Loren Data's SAM Daily™

FBO DAILY ISSUE OF MARCH 19, 2011 FBO #3402
SOLICITATION NOTICE

B -- Data Collection From Pharmaceutical Prescription Database

Notice Date

3/17/2011
 

Notice Type

Combined Synopsis/Solicitation
 

NAICS

621511 — Medical Laboratories
 

Contracting Office

Department of Health and Human Services, Centers for Disease Control and Prevention, Procurement and Grants Office (Atlanta), 2920 Brandywine Road, Room 3000, Atlanta, Georgia, 30341-4146
 

ZIP Code

30341-4146
 

Solicitation Number

00HCVGEC-2011-95343
 

Archive Date

3/25/2011
 

Point of Contact

Linda M Young, Phone: (770) 488-2655
 

E-Mail Address

lml3@cdc.gov
(lml3@cdc.gov)
 

Small Business Set-Aside

N/A
 

Description

The Centers for Disease Control and Prevention intends to issue a sole source purchase order to IMS Health, Inc., 16128 Red Mountain Trail, Fountain Hills, AZ, 85268 for Data Collectiion for Evaluation of the Effectiveness of 13-valent Pneumococcal Conjugate Vaccine: Impact of Antibiotic Prescribing on Antibiotic-Resistant Pneumococcal Disease Background and Need - The introduction of PCV7 in 2000 led to sharp reductions in the incidence of antibiotic resistant pneumococcal disease. However, small increases in pneumococcal disease caused by non-PCV7 serotypes have also been observed. This phenomenon-known as serotype replacement-has been marked by increases in antibiotic resistant pneumococcal strains more than antibiotic susceptible strains. One potential explanation for this observation is the increasing use of azalide antibiotics, such as azithromycin, for outpatient treatment of respiratory infections over the past decade. If this were true, it would have important implications for antibiotic prescribing practices and for the interpretation of any increases in antibiotic resistant pneumococcal disease that might occur after PCV13 introduction. To test this hypothesis, it is necessary to obtain information on outpatient antibiotic use. The purpose of this contract is to engage the services of a contractor to provide retail pharmacy data to assess the relationship, if any, between outpatient antibiotic use, PCV13 effectiveness, and trends in antibiotic resistant pneumococcal disease. Project Objective - 1. To compare outpatient antibiotic use data to trends in antibiotic resistant pneumococcal disease to understand the forces contributing to the spread of resistance; 2. To assess antibiotic use by: a. Patient age and sex, b. Calendar month prescribed, c. Prescriber specialty, d. Geographic location (defined by county), e. State, f. Year, and g. Anti-infective category; 3. To identify provider types and geographic areas where interventions by the CDC's Get Smart: Know When Antibiotics Work program will help reduce the spread of antibiotic-resistant pneumococcal disease. Scope of Work - The Contractor will provide a customized extract of data as outlined below. The Contractor will support the analyses of the data in collaboration with CDC as well as contribute to interpretation of data and authorship of any articles. Technical Requirements - This study is a retrospective analysis of a national representative database of outpatient anti-infective prescriptions. The data required for analysis is from information collected 1/1/2005-12/31/2009 that has been extrapolated to reflect the U.S. population with an extract of additional data from 1/1/2010- 12/31/2010. Pertinent variables Anti-infective name Anti-infective prescribed time period (defined by calendar month and year) Patient age (categorized) Patient sex Geographic area prescribed Prescriber specialty Evaluation, data analysis, and sample size collection 1. All patients prescribed an anti-infective will be included in the analysis. Only systemic (oral and injectable), acute anti-infectives will be included. Prescribing will by compared by differences based on age, sex, geographic area, time prescribed, and anti-infective class. Patient age will be categorized by the following standardized categories (0-2, 3-9, 10-19, 20-39, 40-59, 60-64, 65-74, 75-84, 85+, unknown). Physician specialty will be defined according to the American Medical Association (AMA); categorized into 17 categories relevant to outpatient prescribing as specified by the research team. The data will be downloaded and stored in electronic tables. The statistical program SAS® Version 9.2 shall be used for statistical and data analyses; 2. Anti-infective class will be defined according to American Hospital Formulary Service (AHFS). Spectrum of anti-infective activity (broad vs. narrow) will be defined according to the anti-infective class; 3. Geographic area will be defined by the county where the medication was dispensed. Geographic area will also be stratified by urban vs. rural locales; defined by the US Census Bureau; 4. The data will be evaluated to examine results for: Frequency of anti-infectives overall, by class, and spectrum of activity; Frequency of anti-infectives by patient age and sex; Percentage of patients prescribed anti-infectives by geographic location and by rural vs. urban areas; Percentage of antibiotic class prescribed by month of the calendar year; Frequency of prescribing by physician specialty by anti-infective class and spectrum of activity. Delivery of two data extracts 1st deliverable within 30 days of award issue (see details under "Deliverables"). The data extract will contain the following variables and will represent a projection to 100% of all US prescriptions in the retail pharmacy setting: a. Calendar month prescribed b. Prescriber specialty c. Geographic location (defined by county) d. State e. Year f. Anti-infective category g. Patient age and gender 1st Extract: January 2005-December 2009 2nd Extract: January 2010-December 2010 SAS Dataset (Fixed Width) CDC will be responsible for data analyses with technical support from the vendor that will require 5 person hours per month for 6 months, followed by 1 person hour per month for an additional 6 months. The vendor will review manuscripts for accuracy as a coauthor. This will require a maximum of 20 hours of person time for this particular request. References - 1. Bergman M, Huikko S, Pihlajamäki M, et al for the FiRe Network. "Effect of macrolide consumption on erythromycin resistance in Streptococcus pyogenes in Finland in 1997 2001." CID. 2004;38:1251-1256. 2. Centers for Disease Control and Prevention. 2009 Active Bacterial Core Surveillance Report, Emerging Infections program Network, Streptococcus pneumoniae, provisional 2008. http://www.cdc.gov/abcs/survreports/spneu08.htm 3. Felmingham D, Canton R, Jenkins SG. "Regional trends in beta-lactam, macrolide, fluoroquinolone and telithromycin resistance among Streptococcus pneumoniae isolates 2001-2004." J. Infect. 2007;55:111-8. 4. Goossens H, Ferech M, Vander Stichele R, Elseviers M and the ESAC project Group. "Outpatient antibiotic use in Europe and association with resistance: a cross-national database study. Lancet. 2005;365:579-587. 5. Goossens H. Ferech M. Coenen S. Stephens P and the European Surveillance of Antimicrobial Consumption Project Group. "Comparison of outpatient systemic antibacterial use in 2004 in the United States and 27 European countries." CID. 2007;44:1091-1095. 6. Grijalva CG, Nuorti JP, Griffin MR. "Antibiotic prescription rates for acute respiratory tract infections in US ambulatory settings." JAMA. 2009;302:758-66. 7. Gupta K, Sahm DF, Mayfield D, Stamm WE. "Antimicrobial resistance among uropathogens that cause community-acquired urinary tract infections in women: a nationwide analysis." CID. 2001;33:89-94. 8. Karlowsky JA, Hoban DJ, Decorby MR, Laing NM, Zhanel GG. "Fluoroquinolone-resistant urinary isolates of Escherichia coli from outpatients are frequently multidrug resistant: results from the North American Urinary Tract Infection Collaborative Alliance-Quinolone Resistance study. Antimicrob Agents Chemother. 2006;50:2251-4. 9. Lautenbach E, Strom BL, Nachamkin I, et al. "Longitudinal trends in fluoroquinolone resistance among Enterobacteriaceae isolates from inpatients and outpatients, 1989-2000: Differences in the emergence and epidemiology of resistance across organisms." CID. 2004;38:655-62. 10. Muller A. Coenen S. Monnet DL. Goossens H and the ESAC project group. "European surveillance of antimicrobial consumption (ESAC): outpatient antibiotic use in Europe, 1998-2005." European Communicable Disease Bulletin. 2007;12:E071011.1. 11. Polk RE, Johnson CK, McClish D, Wenzel RP, Edmond MB. "Predicting hospital rates of fluoroquinolone-resistant Pseudomonas aeruginosa from fluoroquinolone use in US hospitals and their surrounding communities." CID. 2004;15:497-503. 12. Scott RD. The Direct Medical Costs of Healthcare-Associated Infections in U.S. Hospitals and the Benefits of Prevention. Centers for Disease Control and Prevention. March 2009. 13. Spellberg B, Guidos R, Gilbert D, et al. "The epidemic of antibiotic-resistant infections: A call to action for the medical community from the Infectious Diseases Society of America. CID. 2008;46:155-164. 14. Steinman MA, Gonzales R, Linder JA, Landefeld CS. "Changing use of antibiotics in community-based outpatient practice, 1991-1999." Annals of Internal Medicine. 2003;138:525-533.   Deliverables - SAS Dataset (Fixed Width) containing data from January 2005-December 2010. The dataset will include anti-infective prescriptions for all 50 states for each oral and injectable anti-infective by: State, State Fips, County, County Fips, Custom Group Physician Specialty, Patient Age, Patient Gender, Total Dispensed RXs; 1 copy on CDs or DVDs, within 30 days of the award. Prescriber Level Data should include (as part of the main dataset): Specialty, practice, location, age, degree, graduation year (The terms and conditions of a AMA/AOA Third Party Data Rider shall apply.), 1 copy of custom physician specialty aggregated group information will be provided to the researchers for internal use only, within 30 days of the award. This vendor collects information from more than 29,000 data sources, including drug manufacturers, wholesalers, retailers, pharmacies, hospitals, managed care providers, and long-term care facilities from around the world and is known to be the most comprehensive source for prescription data. Data is required that can be compared across time and geographic area (county) with one sample and one estimation, allowing CDC to make accurate product- and provider-level prescription estimates which are required to test hypotheses and understand where public health interventions are needed. CDC believes that this requirement is met by only one provider. This procurement will be processed under the authority of FAR 6.302-1 and 6.302-2. Only one responsible source and no other sources will satisfy agency requirements. No solicitation is being issued. Interested persons may identify their interest and capability to respond to this requirement. This procurement is not set-aside for small business. For contractual questions contact Linda M. Young. NOTE: This will be awarded subject to availability of funds.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/CDCP/PGOA/00HCVGEC-2011-95343/listing.html)
 

Place of Performance

Address: 1600 Clifton Road, Building 18, Atlanta, Georgia, 30333, United States

Zip Code: 30333
 

Record

SN02403768-W 20110319/110317235028-6741e9a68d8fcf17ac67298d6a7b3e12 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

---

| FSG Index  |  This Issue's Index  |  Today's FBO Daily Index Page |