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Franklin Firm Handles Return or Disposal of Unwanted Prescription Drugs

Jokingly describing himself as "the trash man of the drug world," Robert H. Wolle Jr. is president and CEO of Franklin-based Pharmaceutical Credit Corp. (PCC), which he founded in 1990. Yet, Wolle acknowledged the company he established nearly two decades ago has evolved into a much more complex enterprise than he ever imagined.

PCC is a pharmaceutical reverse distributor, meaning it handles expired and recalled pharmaceutical products for a wide variety of healthcare clients – from hospitals and surgical centers to dental practices, veterinarian offices, homecare agencies and drug stores. "We're the end of the loop for disposal of controlled substances and legend pharmaceuticals," Wolle said.

A native of Brentwood and a Belmont University graduate, Wolle was a pharmacy technician at Saint Thomas Hospital early in his career. By the late 1980s, after 13 years as a pharmaceutical representative in Tampa, Fla., Wolle had identified a market niche.

First, the federal Environmental Protection Agency tightened regulations on hospital incinerators. Hospitals got out of the incineration business as a result, leaving a disposal gap. Then, drug reps like Wolle were left to write up more and more product returns, which didn't do much for their commission schedules. Finally, federal Drug Enforcement Administration officials at the local level were spread thin, with agents required to witness drug destructions (such as flushing into the local wastewater system) or taking possession of the pharmaceuticals themselves.

"The premise behind the business was originally to send product back for credit from the manufacturer," Wolle explained. "Over time, with the different regulations that have come out with regard to disposal, more and more we're becoming more of a disposal-company model."

PCC is one of about 40 reverse distributors nationwide, according to the DEA Web site. Some companies are highly specialized, handling for example only Schedule 1 pharmaceuticals or only illegal drugs or drug compounds such as methamphetamine seized by the DEA or other law enforcement authorities. One of the oldest reverse distributors in the country, PCC handles Schedule II through V drugs. "We're one-stop shopping," Wolle said.

The company is regulated and/or licensed by the DEA, the EPA and various state agencies and is permitted as a large waste generator. "There is a lot of detail to the job, a lot of different protocols and a lot of documentation," Wolle said, noting as an example that nicotine patches are defined as hazardous waste and weighed by the ounce. The regulation is certainly different than it used to be. "When I started out, it was basically working with the local DEA, and all the interpretation came from the field," he said, likening those times to "the wild, wild West."

Beginning in 2002, Wolle was a member of a working group that toiled with DEA regulators to write what he calls "the playbook" for the pharmaceutical reverse-distribution industry. The first definition and registration requirements appeared in the Federal Register in 2003 and refining of the regulations continues.

"It's been an evolving process, and that's why we had to go to Washington to sit down with DEA and come up with questions, answers and resolutions to these issues. … Now there's consistency across the board," he said.

PCC boasts clients in 49 states and … because of its contracts with major pharmaceutical group-purchasing organizations … the company handles products for about three-quarters of the nation's hospitals, Wolle said. PCC's clients ship the drugs to the company's Franklin location via common ground carriers. For security reasons, Wolle preferred not disclose the warehouse location. He called his business a "clearinghouse," where the pharmaceuticals are processed by lot numbers, expiration dates and quantities and then inventoried. For some pharmaceuticals, particularly very expensive drugs used to treat HIV and cancer, a manufacturer's credit is available. Those drugs are shipped to the manufacturer by PCC, which receives a percentage of the credit, and the client receives the rest. Most of the drugs, however, are shipped after processing to a specially permitted incinerator in Huntsville, Ala., for destruction.

Wolle had nothing but praise for the highly regulated incinerators that today are handling a growing percentage of America's unused pharmaceuticals.

"These incinerators offer a valuable service, because they basically eliminate the use of landfills and keep the products from going into the waterways. … The story is let's build more of these facilities and do them right," he said.

In fact, an incineration plant in Indianapolis owned by Covanta Energy Corp. burns drugs and sells the steam energy to a local utility. Wolle said the Huntsville facility is considering renewable-energy options. He also noted that household pharmaceutical collection is gaining a foothold in some areas of the country.

PCC has about 25 employees, mostly in sales and marketing and shipping and receiving. "To be honest with you, everybody's happy that we're here. The DEA is happy, and folks who are concerned about the environment should be happy because we get rid of this product in a proper manner. It's a needed service, and I see it growing. I do not see it affected much by the economy," said Wolle, adding, "I think there are opportunities in other areas to expand and even go more into the environmental side – going into hospitals and making sure their waste streams are followed with regard to pharmaceutical waste versus biomedical waste."

Tags:

disposal of controlled substances, Drug Enforcement Administration, Pharmaceutical Credit Corp., pharmaceutical incineration, Pharmaceutical reverse distribution, Robert H. Wolle Jr.

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