SOURCES SOUGHT
D -- Access to Outpatient Prescription and Patient Level Drug Utilization Data - RFI 1205558
- Notice Date
- 8/27/2018
- Notice Type
- Sources Sought
- NAICS
- 541519
— Other Computer Related Services
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services - Rockville, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001, United States
- ZIP Code
- 20857-0001
- Solicitation Number
- RFI_1205558
- Archive Date
- 11/1/2018
- Point of Contact
- Piya Sawhney, Phone: 2404028709
- E-Mail Address
-
piya.sawhney@fda.hhs.gov
(piya.sawhney@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- RFI 1205558 - Access to Outpatient Prescription and Patient Level Drug Utilization Data REQUEST FOR INFORMATION Access to Outpatient Prescription and Patient Level Drug Utilization Data Description The FDA has access to multiple drug utilization databases, some of which contain data characterizing outpatient drug use patterns. Identifying data sources to support an improved view of the number of patients exposed to drugs and the number of prescriptions dispensed nationwide in the outpatient setting could greatly improve our understanding of how drugs are being prescribed under real-world conditions. The Agency would like to determine sources available to provide direct, continuous, internet or network-based access to current and historical longitudinal data containing outpatient prescription and patient level drug utilization. Outpatient settings of interest include retail and mail-order pharmacies, and if available, outpatient clinics or long-term care pharmacies. The data will be used to describe national patterns of outpatient prescribing and patient-level drug utilization in the U.S. THIS IS A REQUEST FOR INFORMATION (RFI) ONLY. This RFI is being issued in accordance with Federal Acquisition Regulation Part 10, Market Research. It is for information, planning and market research purposes only and is not to be construed as a commitment by the Government to issue a solicitation or ultimately award a contract. Background A vital part of FDA and CDER's mission is to protect the public health. The mission of the Office of Surveillance and Epidemiology (OSE) is to evaluate drug risks and promote the safe use of drugs by the American people. The statutory provisions of the Federal Food, Drug, and Cosmetic Act as amended by the Food and Drug Administration Modernization Act (FDAMA, Section 406), Title 21 Code of Federal Regulations, Section 310.305, and Title 21 Code of Federal Regulations, Section 314.80 require FDA to ensure the safety and effectiveness of regulated marketed products. In response to reports from the Institute of Medicine (IOM), the FDA is authorized by the FDA Amendments (2007) Act to expand database resources for providing advanced analyses of drug safety data to improve the quality of post-market risk/benefit analyses, and enhance the ability of FDA to make timely assessments of drug safety data. In addition, the Act calls for enhanced authorities for accessing disparate data sources, and to establish and improve procedures to identify data trends and prescribing patterns for health care practitioners on a national level in the outpatient setting. The 21st Century Cures Act, enacted in December 2016, also contains provisions for the FDA to increase surveillance and monitoring of certain medications such as opioids, which aligns with CDER's mission. This section of the Act encourages the use of real world evidence in the analysis of post market surveillance data to enable the Agency to respond promptly to serious public health issues. The ability of FDA to respond expeditiously to the increasing number of drug safety issues is of paramount importance to the overall public safety. Continued access to outpatient prescription and patient level data will complement and strengthen the utility of FDA Adverse Event Reporting System (FAERS) currently in place by providing estimates of the numbers of patients exposed to drugs and the numbers of prescriptions dispensed nationwide in the outpatient setting. This data provides a denominator, or context, for understanding adverse event reports; for modeling drug risk based on usage patterns; and for calculating patient-based reporting rates for drugs used in the outpatient setting. Access to this data also increases the FDA's ability to perform regulatory impact studies; in particular, those studies that assess the impact of risk management plans and labeling changes on prescribing habits and usage patterns for prescription drugs. Finally, direct access to this data in real time enhances and accelerates the pace of FDA's regulatory decision-making process. The purpose of this RFI is to help the Food and Drug Administration (FDA) understand the diverse industry best practices, technical solutions, and sources capable of meeting the FDA's requirements. Specifically, the Government is seeking verification that its data requirement is commercially available, determine if there are any questions about the FDA's requirements, determine if industry notes any omissions in the requirements, and information about sources available to meet the FDA's requirements. FDA understands that teaming arrangements/partnerships may be required to address the governments requirements and are encouraged. Requested Information Interested parties should provide responses to the following questions (where available) regarding their data sources. 1)Timeframe - How many calendar years of data are available on-line and how many are available offline? Are there differences in the number of patients/prescriptions captured each year? How often is the data source updated? 2)Demographics - Number of pharmacies captured, pharmacy type (e.g., outpatient retail chain pharmacy, independent pharmacy, long-term care, and mail-order pharmacy), geographic distribution of pharmacies, and number of prescriptions/patients per year by age, gender and race/ethnicity (if available). 3)Data Type/Data Formation - How is clinical information captured from the healthcare system? Does it capture billing claims, and if so, in what format? Does it capture electronic healthcare records? 4)External linkable databases - What additional external databases can be or have been linked to the data source (e.g. PDMP-Prescription Drug Monitoring Program)? If not, are such linkages possible? 5)Patient capture - How many unique, de-identified patients does the data source capture? How are these patients captured, de-identified, and estimated? 6)Methodologies - a description of the data acquisition process for the prescription-, patient-level, and medical claims drug utilization data. Data flow and management procedures shall be described, including: (1) data acquisition, cleaning, and editing procedures, (2) data de-identification procedures, specification and description of all coding systems used for diagnoses, procedures and drugs, (3) methods for coding data, (4) percentage of missing or incomplete information and the method of coding missing data, (5) methods for projecting nationally, (6) availability of raw/sample numbers, as well as projected numbers, and (7) the methods for updating the data and frequency of data updates. 7)Drug exposure - How are drug exposures captured (e.g. billing, patient interview, medical records)? Are data available to confirm the complete capture of prescribed treatments (e.g. a validation study)? Is there information regarding the route of administration, prescribing specialty, dosage, duration, or frequency? Are NDC codes available? 8)Type of prescriptions - What type of prescriptions/drugs are captured (e.g., compounded prescriptions, specialty drugs, biologic products, mail-order prescriptions, over-the-counter products)? 9)Covariates - Does the data source captures patient comorbidity (e.g. disease states other than the one that caused admission to hospital) or risk factors for disease (e.g. BMI, lifestyle factors, etc.)? If so, how are they captured? Is there information regarding indications for drugs administered/taken (e.g. ICD-9 and ICD-10 diagnoses codes)? 10)Data access - How customizable are data searches? Is immediate automated access to the data possible via an existing user-friendly data query tool(s)? 11)Strengths - What are the particular strengths of the data source with regard to ascertaining nationally representative information about outpatient prescription and patient-level drug utilization? 12)Limitations - What are the limitations of the data source with regard to ascertaining nationally representative information about outpatient prescription and patient level drug utilization? Capabilities and Technical Experience Provide a capability statement describing how your company would meet the requirements. Please provide the follow Business information: 1.DUNS Number 2.Company Name 3.Company Address. 4.Company Point of Contact, phone number and email address 5.Type of company under NAICS, as validated via the System for Award Management (SAM). Additional information on NAICS codes can be found at www.sba.gov. Please note that any potential government contract must be registered on SAM located at http://www.sam.gov/index.asp. 6.Corporate structure (corporation, LLC, sole proprietorship, partnership, limited liability partnership, professional corporation, etc.); 7.Current GSA Schedules appropriate to this Request for Information 8.Current Government Wide Agency Contracts (GWACs) 9.Point of Contact, phone number and email address of individuals who can verify the demonstrated capabilities identified in the responses. Interested parties having the capabilities necessary to provide the stated requirements may submit capability statements via email or regular mail to the point of contact listed below. Submissions cannot exceed 10 pages, single spaced, 12-point type with at least one-inch margins on 8 1/2" X 11" page size. Oral communications are not permissible. FedBizOpps will be the sole repository for all information related to this RFI. Responses must be received not later than 3:00 PM ET, September 27, 2018. Capability statements will not be returned and will not be accepted after the due date. Documentation should be emailed to the Contract Specialist at Piya.Sawhney@fda.hhs.gov with subject line titled "Request for Information 1205558". Disclaimer and Important Notes All information contained in the RFI is preliminary as well as subject to modification and is in no way binding on the Government. FAR clause 52.215-3, "Request for Information or Solicitation for Planning Purposes" is incorporated by reference in this RFI. Respondents are advised that the Government will not acknowledge receipt of the information received, nor will it provide feedback to respondents with respect to any information submitted. Questions regarding this announcement may be submitted in writing by e-mail to the Contract Specialist at Piya.Sawhney@fda.hhs.gov. The FDA does not intend to respond to the questions received, however, information addressing industry concerns may be reflected in the subsequent solicitation, if issued. The FDA does not intend to hold discussions concerning this RFI with any interested parties. The FDA reserves the right to contact one or more of the respondents if additional information is required or to request demonstrations of available systems. This RFI is not to be construed as a commitment on the part of the Government to issue a solicitation or award a contract. The Government will not pay for any information or administrative costs incurred in response to this RFI; responders to this invitation are solely responsible for all expenses associated with responding to this RFI. This RFI is issued solely for information and planning purposes, and may result in revisions in both the Government's requirements and acquisition strategy based on industry responses. Proprietary information and trade secrets, if any, must be clearly marked on all materials. All information received in this RFI that is marked "Proprietary" will be handled accordingly. Please be advised that all submissions become Government property and will not be returned. In accordance with FAR 15.201(e), responses to this RFI are not offers and cannot be accepted by the Government to form a binding contract. Not responding to this RFI does not preclude participation in any future solicitation, if any is issued. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. Please note that responses to this notice will not be considered adequate responses to a solicitation.
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