky, roll-out of state-wide PDMPs coincided with closer regulation of pain clinics and opioid prescribing decreased as a result (Figure 2).16 Further, Dr. Lilly did not discuss the matter of the substantial direct and indirect costs to the state due to the opioid crisis.11 Additionally, many states with effective PDMPs increased the number of patients enrolled in Medication Assisted Treatment (MAT), which will be discussed in a subsequent installment in this series.
Weiner et al. investigated emergency physicians’ opioid prescribing in Ohio after a PDMP was introduced there in 2011 and after the state distributed opioid prescribing guidelines in 2012 advocating for prescribing no more than a three-day supply. After PDMP introduction, the number of opioid prescriptions decreased in 85% of the jurisdictions evaluated. Weiner’s group found that the issuance of the guideline accelerated the already-declining rate of total opioid prescriptions and number of pills prescribed, which began after the PDMP was initiated.17 Similar data were derived in Pennsylvania, where Suffoletto et al. found that at 15 Emergency Departments (EDs), opioid prescribing decreased in the first month after PDMP implementation (September, 2016) from 12.4 to 10.2% of patients. This decrease continued for each month between September 2016 and March 2017.18 Bao et al. demonstrated a 30% reduction in ambulatory care center prescriptions of schedule II opioids associated with the implementation of PDMPs in 24 states.19 Limiting the number of opioid prescriptions and pill counts could also limit the potential “black market” for prescription opioids, which was discussed at Senate hearings.20
Can PDMPs Assist Balancing Opioid Prescribing and Properly Managing Pain?
The goal of effective PDMPs is not to eliminate opioid prescribing, as opioids are necessary and appropriate to treat many painful medical conditions. The goal is instead to reduce inappropriate opioid prescribing, although reduction in total prescribing may be a natural consequence.
Physicians are public health advocates and take an oath to first do no harm (primum non nocere). It is challenging to balance the mission to alleviate suffering with the risk of contributing to a patient’s likelihood of developing an OUD. Over the last 20 years, most OUDs began with oral opioids prescribed by physicians. While an increasing number of patients initiate OUDs with illicit opioids such as heroin and more are dying from illicit opioids, the fact remains that the majority of patients with an OUD still started with prescription opioids.21–23 While most patients exposed to opioids will not develop an OUD, our ability to predict who will is limited.
Physicians treating patients with pain must weigh the possibility of inappropriate prescribing against the possibility of under-treatment of pain. The 2016 CDC clinical guidelines for prescribing opioids for chronic pain stated that opioids were only indicated when their benefits outweigh their risks.24 Additionally, multiple studies question the efficacy of opioids in the management of chronic pain, although they may still be indicated in patients with both acute and chronic pain.25–27
It is difficult to distinguish patients with pain who require opioids from those seeking opioids for inappropriate use or diversion. Many physicians believe that vital sign abnormalities such as hypertension and tachycardia are good indicators of pain. However, these are probably not useful surrogates.28 Laboratory data also fail to provide accurate evidence of drug abuse. Standard urine drug screens (UDSs) only reliably detect morphine, codeine, and heroin (both metabolized to morphine). UDSs are less sensitive for semisynthetic opioids like oxycodone and hydrocodone and are ineffective tests for synthetic opioids such as fentanyl, meperidine, and methadone.29 Further, collecting the specimen is challenging in busy environments such as EDs or hospital wards, and not useful at physician’s offices, where test results may take multiple days to return.
Doctors thus often rely on clinical gestalt, but this is also imperfect and susceptible to racial/ethnic/gender biases, that can swing the pain management pendulum to oligoanalgesia. For example, numerous studies demonstrate a discrepancy in opioid analgesic use in Caucasian versus other racial and ethnic groups (Table 1).30–33 Additionally, physician gestalt is not nearly as accurate as widely believed and has a poor ability to detect OUD.34
Table 1.
Report | Study Subjects | Study Years | Principal Findings |
---|---|---|---|
Chen I, Kurz J, Pasanen M, et al. Racial Differences in Opioid Use for Chronic Nonmalignant Pain | 397 patients over 18 years old with chronic pain presenting to 12 academic primary care settings throughout the U.S. | 2002–2003 | Among patients treated in primary care clinics for chronic pain, 45.7% of Caucasians received an opioid prescription while only 32.2% of African Americans received an opioid prescription |
Pletcher MJ, Kertesz SG, Kohn MA, Gonzales R. Trends in Opioid Prescribing by Race/Ethnicity for Patients Seeking Care in US Emergency Departments | 156,729 patients of any age with any painful complaint presenting to noninstitutional general and short-stay hospital emergency departments throughout the U.S. | 1993–2005 | Among patients who presented to an emergency department with pain-related complaints, 40% of Caucasians received an opioid prescription at discharge while only 32% of all other races received an opioid prescription at discharge |
Tamayo-Sarver JH, Hinze SW, Cydulka RK, Baker DW. Racial and Ethnic Disparities in Emergency Department Analgesic Prescription | 67,487 patients of any age with any complaint presenting to nonfederal, short-stay hospital emergency departments throughout the U.S. | 1997–1999 | Among patients who presented to the ED with pain and received some type of analgesic during their stay, 34% of Caucasians, 23% of African Americans, and 23% of Latinos received an opioid analgesic |
Heins JK, Heins A, Grammas M, et al. Disparities in Analgesia and Opioid Prescribing Practices for Patients With Musculoskeletal Pain in the Emergency Department | 868 patients over 18 years old with musculoskeletal pain presenting to an academic emergency department in Alabama | 2004 | Among patients presenting with musculoskeletal pain to this emergency department, Caucasians were 86% more likely to receive an opioid during their stay, 81% more likely to receive a prescription analgesic at discharge, and 98% more likely to receive an opioid prescription analgesic at discharge than African Americans with similar complaints |
It is important to remember that decreased opioid prescribing via the use of a PDMP and proper analgesia are not mutually exclusive principles. However, oligoanalgesia is a potential side effect of stricter opioid prescribing policies. Nobody wants patients’ pain to go untreated. The fear of opioids being under-prescribed, and the fear of patients suffering from widespread oligoanalgesia is a common argument against PDMPs. However, when PDMP data are used as intended, and when a patient experiencing pain presents for care while not receiving opioids from multiple prescribers, the PDMP may alleviate physician concerns about possible inappropriate prescribing. This may have been what occurred in the previously mentioned study from Washington where prescribing increased in some cases due to lack of concerning findings in the PDMP.13
Physicians may also worry that a tool reducing opioid prescribing may affect their patient satisfaction scores. One study evaluating the implementation of opioid prescribing guidelines demonstrated that physicians believed their patients’ pain was just as well controlled with fewer opioids.35 While not definitive proof of pain improvement, as patients were not surveyed, physicians did not have evidence that pain control was worse. Another study also did not demonstrate an association between opioid administration and patient satisfaction scores.36 While not a PDMP study, it shows that decreased opioid prescribing is not necessarily associated with decreased patient satisfaction. However, governmental agencies and hospital administration need to support physicians if satisfaction scores are negatively impacted by responsible opioid prescribing.
Despite this data, it is important to note that if not used properly as a tool or part of a larger plan, PDMPs do have the ability to drive patients to more dangerous illicit opioid use. Simply “cutting off ” opioid prescriptions does not treat a patient’s OUD and may increase the probability of them purchasing diverted prescription opioids or illicit opioids such as heroin.
Data derived from a PDMP should be used as a tool to initiate a discussion with the patient, and invites an opportunity to screen for SUDs. If the patient, once confronted, expresses interest in OUD treatment, then appropriate referral can follow. MAT improves mortality, and identification of an OUD via a PDMP assists physicians in discussing treatment prior to a patient overdosing. For patients with inadequate analgesia, the encounter represents an opportunity to place stricter limits on their prescribing plan, refer them to addiction or pain specialists, or introduce non-opioid analgesics and physical therapy where appropriate.
What is the St. Louis County Prescription Drug monitoring Program?
The St. Louis County PDMP started as a grassroots project. Its belated launch in 2017, as well as its unusual “bottom-up” structure, can be attributed to opposition against establishing a PDMP by a powerful minority in the Missouri legislature. Opponents express privacy concerns, such as the Missouri government having access to medical information, cybersecurity threats, and the threat that someone might improperly obtain the information and use it inappropriately (e.g., commit a Health Insurance Portability and Accountability Act violation, which is a felony). However, many of these same concerns apply to any electronic health record or insurance-maintained database.
St. Louis County Council member Sam Page, MD, a former member of the Missouri General Assembly, supported a state-wide PDMP while a member of the legislature. Dr. Page later became a St. Louis County Councilman, and a locally-based PDMP was launched on April 25, 2017, in St. Louis County and City and 12 other participating jurisdictions. Subsequently, due to the hard work by many at the Saint Louis County Department of Public Health, the number of residents, fully-licensed doctors, and pharmacists in counties participating in the St. Louis County PDMP continues to grow. (https://www.stlouisco.com/Portals/8/docs/document%20library/PDMP/SubscribingCountyList.pdf)
The St. Louis County PDMP is fast and convenient to use. Any Missouri physician can register and utilize the PDMP as part of patient care, and can allow delegate access so that a medical assistant can use the PDMP for them, which saves physicians’ time.37 The PDMP also allows for bulk searching to further increase efficiency. Unfortunately, many Missouri providers are either not enrolled or not using the PDMP. Physicians may perceive time restraints, despite the fact that the query process takes less than 90 seconds. Even in the fast-paced environment of the ED, the authors often use it multiple times each shift. We hope that in the future the PDMP becomes embedded in the electronic medical record, similar to that which occurred in Washington. Lastly, use of the PDMP is voluntary. Depending on the situation, providers can choose not to check the PDMP prior to writing a prescription.
A St. Louis County PDMP query result shows the number of prescriptions filled by a patient, date written, date filled, filling location, and prescriber. It receives data from pharmacies in participating jurisdictions for schedule II-IV controlled substances, which is transmitted according to national standards established by the American Society for Automation in Pharmacy. Once uploaded, the PDMP vendor, Appriss®, validates, processes, and cleans the data prior to publication in the registry. Patients are identified by their name and date of birth. The provider can also view the patient’s address and who wrote the prescription, if other safeguards are needed to verify the data’s accuracy. This contrasts with the monitoring program established by an executive order of the former Governor.38 That tool did not enable access to real-time, individual patient-level data as the St. Louis County PDMP does now.
So How Can I Use a PDMP To Improve the Quality of Care to My Patient?
So, what does the provider do if after reviewing the PDMP, they believe their patient has an OUD? PDMP data provide an opening for a conversation about drug abuse, the patient’s readiness to quit, and drug abuse treatment options like MAT which includes methadone, buprenorphine, and naltrexone therapies. Fortunately, the St. Louis County PDMP can assist with this as well, as it provides links to organizations such as the Substance Abuse and Mental Health Services Administration (SAMHSA). SAMHSA provides physicians with free tools and resources to assist patients with treatment once an OUD is diagnosed, runs a 24/7 referral helpline and MAT practitioner locator, and more.39 While there are not enough resources for SUD treatment for those currently in need, it is hoped that increases in state and federal funding could improve what is currently available.
By failing to access information provided by the St. Louis County PDMP, the diagnosis of OUD may be missed or appropriate prescriptions could be withheld. While drug abuse treatment is the ideal outcome, there is value in identifying and documenting concerns to help future providers appropriately treat these patients or discuss other harm reduction practices. The St. Louis County PDMP was designed to be a non-intrusive tool used in conjunction with other care. However, if used in isolation, any PDMP is unlikely to improve care and may cause harm.
The Bottom Line
By obtaining access to and utilizing the St. Louis County PDMP, physicians have the ability to better identify and treat patients with OUD and can assist in changing the future of the opioid crisis in Missouri and the greater Midwest.
If the reader is interested in becoming a registered user of the St. Louis County PDMP, please follow the instructions in Figure 3.
Conclusion
The St. Louis County PDMP is likely to continue to be the de-facto Missouri state PDMP for the foreseeable future. It is user-friendly, rapidly accessible and presents information in a clear and useful format. Further, residents can become delegate-users once they secure a fully-licensed physician to serve as their supervising physician.
The Saint Louis County Department of Public Health continues to attract more counties to participate in its PDMP, and they have secured federal funding to ensure that new countries can join at no cost to the county until September 2019!
Footnotes
Julia Lange, MD, (above), is a PGY-2 Emergency Medicine Resident; Gary Gaddis, MD, PhD, MSMA member since 2002, is Professor of Emergency Medicine; and Evan Schwarz, MD, FACEP, FACMT, MSMA member since 2014, is Associate Professor of Emergency Medicine, Section Chief Medical Toxicology, Division of Emergency Medicine; all are at Washington University School of Medicine in St. Louis, Missouri. At the Saint Louis County Department of Public Health, Spring Schmidt, PhD(c), is the Acting Director; Emily varner, MPH, is the PDMP Coordinator; and Rachel Cohen, MPH, is the Public Health Coordinator.
Contact: jmlange@wustl.edu
Author’s Note
We use the term “opioids” to capture the more precise terms “opiate” (a naturally-occurring medication, such as morphine and codeine) and “opioid” (synthetic or semi-synthetic medications that have opiate-like effects and chemical structures). The word “narcotic” will not be utilized, because “narcotic” is a legal term, not a pharmacologic class of medications.
Disclosure
None reported.
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