PSM Interchange 2014 Panel 4: Jim Dahl, How the Black Market Impacts Patients

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1. How the Black Market ImpactsPatientsJim Dahl, Board Member, PSM 2. How does the US regulate medicine distributionto keep patients safe?The FDA regulates manufacturers…

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1. How the Black Market ImpactsPatientsJim Dahl, Board Member, PSM 2. How does the US regulate medicine distributionto keep patients safe?The FDA regulates manufacturers ofmedicines wherever the productionfacilities are, in the US and beyond.Wholesalers are regulated by the USstates, each with different rules. Avoluntary cross-state licensing program(VAWD) helps ease license verification. 3. How does the US regulate medicine distribution tokeep patients safe?Doctors, pharmacists and pharmaciespurchase from wholesalers, and arethemselves regulated by each state.Patients are protected by the closed,secure supply chain. Every entity in thechain is answerable to a regulator. 4. How a closed supply chain gets broken● Patients buy directly from unlicensed sources, i.e.flea markets, non-pharmacy stores, individuals orthe Internet.● Wholesalers forge documentation to passcounterfeit drugs off as authentic.● Doctors and pharmacists buy from counterfeitdistributors. 5. How a closed supply chain gets broken● Stolen and partially used medicines are sold assafe drugs through clearinghouses back into thelegitimate supply chain.● Counterfeiters send mass quantities throughcustoms in disguised packages (i.e. speakers fullof fake aspirin) and distribute them to pharmaciesand stores looking for discounted products. 6. How common is black market medicine?Ads for cheap prescriptionmedicines are ubiquitous97% of websites sellingprescription drugs do notfollow safe practices1 in 6 Americans buys drugs on theinternet without a prescription 7. Are we overstating the problem? 8. What is the acceptable risk? 9. Let’s Compare Another Highly RegulatedIndustry: Air Travel 10. In April 2014, IAD and DCA’s average dailycommercial flight operations averaged 1527take offs and landings every day.source: www.mwaa.com/file/ATS_April_2014.pdf 11. What if 1% of those flights (153) had planeswith substandard or counterfeit parts?Would you fly out of IAD or DCA today? 12. What if just 0.1% of the flights in and out of DCAand IAD – just 15 flights - might have a counterfeitpart that could cause a catastrophic event?Would you fly today? 13. (canadian slide) 14. Panelists:● Jim Dahl, Board Member, PSM; Asst. Director of theFDA's Office of Criminal Investigations (retired)● Kimberly New, National Association of Drug DiversionInvestigators● Gaurvika Nayyar, Program Manager for Asia, USPharmacopeia’s Promoting the Quality of MedicinesProgram● Eric Sampson, Advisor to the CDC Foundation