Therapeutic plasma exchange (TPE) removes coagulation proteins, but its impact on therapeutic anticoagulation is unknown. We performed a systematic review of the literature to determine the coagulation effects of TPE in patients receiving systemic anticoagulation. We searched MEDLINE, CINAHL, EMBASE, and Web of Science until June 2018 for studies combining controlled vocabulary and keywords related to therapeutic plasma exchange, plasmapheresis, anticoagulants, and therapy. The primary outcome was the effect of TPE on anti‐Xa activity, activated partial thromboplastin time (aPTT), or international normalized ratio (INR). The secondary outcome was reports of post‐TPE bleeding or thrombosis. A total of 1830 references were screened and eight studies identified. Our selected studies (five case reports and three case series) involved 23 patients and evaluated the effects of seven anticoagulants. Six studies of unfractionated heparin, low‐molecular‐weight heparins, and direct oral anticoagulants demonstrated an anti‐Xa level decline. Two studies of unfractionated heparin and low‐molecular‐weight heparins showed an aPTT increase. One study of warfarin showed a post‐TPE INR increase. Reports of post‐TPE bleeding occurred in two patients and thrombosis in one. In patients receiving therapeutic anticoagulation, TPE is associated with anti‐Xa activity decline and aPTT and INR increase. These coagulation changes do not appear to significantly increase bleeding or thrombotic risk. Our data suggest the need for prospective studies to investigate the true clinical impact of TPE on therapeutic anticoagulation.
Purpose: The purpose of this quality-improvement project was to assess risk evaluation and mitigation strategies (REMS) program compliance for pulmonary arterial hypertension (PAH) drugs following the initiation of more rigid protocols and informatics changes. The primary objective of the study was to determine the effects of these changes on overall compliance of the REMS program requirements. Method: This was a single-center, retrospective evaluation of protocols and informatics updates that were developed to increase compliance with REMS programs for four drugs used to treat PAH. Two separate time periods were examined for comparison: the preinformatics period, January 2015 to February 2016, and the postinformatics period, October 2016 to April 2017. To be included in the study, patients must have been at least 18 years of age and have been ordered one of the following agents: riociguat, macitentan, bosentan, or ambrisentan. Results: Overall, 94 patients were evaluated with 50 in the preinformatics group and 44 in the postinformatics group. The overall mean age of included patients was 55 years, 57.9% of patients were white, 69.1% were female, and 43.6% were prescribed ambrisentan during the study period. The primary composite endpoint of adherence to REMS protocol (pregnancy tests performed within 30 days of medication initiation for female patients of childbearing potential, liver function tests [LFTs] ordered within 30 days of bosentan initiation, and initiation of therapy order documented by an attending provider enrolled in the REMS program) showed an overall improvement in the postinformatics period, 95% vs 71% ( P = .07).There was a statistically significant increase in pregnancy tests performed within 30 days of medication order in the postinformatics period (36.4% vs 100%; P = .01). Furthermore, during the postinformatics period, the number of documented interventions (iVents) performed by a pharmacist was 90.9%. Conclusion: Initiation of more rigid ordering protocols for the endothelin receptor antagonists (macitentan, bosentan, or ambrisentan) and riociguat improved pharmacist and physician compliance with REMS requirements.
Background/Objectives Prothrombin complex concentrates (PCC) are increasingly administered off-label in the United States to treat bleeding in cardiovascular surgical patients and carry the potential risk for acquired thromboembolic sideeffects after surgery. Therefore, we hypothesized that the use of low-dose 3-factor (3F) PCC (20-30 IU/kg), as part of a transfusion algorithm, reduces bleeding without increasing postoperative thrombotic/thromboembolic complications. Materials/MethodsAfter IRB approval, we retrospectively analysed 114 consecutive, complex cardiovascular surgical patients (age > 18 years), between February 2014 and June 2015, that received low-dose 3F-PCC (Profilnine â ), of which seven patients met established exclusion criteria. PCC was dosed according to an institutional perioperative algorithm. Allogeneic transfusions were recorded before and after PCC administration (n = 107). The incidence of postoperative thromboembolic events was determined within 30 days of surgery, and Factor II levels were measured in a subset of patients (n = 20) as a quality control measure to avoid excessive PCC dosing. ResultsTotal allogeneic blood product transfusion reached a mean of 12Á4 -9Á9 units before PCC and 5Á0 -6Á3 units after PCC administration (P < 0Á001). The mean PCC dose was 15Á8 -7Á1 IU/kg. Four patients (3Á8%) each experienced an ischaemic stroke on postoperative day 1, 2, 4 and 27. Seven patients (6Á5%) had acquired venous thromboembolic disease within 10 days of surgery. Median factor II level after transfusion algorithm adherence and PCC administration was 87%.Conclusions 3F-PCC use for refractory bleeding after cardiovascular surgery resulted in reduced transfusion of allogeneic blood and blood products. Adherence to this algorithmic approach was associated with an acceptable incidence of postoperative thrombotic/thromboembolic complications.
Introduction: Emergency departments (ED) use many medications with a range of therapeutic efficacy and potential significant side effects, and many medications have dosage adjustment recommendations based on the patient’s specific genotype. How frequently medications with such pharmaco-genetic recommendations are used in United States (US) EDs has not been studied. Methods: We conducted a cross-sectional analysis of the 2010–2015 National Hospital Ambulatory Medical Care Survey (NHAMCS). We reported the proportion of ED visits in which at least one medication with Clinical Pharmacogenetics Implementation Consortium (CPIC) recommendation of Level A or B evidence was ordered. Secondary comparisons included distributions and 95% confidence intervals of age, gender, race/ethnicity, ED disposition, geographical region, immediacy, and insurance status between all ED visits and those involving a CPIC medication. Results: From 165,155 entries representing 805,726,000 US ED visits in the 2010–2015 NHAMCS, 148,243,000 ED visits (18.4%) led to orders of CPIC medications. The most common CPIC medication was tramadol (6.3%). Visits involving CPIC medications had higher proportions of patients who were female, had private insurance and self-pay, and were discharged from the ED. They also involved lower proportions of patients with Medicare and Medicaid. Conclusion: Almost one fifth of US ED visits involve a medication with a pharmacogenetic recommendation that may impact the efficacy and toxicity for individual patients. While direct application of genotyping is still in development, it is important for emergency care providers to understand and support this technology given its potential to improve individualized, patient- centered care.
Aim: To investigate the current state of TPMT testing at a single-academic medical center. Methods: Single-center, retrospective chart review for patients newly prescribed a thiopurine. Data collection and evaluation included the prevalence and timing of TPMT testing, correct dosage adjustment if applicable, and incidence of myelosuppression. Results: 121 patients (71%) received TPMT testing. Out of the tested patients, 110 (90.9%) were designated as wild-type with normal metabolism. Dosing modification was appropriate in applicable patients. In unadjusted analysis, there was a lower incidence of myelosuppression among patients who were tested versus those who were not (16.5 vs 36.7%). Conclusion: Based on the study results, TPMT testing opportunities exist for nearly 30% of patients. Testing may reduce the incidence of myelosuppression.
Objective: To report the utilization of emicizumab in a patient with severe hemophilia A with inducible inhibitors and the reduction of drug costs related to decreased on-demand recombinant factor VIIa use. Case Summary: A 65-year-old African American man with established hemophilia A with an inducible factor VIII inhibitor presented with a bleeding hematoma from the right posterior thigh. The patient was historically managed on frequent administration of recombinant factor VIIa to achieve hemostasis and was started on every 2-hour dosing during this admission. Emicizumab, a new therapy for hemophilia A, became available during this admission, and the patient discontinued recombinant factor VIIa and transitioned to weekly emicizumab injections. The patient did not require any recombinant factor VIIa during the following 12 months resulting in substantial drug cost savings. Discussion: After initiation of emicizumab therapy, the patient no longer required on-demand treatment with recombinant factor VIIa for bleeds. Through this reduction in recombinant factor VIIa, there was a large decrease in inpatient drug costs and inpatient admissions for bleeding events. Conclusion: The potential reduction in drug costs and inpatient admissions should be considered when determining if emicizumab therapy is appropriate for hemophilia A patients with inhibitors. Further research is needed to confirm that continued long-term use of emicizumab remains associated with a reduction in on-demand treatment.
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