Summary of HDMA Presentation for July 26 Public Meeting Regarding Bar Code Labeling Requirements

Transcription

1 - - Summary of HDMA Presentation for Juy 26 Pubic Meeting Regarding Bar Code Labeing Requirements The HDMA speaker woud be Robert Schwartz, current HDMA Chairman of the Board and Presideht of the Barnes Division of H.D. Smith Whoesae Drug Company. Mr. Schwartz wi present an overview of HDMA and its membership, discuss the current state of the industry s acceptance of bar codes, and describe the technoogy avaiabe to support this initiative. Mr. Schwartz wi aso highight the benefits of bar coding, provide industry statistics reated to bar code usage in the manufacturer, distributor and customer settings and expain the impact changes to identificatiin systems woud have on the heathcare suppy chain.. ) HDMA s Support of Efforts to Reduce Medica Errors and Histon/ with Bar Codes: HDMA has been an active participant in the Natrona Coordinating Counci for-& Medication Error Rates and Prevention since We have been pioneers it?- promoting the usage of bar code standards in the heathcare industry since the-eary 90 s. We have worked coaborativey with the Heath Industry Business. Communications Counci (HIBCC) and the Uniform Code Counci (UCC) to deveop vountary guideines for the industry, and have deveoped an industry position on the usage of bar codes 0 Current State of the Industry and Technooqv Capabiities Mr. Schwartz wi review a fow map showing the entire pharmaceutica distribution chain, noting the paces where a bar code abeing requirement woud have the most impact, He wi discuss current eves of bar code usage, providing statistics reated to manufacturer? distributor and pharmacy settings. Benefits of Bar Coding Mr. Schwartz wi discuss the benefits of bar coding in ensuring the accuracy of medication identification and administration and improving efficiencies within the medication-use process, monitoring of drug-use trends, and overa efficiencies in the suppy system and pubic heath and patient safety, HDMA s Position on Bar Codes 0 V Identify a eves of packaging, (SKUs, inner packs and shipping cases) with a barcode symbo or symbos that compy with the HDMA Numerica and Automatic Identification of Drug Products Guideine, as revised. Use the Nationa Drug Code (NDC) as defined by the Food and Drug Administration (FDA) as the preferred numbering system for drug products. Ts 2Q - - -I ~ _-. _ E0 33Gd L6ZZS08T0ET qt:t0 Z00ZIZT/L0

2 _ _ -_ HDMA Summary - page 2 Foow bar code standards pubished by the Uniform Code Counci (UCC) for OTC drug products and Heath Industry Business Communications Counci (HIBCC) for medica-surgica devices for a packaging eves. Appy bar code abeing as eary In the suppy system as possibe, e.g. manufacturing or packaging. Conduct appropriate symboogy evauations to determine optima technoogy in appying and scanning bar codes. Impement bar coding of unit of use and sma packages (goa: to have a drug and device products used at the patient bedside carrying a barcode). Use bar codes internay wherever possibe. Use of bar codes to identify heathcare products has been shown to reduce abor costs in distribution and dispensing whie, at the same time, reducing errors. Impact of Bar Code Changes Mr. Schwartz wi discuss the potentia impacts of a bar code requirement on the heath care distribution chain. He wi discuss the arge costs that woud be incurred if ot number and expiration date were required as part of the bar code abe, as is being discussed. He WIII discuss the HDMA view that FDA be fexibe as to symboogy chosen. He wi describe the overa huge economic impact on manufacturers and distributors in the areas of packaging technoogy, equipment components, integration of computer systems, and other impementation costs. P0 13 Gd L6ZZS08T0EI 9::To ZOOZ/ZT/LQ

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4 0. An Aternative Machine- Readabe Coding Scheme for Unit Dose Medications Presentation to the US Food & Drug Administration Juy 26, 2002 Presenter: Stuart Creque VP, Business Deveopment (510) ext 204 stuartcodfindthedot.com

5 a Presentation Patient Safety Depends on Verifying the Five Rights of Medication Administration Quaity Depends on Measurabe Systems Bar Codes and the Bad Trade-off Bar Code Legacy Systems: What Do They Have in Common? The Answer: a Linking Code Comparing Med Dots to Bar Codes The Med Dot Patient Safety Soution Soution Architecture & Its Advantages Cost Advantages Licensing Med Dots ndustrywide

6 I J Five Rights of Medication Administration Right patient Right medication Right dose Right time Right route - deivery method (ora, injected, etc.) and site (right or eft eye, etc.)

7 0 Quaity Depends on Measurabe Systems The vaue of the system ies in verifying 100 percent of medication administration actions and recording (measuring) every one of those actions Measurement is critica to subsequent root-cause anaysis and other systemic approaches to error prevention The measurement gives a denominator to cacuate true error rates Ever?/ patient caregiver (RN, LVN/LPN, etc.) must have a vaidation and measurement too

8 Bar Code-Based Approaches Data about medication is embedded in the code Impies generating & printing codes on the fy New data requirements = new codes on packages More data = bigger code Sti requires ookup from database to compare content of code to medication order

9 a a The Bad Trade-off of Bar Codes Symbo size vs. cost of equipment 1-D (traditiona) bar codes require arge packaging area Increases costs of packaging, storage, transportation * Require aser scanners for maximum reiabiity and convenience RSS or 2-D (matrix) codes require ess packaging area Decreases packaging & reated costs Substantiay increases system impementation costs due to more sophisticated, expensive readers

10 No Good Answer with Bar Codes With traditiona bar codes, packaging costs (incuding retooing production ines) dissuade manufacturers and hospitas have dtffcuty justtfiing moderatey expensive bar code readers If the manufacturer tries to reduce packaging costs using RSS or matrix codes, the hospita is even ess abe to afford to impement the system due to the prohibitive cost of the code readers

11 u 6 n The Bar Code Legacy Vendors Baxter (Deerfied, IL) - AutrosTM Becton, Dickinson (Frankin Lakes, NJ) - BD.id-RxTM Bridge Medica (Soana Beach, CA) - MedPointTM Cardina Heath (Dubin, OH) - Pyxis division - VeriF ivetm McKesson (San Francisco, CA) - Horizon Admin-Rx TM Siemens Heath Services (Mavern, PA) - Med Administration Check

12 What Do They Have in Common? A offer simiar soutions A use 20-year od industria bar-code technoogy Tota market share is 3% The shortcomings of bar codes compromise patient safety: 97% of US hospitapatients don t have protection against bedside medication errors

13 The Answer A new code symbo and reader with these idea characteris tics: A inking code that inks the medication to a database entry that can be dynamicay updated Large code space: every dose of every medication gets a unique seria number (critica in the era ofgenomics) Sma size: fits onto economicay-sized unit dose packages with itte, if any, redesign Low-cost reader: equipping every patient caregiver with a code reader is affordabe Ease of operation: doesn t require carefu aignment, extensive software training

14 Advantages of a Linking Code Static information (e.g., manufacturer, NDC number, ot, expiration date, etc.) can be added to database at any time Codes can be pre-printed on packaging materia, then associated to specific product/@zant/ine/ ot/date information afterpackaging run o Dynamic information (e.g., saes history, medication order detais, dispensing history, administration detais, genomic customization, ot recas, etc.) can be tracked for each individua dose Same code symbo can be used to identify patient, caregiver, port on IV or other ine, etc. Same code symbo on paperwork and accessory cards permits automatic charting, documentation, charge capture, etc.

15 Med Dots v. Bar Codes a Sma - 5 mm diameter 0 Reiabe - Forward Error Correction; round shape can be read at any ange 0 Low Cost Reader - a persona reader can se for under $ Encrypted - unique and encrypted 0 Huge Code Space unique Med Dots for every human being on Earth, every day, for 1,000 years

16 Functiona Comparison Existing Approaches Med Dot Soution cost Bar code readers cost $300 to $1150 each. Wrreess Med Dot readers cost $100. Ease of Depoyment Compatibiity Ease of Use Safety A Five Rights Expandabiity Other systems require expensive and potentiay interfering hospita-wide wireess network Extensive training required. 1 -D bar codes are 20X times arger and require secondary drug packaging to hod the arge bar code abe. industria bar code scanners weight 8 oz to 2.5 Ibs. Often must be attached fragie PDA. Mutipe steps are required to scan a bar code. Existing systems often miss key rights (such as omission, abuse, or wrong time) because bar codes are not unique nor specific to patient. Bar code systems are force-fit into other appications within the hospita. No new network required. The wireess ink is direct to the nurse s station PC-30 foot range, in 900 MHz ISM band.minima training required. Sma (5 mm), round Med Dot fits on unit-dose packaging. Dedicated wireess Med Dot reader weighs 1.25 oz. Shirt-pocket friendy. No keyboard. No docking. Automatic data synchronization and recording. Each Med Dot is unique to a singe-dose for a singe patient. Prevents abuse, and tracks errors to the cause of the error. Med Dots naturay fit into biing, ordering, and other hospita appications.

17 Med Dot Patient Safety Soution Med Dots in a Patient Medication Safety System Medications are prepared in the hospita pharmacy in unit doses. Each dose is marked with a Med Dot (unique machine-readabe code) The nurse taps the Med Dots with her Dot Finder (compact wireess reader) The eectronic Dot Finder provides instant vaidation of a five rights. The system automaticay records detais of medication given (patient, nurse, time, drug, dose, route. notes)

18 Soution Architecture Pick ist Order data,