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Drug Shortages in Pediatric Oncology

This article discusses the recent shortages of important drugs in pediatric oncology, the reasons for these shortages, and suggests solutions.

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Drug Shortages in Pediatric Oncology

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  1. Drug Shortages in Pediatric OncologyMarch 2006 ODAC Wayne Rackoff, M.D. Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

  2. Introduction • Important drugs • Recent shortages • Reasons for shortages • Manufacturing issues • Problems unique to pediatric oncology • Suggestions

  3. Important Drug List (COG IAC Meeting 2003)

  4. Recent Shortages(9 Feb 2006, CDER website) • Ongoing (6 drugs total) • Oncology • BCNU • Resolved (13 drugs total) • Oncology • Flourouracil • Methotrexate

  5. Reasons for Shortages(Am J Health-Syst Pharm, 2002;59:2173-82) • Manufacturing • Communication • Economics • Distribution and use • Regulation and enforcement

  6. Manufacturing • Raw materials shortages • Regulatory issues • Batch failures • Limited worldwide manufacturing capacity for cytotoxics

  7. Manufacture & Release Timeline (Typical Batch of an Oral Pharmaceutical) Ship Supplies QA Release Labeling Packaging QC Release Testing Manufacture Bulk Supplies Prepare Batch Records 0 2 4 6 8 10 12 14 16 Time (Weeks)

  8. Communication • No lead time for other manufacturers when one leaves the market • Single source may leave the market without warning • Pediatric oncology not tracked very well • Level of use is low in absolute terms • Level of use may spike with a new treatment protocol • Lack of contact with manufacturers

  9. Pediatric Oncology • Small population • Difficult for manufacturers to track • Older drugs • Little contact with pediatric oncology providers • Spikes in use related to protocol-based treatment • Can not be anticipated without communication

  10. Fall 2002 COG Meeting • Establish points of contact at each company that manufactures a drug critical to pediatric oncology • Establish a line of communication between FDA-ODSM to • obtain and disseminate information on shortages and the management plan in effect • establish COG input into management plan • Establish communication with PharMA

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