HIMSS Q&A Document Surrounding the FDA Bar Code
                        Regulation
                                       ...
errors. Studies have shown that close to half the errors associated with medications
involved dispensing and administratio...
In addition, once the infrastructure is put in place to support bar coded medication
administration (e.g., wireless networ...
Q: What are the components of a bar-coded medication administration system and what
will it cost to install and maintain?
...
quality to be easily readable; issues of curvature of the bar code on the wrist are
addressed); the right bar code scanner...
vendors complained that they would not have enough time to sell their “superior”
solutions to all the hospitals in the cou...
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HIMSS_FDABarCodeQA.doc

  1. 1. HIMSS Q&A Document Surrounding the FDA Bar Code Regulation June, 2006 Chicago: The Healthcare Information and Management Systems Society (HIMSS), representing over 15,000 individual and 250 corporate members, is exclusively focused on providing leadership for the optimal use of healthcare information and management systems for the betterment of healthcare. The HIMSS Auto-ID and Bar Code Task force operates under the HIMSS Patient Safety and Quality Outcomes Steering Committee. The Auto-ID and Bar Code Task Force has published this Q&A document to provide assistance to healthcare organization in understanding and leveraging the FDA Bar Code Regulation that went into full effect on April 26, 2006. The following Questions are addressed in this document:  What is the FDA Bar Code Regulation and who will it impact?  What additional guidance has the FDA provided surrounding this regulation  What can hospitals do to leverage this regulation?  What percentage of medications will be readily available with a unit-dose bar code and at what price?  What meds will a hospital still have to bar code and how?  What are the components of a bar-coded medication administration system and what will it cost to install and maintain?  What percentage of hospitals are using bar code meds administration systems today?  What are some best and worst practices?  Will the FDA enforce/modify/extend the regulation?  What role will JCAHO and other organizations play?  How will RFID mesh/compete with the bar code regulation? Q: What is the FDA Bar Code Regulation and who will it impact? A: The US FDA bar code regulation (21 CFR Parts 201,606 and 610) requires pharmaceutical manufacturers, repackers and relabelers of certain human drug and biological products (e.g., medications) that will be dispensed/administered in a hospital pursuant to an order to have a linear bar code on the lowest level of packaging (e.g., the immediate packaging – often the unit dose) with the drug’s NDC (National Drug Code) number. Blood products used for transfusion must also contain machine readable information. The purpose of the bar code regulation is to ensure that the right drug is given to the right patient in the right dose at the right time via the right route of administration (“5 Rights Checking”). The regulation was finalized two years ago (Feb 2004) for new drugs and went into full effect on April 26, 2006 for existing drugs (basically all prescription drugs and many over the counter drugs). The bar codes must conform to either EAN.UCC or HIBCC approved standards. Although the regulation does not require hospitals to scan the bar codes on the medications, it is expected to encourage hospitals to invest in scanning equipment and applications. The Institute of Medicine estimated that 7000 people die in US hospitals each year from medication
  2. 2. errors. Studies have shown that close to half the errors associated with medications involved dispensing and administration. In addition to the pain and suffering associated with medication errors, a typical adverse drug event is estimated to cost a hospital a few thousand dollars, not counting potential litigation or settlement costs. The FDA estimates the regulation will result in a 50% reduction in medication errors that would otherwise occur when drugs are dispensed or administered, even though some hospitals that currently have bar code systems in place report a higher error reduction from bar code usage. In total, the FDA expects the regulation to lead to 500,000 fewer adverse events and savings of $93 Billion over the next 20 years. Q: What additional guidance has the FDA issued surrounding this regulation? A: Related to this regulation, the FDA also issued: • Guidance for Industry Bar Code Label Requirements, Questions and Answers (http:// www.fda.gov/cber/gdlns/barcode.htm) This FDA Guidance was important in that is clarified the Bar Code rule in some critical areas. The broadest clarification was that the April 26 effective date was for the manufacture, re-packaging or re-labeling date, not the ship date. Products will be considered compliant if they were manufactured without a bar code label before April 26, but shipped after April 26. However, the FDA stated that it would exercise their enforcement discretion to assure that product without bar codes were used or removed from distribution as quickly as possible. • “Frequently Asked Questions Bar Code Label Requirements for Blood and Blood Components” (http://www.fda.gov/CBER/faq/barcodefaq.htm) Under the bar code label requirements final rule of Feb 26, 2004, products subject to the rule, including blood and blood components intended for transfusion, must be in compliance by April 26, 2006. Specific bar code formats, contents and standards are to be approved for use by the Director, Center for Biologics Evaluation and Research. Currently, two types of machine-readable label types are recognized by FDA: FDA recognized the use of Codabar (a specific bar code symbology) in 1985; and FDA accepted the use of ISBT 128, version 1.2.0, in 2000. Q: What can hospitals do to leverage this regulation? A: Hospitals that have wanted to scan bar codes at the bedside have been faced in the past with the expense and effort (and potential for mislabeling and related risks) of having to bar code label many of the drugs themselves. With this regulation, most drugs will now arrive at the hospital already labeled, therefore removing a major barrier for hospitals for this crucial application in support of patient safety. Hospitals that wish to leverage the regulation are encouraged to launch a bar coded medication administration initiative – benefits of a well-implemented system should include reduced errors, lower costs, more accurate documentation, better charge capture and improved workflow and efficiencies.
  3. 3. In addition, once the infrastructure is put in place to support bar coded medication administration (e.g., wireless networks, bar code scanners, computers on wheels, mobile computers, wristband printers), it can also be used to support related applications such as specimen collection, blood transfusion verification, mobile rounding, wireless voice communications, remote patient monitoring and asset management. Q: What percentage of medications will be readily available with a unit-dose bar code and at what price? A: When the regulation was finalized in 2004, it was estimated that 30-40 percent of drugs were already available in unit dose packaging with bar codes. Since that time, the percentage has likely increased (it was estimated at 50 percent in mid 2005), although gaining an accurate estimate has proved to be difficult. Most hospitals buy from more than one drug distribution source and many buy some of their meds in bulk packaging to save money. Some manufacturers took the FDA regulation as an opportunity to show leadership – for example in pioneering the use of reverse contrast labeling on clear IV bags. On the other hand, there were indications that the percentage of drugs available in unit-dose packaging from some distribution sources decreased by as much as 30 percent as companies looked to avoid the expense of unit-dose labeling. A recent poll of a number of hospitals showed that on average, they were receiving only 40-60 percent of their meds in unit dose with a bar code, although many of the most commonly used drugs were in that format. Although costs for unit dose medications will generally be higher (pennies or tens of cents per dose, for example), the cost to the manufacturer, repacker or relabler of printing the bar code on the label of a unit dose package is generally minor (perhaps less than a penny depending on volume). Over time, market forces will likely be the determiner of unit dose availability, and hospital systems able to shop around or pay higher costs could likely get the majority of their meds in unit dose format – if not from the manufacturers, than from a growing number of repackagers, relabelers and distributors willing to fill the gap. Q: What meds will a hospital still have to bar code and how? A: Although most medications will arrive at the hospital with unit dose bar codes (the regulation excluded medical gases, allergenic extracts, and a few other items that would have been impractical to bar code), there will likely be a number of exceptions that a hospital will have to decide on how to handle on an individual basis. For example, creating pediatric doses (cutting pills in half), mixing special cocktails, or working with injectables where every administration is a custom amount (e.g., based on age and/or weight) would all require the hospital to take special measures to be able to bar code verify at the bedside. There are a number of companies that offer various packaging/labeling equipment to meet this need – everything from inexpensive “meds in a baggie” devices and bar code label printers up to and including larger machines and sophisticated robot systems that can serve even the largest packaging/labeling requirements.
  4. 4. Q: What are the components of a bar-coded medication administration system and what will it cost to install and maintain? A: Major components of a bar code medication administration system include the medication administration application package; an interface to the pharmacy system; bar code scanners that can be attached to a laptop on a cart or wall-mounted unit or PDAs with integral bar code scanners; and patient wristband printers. Most applications will require a wireless network (WLAN) for real-time connectivity. Costs for the full system including implementation for a typical hospital could run from $400,000 (approaching $2000 a bed) to $2 Million depending on the sophistication of the software, whether the wireless network is already in place, the use of PDAs vs. handheld scanners with laptops on carts, the amount of expertise of the IT staff, etc. Medication administration software will often be the most costly component, although license/purchase fees could vary considerably – e.g., the cost might be bundled in with a larger group of software modules. Hardware costs will also vary depending on whether they are bundled in with an overall solution or broken out by line item. Generally, corded bar code scanners that can only read linear bar codes cost $150-$250 – cordless versions generally are double the cost. Bar code scanners capable of reading 2D codes (used to read the additional information that some manufacturers include beyond just the required NDC such as lot and expiration date) cost 20-50% more than linear models. Laptops on carts can cost $3000-$6000. Rugged/sealed mobile computers with integral bar codes scanners cost from $1000- $2000. Complete wireless infrastructure coverage for a 200 bed hospital could cost $150,000 total for the site survey, design, install and cost of the hardware. Maintenance of all the above components would run from 10-20 percent yearly. Ongoing operating costs of the system are estimated at approximately $1000 per bed, although most users have found that efficiencies gained from the system such as electronic documentation and inventory supply chain savings at least equal the operating costs. Q: What percentage of hospitals are using bar code meds administration systems today? A: It is estimated that about 10 percent of US hospitals (500+ or so) are doing bar coded medication administration at the bedside. The Veterans Administration and HCA account for the majority of these hospitals, with a few additional large and well known systems like Sutter Health and Partners Healthcare and dozens of smaller facilities (e.g., Beloit Memorial, Ohio Valley General Hospital) also using these technologies. It is also estimated that another 10 percent of hospitals are in the process of either contracting for or implementing a bar coded medication administration system and another 10 percent will start down this road in 2006 (a typical range for implementation is 6-18 months). Q: What are some best and worst practices? A: With hundreds of organizations having implemented or in the process of implementing bar code meds administration, and a growing number of vendors with mature products, there is much experience to draw upon. Best practices include ensuring that positive-patient ID is well-handled (e.g., the right kind of wristbands in terms of size and materials are chosen for the patient; the bar codes are printed with a high-enough
  5. 5. quality to be easily readable; issues of curvature of the bar code on the wrist are addressed); the right bar code scanners are used and properly programmed/configured (scanners will likely need to support Reduced Space Symbology (RSS) codes for smaller packages); there is adequate WLAN coverage (dropped connections can be infuriating to staff); and proper training of nurses and other workers takes place (bar code readers have certain ranges where they work best and must generally be held steady and not waved, for example). Worst practices include buying hardware that does not hold up to hospital use (and not considering break-fix contracts); not considering how the infrastructure will eventually need to be shared for additional or related applications, and forcing the solution on the staff without their input and buy-in. Overall, Clinical, IT and financial staff must work together to ensure the right solution is implemented and that it can be properly supported. Q: Will the FDA enforce/modify/extend the regulation? A: When the rule was first being formulated, there was much discussion about the need for the FDA to go further than it did, such as requiring additional information on the label via 2D bar codes (e.g., lot and expiration date); or to allow or require the use of more advanced technologies, such as RFID. In the end, the FDA settled on what many consider a lowest common denominator approach (linear bar codes) that can be read by most all scanners on the market. As such, the FDA felt that the regulation was not that onerous to the drug companies – and in fact, decided that these companies would have just two years to comply instead of the originally proposed three years. Regarding enforcement, the final regulation stated that if products didn’t have the proper bar codes, there could be seizure, injunction, prosecution and withdrawal of a new drug application (NDA) or biologic license application (BLA). Hospitals can play an important role in enforcement by reporting lack of manufacturer/repacker/relabeler compliance (e.g., if bar codes are missing or not of at least “C” quality). The FDA also left open the door to reevaluate and extend the regulation after it went into full effect, although it seems likely that the initial focus will be on seeing how the current regulation is complied with and if the expected benefits are realized. Related areas that HIMSS believes the FDA should address include: • a revamping of the NDC numbering system, which currently allows some ambiguity in terms of dosage packaging • the support of RxNorm as a standard clinician-level dictionary of medications. • the bar code labeling of medical equipment as it relates to the tracking and management of these devices for patient safety. Q: What role will JCAHO and other organizations play? Soon after the regulation was finalized in 2004, the Joint Commission on Accreditation of Healthcare Organizations issued proposed National Patient Safety Goals that would have required hospitals to read the bar codes at the bedside by 2007. Many hospitals pushed back, claiming that they had too many other competing initiatives and wanted to make their own choices; that this was an unfunded mandate; and that the vendors – both software and hardware – were not prepared to meet their needs. Even some of the
  6. 6. vendors complained that they would not have enough time to sell their “superior” solutions to all the hospitals in the country in the allocated timeframe. As such, the proposal was withdrawn. As to whether it will be reintroduced – it’s been discussed that JCAHO looks to see an adoption of at least 15 percent in the industry for a technology before it would mandate its use. Given the current estimates – it seems likely that the 15 percent threshold for bar coded meds administration will be crossed this year. Should JCAHO issue new National Patient Safety Goals, it is likely that hospitals would still have a few years to actively investigate and provide plans to comply, and have additional time to put the systems in place. In the meantime, other organizations such as the Institute for Safe Medication Practices (ISMP), the Agency for Healthcare Research and Quality (AHRQ), HIMSS and others continue to press for greater IT adoption. Even if regulations are not enforced, the bar will likely continue to rise – driving more organizations to make the necessary investments. Q: How will RFID mesh/compete with the bar code regulation? A: RFID has many benefits over bar coding, such as the ability of an interrogator/scanner to read many tags at once – the ability to read tags without the need for line of sight, and the ability to write to a tag and update it with new information. RFID is increasingly being considered and used for the pharmaceutical supply chain for anti-counterfeiting and track and trace on large packaging, such as pallets, cases, and in some instances down to smaller bulk containers (pill bottles). The FDA has in fact been activity promoting this use. However, for unit dose packaging, the effects of RFID energy on certain medications has not yet been fully explored; the cost of RFID chips is still an order of magnitude or two more expensive than bar code labels (tags are generally cost at least 20 cents); and the standards are still being discussed (although progress is being made). In addition, ironically, the Omni directional nature of RFID technology makes it difficult to determine one item from an other when they are in close proximity to each other (such as when a nurse has meds in each hand), whereas a bar code scanner gives the user more certainly as to which item is which due to the line of sight requirement and directionality of bar code reading. Although RFID may eventually become common in patient wristbands and used for asset management, it’s unlikely that it will be used on unit-of use medications through the rest of the decade. Therefore, hospitals should not be dissuaded from implementing bar coding initiatives by RFID hype.

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