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

Pharmacy Times

Suggestions for providers featured in the guidelines include determining if opioids should take place, selecting appropriate dosages, determining prescription length and follow-up, and assessing and reducing risks of misuse, overdose, and opioid use disorder.

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New Frontline BTK Inhibitor Strategy Gains FDA Approval in Untreated Mantle Cell Lymphoma

Pharmacy Times

Pharmacists are well positioned to perform drug interaction checks, counsel patients on adherence and administration, and coordinate supportive care, including prophylaxis for infections (eg, granulocyte colony-stimulating factor, vaccines).

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Continuous Subcutaneous Lenalidomide Shows Promise in Reducing Toxicity in R/R Multiple Myeloma

Pharmacy Times

It will be interesting to see what dosage form these data prompt the future development of. It also introduces a question on how to optimize the PK/pharmacodynamic profile for protein degraders, such as cereblon E3 ligase modulatory drugs and proteolysis-targeting chimeras, which are a burgeoning area of therapeutic development.”

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Pharmacists Can Simplify the Vaccine Schedule

Pharmacy Times

RSV vaccines are recommended for older adults and those with specific health conditions, with options like Arexvy, mResvia, and Abrysvo available. Influenza and COVID-19 vaccines should be administered in the fall, with Novavax approved for specific age groups and health conditions.

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Daily CBD Use at Consumer-Level Doses May Elevate Liver Enzymes, FDA-Led Trial Shows

Pharmacy Times

Animal studies reveal dose-dependent hepatic responses to CBD, supporting the need for cautious monitoring even at consumer-relevant dosages. Clinical trials show low-dose CBD can cause significant liver enzyme elevations in 5.6% of healthy adults, necessitating liver function monitoring.

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The Value of a Medically Integrated Pharmacy to Maximize Cost Avoidance and Reduce Waste of Oral Oncolytic Medications

Pharmacy Times

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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 the 505(j) ANDA approval pathway, on the other hand, submissions can be multisource generic drugs; however, this pathway requires bioequivalence to the RLD.