From: Jan Weber [jan13@cox.net] Sent: Friday, June 13, 2003 4:06 PM To: fdadockets@oc.fda.gov Subject: Comments Re: Docket : 2002N-0204 Respectfully submitted by: The American Association of Critical Care Nurses 101 Columbia Aliso Viejo, CA 92656 949-362-2050 Comments from the American Association of Critical Care Nurses Regarding: Docket: 2002N-0204: Bar Code Label Requirements for Human Drug Products and Blood The American Association of Critical-Care Nurses (AACN) supports the proposed FDA rule requiring Bar Code Labels on medications and blood products. AACN is the world’s largest specialty nursing organization representing over 400,000 nurses who care for the critically ill population in a variety of settings. Patient Safety Prevention of medical errors has become front and center in many health care systems’ strategic goals. The public’s awareness has been raised regarding this issue through reports in the popular media. A large percent of medical errors pertain to the administration of medications. Nurses, as the primary administrator of medications in the inpatient environment, play a distinct, yet primary role in the prevention of these errors. Shipping, warehouse and distributor bar code applications are widely used for health care supplies, while bar coding of unit-of-use pharmaceuticals has not been widely implemented. Thus, AACN supports the proposed ruling. We believe it will decrease some of the initial barriers to successful implementation of bar code systems in health care systems. AACN is concerned about the impact of a bar code medication system has on the nursing workflow. This technology has changed the way nurses administer medications. Although many critical care nurses recognize the ultimate benefits, they are extremely concerned about the significant effect on the workload. We have nurses who tell us it takes them much more time to use a bar code system. They have designed shortcuts, such as hand entering patient identifiers, or staff identifiers. They have hand entered patient identifiers and then scanned the medications outside the room. They have even located the NDC and hand entered that when medications would not scan or somehow had no bar code. Wrong labels have been posted on medications, when labels were not pre-printed on the package. Patient identifiers have been found posted at the computer in order to speed up the process. Another obstacle that limits the use of bar coding in healthcare is the consequence of an error in marking or scanning. A misread in a patient care setting can have vastly greater consequences than in other settings. Nurse must have a reliable, accurate and efficient system that reduces workload. As 20-30% of nursing time in a shift of care involves medications, it is important that systems be designed which optimally use nursing skills and time. Nurses, in their creativity are trying to accomplish medication administration in a safe and expedient manner. However, safety checks inherent within the bar code system are circumvented when these workarounds exist. Continued involvement by the end users (nurses) must be at both the industry design level as well as the regulatory level. A national interdisciplinary advisory group composed of current and actual USERS as well as design experts should remain involved so that the myriad of issues can be addressed. Examples of design issues include the placement of bar codes on a curved patient wristband, or fading bar codes that become unreadable within a few days. Simple things such as not continually “refreshing” the computer screen on the program can result in errors. There must be a feedback mechanism for program design issues to be addressed in a timely fashion. In addition, there is a significant learning curve with many of these systems, which often involves many months. It is essential that nurses have round the clock technological support and general troubleshooting for a lengthy period surrounding implementation. In addition, AACN would like to offer the following comments: 1. The device that scans must be ergonomically designed and readily available. 2. Scanning units that are located in patient rooms or worn by the nurse are far preferable than large mobile computers. 3. There must be sufficient scanners available particularly in peak medication times. 4. Labels should be small enough to “fit” on unit-of-use medications. 5. Labels should include at the minimum: National Drug Code (NDC), the expiration date, and the lot number at the unit-of-use package. 6. Labels should be pre-made by manufacturers for unit dose, as well as for pre-filled vials and syringes. Nurses currently compute and administer a partial dose of a medication, and thus room for error in this final phase of medication administration exists. 7. Labels should be easily read from a curved surface; this includes ampules, vials, elixir containers, and pill bottles. Vertical labels for these items would be advised. 8. Exemption to labeling should be considered for highly individualized medications such as antineoplastic agents that would require individual institution re-labeling. In addition, the re-packaging of these medications may be unsafe when used with certain materials. 9. TPN, lipids, blood, and blood products, etc. should be included in ruling. AACN recognizes that the fiscal and administrative investment of implementing bar code technology is significant. However, we believe that the ultimate outcomes will be worth the investment for the manufacturers, the providers, and ultimately the patients. Factors such as the current nurse shortage, the vast array and complexity of medication products, and an overwhelming acutely ill population all point to the need for the use of bar code technology to prevent medication errors. Thank you for the opportunity to comment on this ruling. AACN Contact: Janice Weber, RN, MSN 101 Columbia Aliso Viejo, CA 92656 800-394-5995 Ext. 508 janice.weber@aacn.org