1219: ANTICOAGULANT DOSE STACKING-RELATED BLEEDING EVENTS WITH A WIDENED MEDICATION ADMINISTRATION WINDOW

SummaryThe pharmacokinetics and tolerability of factor XIII (FXIII) from plasma were compared with those of FXIII from placenta in a randomised, double-blind, crossover study involving 13 patients with congenital FXIII deficiency. Both FXIII activity and FXIII antigen were monitored. No difference was seen in the mean half-lives of the two preparations (9.3 days and 9.1 days for plasma and placenta FXIII activity, respectively). Response was similar for both preparations, but was slightly greater for FXIII from plasma.Similar results were found for recovery (65% vs 60%). The area under the data completed by extrapolation was significantly higher for FXIII from plasma. No differences between preparations in terms of efficacy or tolerability were observed. It can be concluded that treatment with FXIII concentrate from plasma is as efficient as with FXIII concentrate from placenta in terms of recovery and half-life. Both preparations were equivalent in terms of safety during the observation period. With the administration of monthly injections of approximately 30 U/kg serious bleeding events were prevented and no other serious adverse events occurred.

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Stroke Prevention in Non-Valvular Atrial Fibrillation

Hämostaseologie ◽

10.1055/s-0038-1659985 ◽

1997 ◽

Vol 17 (03) ◽

pp. 166-169

Author(s):

Judith O’Brien ◽

Wendy Klittich ◽

J. Jaime Caro

Keyword(s):

Atrial Fibrillation ◽

Clinical Trials ◽

Care Home ◽

Relevant Literature ◽

Clinical Trial Data ◽

Outcome Data ◽

Sensitivity Analyses ◽

Bleeding Events ◽

Discharge Data ◽

The Cost

SummaryDespite evidence from 6 major clinical trials that warfarin effectively prevents strokes in atrial fibrillation, clinicians and health care managers may remain reluctant to support anticoagulant prophylaxis because of its perceived costs. Yet, doing nothing also has a price. To assess this, we carried out a pharmacoe-conomic analysis of warfarin use in atrial fibrillation. The course of the disease, including the occurrence of cerebral and systemic emboli, intracranial and other major bleeding events, was modeled and a meta-analysis of the clinical trials and other relevant literature was carried out to estimate the required probabilities with and without warfarin use. The cost of managing each event, including acute and subsequent care, home care equipment and MD costs, was derived by estimating the cost per resource unit, the proportion consuming each resource and the volume of use. Unit costs and volumes of use were determined from established US government databases, all charges were adjusted using cost-to-charge ratios, and a 3% discount rate was applied to costs incurred beyond the first year. The proportions of patients consuming each resource were estimated by fitting a joint distribution to the clinical trial data, stroke outcome data from a recent Swedish study and aggregate ICD-9 specific, Massachusetts discharge data. If nothing is done, 3.2% more patients will suffer serious emboli annually and the expected annual cost of managing a patient will increase by DM 2,544 (1996 German Marks), from DM 4,366 to DM 6,910. Extensive multiway sensitivity analyses revealed that the higher price of doing nothing persists except for very extreme combinations of inputs unsupported by literature or clinical standards. The price of doing nothing is thus so high, both in health and economic terms, that cost-consciousness as well as clinical considerations mandate warfarin prophylaxis in atrial fibrillation.

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New Drugs for Thromboembolic Prevention in Atrial Fibrillation

European Cardiology Review ◽

10.15420/ecr.2010.6.4.64 ◽

2010 ◽

Vol 6 (4) ◽

pp. 64

Author(s):

Jose L Merino ◽

Jose López-Sendón ◽

◽

Keyword(s):

Atrial Fibrillation ◽

Vitamin K ◽

Negative Impact ◽

Vitamin K Antagonists ◽

Coagulation Factor ◽

Developed Countries ◽

New Drugs ◽

Risk Scores ◽

Bleeding Events ◽

Risk Patients

Atrial fibrillation (AF) is the most frequent sustained arrhythmia and its prevalence is increasing in developed countries. This progressive increase and the negative impact of this arrhythmia on the patient’s prognosis make AF one of the main healthcare problems faced today. This has led to intense research into the main aspects of AF, one of them being thromboembolism prevention. AF patients have a four to five times higher risk of stroke than the general population. Several factors increase thromboembolic risk in patients with AF and the use of risk scores, such as the Congestive Heart Failure, Hypertension, Age Greater than 75, Diabetes, and Prior Stroke or Transient Ischemic Attack (CHADS2), have been used to identify the best candidates for anticoagulation. Antithrombotic drugs are the mainstay of therapy for embolic prevention. The clinical use of these drugs is based on the risk–benefit ratio, where benefit is the reduction of stroke and systemic embolic events and risk is mostly driven by the increase in bleeding events. Generally, antiplatelets are indicated for low-risk patients in light of the fact anticoagulants are the drug of choice for moderate- or high-risk patients. Vitamin K antagonists have been the only option for oral anticoagulation for the last 50 years. However, these drugs have many pharmacodynamic and pharmacokinetic problems. The problems of anticoagulation with vitamin K antagonists have led to the investigation of new drugs that can be administered orally and have a better dose–response relationship, a shorter half-life and, in particular, higher efficacy and safety without the need for frequent anticoagulation controls. The drugs that have been studied most thoroughly in patients with AF are inhibitors of the activated coagulation factor X and inhibitors of coagulation factor II (thrombin), including ximelagatran and dabigatran. In addition, non-pharmacological therapies have been developed to prevent recurrent embolism in certain patient populations.

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TWILIGHT: A Randomized Trial of Ticagrelor Monotherapy Versus Ticagrelor Plus Aspirin Beginning at 3 Months in High-risk Patients Undergoing Percutaneous Coronary Intervention

US Cardiology Review ◽

10.15420/usc.2019.02 ◽

2020 ◽

Vol 14 ◽

Author(s):

Johny Nicolas ◽

Usman Baber ◽

Roxana Mehran

Keyword(s):

Percutaneous Coronary Intervention ◽

High Risk ◽

Antiplatelet Therapy ◽

Dual Antiplatelet Therapy ◽

Coronary Intervention ◽

Bleeding Events ◽

High Risk Patients ◽

Risk Of Death ◽

Percutaneous Coronary ◽

Risk Patients

A P2Y12 inhibitor-based monotherapy after a short period of dual antiplatelet therapy is emerging as a plausible strategy to decrease bleeding events in high-risk patients receiving dual antiplatelet therapy after percutaneous coronary intervention. Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention (TWILIGHT), a randomized double-blind trial, tested this approach by dropping aspirin at 3 months and continuing with ticagrelor monotherapy for an additional 12 months. The study enrolled 9,006 patients, of whom 7,119 who tolerated 3 months of dual antiplatelet therapy were randomized after 3 months into two arms: ticagrelor plus placebo and ticagrelor plus aspirin. The primary endpoint of interest, Bleeding Academic Research Consortium type 2, 3, or 5 bleeding, occurred less frequently in the experimental arm (HR 0.56; 95% CI [0.45–0.68]; p<0.001), whereas the secondary endpoint of ischemic events was similar between the two arms (HR 0.99; 95% CI [0.78–1.25]). Transition from dual antiplatelet therapy consisting of ticagrelor plus aspirin to ticagrelor-based monotherapy in high-risk patients at 3 months after percutaneous coronary intervention resulted in a lower risk of bleeding events without an increase in risk of death, MI, or stroke.

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Analisis Faktor Perawat Dalam Pelaksanakan Keselamatan Pasien Terhadap Kejadian Medication Administration Error di Rumah Sakit

10.31219/osf.io/dxnpj ◽

2020 ◽

Author(s):

Bintang Marsondang Rambe

Keyword(s):

Patient Safety ◽

Literature Review ◽

Medication Error ◽

Medication Errors ◽

Medication Administration ◽

Prescribing Error ◽

Medication Administration Error ◽

Administration Error

Latar Belakang Keselamatan pasien (patient safety) rumah sakit adalah suatu sistem dimana rumah sakit membuat asuhan pasien lebih aman yang meliputi assessment risiko, identifikasi dan pengelolaan hal yang berhubungan dengan risiko pasien, pelaporan dan analisis insiden, kemampuan belajar dari insiden dan tindak lanjutnya serta implementasi solusi untuk meminimalkan timbulnya risiko dan mencegah terjadinya cedera yang disebabkan oleh kesalahan akibat melaksanakan suatu tindakan atau tidak mengambil tindakan yang seharusnya diambil yang dilakukan oleh perawat (Kemenkes, 2011).Salah satu kesalahan yang dapat merugikan pasien adalah medication error. Menurut WHO (2016) medication error adalah setiap kejadian yang dapat dicegah yang menyebabkan penggunaan obat yang tidak tepat yang menyebabkan bahaya kepasien, dimana obat berada dalam kendali profesional perawatan kesehatan. proses terjadi medication error dimulai dari tahap prescribing, transcribing, dispensing,dan administration. Kesalahan peresepan (prescribing error), kesalahan penerjemahan resep (transcribing erorr), kesalahan menyiapkan dan meracik obat (dispensing erorr), dan kesalahan penyerahan obat kepada pasien (administration error). Medication error yang paling sering terjadi adalah pada fase administration / pemberian obat yang dilakukan oleh perawat.Administration error terjadi ketika pemberian obat kepada pasien tidak sesuai dengan prinsip enam benar yaitu benar obat, benar pasien, benar dosis, benar rute pemberian, benar waktu pemberian dan benar pendokumentasian. Secara global, kesalahan pemberian obat (medication errors) sampai saat ini masih menjadi isu keselamatan pasien dan kualitas pelayanan di beberapa rumah sakit (Depkes RI, 2015; AHRQ, 2015). Perawat sebagai bagian terbesar dari tenaga kesehatan di rumah sakit, mempunyai peranan dalam kejadian medication error. Perawat berkontribusi karena perawat banyak berperan dalam proses pemberian obat. Pemberian obat/ Medication Administration adalah salah satu intervensi keperawatan yang paling banyak dilakukan, dengan sekitar 5- 20% waktu perawat dialokasikan untuk kegiatan ini (Härkänen et al.,, 2019). Pemberian obat juga mencakup tugas-tugas lain, seperti menyiapkan dan memeriksa obat obatan, memantau efek obat-obatan, mengedukasi pasien tentang pengobatan, dan memperdalam pengetahuan perawat tentang obat – obatan sendiri (DrachZahavy et al., 2014 dalam Yulianti et al., 2019)Berdasarkan isu tersebut, penulis tertarik untuk melakukan literature review terkait faktor perawat dalam pelaksanakan keselamatan pasien terhadap kejadian medication administration error di Rumah Sakit.

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