Opioid Prescribing Laws Are Not Associated with Short-term Declines in Prescription Opioid Distribution.

OBJECTIVE: To determine whether the adoption of laws that limit opioid prescribing or dispensing is associated with changes in the volume of opioids distributed in states. METHODS: State-level data on total prescription opioid distribution for 2015-2017 were obtained from the US Drug Enforcement Administration. We included in our analysis states that enacted an opioid prescribing law in either 2016 or 2017. We used as control states those that did not have an opioid prescribing law during the study period. To avoid confounding, we excluded from our analysis states that enacted or modified mandates to use prescription drug monitoring programs (PDMPs) during the study period. To estimate the effect of opioid prescription laws on opioid distribution, we ran ordinary least squares models with indicators for whether an opioid prescription law was in effect in a state-quarter. We included state and quarter fixed effects to control for time trends and time-invariant differences between states. RESULTS: With the exception of methadone and buprenorphine, the amount of opioids distributed in states fell during the study period. The adoption of opioid prescribing laws was not associated with additional decreases in opioids distributed. CONCLUSIONS: We did not detect an association between adoption of opioid prescribing laws and opioids distributed. States may instead wish to pursue evidence-based efforts to reduce opioid-related harm, with a particular focus on treatment access and harm reduction interventions.

Effect of pill mill laws on opioid overdose deaths in Ohio & Tennessee: A mixed-methods case study.

Pill mill laws impose strict regulations on pain management clinics to prevent them from issuing opioid prescriptions without medical indication. To date, little is known about the implementation or effects of these laws on opioid overdose deaths. A previously untested concern is that by restricting access to prescription opioids, pill mill laws could increase overdose from heroin and synthetic opioids, like illicitly produced fentanyl. We evaluated the effects of pill mill laws on opioid overdose deaths in Ohio and Tennessee. Of the 11 total U.S. states with pill mill laws, Ohio and Tennessee were the only two where: (1) the pill mill law was the only state law designed to curb opioid prescribing implemented in a two-year period, one-year pre/post law; and (2) high-quality drug-specific overdose death data were available from CDC. We conducted synthetic control analyses examining differences in post-pill mill law trends in overdose deaths in Ohio and Tennessee compared to weighted combinations of comparison states. We also conducted qualitative interviews with 11 leaders responsible for pill mill law implementation and enforcement in Ohio and Tennessee. Pill mill law enactment had no effects on overall, prescription opioid, heroin, or synthetic opioid overdose deaths in Ohio or Tennessee. Interview results suggest that both states engaged in robust enforcement and implementation of the law. A multi-pronged policy approach, including but not limited to pill mill laws, may be required to effectively address opioid overdose deaths.

Government Legislation in Response to the Opioid Epidemic.

PURPOSE OF REVIEW: Opioid misuse and abuse in the USA has evolved into an epidemic of tragic pain and suffering, resulting in the estimated death of over 64,000 people in 2016. Governmental regulation has escalated alongside growing awareness of the epidemic's severity, both on the state and federal levels. RECENT FINDINGS: This article reviews the timeline of government interventions from the late 1990s to today, including the declaration of the opioid crisis as a national public health emergency and the resultant changes in funding and policy across myriad agencies. Aspects of the cultural climate that fuel the epidemic, and foundational change that may promote sustained success against it, are detailed within as well. As a consequence of misuse and abuse of opioids, governmental regulation has attempted to safeguard society, and clinicians should appreciate changes and expectations of prescribers.

Regulating gabapentin as a drug of abuse: A survey study of Kentucky community pharmacists.

OBJECTIVES: As the number of gabapentin prescriptions has increased, so have reports of its misuse and diversion. This trend has led some states to closer monitoring of gabapentin dispensing through prescription drug monitoring programs (PDMPs). The objective of this study was to collect and analyze Kentucky community pharmacists' perceptions of gabapentin misuse and diversion, and their support or opposition to regulatory efforts to reclassify the drug as a controlled substance (CS). METHODS: Responses were collected using an online survey sent by e-mail to all pharmacists practicing in Kentucky in August 2016. The survey collected basic demographic characteristics and pharmacists' experience with gabapentin dispensing. Descriptive statistics were calculated using question response frequencies. Pearson's chi-squared statistics were calculated to examine the distribution of support for gabapentin as a CS in Kentucky across each of the categories of the individual variables. Logistic regression was used to estimate the effects of pharmacist demographic characteristics and experiences with gabapentin on their support of gabapentin reclassification as a CS. RESULTS: One thousand seven hundred sixty-nine surveys were collected (response rate = 34.2%). Responding community pharmacists (n = 1084) believe that the abuse and diversion of gabapentin are a problem in their communities, with 9 in 10 (89.6%) indicating that they agree or strongly agree. More than three-fourths (87.5%) indicated support for reclassifying gabapentin as a CS. Common reasons for opposition to gabapentin regulatory changes were that they would not reduce or eliminate abuse (45.8%) and that they would be an inconvenience to patients (17.0%). Pharmacists practicing in independent pharmacies and pharmacists in practice greater than 20 years were less likely to indicate support for gabapentin reclassification. CONCLUSION: Kentucky community pharmacists express considerable concern over the possible misuse and diversion of gabapentin and widely support regulatory changes reclassifying gabapentin as a CS.

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.

Impact of Florida's prescription drug monitoring program and pill mill law on high-risk patients: A comparative interrupted time series analysis.

PURPOSE: We quantified the effects of Florida's prescription drug monitoring program and pill mill law on high-risk patients. METHODS: We used QuintilesIMS LRx Lifelink data to identify patients receiving prescription opioids in Florida (intervention state, N: 1.13 million) and Georgia (control state, N: 0.54 million). The preintervention, intervention, and postintervention periods were July 2010 to June 2011, July 2011 to September 2011, and October 2011 to September 2012. We identified 3 types of high-risk patients: (1) concomitant users: patients with concomitant use of benzodiazepines and opioids; (2) chronic users: long-term, high-dose, opioid users; and (3) opioid shoppers: patients receiving opioids from multiple sources. We compared changes in opioid prescriptions between Florida and Georgia before and after policy implementation among high-risk/low-risk patients. Our monthly measures included (1) average morphine milligram equivalent per transaction, (2) total opioid volume across all prescriptions, (3) average days supplied per transaction, and (4) total number of opioid prescriptions dispensed. RESULTS: Among opioid-receiving individuals in Florida, 6.62% were concomitant users, 1.96% were chronic users, and 0.46% were opioid shoppers. Following policy implementation, Florida's high-risk patients experienced relative reductions in morphine milligram equivalent (opioid shoppers: -1.08 mg/month, 95% confidence interval [CI] -1.62 to -0.54), total opioid volume (chronic users: -4.58 kg/month, CI -5.41 to -3.76), and number of dispensed opioid prescriptions (concomitant users: -640 prescriptions/month, CI -950 to -340). Low-risk patients generally did not experience statistically significantly relative reductions. CONCLUSIONS: Compared with Georgia, Florida's prescription drug monitoring program and pill mill law were associated with large relative reductions in prescription opioid utilization among high-risk patients.

Opioid Prescriptions by Specialty in Ohio, 2010-2014.

Background: The current US opioid epidemic is attributed to the large volume of prescribed opioids. This study analyzed the contribution of different medical specialties to overall opioids by evaluating the pill counts and morphine milligram equivalents (MMEs) of opioid prescriptions, stratified by provider specialty, and determined temporal trends. Methods: This was an analysis of the Ohio prescription drug monitoring program database, which captures scheduled medication prescriptions filled in the state as well as prescriber specialty. We extracted prescriptions for pill versions of opioids written in the calendar years 2010 to 2014. The main outcomes were the number of filled prescriptions, pill counts, MMEs, and extended-released opioids written by physicians in each specialty, and annual prescribing trends. Results: There were 56,873,719 prescriptions for the studied opioids dispensed, for which 41,959,581 (73.8%) had prescriber specialty type available. Mean number of pills per prescription and MMEs were highest for physical medicine/rehabilitation (PM&R; 91.2 pills, 1,532 mg, N = 1,680,579), anesthesiology/pain (89.3 pills, 1,484 mg, N = 3,261,449), hematology/oncology (88.2 pills, 1,534 mg, N = 516,596), and neurology (84.4 pills, 1,230 mg, N = 573,389). Family medicine (21.8%) and internal medicine (17.6%) wrote the most opioid prescriptions overall. Time trends in the average number of pills and MMEs per prescription also varied depending on specialty. Conclusions: The numbers of pills and MMEs per opioid prescription vary markedly by prescriber specialty, as do trends in prescribing characteristics. Pill count and MME values define each specialty's contribution to overall opioid prescribing more accurately than the number of prescriptions alone.

Medicare Program; Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan, Medicare Fee-for-Service, the Medicare Prescription Drug Benefit Programs, and the PACE Program. Final rule.

This final rule will revise the Medicare Advantage (MA) program (Part C) regulations and Prescription Drug Benefit program (Part D) regulations to implement certain provisions of the Comprehensive Addiction and Recovery Act (CARA) to further reduce the number of beneficiaries who may potentially misuse or overdose on opioids while still having access to important treatment options; implement certain provisions of the 21st Century Cures Act; support innovative approaches to improve program quality, accessibility, and affordability; offer beneficiaries more choices and better care; improve the CMS customer experience and maintain high beneficiary satisfaction; address program integrity policies related to payments based on prescriber, provider and supplier status in MA, Medicare cost plan, Medicare Part D and the PACE programs; provide an update to the official Medicare Part D electronic prescribing standards; and clarify program requirements and certain technical changes regarding treatment of Medicare Part A and Part B appeal rights related to premiums adjustments.

The Role of Direct-Injury Government-Entity Lawsuits in the Opioid Litigation.

The opioid epidemic has ravaged the United States, killing over 100 Americans every day and costing the nation upward of $90 billion a year. All branches and levels of the government have pursued measures to combat the epidemic and reduce its societal costs. Perhaps the most interesting response is the emergence of direct-injury government-entity lawsuits, which seek to recover damages from opioid companies that facilitated prescription pill addictions. Cities, counties, and states across the country are suing opioid manufacturers and distributors in unprecedented numbers. This Note explores the role of direct-injury government-entity claims as compared to other forms of civil litigation employed in the opioid crisis. It highlights the obstacles faced by parens patriae actions, individual lawsuits, class actions, and aggregate actions in general. This Note argues that direct injury government claims have important advantages over other forms of civil litigation because they overcome certain defenses related to victim blame worthiness and because they function as inherently representative actions that bypass the certification requirements of traditional aggregate actions.

The US Opioid Crisis: Current Federal and State Legal Issues.

The United States is in the midst of a devastating opioid misuse epidemic leading to over 33,000 deaths per year from both prescription and illegal opioids. Roughly half of these deaths are attributable to prescription opioids. Federal and state governments have only recently begun to grasp the magnitude of this public health crisis. In 2016, the Centers for Disease Control and Prevention released their Guidelines for Prescribing Opioids for Chronic Pain. While not comprehensive in scope, these guidelines attempt to control and regulate opioid prescribing. Other federal agencies involved with the federal regulatory effort include the Food and Drug Administration (FDA), the Drug Enforcement Agency (DEA), and the Department of Justice. Each federal agency has a unique role in helping to stem the burgeoning opioid misuse epidemic. The DEA, working with the Department of Justice, has enforcement power to prosecute pill mills and physicians for illegal prescribing. The DEA could also implement use of prescription drug monitoring programs (PDMPs), currently administered at the state level, and use of electronic prescribing for schedule II and III medications. The FDA has authority to approve new and safer formulations of immediate- and long-acting opioid medications. More importantly, the FDA can also ask pharmaceutical companies to cease manufacturing a drug. Additionally, state agencies play a critical role in reducing overdose deaths, protecting the public safety, and promoting the medically appropriate treatment of pain. One of the states' primary roles is the regulation of practice of medicine and the insurance industry within their borders. Utilizing this authority, states can both educate physicians about the dangers of opioids and make physician licensure dependent on registering and using PDMPs when prescribing controlled substances. Almost every state has implemented a PDMP to some degree; however, in addition to mandating their use, increased interstate sharing of prescription information would greatly improve PDMPs' effectiveness. Further, states have the flexibility to promote innovative interventions to reduce harm such as legislation allowing naloxone access without a prescription. While relatively new, these types of laws have allowed first responders, patients, and families access to a lifesaving drug. Finally, states are at the forefront of litigation against pharmaceutical manufacturers. This approach is described as analogous to the initial steps in fighting tobacco companies. In addition to fighting for dollars to support drug treatment programs and education efforts, states are pursuing these lawsuits as a means of holding pharmaceutical companies accountable for misleading marketing of a dangerous product.

Opioid Misuse Trends in Treatment Seeking Populations: Revised Prescription Opioid Policy and Temporally Corresponding Changes.

BACKGROUND: Over the last two decades, U.S. rates of prescription opioid (PO) misuse have risen drastically. In response, federal and state governments have begun to implement new PO policies. Recent legislative changes warrant up-to-date assessments of today's misuse rates. OBJECTIVE: To explore potential changes in opioid misuse trends among substance-using treatment seekers, in temporal relation to legislative response. METHODS: Substance-use data were collected from two cross-sectional Florida-based inpatient cohorts during periods preceding (pre-policy; n = 647) and following (post-policy; n = 396) statewide PO policy initiatives. Participants provided information concerning their most frequently used drugs before treatment. PO and illicit opioid (IO) use prevalence, frequency and route of administration were examined for pre-policy vs. post-policy cohort differences. RESULTS: Relative to the pre-policy cohort, a greater percentage of the post-policy cohort reported recent misuse, daily use, and intravenous administration of POs. IO use was also more frequently reported post-policy. Non-opioid drug use prevalence did not significantly differ between cohorts. Among the opioid-using subsample, equivalent percentages of the pre- and post-policy cohorts reported the use of POs without IOs, IOs without POs, and POs/IOs concurrently. Conclusions/Importance: Florida's PO policy amendments were temporally accompanied by a higher prevalence of PO misuse and IO use among treatment-seekers assessed in this study. Whether our data reflect increased awareness of and treatment seeking for opioid use disorders or insufficient efficacy of new policies to reduce opioid misuse remains in question. Regardless, findings suggest the need for enhanced emphasis on mitigating hazardous PO-use behaviors (e.g., IV use).

Barriers to access to opioid medicines: a review of national legislation and regulations of 11 central and eastern European countries.

Control measures designed to prevent the misuse of opioid medicines can often unintentionally restrict legitimate medical use, leaving patients with cancer in pain. This study aimed to develop and validate an assessment instrument based on WHO policy guidelines to systematically identify legal and regulatory barriers to opioid access in 11 European countries (Bulgaria, Cyprus, Estonia, Greece, Hungary, Latvia, Lithuania, Serbia, Slovakia, Slovenia, and Turkey) as part of the Access to Opioid Medication in Europe project. Relevant legislation and regulations were independently assessed by three reviewers and potential barriers were identified within nine categories including prescribing, penalties, and others. Potential barriers were identified in all countries, ranging from 22 potential barriers (Cyprus) to 128 potential barriers (Lithuania). The total number of barriers in a single category varied from one (Slovenia, usage category) to 49 (Greece, prescribing category). Differences, such as prescription validity, varied within one category, ranging from 5 days (Hungary) to 13 weeks (Cyprus). The results of this Review should give rise to a national review and revision of provisions that impede access to opioids, disproportionate to their (intended) benefit in preventing misuse, in these 11 European countries.

Disciplining virtue: investigating the discourses of opioid addiction in nursing.

Two nurses diagnosed with opioid addiction launched legal action after being found guilty of unprofessional conduct due to addiction-related behaviors. When covered by the media, their cases sparked both public and legal controversies. We are curious about the broader discursive framings that led to these strong reactions, and analyze the underlying structures of knowledge and power that shape the issue of opioid addiction in the profession of nursing through a critical discourse analysis of popular media, legal blogs and hearing tribunals. We argue that addiction in nursing is framed as personal choice, as a failure in the moral character of the nurses, as decontextualized from addiction as disease arguments, and as an individualized issue devoid of contextual factors leading to addiction. Our investigation offers a critical case study of a nursing regulatory body that upheld popular assumptions of addiction as an autonomous, rational choice replete with individual-based consequences - a framing that is inconsistent with evidence-based practice in health-care. We put forth this critical interrogation to open up possibilities for counterdiscourses that may promote more nuanced and effective responses to the issue of addiction in nursing.

A comprehensive approach to address the prescription opioid epidemic in Washington State: milestones and lessons learned.

An epidemic of morbidity and mortality has swept across the United States related to the use of prescription opioids for chronic noncancer pain. More than 100,000 people have died from unintentional overdose, making this one of the worst manmade epidemics in history. Much of health care delivery in the United States is regulated at the state level; therefore, both the cause and much of the cure for the opioid epidemic will come from state action. We detail the strong collaborations across executive health care agencies, and between those public agencies and practicing leaders in the pain field that have led to a substantial reversal of the epidemic in Washington State.

Increased Incidence of Spinal Abscess and Substance Abuse after Implementation of State Mandated Prescription Drug Legislation.

OBJECTIVES: To investigate the incidence of spinal abscess and substance abuse in a tertiary care hospital after state legislation titled "House Bill 1" (HB1) mandated stricter regulation of prescription drugs of abuse in Kentucky in 2012. DESIGN: A retrospective case series study design was used to review the incidence of spinal abscess and drug abuse diagnoses admissions from 2010 to 2014. Variances in the incidence of spinal abscess and substance abuse were plotted across this time frame. RESULTS: The incidence of intraspinal abscess increased 1.56-fold in 2011 (n = 26) and 2012 (n = 25) relative to 2010 (n = 16). However, in 2013, the year following implementation of HB1 legislation, the incidence of intraspinal abscess increased 2.38-fold (n = 38) and then 4.19-fold (n = 67) in 2014. The incidence of intraspinal abscess in subjects with drug abuse diagnosis remained constant between 2010 (n = 3) and 2012 (n = 3). However, it increased twofold (n = 7) in 2013 and then ninefold (n = 27) in 2014. A correlation coefficient (rSAD ) of 0.775 revealed a strong association between the increase incidence of intraspinal abscess and diagnosis of drug abuse. CONCLUSIONS: The results of this retrospective study demonstrate an increased incidence of intraspinal abscess associated with drug abuse after passage of HB1 legislation regulating prescriptions of controlled medications in Kentucky. This increased incidence may be related to individuals relying on nonprescription drugs of abuse due to more highly regulated access to controlled prescription medications. However, additional factors unrelated to HB1 legislation must be taken into account.

Prescription opioid related deaths in New York City: a 2 year retrospective analysis prior to the introduction of the New York State I-STOP law.

The United States is in the midst of an unprecedented drug epidemic. Illicit use of prescription medicine, predominantly opioids, has become one of the nation's fastest-growing drug problems. We have conducted a retrospective review of prescription opioid fatalities in New York City (NYC) prior to the introduction of a 2013 law intended to curtail prescription drug abuse. Over the 2 years of our study, there were 1286 chemical intoxication fatalities in NYC. Of these, 547 (42.5%) were associated with prescription opioids (6.5/100,000 population). Methadone was most frequently encountered followed by oxycodone. Only 36.7% of decedents had a valid opioid prescription. Of non-opioid medications associated with the prescription opiate deaths, benzodiazepines were the most frequently encountered (68.4%), and alprazolam (35.1%) was most common. Though prescribers have no control over drug diversion they should be cognizant of the urgent public health concern regarding prescription opioid abuse and associated fatalities and attempt to identify doctor shoppers and limit prescription of these potent drugs to those with a legitimate need for pain control. They also need to be aware of the high incidence of fatalities due to combined opioid and benzodiazepine use/abuse and refrain from prescribing them in tandem.

Combating the prescription painkiller epidemic: a national prescription drug reporting program.

Prescription painkiller abuse is the fastest growing drug problem in the United States. In the past year, approximately one out of twenty Americans reported misuse or abuse of prescription painkillers. Several factors contribute to the prescription painkiller epidemic. Drug abusers use various methods--such as doctor shopping, paying with cash, and filling prescriptions in different states--to avoid detection and obtain prescription painkillers for illegitimate uses. A few rogue physicians and pharmacists, lured by substantial profits, enable drug abusers by illegally prescribing or supplying controlled substances. Even ethical physicians rarely have adequate training to recognize and address prescription drug abuse, and as a result, prescribe painkillers to patients who are not using them for legitimate medical purposes. Similarly, although the majority of pharmacies have taken steps to combat drug abuse and reduce prescription painkiller dispensing, under current reporting systems, pharmacists lack visibility into several important indicators of drug abuse. As a result, even the most vigilant pharmacists find it extremely difficult to identify and detect drug abuse with certainty. While state governments have established prescription drug monitoring programs (PDMPs) to crack down on prescription drug abuse, these programs have proven to be inadequate. The programs currently suffer from inadequate data collection, ineffective utilization of data, insufficient interstate data sharing, and constraints on sharing data with law enforcement and state agencies. By contrast, third-party prescription payment systems run by pharmacy benefit managers (PBMs) or health insurers have been effective in detecting prescription drug abuse. This paper suggests that a national prescription drug reporting program building on existing PBM networks could be significantly more effective than existing state PDMPs in detecting prescription drug abuse.