PPM Exam 2

  1. Drug shortages in the united states predominantly involve
    generic drugs
  2. there have been dramatic increases in
    the types of drugs in short supply
  3. Recent drugs in short supply
    • epinephrine
    • hydromorphone
    • propofol
    • cancer chemotherapy
  4. Gray market suppliers
    • secondary wholesalers
    • repackage and sell for higher amount to make profit
    • consequences for patient care
  5. FDA and Drug Shortages
    • FDA is criticized for not being as assertive as they should be
    • FDA is criticized for being lax in oversight of drug mfg
    • lack of oversight of precursor chemicals from foreign sources
  6. FDA allows importation of
    • methotrexate
    • doxorubicin
  7. Importing heparin from china
    • need to have more safeguards in place
    • need quality control and GMP to be verified in other countries
  8. FDA regulatory authority reguarding discontinuation of drug manufacture
    • FDA can only ask that mfg will let them know when discontinuing manufacture of a drug
    • cannot mandate
  9. Reimbursement fraud
    • mfg may see these penalties as cost of doing business
    • harms medicare and medicaid recipients
  10. Major issues in mfg
    • breakdown or total absence of quality assurance
    • unstable water used
    • production line problems
    • contamination of products
    • batch mix ups
  11. major issues in supply chain
    • fraud and abuse in pricing by mfg
    • online predators: websites, advertising, foreign sources
    • drug recalls
Card Set
PPM Exam 2
Drug Shortages