• Some drug products do not have any identifying barcode.

• Lot number and expiration date information is not in barcode format.

• Bar codes in use do not always allow positive identification of drug products.

• There are fundamental flaws in the systems that assign identifying numbers and barcodes to drug products.  This results in multiple drug products having the same barcodes and other problems.         

a.  A drug product is identified by its National Drug Code (NDC number), which is assigned pursuant to a plan administered by the FDA.   

b.  Most drug stock bottles and packages display the NDC in character form, and also as both character and graphic elements of the Uniform Product Code (UPC number and barcode).  The UPC is an industry assigned number used primarily for stockkeeping purposes.

c.  However, some drugs (and prescribed medical supplies) do not have UPC barcodes on them.  These drugs normally display the NDC, which is used to identify and verify the drug manually during the dispensing process.  Also, some drugs do not display the NDC at all, and display only the UPC.

d.  The NDC number is normally the middle part of the UPC number, but there is no industry standard (or consistent practice) that assures that the NDC can be determined from the UPC.  Sometimes the NDC and UPC are completely different numbers. 

e.  This means that guesswork is sometimes required to identify a dispensed drug product.  This not only wastes time, but it also opens the door for errors.

f.  We recommend that the NDC be displayed clearly on all pharmaceutical products and prescribed medical supplies, and that the NDC also be included and displayed on these products in barcode form in a standard way (such as in a standard position within the UPC).  This will allow all drug stock bottles and packages to be positively identified via their UPC barcode.

a.  Drug stock bottles and packages typically display a lot number and expiration date, but not in barcode form.  Those that do, typically display this information in a separate barcode.  Dispensing pharmacies must track lot numbers and expiration dates to ensure that drugs are not used beyond expiration dates, deal with recalls, etc.  This information is typically entered manually, and sometimes omitted or entered incorrectly.

b.  A simple calculation shows that pharmacists and technicians can waste tremendous amounts of time manually entering and tracking lot numbers and expiration dates.  There are approximately three billion prescriptions filled annually in community and ambulatory pharmacies.  Assuming a conservative time figure of 15 seconds to enter lot number and expiration date information for each prescription, 12.5 million hours per year are spent on this task alone.  This accounts for more than 6,000 Full-Time Employees (FTEs).

c.  Prescription volumes are expected to increase by 40% over the next 3-5 years.  In other words, in addition to an estimated 6,000 FTE's currently spent on this task, approximately 2,400 additional FTE's will be wasted over the next 3-5 years simply entering lot numbers and expiration dates while dispensing drugs.  

d.  The shortage of pharmacists has reached a critical level and all projections show that the crisis is in a very early stage with no relief in sight.  We are now hearing reports of pharmacy technician shortages.

e.  A comparison with pharmacy school projections shows that continued manual entry of lot numbers and expiration dates has the potential to waste 25% or more of the supply of new pharmacists graduating each year.

f.  We recommend that all drug products and prescribed medical supplies include, within the identifying bar code (such as within the UPC), the lot number and expiration date so that a single scan of the product can obtain the identity of the product, its lot number and its expiration date.  This will allow pharmacy dispensing systems to automatically obtain and utilize lot number and expiration date information without manual entry. 

a.  Manufacturers sometimes make changes in the manufacturing process that modify the physical appearance of a drug without changing it from a therapeutic standpoint.  This is sometimes done without assigning a different NDC.  For example, the drug might have initially been green.  One day the drug is changed to white.  However, the manufacturer does not change the NDC since it is considered to be "the same drug."  We call this the "multi-version drug" problem.  See Appendix B for examples of the multi-version drug problem.  Appendix B shows one case where a manufacturer has produced four versions of the drug, all labeled with the same NDC number.

b.  Distributors often obtain drugs from manufacturers and repackage or relabel them to sell under their own name.  Sometimes these packages are assigned a new NDC and sometimes they are not.  Sometimes the packages display two NDC numbers, the original number from the manufacturer and a new number assigned by the distributor.  (See Appendix C for example.)

c.  Many drugs come in an outer package (such as a box) with multiple interior packages.  The outer package can be dispensed, or it can be opened and the interior packages dispensed separately.  Sometimes there is no NDC on the outer package.  Sometimes there is no NDC on the interior packages.  Sometimes the same NDC is shown on both the outer and interior packages.  (See Appendix D for example.)

d.  The above situations greatly complicate the dispensing process.  They also undermine the ability of dispensing personnel and patients to use visual inspection aids to verify dispensing accuracy.

e.  We recommend that a separate NDC (and a separate, single identifying barcode) be used when the appearance of the drug or drug package changes, and that each package that can be dispensed be assigned a unique NDC.

f.  Positive identification is important not only for pharmacists, but also for patients.  The state of Oregon has implemented regulations requiring prescription labels to display descriptive information to allow patients to positively identify the drugs they are taking.  In order to do this, computer systems must be able to determine from the NDC of the drug being dispensed which picture and descriptive information to print on the label.  Given the present state of affairs, there are cases where neither the dispensing pharmacist nor the patient can be sure what the drug will look like until the package is actually opened. 

a.  “Labelers” of drug products (i.e. manufacturers and those that repackage or relabel products) typically display both the NDC and the UPC on their product labels.

b.  The UPC is displayed in barcode format with the actual number printed below.

c.  For drug products, the middle 10 digits of the UPC is typically identical to the NDC, with the first digit of the 12-digit UPC set to “3” and the last digit set as a check digit.  However, this is not always the case.  Sometimes there is no numerical resemblance between these numbers.  (See Appendix E for example.)

d.  We recommend that the identifying barcode contain the NDC number in a standard position so that the drug NDC can be positively and directly identified via barcode scan.

a.  The NDC numbering system is based on three separate numbers:  Labeler Code, Product ID and Pack Size.  However, there is not a coordinated plan as to the exact number of digits in those three numbers.

b.  As it has turned out, the Labeler Code can be either four or five digits;  the Product ID can be either three or four digits;  and the Pack Size can be either one or two digits.

c.  However, drug manufacturers, repackagers and labelers, for stockkeeping purposes, need a single number—not three—to identify their drugs.  Also, they need the number to be 10 digits so that it fits within the 12-digit UPC number scheme (allowing for a standard leading digit and a trailing check digit).  Thus, on drug stock bottles and packages one typically finds the "NDC Number" as a 10-digit concatenation of the three numbers established as the NDC.  Sometimes dashes are entered separating these numbers, sometimes not.

d.  In other words, the NDC Number is:

The FDA assigned Labeler Code, which may be either four or five digits.

The Manufacturer (or Labeler) assigned Product ID, which may be either three or four digits.

The Manufacturer (or Labeler) assigned Pack Size (package identifier), which may be either one or two digits.

e.  In order for the manufacturers to keep the NDC number to 10 digits, they require that one of the three component numbers be of the "small" size while the other two must be of the "large" size.  

f.  This plan produced NDC numbers that did not duplicate for a given manufacturer, repackager or relabeler, since the first of the three numbers was assigned uniquely to each of them.  However, it did not produce NDC numbers that were unique across the industry as a whole.  For example, the concatenation of 0001+1000+01 yields the 10-digit number 0001100001.  Likewise, the concatenation of 00011+000+01 yields the same 10-digit number. 

g.  Pharmacy database providers could not work directly with this numbering system.  They could not tolerate duplicate NDC numbers in their databases.  Their solution was to convert the 10-digit NDC numbers to 11 digit numbers by adding a zero in front of whichever of the three fields came in the "small" size.  Thus, the "NDC" numbers found in most drug databases and displayed on the computer screens and prescription labels used by pharmacists every day are 11 digits.  These numbers are derived from the NDC numbers used by the manufacturers by adding a zero either at the front, in the middle, or near the end.

Unfortunately, duplications sometimes occur when converting 11-digit NDC numbers back to 10-digit NDC numbers.  This allows drug products to mis-identified.  (See Appendix F.)

h.  Given this situation of padding the NDC with a zero (somewhere), it is not trivial to determine from a drug database NDC what the manufacturer NDC is.  The procedure is as follows:

i.      First, determine who the Labeler is and look up the Labeler code.  This will be either four or five digits.

ii.     If the labeler code is four digits, remove the leading zero from the "NDC" number in the database and you have the manufacturer NDC number.

iii.    If the labeler code is five digits, check other reference materials to determine whether the Product ID or the Pack Size has been specified in the "small" size to determine where to add the leading zero.

Appendix G shows examples of the difficulties of translating UPC barcodes to NDC numbers.  

i.  Some manufacturers have used the “Pack Size” field (i.e. the third element of the NDC) to indicate a property of the product rather than the packaging quantity of the product.  Normally, Pack Size is used to distinguish the various package sizes that are available.  However, as shown in Appendix H, this field has also been used to designate the length of the needles for various syringes.

j.  Sometimes the same barcode references multiple drug products.  (See Appendix I for example.)

k.  Various types of barcodes are found on drug products and related medical supplies.  (See Appendix J for examples.)

l. Appendix K shows an example where three entries in the National Drug Data File (NDDF, supplied by FirstDataBank, Inc.) appear, from their NDC numbers, to be three different package sizes for the same drug.  However, the third entry is actually a completely different drug.  The source of this misleading data is apparently an error in the expansion of a 10-digit NDC to an 11-digit NDC (described above).  Most pharmacy computer applications use the NDDF to perform Drug Utilization Reviews and adjudicate prescription claims.  The NDDF is also used by payors to pay prescription claims.

m.  Problems such as these are encountered the very first hour of the very first day on the job by anyone who works in a pharmacy.  Unfortunately, encountering the problems does not mean that they are understood or solved.  As can be seen from the above, translating from database NDC numbers to manufacturer NDC numbers and interpreting the NDC numbers is cumbersome.  It wastes time and confuses people.

These problems cause stress and errors.  They are classic "Murphy's Law" examples of how lack of coordination and clarity in establishing standards can produce an incredible, large scale mess.  We should clean up this mess before multiplying it by bringing in an even wider range of products.  How can we expect those who work in pharmacies to keep up with staggering workloads and avoid dispensing the wrong drugs when they need a road map to identify the very products that the industry provides for them to dispense?