RFI_SafeMedUse.pdf

REQUEST FOR INFORMATION (RFI)

FOR: Center for Drug Evaluation and Research (CDER)

DEPT/AGENCY INFORMATION: Department of Health and Human Services U.S. Food and Drug Administration (FDA)

Requiring Offices: Office of Surveillance and Epidemiology (OSE)

GENERAL INFORMATION

The U.S. Food and Drug Administration (FDA) is issuing this request for information (RFI) as a means of conducting market research, pursuant to FAR Part 10 Market Research, to identify potential parties from the marketplace capable of providing medication error reports, access to an analytics platform, and services focused on prevention and analysis of medication errors.

This is a REQUEST FOR INFORMATION ONLY, not a Request for Quote (RFQ) and does not commit the Government to award a contract now or in the future. The purpose of this RFI is to identify sources with the capabilities to provide the services stated herein. Submission of any information in response to this market survey is purely voluntary and FDA welcomes responses from all interested parties; the Government assumes no financial responsibility for any costs incurred. Small businesses are encouraged to submit a response.

The FDA will use the results of the market research to determine if sources capable of satisfying the agency's requirements exist based on its response to the objectives described in this notice. The FDA does not intend to make a selection decision or award a contract on the basis of responses.

Acknowledgement of receipt of responses will not be made, nor will respondents be notified of the outcome of the FDA's review of the information received. Additionally, the FDA does not intend to hold discussions concerning this RFI with any interested parties. However, FDA reserves the right to contact vendors if additional information is required.

INSTRUCTIONS

Responses should not exceed 15 pages in length. A complete response should include answers to all the questions below. Please note that a respondent's failure to provide a complete response to a question will be interpreted to mean that it does not understand the question and does not demonstrate the capability to provide services required. Responses should demonstrate capability, not merely affirm the respondent's capability (i.e., the response must go beyond the statement that, "XYZ company can provide technical support").

Respondents will not receive individualized feedback on any suggestions. No basis for claims against the United States government shall arise as a result of a response to this request for information or from the United States government's use of such information. Proprietary, classified, confidential, or sensitive information should not be included in your response. The Federal Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).

While the Government anticipates establishing a contract for medication error which requires contractual support, A SOLICITATION IS NOT CURRENTLY AVAILABLE. The Government is not obligated and will not pay for any information received from potential sources as a result of this RFI.

Companies are encouraged to respond if they have the capability and capacity to provide the identified services. Interested small business are encouraged to respond to this notice.

However, be advised that generic capability statements are not sufficient for effective evaluation of respondents' capacity and capability to perform the specific work as required.

Responses should be emailed to Brian Wodzisz Contract Specialist, at Brian.Wodzisz@fda.hhs.gov by 2pm ET, Monday, January 6th, 2025.

Please include the RFI number FDA-RFI-126495 Safe Medication Use in the subject line. No phone calls will be accepted for this notice.

REQUEST FOR INFORMATION FOR MEDICATION ERROR REPORTS, ACCESS TO AN ANALYTICS PLATFORM, AND SERVICES FOCUSED ON PREVENTION AND ANALYSIS OF MEDICATION ERRORS

CAPABILTY STATEMENTS

Interested, capable vendors (parties) shall submit a Capability Statement in response to this notice with the following information:

A. Contact information:

1) Company Name

2) Mailing Address

3) Name, telephone number, and e-mail address of a point of contact having the authority and knowledge to clarify responses with Government representatives.

4) UEI

5) Business size for NAICS 541990 with size limitation standards of $19,500,000.00 and status, if qualified as an 8(a) firm (must be certified by the Small Business Administration (SBA), Small Disadvantaged Business (must be certified by SBA), Woman-Owned Small Business, HUBZone firm (must be certified by SBA), and/or Service-Disabled Veteran Owned Small Business (must be listed in the VetBiz Vendor Information Pages).

6) Company structure (Corporation, LLC, partnership, joint venture, etc.). Companies also must be registered in the SAM (www.sam.gov) to be considered as potential sources.

7) Any Governmentwide Acquisition contract number(s) with period of performance to include option periods.

8) If a small business, demonstrate the firm’s capability to meet the requirements of FAR 52.219-14, Limitations on Subcontracting.

9) If a large business, identify the subcontracting opportunities that would exist for small business concerns.

10) Proposed NAICS for this effort if different from the code listed in bullet #5.

mailto:Brian.Wodzisz@fda.hhs.gov

B. We are interested in learning from you whether the following Scope of Work is reasonable based on what a vendor like yours might generally agree to. Please provide responses to the following questions regarding capability/experience relevant to providing nationwide medication error reports, access to an analytics platform, and services focused on prevention and analysis of medication errors:

1. Experience: Provide a brief narrative to demonstrate your company’s experience offering this type of product in the context of medication error surveillance, prevention, and analysis (commercial or Government). Describe if your experience is local, regional, or nationwide.

2. What are the most cost-effective analytical solutions you or your organization are aware of?

3. Are there any particular considerations the Government should be aware of if it pursues a model in which we fund this scope of work?

4. What potential risks do you foresee and how might you mitigate them?

5. What types of reports does your organization produce? What has been successful in past experience?

6. What (if any) additional resources would be required to make your project successful?

7. How has your organization protected or disseminated information (public and/or private)?

8. What types of support has you organization employed to gain necessary knowledge of systems or processes?

9. Does your organization have any publicly available pricing?

10. Any feedback on the scope of work that would be beneficial to the overall requirement.

ATTACHMENT 1 - DRAFT Statement of Work (SOW)

BACKGROUND

The Food and Drug Administration (FDA)/Center for Drug Evaluation and Research (CDER) is interested in obtaining medication error reports, access to an analytics platform, and services focused on prevention and analysis of medication errors.1

FDA considers risks from medication errors in its overall assessment of drug safety. For example, regulatory actions to minimize medication error risks include requiring a boxed warning in the Prescribing Information to prevent dosing errors, changing a proprietary name to prevent wrong drug errors, and revising container labels to prevent wrong route of administration errors.2,3,4

The FDA seeks partnership with well-established organizations with a nationwide network capable of providing medication error reports, access to an analytics platform, and services focused on prevention and analysis of medication errors to complement the Agency’s currently available data streams to inform regulatory and routine surveillance activities associated with FDA regulated drug products. FDA seeks nationwide data from healthcare providers, consumers, patient safety organizations, and other sources of safety information such as published literature.

OBJECTIVE

The objective is to obtain medication error reports, access to an analytics platform, and services focused on prevention and analysis of medication errors. The FDA perceives that the Contractor shall provide the following:

• Medication error reports associated with FDA regulated drug products and collected nationwide from healthcare providers, consumers, patient safety organizations, and other sources of safety information including published literature.

• Robust medication error report data including the type of medication error, causes and contributing factors for the error, specific product(s) involved in the error, actions taken or

1 The National Coordinating Council for Medication Error Reporting and Prevention, of which FDA is a member, defines a medication error as, “any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer. Such events may be related to professional practice, health care products, procedures, and systems, including prescribing, order communication, product labeling, packaging, and nomenclature, compounding, dispensing, distribution, administration, education, monitoring, and use." Available at: https://www.nccmerp.org/about-medication-errors.

2 Methadone hydrochloride oral solution Prescribing Information. Accessed 2024 Oct 1. Available at:

https://fdalabel.fda.gov:8443/fdalabel/services/spl/set-ids/8c363f90-c378-48ae-abbc-aeb25c9bf5cb/spl-doc.

3 FDA Drug Safety Communication: FDA approves brand name change for antidepressant drug Brintellix (vortioxetine) to avoid confusion with antiplatelet drug Brilinta (ticagrelor). 2016 May 2 [accessed 2024 Oct 1].

Available at: https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-fda-approves-brand-name-change-antidepressant-drug-brintellix#:~:text=The%20new%20brand%20name%20of,medicine%20is%20exactly%20the%20same.

4 FDA Alerts Healthcare Professionals About the Risk of Medication Errors with Tranexamic Acid Injection Resulting in Inadvertent Intrathecal (Spinal) Injection. 2020 Dec 3. Available at: https://www.fda.gov/drugs/drug-safety-and-availability/fda-alerts-healthcare-professionals-about-risk-medication-errors-tranexamic-acid-injection-resulting.

https://www.nccmerp.org/about-medication-errors https://fdalabel.fda.gov:8443/fdalabel/services/spl/set-ids/8c363f90-c378-48ae-abbc-aeb25c9bf5cb/spl-doc https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-fda-approves-brand-name-change-antidepressant-drug-brintellix#:%7E:text=The%20new%20brand%20name%20of,medicine%20is%20exactly%20the%20same https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-fda-approves-brand-name-change-antidepressant-drug-brintellix#:%7E:text=The%20new%20brand%20name%20of,medicine%20is%20exactly%20the%20same https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-fda-approves-brand-name-change-antidepressant-drug-brintellix#:%7E:text=The%20new%20brand%20name%20of,medicine%20is%20exactly%20the%20same https://www.fda.gov/drugs/drug-safety-and-availability/fda-alerts-healthcare-professionals-about-risk-medication-errors-tranexamic-acid-injection-resulting https://www.fda.gov/drugs/drug-safety-and-availability/fda-alerts-healthcare-professionals-about-risk-medication-errors-tranexamic-acid-injection-resulting recommended to prevent the medication error, and adverse events or patient outcomes captured through an industry standard web-portal and automated follow-up of cases.

• Access to a user-friendly analytic platform that includes a dashboard with capability for data analysis and visualization.

• Advanced training and subject matter expertise to supplement existing medication error knowledge of best practices and experience within FDA.

Description of Work & Task Areas

The Contractor shall furnish the required personnel, operations, maintenance, enhancements, analytic and technical capabilities, facilities, and all other aspects of the statement of work delivery and administration necessary for the performance of the work, as described below. The Contractor shall ensure end user is kept informed and trained on how to use the system and the available features.

Description of Tasks

The Contractor shall perform the following tasks under this Scope of Work.

Task 1: Medication Error Reports

The Contractor shall provide the following:

a. Medication error reports related to product labeling, packaging, name, or design associated with FDA regulated drug products. The provided reports shall include information obtained from follow up with the reporter or designee as applicable.

b. Biennial summary of the medication error reports that includes the types of error, product(s) involved, contributing factors, and outcomes.

Task 2: Access to an Analytics Platform

a. User Access FDA User Access is the ability of authorized FDA users to conduct data analysis and generate reports on any products or substances, to share retrieved medication error data across the FDA, and publicize the data in support of public health issues tracked and regulated by the FDA in accordance with the license agreement between FDA and the Contractor. Access structure shall provide the following representative features and functionalities:

Access to detailed medication error report data dating back to the available data years through a user friendly analytic platform

Enterprise access rights for unlimited number of FDA users, including third-party users (i.e., FDA’s contractors who are bound by confidentiality requirements as applicable to FDA employees). Access to the medication error data shall be limited to only those individuals as determined by FDA.

A range of 2 to 10 concurrent users at any given time shall be allowed.

b. Activities FDA users shall have the ability to perform following activities:

Search, visualize, and download medication error data from a user friendly analytic platform

Run reports with high level aggregate data and accompanying graphs and tables

Run complex unlimited reports that may include granular detailed information about each case

Filter cases based on a specific set of products or other structured data fields during a user defined time period

Create surveillance definitions for automated alerts Extract data and download available reports in the following formats: CSV, PDF, XLSX, DOCX

Task 3: Services

The Contractor shall provide the following services.

a. Training

The contractor shall coordinate and manage at least two (2) training sessions annually to ensure FDA users become familiar with the data system. Contractor shall provide up to five (5) additional ad hoc training sessions annually when requested.

Training shall include instructions on how to query, how to interpret the retrieved data, how to set up surveillance alerts, and other information on optimal use of the data and the data system.

Of note, surveillance alerts when set up may allow a system to generate reports at set intervals triggered by predefined criteria to enable users to monitor reported cases involving one or more products or substances.

Training and/or tutorial videos on how to use the analytics platform Updated user manual with clear instructions

b. Professional Consulting Services

The Contractor shall provide professional consulting services for data management, customized data searches and reports, risk assessment and analysis, data quality improvements, and effective use and interpretation of the data. These services include:

Supporting FDA with specific information and in categories of specific interest to FDA o This may include detailed information request for analysis of internal data and resources, and creation of tables and reports to accommodate user requests o Respond to ad hoc data call as requested

Surveillance reports – reports generated at set intervals triggered by predefined criteria to enable FDA to monitor cases to one or more products or types of medication errors. Search parameters will be agreed upon between FDA and the Contractor.

Ad hoc and emergency requests associated with current public health safety issues, medication errors and adverse events, and/or market analysis for specific categories of FDA regulated products

The Contractor shall be available to support emergency requests within 24 to 48 hours related to urgencies involving FDA regulated products, advisory meetings, congressional testimony, etc.

These activities may include specific data collection (e.g., follow-ups), data retrieval, data integration, and data analysis activities.

If the Contractor recognizes any concerning trends related to FDA regulated products, Contractor shall promptly notify FDA’s Project Scientific Lead.

c. Data Analysis and Subject Matter Expertise Service

The Contractor shall provide subject matter expertise services, which may include:

Support and collaboration on medication error data used by FDA Support for utility/usability of collected data for analysis to address complex data needs Advise and develop new data collection algorithms to meet FDA’s specific data needs not currently met

d. Technical Support and Services

The Contractor shall provide technical support that shall be available Monday–Friday, 9:00 am–6:00 pm ET. Representative activities include: phone, online, or email support on system access issues; respond to general inquiries on how to use the system and run reports; address and resolve system availability and functionality issues; track issues and usage; follow escalation procedures; and respond to any other general technical issues.

e. Surveillance Definition Maintenance Services

The Contractor shall create and maintain surveillance definitions on behalf of the FDA user. This service also includes technical support.