From: JSensmeier@himss.org Sent: Thursday, June 12, 2003 4:54 PM To: fdadockets@oc.fda.gov Cc: jsensmeier@himss.org Subject: comments on bar code requirements 21 CFR Parts 201, 606, 610 Attention: Jennie Butler Please find below the comments to the FDA proposed rule from the Healthcare Information and Management Systems Society (HIMSS). Please let me know if you have difficulty with the attachment. Thank you for the opportunity to comment. Joyce Sensmeier Comments on the FDA Proposed Rule – Bar Code Label for Human Drug Products and Blood The Healthcare Information and Management Systems Society (HIMSS) is the healthcare industry's only membership organization exclusively focused on providing leadership for the optimal use of healthcare information technology and management systems for the betterment of human health. HIMSS represents more than 13,000 individual and 150 corporate members that employ more than 1 million people. HIMSS seeks to shape and guide healthcare public policy and industry practices through its advocacy, educational and professional development initiatives designed to promote information and management systems' contributions to quality patient care. In March HIMSS announced that it would fully support the efforts of the FDA to put patient safety as a priority by proposing the bar coding and safety reporting rules. The bar coding initiative is a crucial step to encourage the use of information technology throughout the healthcare industry in the United States. Use of this technology in combination with information systems that incorporate decision support will reduce medical errors and improve productivity. We are pleased therefore to provide our comments on the FDA Proposed Rule. HIMSS offers its support and appreciation to the FDA for taking this bold step Prior to addressing the specific questions raised in the Proposed Rule, there are several items HIMSS would like to put forward for final rule consideration. 1.. Rapidly moving to widespread use of bar code enabled Medication Administration Recording (MAR) systems is the paramount priority. Given a choice between delay for any refinement of the rule and publication of a final rule, HIMSS supports the prompt publication of a final rule. 2.. As a founding member of the National Alliance for Health Information Technology (NAHIT) our comments parallel and support those submitted by NAHIT. 3.. As drafted, it appears that hospitals and other provider organizations would be governed under the rule as repackagers and relabelers. The discussion in the Proposed Rule focuses on manufacturer-provided bar code labeled products. If the proposed rule becomes final, much of the current provider relabeling could be replaced with purchased bar coded products. However there will still remain a need for hospitals and other providers to repackage and relabel. IV solutions and mixes are a high volume example. It would be unrealistic to expect hospitals and other provider organizations to obtain an NDC Labeler Code and participate in the NDC system for just for this purpose. Just as retail pharmacies are excluded from the rule when filling prescriptions for an individual, so too should hospitals, other institutional providers, and large clinics. The Final Rule should recognize the exclusion for more than the “typical” hospital and include health systems with a shared pharmacy. Such shared pharmacies could be separate legal entities. Furthermore there are models wherein hospitals have outsourced their pharmacy. HIMSS seeks clarification in the final rule and requests that hospitals are specifically excluded as relabelers and repackager. 4.. HIMSS supports the FDA’s proposal to update the regulation and administration of the NDC number. However, we believe that it needs to be done carefully as it has broad implications across the entire clinical and supply chain. It is critical that the FDA consult the various stakeholder before making changes to the NDC number. 5.. While the Proposed Rule is a critical and necessary step it is not sufficient by itself to realize meaningful reductions in Adverse Drug Events (ADE’s). Unless hospitals also implement bar code enabled Medication Administration Record systems, and related support systems the impact on reduction of medical errors, ADE’s, and overall patient safety will be minimal. From this perspective HIMSS requests that the following items be considered in the Final Rule: 1.. Include the expiration and lot number in the bar code label. (See response to Question number 4) 2.. Require manufacturers to offer “unit dose” packaging with bar coded labels. HIMSS is concerned that manufacturers will reduce the number of unit dose packages. Our members have identified a recent trend by manufacturers to reduce their unit dose offerings. If manufacturers can change their ‘dispensing unit’ to quantity packaging as a way to circumvent the rule, its value will be sabotaged. 3.. Consider the use of bar code labels on medical and surgical supplies. This could be included in the next phase of implementation or in a companion rule. This would enhance productivity and give providers additional benefit for their investment in bar code technology. 6.. In our response to Question number 12, we conclude that the economic analysis adequately reflects the cost and benefits of bar coding medications. However HIMSS questions the assumption in the economic analysis regarding the QALY. QALY assume a “willingness to pay” the costs associated with avoiding ADE. Given current medical care reimbursement in this country, patients/consumers are not economic buyers. The economic buyers of medical care, predominantly employers and Government have shown a clear unwillingness (or inability) to pay for quality, instead utilizing across the board reimbursement without any quality considerations. HIMSS offers these comments from industry experts that are actively implementing, designing, using, and supporting healthcare information and management systems. It is our intent that they be used as a guide to the FDA as it considers the Final Rule. However, we strongly encourage the FDA to move forward quickly with a Final Rule rather than spend time in protracted debate about inclusion of additional items. Further delay will only have a negative impact on the ability of the rule to improve patient safety and improved quality of care. Response to questions In addition to requesting general comments on the proposal, and the specific requests on assumptions contained in the economic analysis, we are seeking comment on the following specific issues identified in the description of the proposed rule (presented here for the convenience of the reader): 1. Whether we should require bar codes on prescription drug samples, and the costs and benefits associated with such bar codes (see section II.B.2.a of this document). HIMSS: Support Proposed Rule as presented. 2. The risks and benefits of including vaccines in a bar code rule (see section II.B.2.a of this document). HIMSS: We agree with the inclusion of vaccines in the final rule for bar code labeling. HIMSS recommends that the FDA require the inclusion of Lot Number and Expiration Date, as well as the NDC, on vaccines within the three-year implementation timeframe of the Proposed Rule. 3. What terms we should use to describe OTC drugs that should be subject to the bar code requirement (see section II.B.2.b of this document). HIMSS: We suggest that when describing an OTC drug product in the FDA Proposed Rule, Section 201.25 (b), the phrase “over-the-counter drug products that are dispensed under an order” be changed to “non-prescription drugs used therapeutically pursuant to a clinician’s order.” HIMSS supports the NAHIT recommendation that the “commonly used in hospitals” reference be expanded to include: “ packaged for hospital use, labeled for hospital use, or marketed, promoted, or sold to hospitals.” 4. Information on the costs and benefits associated with putting lot number and expiration date information in the bar code (see section II.C.2 of this document). HIMSS: We appreciate the challenges of including lot number and expiration date using current technology and the Proposed Rule’s accommodation for optional use. However, a standard should be specified if a manufacturer chooses to include lot number and expiration date. Since a number of manufacturers have announced their intent to include lot number and expiration date, the Final Rule should specify the UCC/EAN or HIBCC standards for such information. More broadly, an implementation schedule for inclusion of lot number and expiration date should be established in the final rule. Specifically, lot number and expiration date be included in the bar code for all package sizes, down to the unit-dose level, within 5 years from the date of the final FDA rule. If the technology to print the lot number and expiration date is not available in five (5) years, then the regulatory language should state that manufacturers will provide the FDA with an unbiased, objective assessment of the current state of technology and valid reasons why the printing of the lot number and expiration date in bar codes is not feasible. The FDA should then be willing to provide pharmaceutical manufacturers a reasonable extension for the required inclusion of lot number and expiration date. This could be achieved by asking the FDA to commit to holding a hearing two (2) years before the five (5) year deadline to affirm the feasibility of adding the expiration date and lot number to bar codes. 5. Whether the rule should refer instead to linear bar codes without mentioning any particular standard of reference or refer to UCC/EAN and HIBCC standards (see section II.D.1 of this document). HIMSS: While future technologies should be accommodated and addressed beyond linear bar coding, the Final Rule should not be delayed as a result. For example, restriction to “ linear” would preclude the option of including lot number and expiration date. Current point-of-care scanned items include capabilities not encompassed by UCC/EAN linear bar codes such as: · Alpha numeric codes · Two dimensional symbologies · RFID (Radio Frequency ID) The final rule should accommodate if not facilitate advances in technology. HIMSS supports linkage of acceptable bar codes or auto identification to UCC/EAN for medications, ISTB for blood products and HIBCC for devices and other items. As Designated Standards Organizations (DSO) these organizations have processes in place that will enable the standards to evolve as conditions require. Expedient publication of a Final Rule using current technology (bar coding) with a process for incorporating the actions of DSOs will maximize the short term patient safety benefit without blocking use of more advanced technology. 6. Additional information regarding bar code scanning technology and the ability of bar code scanners to read different symbologies (see section II.D.1 of this document). HIMSS: The Proposed Rule presents too limited a view of scanning technology. Current linear scanners read multiple symbologies included in the UCC/EAN standards. HIMSS believes that if reading technology (e.g. scanners, readers, imagers, CCD, etc ) retains a price point similar to today's linear scanners, hospitals will purchase devices that read multiple symbologies including, but not limited to: a.. CodeAbar a.. 128 a.. RSS a.. Composite RSS a.. PDF a.. Data Matrix a.. Other ISO standards A) Technology prices are falling and will continue to fall. "Moore's Law" has and will be reflected in technology price performance. B) "Scanner" prices have fallen and will continue to fall. - By and large they are solid state devices with few, if any moving parts. C) The FDA rule will create a market potential up to 2 million scanners within the next 3 to 7 years, D) Scanners will be one of smaller components of a hospital’s patient safety investment. HIMSS is concerned that if the standard is set too low, hospitals may acquire an absolute minimal specification scanner, and legacy limited capability scanners would inhibit future patient safety initiatives. HIMSS will recommend that members acquiring "scanners" specify reading technology that includes multiple linear and two-dimensional symbologies including but is not limited to: a.. CodeAbar a.. 128 a.. RSS a.. Composite RSS a.. PDF a.. Data Matrix a.. Other ISO standards 7. Whether the rule should adopt a different format (whether that format is a symbology, standard, or other technology), considering the following issues: HIMSS: We encourage the FDA to have enough flexibility in the Final Rule to encourage the adoption of improved auto identification technology as it develops. By referencing a class of standards administered through a DSO, such as UCC/EAN and HIBCC, rather than a particular technology or format, the FDA can provide for such flexibility in the rule (reference HIMSS response to questions 5 and 6). o What other symbol, standard, or technology should we consider, either in place of a linear bar code or in addition to it? HIMSS: We understand that a formal request has been made to UCC/EAN for the inclusion of Data Matrix symbology. As this symbology has many advantages and is currently embraced by HIBCC we consider this a positive step. Radio Frequency ID is being rapidly accepted in other industries. Because of the advantages AutoID offers in the healthcare setting, it should also be considered near term. o How accepted is that symbol, standard, or technology among firms that would have to affix or use that symbol, standard, or technology? HIMSS: HIBCC standards are widely used for Medical/Surgical supplies. Early adapters are using Radio Frequency ID. o Will hospitals be able to read or use the symbol, standard, or technology, either with existing equipment or equipment under development? (see section II.D.1 of this document). HIMSS: Yes, (reference HIMSS response to questions 5 and 6) 8. Whether any specific product or class of products should be exempt from a bar code requirement and the reasons why an exemption is considered to be necessary (see section II.F of this document). In addition, how could we create a waiver provision that would minimize the potential for misusing the waiver? HIMSS: No specific human drug products or class of human drug products should be exempt. Recognizing that some unanticipated situation may arise, it would be advantageous to have in place a mechanism for very narrow waivers, which could be applied on an exceptional case-by-case basis through a reasonable and expeditious process. 9. Whether the implementation period for a final rule can and should be shortened from 3 years to some other specific time period (see section II.G of this document). HIMSS: For the patients who will suffer ADEs, 3 years is too long. For technology transformation, 3 years is a good balance for existing drugs. For new drug product applications however, two (2) months after the effective date of the Final Rule would be appropriate. As recommended in our comments on Question 4, Inclusion of the lot number and expiration date should be phased in over five (5) years. 10. Whether we should require the use of ISBT 128 for blood products, a specific symbology that is consistent with that required for drugs in proposed Sec. 201.25, or ``machine-readable symbols'' as approved by the Director of CBER (see section II.H of this document). HIMSS: If ISBT license fees for hospitals are minimal, ISBT 128 should be mandated. It would be most advantageous if the FDA negotiated a national license for ISBT 128 Code. We also note that because blood and blood products can be frozen and stored for up to 10 years a lengthy transition period to ISBT 128 will be required. 11. How the proposed rule might affect hospitals where patients receive blood or blood components, particularly with respect to a hospital's decision to purchase a machine reader (e.g., scanner) that can properly identify the intended recipient of the blood or blood component, the machine readable information encoded on the blood or blood component label, and perhaps the linear bar codes appearing on drugs and OTC drugs that are dispensed pursuant to an order and commonly used in the hospital (see section II.H of this document). HIMSS: Scanners can accommodate multiple symbologies, and multiple formats (see response to Question 6.) The Final Rule should be consistent with a vision where not only drugs and blood products, but medical supplies, portable equipment, and documents are scanned at the point of care. 12. Whether any of the alternatives discussed in the economic analysis have merit (see section VII.O of this document). HIMSS: Early adopter’s cost and benefit experience has been varied. We have examples and comments of both better and worse experience than the assumptions in the FDA economic analysis. For the purpose of this Proposed Rule, we believe the economic analysis correctly shows that the Societal Values of the Proposed Rule far outweigh the cost. Director of Professional Services HIMSS 230 East Ohio Street, Suite 500 Chicago, IL 60611 708-955-4377 Joyce Sensmeier MS, RN, BC, CPHIMS Director of Professional Services HIMSS. The Source for Healthcare Information 230 East Ohio Street, Suite 500 Chicago, IL 60611-3269 http://www.himss.org Phone: (312) 915-9281 Fax: (312) 664-6143 E-mail: Jsensmeier@himss.org Spending on healthcare IT totaled $21.6 billion in 2002. It's projected to reach $23.5 billion in 2003 and $25.6 billion in 2004.--Dorenfest and Associates You can't afford not to attend HIMSS Summer Conference 2003 “Strategic Issues | Strategic IT Solutions,” June 9-10, at the Sheraton Chicago Hotel and Towers, in Chicago. Register now at www.himss.org/summerconference