Statement_of_Work _LactMed.pdf

STATEMENT OF WORK

Project Title: Drugs and Lactation (LactMed): An Evidence-Based Database

BACKGROUND:

The National Library of Medicine’s (NLM) LactMed, is a searchable database of records on drugs and other chemicals, including herbals and diagnostic agents, and their use during lactation. It includes information on the levels of such substances in breast milk and infant blood, and the possible adverse effects in the nursing infant.

Suggested therapeutic alternatives to those drugs are provided, where appropriate.

LactMed, https://toxnet.nlm.nih.gov/newtoxnet/lactmed.htm is a component of NLM’s Toxicology Data Network (TOXNET), a Web-based collection of resources covering toxicology, chemical safety, environmental health and can be accessed at http://toxnet.nlm.nih.gov. NLM’s Toxicology and Environmental Health Information Program (TEHIP), where TOXNET resides organizationally, offers additional databases with information on other aspects of drugs, including their pharmacology and toxicology; these include the Drug Information Portal, Pillbox and the Dietary Supplement Label Database. Bibliographic information related to drugs may be found in the TOXLINE database. LactMed can be searched together with TOXNET’s other databases in a multi-database environment to obtain other relevant information about drugs.

OBJECTIVES:

The objective of this requirement is to continue to expand and enhance LactMed, a database on possible adverse effects of prescription and non-prescription drugs, relevant herbals, nutraceuticals and diagnostic agents in infants that result from transmission during human breastfeeding. As a work in progress, LactMed will continue to expand with additional drugs and begin to integrate vitamin and mineral monographs into its content. Future plans call for enhancement with other substances, such as industrial chemical and radiation.

PROJECT REQUIREMENTS:

The Contractor will compile the world’s professional and scientific literature relating to the use of drugs and related products during human lactation and organize this literature into a professionally acceptable system for ease of access to monographs on specific drugs and, where appropriate, to classes of pharmacologic and/or therapeutic agents. Drug names should be at the generic level and include, at a minimum, United States Adopted Names. Further, the Contractor must be willing to have such data placed in the public domain, without any intellectual property right constraints or fees imposed with respect to its use. While the database will become the property of https://toxnet.nlm.nih.gov/newtoxnet/lactmed.htm http://toxnet.nlm.nih.gov/

NLM, this will not preclude the Contractor from reconfiguring or otherwise using the source data for preparing other information products or publications. The database content must be fully supported by an evidence-based approach that involves critical case evaluations of reports in peer-reviewed literature. The database needs to be a principal focus of the Contractor who needs to have a high level of professionally recognized expertise in drugs and lactation.

NLM is seeking both to continue to build the database with new records, including vitamins and minerals, and to maintain the existing records to ensure consistency and data currency. New and updated information will be input via the SIS SSEUS data entry system. The Contractor will comprehensively review the literature and conduct necessary online searches and therefore, must be conversant with searching a broad range of bibliographic and other databases. At a minimum, database records should include the drug names specified above, drug class (es), pharmacologic and pharmacokinetic data such as drug concentrations in breast milk and infant serum, time course of such levels, and weight-adjusted percent of maternal dose in breast milk. When it can be determined from case report evaluations and other analyses of published literature, it should also provide possible drug effects on maternal lactation and in breast-fed infants, indicating a quantifiable probable causation.

Information should also be provided with respect to those drugs that present no safety problems where published literature specifically makes that determination. All drug data within records must follow the approved drug record template at http://toxnet.nlm.nih.gov/help/LactMedRecordFormat.htm, and be referenced to available source references.

GOVERNMENT FURNISHED EQUIPMENT AND RESOURCES:

The National Library of Medicine shall provide the Contractor with any literature search capabilities possible through the Library’s MEDLINE/PubMed Systems.

NLM will also provide the information technology resources necessary for file building and display purposes.

CONTRACTOR FURNISHED EQUIPMENT AND RESOURCES:

The Contractor shall furnish all materials, equipment, and source references that are necessary to fulfill project specifications. The Contractor shall be responsible for employing any qualified staff needed to perform the project tasks. Work shall be performed at Contractor provided facilities including remote facilities with proper connectivity.

REPORTING REQUIREMENTS:

The Contractor shall provide the following reports:

Semi Annual Progress Reports: To coincide with semi-annual invoices, the contractor shall submit a report detailing progress on, and status of, each task performed during the preceding 6 months.

http://toxnet.nlm.nih.gov/help/LactMedRecordFormat.htm

Other Requirements: The NLM Project Officer shall be notified immediately about any important issues or problems that arise during project performance that might affect the outcome of the project.

DELIVERABLES:

The Contractor shall, by the 10th of each month, provide the Project Officer with completed drug records.

INSPECTION AND ACCEPTANCE REQUIREMENTS:

All deliverables shall be inspected and approved by the Project Officer.

PERIOD OF PERFORMANCE:

The project will be for the duration of a base period (one year) with two

(2) successive one-year option periods.

LEVEL OF EFFORT:

Labor Hour Estimate for LactMed Database:

Direct Labor (Creating new records) = 250 hours Direct Labor (Maintenance of existing records) = 125 hours Uploading records to database = 15 Answering user queries = 10