THE FOOD AND DRUG ADMINISTRATION FINAL BAR CODE RULE PUBLISHED

this past February tackled what should be one of the most preventable problems plaguing the health care industry today—medication errors. The new FDA rule requires that most prescription drugs and over-the-counter drugs commonly used in hospitals and dispensed pursuant to an order be bar coded with identifying information that can be compared to a patient’s medical record, thereby reducing the risk of incorrect drug administration. The FDA predicts that the institution of such safety procedures will prevent 500,000 medication errors over 20 years. This 20year projection also includes a savings of $93 billion by patients and hospitals, as well as additional financial benefits for hospitals through reduced litigation fees and lower malpractice liability insurance.

The implementation of bar code systems in hospitals can lead to increased efficiency as well, freeing nurses to spend more time with patients. Bar codes also enable hospitals to keep more accurate inventory records and create exact supply orders.

As more hospitals embrace bar coding, the need for bar coded unit dose drugs will increase.

As more hospitals embrace bar coding, the need for bar coded unit dose drugs will increase. The growing awareness of the significant benefits of bar coding, in combination with the FDA rule, will result in an increase in the demand for unit dose bar coded medications. The challenge lies in convincing the manufacturers to meet this demand. According to an ISMP (Institute for Safe Medication Practices) survey, 76% of surveyed hospitals have reported decreases in the number of items available in unit dose packaging over the last five years.

Advantages of Buying Unit Dose Products
There are advantages for hospitals that purchase prepackaged unit dose drugs from manufacturers rather than repackage from bulk. By buying unit dose products, hospitals avoid the labor, packaging, and equipment costs that accompany the in-houserepackaging and bar coding of bulk products. Repackaging a product may also shorten the shelf life of a medication since most state laws restrict the expiration dates of repackaged products to between six months and one year. In contrast, stability and shelf-life testing allows expiration dates on products prepackaged by the manufacturer to be several years in length. Depending on a hospital’s distribution system, utilizing prepackaged items may also allow the hospital to recycle unused drugs that were dispensed, but never administered to a patient and instead returned to the pharmacy.

Repackaging a product may also shorten the shelf life of a medication since most state laws restrict the expiration dates of repackaged products...

The Role of GPOs
Group purchasing organizations (GPOs) are active participants in the move to adopt bar coded unit dose products. Many GPOs demonstrated their support for the FDA bar coding initiative. They educate their members about the industry and advocate for their affiliated institutions with manufacturers.
Compliance with the FDA rule prior to the two-year deadline may be spurred by the actions of GPOs. When GPOs consider which manufacturers should be awarded contracts, the availability of bar coded packaging is one of many criteria used in making the decision. When all factors are equal, a GPO such as MedAssets would choose a manufacturer with bar coded products. If the costs of bar coded drugs were higher, MedAssets would then evaluate the differences, and would possibly award contracts to two vendors so both options would be available to their members.

Generic Manufacturers Move Toward Bar Coded Unit Dose Packaging One of the challenges facing hospitals today is the limited availability of unit dosed products (whether bar coded or not) from branded manufactures, for reasons that are primarily economic. Since the FDA Rule does not mandate unit dose packaging for products, there is no regulatory pressure to change this situation. However, it is hoped that more bar coded, unit dose products will become available because of patient safety initiatives and the manufacturers’ efforts to “do the right thing.” The situation is different in the generic marketplace. Competition and opportunities to generate sales provide ample incentive for generic drug manufacturers to produce products in bar coded, unit dose packaging without any outside regulatory pressure to avoid giving their competitors an advantage.

Companies in the Forefront of Bar Coded Unit Dose Packaging
Certain companies have taken the initiative to be at the forefront of the bar coding movement. For example, UDL Laboratories, Inc., has been a leader for years in the placement of bar codes on its products. They provide an image that is well positioned, clearly printed, scanner readable and durable. The company now utilizes bar codes at every packaging level, from unit dose to shipping, and features an expanding product line. Sky Pharmaceuticals Packaging and American Health Packaging offer growing selections of products as well. MedAssets recently gave both repackagers suggestions of items needed in the marketplace. In March 2003, Abbott Laboratories became the first manufacturer to place bar codes on all of its injectable drugs and intravenous solutions created for hospital use. Baxter Healthcare has since attempted the same endeavor with all of its intravenous products.

According to the U.S. Department of Health and Human Services, hospitals that have already implemented bar coded bedside medication and verification have reduced the incorrect administration of drugs by almost 85 percent. Clearly, the availability of bar coded unit dose products will be a factor in the widespread achievement of these patient safety goals throughout the health care industry.

Ron Hartmann, PharmD, is vice president for pharmacy at MedAssets, a company that provides supply chain and revenue cycle initiatives for health care systems. In addition to over 20 years of health care experience, prior to joining MedAssets in 2000, he served on the MedAssets Pharmacy Advisory Committee while Director of Pharmacy at St. John’s Mercy Medical Center and the Sisters of Mercy Health System in St. Louis.