The Supreme Court Decision on Federal Prescribing Rules for Controlled Substances.

This Viewpoint explains how a recent Supreme Court decision clarifies rules for prescribing controlled substances so that patients are not denied appropriate care and physicians are not unjustly prosecuted.

The synthetic CB1 cannabinoid receptor selective agonists: Putative medical uses and their legalization.

More than 500 molecules have been identified as components of Cannabis sativa (C. sativa), of which the most studied is Δ9-tetrahydrocannabinol (Δ9-THC). Several studies have suggested that Δ9-THC exerts diverse biological effects, ranging from fragmentation of DNA to behavioral disruptions. Currently, it is accepted that most of the pharmacological properties of Δ9-THC engage the activation of the cannabinoid receptors, named CB1 and CB2. Interestingly, multiple pieces of evidence have suggested that the cannabinoid receptors play an active role in the modulation of several diseases leading to the design of synthetic cannabinoid-like compounds. Advances in the development of synthetic CB1 cannabinoid receptor selective agonists as therapeutical approaches are, however, limited. This review focuses on available evidence searched in PubMed regarding the synthetic CB1 cannabinoid receptor selective agonists such as AM-1235, arachidonyl-2' chloroethylamide (ACEA), CP 50,556-1 (Levonantradol), CP-55,940, HU-210, JWH-007, JWH-018, JWH-200 (WIN 55,225), methanandamide, nabilone, O-1812, UR-144, WIN 55,212-2, nabiximols, and dronabinol. Indeed, it would be ambitious to describe all available evidence related to the synthetic CB1 cannabinoid receptor selective agonists. However, and despite the positive evidence on the positive results of using these compounds in experimental models of health disturbances and preclinical trials, we discuss evidence in regards some concerns due to side effects.

Controlled substance prescribing and education in orthopedic residencies: A program director survey.

BACKGROUND: Opioid misuse is currently plaguing the US. Efforts to reduce this include opioid prescribing education (OPE). Orthopaedic residents often prescribe opioids but, their education is unknown. METHODS: A survey was sent to orthoapedic residency program directors (PDs) regarding their program's controlled substance (CS) policies and knowledge of local CS regulations. RESULTS: There were 60 (36.8%) completed surveys. 54 (90.0%) programs allow resident outpatient opioid prescribing. Nine (16.7%) programs require individual DEA registration and 7 (13.0%) were unsure about DEA registrations. State laws regarding PDMP utilization and OPE for fully licensed physicians were correctly answered by 52 (86.7%) and 43 (71.6%), respectively. 27 (45.0%) programs had a mandatory OPE. Six (10.0%) PDs were unsure about a mandatory OPE. 16 (48.5%) programs that did not confirm an OPE were considering adding one. CONCLUSIONS: The majority of programs permit residents outpatient opioid prescribing; less than half provide mandatory OPE. Several PDs were unaware local CS prescribing regulations and education. This study demonstrates opportunities to improve OPE among orthopaedic residencies and PDs' knowledge regarding CS regulations.

Controlled Substances Compliance for Transport Programs.

Transport programs are highly regulated health care organizations. Of the many imposers of regulations, those controlled by the Drug Enforcement Administration are some of the least understood by transport programs. This article serves to lift the regulatory fog surrounding controlled substances and to provide clear and actionable guidance to transport programs. Storage, security, and recordkeeping requirements for emergency medical service organizations can be confusing given that there are no specific regulations for emergency medical services. Transport programs are subject to all the current regulations, and nonadherence can result in significant fines and loss of public trust for any transport program found to be in violation.

Drug Enforcement Administration Rescheduling of Hydrocodone Combination Products Is Associated With Changes in Physician Pain Management Prescribing Preferences.

Due to rising misuse, the Drug Enforcement Administration (DEA) moved hydrocodone combination products (HCPs) from DEA Schedule III to DEA Schedule II in October 2014. Aside from increasing regulatory scrutiny, rescheduling may have increased the administrative burden surrounding HCP prescribing. This study explored how HCP rescheduling and associated administrative barriers may have affected physician treatment of acute (aNCP) and chronic (cNCP) noncancer pain. To this end, physician members of the Texas Medical Association completed a self-administered online questionnaire. Pharmacotherapy treatment plan was measured with two questions asking physicians whether they were more likely to recommend HCPs, acetaminophen/codeine (APAP/codeine), nonsteroidal anti-inflammatory drugs (NSAIDs), tramadol, or other agents for the treatment of aNCP and cNCP. Two Likert-scaled items were used to assess administrative burden. In total, 1365 physicians responded (response rate = 15.39%). Physicians more frequently selected APAP/codeine (37%) for aNCP and tramadol (44%) for cNCP. A majority (78.8%) of physicians agreed that rescheduling led to modified prescribing, and those in agreement were significantly less likely than those who disagreed to prescribe HCPs for aNCP (24.2% vs. 56.4%; χ2 = 68.6, P < .001) and cNCP (16.9% vs. 37%; χ2 = 36.1, P < .001). Rescheduling and associated administrative burden are both associated with modified physician HCP prescribing in both aNCP and cNCP.

Effect of Controlled Substance Use Management on Prescribing Patterns and Health Outcomes Among High-Risk Users.

BACKGROUND: The misuse of prescription drugs is a serious public health problem. Although controlled substance (CS) prescribing, in particular, opioid analgesics, has recently declined, the volume of prescriptions in 2015 was still 3 times higher than in 1999. To curb the high volume of CS prescribing, a national health plan has implemented a controlled substance utilization management (CSUM) program, a prescriber-focused educational intervention regarding patients at risk for CS misuse. OBJECTIVE: To characterize the effect of the CSUM program on CS prescribing volumes, number of prescribers and other health outcomes (opioid overdoses, all-cause emergency department visits, and all-cause hospitalizations). METHODS: The CSUM program identified patients who received ≥10 CS prescriptions within any 3-month window for noncancer pain as being high risk for CS misuse and mailed patient medication profiles to their CS prescribers. This retrospective study was conducted on patients whose prescribers were contacted by the CSUM program from January 2014 to December 2015. The reference group included patients with carved-out pharmacy benefits who were 1:1 propensity score matched to the program group. CS prescribing volumes, number of CS prescribers, and other health care utilization measures were assessed in the 6-month pre-intervention (baseline) period and 6-month post-intervention (follow-up) period using difference-in-difference (DID) analysis. RESULTS: After matching, each group had 17,295 patients, and there were no differences in baseline demographic and clinical characteristics. During the follow-up period, the CSUM group had 1.1 fewer prescriptions for CS (mean difference [MD] within group -3.2 vs. -2.1 prescriptions), 21 fewer days of supply (MD -27 vs. -6 days), and 0.2 fewer number of CS prescribers (MD -0.8 vs. -0.6 prescribers) per patient when compared with the reference group; all P values were < 0.001. The reductions in CS prescribing volumes and number of prescribers within the CSUM group were mainly driven by opioid analgesics, with minimal differences in benzodiazepines and stimulants between the 2 groups. The CSUM program had no significant effect on the opioid dosage strength but was associated with a lower rate of all-cause emergency department visits. CONCLUSIONS: The CSUM program had a moderate positive effect on reducing CS prescribing volumes and number of CS prescribers compared with a reference group. Beside the focus on patients who have already received 10+ CS prescriptions, there remains a need for more intensive approaches for accelerating targeted declines in CS in general and opioids in particular. DISCLOSURES: Funding for this study was provided by Anthem, which had no role in study design, data interpretation, manuscript development, or the decision to publish. Chen, Ma, Barron, DeVries, and Agiro are employees of HealthCore, a wholly owned subsidiary of Anthem. Horn is an employee of Anthem.

Using Lean Six Sigma to Improve Controlled Drug Processes and Release Nursing Time.

BACKGROUND: Hospital controlled drug processes are established to adhere to legislation, with little consideration of efficiency of processes. LOCAL PROBLEM: A controlled drug process existed, where nurses requested a porter to collect a hand-written order; however, only 19% of drug orders were processed this way. Instead, an unscheduled, ad hoc process led to an average of 17 nurse journeys to pharmacy daily. We aimed to reduce nurse journeys to the pharmacy by 25% to release nursing time. METHODS: A pre-/postintervention design was used with Lean Six Sigma methods. INTERVENTIONS: A multifaceted intervention involved process redesign, increasing the frequency of a porter-led delivery service, amending delivery times to reflect times of greatest need, and streamlining checking requirements. RESULTS: Following implementation, there was a statistically significant 44% decrease in nurse journeys to pharmacy for drug collections, which was maintained after 18 months. CONCLUSIONS: Interprofessional collaboration improving hospital-wide processes can have significant benefits for the release of nursing time.

Prescribers' perceptions on the impact of hydrocodone rescheduling on geriatric pain management: A qualitative study.

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.

A Before and After Analysis of Health Care Utilization by Patients Enrolled in Opioid Controlled Substance Agreements for Chronic Noncancer Pain.

OBJECTIVE: To evaluate the impact of opioid controlled substance agreements (CSAs) enrollment on health care utilization. PATIENTS AND METHODS: We retrospectively evaluated health care utilization changes among 772 patients receiving long-term opioid therapy for chronic noncancer pain enrolled in a CSA between July 1, 2015, and December 31, 2015. We ascertained patient characteristics and utilization 12 months before and after CSA enrollment. Decreased utilization was defined as a decrease of 1 or more hospitalizations or emergency department visits and 3 or more outpatient primary and specialty care visits. Multivariate modeling assessed demographic characteristics associated with utilization changes. RESULTS: The 772 patients enrolled in an opioid CSA during the study period had a mean ± SD age of 63.5±14.9 years and were predominantly female, white, and married. The CSA enrollment was associated with decreased outpatient primary care visits (odds ratio [OR], 0.16; 95% CI, 0.14-0.19) and increased diagnostic radiology services (OR, 1.22; 95% CI, 1.02-1.47). After CSA enrollment, patients with greater comorbidity (Charlson Comorbidity Index score >3) were more likely to have reduced hospitalizations (adjusted OR, 2.8; 95% CI, 1.3-6.0; P=.008), reduced outpatient primary care visits (adjusted OR, 2.0; 95% CI, 1.2-3.2; P=.005), and reduced specialty care visits (adjusted OR, 2.0; 95% CI, 1.2-3.3; P=.006). CONCLUSION: For patients receiving long-term opioid therapy for chronic noncancer pain, CSA enrollment is associated with reductions in primary care visits and increased radiologic service utilization. Patients with greater comorbidity were more likely to have reductions in hospitalizations, outpatient primary care visits, and outpatient specialty clinic visits after CSA enrollment. The observational nature of the study does not allow the conclusion that CSA implementation is the primary reason for these observed changes.

Ensuring and Restoring Balance on Access to Controlled Substances for Medical and Scientific Purposes: Joint Statement from Palliative Care Organizations.

The central principle of "balance" represents the dual obligation of governments to establish a system of control that ensures the adequate availability of controlled substances for medical and scientific purposes while simultaneously preventing their nonmedical use, diversion, and trafficking, two primary goals of the international control system. On the one hand, although strong opioids, including morphine, are absolutely necessary for the relief of severe pain, legitimate access to opioids for pain treatment and palliative care is lacking in the majority of the world's countries. On the other hand, in a few high-income countries with higher consumption of prescription opioids, diversion and nonmedical use are increasingly prevalent. This report presents examples of unbalanced systems and a joint statement from global and regional palliative care organizations to promote development of balanced systems for optimal public health outcomes. Although nonmedical use of controlled substances poses a risk to society, the system of control is not intended to be a barrier to their availability for medical and scientific purposes, nor to interfere in their legitimate medical use for patient care. As representatives of palliative care organizations, we urge heads of state to act and to take measures to ensure and restore balanced systems in their countries and call on public health leaders and regulators to work together.

A 15-year overview of increasing tramadol utilisation and associated mortality and the impact of tramadol classification in the United Kingdom.

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 (ß2 : -12.9, ß3 : -1.6) and prevalence of tramadol users (ß2 : -6.4, ß3 : -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.

The abuse potential of kratom according the 8 factors of the controlled substances act: implications for regulation and research.

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.

The Effect of a Federal Controlled Substance Act Schedule Change on Hydrocodone Combination Products Claims in a Medicaid Population.

BACKGROUND: In 2012, hydrocodone combination products (HCPs) were the most prescribed medications in the United States. Under the Controlled Substance Act of 1970, hydrocodone alone was classified as a Schedule II drug, while HCPs were classified as Schedule III, indicating a lower risk for abuse and misuse. However, according to a Drug Enforcement Agency analysis, the addition of nonopioids has not been shown to diminish abuse potential of hydrocodone. In response to concerns for drug abuse and overdose, the Drug Enforcement Agency rescheduled HCPs to Schedule II in October 2014, with the intent of limiting overprescribing and increasing awareness of their abuse potential. However, it is unknown whether this has affected the overall claims for HCPs in a Medicaid population. OBJECTIVES: To (a) compare the trend in HCP prescription claims with select non-HCP (opioid and nonopioid) analgesic claims before and after the HCP schedule change in the Massachusetts Medicaid fee-for-service/Primary Care Clinician plan population and (b) identify if there was a change in HCP new start member and claim characteristics before and after the HCP schedule change. METHODS: This quasi-experimental, retrospective study used enrollment and pharmacy claims data to evaluate all members in the study population 1 year before and after the HCP schedule change. The number of claims for HCPs and select non-HCP analgesics was reported as the monthly rate per total population, and an interrupted time series analysis compared the change in the monthly rate of claims across groups. Members with 1 or more pharmacy claims for a new HCP prescription during a 5-month period before or after the HCP schedule change were analyzed to determine member demographics (age, gender, and number of claims) and claim characteristics (average daily dose, average quantity per claim, and days supply). RESULTS: The rate of HCP claims increased before and decreased after the HCP schedule change. Controlling for the trend during the period before the HCP schedule change, the rate of HCP claims per 1,000 members per month decreased at a greater rate than non-HCP analgesics in the period after the HCP schedule change (P < 0.001). The percentage of HCP claims for new start members decreased after the HCP schedule change (44.9% vs. 34.1% of all HCP claims pre- to post-schedule change; P < 0.001). In the group of new starts, there was not a significant difference in the average daily dose (26.3 mg vs. 26.4 mg; P = 0.69), while there was a decrease in average number of tablets dispensed per claim (from 37.1 to 20.3 tablets; P < 0.001) and an increase in the percentage of claims for a shorter days supply (from 57.7% to 81.6%; P < 0.001). CONCLUSIONS: The findings of this study suggest that the HCP schedule change may have contributed to the decrease in claims for HCPs in a Medicaid population. After the HCP schedule change, there was a trend towards decreased HCP use among new starts. DISCLOSURES: No outside funding supported this study. The authors have nothing to disclose. Study concept and design were contributed by all authors except for Arnold and Clements. Tran, Arnold, and Clements took the lead in data collection, along with Peristere, and data interpretation was performed by all the authors, except Arnold. The manuscript was written primarily by Tran, along with Lavitas, Stevens, and Greenwood, and revised by all the authors except Arnold and Peristere. A poster of this research project was presented at the Academy of Managed Care Pharmacy's 2016 Annual Meeting in San Francisco, California, April 2016.

Physicians' intention to prescribe hydrocodone combination products after rescheduling: A theory of reasoned action approach.

BACKGROUND: The U.S. Drug Enforcement Administration (DEA) rescheduled hydrocodone combination products (HCPs) in an attempt to mitigate the prescription opioid epidemic. Many in the medical and pharmacy community expressed concerns of unintended consequences as a result of rescheduling. OBJECTIVES: This study examined physicians' intentions to prescribe HCPs after rescheduling using the framework of the theory of reasoned action (TRA). METHODS: A cover letter containing a link to the online questionnaire was sent to physicians of the Texas Medical Association who were likely to prescribe opioids. The questionnaire assessed physicians' intentions to prescribe HCPs after rescheduling. Predictor variables included attitude toward rescheduling, subjective norm toward HCP prescribing, and past prescribing behavior of schedule II prescriptions. All variables were measured on a 7-point, Likert-type scale. Intention to prescribe as a dependent variable was regressed over TRA variables and respondent characteristics. RESULTS: A total of 1176 usable responses were obtained, yielding a response rate of 13.3%. Mean (M) age was 53.07 ± 11 and most respondents were male (70%) and Caucasian (75%). Physicians held a moderately positive intention to prescribe HCPs (M = 4.36 ± 2.08), held a moderately negative attitude towards rescheduling, M = 4.68 ± 1.51 (reverse coded). Subjective norm was moderately low, M = 3.06 ± 1.78, and past prescribing behavior M = 2.43 ± 1.21. The linear regression analysis indicated that attitude (ß = 0.10; P = 0.006), subjective norm (ß = 0.35; P < 0.0001) and past prescribing behavior (ß = 0.59; P < 0.0001) were significant predictors of intention to prescribe HCPs after rescheduling. CONCLUSIONS: TRA was shown to be a predictive model of physicians' intentions to prescribe HCPs after rescheduling. Overall, physicians held a moderately positive intention to prescribe HCPs. Past behavior concerning schedule II prescribing was found to be the most significant predictor of intention. Understanding the impact of federal rule changes on pain management care and patient satisfaction is necessary to determine whether this change has produced the intended consequences without harming patients in need of HCPs.

Association of a Controlled Substance Scoring Algorithm with Health Care Costs and Hospitalizations: A Cohort Study.

BACKGROUND: Patients often misuse a combination of prescription drugs including opioids; however, the relationship between a controlled substance (CS) score and health outcomes is unknown. OBJECTIVE: To examine the association between a CS scoring algorithm and health care use, specifically total cost of care, hospitalizations, and emergency room (ER) visits. METHODS: This analysis was a retrospective cohort study using administrative claims data from a large U.S. health insurer. Included in the analysis were 999,852 members with a minimum CS score of 2.5 in the fourth quarter (4Q) of 2012, who were continuously enrolled from January 1, 2012, to December 31, 2013, and who were aged 18 years or older. A CS score was calculated using 4Q 2012 (3 months) prescription claims data and divided into 3 components: (1) number of CS claims, (2) number of unique pharmacies and unique prescribers, and (3) evidence of increasing CS use. The primary outcomes were total cost of care (pharmacy and medical costs), all-cause hospitalizations, and ER visits in 2013. We also quantified what a 1-point change in CS score meant for the primary outcomes. RESULTS: 47% of members had a CS score of 2.5, indicating a single CS claim, and 51% of members had a score between 3 and less than 12. The remaining 2% (20,858 members) had a score of 12 or more. There was a statistically significant and consistently increasing association between the 4Q 2012 CS score and hospitalizations, ER visits, and total costs of care in 2013. A 1-point change in CS score was associated with a $1,488 change in total cost of care, 0.9% change in the hospitalization rate, and 1.5% change in the ER visit rate. CONCLUSIONS: There is a linear association between increasing CS score and negative health outcomes. Insurers should consider interventions to lower member CS scores. DISCLOSURES: This study was funded internally by Prime Therapeutics. Starner, Qiu, and Gleason are employees of Prime Therapeutics, a pharmacy benefits management company. Karaca-Mandic is an employee of the University of Minnesota and did not receive any compensation related to this work. The results of this study were presented as a poster at the Academy of Managed Care Pharmacy's 27th Annual Meeting and Expo; San Diego, California; April 7-10, 2015. Study concept and design were contributed by Starner, Gleason, and Qiu. Qiu took the lead in data collection, assisted by Starner and Gleason. Data interpretation was performed by all the authors. Starner primarily wrote and revised the manuscript, along with the other authors.

Model of Current Practice Regarding Prescriptions of Controlled Substances and the Perceived Benefits of E-Prescribing in an Academic Medical Center.

To review current practices regarding prescribing controlled substances at an academic medical center and describe possible advantages of electronic prescribing of controlled substances (EPCS). A 10-question multiple choice survey was sent electronically to all house staff at an academic medical center. Aggregated data was analyzed for trends. 193 surveys (18.8 %) were completed. Of all respondents, 46.6 % were not able to write their own prescriptions. 70.0 % have used another provider's prescription pad to write prescriptions. 53.4 % have had prescriptions rejected or not filled by a pharmacy for being written incorrectly. 59.6 % kept a patient as an inpatient for a longer period of time due to the inability to obtain a prescription, costing an estimated $3.28 million per year. 58.0 % needed to have a patient return to the hospital to pick up prescriptions for an estimated 1583 return trips to the hospital yearly. 35.1 % had a patient return to the emergency department due to uncontrolled pain, estimated at $139,000 in yearly emergency department patient charges. The authors' survey highlights some of the financial, legal, efficiency, and satisfaction disadvantages due to the inability to use EPCS. Implementing EPCS and making it ubiquitous may limit some inefficiencies in academic hospital systems.

Preparing a prescription drug monitoring program data set for research purposes.

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.

Childhood Attention-Deficit/Hyperactivity Disorder Prescribing by Prescriber Type and Specialty in Oregon Medicaid.

OBJECTIVE: This study compares nurse practitioner (NP) and physician (MD/DO) prescribing patterns for treatment of children with an attention-deficit/hyperactivity disorder (ADHD)-related diagnosis covered by Oregon Medicaid from 2012 to 2013. METHODS: This study is a limited data set review of Oregon pharmacy claims for youth aged 3-18 at time of prescription fill, who were continuously enrolled for at least 10 months of the index year. Claims with selected ICD-9 codes (n = 197,364) were further defined by 30-day prescriptions and prescription drug events (PDE) linked to each prescriber type of interest. Descriptive statistical analysis of variables included prescriber type (NP vs. physician) and specialty (generalist vs. specialist), child age, and controlled versus noncontrolled drug type. RESULTS: A total of 82,754 complete 30-day prescriptions for 10,753 children from 1785 unique prescribers (78 NP specialists; 303 NP generalists; 162 physician specialists; and 1242 physician generalist prescribers) and 16,669 PDE were analyzed. Physicians prescribed more than 81% of all ADHD medications, and physician generalists prescribed nearly 60% of all prescriptions. Sixty-four percent of 30-day supply prescriptions (n = 52,678) were controlled substances. Generalists, both NPs and physician prescribers, prescribed controlled medications more often than specialists. Physician specialists consistently prescribed controlled substances for all age groups, while NP specialists prescribed more controlled substances as child age increased. Rates of controlled medications prescribed generally increased, as children got older, regardless of provider type. CONCLUSION: NPs overall prescribe in a similar pattern to physicians when given the authority to prescribe controlled substances for ADHD. Comparisons between prescriber types for controlled substance prescribing by age should be explored further to identify possible variance from national guidelines.

Characteristics of state prescription drug monitoring programs: a state-by-state survey.

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.