Spatiotemporal Analysis of the Association Between Pain Management Clinic Laws and Opioid Prescribing and Overdose Deaths.

Pain management clinic (PMC) laws were enacted by 12 states to promote appropriate opioid prescribing, but their impact is inadequately understood. We analyzed county-level opioid overdose deaths (National Vital Statistics System) and patients filling long-duration (≥30 day) or high-dose (≥90 morphine milligram equivalents per day) opioid prescriptions (IQVIA, Inc.) in the United States in 2010-2018. We fitted Besag-York-Mollié spatiotemporal models to estimate annual relative rates (RRs) of overdose and prevalence ratios (PRs) of high-risk prescribing associated with any PMC law and 3 provisions: payment restrictions, site inspections, and criminal penalties. Laws with criminal penalties were significantly associated with reduced PRs of long-duration and high-dose opioid prescriptions (adjusted PR = 0.82, 95% credible interval (CrI): 0.82, 0.82, and adjusted PR = 0.73, 95% CI: 0.73, 0.74 respectively) and reduced RRs of total and natural/semisynthetic opioid overdoses (adjusted RR = 0.86, 95% CrI: 0.80, 0.92, and adjusted RR = 0.84, and 95% CrI: 0.77, 0.92, respectively). Conversely, PMC laws were associated with increased relative rates of synthetic opioid and heroin overdose deaths, especially criminal penalties (adjusted RR = 1.83, 95% CrI: 1.59, 2.11, and adjusted RR = 2.59, 95% CrI: 2.22, 3.02, respectively). Findings suggest that laws with criminal penalties were associated with intended reductions in high-risk opioid prescribing and some opioid overdoses but raise concerns regarding unintended consequences on heroin/synthetic overdoses.

Systematic Evaluation of State Policy Interventions Targeting the US Opioid Epidemic, 2007-2018.

Importance: In response to the increase in opioid overdose deaths in the United States, many states recently have implemented supply-controlling and harm-reduction policy measures. To date, an updated policy evaluation that considers the full policy landscape has not been conducted. Objective: To evaluate 6 US state-level drug policies to ascertain whether they are associated with a reduction in indicators of prescription opioid abuse, the prevalence of opioid use disorder and overdose, the prescription of medication-assisted treatment (MAT), and drug overdose deaths. Design, Setting, and Participants: This cross-sectional study used drug overdose mortality data from 50 states obtained from the National Vital Statistics System and claims data from 23 million commercially insured patients in the US between 2007 and 2018. Difference-in-differences analysis using panel matching was conducted to evaluate the prevalence of indicators of prescription opioid abuse, opioid use disorder and overdose diagnosis, the prescription of MAT, and drug overdose deaths before and after implementation of 6 state-level policies targeting the opioid epidemic. A random-effects meta-analysis model was used to summarize associations over time for each policy and outcome pair. The data analysis was conducted July 12, 2020. Exposures: State-level drug policy changes to address the increase of opioid-related overdose deaths included prescription drug monitoring program (PDMP) access, mandatory PDMPs, pain clinic laws, prescription limit laws, naloxone access laws, and Good Samaritan laws. Main Outcomes and Measures: The outcomes of interests were quarterly state-level mortality from drug overdoses, known indicators for prescription opioid abuse and doctor shopping, MAT, and prevalence of drug overdose and opioid use disorder. Results: This cross-sectional study of drug overdose mortality data and insurance claims data from 23 million commercially insured patients (12 582 378 female patients [55.1%]; mean [SD] age, 45.9 [19.9] years) in the US between 2007 and 2018 found that mandatory PDMPs were associated with decreases in the proportion of patients taking opioids (-0.729%; 95% CI, -1.011% to -0.447%), with overlapping opioid claims (-0.027%; 95% CI, -0.038% to -0.017%), with daily morphine milligram equivalent greater than 90 (-0.095%; 95% CI, -0.150% to -0.041%), and who engaged in drug seeking (-0.002%; 95% CI, -0.003% to -0.001%). The proportion of patients receiving MAT increased after the enactment of mandatory PDMPs (0.015%; 95% CI, 0.002% to 0.028%), pain clinic laws (0.013%, 95% CI, 0.005%-0.021%), and prescription limit laws (0.034%, 95% CI, 0.020% to 0.049%). Mandatory PDMPs were associated with a decrease in the number of overdose deaths due to natural opioids (-518.5 [95% CI, -728.5 to -308.5] per 300 million people) and methadone (-122.7 [95% CI, -207.5 to -37.8] per 300 million people). Prescription drug monitoring program access policies showed similar results, although these policies were also associated with increases in overdose deaths due to synthetic opioids (380.3 [95% CI, 149.6-610.8] per 300 million people) and cocaine (103.7 [95% CI, 28.0-179.5] per 300 million people). Except for the negative association between prescription limit laws and synthetic opioid deaths (-723.9 [95% CI, -1419.7 to -28.1] per 300 million people), other policies were associated with increasing overdose deaths, especially those attributed to non-prescription opioids such as synthetic opioids and heroin. This includes a positive association between naloxone access laws and the number of deaths attributed to synthetic opioids (1338.2 [95% CI, 662.5 to 2014.0] per 300 million people). Conclusions and Relevance: Although this study found that existing state policies were associated with reduced misuse of prescription opioids, they may have the unintended consequence of motivating those with opioid use disorders to access the illicit drug market, potentially increasing overdose mortality. This finding suggests that there is no easy policy solution to reverse the epidemic of opioid dependence and mortality in the US.

Florida's Opioid Crackdown and Mortality From Drug Overdose, Motor Vehicle Crashes, and Suicide: A Bayesian Interrupted Time-Series Analysis.

In 2011, Florida established a prescription drug monitoring program and adopted new regulations for independent pain-management clinics. We examined the association of those reforms with drug overdose deaths and other injury fatalities. Florida's postreform monthly mortality rates-for drug-involved deaths, motor vehicle crashes, and suicide by means other than poisoning-were compared with a counterfactual estimate of what those rates would have been absent reform. The counterfactual was estimated using a Bayesian structural time-series model based on mortality trends in similar states. By December 2013, drug overdose deaths were down 17% (95% credible interval: -21, -12), motor vehicle crash deaths were down 9% (95% credible interval: -14, -4), and suicide deaths were unchanged compared with what would be expected in the absence of reform. Florida's opioid prescribing reform substantially reduced drug overdose deaths. Reforms may also have reduced motor vehicle crash deaths but were not associated with a change in suicides. More research is needed to understand these patterns. Bayesian structural time-series modeling is a promising new approach to interrupted time-series studies.

Effect of State Policy Changes in Florida on Opioid-Related Overdoses.

INTRODUCTION: With a rapid increase in prescription opioid overdose deaths and a proliferation of pain clinics in the mid-2000s, Florida emerged as an epicenter of the opioid overdose epidemic. In response, Florida implemented pain clinic laws and operationalized its Prescription Drug Monitoring Program. This study examines the effect of these policies on rates of inpatient stays and emergency department visits for opioid-related overdoses. METHODS: Using data from the 2008-2015 State Emergency Department Databases and State Inpatient Databases, quarterly rates of inpatient stays and emergency department visits for prescription opioid-related overdoses and heroin-related overdoses were computed. A comparative interrupted time series analysis examined the effect of these policies on opioid overdose rates. North Carolina served as a control state because it did not implement similar policies during the study period. The data were analyzed in 2019. RESULTS: Compared with North Carolina, Florida's polices were associated with reductions in the rates of prescription opioid-related overdose inpatient stays and emergency department visits, a level reduction of 2.31 per 100,000 and a reduction in the trend of 0.16 per 100,000 population each quarter. The policies were associated with a reduction of 13,532 inpatient stays and emergency department visits for prescription opioid-related overdoses during the study period. No statistically significant association was found between the policies and heroin-related overdose inpatient stays and emergency department visits. CONCLUSIONS: To address the opioid overdose epidemic, states have implemented policies such as Prescription Drug Monitoring Programs and pain clinic laws designed to reduce inappropriate opioid prescribing. Such laws may be effective in reducing prescription opioid-related overdoses.

The association between pain clinic laws and prescription opioid exposures: New evidence from multi-state comparisons.

OBJECTIVES: States in the US are controlling opioid prescribing to combat the opioid epidemic. Prescription Drug Monitoring Programs (PDMPs) were widely adopted, whereas less attention was given to pain clinic laws. This study examined the associations of mandatory use of PDMPs and pain clinic laws with prescription opioid exposures. METHODS: State-level quarterly prescription opioid exposures reported to the National Poison Data System during 2010-2017 were analyzed. The primary outcome was age-adjusted rates of prescription opioid exposures per 1,000,000 population. The primary policy variables included the implementation of mandatory use of PDMPs alone, the implementation of pain clinic laws alone, and the implementation of both mandatory use of PDMPs and pain clinic laws. Linear regressions were used to examine the associations, controlling for other opioid policies, marijuana policies, socioeconomic factors, state fixed effects, time fixed effects, and state-specific time trends. RESULTS: Requiring mandatory use of PDMPs alone was not associated with significant changes in prescription opioid exposures. The implementation of pain clinic laws with or without concurrent mandatory use of PDMPs was associated with 5 fewer prescription opioid exposures per 1,000,000 population or a 9 % reduction compared to the pre-policy period (p < 0.01). Further analysis revealed that the reduction associated with pain clinic laws was pronounced in exposures reported by healthcare facilities. CONCLUSIONS: This multi-state study provided new evidence that the implementation of pain clinic laws was associated with a significant reduction in prescription opioid exposures. Pain clinic laws may deserve further evaluation and consideration.

Prescriber responses to a pain clinic law: Cease or modify?

BACKGROUND: Pain clinic laws are designed to cease or modify high-risk prescribing behavior. However, prior evaluations have not differentiated between these types of prescriber responses in their analysis, even though they may have different implications for patients. The purpose of this analysis is to investigate the effect of a 2016 Tennessee pain clinic law on the two types of prescriber responses. METHODS: We used data on opioid prescriptions from the Tennessee Controlled Substances Monitoring Database (CSMD) between July 1st, 2015 and July 1st, 2017. Prescribers were assigned to the cessation or modification group based on the date of their last opioid prescription during the time period July 1st, 2015 to July 1st, 2018 and its relationship to the change in law. A risk score was developed based on five indicators to capture two categories of risky prescriber behavior: increased risk for diversion or increased patient's risk of overdose. Within-prescriber differences were used to assess the effect of the law on several outcomes that capture the quantity and content of opioid prescriptions. RESULTS: There was a significant decline in the number of prescriptions (cessation mean = -45.18 pval<0.001; continuation mean = -24.41 pval<0.001) and patients (cessation mean = -16.68pval<0.001; continuation mean = -10.92 pval<0.001) in both prescriber response groups, but the magnitude of decline was much larger in the cessation group. High-risk prescribers were more likely to cease prescribing than modify. CONCLUSIONS: Prescribers who ceased prescribing in response to the pain clinic law disproportionately contributed to overall declines in opioid prescriptions.

The Meaning of Monthly: Court Ruling Offers Hope on Pain Clinic Registrations.

Physicians can encounter a web of confusion and unfairness when it comes to navigating the Texas Medical Board (TMB). A Travis County district court has given Texas physicians clarity and hope when it comes to certain medical board investigations. The court's decision, if it holds up, establishes an important precedent for when physicians are required to register their facility as a pain management clinic.

Pain clinic definitions in the medical literature and U.S. state laws: an integrative systematic review and comparison.

BACKGROUND: In response to widespread opioid misuse, ten U.S. states have implemented regulations for facilities that primarily manage and treat chronic pain, called "pain clinics." Whether a clinic falls into a state's pain clinic definition determines the extent to which it is subject to oversight. It is unclear whether state pain clinic definitions model those found in the medical literature, and potential differences lead to discrepancies between scientific and professionally guided advice found in the medical literature and actual pain clinic practice. Identifying discrepancies could assist states to design laws that are more compatible with best practices suggested in the medical literature. METHODS: We conducted an integrative systematic review to create a taxonomy of pain clinic definitions using academic medical literature. We then identified existing U.S. state pain clinic statutes and regulations and compared the developed taxonomy using a content analysis approach to understand the extent to which medical literature definitions are reflected in state policy. RESULTS: In the medical literature, we identified eight categories of pain clinic definitions: 1) patient case mix; 2) single-modality treatment; 3) multidisciplinary treatment; 4) interdisciplinary treatment; 5) provider supervision; 6) provider composition; 7) marketing; and 8) outcome. We identified ten states with pain clinic laws. State laws primarily include the following definitional categories: patient case mix; single-modality treatment, and marketing. Some definitional categories commonly found in the medical literature, such as multidisciplinary treatment and interdisciplinary treatment, rarely appear in state law definitions. CONCLUSIONS: This is the first study to our knowledge to develop a taxonomy of pain clinic definitions and to identify differences between pain clinic definitions in U.S. state law and medical literature. Future work should explore the impact of different legal pain clinic definitions on provider decision-making and state-level health outcomes.

Questions Abound.

The Texas Medical Board's new rules on inspecting clinics for failure to register as pain management clinics have provisions of potential concern for doctors.

The effect of state laws designed to prevent nonmedical prescription opioid use on overdose deaths and treatment.

Nonmedical use of prescription opioids has reached epidemic levels in the United States and globally. In response, federal, state, and local governments are taking actions to address substantial increases in prescription opioid addiction and its associated harms. This study examines the effect of two state laws specifically designed to curtail access to prescription opioids to nonmedical users: pain management clinic and doctor shopping laws. We use administrative data on overdose deaths and admissions to specialty substance use disorder treatment coupled with a differences-in-differences design. Our findings suggest that both pain management clinic and doctor shopping laws have the potential to reduce prescription opioid overdose deaths. Moreover, doctor shopping laws appear to reduce prescription opioid treatment admissions. As many states have adopted these laws in recent years, the full effects of the laws may not yet be realized. Future research using more postlaw passage data should reevaluate the effectiveness of these laws.

A Contemporary Medicolegal Analysis of Outpatient Medication Management in Chronic Pain.

BACKGROUND: Opioids are frequently used in chronic pain management but are associated with significant morbidity and mortality in some patient populations. An important avenue for identifying complications-including serious or rare complications-is the study of closed malpractice claims. The present study is intended to complement the existing closed claims literature by drawing on claims from a more recent timeframe through a partnership with a large malpractice carrier, the Controlled Risk Insurance Company (CRICO). The goal of this study was to identify patient medical comorbidities and aberrant drug behaviors, as well as prescriber practices associated with patient injury and malpractice claims. Another objective was to identify claims most likely to result in payments and use this information to propose a strategy for reducing medicolegal risk. METHODS: The CRICO Strategies Comparative Benchmarking System is a database of claims drawing from >350,000 malpractice claims from Harvard-affiliated institutions and >400 other academic and community institutions across the United States. This database was queried for closed claims from January 1, 2009, to December 31, 2013, and identified 37 cases concerning noninterventional, outpatient chronic pain management. Each file consisted of a narrative summary, including expert witness testimony, as well as coded fields for patient demographics, medical comorbidities, the alleged damaging event, the alleged injurious outcome, the total financial amount incurred, and more. We performed an analysis using these claim files. RESULTS: The mean patient age was 43.5 years, with men representing 59.5% of cases. Payments were made in 27% of cases, with a median payment of $72,500 and a range of $7500-$687,500. The majority of cases related to degenerative joint disease of the spine and failed back surgery syndrome; no patients in this series received treatment of malignant pain. Approximately half (49%) of cases involved a patient death. The use of long-acting opioids and medical conditions affecting the cardiac and pulmonary systems were more closely associated with death than with other outcomes. The nonpain medical conditions present in this analysis included obesity, obstructive sleep apnea, chronic obstructive pulmonary disease, hypertension, and coronary artery disease. Other claims ranged from alleged addiction to opioids from improper prescribing to alleged abandonment with withdrawal of care. The CRICO analysis suggested that patient behavior contributed to over half of these claims, whereas deficits in clinical judgment contributed to approximately 40% of the claims filed. CONCLUSIONS: Claims related to outpatient medication management in pain medicine are multifactorial, stemming from deficits in clinical judgment by physicians, noncooperation in care by patients, and poor clinical documentation. Minimization of both legal risk and patient harm can be achieved by carefully selecting patients for chronic opioid therapy and documenting compliance and improvement with the treatment plan. Medical comorbidities such as obstructive sleep apnea and the use of long-acting opioids may be particularly dangerous. Continuing physician education on the safest and most effective approaches to manage these medications in everyday practice will lead to both improved legal security and patient safety.

Care strategies and therapeutic pathways for chronic pain patients in Abruzzo Region, Italy.

BACKGROUND: Chronic pain is considered to be among the most disabling and costly diseases in North America, Europe and Australia. A large survey was conducted on chronic pain in Europe, called Pain in Europe. Italy ranks third in Europe in terms of prevalence, with 26% of the population suffering from chronic pain at some point. In 2010 Italy passed Law 38/2010, to ensure treatment for pain control in patients with oncological diseases as well as in patients with chronic non-cancer pain through a network of care services. This study aims to provide preliminary information regarding the application of L.38/2010 in the Abruzzo region of Italy. METHODS: A descriptive study was conducted on a non-probabilistic sample of people who attended pain therapy centres of the local health service in 2014. The patients (129) were interviewed by centre staff using a validated questionnaire. Recruitment was carried out by enrolling consecutive cases over a three-month period (February to April). RESULTS: Almost two-thirds of the patients had visited several physicians before requesting help. The initial visit to the pain therapy centre was made after some months in 37.2% of cases, and in 38% of patients it was made years after the onset of pain. The reasons given for this long wait before seeking specialist medical treatment for chronic pain reveal a wait-and-see attitude on the part of patients, who controlled their pain by taking painkillers. Responsibility for this delay in requesting assistance can however also be attributed 'externally' to the fact that patients were not aware that this kind of centre was available. CONCLUSION: The results of the study describe, in a regional context, a situation in which L.38/2010 is hard to apply. The study showed how the care pathway for these patients is still characterised by difficulty in accessing the network of local services. Clearly, more effort needs to be directed towards an effective application of L.38/2010, with increased availability of resources to develop and strengthen the network of services at regional level.

Mandatory Provider Review And Pain Clinic Laws Reduce The Amounts Of Opioids Prescribed And Overdose Death Rates.

To address the opioid overdose epidemic in the United States, states have implemented policies to reduce inappropriate opioid prescribing. These policies could affect the coincident heroin overdose epidemic by either driving the substitution of heroin for opioids or reducing simultaneous use of both substances. We used IMS Health's National Prescription Audit and government mortality data to examine the effect of these policies on opioid prescribing and on prescription opioid and heroin overdose death rates in the United States during 2006-13. The analysis revealed that combined implementation of mandated provider review of state-run prescription drug monitoring program data and pain clinic laws reduced opioid amounts prescribed by 8 percent and prescription opioid overdose death rates by 12 percent. We also observed relatively large but statistically insignificant reductions in heroin overdose death rates after implementation of these policies. This combination of policies was effective, but broader approaches to address these coincident epidemics are needed.

State laws regulating prescribing of controlled substances: balancing the public health problems of chronic pain and prescription painkiller abuse and overdose.

Today, opiate-based prescription painkillers account for significant morbidity and mortality in the U.S. According to the Centers for Disease Control and Prevention, prescription painkiller overdose has reached epidemic proportions over the past decade. This article explores the focus on inadequate treatment of pain in the U.S. and the subsequent rise of prescription painkiller abuse, misuse, and overdoses. Since 2007, states have increasingly used their authority to address inappropriate prescribing. State strategies to address this complex problem have included: establishing and strengthening prescription drug monitoring programs, regulating pain management facilities, and establishing dosage thresholds above which a consult with a pain specialist is required. With chronic pain affecting at least 116 million adults in the United States, it will also be important to evaluate the impact these policies are having on legitimate access to pain care.

Accountable disease management of spine pain.

The health care landscape has changed with new legislation addressing the unsustainable rise in costs in the US system. Low-value service lines caring for expensive chronic conditions have been targeted for reform; for better or worse, the treatment of spine pain has been recognized as a representative example. Examining the Patient Protection and Affordable Care Act and existing pilot studies can offer a preview of how chronic care of spine pain will be sustained. Accountable care in an organization capable of collecting, analyzing, and reporting clinical data and operational compliance is forthcoming. Interdisciplinary spine pain centers integrating surgical and medical management, behavioral medicine, physical reconditioning, and societal reintegration represent the model of high-value care for patients with chronic spine pain.