Docket Management
Docket: 02N-0528 - Risk Management; Public Workshop
Comment Number: EC -7

Accepted - Volume 3

Comment Record
Commentor Dr. Terry Knapp Date/Time 2003-04-30 12:11:14
Organization PrivaComp, Inc.
Category Company

Comments for FDA General
1. General Comments PrivaComp, Inc., and this individual responder strongly supports FDA initiatives to develop a strong set of product risk management criteria for the drug, biotechnology and medical device industry as it pertains to products (drugs, devices and biologicals) throughout the product lifecycle, from development and clinical research through commercialization. Specifically with regard to how risk management tools are related to RMP objectives and goals, as describes in lines 138 - 173 of the Concept Paper Risk Management Programs, PrivaComp wishes to point out that electronic, Web-based implementation of such tools, and the connectivity among stakeholders (manufacturer, patient, prescriber, dispenser, and FDA) will create the most effective and meaningful exercise of risk management. Moreover, the institution of electronically-driven tools in a private, secure network environment contributes to an automated continuous improvement (quality systems)process for the risk management programs themselves. The following illustrations relate directly to proposed electronically-driven, network-based risk management tools as they relate to the example cited on lines 138 - 141: Example: “Because of potential harm and associated risk, no patient with Condition A should use Product B.” This example leads to the following FDA-stipulated objectives to achieve the goal, and the associated tools described by the FDA to meet the objectives: Objective #1: Assure that physicians are fully knowledgeable about withholding Product B from patients with Condition A. Generic tools (FDA): 1. Educate physicians with product labeling, detailing, CME, or other methods 2. Have physicians self-attest or be tested/certified that they possess appropriate knowledge 3. Require documentation that Condition A is not present prior to prescribing and dispensing 4. Limit prescribing only to registered practitioners who meet certain requirements including being skilled in recognizing and monitoring Condition A. PrivaComp solution to address Objective #1: PrivaComp’s platforms and education-and-verification tools more than meet this Objective. The steps are simple, economical, and auditable. They reduce risk for the manufacturer, the prescriber and (most important) the patient. First, the manufacturer creates a Prescriber Education Module (PEM) detailing the information about the product and the contraindications for use in patients with Condition A. The multimedia, interactive module, hosted on PrivaComp’s PrivaSure delivery platform educates the physician, verifies physician understanding, signals physician compliance via signature, provides for CME logging, and creates auditable “certification” that the prescriber is qualified according to criteria stipulated by the manufacturer. The manufacturer may then limit product access to only qualified prescribers and share the information with qualified dispensing pharmacists. Moreover, the “survey” element of patient education (See below.) closes the loop that requires documentation that Condition A is not present before a prescription is issued to a specific patient. All information delivery, exchange, documentation and reporting is private, secure, electronic and Web-based. Objective #2: Create patients who are fully knowledgeable that Condition A is contraindicated with Product B and are able to help their prescriber know if they have Condition A. Generic Tools (FDA): 1. Educate patients and provide self-assessment materials about Condition A and its contraindications with Product B 2. Provide prescribers with a checklist that actively solicits patient history or symptoms consistent with Condition A. PrivaComp solution to address Objective #2: PrivaComp’s Clinical Research Informed Consent (CRIC) attributes are directly transferable to Product Informed Consent (PIC), with the following immediate benefits: · Patients are educated, with verified understanding, of the specific benefits and risks of the product. · Built-in customized surveys or checklists gather information that the prescriber needs to ascertain patient status relative to a specific contraindication (Condition A). · Patients may pose questions and concerns directly to the prescriber, even when the education session occurs at home. · Patient acknowledgement and/or consent to product use can be captured in the form of digital signature. · All sessions are logged and archived. · The Web-based tools are private and secure. · Enrollment in a registry (if so stipulated by the manufacturer) is automatic and establishes the requisite connectivity for subsequent tracking (if so stipulated by the manufacturer). · The report of patient knowledge, verification of status relative to Condition A, and online validated prescription (if criteria are met) for Product B is available online and any time to licensed pharmacists. Objective #3: Pharmacists must be able to confirm that a patient with a product B prescription does not have Condition A. Generic Tools (FDA): 1. Provide education materials and training of pharmacists to ask patients if they have Condition A. 2. Have the pharmacist check for documentation from the prescriber that Condition A is absent in a given patient. 3. Have the pharmacist check from pharmacy records for evidence that Condition A is likely to be present. PrivaComp solution to address Objective #3: The solutions to this Objective have already been described. First, have pharmacists who intend to dispense Product B avail themselves of the Prescriber Education Module described in PrivaComp solution to address Objective #1. Second, the patient education, data acquisition, response and consent elements of the Product Informed Consent module and the online attestation of the prescriber that the patient is free of Condition A, plus the online prescription, coupled with pharmacist’s access to the information online with documentation of the dispensation of Product B, creates a seamless, electronically assisted process that serves as a product risk management system (PRMS) for any given product Furthermore, the PrivaComp Product Risk Management System creates the easy addition of a tracking function, because authorized and authenticated access to reporting (as stipulated by the manufacturer and/or FDA) is always available via the Internet to doctor, pharmacist or patient. This solves mobility problems and creates a permission-based connectivity whereby the manufacturer can proactively seek outcome data or customer (doctor, patient, pharmacist) satisfaction indices. PrivaComp is addressed in these comments only because it focuses on product risk management in specific ways called for by the FDA. Other entities, methods and approaches may indeed address the subject of product risk management legitimately, and such approaches are to be commended. Respectfully submitted, Terry R. Knapp, MD

EC -7