Implications of Recent Controlled Substance Policy Initiatives

Recent legislative and regulatory activity designed to address controlled substance diversion and overuse of narcotics is having a significant impact on prescription drug utilization and patient care in the United States. Although providers and patients are the focus of these new requirements, the designers and implementers of formularies and medication use protocols need to be aware of salient features of these initiatives. Formulary drug product selection, prior authorization procedures and drug utilization strategies should be reconsidered in accordance with the changes in controlled substance oversight. The primary focus of this article involves recent approaches to controlling the illegal acquisition of licit prescriptions, particularly opioid pain relievers (OPR). According to the Centers for Disease Control and Prevention (CDC), in 2008 OPRs were involved in 74% of the 20,000 fatal prescription drug overdoses in the United States. This represents an increase of over 300% since 1999 and these fatalities now exceed death by cocaine and heroin combined. [Interestingly, the death rate varied five-fold by state, largely reflecting different levels of opioid regulation and oversight. They also noted that sales of OPRs quadrupled between 2000 and 2010 and that OPR abuse cost health insurers over $72 billion annually in healthcare costs

Demographics and the Cost of Pharmaceuticals in a Private Third-Party Prescription Program

Objective: To compare variance in the cost of pharmaceuticals attributable to demographic variables with variance explained by plan characteristics, using prescription claims data within various therapeutic categories, and to examine differences in average cost of pharmaceuticals among demographic variables after controlling for covariates. Design: Retrospective, cross-sectional study. Data Collection: Data for this study were obtained from 1996 prescription claims information for the commercial population administered by a Rhode Island-based pharmacy benefit management (PBM) company. Six therapeutic categories with the highest expenditures were analyzed. Information on claims for six drug categories was extracted using database management software. Statistical analyses using multiple regression and analysis of covariance were carried out. Results: Plan characteristics outperformed demographic variables sixteenfold for all drug categories combined in explaining variance in cost of pharmaceuticals among plan enrollees. Average cost of pharmaceuticals differed among demographic variables such as age, gender, location, and place of employment after controlling for average wholesale price and days supply. Conclusions: The results obtained in this study have practical significance in the determination of capitation rates when utilization history of prospective members is not available. In this situation, managed care organizations (MCOs) or PBMs may have to set capitation rates based solely on eligibility data. Significant differences in average drug costs among the members based on place of employment suggest that benefit managers should consider differentiating capitation rates according to their clients\u27 businesses. Finally, the data from this study indicated that commercial members residing in Tennessee had the lowest average cost of pharmaceuticals among all states evaluated. The fact that one PBM manages more than 80% of the TennCare prescription program along with a significant commercial client base suggests that a spillover effect may exist

Treating clinical mastitis in dairy cows with essential oils

Clinical mastitis is the main concern in dairy farming today, but there are very few drugs that are compatible with organic specifications. Our study was conducted in order to evaluate the therapeutic efficiency of the intramammary infusion of three essential oils, Thymus vulgaris, Rosmarinus verbenone and Laurus nobilis. Fifty-five cases of mastitis were treated with 10 ml of a mixture of the three oils (1.5% each in sunflower oil). Forty-five others were treated with 10 ml of a mixture of Thymus vulgaris and Rosmarinus verbenone (6% of each in sunflower oil or in water). The recovery rate was only 40%, which is deemed unsatisfactory

The Risk of Hepatotoxicity with Fluoroquinolones: A National Case-Control Safety Study

Purpose. Fluoroquinolones are generally considered safe and well-tolerated. However, suspected fluoroquinolone induced hepatotoxicity has been increasingly reported, but data are lacking. Thus, the objective of this study was to assess the risk of hepatotoxicity in patients using fluoroquinolones compared to non-users. Methods. National Veterans Affairs (VA) hospital admissions were assessed between January 1, 2002 and December 31, 2008. Our case-control study matched patients with a primary diagnosis of hepatotoxicity (cases) to those with myocardial infarction (controls) on admission date (matched up to 1:6). Conditional logistic regression was used to compute adjusted odds ratios (OR) and 95% confidence intervals (CI) of hepatotoxicity associated with fluoroquinolone exposure. Results. Our study included 7,862 cases and 45,512 matched controls. The majority of study patients were white (63.4%), males (97.7%), with a mean age of 61 years. After adjusting for confounders, fluoroquinolone use was significantly associated with a 20% increased risk of hepatotoxicity development (OR 1.20, 95% CI 1.04-1.38) compared to non-users. A statistically significant increased risk of hepatotoxicity was associated with ciprofloxacin use individually (OR 1.29, 95% CI 1.05-1.58), but not with levofloxacin or moxifloxacin use. Conclusion. The use of fluoroquinolones was associated with an increased risk of hepatotoxicity relative to non-users in our national VA study population

Wireless coils based on resonant and nonresonant coupled-wire structure for small animal multinuclear imaging

Earlier work on RF metasurfaces for preclinical MRI has targeted applications such as whole‐body imaging and dual‐frequency coils. In these studies, a nonresonant loop was used to induce currents into a metasurface that was operated as a passive inductively powered resonator. However, as we show in this study, the strategy of using a resonant metasurface reduces the impact of the loop on the global performance of the assembled coil. To mitigate this deficiency, we developed a new approach that relies on the combination of a commercial surface coil and a coupled‐wire structure operated away from its resonance. This strategy enables the extension of the sensitive volume of the surface coil while maintaining its local high sensitivity without any hardware modification. A wireless coil based on a two parallel coupled‐wire structure was designed and electromagnetic field simulations were carried out with different levels of matching and coupling between both components of the coil. For experimental characterization, a prototype was built and tested at two frequencies, 300 MHz for 1H and 282.6 MHz for 19F at 7 T. Phantom and in vivo MRI experiments were conducted in different configurations to study signal and noise figures of the structure. The results showed that the proposed strategy improves the overall sensitive volume while simultaneously maintaining a high signal‐to‐noise ratio (SNR). Metasurfaces based on coupled wires are therefore shown here as promising and versatile elements in the MRI RF chain, as they allow customized adjustment of the sensitive volume as a function of SNR yield. In addition, they can be easily adapted to different Larmor frequencies without loss of performance

Magnetic Resonance Thermometry at 7T for Real-Time Monitoring and Correction of Ultrasound Induced Mild Hyperthermia

While Magnetic Resonance Thermometry (MRT) has been extensively utilized for non-invasive temperature measurement, there is limited data on the use of high field (≥7T) scanners for this purpose. MR-guided Focused Ultrasound (MRgFUS) is a promising non-invasive method for localized hyperthermia and drug delivery. MRT based on the temperature sensitivity of the proton resonance frequency (PRF) has been implemented in both a tissue phantom and in vivo in a mouse Met-1 tumor model, using partial parallel imaging (PPI) to speed acquisition. An MRgFUS system capable of delivering a controlled 3D acoustic dose during real time MRT with proportional, integral, and derivative (PID) feedback control was developed and validated. Real-time MRT was validated in a tofu phantom with fluoroptic temperature measurements, and acoustic heating simulations were in good agreement with MR temperature maps. In an in vivo Met-1 mouse tumor, the real-time PID feedback control is capable of maintaining the desired temperature with high accuracy. We found that real time MR control of hyperthermia is feasible at high field, and k-space based PPI techniques may be implemented for increasing temporal resolution while maintaining temperature accuracy on the order of 1°C