10 Steps to Develop and Implement a Pharmaceutical Waste Management Program

Step 10. Launching the Program

1. Educating and Training Staff
   
   After the policies and procedures are prepared and the information obtained from the pilot program has been applied, it is time to conduct training sessions for all pharmacy and nursing personnel in the selected units on all shifts.
   
   
2. Staging the Roll-Out
   
   Successful implementation involves carefully staged roll-outs that have been developed with the input of all involved personnel. All required equipment and supplies are in place prior to the start date. Personnel are trained in the items to be managed as hazardous waste (HW).
   
   
3. Filling out the Forms
   
   
   1. Hazardous Waste Manifest - a form which has both EPA and DOT components.
   2. Land Disposal Restrictions Form - must accompany the manifest and indicates what wastes are being disposed of and how they will be treated prior to application on the land. (The HW vendor can prepare this for you.)
      
      
4. Tracking, Measuring, and Recording Progress - Involves the following:
   
   Identification
   Labeling
   Compliance
   Quantity
   Costs
   Joint Commission Performance Improvement Initiative
   Practice Green Health Award Opportunity
   EPA Regional Awards and State Environmental Awards

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

News

Concerns Mount About Two Studies on Drugs for Coronavirus: Scientists Question Medical Data Used in Second Coronavirus Study
Concerns are mounting about studies in two influential medical journals on drugs used in people with coronavirus, including one that led multiple countries to stop testing a malaria drug. Medical records from a little-known company were used in two studies published in major journals.

1. The New England Journal of Medicine (NEJM) issued an "expression of concern" about the study it published that "suggested widely used blood pressure medicines were not raising the risk of death for people with COVID-19." In its communication, the journal expressed concerns about the reliability of the database.
   
   
2. Similarly, The Lancet issued an expression of concern about the study it published that "tied the malaria drugs hydroxychloroquine and chloroquine to a higher risk of death in hospitalized patients with the virus." The Lancet said questions have been raised about the data used in the study.
   
   

The studies share some of the same authors and both relied on the same database, which the group of scientists say may not be reliable.

The NEJM study relied on a database with health records from hundreds of hospitals around the world. "Substantive concerns" have been raised about the quality of the information, and the journal has asked the authors to provide evidence it's reliable, the editors wrote.

The same database by the Chicago company Surgisphere Corp. was used in an observational study of nearly 100,000 patients published in The Lancet that tied the malaria drugs hydroxychloroquine and chloroquine to a higher risk of death in hospitalized patients with the virus. On Tuesday, The Lancet issued a similar expression of concern about its study saying it was aware "important scientific questions" had been raised.

Dr. Mandeep Mehra of Brigham and Women's Hospital in Boston led both studies, and the authors include Desai Sapan, Surgisphere's founder.

A statement on Surgisphere's site notes that observational data like what it supplied from electronic health records are not a substitute for rigorous experiments to test a drug.
https://apnews.com/2e1f1e67c42ea14f47eefcf8b19b06dc
https://www.nytimes.com/2020/06/02/health/coronavirus-study.html

FDA Takes Actions to Enhance the Utility of the Orange Book
"First published as an official list in 1980, one of the fundamental tools for providing information about generic drugs to the public is the FDA publication Approved Drug Products with Therapeutic Equivalence Evaluations, more commonly known as the Orange Book.

"In October, we will celebrate the 40th anniversary of the Orange Book, which is one of the most used resources on FDA.gov. Although the Orange Book already provides extensive information about approved drug products, we want to ensure that it provides as much value as possible to those that rely on it, including consumers, health care professionals and drug developers. To this end, we are providing draft guidance and seeking additional feedback from a wide range of stakeholders and the public to help us consider how we may enhance this resource as we pursue the ultimate goal of improving access to high quality, affordable treatment options for Americans."
https://www.fda.gov/news-events/fda-brief/fda-brief-fda-takes-actions-enhance-utility-orange-book

Did You Know ...

...that Mark Twain said the following regarding "Science"?

"Such wholesale returns of conjecture out of such a trifling investment of fact."

Homer Adkin, an American organic chemist, said the following:

"Basic research is like shooting an arrow into the air and, where it lands, painting a target."

Wernher von Braun said the following:

"Basic research is what I am doing when I don't know what I am doing."

Lev Landau, a Russian physicist, said the following:

"Cosmologists are often in error, but never in doubt."

Tip of the Week

With all the "hullaballoo" on the research to develop vaccines, tests, and treatments for Covid-19, the credibility of "science" has had some ups and downs over recent months. Also, over the years, science has come under fire, and it no longer commands the near universal respect it once held. Many in the public may not realize that a lot of science changes over time, is fallible, oftentimes is based on a little fact and a lot of opinion, and is not perfect; it also has limits! It's also interesting that when a new hypothesis is developed, there is a lot of media coverage, but, when it eventually fails, nothing is said and the public is often left with the impression that it was proven.

We need to realize this in our own profession as many things in practice yesterday have been discarded as being incorrect; drugs formerly widely used now being deemed unsafe and many promises that are made by "scientists" seeking their moment of fame and grant renewals result in nothing coming at the end!

Let's end with a short lyric written in 1923 called "Relativity" by Arthur Buller.

There was a young lady named Bright,
Whose speed was far faster than light;
She set out one day,
In a relative way
And returned on the previous night.

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Looking Back

Every day,
We do our part,
To make your face,
A work of art!
     Burma-Shave