National Drug Code (NDC) system was created by the Food and Drug Administration (FDA) in 1969. FDA using the Drug Listing Act of 1972, which provides them with a current list of all drugs manufactured, prepared, propagated, compounded, or processed by a drug establishment registered under the Federal Food, Drug, and Cosmetic Act.
Definition: National Drug Code system is a universal product code used to identify every unique commercially available drug product in the computerized health care industry. It provides a directory of selected over-the-counter agents, insulin formulations, and prescription drug products, and herbal drugs distributed in the United States.
NDC directory
Originally, the system was established by Medicare as part of an outpatient drug reimbursement program and a method to identify drugs during commercial distribution. It now enjoys a more widespread application; however products may not be included in the directory if the firm has not communicated the most recent status to the FDA (e.g., drug has been discontinued).
Decoding the codes:
Drugs listed under the NDC are identified by a 10-digit number comprised of three
segments. The first segment, assigned by the FDA, identifies the vendor (or labeler)
involved with the manufacturing, packaging, or distribution of the drug. Product codes,
listed in the second segment, comprise the generic entity, strength, and dosage form.
The third segment, or package code, indicates the package size. The manufacturer
assigns the second and third segments of the code for a given product. The NDC is in one
of the following configurations: 4-4-2, 5-3-2, or 5-4-1.
Notably, government agencies such as Medicaid or Medicare, display the code in an eleven
digit format with leading zeros.
The Directory is organized as follows:
* Product Trade Name or Catalog Name
* National Drug Code (unique 10 digit, 3 segment number). The segments represent
the labeler code, the product code and the package code.
* Dosage Form
* Routes of Administration
* Active Ingredients
* Strength
* Unit
* Package Size and Type
* Major Drug Class
* FDA approved application number (note that .other. in this field means it may
not have been approved).
For more details for the NDC directory and how it is organized follow the link below:
New rules from the Food and Drug Administration (FDA) that are designed to improve
patient safety by reducing medication errors and by more quickly identifying potential
errors that may occur.
The NDC system may assist in ensuring the safe dispensing of prescription medications. For example,
outpatient pharmacists may use the NDC system to avoid confusion with look-alike/sound-alike drugs.
The new regulation require bar codes on all prescription, some over-the-counter drugs, and vaccines. Bar codes identify the specific product and allow software to link the product to price and other sales- and inventory-related information. FDA's bar code rule would uses bar codes to address an important public health concern - medication errors associated with drug products.
Example:
The bar code, at a minimum, contains the drug's National Drug Code number, which uniquely identifies the drug, its strength, and its dosage form (e.g., 10 mg. capsule). The rule also covers blood and blood components. The bar code, when used in conjunction with a bar code scanning system and computerized database , works as follows:
1. A patient is admitted to the hospital. The hospital gives the patient a bar-coded
identification bracelet to link the patient to his or her computerized medical record.
2. Every prescription drug and certain over-the-counter (OTC) drugs would have a bar code on
its label. The bar code would reflect the drug's National Drug Code number.
3. The hospital must have bar code scanners or readers that are linked to the hospital's
computer system of electronic medical records.
4. Before a healthcare worker administers a drug to the patient, the healthcare worker scans
the patient's bar code. This allows the computer to pull up the patient's computerized
medical record.
5. The healthcare worker then scans the drug(s) that the hospital pharmacy has provided to be
administered to the patient. This scan informs the computer which drug is being administered.
6. The computer then compares the patient's medical record to the drug(s) being administered
to ensure that they match what is prescribed for the patient.
7. If there is a problem, the computer sends an error message, and the healthcare
worker investigates the problem.
Several problems could be occur:
- Wrong dose of drug
- Wrong drug
- Wrong time to administer the drug
- The patient's chart has been updated and the prescribed medication has changed
In addition, lack of information could lead to problems. "If drugs are being used for the
wrong indication or an unapproved indication, or a whole lot of extra drug is being shipped
that does not need to be shipped, those are abuses of the system," says L. Peter Smith,
CEO of Medmark Specialty Pharmacy, in Pittsburg.
These kind of errors can be reduced using the bar code technology.
The required bar code contains the National Drug Code (NDC) number, unique identifying
information about the drug that is to be dispensed to the patient, in a linear bar code
as part of the drug label.
The design allows manufacturers to include additional information, and more information
could also be added to the bar code standards as information technology progresses.
When used with bar code scanners and computerized patient information systems, bar code
technology can prevent many medication errors including administering the wrong drug,
administering a drug to a patient who is known to be allergic, administering the wrong
dose, administering the drug at the wrong time, or using the wrong route of
administration (for example, by injection rather than by mouth).
FDA issues rule requiring bar codes. Some of the products which oblige bar codes are:
* Prescription drugs, except for drug samples, allergenic extracts, intrauterine contraceptive
devices that are regulated as drugs, medical gasses, radiopharmaceuticals,
and low-density
form fill and seal containers that are not packaged with an overwrap.
* Biological products
* Over-The-Counter (OTC) drugs dispensed pursuant to an order and are commonly used in
hospitals (defined as: if it is packaged for hospital use, labeled for hospital use,
or marketed, promoted, or sold to hospitals).
Bar codes make it easier for hospitals and other health care facilities to enter medication order entries into a patient's electronic medical records, help in inventory control and billing, and conserve hospital or healthcare staff resources or free those resources so that they can be devoted to patient care.
Pharmacists can use the bar codes, in conjunction with computerized prescription orders, to confirm that the right drug is being dispensed to the right patient. Pharmacies will benefit from standard codes that will be used by all prescription manufacturers.
Drug manufacturers will benefit from uniform standards, rather than having to worry about conflicting requirements from different purchasers that would add to the cost of adopting bar coding. It is likely that, once the FDA standards are finalized, many manufacturers may quickly begin incorporating the bar codes on their products - even before the rule takes effect.
Various NDC database systems are currently used for
(i) the drug claim process,
(ii) inventory control, and
(iii) drug utilization review in the industry.
Studies have shown that a public central repository of a completed NDC database system is needed as a standard NDC reference for the health care industry, in order to improve the comparability, accessibility, and quality of drug information.