Impact of Pharmacists’ audit on improving the quality of prescription of dabigatran etexilate methanesulfonate: a retrospective study

Shimizu, Thomas S.; Momose, Yoshika; Ogawa, Ryuichi; Takahashi, Masahiro; Echizen, Hirotoshi

doi:10.1186/s40780-017-0077-8

Cited by 5 publications

(11 citation statements)

References 16 publications

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“…In the setting of moderate, mild or no renal impairment, off‐label use of the 75 mg dose might result in underdosed patients and may explain why no differences were observed in risk of ischaemic stroke, major gastrointestinal bleeding or mortality between warfarin and the lower dose of dabigatran. This was also seen in a retrospective study conducted in Japan, where 54 patients from 228 (23.7%) presented inappropriate dabigatran prescriptions.…”

Section: Resultssupporting

confidence: 58%

“…(C) Real‐world studies results concerning dose adjustments of apixaban. (D) Results from direct oral anticoagulants overall adjustments regarding dose appropriateness…”

Section: Resultsmentioning

confidence: 99%

“…Canadian study, 44 where a total of 47 patients were included, among (D) Results from direct oral anticoagulants overall adjustments regarding dose appropriateness 5,9,11,25,27,28,32,34,37,39,40,42,44,[47][48][49][50][51][52][53][54][55][56][57][58][59][60][61][62][63][64] whom 25 (53%) were receiving apixaban inconsistent with the ARIS-TOTLE trial and the product monograph.…”

Section: Study and Also By A Smallmentioning

confidence: 99%

“…However, these recommendations are not uniform worldwide, hampering the selection of the preferable posology and the identification of DOAC suboptimal use. Indeed, the approved doses and dose adjustment criteria defined by European Medicine Agency (EMA) and Food and Drugs Administration (FDA) are summarized in Table while the recommendations reported by Health Canada regulatory agency, European Society of Cardiology and Japanese guidelines, regarding DOAC dose adjustment in patients with AF, are presented in Table . Note that Japanese guidelines mention some differences in relation to EMA and FDA, particularly related to the smaller body size, different pharmacokinetic and genetic profiles of Asian populations when compared with European or American patients.…”

Section: Introductionmentioning

confidence: 99%

“…Indeed, the approved doses and dose adjustment criteria defined by European Medicine Agency (EMA) and Food and Drugs Administration (FDA) are summarized in Table 1 16,[18][19][20][21][22][23][24][25][26][27][28][29][30][31] while the recommendations reported by Health Canada regulatory agency, European Society of Cardiology and Japanese guidelines, regarding DOAC dose adjustment in patients with AF, are presented in Table 2. 7,19,[32][33][34][35][36][37][38][39][40] Note that Japanese guidelines mention some differences in relation to EMA and FDA, particularly related to the smaller body size, different pharmacokinetic and genetic profiles of Asian populations when compared with European or American patients. All these guidelines were, hence, herein taken into consideration to assess whether DOAC dose adjustment were justified or not and, therefore infer about the impact of DOAC off-label doses on clinical outcomes of patients with AF.…”

Section: Introductionmentioning

confidence: 99%

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Impact of direct oral anticoagulant off‐label doses on clinical outcomes of atrial fibrillation patients: A systematic review

Santos

António

Rocha³

et al. 2020

Brit J Clinical Pharma

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Aims Worldwide observational studies are evidencing discordance between guidelines and real‐world practice regarding direct oral anticoagulant drug (DOAC) doses. This systematic review summarizes and evaluate DOACs use in real‐world practice. Methods This review was performed following the preferred reporting items for systematic reviews and meta‐analyses (PRISMA) guidelines searching PubMed (MEDLINE) and Medscape databases. Results Data from 75 studies showed that most of the patients treated with DOACs for stroke prevention in atrial fibrillation received doses in accordance to the guidelines. However, a significant number of patients received off‐label doses (25–50% in most of the studies evaluated). DOAC overdosing was associated with increased all‐cause mortality and worse bleeding events while underdosing was associated with increased cardiovascular hospitalization and, particularly for apixaban, with a nearly 5‐fold increased risk of stroke. Conclusion Patients prescribed with off‐label DOAC doses did not receive the full benefit of anticoagulation and presented an increased risk of stroke, bleeding and/or adverse effects.

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Section: Resultssupporting

confidence: 58%

“…(C) Real‐world studies results concerning dose adjustments of apixaban. (D) Results from direct oral anticoagulants overall adjustments regarding dose appropriateness…”

Section: Resultsmentioning

confidence: 99%

Section: Study and Also By A Smallmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Impact of direct oral anticoagulant off‐label doses on clinical outcomes of atrial fibrillation patients: A systematic review

Santos

António

Rocha³

et al. 2020

Brit J Clinical Pharma

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Development of Quality Indicators to Assess Oral Anticoagulant Management in Community Pharmacies for Patients with Atrial Fibrillation

Chartrand

Guénette

Brouillette

et al. 2018

JMCP

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This research was supported by the Réseau Québécois de recherche sur le médicament (RQRM); the Blueprint for Pharmacy in collaboration with Pfizer Canada; and the Cercle du Doyen of the Faculty of Pharmacy, University of Montreal. The study sponsors were not involved in the study design, data collection, data interpretation, the writing of the article, or the decision to submit the report for publication. Chartrand received a scholarship from the Fonds de Recherche du Québec en Santé (FRQ-S), the Réseau Québécois de recherche sur l'usage des médicaments with Pfizer, and the Faculty of Pharmacy, University of Montreal. Guénette holds a Junior-1 Clinician Researcher Award from the FRQ-S in partnership with the Société québécoise d'hypertension artérielle. Williamson holds a Junior-1 Career Award from the FRQ-S. Côté reported being a medical speaker for Bayer, Boehringer Ingelheim Canada, and Pfizer Canada. The other authors reported no conflicts of interest. Study concept and design were contributed by Lalonde, Chartrand, and Martin. Chartrand, Martin, and Lalonde collected the data, along with Brouillette, Côté, Huot, Landry, Martineau, Perreault, Williamson, and White-Guay. Data interpretation was performed by Chartrand, Gagnon, and Lalonde, along with Guénette and Martin. The manuscript was primarily written by Chartrand, along with Guénette and Lalonde, and revised by Chartrand, Guénette, and Lalonde, along with the other authors. A portion of this study's results was presented at the 4th RQRM Annual Meeting on September 22-23, 2014, in Orford, Quebec, Canada, in the form of an abstract, which was published in the Journal of Population Therapeutics and Clinical Pharmacology, 2014;21(2):e312.

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Az antikoaguláció szerepe a stroke-megelőzésben: a megfelelő NOAC-dózis választása

Oláh¹

2022

Cardiologia Hungarica

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A pitvarfibrilláció (PF) a népesség öregedésével egyre gyakoribb, s az iszkémiás stroke rizikóját ötszörösére emelve jelentősen hozzájárul a stroke-ok nagy számához. A PF okozta stroke-rizikó nagymértékben csökkenthető az antikoaguláns szerek használatával. Az elmúlt évtizedben megjelent új típusú orális antikoagulánsok (NOAC) számos előnnyel rendelkeznek a warfarinnal szemben. Bár a NOAC-ok esetében nincs szükség folyamatos dózismódosításra, az öszszes NOAC esetén döntenünk kell, hogy standard, vagy csökkentett dózist javaslunk. A valóélet-adatok azt mutatták, hogy a pitvarfibrilláló betegek sokkal gyakrabban (36-64%-ban) kapnak csökkentett adagú NOAC-ot a mindennapi gyakorlatban, mint a klinikai vizsgálatokban. Az előírásoknak megfelelő (on-label) csökkentett dózisú NOAC-ok hatásossága és biztonságossága hasonló volt a warfarinhoz, de az apixaban esetén a major vérzések, a dabigatran esetén pedig a halálozás rizikója kisebb volt a warfarinhoz képest. Az off-label NOAC-dózisok használata szintén nem elhanyagolható: az előírttól kisebb adagot a betegek kb. 20%-a, nagyobb adagot 5%-a kap. A nagy metaanalízisek eredményei szerint az on-label adagoláshoz képest az off-label aluldozírozás esetén nem csökken a major vérzés rizikója, de nő a halálozás és a tromboembóliás események száma, vagyis a dóziscsökkentés ellenére nem nő a biztonság, de romlik a hatásosság. Az off-label túldozírozás esetén nő a major vérzések és a halálozás rizikója, s a várttal ellentétben nem csökken a stroke kockázata. A közlemény a NOAC-ok off-label adagolásának a gyakoriságára, s a dozírozással kapcsolatos potenciális veszélyekre hívja fel a figyelmet.

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Impact of Pharmacists’ audit on improving the quality of prescription of dabigatran etexilate methanesulfonate: a retrospective study

Cited by 5 publications

References 16 publications

Impact of direct oral anticoagulant off‐label doses on clinical outcomes of atrial fibrillation patients: A systematic review

Impact of direct oral anticoagulant off‐label doses on clinical outcomes of atrial fibrillation patients: A systematic review

Development of Quality Indicators to Assess Oral Anticoagulant Management in Community Pharmacies for Patients with Atrial Fibrillation

Az antikoaguláció szerepe a stroke-megelőzésben: a megfelelő NOAC-dózis választása

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