Handling the Problem of Hazardous Drug Waste

Entrepreneur Charlotte Smith (BS ‘68) finds opportunity in little-known areas of pharmacy

By Katie Ginder-Vogel

Growing up in Milwaukee, Charlotte Smith (BS ’68) was a typical high school student: She spent a lot of time with friends, was co-editor of the yearbook, and built particle accelerators in her spare time. Well, technically, she attempted to build just one particle accelerator — a cyclotron, which was invented at the University of California, Berkley in 1929 — with three of her female friends.

“We wrote to UC Berkeley — there was no internet in 1962 — and got the plans for the cyclotron,” Smith says. “Luckily, my dad was a mechanical engineer, and my friend’s dad was a professor at the Milwaukee School of Engineering, so we had help.” 

With donated supplies, like copper wire and steel, the students wound their own coils and got the magnet working. The cyclotron went to the Marquette Science Fair and her group traveled to the National Science Fair in Albuquerque, New Mexico. 

Smith’s penchant for doing the unexpected persisted throughout her career, which vacillated from a planned major in physics, to pharmacy school, to launching a natural foods business, and eventually founding a company to fill a national need in the management of hazardous pharmaceutical waste: PharmEcology.

Smith received the Alumnus of the Year award from the School’s Pharmacy Alumni Association in 2002, a School of Pharmacy Citation of Merit in 2005, and the Pharmacy Society of Wisconsin’s Innovative Pharmacy Practice Award in 2009.

“It’s been a great ride,” Smith says of her career. “I could never have predicted it.”

Changing plans

When Smith came to UW–Madison as an undergraduate, an advising mishap landed her in what she refers to as “baby Physics,” and theoretical calculus, instead of engineering calculus. 

“I was a freshman, terrified of making changes, and when I realized I should change courses, I was already six weeks in,” Smith says.

Smith decided to change direction and planned on becoming a teacher. But when her classmate and future husband, Brad Anderson (BS ’67), started pharmacy school, it gave her a new goal.

“Start looking around for problems that haven’t been discovered or solved, where you can use your expertise to make society better.”
—Charlotte Smith

“I was very interested in the coursework Brad described, including physiology and pharmacology, and how it applied to human health,” says Smith, whose father passed away shortly before she changed majors. “I think my dad’s passing emphasized to me the need to have a licensed profession to support myself, given life’s uncertainties.”

Smith was admitted to the School of Pharmacy her junior year and started taking chemistry classes to get up to speed. At the time, she was one of few women enrolled, but she was undeterred.

After graduating, she interned for a year at Methodist Hospital and completed her boards, at which point Anderson, whom she had married her senior year, joined the U.S. Air Force and was stationed in Del Rio, Texas, on the U.S.-Mexico border.

“I got my Texas license after my Wisconsin license and worked on the border in Del Rio, at Ross Drug Store, filling Mexican prescriptions in Spanish,” says Smith. 

Smith worked as a retail pharmacist so she could travel with her husband from base to base and spent several years in North Dakota and Denver, before returning to Milwaukee in the 1970s. She wound up back on campus, briefly working as School of Pharmacy Dean George Zografi’s assistant, earning her master’s in adult education from the School of Agriculture and Life Sciences, and working for the UW Extension before going back to practicing in Watertown and Oconomowoc.

“The pharmacy degree is so versatile,” she says. “It gives you credibility. I have used my degree so many times as a backstop to allow me to make changes.” 

Finding direction, founding companies

While her career and her first marriage had taken her around the country and through myriad opportunities, she still didn’t feel fulfilled. So she did what people who build cyclotrons in high school do: She bravely tried something new. Smith re-married, started her own natural foods business and kept her pharmacy job to cover her costs.

“I made granola in a licensed bakery from our farmhouse for five years,” Smith says. “Unfortunately, granola was the only thing I made…not money! I learned what not to do in business — that was my internship for being an entrepreneur.” 

With the natural foods business closed, Smith went into medical sales, spent two years with David Hamacher at D.P. Hamacher & Associates, then saw an opportunity in pharmaceutical returns, also known as reverse distribution, in which a company takes a pharmacy’s unsold or expired drugs and either returns them for credit or disposes of them. While she was with the Hamacher organization, she also met Monica Livingston, who was to be instrumental in the development of her next two business opportunities: Capital Returns, Inc. and PharmEcology Associates, LLC.

In 1991, Smith co-founded Capital Returns, Inc., one of the first pharmaceutical reverse distribution companies in the country. Smith served as president and chief regulatory advisor for 10 years and pioneered hazardous waste classification and controlled substance management.

Capital Returns became nationally known, and Smith sold the company to a private equity firm in 1997. The company was based in Milwaukee under several owners until August 2019, when the Milwaukee facility was closed after it was acquired by Inmar, another reverse distributor.

“Nobody knew there was a problem, but we needed to come up with a solution.”
—Charlotte Smith

“I learned about hazardous waste and how it applies to drugs, and I realized my colleagues didn’t know about it,” Smith says.

At the time, intravenous fluids were often dumped down the drain, and other drug waste was disposed in red sharps containers or in the trash. Smith found that when she talked with her pharmacy colleagues about epinephrine, warfarin, and nicotine being hazardous chemical wastes, they were flabbergasted.

“Nobody knew there was a problem, but we needed to come up with a solution,” she explains.

Smith was determined to educate other pharmacists, healthcare providers, and environmental services professionals about drug waste and the U.S. Environmental Protection Agency (EPA)’s hazardous waste regulations. Smith and Livingston teamed up with an angel investor to build a database that would track new drugs coming onto the market every week and categorize their hazardous waste and NIOSH hazardous drug status. Smith called it the PharmE® Waste Wizard® and made it available online in 2003. It was the first of many products provided by PharmEcology, the company she launched in 2000. 

Next, Smith created an inventory analysis tool for pharmacies, hospitals, and clinics. The PharmE® Inventory Analysis provides a complete waste categorization of every drug product a pharmacy purchases in a calendar year. 

“They can send us their annual wholesaler file for all their purchases, and we run it through our database and give them a report back that tells them which products to label as a hazardous waste,” Smith says. The labels can be placed on pharmacy shelves and the disposal information added to the medication administration record for nursing staff. 

“Nurses dispose of most of the drug waste in a healthcare facility, so it’s important they understand where to dispose of unused medications,” Smith explains. “Many facilities have now put various disposal codes into their electronic medication administration records at the bedside.”

PharmEcology also offers on-site risk assessments that have evolved to include state-specific training programs and policy and procedure templates. The company grew to operate nationwide. PharmEcology currently has a presence in all 50 states and provides a comprehensive waste management solution, including the identification, separation, management, and disposal of pharmaceutical waste.

Becoming a national consultant

In 2006, Smith collaborated with the nonprofit Hospitals for a Healthy Environment, now known as Practice Greenhealth, to write a 10-step blueprint for managing pharmaceutical waste, which continues to be promoted by the EPA

Smith sold PharmEcology to Waste Management in 2009 and stayed on as a director until 2012, when she shifted to a consultant role, in which she works with another UW–Madison School of Pharmacy alumna, Kathleen Skibinski (BS ’86, MS ’88) to manage PharmEcology’s state-specific database information; review  state and federal hazardous waste regulations as they pertain to pharmaceutical waste; and provide input on proposed EPA and U.S. Drug Enforcement Administration (DEA) regulatory changes pertaining to pharmaceutical waste.

“The pharmacy degree is so versatile; it gives you credibility.”
—Charlotte Smith

“Dealing with pharmaceutical waste isn’t perceived as appealing,” says Smith. “When we started, the idea of not putting drugs down the drain was still in its infancy. There’s been a sea change in recognizing that we shouldn’t do that and in helping pharmacies make a plan for handling drug waste.”

Smith now works on an as-needed basis, providing continuing education and helping hospitals register with the EPA under the new Subpart P Hazardous Waste Pharmaceuticals Rule adopted last year. 

She sees the concerns around NIOSH hazardous drug handling, USP 800, and industrial hygiene principles applied to pharmacy practice as a growing opportunity for pharmacists interested in blazing a novel career path.

“The industrial hygiene area needs help keeping healthcare employees safe, so if a pharmacist also got an industrial hygiene degree, they could be dynamite,” she says. But opportunity is everywhere, Smith says, and pharmacists have the broad knowledge base and skillsets to be disruptors and innovators.

“Society will continue to change, and what a young person needs to do is get the basics of pharmacy practice down and make sure you can support yourself,” Smith says. “Then start looking around for problems that haven’t been discovered or solved, where you can use your expertise to make society better. And stay in touch with your friends and colleagues. None of us does this on our own. We all need the support and encouragement of each other, now and in the future.”