Prescription Fills Research Articles

Pharmacy Closures and Anticonvulsant Medication Prescription Fills

This study examines the relationship between pharmacy closures and anticonvulsant prescription fills and number of days supplied.

The role of prescribed controlled substance acquisition as potential triggers of opioid overdose: A case-crossover study

Background: The role of prescribed opioids and benzodiazepines as risk factors for opioid overdose are well established, however, their role as potential ‘triggers’ of opioid overdose has not been formally investigated. Objective: The objective of this study was to evaluate the temporal relationship between controlled substance acquisition and opioid overdose utilizing a case-crossover design. Methods: This study utilized Arkansas statewide data between 2014 and 2020. Prescription Drug Monitoring Program (PDMP) data were used to assess controlled substance acquisition and fatal and non-fatal opioid overdose were assessed using linked death certificate, inpatient discharge, and emergency department (ED) data. All persons residing in Arkansas who experienced an opioid overdose or had ≥ 1 Arkansas PDMP prescription fill(s) were included. Controlled substance characteristics were described in the 7 days prior to overdose and compared to the controlled substance characteristics in 11 weekly (7-day) control windows prior to overdose. Binary controlled substance variables indicating presence or absence of: any controlled substance, opioid, benzodiazepine, stimulant, sedative, carisoprodol, opioid and benzodiazepine, and opioid and benzodiazepine and carisoprodol were created. Additionally, total morphine milliequivalents were calculated for each time window. Conditional logistic regression models were estimated and adjusted odds ratios for each controlled substance characteristic after accounting for other controlled substance, and prior overdose, and clinical characteristics derived from ED and inpatient data are reported. Results: A total of 2,818,135 individuals with ≥1 Arkansas PDMP record(s) (45.10 % male; 39.94 mean age) were included, of which 28,670 (1.02 %) experienced ≥1 opioid overdose. There was a significant association between opioid overdose and the acquisition of a controlled substance (OR=1.785; p < 0.001), opioid (OR=1.992; p < 0.001), benzodiazepine (OR=1.379; p < 0.001), carisoprodol (OR=1.744; p < 0.001), opioid and benzodiazepine (OR=2.203; p < 0.001), and opioid and benzodiazepine and carisoprodol (OR=2.503; p < 0.001), in the 7 days prior to an opioid overdose event. Conclusion: Controlled substance prescription acquisition, particularly opioids in combination with carisoprodol and/or benzodiazepines, are potential triggers of opioid overdose.

Cannabis

Objective: Almost half of U.S. states have passed recreational cannabis laws as of May 2024. While considerable evidence to date indicates cannabis may be a substitute for prescription opioids in the treatment of pain, it remains unclear if patients are treating pain with cannabis alone or concomitantly with other medications. Method: Using data from a national sample of commercially insured adults, we examine the effect of recreational cannabis legalization (through two sequential policies) on prescribing of opioids, NSAIDS, and other pain medications by implementing synthetic control estimations and constructing case-study level counterfactuals for the years 2007-2020. Results: Overall, we find recreational cannabis legalization is associated with a decrease in opioid fills among commercially insured adults in the U.S., and we find evidence of a compositional change in prescriptions of pain medications more broadly. Specifically, we find marginally significant increases in prescribing of non-opioid pain medications after recreational cannabis becomes legal in some states. Once recreational cannabis dispensaries open, we find statistically significant decreases in the rate of opioid prescriptions (13% reduction from baseline, p &lt; .05) and marginally significant decreases in the average daily supply of opioids (6.3% decrease, p &lt; .10) and number of opioid prescriptions per patient (3.5% decrease, p &lt; .10). Conclusions: These results suggest that substitution of cannabis for traditional pain medications increases as the availability of recreational cannabis increases. There appears to be a small shift once recreational cannabis becomes legal, but we see stronger results once users can purchase cannabis at recreational dispensaries. The decrease in opioids and marginal increase in non-opioid pain medication may reflect patients substituting opioids with cannabis and non-opioid pain medications, either separately or concomitantly. Reductions in opioid prescription fills stemming from recreational cannabis legalization may prevent exposure to opioids in patients with pain and lead to decreases in the number of new opioid users, rates of opioid use disorder, and related harms.

Benzodiazepine Utilization in Ischemic Stroke Survivors: Analyzing Initial Excess Supply and Longitudinal Trends.

Benzodiazepines are commonly prescribed for post-acute ischemic stroke for anxiety, insomnia, and agitation. While guidelines discourage use in those aged ≥65 years, little is known about prescription patterns at the national level. We analyzed a 20% sample of US Medicare claims from April 1, 2013, to September 30, 2021. We selected beneficiaries aged ≥65 years discharged alive following an acute ischemic stroke who had traditional Medicare coverage and 6 months' prior enrollment in Parts A (hospital insurance), B (Medical insurance), and D (drug coverage). We excluded those with prior benzodiazepine prescriptions, self-discharges, or discharge to skilled nursing facilities. We examined demographics, comorbidities, first prescription days' supply, cumulative incidences of benzodiazepine first prescription fills within 90 days after discharge, and geographic and yearly trends. We included 126 050 beneficiaries with a mean age of 78 years (SD, 8); 54% were female and 82% were White. Within 90 days, 6127 (4.9%) initiated a benzodiazepine. Among new prescriptions, lorazepam (40%) and alprazolam (33%) were the most prescribed. Most (76%) of first fills had a day's supply over 7 days and 55% between 15 and 30 days. Female initiation rates were higher (5.5% [95% CI, 5.3-5.7]) than male initiation rates (3.8% [95% CI, 3.6%-3.9%]). Rates were highest in the southeast (5.1% [95% CI, 4.8%-5.3%]) and lowest in the midwest (4.0% [95% CI, 3.8%-4.3%]), with a modest nationwide initiation decline from 2013 to 2021 (cumulative incidence difference, 1.6%). Despite a gradual decline in benzodiazepine initiation from 2013 to 2021, we noted excessive supplies in prescriptions post-acute ischemic stroke discharge, underscoring the need for improved policies.

A real-world study of persistence and adherence to prescription medications in patients with chronic idiopathic constipation in the United States.

At present, 4 prescription therapies have been approved by the US Food and Drug Administration for the treatment of chronic idiopathic constipation (CIC) in adults. To compare persistence with and adherence to prucalopride vs 3 other prescription medications for CIC in a US population. This retrospective, observational cohort study used data from the IBM MarketScan Commercial Claims and Encounters and Medicare Supplemental Databases (January 2015-June 2020). Inclusion criteria were patients (aged ≥18 years) with at least 1 prescription fill for prucalopride, lubiprostone, linaclotide, or plecanatide on or after April 2, 2019 (commercial availability of prucalopride), and at least 1 constipation-related diagnosis code. Persistence was assessed by time to discontinuation, and adherence was assessed by the proportion of days covered (PDC) and the proportion of patients who achieved PDC of at least 80%. Adjusted hazard ratios (HRs) for discontinuation and odds ratios for adherence were calculated. A total of 14,700 patients (mean age = 48.3 years; female = 81.9%) were included (prucalopride, n = 675; lubiprostone, n = 1,591; linaclotide, n = 11,105; plecanatide, n = 1,329). After adjusting for confounding factors, the HRs for discontinuation were significantly higher for all comparator medications compared with prucalopride after 2 months (HR [95% CI]: lubiprostone, 1.70 [1.48-1.95]; linaclotide, 1.25 [1.10-1.41]; plecanatide, 1.31 [1.13-1.51], all P < 0.001). The unadjusted mean (SD) PDC was 0.53 (0.32) with prucalopride compared with 0.41 (0.31); P less than 0.001 with lubiprostone, 0.48 (0.31), P less than 0.05 with linaclotide, and 0.48 (0.29), P = 0.98 with plecanatide. The comparator medications were all associated with lower odds of achieving PDC of at least 80% relative to prucalopride (odds ratio [95% CI]: lubiprostone, 0.52 [0.40-0.69], P < 0.001; linaclotide, 0.73 [0.58-0.93], P = 0.009; plecanatide, 0.70 [0.53-0.93], P = 0.015). The findings of this study indicate that prucalopride has higher treatment persistence and adherence compared with other CIC prescription medications. This research represents the first instance of a real-world claims study showcasing such outcomes.

Real-world impact of acupuncture on analgesics and healthcare resource utilization in breast cancer survivors with pain

BackgroundThis study evaluated the real-world impact of acupuncture on analgesics and healthcare resource utilization among breast cancer survivors.MethodsFrom a United States (US) commercial claims database (25% random sample of IQVIA PharMetrics® Plus for Academics), we selected 18–63 years old malignant breast cancer survivors experiencing pain and ≥ 1 year removed from cancer diagnosis. Using the difference-in-difference technique, annualized changes in analgesics [prevalence, rates of short-term (< 30-day supply) and long-term (≥ 30-day supply) prescription fills] and healthcare resource utilization (healthcare costs, hospitalizations, and emergency department visits) were compared between acupuncture-treated and non-treated patients.ResultsAmong 495 (3%) acupuncture-treated patients (median age: 55 years, stage 4: 12%, average 2.5 years post cancer diagnosis), most had commercial health insurance (92%) and experiencing musculoskeletal pain (98%). Twenty-seven percent were receiving antidepressants and 3% completed ≥ 2 long-term prescription fills of opioids. Prevalence of opioid usage reduced from 29 to 19% (P < 0.001) and NSAID usage reduced from 21 to 14% (P = 0.001) post-acupuncture. The relative prevalence of opioid and NSAID use decreased by 20% (P < 0.05) and 19% (P = 0.07), respectively, in the acupuncture-treated group compared to non-treated patients (n = 16,129). However, the reductions were not statistically significant after adjustment for confounding. Patients receiving acupuncture for pain (n = 264, 53%) were found with a relative decrease by 47% and 49% (both P < 0.05) in short-term opioid and NSAID fills compared to those treated for other conditions. High-utilization patients (≥ 10 acupuncture sessions, n = 178, 36%) were observed with a significant reduction in total healthcare costs (P < 0.001) unlike low-utilization patients.ConclusionsAlthough adjusted results did not show that patients receiving acupuncture had better outcomes than non-treated patients, exploratory analyses revealed that patients treated specifically for pain used fewer analgesics and those with high acupuncture utilization incurred lower healthcare costs. Further studies are required to examine acupuncture effectiveness in real-world settings.

Evaluation of a drug deactivation system for safe disposal of opioids after ambulatory surgery

BackgroundPrescription opioids are commonly prescribed postoperatively and increase the risk of diversion or misuse when left unused and accessible. Despite awareness of the risks associated with unused opioids, harm reduction strategies like safe storage and drug take-back events may be limited by inconvenience and patient-specific barriers to access. ObjectiveTo evaluate a quality improvement project designed to facilitate at-home disposal of unused opioids after day surgery. MethodsAn observational, prospective quality improvement project was conducted in patients undergoing elective outpatient surgery at Newton-Wellesley Hospital from December 2019 to June 2020. Upon discharge, eligible patients received a Deterra drug disposal packet which deactivates unused medication. Follow-up surveys assessed packet use and reasons for nonuse 1 to 2 weeks after surgery. ResultsOne hundred six participants received a disposal packet and responded to the survey. Among the 67 respondents with unused medication, 30% used the packet. Women were more likely to use the packet than men (predicted probability 30.2% vs. 10.4%, P = 0.033), and patients aged 18–25 were more likely to use the packet than those aged 26–40 (40.0% vs. 9.5%, P = 0.049). The most common reasons for packet nonuse included procrastination, holding onto prescriptions in case of future pain, and waiting to dispose of multiple medications. ConclusionThe majority of patients surveyed had unused opioids 1 to 2 weeks after surgery, and approximately 1 in 3 patients with unused doses utilized the disposal packet. Common reasons for nonuse included procrastination and concerns about needing future medication for pain. Going forward, safe drug disposal efforts may emphasize improved patient education, partial prescription fill options, or alert systems to remind patients to safely dispose of unused medication.

Association of Pre–Lung Transplant Opioid Use With Posttransplant Opioid Use and Outcomes

BackgroundPreoperative opioid use (OU) is a strong risk factor for poor postoperative outcomes in other surgical populations but has not been explored in lung transplant (LT) recipients nationally. MethodsThe study identified adult (aged ≥18 years) US lung transplant (LT) recipients from 2011 to 2021 in the Scientific Registry of Transplant Recipients with prescription data through a pharmacy data set. Posttransplantation ventilatory support, infection, and mortality by pretransplantation OU (prescription fill ≤6 months before transplantation) were compared using multivariable regression. ResultsAmong 17,285 LT recipients, 17.9% had pretransplantation OU. The odds of posttransplantation opioid prescription fill were 3.18-fold higher 0 to 6 months after transplantation (adjusted odds ratio [aOR], 3.18; 95% CI, 2.91-3.47; P < .001) and 14.29-fold higher 6 to 12 months after transplantation (aOR, 14.29; 95% CI, 12.61-16.19; P < .001) among LT recipients with vs without pretransplantation OU. Pretransplantation OU was associated with 16% higher posttransplantation mortality (adjusted hazard ratio, 1.16; 95% CI, 1.09-1.25; P < .001) and a higher risk of ventilator use >48 hours (aOR, 1.14; 95% CI, 1.04-1.25; P = .006). ConclusionsPretransplantation OU was the strongest independent risk factor for posttransplantation OU and was associated with greater morbidity and mortality. Reducing pretransplantation and posttransplantation OU could benefit LT recipients and should be explored.

Abstract P121: Weight Loss is not a Major Mediator of GLP1-Receptor Agonists’ Risk Reduction in Heart Failure with Preserved Ejection Fraction

The cardioprotective effects of GLP1-Receptor Agonists (GLP1-RA) and SGLT2 Inhibitors (SGLT2i) are incompletely understood. We compared these two drug classes and their effect on HFpEF hospitalizations and examined the hypothesis that weight loss is a significant mediator of these agents’ HFpEF protection. Methods: Using the VA Informatics and Computing Infrastructure, we generated a national cohort of veterans with type 2 diabetes on metformin who initiated SGLT2i, GLP1-RA or Insulin Glargine for the first time from 1/1/18 to 12/31/21. The index date was the date of first outpatient prescription fill. We defined 6-month weight change as change from baseline weight (closest outpatient value prior to index date within 1 year) to 6 months (all averaged outpatient weights from index date to 6 months). Those with prior prescriptions for the study drugs from 1/1/08 and missing baseline or 6-month weights were excluded. HFpEF hospitalizations were defined by a previously-validated natural language processing algorithm using inpatient HF diagnostic codes and cardiac imaging dated closest to and within 180 days of the new code with ejection fraction ≥50%. Follow up was through 3/31/23. We performed mediation analyses to separate the direct effects (independent of 6-month weight change) and indirect effects (mediated through 6-month weight change) of the drug classes on time to HFpEF hospitalizations, adjusted for demographics, comorbidities, baseline labs and other medications, and diabetes severity. Results: Overall, 161,405 veterans initiated one of the study drugs and 105,439 had weight data. After excluding 760 veterans with HFpEF hospitalizations in the first 6 months, 104,679 were included in the analysis. Baseline demographics included mean age 64±11 years, 94% male and 75% white. Baseline BMI was 33±6 kg/m 2 . There were 1494 HFpEF hospitalizations/ 256,101 years of follow-up. Figure 1 shows weight over time by study drug class. Table 1 shows mediation analyses results. Conclusion: GLP1-RA lowered the risk of HFpEF hospitalizations versus the active comparator insulin glargine. This cardioprotection was not mediated by weight loss. GLP1-RA and SGLT2i show equivalent risk reduction. These agents' direct cardiac and vascular effects deserve further exploration.

Healthcare resource use and costs associated with the misdiagnosis of migraine.

To compare healthcare resource utilization and healthcare costs in patients with migraine with or without a history of misdiagnosis. Despite the high prevalence of migraine, migraine is commonly misdiagnosed. The healthcare resource use and cost burden of a misdiagnosis is unknown. This retrospective cohort study identified adults with an incident migraine diagnosis from the Merative™ Marketscan® Commercial and Medicare Supplemental Databases between June 2018 and 2019. Patients with a diagnosis of commonly considered misdiagnoses (headache, sinusitis, or cervical pain) before their migraine diagnosis were classified as the "misdiagnosed cohort." Patients in the misdiagnosed cohort were potentially misdiagnosed, then eventually received a correct diagnosis. Patients without a history of commonly considered misdiagnoses prior to their migraine diagnosis were classified as the "correctly diagnosed cohort." Healthcare resource utilization and healthcare costs were assessed in the period before migraine diagnosis and compared between the cohorts. Outcomes were reported as per patient per month and compared with incidence rate ratios. A total of 29,147 patients comprised the correctly diagnosed cohort and 3841 patients comprised the misdiagnosed cohort and met the inclusion criteria. Patients in the misdiagnosed cohort had statistically significantly higher rates of inpatient admissions (0.02 vs. 0.01, incidence rate ratio [IRR] 1.61, 95% confidence interval [CI] 1.47-1.74), emergency department visits (0.10 vs. 0.05; IRR 1.89, 95% CI 1.79-1.99), neurologist visits (0.12 vs. 0.02; IRR 5.95, 95% CI 5.40-6.57), non-neurologist outpatient visits (2.64 vs. 1.58; IRR 1.67, 95% CI 1.62-1.72) and prescription fills (2.82 vs. 1.84; IRR 1.53, 95% CI 1.48-1.58) compared to correctly diagnosed patients. Misdiagnosed patients had statistically significantly higher rates of healthcare cost accrual for inpatient admissions ($1362 vs. $518; IRR 2.62, 95% CI 2.50-2.75), emergency department visits ($222 vs. $98; IRR 2.27, 95% CI 2.18-2.36), neurologist visits ($42 vs. $9; IRR 4.39, 95% CI 4.00-4.79), non-neurologist outpatient visits ($1327 vs. $641; IRR 2.07, 95% CI 1.91-2.24), and prescription fills ($305 vs. $215; IRR 1.41, 95% CI 1.18-1.70) compared to correctly diagnosed patients. Patients with migraine who have a history of misdiagnoses have higher rates of healthcare resource utilization and cost accrual versus those without such history.

Medications for Alcohol Use Disorder: Rates and Predictors of Prescription Order and Fill in Outpatient Settings.

Alcohol use disorders (AUD) are prevalent and responsible for substantial morbidity and mortality; yet efficacious treatments are underused. Previous studies have identified demographic and clinical predictors of medication fills, yet these studies typically do not include patients who were prescribed a medication but did not fill it. To examine rates of and factors associated with prescription order and prescription fill for medications for AUD (MAUD) among individuals diagnosed with AUD in outpatient settings. In a cross-sectional analysis, we used multivariate logistic regression to identify factors associated with prescription order and fill. We used data from the Optum Labs Data Warehouse that linked 2016-2021 de-identified claims and electronic health record (EHR) data, allowing us to observe prescription orders and whether they were filled. We identified 14,674 patients aged ≥ 18 who had an index outpatient encounter with an AUD diagnosis in the EHR. We computed the proportion for whom a MAUD prescription was ordered within 1year of index visit, and for whom one was filled within 30days of the order. 5.8% of the sample had a MAUD prescription order within 1year of their index visit. Among those with an order, 87% filled their MAUD prescription within 30days of receipt (i.e., 5.1% of full sample). After multivariable adjustment, receipt of a MAUD prescription order was more likely for patients who were female (adjusted odds ratio (aOR) [95%CI] = 1.44 [1.24-1.67]), orhad moderate or severe AUD (1.74 [1.50-2.01]). Patients receiving an order were more likely to fill it if they had a comorbid mental disorder (1.64 [1.09-2.49]). The low rate of prescription orders was notable. Low use of MAUD appears to result chiefly from prescription order decisions, rather than from prescription fill decisions made by patients.

Disparities in time to treatment with oral antimyeloma medications

This retrospective cohort study used Taussig Cancer Center’s Myeloma Patient Registry to identify adults with multiple myeloma diagnosed between January 2017-December 2021. Electronic health records data captured time from diagnosis to initial prescription fill for oral antimyeloma medications and initiation of facility administered or oral antimyeloma treatment. We identified 720 patients with a mean age at diagnosis of 67 years ±11; 55% were male, 77% White, 22% Black, 1% other races, covered by private insurance (36%), traditional Medicare (29%), Medicare Advantage (25%), and Medicaid (8.3%). Over a third of patients (37%) resided in an area in the most disadvantaged area deprivation index (ADI) quartile. The median available follow-up was 765 days. Seventy-five percent of the cohort filled an oral antimyeloma medication prescription (excluding corticosteroids), with a median time to fill of 28 days (IQR, 15–61). In the multivariable Cox regression model, Black race (vs. White, adjusted hazard ratio [aHR], 0.61, 95% CI, 0.42–0.87), older age at diagnosis (aHR per 1 year, 0.97, 95% CI, 0.95–0.98), diagnosis during an inpatient admission (aHR, 0.63, 95% CI, 0.43–0.92), and estimated glomerular filtration rate ≤29 ml/min/1.73 m2 (vs. ≥60, aHR, 0.46, 95% CI, 0.29–0.73) were negatively associated with prescription fill for oral antimyeloma medication at 30 days, while insurance type and ADI were not significant predictors.

Prescribing of extended release buprenorphine injection for Medicaid beneficiaries, 2018-2022.

Extended release buprenorphine injection (INJ-BUP) has been available in the United States since 2018. INJ-BUP has the potential to positively impact opioid use disorder (OUD) treatment outcomes by providing additional treatment options . As one of the largest payers of OUD treatment in the US, Medicaid coverage is important for access and uptake of INJ-BUP. Uptake of INJ-BUP among Medicaid beneficiaries has not been described since 2019 and variation in uptake by state has not previously been explored. We aimed to measure prescribing of INJ-BUP for Medicaid beneficiaries since 2018, nationwide and by state. We analyzed State Drug Utilization Data from 2017 to 2022 and calculated the number of prescription fills for INJ-BUP and oral buprenorphine paid by Medicaid. To compare across states, we calculated the number of prescription fills per 100 Medicaid beneficiaries treated for OUD using data from Transformed Medicaid Statistical Information System Substance Use Disorder (T-MSIS SUD) Data Books. Data sources are publicly available. The number of prescription fills for INJ-BUP paid by Medicaid increased from 4322 (0.1% of all buprenorphine prescription fills) in 2018 to 186 861 (2.0%) in 2022. Each year the increase in fills exceeded the prior year change, indicating accelerating uptake. There was notable variability across states. The number of extended release buprenorphine injection prescriptions among US Medicaid beneficiaries treated for opioid use disorder increased from over 4000 prescriptions in 2018 to over 185 000 in 2022 but uptake is much less than observed in other countries over shorter time periods.

Risk of Perinatal and Maternal Morbidity and Mortality Among Pregnant Women With Epilepsy

Maternal epilepsy is associated with adverse pregnancy and neonatal outcomes. A better understanding of this condition and the associated risk of mortality and morbidity at the time of delivery could help reduce adverse outcomes. To determine the risk of severe maternal and perinatal morbidity and mortality among women with epilepsy. This prospective population-based register study in Denmark, Finland, Iceland, Norway, and Sweden took place between January 1, 1996, and December 31, 2017. Data analysis was performed from August 2022 to November 2023. Participants included all singleton births at 22 weeks' gestation or longer. Births with missing or invalid information on birth weight or gestational length were excluded. The study team identified 4 511 267 deliveries, of which 4 475 984 were to women without epilepsy and 35 283 to mothers with epilepsy. Maternal epilepsy diagnosis recorded before childbirth. Prenatal exposure to antiseizure medication (ASM), defined as any maternal prescription fills from conception to childbirth, was also examined. Composite severe maternal morbidity and mortality occurring in pregnancy or within 42 days postpartum and composite severe neonatal morbidity (eg, neonatal convulsions) and perinatal mortality (ie, stillbirths and deaths) during the first 28 days of life. Multivariable generalized estimating equations with logit-link were used to obtain adjusted odds ratios (aORs) and 95% CIs. The mean (SD) age at delivery for women in the epilepsy cohort was 29.9 (5.3) years. The rate of composite severe maternal morbidity and mortality was also higher in women with epilepsy compared with those without epilepsy (36.9 vs 25.4 per 1000 deliveries). Women with epilepsy also had a significantly higher risk of death (0.23 deaths per 1000 deliveries) compared with women without epilepsy (0.05 deaths per 1000 deliveries) with an aOR of 3.86 (95% CI, 1.48-8.10). In particular, maternal epilepsy was associated with increased odds of severe preeclampsia, embolism, disseminated intravascular coagulation or shock, cerebrovascular events, and severe mental health conditions. Fetuses and infants of women with epilepsy were at elevated odds of mortality (aOR, 1.20; 95% CI, 1.05-1.38) and severe neonatal morbidity (aOR, 1.48; 95% CI, 1.40-1.56). In analyses restricted to women with epilepsy, women exposed to ASM compared with those unexposed had higher odds of severe maternal morbidity (aOR ,1.24; 95% CI, 1.10-1.48) and their neonates had an increased odd of mortality and severe morbidity (aOR, 1.37; 95% CI, 1.23-1.52). This multinational study shows that women with epilepsy were at considerably higher risk of severe maternal and perinatal outcomes and increased risk of death during pregnancy and postpartum. Maternal epilepsy and maternal use of ASM were associated with increased maternal morbidity and perinatal mortality and morbidity.

Prescription Fills for Semaglutide Products by Payment Method

Prescription Fills for Semaglutide Products by Payment Method

Pregnancy and Infant Outcomes After Prenatal Exposure to Golimumab in Denmark, Finland, and Sweden 2006-2019.

To present the main findings of a post-authorization safety study assessing pregnancy and infant outcomes after prenatal golimumab exposure in a real-world setting. This observational population-based cohort study included data from pregnancies ending in 2006-2018 (Finland) or 2019 (Denmark, Sweden). Infants born to women with rheumatic diseases or ulcerative colitis diagnoses were identified. Based on prescription fills from 90 days prior to pregnancy until delivery, infants were assigned to one of the four drug-exposure cohorts: golimumab, other anti-TNF biologics, other biologics, and nonbiologic systemic therapy, and the general population. Prevalence of adverse pregnancy outcomes, mortality, diagnoses of major congenital anomalies (MCA), and inpatient infections in the infants' first year of life were assessed. Odds ratios and 95% CIs were calculated for MCA and infection. Among 134 infants in the golimumab cohort, none were stillborn or died in the first year of life. MCA were diagnosed in 4.5% of the infants in the golimumab cohort, versus 6.8%, 10.9%, 5.5%, and 4.6% in the other anti-TNF biologics, other biologics, nonbiologic systemic therapy and general population cohorts, respectively. Inpatient infections were diagnosed in 11% of golimumab-exposed infants, compared with 9%-11% of infants in the other cohorts. Unadjusted and selected adjusted comparisons showed no association between prenatal golimumab exposure and MCA or infection compared with the other exposure cohorts or general population. The number of infants with prenatal golimumab exposure was low, but results are reassuringly consistent with the evidence available for other anti-TNF biologics. Continued monitoring is needed.

Schizophrenia, antipsychotic treatment adherence and driver responsibility for motor vehicle crash: a population-based retrospective study in British Columbia, Canada

ObjectiveTo examine the relationship between schizophrenia, antipsychotic medication adherence and driver responsibility for motor vehicle crash.DesignRetrospective observational cohort study using 20 years of population-based administrative health and driving data.SettingBritish Columbia,...

Real-world comparison of health care costs of venetoclax-obinutuzumab vs Bruton's tyrosine kinase inhibitor use among US Medicare beneficiaries with chronic lymphocytic leukemia in the frontline setting.

Bruton's tyrosine kinase inhibitors (BTKis) and the BCL-2 inhibitor venetoclax in combination with obinutuzumab (VEN-O) are both recommended as frontline therapy in chronic lymphocytic leukemia (CLL). However, VEN-O is a 12-month fixed-duration therapy generating durable remissions whereas BTKis are continuous treat-to-progression treatments. To examine costs before and after the fixed-duration treatment period for VEN-O relative to that observed for BTKis in a national sample of older US adults with CLL in the frontline setting. This retrospective analysis used Medicare Parts A, B, and D claims from 2016 to 2021. Fee-for-service Medicare beneficiaries aged 66 years or older initiating frontline CLL treatment with VEN-O or a BTKi treatment between June 1, 2019, and June 30, 2020 (index date = first prescription fill date), were included in the sample. Mean cost measures were captured for both groups over 2 fixed time periods calculated from the index date: Month 0 to 12 (proxy for VEN-O on-treatment period) and Month 13 to 18 (proxy for VEN-O off-treatment period). A difference-in-difference approach was used. Multivariate generalized linear models estimated changes in adjusted mean monthly costs during Month 0 to 12 vs Month 13 to 18, for the VEN-O group relative to the BTKi group. The final sample contained 193 beneficiaries treated with VEN-O and 1,577 beneficiaries treated with BTKis. Risk-adjusted all-cause monthly total costs were similar for VEN-O patients ($13,887) and BTKi patients ($14,492) between Month 0 and 12. Moreover, during Month 13 to 18, the mean monthly all-cause total costs declined by 67% for VEN-O ($13,887 to $4,462) but only by 10% for BTKi ($14,492 to $13,051). Hence, the relative reduction in costs across the 2 periods was significantly larger for VEN-O (-$9,425) vs BTKi (-$1,441) patients (ie, difference in difference = -$7,984; P < 0.001). Similar patterns were observed for CLL-related costs, with the substantially larger reductions in CLL-related total monthly costs (-$9,880 VEN-O vs -$1,753 BTKi; P < 0.001) for the VEN-O group primarily driven by the larger reduction in CLL-related monthly prescription costs (-$9,437 VEN-O vs -$2,020 BTKi; P < 0.001). This real-world study of older adults with CLL found a large reduction in monthly Medicare costs in the 6 months after completion of the fixed-duration treatment period of VEN-O, largely driven by the reduction in CLL-related prescription drug costs. A similar decline in costs was not observed among those treated with BTKis. Our study highlights the substantial economic benefits of fixed-duration VEN-O relative to treat-to-progression therapies like BTKis in the first-line CLL setting.

New persistent opioid use following robotic-assisted, laparoscopic and open surgery inguinal hernia repair

IntroductionPost-operative prescription opioid use is a known risk factor for persistent opioid use. Despite the increased utilization of robotic-assisted surgery (RAS) for inguinal hernia repair (IHR), little is known whether this minimally invasive approach results in less opioid consumption. In this study, we compare long-term opioid use between RAS versus laparoscopic (Lap) versus open surgery for IHR.MethodsA retrospective cohort study of opioid-naïve patients who underwent outpatient primary IHR was conducted using the Merative™ MarketScan® (Previously IBM MarketScan®) Databases between 2016 and 2020. Patients not continuously enrolled 180 days before/after surgery, who had malignancy, pre-existing chronic pain, opioid dependency, or invalid prescription fill information were excluded. Among patients exposed to opioids peri-operatively, we assessed long-term opioid use as any opioid prescription fill within 90 to 180 days post-surgery. Secondary outcomes were controlled substance schedule II/III opioid fill, and high-dose opioid fill defined as > 50 morphine milligram equivalent per day. An Inverse-probability of treatment weighted logistic regression was used to compare outcomes between groups with p-value of < 0.05 considered statistically significant.ResultsA total of 41,271 patients were identified (2070 (5.0%) RAS, 16,704 (40.5%) Lap, and 22,497 (54.5%) open surgery). RAS was associated with less likelihood of prescription fills for any opioid (OR 0.78, 95% CI 0.60 to 0.98 versus Lap; OR 0.67, 95% CI 0.52 to 0.85 versus open), and schedule II/III opioid (OR 0.74, 95% CI 0.56 to 0.96 versus Lap; OR 0.68, 95% CI 0.51 to 0.88 versus open), but comparable high-dose opioid fill (OR 0.95, 95% CI 0.54 to 1.55 versus Lap; OR 0.96, 95% CI 0.56 to 1.52 versus open). Lap and open surgery had no significant difference.ConclusionIn this cohort of patients derived from a national commercial claims dataset, patients undergoing RAS had a decreased risk of long-term opioid use compared to laparoscopic and open surgery patients undergoing IHR.

Reductions in renin-angiotensin system inhibitors following hospitalization for heart failure.

Limited data are available that evaluate the efficacy of renin-angiotensin system inhibitor (RASI) dose-reduction in older adults with heart failure with reduced ejection fraction following a heart failure hospitalization. We examined a 5% random sample of Medicare beneficiaries with prescription coverage who were discharged to home following a hospitalization for heart failure with reduced ejection fraction between 1 January 2007 and 30 June 2018 and were treated with RASI prior to hospitalization. We classified patients into three mutually exclusive groups based on RASI dosage before (prescription fills up to 90days prior to) and after a hospitalization (prescription fills up to 365days that were most proximate to the discharge date as possible)-same/increased dose, dose-reduction, and discontinuation. We examined associations between RASI prescribing patterns and outcomes (mortality and all-cause readmission at 30days and 1year) using Cox proportional hazards models. Among 12794 unique older adults, 36.8% experienced a RASI reduction following their hospitalization for HFrEF-15.7% had a dose-reduction and 21.1% had a discontinuation. Neither dose-reduction nor discontinuation was associated with 30-day mortality. Discontinuation was associated 1-year mortality, 30-day all-cause readmission, and 1-year all-cause readmission, whereas dose-reduction was not. RASI dose-reduction occurs in 1 out of 7 HF hospitalizations. In contrast to RASI discontinuation, RASI dose-reduction was not associated with adverse short or long-term outcomes. These findings indicate that RASI dose-reduction is preferred over RASI discontinuation in selected situations where RASI reduction is needed.