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DONALD SULLIVAN RPH., PHD., AND THE FOLSON AMICUS BRIEF
This episode is also available as a blog post: https://youarewithinthenorms.com/2020/06/09/the-folson-amicus-brief/
BACKGROUND
As far as can be determined as a practicing Pharmacist who is not an attorney the Red Flags of Diversion gained the most traction in the Holiday CVS, L.L.C., d/b/a CVS/Pharmacy Nos. 219 and 5195 cases.
However, in that case, the Pharmacies in question were regular chain drug stores but Pronto Pharmacy is a specialty pharmacy that specializes in pain management and compounding. Therefore, they are in different classes. It’s like the difference between a general practitioner and a surgeon.
True, they are both doctors, but their level of training is not the same and the selection of patients is not the same. A general practitioner might be able to stitch you up after a fall but removing your gall bladder would clearly be beyond his scope of practice. With that in mind consider that Dr. Clement has advanced training in therapeutics, pain management, Dentistry, Forensics, and more than 45 years, experience, and the typical CVS Pharmacist has less than 5 years, experience.
The business model for CVS focuses on high-speed production and Pronto Pharmacy is focused on disease state management. And, just like people might travel long distances to seek out a surgeon that has a high level of training and a history of positive outcomes the same would be true of Pronto Pharmacy. You would be hard-pressed to find a CVS Pharmacist that could have the time to investigate chronic pain treatment modalities and how they impact severely compromised patients.
However, Dr. Clement has numerous sources of information that the typical Pharmacist would not be aware of. As a Clinical Pharmacist, I have seen some of his vast library of information and was suitably impressed. So, things that might be a “red flag” to the inexperienced Pharmacist are little more than a footnote for us. Many of our patients have been on service for many years so the red flags may have been resolved years or even decades ago. Therefore, the documentation of the same might not be captured by an investigator that does not interview the patient, the Physician, or the Pharmacist. Often, the pertinent information is archived.
In the Holliday CVS case one issue was the dispensing of narcotic prescriptions from prescribers with expired or revoked DEA registrations. This did not happen at Pronto Pharmacy.
HIGH DOSE OPIOIDS
At trial, the expert witness for the DEA, Dr. Donald Sullivan contended that the Oxycodone and Hydrocodone were the highest available dosage form. However, this is misleading in the world of pain management. Many states require that the prescriptions for C-2 narcotics contain a maximal daily dose, and in the Holliday CVS case, the maximum daily dose for Oxycodone was 6 tablets of 30mg which is 180 mg per day. I have seen this dose in several states, and it is considered the top of the Oxycodone range for severe pain.
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By Norman J ClementThis episode is also available as a blog post: https://youarewithinthenorms.com/2020/06/09/the-folson-amicus-brief/
BACKGROUND
As far as can be determined as a practicing Pharmacist who is not an attorney the Red Flags of Diversion gained the most traction in the Holiday CVS, L.L.C., d/b/a CVS/Pharmacy Nos. 219 and 5195 cases.
However, in that case, the Pharmacies in question were regular chain drug stores but Pronto Pharmacy is a specialty pharmacy that specializes in pain management and compounding. Therefore, they are in different classes. It’s like the difference between a general practitioner and a surgeon.
True, they are both doctors, but their level of training is not the same and the selection of patients is not the same. A general practitioner might be able to stitch you up after a fall but removing your gall bladder would clearly be beyond his scope of practice. With that in mind consider that Dr. Clement has advanced training in therapeutics, pain management, Dentistry, Forensics, and more than 45 years, experience, and the typical CVS Pharmacist has less than 5 years, experience.
The business model for CVS focuses on high-speed production and Pronto Pharmacy is focused on disease state management. And, just like people might travel long distances to seek out a surgeon that has a high level of training and a history of positive outcomes the same would be true of Pronto Pharmacy. You would be hard-pressed to find a CVS Pharmacist that could have the time to investigate chronic pain treatment modalities and how they impact severely compromised patients.
However, Dr. Clement has numerous sources of information that the typical Pharmacist would not be aware of. As a Clinical Pharmacist, I have seen some of his vast library of information and was suitably impressed. So, things that might be a “red flag” to the inexperienced Pharmacist are little more than a footnote for us. Many of our patients have been on service for many years so the red flags may have been resolved years or even decades ago. Therefore, the documentation of the same might not be captured by an investigator that does not interview the patient, the Physician, or the Pharmacist. Often, the pertinent information is archived.
In the Holliday CVS case one issue was the dispensing of narcotic prescriptions from prescribers with expired or revoked DEA registrations. This did not happen at Pronto Pharmacy.
HIGH DOSE OPIOIDS
At trial, the expert witness for the DEA, Dr. Donald Sullivan contended that the Oxycodone and Hydrocodone were the highest available dosage form. However, this is misleading in the world of pain management. Many states require that the prescriptions for C-2 narcotics contain a maximal daily dose, and in the Holliday CVS case, the maximum daily dose for Oxycodone was 6 tablets of 30mg which is 180 mg per day. I have seen this dose in several states, and it is considered the top of the Oxycodone range for severe pain.