Executive Summary: Reducing Prescription Drug Misuse Through the Use of a Citizen Mail-Back Program in Maine
Reducing Prescription Drug Misuse
Through the Use of a Citizen Mail-Back Program
(Safe Medicine Disposal for ME)
Funded by the U.S. EPA Grant # CH-83336001-0
Lenard Kaye, Principal Investigator and Director
Jennifer Crittenden, Program Manager and Research Associate
University of Maine Center on Aging
Stevan Gressitt, Co-Principal Investigator
and Medical Director
Maine Office of Adult Mental Health Services, Maine Department of Health and Human Services
The Safe Medicine Disposal for ME (SMDME) program is a statewide model for the disposal of unused household medications using a mail-back return envelope system. Established through state legislation and implemented in 2007 with a grant from the U.S. Environmental Protection Agency’s Aging Initiative, the program is authorized to handle both controlled and non-controlled medications. All drugs collected undergo high-heat incineration, according to the procedure already established for Maine’s law enforcement drug seizures.
Maine's high degree of rurality and its distinction as being the oldest state in the nation (based on median age) was known to pose challenges in terms of the distribution and collection methods as well as financial challenges for mounting an expired and unwanted prescription drug return program. Furthermore, diverted, abused, and misused prescription drugs are a major cause of accidental poisonings and arrests in the state. The state ranks number one in the country in terms of the perceived relationship of pharmaceuticals to violent crime and property crime, and second in terms of the availability of pharmaceuticals for abuse. Forty percent of Maine law enforcement agencies perceive prescription drug misuse as the state’s most serious drug threat.
The Athens Declaration, developed in 2007 at the 2nd International Conference on the Environment in Athens, Greece, supported six reasons for citizens to tackle unused drug disposal: (1) to curtail childhood overdoses; (2) to restrict household drug theft; (3) to limit accumulation of drugs by the elderly; (4) to protect our physical environment; (5) to restrain improper international drug donations; and (6) to eliminate waste in the international health care systems of all countries.
Using the U.S. Postal Service, the mail-back system was conceived as one method for solving these challenges given that virtually all of Maine’s citizens have access to the mail.
Program Development and Operation
The goals for the prescription drug return program in Maine included: 1) to devise, implement and evaluate a mail-back plan to remove unused and unwanted medications, both prescription and over-the-counter, from residences and dispose of them in compliance with applicable state and federal laws and sound environmental practices, and 2) to test the effectiveness of an educational campaign about the hazards to life, health, and the environment posed by improper storage and disposal of unwanted medications.
A cost-effective model for the disposal of unwanted medication was created and implemented, and an educational campaign was instituted in each of Maine's 16 counties. Further, the project addressed potential barriers to participation due to age, infirmity, rural locale, and other challenges.
Program objectives included: 1) calculating the weight, type and hazardous characteristics of returned medications by actual pill count and drug classification; 2) calculating the cost of the mail-back program as a model for future use nationally, by other organizations and states; and 3) offering a statewide education campaign targeted toward the proper use and disposal of prescription drugs with an initial focus on citizens 65 and older.
Many project partners throughout the state and nation contributed significantly to program success including: the Maine Drug Enforcement Agency, the Maine Department of Health and Human Services and its Offices of Adult Mental Health Services and Substance Abuse, the Maine Benzodiazepine Study Group, the Maine Department of Environmental Protection, the U.S. Postal Service, the Maine Department of Health, the Maine Office of the Attorney General, the U.S. District Attorney for Maine, and the University of Maine Center on Aging. A technical expert advisory task force was formed that included members from each of these and a cadre of other partnering organizations. A community advisory group provided a critical consumer perspective, including the perspectives of individuals involved "on the front line:" the older adult project volunteers handling community education and marketing.
A number of national specialists and associations also committed to the project including the Community Medical Foundation for Patient Safety and the National Council on Patient Information and Education. Rite Aid Corporation, the nation’s third largest drugstore chain and the largest on the east coast, formally committed to participation in the pilot project with their pharmacies serving as distribution site locations. Researchers from the University of Maine Margaret Chase Smith Policy Center contributed to project evaluation and replication manual development.
An "operational test agreement" was formed between the U.S. Postal Service and the Maine Drug Enforcement Agency as part of this program – the first of its kind. The pilot program began with 11 participating pharmacies in four counties serving as envelope distribution sites, and over a period of two years expanded to include approximately 150 pharmacies and health and human services agencies in all 16 counties of Maine. The program broadened from the original target audience of older adults (65 years and older) and their caregivers to include adults of all ages. The program currently maintains a waiting list of interested community-based envelope distribution sites.
Using a double verification process, MDEA law enforcement personnel have counted and collected returned mailers from the Post Office on a regularly scheduled basis and taken them directly to a secure consolidation facility. The audit process involved a repeat count of the number of packages received and verification of accounting logs conducted by the UMaine Center on Aging. Throughout the process, the MDEA maintained continuous, unbroken custody of the returned medicine.
Cataloging of returned drugs was done under law enforcement supervision by volunteer project pharmacists, pharmacy techs, and pharmacy students. As citizen participation in the program has increased over time, the program moved from cataloging 100% of returns to a 25% random sample and finally to a 20% random sampling procedure. Using a sampling method was found to be both cost effective and yielded a data sample that was statistically representative of the full inventory data set. For the envelopes that did not receive a full inventory, all non-controlled drugs were sorted for disposal, and all controlled drugs were fully inventoried.
During the cataloging, drugs were sorted according to whether they were controlled drugs or not and further into controlled hazardous or controlled non-hazardous categories. This sorting method facilitated appropriate disposal and therefore helped control disposal costs.
Program Results and Findings
The mail-back program, during its first two phases of EPA-funded operation, has disposed of more than 2,300 lbs of drugs, representing 3,926 returned envelopes. A total of 9,400 enveloped were distributed during this period representing a 42% envelope utilization and return rate. There have been eight cataloging events during this period.
Additionally, over 380,000 pills were cataloged via the drug inventory process, 2,777 telephone calls were answered via the program helpline, 250 pounds of controlled drugs have been destroyed, the average weight of a returned envelope was 7 ounces, and the Estimate Average Wholesale Price (AWP) of medicine collected was $572,772.35 (US Dollars).
Approximately 17% of the drugs were schedules II, III, and IV - "controlled drugs." These included narcotic pain relievers, tranquilizers and sedatives, as well as stimulants.
Most returns were in pill form. Fourteen percent of returns represented liquids, gels, ointments and patches. A negligible amount of medical supplies and devices were returned including unused morphine pumps. Full, unused bottles were sometimes returned, including prescriptions from mail-order pharmacies or VA pharmacy services, as well as anti-retroviral drugs for HIV/AIDS treatment. It was not uncommon to find a mix of returns from both local and mail order pharmacies sometimes where a patient was receiving the same drug from both sources.
Based on surveys and analysis of returned drugs, it is estimated that the percentage of program participants who would have used the trash or toilet to dispose of drugs prior to program implementation = 83% x 2,373 lbs of drugs = 1,970 lbs of drugs that were prevented from entering the water supply and landfills.
Findings from program participant surveys confirm multiple reasons for drug accumulation in their homes, including:
- Medicine belonged to a deceased family member (19.6%)
- A physician told the patient to stop taking the medication or gave the patient a new prescription (27.3%)
- The person had a negative reaction or allergy to the medicine (11.9%)
- The person felt better or no longer needed the medicine (18%)
Participants had multiple reasons for removing the drugs from their homes, including concerns for the environment, drug compliance, drug safety, as well as preventing drug diversion. Some noted they did not want anyone else to use the medicine. Some were concerned about the potential poisoning dangers to children, or the risk of drug abuse diversion. Often the medicine was expired or outdated and no longer useful. Nearly half (46%) of those surveyed reported that, in the absence of a take back program, they would have flushed drugs down the toilet. Another one third (37%) would have dumped left over prescriptions into their trash. Overwhelmingly, 77% of program survey respondents cited participation because, "it's best for the environment."
The per-envelope cost in the initial years of the program was shown to be greatest given the staff time and effort needed to design and operationalize such an initiative. Donated time and effort by pharmacists and pharmacy tech staff and older adult volunteers reduced operational costs. Aggregated Phase I and II actual and in-kind contributions calculate to $18.79 per unit mailer. Subsequent mailer costs (Phase III) are calculated at $7.50 per unit mailer.
Program Conclusions and Recommendations
The Safe Medicine Disposal for ME program has allowed drugs to be returned directly to one agency, which reduced coordination costs and provides for secure collection and consolidation of returns. In Maine, the Maine Drug Enforcement Agency (MDEA) has statewide jurisdiction and was involved from the outset in concept development. This program partnership with the Maine Drug Enforcement Agency facilitated review and subsequent approval of the program by the federal Drug Enforcement Agency. The statewide mail-back model offers a centralized coordination component, adds an element of confidentiality and anonymity not found with in-person take back programs and is the least burdensome of all models in terms of consumer access and utilization.
Maine's citizen mailback program has demonstrated that this approach is not only feasible, but effective. The program utilized a phased implementation plan, beginning by targeting elders and focusing on pharmacies as distribution sites for the mailback envelopes. A broadened target population was then phased in, adults of all ages, as well as a wider range of distribution sites (other providers of health and social services).
The mailback envelope take-back method returned a large quantity of drugs that would have otherwise been disposed of directly into the water system through flushing or into landfills through the trash. A short survey inserted in the envelope allowed us to track the reasons for participation, the sources of the drugs, and the demographic profile of the participants. This is information that is useful not only for project planning and education, but also policy development. Research data gathered during this project has already begun to shape policy both statewide and nationally. For example, a recent MaineCare (Maine’s Medicaid program) policy change, has led to the enactment of limits for some drugs on how much of a supply can be filled in an initial prescription.
The mailback program provides a rich opportunity to educate a broad public citizenry about prescription drugs and the environment via community outreach and information distributed with the mailer. It involves citizens in an easy, "DIY" (do it yourself) problem-solving program that prevents environmental harm, prevents drug diversion, and prevents poisoning. Community education by older adults was found to be both effective and engaging while encouraging new users of the program to spread the word in their local communities. It is for this reason that consumer involvement should be a key component in any drug return program model.
The major challenge for this and other disposal programs continues to be funding to sustain such efforts. All disposal programming, whether mailback or event-based takeback programs, requires a considerable amount of time and effort to plan, execute, and market. The first two phases of this program have shown that community interest and need exist and in fact, clearly outweigh the resources available to address the issue of drug disposal. It is imperative to continue as many programming and outreach efforts as possible to provide drug disposal options directly to the consumer at the same time that information is disseminated so as to avoid the confusion and misinformation that surrounds the issue of drug disposal.
The state of Maine legislature has recognized the efficacy of this initiative by enacting LD 411 "An Act to Establish a Pilot Program for the Return of Unused Prescription Drugs by Mail" and has provided additional resources to the pilot which is allowing the program to continue for an additional two years beyond the initial U.S. EPA grant.