A Pilot Study Assessing Common Medication Organizers for Child-Resistant Features

Abstract

HIGHLIGHTS

INTRODUCTION

Approximately 15% of all adults aged 40–59 years and 35% of adults aged >65 years regularly take 5 or more medications each month.1, 2, 3 Many of these adults use medication organizers to help simplify the daily administration of multiple medications.4, 5, 6 Medication organizers are also employed when taking medicines away from home (e.g., at work or when traveling), when the transport of larger medication containers is not practical but medications still must be accessible.

Unfortunately, when medications are easily accessible, it is more likely for young children to find and ingest them. Poison centers received nearly 890,000 calls in 2020 for medication exposures, and more than 40,000 young children are brought to emergency departments for unsupervised medication exposures annually.^7,8 In over 50% of calls to poison centers involving prescription pills and over 20% of calls involving over-the-counter (OTC) pills, children ingested pills that had been removed from their original bottles or packaging and put in other containers or left out.⁹

However, unlike the original packaging of prescription and most OTC medicines, medication organizers and other containers advertised to hold medications are not required to be child resistant (CR). Therefore, this study sought to identify the key characteristics of commonly purchased medication organizers and assess whether they have CR features and instructions for safe use in the presence of young children.

METHODS

On September 17, 2019, at 12:00pm, the 25 most frequently purchased medication organizers from Amazon.com were identified using website's top 100 best sellers search feature and were purchased. When reviewing the top 100 list, it was observed that organizers with unique characteristics were not included, or some did not have enough representation. Four additional medication organizers were purchased, including 1 circular organizer to ensure that at least 5 organizers were circular, one 30-day organizer to ensure that at least 5 organizers had a maximum duration of 30-days of use, and 2 electronic organizers, which was a design feature not seen in the top 25 list. Product identifiers, design characteristics, and safety characteristics were recorded independently by 2 authors for each product using a standardized instrument in 2020 (^{Appendix Table 1}, available online). Frequency and proportion of each design and safety characteristics were calculated in 2021–2022.

RESULTS

Of the 29 medication organizers evaluated, the most common design characteristics observed were plastic materials (100%), flip-top openings for pill compartments (97%), no electronic mechanisms (93%), rectangular shape (83%), and 7-day usage (83%) (Table 1). Most medication organizers (79%) had all 5 characteristics. A minority had detachable compartments (41%) and compartments for dosing multiple times per day (15%).

None of the purchased medication organizers were labeled as CR containers (Table 2). A minority of organizers had safety information written on the packaging, including instructions to store the organizer out of the reach of children (41%) and/or warning that the organizer was not CR (34%). Most organizers (17 of 29, 59%) provided neither a warning that the organizer was not CR nor instructions to store out of reach of children. One organizer required multiple steps to access the medication compartment, but the organizer was not labeled as a CR container (Figure 1).

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Figure 1

Single medication organizer observed with 2-step flip-top opening. User must press down plastic bar before opening each individual compartment.

The average price of the 29 organizers was $12.91 (U.S. currency), median of $9.99, with prices ranging from $2.49 to $79.95 (IQR=$4.84–$11.93). Average cost of medication organizers increased with duration of use and dosage frequency supported. Two electronic organizers were the costliest ($63.71 and $79.95); both shared features, including an alarm, clock, and battery level display. The most expensive model offered a locking mechanism that required a physical key to open.

DISCUSSION

None of medication organizers most commonly sold by the most popular online retailer in the U.S. were identified to be CR. On one hand, this finding should not be surprising, given that the Poison Prevention Packaging Act (PPPA) requirements for CR testing for the primary packaging of medicines do not apply to medication organizers. On the other hand, this finding is quite concerning because when consumers take prescription or OTC medicines from CR containers or packaging and place them into non-CR medication organizers, there is an increased risk of unsupervised ingestions (UIs).⁹ Moreover, medication organizers are not required to display any specific instructions to help minimize UIs such as a warning to “Keep out of reach of young children.” Indeed, nearly 60% of the top-selling organizers purchased do not include instructions to store out of reach of children nor identify their lack of CR.

Although there are no mandatory or even voluntary standards regarding CR features and warnings on medication organizers to help prevent UIs, there are short-term and longer-term opportunities that can help keep young children safe. First, all medication organizers and their carton labeling should clearly state that the container should be kept out of reach and sight of young children at all times. This is especially important when medication organizers are used in environments where young children may be present. Second, manufacturers could begin to produce organizers that have CR features, such as 2-step mechanisms, that are tested in a manner similar to PPPA protocols.^10,11

A single medication organizer evaluated in this study had a 2-step opening mechanism (plastic bar extending behind individual pouches needed to be depressed to open pouches) that may make the device more difficult for children to access (Figure 1). Labeling on this organizer appropriately indicated that this product was not tested to be CR because, currently, there are no CR testing standards for medication organizers. Until a methodology is developed to address this gap in safety standards, such as the voluntary testing protocols for flow restriction for liquid medications, there is no standardized way to assess the ease or difficulty at which young children can self-access the contents of medication organizers. As noted earlier, manufacturers could volunteer to test medication organizers using methods available in PPPA protocols.^10,11

CONCLUSIONS

Few medication organizers evaluated alerted users, who may be taking treatment or OTC medicines from containers and packaging that are CR, that the medication organizer they are putting individual doses into does not provide a similar type of protection against UIs. Opportunities exist for manufacturers to improve product design and incorporate features, such as 2-step mechanisms, which have been demonstrated to decrease access by curious young children and provide instructions to “Keep out of reach of children” that incorporate prevention strategies. Innovation research, including developing a testing methodology, could support introduction of features or lock mechanisms on medication organizers designed to limit access by young children and decrease risk for unsupervised ingestions by children.

CRediT authorship contribution statement

Lilai Teum: Conceptualization, Methodology, Validation, Formal analysis, Investigation, Writing – original draft, Writing – review & editing, Visualization. Fallon Gokhman: Conceptualization, Methodology, Validation, Formal analysis, Investigation, Writing – original draft, Writing – review & editing, Visualization. Sophia Park: Conceptualization, Methodology, Validation, Formal analysis, Investigation, Writing – original draft, Writing – review & editing, Visualization. Daniel S. Budnitz: Formal analysis, Writing – review & editing, Visualization. Joseph W. Aquilina: Conceptualization, Methodology, Writing – original draft, Writing – review & editing, Visualization, Supervision. Edwin K. Kuffner: Conceptualization, Methodology, Writing – review & editing, Visualization, Supervision, Funding acquisition.

ACKNOWLEDGMENTS

Footnotes

REFERENCES