from youarewithinthenorms.com
NORMAN J CLEMENT RPH., DDS, NORMAN L. CLEMENT PHARM-TECH, MALACHI F. MACKANDAL PHARMD, BELINDA BROWN-PARKER, IN THE SPIRIT OF JOSEPH SOLVO ESQ., INC., SPIRIT OF REV. IN THE SPIRIT OF WALTER R. CLEMENT BS., MS, MBA. HARVEY JENKINS, MD, PH.D., IN THE SPIRIT OF C.T. VIVIAN, JELANI ZIMBABWE CLEMENT, BS., M.B.A., IN THE SPIRIT OF THE HON. PATRICE LUMUMBA, IN THE SPIRIT OF ERLIN CLEMENT SR., EVELYN J. CLEMENT, WALTER F. WRENN III., MD., JULIE KILLINGSWORTH, RENEE BLARE, RPH, DR. TERENCE SASAKI, MD LESLY POMPY MD., CHRISTOPHER RUSSO, MD., NANCY SEEFELDT, WILLIE GUINYARD BS., JOSEPH WEBSTER MD., MBA, BEVERLY C. PRINCE MD., FACS., NEIL ARNAND, MD., RICHARD KAUL, MD., IN THE SPIRIT OF LEROY BAYLOR, JAY K. JOSHI MD., MBA, AISHA GARDNER, ADRIENNE EDMUNDSON, ESTER HYATT PH.D., WALTER L. SMITH BS., IN THE SPIRIT OF BRAHM FISHER ESQ., MICHELE ALEXANDER MD., CUDJOE WILDING BS, MARTIN NJOKU, BS., RPH., IN THE SPIRIT OF DEBRA LYNN SHEPHERD, BERES E. MUSCHETT, STRATEGIC ADVISORS
These segment from Democracy Now and Jonella Elgaway explores the less-discussed issue of PDMP and the underprescribing opioids for patients with chronic pain, a consequence of updated federal guidelines aimed at curbing the opioid crisis.
While intended to prevent addiction in new cases, these guidelines have been broadly applied, leading to patients who previously managed severe, complex conditions responsibly having their medication reduced or discontinued.
This has resulted in worse pain and quality of life for many, with some even considering suicide due to inadequate pain management and a lack of viable, accessible alternative treatments and support systems.
THE MME
A significant limitation is the lack of a universally standardized method for calculating MME per day, despite its widespread use in guidelines and regulations.
The conversion factors used to determine equivalent analgesic effects have been adopted to also represent toxicological risks, even though they are based on pain relief and not necessarily on overdose risk.
Different definitions of “day” in the “MME per day” calculation can lead to substantial variations in the determined daily dose for the same patient, potentially misclassifying patients as high-dose or not.
Algorithms based solely on data related to opioid dispensing and use, without considering patient characteristics, benefits of treatment, or alternative sources of opioids, are inherently biased towards finding “risk of harm.”
PDMP RISK OF HARM
This collection of documents primarily focuses on Prescription Drug Monitoring Programs (PDMPs) and their increasing integration with artificial intelligence and predictive modeling, particularly concerning opioid prescriptions.
BACKGROUND
What role does the FDA play in regulating PDMP software and what are some key considerations regarding its oversight?
The FDA is responsible for ensuring the safety and effectiveness of medical devices, which includes “Software as a Medical Device” (SaMD) that provides clinical decision support (CDS). PDMP software that analyzes patient-specific data to identify risks of substance misuse, predict the likelihood of developing a substance use disorder, or suggest diagnoses can be considered a medical device subject to FDA regulation.
The FDA distinguishes between “Device” and “Non-Device” CDS based on criteria outlined in the 21st Century Cures Act. Software that provides specific diagnostic or treatment outputs or directives, rather than just supporting or recommending, is generally considered a device.
For PDMP software that falls under the device category, the FDA has enforcement authority over misbranded devices, which can include those not properly registered or listed.
Transparency regarding the algorithms, data inputs, and validation used by these software systems is crucial for healthcare providers to independently evaluate the basis of the recommendations and to ensure they are not replacing their own clinical judgment.
A key theme is the potential for bias within these systems, as algorithms often prioritize identifying “aberrant behavior” linked to fraud and abuse based on limited data points like dosage and frequency, while failing to account for appropriate medical use or positive patient outcomes.
The source also highlights efforts to broaden third-party payer access to PDMP data to potentially reduce costs and improve care, alongside concerns about data privacy, security, and the need for transparent data sharing protocols and rigorous evaluation of these complex systems.
This article features a panel discussion exploring the impact of Prescription Drug Monitoring Programs (PDMPs), which are electronic databases tracking controlled substance prescriptions now used in all 50 states.
While originally intended to combat the opioid crisis by deterring “doctor shopping” and reducing prescription volumes, speakers argue that these programs have limitations and unintended consequences, including potentially harming patients by creating barriers to necessary pain treatment and driving them to illicit substances.
Conclusion
The excerpts reveal a complex and multifaceted debate surrounding PDMPs. While intended to combat the opioid crisis, concerns are raised about their effectiveness, potential harm to patients with legitimate pain, privacy violations, and the blurring of lines between healthcare and law enforcement.
The speakers emphasize the need for further research, stronger legal protections, and a more nuanced approach that balances the goals of reducing opioid misuse with the need to treat pain appropriately and respect patient rights.
OR SEND
TO CASH APP:$docnorm
ZELLE 3135103378
ALL WATCHED OVER BY MACHINES OF LOVING GRACE
BE SURE TO DONATE TO THE MARK IBSEN GOFUNDME DEFENSE FUND, WHERE THE SON ALWAYS RISES!!!
FOR NOW, YOU ARE WITHIN
THE NORMS
