Bar Code Labels With NDC Numbers Possible In 2-3 Years, PhRMA Predicts

Pharmaceutical manufacturers could include National Drug Code numbers in bar code labels within two to three years, the Pharmaceutical Research & Manufacturers of America said.

"It would be possible for pharmaceutical manufacturers to extend the use of machine-readable bar codes on container labels where there is available space and to have those bar codes on such container labels within two to three years," PhRMA representative Richard Johnson said at a July 26 meeting in Bethesda, Md.

Johnson, Abbott director-information & policy, said that the two-to-three-year timeframe could be contingent on a modification of FDA's current requirements for product packaging.

"It may be necessary to amend current FDA text requirements so that certain human readable information now required to be on all primary drug or biologic container labels be exempted. This will provide sufficient space to print a high quality, machine-readable bar code and more prominent human readable text to help reduce medication errors."

FDA convened the meeting to solicit stakeholder opinion about the feasibility of requiring bar codes on packaging for prescription drugs, over-the-counter drugs, vaccines and medical devices (¹ (Also see "FDA Bar-Coding Requirements To Be Discussed At Public Meeting In July" - Pink Sheet, 24 Jun, 2002.), p. 30).

While a panel of hospital and pharmacy associations overwhelmingly supported labeling requirements that would include the NDC number, the lot number and the expiration date, drug manufacturers questioned the feasibility of including all three elements.

"This morning we heard a lot...from the health professional panel, a lot of 'hurry up FDA, we're waiting for you to do this, you should have done this, get moving, let's get this out of there,'" FDA Associate Commissioner for Policy Margaret Dotzel said. "And this afternoon [from the manufacturers panel], I think we're hearing a little bit more of 'whoa, slow down, create a task force, study this a little bit more.'"

Johnson said that "the present technology is limited in its ability to support the application of machine-readable bar codes incorporating additional information beyond that contained within the NDC number, such as product lot number and expiration date."

"The material benefit of a bar coded lot number and expiration date to achieve a reduction in medication errors warrants further discussion among stakeholders."

PhRMA said it is prepared to convene a group of interested stakeholders that would conduct a "needs assessment and evaluate further application of bar code technology for human drug and biologic products."

"I think we would all urge action as quickly as possible. But I hope that we also would express that there are things that can't be done in the near term. Things that there need to be more discussion [on] before a reasonable timeline can be agreed upon," Johnson said.

A PhRMA-sponsored task force already has looked at methods pharmaceutical companies could use to help reduce reporting errors, including bar coding (² (Also see "PhRMA Medication Error Reduction Plan Slated For July Release" - Pink Sheet, 13 Mar, 2000.), p. 12). The task force, which included Johnson, did not make its findings externally available, but did provide some technical recommendations on bar code readability in PhRMA's comments submitted to the docket.

American Hospital Association Senior Medical Advisor John Combes, MD, maintained that "we should be able to get the bar code onto the label of unit of use packaging with at least the NDC number almost immediately."

"There are some issues that we need to work on, technical issues about getting the lot and expiration date, but I don't think that those should take longer than a year to 18 months."

FDA expressed concern about a multi-phase implementation approach. "One of the problems [with] phasing in, we run the risk of losing momentum. We believe that this is very important from a public health point of view," Acting FDA Commissioner Crawford said.

FDA's goal is to publish a proposed rule by November, and solicit further public comment on the issue.

However, some hospital purchasers are moving ahead with their own bar code labeling mandates.

Premier plans to institute a bar code labeling requirement on all pharmaceutical product contracts signed after July 1, 2003. "Premier has requested that the NDC code be used initially, with respect to drugs and biologics, in the context of a gradual transition toward inclusion of the lot number and expiration date in the code."

Abbott expects to include unit of use bar code labeling in its entire hospital injectable pharmaceuticals and I.V. solutions product lines by early 2003. The company said July 24 it already has bar coded 45% of more than 1,000 of its injectable pharmaceuticals and I.V. solutions. Abbott plans to bar code 70% of those products by the end of the year.

Aventis currently prints UPC codes containing the NDC number on all sales units of prescription drug products for retail sale. "A bar code containing only a dose-specific identifying number can be pre-printed and would not affect packaging line speeds," Aventis' comments say.

However, the company observed that "at this time, we are not aware of any on-line printing systems capable of printing bar codes for lot [and] expiration [date] on our fastest lines (up to 400 units/minute). Requirements for lot/exp bar coding would likely require slowing down packaging lines up to 40%, which would have a severe negative impact on cost of goods."

Aventis advocated a two-tiered implementation schedule with a minimum of two years to comply with a "primary product identification" or NDC number mandate. The company said a minimum of four years would be needed to comply with a mandate including lot and expiration numbers.

North Chicago VA Medical Center Chief of Pharmacy Kay Willis told the meeting that the VA's Veterans Health Administration "will likely make bar coding a contract requirement for the next solicitation" of IV solution packaging.

FDA highlighted VA's Bar Code Administration System, which was initiated in June 2000 at 173 medical centers and long-term care facilities.

Crawford noted that a VA hospital in New Hampshire saw an 80% reduction in medication errors after the bar code system was introduced. Another medical center in Colorado reduced its medication error rate by more than 70%. "A 70% reduction in medication error rate is probably as good as it can get," he said.

However, the VA's Inspector General found that multiple equipment breakdowns occurred during the first six months of the program. "Nurses reported difficulty using hand-held scanners on patient wristbands, problems with scanner batteries...and concerns with BCMA computers running slow or locking up for several hours," a January 2001 report states.

"Although we could find no evidence of adverse events related to inoperable BCMA equipment, several clinicians asserted that...several nurses 'found ways around' using the system," the OIG reported. VA plans to upgrade its BCMA software by the end of November.

Technology consulting firm Automatic Identification Systems told FDA that "approximately 3% of retail products have bar codes that are difficult for even the best of scanners to read accurately, or cannot be read at all....Projected into healthcare applications, [these] data indicate that perhaps 1% of all bar code-based transactions could result in error."

AIS suggested that FDA take a GMP approach and mandate testing and verification of bar codes "to avoid accidental or intentional mis-marking of products."

McKesson noted that there is no national standard for lot number formatting, and that format and length of lot numbers vary significantly. "A requirement to track lot numbers would also necessitate changes to existing systems or the design of new systems."

AHA's Combes said that "what we're asking the FDA to do here is to put the bar code on the label of all drugs...every unit dose would have a bar code on it and any unit packaging would have a bar code on it. How that's used is going to be a whole different issue. And I don't think we're asking the FDA to tell us how to use it; we're asking them to give us the tools so we can use it."

Center for Devices & Radiological Health Office of Compliance electronics engineer John Murray, suggested the rule could impact legal liability. "Will now we shift the big arrow of blame to the IT system? Take the human out of the loop and who is liable? Is it the hospital, the bar code maker, the label maker? I'm just wondering how this could shift the scale of justice?"