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| <p><strong>Statement of the National Alliance of Health Information Technology in Response to the Food and Drug Administration of the Department of Health and Human Services on Bar Code Label Requirements for Human Drug Products </strong></p> |
| <p><strong>Docket No. 02N-0204</strong></p> |
| <p><strong>July 26, 2002</strong></p> |
| <p><em>The following statement is provided by Tim Zoph., chief information officer for The Northwestern Memorial Hospital, Chicago Illinois.</em> </p> |
| <p>Ladies and Gentleman, I am Tim Zoph., chief information officer for The Northwestern Memorial Hospital, Chicago Illinois. I am here today on behalf of the National Alliance of Health Information Technology (NAHIT), a group of approximately fifty organizations representing providers, purchasers, manufacturers and standard setting organizations that is committed to “mobilize the field to address the fragmentation and lack of coordination in healthcare…improving quality and performance through standards-based information systems.” We are pleased to have the opportunity to testify on an issue of critical importance for the healthcare industry and the people they serve: the bar coding of drug labels for unit-of-use pharmaceuticals. </p> |
| <p>Northwestern Memorial Hospital is a founding member of the NAHIT and is committed to the first initiative of the Alliance - promoting the use of bar coding technology to create safer more efficient and effective patient care. I am here today to present the consensus recommendations of NAHIT to the FDA for their consideration as they develop a rule for the bar code labeling of human drug products. </p> |
| <p><strong>BACKGROUND</strong> Health care has trailed virtually every other industry in reaping the benefits of information technology advances due at least in part to (1) a lack of consistent and uniform standards and protocols and (2) its dependence on multiple scientific disciplines and medical specialties each with its attendant technical requirements and demands. As a result, the health care environment is extremely fragmented, with isolated systems and databases. To improve the situation, the industry must begin to approach this more strategically. The recent Institute of Medicine Report <em>“Crossing the Quality Chasm” </em>calls for “a national consensus on comprehensive standards for the definition, collection, coding and exchange of clinical data.” In comparison to other industries, health care has been slow to achieve this consensus and, therefore, has failed to leverage even their limited investment in information technology to improve patient outcomes and operational efficiency.</p> |
| <p>The lack of use of bar coding technology in bedside care is one such example of the failure of healthcare to leverage a technology widely used by other industries. There are multiple causes for this failure but one important cause is the absence of a standardized bar code on the label of the unit-of-use pharmaceutical packaging. Only approximately 35% of all drugs administered at the bedside contain a bar code which when used in conjunction with r decision support tools could dramatically reduce the incidence of medication errors.</p> |
| <p>NAHIT recognizes that implementation of bar codes on the unit-of-use medication packaging is only the first vital step in realizing the promise of bar code technology in making our healthcare systems safer. In pursuing its ultimate goal to achieve standards-based information systems for the U.S. health care system, NAHIT has developed consensus recommendations for the implementation of bar codes on the labels of unit-of-use pharmaceuticals. Accomplishing this objective will help create the environment that can foster progress in developing interoperability of our fragmented information systems to achieve the maximum benefit for patient safety of a bar coded medication delivery process. </p> |
| <p>A set of recommendations from the National Coordinating Council for Medical Error Reporting and Prevention already exists and is a good starting point for a discussion of bar coded labeling standards. NAHIT has reviewed these standards and building upon them offers the following recommendations in response to the FDA’s questions. </p> |
| <p><strong>THE FDA’S PROPOSED RULE FOR BAR CODE LABEL REQUIREMENTS </strong> NAHIT supports the FDA’s effort to propose a rule to require a bar code on the label of human drug products down to the unit-of-use packaging. Our recommendations, based on the considerable expertise of our member organizations, can help the FDA to further define the details of a bar code implementation process for human drug products. Additionally, we desire to work with the FDA on the further implementation of bar coding in healthcare to promote patient safety and to protect patients from human and system errors. It is our desire that today’s public meeting will aid the healthcare field and the FDA in achieving consensus on the prompt establishment of regulations for the bar code labeling of human drug products down to the unit-of-use level.</p> |
| <p><strong>DRUGS AND BIOLOGICALS</strong> NAHIT supports the implementation of requirements for bar coding for <strong>all</strong> commercially available prescription and non-prescription medications. The bar code should be included on the labels of all unit-of-use pharmaceutical packaging. All dosage forms including oral solids, oral liquids, injectables, inhalers, nasal sprays, topicals, and other forms of specialized drug product packaging should include a bar code on their label. In addition to unit-of-use packages, intermediate containers and cartons and Shelf Keeping Units (SKUs) should also be labeled with a bar code. Eventually, vaccines, blood and blood products should have an FDA requirement for labeling with a standardized bar code. Currently only blood has a bar code and even it is not mandatory. Bar codes for vaccines are currently under investigation by the CDC. The absence of bar codes on blood products could raise safety issues especially for the tracking of contaminated products. </p> |
| <p>The National Drug Code (NDC), as established by the FDA, should be the initial data element included in the bar code. This should be implemented as quickly as possible. Inclusion of the expiration date and lot number, especially to track recalled and out-of-date products, should be added to the bar code as soon as it is technically feasible. These components can be phased in over a longer period of time. Working out the technical problems related to the lot number and expiration date should not delay the implementation of a bar coded label that at minimum identifies the drug, its strength and manufacturer. If the FDA proceeds with the rule including only the NDC number, NAHIT has the technical expertise and is willing to work with the FDA to identify solutions and timeframes for implementation.</p> |
| <p>The choice of the symbology for the bar code is a critical element of the proposed rule and should be governed by specific principles. The NAHIT recommends that only existing symbologies utilized in healthcare with the capacity to include the NDC, lot number and expiration date be used for the bar coded label. Additionally, symbologies appropriate to the pharmaceutical packaging size and capable of being scanned by existing and readily available commercial scanning technology should be selected. These principles would allow flexibility to pharmaceutical manufacturers while providing for a level of standardization for the users of the scanning devices without significantly increasing their costs.</p> |
| <p>The placement of the bar code on the packaging for human drug products should be in a position where the typical user of the scanning device can reliably and consistently scan it. The printing quality of the bar code should be at the C or better ANSII standard. There should only be one unique bar code for each unit-of-use package.</p> |
| <p>Blood and blood products, laboratory specimens and reagents, x-rays and scans, and some unit-of-use pharmaceuticals are currently bar coded. Additionally, pharmaceuticals at the SKU, case and intermediate packaging size have bar coded labels. Most bar coding in healthcare organizations is used for inventory control, tracking of radiology records and in the dispensing of pharmaceuticals. Hospitals have employed bar coding in their medication administration system or in automated dispensing cabinets but only after extensive repackaging of their pharmaceuticals have been undertaken since only approximately 35% of medications at the unit-of-use level have a bar code. This lack of the preprinted bar code creates the attendant risk of introduction of new error through repackaging and relabeling into the medication process. Currently, the major users of the bar codes in healthcare institutions are materials management personnel, pharmacists and pharmacy techs, laboratory and radiology techs. Nurses and physicians have had limited experience with bar code technology in the clinical setting.</p> |
| <p><strong>MEDICAL DEVICES</strong></p> |
| <p>NAHIT, with its strong interest in patient safety, supports the eventual inclusion of certain medical devices in a bar code labeling recommendation. Because of the complexity of this issue, in selecting the devices to be covered and the information to be included, NAHIT feels strongly that progress in labeling human drug products with bar codes should not be impeded by the issue related to medical devices. NAHIT recommends that the FDA complete its proposed rule on human drug products and biologics and then explore the feasibility of creating a bar code rule for selected medical devices.</p> |
| <p>Not all medical devices would need a bar code. Priority should be given to those devices that have the potential to or the history of adversely effecting patient safety.</p> |
| <p>Since the reprocessing of devices can lead to safety concerns, bar coding may be helpful in tracking reprocessed device failure or infection. Bar codes should be similar in content and format to those the FDA may require from the original manufacturer; however; they may also need to contain additional information such as reprocessing date and identification of the reprocessor to enable efficient tracking of the device.</p> |
| <p>Bar codes on medical devices could enhance patient safety at the bedside by tracking device failures, device related infections and unexpected outcomes related to both the proper and improper use of the devices. Having a bar code on the device and the information captured in an integrated database would allow the easy identification of patients who may be potentially harmed by device failure. This type of data would also facilitate the review of device performance and allow for the development of an early warning system when problems occur in the use of medical devices.</p> |
| <p><strong>OBSTACLES AND BENEFITS</strong></p> |
| <p>NAHIT recognizes that while the costs to the manufacturer to place the bar code on the unit-of-use label is not insignificant, much larger expenditures will have to be made by healthcare organizations to take full advantage of a bar coded medication delivery that can draw information from other existing systems for dosage limits, drug-drug, drug-food interactions, laboratory values, allergies and decision support. The incompatibility of current legacy information systems is a significant obstacle to use of a bar coding system; however, this consideration and the costs to achieve interoperability should not discourage the widespread promulgation of bar code labeled products. Health care has always had early adopters who, when given the basic tools, have led the field to new levels of quality and service. We expect the same to happen once bar codes are widely available on human drug product labels. </p> |
| <p>Implementing a medication delivery system with the support of an enhanced information technology infrastructure is a complex undertaking. Issues related to training, process design, and work-arounds will still need specific attention prior to successful implementation of bar coded medication delivery systems. NAHIT is committed to work collaboratively with the FDA and other stakeholders to address these issues and provide its expertise in the education and consensus building necessary to get the full benefit for patient safety as a result of the proposed rule.</p> |
| <p><strong>TIMEFRAMES</strong></p> |
| <p>Today’s hearing will raise many concerns related to issuing a final rule requiring bar coding for human drug products. However, realizing the NDC is the data element most easily incorporated into the bar code, we encourage the FDA to move as soon as possible in establishing the requirement for bar coded labeling with at least the NDC. NAHIT offers its assistance to work with the FDA in identifying a specific date for this requirement and in developing a phase-in schedule for the inclusion of other data elements such as the lot and expiration date in the bar code. We will also work with the FDA to identify the timeframes for the labeling of certain medical devices and biologicals with bar codes.</p> |
| <p><strong>CONCLUSION</strong></p> |
| <p>NAHIT would like to thank the FDA for this opportunity to address the issues raised in proposing a rule on bar code labeling for human drug products and biologicals. We stand ready to work with the FDA, drawing on the expertise of our diverse member organizations, to resolve the outstanding issues related to the bar coding of drugs, biologicals and devices. We are committed to a consensus approach that places the patients and their safety above all other interests. Only through such a broad-based and committed partnership will we achieve the promise of high quality patient care.</p> |
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