With a two-year time clock ticking, drug companies face a confusing, many branched bar coding decision-tree, which may turn out to be a weeping willow for quite a few. Brand-name, generic and over-the-counter manufacturers must quickly decide whether they need to alter product labels and, if so, scurry into the design process while at the same time planning and implementing production line changes.
First, drug companies must decide whether brand-name, generic and over-the-counter drugs are covered. Then the question becomes whether a linear bar code can fit on the current product label. If “yes,” then a choice must be made between an alphanumeric and numeric bar code. Either must contain the National Drug Code (NDC) number at a minimum.
But wait! The FDA says in its final rule that is about to roll out a separate rulemaking which may force some companies to change current NDC numbers. So should a company start bar coding its SKUs now, or delay until it is sure its current NDC will remain on its product? Regardless, some companies will want to include lot number and expiration date in the bar code, even though that is not required. If they do, that will occasion a whole other set of tumbling dominoes. If a linear code doesn’t fit on the current label, which will be true for many hospital unit dose (HUD) packages, be they solid form, injectables or otherwise, then the packaging folks have a host of packaging design decisions to make, all of which will cause the corporate cash register to start ringing.
For brand-name and generic companies, that repeated ringing will add up to $28.1 million over the next two years, mostly attributable to redesign and bar coding of unit-dose interior packaging. That is the FDA estimate. Exterior packaging modifications that include NDC information would cost $6.1 million over the 2-year period. OTC drug manufacturers, repackers, and relabelers will spend $19.9 million over the next two years, according to the FDA’s economic analysis.
The FDA decision tree has a couple of sharp, interior limbs that will provide a poke in the eye. For example, the brand-name industry expected the rule to only apply to unit-dose drugs, not bulk shipments which end up in hospital pharmacies and are then broken down by the hospital pharmacist. “I’m shocked,” says one packaging director at a Top Three brand-name company, when informed all bulk packages require a bar code. Moreover, the FDA limited the type of bar code which can be used to linear varieties. This wasn’t a major surprise; but the issue has become much more prickly as fast technological developments in the scanner industry have made decisions made by the FDA two years ago, which have been carried through to the final rule, seem somewhat dynosaurish. Restricting bar codes to “old” technology linear varieties was done out of concern for hospitals, who might not have been able or willing to afford more sophisticated, expensive scanners needed to read two-dimensional bar codes, which have some major advantages, especially from a packaging standpoint, over the Reduced Space Symbology (RSS) code, which is classified as linear although is has some of the features of a 2D code.
The major 2D bar code is called Data Matrix. The FDA explicitly prevented its use in the bar codes drug companies develop over the next two years to comply with the FDA rule.”If I had it to do all over again,” says one drug packaging executive whose company has put RSS codes on almost all its hospital unit dose (HUD) products, “I would use Data Matrix codes. But I understand why the FDA specified linear codes.” The FDA’s final rule on bar coding tracks closely with its proposed rule in that it applies to prescription drugs, over-the-counter drugs and blood and vaccine products commonly used in hospitals and dispensed pursuant to an order. It wouldn’t have hurt the FDA to have sprayed a little Windex on those last 10 words, though, and cleared them up a little. More on that in a second.
The good news is that the final rule adds some notable wiggle room. First, there are new blanket exemptions for drug samples, allergenic extracts, intrauterine contraceptive devices that are regulated as drugs, medical gases, radiopharmaceuticals, low-density polyethylene form fill and seal containers, and prescription drugs sold directly to patients. In addition, the FDA tossed in a general exemption which was not included in the proposed rule issued in March 2003. The FDA had said there that RSS bar codes could fit on any and all packages now matter how small. So, the message went, “tough luck.” No exemptions.
The agency changes its tune in the final rule, perhaps because it realized some of the problems related to RSS bar codes, more on which later. But in the final rule, the agency kicks open the exemption door pretty wide. Companies can ask for a general exemption if they can prove that “compliance with the bar code requirement would adversely affect the drug’s safety, effectiveness, purity, or potency or not be technologically feasible.” The request must also explain why the problem cannot be reasonably remedied by measures such as package redesign or use of overwraps. There is even a second way to breeze through that door, by arguing that “an alternative regulatory program or method of product use renders the bar code unnecessary for patient safety.” But the agency contends it will issue general exemptions only in “rare cases,” and not to companies who argue bar coding will cost too much, or that their product doesn’t cause medication errors.
Of course a company will have to figure out whether its drug is covered by the final rule before pushing the panic button and writing a general exemption request. There was considerable confusion after the proposed rule came out in March 2003 with what the FDA meant by “commonly used in hospitals.” Part of that confusion stemmed from questions from the brand-name industry about whether bulk packages which don’t end up at a patient’s bedside (as opposed to HUD packages) fell under that definition. The answer, according to a top FDA official, is “yes.”
The OTC industry was, and remains, a bit perplexed, too. By using the terminology “dispensed pursuant to an order” the FDA was signaling that things like mouthwash, which the FDA considers a drug, do not have to be bar coded when sold to hospitals. But the FDA guidance in the final rule was way to vague for people like Dave Spangler, vice president international and assistant general counsel for the Consumer Healthcare Products Association (CHPA). “We’re looking for clarification on what OTC drugs are covered,” he explains. “The final rule is not particularly clear.”
There was no question the final rule would cover unit dose packaging. Again, though, the language of the rule is a little uncertain with regard to whether individual blister cells need bar codes, which is a big issue, of course, given their lack of packaging “real estate.” The final rule states: “Regarding unit-of-use packages, the rule does require bar codes on such packages because Sec. 201.25(c)(2) states that the bar code must appear on the drug’s label.” The word “label” is not defined. But an FDA official confirms that the individual foil backing on each blister cell is indeed the “label” in the FDA’s mind. All blister cells must have bar codes, he emphasizes.
CHPA’s Spangler thinks that requirement will be problematic for some of his members. “If they have to put a bar code on the blister cell, there won’t be enough room for the other information the FDA requires them to put there.”The bar codes the FDA has mandated must contain the NDC in an EAN.UCC or HIBCC (Health Industry Business Communication Council) format. The FDA rejected appeals from a number of groups that the lot number and expiration date also be included in the bar code. The brand-name drug manufacturers’ association PhRMA had pleaded with the FDA to reject inclusion of lot number and expiration date, although a number of member companies privately dissented with that public stance. That dissension stemmed from the fact that many hospital pharmacies demand lot number and expiration date.
What PhRMA opposed even more vehemently was a requirement that all drugs destined for a hospital be put in HUD packaging. The major advocate for this was the Healthcare Complaince Packaging Council (HCPC) which equates HUD packaging with lower medication errors in hospitals which, after all, was what the FDA is trying to achieve on the heels of the influential 1999 report from the Institute of Medicine called To Err is Human. That report estimated that at least 44,000 Americans die each year as a result of medical errors in hospitals, most of them in the medication area.
HCPC has been concerned that the number of prescription drugs packaged in HUD has been dramatically declining over the past decade because hospitals prefer to buy drugs more cheaply in bulk, and then repackage them in the hospital pharmacy, where they are often converted to HUD and a bar code is applied. “I talked with a brand-name executive a year ago and he told me that he had reduced by 60 percent the number of products packaged in HUD,” states Peter Mayberry, executive director of the HCPC.
“We have seen a drop in HUD packaging,” admits Renard Jackson, executive vice president for Cardinal Health (Philadelphia, PA) packaging services. “HUD has always been considered a lost leader, an investment by the manufacturer with the intention of keeping the patient with the drug once he or she leaves the hospital and buys the drug at the local pharmacy. But we have seen very recently a bit of an increase in HUD availability.” Despite the contention that a unit-dose packaging requirement would dramatically reduce hospital medication errors, the FDA declined to go that far. That disappointed Kasey Thompson, director of patient systems for the American Society of Health-System Pharmacists (ASHP). He says hospitals who are accredited by the Joint Commission will repackage bulk shipments from manufacturers in HUD because that is a requirement of accreditation. But the ASHP is uneasy with the notion of pharmacists being turned into packaging professionals. “Manufacturers can do the job of HUD packaging much better,” Thompson says.
Rich Hollander, senior director of packaging services at Pfizer, Inc. (New York, N.Y.), couldn’t agree more. Pfizer completed bar coding of all 30 SKUs of its HUD solid-dose products at the end of December. Pfizer is using RSS/CC codes-complete with NDC and lot number and expiration date–on its blister cells, which are packaged at three Pfizer locations in Puerto Rico, one in Brooklyn, N.Y. and at the DPT contract packaging plant in Lakewood, New Jersey. The “CC” in RSS/CC stands for “composite code.” It is a variant of a more standard RSS code developed by the Uniform Code Council Hollander says that the company made only minimal investments to accommodate printing of the RSS codes prior to their full implementation. Recently, though, Pfizer did invest in improved printing technologies at two of their sites to improve print quality and gain production efficiencies. “Those new printers use UV-curable ink, which controls the spread of the ink when it is laid down on the package,” Hollander explains. The print quality of those bar codes at all five sites is well above the level of “C” (ANSI standards specify print clarity levels of descending order from “A’ to “F”) or better. “And “Cs” are rare,” Hollander adds.
The types of blister packaging lines which apply RSS/CC bar codes run at speeds of 200-plus units a minute and package drugs like Lipitor. The physical dimensions of an RSS/CC code printed by Pfizer is approximately 1/2 inch x 5/8 inch. Those dimensions become more of an issue as Pfizer now turns to Pharmacia’s (Pfizer bought that company in 2003) large variety of smaller sized packages such as pre4-filled syringers, small vials and ampules, in addition to its own non-solid dose blister packages, which Pfizer must bar code in the next two years.
Will RSS/CC codes work on the rest of the Pfizer small packages. Maybe yes, maybe no. There is less real estate on some of those containers than on a blister cell. In addition, some of the containers have a curved surface which can impact the readability of an RSS/CC code. It may be easier to get a Data Matrix code, which measures 1/4 inch x 1/4 inch, on ampules, for example. A Data Matrix code is also more versatile. It uses multiple data encodation modes with the capacity to encode 2,335 alphanumeric characters and 3,116 numeric digits.
But the FDA has prohibited the use of two dimensional codes like Data Matrix in part because it believed, at the time this rulemaking began three or so years ago, that hospitals who had already purchased scanners-estimates are that 10-15 percent of hospitals have already bought bedside scanners-would have had to purchase new scanners which cost, typically, $200/per more than the old scanners they owned.
A third potential problem for companies with ampules and other small, curved packages is that their labels are currently being etched by lasers, or printed by ink jet or hot stamp printing equipment which run on packaging lines with speeds of up to 600 units per minute. HUD Blister cells, by contrast, typically use flexography printing for their labels. Laser etching and RSS/CC bar codes containing all three data elements may be a bad match due to longer processing speeds required to etch away so much ink. So companies may have to consider alternative options such as an RSS code for just the NDC number and a second, two dimensional code which would include all three data elements. The RSS would meet the FDA requirement and satisfy some hospital needs, while the second more inclusive code would meet the needs of hospitals clamoring for NDC and lot number plus expiration date.
Companies who decide only to use the NDC will have less of a problem fitting an RSS code on a small package, although printing quality and packaging line speed could still be an issue. There is another option, however. Some drug manufacturers have shrunk traditional, linear UPC codes (which generally contain an SKU’s NDC, but not expiration date and lot number) to get them on to packages with minimal real estate. American Pharmaceutical Partners (Schaumburg, IL) sells around 300 SKUs, all hospital injectables, and some in vials as small as 2 mLs. To address the needs of its customers, APP began putting bar codes on its products at the individual unit of use beginning in 2001. It did that by reducing the UPC code in some instances below 80 percent of standard size.
The only problem with that approach is that Uniform Code Council (UCC) guidelines say that a UPC bar code can only be reduced to 80 percent of its conventional size. Companies take a risk when they drop down the size of the bar code below 80 percent of normal; a scanner may not be able to read the code. Drug stores can, and have, fined drug manufacturers whose bar codes have proven unreadable. Hospitals can do the same thing. The UCC’s Roberts says that when he was at a recent show put on by the National Association of Chain Drug Stores (NACDS) he heard from some drug companies who had been fined. He declines to identify them. “A 50 cents per case fine may not seem like much at first,” he says. “But if you sold 10,000 to a drug chain, it can be substantial.”
Deena Reyes, director of marketing for APP, says the reduced UPC codes on her company’s injectables can be read at 90 percent on the first swipe with a scanner and 98 percent on the second swipe. “RSS wasn’t available when we put our bar codes on,” she explains.
UPC codes used by APP and almost all other drug manufacturers are formatted according to specifications developed by the UCC, which also has a EAN.UCC format for encoding NDC numbers. That numeric format is used by almost 100 percent of drug manufacturers because it is demanded by U.S. retailers. However, in the final rule, the FDA threw in a bit of a change up by allowing drug companies to use a rival alphanumeric format developed by the Health Industry Business Communication Council (HIBCC). HIBCC argues their alphanumeric symbology is more accurate than UCC symbology, although Bob Hankin, president and CEO of HIBCC concedes that “some may argue that the accuracy claim is quibbling.” Another advantage is that a single product identification alphanumeric code can be used on all levels of a product’s packaging, from shipping carton on down the line. EAN.UCC numeric codes are different for different packaging levels.
Hankin argues alphanumeric codes have caught on in industries such as aerospace, semiconductors and chemicals where companies cannot afford to make a mistake. But alphanumeric codes are a much harder sell in the drug industry, where the market is 80 percent retail, and where drug stores scan in products at the cash register, more for purposes of inventory control than safety. “Because hospitals are a small part of the drug market, and it remains to be seen whether hospitals will even buy scanners, alphanumeric codes on drug packaging won’t happen overnight,” concedes Hankin. “But the FDA’s decision to require linear codes only means that in terms of patient safety, the rule won’t have much of an impact, especially since hospitals would have to buy expensive scanners to read RSS bar codes.”