aan testifies before the fda on bar code labeling for human drug products
TRANSCRIPT
The next phase of the project will con-centrate on assessing the types and useful-ness of the technology in use in care de-livery environments today. These will beevaluated in terms of their usage and thedegree to which they create the efficien-cies that might be desired and/or possible.
The final phases are envisioned as pro-ducing opportunities for research and de-velopment of new products. We are plan-ning that this will be a partnershipendeavor with other organizations andwill involve an array of practice settings.
QUALITY CONFERENCEPROCEEDINGSIn April 2002, the Expert Panel onQuality held an invitational conference inconjunction with the University of Penn-sylvania School of Nursing. Each partici-pant was required to make a formal pre-sentation, and the outcome was a seriesof scholarly, thought-provoking papers.The conference was led by Norma Langand was sponsored by a grant from theAgency for Healthcare Research andQuality.
Clearly, the proceedings from the con-ference need further dissemination. Tothat end, the plan is now to publish themin a supplemental issue of Medical Care.The cost for such a supplement is signifi-cant, and the money was not availableeither from the original conference grantnor from the AAN operating budget.Therefore, the Academy Board decided toallocate a portion of this year’s develop-ment monies specifically to the cost of thepublication. As a result, the work of thescholars involved will soon be available tothe wider health care audience.
INVITATIONAL CONFERENCEFOR WORKFORCERESEARCHERSAnother initiative that has been sup-ported by our development fund was aninvitational conference that was held inconjunction with our annual meeting inNaples, Florida. This effort was led byJulie Sochalski and Joanne Disch, who areto be commended for the fine work theydid.
The goal of the meeting was to bringtogether all the researchers who are cur-rently studying nursing workforce con-cerns and to create an environment inwhich they could discuss the issues theyface in their work, identify the gaps in ourknowledge to date, and propose a researchagenda for the future.
I think that you will agree that each ofthese 3 programs is central to the missionof the AAN and is deserving of our sup-port.
The future of our development effortcontinues to be under discussion. Clearlywe will be striving to create an endow-ment so that a proportion of our contri-butions will be held in perpetuity, provid-ing a steady income from the earningsthat will be generated in the years tocome. In addition, there will soon be theopportunity for an estate planning ar-rangement that will serve the needs of ourdonors as well as the organization.
We would certainly encourage everyfellow to give as generously as possible tothe academy and to assist us in promotingthese worthy endeavors. �
AAN Testifies Before the FDA on Bar Code Labeling for Human Drug Products
Pamela Cipriano, PhD, RN, FAAN,recently represented the American
Academy of Nursing before the Food andDrug Administration to discuss the im-plications of bar code labeling for humandrug products and the academy’s con-cerns regarding patient safety and medicalerrors.
Noting that the majority of medicalerrors do not result from provider incom-petence or recklessness but from basicflaws in the health care delivery system,Dr. Cipriano stated, “the American Acad-
emy of Nursing (AAN) embraces the de-velopment of point-of-care technologiesthat reduce medical errors.” Studies indi-cate that bar code labeling of drugs inacute care settings can prevent over 7,000deaths a year and save nearly $4,700 peradmission. Thus, the opportunity for er-ror reduction with bar code labeling forhuman drug products, biologicals, andmedical devices, promises to be signifi-cant.
The American Academy of Nursing,with the support of over 20 organizations,
convened an interdisciplinary conferencefocused on using innovative technologyto enhance patient care delivery. Nurses,pharmacists, physicians, hospital trustees,administrators, manufacturers, healthpolicy analysts, architects, software engi-neers and others gathered in Washington,DC, July 12-14, 2002, to begin harness-ing the strength of technology in rede-signing the practice environment and caredelivery system in order to improve nurseretention and health care quality. Partici-pants called for systems that utilize tech-
AAN News & Opinion..................................................................................................................................A m e r i c a n A c a d e m y o f N u r s i n g
A A N P u b l i c a t i o n A d v i s o r y C o m m i t t e e : Suzanne Bakken, DNSc, RN, FAAN, JacquelineFawcett, PhD, RN, FAAN, Suzanne L. Feetham, PhD, RN, FAAN, Roxie L. Foster, PhD, RN, FAAN, Mary R. Haack, PhD, RN,FAAN, Nancy Olson Hester, PhD, RN, FAAN, Judith A. Lewis, PhD, RNC, FAAN, Diane S. Pravikoff, PhD, RN, FAAN, JeanneSorrell, PhD, RN, Mary E. Stainton, MS, RNC, FAAN, Judith A. Vessey, PhD, RN, FAAN, Antonia Villarruel, PhD, RN, FAAN,Mary Wakefield, PhD, RN, FAAN, Donna Jean Zazworsky, MS, RN, CCM, FAAN, and Carole Kenner, DNS, RNC, FAAN, chair
262 VOLUME 50 • NUMBER 6 NURSING OUTLOOK
nology to improve productivity and safetythrough automation, improve medica-tion administration processes, and pro-
vide interactive, automatically recordeddata at the point of care. Bar code labelingfor human drug and biologic products is
one means of applying simple technologyto a broad spectrum of high-risk processesand realizing a significant safety impact. �
Statement of the American Academy of Nursing and the American Organization of NurseExecutives for the Food and Drug Administration Regarding Bar Code Labeling for Human
Drug Products
Presented by Pamela F. Cipriano, PhD, RN, FAAN, July 26, 2002
Good morning madam chair, com-missioners, and members of the
panel. I am Pamela Cipriano, PhD, RN,FAAN, chief clinical officer, University ofVirginia Health System and am repre-senting the American Academy of Nurs-ing and the American Organization ofNurse Executives. Thank you for the op-portunity to discuss our concerns regard-ing patient safety and medical errors. TheAmerican Academy of Nursing, a subsid-iary of the American Nurses Association,was established in 1973 to transformhealth care policy and practice throughnursing knowledge. Today the academyserves as the nursing profession’s thinktank. The American Organization ofNurse Executives, founded in 1967, is asubsidiary of the American Hospital As-sociation and is comprised of registerednurses who design, facilitate, and managecare.
As front line health care workers, thenation’s workforce of 2.7 million regis-tered nurses have made and continue tomake substantial contributions to reducehealth care errors. The American Acad-emy of Nursing (AAN) and the AmericanOrganization of Nurse Executives(AONE) embrace the development ofpoint-of-care technologies that reducemedical errors and increase productivity,and appreciate the opportunity to discussour view on the particular issue of barcode labeling for human drug products,biologicals, and devices.
A few weeks ago, the American Acad-
emy of Nursing, in conjunction with over20 organizations, convened an interdisci-plinary conference focused on using inno-vative technology to enhance patient caredelivery. Nurses, pharmacists, physicians,hospital trustees, administrators, manu-facturers, health policy analysts, archi-tects, software engineers, and others gath-ered in Washington, DC, July 12-14,2002, to begin harnessing the strength oftechnology in redesigning the practice en-vironment and care delivery system inorder to improve nurse retention andhealth care quality. Conference partici-pants supported the establishment of asystem that:● Utilizes technology to improve produc-
tivity and safety through automation● Improves medication administration
processes and● Provides interactive, automatically re-
corded data at the point of care
The opportunity for error reductionwith bar code labeling for human drugproducts, biologicals, and medical devicespromises to be significant. Bar codes, andother machine-readable codes, are mosteffective when they are in a standard for-mat, not yet consistently found in healthcare applications. Bar coding is currentlyavailable to assist in the identification ofpatients, caregivers, specimens, medica-tions, and equipment. It further facilitatesautomated documentation, recordkeep-ing, billing, inventory tracking, and thestudy of “near misses” and errors.
Ensuring appropriate medication ad-
ministration is a complex process involv-ing a series of inter-related decisions andactions among a variety of professionals.Errors can occur at any point in the pro-cess. Automated information and deci-sion support systems have proven effec-tive in reducing many types of medicalerrors. More specifically, bar code tech-nology can minimize the variation in themedication cycle and decrease medicationerrors. Use of bar coding automates thedistribution, management, and control ofmedications. Such technology not onlyallows professional registered nurses tomore accurately and efficiently adminis-ter medications, but it also streamlinesnursing’s workload—thus allowing moretime to be devoted to direct patient careactivities. Studies indicate that bar codelabeling of drugs in acute care settings canprevent over 7000 deaths a year and savenearly $4700 per admission.
Further development and wide-scaledeployment of bar coding require thehealth care industry to address issues ofstandardization of bar code technology,compatibility, reliability, and affordabil-ity. Keys to the successful application ofsuch technology include:● Ensuring end-users are involved in the
process from the beginning● Creating integrated systems that do not
require re-entry or rekeying of data and● Reducing workload burden on nurses
While the literature indicates that themandated use of bar code labeling forhuman drug administration can provide
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NURSING OUTLOOK NOVEMBER/DECEMBER 2002 263