Drug Repositories Aim to Solve Access Issues

Julie KennerlyShah, PharmD, MS, MHA, BCPS

Financial issues are among the top concerns burdening patients with cancer.¹ Even with insurance, patients often face unpredictable costs, including high co-insurance and deductibles.² The average annual cost of new medicines continues to trend upward, with the median cost at $149,000 in 2018.³ These high costs can lead to nonadhereance and drug abandonment.⁴

At the same time, patients with cancer and facilities often throw away unused or leftover medications. In fact, according to a 2016 study in the British Medical Journal, an estimated $3 billion in leftover cancer drugs are discarded in the United States every year.⁵ This is especially true for medications that are based on a patient’s weight and that come in single-dose packages, which have to be discarded.

One solution to address increased medication waste and access has been the use of drug repositories. So far, 38 states have enacted laws related to the donation and reuse of medication, and 20 states have operational programs.^4,6 Laws in 13 states allow repositories to accept and distribute cancer prescription drugs, and 7 of these have operational programs (Table).⁴ The American Society of Clinical Oncology supports the use of repositories as a way to lower costs and improve access to therapies for oral medications in a closed system.

Table. Operational Drug Repository Programs With Cancer Provisions⁴

Repurposing Cancer Drugs

A drug repository is a program that receives eligible donated drugs that can then be provided to patients who have a financial need or who are patients of a nonprofit clinic, explained Julie Kennerly-Shah, PharmD, MS, MHA, BCPS, a pharmacist and associate director of pharmacy at the Ohio State University Comprehensive Cancer CenterJames Cancer Hospital (OSUCCC-James) in Columbus, Ohio.

“There are varying rules from state to state as to which drugs are eligible to be donated to a drug repository program,” said KennerlyShah. “In Ohio, for example, we recently expanded to oral chemotherapy agents that had been in the possession of a patient. But we do not allow injectables.”

According to Doug Englebert, MBA, RPh, a pharmacy practice consultant, at the Wisconsin Department of Health Services, who is involved in the state’s drug repository program, pharmacies and clinics can sign up to participate in the program. “They get placed on our provider list and then any consumer or business can donate medications that fit the criteria, which usually means it’s in a package that’s tamper-evident sealed and that the medication still has viable life in it, so that means usually at least 90 days left on the expiration date,” he explained.

Englebert also noted that certain drugs cannot be used in the program, including controlled substances, such as morphine and high-risk medications that are part of federal monitoring programs. One example of this is lenalidomide (Revlimid), which is an oral medication for multiple myeloma. Because of the risk of birth defects, lenalidomide, a derivative of thalidomide (Thalomid), is monitored through an FDA-required Risk Evaluation and Mitigation Strategy.

Some hospitals, such as OSUCCC-James, have coordinators who are dedicated to finding options for patients to access medications. Patients are evaluated for inclusion in manufacturer assistance programs or other sources that may help with medication costs. “Once we exhaust other options, the medication assistance coordinator would present this as an option to the team and to the patient to see if they would be interested in utilizing the drug repository,” Kennerly-Shah said.

In contrast, volunteer-based programs provide lists of participating facilities on a website, for example, from which patients can contact a facility to determine whether there is a need for a donation or whether a product is available that can be redistributed.

Large medical groups with multiple participating sites will often pool donations and designate a single site to manage the dispensing so that patients can more easily determine availability and access to medications in a particular geographic location.

“What they’re doing is packaging the medications in a way that can be tamper evident, they dispense these medications, and they tell the patients to donate them back if they become intolerant and discontinue medications,” Englebert explained.

“In oncology, it’s very common for patients to change medications or have a dose reduction, and they end up with a surplus of medication that is quite expensive that another patient could significantly benefit from,” Kennerly-Shah said.

OSUCCC-James worked with the Ohio Board of Pharmacy to create new rules allowing them to take medications that one patient cannot use into the drug repository program and then provide that drug to another patient who is in need, at no cost to that patient. Kennerly-Shah noted that to her knowledge, no donated medications have been deemed ineligible through the inspection process.

Challenges Related to Drug Repositories

Drug repositories are resource-intense commitments. “You need pharmacists to inspect the medication,” Kennerly-Shah explained. “You need a place to store the medication safely. You need a process to identify who should be eligible to receive the donated drug. And then, of course, you need the resources to be able to actually redispense that drug to another patient.”

Patients are required to have a prescription and records must be kept about the dispensing of any prescription drug.

Some states, such as Wisconsin, do not have a statewide central inventory of medications that are available in the repository program that practitioners or patients can access. Currently, practitioners and patients must connect with local facilities to determine medication availability. A local control model works in some environments, so there hasn’t been a push to evolve into a statewide initiative. There are other challenges as well. It’s often an unreliable source of medications for patients and their physicians.

“Practitioners never know if they will get the product and when they do, they need to have space to store it and it’s a separate inventory,” Englebert said. “It becomes a challenge on the management side a little bit.”

Larger programs, such as Iowa’s SafeNetRx, have statewide support and a budget. They essentially manage all their medications and dispense out of there. This type of program is used differently than other programs across the country.

Implications for Oncologists

Oncologists who may be associated with a large health system or a large academic medical center may benefit from resources that are already in place at the health system to operationalize a repository program. However, smaller practices may experience difficulties due to the resource-intense nature of the process.

“The more patients you see, the higher likelihood that you have a large donation pool as well,” noted Kennerly-Shah. “So, one of the things that we thought very hard about when we were launching was which medications to start with,” she explained. They also considered which medications had a need and which medications had a surplus in the community in which they were likely to receive significant donations.

Kennerly-Shah noted that she hopes to expand to include every oral oncolytic and supportive care medication.

At OSUCCC-James, patients and their caregivers have expressed their gratitude for the opportunity to donate oral chemotherapy medications. Patients deciding to discontinue treatment and transition to hospice have been happy to give that medication to another patient with cancer.

“I’m always humbled by the camaraderie and the sense of oneness that I see from one cancer patient to another and a true desire to help others in the cancer community,” explained Kennerly-Shah. “I just am so impressed with our patient population and how much they’ve embraced this program and desire to help other patients that are going through a similar challenge in life."

References

1. Hendren S, Chin N, Fisher S. Patients’ barriers to receipt of cancer care and factors associated with needing more assistance from a patient navigator. J Natl Med Assoc. 2011 Aug; 103(8): 701-710. doi:10.1016/s0027-9684(15)30409-0
2. American Cancer Society. The costs of cancer care: addressing patient costs. Published April 2017. Accessed June 8, 2020. https://www.fightcancer.org/sites/default/files/Costs%20of%20Cancer%20-%20Final%20Web.pdf
3. The IQVIA Institute. Global oncology trends 2019. Published May 30, 2019. Accessed June 8, 2020
4. American Society of Clinical Oncology. Position statement on drug repository programs. Accessed June 8, 2020. https://www.asco.org/sites/new-www.asco.org/files/content-files/advocacy-and-policy/documents/2020-DrugRepositoryPositionStatement.pdf
5. Bach P, Conti RM, Muller RJ, et al. Overspending driven by oversized single dose vials of cancer drugs. BMJ. 2016;352:i788. doi.org/10.1136/bmj.i788
6. National Conference of State Legislatures. State prescription drug return, reuse and recycling Laws. Published October 1, 2018. Accessed May 7, 2020. http://www.ncsl.org/research/health/state-prescription-drug-return-reuse-and-recycling.aspx