The importance of data source in prescription drug monitoring program research.

OBJECTIVE: To develop a legal research protocol for identifying various measures of prescription drug monitoring program (PDMP) start dates, apply the protocol to create a useable PDMP database, and test whether the different legal databases that are meant to contain the same information produce divergent results when used in an illustrative empirical exercise. DATA SOURCES: Original research from state statutes, regulations, policy statements, and interviews; alternative PDMP data from the National Alliance for Model State Drug Laws and Prescription Drug Abuse Policy System; claims from a 40 percent random sample of Medicare beneficiaries, 2006-2014. STUDY DESIGN: Collaborative research effort among a group of lawyers to develop protocol. Legal research to produce an original database of dates state PDMP laws: (a) were enacted, (b) became operational, and (c) required query before prescribing controlled substances. Descriptive analyses characterize differences in dates of enactment, operation, and must query requirements. Regression analyses estimating, for each beneficiary annually any opioid prescription received in a calendar year, among other measures. Estimates conducted on under age 65 and full Medicare population. DATA COLLECTION/EXTRACTION METHODS: PDMP legal databases were linked to annual Medicare claims. PRINCIPAL FINDINGS: An original database differs from commonly used, publicly available data. Outcomes tested depend on the measure of PDMP date used and differ by data source. Must-query laws show the largest effects among all the laws tested. CONCLUSIONS: Data choices likely have had large consequences for study results and may explain contradictory outcomes in prior research. Researchers must understand and report protocol for dates used in PDMP research to ensure that results are internally consistent and verifiable.

Confronting challenges to opioid risk mitigation in the U.S. health system: Recommendations from a panel of national experts.

BACKGROUND: Amid the ongoing U.S. opioid crisis, achieving safe and effective chronic pain management while reducing opioid-related morbidity and mortality is likely to require multi-level efforts across health systems, including the Military Health System (MHS), Department of Veterans Affairs (VA), and civilian sectors. OBJECTIVE: We conducted a series of qualitative panel discussions with national experts to identify core challenges and elicit recommendations toward improving the safety of opioid prescribing in the U.S. DESIGN: We invited national experts to participate in qualitative panel discussions regarding challenges in opioid risk mitigation and how best to support providers in delivery of safe and effective opioid prescribing across MHS, VA, and civilian health systems. PARTICIPANTS: Eighteen experts representing primary care, emergency medicine, psychology, pharmacy, and public health/policy participated. APPROACH: Six qualitative panel discussions were conducted via teleconference with experts. Transcripts were coded using team-based qualitative content analysis to identify key challenges and recommendations in opioid risk mitigation. KEY RESULTS: Panelists provided insight into challenges across multiple levels of the U.S. health system, including the technical complexity of treating chronic pain, the fraught national climate around opioids, the need to integrate surveillance data across a fragmented U.S. health system, a lack of access to non-pharmacological options for chronic pain care, and difficulties in provider and patient communication. Participating experts identified recommendations for multi-level change efforts spanning policy, research, education, and the organization of healthcare delivery. CONCLUSIONS: Reducing opioid risk while ensuring safe and effective pain management, according to participating experts, is likely to require multi-level efforts spanning military, veteran, and civilian health systems. Efforts to implement risk mitigation strategies at the patient level should be accompanied by efforts to increase education for patients and providers, increase access to non-pharmacological pain care, and support use of existing clinical decision support, including state-level prescription drug monitoring programs.

Dental opioid prescribing rates after the up-scheduling of codeine in Australia.

The misuse of pharmaceutical opioids is a major public health issue. In Australia, codeine was re-scheduled on 1 February 2018 to restrict access; it is now only available on prescription. The aim of this study was to measure the change in dental opioid prescriptions, one year before and after the codeine re-scheduling in Australia and to assess dental prescribing rates of opioids for 2018 by population and by clinician. Data was extracted for dental opioids for the year immediately prior and after the codeine up-schedule (1 February 2017-31 January 2019) from the publicly-available national prescription database (Pharmaceutical Benefits Scheme). Descriptive statistics, T-tests and odds ratios were used to identify significant prescribing differences. Codeine, codeine/paracetamol, oxycodone and tramadol use increased significantly the year after the codeine restriction than the previous year (13.8-101.1%). Australian dentists prescribed 8.6 prescriptions/1,000 population in 2018, with codeine/paracetamol accounting for most prescriptions (96%). The significant increase in opioid prescribing highlights that Australian dentists may be contributing to the misuse of pharmaceutical opioids. Educational efforts should be targeted at the appropriate use of opioids and patient selection. Dentists should be added to the prescription monitoring system SafeScript so they can make informed decisions for patients who are potentially misusing opioids.

Prevalence of zolpidem use in France halved after secure prescription pads implementation in 2017: A SNDS database nested cohort study.

Our objective was to quantify the impact on the use of zolpidem of the obligation implemented in France in 2017 to use secure prescription pads to prescribe it. We conducted a cohort study within the French SNDS healthcare database. Patients aged over 18 years of age were considered for inclusion. The number of prevalent users and incident episodes of zolpidem use were compared before the change in law (July 1, 2016 to January 1, 2017) and after (July 1, 2017 to January 1, 2018). A prevalent user was a patient who has been reimbursed for zolpidem at least once. An incident episode of zolpidem use was defined by a first administration of zolpidem without any prior administration within the previous six months. Regarding prevalence of zolpidem users, we observed a decrease from 2.79% (CI95%:2.75-2.83) to 1.48% (1.44-1.51), with a number of patients who stopped taking it after the change in law being approximately 4.3 times higher than the number of patients who started. We observed a negative association between the post-law change period (OR = 0.52 (0.51-0.53)) and the probability of receiving zolpidem, adjusting for sex, aging, low income and chronic disease. We observed a decrease from 183 treatment episodes per 100,000 insured months on average to 79 episodes per 100,000 insured months, with an incidence rate ratio (IRR) equal to 0.43 (0.38-0.49). The use of secure prescription pads seems to have reduced the exposure of the French population to zolpidem.

Factors Influencing Judgments to Consult Prescription Monitoring Programs: A Factorial Survey Experiment.

BACKGROUND: Prescription monitoring programs (PMPs) can provide health care professionals with valuable information. However, few studies have explored providers' decision making for accessing PMPs. AIMS: This study aimed to identify provider characteristics and situational factors most influencing perceived importance of consulting the PMP for patients in a simulated context. DESIGN: The study used a cross-sectional factorial survey. SETTINGS: The survey was administered electronically. PARTICIPANTS/SUBJECTS: Community pharmacists, advanced practice registered nurses (APRNs), and physicians in Iowa. METHODS: Participants were recruited by mail which included a link to the online survey. The survey consisted of demographic questions, eight randomly generated vignettes, and one ranked item. The vignettes described a hypothetical prescription using eight experimental variables whose levels were randomly varied. Respondents evaluated each vignette for importance to access the PMP. Analyses used linear mixed-effects models in R (Version 3.5.0). RESULTS: A total of 138 responses were available for multilevel analysis. Women, physicians, and APRNs rated it more important to consult the PMP for a given prescription compared with men and pharmacists. Accessing a PMP was perceived as more important with cash payments, quantity dispensed, suspicion for misuse, hydromorphone and oxycodone prescriptions, and headache. Advancing age, postoperative pain, and anxiety or sleep indications were associated with less importance. CONCLUSIONS: Age, indication for prescribing, misuse, and payment mode each independently had greater importance to providers in accessing the PMP. This was the first study to isolate the influence of different controlled substances on how important it was to consult the PMP.

Substance Use Stigma, Primary Care, and the New York State Prescription Drug Monitoring Program.

Prescription drug monitoring programs (PDMPs) are databases that track controlled substances at the provider, patient, and pharmacy levels. While these databases are widely available at the state level throughout the United States, several jurisdictions in recent years have mandated the use of these systems by health care providers. This study explores the implementation of mandatory PDMP technology in primary care practice and the effects on treatment of people with possible substance use disorders. Findings are based on 53 in-depth interviews with primary care providers in New York City, collected shortly following the passage of legislation mandating use of a PDMP by health care providers in New York State. Findings suggest that use of the PDMP highlighted tensions between provider stigma toward substance use disorders and the clinical care of people who use drugs, challenging their stereotypes and biases. The parallel clinical and law enforcement purposes of PDMP technology placed providers in dual roles as clinicians and enforcers and encouraged the punitive treatment of patients. Finally, PDMP technology standardized the clinical assessment process toward a "diagnosis first" approach, consistent with prior scholarship on the implementation of emerging medical technologies.

Validation of the prescription drug monitoring program Web site.

OBJECTIVE: Evaluate the accuracy of the Pennsylvania Prescription Drug Monitoring Program (PA PDMP) in patients undergoing upper extremity procedures. The authors hypothesized that the PA PDMP would provide an accurate account of the prescriptions that were filled. DESIGN: The authors prospectively collected post-operative pain prescription information of patients undergoing outpatient upper extremity surgery over a 2-week period. Patient-reported prescription-filling of opioid was cross-referenced with the PA PDMP information. SETTING: The study was performed at one private institution. PATIENTS: One hundred and thirty-nine consecutive patients undergoing upper extremity procedures. MAIN OUTCOME MEASURE(S): The PA PDMP information was cross-referenced with the post-operative prescription in the medical record to confirm the patient filled the surgeon's prescription. RESULTS: Of the 111 patients who reported filling their prescription, 107 (96.4 percent) of these were confirmed on the PA PDMP Web site (96.4 percent sensitivity; 95% confidence interval [CI]: 91.0-99.0 percent). None of 28 patients who did not fill their prescription appeared in the database search, resulting in 100 percent specificity (95% CI: 87.7-100 percent). Consequently, the overall accuracy of the PA PDMP was shown to be 97.1 percent (95% CI: 92.8-99.2 percent). CONCLUSIONS: The authors' results suggest that the PA PDMP and its many supplementary databases are accurate as it relates to monitoring opioid prescriptions.

Overlapping prescriptions of opioids, benzodiazepines, and carisoprodol: "Holy Trinity" prescribing in the state of Florida.

BACKGROUND: High-risk combinations of controlled medications, such as those involving opioid analgesics, are under increased scrutiny because of their contribution to the opioid epidemic in the United States. Responsible prescribing guidelines indicate that the triple drug combination--opioids, benzodiazepines and skeletal muscle relaxants, especially carisoprodol--should not be concurrently prescribed. METHODS: This pharmacoepidemiologic study was designed to primarily examine the characteristics of patients receiving this triple combination compared to the group receiving only opioids and benzodiazepines. RESULTS: Results show that, while the number of exposed patients has declined since 2012, approximately 17,000 Floridians were prescribed this combination in 2017 alone. Demographically, recipients of these prescriptions were younger, more likely to be female, and geographically-localized. Furthermore, these patients were more frequently associated with a prescriber in the top 1% of opioid and/or benzodiazepine prescribing, have more multiple provider episodes ("doctor shopping"), and receive higher mean daily opioid dosages. CONCLUSIONS: These findings raise important questions as to how frequently prescribers are checking prescription drug monitoring programs, following US Centers for Disease Control and Prevention opioid prescribing guidelines, and/or handling the clinical challenges associated with pharmaceutical management of patients with complex, painful health conditions.

Impact of a Prescription Drug Monitoring Program on Health Information Exchange Utilization, Prescribing Behaviors, and Care Coordination in an Emergency Department.

Timely access to patient data is critical in patient care. The utilization of health information exchange and prescription drug monitoring programs can make pertinent data readily accessible for emergency department providers to coordinate care. A quasi-experimental preintervention-postintervention design, with 62 providers and 53 554 emergency department visits linked to a health information exchange and prescription drug monitoring program, was used to evaluate rates for utilization, laboratory/imaging orders, narcotic prescribing and readmission. Health information exchange utilization increased significantly after the drug monitoring program was implemented (mean = 119.33 to mean = 231.33, t2 = -15.79, P < .001). There was no significant effect postprescription drug monitoring program for laboratory/imaging orders or narcotics at discharge, although narcotic orders during emergency visits increased (F1,23 = 7.953, P = .010), which may suggest the data confirmed the immediate need to control acute or chronic conditions. In addition, readmission rates decreased from 14.64% to 12.58%. Through streamlining processes, health information exchange and prescription drug monitoring program usage were increased, which can improve care. As organizations promote interoperability of health information, the nurse informaticist plays a significant role in managing access to systems that can assist all providers in coordinating care.

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

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

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

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

Detecting and Visualizing Outliers in Provider Profiling Using Funnel Plots and Mixed Effects Models-An Example from Prescription Claims Data.

When prescribing a drug for a patient, a physician also has to consider economic aspects. We were interested in the feasibility and validity of profiling based on funnel plots and mixed effect models for the surveillance of German ambulatory care physicians' prescribing. We analyzed prescriptions issued to patients with a health insurance card attending neurologists' and psychiatrists' ambulatory practices in the German federal state of Saarland. The German National Association of Statutory Health Insurance Physicians developed a prescribing assessment scheme (PAS) which contains a systematic appraisal of the benefit of drugs for so far 12 different indications. The drugs have been classified on the basis of their clinical evidence as "standard", "reserve" or "third level" medication. We had 152.583 prescriptions in 56 practices available for analysis. A total of 38.796 patients received these prescriptions. The funnel plot approach with additive correction for overdispersion was almost equivalent to a mixed effects model which directly took the multilevel structure of the data into account. In the first case three practices were labeled as outliers, the mixed effects model resulted in two outliers. We suggest that both techniques should be routinely applied within a surveillance system of prescription claims data.

Evaluation of an Integrated, Multidisciplinary Program to Address Unsafe Use of Opioids Prescribed for Pain.

Objectives: Unsafe use of opioids prescribed for pain is a common challenge in primary care. We aimed to describe a novel clinical program designed to address this issue-the Opioid Reassessment Clinic-and evaluate preliminary efficacy. Methods: The Opioid Reassessment Clinic is a multidisciplinary care team staffed by an internist, addiction psychiatrist, advanced practice nurse, and health psychologist designed to perform enhanced assessment and longitudinal treatment of patients with unsafe use of opioids prescribed for pain. We assessed preliminary efficacy of the clinic using a priori-defined metrics at the patient, provider, clinic process, and health system levels. Results: Of referred patients (N = 87), 84% had a history of substance abuse/dependence and 70% had current misuse of prescribed opioids; 22% received a new substance use disorder diagnosis, each of whom engaged in addiction treatment. Among primary care physicians, 48% referred a patient to the clinic. In terms of process metrics, high fidelity to structured clinical assessments was assisted by templated electronic progress notes. Wait time averaged 22.1 days while length of treatment averaged 137 days. Urine drug testing was performed on 91% of patients an average of 6.4 times, while assessing out-of-system opioid receipt occurred universally. Systems-level findings included evidence of institutional support: hiring a nurse case manager to help with care coordination. Conclusions: Results suggest the Opioid Reassessment Clinic was effective in the management of a small group of high-complexity patients. Wide-scale dissemination may require adapted care models.

Past-year Prescription Drug Monitoring Program Opioid Prescriptions and Self-reported Opioid Use in an Emergency Department Population With Opioid Use Disorder.

BACKGROUND: Despite increasing reliance on prescription drug monitoring programs (PDMPs) as a response to the opioid epidemic, the relationship between aberrant drug-related behaviors captured by the PDMP and opioid use disorder is incompletely understood. How PDMP data should guide emergency department (ED) assessment has not been studied. OBJECTIVES: The objective was to evaluate a relationship between PDMP opioid prescription records and self-reported nonmedical opioid use of prescription opioids in a cohort of opioid-dependent ED patients enrolled in a treatment trial. METHODS: PDMP opioid prescription records during 1 year prior to study enrollment on 329 adults meeting Diagnostic and Statistical Manual IV criteria for opioid dependence entering a randomized clinical trial in a large, urban ED were cross-tabulated with data on 30-day nonmedical prescription opioid use self-report. The association among these two types of data was assessed by the Goodman and Kruskal's gamma; a logistic regression was used to explore characteristics of participants who had PDMP record of opioid prescriptions. RESULTS: During 1 year prior to study enrollment, 118 of 329 (36%) patients had at least one opioid prescription (range = 1-51) in our states' PDMP. Patients who reported ≥15 of 30 days of nonmedical prescription opioid use were more likely to have at least four PDMP opioid prescriptions (20/38; 53%) than patients reporting 1 to 14 days (14/38, 37%) or zero days of nonmedical prescription opioid use (4/38, 11%; p = 0.002). Female sex and having health insurance were significantly more represented in the PDMP (p < 0.05 for both). CONCLUSION: PDMPs may be helpful in identifying patients with certain aberrant drug-related behavior, but are unable to detect many patients with opioid use disorder. The majority of ED patients with opioid use disorder were not captured by the PDMP, highlighting the importance of using additional methods such as screening and clinical history to identify opioid use disorders in ED patients and the limitations of PDMPs to detect opioid use disorders.

Unsolicited Reporting to Prescribers of Opioid Analgesics by a State Prescription Drug Monitoring Program: An Observational Study with Matched Comparison Group.

Objective: State prescription drug monitoring programs (PDMPs) can help detect individuals with multiple provider episodes (MPEs; also referred to as doctor/pharmacy shopping), an indicator of prescription drug abuse and/or diversion. Although unsolicited reporting by PDMPs to prescribers of opioid analgesics is thought to be an important practice in reducing MPEs and the potential harm associated with them, evidence of its effectiveness is mixed. This exploratory research evaluates the impact of unsolicited reports sent by Massachusetts' PDMP to the prescribers of persons with MPEs. Methods: Individuals with MPEs were identified from PDMP records between January 2010 and July 2011 as individuals having Schedule II prescriptions (at least one prescription being an opioid) from four or more distinct prescribers and four or more distinct pharmacies within six months. Based on available MA-PDMP resources, an unsolicited report containing the patient's 12-month prescription history was sent to prescribers of a subset of patients who met the MPE threshold; a comparison group closely matched on demographics and baseline prescription history, whose prescribers were not sent a report, was generated using propensity score matching. The prescription history of each group was examined for 12 months before and after the intervention. Results: There were eighty-four patients (intervention group) whose prescribers received an unsolicited report and 504 matched patients (comparison group) whose prescribers were not sent a report. Regression analyses indicated significantly greater decreases in the number of Schedule II opioid prescriptions (P < 0.01), number of prescribers visited (P < 0.01), number of pharmacies used (P < 0.01), dosage units (P < 0.01), total days' supply (P < 0.01), total morphine milligram equivalents (MME; P < 0.01), and average daily MME (P < 0.05) for the intervention group relative to the comparison group. A post hoc analysis suggested that the observed intervention effects were greater for individuals with an average daily dose of less than 100 MMEs. Conclusions: This study suggests that PDMP unsolicited reporting to prescribers can help reduce risk measures in patients' prescription histories, which may improve health outcomes for patients receiving opioid analgesics from multiple providers.

Resident Access to the St. Louis County Prescription Drug Monitoring Program: Why PDMPs Matter and How to Gain Access.

Prescription Drug Monitoring Programs (PDMPSs) permit physicians to determine whether patients obtained addictive substances from multiple physicians or pharmacies. In April 2017, the Saint Louis County Department of Public Health created its own PDMP. This manuscript evaluates evidence regarding the efficacy of PDMPs, in addition to discussing their impact on patient care and a provider's workflow. It also details how physicians can register to use the St. Louis County PDMP, Missouri's de-facto PDMP.

The Last State to Grant Nurse Practitioners DEA Licensure: An Education Improvement Initiative on the Florida Prescription Drug Monitoring Program.

Nurse practitioners (NPs) now have prescriptive authority for controlled substances in all 50 states in the United States. Florida, the last state to grant NPs DEA licensure, has been wrought with prescription diversion practices for a number of years as pill mills, doctor shopping, and overprescribing proliferated. Prescription Drug Monitoring Programs (PDMPs) help curb drug diversion activity and play a key role in reducing the abuse of controlled substances. The primary objective of this education improvement initiative was to increase knowledge of actively licensed NPs in the state of Florida regarding the state's PDMP. The main themes included the drug abuse problem, description and progression of the PDMP, and how to use the Florida PDMP. Upon approval from the institutional review board, this education improvement initiative gauged NP knowledge of the PDMP and main themes before and after an educational PowerPoint intervention. A pretest/posttest questionnaire was administered for assessment of all knowledge questions. One hundred forty-five NPs with active advanced registered NP licenses in Florida completed both the pretest and posttest questionnaires. Descriptive statistics and paired t tests were used for statistical significance testing. Knowledge of the PDMP and the main themes of the education improvement initiative significantly increased (p < .001) from pretest to posttest results. This education improvement initiative had positive effects for NPs on the knowledge of the Florida PDMP and the main themes. This indicated that Florida NPs are able to acquire greater comprehension of the PDMP by an education intervention.

Research to support optimization of prescription drug monitoring programs.

PURPOSE: Research is needed to evaluate the impact of prescription drug monitoring programs (PDMPs). This paper describes research priorities for PDMPs that were initially discussed at a 2015 meeting of PDMP administrators, researchers, public health officials, and other stakeholders. METHODS: Meeting participants defined the current landscape of PDMP research and identified research gaps. Research priorities were grouped by theme. RESULTS: Prescription drug monitoring program research priorities were identified for 3 key areas: individual patient health outcomes, prescriber use and decision making, and population-level outcomes. Research areas for individual patient outcomes include examining drug-use thresholds that best predict risk for overdose or substance use disorder and unintended consequences of PDMP use. Proposed research on prescriber PDMP use include evaluating how enhancements to the content and format of PDMP reports informs clinical decision making and optimal clinician actions in response to a concerning PDMP report. Finally, research topics related to population-level outcomes include measuring the impact of PDMP policies on the incidence of substance misuse and harms and assessing the return on investment for these databases. CONCLUSIONS: The clinical, public health, and economic impacts of PDMPs must be evaluated, using both quantitative and qualitative methods. In addition to assessing patient outcomes, qualitative research should examine how clinicians use and interpret PDMP information. Research should also examine the impact of PDMP features and policies on prescriber utilization. Comparative analyses across states with differing PDMP policies should be conducted to inform best practices.