Drug Safety and Risk Management Advisory Committee May 5, 2004

1
Drug Safety and Risk Management Advisory
CommitteeMay 5, 2004

• Low Density Polyethylene Vials (LDPE)
• Paul Seligman, M.D., M.P.H.
• Director
• Office of Pharmacoepidemiology Statistical
  Science

2
LDPE Current Labeling Techniques

• Emboss/deboss LDPE containers
• Printed and elongated bottom tabs to LDPE
  container
• Paper label
• Shrink wrap labels

3
LDPE Current Labeling Techniques

• Tactile recognition (use of textures on LDPE
  vial)
• Glass vials
• Unit package overwrap (printed foil pouch
  containing one embossed LDPE vial)

4
LDPE Issues for Discussion

• Please identify creative solutions or alternative
  packaging designs that improve legibility and
  address the problem of ingress of chemical
  contaminants and at the same time, do not create
  additional problems.

5
LDPE Issues for Discussion

• Please consider which stakeholder groups
• manufacturers, practitioners, consumers, etc.,
  can best advise the FDA about possible new
  packaging configurations that may resolve these
  issues.

6
LDPE Issues for Discussion

• Given what you have heard today, please describe
  an appropriate course of action to address the
  problem of ingress and medication errors due to
  legibility and similar packaging.