fda bar code rule richard a. nickel, m.s., r.ph. mallinckrodt inc. st. louis, mo
TRANSCRIPT
![Page 1: FDA Bar Code Rule Richard A. Nickel, M.S., R.Ph. Mallinckrodt Inc. St. Louis, MO](https://reader033.vdocuments.us/reader033/viewer/2022051416/56649e235503460f94b10fc3/html5/thumbnails/1.jpg)
FDA Bar Code Rule
Richard A. Nickel, M.S., R.Ph.
Mallinckrodt Inc.
St. Louis, MO
![Page 2: FDA Bar Code Rule Richard A. Nickel, M.S., R.Ph. Mallinckrodt Inc. St. Louis, MO](https://reader033.vdocuments.us/reader033/viewer/2022051416/56649e235503460f94b10fc3/html5/thumbnails/2.jpg)
FDA Bar Code Rule• 14 Mar 2003 Proposed Rule
• 26 Feb 2004 Final Rule– Applied to “certain human drugs and biological
products”– Required linear bar code containing NDC
number on product label
![Page 3: FDA Bar Code Rule Richard A. Nickel, M.S., R.Ph. Mallinckrodt Inc. St. Louis, MO](https://reader033.vdocuments.us/reader033/viewer/2022051416/56649e235503460f94b10fc3/html5/thumbnails/3.jpg)
FDA Bar Code Rule• Revises 21 CFR Parts 201, 606 and 610• Revision intended to improve patient safety
– Geared toward needs of hospital pharmacies and the growing use of bar-coding equipment
– “Bar codes can help reduce or detect potential medication errors by enabling health care professionals to check whether they are giving the right drug via the right dose and right route of administration to the right patient at the right time.” (i.e. 5 rights)
![Page 4: FDA Bar Code Rule Richard A. Nickel, M.S., R.Ph. Mallinckrodt Inc. St. Louis, MO](https://reader033.vdocuments.us/reader033/viewer/2022051416/56649e235503460f94b10fc3/html5/thumbnails/4.jpg)
P a tie n t
P h a rm a cy
W h o le sa le r/D ru g D is trib u to r
D ru g M fr
![Page 5: FDA Bar Code Rule Richard A. Nickel, M.S., R.Ph. Mallinckrodt Inc. St. Louis, MO](https://reader033.vdocuments.us/reader033/viewer/2022051416/56649e235503460f94b10fc3/html5/thumbnails/5.jpg)
• Mfr to Wholesaler– NDC codes used **
• Wholesaler to Pharmacy– NDC codes used **
• Pharmacy to patient– Rx numbers used **
**used to tie into a record or link multiple tables in a relational database system
![Page 6: FDA Bar Code Rule Richard A. Nickel, M.S., R.Ph. Mallinckrodt Inc. St. Louis, MO](https://reader033.vdocuments.us/reader033/viewer/2022051416/56649e235503460f94b10fc3/html5/thumbnails/6.jpg)
P a tie n t
P h a rm a cy
W h o le sa le r/D ru g D is trib u to r
D ru g M fr
NDC Number
NDC Number
Rx Number
![Page 7: FDA Bar Code Rule Richard A. Nickel, M.S., R.Ph. Mallinckrodt Inc. St. Louis, MO](https://reader033.vdocuments.us/reader033/viewer/2022051416/56649e235503460f94b10fc3/html5/thumbnails/7.jpg)
FDA Bar Code Rule
• Radiopharmaceuticals are exempt– ‘low misadministration rate’ cited
• FDA correctly indicates there is no threshold level to determine applicability of rule
– NRC ‘written directive’ requirement cited
![Page 8: FDA Bar Code Rule Richard A. Nickel, M.S., R.Ph. Mallinckrodt Inc. St. Louis, MO](https://reader033.vdocuments.us/reader033/viewer/2022051416/56649e235503460f94b10fc3/html5/thumbnails/8.jpg)
FDA Bar Code RuleFR Discussion
– “We believe that NRC regulations pertaining to the use of radiation byproducts provide sufficient safeguards in preventing medication errors involving radiopharmaceuticals,…”
Most users purchase their radiopharmaceuticals from central nuclear pharmacies instead of direct from mfr. NDC codes do not exist for many pharmacy-dispensed products.
![Page 9: FDA Bar Code Rule Richard A. Nickel, M.S., R.Ph. Mallinckrodt Inc. St. Louis, MO](https://reader033.vdocuments.us/reader033/viewer/2022051416/56649e235503460f94b10fc3/html5/thumbnails/9.jpg)
FDA Bar Code Rule
FR Discussion
– In the comments received, there may have been confusion about
• Whether or not the final rule would apply to a state-licensed pharmacy, and,
• The perceived value of a bar code in a nuclear pharmacy.
![Page 10: FDA Bar Code Rule Richard A. Nickel, M.S., R.Ph. Mallinckrodt Inc. St. Louis, MO](https://reader033.vdocuments.us/reader033/viewer/2022051416/56649e235503460f94b10fc3/html5/thumbnails/10.jpg)
Radiopharmaceuticals are exempt• Nuclear pharmacies may use bar coding
equipment to prevent errors in dose preparation, packaging and delivery
• Lack of bar codes on radiopharmaceutical vial creates a weakness in the use of bar coding
• Preserves the situation the Rule was intended to remedy
![Page 11: FDA Bar Code Rule Richard A. Nickel, M.S., R.Ph. Mallinckrodt Inc. St. Louis, MO](https://reader033.vdocuments.us/reader033/viewer/2022051416/56649e235503460f94b10fc3/html5/thumbnails/11.jpg)
Radiopharmaceuticals are exempt• Patient Safety, as applied in nuclear
pharmacy, is not optimized as a result.
• Facilities utilizing bar coding equipment from source to final dose are left with a gap at the beginning of the process
![Page 12: FDA Bar Code Rule Richard A. Nickel, M.S., R.Ph. Mallinckrodt Inc. St. Louis, MO](https://reader033.vdocuments.us/reader033/viewer/2022051416/56649e235503460f94b10fc3/html5/thumbnails/12.jpg)
Scan The Rx
BOL
Packing
Slip
Bar Code
Sheet
Bill Of Lading
Select Orders, Generate
And Print Documents
Pharmacy Processes
Ship
Select Items To Deliver
And Mark Them Shipped
Stage
Scan The Case ID
Scan The BOL and
Package ID
Scan each Pig
Scan Customer
Luggage Tag To
Confirm
Driver Delivers
Product
Deliver
Dispense Rx
Dispense
Scan The Vial
![Page 13: FDA Bar Code Rule Richard A. Nickel, M.S., R.Ph. Mallinckrodt Inc. St. Louis, MO](https://reader033.vdocuments.us/reader033/viewer/2022051416/56649e235503460f94b10fc3/html5/thumbnails/13.jpg)
Net result…
…critical opportunity for patient safety improvement is missed.
The nuclear pharmacist is left without one more engineering control to reduce/eliminate errors.
![Page 14: FDA Bar Code Rule Richard A. Nickel, M.S., R.Ph. Mallinckrodt Inc. St. Louis, MO](https://reader033.vdocuments.us/reader033/viewer/2022051416/56649e235503460f94b10fc3/html5/thumbnails/14.jpg)
Recently, another final rule was published in the Federal Register that is related to this issue
![Page 15: FDA Bar Code Rule Richard A. Nickel, M.S., R.Ph. Mallinckrodt Inc. St. Louis, MO](https://reader033.vdocuments.us/reader033/viewer/2022051416/56649e235503460f94b10fc3/html5/thumbnails/15.jpg)
Prescription Drug Marketing Act of 1987• Address Drug Diversion
– Called “The Drug Diversion Bill”
• Two 2-year delays in implementation passed by congress in response to lobby
• Pedigree requirement delayed to present day– Individual states implementing pedigree
requirement (e.g. Florida)
![Page 16: FDA Bar Code Rule Richard A. Nickel, M.S., R.Ph. Mallinckrodt Inc. St. Louis, MO](https://reader033.vdocuments.us/reader033/viewer/2022051416/56649e235503460f94b10fc3/html5/thumbnails/16.jpg)
Prescription Drug Marketing Act of 1987• FDA’s counterfeit drug initiative-today
• FR of 23 Feb 2004 published a delay of effective date for pedigree requirement
• Intent is to implement rule using “electronic pedigrees” for all legend drugs
• Deadline for implementation is 1 Jan 2007
![Page 17: FDA Bar Code Rule Richard A. Nickel, M.S., R.Ph. Mallinckrodt Inc. St. Louis, MO](https://reader033.vdocuments.us/reader033/viewer/2022051416/56649e235503460f94b10fc3/html5/thumbnails/17.jpg)
Electronic Pedigree• Pedigree: A statement, required by the PDMA, that
includes the names and addresses of all parties to each prior transaction involving the drug.
• Electronic Pedigree– Use of RFID (radio frequency identification
device)– Could contain more information than NDC
number
![Page 18: FDA Bar Code Rule Richard A. Nickel, M.S., R.Ph. Mallinckrodt Inc. St. Louis, MO](https://reader033.vdocuments.us/reader033/viewer/2022051416/56649e235503460f94b10fc3/html5/thumbnails/18.jpg)
RFID• Ubiquitous (almost)
– Employee ID badges used for access– Computer access (e.g. Xyloc)– Mobil Speedpass– PA and NJ turnpike EZPass– “Pet Chips” used in companion animals
![Page 19: FDA Bar Code Rule Richard A. Nickel, M.S., R.Ph. Mallinckrodt Inc. St. Louis, MO](https://reader033.vdocuments.us/reader033/viewer/2022051416/56649e235503460f94b10fc3/html5/thumbnails/19.jpg)
Bar Codes Vs. RFID• Bar Code
– Patent issued in 1952
• RFID– Patent issued in 1973
![Page 20: FDA Bar Code Rule Richard A. Nickel, M.S., R.Ph. Mallinckrodt Inc. St. Louis, MO](https://reader033.vdocuments.us/reader033/viewer/2022051416/56649e235503460f94b10fc3/html5/thumbnails/20.jpg)
Bar Codes Vs. RFID• Bar Code (Patent issued in 1952)
– 1984, 15,000 suppliers used bar code technology
– 1987, 75,000 suppliers used bar code technology
1987: Wal-Mart required suppliers to use or lose their business
![Page 21: FDA Bar Code Rule Richard A. Nickel, M.S., R.Ph. Mallinckrodt Inc. St. Louis, MO](https://reader033.vdocuments.us/reader033/viewer/2022051416/56649e235503460f94b10fc3/html5/thumbnails/21.jpg)
Bar Codes Vs. RFID• RFID(Patent issued in 1973)
– Required for military suppliers– 2005: Wal-Mart requiring 100 largest suppliers
to use– Soon to be used in..
• Gillette razors (recently purchased 500 million)
• VISA Smart Cards
• Michelin tires (embedded) mfrs 800,000 tires/day
• Euro notes (embedded)
![Page 22: FDA Bar Code Rule Richard A. Nickel, M.S., R.Ph. Mallinckrodt Inc. St. Louis, MO](https://reader033.vdocuments.us/reader033/viewer/2022051416/56649e235503460f94b10fc3/html5/thumbnails/22.jpg)
Bar Codes Vs. RFID• Deadlines for RFID
– Wal-Mart: 2005 (screws begin to tighten on suppliers)
– FDA: 2007 (proposed)
– Result should be increased acceptance and awareness of RFID technology and adoption by manufacturers
![Page 23: FDA Bar Code Rule Richard A. Nickel, M.S., R.Ph. Mallinckrodt Inc. St. Louis, MO](https://reader033.vdocuments.us/reader033/viewer/2022051416/56649e235503460f94b10fc3/html5/thumbnails/23.jpg)
Bar Codes Vs. RFID• Incentives for electronic pedigree
– Drug counterfeiting– Drug diversion– Inventory control– “smart” RFID versus “dumb” bar codes
• Devices can be written to, as well as read
• Bar codes have limits to info, while RFID may contain large amount of info
![Page 24: FDA Bar Code Rule Richard A. Nickel, M.S., R.Ph. Mallinckrodt Inc. St. Louis, MO](https://reader033.vdocuments.us/reader033/viewer/2022051416/56649e235503460f94b10fc3/html5/thumbnails/24.jpg)
Nuclear Pharmacy’s Role in the FDA Bar Code Rule
• Wait until 2007 to include radiopharmaceuticals?• Continue to hold patient safety as a top priority• Approach radiopharmaceutical manufacturers to
implement• Request FDA to eliminate exemption