bluuebunny/crossref_metadata_2025 huggingface dataset:
Perspective of Vaccine Manufacturers on Financing Pediatric and Adolescent Vaccines in the United States
Authors: Shen Angela K. , Rodewald Lance E. , Birkhead Guthrie S.
Published: November 2009

OBJECTIVE: The goal was to understand vaccine manufacturers' perspectives on vaccine financing as a barrier to immunization.

METHODS: Individual telephone interviews with representatives of the 6 manufacturers that produce routinely recommended vaccines for children and adolescents in the United States were conducted in November and December 2006.

RESULTS: Although manufacturers acknowledged that the price of newer vaccines presents challenges to optimal vaccine use, they asserted that children and adolescents have access to vaccinations through public and private insurance. Respondents suggested that the system could be improved through adequate funding of the public-sector safety net. Respondents stated that providers should receive timely reimbursement for the full costs of vaccine purchase and administration, and manufacturers who sell directly to health care providers may provide flexible payment terms for vaccine purchases. Manufacturers supported targeted expansion of the Vaccines for Children program to allow children with incomplete insurance coverage for vaccines to receive vaccines at health department clinics. Manufacturers perceived delays in publication of Advisory Committee on Immunization Practices recommendations as a potential barrier to vaccine uptake. They viewed the perceived lack of public value for vaccines as a potential barrier to adequate reimbursement and optimal utilization. Respondents also maintained that their ability to negotiate vaccine prices through the private market is a crucial priority.

CONCLUSIONS: Manufacturers assert that children and adolescents have access to immunizations through public and private insurance. Manufacturers think that they have mitigated the challenge most directly in their control: the large financial outlays required for up-front vaccine purchases.
Pediatrician-Family-Patient Relationships: Managing the Boundaries
Authors:   Committee on Bioethics
Published: November 2009

This Policy Statement was reaffirmed January 2014 and October 2020.

All professionals are concerned about maintaining the appropriate limits in their relationships with those they serve. Pediatricians should be aware that, under normal circumstances, caring for one's own children presents significant ethical issues. Pediatricians also must strive to maintain appropriate professional boundaries in their relationships with the family members of their patients. Pediatricians should avoid behavior that patients and parents might misunderstand as having sexual or inappropriate social meaning. Romantic and sexual involvement between physicians and patients is unacceptable. The acceptance of gifts or nonmonetary compensation for medical services has the potential to affect the professional relationship adversely.
Supplemental Security Income (SSI) for Children and Youth With Disabilities
Authors:   Council on Children With Disabilities
Published: November 2009

This Policy Statement was reaffirmed February 2015 and August 2021.

The Supplemental Security Income (SSI) program remains an important source of financial support for low-income families of children with special health care needs and disabling conditions. In most states, SSI eligibility also qualifies children for the state Medicaid program, providing access to health care services. The Social Security Administration (SSA), which administers the SSI program, considers a child disabled under SSI if there is a medically determinable physical or mental impairment or combination of impairments that results in marked and severe functional limitations. The impairment(s) must be expected to result in death or have lasted or be expected to last for a continuous period of at least 12 months. The income and assets of families of children with disabilities are also considered when determining financial eligibility. When an individual with a disability becomes an adult at 18 years of age, the SSA considers only the individual's income and assets. The SSA considers an adult to be disabled if there is a medically determinable impairment (or combination of impairments) that prevents substantial gainful activity for at least 12 continuous months. SSI benefits are important for youth with chronic conditions who are transitioning to adulthood. The purpose of this statement is to provide updated information about the SSI medical and financial eligibility criteria and the disability-determination process. This statement also discusses how pediatricians can help children and youth when they apply for SSI benefits.
The Effects of Chilean Coho Salmon and Rainbow Trout Aquaculture on Markets for Alaskan Sockeye Salmon
Authors: Williams Abby , Herrmann Mark , Criddle Keith R.
Published: November 2009

A simultaneous-equation equilibrium model of international salmonid markets is used to examine the combined effect of variability in the landings of Alaska's sockeye salmon Oncorhynchus nerka and increases in the production of Chile's Atlantic salmon Salmo salar, coho salmon O. kisutch, and rainbow trout O. mykiss on Alaska's sockeye salmon exvessel prices and revenues. While Atlantic salmon, coho salmon, and rainbow trout from Chile and sockeye salmon from Alaska are not identical commodities, they compete in many of the same domestic and international markets, and Alaska's earnings in those markets have declined as Chile's production has increased. Although Alaska's average annual harvests have remained nearly constant, Alaska's production is now a small percentage of the total salmonid production in a world that eats significantly more salmonids than it did 25 years ago. Nevertheless, our model indicates that sockeye salmon prices continue to be sensitive to interannual variations in the quantity of sockeye salmon harvested in Alaska and to changes in the quantity of Atlantic salmon, coho salmon, and rainbow trout produced in Chile. However, the model indicates that exvessel revenues are less sensitive than exvessel prices and that Alaska's recent levels of sockeye salmon landings have been near the maximum of the total exvessel revenue curve. In addition, the model suggests that because Alaska's share of the production of high-value salmon (Chinook, coho, and sockeye salmon) has declined, exvessel prices for sockeye salmon are now less sensitive to changes in Chilean production of Atlantic salmon, coho salmon, and marine-reared rainbow trout. The implication of these findings is that, under current market conditions, exvessel revenues from Alaska's sockeye salmon fisheries can be maximized by maintaining catches at or near historic levels and that exvessel prices are unlikely to continue to decline as rapidly as they did in the 1990s.
Potential Sources of Survey Bias Associated with Hand-Retrieved Longline Catches of Subadult Sharks in Georgia Estuaries
Authors: Belcher Carolyn N. , Jennings Cecil A.
Published: November 2009

Lunar phase, tide stage, and bait type were examined as potential sources of survey bias affecting catch rates of subadult sharks on hand-retrieved longlines in Georgia estuaries. Sampling occurred during April–September from 2001 to 2003 in eight of Georgia's nine estuaries; this sampling period coincides with the pupping seasons for a variety of shark species. The effects of lunar phase and tide stage on catch rates of sharks were evaluated during 2001 and 2002. The effect of bait type (i.e., squid Loligo spp. or spot Leiostomus xanthurus) on shark catch rates was evaluated during 2003. During 2001 and 2002, 420 subadult sharks representing two families (Carcharhinidae and Sphyrnidae) and nine species were caught during 212 longline sets. Catch rates were evaluated for the four most commonly occurring shark species: the Atlantic sharpnose shark Rhizoprionodon terraenovae, bonnethead Sphyrna tiburo, blacktip shark Carcharhinus limbatus, and sandbar shark C. plumbeus. Neither lunar phase nor tide stage affected catch rates of any species other than blacktip sharks. In 2003, longline sets (n = 80) resulted in the capture of 177 subadult sharks from seven species. Overall catch rates were higher with squid bait than with spot, and bait type also affected shark species catch composition. Mean sizes of Atlantic sharpnose sharks were significantly different between the two bait types, indicating a possible ontogenetic shift in bait preference. For example, catch of neonate Atlantic sharpnose sharks was higher on hooks baited with squid than on hooks baited with spot, whereas catch of juveniles was higher on hooks baited with spot. Although timing of sampling events did not influence catch rates of subadult sharks, bait choice could bias estimates of abundance for certain life stages and affect the probability of detecting some species.
Microsatellite Stock Identification of Chum Salmon on a Pacific Rim Basis
Authors: Beacham Terry D. , Candy John R. , Wallace C. , Urawa Shigehiko , Sato Shunpei , Varnavskaya Natalia V. , Le Khai D. , Wetklo Michael
Published: November 2009

The variation at 14 microsatellite loci was analyzed for more than 53,000 chum salmon Oncorhynchus keta from 381 locations ranging from Korea to Washington State and used to estimate the stock composition of mixed-stock fishery samples. High resolution of the samples was possible, the number of reporting groups being distributed as follows: Korea = 1, Japan = 7, Russia = 8, Alaska = 15, Canadian Yukon River = 5, British Columbia = 16, and Washington State = 5. The number of alleles observed at a locus was related to the power of the locus in providing accurate estimates of the stock composition of single population mixtures. Approximately 800 alleles were observed across the 14 microsatellites, providing the basis for high-resolution stock identification. Analysis of known-origin samples indicated that accurate regional estimates of stock composition were obtained. The estimated stock compositions of mixed-fishery samples from coastal Japan, the Sea of Okhotsk, the western Pacific Ocean, the Gulf of Alaska, and coastal British Columbia were quite different among samples and clearly reflected the presence of local populations. Microsatellites have provided the ability to obtain accurate estimates of the stock composition of chum salmon from many locations in the Pacific Rim.
Mixed-Stock Analysis of Lake Sturgeon in the Menominee River Sport Harvest and Adjoining Waters of Lake Michigan
Authors: Bott Kristin , Kornely Gregory W. , Donofrio Michael C. , Elliott Robert F. , Scribner Kim T.
Published: November 2009

Lack of information about the rates and sources of population-specific mortality and habitat use during nonspawning periods has impeded the restoration of lake sturgeon Acipenser fulvescens. Using eight microsatellite loci and mixed-stock analyses, we estimated the proportional contributions of spawning populations from throughout the Lake Michigan basin (n = 5) to the fall sport fishery in the lower Menominee River, Wisconsin. We compared estimates of harvest composition with estimates from collections made in adjacent open-water habitats in Green Bay. The analyses revealed that 81% (90% confidence interval [CI] = 72.9–89.3%; N = 104) of harvested individuals originated from the Menominee River; all of the bycaught fish originated in adjacent streams. The harvest composition estimates differed significantly from those of open waters immediately offshore (26.7% Menominee River; 90% CI = 9.7–44.8%; N = 36) and across Green Bay (27% Menominee River; 90% CI = 19.5–34.7%; N = 214), indicating that the harvest was not a random sample from across the basin. The harvest composition estimates were not consistent with the estimates of individuals in prespawning condition (females = 50%; males = 83%), suggesting that not all of the harvested fish were staging for spring spawning. The contributions of nontargeted and numerically depressed populations to the fishery are of management concern given efforts to rehabilitate populations. Spatially restricted harvests during nonbreeding periods may not protect numerically depressed populations originating in nearby streams.
A Spatially Explicit Model to Predict Walleye Spawning in an Eastern Lake Ontario Tributary
Authors: Kelder Brian F. , Farrell John M.
Published: November 2009

Field egg collections coupled with physical habitat measurements were used to develop, apply, and validate a spatially explicit model to predict the spawning sites of walleyes Sander vitreus in an eastern Lake Ontario tributary. We collected 22,246 walleye eggs using passive traps and measured the attendant habitat variables, including substrate composition and heterogeneity, water depth and velocity, and cumulative spring water temperature. The squared term that we used for water depth in our regressions and selected over linear and polynomial fits better represented the relationship between spawning probability and depth. To predict walleye spawning likelihood, we developed 10 candidate models based on the available spawning data; following an information-theoretic approach, we compared the models by means of Akaike's information criterion. The best model had an area under the receiver operating curve of 0.89 and a weight of evidence of 0.32, where the probability of spawning (egg presence) was associated with predominance of course substrate and shallow depth and timing was associated with the accumulated spring water temperature. The model was applied to the study stream and validated by additional egg collections. The model correctly classified egg presence/absence in 66.7% (10 of 15) of egg traps in the initial validation sample. After a high-flow event, classification success decreased to only 20% (3 of 15 traps), probably because of the redistribution of eggs to less suitable habitats in depositional areas. Prediction of walleye spawning distribution allows for reach-scale assessment of critical habitat to help guide spawning habitat restoration efforts.
Physiological Development and Vulnerability to Ceratomyxa shasta of Fall-Run Chinook Salmon in the Upper Klamath River Watershed
Authors: Maule Alec G. , VanderKooi Scott P. , Hamilton John B. , Stocking Richard , Bartholomew Jerri
Published: November 2009

We evaluated a stock for restoring runs of fall Chinook salmon Oncorhynchus tshawytscha in the Upper Klamath River basin by monitoring its development in Iron Gate Hatchery and in net-pens in the Williamson River and Upper Klamath Lake in Oregon. We transferred age-1 hatchery fall Chinook salmon to net-pens in October 2005 and age-0 fall Chinook salmon in May 2006. Indices of smolt development were assessed in the hatchery and after 3 and 14 d in net-pens. Based on gill Na+, K+-ATPase activity and plasma thyroxine (T4) concentration, age-1 Chinook salmon were not developing smolt characteristics in the hatchery during October. Fish transferred to the river or lake had increased plasma cortisol in response to stress and increased T4 accompanying the change in water, but they did not have altered development. Variables in the age-0 Chinook salmon indicated that the fish in the hatchery were smolting. The fish in the river net-pens lost mass and had gill ATPase activity similar to that of the fish in the hatchery, whereas the fish transferred to the lake gained mass and length, had reduced condition factor, and had higher gill ATPase than the fish in the river. These results, along with environmental variables, suggest that the conditions in the lake were more conducive to smoltification than those in the river and thus accelerated the development of Chinook salmon. No Chinook salmon in the hatchery or either net-pen became infected with the myxosporean parasite Ceratomyxa shasta (the presence of which in the river and lake was confirmed) during either trial or when held for 90 d after a 10-d exposure in net-pens (2006 group). We concluded that that there is little evidence of physiological impairment or significant upriver vulnerability to C. shasta among this stock of fall Chinook salmon that would preclude them from being reintroduced into the Upper Klamath River basin.
The Incidence and Consequences of Barotrauma in Fish in the St. Lawrence River
Authors: Schreer Jason F. , Gokey Jason , DeGhett Victor J.
Published: November 2009

Barotrauma is increasingly being recognized as a serious conservation and management issue in catch-and-release fisheries. Barotrauma results from decompression that can cause physiological alterations and physical injuries. During the summers of 2007 and 2008, we angled for fish in the St. Lawrence River to determine the incidence of barotrauma injuries and the related mortality rates. An angler survey was also conducted in 2008. A total of 212 fish were caught at depths ranging from 1 to 21 m. Sixty-three fish (30%) showed signs of barotrauma, 99% of these being smallmouth bass Micropterus dolomieu, walleyes Sander vitreus, and yellow perch Perca flavescens. These three species represented 77% of all the fish caught and, excluding round goby Neogobius melanostomus, represented 94% of the fish caught at depths greater than 6 m. Signs of barotrauma were bloating (89%), loss of equilibrium (66%), stomach eversion (62%), bulging eyes (18%), hemorrhaging in the eyes and fins (12%), and anal eversion (5%). Most fish had multiple signs, approximately 50% showing loss of equilibrium, bloating, and stomach eversion. The incidence of barotrauma increased with depth, first appearing at 6.1 m. There was a threshold at approximately 10 m, from which the incidence rapidly increased to 100% at 21 m. Mortality occurred in 67% of the fish with barotrauma, even in those with less severe signs (e.g., mild bloating and slight loss of equilibrium only when stationary) and showed a similar rate of increase starting at 9 m. There were interspecific differences in the susceptibility to barotrauma that may be related to habitat preferences and physiological and physical differences that should be considered when targeting different species and depths.
Seasonal Movement of Dolly Varden and Cutthroat Trout with Respect to Stream Discharge in a Second-Order Stream in Southeast Alaska
Authors: Bryant M. D. , Lukey M. D. , McDonell J. P. , Gubernick R. A. , Aho R. S.
Published: November 2009

The relationship between the movement of small (<150-mm) Dolly Varden Salvelinus malma and cutthroat trout Oncorhynchus clarkii and stream discharge is not well known in streams of southeast Alaska. We measured movement in a small headwater stream using passive integrated transponder (PIT) tags and stationary antennas to record time and date of movement. Fish with PIT tags were detected by transceivers and stationary antennas in the stream. The date and time of detection at an antenna were matched with stream discharge (m3/s) at the same date and time. Most Dolly Varden moved upstream during late summer and early fall. Most cutthroat trout movement was in May, and movement declined through the summer. Few fish moved during the winter. Most fish moved within a narrow discharge range, with a few moving at higher discharges. More than 97% of fish from both species were detected as moving upstream at discharges below the 5% exceedance level during the 4-year period of discharge measurements. Dolly Varden and cutthroat trout moved throughout the entire length of usable habitat in the stream. Connectivity throughout watersheds even within headwater streams is important and can be maintained for these species by use of road crossings that ensure passage over a range of flow conditions such as those described here.
Accuracy and Precision of Estimates of Back-Calculated Channel Catfish Lengths and Growth Increments Using Pectoral Spines and Otoliths
Authors: Michaletz Paul H. , Nicks Dean M. , Buckner Earl W.
Published: November 2009

Back-calculation of lengths at previous ages using measurements of growth increments on the bony structures of fish is a common practice, yet studies validating this procedure are few. Our objective was to determine the accuracy and precision of back-calculated lengths and the last growth increment for channel catfish Ictalurus punctatus using pectoral spines and otoliths. In recent studies, the last growth increment has been related to the length of the fish at the start of the growing season to determine size-specific growth. Growth increments on basal sections of pectoral spines were measured along three radii—posterior (SP), anterior (SA), and lateral (SL)—and otoliths were measured along the ventral radius by three independent readers. Back-calculated lengths derived from eight models (biological intercept, body-proportional hypothesis [BPH] linear, BPH nonlinear, Dahl–Lee, Fraser–Lee, Morita–Matsuishi, scale-proportional hypothesis [SPH] linear, and SPH nonlinear) for each bony structure radius were compared with the actual growth histories of captive channel catfish to determine the best model and radius (for pectoral spines) for the two bony structures. The SPH linear model for SL provided the most accurate data for pectoral spines and was also appropriate for otoliths. Back-calculated lengths and last growth increments were considerably more accurate and precise for SL than for otoliths. The SPH linear model provided an initial length–last growth increment relationship that was similar to the observed relationship for SL but not for otoliths. We also estimated last growth increments and the initial length–last growth increment relationship from the traditionally used Dahl–Lee model for SP and found that these estimates were similar to those derived from the SPH linear model for SL. We recommend using the SPH linear model for SL to estimate length-at-age and growth increment data. However, the Dahl–Lee model for SP also provides reasonable estimates of the last growth increment.
Physiological Stress Responses of Rio Grande Silvery Minnow: Effects of Individual and Multiple Physical Stressors of Handling, Confinement, and Transport
Authors: Cho Sung Jin , Caldwell Colleen A. , Gould William R.
Published: November 2009

In an attempt to reestablish populations of Rio Grande silvery minnow Hybognathus amarus within its former range, initiatives were set forth to propagate the species in hatcheries, augment wild populations through repatriation, and rescue the species from isolated and receding pools. Physical stressors associated with these recovery efforts, however, result in stress that increases the vulnerability of the minnow to opportunistic pathogens and predation, possibly decreasing poststocking survival. We assessed the physiological stress response to standard management practices by characterizing the changes in plasma cortisol, glucose, and osmolality. When subjected to the individual stressors of 30 s of handling, 3 h of confinement (density, 100 kg/m3), or 3 h of transport (density, 40 kg/m3), moderate changes in plasma glucose and plasma osmolality were observed during recovery whereas changes in plasma cortisol were not detectable. When fish were subjected to consecutive stressors (30 s of handling only, 30 s of handling plus 3 h of confinement, or 30 s handling plus 3 h of confinement and 3 h of transport), plasma glucose exhibited a cumulative increase that was not observed for plasma cortisol. This increase in plasma glucose was observed within 3 h poststress when fish were subjected to a single stressor (22 mg/dL), two consecutive stressors (28 mg/dL), and three consecutive stressors (63 mg/dL). Plasma osmolality decreased from 282 to 269 mosmol/kg (compared with unstressed levels of 279 mosmol/kg) when minnows were subjected to three consecutive stressors, indicating moderate osmoregulatory dysfunction. Plasma glucose and osmolality returned to unstressed levels within 48 h, indicating that the species can regain its physiological homeostasis within a relatively short time as long as the stressors are reasonable in duration and intensity.
Risk of Upper Gastrointestinal Complications Associated with Cyclooxygenase‐2 Selective and Nonselective Nonsteroidal Antiinflammatory Drugs
Authors: Castellsague Jordi , Holick Crystal N. , Hoffman Clorinda C. , Gimeno Victoria , Stang Mary‐Rose , Perez‐Gutthann Susana
Published: November 2009

Study Objective. To estimate the risk of upper gastrointestinal complications associated with use of cyclooxygenase‐2 (COX‐2) selective (celecoxib and rofecoxib) and individual nonselective nonsteroidal antiinflammatory drugs (NSAIDs) compared with nonuse of these drugs.

Design. Nested case‐control study.

Data Source. Administrative health care databases of Saskatchewan, Canada.

Patients. Among a population of men and women aged 20–89 years who were covered by public health insurance with prescription drug benefits between November 15, 1999, and December 31, 2001, 726 case patients with first hospitalization for upper gastrointestinal complications (with validation of cases through review of hospital medical records) were confirmed from 1,054,532 person‐years of follow‐up, and 20,002 control patients were randomly selected from all eligible controls, frequency matched to cases on their index date (± 3 mo).

Measurements and Main Results. Logistic regression was used to estimate adjusted odds ratios (ORs) and 95% confidence intervals (CIs) for the association between upper gastrointestinal complications and use of NSAIDs. Current rofecoxib and naproxen users had the highest risk for upper gastrointestinal complications with adjusted ORs of 3.6 (95% CI 2.2–5.7) and 3.4 (95% CI 1.8‐6.7), respectively. No association was found between the risk of upper gastrointestinal complications and use of celecoxib (OR 1.1, 95% CI 0.7‐1.8) or the use of diclofenac plus misoprostol (OR 0.7, 95% CI 0.3‐1.8). A dose‐response relationship was observed for rofecoxib and naproxen with ORs for high dose of 5.2 (95% CI 2.5–10.6) and 5.1 (95% CI 2.1–12.3), respectively. Short‐term users of celecoxib and naproxen had a higher risk than long‐term users, whereas among users of rofecoxib the risk was higher among long‐term than short‐term users.

Conclusion. These findings support the variability of individual NSAIDs in the elevated risk of upper gastrointestinal complications. Our results suggest that the risk for rofecoxib is similar to that for naproxen. Celecoxib users appear to have a similar risk for upper gastrointestinal complications as nonusers; however, the risk may be increased at the start of treatment with celecoxib.
Last‐Observation‐Carried‐Forward Imputation Method in Clinical Efficacy Trials: Review of 352 Antidepressant Studies
Authors: Woolley Stephen B. , Cardoni Alex A. , Goethe John W.
Published: November 2009

Study Objective. To determine the prevalence, over 40 years, of using the last‐observation‐carried‐forward (LOCF) imputation method in clinical trials, the association between use of LOCF and how the trials were conducted, and the extent of information about attrition and LOCF use in published reports.

Design. Retrospective analysis of the reports of randomized antidepressant efficacy trials published over a 40‐year period (1965–2004).

Data Sources. MEDLINE database, Cochrane reviews, reference‐ and bibliography‐based manual search, and publication list services.

Measurements and Main Results. A total of 352 trials met the following criteria for analysis: antidepressant comparative efficacy trial, randomized design, patients with major depressive disorder, English‐language article, published during 1965–2004, and first report of a trial. Design, attrition, and data analysis characteristics were recorded by investigators and trained assistants. Analyses included descriptive statistics of the trial size, duration, and number of patients who dropped out in LOCF versus non‐LOCF studies, as well as the extent to which dropouts and the potential bias associated with attrition was discussed in the published report. The frequency of published antidepressant clinical trials increased from less than 1 trial/year (1965–1974) to 19 trials/year (1990–1994). Trials using the LOCF method were significantly larger than non‐LOCF trials (p<0.01), and the proportion of subjects dropping out was significantly greater (p<0.05) in LOCF versus non‐LOCF trials. The proportion of subjects dropping out remained relatively constant over time (˜30%) but was significantly greater among LOCF (30.9%) than non‐LOCF (28.8%) trials (p<0.01). The LOCF study articles were more likely to report dropouts, but only 7% of these articles reported outcomes recorded for subjects before they dropped out. Less than 16% of articles discussed bias associated with dropouts, 6.8% discussed the direction of bias, and only about 2% suggested the magnitude of the bias.

Conclusion. The percentage of clinical antidepressant trials using the LOCF method and the percentage of study subjects' data imputed by using LOCF increased many‐fold during 1965–2004. Published reports of trials provided little information to allow readers to assess possible bias introduced by use of the LOCF method.
Patterns and Predictors of Discontinuation of Rhythm‐Control Drug Therapy in Patients with Newly Diagnosed Atrial Fibrillation
Authors: Kim Michael H. , Klingman David , Lin Jay , Battleman David S.
Published: November 2009

Study Objective. To assess patterns and predictors of discontinuation of rhythm‐control drug therapy in managed care patients with newly diagnosed atrial fibrillation and the direct medical costs of atrial fibrillation in these patients.

Design. Retrospective cohort study.

Data Source. PharMetrics Patient‐Centric Database.

Patients. A total of 3549 adults with a new diagnosis of atrial fibrillation between April 1, 2002, and March 31, 2006, and who had at least one claim for rhythm‐control drug therapy within 6 months of the initial diagnosis.

Measurements and Main Results. Discontinuation (defined as a gap in rhythm‐control drug therapy coverage [days' supply] 30 days) was assessed after the initiation of rhythm‐control therapy. Among the 3549 patients included in the analysis, 2688 (75.7%) discontinued initial rhythm‐control therapy in the first 12 months, with a median time to discontinuation of 89 days. Significant predictors of rhythm‐control therapy discontinuation included cardiac arrest (odds ratio [OR] 2.24, 95% confidence interval [CI] 1.04‐4.83), history of coronary artery bypass graft surgery (OR 2.03, 95% CI 1.02–4.05), valvular heart disease (OR 1.67, 95% CI 1.33‐2.09), ischemic heart disease (OR 1.44, 95% CI 1.13‐1.82), and severity of illness (Charlson Comorbidity Index score; OR 1.09, 95% CI 1.01‐1.17). Over 12 months, 661 (18.6%) of the 3549 patients had a hospital stay and 285 (8.0%) had an emergency department visit that were related to atrial fibrillation. Total annual atrial fibrillation‐related costs/patient were $6165: $3872 for inpatient costs, $1503 for outpatient costs, and $790 for pharmacy costs.

Conclusion. Initial rhythm‐control drug therapy is associated with a high rate of discontinuation, especially early in therapy. Such rates of discontinuation will likely have an impact on the effectiveness of disease management and the quality of care in patients with atrial fibrillation.
Impact of Dexmedetomidine on Analgesic Requirements in Patients After Cardiac Surgery in a Fast‐Track Recovery Room Setting
Authors: Barletta Jeffrey F. , Miedema Sherri L. , Wiseman Douglas , Heiser John C. , McAllen Karen J.
Published: November 2009

Study Objective. To compare postoperative opioid requirements in patients who received dexmedetomidine versus propofol after cardiac surgery.

Design. Retrospective cohort study.

Setting. Large, community teaching hospital that uses a fast‐track cardiovascular recovery unit (CVRU) model.

Patients. One hundred adults who underwent coronary artery bypass graft surgery and/or valvular surgery, and who received either dexmedetomidine (50 patients) or propofol (50 patients) for perioperative sedation.

Measurements and Main Results. Patients were matched according to surgery type and left ventricular ejection fraction. Opioid requirements were assessed over two time intervals: from arrival in the CVRU to discontinuation of the sedative infusion, and from CVRU arrival to CVRU discharge, up to a maximum of 72 hours if admission to the intensive care unit was necessary. All postoperative opioid doses were converted to morphine equivalents. Length of mechanical ventilation, quality of sedation, adverse drug events, and sedation‐related costs were determined. Opioid requirements were significantly lower during the sedative infusion period for dexmedetomidine‐treated patients than for propofol‐treated patients (median [range] 0 [0–10 mg] vs 4 mg [0–33 mg], p<0.001), but not through the entire CVRU admission (median [range] 26 mg [0–119 mg] vs 30 mg (0–100 mg], p=0.284). The proportion of patients who did not require opioids during the infusion was significantly higher in the dexmedetomidine group compared with the propofol group (32 [64%] vs 13 [26%], p<0.001). No significant differences were noted between the groups for length of mechanical ventilation, quality of sedation, or adverse events. Sedation‐related costs were significantly higher (˜$50/patient higher) with dexmedetomidine (p<0.001)

Conclusion. Dexmedetomidine resulted in lower opioid requirements in patients after cardiac surgery versus those receiving propofol, but this did not result in shorter durations of mechanical ventilation, using a fast‐track CVRU model.
Reduced Drug Use and Hospitalization Rates in Patients Undergoing Hemodialysis Who Received Pharmaceutical Care: A 2‐Year, Randomized, Controlled Study
Authors: Pai Amy Barton , Boyd Alex , Depczynski Joseph , Chavez Isela Martinez , Khan Nasreen , Manley Harold
Published: November 2009

Study Objective. To investigate the impact of a pharmaceutical care program managed by clinical pharmacists on drug use, drug costs, hospitalization rates, and drug‐related problems (DRPs) in ambulatory patients undergoing hemodialysis.

Design. Prospective, randomized, controlled, longitudinal, 2‐year pilot study.

Setting. Nonprofit university‐affiliated dialysis clinic.

Patients. One hundred four patients older than 18 years with end‐stage renal disease (ESRD) who were undergoing a stable hemodialysis regimen for at least 3 months.

Intervention. Patients were randomly assigned to receive either pharmaceutical care, consisting of one‐on‐one care, with in‐depth drug therapy reviews conducted by a clinical pharmacist (57 patients), or standard of care, consisting of brief drug therapy reviews conducted by a nurse (47 patients).

Measurements and Main Results. Baseline data on demographic and clinical characteristics were collected. Mean numbers of concomitant drugs, drug costs, hospitalization rates, and lengths of stay were compared between the groups. In the pharmaceutical care group, DRPs were identified and recorded. Baseline age, length of time receiving hemodialysis, and etiology of ESRD were not significantly different between the groups. Mean number of concomitant drugs at baseline was similar between the groups. At the end of the 2‐year follow‐up, pharmaceutical care was associated with a significant decrease of 14% fewer drugs compared with standard of care, as documented during each drug therapy review (p<0.05). There were significantly fewer all‐cause hospitalizations among patients assigned to pharmaceutical care compared with those receiving standard of care (mean ± SD 1.8 ± 2.4 vs 3.1 ± 3 hospitalizations, p=0.02), and the cumulative time hospitalized was shorter in the pharmaceutical care group compared with the standard of care group (9.7 ± 14.7 vs 15.5 ± 16.3 days, p=0.06). During the study period, 530 DRPs were identified and resolved.

Conclusion. Identification and resolution of DRPs through pharmaceutical care resulted in decreased drug use and costs for patients undergoing hemodialysis. Hospitalization rates were significantly lower in the pharmaceutical care group, with a trend toward shorter duration. Provision of pharmaceutical care is associated with tangible benefits on outcomes in ambulatory patients undergoing hemodialysis and should be considered in health care policy decisions.
Prasugrel: A Critical Comparison with Clopidogrel
Authors: Reinhart Kurt M. , White C. Michael , Baker William L.
Published: November 2009

Thienopyridine antiplatelet drugs have been used for 15 years for the prevention of coronary stent thrombosis in patients undergoing percutaneous coronary intervention with stent placement. Ticlopidine, the first approved thienopyridine, has in large part been replaced by clopidogrel, a more potent and better tolerated thienopyridine. Now, prasugrel, the newest agent, is currently available for use in the United States. Although prasugrel is similar to clopidogrel, it is about 10 times more potent and has a quicker onset of action. Data from the largest trial comparing clopidogrel and prasugrel indicate that this increased potency and quicker onset of prasugrel equate to a reduction in major adverse cardiovascular events, although higher rates of major bleeding were reported. Prasugrel also differs from clopidogrel in that it may be less prone to drug‐drug interactions and patient nonresponsiveness, although further research is needed in both of these areas. Given the totality of data available, prasugrel appears to be a promising treatment option for patients with acute coronary syndromes who are undergoing percutaneous coronary interventions.
Dexmedetomidine‐Associated Bradycardia Progressing to Pulseless Electrical Activity: Case Report and Review of the Literature
Authors: Gerlach Anthony T. , Murphy Claire V.
Published: November 2009

Dexmedetomidine is an α2‐agonist indicated for sedation in critically ill patients and procedural sedation in nonintubated patients. It is a distinctive sedative because it does not cause respiratory depression, but it may cause hypotension and bradycardia. We describe a 74‐year‐old man who was receiving dexmedetomidine for agitation and experienced progressive bradycardia. The patient experienced a postoperative myocardial infarction 3 days after repair of an abdominal aortic aneurysm. A dexmedetomidine infusion was started at 0.11 μg/kg/hour, without a loading dose, for agitation; the patient's heart rate was 123 beats/minute and blood pressure was 147/70 mm Hg, both within normal limits. Over the next 6 hours, the dexmedetomidine infusion rate was increased to a maximum of 0.7 μg/kg/hour; the patient's heart rate progressively decreased to 21 beats/minute, followed by pulseless electrical activity. After 2 minutes of chest compressions and an intravenous bolus of atropine 0.4 mg, the patient regained a pulse. Dexmedetomidine was discontinued, and the patient's heart rate and blood pressure returned to within normal limits. The patient was discharged home 7 days later without any cardiac or neurologic sequelae. Clinicians need to be educated about the potential for dexmedetomidine to cause bradycardia progressing to pulseless electrical activity, and patients need to be closely monitored. Patients who receive dexmedetomidine and develop a greater than 30% decrease in heart rate may be at high risk for severe bradycardia leading to pulseless electrical activity. We urge caution when using dexmedetomidine, especially in patients with significant cardiac disease.
Postgraduate Year One Pharmacy Residency Program Equivalency
Authors:   American College of Clinical Pharmacy, Jordan Ché J. , Wall Geoffrey C. , Lobo Bob , Wilkinson Julie , Creekmore Freddy M. , Sorrells Kelli , Hartis Charles , Miller Shannon , Uchal Linda
Published: November 2009

In 2006, the American College of Clinical Pharmacy (ACCP) charged the Task Force on Residency Equivalency to define the professional experience expected of a clinically mature practitioner that would meet or exceed the knowledge and skills of an accredited postgraduate year one residency‐trained pharmacist. In this commentary, the Task Force discusses both the qualitative and quantitative components of documentation by means of a residency equivalency portfolio. The potential roles of academia, pharmacy professional organizations, and employers and the possible barriers to an equivalency process are addressed. This commentary lays the foundation for establishing a residency equivalency process that could promote the growth and development of existing and future residency programs and allow qualified practitioners to demonstrate their capabilities. The ACCP implores invested stakeholders to take an active part in this collaborative effort as the profession transitions toward residency training as a prerequisite for all pharmacists providing direct patient care by 2020.
Pharmacokinetics and Pharmacodynamics of Liraglutide, a Long‐Acting, Potent Glucagon‐Like Peptide‐1 Analog
Authors: Meece Jerry
Published: November 2009

Despite the continued development of new pharmacologic agents, and the use of several existing drug therapies, almost two thirds of patients with type 2 diabetes mellitus do not reach the American Diabetes Association‐targeted hemoglobin A1c level of less than 7.0%. Therefore, maintaining adequate metabolic control remains a primary concern for many clinicians and patients. It is now well recognized that in addition to defective secretion and action of insulin, other hormones also potentially play a role in the development and progression of type 2 diabetes. Glucagon‐like peptide‐1 (GLP‐1) is a gastrointestinal hormone from the incretin family, which stimulates insulin secretion and plays an important role in regulating the enteroinsular axis. Incretin‐based therapies are the newest class of glucose‐lowering drugs for the treatment of type 2 diabetes and may help address some of the unmet needs in this therapeutic area. Liraglutide is a once‐daily GLP‐1 analog that has been recently approved by the European Union regulatory agency and is in late‐stage review by the United States Food and Drug Administration for the treatment of type 2 diabetes. The pharmacokinetic and pharmacodynamic properties of liraglutide and mechanisms behind its protracted action, which in turn enables enhanced glycemic control, are reviewed.
Scale Squeeze Evaluation Through Improved Sample Preservation, Inhibitor Detection, and Minimum Inhibitor Concentration Monitoring
Authors: Ramstad Kari , Rohde Hans Christian , Tydal Trine , Christensen Dorthe
Published: November 2009

In North Sea oil and gas fields, seawater injection is used for reservoir pressure support. Formation water and seawater mixing may lead to sulphate scaling in the near-wellbore area, tubing, and process systems. Scale-inhibitor squeeze treatments are applied to protect the producers and extend the field lifetime. Reducing cost and prolonging the squeeze lifetime is essential. In some Statoil Hydro-operated fields, squeeze lifetime has been evaluated based on inhibitor-return concentration and cumulative-water treated. Field experience and laboratory studies have determined the criteria for resqueezing the wells.

One critical aspect of downhole-scale management is the laboratory determined minimum inhibitor concentration (MIC) of the squeeze inhibitor. If the MIC is lower than the concentration of inhibitor required to prevent scale at real conditions, the well may scale up. Field examples are given in which sulphate scale was observed downhole and in the tubing around the safety valve even if the inhibitor concentration was higher than the laboratory-determined MIC. MIC varies throughout the well lifetime according to variation in brine chemistry/operating conditions and should be re-evaluated frequently.

Polymer squeeze inhibitors are difficult to measure with sufficient accuracy at a low concentration. However, adequate preservation of the water samples may improve the detection. The volume of water produced before reaching MIC can be significantly increased with improved inhibitor-detection methods.

Laboratory studies have been performed addressing the sensitivity of inhibitor detection as a function of ion composition, inhibitor concentration, as well as a particles and preservation additive. Parallel samples have been taken offshore. MIC has been determined for a range of formation/seawater mixtures.

This paper describes laboratory analyses, sampling procedures, well monitoring, inhibitor-return detection, and field/well-lifetime MIC determination as methods to obtain a long but safe squeeze lifetime.
Successful Optimization of Viscoelastic Foamed Fracturing Fluids With Ultralightweight Proppants for Ultralow-Permeability Reservoirs
Authors: Cawiezel Kay E. , Gupta D.V.S.. V.S.
Published: November 2009

Successful fracturing treatments in ultralow-permeability reservoirs require combining the most recent innovations in fracturing technologies. Viscoelastic surfactants, foams, and ultralightweight proppants (ULWPs) have specific properties that when combined offer the unique performance required in fracturing these reservoirs. Viscoelastic-surfactant foams are particularly suited for treating ultralow-permeability reservoirs because they minimize the interfacial tension and minimize the amount of water used in the fracturing fluid. This significantly reduces the permanent retention of water and the amount of water trapped in the near-wellbore region that would impair the ability of gas to flow (Gupta 2009).

Inexpensive, logistically simple, polymer-free viscoelastic surfactants provide exceptionally high viscosity under low-shear conditions required for proppant transport. They also provide excellent cleanup characteristics. Foamed viscoelastic surfactants provide increased viscosity for frac width, provide better leakoff control, and further improve fluid cleanup characteristics, particularly in low-pressure reservoirs. ULWPs provide excellent transport properties in conventional fracturing fluids with minimal viscosity, which ensures desired effective propped-fracture conductivity. Use of these ULWPs in foamed viscoelastic fluids provides fracturing treatments with optimum proppant placement and excellent cleanup. As with all successfully applied fracturing fluids, the fluid systems must be optimized. These combined systems require significant laboratory testing to characterize and optimize the fluid system successfully for the demands of ultralow-permeability reservoirs. This paper focuses on small- and large-scale laboratory testing performed to optimize these viscoelastic foamed systems in an effort to test the technical limit of this new technology for future field developments.
Assessing Reverse Osmosis for Water Recycling in Alcoholic Fermentation Processes
Authors: Gavach Marjorie , Sagne Camille , Fargues Claire , Bouix Marielle , Decloux Martine , Lameloise Marie-Laure
Published: November 2009

Recycling the stillage condensates to dilute worts in the fermentation stage would be an effective way to decrease wastewater production and ground water consumption. However, condensates contain fermentation inhibiting solutes, such as volatile acids, alcohols and aromatic compounds that should be removed. Reverse osmosis was investigated as a clean process for such a purpose. Pilot scale experiments were carried out with industrial condensates and using Hydranautics ESPA2 membrane. The influence of transmembrane pressure (TMP), volume reduction factor (VRF) and pH on permeate flow rate and rejection rates of inhibitory compounds were investigated. The optimal operating conditions were TMP=10 bar to get the maximal admissible permeate flow, a low VRF to produce the less concentrated permeate and a pH ? 6 to obtain the highest rejection rates of the acids. Results were confirmed by trials at pre-industrial scale in a distillery. However, the permeate produced at pH 6 proved to be less fermentable than the permeate produced at natural pH because of an increase in the osmotic pressure. Natural pH permeate displayed a fermentation activity almost equivalent to tap water chosen as the blank. The remaining inhibitory acids did not seem to significantly hinder yeast growth nor yeast physiology.