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The role of pharmacovigilance centres - Reporting and learning systems for medication errors: Part 2

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Nội dung chi tiết: The role of pharmacovigilance centres - Reporting and learning systems for medication errors: Part 2

The role of pharmacovigilance centres - Reporting and learning systems for medication errors: Part 2

6. Identifying and reporting medication errorsit is well known that patients undergoing medical, pharmaceutical and paramedical interventions run a ri

The role of pharmacovigilance centres - Reporting and learning systems for medication errors: Part 2isk of MEs. Identifying MEs and finding their underlying causes arc the first steps in establishing prevention strategics to avoid their recurrence, h

l certain situations, MEs are easily recognized by practitioners, but in other cases MEs are not clearly visible and arc then reported as ADRs.The obj The role of pharmacovigilance centres - Reporting and learning systems for medication errors: Part 2

ective of this section is to outline the different methods that could be used to identify an ME through ICSRs that arc sent to a PVC. This section als

The role of pharmacovigilance centres - Reporting and learning systems for medication errors: Part 2

o aims to describe methods for collecting and reporting MEs. Reports of both ADRs and MEs could be collected from IICPs, the pharmaceutical and medica

6. Identifying and reporting medication errorsit is well known that patients undergoing medical, pharmaceutical and paramedical interventions run a ri

The role of pharmacovigilance centres - Reporting and learning systems for medication errors: Part 2portant number of ICSRs that were reported as “ADRs” were possibly due to some aspect of xME and were thus “preventable" ADRs. According to the litera

ture, the rate of preventable ADRs may vary from 18.7% to 80% (Yu, Nation & Dooley, 2005).PVCs should develop their tools and their skills to identify The role of pharmacovigilance centres - Reporting and learning systems for medication errors: Part 2

MEs from ADR reports and to investigate their preventability. Currently, two aspects of phar-macovigilancc could be enhanced to address these objecti

The role of pharmacovigilance centres - Reporting and learning systems for medication errors: Part 2

ves: the reporting form for ICSRs and a tool for assessing the preventability of ADRs.6.1.1The yellow card and other individual case safety reporting

6. Identifying and reporting medication errorsit is well known that patients undergoing medical, pharmaceutical and paramedical interventions run a ri

The role of pharmacovigilance centres - Reporting and learning systems for medication errors: Part 2ealth-care professionals regarding health products.The information contained in the yellow card and in other forms of ICSRs is of great value for PVCs

in establishing a causal relationship between the observed adverse effect and the medicine. At a minimum, an ICSR should contain information on the f The role of pharmacovigilance centres - Reporting and learning systems for medication errors: Part 2

ollowing (Uppsala Monitoring Centre, 2012):28•the patient•adverse event•suspected drug(s)•all other drugs used (including self-medication)•risk factor

The role of pharmacovigilance centres - Reporting and learning systems for medication errors: Part 2

s•name and address of reporter.Over the years, reporting forms have been redesigned as the information required has changed.There arc many adaptations

6. Identifying and reporting medication errorsit is well known that patients undergoing medical, pharmaceutical and paramedical interventions run a ri

The role of pharmacovigilance centres - Reporting and learning systems for medication errors: Part 2 or medical devices) or targeted for public health programmes (e.g. tuberculosis, malaria and AIDS), rhe reporting forms allow PVCs to operate and pro

vide continuous safely monitoring throughout the lifespan of a medicinal product. Initially, there was only a paper version, but with the advent of em The role of pharmacovigilance centres - Reporting and learning systems for medication errors: Part 2

ail and the Internet, electronic and web-based versions of reporting forms are now also available.Recently, the scope of pharmacovigilance has widened

The role of pharmacovigilance centres - Reporting and learning systems for medication errors: Part 2

in some countries to include identification ol'MEs. In view of this development, some centres may consider reviewing the forms they use for ICSRs. Th

6. Identifying and reporting medication errorsit is well known that patients undergoing medical, pharmaceutical and paramedical interventions run a ri

The role of pharmacovigilance centres - Reporting and learning systems for medication errors: Part 2ndly design.A working group, convened under the aegis of the Monitoring Medicines project, has reviewed the existing elements in common ICSR reporting

forms and examined their value in detecting and assessing MEs. The group considered that the following elements are important for the identification The role of pharmacovigilance centres - Reporting and learning systems for medication errors: Part 2

of MEs from ICSRs and for the assessment of preventabilily of MEs (Figure 2, page 30):•Patient weight, to detect dose errors: this is particularly imp

The role of pharmacovigilance centres - Reporting and learning systems for medication errors: Part 2

ortant for children, for whom the dose prescribed is calculated according to their weight, and also for adults when the dose for the prescribed drug i

6. Identifying and reporting medication errorsit is well known that patients undergoing medical, pharmaceutical and paramedical interventions run a ri

The role of pharmacovigilance centres - Reporting and learning systems for medication errors: Part 2lp understand whether underlying pathology and known history of allergy were considered when prescribing.•Strength of the formulation, to detect presc

ribing errors.6. IDENTIFYING AND REPORTING MEDICATION ERRORS29Figure 2. A model ICSR reporting form with important data fields to support ME detection The role of pharmacovigilance centres - Reporting and learning systems for medication errors: Part 2

National Pharmacovigilance CentreREPORTING ADVERSE EVENTS RELATED TO DRUGS AND OTHER HEALTH PRODUCTSPatientName:Age:Sex: Mil Fn unknown□Weight (kg):If

The role of pharmacovigilance centres - Reporting and learning systems for medication errors: Part 2

pregnant, gestation term:Locality/city:Phone number:

6. Identifying and reporting medication errorsit is well known that patients undergoing medical, pharmaceutical and paramedical interventions run a ri

6. Identifying and reporting medication errorsit is well known that patients undergoing medical, pharmaceutical and paramedical interventions run a ri

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