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Compounding This Week Newsletter from www.CompoundingToday.com
Our Compounding Knowledge, Your Peace of Mind
May 8, 2020  |  Volume 17  |  Issue 19
IN THIS ISSUE
 
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Loyd V. Allen, Jr., Ph.d., R.Ph Letter from the Editor
Environmental Protection Agency, Part 9

10 Steps to Develop and Implement a Pharmaceutical Waste Management Program

Step 1 begins with some action items that you can begin immediately.
Step 2 is an overview of how the federal Resource Conservation and Recovery Act (RCRA) regulations apply to pharmaceutical waste management.
Step 3 begins where the regulations leave off providing guidance on how to manage nonregulated hazardous pharmaceutical waste.
Step 4 walks you through the steps necessary to perform a drug inventory review. This step can be very tedious and time consuming.
Step 5 alerts you to waste minimization opportunities.

Step 6. Assessing Current Practices

  1. Performing Department Reviews

    Gathering current waste generation and disposal practice information (estimated volumes and weights) will assist in;
    • designing your program,
    • establishing a baseline to estimate waste management costs and track progress over time, and
    • identifying ideas for reducing your pharmaceutical waste stream.

  2. Conducting a Frequency Analysis

    It is helpful to analyze which drugs are dispensed to each unit and in what quantities over a specific period of time (e.g., 30 days). It is advantageous if this can be done utilizing current software.

  3. Confirming Your Generator Status

    Hazardous waste is generated from various activities and events, including:

    • preparing IVs,
    • general compounding,
    • cleaning up of spills and breakage, and
    • discarding partially used vials, IVs, discontinued medications such as ointments and inhalers, unused unit-dose repacks, patients' personal medications, outdated pharmaceuticals, and contaminated PPE.

For the complete document, go to:
http://www.hercenter.org/hazmat/tenstepblueprint.pdf


Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief

IJPC
Remington: The Science and Practice of Pharmacy Twenty-second edition

 

News

USP 2020 Convention Results for Compounding

  1. Congratulations to Brenda Jensen, M.A., B.A., for her election as Chairperson of the Pharmacy Compounding Expert Committee.

  2. USP Convention Resolution 9 was passed that states:
    "USP will continue to collaborate with stakeholders on standards to help ensure the quality of compounded drug preparations. New and revised standards for compounding, including beyond-use dates, will be developed based on data, scientific evidence, and input from recognized healthcare professionals and state and federal regulators."

(Editor's Note: The USP Convention meets every five years.)

Coronavirus Vaccine Enters Human Testing in U.S.
An experimental vaccine against COVID-19 developed by Pfizer and BioNTech is now being injected into healthy volunteers in the U.S. Scientists are administering the first of four vaccine candidates from the two companies. Results could be available as early as June, but the strongest vaccine candidate would still need to undergo additional testing in more patients. The plan is to weed out less-effective vaccines and focus on what's good and move on.
https://www.wsj.com/articles/coronavirus-vaccine-enters-human-testing-in-u-s-11588675501

Children are Falling Ill With a Baffling Ailment Related to Covid-19
No children are known to have died so far, but several have ended up in intensive care with mysterious symptoms ranging from reddened tongues to enlarged coronary arteries. In total, about 25 children have been admitted to the Long Island hospital in recent weeks with symptoms. The number of children in the U.S. showing signs of this new syndrome - which first was detected in Europe last month - is still small. None is known to have died, and many have responded well to treatment.
https://www.nytimes.com/2020/05/05/nyregion/kawasaki-disease-coronavirus.html?searchResultPosition=6

Drug Shortages are on the Rise Again - from 2014 to Current

National Drug Shortages: Active Shortages by Quarter

National Drug Shortages by Quarter

Note: Each point represents the number of active shortages at the end of each quarter. Source: University of Utah Drug Information Service.

Below are the current drug shortage lists from the FDA and ASHP. The compounding opportunities continue.

Drug Shortages - FDA List
There are 159 entries in the current list. Some have been resolved and others are still in shortage status. For a complete current list go to:

https://www.accessdata.fda.gov/scripts/drugshortages/default.cfm?utm_campaign=05-04-2020%20Drug%20Shortages

Drug Shortages - ASHP List
There are 212 entries in the current list available at:

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortages-List?page=CurrentShortages&loginreturnUrl=SSOCheckOnly

 

Did You Know ...

...that Nelson A. Rockefeller said the following regarding "responsibility"?

"The nourishing of the American system requires a sense of responsibility, not only on the part of individual citizens, but especially on the part of America's leadership. I am not speaking alone of political leaders, but of the leaders of all phases of our society as well. To the extent that they do not exercise their power and influence in the direction of the common good, they are undermining the very system that has given them that power and influence."
 

Tip of the Week

Some observations on our leaders:

  • some have a vision and the drive and intelligence to succeed
  • some keep the common man in mind and keep their feet on the ground and their head in place
  • some have no vision, no drive, and lack the intelligence to lead anyone anywhere
  • some are quiet and enjoy the ride and take advantage of the benefits
  • a few cannot handle the power and abuse it and abuse their citizens
  • some have personal agendas and take advantage of their position
  • many seem to make a lot of money outside their salary while in office
  • when you have a good leader, they should be supported

 

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Looking Back

At intersections
Look each way,
A harp sounds nice,
But it's hard to play!
     Burma-Shave

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