Search

Objective: Electronic prescriptions are now the standard of practice for all discharge and outpatient prescriptions. The intention is to increase patient safety, provide a more complete medication record for patients, lessen the burden on prescribers, and shorten the time it takes for medication orders to reach the pharmacy., Design: This cross-sectional questionnaire survey study was conducted between January and August 2022 in three areas of a large urban safety net hospital., Setting: A large single academic medical center., Participants: Emergency department, inpatient clinicians, and procedural areas. The subjects of the study were trainees, attending physicians, and advance practice providers (APPs) Interventions: Data were collected from the participants using a self-reported questionnaire, including sociodemographic characteristics, ease of use, reliability, and preference. Additionally, the perception of the strengths and limitations associated with electronic prescribing (e-prescribing) were analyzed., Main Outcome Measure: The purpose of this study was to evaluate the barriers to e-prescribing of opioids., Results: A total of 121 prescribers completed the survey. The majority trusted that e-prescribing were transmitted successfully (62 percent), saved time (78 percent), and did not interrupt their workflow (78 percent). However, many prescribers indicated that additional improvements are needed, such as updating the patient's preferred pharmacy in the electronic medical record during each visit (52 percent) and having a 24-hour pharmacy readily available (66 percent)., Conclusion: Prescribers value the ease of use of e-prescribing and how time efficient the process can be. Nevertheless, there is a need to improve the system's service, design, and usefulness.

Objective: Understanding the impact of substance use during pregnancy on fetal development and child health is essential for designing effective approaches for reducing prenatal substance exposures and improving child outcomes. Research on the developmental impacts of prenatal substance exposure has been limited by legal, ethical, and practical challenges. This study examined approaches to engage substance-using (with an emphasis on opioids) pregnant persons in longitudinal research, from multi-stakeholder perspectives., Methods: The present study solicited the expertise of 1) an advisory group of community stakeholders, including people with lived experienced of opioid/substance use; and 2) an online survey with content experts. Qualitative analysis examined facilitators and barriers to recruiting and retaining substance-using pregnant persons through a socioecological lens at the individual, interpersonal, organizational, community, and policy levels., Results: Stakeholders (N = 19) prioritized stigma, loss of confidentiality, legal consequences, and instability (e.g., homelessness and poverty) as important barriers that prevent substance-using persons from enrolling in research studies. Of 70 survey respondents, most self-identified as researchers (n = 37), followed by clinicians (n = 19), and 'others' (n = 14). Survey respondents focused on retention strategies that build trusting relationships with participants, including incentives (e.g., transportation and childcare support), participant-friendly study design, and team-related factors, (e.g., attitudes and practices)., Conclusion: The stakeholder input and survey data offer key insights strengthening our understanding of facilitators and barriers to research participation, and ways to overcome barriers among substance-using pregnant persons. A socioecological framework can be used to identify and address these factors to increase recruitment and long-term retention of high-risk populations., (Copyright © 2021 Elsevier Inc. All rights reserved.)

The exposure prediction component of the Control of Substances Hazardous to Health (COSHH) Essentials model (paper version) was evaluated using field measurements from National Institute of Occupational Safety and Health (NIOSH) Health Hazard Evaluation (HHE) reports. Overall 757 measured exposures for 94 similar exposure groups (SEGs) were compared with the COSHH Essentials predicted exposure range (PER). The SEGs were stratified based on the magnitude of measured exposures (high, medium, or low) and physical state of the substance (vapor or particulate). The majority of measured exposures observed involved low-level exposure to vapors; thus, overall findings from the current study are limited to low-level vapor exposure scenarios. Overall, the exposure prediction component of COSHH Essentials vastly overestimated low-level exposures to vapors. This study went beyond the scope of previous studies and investigated which model components led to the overestimation. It was concluded that COSHH Essential's tendency to overestimate was due to multiple complex interactions among model components. Overall, the magnitude of overestimation seems to increase exponentially as values for predictor variables increase. This is likely due to the log-based scale used by the model to allocate concentration ranges. In addition, the current banding scheme used to allocate volatility appears to play a role in the overestimation of low-level exposures to vapors.

Background: Perioperative controlled substance diversion and tracking have received increased regulatory focus throughout the United States. The authors' institution developed and implemented an automated web-based software application for perioperative controlled substance management. The authors hypothesized that implementation of such a system reduces errors as measured by missing controlled substance medications, missing controlled substance kits (a package of multiple controlled substance medications), and missing witness signatures during kit return., Methods: From December 1, 2014 to March 31, 2017, the authors obtained missing controlled substance medication, controlled substance kit, and witness return signature data during the preimplementation, implementation, and study period of the controlled substance management application at a single university hospital. This before and after study was based on a QI project at the authors' institution. The authors included all cases requiring anesthesia services. The primary outcome of this study was the rate of missing controlled substance medications. Secondary outcomes included rates for kits not returned to pharmacy and missing kit return witness signatures., Results: There were 54,302 cases during the preimplementation period, 57,670 cases during the implementation period, and 65,911 cases during the study period. The number of missing controlled substance medication (difference 0.7 per 1,000 cases; 95% CI, 0.38-1.02; P < 0.001) and kit return errors (difference 0.45 per 1,000 cases; 95% CI, 0.24-0.66, P < 0.001) declined after implementation of the application. There was no difference in the number of missing witness return signatures (difference 0.09 per 1,000 cases; 95% CI, -0.08 to 0.26, P = 0.350). A user survey with 206 of 485 (42%) response rate demonstrated that providers believed the new application managed controlled substances better than the previous system., Conclusions: A software application that tracks perioperative controlled substance kits with deep integration into the electronic health record and pharmacy systems is associated with a decrease in management errors.

Background and Rationale: Cathinones are amphetamine analogues that produce stimulant effects with rewarding properties. For many decades, synthetic cathinones have been used in the United States (USA) for abuse purposes, leading to concern about public safety by the federal government. Under the Controlled Substances Act (CSA), the federal government may place drugs with high abuse potential but no currently accepted medical use into Schedule I of the CSA. The process of scheduling an abusable drug involves both the Department of Health and Human Services (HHS), through the Food and Drug Administration (FDA) and the National Institute on Drug Abuse (NIDA), and the Department of Justice, through the Drug Enforcement Administration (DEA)., Results: This paper details how numerous synthetic cathinones were placed under CSA control between 1973 and 2018, with an emphasis on 10 cathinones that were placed into Schedule I in 2017 (butylone, naphyrone, pentylone, pentedrone, 3-fluoro-N-methylcathinone (FMC), 4-FMC, 4-methyl-N-ethylcathinone, 4-methyl-pyrrolidinopropiophenone, alpha-pyrrolidinobutiophenone, and α-pyrrolidinopentiophenone). A summary is provided of the scientific and medical analysis performed by HHS, in the form of an Eight-Factor Analysis (8FA), as prescribed by the CSA. This 8FA was then evaluated and signed by the Assistant Secretary for Health at HHS and transmitted to DEA, which permanently placed the 10 cathinones into Schedule I after public notices were published into the Federal Register., Discussion and Conclusions: Understanding the scientific data, analysis, and complex process utilized by the US federal government in the CSA scheduling of cathinones with abuse potential and no accepted medical use is important for transparency in governmental decision-making.

Purpose: "Lock-in" programs (LIPs) are used by health insurers to address potential substance (eg, opioid) misuse among beneficiaries. We sought to (1) examine heterogeneity in trajectories of dispensed opioids (in average daily morphine milligram equivalents (MMEs)) over time: prior to, during, and following release from a LIP, and (2) assess associations between trajectory patterns and beneficiary characteristics., Methods: Medicaid claims were linked to Prescription Drug Monitoring Program records for a cohort of beneficiaries enrolled in the North Carolina Medicaid LIP (n = 2701). Using latent class growth analyses, we estimated trajectories of average daily MMEs of opioids dispensed to beneficiaries across specific time periods of interest., Results: Five trajectory patterns appeared to sufficiently describe underlying heterogeneity. Starting values and slopes varied across the 5 trajectory groups, which followed these overall patterns: (1) start at a high level of MMEs, end at a high level of MMEs (13.1% of cohort); (2) start medium, end medium (13.2%); (3) start medium, end low (21.5%); (4) start low, end medium (22.6%); and (5) start low, end low (29.6%). We observed strong associations between patterns and beneficiaries' demographics, substance use-related characteristics, comorbid conditions, and healthcare utilization., Conclusions: In its current form, the Medicaid LIP appeared to have limited impact on beneficiaries' opioid trajectories. However, strong associations between trajectory patterns and beneficiary characteristics provide insight into potential LIP design modifications that might improve program impact (eg, LIP integration of substance use disorder assessment and referral to treatment, assessment and support for alternate pain therapies)., (© 2018 John Wiley & Sons, Ltd.)

The United States is facing an opioid epidemic that is virulent in its lethality and includes morbidity and mortality related to prescription opioids. Overuse of another class of drugs- benzodiazepines-has received less media attention, but also poses the threat of tolerance, dependence, and death, especially in combination with opioids or alcohol. These negative outcomes are not distributed evenly over the population but are especially prevalent in vulnerable populations. One such vulnerable population comprises individuals with serious mental illness. Professionals who serve this population are challenged by an often-fragmented health care system to collaborate with patients and other professionals to reduce risks and improve outcomes. This article examines strategies for addressing risks associated with the use of benzodiazepines and opioids in this population within the context of an integrated interprofessional team. Recommendations include (a) building consensus on the team, (b) providing education for all stakeholders, and (c) enhancing care coordination and patient access to effective treatments. [Journal of Psychosocial Nursing and Mental Health Services, 56(12), 11-15.]., (Copyright 2018, SLACK Incorporated.)

Objective: To qualitatively assess prescribers) perceptions regarding the consequences associated with hydrocodone rescheduling among geriatric patients being discharged from inpatient settings., Design: This was a cross-sectional study., Setting: Two focus groups were conducted by a trained facilitator in a metropolitan academic medical center in January 2016., Participants: Prescribers who manage noncancer pain for geriatric patients were recruited. Focus groups were recorded, transcribed, and then analyzed using ATLAS.ti Qualitative Data Analysis software. Codes were derived from six primary research questions and results were summarized into key themes regarding the impact of rescheduling., Main Outcome Measures: Prescribers) perceptions regarding hydrocodone rescheduling., Results: Prescribers mentioned that they review the prescription monitoring program (PMP) more often before prescribing opioids after rescheduling. They expressed concern regarding the required special serialized prescription forms needed to issue schedule II prescriptions. This led to substituting hydrocodone with potentially less effective pain medications, the inability to issue refills on hydrocodone prescriptions, and an ethical concern over prescribing hydrocodone to patients not under their direct care. Additionally, rescheduling has affected the coordination of care upon discharge, as patients moving to long-term care or skilled nursing facilities may not have adequate pain management when transferred., Conclusions: The majority of physicians felt rescheduling negatively impacted both practical and ethical aspects of patient care related to pain management after discharge. Rescheduling has changed physicians) hydrocodone prescribing patterns, leading to more caution when prescribing hydrocodone and greater use of the PMP. Future studies should assess geriatric patients) satisfaction and quality of life regarding pain management since hydrocodone was rescheduled.

Background: Opioid misuse is a public health crisis that stems in part from overprescribing by health-care providers. Surgical residents are commonly responsible for prescribing opioids at patient discharge, and residency program directors (PDs) are charged with their residents' education. Because each hospital and state has different opioid prescribing policies, we sought to assess PDs' knowledge about local controlled substance prescribing polices., Methods: A survey was emailed to surgery PDs that included questions regarding residency characteristics and knowledge of state regulations., Results: A total of 247 PDs were emailed with 110 (44.5%) completed responses. One hundred and four (94.5%) allow residents to prescribe outpatient opioids; one was unsure. Sixty-three (57.3%) respondents correctly answered if their state required opioid prescribing education for full licensure. Twenty-two (20.0%) were unsure if their state required opioid prescribing education for licensure. Sixty-four (58.2%) respondents answered correctly if a prescription monitor programs use is required in their state. Twenty-nine (26.4%) were unsure if a state prescription monitor programs existed. Seventy-six (69.1%) PDs answered correctly about their state's requirement for an additional registration to prescribe controlled substances; 10 (9.1%) did not know if this was required. Twenty-nine (27.9%) programs require residents to obtain individual drug enforcement agency registration; 5 (4.8%) were unsure if this was required., Conclusions: Most programs allow residents to prescribe outpatient opioids. However, this survey demonstrated a considerable gap in PDs' knowledge about controlled substance regulations. Because they oversee surgical residents' education, PDs should be versed about their local policies in this matter., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Purpose: This study aimed to develop hypotheses to explain the increasing tramadol utilisation, evaluate the impact of tramadol classification, and explore the trend between tramadol utilisation and related deaths in the United Kingdom., Methods: This cross-sectional study used individual patient data, the Clinical Practice Research Datalink from 1993 to 2015, to calculate monthly defined daily dose (DDD)/1000 registrants, monthly prevalence and incidence of tramadol users, annual supply days, and mean daily dose of tramadol. Aggregated-level national statistics and reimbursement data from 2004 to 2015 were also used to quantify annual and monthly tramadol DDD/1000 inhabitants and rate of tramadol-related deaths in England and Wales. Interrupted time-series analysis was used to evaluate the impact of tramadol classification in June 2014., Results: Prevalence of tramadol users increased from 23 to 97.6/10 000 registrants from 2000 to 2015. Both annual dose and annual supply days of existing tramadol users were higher than new users. Level and trend of monthly utilisation (β 2 : -12.9, β 3 : -1.6) and prevalence of tramadol users (β 2 : -6.4, β 3 : -0.37) significantly reduced after classification. Both annual tramadol utilisation and rate of tramadol-related deaths increased before tramadol classification and decreased thereafter., Conclusions: Increasing tramadol utilisation was influenced by the increase in prevalence and incidence of tramadol users, mean daily dose, and day of supply. Prevalence of tramadol users, tramadol utilisation, and reported deaths declined after tramadol classification. Future studies need to evaluate the influencing factors to ensure the safety of long-term tramadol use., (Copyright © 2017 John Wiley & Sons, Ltd.)

Rationale: Consideration by the US Drug Enforcement Administration and Food and Drug Administration of placing kratom into Schedule I of the Controlled Substances Act (CSA) requires its evaluation of abuse potential in the context of public health., Objective: The objective of the study is to provide a review of kratom abuse potential and its evaluation according to the 8 factors of the CSA., Results: Kratom leaves and extracts have been used for centuries in Southeast Asia and elsewhere to manage pain and other disorders and, by mid-twentieth century, to manage opioid withdrawal. Kratom has some opioid effects but low respiratory depression and abuse potential compared to opioids of abuse. This appears due to its non-opioid-derived and resembling molecular structure recently referred to as biased agonists. By the early 2000s, kratom was increasingly used in the US as a natural remedy to improve mood and quality of life and as substitutes for prescription and illicit opioids for managing pain and opioid withdrawal by people seeking abstinence from opioids. There has been no documented threat to public health that would appear to warrant emergency scheduling of the products and placement in Schedule I of the CSA carries risks of creating serious public health problems., Conclusions: Although kratom appears to have pharmacological properties that support some level of scheduling, if it was an approved drug, placing it into Schedule I, thus banning it, risks creating public health problems that do not presently exist. Furthermore, appropriate regulation by FDA is vital to ensure appropriate and safe use.

Purpose: The success of a patient-centered medical home in providing population health management (PHM) services through controlled substance stewardship is described., Summary: In 2013, Penobscot Community Health Care (PCHC), in Bangor, Maine, was fully engulfed in the prescription opioid crisis. At PCHC, patients' opioid doses were startlingly high. Within the organization, measures to ensure that prescriptions were being used as prescribed, and not diverted, were underutilized. PCHC responded to these challenges by developing a comprehensive approach to controlled substance stewardship, defined as a coordinated effort to promote the appropriate use of controlled substances, improve patient outcomes, reduce misuse and abuse, and decrease patient morbidity and mortality attributed to these high-risk medications. Since the establishment of the program, over 1,300 patient reviews have been conducted. During this time, the number of PCHC patients receiving chronic opioids has decreased by 67.2% and continues to drop, with a corresponding 65.6% decrease in the number of patients receiving benzodiazepines. Premature deaths were reviewed to identify associations with opioids prescribed at the time of death, which revealed a decline of 50% between 2013 and 2015. Since program inception, the reviews conducted based on internal quality-improvement reports have been expanded to include patients on combinations of opioids and benzodiazepines, high-dose opioids, and carisoprodol., Conclusion: Systematic approaches addressing areas of critical need in high-risk populations are integral to PHM efforts in small health systems. The pharmacy team can serve a unique role in identifying, developing, and implementing key PHM services. Coupled with strategic community partnerships, successful PHM integration can assist in the financial survival of small health systems., (Copyright © 2017 by the American Society of Health-System Pharmacists, Inc. All rights reserved.)

Objective: Prescription opioid abuse poses a significant public health concern. House Bill 1 (HB1) was enacted in 2012 to address prescription drug abuse in Kentucky. The authors investigated the impact of HB1 on primary care providers' (PCPs) prescribing practices of Schedule II controlled substances., Design: Retrospective evaluation of PCPs' prescribing practices in an adult outpatient setting., Methods: A review of the prescribing practices for Schedule II controlled substances written by 149 PCPs. The number of prescriptions for Schedule II controlled substances written by 149 PCPs was compared to the top 10 PCP prescribers. Attention was focused on providers who wrote for oxycontin and/or opana and prescriptions with > 90 pills dispensed., Results: The top 10 PCP prescribers accounted for 38.4 percent of the Schedule II controlled substances and 47.8 percent of the Schedule II controlled substances with > 90 pills dispensed. Of the 60 PCPs who prescribed opana and/or oxycontin, the average number of prescriptions was 14.7 compared to 51.0 for the top 10 PCP prescribers. The average percentage of Schedule II controlled substance prescriptions compared to the total number of prescriptions was 27.9 percent for the top 10 PCP prescribers and 7.05 percent of all PCPs. The average percentage of office visits with Schedule II controlled substance prescriptions compared to total office visits was 24.8 percent for the top 10 PCP prescribers versus 7.7 percent for all PCPs., Conclusions: Further scrutiny is warranted to more closely analyze provider opioid prescribing habits and ensure that the providers at our Institution are prescribing Schedule II controlled substances in compliance with HB1.

Controlled substance lock-in programs are garnering increased attention from payers and policy makers seeking to combat the epidemic of opioid misuse. These programs require high-risk patients to visit a single prescriber and pharmacy for coverage of controlled substance medication services. Despite high prevalence of the programs in Medicaid, we know little about their effects on patients' behavior and outcomes aside from reducing controlled substance-related claims. Our study was the first rigorous investigation of lock-in programs' effects on out-of-pocket controlled substance prescription fills, which circumvent the programs' restrictions and mitigate their potential public health benefits. We linked claims data and prescription drug monitoring program data for the period 2009-12 for 1,647 enrollees in North Carolina Medicaid's lock-in program and found that enrollment was associated with a roughly fourfold increase in the likelihood and frequency of out-of-pocket controlled substance prescription fills. This finding illuminates weaknesses of lock-in programs and highlights the need for further scrutiny of the appropriate role, optimal design, and potential unintended consequences of the programs as tools to prevent opioid abuse., (Project HOPE—The People-to-People Health Foundation, Inc.)

Purpose: To develop a complete and consistent prescription drug monitoring program (PDMP) data set for use by drug safety researchers in evaluating patterns of high-risk use and potential abuse of scheduled drugs., Methods: Using publically available data references from the US Food and Drug Administration and the Centers for Disease Control and Prevention, we developed a strategic methodology to assign drug categories based on pharmaceutical class for the majority of prescriptions in the PDMP data set. We augmented data elements required to calculate morphine milligram equivalents and assigned duration of action (short-acting or long acting) properties for a majority of opioids in the data set., Results: About 10% of prescriptions in the PDMP data set did not have a vendor-assigned drug category, and 20% of opioid prescriptions were missing data needed to calculate risk metrics. Using inclusive methods, 19 133 167 (>99.9%) of prescriptions in the PDMP data set were assigned a drug category. For the opioid category, augmenting data elements resulted in 10 760 669 (99.8%) having required values to calculate morphine milligram equivalents and evaluate duration of action properties., Conclusions: Drug safety researchers who require a complete and consistent PDMP data set can use the methods described here to ensure that prescriptions of interest are assigned consistent drug categories and complete opioid risk variable values. Copyright © 2016 John Wiley & Sons, Ltd., Competing Interests: and Conflicts of Interest: None of the authors have conflicts of interest to declare., (Copyright © 2016 John Wiley & Sons, Ltd.)

Objectives: Prescription drug monitoring programs (PDMPs) are state-based data collection systems recording controlled substance medications. Currently, 49 states have PDMPs. There are discrepancies in reporting patterns, infrastructure, and oversight between programs. We characterized aspects of each state's PDMP., Methods: A web search of each state's PDMP was conducted, and a list of all PDMP administrators was obtained. From August 1 to November 31, 2014, a link to a web-based survey was sent to each PDMP administrator. Closed-ended questions included type of access, mandatory-use programs, data sharing, proactive contact with patients or health care providers, details of pharmacy reporting, and protocols for identifying "high-risk" patients. Descriptive statistics were used for analysis., Results: We received a 100% response rate (49/49). Ninety-six percent (47/49) have a physician-accessible PDMP. Most, 68% (32/49), do not have an enrollment mandate for physicians. Prior to prescribing controlled medications, 16% (8/49) require prescribers to access their state's PDMP. More than half of states (53%, 26/49) reported patient prescriptions over the past two or more years. Most, 57% (28/59), reported a lag time of 1 week or longer for patients to appear in a PDMP database after prescription filling. A majority of states (65% 32/49) share data with at least one other state. Protocols exist to identify high-risk patients for prescription drug misuse in 55% (27/49) of states., Conclusion: Characteristics of PDMPs are heterogeneous throughout the country. Standardizing data capture, availability, and reporting would improve their usefulness for providers. Copyright © 2016 John Wiley & Sons, Ltd., (Copyright © 2016 John Wiley & Sons, Ltd.)

Background: Prescription drug abuse is a serious health concern and is considered a nationwide epidemic. Patients often fail or refuse to disclose the use of controlled substances, leaving prescribers and pharmacies unaware of the potential for harmful drug interactions and risk of overdose. Psychiatric patients are especially vulnerable to controlled substance misuse., Objectives: To determine hazardous patterns of prescription drug use among psychiatric outpatients and to raise awareness about the importance of reviewing information provided by prescription drug monitoring programs (PDMPs)., Methods: The medical records of 150 patients attending the Adult Outpatient Psychiatric Clinic at the Los Angeles County+University of Southern California (LAC+USC) Medical Center from July 2012 through May 2013 were reviewed. Patient activity reports were generated from California's PDMP. Nondisclosure of controlled substance use was identified by a discrepancy between patient reporting of prescriptions according to the medical records and PDMP reports. A "pattern suggestive of prescription drug abuse" was defined as having one or more of the following: within-class prescriptions from multiple providers and/or within-class early refills or within-class overlapping prescriptions picked up within 10 days of each other., Results: Of the 150 patients, 113 were found in California's PDMP database. Of these 113 patients, 81 had obtained 111 prescriptions for controlled substances in the past 12 months. Of these 111 prescriptions, 52 (47%) were not disclosed to the primary psychiatrist, of which 14 (27%) revealed patterns consistent with prescription drug abuse., Conclusions: Reviewing PDMP databases before prescribing controlled substances should be considered a standard prescribing practice to prevent abuse, diversion, and adverse medical outcomes.

Objective: To present the development of a multidisciplinary controlled substances committee and describe its effectiveness in relation to prescribers' acceptance of committee recommendations, the number of premature deaths associated with controlled substances, and prescribers' need for education on controlled substances., Setting: A patient-centered medical home and accountable care organization in Maine that serves more than 60,000 patients across a large rural area, 70% of whom are classified as lower income., Practice Description: A multidisciplinary group of prescribers and PharmD residents created a committee to influence organizational culture regarding controlled substances. The Controlled Substances Initiative Committee (CSIC) updated institutional policies, developed provider education, and made personalized patient recommendations to prescribers., Main Outcome Measures: The primary outcome was average change in daily morphine equivalent dose (MED) in patients for whom CSIC recommended a dose reduction to the patient's prescriber. Secondary outcomes included the proportion of patients who died of a known overdose or suspected drug-related death during 2012-2013 or 2013-2014. In addition, prescriber beliefs about controlled substances were measured via a needs assessment., Results: The average daily MED for patients whom CSIC recommended dose reduction was lower after 3 months compared with at baseline (175.5 ± 344.3 mg vs. 292.7 ± 466.5 mg; P <0.05). The proportion of patients who died of a known overdose did not differ between 2012-2013 and 2013-2014 (11.8% vs. 11.1%; P = 1.00). However, a greater number of patients had a suspected drug-related death during 2013-2014 compared with during 2012-2013 (0% vs. 27.3%; P = 0.05)., Conclusion: A multidisciplinary controlled substances committee may improve patient safety and outcomes by offering prescriber support and helping alter prescribing culture.

Opioids have become a mainstay of treatment for pain in the United States, with over 250 million prescription issued in 2012 alone. The increased prescribing of these medications has also contributed to the unintended consequence of a widening prevalence of abuse and misuse, and therefore safety has become a top agenda item for both government and health care providers alike. The move toward new abuse-deterrent formulation technologies, enhanced regulatory requirements from the Food and Drug Administration (FDA) and Drug Enforcement Administration (DEA), and developments in national/state policies have worked together to target a goal of promoting safer clinician prescribing, pharmacy dispensing and patient use of opioids. Hydrocodone in particular, as the most widely prescribed opioid product, has recently been subject to a myriad of changes, both through the federal rescheduling of hydrocodone-combination products (HCPs) to Schedule II, as well as the introduction of two new extended-release formulations to the USA market. These efforts represent a first step toward tackling the opioid harms epidemic, although continuing follow-up through research and policy implementation is needed to see any measureable impact on safety in the future., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Prescription drug abuse and overdose are rapidly growing problems in the United States. The United States federal Disposal of Controlled Substances Rule became effective 9 October 2014, implementing the Secure and Responsible Drug Disposal Act of 2010 (Disposal Act). These regulations target escalating prescription drug misuse by reducing accumulation of unused controlled substances that may be abused, diverted or accidentally ingested. Clinical areas that can now participate in collecting unused controlled substances include retail pharmacies, hospitals or clinics with an onsite pharmacy, and narcotic treatment programs. Collection methods include placing a controlled substance collection receptacle or instituting a mail-back program. Because prompt onsite destruction of collected items is required of mail-back programs, collection receptacles are more likely to be used in clinical areas. Retail pharmacies and hospitals or clinics with an onsite pharmacy may also place and maintain collection receptacles at long-term care facilities. The Act and Rule are intended to increase controlled substance disposal methods and expand local involvement in collection of unused controlled substances. Potential barriers to participating in controlled substance collection include acquisition of suitable collection receptacles and liners, lack of available space meeting the necessary criteria, lack of employee time for verification and inventory requirements, and program costs.

The epidemic of prescription opioid-related morbidity and mortality demonstrates the need for a fresh, open, and balanced approach to managing pain while minimizing adverse personal and public health outcomes. Interventions by pharmacists in situations in which prescriptions are felt to be inappropriate have raised the ire of prescribers who feel their professional judgment is being questioned and their time is being usurped from patient care. Pharmacists, however, represent an important check and balance in the opioid analgesic prescribing chain, and prescribers should embrace their involvement and recognize that the time and effort of the pharmacist are directed at improving care of individual patients and keeping a watchful eye on the public health. Pharmacies need to keep a mindful eye toward professional practices of physicians and use noninvasive means, such as database inquiries, prior to directly contacting a prescriber. Collaboration is the most professional approach that can be taken to assure that our joint priority of caring for patients in distress will be accomplished effectively and safely., (Wiley Periodicals, Inc.)

Since the late 1990s, the number of opioid analgesic overdose deaths has quadrupled in the United States of America (from 4 030 deaths in 1999 to 16 651 in 2010). The objectives of this article are to provide an overview of the problem of prescription drug overdose in the United States and to discuss actions that could help reduce the problem, with particular attention to the characteristics of prescription drug monitoring programs (PDMPs). These programs consist of state-level databases that monitor controlled substances. The information compiled in the databases is at the disposal of authorized persons (e.g., physicians, pharmacists, and other health-care providers) and may be used only for professional purposes. Suppliers can use such information to prevent interaction with other drugs or therapeutic duplication, or to identify drug-search behavior. Law enforcement agencies can use these programs to identify improper drug prescription or dispensing patterns, or drug diversion.

Nonmedical use of prescription medications--particularly controlled substances--has risen dramatically in recent decades, resulting in alarming increases in overdose-related health care utilization, costs, and mortality. The Centers for Disease Control and Prevention estimate that 80% of abused and misused controlled substances originate as legal prescriptions. As such, policymakers and payers have the opportunity to combat nonmedical use by regulating controlled substance accessibility within legal prescribing and dispensing processes. One common policy strategy is found in Medicaid controlled substance lock-in programs. Lock-in programs identify Medicaid beneficiaries exhibiting high-risk controlled substance seeking behavior and "lock in" these patients to, typically, a single prescriber and pharmacy from which they may obtain Medicaid-covered controlled substance prescriptions. Lock-in restrictions are intended to improve care coordination between providers, reduce nonmedical use behaviors, and limit Medicaid costs stemming from nonmedical use and diversion. Peer-reviewed and gray literature have been examined to assess the current prevalence and design of Medicaid lock-in programs, as well as the current evidence base for informing appropriate program design and understanding program effectiveness. Forty-six state Medicaid agencies currently operate lock-in programs. Program design varies widely between states in terms of defining high-risk controlled substance use, the scope of actual lock-in restrictions, and length of program enrollment. Additionally, there is a remarkable dearth of peer-reviewed literature evaluating the design and effectiveness of Medicaid lock-in programs. Nearly all outcomes evidence stemmed from publicly accessible internal Medicaid program evaluations, which largely investigated cost savings to the state. Lock-in programs are highly prevalent and poised to play a meaningful role in curbing the prescription drug abuse epidemic. However, achieving these ends requires a concerted effort from the academic and policy communities to rigorously evaluate the effect of lock-in programs on patient outcomes, determine optimal program design, and explore opportunities to enhance lock-in program impact through coordination with parallel controlled substance policy efforts, namely prescription drug-monitoring programs.

Objectives: To examine situations that prompt pharmacists to access a prescription drug monitoring program (PDMP) database and management of opioid abuse/addiction; assess pharmacists' actions when abuse is suspected; describe pharmacists' tasks when dispensing controlled substance prescriptions (CSPs); and their continuing pharmacy education (CPE). DESIGN Cross-sectional mail survey of 1,000 randomly selected pharmacists., Setting: Texas from February 2012 to April 2012., Participants: 1,000 Texas community pharmacists., Intervention: Mail survey instrument., Main Outcome Measures: Prompts to use a PDMP and pharmacists' views actions, and related CPE programs. RESULTS The usable response rate was 26.2%. Pharmacists were more supportive of mandated PDMP use by physicians than by pharmacists (mean ± SD 4.1 ± 1.2 versus 3.2 ± 1.5; P <0.001), based on a 5-point Likert scale (1, strongly disagree, to 5, strongly agree). Most pharmacists would be prompted to use a PDMP if the prescription contains mistakes (68.1%) or the patient requests an early refill (66.3%). Bivariate statistics showed that men pharmacists, those with BSPharm degrees, and pharmacists ≥50 years of age reported a greater number of CPE hours related to prescription opioid abuse and pain management. An analysis of variance showed that pharmacy owners reported significantly more (P <0.05) CPE compared with manager and staff pharmacists., Conclusion: Older pharmacists with a BSPharm degree may be more willing to provide counseling to patients with opioid addiction based on their work experience and additional CPE related to controlled substances. As PDMP use becomes more prevalent, pharmacists should be prepared to interact and counsel patients identified with aberrant controlled prescription drug use and properly deliver pain management care. Additionally, schools of pharmacy curricula must prepare new pharmacists to prevent abuse and diversion, as well as intervene when aberrant use is identified.

Background: Prescription drug abuse has prompted considerable concern. We evaluated a retrospective drug utilization review program to reduce controlled substance use among individuals with high-risk utilization., Methods: We analyzed pharmacy claims from a large pharmaceutical benefits manager. For each eligible member, we calculated a controlled substance score based on the number and type of claims, prescribers and pharmacies, and utilization patterns over three months. Two state health plans sent controlled substance letters to prescribers of members meeting or exceeding a plan- and pre-specified controlled substance score. Two different state health plans did not send such letters. We used a difference-in-difference design and generalized estimating equations to quantify the impact of the program on the mean difference in reduction of the controlled substance score over six months., Results: Eligible members in the intervention and comparison states had similar baseline mean controlled substance scores (19.0 vs. 18.6, p = 0.36). Adjusting for individuals' age, sex and pharmacy risk group score, reductions in the mean controlled substance score were greater in the intervention than comparison cohort (5.67 vs. 4.31, p = 0.01), corresponding with a 34.0% reduction in the intervention cohort compared to a 25.5% reduction in the comparison cohort. Changes were driven primarily by reductions in the number of controlled substance claims filled (30.5% vs. 23.1%, p = 0.01), as well as by a non-statistically significant trend towards reductions in the number of prescribers and pharmacies used (26.9% vs. 20.1%, p = 0.07)., Conclusions: Retrospective drug utilization review programs may reduce controlled substance scores and claims among individuals with patterns suggesting high-risk utilization., (Copyright © 2013 John Wiley & Sons, Ltd.)

Identifying the abuse potential of drug products in the premarketing and postmarketing environment has been a critical component in the implementation of drug abuse control laws worldwide. In the US, the Controlled Substances Act of 1970 (CSA) is a comprehensive federal law enacted to prevent the abuse or diversion of substances with abuse liability or addiction potential (for present purposes, these terms are used interchangeably). Under the jurisdiction of the Drug Enforcement Administration, the law applies to the manufacture and distribution of narcotics and other drug substances with potential of abuse. The CSA classifies substances with abuse potential into schedules I-V based on the substance's risk of diversion or abuse, and thus provides a legal framework for the assessment of abuse liability of New Molecular Entities. When the Food and Drug Administration reviews the safety and efficacy of a New Drug Application it also determines whether the drug has potential for abuse, and if so, will begin the process to schedule the drug under the CSA. As the assessment of abuse potential is a critical component of a marketing application, pharmaceutical companies (sponsors) bear the responsibility of generating a comprehensive preclinical and clinical data package for regulators to review and make decisions on labeling and the corresponding postmarketing surveillance. Recent regulatory guidelines adopted in the European Union (EU) (2006), Canada (2007), and USA (2010) provide recommendations to sponsors on preclinical and clinical methodologies for the assessment of abuse potential. This paper reviews the legal framework of the assessment of abuse liability and scheduling of controlled substances in the USA and describes the current global regulatory environment and the challenges that sponsors and regulators face when assessing abuse liability of New Molecular Entities, from the early stages of development through the late stages, review, and approval.

The Deputy Administrator of the Drug Enforcement Administration (DEA) is issuing this final order to temporarily schedule three synthetic cannabinoids under the Controlled Substances Act (CSA) pursuant to the temporary scheduling provisions of 21 U.S.C. 811(h). The substances are (1-pentyl-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone (UR-144), [1-(5-fluoro-pentyl)-1H-indol-3-yl](2,2,3,3-tetramethylcyclopropyl)methanone (5-fluoro-UR-144, XLR11) and N-(1-adamantyl)-1-pentyl-1H-indazole-3-carboxamide (APINACA, AKB48). This action is based on a finding by the Deputy Administrator that the placement of these synthetic cannabinoids and their salts, isomers and salts of isomers into Schedule I of the CSA is necessary to avoid an imminent hazard to the public safety. As a result of this order, the full effect of the CSA and the Controlled Substances Import and Export Act (CSIEA) and their implementing regulations including criminal, civil and administrative penalties, sanctions and regulatory controls of Schedule I substances will be imposed on the manufacture, distribution, possession, importation, and exportation of these synthetic cannabinoids.

This article provides an overview on prescription drug abuse and highlights a number of related legislative bills introduced during the 112th Congress in response to this growing epidemic. Prescription drug abuse has emerged as the nation's fastest growing drug problem. Although prescription drugs have been used effectively and appropriately for decades, deaths from prescription pain medicine in particular have reached epidemic proportions. Bills related to prescription drug abuse introduced during the 112th Congress focus on strengthening provider and consumer education, tracking and monitoring prescription drug abuse, improving data collection on drug overdose fatalities, combating fraud and abuse in Medicare and Medicaid programs, reclassifying drugs to make them more difficult to prescribe and obtain, and enforcing stricter penalties for individuals who operate scam pain clinics and sell pain pills illegitimately. This article underscores the importance of a multifaceted approach to combating prescription drug abuse and concludes with implications for nursing., (Copyright © 2013. Published by Mosby, Inc.)

Almost all countries are parties to the international drug conventions of 1961, 1971 and 1988. These strongly bind parties with respect to their domestic regulation of controlled substances, including requirements that possession, growing or use be a criminal offense and that any regulated market in the substances be limited to use only for medical or scientific purposes. Even where countries have argued they have "wiggle room", reform within the bounds of the conventions has often resulted in "net-widening" which nullifies the intent of the reform. Among the options for effective reform, probably the most immediately viable is the route of denunciation and reaccession with reservations--the route which Bolivia has now taken in order to legalise a regulated domestic market in coca leaves for chewing. The paper considers the existing record of reservations (by more than 30 parties to each of the conventions). Also discussed are the options for response to the reservations by other parties, which vary between the treaties, and how pursuing the option of denunciation and reaccession with reservation might potentially play out., (Copyright © 2012 Elsevier B.V. All rights reserved.)

The escalation of prescription drug abuse in the U.S. has attracted the attention of public health and safety officials as well as others puzzled by how such a tightly regulated enterprise could so easily be breached by those seeking controlled substances for nonmedical use. Prescribers and patients who use, misuse, or, in some cases, redistribute or divert these drugs have figured prominently in government strategies aimed at addressing this issue. This review departs from this paradigm and focuses on wholesale drug distributors, a highly efficient and largely behinds-the-scene link in the supply chain of controlled substances. By law, distributors are required to identify and report to the Drug Enforcement Administration (DEA) orders for controlled substances that are suspicious and may indicate drug diversion. Ten cases are examined in which distributors were each charged with failing to prevent the diversion of millions of doses of controlled substances. Special attention is given to a payment system employed by the industry that may encourage this unlawful commerce. Court records, agency and industry reports, and other published sources are used to document referenced cases and their disposition, and recommendations are offered for improving distributors' compliance with the law.