Pharmacy

[Full disclosure: your author is a Canadian import] After several months of D.C. chatter and countless state importation bills, FDA recently took two significant regulatory steps to allow for prescription drug importation from Canada. Wait, you thought importation was already happening in Florida? Not quite. More

We’ve recently shared communications about updates to existing United States Pharmacopeia Convention (USP) Chapters surrounding pharmaceutical compounding regulations as well as a new regulation for handling hazardous drugs in health care facilities. The new and updated rules were scheduled to go into effect Dec. 1. More

In recent years, there has been a significant amount of regulatory focus on compounding pharmacies. Specifically, regulatory agencies want to establish guidance for quality and sterility of products with the goal of providing the highest standard of finished product for patient administration. While new guidelines were created in various USP chapters, there has not been guidance for every aspect of compounding pharmacy practices. One notable exclusion was radiopharmaceutical compounding and... More

There are areas in health care facilities that require specific environmental controls and operational procedures to ensure safety, such as patient isolation rooms, surgical suites and compounding areas. Environmental or procedural breaches in these “high consequence” spaces may lead to adverse events, causing harm, or even death, for pharmacists, caregivers and patients. More

Plasma-derived therapeutics are part of a complex dynamic of global supply chain economics and clinical contributing factors, all of which can affect the ability to obtain the product needed for patient care. Immunoglobulin (Ig), the main driver in current plasma manufacturing, has experienced double-digit growth within North American markets, leading to an increased demand the manufacturing community has been challenged to meet.* More

Last week, we received news of an industry-wide shortage on vital radiopharmaceuticals, Tc-99m and Mo-99, due to international reactors being shut down for scheduled and unscheduled maintenance. While we believe the shortage will be temporary – leading to supply challenges for the next few weeks – the production of Tc-99m and Mo-99 are currently delayed. More

In July, several major pharmaceutical companies responded to President Trump’s call to action to lower drug prices by announcing they would freeze price increases through the end of 2018. While much was made in the media about the effectiveness of the president’s request and the public announcements by some pharmaceutical companies at the time, no one really knew what the real impact would be on the actual cost of medications. More

I recently had the pleasure and privilege to represent Vizient and present at a public hearing by the U.S. Food and Drug Administration (FDA), focused on removing barriers affecting the uptake of biosimilars, which offer a cost savings for some of the most expensive drugs on the market. Given the steep price for medications in our country, the importance of conversations like this cannot be overstated. More

It was a pleasant surprise to see not one, but two recent commentaries on the subject of biosimilars in prestigious publications such as the New England Journal of Medicine (NEJM) and the Journal of Clinical Oncology (JCO). Given the novelty and complexity of biosimilars, new commentary in highly regarded clinical journals such as these is important to increasing the level of understanding and confidence necessary to boost adoption by clinicians.   More

Here’s a scenario: Department leaders across the health system are meeting to look for untapped sources of incremental revenue. They hope to find a traditional cost center that could become a strategic asset. An added bonus would be if it also enabled them to gain influence over patient care after discharge. Any ideas? I have one — specialty pharmacy.

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