Medical Record (EMR) analysis were to understand patient characteristics within current clinical care, to optimize the study design, and to reduce burden on sites and patients. Methods: We conducted an analysis of 11 country-specific EMR data sources (USA,
A 1 -A 3 1 8 classes that HIV patients were receiving in the two groups were recorded. T-test, Chi-square and Fisher's exact tests were used for the statistical analysis between two groups. Results: A total of 65 patients were in the MDM group and 864 patients were in PHM group. The TNMC that the HIV patients were on had no significant difference between the PHM and the MDM groups (6.77±2.56 vs 6.2±2.91, p= 0.1268). The PHM group had significantly higher rates of HIV patients who were on antihyperlipidemics (p=0345), dermatologicals (p< 0.0003), endocrine (p= 0.0014), and gastrointestinal (p=0.0003) than the PHM group. PHM group had a higher rate of genitourinary medications than the MDM group (p= 0.0378). ConClusions: The PHM HIV patients in correctional facilities were less likely to be on multiple medication classes than MDM. Medications for chronic conditions and antibiotics were more common in the MDM group. More analysis is
Introduction:
Pregabalin, a structural analog to λ-aminobutyric acid, is prescribed for neurological disorders. Through actions to cause sodium/water retention, the agent may increase the risk of acute heart failure (AHF).
Methods:
We performed a retrospective cohort study using a repository of healthcare records obtained from a large U.S. academic healthcare system. HF patients were identified between 1/1/2016-12/31/2020. Patients who had initiated treatment with pregabalin were compared to patients with no post-HF pregabalin over a 365-day post-pregabalin period or post-HF period. Study outcomes were per-patient per-year (PPPY) emergency department (ED) admissions or PPPY hospitalizations, time-to first ED admission, and time-to hospitalizations. Outcomes encounters were adjudicated by a HF diagnosis (ICD-10, I50.x) at any position. We tested the association between the pregabalin exposure and outcomes using generalized linear regression and Cox-proportional hazard regression approach.
Results:
The study cohort included 483 pregabalin-HF patients and 21,150 pregabalin-naïve HF patients. The pregabalin-HF patients age was (mean±SEM: 62.2±0.7 vs. 66.2±0.1 years,
p
<0.0001) and more females (54.9% vs, 44.4%,
p
<0.0001) than pregabalin-naïve HF patients. Charleston comorbidity score was 3.66±0.14 vs. 3.23±0.02 (
p
=0.007). Pregabalin use was associated with a 13% increase in PPPY AHF hospitalizations (
p
<0.036). A 15% increase in the PPPY ED pregabalin admissions was noted (
p
=0.1142). Pregabalin ED admission or AHF hospitalization were 1.492 (95% CI: 1.204 ̶ 1.850 [
p
=0.0003]) and 1.112 (95% CI: 0.922 ̶ 1.340 [
p
=0.2663]).
Conclusion:
This retrospective cohort study shows pregabalin is associated with an increased risk of AHF in patients with existing HF. Pregabalin prescribing in HF should be considered with caution. Further signal evaluation to test the robust association between pregabalin and AHF is warranted.
To estimate healthcare resource utilization, associated costs, and number needed to harm (NNH) from a physician's decision to prescribe extended-release (ER) non-abuse-deterrent opioids (ADO) as compared to ER ADOs in a chronic pain population. MethOds: A 12-month probabilistic sampling TreeAge model was developed to estimate the reduction of misuse and/or abuse from a physician's decision to prescribe ER non-ADOs instead of ER ADOs in 10,000 patients. Model inputs included monthly probabilities for opioid misuse and/or abuse-related events, death from misuse and/or abuse, opioid discontinuation, and switching from ADO to non-ADO. Estimated reductions in abuse associated with ADOs were obtained from positive subjective measures using human abuse liability studies. The model was run separately using inputs for commercial, Medicare, Medicaid, and Veterans Health Administration (VHA) populations. The difference in healthcare resource utilization and associated costs between the ADO and non-ADO simulations was calculated. NNH for non-ADO was also calculated. Prevalence, probabilities, and misuse and/or abuse-related event costs (2015 USD) were derived from literature. Results: Misuse and/or abuse-related events for patients prescribed ER non-ADOs ranged from 199-1,305
requires each drug to be listed in the national drug formulary according to a law passed in 2002. The objective of this law was to certify not only the safety profile of every new drug, but also its economical benefits based on a pharmacoeconomical study that must be presented for evaluation. OBJECTIVES: To analyze if the expenditure made by the IMSS in 2011 used the costeffectiveness criteria based on the drugs listed in the national formulary. METHODS: Six high resource consuming diseases in the country were selected together with their respective prescribed treatments. Each prescribed treatment was classified according to three parameters: -Less expensive treatment -Most expensive treatment -Cost-effective treatment Prices of each treatment and its total expenditure were obtained through the institute's official purchase portal. Pharmacoeconomical studies needed to obtain the cost effective treatment were already evaluated for drug's inclusion in the national formulary. Results were analyzed to evaluate the expenditure's nature. RESULTS: In a half of the studied diseases, the expenditure on other none cost-effective treatments represented at least 50% more than for the cost-effective ones. The total expenditure on the studied cases was US $226,881,190.64. From these consumed resources, 33.54% was used to buy other non cost-effective drugs. From the observed purchases made, 40% were direct adjudications not open to competition. CONCLUSIONS: Even though every new drug is being evaluated since year 2002 to show its economical benefits, the studied institution in not fully using the costeffectiveness criteria to buy its drugs in Mexico, even in some of the most resource consuming diseases.
A113Objectives: Regulatory policies, including economic incentivization through patent extensions, have been implemented to stimulate pediatric research, however disparity exists for the neonatal subpopulation. This analysis was conducted to identify the availability of neonate-specific data for frequently used medications in Neonatal Intensive Care Units (NICUs) and to determine the extent to which pediatric exclusivity has increased information for drugs used in neonates. MethOds: A search was conducted utilizing the FDALabels database to identify all FDAapproved NDA, BLA and ANDAs from 01/01/1980 to 08/01/2013 searching for the terms "neonate", "newborn" and "infant" present in any of the following label sections; "Indication and Usage", "Dosage and Administration" and "Pediatric Use". The results were cross-referenced with a recently published list of 100 frequently prescribed drugs in NICUs and drugs granted pediatric exclusivity by the FDA as of August, 2013. Results: A total of 737 unique labels for 110 distinct drugs were identified (including 18 combination products and 15 modified versions of previously marketed drugs). "Newborn" was identified in 450 labels; "infant" in 414 labels and "neonate" in 167 labels. More than one search term was found in 294 labels. Only 19% of drugs frequently used in NICUs mentioned neonates, newborns or infants on their labels. Mention of neonates, newborns or infants occurred in 4.5% (n= 9) of the drugs with pediatric exclusivity; while 8.7% (n= 17) of drugs granted pediatric exclusivity were used frequently in the NICU. Only two drugs frequently used in NICUs mentioned neonate, newborn or infant on their label and had pediatric exclusivity. cOnclusiOns: Despite regulatory incentives, a paucity of neonatal data exist for drugs frequently used in NICUs. Our data suggest that pediatric exclusivity did not yield sufficient neonatal data.
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