GENERAL REQUIREMENTS - Drug Database and Decision …



GENERAL REQUIREMENTS - Drug Database and Decision Support Tools for Pharmacy Reengineering OverviewThe VA requires a commercial database for pharmacy information. The current brand name Commercial-Off-the-Shelf (COTS) database from First Databank (FDB) Inc, MedKnowledge provides for clinical decision support software used in the VA Computerized Patient Record System (CPRS) system, as well as the pharmacy packages. These clinical decision support tools are required for medication order checks such as drug-drug interactions, duplicate therapy, and dosing. These order checks are vital to the mission of VA and will place patients at significant risk if they are not available. The database shall include every drug product approved by the Food and Drug Administration (FDA) for manufacture and distribution of healthcare. This would encompass prescription and over-the-counter pharmaceuticals, herbals, chemicals used for compounding, medical devices, and supplies. The COTS database is also required for inventory control, claims adjudication, and market research for contracting. COTS data is also used to validate internal VA data such as National Drug Code (NDC) and pricing information.Currently the Veterans Health Administration (VHA) has a system that is maintained nationally called the Pharmacy Product System-National (PPS-N). PPS-N is a VA developed system that is used to manage updates to the local copies of the National Drug File (NDF). These updates occur monthly. The PPS-N/NDF system has been used since 1987 as a way to tie local drug files to a national standard. MedKnowledge is linked to the PPS-N/NDF system and allows VA to utilize both VA and COTS information in a coordinated and seamless process. Examples of this include NDC information, Patient Mediation Information (PMI) and auxiliary warning labels. PPS-N/NDF also coordinates with the Medication Order Check Healthcare Application (MOCHA) to complete order checks on each prescription as part of the ordering process. VA requires renewal of the existing brand name FDB MedKnowledge products or alternative solution capable of providing seamless support required by January 18, 2017. Any vendor system selected will be used enterprise wide. In addition any non-proprietary information may also be shared with users outside the VA, for example DoD, and other VA vendors. In addition non-proprietary information will be used to prepare reports needed within VA. The vendors system will become integrated into the new reengineered pharmacy packages. In order to accomplish this, the vendor must have an Application Programming Interface (API). The goal would be to have a seamless interface between VHA software and the vendor’s software.It is a pre-requisite of VHA that potential suppliers are prepared to adopt a flexible approach in providing the data collection solution, to reflect the changing nature of VHA business and technological requirements.Vendors proposing alternate solutions shall provide all resources necessary to accomplish the deliverables described in General Requirements listed below, except as may otherwise be specified. Vendors proposing renewal of the existing brand name FDB MedKnowledge products shall provide the requirements identified in the Product Description attached to the RFI. 1.) General Requirements:Enterprise wide. All data must be available VA wide. Non-proprietary information may also be shared with users outside the VA, such as DoD and other VA vendors. In addition non-proprietary information will be used to prepare reports needed with in the VA. If the vendor is not the originator of the source file data, a copy of the signed agreement between the vendor and the manufacturer must be provided. The agreement must be for the maximum term of the contract. Files must be updated at least as frequently as weekly. The mechanism that updates to the drug data are distributed must be done via SFTP. All upgrades and enhancements shall be provided at no additional cost. 2.) Seamless Support and Transition:The minimum requirements for the seamless support and transition are specified below:The creation and instillation of a vendors system on the VA networkUpdate of VistA and CPRS code base to support the following order checks;Duplicate TherapyDrug-drug Interactions (DDI)DosingUpdate to Pharmacy Product System National code base to support the new systemTraining of VA staff on how to use the new functionality.Customization of vendors order checks to meet VA specific patient population. 3.) Application Programming Interface (API):The minimum requirements for the API are specified below:J2EE (Java 2 Enterprise Edition) Support:? Commercial application servers support such as (WebLogic, WebSphere, etc.). Must be able to run in an EJB (Enterprise Java Beans) environment.??Services Support:? Access to support personal of development and software engineering background, or the ability to escalate programmatic?or?implementation issues to experienced engineers. The system must have the ability to install in Cache as well as Oracle 10g.? The data must be accessible via JDBC and SQL interfaces in accordance with their respective standards. ?? Documentation: Complete development guides are available with examples. Javadocs?for?the?Java libraries are also needed. This will be part of a complete SDK for integrating and accessing the libraries and API's?provided by the vendor ??? Decision support: ?The API shall support?operations?checking for duplicate therapy, Drug-Drug Interactions, and dosing. Multi-Language support: ?The API shall explicitly support the use of different languages such as Spanish. ??? 3.) Drug File Database requirements:The drug file database must meet the following minimum requirements for the drug file as specified below:NDC, or other unique identifier such as UPC, UPN. ManufacturerRoute of administrationPackage size, package typeInactivation dataOld NDC Dosage formStrength, unitsDispense unitGeneric nameControlled substance scheduleOrange Book CodeClassification systemNew items indicatorUpdated wholesale prices. The database should also contain have historical information on pricing including but not limited to: average wholesale prices, wholesale acquisition cost.The database shall include both active and inactive items. Items must be actively reviewed and updated at least weekly. The vendor is also responsible for matching their database to the VA NDF database. If products cannot be matched they must be checked to determine if they are inactive. The vendor must also develop a system for requests for updates to their system. The system will enable VA personnel or other vendors a method to request additions to the vendor’s database. 4.) Patient Medication Information:The Patient Medication Information Records (PMI) for medications. The minimum requirements for the PMI for each medication included in the database are specified below:a. The PMI database must contain the following information:Medical Condition for which the medication is usedPotential drug interactionsProper use of medication (e.g. “take with food”)Possible side effects with distinction between those that may, or may not require medical attentionProper storage recommendationsPhonetic PronunciationThe PMI shall include both the generic and trade names associated with the medication.The PMI shall provide medication information in both English and Spanish text.The source file must be in a relational database format. Each section must be broken down into its individual components. Each component must be indexed for data manipulation.A multi-disciplinary editorial staff, consisting of pharmacists, physicians, nurses and dietitians when appropriate shall develop the medication information provided in the PMI database. PMI shall meet the requirements of the Omnibus Budget Reconciliation Act (OBRA) of 1990. In addition it must meet all requirements of the Keystone Agreements.5.) Drug-Drug Interaction:The minimum requirements for the drug-drug interaction database included are specified below:Drug-Drug Interactions must include a trigger for order checks on all new and active orders, including prescription, OTC and herbal products at the drug ingredient (multiple) and drug class (multiple) level, where appropriate.The vendor system must rank interactions in order of clinical significance and severity.The vendor system must screen by route of administration.The vendor system must include a short description of the interaction.The vendor system must include a professional description of the interaction including recommendations for action and references.The vendor system must allow customization to site-specific clinical practices.6.) Drug-Disease:The minimum requirements for the drug-disease database are specified below:Drug-disease contraindications must include a trigger for order checks on all new and active orders, including OTC and herbal products at the drug ingredient (multiple) and Drug Class (multiple) level, where appropriate and a disease state or medical condition for a specific patient based on an ICD-9CM code or SNOMED CT (preferred) inferred by proxy based on the patient's current medication profile.The vendor system must include a short description of the interaction, severity and plausibility of the contraindication.The vendor system must screen by route of administration.The vendor system must allow customization so that individual sites can better manage or alert providers of appropriate therapy.The vendor system may also include:The ability to generate an alert based on other patient parameters, such as age, gender, smoking habits or alcohol use.7.) Drug Dosing:The minimum requirements for the drug dosing are specified below:Drug dosing must provide information on minimum, maximum and usual daily doses based on patient-specific parameters such as age, height, weight, renal function, hepatic function, indication and other parameters as deemed appropriate for the drug and route of administration.The vendor system must provide information on the frequency of dosing maximum single, and maximum daily. The vendor system must provide information on the minimum, usual and maximum duration of therapy based on patient-specific parameters.The vendor system must provide some type of warning that a dose must be modified due to patient-specific parameters.The vendor system must handle non-numeric, multiple ingredient or % products.The vendor system must allow customization to site-specific clinical practices.8.) Drug Indication:The minimum requirements for the drug-indication database are specified below:Drug indication must provide information on the appropriate therapeutic agents and alternatives, both labelled and unlabelled, for a given indication based on ICD-9-CM codes or SNOMED CT.The vendor system must also provide an indication of the probability (plausibility) that a drug product will be used to treat the indication. VA reserves the right to match to any other outside indication source.9.) Warning Labels:The minimum requirements for the warning label database are specified below:A comprehensive text file of warning labels must be supplied.Warning labels must be matched to individual products. For each product the warning labels must be prioritized in order of importance. 10.) Pregnancy-Lactation Warnings:The minimum requirements for the warning label database are specified below:a. Pregnancy and lactation information should be displayed for each product. b. Pregnancy and lactation warnings must alert and the time or order entry. For pregnancy alerts it must display FDA established categories to indicate a drug's potential for causing teratogenicity. For lactation the alert must display whether it is safe, unsafe or unknown for breast-feeding.c. All information should be referenced.11.) Duplicate-Therapy:The minimum requirements for the duplicate-therapy database are specified below:Duplicates should be identified at the generic drug level or any of the other levels of a multi-level (will be rated good) or variable-level (will be rated better) drug classification hierarchy. Includes checks for duplicates within controlled substances, legend Rx drugs, OTCs, and herbals.The vendor system must allow customization to site-specific clinical practices.The vendor system may also include:The ability to control duplicate therapy alerts using numeric thresholds by product class.12.) Product Identification:The database must contain the following information:Imprint data Color Shape Form Product imageThe vendor system must be capable of using the product information to identify a product. This information will be used as a stand-alone option, as a tool in double-checking as a way of helping the patient identify a product.13.) Drug-Allergy:The minimum requirements for the duplicate-allergy database are specified below:Drug-Allergy, include a trigger for order checks on the followingDRUG INGREDIENTS (multiple)DRUG CLASSES (multiple). The vendor system must include a monograph. The monograph must include recommendations for alternative therapy if applicable, allergy symptoms and/or adverse reactions. All monographs must be referenced.The vendor system must have classifications of clinical relevance, similar to Severity: Minor, Significant, Severe14.) Drug-Food: The VA desires an extensive database used to identify drug-food interactions. The minimum requirements for the drug-food interaction system are specified below. The vendor system must include the ability to trigger order checks by ingredient and drug class.The vendor system must include a monograph. The monograph should include a summary, adverse effect, onset and probable mechanism with source reference. All monographs must be referenced.The vendor system must have classifications of clinical relevance, similar to Severity: Minor, Significant, and Severe.15.) IV CompatibilityThe VA desires an extensive database used to determine the compatibility of products used in the preparation of intravenous medications. The minimum requirements for the IV system are specified below. The vendor system will be used in a stand-alone option, as a tool to evaluate the compatibility of IV admixtures.The vendor system may also include:The ability to incorporate IV compatibility information into the order entry process.16.) Referential ResourcesThe minimum requirements for the referential resources specified below.Chemical description of the product.Therapeutic class information.IndicationsPatient dosing, normal as well as age and disease specific.How supplied, including trade names.Clinical monitoringAdverse events such as interactions, precautions, pregnancy information.ContraindicationsThe vendor system may also include:The ability to look up and review information based on the National Drug Code (NDC). ................
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