Cancer Drug Recyclers Chosen for FDA Pilot

Leftover Drugs Are Stigmatized

Nick Mulcahy

April 30, 2019

Two organizations devoted to recycling expensive oral cancer drugs are part of a consortium of healthcare entities recently chosen by the US Food and Drug Administration for a drug supply-chain pilot project.

Good Shepherd Pharmacy and RemediChain, two start-ups located in Memphis, Tennessee, take unused chemotherapy capsules and pills donated by individuals and cancer clinics and give them to patients who cannot afford them.

Cancer drug recycling is gaining traction in the oncology community, as evidenced by a recent essay by five prominent physicians who called the concept "medically sound" and environmentally sensible.

The basic idea is that donating unused cancer drugs is better than flushing them down the toilet or tossing them in the trash.

"I'm so excited about the FDA pilot project because it adds credibility to our innovative work, which is reclaiming high-value, life-saving prescription medicines," said Phil Baker, PharmD, cofounder of both Good Shepherd Pharmacy and RemediChain, in an interview with Medscape Medical News.

Good Shepherd and RemediChain are small, recently established organizations with less than 10 employees. However, despite their modest beginnings, both use cutting-edge "blockchain-enabled" data technology, which works well for heavily regulated industries such as pharmaceuticals to track "medicine transfers" in the drug supply chain.

At Good Shepherd Pharmacy, medicine transfers take place when, for example, the family of a deceased metastatic breast cancer patient donates unused palbociclib (Ibrance, Pfizer) to the organization.

RemediChain, which is the logistical backbone of Baker's recycling concept, then matches those donated medicines with the most appropriate patients in multiple US states.

The process is full of challenges, Baker said, including the fact that leftover drugs are stigmatized.

"Some needy patients may be reluctant to take donated medicines because they don't know 'where they've been,' so to speak," Baker said.

This is where innovative drug supply-chain management comes into play.

RemediChain, which handles donations from a variety of sources, including individuals and cancer clinics, "taps back into" the supply chain data and re-creates any missing information, such as manufacturing and expiration dates, explained Baker.

This re-creation of the "chain of custody" via blockchain technology assures a medication's origin and quality, he commented.

Why Cancer Drugs Are Suited for Recycling

The supply of — and demand for — leftover cancer drugs is great, said Baker.

"All the new chemos are coming out as pills, but they cost $30,000 and up for 1-month. With more than 40% of cancer patients passing away, it is a double whammy: most patients can't afford them, yet nearly half of the drugs are getting thrown away," he told Medscape Medical News last year.

For its supply chain pilot project, the FDA chose a consortium led by the blockchain company Rymedi. The group included Baker's two tiny Memphis start-ups, along with two huge health systems, Indiana University Health and WakeMed Hospitals and Health. Three other groups round out the consortium: Temptime/Zebra Technologies, Global Health Policy Institute, and the Center for Supply Chain Studies.

Good Shepherd Pharmacy has previous ties to Indiana University Health, said Baker, due to an oncology pharmacist at one of their cancer clinics reading a Medscape Medical News article last year about cancer drug recycling. The pharmacist then started donating unused cancer drugs to Baker's program.

The new pilot project is the result of the federal Drug Supply Chain Security Act. The FDA wants to evaluate new tools to see if they "enhance the safety and security of the drug supply chain."

The pharmaceutical industry was an early user of blockchain, said Baker. Drug companies use it to track products from their creation at a manufacturing facility to the pharmacy where medicines are dispensed.

Baker explained that the tracking data stops at that point.

"Once a medicine leaves the pharmacy that has purchased it, that medicine is off the grid," he said.

There is no tracking process after a drug, for example, goes from a pharmacy to another facility (such as chemotherapy infusion clinic or a nursing home) or to a hospital in a multi-facility health system, he added. There is also no tracking once a drug is provided to an individual patient.

The FDA is interested in seeing if tracking the supply chain further is helpful and, as a result, created the pilot project.

The agency explains: "The program is intended to assist drug supply chain stakeholders in developing the electronic, interoperable system that will identify and trace certain prescription drugs as they are distributed within the United States."

The FDA did not respond to a request from Medscape Medical News to comment on this story.

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