The Impact of the Long-term Care Homes Act and Public Reporting on Physical Restraint and Potentially Inappropriate Antipsychotic Use in Ontario's Long-term Care Homes.

BACKGROUND: We report on the impact of two system-level policy interventions (the Long-Term Care Homes Act [LTCHA] and Public Reporting) on publicly reported physical restraint use and non-publicly reported potentially inappropriate use of antipsychotics in Ontario, Canada. METHODS: We used interrupted time series analysis to model changes in the risk-adjusted use of restraints and antipsychotics before and after implementation of the interventions. Separate analyses were completed for early ([a] volunteered 2010/2011) and late ([b] volunteered March 2012; [c] mandated September 2012) adopting groups of Public Reporting. Outcomes were measured using Resident Assessment Instrument Minimum Data Set (RAI-MDS) data from January 1, 2008 to December 31, 2014. RESULTS: For early adopters, enactment of the LTCHA in 2010 was not associated with changes in physical restraint use, while Public Reporting was associated with an increase in the rate (slope) of decline in physical restraint use. By contrast, for the late-adopters of Public Reporting, the LTCHA was associated with significant decreases in physical restraint use over time, but there was no significant increase in the rate of decline associated with Public Reporting. As the LTCHA was enacted, potentially inappropriate use of antipsychotics underwent a rapid short-term increase in the early volunteer group, but, over the longer term, their use decreased for all three groups of homes. CONCLUSIONS: Public Reporting had the largest impact on voluntary early adopters while legislation and regulations had a more substantive positive effect upon homes that delayed public reporting.

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.

Doctors, drugs of dependence and discipline: a retrospective review of disciplinary decisions in New Zealand, 1997-2016.

AIM: To describe disciplinary cases for inappropriate prescribing of drugs of dependence by doctors in New Zealand, 1997-2016. METHODS: A retrospective analysis of disciplinary decisions to describe characteristics of cases (setting, drugs, outcome) and doctors (sex, specialty, years since qualification). RESULTS: There were 25 disciplinary decisions involving 24 doctors. Disciplined doctors were mostly male (19;76%), working in general practice (19;76%), and older (mean 24 years in practice). Pharmacists were the most common source of notification to the authorities (6;24%); medical colleagues reported only four (16%). The alleged misconduct often involved behaviour in addition to inappropriate prescribing. In all cases the doctor was found guilty of professional misconduct. Penalties were severe: six doctors were removed from practice, 11 were suspended, and of the remainder all but one had restrictions on practice imposed. In many decisions there was no patient harm documented. CONCLUSION: Disciplinary cases for inappropriate prescribing of drugs of dependence by doctors in New Zealand are not common, but the consequences can be dire. The role of discipline in doctors with drug dependence is unclear.

Comparison of Prescribing Patterns Before and After Implementation of a National Policy to Reduce Inappropriate Alprazolam Prescribing in Australia.

Importance: Benzodiazepines have been a common target for policy interventions to curtail inappropriate use, with mixed results. To reduce alprazolam misuse, in February 2017, Australia delisted the 2-mg tablet strength from public subsidy, eliminated refills, and reduced the pack size from 50 tablets to 10 tablets. Objective: To describe changes in alprazolam dispensing, prescribing, and poisonings associated with the implementation of a new policy to reduce inappropriate prescription of alprazolam in Australia. Design, Setting, and Participants: This interrupted time series analysis and cross-sectional study included data from a 10% sample of Australian people who received publicly subsidized dispensing claims and prescribing approvals for alprazolam from January 1, 2015, to December 31, 2018, and all calls to a poison information service involving alprazolam from February 1, 2015, to October 31, 2018. Autoregressive error models were used to quantify changes over time and compare patterns of use before and after the intervention. Data analyses were conducted from November 2018 to May 2019. Exposure: Implementation of the policy change on February 1, 2017. Main Outcomes and Measures: Monthly trends in alprazolam prescribing approvals and dispensings, quarterly trends in telephone calls involving alprazolam to a poison information service, and patterns of prescribing and dispensing before and after the intervention. Results: From 2015 to 2018, there were 71 481 alprazolam dispensings to 6772 people. After the intervention, overall dispensing decreased by 51.2% (95% CI, 50.5%-51.9%) and prescribing approvals increased by 17.5% (95% CI, 13.0%-22.2%). Overall, the proportion of dispensing of packs of 51 to 100 tablets increased from 5776 of 24 282 dispensings (23.8%) to 4888 of 10 676 dispensings (45.8%) (risk difference [RD], 22.0% [95% CI, 19.4%-24.6%]) and dispensing of packs of more than 100 tablets increased from 1029 of 24 282 dispensings (4.2%) to 1774 of 10 676 dispensings (16.6%) (RD, 12.4% [95% CI, 10.6%-14.2%]). Among people receiving their first alprazolam prescription, initiation with packs of 10 tablets or fewer increased from 16 of 1127 people (1.4%) before the intervention to 139 of 589 people (23.6%) after the intervention (RD, 22.2% [95% CI, 18.7%-25.7%]). Alprazolam treatment initiation with packs of more than 50 tablets also increased from 63 of 1127 people (5.6%) before the intervention to 144 of 589 people (24.4%) after the intervention (RD, 18.9% [95% CI, 15.1%-22.6%]). During 1 year before the intervention, patients received a median (interquartile range [IQR]) total of 250 (50-600) tablets and median (IQR) total combined tablet strength of 188 (50-550) mg. During 1 year after the intervention, people were dispensed less alprazolam, with a median (IQR) total of 200 (50-500) tablets and median (IQR) total combined tablet strength of 120 (30-360) mg. There was little change in poisoning calls involving alprazolam. Conclusions and Relevance: This study found that after the policy intervention, subsidized alprazolam use decreased, but the increase in prescribing approvals placed additional burden on prescribers. Even after the intervention, most people who were dispensed alprazolam were still receiving treatment contrary to best-practice recommendations. Furthermore, the poison information center data suggested that people were still being dispensed the 2-mg tablet strength, presumably as nonsubsidized (ie, private) prescriptions.

Impact of State Regulations on Initial Opioid Prescribing Behavior in Rhode Island.

The opioid epidemic presents an urgent public health problem. Rhode Island has enacted comprehensive rules to address primary prevention of opioid overdose. This study evaluates the efficacy of those regulations in altering prescribing behavior, specifically regarding the initial prescription. Using data extracted from the Rhode Island Prescription Drug Monitoring Program (PDMP), before and after the publication of updated acute pain management regulations, we studied the rate of opioid prescribing using statistical process control (SPC) charts and found that the rate of prescribing unsafe doses of opioids, more than 30 morphine milligram equivalents (MMEs) per day or more than 20 doses to opioid naïve patients, decreased significantly.

The opioid crisis: Origins, trends, policies, and the roles of pharmacists.

PURPOSE: The purpose of this review is to (1) provide information concerning the opioid crisis including origins, trends, and some important related laws/policies; and (2) summarize the current involvement and impact of pharmacists in helping to address the crisis, as well as examine practices in other healthcare disciplines from which pharmacists might derive guidance and strategies. SUMMARY: Contributors to the opioid crisis included campaigns to treat pain as a fifth vital sign and to use opioids in treatment of non-cancer-related pain, as well as aggressive marketing of opioid analgesics by pharmaceutical companies. To address the crisis, numerous strategies have been implemented at the policy/legislative, health-system, and patient levels, such as prescription drug monitoring programs (PDMPs), increased regulation of pain clinics, and expanded use of naloxone. Pharmacists have a critical role to play in interventions to address opioid misuse and reduce harm resulting from misuse. Such interventions include patient screening and risk stratification, patient and community education and outreach concerning appropriate pain management, medication reviews/medication therapy management, education on safe storage and disposal, distribution of naloxone/opioid rescue kits and training on their proper use, and referral of patients to addiction treatment, among other strategies. CONCLUSION: Pharmacists have multiple, complex roles in addressing the opioid crisis. Outcomes of several studies provide substantial evidence that pharmacists can make an impact through appropriate pain management, use of PDMPs, opioid overdose prevention training, and medication reviews and counseling, among other interventions.

Effects of mandatory prescription drug monitoring program (PDMP) use laws on prescriber registration and use and on risky prescribing.

BACKGROUND: Comprehensive mandatory use laws for prescription drug monitoring programs (PDMPs) have been implemented in a number of states to help address the opioid overdose epidemic. These laws may reduce opioid-related overdose deaths by increasing prescribers' use of PDMPs and reducing high-risk prescribing behaviors. METHODS: We used state PDMP data to examine the effect of these mandates on prescriber registration, use of the PDMP, and on prescription-based measures of patient risk in three states-Kentucky, Ohio, and West Virginia-that implemented mandates between 2010 and 2015. We conducted comparative interrupted time series analyses to examine changes in outcome measures after the implementation of mandates in the mandate states compared to control states. RESULTS: Mandatory use laws increased prescriber registration and utilization of the PDMP in the mandate states compared to controls. The multiple provider episode rate, rate of opioid prescribing, rate of overlapping opioid prescriptions, and rate of overlapping opioid/benzodiazepine prescriptions decreased in Kentucky and Ohio. Nevertheless, the magnitude of changes in these measures varied among mandates states. CONCLUSIONS: These findings indicate that PDMP mandates have the potential to reduce risky opioid prescribing practices. Variation in the laws may explain why the effectiveness varied between states.

Success of Hospital Intervention and State Legislation on Decreasing and Standardizing Postoperative Opioid Prescribing Practices.

BACKGROUND: We sought to evaluate change in postoperative prescription practices in an independent community-based hospital after hospital interventions and a state legislation change. STUDY DESIGN: This is a retrospective review of opioid-naïve adult subjects who underwent 5 common general surgical procedures between 2015 and 2017, including cholecystectomy, appendectomy, minimally invasive inguinal hernia repair, open inguinal hernia repair, and breast lumpectomy. Educational interventions were introduced, new statewide legislation was passed, and 129 subsequent cases were reviewed. RESULTS: Mean ± SD oral morphine equivalent (OME) prescribed for all procedures on retrospective review was 218.8 ± 113.7 (n = 722), cholecystectomy 235.3 ± 133.8 (n = 248), appendectomy 220.2 ± 103.2 (n = 175), open inguinal hernia repair 214.4 ± 97.2 (n = 119), minimally invasive inguinal hernia repair 187.7 ± 87.8 (n = 117), and lumpectomy 212.5 ± 114.5 (n = 63). There was significant variation in OME prescribed by procedure and by surgeon (p = 0.006 and p = 0.008, respectively). Review of post-intervention cases showed a significant reduction in the OME prescribed each year (mean OME 197.6 in 2015 to 2017 vs 72.3 in 2018; p < 0.005), and a 60% to 70% reduction in mean OME per procedure. Post-intervention data also revealed resolution of previously seen variation in prescription practices, and a significant increase in the percentage of patients prescribed multimodal pain therapy (23.5% in 2015 to 2017 to 31.5% in 2018; p < 0.05). CONCLUSIONS: We achieved a 60% to 70% decrease in postoperative opioid prescription at our community hospital for 5 common surgical procedures, and resolution of variation in opioid prescription practices after a hospital-wide intervention and statewide legislation.

Serious Ethical Violations in Medicine: A Statistical and Ethical Analysis of 280 Cases in the United States From 2008-2016.

Serious ethical violations in medicine, such as sexual abuse, criminal prescribing of opioids, and unnecessary surgeries, directly harm patients and undermine trust in the profession of medicine. We review the literature on violations in medicine and present an analysis of 280 cases. Nearly all cases involved repeated instances (97%) of intentional wrongdoing (99%), by males (95%) in nonacademic medical settings (95%), with oversight problems (89%) and a selfish motive such as financial gain or sex (90%). More than half of cases involved a wrongdoer with a suspected personality disorder or substance use disorder (51%). Despite clear patterns, no factors provide readily observable red flags, making prevention difficult. Early identification and intervention in cases requires significant policy shifts that prioritize the safety of patients over physician interests in privacy, fair processes, and proportionate disciplinary actions. We explore a series of 10 questions regarding policy, oversight, discipline, and education options. Satisfactory answers to these questions will require input from diverse stakeholders to help society negotiate effective and ethically balanced solutions.

Laws limiting the prescribing or dispensing of opioids for acute pain in the United States: A national systematic legal review.

BACKGROUND: Opioid overdose is a continuing public health crisis. In response to an increasing recognition of the negative outcomes sometimes associated with the use of opioid analgesics, states have taken a number of steps attempting to reduce inappropriate prescribing of these medications. These include the imposition of strict legal limitations on the amount or duration that opioid analgesics may be prescribed or dispensed to patients with acute pain. METHODS: We conducted a systematic, multi-source legal review of state laws that impose mandatory limits on the ability of medical professionals to prescribe or dispense opioids for the treatment of acute pain. We also systematically searched for and examined publicly available documents on state legislative and regulatory bodies' websites. All relevant laws were downloaded and systematically coded. RESULTS: By the end of 2017, twenty-six states had passed laws that impose mandatory limits on the prescribing or dispensing of opioids for acute pain. The oldest of these laws became effective as early as 1989, but most are much newer: approximately 65% (17/26) were passed in 2017. There is wide variation in the characteristics of these laws. CONCLUSION: Just over half of all states have enacted laws that restrict the prescribing or dispensing of opioids for acute pain. To date, there is no data on whether and to what extent these laws mediate opioid-related morbidity and mortality, as well as whether they are associated with negative unintended outcomes. Research into these questions is urgently needed.

Where Is the Opioid Use Epidemic in Mexico? A Cautionary Tale for Policymakers South of the US-Mexico Border.

In North America, opioid use and its harms have increased in the United States and Canada over the past 2 decades. However, Mexico has yet to document patterns suggesting a higher level of opioid use or attendant harms.Historically, Mexico has been a country with low-level use of opioids, although heroin use has been documented. Low-level opioid use is likely attributable to structural, cultural, and individual factors. However, a range of dynamic factors may be converging to increase the use of opioids: legislative changes to opioid prescribing, national health insurance coverage of opioids, pressure from the pharmaceutical industry, changing demographics and disease burden, forced migration and its trauma, and an increase in the production and trafficking of heroin. In addition, harm-reduction services are scarce.Mexico may transition from a country of low opioid use to high opioid use but has the opportunity to respond effectively through a combination of targeted public health surveillance of high-risk groups, preparation of appropriate infrastructure to support evidence-based treatment, and interventions and policies to avoid a widespread opioid use epidemic.

The United States opioid epidemic: a review of the surgeon's contribution to it and health policy initiatives.

Opioid abuse and addiction is causing widespread devastation in communities across the USA and resulting in significant strain on our healthcare system. There is increasing evidence that prescribers are at least partly responsible for the opioid crisis because of overprescribing, a practice that developed from changes in policy and reimbursement structures. Surgeons, specifically, have been subject to scrutiny as 'adequate treatment' of post-surgical pain is poorly defined and data suggest that many patients receive much larger opioid prescriptions than needed. The consequences of overprescribing include addiction and misuse, dispersion of opioids into the community, and possible potentiation of illicit drug/heroin use. Several solutions to this crisis are currently being enacted with variable success, including Prescription Drug Monitoring Programmes, policy-level interventions aimed to de-incentivize overprescribing, limiting opioid exposures through Enhanced Recovery After Surgery protocols, and the novel idea of creating surgery- and/or procedure-specific prescribing guidelines. This problem is likely to require not one, but several potential solutions to reverse its trajectory. It is critical, however, that we as physicians and prescribers find a way to stop the needless overprescribing while still treating postoperative pain appropriately.

Federal Bill Would Limit Opioid Scrips for Acute Pain.

The proposed three-day limit on opioid prescriptions for acute pain would be one of the more impactful provisions for pain doctors and their patients. Exceptions would include prescriptions for chronic pain, cancer care, hospice or end-of-life care, and pain treatment that's part of palliative care.