Why States Are Allowing Pharmacies to Dispense Returned Oncology Drugs

A patient tries to fill their oncology prescription, but the co-pay is too high. If they go without it while trying to qualify for financial assistance, their cancer will progress. Their doctor has patients with unused pills after switching treatments, but legally, those medications must be destroyed. However, if the patient is in one of 13 states that allows cancer medication donation and redistribution, they could potentially get their prescription filled quickly and for free.

With out-of-pocket specialty drug costs reaching $12,000 per drug, it’s no wonder that even insured patients have difficulty paying for treatment. “One of the reasons to advocate for drug donation is so many patients are having to choose (whether) they’re going to pay for their food, rent or medicine. They simply just can’t afford to pay for all three,” says Kenzie Harder, Pharm.D., drug donation repository manager for SafeNetRx, which is Iowa’s state drug repository program.

The cost of these wasted drugs is astounding. Hospitals discarded an estimated $3 billion in 2015, and long-term care facilities discarded an additional $2 billion. That doesn’t necessarily include discontinued oral chemotherapy from outpatients. Dose changes can yield unfinished prescriptions, and some patients die with unused medication at the bedside. These must be destroyed unless the state law allows donation to a drug repository.

Currently, 38 states plus Guam and Washington, D.C., have enacted laws allowing prescription drug repository programs, although programs are only operational in 27 states plus Washington D.C. Of these, 13 allow oncology medication collections and dispensing. A few are statewide and others are run by individual health systems.

Win-win-win

Oncologists and pharmacists constantly field patient questions about unused medications. They’re typically advised to return them to the pharmacy for safe disposal, which is a waste for patients whose medications are often expensive and could benefit others. Scenarios like this led Julie Kennerly-Shah, Pharm.D., M.S., M.H.A., associate director of pharmacy at The Ohio State University Comprehensive Cancer Center-James Cancer Hospital, to work with OSU and Ohio’s Board of Pharmacy to pass legislation allowing pharmacies to collect and redistribute oral chemotherapy to those in need. They launched their program in January 2020, which is now one of several in Ohio.

Kettering Health followed in January 2022. Typically, if a patient’s insurance has a high deductible or they can’t afford to fill the prescription for other reasons, the health system helps find a solution, whether a manufacturer’s co-pay assistance program or free drug, cancer grants or Medicaid enrollment. “It’s a terrible feeling when you have a patient with a cancer diagnosis and we’re kind of stuck,” says Kevin Blackburn, director of retail, long-term care and specialty pharmacy at Kettering Health. The repository of donated drugs is the last option.

Patients with cancer are the primary beneficiaries of drug repositories, but there are many winners. Pharmacies pay to destroy medications. Redistributing them can keep them out of the landfill and protect the environment.

The patients and families donating medications also benefit and are appreciative of the opportunity to help others. “Often, cancer is a disease where you feel you lost a lot of power, and they’re taking some of this power back by being able to give medication to another patient,” Kennerly-Shah says.

Donation amounts add up. Iowa’s SafeNetRx was the first statewide drug repository collecting medications for chronic diseases and cancer treatment. Since 2007, SafeNetRx has distributed over $15 million in cancer medications based on the average wholesale price of almost 85,000 doses.

Setting up a program

Even with a law, state public health departments or health systems still need to develop their programs. The drugs are often collected by clinics or pharmacies. They can distribute them there or centralize dispensing into one pharmacy, as donated drugs must be stored separately from regular inventory. State laws determine whether the drugs must be in blister packs or tamper evident sealed containers or whether open bottles can be used. Unlike Wisconsin and Iowa, the programs in Ohio can accept open bottles, giving it wider latitude. “You’d severely limit yourself if you only accept donations out of a prepack setting,” Kennerly-Shah says.

When patients make donations, they complete forms attesting that the drug is what they say, that it was stored properly, and that it was always in their possession. Pharmacists talk to the donators, inspect the drugs and check the expiration dates. Programs can’t accept drugs outside a specified expiration date, such as six months. The patients who are receiving the drugs also consent in writing that they are receiving donated drugs, which releases the pharmacy from liability.

None of the experts have seen drug tampering issues. Kennerly-Shah initially thought patients might hesitate to accept donated drugs, but she was surprised “at the camaraderie between (patients with) cancer. They trust that they’re in it together.”

There is some cost to the programs, although experts could not quantify them. The costs include paperwork, separate medication storage, and pharmacist time to talk with patients. “It’s a minor cost, but it’s something worth doing regardless of any cost associated with it,” Blackburn says.

Mind the gap

Repository programs are similar to food banks. Pharmacies can only dispense what’s been donated. If a patient receives treatment one month but none is available the next month, that can impact treatment. Fortunately, it’s not a big problem, but this is why Kettering Health collected oncology drugs for six months before beginning to dispense them in 2022. “You don’t want to provide someone with a donated drug, which is typically only going to be a month’s supply, then not do anything for them the next month,” Blackburn says. Kettering Health collected 81 patient donations since January and dispensed about 10 prescriptions starting this summer.

With that said, many patients who are using the repositories only need the donations until they qualify for free or discounted drugs from the manufacturer, when they’re in between insurance plans or if they’re facing a short-term, high co-pay as Medicare beneficiaries do when they are in the donut hole phase of Medicare Part D coverage. The best scenarios are when repositories don’t have to worry about continuing a prescription from the repository on an ongoing basis, according to Blackburn.

Some programs only serve their own patients, such as at James Cancer Hospital and Kettering Health. If the health system doesn’t have the available medication, the patient cannot access it from another repository. “I would love to have a statewide repository,” Kennerly-Shah says. “We have a large system, so we receive a lot of donations, but if you’re a smaller community practice, you may not have that frequent influx of medications.”

In Wisconsin, participating pharmacies can call other pharmacies to locate available donated drugs, but the state doesn’t maintain an online directory or track medication. Instead of seeking out other pharmacies, pharmacists typically help patients access patient assistance programs, according to Douglas Englebert, RPh, MBA, pharmacy practice consultant to the Wisconsin Department of Health Services.

Through SafeNetRx, Iowa maintains a state dispensing pharmacy for its residents that is funded mostly by its public health system, according to Harder. The organization is advocating for a national drug repository program to ensure donations can make it to patients who need them, with less waste and lower operational costs.