The Food and Drug Administration's proposed rules requiring bar codes on prescription drugs and over-the-counter drugs that may be ordered for patients in hospitals are a welcome response to the National Academy of Sciences Institute of Medicine 1999 report on medical errors.
That report, you'll recall, highlighted the dangers and the costs of medication errors due to dosage mistakes, the adverse effects of interacting drugs, and illegible written prescriptions.
The final rule is expected later this year after the FDA has evaluated comments and becomes effective three years after it is published. It will apply to drug manufacturers, repackagers, relabelers, and private label distributors.
This means that all drugs that fall under the rules will require a linear bar code that includes the 10-character National Drug Code (NDC) that identifies drug, dosage, form, and strength. Companies may also add lot number and expiration date to the bar code.
The bar code is to go on the product label that is on the immediate container and any outer container. For instance, individual doses of a drug that are packaged in quantity must have a bar code on each unit dose as well as a bar code on the container, which indicates the total number of doses.
This rule is intended to improve patient safety in hospital settings by reducing medication errors. The bar coding is designed to work this way:
- Upon admission, a patient receives a bar-coded identification bracelet that, when scanned, enables the patient's computerized medical record to be accessed.
- Before a patient is given a drug, the health care worker scans the patient's bar code, displaying the patient's medical record on a computer screen. Then the worker scans the drug's bar code. The computer automatically checks to see that the drug matches the medication order in the patient's medical record.
- If there is an error, the computer automatically alerts the health care worker before the medication is administered.
With this rule, the FDA predicts a 50-percent increase in catching medication errors while dispensing and administering drugs to patients in hospitals. The FDA also estimates that the reduction in patient pain and suffering and related hospital stays will result in savings of more than $41 billion over 20 years.
Although right now the focus is on hospitals, bar code technology will also be used with prescription drugs outside hospitals in a relatively short time. For a number of reasons, the major industry participants are ready to move quickly.
First of all, bar coding is an established technology that has been used for years in the retail industry. In fact, many drug stores and pharmacies already use similar scanning equipment for non-drug products with bar codes.
Second, pharmaceutical manufacturers and repackagers will put bar codes on all their products. No additional work will be required to code drugs for retail stores.
According to the National Association of Chain Drug Stores, community pharmacies are expected to fill roughly 4 billion prescriptions in 2005.
Accuracy in preparing prescriptions and avoiding liability are sensitive issues for the industry. Coupled with the fact that there is a continuing shortage of pharmacists, a technology that helps prevent errors and automates processes will be well received.
Finally, scanning technology is relatively inexpensive. According to John Roberts, director of health care development for the Uniform Code Council, a scanner costs around $700. Large chain drug stores buying in quantity pay significantly less.
What's happening now
"Bar coding is on the priority list of a lot of pharmacies," says Bill Lockwood, executive director of the American Society for Automation in Pharmacy. "It is becoming the standard of practice to ensure the right drug is being dispensed."
According to Lockwood, bar coding ties into robotic systems technology that is used in many pharmacies to fill prescriptions for the most frequently prescribed drugs. Even where a robotic system is not practical, stand-alone bar coding of drugs is becoming accepted, says Lockwood. He predicts that 75 percent of all pharmacies will be using bar code scanning for prescriptions within two years.
A representative of the Academy of Managed Care Pharmacy says that bar coding is "definitely on everyone's radar screen," and the heaviest users currently are mail service facilities.
The National Association of Chain Drug Stores says that its members use bar codes when available. The technology promotes patient safety and frees up the pharmacist, especially when combined with robotic prescription filling systems.
NACDS is among those who would like to see the bar code also include the lot number and expiration date of the drug. This information would help pharmacies with inventory control and drug recalls. Currently, pharmacies contact every patient who has received a recalled medication. If the lot number were on the bar code, pharmacies would know who received the affected lot number and would need to contact them only.
John Roberts is director of health care development at the Uniform Code Council, the group that developed the National Drug Code chosen by the FDA for bar coding. It is possible, according to Roberts, to include the lot number and the expiration date in the designated format, and several of the larger drug manufacturers are already including this information on some of their products. He believes that at least 50 percent of all pharmaceutical products will have bar codes, and that the industry will be ready well before the three-year deadline.
Roberts estimates that perhaps half of all drug stores and pharmacies already have scanners that can read the proposed drug bar codes. "Scanning is a database issue," he notes. Manufacturers will collect and send bar code data to the pharmacies. The pharmacies will need computer systems large enough to handle all the data.
Bar coding drugs is applying an accepted technology to an ancient industry. This fact, plus the unarguable benefit of preventing medication errors, is fostering rapid adoption in health care. It is likely that by the time the FDA rule takes effect for in-hospital drugs it will already be operative in retail pharmacy. The safety net will be complete when electronic prescriptions replace handwritten scripts.