DSCSA and NDC-12: Interview with Mark Karhoff, Tencount Consulting

Imitation Nation Podcast No 32 Counterfeit News AUDIO Version

This week's episode of your Counterfeit New podcast, Imitation Nation, is now live! This week we feature news stories on somebody who was writing fake checks on behalf of a whole town, the perils of counterfeit World Cup merchandise, and a segment on a $600 million dollar judgment for the family who lost a loved one to faulty counterfeit airbags.

DSCSA and NDC-12: Interview with Mark Karhoff, Tencount Consulting

In this interview, Mark Karhoff and Shabbir Imber Safdar talk about the groundbreaking warning letter the FDA sent to a small medspa dispenser citing violations of the DSCSA.   They also cover the coming changeover from NDC codes from 10 to 12 digits. Mark says it's a Y2K-level event with nearly infinite downside if not handled correctly.

A Sheriff's recounting of the case of an illegal online pharmacy.

Lt. Justin Wright has decades of experience in law enforcement and is currently at the Ada County, Idaho Sheriff's Office. In this episode, Shabbir and Justin talk about an unusual case involving an illegal online pharmacy mailing fake controlled substances that took a life in the county, and how that was connected to a nationwide investigation. They also touch on the evolution of the illicit drug crisis, where it might be going, and what needs to be done to address it. You can learn more about the Ada County Sheriff's office at https://adacounty.id.gov/sheriff/ [https://adacounty.id.gov/sheriff/] and https://www.facebook.com/adacosheriff.  [https://www.facebook.com/adacosheriff]

The Drug Supply Chain and the Future of Pharmacy Practice

In this episode of the PSM Podcast, host Shabbir Imber Safdar sits down with Jeffrey Bratberg, Clinical Professor of Pharmacy Practice and Clinical Research at the University of Rhode Island College of Pharmacy, to explore a groundbreaking model for expanding access to treatment for opioid use disorder. Dr. Bratberg shares how his early work in infectious disease and harm reduction, particularly expanding access to Narcan, led him to a larger question: why are life-saving addiction medications still so hard to access when pharmacies are located within five miles of most Americans? The conversation centers on an innovative pilot program that allows patients to walk into a community pharmacy and begin treatment with buprenorphine the same day. Instead of waiting weeks for a specialist appointment or navigating complex referral systems, individuals ready for help can leave the pharmacy with medication in hand. Outcomes from this work, published in the New England Journal of Medicine, showed strong patient retention and overwhelming preference for pharmacy-based care. The episode highlights how reducing friction at the critical moment when someone decides to seek treatment can dramatically change trajectories for individuals and families affected by opioid use disorder. Shabbir and Dr. Bratberg also discuss the policy and payment barriers that still limit pharmacists’ ability to practice at the top of their training. From collaborative practice agreements to inconsistent reimbursement models, the regulatory landscape varies widely by state. Through the PharmacyBridge initiative, Dr. Bratberg and his colleagues are mapping these barriers and promoting best practices to help scale pharmacy-based addiction care nationwide.    Learn more about Dr. Bratberg's work at https://www.pharmacybridge.org/ [https://www.pharmacybridge.org/].  Visit https://www.safemedicines.org/ [https://www.safemedicines.org/] to learn more about drug safety and see our other podcasts!

The Doses He Never Should Have Missed

What happens when the medication you depend on to prevent a medical emergency suddenly doesn’t arrive? In this episode of the PSM Podcast, host Shabbir Imber Safdar sits down with Donovan Guerrero, a 25-year-old engineering student living with Hemophilia A. Born with less than 1% of the clotting factor his body needs, Donovan relies on consistent preventive treatment to avoid dangerous internal bleeds.   After his insurer implemented an alternative funding program, Donovan’s regular shipments of preventive factor were interrupted. What followed was a year of uncertainty, missed doses, mounting anxiety, and three hospitalizations, including one on Christmas Day. At one point, he required 16 doses of emergency treatment in just three days to manage a suspected bleed that prevention likely would have avoided.   Shabbir and Donovan unpack how alternative funding programs work, why removing drugs from formularies can destabilize patients who rely on specialty medications, and how cost-containment strategies can end up increasing overall healthcare spending when prevention is replaced with emergency care. They also discuss the emotional toll of living month to month without knowing whether life-sustaining medicine will arrive on time.   Learn more about bleeding disorders at https://www.bleeding.org/ [https://www.bleeding.org/], and learn more about AFPs at https://www.safemedicines.org/2024/04/afps-offshoring-patients-importing-risks.html [https://www.safemedicines.org/2024/04/afps-offshoring-patients-importing-risks.html].