Category: Nevin Manimala

J Pharm Biomed Anal. 2021 May 24;202:114165. doi: 10.1016/j.jpba.2021.114165. Online ahead of print.

ABSTRACT

The purpose of this study is to elucidate uncertainty structures of internal standard (IS) methods as compared with absolute calibration methods in liquid chromatography. A quantitative test of indomethacin with butyl 4-hydroxybenzoate as an IS in high-performance liquid chromatography with ultra-violet detection is taken here as an example. The repeatability is evaluated by both a usual statistical method of repetition and a theoretical approach, called the function of mutual information (FUMI) theory. The latter predicts the precision from noise and signals of instrumental output. Plots of relative standard deviations (RSDs) of measurements against analyte amounts, called precision profiles, are compared between the IS methods for indomethacin and their corresponding absolute calibration methods over a wide range of amount. Sample injection errors are observed to be effectively eliminated at high amounts by the IS methods, but at low amounts where background random noise dominates over the other error, the superiority of the IS methods is overshadowed and the precision of both the methods is almost comparable. The smallest possible amount of IS material without spoiling the integrity of analysis is estimated from the precision profiles.

PMID:34058536 | DOI:10.1016/j.jpba.2021.114165

J Pharm Biomed Anal. 2021 May 24;202:114167. doi: 10.1016/j.jpba.2021.114167. Online ahead of print.

ABSTRACT

In this study a volatolomic approach is proposed for the characterization of the volatile organic compound (VOC) composition of essential oils (EOs) extracted from common aromatic plants. Five species (Prunus spinosa L., Salvia officinalis L., Eucalyptus globulus L., Melissa officinalis L. and Mentha x piperita L.), particularly widespread in Southern Italy, were selected as recognized sources of natural bioactive compounds with beneficial properties. Hydro distillation and solid-liquid extraction with ethanol at different percentages were used to obtain EOs, and their extraction capabilities were compared analyzing chromatographic profiles obtained by headspace solid-phase microextraction (HS-SPME) coupled with gas chromatography – mass spectrometry (GC-MS). The analytical procedure was optimized in term of SPME fiber, adsorption time and desorption time. GC-MS analyses were performed allowing the profiling of the VOC fingerprint in each plant extract. Experimental data were processed by a statistical multivariate approach (Analysis of Variance and Principal Component Analysis obtained for compounds and chemical classes), confirming that EO aroma profiles were statistically different for each of the selected five plants. The proposed volatolomic approach has proved to be an easy and efficient tool to study the aroma profile, allowing the collection of specific information and opening new perspectives and opportunities for the detection and identification of VOCs in agricultural and ecological applications.

PMID:34058537 | DOI:10.1016/j.jpba.2021.114167

J Manag Care Spec Pharm. 2021 Jun;27(6):772-778. doi: 10.18553/jmcp.2021.27.6.772.

ABSTRACT

BACKGROUND: 50% of prescriptions dispensed in the United States are not taken as prescribed, leading to approximately 125,000 deaths and 10% of hospitalizations per year. Incentives are effective in improving medication adherence; however, information about patient perceptions regarding incentives is lacking. OBJECTIVES: To (1) explore perceived appropriateness of incentives among patients prescribed at least 1 medication for chronic hypertension, hyperlipidemia, heart disease, diabetes, and/or asthma/chronic obstructive pulmonary disease and (2) examine associations between perceived appropriateness and patient characteristics. METHODS: A cross-sectional online survey was administered via Qualtrics Panels to US adults taking at least 1 prescription medication for a chronic condition. The results describe patient preference for financial or social recognition-based incentive, perceived appropriateness of adherence incentives (5-point Likert scale), self-reported adherence (Medometer), and demographics. Analyses included descriptive statistics with chi-square and independent t-tests comparing characteristics between participants who perceived incentives as being appropriate or inappropriate and logistic regression to determine predictors of perceived appropriateness. RESULTS: 1,009 individuals completed the survey. Of the 1,009 total survey participants, 933 (92.5%) preferred to receive a financial (eg, cash, gift card, or voucher) rather than a social recognition-based incentive (eg, encouraging messages, feedback, individual recognition, or team competition) for medication adherence. 740 participants (73%) perceived medication adherence incentives as being appropriate or acceptable as a reward given for taking medications at the right time each day, whereas 95 (9%) perceived incentives as being inappropriate. Remaining participants were neutral. Hispanic ethnicity (OR = 0.57; 95% CI = 0.37-0.89); income under $75,000 (OR = 0.48; 95% CI = 0.28-0.84); no college degree (OR = 0.60; 95% CI = 0.37-0.96); and adherence (OR = 0.99; 95% CI = 0.98-0.99) were significant predictors. CONCLUSIONS: The majority of patients perceived incentives as appropriate and preferred financial incentives over social recognition-based incentives. Perceived appropriateness for medication adherence incentives was less likely among certain groups of patients, such as those with Hispanic ethnicity, lower annual income, no college degree, and higher levels of adherence. These characteristics should be taken into account when structuring incentives. DISCLOSURES: This study was funded by the Auburn University’s Intramural Grants Program. Hansen, Qian, and Garza are affiliated with Auburn University. Hansen has provided expert testimony for Daiichi Sankyo and Takeda on unrelated matters. The other authors have no potential conflicts of interest to declare. This study was presented as a poster presentation at the American Association of Colleges of Pharmacy Annual Meeting held July 2018 in Boston, MA.

PMID:34057397 | DOI:10.18553/jmcp.2021.27.6.772

Anim Biotechnol. 2021 May 31:1-9. doi: 10.1080/10495398.2021.1924182. Online ahead of print.

ABSTRACT

The objective of this study was to investigate the effects of feeding rice gluten meal (RGM) as an alternative protein source along with protease enzyme supplementation on growth performance, expression of nutrient transporter genes, nutrient digestibility, immune response and gut histomorphometry of broiler chicken. Proximate analysis of RGM revealed 923 g dry matter (DM), 500 g crude protein (CP), 69.2 g ether extract, 94.7 g crude fiber, 215.4 g nitrogen-free extract, 43.7 g ash, 6.20 g calcium, 7.80 g total phosphorus, 18.99 MJ gross energy and 12.68 MJ metabolizable energy per kg diet. Significant upregulation of nutrient transporter genes (PepT1, EAAT3 and mucin) and better growth performance was observed in the birds fed control diet which was statistically similar to the birds fed 150 g RGM compared to birds fed higher RGM levels. Histomorphometry of jejunum, nutrient digestibility, and immune response of birds did not reveal any significant effect of RGM or protease enzyme supplementation. However, the inclusion of RGM up to 150 g/kg diet resulted in significant decline of feed cost/kg live weight gain, dressed meat yield and eviscerated meat yield by 13.13%, 12.99% and 13.36%, respectively compared to control. Thus, it was concluded that the inclusion of 150 g RGM/kg diet in broiler chicken ration has no adverse effects on the growth pattern of birds and can be used for least-cost feed formulation for chicken.

PMID:34057400 | DOI:10.1080/10495398.2021.1924182

J Manag Care Spec Pharm. 2021 Jun;27(6):753-759. doi: 10.18553/jmcp.2021.27.6.753.

ABSTRACT

BACKGROUND: Traditionally, treatment for chronic conditions addressed symptoms or was disease modifying and required lifelong periodic administration and recurring costs. Cell and gene therapies for rare diseases often require a short administration period relative to their expected long-term clinical benefit. Costs have historically been recognized when the service or treatment is administered, resulting in the potential for the cost associated with the possible long-term clinical benefit of cell and gene therapies being incurred during a short administration period. Innovative payment arrangements have been proposed to improve the synchronization of the payment and the emergence of the clinical benefit. Expected payments associated with a multiyear payment arrangement will depend on many factors, but key drivers of the payments include efficacy, durability of effect, mortality, and member retention. This research extends a previous study by analyzing member retention for adult patients with certain rare diseases. OBJECTIVE: To develop member retention estimates from a US commercial payer’s perspective for adults diagnosed with certain rare diseases during a 10-year period. METHODS: Four population cohorts were examined: (1) self-insured – all subscribers, (2) self-insured – rare medical condition, (3) fully insured – all subscribers, and (4) fully insured – rare medical condition. Seven rare medical conditions were prospectively selected: cerebral palsy, cystic fibrosis, Gaucher disease, hemophilia, sickle cell disease, spina bifida, and thalassemia. We limited the study cohort to members who were either the subscriber or the subscriber’s partner and were aged 18 years or older; dependent children were excluded from the analysis, regardless of age. The IBM MarketScan Commercial Claims and Encounters research database for the 10 years ending December 31, 2016, was used as the basis for the analysis. The analysis was completed using the lifetest procedure available in version 9.4 of the SAS Software System for Windows. The Kaplan-Meier method was used to produce retention rates. A log-rank test with chi-square statistic was used to determine statistically significant differences between pairs of curves. RESULTS: The study found that the subscriber retention for the rare medical condition cohort is significantly higher than the all-subscribers cohort by at least 12 points at each 1-year period. The finding was statistically significant (P < 0.0001) for the self-insured and fully insured cohorts. At year 5, approximately 20% more of the rare medical condition cohort was retained as compared with the all-subscribers cohort regardless of payer type. In addition, the study found that the probability of retention for adults with each rare medical condition in the rare disease cohort was also statistically significantly higher than all subscribers regardless of payer type. CONCLUSIONS: In multiyear payment arrangements, it may be important to set expectations for member retention based on studies specific to particular member cohorts. Health insurers and plan administrators may have inaccurate expectations if standard assumptions based on all member populations are used. This study found that adults diagnosed with 1 of 7 rare medical conditions are retained longer, on average, than all adult subscribers. DISCLOSURES: Milliman received funding from bluebird bio for the conduct of this study and fees from AveXis, outside the submitted work. Jackson, Runyan, and Metz are employed by Milliman. Jackson and Metz are members of the American Academy of Actuaries and meet the qualification standards for performing the analyses in this report. Kenney is an independent managed care consultant and received consulting fees from Milliman during the conduct of this study; Kenney also serves as preceptor for the Massachusetts College of Pharmacy and Health Sciences, is immediate past president of the Academy of Managed Care Pharmacy, and is a member of the Massachusetts Pharmacists Association Legislative Committee.

PMID:34057393 | DOI:10.18553/jmcp.2021.27.6.753

J Manag Care Spec Pharm. 2021 Jun;27(6):696-705. doi: 10.18553/jmcp.2021.27.6.696.

ABSTRACT

BACKGROUND: Medication nonadherence in individuals with type 2 diabetes can lead to poor glycemic control, resulting in increased risk for diabetes-related complications. OBJECTIVE: To examine associations between factors (ie, drug coverage satisfaction and cost-reducing behavior) and medication nonadherence among Medicare beneficiaries with type 2 diabetes. METHODS: We analyzed the 2016 Medicare Current Beneficiary Survey Public Use File for beneficiaries aged 65 years and older with reported type 2 diabetes (n=1,430; weighted n=5,846,943). Medicare beneficiaries were considered to have medication nonadherence if they reported skipping doses or taking smaller doses than prescribed. A survey-weighted logistic model, adjusted for sociodemographics and comorbidities, was conducted to examine associations of drug coverage satisfaction and cost-reducing behavior with medication nonadherence. RESULTS: Among Medicare beneficiaries aged 65 years and older with type 2 diabetes, 10.3% reported medication nonadherence. In the adjusted analysis, the risk for medication nonadherence was higher among those who were dissatisfied with the amount paid for medications (OR = 2.43; P = 0.002) compared with those who were satisfied, and those who spent less on basic needs to save for medications were more likely to report medication nonadherence (OR = 2.23; P = 0.011) than those who did not. CONCLUSIONS: Our findings suggest that medication nonadherence among Medicare beneficiaries with type 2 diabetes is associated with dissatisfaction with the amount paid for medications and cost-reducing behavior. Interventions that lower medication costs for Medicare beneficiaries may help to improve medication adherence among this at-risk population. DISCLOSURES: No outside funding supported this study. The authors have no conflicts of interest to disclose.

PMID:34057396 | DOI:10.18553/jmcp.2021.27.6.696

J Manag Care Spec Pharm. 2021 Jun;27(6):714-723. doi: 10.18553/jmcp.2021.27.6.714.

ABSTRACT

BACKGROUND: Asthma is one of the leading chronic disease states in pediatric patients in Texas. Pharmacy-led interventions such as targeted asthma education, scheduled consultations, and monitoring have shown success in improving asthma outcomes. However, no studies have evaluated the impact of the pharmaceutical care incentive (PCI) programs on Texas Medicaid pediatric beneficiaries. OBJECTIVES: To (1) describe the prevalence of asthma medication utilization and persistent asthma among Medicaid pediatric patients in Texas Health Service Region 11 (HSR 11) and (2) describe the prevalence and impact of PCI program interventions offered by pharmacists to Medicaid pediatric patients or their caregivers at the point-of-service in their medication utilization and asthma medication ratio (AMR). METHODS: This study used a 2-year longitudinal assessment of Medicaid pharmacy claims for beneficiaries aged between 0 and 18 years, with continuous enrollment, and at least 1 asthma medication claim during 2018 and 2019. The prevalence of asthma medication utilization during the study period was described. Also, the prevalence of PCI interventions among beneficiaries with at least 1 asthma medication was described. The prevalence of PCI interventions was also estimated for beneficiaries with persistent asthma. The AMR for beneficiaries with persistent asthma was calculated and compared for those with and without at least 1 PCI intervention. RESULTS: 22,051 beneficiaries with continuous enrollment between the ages of 0 and 18 years and with at least 1 pharmacy claim for an asthma medication during the study period were included. The overall prevalence of asthma medication utilization was 14.55%. 374 (1.70%) beneficiaries with at least 1 asthma medication received at least 1 asthma PCI intervention. Among beneficiaries that received at least 1 asthma PCI intervention, 158 (42.25%) were on rescue medication only; 4 (1.07%) were on maintenance medication only; and 212 (56.68%) were on rescue and maintenance medications. The overall prevalence of persistent asthma was 4.86%. 52 (0.76%) persistent asthma cases received at least 1 asthma PCI intervention after the index date. The overall unadjusted mean AMR (SD) for the 6,885 beneficiaries with persistent asthma was 0.50 (0.19). The adjusted AMR (SD) among beneficiaries with persistent asthma was reported at 0.530 (0.026) for beneficiaries who received at least 1 PCI intervention and 0.483 (0.002) for beneficiaries who did not receive a PCI intervention (P = 0.066). Beneficiaries with persistent asthma generated 64.35% of the total asthma pharmacy claims during 2019. CONCLUSIONS: Despite a high utilization of asthma medications among Medicaid pediatric beneficiaries, pharmacists servicing this group are underusing the PCI program interventions. An increase in the AMR among patients with persistent asthma receiving PCI interventions was observed when compared with those without PCI interventions. However, the difference was not statistically significant. Subsequent studies should include larger groups of beneficiaries receiving PCI interventions to establish the effect of PCI interventions on AMR before widespread implementation. DISCLOSURES: This research project was supported by the Global Institute for Hispanic Health (GIHH) through research grant M1803961. The authors have nothing to disclose. A part of this study was presented as a poster at the AMCP 2020 Virtual Annual Meeting and Exposition Meeting, April 21-24, 2020.

PMID:34057388 | DOI:10.18553/jmcp.2021.27.6.714

J Manag Care Spec Pharm. 2021 Jun;27(6):779-784. doi: 10.18553/jmcp.2021.27.6.779.

ABSTRACT

BACKGROUND: Florida’s House Bill 21 (HB21), implemented into law on July 1, 2018, limited opioid prescriptions for acute pain to a 3-day supply. While the law has been associated with a decrease in opioid prescribing for acute pain, its effect on opioid volume dispensed at the plan level remains unknown. OBJECTIVES: To assess the impact of HB21 on the total volume dispensed of oral Schedule II opioids. We evaluated the change from before to after the law’s implementation in (1) total number of opioid units dispensed per month and (2) total morphine milligram equivalent (MMEs) dispensed per month. METHODS: Pharmacy claims from July 2017 to June 2019 were analyzed from a private health plan serving a large Florida employer. We summed the number of units and the total MMEs dispensed for each month per 1,000 enrollees. Units were defined as the total quantity of tablets/capsules dispensed for each Schedule II oral opioid prescription. We used interrupted time series (ITS) models, accounting for autocorrelation, to determine any immediate change after the policy implementation and to estimate trends before and after the policy. RESULTS: We identified 16,226 prescriptions of oral Scheduled II opioids dispensed to 6,315 enrollees over a 2-year period. The HB21 law was associated with an immediate but not statistically significant decrease of 110.25 units dispensed per 1,000 enrollees in the month after implementation (95% CI: -218.84, -1.67; P = 0.06). There was an immediate but not statistically significant decrease of 1,456.29 MMEs dispensed per 1,000 enrollees following HB21 implementation (95% CI: -2,983.87, 71.29; P = 0.07). There were no significant changes in the slopes of the trends for total number of opioid units and total MMEs dispensed after HB21. CONCLUSIONS: Despite substantial lower quantities, there were no significant immediate reductions in total opioid units and MMEs dispensed in the year following the implementation of HB21. Our findings can inform other health plans on the potential effect of such restrictive laws and policies in other states where preexisting declining trends might have a higher impact than restriction policies. Future studies are needed to evaluate long-term intended and unintended consequences, including effects on patients’ access to care, resulting from this type of restrictive law. DISCLOSURES: No outside funding supported this study. The authors report no conflicts of interest. Preliminary results of this study were presented at the Virtual ISPOR 2020 Conference held May 18-20, 2020.

PMID:34057389 | DOI:10.18553/jmcp.2021.27.6.779

J Manag Care Spec Pharm. 2021 Jun;27(6):732-742. doi: 10.18553/jmcp.2021.27.6.732.

ABSTRACT

BACKGROUND: There is concern that increasingly common use of patient assistance programs (PAPs), out-of-pocket assistance provided by manufacturers or foundations, distorts our understanding of patient behavior and insurance design incentives. Yet the current literature on prescription drug cost sharing largely overlooks their use. PAPs prevalence and impact on drug demand and price elasticity is a major knowledge gap. OBJECTIVE: To examine the use of PAPs among patients with multiple sclerosis (MS) and the association with drug demand in a specialty pharmacy program within a regional integrated health system that facilitates their use. METHODS: We used pharmaceutical claims data from December 2017 to December 2018 linked to detailed payer information from Kaiser Permanente Washington to characterize the prevalence of PAPs for users of 7 MS specialty drug molecules. We estimated price elasticity of demand (PED) in a two-part model by using the presence of copayment assistance as a source of cost variation. The first part estimated marginal probability of a claim in a given month with a probit model, comparing PAP users and nonusers, whereas the second part estimated days supplied of a medication, given a claim was made as a measure for demand. RESULTS: Of 789 unique patients, 480 (60.7%) used PAPs in at least 1 drug claim during the 13-month time frame, and 248 patients (31.4%) used PAPs for all of their MS drug claims. When used, copay assistance covered 100% of out-of-pocket (OOP) charges for 98% of claims and reduced patient annual OOP cost by $3,493 on average. People who used PAPs had much higher OOP charges, a lower Charlson comorbidity score, and were more likely to have insurance through an exchange. The OOP costs charged to patients was higher for claims where patient assistance was used than claims where assistance was not used ($294 vs $42, P < 0.001). Total claim amount was higher for claims that used assistance ($6,169) than claims that did not ($5,503, P < 0.001). The probability of a patient having a drug claim in a given month was 1.9% higher among those using patient assistance, although this finding was not significant (P = 0.258). An average change in price of -$168.21 with PAP use led to an average change in demand of -0.05 days, for an overall price elasticity of demand (SD = 0.028, P = 0.852) given PAP use of 0.005, indicating that the presence of PAPs did not significantly affect demand. PED estimates were not statistically significant by drug, and the exclusion of Medicare patients did not change this interpretation. CONCLUSIONS: In a mid-size integrated health system in the state of Washington, a program that promotes adherence to specialty drugs via facilitated PAP use was found to reduce patient OOP costs but had no effect on prescription drug utilization. Payers may consider embracing PAPs to remove patient financial barriers to necessary medications and use tools other than cost sharing to influence patient consumption of specialty drugs. DISCLOSURES: This manuscript was funded in part through a Pre-Doctoral Fellowship in Health Outcomes from the PhRMA Foundation awarded to Brouwer for the completion of her dissertation work. Yeung receives some salary support from Kaiser Permanente. The other authors have nothing to disclose.

PMID:34057391 | DOI:10.18553/jmcp.2021.27.6.732

J Dermatolog Treat. 2021 May 31:1-10. doi: 10.1080/09546634.2021.1937484. Online ahead of print.

ABSTRACT

INTRODUCTION: Data on pediatric HS presentation and response to treatment are limited. We investigated disease characteristics, prescribed treatments, and treatment responses in a pediatric HS cohort.

METHODS: Pediatric HS patients were identified through an electronic medical record search using ICD9/10 codes for HS. Inclusion criteria included a diagnosis of HS before 18 years of age. Data on demographics, disease presentation, and treatment was collected.

RESULTS: 73 patients (59 female, 14 male) were identified. Mean age of symptom onset was 12.6 +/- 2.9 years (range 6-17). Axillary involvement disproportionately affected males (92.9% v 62.7%, p = 0.029), while females had higher groin (59.3% v 28.6%, p = 0.038) involvement. Non-White patients trended toward disproportionately presenting with Hurley-2/3 disease (44.1% v 21.1%, p = 0.093), while females trended toward having a younger age of symptom onset (12.3 v 13.9, p = 0.063), and higher likelihood of HS treatment (93.2% v 78.6%, p = 0.094). The most frequently prescribed treatments were topical clindamycin (61.6%), doxycycline (35.6%), and benzoyl peroxide wash (31.5%).

CONCLUSIONS: Pediatric HS patients have varied presentations and response to treatment. Further studies are needed to characterize the disease and the most effective treatments.

PMID:34057384 | DOI:10.1080/09546634.2021.1937484