Counterfeit Prescription Drugs
U.S. Drug Distribution System <ul><li>Reputation </li></ul><ul><ul><li>Safest in the World </li></ul></ul><ul><li>Federal ...
FDA Personal Importation Policy <ul><li>Patient with serious medical condition </li></ul><ul><li>Under Direct Physician Su...
FDA Counterfeit Problem <ul><li>Case Count </li></ul><ul><ul><li>1997  Six cases </li></ul></ul><ul><ul><li>1998  Four cas...
<ul><li>Recently the FDA ordered three medicines from “Canada” </li></ul><ul><li>When they arrived one thing was clear….. ...
After receiving a spam email from a Web site offering cheaper generic drugs from Canada, the FDA ordered &quot;Ambien, Lip...
The FDA called the Web Site twice to find out where they are based. The 1st answer the USA. The 2nd answer they were told ...
The FDA checked the credit card company and was told that a company in St. Kitts received payment. The FDA tested the prod...
<ul><li>Where did the medicines come from? </li></ul><ul><li>What exactly is in them? </li></ul><ul><li>Getting medicines ...
Defining Counterfeits <ul><li>No active ingredients </li></ul><ul><li>Incorrect amount of active ingredients </li></ul><ul...
Dangers of Illegal Drug Importation <ul><li>Counterfeit </li></ul><ul><li>Allergic reactions </li></ul><ul><li>Improper me...
Importation By the Numbers <ul><li>If all USA residents bought their rx drugs from Canada that nation’s supply would be ex...
Did you know……. <ul><li>Canada doubled the value of its drug imports since 1999 from 2.4 billion to 4.7 billion last year....
Did you know….. <ul><li>Health Canada will not guarantee the safety of medicines shipped outside its borders, and the FDA ...
Effective and Timely Change? <ul><li>“What drives patients to illegally import drugs from countries where they are afraid ...
Anti Drug Counterfeit Strategy <ul><li>FDA Actions </li></ul><ul><li>Manufacturers </li></ul><ul><li>Distribution System <...
NABP Consumer Incidents <ul><li>Consumer Fraud </li></ul><ul><ul><li>Delayed/no delivery </li></ul></ul><ul><li>Bait & Swi...
Suspect Counterfeit Drugs <ul><li>Voluntary Reporting  </li></ul><ul><li>FDA MedWatch </li></ul><ul><ul><li>1-800-332-1088...
Caveat  Emptor Let the Buyer Beware
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Counterfeiting prescription drugs

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Counterfeiting prescription drugs

  1. 1. Counterfeit Prescription Drugs
  2. 2. U.S. Drug Distribution System <ul><li>Reputation </li></ul><ul><ul><li>Safest in the World </li></ul></ul><ul><li>Federal Food, Drug and Cosmetic Act </li></ul><ul><ul><li>Overseen by the FDA </li></ul></ul><ul><ul><ul><li>FDA Approval Process </li></ul></ul></ul><ul><ul><li>Prohibits interstate </li></ul></ul><ul><ul><li>Importation shipping </li></ul></ul><ul><li>Closed System </li></ul>
  3. 3. FDA Personal Importation Policy <ul><li>Patient with serious medical condition </li></ul><ul><li>Under Direct Physician Supervision </li></ul><ul><li>Drug unapproved in the USA </li></ul><ul><li>Maximum 3 month supply </li></ul><ul><li>Effective treatment NOT available domestically </li></ul><ul><li>Drug NOT available in the USA </li></ul>
  4. 4. FDA Counterfeit Problem <ul><li>Case Count </li></ul><ul><ul><li>1997 Six cases </li></ul></ul><ul><ul><li>1998 Four cases </li></ul></ul><ul><ul><li>1999 Six Cases </li></ul></ul><ul><ul><li>2000 Six Cases </li></ul></ul><ul><ul><li>2001 20 cases </li></ul></ul><ul><ul><li>2002 22 cases </li></ul></ul><ul><li>Recent Counterfeits </li></ul><ul><ul><li>2002 </li></ul></ul><ul><ul><ul><li>Epogen/Procrit </li></ul></ul></ul><ul><ul><ul><li>Zyprexa/Serostim </li></ul></ul></ul><ul><ul><ul><li>Diflucan </li></ul></ul></ul><ul><ul><li>2003 </li></ul></ul><ul><ul><ul><li>Procrit </li></ul></ul></ul><ul><ul><ul><li>Lipitor/Viagra </li></ul></ul></ul>
  5. 5. <ul><li>Recently the FDA ordered three medicines from “Canada” </li></ul><ul><li>When they arrived one thing was clear….. </li></ul>..... they were not from Canada!
  6. 6. After receiving a spam email from a Web site offering cheaper generic drugs from Canada, the FDA ordered &quot;Ambien, Lipitor and Viagra&quot; Medicines arrived post marked from Dallas, but with a return address of Miami.
  7. 7. The FDA called the Web Site twice to find out where they are based. The 1st answer the USA. The 2nd answer they were told Belize. The FDA checked the computer server for the Web site and discovered it's in China.
  8. 8. The FDA checked the credit card company and was told that a company in St. Kitts received payment. The FDA tested the products: Ambien had too much medication. Lipitor and Viagra had too little medication and too many impurities.
  9. 9. <ul><li>Where did the medicines come from? </li></ul><ul><li>What exactly is in them? </li></ul><ul><li>Getting medicines from Canada isn’t the answer, but it does raise a lot of questions. </li></ul><ul><li>SOURCES-- </li></ul><ul><li>US Senate Drug Importation Hearings: Health, Education, Labor & Pensions Committee May 20 th , 2004 & Judiciary Committee July 14 th , 2004 </li></ul><ul><li>US Food and Drug Administration: FDA Tests Results of Prescription Drugs from Bogus Canadian Website Show All Products Are Fake or Substandard July 13 th 2004. </li></ul>
  10. 10. Defining Counterfeits <ul><li>No active ingredients </li></ul><ul><li>Incorrect amount of active ingredients </li></ul><ul><li>Wrong ingredients </li></ul><ul><li>High levels of impurities </li></ul><ul><li>Expired products </li></ul><ul><li>Stored at wrong temperature </li></ul><ul><li>Stored under unsafe conditions </li></ul>
  11. 11. Dangers of Illegal Drug Importation <ul><li>Counterfeit </li></ul><ul><li>Allergic reactions </li></ul><ul><li>Improper medical supervision </li></ul><ul><li>Consumer Protection Laws </li></ul><ul><ul><li>HIPAA </li></ul></ul><ul><li>Safety and Liability </li></ul><ul><li>Potential Venue </li></ul><ul><ul><li>Organized crime/terrorism </li></ul></ul>
  12. 12. Importation By the Numbers <ul><li>If all USA residents bought their rx drugs from Canada that nation’s supply would be exhausted in 38 days. </li></ul><ul><li>If just ½ of the elderly in the USA were to buy drugs from Canada, it would have to boost its drug supply by 2.5 times. </li></ul>
  13. 13. Did you know……. <ul><li>Canada doubled the value of its drug imports since 1999 from 2.4 billion to 4.7 billion last year. In 2003, 44% of those drugs came for the USA. The rest came from over 80 countries, including Ireland, Italy, Mexico, India, Cuba, Colombia and Guyana. </li></ul>
  14. 14. Did you know….. <ul><li>Health Canada will not guarantee the safety of medicines shipped outside its borders, and the FDA does not have the fiscal wherewithal to manage Canadian imports. </li></ul><ul><li>A Prudential Financial report disclosed Canada initially purchases from Bulgaria, Singapore, Argentina, South Africa and Pakistan. </li></ul>
  15. 15. Effective and Timely Change? <ul><li>“What drives patients to illegally import drugs from countries where they are afraid to drink the water, but not afraid to put their lives in the hands of unregulated drug distributors?” </li></ul><ul><li>“If the importation of drugs from Canada is unsafe, then show us the bodies!” </li></ul>
  16. 16. Anti Drug Counterfeit Strategy <ul><li>FDA Actions </li></ul><ul><li>Manufacturers </li></ul><ul><li>Distribution System </li></ul><ul><li>RFID Technology </li></ul><ul><ul><li>Digital Electronic Pedigree </li></ul></ul><ul><li>Counterfeit Alert Network </li></ul>
  17. 17. NABP Consumer Incidents <ul><li>Consumer Fraud </li></ul><ul><ul><li>Delayed/no delivery </li></ul></ul><ul><li>Bait & Switch </li></ul><ul><li>Incorrect Charges $ </li></ul><ul><li>No/invalid prescription </li></ul><ul><li>Foreign Language Label </li></ul><ul><li>Drug switching/wrong product </li></ul><ul><li>Duplicate therapy </li></ul><ul><li>Appear to be in Canada, based elsewhere </li></ul>
  18. 18. Suspect Counterfeit Drugs <ul><li>Voluntary Reporting </li></ul><ul><li>FDA MedWatch </li></ul><ul><ul><li>1-800-332-1088 </li></ul></ul><ul><ul><li>www.fda.gov/medwatch/safety </li></ul></ul><ul><li>Contact Manufacturer </li></ul><ul><li>Nation Boards of Pharmacy </li></ul><ul><ul><li>www.nabp.org </li></ul></ul>
  19. 19. Caveat Emptor Let the Buyer Beware
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