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

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

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 extend the Newborn Metabolic Screening use case to support automated adverse event reporting using electronic health record (EHR) data to the US Food and Drug Administration (FDA). The user story assumes: (1) automated laboratory reporting to the hospital EHR and state public health agency, and (2) the hospital subscribes to FDA Really Simple Syndication (RSS) feeds, which provides important risk communication and warnings about FDA regulated products. //
 * 1.2 User Story Narrative: FDA Spontaneous Triggered Event Reporting **

//__High-Level Functional Description: __// Laboratory test results and RSS feeds are used to help initiate a series of related healthcare, case management and reporting activities for a newborn and its parents. However, follow up laboratory and diagnostic testing reveals that the testing method (test kit) used by the contract laboratory is defective, which requires reporting to FDA, and subsequent changes to the newborn and mother’s health records. The hospital’s EHR and incident reporting systems are programmed with a pre-defined set of criteria, or “triggers” that are used to prompt the healthcare provider and hospital risk manager to take appropriate action to manage the health concern and complete reporting requirements.

//__Detailed Narrative Description: __// A hospital’s contract testing laboratory returns results from a recent newborn metabolic screening panel. The result indicates that the infant has the rare genetic disorder, Isovaleric Acidemia (IVA). The pediatrician contacts the mother and requests a follow up appointment within the next two weeks so that additional diagnostic tests can be performed. In the interim, the pediatrician advices the mother to start using a leucine-free infant formula and contact the state’s public health agency to obtain more information about the disease, including available services, such as listings for specialists, dieticians, medical foods and other therapies used to manage the disease. The pediatrician also advises genetic testing for both parents.

The mother contacts her OB/GYN and primary care physician about the infant’s test results and requests a referral for genetic testing for her and her husband. Activities over the next two weeks include verification of the state’s receipt of the initial laboratory report, assignment of an IVA services case manager, parental genetic testing, and a second newborn screening panel. The mother returns to the pediatrician’s office to review all laboratory tests and activities. The pediatrician informs her that the second panel was negative, and the mother also confirms negative genetic testing results for the disease, per separate follow up with her primary care physician. The pediatrician advises the mother to continue using the leucine-free formula and that she should return in 4-6 weeks for another series of diagnostic tests and clinical follow up.

A few weeks later, the hospital’s risk manager contacts the pediatrician concerning an FDA RSS product recall alert for a manufacturer’s A mino Acids and Acylcarnitines Tandem Mass Spectrometry Test Kits, which product lot numbers are confirmed to be used by the contract laboratory facility. The risk manager coordinates follow up discussions with the pediatrician, primary care physician, OB/GYN, and test laboratories (genetic and newborn screening) to consult on the case and determine next steps. The consensus opinion is that the IVA test kit used for the initial screening produced a “false positive” result, and that all records for the infant and mother should be updated to reflect the correction. The newborn screening test laboratory facility sends a corrected laboratory report to the hospital and state public health agency. The risk manager confirms that the corrected report contains information that meets FDA reporting criteria for a device malfunction report. The risk manager initiates an incident report, which is auto-populated with EHR patient/parent information, medical/birth history, laboratory tests, and product information (e.g., list of all medications/treatments, including the defective test kit information). A report is generated and sent electronically to FDA.

1.2.1 Goal
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.

This user story raises awareness for the need for accurate newborn screening methods, and is based upon the complementary activities of the FDA Office of Orphan Products Development (OOPD) and the Center for Devices and Radiological Health (CDRH). OOPD’s mission is to advance the evaluation and development of products (drugs, biologics, devices, or medical foods) that demonstrate promise for the diagnosis and/or treatment of rare diseases or conditions. In fulfilling that task, OOPD evaluates scientific and clinical data submissions from sponsors (product manufacturers) to identify and designate products as promising for rare disease and to further advance scientific development of such promising medical products. CDRH manages the Medical Products Safety Network (MEDSUN) and the Manufacturer and User Facility Device Experience Database (MAUDE). Collectively, these systems help pro tect and promote public health by assuring the safety, effectiveness, and quality of medical devices, assuring the safety of radiation-emitting products, fostering innovation, and providing the public with accurate, science-based information about the products they oversee throughout the total product life cycle.

All States and Washington, DC have newborn screening programs. These programs help integrate genetics into public health and population health by supporting state newborn screening programs, genetic education programs and health information technology initiatives that work to link families, consumers and providers.[2]
 * <span style="color: #000000; font-family: 'Arial','sans-serif'; font-size: 13.3333px;">1.2.2 Description of Data Reporting Events, Actors and Triggers **

<span style="font-family: 'Arial','sans-serif'; font-size: 13.3333px;">//For the purposes of this user story:// <span style="color: #000000; font-family: 'Arial','sans-serif'; font-size: 13.3333px;">The minimum event triggers are: 1) receipt of confirmed “negative” test rests, and 2) risk manager’s discovery of a potential AE. The initial data collection occurs within 24 hours at the birthing center/hospital. The attending pediatrician obtains a blood sample (heel-stick) from the infant and completes the appropriate forms and sends the sample to the hospital’s contract testing laboratory for a NBS (newborn screening) analysis. NBS results are used to help verify the overall health status of the infant, and work to reduce morbidity and mortality in newborns and children who have or are at risk for heritable disorders. The accuracy and reliability of approved test methods, procedures and devices used for diagnosing rare diseases is a critical first step in mitigating risk or harm by insuring that newborns obtain the immediate and appropriate healthcare required to manage the disease. <span style="color: #000000; font-family: 'Arial','sans-serif'; font-size: 13.3333px;">Since this user story is an extension of the Newborn Metabolic Screening use case, we expect that there is a combination of paper-based and electronic data sources. For example, some diagnostic laboratories have the ability to receive orders electronically (e.g., request for service/test) sample tracking and linking (samples sent via mail/courier to electronic orders, which help pre-populate the lab system), or one-way communication to a state/local public health entity (agency or registry). Or, conversely, the entire process is paper-based and begins with the receipt of the NBS screening form and sample.

<span style="color: #000000; font-family: 'Arial','sans-serif'; font-size: 13.3333px;">Furthermore, because the user story is leveraging preexisting work efforts (Newborn Screening and Electronic Laboratory Reporting), it is expected that the common data elements or content of the “base record or report”, that is, patient demographics, parent information, medical history, etc. would already exist in the EHR or other format (albeit that the formats may not be immediately interchangeable or interoperable). The frequency of reporting is considered ad hoc – that is, there is no predefined interval for when an adverse event report is required. The end-to-end processing of the report is dependent upon the initial criteria or trigger used initiate other programs or processes that would extract relevant data from the EHR and render it in such a way that a human (physician, risk managers, etc.) could review the data and append additional information prior to release to FDA. Once FDA receives the report (via FDA’ Electronic Submissions Gateway), the report can be validated and immediately parsed into the appropriate database for immediate review and follow up. Current reports are paper-based and are often incomplete or have data quality issues. For example, a “dump” of patient laboratory data that is not relevant to the adverse event and/or therapy dates. Automated reporting will help reduce manual data entry costs (healthcare provider and FDA), ease reporting burden and facilitate timely reporting of serious adverse events.

<span style="color: #000000; font-family: 'Arial','sans-serif'; font-size: 13.3333px;">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<span style="color: #000000; font-family: 'Arial','sans-serif'; font-size: 13.3333px;">[3].
 * <span style="color: #000000; font-family: 'Arial','sans-serif'; font-size: 13.3333px;">1.2.3 Data **

<span style="color: #000000; font-family: 'Arial','sans-serif'; font-size: 13.3333px;">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:
 * <span style="font-family: 'Arial','sans-serif'; font-size: 13.3333px;">Patient Demographics:
 * <span style="color: #000000; font-family: 'Arial','sans-serif'; font-size: 13.3333px;">Age, date of birth or patient age group
 * <span style="color: #000000; font-family: 'Arial','sans-serif'; font-size: 13.3333px;">Sex/Gender
 * <span style="color: #000000; font-family: 'Arial','sans-serif'; font-size: 13.3333px;">Weight
 * <span style="color: #000000; font-family: 'Arial','sans-serif'; font-size: 13.3333px;">Height
 * <span style="color: #000000; font-family: 'Arial','sans-serif'; font-size: 13.3333px;">Race
 * <span style="color: #000000; font-family: 'Arial','sans-serif'; font-size: 13.3333px;">Associated Person Information
 * <span style="color: #000000; font-family: 'Arial','sans-serif'; font-size: 13.3333px;">Parent or Sibling
 * <span style="color: #000000; font-family: 'Arial','sans-serif'; font-size: 13.3333px;">Medical History (Patient and Associated Person)
 * <span style="color: #000000; font-family: 'Arial','sans-serif'; font-size: 13.3333px;">Medications History, including concomitant medications (therapy dates and duration)
 * <span style="color: #000000; font-family: 'Arial','sans-serif'; font-size: 13.3333px;">Relevant Laboratory/Procedure Information (including relevant dates and results)
 * <span style="color: #000000; font-family: 'Arial','sans-serif'; font-size: 13.3333px;">Product Information
 * <span style="color: #000000; font-family: 'Arial','sans-serif'; font-size: 13.3333px;">Name or ingredients
 * <span style="color: #000000; font-family: 'Arial','sans-serif'; font-size: 13.3333px;">Product identifiers (e.g., NDC or UDI)
 * <span style="color: #000000; font-family: 'Arial','sans-serif'; font-size: 13.3333px;">Manufacturer
 * <span style="color: #000000; font-family: 'Arial','sans-serif'; font-size: 13.3333px;">Dosage Form, Route of Administration and Approach Site
 * <span style="color: #000000; font-family: 'Arial','sans-serif'; font-size: 13.3333px;">Product strength and dose amount
 * <span style="color: #000000; font-family: 'Arial','sans-serif'; font-size: 13.3333px;">Adverse Event and Actions Taken
 * <span style="color: #000000; font-family: 'Arial','sans-serif'; font-size: 13.3333px;">AE/Patient narrative (describing the event, actions taken, patient status, etc.)
 * <span style="color: #000000; font-family: 'Arial','sans-serif'; font-size: 13.3333px;">Report Sender Information (organization name, contact party, etc,)
 * <span style="color: #000000; font-family: 'Arial','sans-serif'; font-size: 13.3333px;">Primary source reporter (person that discovered the event and/or healthcare provider)

<span style="color: #000000; font-family: 'Arial','sans-serif'; font-size: 13.3333px;">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:
 * <span style="color: #000000; font-family: 'Arial','sans-serif'; font-size: 13.3333px;">1.2.4 Other information **
 * <span style="color: #000000; font-family: 'Arial','sans-serif'; font-size: 13.3333px;">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)
 * <span style="color: #000000; font-family: 'Arial','sans-serif'; font-size: 13.3333px;">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
 * <span style="color: #000000; font-family: 'Arial','sans-serif'; font-size: 13.3333px;">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.
 * <span style="color: #000000; font-family: 'Arial','sans-serif'; font-size: 13.3333px;">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

<span style="color: #000000; font-family: 'Arial','sans-serif'; font-size: 13.3333px;">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).
 * <span style="color: #000000; font-family: 'Arial','sans-serif'; font-size: 13.3333px;">1.3 Stakeholder Commitment **

<span style="color: #000000; font-family: 'Arial','sans-serif'; font-size: 13.3333px;">Lise Stevens, Data Standards Project Manager <span style="color: #000000; font-family: 'Arial','sans-serif'; font-size: 13.3333px;">Bioinformatics Support Staff <span style="color: #000000; font-family: 'Arial','sans-serif'; font-size: 13.3333px;">FDA Center for Biologics Evaluation and Research <span style="font-family: 'Arial','sans-serif'; font-size: 13.3333px;">Lise.Stevens@fda.hhs.gov <span style="color: #000000; font-family: 'Arial','sans-serif'; font-size: 13.3333px;">(301) 827-2743
 * <span style="color: #000000; font-family: 'Arial','sans-serif'; font-size: 13.3333px;">1.4 Contact Information: **

References: <span style="font-family: 'Times New Roman','serif'; font-size: 13.3333px;">[1] <span style="color: #0f1419; font-family: 'Arial','sans-serif'; font-size: 12px;">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: <span style="font-family: 'Arial','sans-serif'; font-size: 12px;">[] <span style="font-family: 'Times New Roman','serif'; font-size: 13.3333px;">[2] US HHS Health Resources and Services Administration’s Maternal and Child Health, Newborn Screening webpage: [] <span style="font-family: 'Times New Roman','serif'; font-size: 13.3333px;">[3] 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 - November 18 2011.docx]] ||  ||

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