PH+Reporting+User+Story+-+FDA+Spontaneous+Triggered+Event+Reporting+2

include component="page" wikiName="siframework" page="PHRI Header" =User Story: FDA Spontaneous Triggered Event Reporting #2=

Contact Info:
Lise Stevens (lise.stevens@fda.hhs.gov, phone: 301.827.2743) -- Data Standards Project Manager, Bioinformatics Support Staff, FDA Center for Biologics Evaluation and Research

Date Received:
11/18/2011

//This user story is based upon the ASTER Study////**[1]**// //and seeks to provide a very high-level example of AE reporting of drug/vaccine reporting. Several triggers could be used to initiate reporting from EHRs://
 * 1.2 User Story Narrative: FDA Spontaneous Triggered Event Reporting #2**
 * Laboratory Test Results: E.g., monitoring of liver toxicity or product efficacy
 * Contraindications
 * Serious adverse events, such as death or birth defects

This user story is an excerpt from storyboards used for the ISO/HL7 27953 Individual Case Safety Report (ICSR) V3 Message Specification:


 * Healthcare Provider Initial Report**

//Purpose//

Mrs. Mary Patient visited her General Practitioner/Family Physician, Dr. Greta Provider last week because she was suffering from a severe urinary tract infection (UTI). Dr. Provider prescribed a course of Ciprofloxacin 250mg tablets to be orally taken twice a day for 5 days. Mrs. Patient's only other regular medication is hormone replacement therapy, for which she takes Prempak C 625 micrograms.

After three days, Mrs. Patient's UTI is resolving well, but she is experiencing increasing soreness of her left ankle. She has no recollection of injuring her ankle in any way. On the fourth day, her ankle is so sore that she makes another appointment to see Dr. Provider later that day. Dr. Provider examines Mrs. Patient and observes that her left ankle is red, stiff, hot and swollen. Mindful of Mrs. Patient's comments that she has no recollection of doing anything that might have injured her ankle, Dr. Provider wonders what other causes there might be for these symptoms. Remembering that she prescribed an antibiotic for a urinary tract infection on Monday for Mrs. Patient, she checks her clinical software for Mrs. Patient's medication record and sees the prescription for Ciprofloxacin. She then checks the electronic drug formulary for information on Ciprofloxacin and Quinolone antibiotics as a family, and it reminds her that Quinolones are known to have an adverse effect of tendonitis, especially of the Achilles tendon. The formulary advises that the medicine should be stopped immediately and the affected joint rested.

Dr. Provider's clinical judgment leads her to be confident that Mrs. Patient is experiencing an adverse drug reaction to her treatment for her UTI. She explains this to Mrs. Patient, and that she must stop the Ciprofloxacin (she feels that the UTI has resolved well), and rest her ankle, and that the ankle soreness will resolve. She may take some painkiller medication (paracetamol/acetaminophen) if she would like to. However, she would like to see her again in a week just to be sure all is well. One week later, Mrs. Patient sees Dr. Patient again. Her ankle is improving nicely and she feels that in a couple of days she will be back to normal. After she has left, Dr. Provider thinks through this incident, and decides that, due to the severity of the event she should report it to a patient safety/quality improvement organization, the relevant drug manufacturer, and regulatory authority. She logs into her clinical support system to complete an electronic Individual Case Safety Report form. The electronic form already includes many of the details of Mrs. Patient's adverse drug event. The form appears on the screen, with some of her relevant information already filled in e.g., Mrs. Patient's demographic information, relevant medical history, lab tests and results and current medications. The form includes Dr. Provider's progress notes and other sections ready for her input. When Dr. Provider is satisfied that the form is complete, she then authorizes her clinical support system to send the electronic report to the appropriate organization(s).

In order to keep effective medical products available on the market, the FDA relies on the reporting of serious adverse events, product quality problems, product use errors or therapeutic inequivalence/failure associated with the use of an FDA-regulated drug, biologic, medical device, dietary supplement or cosmetic. FDA uses these data to maintain our safety surveillance of these products, and reporting from healthcare providers and product manufacturers is a critical action that prompts a modification in use or design of the product, improves its safety profile and leads to increased patient safety.
 * 1.2.1 Goal**

//See user stories for medical device reporting and AHRQ Common Formats. Many of the reporting events, actors and triggers are common across these use cases//
 * 1.2.2 Description of Data Reporting Events, Actors and Triggers**

FDA considers the content of the MedWatch (MW) Form 3500 and 3500A as the minimum required dataset, and represents an historic, unstructured reporting format. Note that FDA has implemented the HL7 Individual Case Safety Report Release 1 standard for electronic medical device reporting based upon the content of the MW 3500A. However, the maximum dataset (which includes the use of controlled terminology and the capture of structured data) is the ISO/HL7 27953-1 V3 message specification. This specification is a multi-part standard, where Part 1 is an overall framework for AE reporting for a variety of FDA-regulated products. Part 2 is a conformance profile for human pharmaceuticals reporting, and covers the content of the International Conference on Harmonisation’s E2B(R3) reporting guideline: “Electronic Transmission of Individual Case Safety Reports (ICSR) Implementation Guide, Data Elements and Message Specification[2].
 * 1.2.3 Data**

For the purposes of this user story, the following high-level information domains are included in the data exchange – note that this is NOT an exhaustive list:
 * Patient Demographics:
 * Age, date of birth or patient age group
 * Sex/Gender
 * Weight
 * Height
 * Race
 * Associated Person Information
 * Parent or Sibling
 * Medical History (Patient and Associated Person)
 * Medications History, including concomitant medications (therapy dates and duration)
 * Relevant Laboratory/Procedure Information (including relevant dates and results)
 * Product Information
 * Name or ingredients
 * Product identifiers (e.g., NDC or UDI)
 * Manufacturer
 * Dosage Form, Route of Administration and Approach Site
 * Product strength and dose amount
 * Adverse Event and Actions Taken
 * AE/Patient narrative (describing the event, actions taken, patient status, etc.)
 * Report Sender Information (organization name, contact party, etc,)
 * Primary source reporter (person that discovered the event and/or healthcare provider)

FDA has been very active in various international Standards Development Groups (SDOs), involved in harmonizing adverse event, product problem and patient safety reporting standards that can be considered as part of this user story:
 * 1.2.4 Other information**
 * HL7 Patient Safety: Provided leadership and sponsorship of the HL7 Individual Case Safety Report (ICSR) V3 messaging standard. ICSR Release 1 – HL7 Normative and ANSI standard 2005 (adopted for FDA CDRH Electronic Medical Device Reporting (eMDR) program in 2006), ICSR Release 2 (aka ISO/HL7 27853): Completed HL7 balloting and ISO Final Draft International Standard ballot October 2011. Final publication expected early 2012. FDA’s Center for Veterinary Medicine is an early adopter of the standard (December 2010)
 * International Conference on Harmonisation (ICH): Common content guideline, terminology and exchange format in use since 1997. Current ICH E2B standard is used for expedited and clinical trial pharmacovilance reporting between global regulatory authorities, pharmaceutical industry and the World Health Organization. ICH parties will adopt ISO 27953-2, which is a conformance profile for 27953-1
 * Global Harmonization Task Force (GHTF): Common set of data elements and terminologies for exchange of medical device reports (referred internally as N87 guideline). Current exchange format unique to GHTF; however, data elements (as of 2008) were harmonized with ISO/HL7 27953-1.
 * IHE Drug Safety Content (DSC) Profile: DSC describes the content and format to be used within the Pre-population Data transaction described within the Retrieve Form for Data Capture (RFD) Integration Profile. The purpose of this profile is to support a standard set of data in CCD format which the Form Filler provides for use in reporting adverse events as it relates to Drug Safety. In addition this profile will reference the ability to convert this output into the ICH E2B(R3) standard

There is significant stakeholder interest in using the ISO/HL7 ICSR 27953 standard. It has already been adopted for global veterinary product surveillance and will replace the existing ICH E2B(M) specification. Currently, reporting by healthcare providers to product manufacturers is a manual process, that is, reports are usually phoned into a hotline or sent to a manufacturer-sponsored product registry. Companies are manually translating and/or data entering information that is then transformed again so that it can be sent to FDA. Consistent data exchange and use of common terminology will facilitate interoperability and data sharing across the product lifecycle: clinical trials, use of products within the market, and patient safety/efficacy experience feedback (via active or passive surveillance methods).
 * 1.3 Stakeholder Commitment**

Lise Stevens, Data Standards Project Manager Bioinformatics Support Staff FDA Center for Biologics Evaluation and Research Lise.Stevens@fda.hhs.gov (301) 827-2743
 * 1.4 Contact Information**

References: [1] The ASTER study was conceived as a proof of concept for a new model of gathering EHR data and reporting spontaneous adverse drug events (ADEs) to FDA: []

[2] ICH E2B(R3) Public Consultation Information: []

Supporting Files:

 * **Description** || **File** ||
 * This document contains the initial draft user story submission. || [[file:Initial Draft Submission - FDA Spontaneous Triggered Event Reporting 2 - November 18 2011.docx]] ||  ||

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