Transcript FDA Bar Code Rule

FDA Bar Code Rule
Richard A. Nickel, M.S., R.Ph.
Mallinckrodt Inc.
St. Louis, MO
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
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)
Drug Mfr
Wholesaler/Drug Distributor
Pharmacy
Patient
• 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
Drug Mfr
NDC Number
Wholesaler/Drug Distributor
NDC Number
Pharmacy
Rx Number
Patient
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
FDA Bar Code Rule
FR 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.
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 statelicensed pharmacy, and,
• The perceived value of a bar code in a nuclear
pharmacy.
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
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
Pharmacy Processes
Dispense
Scan The Vial
Bill Of Lading
Stage
Ship
Select Orders, Generate
And Print Documents
BOL
Select Items To Deliver
And Mark Them Shipped
Scan The Case ID
Scan The Rx
Packing
Slip
Scan The BOL and
Package ID
Dispense Rx
Bar Code
Sheet
Scan each Pig
Scan Customer
Luggage Tag To
Confirm
Deliver
Driver Delivers
Product
Net result…
…critical opportunity for patient safety
improvement is missed.
The nuclear pharmacist is left without one
more engineering control to
reduce/eliminate errors.
Recently, another final rule was published in
the Federal Register that is related to this
issue
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)
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
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
RFID
• Ubiquitous (almost)
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Employee ID badges used for access
Computer access (e.g. Xyloc)
Mobil Speedpass
PA and NJ turnpike EZPass
“Pet Chips” used in companion animals
Bar Codes Vs. RFID
• Bar Code
– Patent issued in 1952
• RFID
– Patent issued in 1973
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
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..
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Gillette razors (recently purchased 500 million)
VISA Smart Cards
Michelin tires (embedded) mfrs 800,000 tires/day
Euro notes (embedded)
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
Bar Codes Vs. RFID
• Incentives for electronic pedigree
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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
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