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Biopharmaceutical contact centers are expanding core skill sets when it comes to addressing inquiries regarding combination products. An inside look at how biopharmaceutical companies are handling this increasingly common scenario is provided through a benchmark survey, which was conducted between December 2012 and January 2013. The purpose of this survey was to collect and share contact center best practices on the handling of combination products in the biopharmaceutical industry. Eleven biopharmaceutical companies participated in the survey, 10 of which were listed in "The Top 50 Pharmaceutical Companies," by Pharmaceutical Executive. The information gathered from the survey responses is reported anonymously and provides perspectives on the trends and best practices that will serve as a practical resource for those involved in establishing or expanding contact center services.

Computerized literature searching was introduced into a family practice residency office site after a series of training sessions. BRS Colleague was the searching program used. Over 15 months, 147 searches were conducted, primarily by faculty. Because residents used the system infrequently, they preferred to find a faculty member to help with the search rather than complete the search by themselves. The mean number of searches per faculty user was 6.4 and the median number of documents found per search was 15. The users were moderately satisfied with the search process (2.4 on a scale of 1 as excellent to 5 as unusable). Search strategies tended to be unsophisticated, often using only one of several possible related search terms. Most searches took a limited amount of time (5 to 20 minutes). The program was sufficiently successful to warrant continuation. Computerized literature searching offers a method to meet the physicians' needs for ready access to information on patient-related questions.

This report describes a case of possible drug interaction in a patient taking chlorpromazine and guanethidine who experienced a hypertensive crisis following initiation of doxepin therapy. (We have been unable to find a report of a similar interaction at the doses described.) It is advised that physicians exercise caution when contemplating concomitant use of doxepin and guanethidine, even in usually recommended doses.

Salicylates are known to be highly protein bound, primarily to albumin. Patients with juvenile rheumatoid arthritis (JRA) are known to have decreased albumin concentrations. Total and free salicylate concentrations were determined for 19 patients with JRA. Although many of these patients were below the normal therapeutic range, the percent of salicylate bound was essentially constant and did not differ significantly regardless of albumin concentrations or total salicylate concentrations. Elevated liver enzymes did not correlate with total or free salicylate concentrations. We conclude that total salicylate concentrations should be used for monitoring aspirin therapy in JRA. Free salicylate concentrations do not appear to be more reliable or feasible.

Data from 722 urine collections (627 patients) from 14 medical facilities were used to compare measured creatinine clearance values with clearance estimates calculated using three "urine-free' mathematical formulas. The influence of two patient weight variables (actual weight, lean body weight) and the level of renal function on clearance prediction was assessed. In addition, site parameters (region, facility), time parameters (month, day, day of the week), and patient parameters (age, sex, height, weight, diagnoses) were evaluated for their statistical influence on the relationship between measured clearance and estimates calculated with one of the methods. Strong, statistically significant correlations were observed between clearance values estimated with each prediction method and measured clearances. Although statistical differences were noticed between mean values predicted with each method, these differences were clinically insignificant. Use of lean body weight for calculation of creatinine excretion produced clearance estimates that were significantly lower than those obtained with actual weight and substantially closer to measured clearance values. Among patient variables, age and two specific diagnoses (congestive heart failure and pregnancy), were statistically associated with variability in the relationship between measured and predicted clearance. Interregional and interfacility differences in the measured-predicted clearance relationship, variability associated with the day of the week of collection, and tendency of the urine-free formulas to over-predict clearance support potential inaccuracy of measured clearance determination. The results suggest that inaccuracies in clearance determination, rather than inadequacies of urine-free prediction methods, account for the majority of the observed variability in the relationship.

Nine other cases of cardiomyopathy in patients taking tricyclic antidepressants have been reported. The patient we have described had been taking tricyclic antidepressants for years before cardiomyopathy developed. While a cause-and-effect relationship between tricyclic antidepressants and cardiomyopathy cannot be proven, physicians should keep in mind the association and discontinue the medication if cardiomyopathy develops. Further, tricyclic antidepressants should be used with great caution in patients with cardiomyopathy because of possible risk of ventricular fibrillation.

Nineteen patients with juvenile rheumatoid arthritis had salicylate concentration determination by 2 different methods in 2 laboratories. Differences in the results from these laboratories prompted testing at 4 laboratories with known samples of salicylates. Significant variation was shown between spectrofluorometric and Trinder methods. We feel that it is imperative that physicians and clinical pharmacists determine the reliability of salicylate determinations performed in their laboratories prior to making recommendations for changes in patients' drug regimens.

Patient data were analyzed retrospectively to evaluate the relationship between several body-weight variables and creatinine production and clearance. Data from 722 creatinine clearance determinations in 627 patients older than 12 years were analyzed. Weight variables were actual body weight (ABW), lean body weight (LBW), ideal body weight (IBW), and lean body mass (LBM). Weight-independent and weight-dependent clearance prediction methods were evaluated. Actual creatinine clearance values were compared with these predictions. Use of LBW and IBW produced equivalent estimates of creatinine clearance that were closer to measured values than those obtained with ABW. The use of LBW or IBW was not appropriate in patients less than 60 inches tall nor in morbidly obese patients. Weight-dependent clearance estimation was superior to weight-independent predictions in morbidly obese patients. A new LBM-based clearance estimation formula was derived; it may be useful for patients less than 60 inches tall. The use of LBM, particularly in patients less than 60 inches tall, should be investigated further.

Warfarin maintenance-dose requirements predicted by six mathematical methods based on initial response to therapy were compared with patients' actual dose requirements in a multicenter trial. Data were collected for patients who had received an initial regimen of warfarin sodium 10 mg orally every 24 hours for three days and for whom a prothrombin time (PT) had been determined 16-20 hours after the third dose. Patients' individual dose requirements and PT values were recorded during one to three follow-up visits after discharge from one of seven medical centers. Prothrombin ratios (patient PT divided by control PT) calculated on day 4 were used for maintenance-dose prediction by five methods; a sixth method was based on the cumulative warfarin dose-PT response curve up to a PT value of 20 seconds. For 54 men and 30 women who qualified for the study, 197 maintenance-dose-PT response measurements were recorded; 95 in the first four weeks of therapy, 76 during weeks 5-12, and 26 at 6-12 months after initial treatment. Prothrombin ratios were within the therapeutic range (PT 1.5-2.5 times the control value) in 154 observations, and the mean actual warfarin sodium maintenance dose associated with therapeutic response was 7.6 mg/day. For patients with therapeutic prothrombin ratios, dose predictions by the five methods using prothrombin ratios (PRs) correlated significantly with actual dose requirements. The formula that predicted doses numerically closest to the actual dose is as follows: Dose = 11.17 - 21.08 (log PR). Only 45 observations were obtained for the sixth prediction method, and the correlation between actual and predicted doses was not significant. Initial warfarin maintenance-dose requirements can be predicted effectively based on one PT determination after administration of three daily 10-mg doses.(ABSTRACT TRUNCATED AT 250 WORDS)