Across the country and beyond, drug donation programs are quietly emerging as a practical channel to connect patients in need of assistance with unused prescription medications. The World Health Organization has developed international guidelines for humanitarian relief as a basis for national and institutional guidelines. In the United States, 44 states have legislatively created drug donation programs, although many are
nonoperational or underutilized.1 In states where drug donation programs have demonstrated success, the benefits of the program are enjoyed by a variety of stakeholders, generating significant cost savings to program donors, healthcare providers, and patients seeking assistance.
For instance, a young, uninsured patient was being treated at a critical access hospital for methicillin-resistant Staphylococcus aureus, a bacterial infection that is highly resistant to some antibiotics. The patient had been hospitalized for 3 days and was receiving intravenous (IV) antibiotic treatment, and he was scheduled to receive an additional 10 days of IV treatment. As an alternative, the hospital received a donation of 24 linezolid (Zyvox) tablets from the state’s centralized drug donation repository. The young man received the oral antibiotic and was able to return home to treat his infection without further hospitalization. The donated linezolid saved the patient more than $41,000 in medication and hospitalization costs. The additional 10-day IV antibiotic treatment was estimated at $5956. The cost of 10 additional days in the hospital (excluding physician fees) was estimated at $35,980.2
Sources of Medication
Drug donation regulations are governed at the state level and contrast greatly from state to state. However, virtually all laws include restrictions designed to ensure the purity, integrity, and safety of the medications donated.3 Most drug donation programs only accept medications that have been in the possession of a licensed healthcare professional, manufacturer, pharmacy, or healthcare institution.1 However, some states also accept unused medications from individuals if the donor can certify that the medications were stored as recommended by the manufacturer and have not been tampered with.
In general, donated medications must have an expiration date greater than 6 months from the date of donation; must be contained in the original sealed, or unit-dose tamper-evident packaging; must not require refrigeration or temperature requirements different from room temperature; and must not be a compounded or controlled substance. Contributed medications that do not meet the donation criteria must be incinerated or destroyed. Because of the donation criteria, any medications dispensed in an amber vial or dispensed in a manner that does not use sealed, tamper-evident packaging is strictly prohibited. As a result, many operational programs rely on dispensing pharmacies for long-term care as the primary source for donated medications. The 31-day or less blister packs that are used in long-term care settings allow for easy visual inspection for drug identification and tampering. Dispensing pharmacies for long-term care have welcomed drug donation repository programs as an economical option to dispose of previously dispensed but unused medications.
Drug donation programs are designed to provide short-term assistance to low-income and under- or uninsured patients. These programs are not intended to provide medication assistance in lieu of state or federal programs, but they do serve patients who need short-term assistance, such as an insured, low-income patient who cannot afford a drug copay, an individual waiting to receive Medicaid benefits, or a senior who has reached the Medicare coverage gap. Assistance is often provided in the form of 30-, 60-, or 90-day supplies of medication.
Although some states allow the drug donation program to dispense directly to the patient in need, many programs are licensed in their state as a wholesale distributor. As distributors, the drug donation programs supply medical facilities, such as free medical clinics or federally qualified health centers, with donated medications that will be dispensed to patients in need. Once the donated medications are received by the medical facility, the medications are dispensed to the patient in its donated format; however, some states also allow the dispensing medical facility to repackage the donated items in a format that is consistent with retail pharmacies.
Drug donation programs with a history of success often use state assistance to underwrite operating costs. As a result, almost all state regulations for drug donation programs stipulate that only state residents are eligible to accept the donated drugs. Most states also specify that the donated drugs must be dispensed to low-income patients lacking prescription insurance. The term “safety-net patient” is often used to identify individuals who are eligible for assistance, and are loosely defined as a patient with a household income less than 200% of the federal poverty level, who is also uninsured or underinsured.
The Role of the Pharmacist
Licensed pharmacists must be engaged in the drug donation process to ensure the safety and effectiveness of the donated medications. All state regulations require a state-licensed pharmacist or pharmacy to be part of the drug inspection and distribution processes.3 Most often, donated medications are collected at a centralized repository or pharmacy where the donated items are inspected by a licensed pharmacist and verified as safe for redistribution. Common medication elements inspected by a pharmacist include the condition of the original or tamper-evident sealed packaging; evidence of medication damage; accurate drug labeling and dosage; drug expiration; and presence of identification markers. Any questionable product is destroyed without hesitation. Pharmacists who regularly handle prescription drugs often excel in the drug inspection process. Online drug identification resources can be helpful during the inspection process. In addition, many states also require a pharmacist to document and return or destroy any controlled substances obtained through the drug donation program.
The operating status, scope, and structure of drug donation programs across the country vary drastically. Most state programs are only a few years old or are still in the development and testing stages. These programs often operate on a limited budget and may rely on part-
time or volunteer pharmacists and program staff to manage the drug donation repository. A small number of states have invested in the drug donation repository model and use full-time administrators, pharmacists, and program staff. In these programs, pharmacists and staff are compensated at rates competitive with the local retail pharmacy market. In states where drug donation programs continue to grow and evolve, professional opportunities with these programs will increase.
Drug donation programs are emerging as practical models to effectively improve access to affordable medications, decrease costs, eliminate waste, and reduce pollution. However, these programs are relatively new models in the healthcare delivery system. Additional detailed analysis is needed to identify program factors that contribute to long-term sustainability, maximize patient safety, and increase utilization. Drug donation programs must also effectively embrace industry changes to address the increasingly complex global supply chain and minimize consumer exposure to substandard drugs. These are changes that could effectively end drug donation programs as they are currently structured. However, 10 years ago, drug donation programs were distant concepts. At this time, states turned to leadership at their boards of pharmacy, state pharmacy associations, and colleges of pharmacy to develop practical and safe regulations for drug donation programs. These same strong, earned partnerships can also lead us through the next 10 years.
- Zhang Y, Sorofman B, Rosmann J. Policy analysis of drug donation regulations in America. J Am Pharm Assoc. 2013;53:(2):e43.
- Data on file. The Iowa Hospital Association; February 2011.
- National Conference of State Legislatures Staff. State Prescription Drug Return, Reuse and Recycling Laws. National Conference of State Legislatures. September 2012. http://www.ncsl.org/issues-research/health/state-prescription-drug-return-re use-and-recycling.aspx. Accessed August 6, 2013