Drug Safety Content

1. Proposed Profile: Drug Safety Content

• Proposal Editor: Landen Bain, CDISC Liaison to Healthcare
• Editor: Michael Ibara, Head of Pharmacovigilance Information Management, Pfizer
• Date: January 2008
• Version: 1.0
• Domain: Patient Care Coordination

2. The Problem

While RFD simplifies data capture for investigator sites, content profiles will extend its value.

RFD has proved itself to be particularly useful in two use cases that pertain to the biopharmaceutical industry: collection of clinical trial data (addressed in the companion profile “Clinical Research Data Collection Fields”, and drug safety, the topic of this proposal. The drug safety use case addressed here is the post-market reporting of adverse drug events. This reporting begins with a trigger event within the EHR which identifies the need to report an adverse event. RFD summons a drug safety data capture form from the appropriate source, and the form is completed by the EHR user, assisted by auto-population scripts within the EHR. The problem which this profile addresses is the lack of standard content for the auto-population.

The proposed content profile will align the data requirements of the RFD data safety report with HL7’s ICSR (E2B) standard. ICSR provides the basis for identifying the data elements required from the EHR, and greatly simplifies the involvement of the EHRs in drug safety reporting. This content profile will also complement the Query for Existing Data profile currently in development. An ICSR-based content profile would provide the list of data elements that an EHR should have on hand to respond to an external query from a drug safety sponsor.

3. Key Use Case

The point of departure for this use case is a patient care site which currently reports drug safety information using RFD without a content profile. The ‘before’ state shows the use of RFD without a content profile. The ‘after’ state describes the use of RFD in concert with the proposed content profile.

Before Drug Safety Content:

A physician discovers a suspected adverse event during a patient outpatient visit. The physician uses RFD to fetch a drug safety form from the appropriate source and completes the form by hand.

After Drug Safety Content:

A physician discovers a suspected adverse event during a patient outpatient visit. The physician uses RFD to fetch a drug safety form from the appropriate source. The EHR automatically provides the data elements specified in the Drug Safety Content Profile, and the forms manager populates the form and returns it to the form filler for display. The physician reviews the partially completed form, and fills in those sections which the content profile did not specify. RFD returns the data to the Forms Receiver.

17.1.3 Pharmaco-vigilance Scenario 355 A community-based physician, Dr. Cramp, sees a patient in an outpatient clinic and accesses the patient’s electronic health record which reveals that the patient is on one of the new statin drugs. The physical examination turns up muscle weakness in the patient’s calves, which the physician recognizes as a possible adverse reaction to the statin. He orders a total creatinine kinase lab test to help in diagnosing the problem. 360 17.1.3.1 Current State Dr. Cramp exits the EHR and, using a web browser, goes to http://www.fda.gov/medwatch/. He brings up form FDA 3500, for ‘voluntary reporting of adverse events noted spontaneously in the course of clinical care’. He navigates through several screens of routing and instructions to arrive at the first screen of the actual form, which requests patient identifier, age at time of event 365 or date of birth, sex, and weight; the second screen requests seven entries: a classification of the event, classification of outcome, event date, report date, description, relevant tests (he notes that a test has been ordered), and other relevant history (the last three fields are text entry); the third and fourth screens ask for details about the product ; and so forth. In actuality, the current state is that this form is seldom completed. 370 17.1.3.2 Desired State Dr. Cramp sees the patient and accesses the EHR as above. Upon finding the potential problem, he clicks on an ‘Adverse Event Reporting’ button which brings up FDA form 3500, which has been styled to fit in with the look and feel of the EHR user interface. The form is presented with the demographics already completed. The product name is part of the working context of the 375 EHR session, and is automatically loaded into the appropriate field. Dr. Cramp completes the empty fields of the form and submits directly to the FDA Medwatch site. RFD takes care of retrieving the form from MedWatch, displaying it, and returning the form to FDA. Note that the profile does not address whether or not the EHR stores a copy of the form or preloads it with EHR data. Simply using the EHR to display, complete, and submit the form is 380 sufficient. The EHR and the site might decide to capture and store the form in the EHR database, which would be a permitted extension of the profile, but not necessary.

4. Standards & Systems

Systems

• Participating EHRs;
• Participating drug safety systems.

Standards

• CDISC standards: ODM, SDTM
• IHE: RFD, QED
• W3C standards: XForm
• HL7 standards: ICSR.

5. Discussion

IHE has successfully reached the biopharmaceutical industry through a content-free integration profile, RFD. Extending the reach of RFD by binding it to drug safety specific content profiles further reinforces this cross-industry alliance. Benefits achieved will result in greater reporting compliance and improved data quality.