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Prescription Drug Supply Chain Data

Drug Supply Chain Data Requires Lot Number and NDC

Federal and State Standards require that the supply chain tracking of drugs and the documentation of the administration of prescription drugs requires that prescription drug supply chain data be included in shipped drugs, and documented in electronic health record and immunization information systems as well as Vaccine Information Statements.  This is essential for both patient safety and determining accurately what drug was provided and billed for.

The CDC, National Childhood Vaccine Injury Act, enacted in 1986, requires that Healthcare Providers Document Lot Number, Manufacturer.

Prescription Drug Supply Chain Data should include the lot number (a.k.a., batch number or code number) and classified by the NDC code.

Drug Supply Chain Data
Drug Supply Chain Data should include the prescription drug Labeler Product and Package in an NDC code as well as the lot number

According to CDC and the Immunization Action Coalition, “Federal requirements for documenting the vaccines administered to your patients require several data elements. The requirements are defined in the National Childhood Vaccine Injury Act (42 U.S.C. §300aa-26).[i], [ii] The law applies to all routinely recommended childhood vaccines, regardless of the age of the patient receiving the vaccines. The only vaccines not included in this law are pneumococcal polysaccharide, zoster, and certain infrequently used vaccines, such as rabies and Japanese encephalitis.

The following information must be documented on the patient’s paper or electronic medical record or on a permanent office log:

  1. The vaccine manufacturer.
  2. The lot number of the vaccine.
  3. The date the vaccine is administered.
  4. The name, office address, and title of the healthcare provider administering the vaccine.
  5. The Vaccine Information Statement (VIS) edition date is located in the lower right corner on the back of the VIS. When administering combination vaccines, all applicable VISs should be given, and the individual VIS edition dates recorded.
  6. The date the VIS is given to the patient, parent, or guardian.

The federally required information should be both permanent and accessible.”

Data Capture, Storage, and Standards Require Lot number and NDC Code in Health IT Systems and When Reporting Temperature Excursions

Lot Number is a Unique Number for Each Batch of the Product (see NDC Product Code)

A lot number is a unique number given to each batch of a manufactured product (see NDC product code below). It is also called a “lot code,” “batch number,” or “code number.” The FDA does not assign it; the manufacturer assigns it for tracking purposes to identify products that were made at the same time if there is ever a Drug Recall of the product.  However, FDA does require a lot number for production and control procedures. [iii]   Sometimes, drug recalls are only for affected batches, and FDA will report specific lot numbers.[iv],[v]

Lot numbers can be a combination of letters or numbers, and because the manufacturer assigns them, they have no pre-specified length and are commonly found near the expiration date.   For example:

CVX and NDC codes are required and accepted according to federal agencies

National Drug Code (NDC) is a numeric code under 21 CFR 207.33. Each finished drug product or unfinished drug subject to the listing requirements of part 207 must have a unique NDC to identify its labeler, product, and package size and type.

CVX (clinical vaccines administered) and NDC are widely accepted and federally required, as noted in this page from the U.S. Health and Human Services Department Office of the National Coordinator:

NDC codes are grouped into three series of numbers:

  1. Labeler Code, which indicates the same manufacturer for the same labeler code
  2. Product code, which indicates the same drug, strength, and dosage form is essential to affirm that the correct product is accessed that matches a prescription, including strength and dosage.
  3. Package code which indicates package size

FDA Recall Procedures require NDC and Lot Number

Drug recalls are only for affected batches, and FDA will report specific lot numbers.  However, NDC codes are also required.[vi],[vii]

Tracking and Supply Chain Lot Numbers and NDC Codes – Homogeneous Case

A homogenous case is defined under section 581(7) of the FD&C Act as “a sealed case containing only a product that has a single National Drug Code number belonging to a single lot.”[viii]

Temperature Excursion Handling Standards Require Documentation and Reporting; Inventories that contain both lot number and NDC are required when there are drug temperature excursions.

CDC requires an “Inventory of affected vaccines” when reporting temperature excursions.  See also State standards for the specific data elements required.

CDC and State Temperature Excursion Documentation Reporting Requires NDC-code and Other Standard Data Level of Specificity

State

  • Minnesota Department of Health Storage and Handling Mishap Checklist requires reporting of lot numbers. A lot number is generally composed of a drug that an NDC code can identify.[ix]
  • North Dakota requires lot number and NDC in its record-keeping and drug Pedigree Standards.[x], [xi]
  • Wisconsin requires lot number and NDC in its temperature excursion incident reporting form. See below.
  • Rhode Island Department of Health requires Lot number and NDC.  Below is an example of the State’s Temperature Excursion Response Worksheet.[xii]

CDC Standards Require that Both Immunization Information Systems (IIS) and Electronic Health Records (E.H.R.) Document Lot Number and NDC Numbers in the normal course of documenting and providing care to patients

According to CDC[xiii] National Drug Codes (NDCs), lot numbers for administered vaccines are required for immunization providers and city/state immunization information system (IIS) staff, and NDCs and lot numbers must be used in either an electronic health record (EHR) or an immunization information system (IIS).  The HL7 Data elements have been specified since at least 2007 by CDC.[xiv]

Immunization Guidance for Recording NDCs Requires that E.H.R.s are Capable of Recording, Storing, and Reporting NDC codes and UO or UoS Codes

Prescription Drug Supply Chain Data is relevant in electronic health records.  According to FDA,

“When recording the NDC for an administered vaccine, a provider may capture the NDC on the UoU [xv] OR

UoS.[xvi], depending on the established clinical workflow.

  • This information should be transmitted or reported (messaged) to the IIS. Typically, this is a function of the EHR and is transmitted in the 5-4-2 format (including the hyphens).
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Michael F. Arrigo

Michael Arrigo, an expert witness, and healthcare executive, brings four decades of experience in the software, financial services, and healthcare industries. In 2000, Mr. Arrigo founded No World Borders, a healthcare data, regulations, and economics firm with clients in the pharmaceutical, medical device, hospital, surgical center, physician group, diagnostic imaging, genetic testing, health I.T., and health insurance markets. His expertise spans the federal health programs Medicare and Medicaid and private insurance. He advises Medicare Advantage Organizations that provide health insurance under Part C of the Medicare Act. Mr. Arrigo serves as an expert witness regarding medical coding and billing, fraud damages, and electronic health record software for the U.S. Department of Justice. He has valued well over $1 billion in medical billings in personal injury liens, malpractice, and insurance fraud cases. The U.S. Court of Appeals considered Mr. Arrigo's opinion regarding loss amounts, vacating, and remanding sentencing in a fraud case. Mr. Arrigo provides expertise in the Medicare Secondary Payer Act, Medicare LCDs, anti-trust litigation, medical intellectual property and trade secrets, HIPAA privacy, health care electronic claim data Standards, physician compensation, Anti-Kickback Statute, Stark law, the Affordable Care Act, False Claims Act, and the ARRA HITECH Act. Arrigo advises investors on merger and acquisition (M&A) diligence in the healthcare industry on transactions cumulatively valued at over $1 billion. Mr. Arrigo spent over ten years in Silicon Valley software firms in roles from Product Manager to CEO. He was product manager for a leading-edge database technology joint venture that became commercialized as Microsoft SQL Server, Vice President of Marketing for a software company when it grew from under $2 million in revenue to a $50 million acquisition by a company now merged into Cincom Systems, hired by private equity investors to serve as Vice President of Marketing for a secure email software company until its acquisition and multi $million investor exit by a company now merged into Axway Software S.A. (Euronext: AXW.PA), and CEO of one of the first cloud-based billing software companies, licensing its technology to Citrix Systems (NASDAQ: CTXS). Later, before entering the healthcare industry, he joined Fortune 500 company Fidelity National Financial (NYSE: FNF) as a Vice President, overseeing eCommerce solutions for the mortgage banking industry. While serving as a Vice President at Fortune 500 company First American Financial (NYSE: FAF), he oversaw eCommerce and regulatory compliance technology initiatives for the top ten mortgage banks and led the Sarbanes Oxley Act Section 302 internal controls I.T. audit for the company, supporting Section 404 of the Sarbanes Oxley Act. Mr. Arrigo earned his Bachelor of Science in Business Administration from the University of Southern California. Before that, he studied computer science, statistics, and economics at the University of California, Irvine. His post-graduate studies include biomedical ethics at Harvard Medical School, biomedical informatics at Stanford Medical School, blockchain and crypto-economics at the Massachusetts Institute of Technology, and training as a Certified Professional Medical Auditor (CPMA). Mr. Arrigo is qualified to serve as a director due to his experience in healthcare data, regulations, and economics, his leadership roles in software and financial services public companies, and his healthcare M&A diligence and public company regulatory experience. Mr. Arrigo is quoted in The Wall Street Journal, Fortune Magazine, Kaiser Health News, Consumer Affairs, National Public Radio (NPR), NBC News Houston, USA Today / Milwaukee Journal Sentinel, Medical Economics, Capitol ForumThe Daily Beast, the Lund Report, Inside Higher Ed, New England Psychologist, and other press and media outlets. He authored a peer-reviewed article regarding clinical documentation quality to support accurate medical coding, billing, and good patient care, published by Healthcare Financial Management Association (HFMA) and published in Healthcare I.T. News. Mr. Arrigo serves as a member of the board of directors of a publicly traded company in the healthcare and data analytics industry, where his duties include: member, audit committee; chair, compensation committee; member, special committee.

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