Refill Patterns Research Articles

Concordance between pharmacy dispensing and electronic monitoring data of direct oral anticoagulants - A secondary analysis of the MAAESTRO study

BackgroundDirect oral anticoagulants are the preferred treatment for stroke patients with atrial fibrillation. Pharmacy dispensing data represent a practical method to identify suboptimal medication adherence. ObjectiveThis study investigates whether pharmacy dispensing data are indicative of real-life adherence behavior, using data from 130 patients in the MAAESTRO study (2018–2022) in Basel, Switzerland. MethodsThis secondary data analysis of the MAAESTRO study (Dietrich, 2024) included patients with electronic monitoring (EM) and dispensing data for 12 months. Patients with at least two refills were included in the analysis.We categorized refill series into three adherence patterns using the Delta T method (Baumgartner, 2022): all refills on time, erratic refills, end-gaps ≥10 days. EM-adherence was assessed through “taking adherence” and “missing days” (24h without intake). We analyzed: i) all dispensing data (“all refills”); ii) all data independently of the MAAESTRO phase (“all phases”); iii) the last two dispensing data (“last”), and iv) EM data from the MAAESTRO phase that match the date of the last refill (“matched”). Associations between refill patterns and adherence were examined using Spearman correlation and Fisher's exact test. ResultsData analyzed from 50 patients (mean age 76.4 ± 9.1 years, 56.0 % male) included 252 refills with a median of 4 refills per patient. Refill patterns were: all refills on time (40.0 %), erratic refills (36.0 %), and end-gaps >10 days (24.0 %). Mean taking adherence was 89.3 ± 13.7 %. EM data revealed missing days in 82.0 % of patients, with 61.0 % having irregular refill patterns. Matched taking adherence was moderately associated with Delta T over all refills (p = 0.034) and the last refill (p = 0.013). ConclusionsDispensing data processed with the Delta T method correlate moderately with EM data. The Delta T value for the last two refills shows promise for estimating irregular adherence, suggesting potential for targeted interventions in pharmacy practice.

P2Y12 Inhibitors Refill Gap Predicts Death in Medicare Beneficiaries on Chronic Dialysis

Oral P2Y12 inhibitors (P2Y12-I) are commonly used antiplatelet drugs in patients with end-stage kidney disease (ESKD) on chronic dialysis. Although gaps in prescription refills are quite common in patients with ESKD, it remains unclear whether P2Y12-I prescription refill patterns are associated with adverse clinical outcomes. We used the United States Renal Data System (USRDS) registry for patients with ESKD to capture new P2Y12-I prescriptions from 2011 to 2015. The primary exposure was prescription refill patterns and the primary outcome was all-cause death. Among the 31,243 patients with new P2Y12-I prescription, median age was 64 years; 54% were male; and 39% were Caucasian, 37% African American, and 18% Hispanic. We observed 3 P2Y12-I refill patterns as follows: continuous users (45.1%), noncontinuous users (3.6%), and users with≥30 days refill gap (51.4%). Prescription refill pattern with≥30 days refill gap (vs. continuous use) was associated with all-cause death (adjusted hazard ratio [HR]: 1.18; 95% confidence interval [CI]: 1.13-1.23). Age and race were the most important risk factors associated with prescription refill pattern. African Americans (vs. Caucasians) were more likely to demonstrate≥30 days refill gap, (adjusted odds ratio [OR]: 1.43; 95% CI: 1.36-1.51). In addition, younger patients (vs. older) were more likely to demonstrate≥30 day refill gap (adjusted OR/decade: 0.9; 95% CI: 0.89-0.92). Nonadherence to P2Y12-I prescriptions is quite common, and disproportionately affects minorities. Younger individuals with ESKD are independently associated with a higher risk of death. The odds of having a refill gap are decreasing for older patients who are more compliant than younger patients. Future studies should investigate whether phenotyping subgroups of patients with ESKD based on prescription refill patterns can help in improving adverse clinical outcomes.

Utilization, Expenditure, and Treatment Patterns Associated With Calcitonin Gene-Related Peptide Monoclonal Antibodies Reimbursed Subject to a Managed Access Protocol in Ireland

ObjectivesCalcitonin gene-related peptide monoclonal antibodies (CGRP mAbs) are novel high-cost treatments for the prevention of migraine. This study presents data on utilization, expenditure, and treatment patterns with CGRP mAbs available under a managed access protocol in Ireland, to a cohort of treatment refractory patients (failed 3 or more previous treatments) with chronic migraine. MethodsData were extracted from the Primary Care Reimbursement Service High Tech claims database and special drug request online system and analyzed using Microsoft Excel and SAS. Treatment persistence was evaluated by refill patterns, and adherence was evaluated using the proportion of days covered method. Expenditure data were extracted directly from the database. ResultsBetween September 1, 2021 and April 30, 2023, 1517 applications for reimbursement approval for a CGRP mAb were received; 1458 (96.1%) were approved for reimbursement. Total expenditure on CGRP mAbs in year 1 (September 1, 2021 to August 31, 2022) was €3.2 million. The majority of patients initiated treatment with fremanezumab (60.8%) or erenumab (37.1%). Almost 90% of patients were considered adherent, and treatment persistence was high, with more than 75% of patients receiving more than 12 months of treatment in our 18-month study time frame. ConclusionsThis study demonstrates the importance of active health technology management, after reimbursement, in enabling cost-effective use of high-cost treatments while providing budget certainty for the healthcare payer. High levels of adherence and persistence suggest that treatment is successfully targeted in situations which unmet clinical need is greatest.

Routine health data describe adherence and persistence patterns for oral diabetes medication for a virtual cohort in the Khayelitsha sub-district of Cape Town, South Africa.

Type 2 diabetes mellitus (T2DM) is managed with combined lifestyle modifications and antidiabetic drugs, but people on treatment often fail to reach glycaemic control. Adherence is important for achieving optimal glycaemic control, and management of diabetes with drugs is a lifelong process, so understanding adherence through analysis of longitudinal medications data is important. Using retrospective routine health data and metformin dispensing records as a proxy for medication use, we describe longitudinal persistence and adherence to oral diabetes medication in a virtual cohort of 10541 people with diabetes (PLWD) in Khayelitsha subdistrict, Cape Town. Adherence was measured in 120-day sliding windows over two years and used to estimate metformin adherence trajectories. Multinomial logistic regression identified factors influencing these trajectories. Analysis of pharmacy dispensing records showed varying medication refill patterns: while some PLWD refilled prescriptions consistently, others had treatment gaps with periods of non-persistence and multiple treatment episodes-from one to five per individual across two years. There was a general trend of decreasing adherence over time across all sliding windows in the two-year period, with only 25% of the study population achieved medication adherence (> = 80% adherence) after two years. Four adherence trajectories; 'low adherence gradual decline (A), 'high adherence rapid decline' (B), 'low adherence gradual increase (C) and 'adherent' (D) were identified. Only trajectory D represented participants who were adherent at treatment start and remained adherent after two years. Taking HIV antiretroviral treatment before or concurrently with diabetes treatment and taking metformin in combination with sulphonylurea and/or insulin were associated with the long-term adherence (trajectory D). Routine data shows real life medication implementation patterns which might not be seen under controlled study conditions. This study illustrates the utility of these data in describing longitudinal adherence patterns at both an individual and population level.

Evaluating patient adherence and persistence to first-line tyrosine-kinase inhibitors for metastatic renal cell carcinoma.

e18856 Background: Tyrosine kinase inhibitors (TKIs) have been approved in treating advanced renal cell carcinoma (RCC) since 2005. More recently, combination therapy with an immune checkpoint inhibitor (ICI) and a kinase inhibitor (TKI) is considered standard of care in the first-line setting of metastatic RCC. While oral neoplastic therapies such as TKIs promote patient autonomy, these therapies pose unique challenges including ensuring patients take medications as indicated (i.e., adherence) and for the recommended duration (i.e., persistence). Persistence and adherence data from prescription dispensing and refill patterns are important to health care providers, systems, and payers in order to assess and/or optimize the therapeutic goal(s) of anticancer treatment. Therefore, we sought to explore adherence and persistence of first-line TKIs when used in combination with ICIs for treating metastatic RCC. Methods: Adults with metastatic RCC who received at least two prescriptions for FDA-approved TKIs used in combination with ICIs between April 29, 2019 and August 29,2022 were identified at University of California Irvine Medical Center. Adherence was determined by calculating the Medication Possession Ratio (MPR) and the Proportion of Days Covered (PDC). TKI persistence was evaluated using the Kaplan-Meier method. Also evaluated was the average length of therapy. We examined additional dispensing and refill pattern indicators, including the monthly total number of prescriptions filled. Results: A total of 66 individuals and 849 prescriptions were discovered. The mean duration of treatment for all patients was 237 days, and the median duration was 201 days (Table 1). The mean persistence was 303 days, whereas the median persistence was 233 days. Over 180 days, the median MPR was 83%, whereas the median PDC was 72%. The median variable PDC was 86%, while the median variable MPR was 105%. September was historically the month with the lowest prescription counts (16 +/- 2). Conclusions: We observed a significantly longer median duration of oral TKIs therapy (201 days) in an academic medical center than the national average ( < 100 days). This analysis of real-world data reveals that lengthier treatment durations for TKI+ICI combinations are feasible. Further research is warranted to identify possible factors such as clinical monitoring or adverse effect management that may prolong adherence and persistence. [Table: see text]

(038) Adherence Patterns And Costs For Flibanserin: A Single Practice Experience

Abstract Introduction Flibanserin is a partial serotonin agonist/antagonist and has been approved for use in premenopausal females with hypoactive sexual desire disorder (HSDD). This medication has been used off-label in males and postmenopausal females in the management of low libido. There is a paucity of data on prescribing patterns for both on and off-label use. Objective This study aims to evaluate costs and refill patterns for flibanserin and to determine if adherence was affected by insurance coverage or off-label use. Methods This was a retrospective review of online pharmacy records for patients from one sexual medicine practice that were prescribed flibanserin. De-identified patient information was collected and included age, gender, menopause status, refill information, and out-of-pocket cost. All prescriptions for premenopausal and perimenopausal females met criteria for on-label use and all prescriptions for men and postmenopausal females were considered off-label. Results Data was available from 109 patients. Forty-nine premenopausal/perimenopausal women were included in the on-label group and 60 patients were assigned to the off-label group as they were males (n=31) or postmenopausal females (n=29). Twelve percent of patients never filled their prescription, 28% filled it once, and 60% filled it ≥2 times. There was no significant difference in the percentage of patients with 0, 1 and ≥2 prescriptions filled between the on and off-label groups (12%, 24%, 63% vs. 12%, 32%, 57%). Out-of-pocket cost of flibanserin without insurance coverage was $99 for a 30-day supply or $199 for a 90-day supply. Twenty-one percent of patients had insurance coverage and their cost was $0 or $20 for a 30-day supply. The average out-of-pocket cost was $67 per 30-day supply (SD=$34). There was no significant difference in the percentage of patients with 0, 1 and ≥2 prescriptions filled between patients with and without insurance coverage (0%, 24%, 76% vs. 3%, 34%, 64%). The percentage of patients with insurance coverage did not significantly differ between those with on and off-label prescriptions (25% vs. 19%). Conclusions This study is the first to explore medication adherence and cost of flibanserin. Sixty percent of patients filled ≥2 prescriptions and refill rates were not affected by off-label use or insurance coverage. Only 21% of patients had insurance coverage for the medication. The limitations of the study include a small sample size from one clinic. The results of this study will help clinicians to recognize costs and adherence with on and off-label use of flibanserin. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Sprout Pharmaceuticals, Absorption Pharmaceuticals.

PATTERNS OF SHORT-ACTING BETA2-AGONIST REFILLS IN US ADULTS AND ADOLESCENTS WITH ASTHMA ACROSS THE DISEASE SEVERITY SPECTRUM

PATTERNS OF SHORT-ACTING BETA2-AGONIST REFILLS IN US ADULTS AND ADOLESCENTS WITH ASTHMA ACROSS THE DISEASE SEVERITY SPECTRUM

Tramadol Versus Codeine in Hand Surgery.

IntroductionTramadol and codeine are both commonly prescribed in the setting of surgery or injury to the upper extremity. Despite their comparable strength in terms of opioid receptor affinity, the drugs differ pharmacologically and thus are not completely interchangeable.MethodsThis study analyzes all prescriptions for codeine and tramadol by a group of hand surgeons over a one-year period and tests the central hypothesis that the prescribing and refill patterns of these two drugs would be similar.ResultsDespite similar prescription amounts in terms of morphine equivalents, patients receiving tramadol required prescription refills at a significantly higher amount than those receiving codeine, and these individuals tended to be older. Additionally, patients treated nonoperatively were prescribed significantly more tramadol than those treated surgically.ConclusionOur findings suggest that codeine and tramadol are not equivalent in managing upper extremity pain. Further study is needed to articulate the situations in which physicians and patients are better served by tramadol versus codeine.

Similar antiseizure medication refill characteristics in Hispanic and White pediatric patients

AimPrevious work has shown that children of Hispanic ethnicity have reduced likelihood to achieve seizure remission, but it was unknown why. The purpose of this study was to evaluate antiseizure medicine (ASM) refill characteristics, comparing Hispanic and non-Hispanic White pediatric patients. MethodsThis was a retrospective population-based study in children between ages 6 months and 15 years. Epilepsy outcome was categorized as seizure free, treatment failure, or undetermined. ASM refill characteristics were determined from an insurance provider. Results247 patients were identified: 52 (21 %) were treatment failure; 181 (73 %) were seizure free; and 14 (5.7 %) were undetermined. ASM refill rates were similar in Hispanic and White patients (38.2, 32.1, respectively). Hispanic and White patients had similar numbers of different ASMs prescribed (2.1 and 2.4). There was not a significant difference in proportion of days covered between Hispanic and White patients (0.99 and 0.95). InterpretationWe found no differences between pediatric Hispanic and White epilepsy patients, for number of ASM refills, the number of ASMs prescribed, the choice of ASMs, the proportion of days covered, or the lateness of refills. Our findings suggest that the observation of reduced likelihood to achieve seizure remission in pediatric Hispanic patients is not associated with ASM refill patterns.

Opioid consumption following orthopedic shoulder surgery: a retrospective analysis.

Prescription opioid misuse has become an epidemic in the United States and is a leading cause of death in Americans. Postoperative opioid prescriptions are a significant contributor to the opioid epidemic, with orthopedic surgeons being the third highest prescribers of opioid prescriptions among physicians across all specialties. Our aim was to retrospectively evaluate overall opioid consumption patterns following surgical treatment for shoulder pathology and recommend evidence-based guidelines for standardized postoperative opioid prescriptions. We conducted a retrospective chart review of patients who underwent shoulder arthroscopy or arthroplasty from a single shoulder/elbow fellowship-trained surgeon (principal investigator). Patient and surgery characteristics were summarized for the entire sample and further stratified by surgery type. Total opioid consumption at the time of the first postoperative visit and refill patterns were compared between each surgery group. Opioid consumption was analyzed in morphine milligram equivalents (MMEs) and is reported in the equivalent number of 5-mg oxycodone tablets. A total of 119 patients were included in our analysis. The average age was 58 ± 13 years, and 59% of patients were male. Rotator cuff repair was the most frequent surgery (n = 52), followed by arthroplasty (n = 35) and arthroscopy (n = 28). On average, the patients in the study used 82.5 ± 233 MME units, equivalent to 11 ± 31.067 tablets of 5-mg oxycodone. Sixteen percent of patients did not use any opioids. There was no significant difference in opioid consumption or refills across surgery type. In the bivariate analysis for the entire sample, age was the only predictor that was statistically significantly associated with the amount of opioid consumption. In the multivariable model for patient demographics, significant predictors of opioid consumption were age, gender, and pain scores. In the multivariate analysis by surgery type, significant predictors of higher opioid consumption were age, gender, pain score, and surgery performed on the dominant side. On the basis of the consumption patterns observed in our patient cohort, we recommend prescribing 112.5 MME (15 tablets of 5-mg oxycodone) for arthroscopic shoulder procedures, and 75 MME (10 tablets of 5-mg oxycodone) for shoulder arthroplasties.

Reduction of Opioid Quantities at Discharge After TKA Did Not Increase the Risk of Manipulation Under Anesthesia: An Institutional Experience

BackgroundIn response to the opioid epidemic, our arthroplasty service sequentially reduced the opioid quantities prescribed at primary total knee arthroplasty (TKA) discharge. However, its effect on postdischarge pain control and rehabilitation is unknown. We assessed if this decrease was associated with an increase in the risk of manipulation under anesthesia (MUA). MethodsWe retrospectively reviewed 8799 patients undergoing primary TKA from 2016 to 2019 at a single institution. There were two institution-wide reductions in the amount of opioids prescribed at discharge; therefore, we divided patients into 3 periods (P1, P2, and P3). The mean discharge morphine milligram equivalents (MMEs) went from 900 MMEs to ~525 MMEs to ~320 MMEs in P1, P2, and P3, respectively. We analyzed MUA rates and if lower discharge MMEs was a risk factor for MUA in a multivariate model. We also compared refill patterns (rates, number, refill MMEs, and total MMEs) between MUA and non-MUA patients. ResultsThe rate of MUA did not increase with reduced discharged opioids (5.5% in P1, 5.8% in P2, and 4.6% in P3, P = .74). In a multivariate analysis, discharge MMEs of <450 was not a significant risk factor for MUA. However, a diagnosis of chronic pain (OR = 1.86, P < .001) and an elevated body mass index (OR = 1.02 per unit increase, P < .001) were significant risk factors. We did not find significant differences in any opioid prescription refill patterns in MUA and non-MUA patients. ConclusionSerial reductions in discharge MMEs after primary TKA did not significantly affect the rate of MUA, a surrogate marker for pain control and the rehabilitative process.

Reduction of Opioids Prescribed Upon Discharge After Total Knee Arthroplasty Significantly Reduces Consumption: A Prospective Study Comparing Two States

BackgroundOpioids prescribed for acute pain after total knee arthroplasty (TKA) play a contributing role in the number of opioid pills in circulation. At the height of an opioid epidemic in the United States, opioids are increasingly diverted, misused, and abused. Therefore, many states have enacted narcotic regulations in an attempt to curb opioid diversion and misuse. The purpose of this study is to evaluate the effect of stricter state prescribing regulations on opioid consumption following TKA. MethodsIn total, 165 opioid-naive patients undergoing primary unilateral TKA at a single institution with a standardized perioperative pain protocol were reviewed. Seventy-one patients (group 1) resided in a state with strict opioid regulations that limit the initial number of pills dispensed and refills, whereas 92 patients (group 2) resided in another state without quantity and refill regulations. Patient demographics were similar between the 2 groups. Mean age was 64 and mean body mass index was 32 kg/m2. Opioid consumption, quantity, and refill patterns were collected for 6 weeks following surgery. ResultsThe average oral morphine equivalents consumed during the 6 weeks postsurgery were significantly lower in group 1 at 446.3 ± 266.3 mg (range 10-992) compared to group 2 at 622.6 ± 313.7 mg (range 20-1416) (P < .001). The average oral morphine equivalent corresponds to 60 tablets of 5 mg oxycodone per patient in group 1 vs 84 tablets per patient in group 2. Fifty-nine (83%) patients in group 1 had stopped taking opioids within 6 weeks of surgery compared to 59 (64%) in group 2 (P = .04). ConclusionBased on our results, the institution of state regulations aimed at decreasing the quantity and refills of postoperative opioids led patients to consume less opioids following TKA. Many patients are prescribed more opioids than they require which increases their consumption and can increase the risk for diversion, addiction, and misuse. Level of EvidenceLevel III; retrospective comparative cohort study.

Epinephrine autoinjector prescription patterns for severe anaphylactic patients in Japan: A retrospective analysis of health insurance claims data

BackgroundCurrent guidelines recommend that any patient who has experienced anaphylaxis should be prescribed one or more epinephrine autoinjectors (EAI) for immediate self-treatment. However, the etiology of anaphylaxis and prescription patterns of EAI have not been widely examined in Japan. MethodsThis was a retrospective cohort study using a large Japanese claims database (JMDC, Tokyo, Japan). We included patients with severe anaphylaxis who received epinephrine in a hospital or outpatient clinic from 2011 to 2016. We extracted patients who were prescribed EAIs and examined the annual trend of EAI prescription rates and refill patterns. ResultsWe identified 1255 eligible patients. Among them, 361 patients (28.8%) were prescribed EAIs within 30 days after their initial severe anaphylactic episode. In patients who were prescribed EAIs, 65.9% were prescribed EAIs from the same facility in which initial treatment was given for severe anaphylaxis. The prescription rates of EAI significantly increased from 11.1% in 2011 to 30.9% in 2016. Among patients with initial EAI prescriptions, 97.3% refilled their EAI prescriptions at least once and 40.5% refilled their prescriptions annually during the 3 year follow up period. ConclusionsEAI prescription rates were relatively low in patients who experienced severe anaphylaxis in Japan. Physicians should prescribe EAIs to all patients who were treated for anaphylaxis under their care and avoid delegating the responsibility of prescribing EAIs to other facilities. Initial prescription of EAIs can result in improved regular refill and dissemination practices.

Development of an algorithm to detect methotrexate wrong frequency error using computerized health care data.

We validated an algorithm to detect frequency errors in computerized healthcare data and estimated the incidence of these errors in an integrated healthcare system. We applied Sentinel System analytic tools on the electronic health records of Kaiser Permanente, Northern California, January 1, 2010, through May 30, 2015,to identify rheumatoid arthritis (RA) patients with new use of methotrexate (365-day baseline period). We identified potential methotrexate frequency errors using ICD-9 code 995.20 (adverse drug event), Current Procedural Terminology (CPT) code 96409 for injection of leucovorin and prescription refill patterns. We performed chart review to confirm the frequency errors, assessed performance for detecting frequency errors, and estimated the incidence of chart-confirmed errors. The study included 24,529 methotrexate dispensings among 3,668 RA patients. Among these, 722 (3%) had one dispensing and 23,807 (97.1%) had ≥2 dispensings during 1-year follow-up period. We flagged 653 (2.7%) with a potential medication error (46 with one dispensing and 607 with ≥2 dispensings). We sampled 94 for chart review, and confirmed three methotrexate errors. All three confirmed frequency errors involved a first methotrexate dispensing followed by injected rescue therapy, leucovorin, (positive predictive value, 60%; 95% confidence interval [CI], 15-95%). No potential errors were found among patients with ≥2 dispensings. We estimated the frequency error incidence among one methotrexate dispensing to be 0.4% (95%CI, 0.1% to 1.2%). Rescue therapy is a specific indicator of methotrexate overdose among first methotrexate dispensings. This method is generalizable to other medications with serious adverse events treated with antidotes.

Beyond Adherence Thresholds: A Simulation Study of the Optimal Classification of Longitudinal Adherence Trajectories From Medication Refill Histories.

Background: The description of adherence based on medication refill histories relies on the estimation of continuous medication availability (CMA) during an observation period. Thresholds to distinguish adherence from non-adherence typically refer to an aggregated value across the entire observation period, disregarding differences in adherence over time. Sliding windows to divide the observation period into smaller portions, estimating adherence for these increments, and classify individuals with similar trajectories into clusters can retain this temporal information. Optimal methods to estimate adherence trajectories to identify underlying patterns have not yet been established. This simulation study aimed to provide guidance for future studies by analyzing the effect of different longitudinal adherence estimates, sliding window parameters, and sample characteristics on the performance of a longitudinal clustering algorithm.Methods: We generated samples of 250–25,000 individuals with one of six longitudinal refill patterns over a 2-year period. We used two longitudinal CMA estimates (LCMA1 and LCMA2) and their dichotomized variants (with a threshold of 80%) to create adherence trajectories. LCMA1 assumes full adherence until the supply ends while LCMA2 assumes constant adherence between refills. We assessed scenarios with different LCMA estimates and sliding window parameters for 350 independent samples. Individual trajectories were clustered with kml, an implementation of k-means for longitudinal data in R. We compared performance between the four LCMA estimates using the adjusted Rand Index (cARI).Results: Cluster analysis with LCMA2 outperformed other estimates in overall performance, correct identification of groups, and classification accuracy, irrespective of sliding window parameters. Pairwise comparison between LCMA estimates showed a relative cARI-advantage of 0.12–0.22 (p < 0.001) for LCMA2. Sample size did not affect overall performance.Conclusion: The choice of LCMA estimate and sliding window parameters has a major impact on the performance of a clustering algorithm to identify distinct longitudinal adherence trajectories. We recommend (a) to assume constant adherence between refills, (b) to avoid dichotomization based on a threshold, and (c) to explore optimal sliding windows parameters in simulation studies or selecting shorter non-overlapping windows for the identification of different adherence patterns from medication refill data.

033 Don't Stop in the Name of Love

Assess patient refill patterns in the treatment of vulvar and vaginal atrophy (VVA). Analysis of compliance metrics of prescriptions for 858,311 women who filled at least one prescription for VVA treatment was longitudinally tracked utilizing LifeLinkTM Longitudal LRx Prescription Data from IMS Health. The study period spanned 34 months (2013-2016), divided into the following: 1) cohort selection period (4-month period to select women who had either a new-to-therapy or continued prescription); 2) look-back period (18-month period preceding the prescription; 3) look-forward (observation) period (12-month period following the prescription used to evaluate adherence). Approximately 33% of women were new to therapy; the majority used Premarin® and Estrace® creams. While vaginal creams are the leaders for new prescriptions, ∼ 60% of women filled only their initial prescription. Women using vaginal ring, tablet, or the oral SERM (Osphena®) were likely to fill more than one prescription (65% vs ∼40% creams). The trend for multiple fills (5+) followed a similar pattern: ∼7% of women using vaginal estrogen creams, ∼22% of women using a vaginal ring or tablet, and 31% using the oral SERM. Overall, the average number of refills for all products is low, ranging from 2.0 (creams) to 3.9 for the SERM. Average time on therapy was: 369 days for creams, 560 and 604 days for tablet and ring, respectively, and 417 days for the SERM.

Adoption of Sacubitril/Valsartan for the Management of Patients With Heart Failure.

The US Food and Drug Administration approved the use of sacubitril/valsartan in patients with heart failure with reduced ejection fraction in July 2015. We aimed to assess the adoption and prescription drug costs of sacubitril/valsartan in its first 18 months after Food and Drug Administration approval. Using a large US insurance database, we identified privately insured and Medicare Advantage beneficiaries who filled a first prescription for sacubitril/valsartan between July 1, 2015, and December 31, 2016. We compared them to patients treated with an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker. Outcomes included adoption, prescription drug costs, and 180-day adherence, defined as a proportion of days covered ≥80%. A total of 2244 patients initiated sacubitril/valsartan. Although the number of users increased over time, the proportion of heart failure with reduced ejection fraction patients taking sacubitril/valsartan remained low (<3%). Patients prescribed sacubitril/valsartan were younger, more often male, with less comorbidity than those taking an angiotensin-converting enzyme inhibitor/angiotensin receptor blocker. Although a majority of prescription costs were covered by the health plan (mean, $328.37; median, $362.44 per 30-day prescription), out-of-pocket costs were still high (mean, $71.16; median, $40.27). By comparison, median out-of-pocket costs were $2 to $3 for lisinopril, losartan, carvedilol, and spironolactone. Overall, 59.1% of patients were adherent to sacubitril/valsartan. Refill patterns suggested that nearly half of nonadherent patients discontinued sacubitril/valsartan within 180 days of starting. Adoption of sacubitril/valsartan after Food and Drug Administration approval has been slow and may be associated with the high cost.

Medication Management Patterns Among Medicare Beneficiaries With COPD Initiating Nebulized Arformoterol Treatment

SESSION TITLE: COPD: Lessons for the Real-World Management of Disease SESSION TYPE: Original Investigation Slide PRESENTED ON: Tuesday, October 31, 2017 at 02:45 PM - 04:15 PM PURPOSE: Global guidelines recommend the use of long-acting bronchodilators (LABD) as maintenance therapy for patients with COPD. However, little is known about the treatment and management patterns associated with initiating nebulized LABD therapy such as arformoterol. This study examined these treatment patterns among Medicare beneficiaries with COPD prior to and after initiating arformoterol. METHODS: Medicare administrative data from 2010-2014 were used to identify beneficiaries with ≥2 COPD outpatient visits within 30 days apart or with ≥1 COPD-related hospitalization(s) (i.e., ICD-9 codes 491.xx, 492.xx, and 496). Patients continuously enrolled in Medicare parts A, B, and D for the entire study period that initiated arformoterol were identified after excluding deaths. The use of the four following COPD medication classes 90-days prior to (pre-period) and after initiation of arformoterol (post-period) were examined: (a) LAMA/LABA: long-acting muscarinic antagonists (LAMAs) and inhaled long-acting beta2 agonists (LABAs) including fixed dose LABA+inhaled corticosteroid (ICS) combinations; (b) ICS/Neb ICS: ICS and nebulized corticosteroids (neb-CS); (c) methylxanthines, and d) other that included medications such as short-acting bronchodilators (SABD), oral corticosteroids and antibiotics. Rates of medication initiation, treatment continuation and discontinuation within these classes were determined based on refill patterns in the post-period. Sociodemographic and clinical characteristics (e.g., comorbidities) were also examined. Descriptive statistics were used to examine means, frequencies, and proportions. All analyses were preformed using SAS Enterprise Guide 7.1. RESULTS: A total of 11,886 nebulized arformoterol users were identified for the analysis. A substantial proportion of the patient cohort was 75 years or older (42%) and dually eligible for Medicaid (37%). Overall, 5,542 (46%) beneficiaries had received no LABD maintenance treatment 90 days prior to initiating arformoterol. Instead, they were being treated with a nebulized (50%) or an inhaled (37%) SABD, a systemic CS (46%), and many were on antibiotics (37%). In the post-period, 58% of beneficiaries received dual-therapy (LABA/ICS/Neb ICS [52%] or LAMA/LAMA [6%]), 21% received triple-therapy (LABA/LAMA/ICS/Neb CS), and 20% received monotherapy (only arformoterol). Nearly 41% of beneficiaries dropped ≥1 classes of medications they were taking prior to initiating arformoterol in the post-period. The largest decrease (-23%) was seen in CS use. CONCLUSIONS: The results suggest that nearly half of beneficiaries with COPD are not being treated with recommended LABD maintenance therapy. Among arformoterol users, dual therapy with a CS was highly prevalent. About 1 in 5 beneficiaries received either triple therapy or monotherapy. CLINICAL IMPLICATIONS: Evaluating the drivers associated with over reliance on SABD in lieu of recommended LABD maintenance treatment for appropriate patients, examining the triggers for initiating arformoterol, and linking arformoterol monotherapy v. combination therapy to outcomes are warranted. These analyses could help advance clinical decision-making for patients with COPD, particularly for those who have a history of exacerbations and hospitalizations. DISCLOSURE: Bartolome Celli: Consultant fee, speaker bureau, advisory committee, etc.: Advance Health Solutions, LLC, University grant monies: Astra Zeneca, Consultant fee, speaker bureau, advisory committee, etc.: Glaxo Smith Kline, Consultant fee, speaker bureau, advisory committee, etc.: Boehringer-Ingelheim, Consultant fee, speaker bureau, advisory committee, etc.: Astra Zeneca, Consultant fee, speaker bureau, advisory committee, etc.: Novartis, Consultant fee, speaker bureau, advisory committee, etc.: Pulmonix Maryam Navaie: Consultant fee, speaker bureau, advisory committee, etc.: Sunovion Pharmaceuticals Inc., Employee: Advance Health Solutions, LLC Vaidyanathan Ganapathy: Employee: Sunovion Pharmaceuticals, Inc. Zhun Xu: Grant monies (from industry related sources): Advance Health Solutions, LLC Soojin Cho-Reyes: Consultant fee, speaker bureau, advisory committee, etc.: Advance Health Solutions, LLC Todd Gilmer: Grant monies (from industry related sources): Advance Health Solutions, LLC No Product/Research Disclosure Information

The frequency of, and adherence to, single maintenance and reliever therapy instructions in asthma: a descriptive analysis.

Inhaled corticosteroid/long-acting β2-agonist (ICS/LABA) fixed-dose combinations are recommended regular maintenance options for asthma. ICS/LABAs containing formoterol may also be indicated for single maintenance and reliever therapy (SMART). This analysis evaluated the frequency of SMART dosing of budesonide/formoterol fixed-dose combination (BFC) in the United Kingdom. Secondary objectives were to assess adherence and use of short-acting ß2-agonists (SABAs). This was a descriptive analysis of treatment patterns using the UK Clinical Practice Research Datalink-GP OnLine Database data (2009–2013). SMART dosing was determined when prescription instructions contained guidance for daily dosing plus ‘and when required’. Treatment and prescription refill patterns of BFC and SABA were described in the year following the index date to identify adherence and SMART dosing instructions versus other dosing regimens. Of 14,818 patients identified, 173 (1.2%) had evidence of prescriptions for SMART dosing at their index BFC prescription. Despite being prescribed SMART dosing, 91 of 173 patients (53%) were additionally dispensed SABA in the year following the index date. The mean number of BFC inhalers used was less than required for daily treatment for SMART and non-SMART dosing groups (4.7 and 4.8, respectively).This analysis suggests that SMART dosing is infrequent when examining dosing instructions. Therefore, results of randomised clinical trials using SMART dosing may not translate to clinical practice in the United Kingdom because of the low level of SMART prescription, concurrent use of SABA, and inadequate refill persistence observed. Further research is needed to understand SMART dosing in real-world clinical practice.

Refill patterns with oral oncolytic medications.

e18216Background: Complexity of oral cancer treatments varies from continuous (CT) daily to cyclical (CY) dosing patterns (e.g., 3 weeks on treatment, 1 week off). CY dosing can cause confusion and...