FDA Bar Code Rule

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FDA Bar Code Rule

• Richard A. Nickel, M.S., R.Ph.
• Mallinckrodt Inc.
• St. Louis, MO

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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

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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)

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• 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

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NDC Number
NDC Number
Rx Number
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• 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

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• 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.

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• 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.

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• 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

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• 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

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Pharmacy Processes
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• Net result
• critical opportunity for patient safety
  improvement is missed.
• The nuclear pharmacist is left without one more
  engineering control to reduce/eliminate errors.

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• Recently, another final rule was published in the
  Federal Register that is related to this issue

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• 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)

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• Prescription Drug Marketing Act of 1987
• FDAs 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

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• 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

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• 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

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• Bar Codes Vs. RFID
• Bar Code
• Patent issued in 1952
• RFID
• Patent issued in 1973

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• 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

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• 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)

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• 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

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• 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

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Nuclear Pharmacys 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