Oral oncology drug donation repository program

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May 20, 2020

Pharmacy
News Story Content

By Lauren Stanz, PharmD, BCPS, PGY2/MS Health-System Pharmacy Administration Resident, The Ohio State University Wexner Medical Center, Department of Pharmacy

The high cost of prescription medications is an ongoing issue for the United States health care system, and oncology practice is no stranger to the problem. The prices of cancer drugs have been increasing exponentially in recent decades, and novel oral agents constitute the extreme of the spectrum with an estimated monthly price of $10,000. The need for access to these medications will likely continue to rise as clinical indications for their use broaden and pricing for individual drugs increase. 

Patient assistance programs have been created to mitigate these inflated costs. These services are sponsored by pharmaceutical companies or private foundations, and provide financial help in the form of free drug, copay coupons and direct payment. However, significant barriers to access continue to exist for patients who do not qualify, and changes to the administration of these programs may result in loss of access for patients who rely on them. As a result of the growing number of oral chemotherapeutics compounded by snowballing out-of-pocket costs, many oncology patients experience financial toxicity and may be unable to afford treatment. 

Apart from these drugs being extremely expensive, going unused creates a similarly exorbitant loss for society. Annually as much as $5 billion of unexpired drug is discarded and the overwhelming majority could be donated for re-use. Re-dispensing medications has the potential to reduce nonadherence, as well as associated health care costs. Whether the cost is lost to the individual patient or to the insurer, preventing such waste is of great importance. Moreover, there are many reasons for this type of waste. For example, if a patient prescribed oral chemotherapy requires a lower dose after experiencing toxicity, he or she now has no use for remaining drug. Likewise, if a patient progresses, his or her treatment is changed and any remaining drug is now a loss. Patient-related factors may also result in a medication going unused. For example, oral chemotherapy is often mailed to patients in advance of evaluation, which could reveal adverse effects or disease progression. In this case, the medication the patient just received is now no longer needed. Societal burden is further amplified by the safe disposal of these hazardous medications and associated environmental impact.

Repository statuses in 38 states allow for donation of prescription medications by patients or facilities. One-third of those states have an active program utilizing this repository concept. The reuse, recycle, and re-dispense rules began in 1997, however, given the length of time these rules have been in place, a surprisingly limited amount of published information regarding such programs is available. The literature that does exist illustrates the provision of free medications to the indigent population having a proven impact on patient-reported hospital use, drug access and perception of health status. Rule-making bodies and legislators must understand these programs are significantly valuable to patients. Historically, oral chemotherapy has been restricted for donation by the State of Ohio Board of Pharmacy. However, Ohio Revised Code 3715.87 was updated in September of 2019 to allow orally administered cancer drugs for donation. The revised code does not require donated drug to be in original sealed and tamper-evident unit dose packaging, but the drug must have been stored according to federal and state requirements, have an expiration date of six months or greater and have no physical signs of tampering or adulteration.

With this rule change, an oral oncology repository pilot program was created to provide a cost-saving and waste-reducing service to oncology patients in need at The Ohio State University Wexner Medical Center (OSUWMC) in Columbus, Ohio. This setting is particularly well suited for an oncology drug donation program as it houses the James Cancer Hospital and Solove Research Institute, the patient-care component of The Ohio State University Comprehensive Cancer Center (OSUCCC). Ultimately, the goal of this initiative was to describe successes and barriers associated with the development and implementation of such a repository program. Throughout the various phases of design and execution, the following aims were identified: 1) define patient eligibility requirements; 2) ensure preferred access to therapy with longevity; 3) select optimal drugs; 4) construct standardized workflow; 5) calculate resource necessity; 6) establish disposal policy; and 7) design marketing materials and host promotional efforts.

The program was first piloted in January 2020 with collection and re-dispense of only two drugs, capecitabine (Xeloda®) and temozolomide (Temodar®), so as to establish best operational practice. It is anticipated that pharmacists with an interest in novel oncology services may be able to utilize this information. Furthermore, this pilot may help provide a foundation for the development of other oral chemotherapy donation programs within the health-system setting. To date, OSUWMC’s repository has received multiple donated collections of both capecitabine and temozolomide. The first redispense of capecitabine occurred in February 2020 to a patient for curative treatment of cancer. This patient had recently lost access to insurance coverage, and pursuit of other benefits or assistance would have delayed treatment. The patient was planning to pay upwards of $4,000 out-of-pocket for drug, an expense well outside the patient’s financial affordability. However, the repository was able to provide this patient with free drug in time for the next scheduled dose, avoiding any deviation from the curative intent therapy plan. This is just one example of the repository’s potential for treatment delay prevention, drug waste reduction, and patient cost savings. With additional resources, the hope is to expand the repository’s scope to include other drugs and reach a greater number of oncology patients.

Reprinted with permission of the Ohio Pharmacist journal, Volume 69, No. 5, May 2020. Read the original article with references here.