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Intentional Warfarin Sodium Overdose | To Establish a Novel Prototype of Clinical Pharmacy Services by Warfarin Consultation in a Pharmacist Clinic

Intentional Warfarin Sodium Overdose research study

What is the primary objective of this study?

Warfarin, the major oral anticoagulant currently available in Taiwan, is used for the prevention and treatment of a variety of thromboembolic disorders. Under dosing of warfarin may cause treatment failure and over dosing may cause bleeding because of its narrow therapeutic index. Therefore, it is important to monitor prothrombin time (PT) and international normalize ratio (INR) periodically in order to evaluate the appropriateness of warfarin dosing. Lots of factors influencing warfarin anticoagulation effects include polymorphisms of Cytochrome P450 2C9(CYP2C9)and Vitamin K epoxide reductase complex subunit 1(VKORC1)genes, age, weight, diet and concurrent medications. Taking into consideration of physicians' work load, pharmacist-managed anticoagulation clinics were set up to help strengthen patient care in US to ensure patient medication safety. In addition, differences in genetic polymorphisms between Chinese and Caucasian have great impacts on warfarin dosage, and there is still no consensus on warfarin utilization guideline in Taiwan. Pharmacist-managed anticoagulation clinics provide individualized care, consistent monitoring and patient education. Through this service, physicians can get the latest integrated information about their patients, patients themselves are more familiar with their medication, and adherence can be improved. Therefore, those who take warfarin will get better INR control, less adverse drug-related events and treatment failure. This is the first prototype of pharmacist clinic for a specific medication in our hospital. The adverse drug events and coagulation function data collected through this program can be used for the implementation of warfarin treatment guideline in Taiwan in the future. The impact of pharmacist clinic can be evaluated by questionnaire of satisfaction and knowledge survey. It can be used as a model for implementing other pharmacist-managed clinics and improving patient medication safety.

Who is eligible to participate?

Inclusion Criteria: - >20 y/o - Has been received warfarin therapy for 3 months and anticipated treatment duration of more than 3 months and a week - Has legitimate indication for warfarin - Has the capacity to understand the condition and implications of anticoagulant therapy Exclusion Criteria: - Who can't be regular follow-up at National Taiwan University Hospital.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Intentional Warfarin Sodium Overdose

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Other:patient educationone by one patient education

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

pharmacist care

Study Status

Unknown status

Start Date: February 2012

Completed Date: July 2016

Phase: N/A

Type: Interventional

Design:

Primary Outcome: percentage of INR in therapeutic range and incidence of complications

Secondary Outcome: patient's warfarin knowledge improvement

Study sponsors, principal investigator, and references

Principal Investigator: Fe-Lin L WU, PhD

Lead Sponsor: National Taiwan University Hospital

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01972971

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