An Emergency Preparedness Response to Opioid-Prescribing Enforcement Actions in Maryland, 2018-2019.

Federal and state enforcement authorities have increasingly intervened on the criminal overprescribing of opioids. However, little is known about the health effects these enforcement actions have on patients experiencing disrupted access to prescription opioids or medication-assisted treatment/medication for opioid use disorder. Simultaneously, opioid death rates have increased. In response, the Maryland Department of Health (MDH) has worked to coordinate mitigation strategies with enforcement partners (defined as any federal, state, or local enforcement authority or other governmental investigative authority). One strategy is a standardized protocol to implement emergency response functions, including rapidly identifying health hazards with real-time data access, deploying resources locally, and providing credible messages to partners and the public. From January 2018 through October 2019, MDH used the protocol in response to 12 enforcement actions targeting 34 medical professionals. A total of 9624 patients received Schedule II-V controlled substance prescriptions from affected prescribers under investigation in the 6 months before the respective enforcement action; 9270 (96%) patients were residents of Maryland. Preliminary data indicate fatal overdose events and potential loss of follow-up care among the patient population experiencing disrupted health care as a result of an enforcement action. The success of the strategy hinged on endorsement by leadership; the establishment of federal, state, and local roles and responsibilities; and data sharing. MDH's approach, data sources, and lessons learned may support health departments across the country that are interested in conducting similar activities on the front lines of the opioid crisis.

Changes in opioid prescribing after implementation of mandatory registration and proactive reports within California's prescription drug monitoring program.

BACKGROUND: In 2016, California updated its prescription drug monitoring program (PDMP), adding two key features: automated proactive reports to prescribers and mandatory registration for prescribers and pharmacists. The effects of these changes on prescribing patterns have not yet been examined. We aimed to evaluate the joint effect of these two PDMP features on county-level prescribing practices in California. METHODS: Using county-level quarterly data from 2012 to 2017, we estimated the absolute change associated with the implementation of these two PDMP features in seven prescribing indicators in California versus a control group comprising counties in Florida and Washington: opioid prescription rate per 1000 residents; patients' mean daily opioid dosage in milligrams of morphine equivalents[MME]; prescribers' mean daily MME prescribed; prescribers' mean number of opioid prescriptions per day; percentage of patients getting >90 MME/day; percentage of days with overlapping prescriptions for opioids and benzodiazepines; multiple opioid provider episodes per 100,000 residents. RESULTS: Proactive reports and mandatory registration were associated with a 7.7 MME decrease in patients' mean daily opioid dose (95 %CI: -11.4, -2.9); a 1.8 decrease in the percentage of patients prescribed high-dose opioids (95 %CI: -2.3, -0.9); and a 6.3 MME decrease in prescribers' mean daily dose prescribed (95 %CI: -10.0, -1.3). CONCLUSIONS: California's implementation of these two PDMP features was associated with decreases in the total quantity of opioid MMEs prescribed, and indicators of patients prescribed high-dose opioids compared to states that had PDMP's without these features. Rates of opioid prescribing and other high-risk prescribing patterns remained unchanged.

Knowledge and practices of community pharmacists towards non-prescription dispensing of antibiotics in Northern Nigeria.

Background Non-prescription dispensing of antibiotics is common in Nigeria and this could contribute to the emergence of microbial resistance. Objectives To evaluate knowledge, perception and practices of community pharmacists towards dispensing antibiotics without prescription. Setting Community pharmacies in two cities in Northern Nigeria. Methods A prospective cross-sectional study was conducted among community pharmacists in two cities in Northern Nigeria, using a validated and pilot-tested questionnaire. The questionnaire was self-administered and data was collected between 06th April and 31st May 2019. The data was analyzed using descriptive and inferential analyses. Main outcome measure Knowledge, perception and practices towards dispensing antibiotics without prescription. Results A total of 98 out of 130 community pharmacists completed and returned the questionnaire (response rate: 75.3%). About two-third (64.3%) of the community pharmacists were aware that dispensing antibiotics without prescription is illegal. However, this malpractice was common as 39.7% of the respondents indicated that they dispensed antibiotics without prescription five times or more in a day. Antibiotics dispensed without prescription were used for the treatment of urinary tract infections (83.7%), typhoid fever (83.7%) and sexually transmitted infections (66.3%). Pharmacist's confidence in knowledge of antibiotic therapy was the most common reason for non-prescription dispensing of antibiotics. Respondents with less than 5 years of working experience (66.7%) were significantly more likely to dispense antibiotics without prescription 5 times or more in a day compared to those with more than 5 years community pharmacy experience (33.3%), P = 0.031. Conclusion Non-prescription dispensing of antibiotics was common among community pharmacists despite awareness about its prohibition and implications. The malpractice was associated with number of years of community pharmacy experience. Confidence in knowledge of antibiotic therapy was the main reason community pharmacists dispensed antibiotics without prescription. Continuous pharmacy education and training on handling of antibiotics may help to reduce inappropriate practices among community pharmacists.

Opioid Prescribing Patterns in Orthopaedic Surgery Patients: the Effect of New York State Regulations and Institutional Initiatives.

BACKGROUND: The opioid epidemic in the United States is a public health crisis. As a result, regulatory agencies, including state governments, have enacted initiatives to decrease the use of opioids in the perioperative setting. The purpose of this study was to compare opioid utilization in orthopaedic surgery patients at discrete points after implementation of State regulatory and institution/physician-led initiatives to decrease opioid utilization in the perioperative period. METHODS: We reviewed the electronic medication orders for all patients who underwent orthopaedic surgery procedures between September 2015 and June 2018 at our urban academic medical center. The outcome measures were the number of patients who were prescribed opioid medications, duration of prescription (days), and average milligram morphine equivalents prescribed. Patients were divided into three time cohorts to assess the effect of the NY State (NYS) policy and institutional initiatives to decrease opioid utilization. RESULTS: A total of 20,483 patients met the inclusion criteria over all three time cohorts. After the initiation of the NYS 7-day supply legislation, there was a decrease in the average supply of opioids prescribed from 10.1 to 7.6 days and the average daily milligram morphine equivalent decreased from 67.9 to 56.7 mg (P < 0.0001). However, with the combination of physician education and surgeon-led institutional initiatives, the percentage of patients who were prescribed opioids decreased by over 10% (96% to 84%), with continued decrease in duration of prescription by 1.0 to 6.4 days (P < 0.0001). CONCLUSIONS: The addition of institution-led initiatives and education programs to previously established government-led prescription limits produced a substantial reduction in the amount of opioids prescribed to orthopaedic surgery patients in the perioperative period. Although mandatory limits set by the state government resulted in a decreased amount of opioid medications being prescribed per patient, it was only after the introduction of educational programs and institution- and physician-led programs that perioperative patient exposure to opioids decreased. LEVEL OF EVIDENCE: Level III.

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.

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.

Standardizing Opioid Prescribing Practices for Cancer-Related Pain Via a Novel Interactive Documentation Template at a Public Hospital.

PURPOSE: Opioid misuse during cancer pain management places patients at risk for harm and physicians for legal liability. Identifying and monitoring patients who are at risk is challenging given the lack of validated clinical tools and evidence-based guidelines. In the current study, we aimed to standardize opioid prescribing practices at a community oncology clinic to help ensure patient safety and physician compliance with Texas state regulations. METHODS: We used the Plan-Do-Study-Act methodology. In the planning phase, current practices of assessing opioid efficacy, toxicity, and misuse were determined by surveying clinic physicians and reviewing patients' charts. We developed a new standardized process that incorporated published literature, the Texas Administrative Code, and expert opinion. Two interactive documentation templates (SmartPhrases) were designed to implement the standardized process. The intervention was studied using repeat physician surveys and chart reviews, which prompted action for refinement and sustainability. RESULTS: At baseline, 9% of providers followed a systematic approach to prescribing opioids and 86% expressed an interest in process standardization. We noted high interprovider variability in the opioid risk stratification and refill process. At 2 months and 6 months postimplementation, provider satisfaction with the intervention was 83% and 75%, whereas compliance with SmartPhrase use was 70% and 54%, respectively. The frequency of state database check improved from 36% to 94% at 6 months. Improvement was also noted in assessment and documentation of baseline risk, chemical coping, and toxicity. CONCLUSION: We implemented a systematic approach for assessing opioid misuse, toxicity, and efficacy during cancer pain management at a community oncology clinic. The approach resulted in notable improvement in provider practices and documentation compliance.

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.

Mandatory Prescription Limits and Opioid Utilization Following Orthopaedic Surgery.

BACKGROUND: Since 2016, over half of the states in the United States have passed mandatory limits on opioid prescriptions, with limited evidence of effectiveness. In this study, we evaluated postoperative opioid prescriptions following orthopaedic surgery before and after the implementation of one of the earliest such laws. METHODS: Following the implementation of state legislation limiting opioid prescriptions for opioid-naïve patients, 2 patient cohorts (pre-law and post-law) were compared. Both opioid-tolerant and opioid-naïve patients undergoing 6 common orthopaedic procedures (total knee arthroplasty, rotator cuff repair, anterior cruciate ligament reconstruction, open reduction and internal fixation for a distal radial fracture, open reduction and internal fixation for an ankle fracture, and lumbar discectomy) met inclusion criteria. Patients undergoing >1 primary procedure in the same operative session were excluded. All benzodiazepine and opioid prescriptions from 30 days before to 90 days after the surgical procedure were recorded. Logistic regression was performed to determine risk factors for prolonged postoperative opioid use. RESULTS: In this study, 836 pre-law patients were compared with 940 post-law patients. The 2 groups were similar with regard to demographic variables, baseline opioid tolerance, and recent benzodiazepine use (all p > 0.05). Post-law, for all patients, there were decreases in the initial prescription pill quantity (49.65 pills pre-law and 22.08 pills post-law; p < 0.001) and the total morphine milligram equivalents (MMEs) (417.67 MMEs pre-law and 173.86 MMEs post-law; p < 0.001), regardless of patient preoperative opioid exposure (all p < 0.001). Additionally, there were decreases in the mean cumulative 30-day MMEs (790.01 MMEs pre-law and 524.61 MMEs post-law; p < 0.001) and the 30 to 90-day MMEs (243.51 MMEs pre-law and 208.54 MMEs post-law; p = 0.008). Despite being specifically exempted from the legislation, opioid-tolerant patients likewise experienced a significant decrease in cumulative 30-day MMEs (1,304.08 MMEs pre-law and 1,015.19 MMEs post-law; p = 0.0016). Opioid-tolerant patients required more postoperative opioids at all time points and had an increased likelihood of prolonged opioid use compared with those who were opioid-naïve preoperatively (odds ratio, 8.73 [95% confidence interval, 6.21 to 12.29]). CONCLUSIONS: A clinically important and significant reduction in opioid utilization after orthopaedic surgery was observed following the implementation of statewide mandatory opioid prescription limits. CLINICAL RELEVANCE: After implementation of mandatory opioid prescription regulations, a clinically important and significant decline in the volume of opioids dispensed in the short term and intermediate term following orthopaedic surgery was observed. Furthermore, important clinical predictors of prolonged postoperative opioid use, including preoperative opioid use and preoperative benzodiazepine use, were identified. These findings have important implications for public health, as well as the potential to influence policymakers and to change practice among orthopaedic surgeons.

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.

Physician Training and Qualification to Educate Patients on Attention-Deficit/Hyperactivity Disorder Stimulant Diversion and Misuse.

OBJECTIVES: The increased number of adolescents diagnosed with attention-deficit/hyperactivity disorder (ADHD) in recent years has raised concerns regarding diversion and misuse of prescription stimulant medications. As prescribers of these medications, physicians must be prepared to educate patients on these issues. This is the first study to evaluate physician training and qualification to educate adolescent patients on stimulant diversion and misuse. METHODS: A questionnaire was developed and mailed to a national sample of child and adolescent psychiatrists (CAPs), child neurologists (CNs), and developmental-behavioral pediatricians (DBPs) in the United States. In addition to descriptive statistics, multivariable regressions (log-binomial and ordinal logistic) were performed to identify differences between subspecialists. RESULTS: The final sample consisted of 826 physicians who currently prescribe stimulants. Only 48% of physicians reported receiving formal training on prescription drug diversion (PDD) in medical school, residency, and/or fellowship. Twenty five percent and 48% of physicians felt inadequately qualified to educate patients on the health and legal consequences, respectively, of stimulant misuse and diversion. CAPs were more likely to have received formal training and felt better qualified to educate patients than CNs and DBPs. Physicians who received formal training were 2.4 times more likely to feel adequately qualified to educate patients on these issues. Only 58% of physicians correctly answered a legal question relating to stimulant diversion. CONCLUSIONS: Most physicians have not received formal training on PDD and many feel inadequately qualified to educate patients on the health and legal consequences of stimulant misuse and diversion. Increased training is needed so physicians can effectively educate patients with ADHD.

Physician Autonomy and the Opioid Crisis.

The scope and severity of the opioid epidemic in the United States has prompted significant legislative intrusion into the patient-physician relationship. These proscriptive regulatory regimes mirror earlier legislation in other politically-charged domains like abortion and gun regulation. We draw on lessons from those contexts to argue that states should consider integrating their responses to the epidemic with existing medical regulatory structures, making physicians partners rather than adversaries in addressing this public health crisis.

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.

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.