10 Steps to Develop and Implement a Pharmaceutical Waste Management Program

Step 8. Considering Management Options

The design of the management program in the pharmacy depends upon your program goals and facility constraints (space, technology, resources). Five models are presented in this section. All five models involve satellite accumulation, and four of the five require drug segregation within the facility. The selection of a "model" should proceed in parallel with Step 9 (to be covered next week).

Model 1: An automated barcode driven sorting device
Model 2: Electronic labeling in the nursing units
Model 3: Manual labeling in the nursing units
Model 4: Segregating waste at the central storage accumulation area
Model 5: Managing all drug waste as hazardous waste

1. Models 1, 2, and 3: Segregating at the Point of Generation

Ideally, hazardous waste (HW) will be segregated where it is generated and discarded in appropriate HW containers conveniently located close by. Appropriate HW containers should be purchased. The most common are black, meet DOT Packing Group II, and are labeled "Hazardous Waste." Different sizes, with and without trolleys, are available. Trained personnel will transfer the HW containers from the satellite accumulation areas at the point of generation to the central storage area (Step 9 next week). Also, management of non-HW will be discussed next week in Step 9. The most common waste streams used for point of generation of pharmaceutical waste segregation are included in Table 8 of the booklet.

2. Model 4: Centralized Segregation

This is where ALL drug waste is discarded in HW containers that are located at the point of generation. An exception is bulk chemotherapy and trace chemotherapy waste, as they should be segregated in the patient care areas to avoid employee exposure. Ultimately the HW containers are moved to the central storage accumulation area and then sorted appropriately. In this Model, containers for all types of generated waste at the facility should be available in the manual sorting area.

3. Model 5: Managing All Drug Waste as Hazardous

Some facilities may choose to manage all pharmaceutical waste as RCRA HW in order to avoid the expense of labeling and training staff to determine which drugs are RCRA HW. Especially in smaller facilities (hospitals with fewer than 50 beds), this may be the simplest and most economical solution. For large facilities, pilot programs may be required to determine the most economical, efficient, and safe approach, as HW costs in excess of $1,000,000 annually have been estimated.

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

News

FDA Memorandum of Understanding Released

MEMORANDUM OF UNDERSTANDING ADDRESSING CERTAIN DISTRIBUTIONS OF COMPOUNDED HUMAN DRUG PRODUCTS BETWEEN THE [insert STATE BOARD OF PHARMACY OR OTHER APPROPRIATE STATE AGENCY] AND THE U.S. FOOD AND DRUG ADMINISTRATION

NOTE: Watermarked "Not For Implementation."

Available at:
https://www.regulations.gov/document?D=FDA-2018-N-3065-0045

Editor's Note: This all started back in the FDA Modernization Act of 1997 that included the development of a "Memorandum of Understanding" between the FDA and the individual state boards of pharmacy for the amount of compounded preparations that could be shipped interstate. Twenty-three years later, it is still being "developed," but still has some serious issues. It is important to read through it carefully and review comments from APC and others to see if it is "workable" for your pharmacy and patients.

Did You Know ...

...that you should consider the following?

For a small amount of perspective at this moment, imagine you were an American born in 1900.

When you are 14, World War I starts, and ends on your 18th birthday with 22 million people killed. Later in the year, a Spanish Flu epidemic hits the planet and runs until you are 20. Fifty million people die from it in those two years. Yes, 50 million.

When you're 29, the Great Depression begins. Unemployment hits 25%, global GDP drops 27%. That runs until you are 33. The country nearly collapses along with the world economy. When you turn 39, World War II starts. You aren't even over the hill yet.

When you're 41, the United States is fully pulled into WWII. Between your 39th and 45th birthday, 75 million people perish in the war and the Holocaust kills six million. At 52, the Korean War starts and five million perish.

At 64 the Vietnam War begins, and it doesn't end for many years. Four million people die in that conflict. Approaching your 62nd birthday you have the Cuban Missile Crisis, a tipping point in the Cold War. Life on our planet, as we know it, could well have ended. Great leaders prevented that from happening.

As you turn 75, the Vietnam War finally ends.

Think of everyone on the planet born in 1900.

How did they survive all of that?

A kid in 1985 didn't think their 85-year-old grandparent understood how hard school was. Yet those grandparents (and now great grandparents) survived through everything listed above.

Tip of the Week

As Abraham Lincoln said,

"The world will little note, nor long remember, what we say here, but it can never forget what they did here."

Memorial Day is a great time to remember our loved ones, those who gave all, our great heritage and some of the blessings we take for granted, as well as the basics upon which this great nation was founded. As a child back in the 40s and 50s, I will always remember the slogan of the television show, Superman, who fought for "Truth, Justice, and the American Way." We need to revive those standards in America!

IJPC Now on Facebook and Youtube

Become a fan of the IJPC Facebook page and share ideas, photos, and keep up to date with the latest compounding information - https://www.facebook.com/IJPCompounding

View our growing collection of educational and training videos at www.ijpc.com/video or by subscribing to our Youtube channel at https://www.youtube.com/IJPCompounding.

Looking Back

Maybe you can't
Shoulder a gun,
But you can shoulder
The cost of one.
Buy defense bonds (1943)
     Burma-Shave