National Drug Codes Research Articles

The National Drug Code explained.

In an effort to expedite the publication of articles, AJHP is posting manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time.

Cross-National Analysis of Opioid Prescribing Patterns: Enhancements and Insights from the OralOpioids R Package in Canada and the United States

Background: The opioid crisis remains a significant public health challenge in North America, highlighted by the substantial need for tools to analyze and understand opioid potency and prescription patterns. Methods: The OralOpioids package automates the retrieval, processing, and analysis of opioid data from Health Canada’s Drug Product Database (DPD) and the U.S. Food and Drug Administration’s (FDA) National Drug Code (NDC) database. It includes functions such as load_Opioid_Table, which integrates country-specific data processing and Morphine Equivalent Dose (MED) calculations, providing a comprehensive dataset for analysis. The package facilitates a comprehensive examination of opioid prescriptions, allowing researchers to identify high-risk opioids and patterns that could inform policy and healthcare practices. Results: The integration of MED calculations with Canadian and U.S. data provides a robust tool for assessing opioid potency and prescribing practices. The OralOpioids R package is an essential tool for public health researchers, enabling a detailed analysis of North American opioid prescriptions. Conclusions: By providing easy access to opioid potency data and supporting cross-national studies, the package plays a critical role in addressing the opioid crisis. It suggests a model for similar tools that could be adapted for global use, enhancing our capacity to manage and mitigate opioid misuse effectively.

Case Definition for Diagnosed Alzheimer Disease and Related Dementias in Medicare

Lack of a US dementia surveillance system hinders efforts to support and address disparities among persons living with Alzheimer disease and related dementias (ADRD). To review diagnosis and prescription drug code ADRD identification algorithms to develop and implement case definitions for national surveillance. In this cross-sectional study, a systematic literature review was conducted to identify unique International Statistical Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) and prescription drug codes used by researchers to identify ADRD in administrative records. Code frequency of use, characteristics of beneficiaries identified by codes, and expert and author consensus around code definitions informed code placement into categories indicating highly likely, likely, and possible ADRD. These definitions were applied cross-sectionally to 2017 to 2019 Medicare fee-for-service (FFS) claims and Medicare Advantage (MA) encounter data to classify January 2019 Medicare enrollees. Data analysis was conducted from September 2022 to March 2024. ICD-10-CM and national drug codes in FFS claims or MA encounters. The primary outcome was counts and rates of beneficiaries meeting each case definition. Category-specific age, sex, race and ethnicity, MA enrollment, dual-eligibility, long-term care utilization, mortality, and rural residence distributions, as well as frailty scores and FFS monthly expenditures were also analyzed. Beneficiary characteristics were compared across categories, and age-standardized to minimize confounding by age. Of the 60 000 869 beneficiaries included (50 853 806 aged 65 years or older [84.8%]; 32 567 891 female [54.3%]; 5 555 571 Hispanic [9.3%]; 6 318 194 non-Hispanic Black [10.5%]; 44 384 980 non-Hispanic White [74.0%]), there were 4 312 496 (7.2%) with highly likely ADRD, 1 124 080 (1.9%) with likely ADRD, and 2 572 176 (4.3%) with possible ADRD, totaling more than 8.0 million with diagnostic evidence of at least possible ADRD. These beneficiaries were older, more frail, more likely to be female, more likely to be dual-eligible, more likely to use long-term care, and more likely to die in 2019 compared with beneficiaries with no evidence of ADRD. These differences became larger when moving from the possible ADRD group to the highly likely ADRD group. Mean (SD) FFS monthly spending was $2966 ($4921) among beneficiaries with highly likely ADRD compared with $936 ($2952) for beneficiaries with no evidence of ADRD. Differences persisted after age standardization. This cross-sectional study of 2019 Medicare beneficiaries identified more than 5.4 million Medicare beneficiaries with evidence of at least likely ADRD in 2019 using the diagnostic case definition. Pending validation against clinical and other methods of ascertainment, this approach can be adopted provisionally for national surveillance.

The limitations of using Medicaid administrative data in abortion research

ObjectivesTo identify limitations of abortion data in national Medicaid claims files by comparing abortion counts in Medicaid claims data with state abortion estimates. Study designWe used procedure (Current Procedural Terminology/Healthcare Common Procedure Coding System) and drug (National Drug Code) codes to identify abortion claims in 2009 and 2010 Medicaid Analytic eXtract (MAX) and 2020 Transformed Medicaid Statistical Information System Analytic File (TAF) data. We compared the number of abortions in MAX and TAF to the number of expected abortions covered by Medicaid overall and by state. Based on recent published research, we estimated expected Medicaid-covered abortions as 62% of total abortions in states using state funds to cover abortion services for Medicaid enrollees and 0.9% in states that follow Hyde restrictions. ResultsMAX data identified 11% (38,668/345,480) of expected Medicaid-covered abortions in 2009 and 13% (44,528/330,801) of expected Medicaid-covered abortions in 2010. In 2020 TAF data, we found 25% (69,728/279,048) of the expected Medicaid-covered abortions. Among the 16 states that used state funds to cover abortions for Medicaid enrollees in 2020, the majority had <10% of expected Medicaid-covered abortions (n = 8). Three states had between 10% and 50% of expected abortions. Four states had between 51% and 75% of expected abortions. One state had insufficient data for reporting. ConclusionsAbortion claims in MAX/TAF are an undercount of abortions covered by Medicaid, and this undercount varies across states. Variation in reporting across states and across time likely introduces bias into research trying to use MAX/TAF abortion claims across states and time. Researchers should use extreme caution when using MAX/TAF for abortion-related research. ImplicationsResearchers should use caution when using the Medicaid Analytic eXtract and Transformed Medicaid Statistical Information System Analytic Files for abortion-related research questions.

Commercial health plan spending on oncology drugs approved via the accelerated approval pathway and later withdrawn from the market.

11134 Background: The U.S. Food and Drug Administration (FDA) introduced the Accelerated Approval Program in 1992 to expedite the approval of drugs that can be used to treat certain conditions and fill an unmet medical need. Clinical trials conducted to achieve accelerated approval status often use surrogate outcomes as primary endpoints to reduce the time it takes to get FDA approval. Drug manufacturers must conduct further research to verify and report the projected clinical benefit and safety. The FDA may issue traditional approval to previously accelerated approved drug or may request the manufacturer to withdraw a drug from the market based on the clinical benefit and/or safety demonstrated in the confirmatory trial(s). We report members impacted, total drug claims, and total drug cost incurred by a commercial health plan associated with the coverage of oncology drugs approved by the FDA and later withdrawn from the market between 2020 to 2023. Methods: Fifteen unique indications associated with oncology drugs that received accelerated approval and later withdrawn by the FDA were identified between 2020 to 2023. A cohort of patients enrolled in commercial health plan was further identified using the ICD-10 code related to the drug indication being withdrawn. To calculate total paid amount for drugs, de-identified administrative claims data submitted on behalf of this cohort were sorted and summed in this time period using either J-code for drugs covered under medical benefits or national drug code (NDC) for drugs covered under pharmacy benefits. Results: Between 2020 to 2023, 8 oncology drugs were withdrawn because of later failing to demonstrate clinical benefit in the confirmatory trials, 2 drugs were withdrawn due to safety concerns, and 5 drugs were withdrawn due to drug manufacturer unable to complete a confirmatory trial. In this population, we identified 18,430 unique members with 103,743 administrative claims. The total paid amount was $1,392,553,995 in this time period. The average drug cost per administrative claim was $13,423 and the average drug cost per member was $75,559. Conclusions: Drug costs established by manufacturers are not differentiated based on the approval status - accelerated or regular. While drugs approved via accelerated approval pathway may provide benefit to certain patient population, the cost associated with accelerated approved drugs needs more attention. Indication-specific pricing model may help alleviate the cost burden associated with drugs approved via accelerated approval pathway. [Table: see text]

522 Testosterone Supplementation in Patients with Burn Hypermetabolism

Abstract Introduction After major burn injuries, patients experience a hypermetabolic response that leads to hyperdynamic circulatory, physiologic, catabolic, and immune system responses. Many transdisciplinary approaches have been tested to mitigate this postburn hypermetabolic syndrome such as comprehensive burn rehabilitation, nutritional support, monitoring, and pharmacological interventions. Oxandrolone, a synthetic analog of testosterone, has been shown to have higher anabolic properties and minimal androgenic effects and studied intensely in burn care. In 2023, the FDA asked all manufacturers of oxandrolone to cease production and subsequently removed the drug from market on June 28, 2023. Our study examines the cost and operationalization of an intramuscular (IM) testosterone protocol as an alternative in male burn patients with ≥20% total body surface area (TBSA). Methods A cost analysis was conducted using the National Drug Codes (NDC) and commercially available benchmarking data. The cost of oxandrolone and testosterone were included in our analysis. Following a thorough literature review, a protocol was developed for adult male patients with &amp;gt;20% TBSA burn injuries. Patients undergoing gender affirming hormone therapy, untreated obstructive sleep apnea, or hormonal blockers for cancer were excluded from the protocol. Results The protocol begins with total serum testosterone levels at the time of admission and weekly thereafter for male patients with ≥20% TBSA injury. Once a testosterone level &amp;lt; 150 ng/dL is detected, supplementation of testosterone with 200 mg IM once weekly for two weeks is started. Weekly evaluations include total body weight, metabolic panels, and nutritional panels. Cost comparison between oxandrolone and testosterone show an equivalent unit cost of $8.62 versus $8.38, respectively. Conclusions Drug shortages and supply chain challenges are becoming more common in burn care. We hypothesize testosterone to be both a clinically effective and cost-effective alternative to oxandrolone in the setting of burn hypermetabolism in male patients with major burns. Currently, burn experts are working with endocrinologists to assess pharmacologic alternatives for female patients and have obtained IRB-approval to evaluate both safety and efficacy of testosterone supplementation in the setting of burn hypermetabolism. Applicability of Research to Practice This study evaluates the safety and efficacy of testosterone supplementation as an alternative to oxandrolone in the setting of burn hypermetabolism. This study helps provide guidance to other burn centers in filling the gap in therapy that now exists in the pharmacologic management of hypermetabolic syndrome in patients with severe burns.

Incidence of Colorectal Cancer After Intestinal Infection Due to Clostridioides difficile.

Clostridioides difficile (C. difficile or C. diff) is a toxin-producing bacteria that is notorious for causing life-threatening diarrhea. Recent literature has investigated various effects of Clostridioides difficile infection (CDI) in cancer patients, but research into the impact of CDI on the development of cancer and its effects on the microbiome is limited. CDI predominately affects the colon, which urges consideration into the sequalae of infection. This study investigated the correlation between CDI and the incidence of colorectal carcinoma (CRC). A retrospective study (2010 - 2020) was conducted using a Health Insurance Portability and Accountability Act (HIPAA) compliant national database. The International Classification of Disease ninth and 10th Codes (ICD-9, ICD-10), Current Procedural Terminology (CPT), and National Drug Codes were used to identify CRC diagnosis, CDI, and matching or control parameters. Patients were matched for age, sex, Charlson Comorbidity Index (CCI), region of residence, and CDI treatment. An additional, but separate, query was executed to include obese patients with and without CDI, who were similarly matched and assessed for CRC. Statistical analyses were implemented to assess significance and estimate odds ratios (ORs). CDI was associated with a decreased incidence of CRC (OR = 0.59, 95% confidence interval (CI): 0.55 - 0.63), and the difference was statistically significant (P < 2.2 × 10-16). CDI treatment, including appropriate antibiotics and fecal microbiota transplant (FMT), was controlled for in both infected and noninfected populations. Patients with a prior CDI who received relevant treatment were compared to patients with no history of CDI and received analogous treatment. Both populations subsequently developed CRC. Results remained statistically significant (P < 2.2 × 10-16) with a relative risk (RR) of 0.57 (95% CI: 0.54 - 0.60). Obesity was explored as a controlled variable in relation to CRC development in patients with and without prior CDI. Obese patients without a history of CDI were found to have a decreased risk of developing CRC. Results were statistically significant (P < 4.3 × 10-13) with an OR of 0.70 (95% CI: 0.63 - 0.77). This study shows a statistically significant correlation between CDI and decreased incidence of CRC. Additionally, there is a statistically significant correlation between obese patients with CDI and an increased incidence of CRC. Further research is needed to explore the mechanism of this striking relationship and the implications of CDIs on the microbiome.

Opioid utilization after orthopaedic trauma hospitalization among Medicaid-insured adults.

Opioids are vital to pain management and sedation after trauma-related hospitalization. However, there are many confounding clinical, social, and environmental factors that exacerbate pain, post-injury care needs, and receipt of opioid prescriptions following orthopaedic trauma. This retrospective study sought to characterize differences in opioid prescribing and dosing in a national Medicaid eligible sample from 2010-2018. The study population included adults, discharged after orthopaedic trauma hospitalization, and receiving an opioid prescription within 30 days of discharge. Patients were identified using the International Classification of Diseases (ICD-9; ICD-10) codes for inpatient diagnosis and procedure. Filled opioid prescriptions were identified from National Drug Codes and converted to morphine milligram equivalents (MME). Opioid receipt and dosage (e.g., morphine milligram equivalents [MME]) were examined as the main outcomes using regressions and analyzed by year, sex, race/ethnicity, residence rurality-urbanicity, and geographic region. The study population consisted of 86,091 injured Medicaid-enrolled adults; 35.3% received an opioid prescription within 30 days of discharge. Male patients (OR = 1.12, 95% CI: 1.07-1.18) and those between 31-50 years of age (OR = 1.15, 95% CI: 1.08-1.22) were found to have increased odds ratio of receiving an opioid within 30 days of discharge, compared to female and younger patients, respectively. Patients with disabilities (OR = 0.75, 95% CI: 0.71-0.80), prolonged hospitalizations, and both Black (OR = 0.87, 95% CI: 0.83-0.92) and Hispanic patients (OR = 0.72, 95% CI: 0.66-0.77), relative to white patients, had lower odds ratio of receiving an opioid prescription following trauma. Additionally, Black and Hispanic patients received lower prescription doses compared to white patients. Individuals hospitalized in the Southeastern United States and those between the ages of 51-65 age group were found to be prescribed lower average daily MME. There were significant variations in opioid prescribing practices by race, sex, and region. National guidelines for use of opioids and other pain management interventions in adults after trauma hospitalization may help limit practice variation and reduce implicit bias and potential harms in outpatient opioid usage.

Classifying Multimorbidity Using Drug Concepts via the Rx-Risk Comorbidity Index: Methods and Comparative Cross-Sectional Study.

The study objective was to update a method to identify comorbid conditions using only medication information in circumstances in which diagnosis codes may be undercaptured, such as in single-specialty electronic health records (EHRs), and to compare the distribution of comorbidities across Rx-Risk versus other traditional comorbidity indices. Using First Databank, RxNorm, and its web-based clients, RxNav and RxClass, we mapped Drug Concept Unique Identifiers (RxCUIs), National Drug Codes (NDCs), and Anatomical Therapeutic Chemical (ATC) codes to Rx-Risk, a medication-focused comorbidity index. In established rheumatoid arthritis (RA) and osteoarthritis (OA) cohorts within the Rheumatology Informatics System for Effectiveness registry, we then compared Rx-Risk with other comorbidity indices, including the Charlson Comorbidity Index, Rheumatic Disease Comorbidity Index (RDCI), and Elixhauser. We identified 965 unique ingredient RxCUIs representing the 46 Rx-Risk comorbidity categories. After excluding dosage form and ingredient related RxCUIs, 80,911 unique associated RxCUIs were mapped to the index. Additionally, 187,024 unique NDCs and 354 ATC codes were obtained and mapped to the index categories. When compared to traditional comorbidity indices in the RA cohort, the median score for Rx-Risk (median 6.00 [25th percentile 2, 75th percentile 9]) was much greater than for Charlson (median 0 [25th percentile 0, 75th percentile 0]), RDCI (median 0 [25th percentile 0, 75th percentile 0]), and Elixhauser (median 1 [25th percentile 1, 75th percentile 1]). Analyses of the OA cohort yielded similar results. For patients with a Charlson score of 0 (85% of total), both the RDCI and Elixhauser were close to 1, but the Rx-Risk score ranged from 0 to 16 or more. The misclassification and under-ascertainment of comorbidities in single-specialty EHRs can largely be overcome by using a medication-focused comorbidity index.

Persistent Opioid Use Following Pediatric Nonfatal Firearm Injury

ObjectiveFirearms are a major cause of pediatric injury. An analysis of opioid use following pediatric firearm injury has not previously been reported. Our objective was to determine the prevalence and factors associated with persistent opioid use among pediatric nonfatal firearm injury victims. MethodsWe performed a retrospective cohort study using 2015–18 claims data from the Merative MarketScan Multi-State Medicaid and Commercial Databases, utilizing International Classification of Diseases, Tenth Revision codes for firearm injury and National Drug Codes for opioids. Dispensed opioid claims were used as a proxy for opioid use. Opioid exposure was defined both dichotomously and continuously (by the total number of opioid days prescribed) in the 30 days following discharge from firearm injury index encounter. Persistent opioid use was defined as ≥1 opioid claim(s) in the 90 to 270 days following index encounter. Multivariable logistic regression analysis was performed to determine whether covariates of interest were associated with greater odds of persistent opioid use. ResultsOur cohort consisted of 2110 children who experienced nonfatal firearm injury (mean age 13.5, 80.9% male, 79.5% Medicaid) with 608 children (28.8%) exposed to opioids. Of patients exposed to opioids, 10.4% developed persistent opioid use. In adjusted analyses, each opioid day dispensed during the exposure period represented 5% greater odds of experiencing persistent opioid use. ConclusionsClinicians caring for children injured by firearms should be aware of the risk of developing persistent opioid use and balance that risk with the need to sufficiently control pain.

Improving Immunization Health Care Data Quality using Two-Dimensional Barcoding and Barcode Scanning Practices.

Manual data entry is time-consuming, inefficient, and error prone. In contrast, leveraging two-dimensional (2D) barcodes and barcode scanning tools is a rapid and effective practice for automatically entering vaccine data accurately and completely. CDC pilots documented clinical and public health impacts of 2D barcode scanning practices on data quality and completeness, time savings, workflow efficiencies, and staff experience. Data entry practices and entered records from routine and mass vaccination settings were analyzed. Data quality improvement opportunities were identified. A sample of 50 million emergency use authorization (EUA) coronavirus disease 2019 (COVID-19) vaccine records were analyzed for accuracy and completeness across three data fields: lot number, expiration date, and National Drug Code (NDC). The EUA COVID-19 vaccines lacked a 2D barcode containing these data fields, which necessitated manual data entry at administration. A CDC pilot at clinic compared scanned and manually entered data for routine vaccines across these same data fields. Analysis of 50 million manually entered EUA COVID-19 vaccine administration records indicated significant gaps in data accuracy and completeness across three data fields. Over half of the analyzed EUA vaccine NDCs (53%) and one-third of the expiration dates (35%) had missing or inaccurate data recorded. Pilot data also showed many errors when manually entered. However, when the pilot's routine vaccines were scanned (out of 71,969 records), nearly all entries were complete and accurate across all three data fields (ranging from 99.7% to 99.999% accurate). Vaccine 2D barcode scanning practices increased data accuracy and completeness (up to 99.999% accurate) across data fields assessed. When used consistently, vaccine 2D barcode scanning can resolve issues demonstrated in manually entered data. To realize these benefits, the immunization community should widely use scanning practices. To increase use, CDC developed a Vaccine 2D Barcode National Adoption Strategy and implementation resources.

Validation of administrative claims to identify ultrasound enhancing agent use

BackgroundUltrasound enhancing agents (UEAs) are an invaluable adjunct to stress and transthoracic echocardiography (STE) to improve left ventricular visualization. Despite multiple single center studies evaluating UEA use, investigation into the rates, sources of variation, and outcomes of UEA use on a national level in the United States (US) has been limited by lack of validation of UEA codes for claims analyses.MethodsWe conducted a retrospective cross-sectional study, 2019–2022, using linked multicenter electronic medical record (EMR) data from > 30 health systems linked to all-payor claims data representing > 90% of the US population. Individuals receiving STE in both EMR and claims data on the same day during the study window were included. UEA receipt as identified by presence of a Current Procedural Terminology (CPT) or National Drug Code (NDC) for UEA use within 1-day of the index STE event. We evaluated the performance of claims to identify UEA use, using EMR data as the gold standard, stratified by inpatient and outpatient status.ResultsAmongst 54,525 individuals receiving STE in both EMR and claims data, 12,853 (23.6%) had a UEA claim in EMR, 10,461 (19.2%) had a UEA claim in claims, and 9140 (16.8%) had a UEA claim in both within the 1-day window. The sensitivity, specificity, accuracy, positive, and negative predictive values for UEA claims were 71.1%, 96.8%, 90.8%, 87.4%. and 91.6% respectively. However, amongst inpatients, the sensitivity of UEA claims was substantially lower (6.8%) compared to outpatients (79.7%).ConclusionsWhile the overall accuracy of claims to identify UEA use was high, there was substantial under-capture of UEA use by claims amongst inpatients. These results call into question published rates of UEA use amongst inpatients in studies using administrative claims, and highlight ongoing need to improve inpatient coding for UEA use.

Estimating rare disease prevalence and costs in the USA: a cohort study approach using the Healthcare Cost Institute claims data

ObjectiveThe study capitalised on national insurance claims data to gather information on patient characteristics and associated costs to better understand the diagnosis and treatment of rare diseases (RDs).Materials and methodsData...

Comparison of methods to identify individuals prescribed opioid analgesics for pain

IntroductionWhile identifying opioid prescriptions in claims data has been instrumental in informing best practises, studies have not evaluated whether certain methods of identifying opioid prescriptions yield better results. We compared...

Medicare formulary restrictions for glucagon-like peptide 1 receptor agonists and sodium glucose cotransporter 2 inhibitors used in type 2 diabetes mellitus: 2019-2023.

Glucagon-like peptide 1 receptor agonists (GLP1-RAs) and sodium glucose cotransporter 2 inhibitors (SGLT2is) have proven benefits in patients with type 2 diabetes mellitus related to decreasing cardiovascular events and heart failure hospitalizations as well as preventing the progression of kidney disease. This led the American Diabetes Association (ADA) to update their guidelines in 2022 to recommend GLP1-RAs and SGLT2is as potential first-line options in patients with cardiorenal conditions. Formulary restrictions, such as step therapy and prior authorizations, can limit access to these beneficial medications. To evaluate trends in Medicare formulary restrictions of GLP1-RAs and SGLT2is following the recommendations by the ADA for first-line use. We conducted a retrospective cohort study of Quarter 1 Medicare formulary restrictions on GLP1-RAs and SGLT2is from 2019 to 2023. We analyzed changes in formulary restrictions by year, before and after the ADA first-line recommendations, single vs combination products, and products with and without other indications on a medication level (ie, each unique National Drug Code number on each unique formulary) and formulary level (ie, any prior authorization or step therapy requirements yield formulary restriction). We analyzed 12,212 unique Medicare formularies. GLP1-RAs were 12.5% less likely (relative risk [RR] = 0.87; 95% CI = 0.84-0.91; P < 0.001) and 33.2% less likely (RR = 0.67; 95% CI = 0.60-0.74; P < 0.001) to have restrictions after the ADA guideline changes on a medication and formulary level, respectively. SGLT2is were 87.8% less likely (RR = 0.12; 95% CI = 0.11-0.13; P < 0.001) and 53.0% less likely (RR = 0.47; 95% CI = 0.27-0.80; P = 0.005) to have restrictions after the ADA guideline changes on medication and formulary levels, respectively. Decreasing trends of medications and formularies with restrictions may indicate payers are recognizing GLP1-RAs and SGLT2is as potential first-line agents, aligning with ADA recommendations.

Designing Human-Centered AI to Prevent Medication Dispensing Errors: Focus Group Study With Pharmacists.

Medication errors, including dispensing errors, represent a substantial worldwide health risk with significant implications in terms of morbidity, mortality, and financial costs. Although pharmacists use methods like barcode scanning and double-checking for dispensing verification, these measures exhibit limitations. The application of artificial intelligence (AI) in pharmacy verification emerges as a potential solution, offering precision, rapid data analysis, and the ability to recognize medications through computer vision. For AI to be embraced, it must be designed with the end user in mind, fostering trust, clear communication, and seamless collaboration between AI and pharmacists. This study aimed to gather pharmacists' feedback in a focus group setting to help inform the initial design of the user interface and iterative designs of the AI prototype. A multidisciplinary research team engaged pharmacists in a 3-stage process to develop a human-centered AI system for medication dispensing verification. To design the AI model, we used a Bayesian neural network that predicts the dispensed pills' National Drug Code (NDC). Discussion scripts regarding how to design the system and feedback in focus groups were collected through audio recordings and professionally transcribed, followed by a content analysis guided by the Systems Engineering Initiative for Patient Safety and Human-Machine Teaming theoretical frameworks. A total of 8 pharmacists participated in 3 rounds of focus groups to identify current challenges in medication dispensing verification, brainstorm solutions, and provide feedback on our AI prototype. Participants considered several teaming scenarios, generally favoring a hybrid teaming model where the AI assists in the verification process and a pharmacist intervenes based on medication risk level and the AI's confidence level. Pharmacists highlighted the need for improving the interpretability of AI systems, such as adding stepwise checkmarks, probability scores, and details about drugs the AI model frequently confuses with the target drug. Pharmacists emphasized the need for simplicity and accessibility. They favored displaying only essential information to prevent overwhelming users with excessive data. Specific design features, such as juxtaposing pill images with their packaging for quick comparisons, were requested. Pharmacists preferred accept, reject, or unsure options. The final prototype interface included (1) checkmarks to compare pill characteristics between the AI-predicted NDC and the prescription's expected NDC, (2) a histogram showing predicted probabilities for the AI-identified NDC, (3) an image of an AI-provided "confused" pill, and (4) an NDC match status (ie, match, unmatched, or unsure). In partnership with pharmacists, we developed a human-centered AI prototype designed to enhance AI interpretability and foster trust. This initiative emphasized human-machine collaboration and positioned AI as an augmentative tool rather than a replacement. This study highlights the process of designing a human-centered AI for dispensing verification, emphasizing its interpretability, confidence visualization, and collaborative human-machine teaming styles.

Trends in Proportion of Medicare Part D Claims Subject to 340B Discounts, 2013-2020

ImportanceDespite controversy surrounding the 340B program, no study has analyzed trends in the proportion of Medicare Part D pharmacy claims eligible for 340B discounts.ObjectiveTo describe trends in the proportion of Medicare Part D claims that are prescribed by 340B-affiliated clinicians and filled in 340B pharmacies.Design and SettingThis longitudinal, retrospective cohort study included 2013 to 2020 claims data from a 5% random sample of Medicare Part D beneficiaries from the Centers for Medicare &amp;amp;amp; Medicaid Services and 6292 nine-digit national drug codes that were used by at least 1000 Part D beneficiaries in a given year. Data analysis was completed from November 2022 to April 2023.Main Outcomes and MeasuresFor each drug and year, there were 3 outcomes: (1) proportion of total Part D claims that were prescribed by a 340B-affiliated clinician; (2) proportion of claims prescribed by a 340B-affiliated clinician that were filled in a 340B pharmacy; and (3) proportion of total Part D claims under the 340B program (ie, prescribed by a 340B-affiliated clinician and filled in a 340B pharmacy).ResultsThe proportion of prescriptions written by a 340B-affiliated clinician doubled from 9.4% in 2013 to 19.3% in 2020. The capture of 340B prescriptions by 340B pharmacies, defined as the proportion of claims prescribed by 340B-affiliated clinicians that were filled by 340B pharmacies, increased from 18.4% in 2013 to 49.9% in 2020. As a result, the total proportion of 340B claims in Part D increased from 1.7% in 2013 to 9.6% in 2020. Rates of 340B prescribing and capture increased consistently across therapeutic classes. In 2020, the antiviral therapeutic class was the class with the largest proportion of 340B claims (16.1%), followed by targeted antineoplastics (15.7%).Conclusions and RelevanceThis cohort study demonstrated that from 2013 to 2020, the share of Medicare Part D claims prescribed by a 340B-affiliated clinician increased; however, the rate at which 340B-eligible prescriptions were filled at 340B pharmacies increased at a faster rate, driving the overall increase in 340B claims. Despite these trends, only half of 340B-eligible prescriptions were subject to the 340B discount in 2020.

Abstract 17671: Comparative Analysis of Warfarin and Direct Oral Anticoagulants for the Treatment of Left Ventricular Thrombus

Introduction: This study aims to evaluate the efficacy and safety of direct oral anticoagulants (DOACs) in the treatment of left ventricular thrombus (LVT). Warfarin has been shown to be an effective treatment in mitigating thrombotic events; however, numerous limitations exist, including the need for frequent monitoring and increased risk of side effects. Despite this, insight into DOAC use for the treatment of LVT remains limited. Thus, this study seeks to investigate the safety and efficacy of DOACs as a potential alternative to warfarin for the treatment of LVT. Hypothesis: DOACs decreases the risk of adverse events compared to Warfarin in patients with LVT. Methods: A retrospective cohort study was conducted using a federated realtime database called TriNetX which is comprised of over 100 million patient records. ICD-10 diagnostic codes and national drug codes were used to stratify adults by warfarin or DOAC treatment within 3 months of an initial LVT diagnosis. A 1:1 matched propensity score analysis was conducted, adjusting for comorbidities and demographics, to calculate adjusted Risk Ratios (aRR) with 95% CI. 90-day risk for mortality, stroke, need for blood transfusion, hemorrhage, and arterial embolism &amp; thrombosis were examined. Results: In a matched sample of 11,206 patients in each cohort, patients with LVT who took warfarin within 3 months of initial diagnosis is at higher risk for stroke (aRR[95%CI]=1.44(1.34,1.55)], need for blood transfusion [1.29(1.11,1.51)], hemorrhage [1.56(1.35,1.8)], and arterial thromboembolism [1.28(1.13,1.45)] than LVT patients who took a DOAC. Risk for death was non-significant between cohorts. Conclusions: The findings from this large electronic medical record patient cohort establish higher rates of adverse events for patients with LVT treated with warfarin versus DOAC, with no statistically significant difference in therapeutic efficacy.

Impact of Prostate Cancer-related Genitourinary Radiation Injury on Mental Health Diagnosis and Treatment: Assessment of 55,425 Men

To investigate the association of low-grade radiation injury (LGRI) and high-grade radiation injury (HGRI) following prostate cancer treatment with mental health diagnoses and therapy. A retrospective study of men diagnosed with prostate cancer who were treated with radiotherapy. Men were followed to assess for LGRI or HGRI using IBM MarketScan. Cohorts included: no injury (no-RI), LGRI, HGRI, and controls. Mental health diagnoses and related treatment (medication/therapy) were identified using ICD-10 codes, CPT codes, and national drug codes. A multivariable Cox proportional hazards model from time of radiation to first instance of mental health diagnosis was modeled against injury group, age, and comorbidities. Between 2011-2020 we identified 55,425 men who received radiotherapy for prostate cancer. 22,879 (41.3%) experienced a LGRI while 4,128 (7.4%) experienced a HGRI. Prior to radiation therapy, mental health diagnoses were equally distributed across cohorts (p>0.05). Every marker of mental health showed a step-wise increase in incidence from no-RI to LGRI to HGRI except for alcohol abuse. Use of mental health medications and therapy visits were slightly more likely in the LGRI and HGRI groups prior to radiation, however this difference was greatly increased post-radiation therapy. LGRI (HR 1.38; p<0.001) and HGRI (HR 2.1;p<0.001) were independently associated with an increased likelihood of mental health diagnoses. LGRI and HGRI following prostate cancer radiotherapy are associated with increased risk of mental health diagnosis, medication use, and therapy need compared to men who do not develop injuries. The most common mental health diagnoses were depression and anxiety.

Back to Basics: Reporting National Drug Codes

When reporting vaccines and medications supplied in a physician practice, it is typically necessary to report an 11-digit National Drug Code (NDC). This article reviews how to appropriately report NDCs, including the following key points: Selection of the appropriate NDC Conversion of a 10-digit NDC to include the required 11 digits Selecting the NDC unit of measure Entering NDC information into the claim