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Hello and Welcome to Book of Lies Podcast. Website: www.bookofliespodcast.comPatreon: https://www.patreon.com/BookofliespodcastIG: @bookofliespodcastTwitter/ X @bookofliespodNECC's story is of pure greed and a disregard for others. Tap in for the Tale of New England Compounding Center, and stay for the colonization lesson.We've been watching a lot lately, and the show that shook us both was Baby Reindeer, good job Netflix and thank you for bringing back another season of The Circle. One of Sunni's favorites.Thanks for listening.
For this episode, I am joined by Charles River's Doug Botkin and Pure Microbiology's Abby Roth to discuss the 2012 NECC meningitis outbreak. Doug and Abby bring their background in microbiology to explain how it happened, and how we can prevent such tragedies in the future.
Ever wonder why compounding prescription have so many regulations? This is in large part no thanks to the issues that arose from the New England Compounding Center. Dr. Peter Koshland and Jim Hrncir, specialized compounding pharmacy owners, speak to some of these major issues and what has arisen out of the regulations put in place by the FDA that may actually limit patient care. This is a great deep dive episode in a specialized niche of pharmacy that all pharmacists are trained on in school, but many never took the extra step with. Jim and Peter share some great concerns and bring up great questions about where and who should be regulating the specialized and important niche of compounding pharmacy. FDA Laws: https://www.fda.gov/drugs/human-drug-compounding/compounding-laws-and-policies Good Compounding info and site: https://compounding.com/ Dr. Koshland's pharmacy: https://www.koshlandpharm.com/ https://www.linkedin.com/in/peterkoshland/ Jim's Pharmacy: https://lascolinaspharmacy.com/ https://www.linkedin.com/in/jim-hrncir-rph-8564711a/
Jason Dearen is the author of Kill Shot: A Shadow Industry, A Deadly Disease and an investigative journalist on the national investigative team with the Associated Press.Jason and I talk through the details of his book, which is “the untold story of the worst contaminated drug crisis in U.S. history” and is the true story of the New England Compounding Center. Even being a pharmacist, I didn't know the depth and details of this tragic case until I read the book. You can find details on where to purchase Kill Shot on his website at jasondearen.com. All pharmacists, health care providers, and anyone who identifies as a patient should read Kill Shot!
Dr. Joshua Sharfstein speaks to Jason Dearen, author of the book Kill Shot: A Shadow Industry, A Deadly Disease. The book covers the nationwide meningitis outbreak caused by the New England Compounding Center, which sold medications contaminated with mold and fungi for injection into joints, the spine, and other sterile spaces. They discussed what led to this catastrophe, the legislation that passed in its aftermath, and the future of oversight in this area.
This week, Stacey is joined by Eric Kastango and Kevin Hansen to talk about compounding and specialty pharmacy, regulations, innovations and reputations. Compounding Pharmacists have a very challenging, and rewarding job, in their development of specialized medicines for individualized patient care. For many, there is satisfaction in working to solve the needs of patients through innovative partnership with the patient and their practitioner. Too often professionals in this space are mired by regulatory inconsistencies, special interest groups, lack of transparency and a tarnished reputation, all of which make this highly challenging job even more difficult. Today we will talk about some of the hurdles and opportunities in Compounding. Eric Kastango, Expert Consultant and PharmacistEric has dedicated his life's work to patient safety through better sterile compounding, aseptic manufacturing, lean production, and robust quality management practices. He has practiced pharmacy in hospital, community, and homecare settings in a variety of roles. He was previously Corporate Vice President of Pharmacy Services for CoramHealthcare and also managed a cGMP outsource manufacturing operation for Baxter Healthcare. In addition to his consulting role, Eric continues to serve as a sterile compounding, 503B outsourcing, and patient safety subject matter expert for his clients, the American Society of Health-System Pharmacists, State Boards of Pharmacy, and was one of the key US Department of Justice expert witnesses during the New England Compounding Center trials from 2017-2019. Kevin Hansen, PharmD, Assistant Director of PharmacyMoses H. Cone Memorial HospitalDr. Kevin Hansen is Assistant Director of Pharmacy at Moses H. Cone Memorial Hospital in Greensboro, North Carolina and provides leadership and operational oversite for pharmaceutical compounding and pharmacy perioperative services. He is a preceptor for the Health-System Pharmacy Administration residency program. In addition, Dr. Hansen serves as adjunct faculty for The University of North Carolina Eshelman School of Pharmacy. Within the Moses H. Cone Memorial Hospital, as part of the Cone Health system, Dr. Hansen is involved in several committees and initiatives related to his practice interests of pharmaceutical compounding, handling hazardous drugs, medication and compounding safety, drug shortage management, and pharmacy perioperative services. He is a member of ASHP and the North Carolina Association of Pharmacists (NCAP). He currently serves a leading role through ASHP’sSterile Products Workgroup, as part of the Section of Pharmacy Practice Managers (SPPM). Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
Stacey Bruzzese welcomes Eric Kastango to the show. Today, Stacey and Eric discuss the how FDA has implemented temporary guidelines and how companies can mitigate their risks to consumers and compounding sites.Eric has dedicated his life’s work to patient safety through better sterile compounding, aseptic manufacturing, lean production, and robust quality management practices. has practiced pharmacy in hospital, community, and homecare settings in a variety of roles. He was previously Corporate Vice President of Pharmacy Services for Coram Healthcare and also managed a cGMP outsource manufacturing operation for Baxter Healthcare. In addition to his consulting role, Eric continues to serve as a sterile compounding, 503B outsourcing, and patient safety subject matter expert for his clients, the American Society of Health-System Pharmacists, State Boards of Pharmacy, and was one of the key US Department of Justice expert witnesses during the New England Compounding Center trials from 2017-2019.Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
Scandalous Behavior is back with another episode of intrigue and infuriation. Today's story focuses on the New England Compounding Center and their involvement with a meningitis outbreak that caused catastrophe across the US in 2012.
Top Stories today: Judge in the New England Compounding Center case tosses 2 convictions. Medical examiner testifies on retrial of Canadian couple accused of negligence for 19 month old toddler who died of meningitis in 2012. Phoenix, Arizona teen, Raymond Reed hospitalized in Germany with bacterial meningitis. Thanks so much for listening! If you like this episode, please subscribe to “Meningitis News” and rate and review where you get your podcasts: Apple Podcasts Stitcher Spotify Google Play Follow us on Social Media: Twitter: https://www.twitter.com/newsmeningitis Facebook: https://www.Facebook.com/meningitisnews Instagram: https://www.instagram.com/meningitisnews Remember our Disclaimer, the content in this podcast are intended as general information only and may not be considered as a substitution for professional medical advice, diagnosis or treatment. Support our show by visiting us on Patreon, https://www.patreon.com/meningitisnews To learn more about Meningitis News visit our website, http://www.MeningitisNews.org WhatPods --- This episode is sponsored by · Anchor: The easiest way to make a podcast. https://anchor.fm/app --- Send in a voice message: https://anchor.fm/meningitis-news/message Support this podcast: https://anchor.fm/meningitis-news/support
Top Stories today: Former New England Compounding Center Employees, Michelle Caetano Thomas and Kathy Chin found guilty. Ireland Minister of Health, Simon Harris approves meningitis ACWY vaccine as student prepare to return back to school this Fall. THE Philippine Foundation for Vaccination takes action against meningitis. Thanks so much for listening! If you like this episode, please subscribe to “Meningitis News” and rate and review where you get your podcasts: Apple Podcasts Stitcher Spotify Google Play Follow us on Social Media: Twitter: https://www.twitter.com/newsmeningitis Facebook: https://www.Facebook.com/meningitisnews Instagram: https://www.instagram.com/meningitisnews Remember our Disclaimer, the content in this podcast are intended as general information only and may not be considered as a substitution for professional medical advice, diagnosis or treatment. Support our show by visiting us on Patreon, https://www.patreon.com/meningitisnews To learn more about Meningitis News visit our website, http://www.MeningitisNews.org --- This episode is sponsored by · Anchor: The easiest way to make a podcast. https://anchor.fm/app --- Send in a voice message: https://anchor.fm/meningitis-news/message Support this podcast: https://anchor.fm/meningitis-news/support
Meritless malpractice cases are propelled by a cocktail of emotions. The exact recipe varies. Most frivolous cases are products of greed, spite, and misinformation. Physicians must not underestimate the role fear plays in such cases. Scared patients and predatory attorneys are drawn together like magnets. The 2012 New England Compounding Center meningitis outbreak created a lot of scared patients. And numerous malpractice claims. Not every claim was warranted, though. Today, Jeff and Mike dissect two such malpractice claims that were inspired by fear, not medical neglect. How can physicians protect themselves from "trigger-happy" patients during such outbreaks? And what can physicians do to assuage a patient's fears?
In this episode of Meningitis News, we recap the current trial in the New England Compounding Center Fungal Meningitis case. Prosecutions have been handed down and charges filed for executives at New England Compounding Center for their alleged involvement in a fungal meningitis outbreak that left 64 dead and 700 people ill in more than 20 states, due to contaminated steroid injections. Lead CDC investigator Dr. Benjamin Park testifies that the outbreak was the result of the use of expired ingredients and a failure to properly test the drugs. Support our show by visiting us on Patreon. To learn more about Meningitis News visit our website, http://www.MeningitisNews.org Subscribe to our Facebook Page for daily updates. Follow our host, Daisi on Instagram and Facebook. Thanks so much for listening! If you like this episode, please subscribe to “Meningitis News” and rate and review where you get your podcasts: Apple Podcasts Stitcher Spotify Google Play Follow us on Social Media: Twitter: https://www.twitter.com/newsmeningitis Facebook: https://www.Facebook.com/meningitisnews Instagram: https://www.instagram.com/meningitisnews Remember our Disclaimer, the content in this podcast are intended as general information only and may not be considered as a substitution for professional medical advice, diagnosis or treatment. Support our show by visiting us on Patreon, https://www.patreon.com/meningitisnews To learn more about Meningitis News visit our website, http://www.MeningitisNews.org --- This episode is sponsored by · Anchor: The easiest way to make a podcast. https://anchor.fm/app --- Send in a voice message: https://anchor.fm/meningitis-news/message Support this podcast: https://anchor.fm/meningitis-news/support
How safe are the special drug compounds you take or put in or on your body? Most people, today, think that they are pretty safe but that has not always been the case. Back in 2012, the New England Compounding Center in Framingham, Massachusetts produced 18,000 vials of a contaminated steroid that was distributed across about 20 states. The tainted compound, to date, has sickened 751 people with fungal meningitis and related illnesses. At last total, there were 64 deaths. In 2015, the company reached a $200 million civil settlement to victims and various creditors but, as of today, nothing has been paid. The federal government also has charged company head Barry J. Cadden, 50, with 96 criminal counts including 25 counts for racketeering acts of second-degree murder. A trial began in Boston on January 9 and the jury just started its deliberations on March 17. No verdicts have been reached at the time of this recording. If convicted of the murder counts, Cadden could be facing life in prison. Today, we talk with Ed Zatta, owner of RXQ Compounding LLC about new federal regulations to guarantee the safety of small batch drug compounding. Before the New England Compounding Center disaster, each state regulated its own drug compounding firms. There are a patchwork of different laws and different safety inspection procedures. After the tragedy, 18 states enacted new regulatory laws and the Federal Drug Administration created a new category of compounding called 503 (b) where each drug compound must be tested for sterility, potency, and whether any of its elements exceeded the “Beyond Use Date.” The new federal law began in January 2017 Zatta took advantage of the federal regulations and created a new “outsourcing facility” under the stricter federal guidelines before they were required. It takes extra care and extra procedures to make drug compounds safe, according to Zatta. But, he thinks that the federal regulations ensure quality and safety for unsuspecting consumers. He asserts that the federal guidelines can prevent future tragedies such as the New England Compounding Center disaster.
The recent 2012 fungal meningitis outbreak posed a new learning and treatment opportunity for doctors, researchers and patients.Fungal meningitis is a type of meningitis caused by a fungal infection in your body that spreads through your blood and into your spinal cord. Any person is at risk for fungal meningitis; but if you have a weakened immune system due to surgeries, other diseases or medications, your chances of getting fungal meningitis drastically increase.Fungal meningitis is not contagious and therefore cannot be passed from person to person. But it can have serious symptoms that are often misdiagnosed or looked over.Why are fungal infections so challenging to diagnose and treat?Fungal meningitis can be a challenge for physicians to diagnose since the symptoms are very similar to other common illnesses like the flu. Symptoms can include a fever, headache, nausea and vomiting.However, if you suspect meningitis you can have samples of your blood or cerebro-spinal fluid tested.Recently, there have been new findings on fungal meningitis that have changed the way doctors and researches look and treat the disease.Dr. Thomas M. Kerkering involved his team's findings related to the highly publicized fungal meningitis outbreak of 2012, linked to tainted steroid injections prepared at the New England Compounding Center in Mass.Chief of Infectious Disease at Carilion Clinic, Thomas M. Kerkering, MD shares what fungal meningitis is and the latest findings to help treat fungal meningitis.
The recent 2012 fungal meningitis outbreak posed a new learning and treatment opportunity for doctors, researchers and patients.Fungal meningitis is a type of meningitis caused by a fungal infection in your body that spreads through your blood and into your spinal cord. Any person is at risk for fungal meningitis; but if you have a weakened immune system due to surgeries, other diseases or medications, your chances of getting fungal meningitis drastically increase.Fungal meningitis is not contagious and therefore cannot be passed from person to person. But it can have serious symptoms that are often misdiagnosed or looked over.Why are fungal infections so challenging to diagnose and treat?Fungal meningitis can be a challenge for physicians to diagnose since the symptoms are very similar to other common illnesses like the flu. Symptoms can include a fever, headache, nausea and vomiting.However, if you suspect meningitis you can have samples of your blood or cerebro-spinal fluid tested.Recently, there have been new findings on fungal meningitis that have changed the way doctors and researches look and treat the disease.Dr. Thomas M. Kerkering involved his team's findings related to the highly publicized fungal meningitis outbreak of 2012, linked to tainted steroid injections prepared at the New England Compounding Center in Mass.Chief of Infectious Disease at Carilion Clinic, Thomas M. Kerkering, MD shares what fungal meningitis is and the latest findings to help treat fungal meningitis.
Pharmacy Podcast Show Episode 76 we interview Christian Hartman - PharmD, MBA, FSMSO. Massachusetts Governor Patrick convened the Special Commission to Make an Investigation into and Study of the Oversight of Compounding Pharmacies (the “Commission”) in the Commonwealth in response to the tragic events of the multi-state meningitis outbreak that has been attributed to products from Massachusetts-based New England Compounding Center. The Commission undertook an intensive and focused study of compounding practices in Massachusetts, relying on perspectives from pharmacists, regulators, physicians, epidemiologists, health law practitioners and legislators to protect the public and to minimize the risk of drug shortages. The findings and recommendations put forward by the Commission offer a framework within which policy changes should be contemplated and further studied. The Commission was chaired by Christian A. Hartman, an expert in pharmacy practice and patient safety. See omnystudio.com/listener for privacy information.
Pharmacy Podcast Show Episode 76 we interview Christian Hartman - PharmD, MBA, FSMSO. Massachusetts Governor Patrick convened the Special Commission to Make an Investigation into and Study of the Oversight of Compounding Pharmacies (the “Commission”) in the Commonwealth in response to the tragic events of the multi-state meningitis outbreak that has been attributed to products from Massachusetts-based New England Compounding Center. The Commission undertook an intensive and focused study of compounding practices in Massachusetts, relying on perspectives from pharmacists, regulators, physicians, epidemiologists, health law practitioners and legislators to protect the public and to minimize the risk of drug shortages. The findings and recommendations put forward by the Commission offer a framework within which policy changes should be contemplated and further studied. The Commission was chaired by Christian A. Hartma