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)

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

• 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

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

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 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.

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.

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

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

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)

– 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..

• 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

– 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