Proxsys Rx

AUGUST 28, 2024

Customized 340B software should be able to automatically document the journey of every eligible prescription written — from the providers to the retail and specialty contract pharmacies, and from billing to claiming-and-qualifying for 340B reimbursement. Don’t expect submitted eligible dispenses to get you 340B price access.

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Proxsys Rx

APRIL 19, 2024

Between late 2019 and the end of 2023, ProxsysRx’s 340B Support program went from Zero to more than $500 million in savings generated for the hospitals and health systems we serve. What we’ve learned. What it means for your 340B program. Nevertheless, notes Chance, “There’s a lot going on in the regulatory area at the state level.”

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GMPSOP

MARCH 3, 2024

Cross contamination is dangerous in pharmaceutical industry as it can severely compromise patient safety if the content is not pure and the product package differs from what is written on the label. – In 2019, the FDA publicly reprimanded 21 companies for cross-contamination. Additional documents included each month.

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Health and Personal Care Stores Packaging Labelling Documentation 52

pharmaphorum

AUGUST 16, 2021

Thankfully, paper-based studies are becoming a thing of the past, but spreadsheets and Word documents are still commonly used to design and build trials. In 2019, Formedix collaborated with a UK-based consortium interested in observing early safety data. This gives great risk for human error and misinterpretation.

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Quality Matters

JUNE 14, 2023

Beyond addressing proper documentation, storage, and transportation, GDPs incorporate appropriate mitigation strategies to control the foreseeable risks. Pre-pandemic, quality problems were responsible for the vast majority of drug shortages – at over 60% – according to a 2019 FDA analysis.

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Pharma in Brief

JANUARY 9, 2022

In 2019, the federal government introduced amendments to the Patented Medicines Regulations (the Amendments ). The Court noted that many of the documents excluded by the FC were not confidential and could be disclosed, and remitted the matter for redetermination on several issues (see here ). b) Continued changes to the PMPRB.

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The Thyroid Pharmacist

JULY 29, 2022

Feel free to use my own health timeline as a guideline to document your health journey. Most filter manufacturers have pictures on their filter packaging that indicate what they will and will not filter, along with the MERV rating. 2019 Apr 5;367:188-193. Published 2019 Sep 16. 2019 Apr 5;367:188-193.

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FDA Law Blog: Biosimilars

SEPTEMBER 30, 2024

Penalties for “Misclassification” The Medicaid Services Investment and Accountability Act of 2019 added new penalties to the Medicaid rebate statute for knowingly misclassifying a covered outpatient drug. The most noteworthy are the following: 1. See 42 U.S.C. 1396r-8(b)(3)(C)(iii).

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Pharmacy Friday Pearls

AUGUST 29, 2022

mmol/L) There was no documented blood glucose concentration <100 mg/dL recording during the first 12 hrs of HIET. Stellpflug S.J., & Kerns II W (2019). Insulin [Lexi-drugs] Dextrose injection package insert High dose insulin therapy. Intensive care medicine , 33 (11), 2019–2024. Greene et al., References.

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RX Note

FEBRUARY 23, 2023

Figures - Elemental iron and calcium content?

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HIV Treatment and Prevention Agents Community Pharmacies Labelling Chemotherapy 58