Putting Patients First Blog

JULY 2, 2024

The NHC requests more clarity on how CMS will exclude QALY-based metrics and highlight when they have been removed from consideration in MFP justification documentation. Off-label usage often emerges from real- world clinical practice and patient experiences, which might not be reflected in the guidelines. doi: 10.1016/j.jaad.2020.06.998

Drug Pricing 52

Drug Pricing Insurance Coverage and Processing Labelling HIPAA 52

Pharma in Brief

JANUARY 17, 2021

Pharmascience obtained approval for a 20 mg strength of its product, Glatect ® , in August 2017. The Court found that the prior art documents cited by Pharmascience ( Pinchasi 2007 and Karussis 2006 ) neither disclosed nor enabled the asserted claims of the 437 Patent. Teva argued that Glatect ® 40 mg will infringe Canadian Patents No.

Dosage 52

Dosage Documentation Labelling 52

The Thyroid Pharmacist

JULY 14, 2023

I’m excited to report that since the initial publication of this article in 2017, various individuals and companies have created more accessible, direct-to-consumer devices to provide red light therapy; most of them use LEDs instead of lasers. While lasers have the most research behind them, they’re also the least accessible. doi:10.1089/thy.2010.0102;

Dosage 98

Dosage Immunity Immunization Documentation 98

The Thyroid Pharmacist

JULY 29, 2022

Perhaps more concerning, of the 133 different VOCs found across all tested products, only one, ethanol, was actually listed on any label! (13, For sunscreens and other over-the-counter drugs, fragrances must be identified on the label. But formaldehyde has been labeled as a known human carcinogen by the U.S.

Health and Personal Care Stores 52

Health and Personal Care Stores Compounding Immunization Immunity 52

Pharmaceutical Technology

JANUARY 6, 2023

In 2020, the Federal Trade Commission issued a report regarding settlements reached between brand and generic manufacturers in FY 2017 and noted that “for the first time since [FY] 2004, no settlement agreement in [FY] 2017 contains a no-[authorized generic] AG commitment.”. Gilenya is an oral medication for multiple sclerosis.

Documentation 97

Documentation Hospitals Dosage Drug Pricing 97

The Thyroid Pharmacist

JANUARY 20, 2023

Please consider the following and be sure to read the precautions on individual labels before you try a new herb, supplement, or blend. (In In one small study published in 2017 in the Journal of Complementary Medicine , after eight weeks of treatment, ashwagandha was found to improve serum TSH, T3 and T4 levels, normalizing serum levels. [14]

HIV Treatment and Prevention Agents 98

HIV Treatment and Prevention Agents Diabetes Immunization Immunity 98

FDA Law Blog: Biosimilars

JANUARY 9, 2025

As part of the Food and Drug Administration Safety and Innovation Act (known as FDASIA) and later under the FDA Reauthorization Act of 2017 (known as FDARA), a drug or medical device can be deemed adulterated if a regulated company delays, denies, or limits an inspection, or refuses to permit an entry or inspection.

Documentation 105

Documentation Labelling 105

FDA Law Blog: Biosimilars

DECEMBER 1, 2024

FDA reports that it told the company that “failure to allow photography would be documented as a refusal,” and the company “acknowledged the refusal.” Management, according to the Warning Letter, “stated that the investigators were not allowed to take photographs of the equipment as part of the inspection.”

Documentation 113

Documentation Labelling 113

The Thyroid Pharmacist

FEBRUARY 10, 2023

A few years ago, I had a few clients with documented elevations in prolactin, and I have seen that lowering prolactin levels can help with reducing thyroid antibodies. Studies have, however, documented that bromocriptine, a medication used to lower prolactin levels, can reduce flares in lupus, another autoimmune condition.

Dosage 98

Dosage Documentation Diabetes Labelling 98

RX Note

FEBRUARY 9, 2025

Labelling format Generic name of medication Name of manufacturer or distributor Dosage form, including special designations (e.g. Repackage only one medication at a time Prepare only the number of labels that will be needed for the repackaging run. Do not prepare extra labels.

Packaging 40

Packaging Labelling Dosage Documentation 40

The Thyroid Pharmacist

NOVEMBER 8, 2024

In 2017, I began using the GI-MAP stool test for most clients and recommending it for participants in my Hashimoto’s Self-Management Program. Between 2017 and 2019, my team and I were able to collect and analyze the data from 298 GI-MAP tests. Those added in December of 2017 were: Epstein-Barr Virus Cytomegalovirus Rhodotorula spp.

Immunization 72

Immunization Immunity Diabetes Adverse Reactions 72