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To Save Lives
BY ELISABETH PENA
As the FDA proposes a rule to require bar coding on almost all medications and blood products, the pharmaceutical and hospital industries are moving forward with efforts to incorporate barcodes on unit-dose packages of drugs as a way to prevent hospital medication errors. But challenges — including a lack of standards and questions about technology — need to be overcome before complete pointofcare automation can be realized.
Almost four years ago, a report by the Institute of Medicine made headlines by calling attention to the need to address medical errors in the U.S. healthcare system. The report found that between 44,000 people and 98,000 peo ple die in hospitals each year as a result of preventable med ical errors. The issue is no less critical today, especially when one considers the highly publicized incident in February when a 17 year-old girl died two weeks after she mistakenly received organs with a different blood type dur ing a heart-lung transplant operation at Duke University Hospital.
Deaths from medication errors that take place both in and out of hospitals — more than 7,000 annually — alone exceed those from workplace injuries, according to the IOM report. The majority of medical errors do not result from individual recklessness, the IOM report found, but from basic flaws in the way the health system is organized. Stocking patient-care units in hospitals, for example, with certain full-strength drugs — even though they are toxic unless diluted — has resulted in deadly mistakes. And illegible writing in medical records has resulted in administration of a drug for which the patient has a known allergy.
Four years ago, the report’s recom mendation was that hospitals and health care organizations should implement proven medication safety practices, such as using automated drug-ordering and barcoding systems.
The Food and Drug Administration also has recognized this critical situation, and as this issue went to press, issued a proposed requirement for bar codes on all pharmaceutical products, excluding samples, to reduce the number of medication errors in hospitals and other healthcare settings.
Of the IOM’s estimates for medical errors, agency officials believe that 30% to 50% of those deaths are associated with errors involving the use of FDA-regulated medical products, drugs, vaccines, blood and blood products, and medical devices. The agency held a public meeting July 26, 2002, to solicit comments about developing a regulation requiring barcode labeling for human drug and biologic products. The purpose of the proposed regulation is to reduce the number of adverse drug events, including deaths that occur every year because of medication errors. The FDAhas released its proposed regulation for comment and will issue a final rule by the end of the year.
The benefits that the use of bar coded unit-dose products could bring to the healthcare system in the United States are virtually undisputed. A small number of hospitals and purchas ing groups already require that the pharmaceuticals they buy and administer be bar coded, and others have plans to make this a requirement. Manufacturers also are recognizing the need for bar codes and are beginning to put bar codes on their unit-dose packaging. But to effect a change across all sectors will require significant investments in technology and staff training, and perhaps a push from the FDA.
Industry experts agree that the problems surrounding medication administration could be greatly reduced with the inclusion of a bar code on the product package that is opened at a patient’s bedside.
“If one looks at the medication administration system, it is made up of prescribing, dispensing, and administering,” says John R. Combes, M.D., chairman of the National Coordinating Council for Medication Error Reporting and Prevention and senior medical advisor of the Hospital & Healthsystem Association of Pennsylvania.
“And 39% of the medication errors occur in the prescribing phase, 11% in the dispensing phase, and 38% in the administering phase,” he says. “Another 12%of errors are due to verification and transcription errors, which are in the dispensing phase but would not be affected by bar codes. So clearly, almost 50% of medication errors could be avoided with bar coding.”
Dr. Combes believes that in an ideal situation, a health practitioner can scan the medication, scan a bar code on the patient’s wristband, and even scan a bar code assigned to the person giving the medication to make sure that the right drug is given to the right patient at the right time through the right administration route and in the right amount.
A BARRIER TO USING BAR CODING AT THE POINT OF CARE IS THE ABSENCE OF THE BAR CODE ON THE UNIT-DOSE PRODUCT. ONLY ABOUT 30% OF THE PRODUCTS RIGHT NOW HAVE BAR CODES ON THEM THAT ARE USEABLE AT THE POINT OF CARE. John Combes
Although the number of hospitals that have the capability to read bar codes at the site of patient care is low, hospitals that do have the system in place report measurable results. The Children’s Medical Center of Dallas has been working for about six years to automate its medication process. In March 2001, the hospital began rolling out bar coding on point-of-care oral and injectable products and more recently installed a barcoding system on its IV pumps.
“The program that was started in March 2001 has reduced our errors by a third,” says John Tourville, Pharm.D., department director for pharmacy at Children’s Medical Center of Dallas. “Through automation in the pharmacy with bar cod ing, robotics, and delivery improvement, we’ve been able to cut errors in half. We cut errors in half again with the pointofcare system. We believe the bar coding on the IV pumps will cut errors again in half.”
The hospital’s recent advance, barcoded IV bags and corre sponding barcoded reading pumps, was a joint effort between the hospital and B. Braun Medical Inc. With B. Braun’s Outlook Safety Infusion System, the prescribed medications come from the pharmacy bar coded. Each patient has a barcoded name band and the clinician who is administering the medication also has a barcoded name badge. The clinician scans the three bar codes and the pump programs itself automatically.
“Through the use of the B. Braun Outlook Safety Infusion System’s bar code technology, the clinician ensures medication administration safety by matching the right medication to the right patient,” says Louise Baran, marketing manager of nursing at B. Braun Medical Inc. “The Out look’s DoseScan technology further ensures safety by notifying the clinician when institution-defined dose limits are exceeded.”
Dr. Tourville says this system also allows staff to download from the hospital’s main system all the data that the pump needs to correctly load itself with infusion parameters. The pump then sends information back into the hospital system as it is infusing.
“Errors with IVs and IV pumps account for 35% of our big errors,” Dr. Tourville says. “With this barcoded pump system, we actually have an ongoing activity between the systems; it is that last great hurdle for our barcoding project at the bedside.”
Because only 35% of all drugs administered at the bedside contain a bar code, The Children’s Medical Center of Dallas repackages many of the pharmaceuticals it receives and applies bar codes to the new packages for use by the hospital staff.
“We are still doing a bulk of the bar coding ourselves; we commit two pharmacists and a couple of technicians to putting bar codes on products,” Dr. Tourville says.
“For example, when ampules of morphine come in we stick a bar code on each ampule and we use a good manufacturing process to double check and triple check everything,” he says. “Once the bar code is put on the product, we rely on that code. I believe in the next two years, manufacturers will assume much of this responsibility.”
A few buyers also have worked to support bar coding. Novation, a supply-chain management company serving VHA Inc. and the University HealthSystem Consortium, requires all pharmaceuticals under its private Novaplus label to be bar coded at the unit-of-use level. Additionally, effective with the 2004 pharmacy portfolio rebid, all Novation contracted pharmaceuticals will be required to have bar coding on unit-of-use packaging.
“The good news is that all of our suppliers want to do this because they are getting the same input from their customers and they know that some form of regulation will be coming from the FDA so they are very in tune to adhering to our standards,” says John H. Riddick, director of QA/RA and supplier certification at Novation.
He says the suppliers he deals with have not shown any resistance to Novation’s barcoding policy, but they do question what technology or symbology to use.
Mr. Riddick says Novation will wait until the FDA issues a final requirement before deciding what it will require on the products his group buys. Currently the group has told the sup pliers to use any technologically readable bar code.
“This has worked out great in every area except for the pharmaceutical products with very small vials,” he continues. “With the very small vials, the FDA requires human readability, where everything on the label must be able to be read. There is so much on the label already that its tough to have any space for even the smallest bar code.”
The Veterans Health Administration, which provides federal benefits to veterans and their dependents, also established a mandate for the installation and implementation for barcode medication administration at Department of Veterans Affairs’ medical centers by November 2002.
The use of a barcode system has been reported to enable a North Chicago VA Medical Center to reduce the occurrence of medication errors by 86%. The group’s barcoding initiatives earned it the 2002 Pinnacle Award for the Institutional category from The American Pharmaceutical Association Foundation, and the Health Care Quality Alliance. The Institute of Medicine also recognized the Veterans Health Administration’s efforts in a report titled Leadership by Example.
DRUG ERROR REPORTING
MedMARx,a national database for hospital medication error reporting,studied reported medication errors in 56 hospitals from January 1999 to December 1999. Here are some of their findings:
- 97% of errors DID NOT RESULT IN PATIENT HARM, although 67% of these errors REACHED THE PATIENT.Errors occurred most often at the POINT OF ADMINISTRATION (40%), rather than during prescribing (11%)
- INSULIN AND ANTICOAGULANTS, such as warfarin and heparin, were the drugs most likely to be INVOLVED IN AN ERROR.
- OMISSION, IMPROPER DOSE,and UNAUTHORIZED DRUGS were the three most frequently reported types of errors.
- PERFORMANCE DEFICITS, FAILURE TO FOLLOW PROCEDURES or PROTOCOLS,and KNOWLEDGE DEFICITS were the most frequent causes identified. Distractions, work load,and inexperience were cited as contributing factors.
Source:U.S. Pharmacopeia, Rockville, Md.,“Summary of 1999 Information Submitted to MedMARx.”
ELIMINATING MEDICATION ERRORS CAN LEAD TO COST REDUCTIONS THROUGH THE ENTIRE SYSTEM. A SIDE BENEFIT OF BAR CODING COULD BE BETTER DATA CAPTURE OF BILLING INFORMATION. Dan Thomas
BARRIERS TO BAR CODING
Despite proven results and industry agreement that bar coding systems can benefit patients by increasing safety, transforming the medication packaging process of the industry’s manufacturers and the medication distribution system of every hospital is not simple.
“Cost is the biggest barrier,” says Dan Thomas, director of information technology, at RxCrossroads and MDI. “And manufacturers typically package drugs in a variety of facilities and we often don’t see corporate standards for bar codes or even answers to the basic question of what the format should be and what information should be included. People are struggling with such questions as whether the lot number and expiration date should be included.”
Additionally, the incompatibility of current information systems with barcoding technology is a significant hurdle. The team at the Children’s Medical Center of Dallas knows the barriers to implementation through firsthand experience.
“One of the biggest barriers is the mentality that `we’ve always done it that way’ and `we can’t afford it,”’ Dr. Tourville says. “We found that if we work on this piece by piece, each piece saves money and then we roll that money into the next piece.”
In addition to cost concerns and working past a traditional mindset, once a decision is made to implement a barcoding system, changes must be made by the hospital’s nursing and physician staff as well.
“There has to be a tremendous change in mentality and work flow,” Dr. Tourville says. “Point of care means that nurses now must document as they are going along instead of whenever they have time. Money wasn’t the biggest issue for us — the biggest challenges were people changing and process changing.”
Once the decision to implement a barcoding system is made, additional issues to be considered include what information the bar code will contain. The National Drug Code (NDC), which serves as a universal product identifier for human drugs, is the standard piece of information all groups agree should be included.
Each drug product listed under Section 510 of the Federal Food, Drug, and Cosmetic Act is assigned a unique 10-digit, 3 segment number. This number — the NDC — identifies the labeler/vendor, product, and trade package size. The first segment, the labeler code, is assigned by the FDA.
A labeler is any firm that manufactures, repacks, or distributes a drug product. The second segment, the product code, identifies a specific strength, dosage form, and formulation for a particular firm. The third segment, the package code identifies package sizes.
Before the FDA issued its proposed rule, only requiring the NDC number, many in the industry were concerned about what information should be included other than the NDC. Many believe the lot number and expiration date also are important pieces of information that should be included, especially for use in tracking recalled and out-of-date products.
But adding the lot and expiration numbers to the bar code can be a costly venture, which some say should be implemented at a later date.
Groups such as the American Society of HealthSystem Pharmacists (ASHP) advocate that the NDC, lot number, and expiration be included on all bar coded unit-dose pharmaceutical product packages used in hospitals.
“We have great expectations that the FDA will come out with a workable rule that mandates that pharmaceutical companies take this very seriously and provide all pharmaceutical products used in hospitals in unit-dose packages with bar codes containing NDC, lot number, and expiration date,” says Kasey K. Thompson, Pharm.D., director of the Center on Patient Safety for ASHP. “This will show a great commitment to patient safety by the pharmaceutical industry.”
Dr. Combes agrees that while the lot and expiration date are important pieces of information, their inclusion could be put off to begin the work necessary to get bar codes on unit-dose pharmaceuticals.
“Other groups have recognized that it will be a little more difficult to get the lot number and expiration date on the product since those have to be printed late in the manufacturing process and they require more dynamic printing, which is of concern in terms of the quality of the bar code,” Dr. Combes says. “Most organizations recognize that the NDC should be included in the bar code immediately.”
GETTING AHEAD START
Even as some hospitals and buyers have begun to work with using and requiring bar coding systems, pharmaceutical companies are not sitting idle. Pfizer is leading the way among pharmaceutical manufacturers with its initiative to use barcode technology on its hospital unit-dose products. The new barcode system identifies each Pfizer unit dose of product by its NDC, expiration date, and lot number in both machine and human readable format.
The miniaturized bar code is applied to product containers at the time of packaging by Pfizer.
The barcode technology used for Pfizer’s products was developed in accordance with the Reduced Space Symbology (RSS) and composite code standards established by the Uniform Code Council (UCC). RSS bar codes are two-dimensional and significantly smaller than conventional linear bar codes.
“The issue, which prevented many drug manufacturers from putting bar codes on our blister packages, was that there was no widely accepted or utilized standard for barcode symbology or data structure; we had a very difficult time trying to understand what direction to go because there was no standard established by either manufacturing companies or by the hospital side of the business,” says Richard Hollander, senior director and team leader of packaging services and global manufacturing at Pfizer.
“The challenge was how to fit all the information, not just the NDC, but also the lot number and expiration date, on our very small pack ages,” Mr. Hollander says.
To address this challenge, Pfizer turned to the work that the UCC had been doing to develop RSS and composite code barcode symbology, which seemed to work well with relatively small packages.
Another manufacturer that is working to begin unit-dose bar coding is Abbott Laboratories, which pledged in July 2002 to affix unit-of-use bar codes to all of its hospital injectable pharmaceuticals and IV solutions product lines by early 2003.
While Pfizer and Abbott are pioneers in the field of bar cod ing unit-dose products, Dr. Combes believes many pharmaceutical companies haven’t begun to include bar codes because the hospital side of the business does not require them to do so.
“Manufacturers haven’t gone to bar coding because there has been no demand to do so nor is there any requirement to do it,” he says. “To prompt change, we believe that the best route would be to require manufacturers to include bar codes through FDA regulation and then encourage the use of them by hospitals and other providers.”
BECAUSE THERE IS NOT A LARGE CRITICAL MASS OF PHARMA COMPANIES PUTTING THIS INFORMATION INTO BARCODE FORMAT, THE HOSPITAL SETTING HAS NOT DEVELOPED THE COMPUTER SYSTEMS TO UTILIZE THE DATA. Richard Hollander
THE BIGGEST BARRIER TO BAR CODING IS THAT THERE ARE SO MANY CHALLENGES — EVERYBODY IS LOOKING FOR THAT ONE SILVER BULLET THAT WILL RESOLVE ALL THEIR PROBLEMS, AND THERE ISN’T ONE. John Tourville
READY OR NOT
Demand for change is low, many industry experts say, because most hospitals in the United States are not ready to use barcoding technology.
A 1999 ASHP survey revealed that only 1.1% of U.S. hospitals use barcode technology to scan a patient’s identification wristband, a nurse’s badge, and a prescribed drug at the bedside.
Pfizer executives recognize that the majority of hospitals were not prepared to use the bar codes on its products at this time.
“Because there is not a large critical mass of pharma companies putting this information into barcode format, the hospital setting has not developed the computer systems to utilize the data,” Mr. Hollander says. “And the hospitals can’t really prepare, in terms of developing a database, until they understand what data they are going to get and in what format the information will be received.”
Mr. Hollander says Pfizer was very focused on developing a standard for the industry for others to consider using.
As technologies improve and the spotlight on medication errors continues to increase, hospitals will feel pressure to upgrade their systems to improve patient safety.
THE FDA SPEAKS …
As the push for bar coding has been gaining momentum, the industry has waited for the FDA to issue a requirement. In March, the FDA issued a proposed rule to require bar codes on all prescription drugs, excluding physician samples, as well as over-the-counter drugs that are commonly used in hospitals and dispensed pursuant to an order. For blood and blood components, the proposal would require the use of machine-readable information in a format approved by the Director of the Center for Biologics Evaluation and Research.
The regulatory group’s proposal requires the linear bar codes to contain, at a minimum, the drug’s NDC number. The FDA intends to issue a final ruling by the end of this year, which will become effective three years after it is published.
Before the FDA’s ruling, the industry speculated about what the agency’s role in issuing barcoding requirements should be and whether the group’s role should extend beyond the compliance requirement into the details of the barcoding technology.
“I don’t think the government should mandate a standard, because then we will be stuck with it for the next 20 years,” Dr. Tourville says. “Technology is evolving so fast that we will have 2D bar codes in four or five years. The groups that should man date a requirement are the group purchasing organizations.”
Mr. Thomas agrees the FDA should not play a role in setting the standards for bar coding.
“There already are a number of standards bodies and this isn’t an area where the FDA should be imposing any immediate regulation, but the agency could serve a role in setting a timetable for manufacturers to be compliant,” he says. “The problem is that bar coding is not a static technology. Today, a simple linear bar code that has basic information may within a few years be two-dimensional or may even be an imbedded chip that transmits data. The FDA shouldn’t jump in and say `companies do this,’ because bar codes on a product are not going to do any good until the hospitals have systems in place to take advantage of the data.”
As the industry begins to prepare for unit-dose bar coding, a group has been formed to, among other goals, explore barcoding standards. The National Alliance for Health Information Technology (NAHIT), a group of about 50 organizations representing providers, purchasers, manufacturers, and standard setting organizations, has set its mission to improve quality and performance through standards-based information systems.
The group supports the implementation of barcoding requirements for all prescription and non-prescription medications and believes that bar codes should be included on the labels of all unit-of-use pharmaceutical packaging.
The NAHIT supports the inclusion of the NDC as the initial data element included in the bar code, with the inclusion of the expiration date and lot number added to the bar code as soon as it is technically feasible and phased in over a longer period of time. Although the bar coding of unit-dose products is seen as a great improvement to the medication error problem in hospitals, Dr. Thompson warns that it will not fix all problems. “Technology is just a tool,” he says. “If we assume that technology will solve all our problems, problems will definitely follow.”
PharmaVoice welcomes comments about this article.Email us at email@example.com.
BARRIERS TO BAR CODING
The costs to the manufacturer to place the bar code on the unit-of-use label are not insignificant,but much larger expenditures will have to be made by healthcare organizations to take full advantage of a barcoded medication delivery system that can draw information from other existing systems for dosage limits, drug-drug interactions, drug-food interactions, laboratory values, allergies, and decision support.
The incompatibility of current legacy information systems is a significant obstacle to use of a barcoding system, according to the National Alliance for Health Information Technology.The perceived need for customization of every system by providers and the need to demonstrate differentiation from other products by developers and manufacturers are the primary barriers to the widespread use of standards in healthcare IT. Other barriers include:
- LEADERSHIP understanding and commitment
- A healthcare organizational and professional culture that PREVIOUSLY STRESSED UNIQUENESS and customization
- Difficulty in GAINING WIDESPREAD CONSENSUS across a fragmented healthcare continuum
- LEGACY INFORMATION TECHNOLOGY SYSTEMS and the challenge of integrating different vendor hard ware and software
- FINANCIAL COST of change/sunk costs/lack of capital
- Meaningful measures/ability to demonstrate a RETURN ON INVESTMENT
- Perceived TRACK RECORD of information technology
- Competing organizational PRIORITIES demanding resources and attention
Source:National Alliance for Health Information Technology,Washington, D.C.For more information,visit nahit.org.
Experts on this topic
LOUISE BARAN.Marketing manager,nursing, B. Braun Medical Inc., Bethlehem,Pa.;B. Braun is a full-line supplier of healthcare products and programs designed to improve both patient and clinician safety. For more information,visit bbraunusa.com.
JOHNR.COMBES,M.D.Chairperson,National Coordinating Council for Medication Error Reporting and Prevention,and senior medical advisor, The Hospital & Healthsystem Association of Pennsylvania, Harrisburg, Pa.; HAP is a statewide membership services organization that advocates for nearly 250 Pennsylvania acute and specialty care, primary care,subacute care, longterm care,home health, and hospice providers, as well as the patients and communities they serve. For more information, visit haponline.org.
RICHARD HOLLANDER.Senior director/team leader of packaging services and global manufacturing,Pfizer Inc., NewYork;Pfizer discovers, develops, manufactures, and markets leading prescription medicines for humans and animals and many of the world’s best-known consumer brands. For more information,visit pfizer.com.
JOHN H.RIDDICK. Director,QA/RA and supplier certification, Novation LLC; Irving,Texas; Novation is a leading supply chain management company in the healthcare industry, serving the more than 2,400 members of VHA Inc. and the University HealthSystem Consortium. For more information, visit novationco.com.
DAN THOMAS. Director, information technology, RxCrossroads and MDI,Louisville,Ky.;RxCrossroads is a healthcare products commercialization support company, providing services that range from prelaunch tactical consulting to implementation and management of complex reimbursement,as well as distribution support programs. For more information, visit rxcrossroads.com.
KASEY K. THOMPSON,PHARM.D.Director,Center on Patient Safety,American Society of HealthSystem Pharmacists, Bethesda, Md.; ASHP is the 30,000member national professional association that represents pharmacists who practice in hospitals, health maintenance organizations, longterm care facilities, home care,and other components of healthcare systems.For more information,visit ashp.org.
JOHNF.TOURVILLE,PHARM.D.Department director, pharmacy,Children’s Medical Center of Dallas,Dallas; Children’s Medical Center is a private, not-for-profit institution. The Center is the only Dallas healthcare facility that deals exclusively with a variety of diseases and disorders among children from birth to age 18. For more information, visit childrens.com.