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Prescribing Red Flags and Suspicious Controlled Substance Orders: Current Cautionary Tales

FDA Law Blog

The government asserted additional allegations that are outside our scope. Prescribing Red Flags The government alleged that from at least 2017 to April 2021 Defendants knowingly filled controlled substance prescriptions “that raised obvious ’red flags’ of potential abuse or diversion.” Zarzamora Press Release. Holiday CVS, L.L.C.

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Risking It All For a New Business Model at Family Physicians of St. Joe

Family Physicians of St. Joseph

Larger companies now dominate the healthcare landscape, yet through innovation and a dedication to exceptional patient care, Family Physicians of St. They have remained independent and committed to caring for patients as a small practice, all the while introducing new ideas and setting new standards in Michigan’s Great Southwest.

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Prescribing Red Flags: Pharmacists Be Wary of What the Doctor Orders

FDA Law Blog

86, 72703 (December 22, 2021), DEA emphasized in the Gulf Med decision that prescribing [r]ed flags are circumstances surrounding a prescription that cause a pharmacist to take pause, including signs of diversion or the potential for patient harm. Patients filling prescriptions at the same time at multiple pharmacies. 81, 86, 251.

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News on FDA’s Quality Management Maturity Program-Maturity to Continually Improve and to not be Reactive

FDA Law Blog

In this report, it’s stated that 62% of drug shortages reported between 2012 and 2017 were due to quality issues which is attributed in part to a lack of recognition or reward for manufacturers with mature quality management systems that focus on continuous improvement and early detection of supply chain issues.

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FDA’s Issues Draft Guidance on Accelerated Approval: A Substantial Evidentiary and Procedural Overhaul to this High-Profile Pathway

FDA Law Blog

Since that time, it was formalized in FDA regulations (21 CFR 314 Subpart H) in 1992, codified in the Food, Drug, & Cosmetic Act by FDAMA (21 USC 356(c)) in 1997, revised by FDASIA in 2012, and described in guidance, most importantly, in the 2014 Expedited Programs for Serious Conditions Drugs and Biologics (2014 Guidance).

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Agitation Podcast Series Episode 2: Non-pharmacologic management of agitated children

PEMBlog

Patient that are agitated should always be treated with dignity and respect. Government. 2012 Jan;109(3):27-32. Structured team approach to the agitated patient in the emergency department. 2012 Feb;13(1):35-40. The combative multitrauma patient: a protocol for prehospital management. Dtsch Arztebl Int.

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Gabapentinoids – Gabapentin and Pregabalin: Tasce Bongiovanni, Donovan Maust and Nisha Iyer

GeriPal

The FDA-approved indications for gabapentin are only for treating patients with partial seizures or postherpetic neuralgia. valproic acid and gabapentin), in nursing homes, particularly patients with Alzheimer’s disease and related dementias. There are a lot of reasons that may explain the massive increase in use of these drugs.