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      Cost minimization analysis of different growth hormone pen devices based on time-and-motion simulations

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      1 , , 2 , 3
      BMC Nursing
      BioMed Central

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          Abstract

          Background

          Numerous pen devices are available to administer recombinant Human Growth Hormone (rhGH), and both patients and health plans have varying issues to consider when selecting a particular product and device for daily use. Therefore, the present study utilized multi-dimensional product analysis to assess potential time involvement, required weekly administration steps, and utilization costs relative to daily rhGH administration.

          Methods

          Study objectives were to conduct 1) Time-and-Motion (TM) simulations in a randomized block design that allowed time and steps comparisons related to rhGH preparation, administration and storage, and 2) a Cost Minimization Analysis (CMA) relative to opportunity and supply costs. Nurses naïve to rhGH administration and devices were recruited to evaluate four rhGH pen devices (2 in liquid form, 2 requiring reconstitution) via TM simulations. Five videotaped and timed trials for each product were evaluated based on: 1) Learning (initial use instructions), 2) Preparation (arrange device for use), 3) Administration (actual simulation manikin injection), and 4) Storage (maintain product viability between doses), in addition to assessment of steps required for weekly use. The CMA applied micro-costing techniques related to opportunity costs for caregivers (categorized as wages), non-drug medical supplies, and drug product costs.

          Results

          Norditropin ® NordiFlex and Norditropin ® NordiPen (NNF and NNP, Novo Nordisk, Inc., Bagsværd, Denmark) took less weekly Total Time (p < 0.05) to use than either of the comparator products, Genotropin ® Pen (GTP, Pfizer, Inc, New York, New York) or HumatroPen ® (HTP, Eli Lilly and Company, Indianapolis, Indiana). Time savings were directly related to differences in new package Preparation times (NNF (1.35 minutes), NNP (2.48 minutes) GTP (4.11 minutes), HTP (8.64 minutes), p < 0.05)). Administration and Storage times were not statistically different. NNF (15.8 minutes) and NNP (16.2 minutes) also took less time to Learn than HTP (24.0 minutes) and GTP (26.0 minutes), p < 0.05). The number of weekly required administration steps was also least with NNF and NNP. Opportunity cost savings were greater in devices that were easier to prepare for use; GTP represented an 11.8% drug product savings over NNF, NNP and HTP at time of study. Overall supply costs represented <1% of drug costs for all devices.

          Conclusions

          Time-and-motion simulation data used to support a micro-cost analysis demonstrated that the pen device with the greater time demand has highest net costs.

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          Most cited references17

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          Adherence in glaucoma: objective measurements of once-daily and adjunctive medication use.

          To determine with electronic monitoring an objective measurement of adherence in two populations of subjects: those using once-daily prostaglandin analogs as sole ocular hypotensive therapy (one-drug group) and those requiring an adjunctive medicine to the prostaglandin analog (two-drug group). Single-site, open-label, nonrandomized, parallel design of 60 days. Sixty-two consecutive adult subjects with a diagnosis of open-angle glaucoma (OAG) or ocular hypertension: 31 were taking one drug and 31 were taking two drugs. An electronic event medication monitoring device was used to record each bottle opening. The main outcome measures were dosing errors (number of under-adherence or over-adherence events) and coverage (proportion of pharmacologic duration covered by dosing) relative to the ophthalmologist-prescribed regimen. Adherence to the prostaglandins once daily was good in both groups by all measures (
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            A multicenter, randomized, open-label, comparative, two-period crossover trial of preference, efficacy, and safety profiles of a prefilled, disposable pen and conventional vial/syringe for insulin injection in patients with type 1 or 2 diabetes mellitus.

            The accuracy and convenience of pen devices for insulin injection have improved quality of life for patients with insulin-treated diabetes mellitus (DM). Prefilled, disposable pens have the advantage of simplicity, with minimal training and attention required and no installation of new cartridges necessary. The aim of this study was to assess patient preference, efficacy, and safety profiles of a prefilled, disposable pen (FlexPen) and conventional vial/syringe injection method for insulin injection therapy among patients with DM. In a multicenter, randomized, open-label, crossover study, patients with type 1 or 2 DM were transferred from previous QD or BID conventional insulin therapy to a mixture of 70% insulin aspart protamine suspension and 30% insulin aspart injection (NovoLog Mix 7030) for 4 weeks of dose optimization using their usual type of syringe. Patients were then randomly assigned to use either vial/syringe or a prefilled, disposable pen to inject the biphasic insulin aspart 7030 mixture for the next 4 weeks, followed by 4 weeks of use of the other injection device. Efficacy, safety profiles, and patient preference for the delivery systems were compared. A total of 121 patients (mean [SD] age, 57.0 [12.4] years; age range, 28-81 years; mean [SD] body mass index, 31 [5.5] kg/m(2)) were enrolled. One hundred three patients completed the study. Seventy-four percent of patients (78105) indicated a preference for the pen over the vial/syringe method (95% CI, 71%-87%), compared with 20% (21105) who preferred the vial/syringe. Eighty-five percent (88104) considered the pen more discreet for use in public (compared with 9% [9104] for the vial/syringe), 74% (77104) considered it easier to use overall (compared with 21% [22104] for the vial/syringe), and 85% (89105) found the insulin dose scale on the pen easier to read (compared with 10% [10105] for the vial/syringe). Patients had statistically significant improvement in glycosylated hemoglobin values during the study (P < 0.05). No statistically significant differences in fasting plasma glucose, mean 4-point blood glucose profiles, or serum fructosamine values were found between groups. Overall, the safety profiles during treatment periods with the pen were comparable to those with the vial/syringe. In this trial, differences in efficacy and safety profiles between the vial/syringe and prefilled, disposable pen appeared negligible. However, more patients expressed a preference to continue use of the pen.
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              Adverse drug events resulting from patient errors in older adults.

              To characterize the types of patient-related errors that lead to adverse drug events (ADEs) and identify patients at high risk of such errors. A subanalysis within a cohort study of Medicare enrollees. A large multispecialty group practice. Thirty thousand Medicare enrollees followed over a 12-month period. Primary outcomes were ADEs, defined as injuries due to a medication, and potential ADEs, defined as medication errors with the potential to cause an injury. The subset of these events that were related to patient errors was identified. The majority of patient errors leading to adverse events (n=129) occurred in administering the medication (31.8%), modifying the medication regimen (41.9%), or not following clinical advice about medication use (21.7%). Patient-related errors most often involved hypoglycemic medications (28.7%), cardiovascular medications (21.7%), anticoagulants (18.6%), or diuretics (10.1%). Patients with medication errors did not differ from a comparison group in age or sex but were taking more regularly scheduled medications (compared with 0-2 medications, odds ratio (OR) for 3-4 medications=2.0, 95% confidence interval (CI)=0.9-4.2; OR for 5-6 medications=3.1, 95% CI=1.5-7.0; OR for >or=7 medications=3.3, 95% CI=1.5-7.0). The strongest association was with the Charlson Comorbidity Index (compared with a score of 0, OR for a score of 1-2=3.8, 95% CI=2.1-7.0; OR for a score of 3-4=8.6, 95% CI=4.3-17.0; OR for a score of >or=5=15.0, 95% CI=6.5-34.5). The medication regimens of older adults present a range of difficulties with the potential for harm. Strategies are needed that specifically address the management of complex drug regimens.
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                Author and article information

                Journal
                BMC Nurs
                BMC Nursing
                BioMed Central
                1472-6955
                2010
                8 April 2010
                : 9
                : 6
                Affiliations
                [1 ]Pharmacotherapy Outcomes Research Center, University of Utah, 421 Wakara Way Suite 208, Salt Lake City, Utah 84108, USA
                [2 ]College of Nursing, University of Utah, 10 South 2000 East, Salt Lake City, Utah 84112-5880, USA
                [3 ]Department of Family and Preventive Medicine, School of Medicine, University of Utah; 375 Chipeta Way, Suite A, Salt Lake City, Utah 84108, USA
                Article
                1472-6955-9-6
                10.1186/1472-6955-9-6
                2858139
                20377905
                2ae218ad-78fb-4b0c-9937-71c50806a854
                Copyright ©2010 Nickman et al; licensee BioMed Central Ltd.

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 25 February 2009
                : 8 April 2010
                Categories
                Research article

                Nursing
                Nursing

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