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FDA Mandates Major Opioid Label Revisions to Highlight Long-Term Risks

Pharmacy Times

Labels now emphasize the risks of higher doses and caution against abrupt discontinuation in dependent patients to prevent withdrawal and other harms. Expanded warnings include interactions with CNS depressants and rare outcomes like esophageal dysfunction, aligning with CDC's 2022 opioid prescribing guidelines.

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NHC Submits Comments on CMS Draft Guidance for IPAY 2028

Putting Patients First Blog

At the same time, the NHC recommends that CMS avoid incorporating the MFP into ASP calculations, as doing so could depress reimbursement rates across both Medicare and commercial markets, compounding access risks and straining provider viability. 15 Inflation Reduction Act of 2022 , Pub. 1818 (2022). 6 (June 2022): e2215227.

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Understanding Recent Changes to 505(b)(2) Drugs and Reimbursement

Pharmacy Times

Additionally, ANDA submissions should extrapolate the RLD safety and effectiveness data for drugs with the same active ingredients, dosage forms, strengths, routes, and labeling. In 2022, CMS reevaluated 505(b)(2) drugs in relation to section 1847A of the Social Security Act (SSA). This went into effect in January 2022.”

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Researchers Evaluate Infection Control Challenges During an RSV Outbreak in a Cognitively Impaired Population

Pharmacy Times

1 RSV Outbreak in Long-Term Care Facility Researchers assessed the RSV outbreak that occurred in a long-term care facility in 2022 to identify successful strategies that other facilities can apply in similar situations.

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Emerging Weight Loss Drugs: Get Ready For Disruption

pharmacy mentor

Mounjaro was approved by the FDA in 2022, and by mid-2023 it was already widely used off-label for weight loss in the US. Its unique compound design may offer a differentiated safety profile and more consistent absorption. It wasnt until December 2024 that tirzepatide was authorised for weight management in the UK.

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Pharmacy Focus: Importance of Mental Health for Patients and Pharmacists Alike

Pharmacy Times

Hillary Blackburn Pharmacy Focus Episode 40: Holistic Wellness for Oncology Patients Pharmacy Focus Episode 41: Medication Adherence Best Practices Pharmacy Focus Episode 42: Current Mental Health Treatment Needs Pharmacy Focus Episode 43: Financial Wellness FAQ with Tim Ulbrich BONUS: APhA 2022 feat.

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Ropeginterferon Alfa 2b Is Well-Tolerated, Efficacious in Treatment of Prefibrotic Myelofibrosis

Pharmacy Times

2-5 In the multicenter, phase 2, open-label prospective study, researchers investigated ropeg-IFN-α2b treatment in patients with profibrotic MF or DIPSS low-intermediate-1 risk MF. Updated October 6, 2022. With phase 3 trial win, PharmaEssentia plots label expansion for rare blood cancer treatment Besremi. REFERENCES 1.