Abstract
BACKGROUND:
Availability of medication disposal receptacles is critical to curbing nonmedical opioid use and diversion; however, availability in community pharmacies is sparse. The objective of this study was to describe implementation of the community pharmacy medication disposal program offered by the HEALing Communities Study in Kentucky (HCS-KY) using the EPIS (Exploration, Preparation, Implementation, and Sustainment) framework.
METHODS:
Sixteen counties participated in the HCS-KY from 1/1/2020 to 12/31/2023. Exploration and Preparation included gathering and review of evidence-based literature, state/community data, and key opinion leader input to develop a detailed implementation plan. Implementation and Sustainment were assessed using implementation outcome data collected (e.g., number of receptacles placed, amount of drug returned) and semi-structured qualitative interviews to evaluate common themes, including barriers and facilitators related to implementation and sustainment.
RESULTS:
Disposal receptacles were placed in 59 pharmacies within the 16 HCS-KY counties. Following implementation, the median number of receptacles per participating county increased significantly from 2.5 to 4.5 (p<0.001). A total of 8,019.9 pounds of drug were returned during the study period, with a median per-county return rate of 230.5 pounds per year. Twenty-one pharmacy representatives participated in qualitative interviews. Most (70.0%) reported weekly receptacle usage; however, few (35.0%) reported routinely discussing disposal with patients. While 42.9% reported no barriers, the most frequently reported barrier (33.3%) was receptacle limitations (e.g., only available during business hours, dosage form restrictions).
CONCLUSIONS:
Implementation of the HCS-KY community pharmacy medication disposal program led to notable increases in disposal locations that were highly utilized by communities.
Keywords: Implementation strategies, opioid epidemic, controlled substances, medication disposal, prescription drug diversion, barriers and facilitators
1. INTRODUCTION
While the opioid epidemic continues to evolve, with rates of prescription opioid-involved deaths decreasing relative to those with illicit fentanyl involvement, prescription opioid use remains a significant contributor to opioid-involved mortality and negative public health consequences (Flanagan et al., 2018). Similar to other Southern and Appalachian states (McDonald et al., 2012; Paulozzi et al., 2014; Rigg et al., 2018), Kentucky has been disproportionately impacted by the opioid epidemic relative to the nation as a whole, with both opioid dispensing rate (61.6 prescriptions per 100 residents) and age-adjusted opioid-related overdose mortality rate (42.4 per 100,000 residents) considerably higher than national figures (46.8 prescriptions per 100 residents and 28.7 deaths per 100,000 residents) as of 2022 (“Opioid Dispensing Rate Maps | Drug Overdose | CDC Injury Center,” 2023; “SUDORS Dashboard,” 2024).
While opioid dispensing rates alone do not necessarily equate to nonmedical use or diversion, data indicate that over 60% of post-surgical opioids dispensed remain unused, creating potential for nonmedical use, unintentional exposures, or diversion (Schirle et al., 2020). Studies focused on prescription opioid disposal have found that, despite public promotion of safe disposal techniques (“Disposal of Unused Medicines,” 2021; “How to Safely Dispose of Drugs,” 2018; “Promote safe storage and disposal of opioids and all medications,” n.d.; “Take Back Day,” n.d.), a large portion of unused prescription opioids are retained (Allen et al., 2020; Egan et al., 2019; Gregorian et al., 2020). This, coupled with data suggesting approximately 3 in 4 patients report unsecured storage of unused opioid prescriptions, raises concern for the potential for nonmedical use and diversion (Bartels et al., 2016; Gregorian et al., 2020). Research conducted regarding nonmedical use of opioids, which has been shown to be a key feature of trajectories into injectable drug use (Lankenau et al., 2012), support this concern, with most people in active use reporting that opioids were obtained from friends or relatives (Jones et al., 2014). Moreover, an additional study of nonmedical use among adolescents found leftover opioids from their own previous prescriptions to be a major source of nonmedical use (McCabe et al., 2013). In addition to potential exposure to nonmedical use, studies have shown that household opioid availability is associated with opioid overdoses among individuals who were not prescribed opioids, shedding further light on the potential consequences of unused opioid availability and highlighting the importance of proper disposal (Hendricks et al., 2023; Khan et al., 2019).
In 2014, to address concerns relating to the potential nonmedical use and diversion of unused prescription opioids, the United States Drug Enforcement Agency (DEA) implemented the Secure and Responsible Drug Disposal Act of 2010 (“DEA Releases New Rules That Create Convenient But Safe And Secure Prescription Drug Disposal Options,” n.d.). This rule change, aimed at increasing opportunities for safe medication disposal, allowed certain entities, including pharmacies, to register as authorized collectors, install medication disposal receptacles, and contract with a reverse distributor for collection, transport, and destruction of received medications (“Preventing Drug Abuse,” n.d.). While this opened the door for expanded disposal opportunities, implementation within pharmacies has been limited. Although 8 in 10 authorized collectors are pharmacies, less than 3% of eligible US pharmacies are registered as authorized collectors (“Preventing Drug Abuse,” n.d.). In addition, distribution of community pharmacy disposal locations is concentrated in urban areas, often leaving rural areas underserved (Egan et al., 2018). Taken together, these data highlight the need for expansion of disposal services beyond existing collectors (“Preventing Drug Abuse,” n.d.). While previous literature has described receptacle availability and barriers in community pharmacies (Egan et al., 2022, 2018; Miracle et al., 2023), data on successful implementation of disposal receptacles is available only anecdotally (McCarthy et al., 2019).
1.1. Objective
The objective of this study was to describe implementation of the community pharmacy medication disposal program offered by the HEALing (Helping to End Addiction Long-term®) Communities Study (HCS) in Kentucky using the EPIS (Exploration, Preparation, Implementation, and Sustainment) framework (Aarons et al., 2011).
2. MATERIALS AND METHODS
2.1. Study Context
The HCS is a multi-state, parallel-group, cluster randomized wait-list controlled trial that tests whether the Communities That HEAL (CTH) intervention decreases opioid-involved overdose deaths in intervention communities relative to wait-list communities (HEALing Communities Study Consortium, 2020). The CTH intervention uses a coalition-driven community engagement process to select and support the implementation of strategies to facilitate the uptake of evidence-based practices (EBPs), including overdose education and naloxone distribution, medications for opioid use disorder, and improved prescription opioid safety (Sprague Martinez et al., 2020). Within each of the four HCS states, highly impacted communities were defined as having ≥150 opioid-related overdose fatalities and a rate of ≥25 opioid-related overdose fatalities per 100,000 people in 2016. Additionally, at least 30% of communities were required to be rural (HEALing Communities Study Consortium, 2020). In Kentucky (HCS-KY), 9 urban and 7 rural counties were selected for participation in the HCS (“Data Access - Urban Rural Classification Scheme for Counties,” 2022). Eight HCS-KY counties were randomized to Wave 1 (active arm), which received the CTH intervention first (January 2020 through June 2022), while the remainder served as a wait-list control (Wave 2), receiving the intervention later (July 2022 through December 2023). Notably, the longer Wave 1 period was due to the COVID-19 pandemic, which required extension of the original period to allow for the modification of implementation plans and delays due to remote work requirements, quarantines, limited access to healthcare facilities, etc.
The Opioid-overdose Reduction Continuum of Care Approach (ORCCA), a key component of the CTH intervention, consists of a menu of strategies and technical assistance guides that facilitate community uptake of EBPs (Winhusen et al., 2020). One of these EBPs is improved prescription opioid safety, which includes strategies to promote safer prescribing, dispensing, and disposal practices. Community coalitions used a data-driven approach to select strategies from the ORCCA menu, with all 16 HCS-KY communities selecting safer disposal practices (Chandler et al., 2023). In HCS-KY, this strategy included installation of permanent collection receptacles in community pharmacies.
This study protocol (Pro00038088) was approved by Advarra Inc., the HCS single Institutional Review Board.
2.2. Conceptual Framework
The EPIS framework is a multi-level, four-phase model of the implementation process (Exploration, Preparation, Implementation, and Sustainment) useful in consideration of the challenges and opportunities of EBP implementation (Aarons et al., 2011). The Exploration phase includes understanding the underlying unmet needs of patients, clients, and/or communities and selection of an EBP that addresses these needs (Moullin et al., 2019). The Preparation phase involves further assessment of implementation needs, identification of potential and existing barriers and facilitators to implementation, and development of a detailed implementation plan, including implementation strategies aimed at addressing key barriers. During the Implementation phase, use of the EBP is initiated within the system, organization, or community. This phase also includes monitoring of the implementation process and adjusting implementation strategies as necessary to support efforts. The Sustainment phase includes continuation of the EBP along with gathering and understanding the structures, processes, and supports required for continued EBP sustainment.
For this study, the EBP in question was safer disposal practices, which, in the HCS-KY, included installation and promotion of permanent collection receptacles in community pharmacies. The Exploration phase included gathering and review of evidence-based literature relative to medication disposal, state/community opioid dispensing data, and key opinion leader input (e.g., officials involved in efforts in other states and leaders of local health systems). The Preparation phase included utilization of this to develop implementation strategies facilitating the recruitment of HCS-KY partner pharmacies and successful implementation of permanent collection receptacles for medication disposal. Implementation strategies utilized by HCS-KY were provide interactive assistance (facilitation, centralized technical assistance), train and educate stakeholders (conduct ongoing training, develop educational materials, distribute educational materials, and conduct educational outreach visits), engage consumers (use mass media, prepare patients/consumers to be active participants), and utilize financial strategies (fund and contract for the clinical innovation) (Waltz et al., 2015).
The Implementation phase involved installation of permanent collection receptacles for medication disposal in partnering community pharmacies. Adoption (i.e., the percentage of pharmacies that installed receptacles) and reach (i.e., the amount of drug returned from participating communities) were assessed overall and across rural-urban strata. The HCS-KY adoption goal for disposal receptacle implementation was to have receptacles installed in at least 30% of community pharmacies located within each participating county or to have a minimum of 1 receptacle per 25,000 county residents. These adoption goals were selected based on a variety of factors, including the number of pharmacies and the number of permanent disposal receptacles available in pharmacies at baseline (Miracle et al., 2023) as well as the estimated funds available for disposal receptacle implementation within each county. The Sustainment phase included semi-structured qualitative interviews conducted virtually with pharmacists and pharmacy technicians at partner pharmacies. Thematic analysis of qualitative interviews conducted during Wave 1 identified barriers and facilitators related to implementation and maintenance as well as feasibility of implementation and sustainment.
2.3. Exploration and Preparation
In preparation for the CTH intervention, a baseline study was conducted to describe county-level availability of drug disposal receptacles in Kentucky community pharmacies and examine the relationship between installed receptacles and opioid analgesic dispensing rates, stratified where possible by urban-rural classification (Miracle et al., 2023). Findings indicated a mismatch between the county-level availability of disposal receptacles located within community pharmacies and the volume of dispensed opioid analgesics, resulting in a lower rate of receptacles per million dispensed opioid analgesic doses in rural counties (rate 0.47; 95% CI: 0.35, 0.61) compared to urban counties (rate 0.31; 95% CI: 0.25, 0.42), with an estimated rate ratio of 1.45 (95% CI: 1.01, 2.10).
Following selection of the disposal receptacle strategy by community coalitions, coalitions were provided local maps of currently placed disposal receptacles (created using data provided by the DEA) and were tasked with identifying priority pharmacies within their community based on ease of access, geographic distribution, likelihood of partnership, and potential to reach diverse populations. Due to likelihood of partnership as a result of their ability to make autonomous decisions, community coalitions prioritized independent pharmacies; however, chain pharmacies were still recruited where possible. An example of the maps provided to coalitions is included in Appendix A. Priority pharmacies identified for disposal implementation and pharmacy contact information were entered by coalition members into a Coalition Implementation Planning Tool. Information for all candidate partner pharmacies was entered into REDCap, a secure web-based software platform designed to support data capture for research studies (Harris et al., 2019, 2009). While priority pharmacies were contacted first, all community pharmacies within the 16 HCS-KY counties without a permanent disposal receptacle were invited to participate. Potential partner pharmacies were contacted initially by a coalition member or by the HCS-KY prevention team. If contacted by a coalition member, follow-up was conducted by the HCS-KY prevention team. Verbal and written material regarding the HCS-KY disposal program and installation process were provided to representatives (e.g., pharmacist/owner at independently owned pharmacies and district or higher-level managers at corporate chain pharmacies) at prospective partner pharmacies. Pharmacy representatives who lacked time to discuss the program were provided a program overview video (Appendix B). At least two follow-up calls were conducted with pharmacies that had neither accepted nor declined. Pharmacies who agreed to partner were enrolled in the HCS-KY disposal program (Appendix C). Pharmacies that were unable to install a drop box but desired to participate in the program (n=23) were offered mail-back medication disposal envelopes, as well as disposal information and patient education materials. Communication throughout this process was tracked using REDCap.
2.4. Implementation
Following enrollment, the Disposal Coordinator (a member of the HCS-KY prevention team) worked with participating pharmacies to facilitate reverse distributor contracting, DEA authorized collector registration, and completion of the receptacle order form. Interactive assistance with implementation and financial coverage of initial costs was provided by the HCS-KY to mitigate major barriers identified in previous literature associated with limited uptake of the authorized collector program at the national level (“Preventing Drug Abuse,” n.d.). Pharmacies, with guidance from the Disposal Coordinator, were instructed to select an appropriate area for receptacle installation, develop relevant policies and procedures, and educate staff on proper use of the disposal receptacles. In addition to the receptacle manufacturer’s materials, a training guide was developed and provided to pharmacies for staff training on basic receptacle details, changing of liners, disposal regulations, and resources for further information (Appendix D). Educational assistance was available to participating pharmacies via virtual meetings, pre-recorded informational videos (Appendix E), and educational outreach visits.
To facilitate patient education regarding disposal, promotional materials were provided to participating pharmacies, including a magnet, flyers, and social media posts developed by the HCS-KY prevention team. Example social media posts provided to pharmacies are included in Appendix F. Pharmacies also had access to the receptacle manufacturer’s toolkit, which included posters, postcards, press release templates, window clings, bag inserts, and other materials. Upon delivery of the disposal receptacle, pharmacies were tasked with attaching the receptacle to a wall or floor and installing the liner. Assistance was provided when requested or if there were significant delays in the receptacle becoming operational. Additional guidance regarding liner installation was provided via the manufacturer’s instructional video. Community-level promotion regarding safe drug disposal and the addition of new collection receptacle locations in the county was provided by the HCS-KY communication team and included billboards, local newspaper articles (“Local pharmacies partner with the University of Kentucky HEALing Communities Study to offer safe medication disposal options,” 2023), radio spots, and video advertisements (Appendix G) for airing by local businesses or television stations. “Clean it out!” bags were also placed in public locations, which listed local disposal locations and encouraged patients to “clean out” their medicine cabinets. Specific promotional methods were chosen by community coalitions. Radio spot scripts and printed materials for disposal promotion within communities are shown in Appendix H.
Outcome data related to implementation, including number of receptacles installed, total number of active receptacles (baseline receptacle count plus installed receptacles), and post-installation follow-up contacts were recorded via REDCap from the beginning of Wave 1 through February 2024. Pharmacy characteristics included rural-urban classification, location, and pharmacy type (chain vs. independent). The amount (in pounds) of drug returned for incineration, which indicates the outcome of reach, was also recorded each month through February 2024.
2.5. Sustainment Interviews
Pharmacies that implemented the EBP during Wave 1 were recruited to participate in semi-structured, qualitative interviews to assess satisfaction and experience associated with implementation and to discuss future sustainment options. Because the decision to participate and location selection was done at a corporate level for the four retail chain pharmacies that partnered with HCS to install a receptacle, interviews were not conducted with these locations. Verbal informed consent was obtained prior to the start of each interview. All interviews were conducted virtually via Zoom as the Wave 1 intervention was ending (between June 1, 2022 and July 14, 2022) and followed a semi-structured interview guide (Appendix I). Questions regarding satisfaction and experience inquired about inner and outer contextual factors related to implementation, including previous consideration for disposal receptacle installation and associated barriers, barriers and facilitators experienced during implementation of the HCS-KY disposal program, utilization of the receptacle, pharmacy characteristics (e.g., dispensing volume, typical staffing, challenges with staff burnout), suggestions for improvement, and advice to other pharmacies considering installation. Prior to the sustainment portion of the interview, a progress report (Appendix J) was reviewed with each pharmacy, indicating the amount of drug returned, number of liners provided, liner pricing, cost forecasting based on current use, and potential options with contact information for future funding. The sustainment portion of the interview outlined resources provided by the HCS-KY, including an additional 1-year supply of liners, a resource website and training videos, and a reproducible promotional flyer file (Appendix K) for future use. Following this, questions asked about plans for sustainment and additional needs relative to support or information, promotional materials, and other resources. All sustainment interviews were recorded and transcribed via Zoom for analysis. While Wave 2 pharmacies were not included in these interviews due to study timing, progress reports were also made available for review and sustainment resources were likewise provided.
2.6. Analyses
Implementation outcomes (number of receptacles installed, total number of active receptacles, and amount of drug returned for incineration) were characterized using descriptive statistics. Population estimates used in assessing the study goal of 1 receptacle per 25,000 residents were sourced per the US Census Bureau’s 2022 County Population Totals (“County Population Totals and Components of Change,” n.d.). Community pharmacies located in each Kentucky county were identified via a list provided by the Kentucky Board of Pharmacy and used to calculate the percentage of pharmacies with an installed drug disposal at baseline and following implementation. Pre-existing receptacles per county were identified via DEA authorized collector lists prior to receptacle implementation for each wave (July 2020 for Wave 1 and December 2021 for Wave 2). A paired-samples Wilcoxon test was used to assess differences between median number of receptacles per county before and after the CTH intervention. Maps were developed via QGIS version 3.22.16 to display adoption and implementation outcomes relative to geographical location.
A thematic analysis was conducted to analyze responses received during sustainment interviews. Transcripts from these interviews were independently assessed and reconciled by two members of the research team to identify common themes. Following identification of major themes, interview transcripts were independently coded and reconciled by the same two team members, with a third available to adjudicate any disputed items (Braun and Clarke, 2006). Quantified themes were then characterized via descriptive statistics. Analyses were conducted using RStudio version 2022.07.01.
3. RESULTS
A total of 59 pharmacies across both Wave 1 and Wave 2 agreed to partner in the HCS-KY community pharmacy medication disposal program, allowing for installation of a permanent disposal receptacle. Of 59 placed receptacles, 55 (94.8%) remained active at the end of the study; the four inactive receptacles were due to pharmacy closures (n=3) or ownership change (n=1). Following implementation, the median number of receptacles per participating county increased significantly from 2.50 (IQR 0.75–3.25) to 4.50 (IQR 3.00–7.50) (p<0.001). The mean rate of receptacles per 25,000 residents of participating HCS-KY counties increased following implementation from 0.84 to 1.59. Likewise, the percentage of community pharmacies withing HCS-KY counties with an installed receptacle nearly doubled, increasing from 14.7% at baseline to 27.7% following implementation. Of the 16 participating counties, 13 (81.3%) achieved the study adoption goal of having receptacles installed in at least 30% of community pharmacies located within each county or to have a minimum of 1 receptacle per 25,000 residents (Figure 1). County-level adoption data are displayed in Table 1.
Figure 1.
County-level adoption of the medication disposal program offered by the HEALing Communities Study in Kentucky
Table 1.
County-level adoption of the HCS-KY community pharmacy medication disposal program
| Pre-implementation |
Post-implementation |
|||||
|---|---|---|---|---|---|---|
| County | Rural/Urban | Pharmacies with receptacles, n (%) | Receptacle rate (per 25,000 residents) | Pharmacies with receptacles, n (%) | Receptacle rate (per 25,000 residents) | |
|
| ||||||
| Wave | A | Urban | 3 (16.7) | 1.56 | 7 (38.9) | 3.64 |
| 1 | B | Rural | 3 (42.9) | 2.43 | 4 (57.1) | 3.24 |
| C | Urban | 0 (0.0) | 0.00 | 4 (44.4) | 2.70 | |
| D | Urban | 12 (15.8) | 0.94 | 19 (25.0) | 1.48 | |
| E | Rural | 0 (0.0) | 0.00 | 9 (32.1) | 6.43 | |
| F | Rural | 3 (23.1) | 1.45 | 4 (30.8) | 1.94 | |
| G | Urban | 3 (11.1) | 0.44 | 6 (22.2) | 0.88 | |
| H | Rural | 4 (18.2) | 1.05 | 10 (45.5) | 2.63 | |
| Wave | I | Urban | 2 (40.0) | 2.49 | 3 (60.0) | 3.73 |
| 2 | J | Urban | 1 (7.1) | 0.27 | 1 (7.1) | 0.27 |
| K | Rural | 0 (0.0) | 0.00 | 3 (37.5) | 2.84 | |
| L | Urban | 2 (22.2) | 1.41 | 5 (55.6) | 3.53 | |
| M | Urban | 24 (15.6) | 0.78 | 33 (21.4) | 1.07 | |
| N | Urban | 4 (30.8) | 1.84 | 6 (46.2) | 2.76 | |
| O | Rural | 0 (0.0) | 0.00 | 1 (7.7) | 0.84 | |
| P | Rural | 1 (14.3) | 1.48 | 2 (14.3) | 2.95 | |
HCS-KY = HEALing Communities Study Kentucky
Adoption was comparable across rural-urban county classification. While a greater number of receptacles were placed in the 9 participating urban counties (37) as opposed to the 7 participating rural counties (22), 85.7% of rural counties met the HCS-KY adoption goal following implementation compared to 77.8% of urban counties. Following implementation, 33.7% of pharmacies in participating rural counties had a disposal receptacle compared to 25.8% of pharmacies in participating urban counties. Similarly, the rate of receptacles per 25,000 residents was higher among participating rural counties (2.89) as compared to participating urban counties (1.35).
A total of 8,019.9 pounds of drug were returned through installed receptacles across all participating counties by the conclusion of the study (February 1, 2024). The median per-county return rate during the study period was 230.5 pounds per year (IQR 100.0–366.0). Adjusted for population, the median annual per-county return rate was 86.9 pounds per 25,000 residents per year (IQR 57.6–103.6). Reach was similar across rural-urban county classification, with a median annual per-county return rate of 82.9 pounds per 25,000 residents per year (IQR 50.3–92.4) among rural counties compared to 93.8 pounds per 25,000 residents per year among urban counties (IQR 57.8–114.7). County-level return rates are shown in Table 2.
Table 2.
County-level drug return rates following implementation of the HCS-KY community pharmacy medication disposal program
| County | Rural/Urban | Annual return rate (pounds per year) | Population-adjusted annual return rate (pounds per year per 25,000 residents) | |
|---|---|---|---|---|
|
| ||||
| Wave 1 | A | Urban | 192.28 | 99.92 |
| B | Rural | 112.52 | 91.02 | |
| C | Urban | 302.66 | 204.16 | |
| D | Urban | 727.81 | 56.80 | |
| E | Rural | 268.77 | 192.10 | |
| F | Rural | 129.69 | 62.83 | |
| G | Urban | 393.81 | 57.81 | |
| H | Rural | 356.77 | 93.70 | |
| Wave 2 | I | Urban | 75.39 | 93.80 |
| J | Urban | 427.94 | 114.67 | |
| K | Rural | 39.88 | 37.77 | |
| L | Urban | 100.40 | 20.90 | |
| M | Urban | 432.36 | 13.98 | |
| N | Urban | 290.05 | 133.65 | |
| O | Rural | 98.73 | 82.85 | |
| P | Rural | 0.00a | 0.00a | |
HCS-KY = HEALing Communities Study Kentucky
County P is a small, rural county with a single receptacle that was installed relatively late during the Wave 2 period. While the receptacle was in use, the participating pharmacy had not returned a filled liner by the conclusion of the study period.
Twenty-one pharmacy representatives participated in sustainment interviews, representing 22 of the 36 (61.1%) participating Wave 1 pharmacies (one participant was the owner of two participating pharmacies). Thematic analysis results are displayed in Table 3. Receptacle installation had been considered prior to the HCS-KY at nearly half (45.5%) of interviewed pharmacies. Among these pharmacies, primary reasons cited for not installing were logistics or regulatory requirements (6 of 10) and cost (5 of 10). While most interview participants (70.0%) reported weekly receptacle usage following installation, few (35.0%) reported routinely discussing disposal with patients. Thematic analysis revealed the primary positive gain of the program to be patient-centered benefits (e.g., disposal access, positive patient perception of disposal) (90.5%). While nearly half of participants (42.9%) reported no barriers, the most frequently reported barrier (33.3%) was receptacle limitations (e.g., only available during business hours, restrictions on disposal of items such as needles/syringes, inhalers, aerosols, etc.) (see Appendix D, page 8). No pharmacy representatives cited staffing or burnout issues as a barrier to implementation. The greatest unmet need reported by the participants was additional promotional materials (e.g., flyers, “Clean it out!” bags) (47.6%).
Table 3.
Results from thematic analysis of Wave 1 pharmacy interviews following disposal receptacle placement (N=21)
| n (%) | |
|---|---|
|
| |
| If previously considered, what prevented you from installing a receptacle before? 1 | |
| Logistics or regulatory requirements | 6 (28.6) |
| Cost | 5 (23.8) |
| Work involved for pharmacy | 4 (19.0) |
| Safety/diversion | 2 (9.5) |
| What has worked well with installation? | |
| Ease of process (ordering, installation, maintaining the receptacle) | 14 (66.7) |
| Help from outside organization | 3 (14.2) |
| What are the positive aspects of having a receptacle? | |
| Patient benefits | 19 (90.5) |
| Meets a need of the community/public health | 9 (42.9) |
| Pharmacy benefits/advertising | 6 (28.6) |
| Environmental impact | 2 (9.5) |
| What are the barriers/challenges you’ve faced? | |
| No barriers to report | 9 (42.9) |
| Limitations of receptacle use | 7 (33.3) |
| Installation | 5 (23.8) |
| Changing liners | 3 (14.2) |
| Do you have any additional needs? | |
| No additional needs | 8 (38.1) |
| Promotional materials | 10 (47.6) |
| Liners/returning liners | 6 (28.6) |
| Contact information | 2 (9.5) |
| How often are patients using the receptacle? 2 | |
| Daily | 1 (5.0) |
| Weekly | 14 (70.0) |
| Monthly | 2 (10.0) |
| Less/infrequently | 0 (0.0) |
| Unsure | 3 (15.0) |
| How often do you discuss disposal with patients? 2 | |
| Routinely | 7 (35.0) |
| Only when brought up by the patient | 11 (55.0) |
| Unsure | 2 (10.0) |
This question was only asked of pharmacies that had reported previously considering installation of a disposal receptacle, therefore n=10 for this question.
One pharmacy had just received their receptacle at the time of interview and thus could not answer questions regarding frequency of use and discussion with patients, therefore n=20 for these two questions.
4. DISCUSSION
Implementation of the HCS-KY community pharmacy medication disposal program resulted in strong adoption and reach within participating communities, providing a promising framework for future efforts. Program adoption led to a dramatic increase in the percentage of community pharmacies registered as authorized collectors with the DEA (from 14.7% to 27.7%), a result particularly promising in relation to 2017 national estimates of just less than 3% (“Preventing Drug Abuse,” n.d.). Findings support existing literature suggesting that cost and uncertainty concerning proper implementation were primary barriers to participation in similar efforts (“Preventing Drug Abuse,” n.d.); however, strong community-level adoption was seen when implementation strategies were tailored to address these barriers, suggesting implementation within communities is feasible when these needs are met. In Kentucky statute 15.291, the criteria for grant awards from the state’s Opioid Abatement Trust Fund includes specific mention of drug disposal initiatives, highlighting the potential for future support of this EBP within the state. Given the nearly $50 billion awarded to states and localities across the nation from opioid-related lawsuits (“State Approaches for Distribution of National Opioid Settlement Funding,” 2022), the processes outlined in this study may serve as a valuable option for direction of opioid abatement funds in other states as well, mitigating barriers to implementation and increasing disposal opportunities within at-risk communities.
Notably, while diversion was a perceived barrier discussed by community coalitions during strategy selection, this was not frequently reported during pharmacy sustainment interviews among those who had previously considered installing a medication disposal receptacle. Additionally, neither diversion nor tampering were reported when asked specifically about concerns during post-installation follow-up communication.
Participating pharmacies saw large amounts of drug returned and cited frequent usage, despite few pharmacies reporting routinely discussing disposal with patients. Additionally, Wave 1 return rates were high, despite installation occurring while many pharmacies were curbside pick-up or drive-thru only due to the SARS-CoV-2 pandemic.
Previous work has shown patients’ likelihood of disposal is highly correlated with the disposal method offered, with the preferred method of drug disposal being no-cost programs offered at the pharmacy, followed by at-home products (i.e., mail-back envelopes or drug deactivation systems) dispensed with the prescription (Varisco et al., 2023). Additional work has corroborated this claim, finding that 3 in 4 patients prefer pharmacy-based disposal compared to other methods (e.g., mail-back envelopes, drug deactivation systems, coffee grounds/cat litter) (Skoy et al., 2023). These results, taken in context with our findings, highlight a continuing need for pharmacy-based drug disposal receptacles, despite the US Food and Drug Administration’s (FDAs) decision to move forward with requiring opioid analgesic manufacturers to provide prepaid mail-back envelopes to pharmacies (“FDA Moves Forward with Mail-back Envelopes for Opioid Analgesics Dispensed in Outpatient Settings,” 2023). While assessing the impact of routine discussion of disposal with patients on receptacle utilization was outside the scope this study, future work may provide more context to the impact of these interventions on disposal utilization.
While fewer receptacles per dispensed opioid analgesic in rural counties compared to urban counties were found at baseline (Miracle et al., 2023). results show both adoption and reach to be similar across rural and urban counties during HCS-KY. Although incorporation of dispensing rates was outside of the scope of this study, the comparable implementation of disposal receptacles noted in this study provides support for potential mitigation of this disparity among participating counties.
4.1. Limitations
This study is not without limitations. First, this study represents findings from 16 counties within a single state and may not be fully generalizable to other states with different policies, dispensing patterns, or perceptions of disposal. Recruitment efforts also prioritized pharmacies chosen by community coalitions, of which the majority were independently owned. While chain pharmacies were partnered with, when possible, communities with a greater number of chain pharmacies were less likely to meet the study adoption goal. Also, HCS-KY communities were chosen via a variety of inclusion criteria, including being highly impacted by opioid-involved overdose, willingness to participate, and having a pre-existing syringe exchange program, a jail, and at least one provider of medication for opioid use disorder (markers of readiness for change) (HEALing Communities Study Consortium, 2020). While results are promising, they may not be fully reflective of communities that do not meet these criteria.
Our findings also report the number of receptacles placed by the HCS-KY in addition to baseline receptacle counts provided by the DEA to assess the impact of EBP implementation alone, and thus final figures may not be reflective of current disposal locations placed independently or through other efforts. Additionally, previous work has described discrepancies between pharmacies registered as an authorized collector and those with a currently available disposal receptacle (Egan et al., 2022). While this may impact baseline measures of disposal receptacles, number of receptacles placed by the HCS-KY were recorded by study personnel and are fully accurate. It should also be noted that this study does not assess the availability of other disposal methods in communities (e.g., law enforcement, take-back events) as they pertain to willingness to participate in the disposal program and utilization of placed disposal receptacles.
Finally, the conclusion of the HCS-KY limits the ability of study personnel to follow-up with participating pharmacies to assess sustainment via procurement of other funding; however, pharmacies were provided local organizations and contact information for potential funding opportunities during sustainment interviews. While previous work has noted that removal of disposal receptacles may occur once funding is no longer available, efforts made to provide alternative funding sources during sustainment interviews may mitigate these concerns (Egan et al., 2024). It is apparent that use of the receptacles continues beyond the end of the CTH intervention due to the ability to trace liners purchased by HCS-KY that are returned for incineration.
5. CONCLUSIONS
The HCS-KY community pharmacy medication disposal program resulted in the successful adoption of permanent medication disposal receptacles in community pharmacies within HCS-KY communities. The demonstrable reach of the program was illustrated by large amounts of drug returned in participating counties, despite limited routine discussions of disposal with patients. Taken together, results lay the foundation for future drug disposal implementation efforts.
Supplementary Material
HIGHLIGHTS.
Safe medication disposal opportunities are important contributors to opioid safety
Implementation of medication disposal programs in community pharmacies is sparse
Results indicate high adoption (receptacles placed) and reach (drug returned)
Education, engagement, assistance, and financing were key implementation strategies
Findings lay the foundation for future disposal implementation efforts
Acknowledgements:
The authors wish to acknowledge the participation of the HEALing Communities Study communities, community coalitions, community partner organizations and agencies, Community Advisory Board, and state government officials who partnered with us on this study.
Role of the Funding Source:
This research was funded by the National Institutes of Health through the NIH HEAL (Helping to End Addiction Long-termSM) Initiative under award number UM1DA049406. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health or the NIH HEAL InitiativeSM. The funding source had no role in the study design, collection, analysis or interpretation of data, or the decision to submit the article for publication.
Footnotes
AUTHOR DISCLOSURES
Conflicts of Interest: The authors have no relevant conflicts of interest to disclose.
DECLARATION OF INTERESTS
The authors have no relevant conflicts of interest to disclose.
None.
Publisher's Disclaimer: This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
REFERENCES
- Aarons GA, Hurlburt M, Horwitz SM, 2011. Advancing a Conceptual Model of Evidence-Based Practice Implementation in Public Service Sectors. Adm. Policy Ment. Health Ment. Health Serv. Res. 38, 4–23. 10.1007/s10488-010-0327-7 [DOI] [PMC free article] [PubMed] [Google Scholar]
- Allen ML, Kim CC, Braat S, Jones K, Winter N, Hucker TR, Chia A, Lang C, Brooks SL, Williams DL, 2020. Post-discharge opioid use and handling in surgical patients: A multicentre prospective cohort study. Anaesth. Intensive Care 48, 36–42. 10.1177/0310057X19895019 [DOI] [PubMed] [Google Scholar]
- Bartels K, Mayes LM, Dingmann C, Bullard KJ, Hopfer CJ, Binswanger IA, 2016. Opioid Use and Storage Patterns by Patients after Hospital Discharge following Surgery. PloS One 11, e0147972. 10.1371/journal.pone.0147972 [DOI] [PMC free article] [PubMed] [Google Scholar]
- Braun V, Clarke V, 2006. Using thematic analysis in psychology. Qual. Res. Psychol. 3, 77–101. 10.1191/1478088706qp063oa [DOI] [Google Scholar]
- Chandler R, Nunes EV, Tan S, Freeman PR, Walley AY, Lofwall M, Oga E, Glasgow L, Brown JL, Fanucchi L, Beers D, Hunt T, Bowers-Sword R, Roeber C, Baker T, Winhusen TJ, 2023. Community selected strategies to reduce opioid-related overdose deaths in the HEALing (Helping to End Addiction Long-term SM) communities study. Drug Alcohol Depend. 245, 109804. 10.1016/j.drugalcdep.2023.109804 [DOI] [PMC free article] [PubMed] [Google Scholar]
- County Population Totals and Components of Change: 2020–2022 [WWW Document], n.d. . Census.gov. URL https://www.census.gov/data/tables/time-series/demo/popest/2020s-counties-total.html (accessed 3.2.24).
- Data Access - Urban Rural Classification Scheme for Counties [WWW Document], 2022. URL https://www.cdc.gov/nchs/data_access/urban_rural.htm (accessed 2.10.23).
- DEA Releases New Rules That Create Convenient But Safe And Secure Prescription Drug Disposal Options [WWW Document], n.d. URL https://www.dea.gov/press-releases/2014/09/08/dea-releases-new-rules-create-convenient-safe-and-secure-prescription (accessed 9.16.22).
- Disposal of Unused Medicines: What You Should Know [WWW Document], 2021. . FDA. URL https://www.fda.gov/drugs/safe-disposal-medicines/disposal-unused-medicines-what-you-should-know (accessed 9.16.22). [Google Scholar]
- Egan KL, Gregory E, Wolfson M, Francisco VT, Strack RW, Wyrick DL, Perko MA, 2019. Disposal of prescription drugs by parents of middle and high school students. J. Child Adolesc. Subst. Abuse 28, 92–98. 10.1080/1067828X.2019.1590272 [DOI] [PMC free article] [PubMed] [Google Scholar]
- Egan KL, Johnston CA, Jackson JT, Foster SE, Lee JGL, 2022. Rates and correlates of medicine disposal program implementation at pharmacies in North Carolina: A longitudinal study, 2016–2021. J. Am. Pharm. Assoc. 62, 1329–1337. 10.1016/j.japh.2022.03.002 [DOI] [PMC free article] [PubMed] [Google Scholar]
- Egan KL, McCallum L, Matthews JC, Eldridge LA, 2024. Elucidating determinants of medication disposal programs at retail pharmacies in North Carolina. J. Am. Pharm. Assoc. JAPhA 64, 111–119. 10.1016/j.japh.2023.10.032 [DOI] [PubMed] [Google Scholar]
- Egan KL, Wolfson M, Dudley WN, Francisco VT, Strack RW, Wyrick DL, Perko MA, 2018. Diffusion of medication drop-boxes in North Carolina from 2007 to 2016. Addict. Behav. 86, 44–50. 10.1016/j.addbeh.2018.03.029 [DOI] [PMC free article] [PubMed] [Google Scholar]
- FDA Moves Forward with Mail-back Envelopes for Opioid Analgesics Dispensed in Outpatient Settings [WWW Document], 2023. . FDA. URL https://www.fda.gov/news-events/press-announcements/fda-moves-forward-mail-back-envelopes-opioid-analgesics-dispensed-outpatient-settings (accessed 3.12.24). [Google Scholar]
- Flanagan CD, Wysong EF, Ramey JS, Vallier HA, 2018. Understanding the Opioid Epidemic: Factors Predictive of Inpatient and Postdischarge Prescription Opioid Use After Orthopaedic Trauma. J. Orthop. Trauma 32, e408–e414. 10.1097/BOT.0000000000001256 [DOI] [PubMed] [Google Scholar]
- Gregorian R, Marrett E, Sivathanu V, Torgal M, Shah S, Kwong WJ, Gudin J, 2020. Safe Opioid Storage and Disposal: A Survey of Patient Beliefs and Practices. J. Pain Res. Volume 13, 987–995. 10.2147/JPR.S242825 [DOI] [PMC free article] [PubMed] [Google Scholar]
- Harris PA, Taylor R, Minor BL, Elliott V, Fernandez M, O’Neal L, McLeod L, Delacqua G, Delacqua F, Kirby J, Duda SN, 2019. The REDCap consortium: Building an international community of software platform partners. J. Biomed. Inform. 95, 103208. 10.1016/j.jbi.2019.103208 [DOI] [PMC free article] [PubMed] [Google Scholar]
- Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG, 2009. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J. Biomed. Inform. 42, 377–381. 10.1016/j.jbi.2008.08.010 [DOI] [PMC free article] [PubMed] [Google Scholar]
- HEALing Communities Study Consortium, 2020. The HEALing (Helping to End Addiction Long-term SM) Communities Study: Protocol for a cluster randomized trial at the community level to reduce opioid overdose deaths through implementation of an integrated set of evidence-based practices. Drug Alcohol Depend. 217, 108335. 10.1016/j.drugalcdep.2020.108335 [DOI] [PMC free article] [PubMed] [Google Scholar]
- Hendricks MA, El Ibrahimi S, Ritter GA, Flores D, Fischer MA, Weiss RD, Wright DA, Weiner SG, 2023. Association of Household Opioid Availability With Opioid Overdose. JAMA Netw. Open 6, e233385. 10.1001/jamanetworkopen.2023.3385 [DOI] [PMC free article] [PubMed] [Google Scholar]
- How to Safely Dispose of Drugs [WWW Document], 2018. . HHS.gov. URL https://www.hhs.gov/opioids/prevention/safely-dispose-drugs/index.html (accessed 9.16.22).
- Jones CM, Paulozzi LJ, Mack KA, 2014. Sources of prescription opioid pain relievers by frequency of past-year nonmedical use United States, 2008–2011. JAMA Intern. Med. 174, 802–803. 10.1001/jamainternmed.2013.12809 [DOI] [PMC free article] [PubMed] [Google Scholar]
- Khan NF, Bateman BT, Landon JE, Gagne JJ, 2019. Association of Opioid Overdose With Opioid Prescriptions to Family Members. JAMA Intern. Med. 179, 1186–1192. 10.1001/jamainternmed.2019.1064 [DOI] [PMC free article] [PubMed] [Google Scholar]
- Lankenau SE, Teti M, Silva K, Jackson Bloom J, Harocopos A, Treese M, 2012. Initiation into prescription opioid misuse amongst young injection drug users. Int. J. Drug Policy 23, 37–44. 10.1016/j.drugpo.2011.05.014 [DOI] [PMC free article] [PubMed] [Google Scholar]
- Local pharmacies partner with the University of Kentucky HEALing Communities Study to offer safe medication disposal options, 2023. . LINK NKY.
- McCabe SE, West BT, Boyd CJ, 2013. Leftover prescription opioids and nonmedical use among high school seniors: a multi-cohort national study. J. Adolesc. Health Off. Publ. Soc. Adolesc. Med. 52, 480–485. 10.1016/j.jadohealth.2012.08.007 [DOI] [PMC free article] [PubMed] [Google Scholar]
- McCarthy BC, Dickerson DM, Knoebel RW, 2019. Implementation of a controlled substance collection receptacle. Am. J. Health. Syst. Pharm. 76, 641–643. 10.1093/ajhp/zxz038 [DOI] [PubMed] [Google Scholar]
- McDonald DC, Carlson K, Izrael D, 2012. Geographic Variation in Opioid Prescribing in the U.S. J. Pain 13, 988–996. 10.1016/j.jpain.2012.07.007 [DOI] [PMC free article] [PubMed] [Google Scholar]
- Miracle DK, Smith N, Slavova S, Stinson LK, Roberts MF, Rock P, Walsh SL, Freeman PR, 2023. Drug disposal deserts: An assessment of receptacle availability in Kentucky community pharmacies. J. Rural Health jrh.12786. 10.1111/jrh.12786 [DOI] [PMC free article] [PubMed] [Google Scholar]
- Moullin JC, Dickson KS, Stadnick NA, Rabin B, Aarons GA, 2019. Systematic review of the Exploration, Preparation, Implementation, Sustainment (EPIS) framework. Implement. Sci. 14, 1. 10.1186/s13012-018-0842-6 [DOI] [PMC free article] [PubMed] [Google Scholar]
- Opioid Dispensing Rate Maps | Drug Overdose | CDC Injury Center [WWW Document], 2023. URL https://www.cdc.gov/drugoverdose/rxrate-maps/opioid.html (accessed 2.19.24).
- Paulozzi LJ, Mack KA, Hockenberry JM, Division of Unintentional Injury Prevention, National Center for Injury Prevention and Control, CDC, 2014. Vital signs: variation among States in prescribing of opioid pain relievers and benzodiazepines - United States, 2012. MMWR Morb. Mortal. Wkly. Rep. 63, 563–568. [PMC free article] [PubMed] [Google Scholar]
- Preventing Drug Abuse: Low Participation by Pharmacies and Other Entities as Voluntary Collectors of Unused Prescription Drugs [WWW Document], n.d. URL https://www.gao.gov/products/gao-18-25 (accessed 9.16.22).
- Promote safe storage and disposal of opioids and all medications [WWW Document], n.d. URL https://www.aafp.org/dam/AAFP/documents/patient_care/pain_management/safe-storage.pdf (accessed 9.16.22).
- Rigg KK, Monnat SM, Chavez MN, 2018. Opioid-related mortality in rural America: Geographic heterogeneity and intervention strategies. Int. J. Drug Policy 57, 119–129. 10.1016/j.drugpo.2018.04.011 [DOI] [PubMed] [Google Scholar]
- Schirle L, Stone AL, Morris MC, Osmundson SS, Walker PD, Dietrich MS, Bruehl S, 2020. Leftover opioids following adult surgical procedures: a systematic review and meta-analysis. Syst. Rev. 9, 139. 10.1186/s13643-020-01393-8 [DOI] [PMC free article] [PubMed] [Google Scholar]
- Skoy E, Frenzel O, Pajunen H, Eukel H, 2023. Implementation of a Pharmacy Follow-Up Program for Dispensed Opioid Medications. Int. J. Environ. Res. Public. Health 20, 6628. 10.3390/ijerph20176628 [DOI] [PMC free article] [PubMed] [Google Scholar]
- Sprague Martinez L, Rapkin BD, Young A, Freisthler B, Glasgow L, Hunt T, Salsberry PJ, Oga EA, Bennet-Fallin A, Plouck TJ, Drainoni M-L, Freeman PR, Surratt H, Gulley J, Hamilton GA, Bowman P, Roeber CA, El-Bassel N, Battaglia T, 2020. Community engagement to implement evidence-based practices in the HEALing communities study. Drug Alcohol Depend. 217, 108326. 10.1016/j.drugalcdep.2020.108326 [DOI] [PMC free article] [PubMed] [Google Scholar]
- State Approaches for Distribution of National Opioid Settlement Funding [WWW Document], 2022. . NASHP. URL https://nashp.org/state-tracker/state-approaches-for-distribution-of-national-opioid-settlement-funding/ (accessed 3.12.24).
- SUDORS Dashboard: Fatal Overdose Data | Drug Overdose | CDC Injury Center [WWW Document], 2024. URL https://www.cdc.gov/drugoverdose/fatal/dashboard/index.html (accessed 3.18.24).
- Take Back Day [WWW Document], n.d. URL https://www.dea.gov/takebackday (accessed 9.16.22).
- Varisco T, Patel H, Saadi RA, Wanat M, Thornton D, 2023. Patients prefer free drug disposal options delivered by pharmacists at the point of care: Results of a decision tree analysis of a national factorial vignette panel survey. Int. J. Drug Policy 116, 104045. 10.1016/j.drugpo.2023.104045 [DOI] [PubMed] [Google Scholar]
- Waltz TJ, Powell BJ, Matthieu MM, Damschroder LJ, Chinman MJ, Smith JL, Proctor EK, Kirchner JE, 2015. Use of concept mapping to characterize relationships among implementation strategies and assess their feasibility and importance: results from the Expert Recommendations for Implementing Change (ERIC) study. Implement. Sci. 10, 109. 10.1186/s13012-015-0295-0 [DOI] [PMC free article] [PubMed] [Google Scholar]
- Winhusen T, Walley A, Fanucchi LC, Hunt T, Lyons M, Lofwall M, Brown JL, Freeman PR, Nunes E, Beers D, Saitz R, Stambaugh L, Oga EA, Herron N, Baker T, Cook CD, Roberts MF, Alford DP, Starrels JL, Chandler RK, 2020. The Opioid-overdose Reduction Continuum of Care Approach (ORCCA): Evidence-based practices in the HEALing Communities Study. Drug Alcohol Depend. 217, 108325. 10.1016/j.drugalcdep.2020.108325 [DOI] [PMC free article] [PubMed] [Google Scholar]
Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.

