Pharmacist Impact on Reducing Medication Costs for Patients and Decreasing Medication Waste: Implementation and Expansion of the South Dakota Drug Repository Pilot Program

Amanda Kuhn, PharmD
PGY2 Health System Pharmacy Administration & Leadership Resident
Avera McKennan Hospital
Sioux Falls, SD

Rachel Elsey, PharmD, BCOP
Oncology Pharmacist
Avera Cancer Institute
Sioux Falls, SD

Robin Lockhorst, PharmD, BCPS, BCOP
Oncology Pharmacy Research Coordinator
Avera Cancer Institute
Sioux Falls, SD

Matthew Toennies, PharmD, CSP
Pharmacy Manager
Avera Specialty Pharmacy
Sioux Falls, SD

Background on Drug Repository Programs
In the United States, state boards of pharmacy are responsible for establishing rules that dictate how patients can safely and legally access medications. As of 2019, 37 states had laws allowing unused medications to be donated and redispensed to patients through drug repository programs.^{1, 2} Drug repository programs are driven by the needs of patient as identified by healthcare providers, pa­tient advocates, pharmacists, nurses, and physicians. Patients who participate must also have a desire to give back in order to decrease the financial burden of medication for others.

In January 2020, the American Society of Clinical Oncology issued a position statement on state drug repository programs. In the statement outlining their support, they noted that widespread use of such programs could lower costs for patients and payers and improve access to treatment for people who are unable to afford high-cost cancer drugs—all while reducing the amount of unused medications in the outpatient setting.¹ Redispensing of unused medication may assist patients in need by offering timely and affordable access to prescription medications, while also saving healthcare dollars from being wasted on things such as hazardous medication disposal. Drug repository programs provide a bridge for patients, allowing them to start therapy immediately, while they await access to medication assistance programs or prior authorizations.

South Dakota Pharmacy Laws and Rules
In South Dakota, returning unused medications is prohibited based on the following rule, ARSD 20:51.13:02 Return of unused drugs, summarized as pharmacists and pharmacies are prohibited to ac­cept unused drugs or prescribed medications from patients or their proxy.

Implementation of South Dakota Drug Repository Pilot Program
Noticing the need for a drug repository program in South Dakota, especially with several nearby states having functioning programs in place, oncology clinic pharmacists and specialty pharmacists within Avera McKennan worked with the South Dakota Board of Pharmacy (SDBOP) to propose the development of a drug reposi­tory pilot program at the Avera Specialty Pharmacy (ASP)^{3, 4, 5}. ASP was originally granted a one-year variance for ARSD 20:51.13:02 to allow the pharmacy to accept the return of unused drugs and redis­pense the drugs under the following stipulations.

1. Only legend drugs in the original, unopened, sealed or tamper-evident container, which includes lot number(s) and expiration date(s), are eligible for donation
2. Drugs packaged in single-unit doses may be accepted and dis­pensed if the outside packaging has been opened and the single unit-dose package is unopened

The variance was granted starting July 1, 2019 and extended for an additional year, through June 30, 2021. Policies and procedures were created for accepting, storing, dispensing, and documenting donated legend drugs. The creation of patient donation and receipt forms helped to ensure transparent communication and adequate documentation of all program transactions. The policies dictated what medications would not be accepted, including controlled substances, drugs with REMS requirements, and drugs with tem­perature sensitive storage requirements. Overall time spent writing policies, protocols, and creating forms amounted to 8-10 hours. For medications that did not meet the donation requirements, pharmacists were able to offer destruction via an onsite MedSafe receptacle. The pharmacists inspected donated medications, and then redistributed to patients in need at no cost to the patient.

Five pharmacists were trained at ASP on donor requirements, the pharmacy acceptance process for donated medications, the storage and dispensing process, and recipient requirements. Time spent training staff and implementing procedures at ASP amounted to two hours. All pharmacists in the hospital and oncology clinics were provided education at a staff meeting. Social workers and patient advocates in the oncology clinic were provided education and reminder e-mails at the initiation of the program.

Expansion of Pilot Program
The pilot program initially focused on oral oncology specialty medications due to the expensive nature of these medications and frequent therapy changes. During the second year, the goal is to in­crease the size and scope of the pilot through increased awareness, education, and advertising. Patient flyers, web pages, and televi­sion broadcasts are being distributed across the rural Avera Health footprint.

The focus has broadened to include medications for the specialty disease states of rheumatology, infectious disease, and transplant/hepatology. The program received a grant from the South Dakota Society of Health-System Pharmacists to assist with shipping costs of repository donations and dispensations to and from ASP; this al­lowed the program to continue to engage the health system outside of the Sioux Falls region and help ensure patients could participate anywhere across the state.

Statistics on Pilot Program
The program has demonstrated significant cost savings for patients through repurposing of medication that would have otherwise been destroyed. Since implementation, over $2 million in prescription drugs have been donated by over 100 patients. Prescriptions have been dispensed to 103 patients in need, totaling over $1 million in medications dispensed through the pilot program (based on Aver­age Wholesale Price).

Data is currently being collected to identify what type of time savings may be achieved by patients and pharmacies having access to this program. Time is likely saved while patients await medica­tion access or prior authorization approvals; also being studied is the potential time and cost savings for participating pharmacies, including time spent counseling patients, maintaining inventory, and providing community awareness of the program. After two years of program operation, the current time spent maintaining the program donations and dispensations is less than one hour per week.

Change in Legislature and Advocacy for Pharmacists
The overall goal of this pilot program is to help support a change to the state law to allow pharmacies to create their own drug reposi­tory programs within South Dakota, or allow for the creation of a statewide drug repository program. A house bill has been drafted to create an act to provide for the redistribution of donated prescrip­tion drugs and medical supplies for this purpose for the 2021 South Dakota legislative session. Data on the pilot program progress, including patients assisted and continued challenges for expansion, will be presented to the SDBOP.

How to Get Involved
Drug donation programs have been shown to improve access to medications, decrease costs for patients, and lessen prescription drug waste. Pharmacists are critical to the success of programs by ensuring the safety and viability of donated medications, along with dispensing and counseling of patients on their medications. Although numerous states have laws allowing repository programs, several of these have no operational programs. Determining if a state BOP has current rules and regulations allowing or prohibiting drug repository programs is a great first step to get involved.

Pharmacists can reach out to members at their state BOP to determine feasible ways to operationalize a program and request a waiver or variance to a rule, if needed. While obtaining a variance to a state rule, pharmacists can work to create policies and procedures to define the program as described in this article. If a state does not have a law defining a drug repository program, reach out to state legislature members to propose language regarding a change to state law. Working through these steps may help pharmacists grow the number of operational drug repository programs throughout the country. This drug repository pilot program not only helps to assist patients in South Dakota, it promotes pharmacists optimiz­ing overall medication access and care.

REFERENCES

1. ASCO Policy Issues and Statements. Position Statement on Drug Repository Programs. https://www.asco.org/sites/new-www.asco. org/files/content-files/advocacy-and-policy/documents/2020- DrugRepositoryPositionStatement%20%281%29.pdf. Approved January 16, 2020. Accessed March 3, 2021.
2. Cauchi R, Berg K. State Prescription Drug Return, Reuse and Recycling Laws. National Conference of State Legislatures. https://www.ncsl.org/ research/health/state-prescription-drug-return-reuse-and-recycling.aspx. Published October 2018. Updated August 4, 2020. Accessed November 10, 2020.
3. Iowa Drug Donation Repository 2016 Performance Update. SafeNetRx. http://safenetrx.org/wp-content/uploads/2017/04/2016-Performance- Update-Drug-Donation-Repository-brochure.pdf. Published 2016. Accessed November 15, 2020.
4. Gilliard S. Wyoming Medication Donation Program July 2019 Newsletter. https://health.wyo.gov/wp-content/uploads/2020/01/Newsletter-July-2019. pdf. Published July 2019. Accessed November 15, 2020.
5. Drug Recycling – Utilization of Unused Prescription Drugs Act. Tulsa County Medical Society. http://tcmsok.org/drug-recycling/. Published 2019. Updated December 2020. Accessed January 8, 2021.