If you are like me, your first reaction to the Drug Supply Chain Security Act (DSCSA) was "that couldn't happen in the US... could it?" I attended the IHFDA Annual Meeting in Frisco, TX last week (some really meaty presentations) and listened to a presentation by Shabbi J. Imber Sadfar, the Executive Director of the Partnership for Safe Medicines on counterfeit drugs. The presentation left me shaken... it can, and does happen in the US. While this happens primarily in the retail and internet sectors, it has also happened to hospitals.
Counterfeit drugs enter the US supply chain either by US citizens purchasing drugs from internet pharmacies or by counterfeiters in the US creating counterfeits of commercial drugs that may contain no drugs at all, or drugs other than what the counterfeit purports to be.
- There is no guarantee that a pharmacy that says it is in any location is truly at that location
- Even if the pharmacy is at that location, there is no guarantee that their medication supply is reliable (often intentionally so)
- Canada cannot supply the US with medications; if only 20% of the prescription drug needs came from Canada, its supply of prescription drugs would be exhausted in approximately 7 months!
- While most counterfeiters target physicians and/or clinics, supplies from counterfeiters have included hospitals.
- In 2012, the FDA discovered 2 lots of an imported counterfeit Avastin that contained no active ingredients, that had been sold to over 900 physicians or clinics across the US whose origin was unknown but whose path to the US included trips through Turkey, Switzerland, Denmark and the UK.
It appears that even our opioid crisis is due in many instances to counterfeit drugs:
- It is incredibly cheap for someone to set up a pill making operation making fake drugs that contain nothing, or, often times, fentanyl
- A pill mold that mimics Xanax or Percocet can be purchased online for less than $200; and entire pill press system with molds can be acquired on the web for less than $1,000
- The drugs themselves (especially the fentanyl derivatives) are so potent, and so cheap, that they enter the US through the international mail system
- As of March, 2018, counterfeit pills have been reported found in 43 states, 22 of which have reported deaths from them.
There are things we can do:
- Inform the public about the dangers
- Now that gag clauses are illegal, actively help patients find the best price for their drugs, even if it means paying cash
- Encourage patients not to shop prescriptions, but to shop pharmacies
- DSCSA
- Support stronger border security around international mail.
I came away from this presentation with a sense of urgency around DSCSA. Not only is it the law, it seems now, more than ever, to be the right thing to do.
What do you think?
Dennis A. Tribble, Pharm.D., FASHP
Ormond Beach, FL
DATdoc@aol.com
The opinions expressed herein are my own, and not necessarily those of my employer or of ASHP