A primer on quality measurement and reporting in pharmacy benefit plans.

Pharmacy benefit plans in the United States are evaluated on quality measures and other requirements of the government and accrediting organizations. This primer describes the roles of key organizations involved in measuring and reporting quality in pharmacy benefit plans and explains the methods that pharmacy benefit plans use to promote quality of medication use.

Benzodiazepine Dose Intensity among Patients Concurrently Prescribed Buprenorphine in Rhode Island.

Background: The concomitant use of buprenorphine and benzodiazepines has been linked to patient fatalities, with greater risk occurring with higher doses of benzodiazepines. We assessed benzodiazepine dose intensity among patients who were concurrently prescribed buprenorphine, as compared with patients prescribed benzodiazepines who were not receiving buprenorphine. Methods: We conducted a cross-sectional analysis of adult patients who received at least a 30-day supply of benzodiazepines during 2018, using data from the Rhode Island (RI) Prescription Drug Monitoring Program. Mean daily diazepam milligram equivalents (DME) were calculated overall and according to patient sex, age group, payment type, and RI county. Multivariable logistic regression analyses were conducted to assess the odds of higher-dose benzodiazepine utilization among patients with concurrent use of buprenorphine, as compared with patients not prescribed buprenorphine, adjusting for patient demographics. Results: Compared to patients prescribed benzodiazepines who were not receiving buprenorphine, those with concurrent buprenorphine utilization had a significantly higher mean DME/day (19.22, 95% CI: 18.70-19.74; vs 10.94, 95% CI: 10.93-10.95; p < 0.001). Patients who were prescribed benzodiazepines with concurrent utilization of buprenorphine also had a comparatively higher odds of a DME/day ≥15 (aOR: 2.86, 95% CI: 2.63-3.10), ≥20 DME/day (aOR: 2.98, 95% CI: 2.75-3.24), and ≥25 DME/day (aOR: 2.99, 95% CI: 2.65-3.18). Conclusion: Compared to patients prescribed benzodiazepines for at least 30 days who were not receiving buprenorphine, patients concurrently utilizing benzodiazepines and buprenorphine had more than twice the odds of higher dose benzodiazepine utilization. Future studies are needed to assess the relationship between benzodiazepine dose intensity, overdose outcomes, and treatment retention among patients receiving buprenorphine.

Tramadol utilization among patients with higher risk of adverse drug events: A claims analysis of commercially insured and Medicare Advantage members.

OBJECTIVE: To assess prescribing of tramadol among patients with contraindications and higher risks of adverse events in a large population of commercially insured and Medicare Advantage members. DESIGN: We performed a cross-sectional analysis evaluating tramadol utilization in patients with higher risk of adverse outcomes. SETTING: This study utilized 2016-2017 data from the Optum Clinformatics Data Mart. PATIENTS AND PARTICIPANTS: Patients with at least one tramadol prescription without a cancer or sickle cell diagnosis during the study period. MAIN OUTCOME MEASURES: We first determined if tramadol was prescribed among patients with contraindications or risk factors for adverse outcomes. We then determined if patient demographic or clinical factors were associated with the use of tramadol in these higher-risk scenarios using multivariable logistic regression models. RESULTS: Among patients with at least one prescription for tramadol, 19.66 percent (99 percent CI: 19.57-19.75) concurrently received an interacting cytochrome P450 isoenzyme medication, 19.24 percent (99 percent CI: 19.15-19.33) concurrently received a serotonergic medication, and 7.93 percent (99 percent CI: 7.88-8.00) concurrently received a benzodiazepine. Additionally, 1.59 percent (99 percent CI: 1.56-1.61) of patients who received tramadol also had a seizure disorder, while 0.55 percent (99 percent CI: 0.53-0.56) of patients were under the age of 18. Overall, nearly one in three patients (31.17 percent) received tramadol in the presence of at least one of these risks (99 percent CI: 31.06-31.27). CONCLUSION: Almost one in three patients prescribed tramadol had a clinically significant drug interaction or contraindication for use, suggesting that prescribers often disregard these concerns. Real-world studies are needed to better understand the likelihood of harms associated with the use of tramadol in these contexts.

Rhode Island Has the Highest Rate of Medicare Part D Claims for Benzodiazepines Among New England States.

BACKGROUND: Benzodiazepine use among older adults is discouraged. METHODS: We analyzed the Medicare Part D Prescribers by Provider and Drug dataset to determine the number of benzodiazepine claims per 100 Medicare enrollees for each NE state between 2016-2020, and to determine the percentage of benzodiazepine claims by provider type. RESULTS: Rhode Island led all NE states the with highest annual rates of Part D benzodiazepine claims for all years from 2016 to 2020. Benzodiazepine claims decreased in all NE states over the 5-year period. Internal medicine and family practice providers were associated with the highest percentage of benzodiazepine claims. CONCLUSION: While Part D benzodiazepine claims declined between 2016-2020, the overall volume of dispensings suggests that these medications remain overprescribed among older adults. Our findings underscore the need for intensified efforts to reduce benzo- diazepine use among Medicare beneficiaries in RI.

PHARMACY DEDUCTIBLES CAN COMPLICATE THE RELATIONSHIP BETWEEN MEASURES OF PATIENT COST SHARING AND MEDICATION ADHERENCE.

DISCLOSURES: This letter pertains to our recent publication in JMCP, which describes a study that was jointly funded by the Pharmacy Quality Alliance and the National Pharmaceutical Council.

The Influence of US Drug Price Dynamics on Cost-Effectiveness Analyses of Biologics.

OBJECTIVES: This study aimed to evaluate the influence of drug price dynamics in cost-effectiveness analyses. METHODS: We evaluated scenarios involving typical US drug price increases during the exclusivity period and price decreases after the loss of exclusivity (LOE). Worked examples are presented using the Institute for Clinical and Economic Review's assessments of tezepelumab for the treatment of severe asthma and targeted immune modulators for rheumatoid arthritis. RESULTS: Tezepelumab case: yearly 2% price increases during the period of exclusivity and a post-LOE price decrease of 25% yielded an incremental cost per quality-adjusted life-year (QALY) gained that increased over the base case from $430 300 to $444 600 (+3.2%). Yearly 2% price increases followed by a steeper post-LOE price reduction of 40% resulted in a cost per QALY gained of $401 400 (6.8% reduction vs the base case). Rheumatoid arthritis case: incorporating post-LOE price reductions for etanercept (intervention) and adalimumab (comparator) ranging from 25% to 40% yielded an incremental cost per QALY of $121 000 and $122 300, respectively (< 3% increase from the base case of $119 200/QALY). Including a 2% yearly price increase during the projected exclusivity periods of both intervention and comparator increased the cost per QALY gained by > 60%. CONCLUSION: Two biologic treatment cases incorporating price dynamics in cost-effectiveness analyses had varied impacts on the cost-effectiveness ratio depending on the magnitude of pre-LOE price increase and post-LOE price decrease and whether the LOE also affected the comparator. Yearly price increase magnitude during the period of exclusivity, among other factors, may counterbalance the effects of lower post-LOE intervention prices.

Real-world utilization of top-down and step-up therapy and initial costs in Crohn disease.

BACKGROUND: Medication treatment strategies for Crohn disease (CD) include step-up (SU) therapy, beginning with oral anti-inflammatory agents, and top-down (TD) therapy, beginning with biologics or immunomodulators. The real-world utilization and short-term medical costs associated with these treatment strategies are not well described. OBJECTIVE: To examine the prevalence of TD therapy use over time and compare the first-year direct medical expenditures among patients initiating CD medication treatment with SU and TD therapy in a real-world setting. METHODS: We conducted a retrospective cohort study of Optum Clinformatics Data Mart examining adult patients with CD newly initiated on medication therapy from 2010 to 2018. Included patients had a CD-indicated medication dispensed within 60 days after their initial CD diagnosis, were continuously enrolled in the health plan throughout the study period, and did not have comorbidities treated with a biologic also indicated for CD. A generalized linear model was used to quantify the differences in adjusted mean first-year CD-specific, direct nonpharmacy medical costs between users of TD and SU therapy. RESULTS: We identified 3,157 patients newly initiating medication therapy for CD (2,392 [75.8%] patients treated with SU therapy and 765 [24.2%] treated with TD therapy). The use of TD therapy over the study period increased from 17% in 2011 to 31% in 2017. TD therapy was also associated with a 149.8% ($1,230) higher adjusted average per-patient first-year CD-direct nonpharmacy medical cost compared with SU therapy (adjusted ratio of cost for TD compared with SU [2.498, 95% CI = 2.12-2.95]). CONCLUSIONS: In patients newly initiating medication therapy for CD, TD therapy use increased between 2010 and 2017 and was associated with higher first-year nonpharmacy medical expenditure. These findings align with the strategy of initiating TD therapy in patients with a higher disease burden. Further research is needed to determine long-term overall health care costs and clinical outcomes associated with SU and TD strategies in a real-world setting. DISCLOSURES: Dr Caffrey received research funding from Gilead, Merck, Pfizer, and Shionogi and is a speaker for Merck. The views expressed are those of the author and do not necessarily reflect the position or policy of the US Department of Veterans Affairs. Material is based on work supported, in part, by the Office of Research and Development.

Application of a diazepam milligram equivalency algorithm to assess benzodiazepine dose intensity in Rhode Island in 2018.

BACKGROUND: Benzodiazepines are indicated for the treatment of many conditions, such as anxiety disorders, muscle spasms, alcohol withdrawal, agitation, movement disorders, and epilepsy, and are one of the most frequently prescribed medication classes. This class of medication has important safety considerations, including an increased risk of dependence and addiction, falls, and death from opioid overdose. Although benzodiazepine safety and prescribing encompasses a rich and important research area, there is a lack of pharmacoepidemiologic literature addressing benzodiazepine dosing intensity in real-world settings. OBJECTIVE: To develop and apply a standardized benzodiazepine milligram equivalency conversion algorithm and assess the dose intensity of benzodiazepine use in Rhode Island (RI) in 2018. METHODS: A systematic literature review was conducted to identify the most commonly used benzodiazepine equivalency values. We then conducted a cross-sectional analysis of 2018 data from the RI Prescription Drug Monitoring Program (PDMP) to calculate the mean daily diazepam milligram equivalency (DME) based on a patient's most recent dispensing. A multivariable logistic regression analysis was conducted to determine the association between higher benzodiazepine doses (≥ 15 DME/day) and recipient characteristics, including concurrent use of opioids or stimulants. RESULTS: We identified 143,026 patients who received at least 1 prescription for a benzodiazepine in RI in 2018. The mean (SD) daily DME was 10.60 (9.05), and 26.2% of individuals had a mean DME per day of at least 15. Approximately 14% (n = 20,168) of patients prescribed a benzodiazepine had concurrent use with a prescription opioid, and 6.7% (n = 9,547) had concurrent use with a prescription stimulant. Females had a 28% lower adjusted odds of receiving a benzodiazepine dose of at least 15 DME per day compared with males (adjusted odds ratio [aOR] = 0.72, 95% CI = 0.70-0.73). The adjusted odds of receiving a benzodiazepine prescription of at least 15 DME per day was lower among the younger (aged 18-34 years) and older age groups (aged 65 years and older) compared with patients aged 35-64 years. Compared with commercial insurance, all other forms of payment had significantly higher adjusted odds of a daily benzodiazepine dose of at least 15 DME per day. The adjusted odds receiving a daily DME of at least 15 was 67% higher among those who also received a concurrent pharmacy dispensing for an opioid and 84% higher among those who also received a concurrent dispensing for a stimulant drug (aOR = 1.67, 95% CI = 1.61-1.72; aOR = 1.84, 95% CI = 1.76-1.93, respectively). CONCLUSIONS: Individuals aged 35-64 years with Medicaid insurance and those aged under 65 years with Medicare were more likely to be prescribed a benzodiazepine of at least 15 DME per day. Higher benzodiazepine DMEs were also dispensed to patients who concurrently used prescription opioids or stimulants who may be at increased risk of medication-related harm. We advocate for routine measurement of benzodiazepine dose intensity as a risk reduction strategy. DISCLOSURES: No funding supported this study. The authors have no conflicts of interest to disclose. The content and results of this study are solely the responsibility of the authors and do not necessarily represent the official views of the Rhode Island Department of Health. Kogut is partially supported by Institutional Development Award Numbers U54GM115677 and P20GM125507 from the National Institute of General Medical Sciences of the National Institutes of Health, which funds Advance Clinical and Translational Research (Advance-CTR) and the RI Lifespan Center of Biomedical Research Excellence (COBRE) on Opioids and Overdose, respectively. The content of this study is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. Contents of this study were presented as a poster presentation at AMCP 2019 Nexus; October 29-November 1, 2019; National Harbor, MD.

Improving the quality and quantity of clinical and translational research statewide: An application of group concept mapping.

INTRODUCTION: Advance Clinical and Translational Research (Advance-CTR) serves as a central hub to support and educate clinical and translational researchers in Rhode Island. Understanding barriers to clinical research in the state is the key to setting project aims and priorities. METHODS: We implemented a Group Concept Mapping exercise to characterize the views of researchers and administrators regarding how to increase the quality and quantity of clinical and translational research in their settings. Participants generated ideas in response to this prompt and rated each unique idea in terms of how important it was and feasible it seemed to them. RESULTS: Participants generated 78 unique ideas, from which 9 key themes emerged (e.g., Building connections between researchers). Items rated highest in perceived importance and feasibility included providing seed grants for pilot projects, connecting researchers with common interests and networking opportunities. Implications of results are discussed. CONCLUSIONS: The Group Concept Mapping exercise enabled our project leadership to better understand stakeholder-perceived priorities and to act on ideas and aims most relevant to researchers in the state. This method is well suited to translational research enterprises beyond Rhode Island when a participatory evaluation stance is desired.

Initial Patterns of Prescription Opioid Supply and Risk of Mortality Among Insured Adults in the United States.

OBJECTIVE: To examine the association between initial patterns of prescription opioid supply (POS) and risk of all-cause mortality among an insured opioid-naïve patient population in the United States (US). METHODS: This retrospective observational cohort study used de-identified, administrative health care claims data from a large national insurer (Optum Clinformatics Data Mart) from 2010 to 2015. Participants included insured, cancer-free adults prescribed opioid analgesics. Prescription opioids received during the first 6 months of therapy were used to categorize initial patterns of POS as daily or nondaily. Cox regression was used to estimate the association of initial patterns of POS with all-cause mortality within one year of follow-up, adjusting for baseline covariates to control for confounding. RESULTS: A total of 4,054,417 patients were included, of which 2.75% had incident daily POS; 54.8% were female; median age was 50 years; mean Charlson comorbidity index (CCI) was 0.21 (standard deviation = 0.77); and mean daily morphine milligram equivalent was 34.61 (95% confidence intervals: 34.59, 34.63). There were 2068 more deaths per 100,000 person-years among patients who were prescribed opioids daily than nondaily. After adjusting for baseline covariates, the hazard of all-cause mortality among patients with incident daily POS was nearly twice that among those prescribed nondaily (hazard ratio [HR] = 1.94; 95% confidence intervals: 1.84, 2.04). CONCLUSIONS: Among insured adult patients with noncancer pain, incident chronic POS was associated with a significantly increased risk of all-cause mortality over at most 1 year of follow-up. Because these results may be susceptible to bias, more research is needed to establish causality.

Concurrent Utilization of Prescription Opioids and Non-opioid Controlled Substances: Rhode Island Prescription Drug Monitoring Program, 2018.

OBJECTIVE: To estimate the prevalence of concurrent prescription opioid and non-opioid controlled substance use in Rhode Island (RI). METHODS: We conducted a cross sectional observational study using data from the RI Prescription Drug Monitoring Program on controlled substance prescriptions dispensed in 2018. We estimated the prevalence of concurrent use of other prescribed controlled substances among adults who received at least one opioid prescription. RESULTS: In 2018, 142,692 RI adult residents received at least one opioid prescription, of whom 25.1% (99% confidence interval [CI]: 24.8-25.4) were concurrently prescribed at least one other controlled substance, including benzodiazepines (17.0%, 99% CI: 16.8-17.3), medications for insomnia (4.0%, 99% CI: 3.9-4.2), and stimulants (3.8%, 99% CI: 3.6-3.9). CONCLUSION: The concurrent use of prescription opioids and other prescribed controlled substances is common. Our findings suggest an urgent need to implement focused initiatives to address controlled substance polypharmacy to reduce the risk of overdose.

Racial disparities in medication use: imperatives for managed care pharmacy.

The COVID-19 pandemic and the social unrest pervading U.S. cities in response to the killings of George Floyd and other Black citizens at the hands of police are historically significant. These events exemplify dismaying truths about race and equality in the United States. Racial health disparities are an inexcusable lesion on the U.S. health care system. Many health disparities involve medications, including antidepressants, anticoagulants, diabetes medications, drugs for dementia, and statins, to name a few. Managed care pharmacy has a role in perpetuating racial disparities in medication use. For example, pharmacy benefit designs are increasingly shifting costs of expensive medications to patients, creating affordability crises for lower income workers, who are disproportionally persons of color. In addition, the quest to maximize rebates serves to inflate list prices paid by the uninsured, among which Black and Hispanic people are overrepresented. While medication cost is a foremost barrier for many patients, other factors also propagate racial disparities in medication use. Even when cost sharing is minimal or zero, medication adherence rates have been documented to be lower among Blacks as compared with Whites. Deeper understandings are needed about how racial disparities in medication use are influenced by factors such as culture, provider bias, and patient trust in medical advice. Managed care pharmacy can address racial disparities in medication use in several ways. First, it should be acknowledged that racial disparities in medication use are pervasive and must be resolved urgently. We must not believe that entrenched health system, societal, and political structures are impermeable to change. Second, the voices of community members and their advocates must be amplified. Coverage policies, program designs, and quality initiatives should be developed in consultation with those directly affected by racial disparities. Third, the industry should commit to dramatically reducing patient cost sharing for essential medication therapies. Federal and state efforts to limit annual out-of-pocket pharmacy spending should be supported, even though increased premiums may be an undesirable (yet more equitable) consequence. Finally, information about race should be incorporated into all internal and external reporting and quality improvement activities. DISCLOSURES: No funding was received for the development of this manuscript. Kogut is partially supported by Institutional Development Award Numbers U54GM115677 and P20GM125507 from the National Institute of General Medical Sciences of the National Institutes of Health, which funds Advance Clinical and Translational Research (Advance-CTR), and the RI Lifespan Center of Biomedical Research Excellence (COBRE) on Opioids and Overdose, respectively. The content is solely the responsibility of the author and does not necessarily represent the official views of the National Institutes of Health.

Association between polypharmacy and health-related quality of life among cancer survivors in the United States.

PURPOSE: Polypharmacy (PP) is present in many cancer survivors and may lead to lower health-related quality of life (HRQoL). The study's objective was to evaluate the association between PP and HRQoL among cancer survivors in the US. METHODS: A cross-sectional analysis of the Medical Expenditure Panel Survey (MEPS) was conducted. Our analytic sample included all adult patients with cancer, during even years 2008-2014. PP was defined as reported use of five or more unique therapeutic classes of prescription medications. The MEPS measured HRQoL using the Short Form 12-Item Health Survey Version 2 (SF-12v2) physical component summary (PCS) and mental component summary (MCS) scores. Ordinary least squares regressions were used to assess associations between PP and HRQoL controlling for demographic, socioeconomic, and clinical factors. RESULTS: PP was prevalent among 44.4% of 10.1 million cancer survivors per calendar year (on average) for years 2008, 2010, 2012, and 2014. The mean adjusted PCS score for cancer survivors with PP was 35.8 points, which was significantly lower compared with cancer survivors without PP (39.5) by 3.7 points (p value < .0001). Conversely, the mean adjusted MCS scores were not significantly lower in cancer survivors with PP compared with cancer survivors without PP (44.9 versus 45.4, p value = 0.3145). CONCLUSIONS: PP was prevalent in 44.4% of cancer survivors and was associated with significantly poorer physical HRQoL than reported in their counterparts without PP. IMPLICATIONS FOR CANCER SURVIVORS: PP should be examined closely among cancer survivors because of increased association with poorer physical HRQoL.

Development and Application of a Measurement Framework to Evaluate Safe, Effective and Efficient Medication Use Among Older Adults.

BACKGROUND: A majority of older adults in the United States (US) use prescription medications. Comprehensive population-level approaches to examine medication safety, effectiveness, and costs among older adults are needed. OBJECTIVES: The objectives of this study were to develop a framework of quality measures spanning the domains of safety, effectiveness, and efficiency of prescription medication use among older adults, and to apply those measures using pharmacy claims data. METHODS: We performed a retrospective study among adults age 65 years and older of a US East Coast state who filled at least one prescription from a particular pharmacy chain during 2016 (N = 99,056). Firstly, we performed an environmental scan to identify quality measures and potentially relevant measures addressing prescription medication use. These measures were reviewed and rated by local geriatric pharmacotherapy experts. After evaluating feasibility, evidence, and relevance, a total of 19 measures representing the domains of safety (n = 7), effectiveness (n = 7), and efficiency (n = 5) were identified. These measures were then applied to an older adult population using prescription data for the year 2016 provided by a national pharmacy chain. All measures were configured such that a score of 100% corresponded to optimal performance. RESULTS: For the domain of safety, 12.8% of patients received a benzodiazepine chronically, 23.6% received central nervous system depressants, 16.7% received fluoroquinolones as first-line antibiotic therapy, and 21.9% of those who were prescribed opioids received them in excessive quantities. For the domain of effectiveness, one-fourth of the diabetes patients did not receive statins and angiotensin-acting medications, while 18.0% were not adherent to oral anticoagulant medications and 54% were not adherent to respiratory inhalers. For the domain of efficiency, 12.0% of the patients received prescriptions from five or more unique prescribers. Overall, 85.7%, 76.1%, and 87.9% of the older adults showed safe, effective, and efficient prescription medication use, respectively. CONCLUSION: A novel approach to comprehensively examine the quality of medication use among older adults using prescription claims data is provided in our study. A considerable proportion of the older adults in our study received safe, effective, and efficient prescription medications. However, within each domain, several opportunities for improving the alignment of prescription medication use with current recommendations were identified.

Real-World Direct Health Care Costs Associated with Psychotropic Polypharmacy Among Adults with Common Cancer Types in the United States.

BACKGROUND: Psychotropic polypharmacy is not uncommon among cancer patients and may contribute to the increased direct health care cost burden in this population. OBJECTIVE: To estimate average direct health care costs in the year following cancer diagnosis among cancer patients receiving psychotropic polypharmacy compared with those without psychotropic polypharmacy, using a multivariable analysis framework. METHODS: A retrospective cross-sectional study was conducted among patients aged 18 years and older diagnosed with the most commonly occurring cancers (breast, prostate, lung, and colorectal) in the United States during 2011-2012 using the deidentified Optum Clinformatics Data Mart commercial claims database. Psychotropic polypharmacy was defined as concurrent use of 2 or more psychotropic medications for at least 90 days. Direct health care costs in the year following cancer diagnosis were estimated as total medical payments made by the health plans and were derived from claims files. A generalized linear regression model with log-link function and gamma distribution was used to model average direct health care costs, controlling for baseline patient demographic and clinical covariates. RESULTS: Average annual direct health care costs for cancer patients with psychotropic polypharmacy ($53,497; SD $72,590) were higher than those without psychotropic polypharmacy ($38,255; SD $59,844), with an unadjusted average cost difference of $15,242 (P < 0.0001). In the adjusted regression model, the average difference in costs shrunk to $5,888 but remained notable. When examined by type of cancer, average direct health care costs for all cancer patients with psychotropic polypharmacy were significantly higher than those for patients without psychotropic polypharmacy, except for colorectal cancer patients. CONCLUSIONS: Overall health care costs were higher among cancer patients with psychotropic polypharmacy compared with those without psychotropic polypharmacy. Our findings support the need for future research to better understand the benefits and risks of psychotropic polypharmacy, given its potential to cause adverse health outcomes and avoidable health care utilization and costs for this vulnerable patient population. DISCLOSURES: This study was funded by the American Association of Colleges of Pharmacy (AACP) New Investigator Award mechanism, which was received by Vyas. Aroke was partially supported by the AACP grant for conducting data analysis of the study. Kogut is partially supported by Institutional Development Award Number U54GM115677 from the National Institute of General Medical Sciences of the National Institutes of Health, which funds Advance Clinical and Translational Research (Advance-CTR). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health and the AACP. The authors report no conflicts of interest. An abstract of this study was presented as a poster at the American Association of Colleges of Pharmacy Annual Meeting on July 22, 2018, in Boston, MA.

Prevalence of Psychotropic Polypharmacy and Associated Healthcare Resource Utilization during Initial Phase of Care among Adults with Cancer in USA.

BACKGROUND: The use of psychotropic medications is not uncommon among patients with newly diagnosed cancer. However, the impact of psychotropic polypharmacy on healthcare utilization during the initial phase of cancer care is largely unknown. METHODS: We used a claims database to identify adults with incident breast, prostate, lung, and colorectal cancers diagnosed during 2011-12. Psychotropic polypharmacy was defined as concurrent use of two or more psychotropic medication classes for at least 90 days. A multivariable logistic regression was performed to identify significant predictors of psychotropic polypharmacy. Multivariable Poisson and negative binomial regressions were used to assess the associations between psychotropic polypharmacy and healthcare utilization. RESULTS: Among 5604 patients included in the study, 52.6% had breast cancer, 30.6% had prostate cancer, 11.4% had colorectal cancer, and 5.5% had lung cancer. During the year following incident cancer diagnosis, psychotropic polypharmacy was reported in 7.4% of patients, with the highest prevalence among patients with lung cancer (14.4%). Compared with patients without psychotropic polypharmacy during the initial phase of care, patients with newly diagnosed cancer with psychotropic polypharmacy had a 30% higher rate of physician office visits, an 18% higher rate of hospitalization, and a 30% higher rate of outpatient visits. The rate of emergency room visits was similar between the two groups. CONCLUSION: Psychotropic polypharmacy during the initial phase of cancer care was associated with significantly increased healthcare resource utilization, and the proportion of patients receiving psychotropic polypharmacy differed by type of cancer. IMPACT: Findings emphasize the importance of evidence-based psychotropic prescribing and close surveillance of events causing increased healthcare utilization among patients with cancer receiving psychotropic polypharmacy.

Stevens-Johnson syndrome and toxic epidermal necrolysis with antiepileptic drugs: An analysis of the US Food and Drug Administration Adverse Event Reporting System.

OBJECTIVE: Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are rare and potentially fatal adverse skin reactions that are most commonly triggered by certain medications. One class of medications that has been highly associated with SJS/TEN reactions is antiepileptic drugs (AEDs). We sought to quantify the risk of SJS/TEN associated with AEDs as a class, as well as individual AEDs, in the United States. METHODS: An analysis was performed of the US Food and Drug Administration Adverse Event Reporting System (FAERS) from July 2014 through December 2017. Rates of SJS/TEN were calculated for each AED compared with all other non-AEDs. Reporting odds ratios (RORs), proportional reporting ratios (PRRs), and 95% confidence intervals (CIs) were calculated using OpenEpi. RESULTS: With 198 reports, AEDs had more reports of SJS/TEN than any other medication class. AEDs as a class had an ROR of 8.7 (95% CI 7.5-10.2) and a PRR of 8.7 (95% CI 7.5-10.2) compared with all other non-AEDs. The AEDs with the highest risk estimates were zonisamide (ROR 70.2, 95% CI 33.1-148.7; PRR 68.7, 95% CI 32.9-143.5), rufinamide (ROR 60.0, 95% CI 8.3-433.5; PRR 58.9, 95% CI 8.4-411.5), clorazepate (ROR 56.0, 95% CI 7.8-404.1; PRR 55.1, 95% CI 7.8-385.0), lamotrigine (ROR 53.0, 95% CI 43.2-64.9; PRR 52.2, 95% CI 42.7-63.7), phenytoin (ROR 26.3, 95% CI 15.5-44.7; PRR 26.1, 95% CI 15.4-44.2), and carbamazepine (ROR 24.5, 95% CI 16.0-37.5; PRR 24.3, 95% CI 16.0-37.1). SIGNIFICANCE: Although AEDs as a class were associated with 9 times the risk of SJS/TEN compared with non-AEDs, there were 6 AEDs with risk estimates greater than 20. Increased awareness of this risk among both prescribers and patients, particularly variations in risk among different AEDs, along with education on early recognition of SJS/TEN signs/symptoms, may help mitigate the number and severity of these adverse events.

Evaluation of differences in percentage of international normalized ratios in range between pharmacist-led and physician-led anticoagulation management services.

BACKGROUND: The safety and efficacy of warfarin depend on maintaining the international normalized ratio (INR) in an established range. OBJECTIVE: The purpose was to determine whether a coordinated pharmacist-led approach improved percentage of INRs in therapeutic range in comparison to a physician-led anticoagulation management service (AMS). METHODS: A retrospective chart review was conducted for patients at a multisite primary care organization. INR data for patients receiving warfarin management by a physician were collected from December 1, 2009 to May 31, 2010. These were compared to INR results from December 1, 2010 to May 31, 2011, during which patients received warfarin management from a pharmacist. The primary end points were percentage of INRs within a goal range of 2.0 to 3.0 and an expanded goal range of 1.8 to 3.2 for the physician-led group versus the pharmacist-led group. RESULTS: The percentage of INR results within the goal range (2.0-3.0) was greater among patients in the pharmacist-led group (n = .130) than the physician-led group (n = 96; 57.5% vs 50.0%, respectively; P = .0004). The percentage of INR results <1.5 (7.3% vs 5.1%) and >3.5 (11.4% vs 7.1%) was also statistically significant in favor of the pharmacist-led AMS, with P values of .03 and .0004, respectively. CONCLUSION: A pharmacist-led AMS improved the percentage of INRs in range, with significantly less out-of-range results.

Evaluation of a program to improve diabetes care through intensified care management activities and diabetes medication copayment reduction.

BACKGROUND: Medication copayment reduction can be integrated with disease management programs to incentivize patient engagement in chronic care management. While disease management programs in diabetes have been evaluated across a range of settings and designs, less is known regarding the effectiveness of copayment reduction as a component of disease management. OBJECTIVE: To evaluate the short-term results of a diabetes-focused disease management program that included copayment reduction, care coordination, and patient goal setting, focusing on rates of evidence-based care processes and all-cause pharmacy and health care costs. METHODS: Blue Cross Blue Shield of Rhode Island offered large employer groups the opportunity to participate in a diabetes disease management initiative that featured reduced copayments (from $7/$25/$40 for generic, tier 2, and tier 3 drugs, respectively, to $0 for generic and $0-$2 for brand drugs) for diabetes-related medications. In return for the copayment reduction, participants agreed to the following: (a) participate in care coordination with a case manager, (b) have an annual physical examination, (c) have a hemoglobin A1c blood test at least twice annually, and (d) have a low-density lipoprotein cholesterol (LDL-C) test at least once annually. Patients received personalized support provided by a registered nurse and dietician, disease-related education provided by nurses, and intensified case management services, including working with a health coach to establish healthy behavioral change goals. All study subjects were aged 18 years or older and had at least 1 ICD-9-CM code for diabetes and at least 1 claim for an antidiabetic drug during a 12-month measurement period, which was each subject's most recent 12-month period of continuous enrollment from January 1, 2008, through May 31, 2010. Administrative claims data were used to determine the percentage of intervention (participating) and nonintervention (nonparticipating) subjects from among all of the plan's employer groups who received at least once-yearly monitoring of A1c, high-density lipoprotein cholesterol (HDL-C), and LDL-C; medical attention (or drug therapy) for nephropathy; and an eye examination. We conducted multivariate logistic regression analyses to assess the effect of the intervention and other patient characteristics and comorbidities on rates of performance of these care processes, aggregating the 5 processes of care into an "all or none" single composite outcome. We also developed a propensity score-weighted model to attempt to adjust for differences between the intervention and nonintervention groups resulting from the nonrandomized study design. Additionally, we quantified average plan payments to providers less patient copayments (i.e., net plan cost) per patient per year (PPPY) for the 12-month follow-up period and compared these costs for the intervention versus nonintervention groups. RESULTS: The study sample consisted of 9,698 patients with diabetes; 649 (6.7%) of whom participated in the intervention. 9,049 (93.3%) patients were identified by the insurer as patients with diabetes receiving usual care. Patients in the intervention and nonintervention groups were similarly likely to have all 5 recommended processes of care performed (40.1% vs. 38.9%, respectively, P = 0.543). Younger patients received all 5 recommended care processes less frequently than older patients (30.5%, 38.0%, and 47.0% for ages 18-48 years, 49-59 years, and 60 years or older, respectively, P < 0.001); in adjusted analyses, patients aged 60 years or older were approximately twice as likely to receive all 5 care processes compared with patients aged 18-48 years (odds ratio [OR] = 1.97, 95% CI = 1.75-2.21). Users of oral antidiabetic monotherapy were least likely to have these processes of care performed compared with users of multiple oral therapies (OR = 1.23, 95% CI = 1.11-1.36) and insulin (OR = 1.59, 95% CI = 1.41-1.78). PPPY prescription drug costs incurred by the plan were greater for intervention than comparison patients (means [SDs] of $3,139 [$3,426] vs. $2,854 [$3,938], respectively, P < 0.001); and the generic-dispensing ratio was slightly lower (means [SDs] of 62.1% [22.4%] and 65.4% [23.0%], respectively, P < 0.001). There were no significant differences between the intervention and comparison groups in mean [SD] PPPY all-cause medical care costs ($7,475 [$17,601] vs. $8,577 [$22,972], respectively, P = 0.213) or total all-cause costs ($10,613 [$18,590] vs. $11,431 [$24,060], P = 0.666). CONCLUSIONS: Patients participating in this incentive program featuring diabetes medication copayment reduction and disease management components did not receive recommended care any more or less frequently than other enrolled members with diabetes. Younger patients and those utilizing oral antidiabetic monotherapy as their drug regimens were less likely to have the recommended processes of care performed. While prescription drug expenditures incurred by the plan were greater for intervention patients, between-group differences in total costs for medications and all-cause medical care were not statistically significant. Further follow-up is required to determine the success of this program over the longer term in promoting quality of care and achieving cost reductions and improved health outcomes.

Concomitant use of triptan, and SSRI or SNRI after the US Food and Drug Administration alert on serotonin syndrome.

OBJECTIVE: The present study was designed to discern the prevalence of concomitant use of a 5-hydroxytryptamine receptor agonist (triptan), and a selective serotonin reuptake inhibitor (SSRI) or a selective serotonin/norepinephrine reuptake inhibitor (SNRI) after the US Food and Drug Administration issued an alert regarding serotonin syndrome in 2006 and to contrast findings with data published prior to the federal warning. BACKGROUND: In July 2006, the US Food and Drug Administration warned patients and health-care professionals to be aware that use of a triptan in combination with an SSRI or SNRI may result in a potentially life-threatening problem known as serotonin syndrome. In 2010, the American Headache Society published a position paper noting that there existed conflicting and insufficient information to discern the risk of serotonin syndrome with the use of triptan, and SSRI or SNRI, and that said Class IV data were not to be used as the basis for limiting the prescribing of triptan with SSRI or SNRI (Level U). Clinicians were cautioned as to the seriousness of serotonin toxicity and that monitoring was warranted. METHODS: We used weighted data from the US National Ambulatory Medical Care Survey for years 2007 and 2008 to derive national estimates of the number of office-based physician-patient encounters (visits), documenting the concomitant use of triptan, and SSRI or SNRI. Results are compared with previously published findings for the years 2003 and 2004. RESULTS: During the time-frame 2007-2008, an annualized mean of 5,256,958 patients were prescribed a triptan (vs 3,874,367 in 2003-2004, a 35.7% increase), and 68,603,600 patients were prescribed an SSRI or SNRI (vs 50,402,149 in 2003-2004, a 36.1% increase). An annualized mean of 1,319,763 patients were simultaneously prescribed or continued use of triptan, along with SSRI or SNRI (vs 694,276 in 2003-2004, a 90.1% increase). CONCLUSION: Our study documents that 1.8% (1,319,763/73,860,558) of patients in 2007-2008 were prescribed triptan, and SSRI or SNRI (vs 1.3% in 2003-04, an increase of 38.5%). While this is a small fraction overall, the actual number of patients on a nationwide basis is substantial. What remains missing from the literature is documentation as to the number of cases of serotonin syndrome and resulting consequences (clinical and economic) because of the concomitant use of triptan, and SSRI or SNRI in the time-frame 2007-2008. Absent in these data, it remains difficult to assess the risk benefit associated with the use of triptan, and SSRI or SNRI.