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.

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.

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.

On-label and off-label prescribing patterns of erythropoiesis-stimulating agents in inpatient hospital settings in the US during the period of major regulatory changes.

BACKGROUND: A number of policy and labeling interventions aimed at reducing inappropriate prescribing of erythropoiesis-stimulating agents (ESAs) were implemented in the U.S. between 2006 and 2010. These interventions included the addition of an FDA Black Box Warning to ESA labeling, the implementation of a Risk Evaluation and Mitigation Strategy program, and the adoption of payment restrictions by the Centers for Medicare and Medicaid Services (CMS). The impact of these safety interventions on different types of ESA prescribing (on-label, off-label; evidence-based, not evidence-based) has not been investigated in a single study. OBJECTIVES: The objective of this study was to explore the prescribing patterns of ESAs for on- and off-label indications in the U.S. hospital inpatients during the period of major policy and labeling changes. METHODS: A retrospective analysis of ESAs utilization patterns was conducted using Cerner Health Facts® database from January 1, 2005 to June 30, 2011. The study population consisted of adult patients admitted to hospitals during the study period who received at least one ESAs order. Indications for ESA use were assigned based on ICD-9 CM diagnosis codes, procedure codes, and medication records. ESA use was then classified based on FDA-approval and the strength of scientific evidence supporting its use. Indication categories included (1) on-label use (ONS); (2) off-label use, supported (OFS); and (3) off-label use, unsupported (OFU). Descriptive statistics were used to examine ESA use by patient, hospital, and physician characteristics and over time. RESULTS: ESAs were most frequently prescribed for ONS (48.7%), followed by OFU (42.7%) and OFS indications (8.6%). Of all off-label use, 83.2% were for unsupported indications. Between 2005 and 2010, the percent of inpatient visits with ESA use decreased for supported indications, both on-label (-63.2%) and off-label (-78.2%), but increased for unsupported indications (80%). OFU use surpassed ONS use as the most common type of ESA use in 2009. CONCLUSIONS: Total and ONS ESA use decreased markedly, while OFU ESA use continued to increase during the period of major policy and labeling changes.

The Impact of WHO Essential Medicines Policies on Inappropriate Use of Antibiotics.

BACKGROUND: Inappropriate overuse of antibiotics contributes to antimicrobial resistance (AMR), yet policy implementation to reduce inappropriate antibiotic use is poor in low and middle-income countries. AIMS: To determine whether public sector inappropriate antibiotic use is lower in countries reporting implementation of selected essential medicines policies. MATERIALS AND METHODS: Results from independently conducted antibiotic use surveys in countries that did, and did not report implementation of policies to reduce inappropriate antibiotic prescribing, were compared. Survey data on four validated indicators of inappropriate antibiotic use and 16 self-reported policy implementation variables from WHO databases were extracted. The average difference for indicators between countries reporting versus not reporting implementation of specific policies was calculated. For 16 selected policies we regressed the four antibiotic use variables on the numbers of policies the countries reported implementing. RESULTS: Data were available for 55 countries. Of 16 policies studied, four (having a national Ministry of Health unit on promoting rational use of medicines, a national drug information centre and provincial and hospital drugs and therapeutics committees) were associated with statistically significant reductions in antibiotic use of ≥20% in upper respiratory infection (URTI). A national strategy to contain antibiotic resistance was associated with a 30% reduction in use of antibiotics in acute diarrheal illness. Policies seemed to be associated with greater effects in antibiotic use for URTI and diarrhea compared with antibiotic use in all patients. There were negative correlations between the numbers of policies reported implemented and the percentage of acute diarrhoea cases treated with antibiotics (r = -0.484, p = 0.007) and the percentage of URTI cases treated with antibiotics (r = -0.472, p = 0.005). Major study limitations were the reliance on self-reported policy implementation data and antibiotic use data from linited surveys. CONCLUSIONS: Selected essential medicines policies were associated with lower antibiotic use in low and middle income countries.

What we know, and don't know, about the impact of state policy and systems-level interventions on prescription drug overdose.

BACKGROUND: Drug overdose deaths have been rising since the early 1990s and is the leading cause of injury death in the United States. Overdose from prescription opioids constitutes a large proportion of this burden. State policy and systems-level interventions have the potential to impact prescription drug misuse and overdose. METHODS: We searched the literature to identify evaluations of state policy or systems-level interventions using non-comparative, cross-sectional, before-after, time series, cohort, or comparison group designs or randomized/non-randomized trials. Eligible studies examined intervention effects on provider behavior, patient behavior, and health outcomes. RESULTS: Overall study quality is low, with a limited number of time-series or experimental designs. Knowledge and prescribing practices were measured more often than health outcomes (e.g., overdoses). Limitations include lack of baseline data and comparison groups, inadequate statistical testing, small sample sizes, self-reported outcomes, and short-term follow-up. Strategies that reduce inappropriate prescribing and use of multiple providers and focus on overdose response, such as prescription drug monitoring programs, insurer strategies, pain clinic legislation, clinical guidelines, and naloxone distribution programs, are promising. Evidence of improved health outcomes, particularly from safe storage and disposal strategies and patient education, is weak. CONCLUSIONS: While important efforts are underway to affect prescriber and patient behavior, data on state policy and systems-level interventions are limited and inconsistent. Improving the evidence base is a critical need so states, regulatory agencies, and organizations can make informed choices about policies and practices that will improve prescribing and use, while protecting patient health.

[Responsibility for prescribing and monitoring an act transfusion and safety blood transfusion]. / La responsabilité en matière de prescription et surveillance d'un acte transfusionnel et sécurité des produits sanguins.

The act to transfuse is a prescription following basic rules similar to drug prescriptions. If harm happens, potentially linked with this prescription, the harm's responsibility is borne by the physician, the paramedics, the care organization but by the supplier laboratory too. The setting of good practice rules consistent with science data at the time when the act is performed, the respect of the patient's rights and the quality of supplied products will be assessed during the expertise. Under restorative responsibility, it is necessary to previously establish a direct and certain causation between the litigious act and the harm to enforce the vicarious liability. Nowadays, legal precedents grant a larger protection to more and more numerous victims, enhancing the field of the fault with the appeal to assumption of fault. At the same time, the lawmaker himself promulgated objective conditions of compensation for many categories of victims of medical risk from which transfused people are part. The law of March the 4th of 2002 went one step closer devoting a new foundation of compensation: national solidarity.