Trends in Incident Prescriptions for Behavioral Health Medications in the US, 2018-2022.

Importance: The COVID-19 pandemic reportedly increased behavioral health needs and impacted treatment access. Objective: To assess changes in incident prescriptions dispensed for medications commonly used to treat depression, anxiety, attention-deficit/hyperactivity disorder (ADHD), and opioid use disorder (OUD), before and during the COVID-19 pandemic. Design, Setting, and Participants: This was a cross-sectional study using comprehensive, population-level, nationally projected data from IQVIA National Prescription Audit on incident prescriptions (prescriptions dispensed to patients with no prior dispensing from the same drug class in the previous 12 months) dispensed for antidepressants, benzodiazepines, Schedule II (C-II) stimulants, nonstimulant medications for ADHD, and buprenorphine-containing medication for OUD (MOUD), from US outpatient pharmacies. Data were analyzed from April 2018 to March 2022. Exposure: Incident prescriptions by drug class (by prescriber specialty, patient age, and sex) and drug. Main Outcomes and Measures: Interrupted time-series analysis to compare changes in trends in the monthly incident prescriptions dispensed by drug class and percentage changes in aggregate incident prescriptions dispensed between April 2018 and March 2022. Results: Incident prescriptions dispensed for the 5 drug classes changed from 51 500 321 before the COVID-19 pandemic to 54 000 169 during the pandemic. The largest unadjusted percentage increase in incident prescriptions by prescriber specialty was among nurse practitioners across all drug classes ranging from 7% (from 1 811 376 to 1 944 852; benzodiazepines) to 78% (from 157 578 to 280 925; buprenorphine MOUD), whereas for patient age and sex, the largest increases were within C-II stimulants and nonstimulant ADHD drugs among patients aged 20 to 39 years (30% [from 1 887 017 to 2 455 706] and 81% [from 255 053 to 461 017], respectively) and female patients (25% [from 2 352 095 to 2 942 604] and 59% [from 395 678 to 630 678], respectively). Trends for C-II stimulants and nonstimulant ADHD drugs (slope change: 4007 prescriptions per month; 95% CI, 1592-6422 and 1120 prescriptions per month; 95% CI, 706-1533, respectively) significantly changed during the pandemic, exceeding prepandemic trends after an initial drop at the onset of the pandemic (level changes: -50 044 prescriptions; 95% CI, -80 202 to -19 886 and -12 876 prescriptions; 95% CI, -17 756 to -7996, respectively). Although buprenorphine MOUD dropped significantly (level change: -2915 prescriptions; 95% CI, -5513 to -318), trends did not significantly change for buprenorphine MOUD, antidepressants, or benzodiazepines. Conclusions and Relevance: Incident use of many behavioral health medications remained relatively stable during the COVID-19 pandemic in the US, whereas ADHD medications, notably C-II stimulants, sharply increased. Additional research is needed to differentiate increases due to unmet need vs overprescribing, highlighting the need for further ADHD guideline development to define treatment appropriateness.

Switching patterns of immediate-release forms of generic mixed amphetamine salts products among privately and publicly insured individuals aged 15-64 years in the United States, 2013-2019.

PURPOSE: Immediate-release forms of generic mixed amphetamine salts (MAS) have been the subject of passive surveillance reports signaling lack of effectiveness. We examined switching patterns that might suggest whether long-term users of specific MAS are more likely to switch away or switch back after use of the MAS of interest in the FDA's Sentinel Distributed Database. METHODS: We required at least 60-day continuous supply of selected MAS grouped by Abbreviated New Drug Application (ANDA) to describe patterns of switching away from and to generics approved under the ANDAs of interest among individuals ages 15-64 years with attention deficit hyperactivity disorder or narcolepsy during 2013-2019. RESULTS: We observed the greatest number of treatment episodes for ANDA 040422 (n = 525 771), followed by ANDA 202424 (n = 181 693), ANDA 040439 (n = 62 363), ANDA 040440 (n = 21 143), and ANDA 040480 (n = 8792). Of those with switches away from their original ANDA, episodes initiated on generic products under ANDA 040422 (48.6%) and ANDA 202424 (43.0%) were most likely to switch back, while those initiated on generic product under ANDA 040480 were least likely (24.1%). Of those episodes with switches to a generic under an ANDA of interest, about one-third (range 27.1% to 37.0%) switched back to the same product. These switches back had a median time to switch of about 30 days. CONCLUSIONS: These descriptive analyses, although subject to limitations, did not suggest increased switching away or switching back after use of the generics of interest. Continued post-marketing surveillance is warranted.

Utilization of hydroxyprogesterone caproate among pregnancies with live birth deliveries in the sentinel distributed database.

BACKGROUND: The U.S. Food and Drug Administration (FDA) approved Makena® (hydroxyprogesterone caproate [HPC] injection) in February 2011 for reducing the risk of preterm birth (PTB) in women with a singleton pregnancy who had a history of singleton spontaneous PTB (sPTB). Makena was approved under accelerated approval and required a postmarketing study to verify its clinical benefits. However, the postmarketing trial (PROLONG) failed to verify Makena's clinical benefit to neonates and substantiate its effect on reducing the risk of recurrent PTB. This study examined the utilization of HPC, along with another progestogen (vaginal progesterone) used to reduce the risk of sPTB during pregnancy, to inform the landscape of HPC use in the United States. METHODS: We included pregnant women aged 10-54 years with a live birth delivery from 1 January, 2008 to 31 December, 2018 in the Sentinel Distributed Database (SDD). We examined the prevalence of injectable HPC (Makena and its generics), compounded HPC, and vaginal progesterone use during the second and third trimesters during the study period. We also assessed the proportion of these HPC-exposed pregnancies with obstetrical conditions of interest as potential reasons for use: (1) history of preterm delivery; (2) cervical shortening in the current pregnancy; and (3) preterm labor in the current pregnancy. RESULTS: We identified a total of 3,445,739 live-birth pregnancies (among 2.9 million women) between 2008 and 2018 in the SDD. Of these pregnancies, 6.5 per 1,000 pregnancies used injectable HPC, 2.3 per 1,000 pregnancies used compounded HPC, and 1.5 per 1,000 pregnancies used vaginal progesterone during the second and/or third trimesters. The yearly uptakeof pregnancies with injectable HPC use increased during the study period from 2.1 per 1,000 pregnancies in 2012 to 12.6 per 1,000 pregnancies in 2018; use of compounded HPC decreased from 3.3 per 1,000 pregnancies to 0.25 per 1,000 pregnancies over the same period. Of 16,524 pregnancies with injectable HPC use, 12,054 (73%) had at least one related obstetrical condition, including 6,439 (39%) with a recorded history of preterm delivery. In addition, 4,665 (28%) had a PTB recorded as the outcome for the current pregnancy. CONCLUSIONS: We found modest use of HPC during the second and/or third trimesters among all live-birth pregnancies in SDD. The majority of pregnancies with injectable HPC use had at least one of three obstetrical indications of interest recorded before or during the pregnancy.

Testosterone Therapy for the Treatment of Age-Related Hypogonadism: Risks with Uncertain Benefits.

Testosterone replacement therapy has been approved in the United States since the 1950s for men with "classical" hypogonadism. These men have specific and well-recognized hypothalamic, pituitary, or testicular conditions leading to deficient or absent endogenous testosterone. A more controversial treatment population is aging men, many with comorbidities, who have low serum testosterone concentrations compared with young healthy men and who do not have the well-recognized medical conditions that cause "classical" hypogonadism. Testosterone continues to be widely used in these men with "age-related hypogonadism" even though the benefits of testosterone for this use are uncertain and there are important risks, including a potential risk of major adverse cardiac events for the testosterone class, and two testosterone products with increases in blood pressure that can increase the risk of myocardial infarction and stroke. Given the uncertain clinical benefit of testosterone in men with "age-related hypogonadism" in the face of known and potential adverse outcomes, none of the testosterone products is FDA approved for such use.

Phosphodiesterase type 5 inhibitor use among pregnant and reproductive-age women in the United States.

PURPOSE: To assess the prevalence and potential indications of PDE5 inhibitor use among pregnant and reproductive-age women in the United States. METHODS: We identified women 15 to 50 years with a livebirth from January 2001 through March 2018 in Sentinel Database. We assessed the prevalence of PDE5 inhibitor use prior to and during pregnancy by trimester, identified potential on- and off-label indications using predefined diagnosis codes recorded within 90 days before the estimated last menstrual period through delivery. Separately, we used data from IQVIA's National Prescription Audit and Total Patient Tracker to estimate the dispensed prescriptions for PDE5 inhibitors and the number of patients with PDE5 inhibitor prescriptions. RESULTS: We identified approximately 3.3 million pregnancies during 2001 to 2018, 96 of which had PDE5 inhibitor use during pregnancy. Prevalence of PDE5 inhibitor use was 2.61, 0.62, and 0.62 per 100, 000 live-born pregnancies during the first, second, or third trimesters, respectively. Among women exposed to a PDE5 inhibitor from 90 days before conception to the end of pregnancy, 25.0%, 31.1%, and 15.5% had a diagnosis code for fetal growth restriction, preeclampsia, and pulmonary arterial hypertension. In IQVIA data, an estimated 223, 000 prescriptions from July 2015 through June 2018 and 58, 000 women received prescriptions for PDE5 inhibitors in 2017, of whom approximately 15, 000 (26%) were aged 15 to 50 years. CONCLUSION: We found a low prevalence of PDE5 inhibitor use in pregnant and reproductive-age women. Given the very low prevalence of use and the inconsistency of neonatal mortality data across STRIDER centers, the risk to public health is low at present.

Patterns of opioid analgesic use in the U.S., 2009 to 2018.

ABSTRACT: Although overall outpatient dispensing of opioid analgesic prescriptions has declined, there may still be overprescribing. Understanding how many opioid analgesic units, primarily tablets, are dispensed with the intention of shorter-vs longer-term use can inform public health interventions. We used pharmacy prescription data to estimate the number of opioid analgesic tablets dispensed annually in the U.S. We studied patterns of new use of opioid analgesics by evaluating how many opioid analgesic prescriptions and tablets were dispensed to patients with no opioid analgesic prescriptions in the previous year. Estimated opioid analgesic tablets dispensed declined from a peak of 17.8 billion in 2012 to 11.1 billion in 2018. Patients newly starting opioid analgesics declined from 47.4 million patients in 2011 to 37.1 million patients in 2017. Approximately 40% fewer tablets were dispensed within a year to patients starting in 2017 (2.4 billion) compared with 2011 (4.0 billion). In 2011, patients with ≥5 opioid analgesic prescriptions within a year were dispensed 2.2 billion tablets (55% of all tablets in our study). This declined by 52% to 1.1 billion tablets (44% of all tablets) in 2017. Tablets dispensed within a year to patients with <5 opioid analgesic prescriptions declined by 26% from 2011 to 2017. Patients with ≥5 prescriptions comprised a small and decreasing proportion of all patients newly starting therapy. However, these patients received almost half of all tablets dispensed within a year to patients in our study, despite a larger decline than tablets dispensed to patients with <5 prescriptions within a year.

Concomitant Filled Prescriptions of Oxymorphone or Oxycodone with CYP3A Inhibitors and Inducers.

BACKGROUND: Oxymorphone's metabolism does not involve the hepatic cytochrome P450 (CYP) system. The effect of this pharmacokinetic feature of oxymorphone on opioid prescribing is unknown. OBJECTIVE: To assess the relative frequency with which oxymorphone and oxycodone (a CYP3A-metabolized opioid analgesic) were each prescribed to patients concomitantly receiving CYP3A-modifying drugs (i.e., inducers and inhibitors) to characterize opioid-prescribing patterns in patients at risk for CYP3A-related drug interactions. METHODS: We analyzed the Sentinel Distributed Database from January 1, 2013, to December 31, 2016, to identify the proportion of patients with concomitant dispensing of selected CYP3A modifiers among initiators of oxymorphone. We then repeated the analysis using oxycodone instead of oxymorphone. We conducted sensitivity analyses that varied the washout periods for each opioid to account for potential opioid switching. RESULTS: In the primary analysis, the proportion of patients with concomitant incident dispensings of oxymorphone and selected CYP3A modifiers was 3.26% (95% CI = 3.09%-3.43%), and the proportion of patients with incident dispensings of oxycodone and selected CYP3A modifiers was 2.82% (95% CI = 2.79%-2.85%). The difference between proportions was 0.43% (95% CI = 0.26%-0.60%). Sensitivity analyses that varied the washout periods for each opioid with respect to the other opioid to account for switching yielded similar results. CONCLUSIONS: We observed similar proportions of patients using selected CYP3A modifiers concomitantly with both oxymorphone and oxycodone. While the CIs of the point estimates did not overlap, the absolute differences between the proportions were small. DISCLOSURES: This project was supported by Task Order HHSF22301001T under Master Agreement HHSF223201400030I from the U.S. Food and Drug Administration (FDA). The FDA approved the study protocol, including the statistical analysis plan, and reviewed and approved the manuscript. Coauthors from the FDA participated in the results interpretation and in the preparation and decision to submit the manuscript for publication. Coyle, Money, Staffa, Meyer, and Woods are employed by the FDA. The other authors have no financial conflicts of interest to report. The views expressed are those of the authors and not necessarily those of the U.S. Department of Health and Human Services, U.S. Food and Drug Administration.

Idelalisib for Treatment of Relapsed Follicular Lymphoma and Chronic Lymphocytic Leukemia: A Comparison of Treatment Outcomes in Clinical Trial Participants vs Medicare Beneficiaries.

Importance: Idelalisib (IDEL) is approved as monotherapy in relapsed follicular lymphoma (FL) and with rituximab (IDEL+R) for relapsed chronic lymphocytic leukemia (CLL). Toxic effects can be severe and treatment-limiting. Outcomes in a real-world population are not yet characterized. Objective: We compared IDEL treatment outcomes in the clinical setting with outcomes in clinical trial data. Design, Setting, and Participants: This cohort study compared clinical trial participants treated with IDEL, aged 65 years or older, in studies 101-09 and 312-0116 with Medicare beneficiaries treated with IDEL of the same disease state and treatment regimen. Study 101-09 was a phase 2, single-group, open-label trial supporting accelerated approval of IDEL for relapsed or refractory FL. Study 312-0116 was a phase 3, multicenter, randomized, double-blind trial supporting approval of IDEL+R for relapsed CLL. Analyses were conducted between February and December 2018. Main Outcomes and Measures: Treatment duration, on-treatment and overall mortality, and serious and fatal infections were compared between trial participants and Medicare beneficiaries. Cox proportional hazards models quantified differences by cohort. Results: We identified 26 trial participants (mean [SD] age, 73 [4.9] years; 12 [46.2%] women) and 305 Medicare beneficiaries (mean [SD] age, 76 [6.9] years; 103 [54.8%] women) receiving IDEL for FL and 89 trial participants (mean [SD] age, 74 [6.0] years; 30 [33.7%] women) and 294 Medicare beneficiaries (mean age, 76 [6.3] years; 111 [37.8%] women) receiving IDEL+R for CLL. Medicare beneficiaries were older with higher comorbidity; had a shorter median treatment duration for CLL (173 days vs 473 days, P < .001) but not FL (114, days vs 160 days, P = .38); a numerically higher mortality rate (CLL: HR, 1.40; 95% CI, 0.93-2.11; FL: HR, 1.39; 95% CI, 0.69-2.78); and a significantly higher fatal infection rate per 100 person-years for CLL (18.4 vs 9.8, P = .04) and a numerically higher rate for FL (27.6 vs 18.6, P = .54), compared with trial participants. Trial participants had approximately twice as many dose reductions (CLL: 32.6% vs 18.0%; P = .003; FL: 38.5% vs 16.1%; P = .02). Among Medicare beneficiaries, a hospitalized infection within 6 months prior to IDEL initiation was associated with a 2.11-fold increased risk for on-treatment fatal infections (95% CI, 1.44-3.10). Despite a March 2016 recommendation for Pneumocystis jirovecii pneumonia prophylaxis in patients treated with IDEL, prophylaxis rates were low after March 2016 (FL: 25%, CLL: 37%). Conclusions and Relevance: We observed substantial imbalances in baseline comorbidities and treatment outcomes between Medicare beneficiaries and trial participants aged 65 years or older. Immunosuppression-related toxic effects, including infections, may have been somewhat reduced in trials by more frequent dose reductions and exclusion of patients with ongoing infections. Selective eligibility criteria and closer monitoring of trial patients may be responsible for limited generalizability of trial data to clinical practice.

A comparison of opioid-involved fatalities captured in the National Poison Data System to data derived from US death certificate literal text.

PURPOSE: The purpose of the study is to describe and compare the number and characteristics of opioid-involved fatal cases captured in the National Poison Data System (NPDS) and in US death certificates. METHODS: NPDS, which collects data on all calls to US poison control centers, and Drug-Involved Mortality (DIM), which combines information from literal text of US death certificates and National Vital Statistics Systems, were queried for opioid-involved fatal cases from 2010 to 2015. Characteristics of the two case series were compared. RESULTS: DIM contained 154 016 opioid-involved overdose deaths, and NPDS contained 2524 fatal opioid exposures, a ratio of 61:1. The number of opioid deaths remained stable in NPDS but increased in DIM over the 6-year period. On average, deaths involving opioids with higher mean dosage strength (in morphine milligram equivalents) per unit among dispensed prescriptions were more likely to be captured in DIM relative to NPDS, as compared with those with a lower mean dosage strength per unit. The increase in fentanyl-related deaths seen in DIM since 2013 was not observed in NPDS. CONCLUSIONS: NPDS is a valuable drug safety surveillance resource due to its timeliness and drug specificity. However, it captures only a small fraction of opioid-involved fatal poisonings, and comparisons with data derived from death certificate literal text indicate that caution is warranted in making inferences about opioid-involved fatality trends over time or comparisons across opioids.

First-Trimester Exposure to Gadolinium-based Contrast Agents: A Utilization Study of 4.6 Million U.S. Pregnancies.

BackgroundThe safety of gadolinium-based contrast agent (GBCA) exposure during pregnancy has not been established, and the use of GBCAs during pregnancy is not recommended unless it is essential to the health of the woman or fetus.PurposeTo examine the prevalence of GBCA exposure in a large sample of pregnancies resulting in a live birth.Materials and MethodsThe Sentinel Distributed Database was used to retrospectively identify U.S. pregnancies that resulted in live births between 2006 and 2017 from 16 data partners. The main outcome was the prevalence of MRI procedures with and without GBCAs, sorted by anatomic location and trimester, among pregnant and matched comparator women.ResultsAmong 4 692 744 pregnancies resulting in a live birth, we identified 6879 exposures to GBCAs in 5457 pregnancies, representing one contrast-enhanced MRI examination per 860 pregnancies (0.12% of all pregnancies). Most contrast-enhanced MRI examinations were performed in the head (n = 3499), although pelvic and abdominal MRI constituted 22.3% (n = 1536) of all contrast-enhanced MRI examinations during pregnancy. The majority (70.2%) of GBCA exposures occurred during the first trimester, with a 4.3-fold greater prevalence compared with that in the second trimester and a 5.1-fold greater prevalence compared with that in the third trimester.ConclusionThis study identified higher rates of gadolinium-based contrast agent (GBCA) exposure during the first few weeks of pregnancy compared with the later weeks of pregnancy, suggesting inadvertent exposure to GBCAs might occur before pregnancy is recognized.© RSNA, 2019Online supplemental material is available for this article.See also the editorial by Kallmes and Watson in this issue.

Trends in oral and vaginally administered estrogen use among US women 50 years of age or older with commercial health insurance.

OBJECTIVE: We aimed to provide information through 2015 about use in the United States of estrogen products, including orally and vaginally administered products, in postmenopausal women. METHODS: We used prescription claims for US commercial health insurance to calculate, in women 50 years of age or older (n = 12,007,364), the age-standardized and age-specific annual prevalence of estrogen use, by formulation and route of administration, for the period 2006 through 2015. RESULTS: The age-standardized annual prevalence of a prescription claim for oral estrogens declined over time, from 83 per 1,000 women in 2007 to 42 per 1,000 women in 2015. The age-standardized annual prevalence of a prescription claim for vaginal estrogens peaked in 2011, at 42 per 1,000 women, before declining to 35 per 1,000 women in 2015. The age-standardized annual prevalence of a prescription claim for transdermal estrogen fluctuated between 15 and 17 per 1,000 women. In age groups under 65 years of age, annual prevalence rates for vaginal rings and inserts declined over the latter half of the study period. CONCLUSIONS: Analyses of US prescription claims data between 2006 and 2015 for women 50 years of age or older showed declining use of oral estrogen generally and vaginally administered estrogen products specifically in age groups less than 65 years of age.

Patterns of NSAIDs Use and Their Association with Other Analgesic Use in CKD.

BACKGROUND AND OBJECTIVES: Avoiding nonsteroidal anti-inflammatory drugs is important for safe CKD care. This study examined nonsteroidal anti-inflammatory drug use patterns and their association with other analgesic use in CKD. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: The Chronic Renal Insufficiency Cohort Study is an observational cohort study that enrolled 3939 adults ages 21-74 years old with CKD between 2003 and 2008 using age-based eGFR inclusion criteria. Annual visits between June of 2003 and December of 2011 were organized into 15,917 visit-pairs (with an antecedent and subsequent visit) for 3872 participants with medication information. Demographics, kidney function, and clinical factors were ascertained along with report of nonsteroidal anti-inflammatory drug or other analgesic use in the prior 30 days. RESULTS: In our study, 24% of participants reported nonsteroidal anti-inflammatory drug use at baseline or at least one follow-up study visit. Having a 10 ml/min per 1.73 m2 higher eGFR level at an antecedent visit was associated with higher odds of starting nonsteroidal anti-inflammatory drugs at a subsequent visit (odds ratio, 1.44; 95% confidence interval, 1.34 to 1.56). Seeing a nephrologist at the antecedent visit was associated with lower odds of starting or staying on nonsteroidal anti-inflammatory drugs at a subsequent visit (odds ratio, 0.70; 95% confidence interval, 0.56 to 0.87 and odds ratio, 0.61; 95% confidence interval, 0.46 to 0.81, respectively). Starting and stopping nonsteroidal anti-inflammatory drugs were both associated with higher odds of increasing the number of other analgesics (odds ratio, 1.52; 95% confidence interval, 1.25 to 1.85 and odds ratio, 1.78; 95% confidence interval, 1.39 to 2.28, respectively) and higher odds of increasing the number of opioid analgesics specifically (odds ratio, 1.92; 95% confidence interval, 1.48 to 2.48 and odds ratio, 1.46; 95% confidence interval, 1.04 to 2.03, respectively). CONCLUSIONS: Nonsteroidal anti-inflammatory drug use is common among patients with CKD but less so among those with worse kidney function or those who see a nephrologist. Initiation or discontinuation of nonsteroidal anti-inflammatory drugs is often associated with supplementation with or replacement by, respectively, other analgesics, including opioids, which introduces possible drug-related problems when taking these alternative analgesics.

Specialist visits and initiation of cancer-directed treatment among a large cohort of men diagnosed with prostate cancer.

BACKGROUND: The urologist generally manages the treatment of men immediately following the diagnosis of prostate cancer (PCa). The role of other physician specialists in this setting is less clear. We investigated whether involvement of other physician specialty types immediately following diagnosis affects initiation of cancer-directed treatment. METHODS: This is a retrospective cohort study using linked cancer registry and claims data from 1999 to 2009, excluding stage I/II PCa. A physician visit index (PVI) served as the exposure variable and captured the "dispersion of care" across specialties, that is, the extent to which patient care involved different types of physician specialties such as the primary care physician, urologist, or oncologist. The PVI score was calculated using visits occurring within 30 days postdiagnosis. This score was dichotomized to measure "low PVI" (reflects seeing multiple specialist types). Competing risk Cox proportional hazard regression models provided adjusted hazard ratios (HR) for treatment receipt associated with a low PVI. RESULTS: The sample included 33,380 patients: 4,910 metastatic and 28,470 nonmetastatic groups. The top 3 visit categories within 30 days postdiagnosis were "urologist only" (59%) and "urologist plus primary care physician" (21%) and no visit (6%). The median time to receipt of cancer-directed treatment was 51 days. Overall, 29% of individuals in the metastatic group and 38% in the nonmetastatic group were categorized as low PVI. A low PVI was associated with a shorter time to treatment receipt in the nonmetastatic (HR = 1.12 [95% CI: 1.09-1.15]) and metastatic (HR = 1.21 [95% CI: 1.14-1.29]) groups. CONCLUSIONS: Multispecialist involvement in the weeks following diagnosis is associated with a shorter time to treatment initiation, highlighting a role for exposure to different specialty types in the weeks following an initial diagnosis of PCa. This study provides important baseline data for future studies examining coordination of care across cancer and noncancer specialists.

Measurement of skeletal related events in SEER-Medicare: a comparison of claims-based methods.

BACKGROUND: Skeletal related events (SREs) are common in men with metastatic prostate cancer (mPC). Various methods have been used to identify SREs from claims data. The objective of this study was to provide a framework for measuring SREs from claims and compare SRE prevalence and cumulative incidence estimates based on alternative approaches in men with mPC. METHODS: Several claims-based approaches for identifying SREs were developed and applied to data for men aged [greater than or equal to] 66 years newly diagnosed with mPC between 2000 and 2009 in the SEER-Medicare datasets and followed through 2010 or until censoring. Post-diagnosis SREs were identified using claims that indicated spinal cord compression (SCC), pathologic fracture (PF), surgery to bone (BS), or radiation (suggestive of bone palliative radiation, RAD). To measure SRE prevalence, two SRE definitions were created: 'base case' (most commonly used in the literature) and 'alternative' in which different claims were used to identify each type of SRE. To measure cumulative incidence, we used the 'base case' definition and applied three periods in which claims were clustered to episodes: 14-, 21-, and 28-day windows. RESULTS: Among 8997 mPC patients, 46 % experienced an SRE according to the 'base case' definition and 43 % patients experienced an SRE according to the 'alternative' definition. Varying the code definition from 'base case' to 'alternative' resulted in an 8 % increase in the overall SRE prevalence. Using the 21-day window, a total of 12,930 SRE episodes were observed during follow up. Varying the window length from 21 to 28 days resulted in an 8 % decrease in SRE cumulative incidence (RAD: 10 %, PF: 8 %, SCC: 6 %, BS: 0.2 %). CONCLUSIONS: SRE prevalence was affected by the codes used, with PF being most impacted. The overall SRE cumulative incidence was affected by the window length used, with RAD being most affected. These results underscore the importance of the baseline definitions used to study claims data when attempting to understand relevant clinical events such as SREs in the real world setting.

Self-reported Medication Adherence and Adverse Patient Safety Events in CKD.

BACKGROUND: Promoting medication adherence is a recognized challenge for prescribers. In this study, we examine whether lower medication adherence is associated with adverse safety events in individuals with decreased estimated glomerular filtration rates (eGFRs). STUDY DESIGN: Cross-sectional baseline analysis of prospective cohort. SETTING & PARTICIPANTS: Baseline analysis of the Safe Kidney Care (SKC) Cohort Study, a prospective study of individuals with eGFRs<60 mL/min/1.73 m(2) intended to assess the incidence of disease-specific safety events. Kidney transplant recipients were excluded. PREDICTOR: Self-reported medication adherence based on responses to 3 questions ascertaining degree of medication regimen adherence. OUTCOMES: Adverse safety events were self-reported at baseline (class I events), such as hypoglycemia or fall thought to be related to a medication, or detected incidentally during the baseline visit (class II events), for example, hypotension or hyperkalemia. Potential drug-related problems (DRPs) were determined by analyzing participants' medications with respect to dosing guidelines based on their screening eGFRs at the time of medication reporting. MEASUREMENTS: Relationship between medication adherence and disease-specific patient safety events. RESULTS: Of 293 SKC participants, 154 (53%) were classified as having lower medication adherence. After multivariable adjustment, lower medication adherence was significantly associated with a class I or II safety event (prevalence ratio [PR], 1.21; 95% CI, 1.04-1.41) and potential DRPs (PR, 1.29; 95% CI, 1.02-1.63). Lower medication adherence was also significantly associated with multiple (≥2) class I events (PR, 1.71; 95% CI, 1.18-2.49), multiple class I or II events (PR, 1.35; 95% CI, 1.04-1.76), and multiple potential DRPs (PR, 2.11; 95% CI, 1.08-2.69) compared with those with higher medication adherence. LIMITATIONS: Use of self-reported medication adherence rather than pharmacy records. Clinical relevance of detected safety events is unclear. CONCLUSIONS: Lower medication adherence is associated with adverse safety events in individuals with eGFRs<60 mL/min/1.73 m(2).

Chronic pain and analgesic use in CKD: implications for patient safety.

BACKGROUND AND OBJECTIVES: Chronic pain in predialysis CKD is not fully understood. This study examined chronic pain in CKD and its relationship with analgesic usage. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: Data include baseline visits from 308 patients with CKD enrolled between 2011 and 2013 in the Safe Kidney Care cohort study in Baltimore, Maryland. The Wong-Baker FACES Pain Rating Scale measured chronic pain severity. Analgesic prescriptions and over-the-counter purchases were recorded up to 30 days before visits, and were classified as a drug-related problem (DRP) based on an analgesic's nephrotoxicity and dose appropriateness at participants' eGFR. Participants were sorted by pain frequency and severity and categorized into ordinal groups. Analgesic use and the rate of analgesics with a DRP were reported across pain groups. Multivariate regression determined the factors associated with chronic pain and assessed the relationship between chronic pain and analgesic usage. RESULTS: There were 187 (60.7%) participants who reported chronic pain. Factors associated with pain severity included arthritis, taking ≥12 medications, and lower physical function. Use of nonsteroidal anti-inflammatory drugs was reported by seven participants (5.8%) with no chronic pain. Mild and severe chronic pain were associated with analgesics with a DRP, with odds ratios of 3.04 (95% confidence interval [95% CI], 1.12 to 8.29) and 5.46 (95% CI, 1.85 to 16.10), respectively. The adjusted rate of analgesics with a DRP per participant increased from the group with none to severe chronic pain, with rates of 0.07 (95% CI, 0.04 to 0.13), 0.12 (95% CI, 0.07 to 0.20) and 0.16 (95% CI, 0.09 to 0.27), respectively. CONCLUSIONS: Chronic pain is common in CKD with a significant relationship between the severity of pain and both proper and improper analgesic usage. Screening for chronic pain may help in understanding the role of DRPs in the delivery of safe CKD care.

Patient-reported and actionable safety events in CKD.

Patients with CKD are at high risk for adverse safety events because of the complexity of their care and impaired renal function. Using data from our observational study of predialysis patients with CKD enrolled in the Safe Kidney Care study, we estimated the baseline frequency of adverse safety events and determined to what extent these events co-occur. We examined patient-reported adverse safety incidents (class I) and actionable safety findings (class II), conditioned on participant use of drugs that might cause such an event, and we used association analysis as a data-mining technique to identify co-occurrences of these events. Of 267 participants, 185 (69.3%) had at least one class I or II event, 102 (38.2%) had more than one event, and 48 (18.0%) had at least one event from both classes. The adjusted conditional rates of class I and class II events ranged from 2.9 to 57.6 per 100 patients and from 2.2 to 8.3 per 100 patients, respectively. The most common conditional class I and II events were patient-reported hypoglycemia and hyperkalemia (serum potassium>5.5 mEq/L), respectively. Reporting of hypoglycemia (in patients with diabetes) and falling or severe dizziness (in patients without diabetes) were most frequently paired with other adverse safety events. We conclude that adverse safety events are common and varied in CKD, with frequent association between disparate events. Further work is needed to define the CKD "safety phenotype" and identify patients at highest risk for adverse safety events.

Worksite interventions: improving lifestyle habits among Latin American adults.

CONTEXT: Worksite-based interventions have been shown to result consistently in significant improvements in weight- and health-related outcomes among the working adult population; however, applicability and effectiveness of studies has often been limited by inadequate reporting of age and ethnicity. This study aimed to examine work-based interventions among Latinos in the U.S. and Latin America. EVIDENCE ACQUISITION: Data were abstracted (and analyzed) from "parent" study Guide to Obesity Prevention in Latin American and the U.S. (GOL), between January 2010 and December 2011. Manuscripts from 1965 to 2010 were evaluated according to inclusion criteria for interventions, including a sample population of at least 50% Latinos or results stratified by ethnicity, at least one obesity-related outcome measure evaluated before and after intervention, and worksite setting and comparison of an intervention group to a non-intervention group (including pre-post designs). EVIDENCE SYNTHESIS: Of 105 interventions abstracted, five were work-based interventions. The average participant age was 45 years, with an average of 58% women. Four of the five interventions had a pre-post study design that received a fair execution score and lowest design-suitability score, whereas one group RCT intervention had the greatest design suitability and good execution. For two studies, Cohen's d effect sizes ranged from 0.09 to 0.603. Effect sizes could not be calculated for three of the interventions. Three interventions found significant outcomes for BMI, three for weight, two for waist circumference, and one for waist-to-hip ratio. CONCLUSIONS: Few studies have focused on work-based interventions specifically aimed at Latinos. This review identified promising strategies for reducing obesity in the workplace.