Adolescents’ Assessment of a Family Medication Safety Plan for Opioid Prescriptions: A Qualitative Usability Study

Abstract

Background:

When children are injured or have surgery, parents can be hesitant to fill opioid prescriptions and youth may be concerned about using these medications to manage pain. Parents cite a myriad of reasons why they worry about their child using opioids. The MedSMA℞T Families intervention, which includes a Family Medication Safety Plan (FMSP), is a tool designed to support families in learning and communicating about safe prescription opioid use in their homes and with healthcare providers.

Objective:

This study’s first aim was to examine adolescents’ experiences with using the Family Medication Safety Plan. The second aim of this study was to identify opportunities for future improvement.

Methods:

Adolescents, aged 12 to 18 years old, were recruited from April 2021 to October 2021. They were recruited through Qualtrics research panels, email listservs, social media, and snowball sampling. Adolescents reviewed the FMSP and then completed a semi-structured follow-up interview with a study team member virtually. The interviews were professionally transcribed verbatim, reviewed by the study team for accuracy, and downloaded into NVivo for analysis. Main themes were identified using content and thematic analysis.

Results:

Adolescents (N=65) reviewed the Family Medication Safety Plan and participated in the study. Adolescents found the FMSP to be acceptable and useful for prompting discussions with parents about not only opioids, but all medications being used by the youth. Study participants suggested key improvements such as the creation of a kid-friendly or Spanish language version to improve accessibility and uptake by a diverse population of teens.

Conclusion:

Adolescents reported that the Family Medication Safety Plan would be a helpful tool for their families. Implementing this tool at the point of prescribing or dispensing is a potential strategy to reduce the rates of opioid misuse, reduce hesitancy, and allow adolescents more agency regarding their healthcare and medication management.

Background

The Centers for Disease Control and Prevention reports that the number of drug overdose deaths increased by nearly 30% from 2019 to 2020 and has quintupled since 1999. Nearly 75% of the 91,799 drug overdose deaths in 2020 involved an opioid.¹ Opioid overdoses can be intentional or unintentional, with the vast majority being unintentional, and risk factors of overdose include, but are not limited to, injection opioid use, high doses of opioids being prescribed, and having chronic health conditions such as heart or lung disease. ^2–4 Efforts were made to reduce the total quantity of opioid prescriptions, but these changes have not been effective in reducing rates of overdose and death and may limit access to opioids for patients that do not have effective alternative pain management strategies.⁵ Instead of focusing on deprescribing opioids, medication education from healthcare providers on safe opioid use, storage, and disposal techniques has been shown to increase safe medication practice and can be effective for prevention.^{6, 7}

In 2019, four million opioid prescriptions were dispensed to adolescents under the age of 21, with 46% of those prescriptions being considered high risk.⁸ Navigating opioid use with youth can be a challenging experience for families. Opioids such as oxycodone and hydrocodone are commonly prescribed to youth postoperatively to manage pain at home.⁹ This may cause concern for parents who have heard of the potential harms of prescription opioids. According to a poll conducted by Vanderbilt University, 78% of parents in Tennessee worry about adolescents becoming addicted to prescription opioids.¹⁰ This may lead to hesitancy in parents filling opioid prescriptions for their child in fear of causing more harm than benefit. However, opioid prescriptions should only be prescribed by providers if the benefits outweigh its potential risks, so withholding this medication from the child can lead to undertreatment and poor outcomes.¹¹

One common reason for hesitancy among parents is they are unsure of what to do with opioids after their child no longer needs them.¹² In one study, over 94% of patients prescribed opioids after a surgical procedure reported having medication leftover.¹³ In the Vanderbilt poll, 51% of parents kept their unused medication at home. Of those that did not keep the medication at home, most parents reported unsafe disposal techniques such as flushing medications down the toilet, giving them to other family members, or throwing them in the trash.¹⁰ While many individuals understand that these are inappropriate disposal techniques, they are not aware of medication disposal sites or take back programs available in their community. A recent study revealed that while over 91% of participants acknowledged that inappropriate disposal can cause environmental harm, over 60% of them admitted to having no knowledge of correct medication disposal.¹⁴ Educating parents and youth on appropriate disposal techniques may aid in dispelling fears of opioid use and ensuring safe medication practices.¹⁵

Both adolescents and parents commonly have questions regarding side effects of opioid medications. Common side effects of prescription opioids include drowsiness, confusion, constipation, and euphoria.¹⁶ These effects can range from mild and acute, to severe and requiring discontinuation.¹⁷ If these side effects (such as confusion and drowsiness) are not communicated effectively by healthcare providers to patients, they can seem alarming and prompt patients to seek unnecessary medical attention. Additionally, opioid use has been shown to decrease cognitive performance scores such as attention span.¹⁸ Thus, it is important for adolescent prescription opioid use to be reported to schools and other relevant organizations while youth are using these medications. Thoroughly educating families on what side effects to expect and providing educational materials to share with teachers and other individuals may alleviate fears, prevent unexpected side effects, and provide youth with increased agency.

In 2016, 3.6% of individuals between the ages of 12 and17 years had misused an opioid.¹⁹ Misuse includes taking medications differently than prescribed by a doctor, including taking higher doses, or for a longer duration, taking a prescription not prescribed to you, or taking prescription opioids in order to feel “high”.²⁰ Many parents are nervous to have opioids prescribed to their children in fear of having them misused.²¹ Having concise instructions on opioid medication use, how to safely store and dispose of it, and who to contact for questions can help ease concerns.

Current approaches to help educate adolescents include the use of printed materials, internet campaigns, multimedia presentations, and other methods.²² Studies suggest that the family system plays an influential role in the establishment and growth of a child’s education and behavior.²³ The MedSMA℞T Families intervention was designed by the Collaborative Research on MEdication use & family health (CRoME) Lab to support adolescents and their families in the safe and appropriate use of prescription opioids.²⁴ The MedSMA℞T Families intervention includes the Family Medication Safety Plan (FMSP) and MedSMA℞T: Adventures in PharmaCity, which is a computer game that teaches players about safe opioid practices.^25,26 The FMSP then allows this knowledge to be translated into the real-world as adolescents apply the information learned in the game to their own medications. Pharmacists have previously assessed the FMSP, finding it to be potentially useful for tailored opioid consultation for adolescents and their families.²⁷ The FMSP is depicted in Figure 1.

Figure 1.

The personalized Family Medication Safety Plan (FMSP). This tool below will help you and your children think about medication use in and outside the home and create goals and rules that align with your family’s values. Medications should work for YOU and work within YOUR family values and parenting style. When used thoughtfully and appropriately, medications can enhance quality of life and improve health outcomes. But when used inappropriately, medications may negatively impact your health and result in unintended harm. By creating a personalized FMSP, you can communicate more effectively with your family members about using medications safety and responsibility to achieve your desired positive health outcomes. To make YOUR FMSP, start by entering your family’s medication questions and information. This information will remain private and confidential. ∗The FMSP was presented to participants as an editable Excel worksheet.

The FMSP was created to educate families and facilitate family discussions on medication safety. The worksheet contains five different sections: medication information, storage and disposal, dosage and instructions, a medication schedule, and positive communication section. The instructions for using the FMSP were left broad to allow for flexibility and personalization of use by different adolescents and to gain perceptions from participants on their potential preferred usage. This open-ended approach of using the FMSP, accommodated for a variability in learning styles and developmentally appropriate tailoring based on the unique needs of the adolescent. This allowed the data collected to reflect a variety of ways in which the adolescents use and perceive the FMSP. The purpose of the FMSP is to support adolescents in developing age-appropriate agency in their medication management process, as well as improve medication understanding and family safety.

Objectives

The first objective of this study was to examine adolescents’ experiences using the Family Medication Safety Plan. The second objective was to identify opportunities for future improvement.

Methods

This study was approved by the University’s Institutional Review Board before recruitment and data collection.

Sample and Recruitment

Study participants were adolescents aged 12 to 18 years old who lived in the United States and had access to virtual videoconferencing. From April 2021 to October 2021, 65 adolescents were recruited through Qualtrics research panels, social media, email lists, and snowball sampling. The study team coordinated with Qualtrics, an online survey hosting service, to recruit a national sample of adolescent participants using their preexisting research panels whose participants indicated a willingness to participate were contacted. Email lists were utilized from the University’s mass email system and the study team’s own email list. Adolescents were identified through their parents and were screened for eligibility. Participants were contacted weekly for up to three weeks to schedule a study session.

Upon confirmation of eligibility, informed consent and youth assent (or consent in the case of study participants aged 18) were collected. Parents were contacted via email to schedule a virtual study session with their child. Participants’ first session comprised of the adolescent playing the MedSMA℞T: Adventures in PharmaCity (MedSMA℞T) and offering feedback. At the completion of the first session they were given the FMSP. All participants who reviewed the FMSP had previously played the serious game. A total of 508 parents completed the interest and pre-eligibility form for both them and their youth. Out of the initial recruitment survey, 72 adolescents met eligibility criteria and played the MedSMA℞T game. Of those who played the game 65 chose to continue with the study and assess the usability of the FMSP. Non-participation occurred due to reported reasons such as changing family priorities and loss to follow-up.

Data Collection

Before the second study session, study participants received the FMSP and were asked to complete it. The FMSP was sent to participants in the form of an editable Excel worksheet. Participants were asked to complete the FMSP in a way that was most intuitive for them. Instructions were left broad to accommodate unique learning styles, exploration of preferred approaches for use, and flexibility to allow adolescents opportunity to personalize it use with their family members.

During the session, parents of the child were asked to leave the room prior to the research staff beginning the study session. This allowed all adolescent study participants to independently review the FMSP and participate in a 30-minute semi-structured interview. All interviews were conducted by a research staff member trained by the principal investigator. Study participants were already familiar with the interviewer since the interviewer was consistent between study sessions. Questions covered topics such as general quality-related feedback, how the youth’s family would use the FMSP, and where they believed it could be implemented. The interview guide is provided in Supplemental Document 1. The interviewer documented extensive interview field and reflection notes after each interview which was then reviewed by the study team. Parents received a $30 Amazon e-gift card for their child’s participation in the study. Data collection continued until data saturation was reached during the interviews. Interviews were transcribed verbatim by professional transcriptionists and their accuracy was verified by study team members.

Data Analysis

Two research members of the study team independently coded the 65 interviews. The members used the software, NVivo, to code the transcripts. First, the study team members familiarized themselves with the data by closely reading the transcripts to generate a preliminary codebook. The coding members used thematic and content analysis to identify codes and summarize themes across the transcripts using the codebook.^28,29 The study team met biweekly to discuss the coding nomenclature, creation of the master codebook, resolve coding discrepancies, and summarize prevalent themes described below.

Results

A total of 65 adolescents participated in this study. The participant demographic characteristics are reported in Table 1. Participants were predominately White (69.2%) and English monolingual (90.8%). More participants identified as Male (60.0%) than Female (30.8%) or Gender Non-Conforming (9.3%). Participants were younger adolescents with an average age of 13.9 years (SD=1.62). The three main themes identified were: FMSP impressions, using the FMSP, and FMSP barriers and quality improvements.

Table 1.

Sample characteristics

Characteristic (n = 65)	Mean	SD
Age	13.88	1.62
Gender(%)	N	Percent
Male	39	60.0%
Female	20	30.8%
Nonbinary	2	3.1%
Transgender	2	3.1%
Identify differently	2	3.1%
Language
English	59	90.8%
English, Spanish	5	7.7%
English, German, French	1	1.5%
Race
White or Caucasian	45	69.2%
Black or African American	6	9.2%
Asian, White or Caucasian	2	3.1%
Hispanic or Latinx	2	3.1%
Other, please specify:	3	4.6%
Asian, Hispanic or Latinx, White or Caucasian	1	1.5%
Hispanic or Latinx, White or Caucasian	4	6.2%
American Indian or Alaskan Native	1	1.5%
Asian	1	1.5%
	Mean	SD
Household size under 18 (excluding participant) [n = 64]a	0.95	0.98

^aParticipants were asked how many children under the age of 18 live in the home not counting themselves.

Theme 1: Youth Impressions of the FMSP

Study participants were receptive to the use of the FMSP, noting that it could improve their family’s ability to openly communicate about how they organized and managed regarding their medications. Adolescents reported positive impressions of using the FMSP stating that the FMSP would be useful and easy to use. They stated that it could be used as a reminder to take, store, and dispose of medications safely. However, a few adolescents noted that information such as proper storage and disposal were relevant and other medication information may be easily accessible online.

“It was a breeze. The, it’s well laid out, and it’s self-explanatory. I love it, and I look forward to using this, you know, for future medications that I have.” Adolescent 1, age 18

“Well, definitely the proper storage and disposal part. The rest of it, you can just google like the benefits and side effects and stuff, but definitely the proper storage and disposal I learned a lot about.” Adolescent 2, age 14

Theme 2: Perceptions of Using the FMSP

Who Uses the FMSP

Participants recounted how their parents or legal guardians managed medications. Although household members generally had access to both prescription and over the counter (OTC) medications, it was the responsibility of the parents to manage medications; therefore, many adolescents mentioned how the FMSP could be most useful for their caretakers. Most participants referenced that often their parents gave them reminders to take medications as well as stored and disposed of their medications. Some adolescents reported that it could be used as a reference tool to ensure safety when their parents or guardians are out of the home.

Youth reported minimal interaction with the healthcare team. Some had experience communicating with healthcare professionals via in person and virtual appointments or through Electronic Health Record (EHR) messaging systems. Few adolescents mentioned talking to healthcare providers at the pharmacy. Some youths were unsure how communication with healthcare providers took place in their family. When speaking to healthcare providers, youth most often reported being curious about side effects and dosage. Others mentioned more detailed questions such as drug interactions, duration of therapy, disposal, storage, and the consequences of taking other people’s medications. Although some youth spoke to the healthcare team, most youth’s parents spoke to the healthcare team on their behalf. Overall, adolescents reported low levels of autonomy in their own healthcare and a dependance on parents for information, direction, and care.

“I am, for the most part, responsible, but my parents will help remind me, and they tell me how to use it and when to use it.” Adolescent 3, age 12

“Yeah, my parents should be the one to dispose it, but like we’d probably store it with the, with our other medications and stuff. And then like when I can take out the dosage that I need and stuff, but then my parents would probably be the people to remind me to take it.” Adolescent 4, age 12

“I would use it like how we would dispose of it like I learned and where to store it. And if my mom isn’t here to read the bottle, and just to say, oh, that’s how many I take, and that what it’s for.” Adolescent 5, age 13

How to Use the FMSP

Adolescents envisioned multiple uses for the FMSP. Many adolescents found the FMSP to be a helpful tool to remind them of safe storage and disposal techniques. Another frequently reported use was that of a medication reminder, wherein they could be reminded to take their medication appropriately at their scheduled times. Adolescents’ responsibilities in medication management involved remembering to take the medication, taking the correct dose in the correct way, and appropriate storage, however, most youths reported that they rely on their parents to manage their medications. Therefore, adolescents typically suggested that the FMSP would be used by the whole family to keep each other accountable to safe medication practices by referencing the FMSP as needed.

“I think it would be uses as probably like a reminder about which medications like, especially if they’re scheduled ones. And then like if, for some reason, we forgot where to put like, where we put our medications if we had written it down, we could probably consult [it]… Whenever like if we got new medication or we stopped needing one, or there was like a change to the type or the dose or whatever.” Adolescent 6, age 15

“We would use it to keep in check of our medicines and how to properly storage and dispose our medicines.” Adolescent 7, age 17

Where to Find the FMSP

Adolescents offered ample examples of locations where they believed the FMSP could be provided. Many suggested doctor’s offices, community pharmacies, and schools. They advocated for both paper and digital formats, reporting that paper formats may be useful to raise awareness of the tool. At school, youth had the knowledge that medication was managed by the nurse or staff and required parental or medical permission to take the medication. Most adolescents did not have experience with how medication was managed at school because they were home schooled, never discussed the process of medication management at school or they did not take medication in general or at school. Although most youth do not take medication at school or do not know the process of medication management at school, some suggested that having an FMSP at school would be beneficial.

“Probably, at like [Large Retail Chain Pharmacy] probably would be very helpful. And if you could just be like, oh, yeah, [Large Retail Chain Pharmacy] has one or, you know, in a bin. Like a pharmacy that you go to probably would be really helpful. Even at school, I feel like that would be really helpful just to be like, the teacher pass out, like if you need one, here it is, and they’ll be in that room.” Adolescent 8, age 14

“It would probably be good at like a pharmacy, doctor’s office, and at schools, I mean, because it could help families keep track of their medicine better.” Adolescent 9, age 13

“I think they could like have pieces of paper of this like in the pharmacy or doctor’s office. Like when, like at the prescription counter back in like different pharmacies and stuff like that, you could do that. Or then just like at the check-in table of a doctor’s office too, just in case you wanted to take one to fill out with your family.” Adolescent 10, age 13

Theme 3: Barriers and Quality Improvements

Barriers

Although many youths indicated that they did not face any challenges in completing the FMSP, some mentioned potential concerns such as losing, misplacing, or forgetting about the FMSP. Adolescents recognized that their limited medication knowledge or autonomy would be barriers to completing or using the FMSP. The youth also reported that they would not use the FMSP because they would forget about it, lose it, would not find it useful, or do not take medication regularly.

“Probably for me, keeping it from filling it out or using it would be if I lose it, and then I wouldn’t want to take the time to fill it out again. Or if I just, yeah, basically, if I just lose it. Like I probably just want to do it once and not want to do it again. And then if I have it in a spot where like I see it every time, and like I’m actively thinking about it, I probably would be able to fill it out like when I get new medications still, rather than just leaving it somewhere where I can’t find, and then I forget about adding that new medication. And then give up on adding it later medications to it, so then, it becomes outdated.” Adolescent 11, age 18

“It would have to be a lack of knowledge of what your parents are taking, what your parents or youth are taking. You have to know what everyone is taking really to effectively fill it out. And if you only know what you’re taking, you can’t really effectively make a plan.” Adolescent 12, age 16

“I think it’s very helpful, and definitely for people who do take medication and take a lot of medication.” Adolescent 12, age 14

Quality Improvements

Youth generally had positive experiences reviewing the FMSP. Some changes that they suggested including more columns or rows for medications and more space to write. Some adolescents proposed that a more child-friendly version with a simpler layout and more child-friendly vocabulary may increase usability. Some youth also reported that the footnotes were confusing because they did not know how footnotes work. Some youth suggested adding instructions on how to fill out the FMSP since they did not know medication information or mostly had their parents help them or fill it out partially or entirely. Youth also recommended that the FMSP be digitally available but also in places such as the pharmacy or the doctor’s office.

“I think when my mom and I were doing it, a little bit more writing space if you’re going to do it, writing... But I think something to navigate and also help people who are filling this out, maybe just like some instructions or kind of like, if there’s a word or like what, like some of the questions like if they don’t know like what the questions mean... I guess that could help.” Adolescent 12, age 14

“I mean, maybe like maybe add more slots because there are people that do have more than this in their house, and there are some people that have less. So if there’s less, they just don’t have to fill out the whole thing. But if there’s more, or maybe make it like I don’t know how you could do it or make, but make it like expandable, I guess.” Adolescent 14, age 13

“Honestly, it’s very cut and dry, very self-explanatory. The only barrier I might see is maybe language barrier, maybe, possibly. It’s very, I mean, very informational, very, very, it’s very easy to understand. But the only barrier I would probably see would be language. You know, somebody might not be as good as, you know, at English, so . . .” Adolescent 1, age 18

Discussion

Overall, adolescents conveyed that the FMSP could be a useful tool to remind them about important medication safety information. In this study, we learned that adolescents experience minimal involvement with medication management, safety, and education at home or in clinical settings. Many adolescents were not aware of appropriate storage and disposal, hence, the FMSP serves as a tool to remind adolescents of safe behaviors. A study found significant associations with families’ utilizing safe management behaviors and adolescents’ behavior with their own prescriptions and household pain relievers.³⁰ In our study, adolescents acknowledged the importance of educational interventions and recognized the FMSP as a valuable tool to organize, track, remind, and properly use medications. This study gave insight into how the FMSP could give youth a larger role in medication safety management at home.

Implementing the FMSP into healthcare settings could help engender adolescents’ agency in their own healthcare. Adolescents have expressed a desire for more conversations and greater inclusion in their healthcare.³¹ Oftentimes, conversations between healthcare professionals and parents about an adolescent’s health excludes adolescents.³² Our findings demonstrate that few adolescents have conversations with their healthcare team or non-guardian household members about medication safety, because they tended to rely on their guardians for healthcare management and advocacy. A study found that parents had conflicting roles in adolescents’ involvement with healthcare representatives.³³ Some adolescents reported that their parents were great resources and provided clarity about their condition to the healthcare team. Parental involvement may also be troubling because parents did not give clear portrayals of their children’s conditions. Hence, the FMSP could be a helpful tool for providers to share with youth to include them in conversations. Moreover, findings suggest that the FMSP may be useful for adolescents who take multiple medications or are beginning new medications simultaneously.

Most adolescents mentioned they were familiar with the idea of going to the nurse to take medication at school and needing prior approval. With approximately 19% of students requiring medication use at school, medication administration at school is a frequent practice. ³⁴ However, with staffing shortages and financial constraints, it is common for staff members without medical backgrounds to administer medications to students.³⁵ Additionally, other common concerns with medication administration at schools include errors in dispensing. In one study, 48.5% of school nurses reported errors with the most common error being missed doses.³⁶ Having information such as a medication dosing schedule, side effects, and the reason for use in an understandable medication plan could reduce administration errors during school.³⁷

The FMSP may improve medication education regarding safe and appropriate storage and disposal. A study found that adolescents with lower medication literacy and knowledge were more likely to engage in inappropriate medication use.³⁸ This study highlights that adolescents were usually unaware of the safe storage and disposal of medications. However, the FMSP was difficult for a few adolescents to understand. Some adolescents found the FMSP’s vocabulary and footnotes hard to understand and suggested a “kid-friendly” version. Revisions to the FMSP can be made including language translations, reading level adjustments and formatting fixes (increasing space, utilizing color, creation of a digital version). While targeting youth for the prevention of opioid misuse can protect against misuse, few community-based participatory studies involve youth in the design of evidence-based practices.^31,39 Based on these findings, the FMSP can be a beneficial tool to educate adolescents and their families about safe opioid use and navigate conversations around medication concerns.

Limitations

This study used self-reported data from adolescents which can be influenced by factors such as language skills. Another factor is that the participants were individuals between the ages of 12 to18 years. Adolescence encapsulates the developmental period between the onset of puberty, and legal adulthood.⁴⁰ As children age, their vocabulary and comprehension skills drastically increase, and a 12-year-old and an 18-year-old likely have different abilities.⁴¹ As our sample was mostly comprised of younger adolescents, findings cannot be assumed generalizable to older adolescents. This would allow for assessing if there are developmentally appropriate recommendations for how the FMSP might be used by diverse adolescents. Future studies should aim to recruit a larger, more diverse sample to allow for further exploration of use by age, gender, race, and language. Several factors could potentially influence how the FMSP is used by adolescents such as the number of medications they are taking, the duration of use of the tool, and the presence of a health professional in the household. Future research should examine whether these factors affect the use of the FMSP by adolescents and their families.

Most adolescents identified as White, male, and monolingual English speakers. As this sample lacks diverse representation, future studies are necessary to elicit impressions from groups systematically made vulnerable. Since this study was conducted during the COVID-19 pandemic, it was necessary to only include adolescents who had access to virtual videoconferencing. Incentives were used to reimburse participants for their time and participation. Remuneration to participants’ parents was approved by the University’s IRB. It is possible that incentivization in this study could bias adolescents towards socially desirable responses.

Conclusion

Implementation of the Family Medication Safety Plan that includes adolescents can encourage medication conversations, support adolescent safety, and provide adolescents with increased agency in medication management. Additionally, the FMSP may be useful to adolescents who need to take medication at school and rely on staff members for correct administration of medication. Future studies will investigate the efficacy of the FMSP and its potential to provide agency to adolescents in various settings. Future studies will need to recruit a wider modality to encompass adolescents from diverse backgrounds considering differences in characteristics such as age, health status, medication use, preferred learning styles, and socioeconomic status.

Key Points:

What was already known?

• Youth are at increased risk of opioid prescription related adverse events.

• Youth often have limited agency and autonomy in their medication behaviors due to parental care.

• There is a dearth of adolescent-focused family interventions to improve household opioid medication safety.

What does this study add?

• Youth tend to rely on their parents for medication management.

• Youth had positive impressions of using the Family Medication Safety Plan.

• Youth suggested many ways in which the present FMSP could be improved, such as language translations or an adaptable format.

• Youth uptake of this tool is reliant on parent and health provider engagement when they are prescribed medications and their level of healthcare autonomy.