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Objective: To examine laboratory testing adherence by persons initiating an oral disease-modifying therapy (DMT) for multiple sclerosis (MS). Methods: Population-based health administrative and laboratory data were accessed in British Columbia, Canada, to identify everyone filling their first prescription for dimethyl fumarate (DMF), fingolimod or teriflunomide (2011–2015). The proportion of people adherent to each drug monograph’s recommended laboratory monitoring schedule, pre- and on-DMT, was estimated. The association between patient characteristics and adherence was examined using multivariable logistic regression. Results: A total of 1016 people were included (DMF 567, fingolimod 253 and teriflunomide 196). The proportions of people adherent to pre-DMT liver and lymphocyte tests ranged from 88% to 91% and 91% to 94%, respectively, while 77% adhered to pre-DMF urinalysis. Adherence to the first on-DMT liver test was 89% for DMF (within 6 months), 61% for fingolimod (within 3 months) and 40% for teriflunomide (within 1 month). Men were less likely than women to have pre-DMF urinalysis (adjusted odds ratio (aOR); 95% confidence interval (CI): 0.40–0.95) or on-DMF liver (aOR: 0.46; 95% CI: 0.23–0.95) or lymphocyte (aOR: 0.47; 95% CI: 0.22–0.98) tests. Conclusions: Adherence to recommended laboratory testing was high (>77%) before oral DMT initiation, but lower once on drug. There is a need to understand the long-term consequences of suboptimal laboratory monitoring and sex differences in the DMT-treated MS population.

Purpose The aim of this study is to understand the frequency of appropriate laboratory monitoring of oral chemotherapy at the Eastern Colorado Health Care System (ECHCS) compared to recommendations set forth in the 2012 Veterans Health Administration (VHA) Guidance on Dispensing and Monitoring of Oral Chemotherapy. Methods This study is a retrospective chart review of patients who have received a subset of oral chemotherapy drugs at ECHCS. Patients 18 to 89 years of age with an active cancer diagnosis who initiated therapy at ECHCS between September 1, 2010 and August 31, 2014 were included in the study. Initial and subsequent prescription fill dates, appropriate labs as defined by VHA guidance and baseline and follow-up lab monitoring dates, and appropriate labs as defined by VHA guidance were collected for up to 12 cycles of chemotherapy per patient. Baseline labs were defined as within three months of the first prescription fill date, and follow-up labs were defined as within seven days of subsequent prescription fill dates. Results Results are presented as complete, partial, or incomplete and as attempt or no attempt at monitoring according to the VHA guidance recommendations. There was 100% attempt at laboratory monitoring at baseline; however, there was a decline in attempt and complete follow-up monitoring overall as well as for drugs that require special monitoring. Conclusion Based on recommendations from the 2012 VHA Guidance on Dispensing and Monitoring Oral Chemotherapy, data presented here demonstrate that ECHCS could benefit from improved lab monitoring in order to ensure safe and effective use of oral chemotherapies. These results provide a unique opportunity to consider the potential role of clinical pharmacists in monitoring and management of patients receiving oral chemotherapies as well as patient and provider education regarding the importance of appropriate lab monitoring.

The currently available oral anti-Xa agents are claimed to produce their anticoagulant and antithrombotic effects solely by the inhibition of factor Xa. This study profiled various anti-Xa drugs in routinely used laboratory assays to demonstrate that their effects are not solely related to the anti-Xa activities. Apixaban, betrixaban, edoxaban, and rivaroxaban were obtained commercially. Native and citrated whole blood was used for the activated clotting time (ACT) and thromboelastography (TEG). Citrated plasma was used for monitoring the prothrombin time (PT), activated partial thromboplastin time (aPTT), Heptest, and prothrombinase-induced clotting time (PiCT) tests. An amidolytic method was used for the determination of anti-Xa effects. Thrombin-induced fibrinokinetics was monitored optically. Thrombin generation studies were carried out using the calibrated automated thrombogram. All of the anti-Xa agents produced concentration- and assay-dependent effects. In the ACT at 2.5 μg/mL and TEG at 1.0 μg/mL, edoxaban exhibited the strongest anticoagulation effect. In the PiCT, PT, and aPTT assay at 1 μg/mL, edoxaban showed stronger effects than other agents. The half maximal inhibitory concentration of these agents for the inhibition of factor Xa ranged from 340 to >1000 ng/mL. In the thrombin generation inhibition assay, apixaban showed the strongest activity. In the fibrinokinetics, different anti-Xa agents produced varying degrees of inhibition. These results demonstrate that the measured anti-Xa activity alone does not fully reflect the overall biologic spectrum of these agents.

Background Point-of-care (POC) testing devices allow laboratory monitoring to be performed in various settings and accessed immediately. Objective To evaluate the outcomes of monitoring anticoagulation patients in pharmacistmanaged, multicenter clinics utilizing i-STAT POC machines. Methods This study was a retrospective, multicenter chart review of 150 patients before and after implementation of the POC intervention for anticoagulation monitoring. Data collected included international normalized ratio (INR) results, indication for warfarin, minor and major bleeds, thromboembolic events, emergency room (ER) visits, and hospitalizations before and after i-STAT POC implementation. Results The time in therapeutic INR range (TTR) was significantly higher after i-STAT POC implementation than before implementation (60.4% ± 21.2% and 52.5% ± 21.5%, respectively; P = .0001). There were no reports of major bleeding during the study period. Twenty-three minor bleeds were reported after i-STAT POC implementation compared to 19 events before implementation ( P < .0001). One thromboembolic event was reported after i-STAT POC implementation. There was a significant difference in the number of hospitalizations before i-STAT POC implementation as opposed to after implementation (2 and 0, respectively; P < .0001). There was also a significant increase in ER visits after i-STAT POC implementation ( P < .0001). Conclusion The results of the study indicate improvement in TTR in pharmacist-managed anticoagulation clinics by 7.8%. Although the use of the i-STAT POC machine detected an increase in minor bleeds, thromboembolic events, and ER visits, there was a decrease in hospitalization. The outcomes of this multicenter study indicate that implementation on this scale provides improvement in regard to safety and cost.

Background: Direct oral anticoagulants (DOACs) share many indications with warfarin but require less frequent follow-up and monitoring. There is limited data available on the prescribing of DOACs and appropriate laboratory monitoring in a real-world clinical setting. Objective: To determine if patients receiving care at 2 University of Florida (UF) Health Internal Medicine clinics are prescribed DOACs according to Food and Drug Administration (FDA)–approved labeling. Secondary objectives were to determine the percentage of patients receiving appropriate baseline laboratory tests prior to DOAC initiation and the frequency of laboratory monitoring. Methods: This retrospective chart review evaluated patients enrolled at 2 UF Health Internal Medicine practices within the UF Health system who were prescribed a DOAC between April 2014 and April 2015. Adherence to FDA-approved dosing recommendations and baseline laboratory tests were compared to previously published data. This study was approved by the UF Institutional Review Board. Results: A total of 194 patients met inclusion criteria. Ninety-six patients (49.5%) were on a DOAC prior to data collection; 98 patients (50.5%) started a DOAC during data collection. Of the 194 patients, 155 (79.9%) were prescribed DOACs per FDA-approved labeling ( P = .0005); 79 (40.8%) obtained a complete blood count, serum creatinine, and liver function tests prior to DOAC initiation. Conclusions: Prescribing practices were significantly better than published data; however, 1 in 5 patients were not prescribed a DOAC according to FDA-approved labeling. Less than half of the patients started on a DOAC obtained the recommended labs prior to medication initiation.

Objective: To describe safety and efficacy laboratory monitoring of statin therapy at the University of Colorado Hospital Outpatient Clinics over a period of 3 years prior to the revised United States Food and Drug Administration statin labeling. Methods: This retrospective, observational study evaluated serum laboratory monitoring for safety and efficacy of statin therapy between July 2008 and June 2011. Adult patients prescribed chronic statin therapy were included. The primary objective of this study was to describe the frequency of outpatient liver function tests, lipid panels, and creatine kinase for patients on chronic statin therapy. Results: A total of 143 patients met study criteria. Over a 3-year period, the mean maximum frequency of measurements per patient of serum hepatic transaminases, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) was higher than lipid panel measurements (5.2 ± 4.4 and 4.2 ± 2.0 respectively, p = 0.021). Only 22 of 143 patients (15.4%) had an elevation in ALT or AST. All elevations were less than three times the upper limit of normal and statin therapy was continued without changes in response to these elevations. Creatine kinase, though not a routine monitoring test, was infrequently measured (mean maximum frequency of measurements per patient 0.3 ± 0.8). Conclusion: Serum hepatic transaminases were routinely monitored in patients treated with chronic statin therapy. Given the absence of significant serum hepatic transaminase elevations, and clinician response to minor elevations, our data indicate that routine serum laboratory evaluations for statin toxicity are excessive.

The anticoagulant drugs which are available currently — coumarins and heparins — are reasonably effective but are insufficiently specific and often inconvenient to manage. An improved understanding of the physiology of blood coagulation and its control mechanisms has led to the identification of target enzymes for novel, specific and potentially safer antithrombotics. These targets include the pivotal coagulation enzyme thrombin as well as other enzymes and co-factors within the tissue factor dependent coagulation pathway. In addition, analogues of physiological anticoagulants hold promise as therapeutic agents. It is likely that the range of drugs available for the management of thrombosis will expand over the next decade. There is the very real possibility of the introduction of orally active agents which may be used in fixed dosage regimens with no requirement for laboratory monitoring.

The management of Human Immunodeficiency Virus-1 (HIV-1) infection has undergone dramatic change since its initial identification. Advances have occurred in drug development, viral pathology understanding, laboratory monitoring and genetic analysis. With the advent of highly active antiretroviral therapy (HAART), there has been a substantial decline in HIV-1-related morbidity and mortality. Today, HIV-1 infection is treated as a chronic disease that requires strict patient adherence to HAART. Pharmacists provide pharmaceutical care to patients with HIV disease in a variety of ways, and they can improve patient adherence rates. Current therapeutic strategies have not resulted in eradication of HIV-1 infection. Present and future therapeutic challenges include viral resistance, reservoirs of virus and drug toxicities. Globally, the spread of HIV-1 infection continues at an alarming rate, and economic and social barriers may limit access and success of HAART. New strategies and novel approaches in managing HIV-1 infection continue to be developed in an effort to cure and eradicate this disease.

Objective: Because a drug utilization evaluation (DUE) showed poor intravenous heparin prescribing practice in our medical center, we developed a preprinted intravenous heparin order form for use by physicians to improve heparin administration. Methods: Two DUEs were performed, one prior to use of a weight-based heparin dosing order form and another after the introduction of the form. Indicators that were evaluated included dosing, laboratory monitoring, and intramuscular injections. DUE results before and after introduction of the order form were statistically compared using Fisher's exact text. Results: The initial DUE showed that only 3% of patients who were administered intravenous heparin received appropriate dosing, and only 60% had a therapeutic activated partial thromboplastin time (aPTT) ratio within the first 24 hours. Blood samples for the aPTTs were drawn at incorrect × in 27% of patients, and 9% of patients received intramuscular injections of other drugs. After implementation of the preprinted intravenous heparin order form, 73% of the patients received appropriate heparin dosing (p < 0.00001), and 79% of the patients had a therapeutic aPTT ratio within the first 24 hours (p = 0.08). The aPTTs were drawn at incorrect × in 12% of patients, and 3% of patients received intramuscular injections (NS for both). All patients receiving appropriate heparin dosing achieved a therapeutic aPTT ratio within the first 24 hours, whereas only 29% of patients on the acute wards and 50% of those in the intensive care units achieved a therapeutic ratio when dosing was inappropriate (p < 0.0001). Conclusions: We improved the intravenous heparin prescribing practice in an academic-affiliated tertiary Veteran's Affairs Medical Center using a preprinted intravenous heparin order form for physician use. The form was also effective in achieving the desired aPTT ratio within 24 hours.

Early case reports of fatal hematologic effects associated with carbamazepine (CBZ) resulted in manufacturer recommendations for extensive laboratory monitoring. Several alternative monitoring protocols have been published, indicating disagreement with those recommendations. The manufacturer has removed specific monitoring guidelines allowing physicians to monitor CBZ during treatment based on their clinical judgment. This study was designed to determine the frequency of CBZ hematologic monitoring in one academic setting. Data on complete blood counts (CBCs) were retrospectively obtained and were compared with 1975–88 Physicians' Desk Reference recommendations for weekly CBCs during the first three months of treatment. Eighty-three patients were identified: 32 psychiatry, 37 neurology, and 14 from other clinics. Only one patient met guidelines for monitoring during the entire first three months of treatment. Comparisons between clinics demonstrated no statistically significant differences in monitoring rates. Prospective studies in academic and private practice settings are needed to provide more information on actual monitoring practices. Due to the removal of specific manufacturer recommendations, a standard approach is needed to establish consistent and adequate monitoring and to provide legal support to prescribers.