COVID-19 Response Requires Innovation from Hospital Labs: 4 Actions to Take Now

08/06/20

At the beginning of the COVID-19 pandemic, medical laboratories immediately experienced a decline in testing volume. And, while the test volumes are inching upward as labs find their footing in the new pandemic environment, the rate of recovery is slower than anticipated.

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Chronic Pain Doesn’t Go Away During a Pandemic. Here’s How to Develop a Program to Connect These Patients Back to the Care They Need

07/17/20

With over 50 million U.S. adults experiencing chronic pain daily, the need for patient care hasn’t disappeared, but it may have grown more complicated due to the pandemic.   

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Drug Importation, eh?

03/07/20
[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

USP Regulatory Updates Delayed on Appeal

10/29/19
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

Understanding the Potential Impacts of USP <825> for Radiopharmaceutical Compounding

09/12/19
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

Maintaining the Integrity of High Consequence Spaces

08/19/19
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

Facing the Challenges of the Plasma Market

06/26/19
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

How to Manage the Ongoing Fragility of the Nuclear Supply Chain

11/05/18
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

Understanding the Real Impact of Recent Drug Pricing Announcements

10/09/18
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

Making the Case for Biosimilars

09/05/18
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