Recycling of Unused Oral Cancer Drugs Endorsed by ASCO

Safety Concerns Overblown?

Nick Mulcahy

February 21, 2020

The movement to "recycle" unused, leftover cancer drugs in the United States has just got a shot in the arm, as the influential American Society of Clinical Oncology (ASCO) has endorsed oral cancer drug donation and reuse in a new position statement on drug repositories.

The move comes more than 20 years after laws that govern state drug depositories were first implemented.

But the statement is disappointingly limited, said recycling advocates in comments to Medscape Medical News, who also expressed gratitude that the US oncology giant addressed the topic.

ASCO said the declaration is in response to members who have "expressed interest" in reuse, in part to help financially needy patients.

"Cancer drugs often are specialty drugs" and tend to be "substantially more expensive than traditional drugs," ASCO pointed out.

For instance, novel oral agents such as immune checkpoint inhibitors, which have demonstrated remarkable results in melanoma, lung cancer, and other malignancies, typically cost $10,000 or more a month.

"Unused medications, if maintained within a closed system, can be made available to patients who would not otherwise be able to afford essential cancer medicines," the society explains.

However, ASCO emphasized the proviso that the donated drugs be "maintained within a closed system" (ie, have not exited a medical setting or been taken home). Thus, cancer drugs donated directly by patients and families are excluded.

Jon-Michael Rosmann, CEO, SafeNetRx, a drug reuse nonprofit organization in Iowa, said the closed-system restriction is a lost opportunity ― both financially and spiritually.

A well-run repository is a highly effective guard against safety risks with drugs donated by patients ― or anyone else, he explained.

"In 12 years of operation, SafeNetRx has experienced zero medication safety issues as a result of medicines donated by an individual or a healthcare facility," said Rosmann.

Patient-to-patient donations are also "uplifting to both parties, and in some instances, aid the grieving process for families who have lost a loved one," he told Medscape Medical News.

Rosmann, who called the ASCO statement "commendable," also pointed out that limiting donations to oral cancer drugs excludes injectable medications in sealed packaging, such as enoxaparin.

"It's great that ASCO weighed in, but their position leaves a lot of drug product on the table and in landfills and out of the hands of patients who need it," said Elizabeth Lindquist, PharmD, of the SwedishAmerican Regional Cancer Center Pharmacy, Rockford, Illinois.

For example, ASCO does not advocate that manufacturers use blister-packs for all oral cancer therapies, said Lindquist, who is a member of a coalition seeking drug recycling legislation in Illinois. The packaging would greatly facilitate both donations and their reception among patients in need, she told Medscape Medical News.

The cancer drug waste stream in the United States is monumental, noted ASCO, citing a 2016 study that said refuse is partly driven by oversized drug vials and is estimated to be $3 billion annually. ASCO members have indicated that waste occurs when, for example, pharmacy benefit managers send an incorrect dosage or type of medication, or medication is sent directly to a patient's home, where it then expires before the recipient can use it. Each mistake and wasted prescription for cancer medication creates additional expense for the healthcare system and may delay the start of, or interrupt, necessary treatment for a patient, the society comments.

Fifty Percent of Drug Donations From Individuals, Says One Program

The ASCO closed-system restriction is in conflict with 16 states from across the United States that allow individuals ― and not just healthcare facilities ― to donate cancer drugs to repositories.

For example, last year, Ohio allowed patient/family donations to repositories and, in a groundbreaking move, also okayed donations of oral chemotherapies that are not in their original packaging, which ASCO does not endorse. The pills must first clear a multipoint inspection by a licensed pharmacist, per Ohio regulations.

In 2018, Tennessee law was changed to allow for direct family/patient donations, as reported by Medscape Medical News. Those contributions represent 50% of all drugs recycled by Memphis, Tennessee–based Remedichain, a nonprofit devoted to drug reuse, said Philip Baker, PharmD, the organization's CEO.

The laws that govern state drug depositories were first implemented in 1997, according to the National Congress of State Legislatures. As of 2018, there were 38 US states with depositories or related laws. Some states are very active. For example, Oklahoma, which created its program in 2004, has filled 227,603 prescriptions, worth about $22 million, with recycled drugs.

In its statement, ASCO calls for states with no such laws to "implement drug repository programs." And it says professional medical associations "should make efforts to educate physicians regarding the existence and value of such programs."

In 2019, a group of American academic physicians called for legal and professional changes to untie the hands of oncologists who regularly come into possession of unused drugs.

In an essay in the Oncologist, they asked for "considerable relaxation or amendment of the rules and regulations that govern typical pharmacies and physician dispensing."

In short, physicians should be able take discarded oral cancer drugs from one patient and pass them on to another — without a pharmacy intermediary, said the authors, led by Jodi Layton, MD, of Tulane University in New Orleans, Louisiana.

Illinois' Lindquist said such transfers already occur.

"Physicians are already doing this on the sly," she said last year.

Rosmann, Lindquist, and Baker have no disclosures.

ASCO. Position Statement on Drug Repository Programs. Full text

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