Locking Pill Bottles Increases MOUD Safety and Access

The Union County Health Department (UCHD) is a government agency that serves approximately 62,784 county residents through its four divisions: Health Promotion & Planning, Environmental Health, Nursing, and Administration (including Vital Statistics). Union County is a primarily rural area, northwest of Columbus, Ohio. According to the 2021 US Census, Population Estimates Program, Union County's population is composed of individuals that are reported as White (90%), high school graduates (94%), and between the ages of 18 and 64 years (56%). The median age of a Union County resident is 38.2 years with the median household income being $88,565.

According to the Ohio Department of Health, in 2007 unintentional drug poisoning became and continues to be the leading cause of injury death in Ohio. In 2017, the United States, including Union County, experienced a sudden sharp increase in fatalities as a result of overdose as the introduction of a new drug ‘Fentanyl' was introduced to the drug supply. In response to this increase, Union County formed the Union County Overdose Prevention and Fatality Review Coalition, now called the Union County Drug Overdose Prevention Coalition (DOPC). Established in 2018, the DOPC focuses on implementing evidence-based strategies and surveillance measures to monitor and respond to drug overdose trends.

In 2020, Ohio experienced the highest number of documented overdoses in a year. During this time, many communities, including Union County, searched for strategies to help curb the sharp increase in overdose deaths. One strategy the DOPC implemented was the use of SafeRx locking pill bottles, specifically for medication-assisted treatment (MAT) patients who had opioid-use disorder (OUD). The primary goal of the Union County Locking Pill Bottle Pilot Project was to increase access to medication for opioid-use disorder (MOUD) by decreasing barriers including stigma and medication safety.

It is important to know that MOUD is a frequently used treatment strategy where clients take controlled medication to mediate their drug-seeking cravings. MOUD works best when paired with cognitive behavioral therapy as well as addressing past trauma. MOUD often involves an individual taking medication repeatedly throughout the day with adherence to a specific time dosing schedule. The Centers for Disease Control and Prevention (CDC) and the Substance Abuse and Mental Health Services Administration (SAMSHA) recommend using a locked box and/or locking pill bottle caps to ensure this medication is safely stored. The SafeRx locking pill bottle meets these recommendations as it offers a portable and secure option as well as allows patients to safely use MOUD. The security of this bottle has been shown to ease the minds of individuals who would benefit from MOUD, yet have concerns about the safety of the medication to prevent diversion. Tragically, Union County has experienced incidents where parents have inadvertently given their MOUD to their child resulting in a youth overdose/poisoning. In these instances, the SafeRx bottle could have prevented misuse overdoses as the bottle is a different color and requires a code to open and obtain the medication.

Using these national recommendations, the DOPC piloted a project prioritizing individual with OUD who were considering or are already enrolled in MOUD and receiving medication in Union County. The health department-led coalition partnered with Lower Lights Christian Health Center (LLCHC), the county's Federally Qualified Health Center (FQHC), and locally-owned pharmacies to implement the SafeRx bottles with their clients. This partnership experienced initial success, and recommendations were made to replicate the process with other pharmacies.

The DOPC worked with additional pharmacies and providers across the county to provide education on MOUD. This education focused on increasing awareness of best practices regarding medication storage and decreasing the stigma surrounding the use of this treatment tool and OUD. Through this education, prescribers in Union County were made aware of specific pharmacies that were using SafeRx bottles and encouraged to include the SafeRx bottle when prescribing MOUD.  When it was identified that a MOUD patient was going to be receiving a bottle from a participating pharmacy, the prescribers were tasked with writing SafeRx in the prescription. Pharmacies were then required to provide the SafeRx bottle with the MOUD medication and include medication safety information. This ensured that patients were receiving education on the benefits of SafeRx from both their prescriber and the pharmacy.

To successfully roll out the project, DOPC worked with first responder agencies including the Ohio State Patrol and the Union County Sheriff's Office. DOPC presented information to these first responder agencies about MOUD, the pilot project, and how to identify the bottles during a crisis intervention training class. The purpose of this training was to ensure that first responders would be able to recognize a SafeRx bottle, feel prepared if they were to encounter one in the field, as well as decrease the stigma surrounding the use of MOUD. Often there is a negative stigma associated with MAT and MOUD. Since individuals use controlled substances to curb their cravings, some individuals do not consider MOUD patients as sober” and, therefore, consider these individuals in active use. This stigma contributes to barriers individuals can face when trying to receive access to this treatment.

LLCHC in Franklin County implemented the locking pill bottles first in 2021 and surveyed participating patients. In November 2022, the DOPC created a survey based on the 2021 LLCHC project and distributed them to the pilot project patients. Before the implementation of the locking pill bottles, 11% of the patients reported they had misidentified their medication, and 39% reported they had noticed medication missing from their regular bottles. After implementation, 100% of the patients reported they had not observed missing medication or misidentifying their medication. Based on the survey results, the bottles have demonstrated that they are serving the intended purpose of making patients feel safer and more comfortable participating in the life-saving treatment of MOUD.

These efforts together helped make MOUD in Union County more accessible, thus decreasing the chances for individuals to return to illicit substance use and potentially experience an overdose.

The UCHD website can be found at: www.uchd.net.

Since the first wave of the opioid epidemic in 1999, communities across the United States have experienced a loss of quality of life and countless deaths due to opioid misuse. According to the National Center for Health Statistics, about 251 people die each day from an overdose in the US, and it is estimated that 2 million people had an opioid-use disorder pre-pandemic in 2018.  Current Ohio statistics indicate that every day fourteen Ohioans die from an overdose that could have been prevented. Union County, Ohio, like many other communities, has been deeply impacted by the opioid epidemic.

In 2020, the DOPC documented 68 overdoses, and in 2021, 61 overdoses were documented by local fire/EMS. Of the 61 overdoses recorded in Union County, a high rate of deaths was experienced with 12 residents losing their lives to overdose. The local hospital in Union County, Memorial Health, recorded a 27% increase in overdoses from 2020 to 2021.

One service that is provided in Union County to individuals struggling with opioid use is MOUD. MOUD is a tool for the treatment of an opioid-use disorder where clients take controlled medication to mediate their drug-seeking cravings in the reward center of their brain. Opioids can severely affect the brain chemistry of a person through stimulation, which over time causes individuals to increase the doses they ingest in order to function normally. MOUD helps allow the brain to continue to function normally while lowering the cravings for the drug. In addition to MOUD medication, patients use cognitive behavioral therapy to address past trauma and identify the root causes that led the individual to begin using. When individuals use this treatment approach it has been shown to improve patient survival, increase the longevity of recovery, and increase their ability to gain and maintain employment. While some individuals may only use MOUD for several years, others may need it for the rest of their lives. MOUD often involves an individual taking medication repeatedly throughout the day and adhering to a strict schedule.

Although MOUD is an effective form of treatment with cognitive behavioral therapy, there have been some challenges with making sure it is accessible and distributed in the safest way possible. In recent years, Union County treatment providers have expressed safety concerns when prescribing MOUD and specifically suboxone (a film/pill form). Many individuals that are prescribed the medication live in sober living housing along with others struggling with substance use disorder. Medications in these houses are encouraged to be put in an inconvenient locked box, however, even with these added safety measures, the houses have frequently experienced medications being stolen or diverted. These controlled substances have a high street value and are often sold to other individuals experiencing addiction or self-prescribing their recovery. Additionally, Union County has experienced overdoses due to young children ingesting the controlled substances unintentionally. Due to these challenges, there have been barriers to MOUD access, as well as clients' perceptions of not feeling safe taking the medication to work, and not wanting to bring the medication into a home where children/teens are present.

In response to community members needing safe access to MOUD, overdose deaths, and the small-scale success of the LLCHC project in Franklin County, the locking pill bottles were implemented county-wide in Union County. In Union County, there are approximately 100 individuals that receive MOUD services on a monthly basis. This figure increased to 130 in the last two months of 2022. Due to only partnering with local pharmacies, the DOPC was able to reach about 30% of these individuals with the Union County pilot project. However, through the project's partnership with LLCHC in Union County, many of those who were reached represent the most vulnerable county residents. LLCHC is a federally qualified health center (FQHC) and serves many individuals facing significant health inequities.

Locking up medication is not a new strategy in the field of public health. Many national organizations recommend that individuals keep their medications locked up and out of reach of those who could otherwise have access to them. In fact, the first child-proof safety locking caps were developed in 1970, however, they have not been updated since. The SafeRx locking pill bottle is a new tool on the market that advances this national recommendation. The SafeRx locking pill bottle features a thick, blue, smash-resistant bottle with a cap featuring a bike lock system that requires a code to open. The security of this bottle eases individuals' minds who need MOUD, yet have concerns about the safety of the medication to prevent diversion. Patients are asked to provide a confidential 4-digit code. After creating the code, prescribers are encouraged to write the code in the patient's file, and patients are encouraged to register their code on the SafeRx website.  Union County is the only county in Ohio that has implemented this medication security for MOUD patients on a countywide level.

The primary goal of the Union County Locking Pill Bottle Pilot Project was to increase access to MOUD by decreasing barriers including stigma and medication safety. By implementing this project and reaching these goals, the DOPC believed that the number of MOUD patients in the county would increase and the number of overdoses would decrease. Prior to the Union County Locking Pill Bottle Project, the LLCHC in Franklin County implemented the locking pill bottles for their MOUD patients. The LLCHC in Franklin County owns a pharmacy so implementation went smoothly.  After seeing small-scale success in Franklin County, LLCHC and UCHD worked to implement the locking pill bottles in a Union County pharmacy, Dave's Pharmacy. Dave's Pharmacy worked with LLCHC to provide their MOUD clients with locking pill bottles in August 2021. After six months of implementation, the team decided to expand the project. DOPC members decided during strategic planning that locking pill bottles were a way to increase medication safety and decrease the diversion of medication and created a subcommittee for the strategy. The DOPC and the Locking Pill Bottle Subcommittee were led by the Drug Overdose Prevention (DOP) Health Educator at UCHD. The coordinator regularly meets with DOPC partners and coalition meetings were held quarterly. In addition to the quarterly facilitated meetings, the monthly Locking Pill Bottle Subcommittee meetings were coordinated by the DOP Health Educator. The committee consisted of treatment providers, UCHD, EMS, and Union County Coroner's Office and started meeting in February 2022. 

Before implementation, the committee was charged with creating an implementation plan. The first step of the plan was to gain support for the project from the Mental Health and Recovery Board of Union County (MHRB), local treatment providers who provided MOUD, and local pharmacies. To complete this stage, the UCHD-led committee set up meetings with each of these agencies and had an open discussion about the possibility of implementing the locking bottles for all MOUD patients and why it was important over a period of 4 months. At each meeting, the UCHD-led committee brought the locking pill bottles to show how easy they were to use and outlined how the project would be implemented. After the first meetings with each agency, all sectors including the local pharmacy businesses, the MHRB, and treatment providers agreed to participate in the pilot project. Corporate pharmacies like Kroger and Walmart were approached and educated on the utilization of the locking pill bottle, but have not yet joined the project. On July 1, 2022, the pilot project was rolled out with Dave's Pharmacy, the Plain City Druggist, and Richwood Pharmacy distributing the bottle to patients from Lower Lights Christian Health Center, Lighthouse Behavioral Health Solutions, and Maryhaven. Both Dave's Pharmacy and the Richwood Pharmacy are located in overdose hot spots in the county. In order to work in areas of the county experiencing the highest number of overdoses, the subcommittee made it a point to partner with the two pharmacies. As mentioned in previous sections, by partnering with the FQHC in Union County, LLCHC, DOPC was able to ensure individuals of all financial statuses were able to receive the bottles.

UCHD used grant funds from the Drug Overdose Prevention Grant from the Ohio Department of Health to purchase the initial bottles for the pilot project. 350 SafeRx locking pill bottles were purchased for $973 which included encoders for each pharmacy to be able to set the bottle codes. To conserve the number of bottles used, the DOPC subcommittee worked with pharmacies to determine a process for clients to bring their old bottles back and refill them. This would encourage the practice of each patient only using one bottle/code and allow for efficient use of resources. Since some patients that received prescriptions from the local pharmacies were required to use the bottles, patients were given a second bottle for free if it was forgotten. However, patients would be charged a small fee set at the individual pharmacies' discretion if they forgot to return the bottle a third time. However, no incidents were reported where participants were charged. 

As described in the previous sections, the goals of the pilot project were to increase access to MOUD, increase medication safety, and decrease the diversion of medication. To meet this goal, UCHD established the Locking Pill Bottle Subcommittee and established the following process objective.  Evaluation measures were identified during the creation of the pilot project to monitor the implementation progress. 

Process outcomes measured included:

Partner with LLCHC, local pharmacies, other local treatment providers, and the MHRB to develop and implement the program.

Develop training materials and assessment forms to be used in pilot project administration.

Provide technical assistance to the pilot project partner(s).

Monitor implementation progress and program outcomes.

The above measures allowed UCHD and program partners to monitor the implementation progress and determine if process objectives and projected timelines were being met. The process outcomes were monitored regularly by UCHD and all process objectives were achieved.

Outcome evaluation measures included:

How many patients had ever had medication missing from their regular bottle?

How many patients had ever had medication missing from their locking pill bottles?

Prior to using the locking pill bottle, how many patients had mistaken their medication or medication bottle for another?

When using the locking pill bottle how many patients had ever mistaken their medication for another?

How many patients transported their medication?

How safe did patients feel transporting their medication in their regular bottles?

How safe did patients feel transporting their medication in their locked pill bottles?

How many patients locked their medication when they were in a regular bottle?

How easy did patients describe using the bottles?

Would patients like to use the locking pill bottles with other medications?

Did patients use resources to help them remember the code to their bottles?

What did patients like most about the locking pill bottles?

What did patients like least about the locking pill bottles? 

Did LLCHC patients receive the bottles?

The outcome evaluation measures above were chosen to help evaluate whether the program was achieving the intended outcomes and to assess the impact of the program on MOUD patients. The outcome evaluation questions were measured through patient surveys that were given 6 months after the initial pilot project implementation. The surveys were then recorded and analyzed to see if any changes needed to be made to the project. When diversion was measured in the survey, 40% of patients reported that they had noticed medication missing from their regular bottles, and after the implementation of the locking pill bottles, no patients reported missing medication. This showed that by using the locking pill bottle medication diversion decreased. Additionally, when patients were asked if they had ever mistaken their bottle or medication for another, 11% of patients reported that they had when they were using the regular bottle. However, no patients reported the mistake after the implementation of the locking pill bottle. The results of the survey also showed that patients felt safe transporting their medication with the locking pill bottles. The surveys recorded a 70% increase in the number of patients who either felt safe or very safe transporting their medication. These findings supported the goal of increasing medication safety and therefore increasing access to MOUD.

Some initial concerns from providers and pharmacies were that patients would not like the locking pill bottle. However, the survey results demonstrated the opposite of these initial concerns. Over 80% of patients reported that it was easy or very easy to use the locking pill bottle, and over 60% reported they would like to use the bottle with other medications. Another concern that pharmacies had was the potential for patients to forget their codes for the bottles. However, 90% of patients did not need any resources to remember their code throughout the pilot project. Finally, the surveys given back indicated that all LLCHC patients that received prescriptions at the three local pharmacies were able to access the bottles. 

When asked, patients reported that the security of having their medication stored safely is what they liked most about the locking pill bottles. Based on these findings, UCHD and LLCHC made contact with corporate pharmacies and are working to implement the bottles in those locations as well. 

While creating the implementation plan, the DOPC locking pill bottle subcommittee discussed project sustainability should funds no longer be available through the Drug Overdose Prevention grant. The subcommittee discussed the potential for MHRB to cover the costs of the bottles. As the pilot was only able to engage local pharmacies, larger pharmacy chains like Kroger, Walmart, and Meijer will continue to be approached in 2023. In addition to patient surveys, the subcommittee surveyed the pharmacies on the ease of implementation and the continuation of the project. Pharmacies reported that they had little to no issues with the implementation of the locking pill bottles. With these findings as well, the subcommittee hopes to be able to onboard these corporate pharmacies. This addition of larger pharmacies would include more patients, prescriptions, and locking bottles. The subcommittee led by UCHD will continue to educate local providers on the SafeRx locking pill bottle and the results of the surveys. Once corporate pharmacies are committed to the project, the subcommittee will look to expand the locking pill bottle to other medications, as there has been interest from primary care providers. 

After seeing the success of the initial implementation of the locking pill bottles, the MHRB has budgeted to purchase bottles in 2023 to continue the growth of this project. 

Additionally, SafeRx is currently working with legislators and Johns Hopkins University to conduct research on the effectiveness of the bottles and hopes to eventually work to require insurance to cover their costs. If the cost of the bottles could be paid for by insurance, local entities would no longer require local resources and the project would be self-sustaining. 

The DOPC Locking Pill Bottle Pilot Project demonstrated the success of implementing locking pill bottles for MOUD patients to increase medication safety and increase access to MOUD. Through working with treatment providers, pharmacies, and private entities, UCHD learned the ins and outs of working on projects with multi-sector involvement. For example, the different phrasing that needs to occur and what each sector values when implementing projects. UCHD will continue to work with partners to implement the bottles for MOUD patients across the county, as the data has shown the effectiveness of using them.