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ORIGINAL CONTRIBUTION |
From the Long Island (NY) Regional Poison and Drug Information Center, the Winthrop University Hospital in Mineola, and the Departments of Preventive Medicine (McFee) and Emergency Medicine (Caraccio) at the State University of New York – Stony Brook. Dr McFee is also president and medical director of Emergistics US Inc, in Austin, Tex.
Address correspondence to Robin B. McFee DO, MPH, Long Island Regional Poison and Drug Information Center, Winthrop University Hospital, 259 First St, Mineola, NY 11501-3957. E-mail: rbmcfee{at}pol.net
Context: Although the circumstances are not well studied, grandparents' medications account for 10% to 20% of unintentional pediatric intoxications in the United States.
Objectives: To characterize circumstances leading to and outcomes from pediatric pharmaceutical exposures. To identify preventable risk factors associated with this pattern of injury, referred to as the "granny syndrome."
Design, Setting, and Participants: Retrospective review of records
of telephone calls made to a certified regional poison control center in the
United States. Records were analyzed for all calls concerning children aged 6
years or younger who were exposed to grandparents' medication(s). For
statistical analysis, regression and 
2 analysis as well as
Fisher exact tests were used. The sample size provided 80% power to detect a
10% difference at the 5% level of significance. Statistical significance was
set at P
.05.
Main Outcomes Measured: Use of child-resistant containers (CRCs), the location of pharmaceuticals prior to pediatric ingestion, and drug classes involved (eg, analgesics, cardiovascular drugs).
Results: Of the 200 incidents analyzed, 90 (45%) cases involved CRCs, and 110 (55%) involved containers that were not child resistant. For these incidents, the average age of the child was 18.8 months; the grandparent was aged on average 58.7 years. Most medications had been placed on tables or countertops (91 [46%]), low shelves (57 [29%]), or in pocketbooks (34 [17%]). The type of container in which the pharmacologic agent was stored (CRC vs non-CRC) was not statistically significant (P>.1). Ease of access to medication, regardless of the type of container used, was the only statistically significant outcome (P<.001). In the present study, accidental pediatric exposures most frequently involved cardiovascular (90 [45%]), analgesic (84 [42%]), and psychotropic (32 [16%]) medications.
Conclusion: Pediatric exposure to pharmaceutical agents is a preventable cause of injury. Physicians have an important opportunity to assist in preventing pediatric pharmaceutical exposures by instructing parents and grandparents on how to better limit children's access to medications as an essential component to enhance child safety.
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Report of Case |
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 Top Report of Case ContextMethodsEnd PointsResultsCommentStudy LimitationsConclusionReferences |
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On inquiry into the history of injury, it was learned that the grandmother came over to bake cookies with her grandson. She placed her pocketbook on the sofa "for just a moment" while she went into the kitchen to place the groceries on the counter. When she returned to the living room, she discovered that her grandson had opened her purse and was playing with her pills. He looked up at her and said, "M&M's, Nana," referring to the well-known chocolate candy.
The child's mother called the local poison control center and was instructed to take the boy to the nearest emergency department. They arrived at the emergency department within 1 hour of ingestion. When asked what the ingested medications were and how many were swallowed by the boy, the grandmother responded that she was taking "a water pill, some other pill for blood pressure, a sugar pill, and one for my heart." She stated that she carries a couple days' worth of each pill in a sandwich bag because it is easier for her to open than a pill bottle. Nevertheless, the grandmother was uncertain exactly how many pills were available to her grandson or how many were ingested by him.
In consultation with the grandmother's geriatrician, we determined that she was taking an ACE (angiotensin converting enzyme) inhibitor, a diuretic, a sulfonamide, and a ß-adrenergic blocker. Given the respective toxicologic profiles of each drug class represented and the time elapsed since ingestion, we determined that one dose of activated charcoal should be initiated. The child's serum glucose levels were monitored and intravenous hydration therapy with 5% dextrose in normal saline was implemented. The patient's vital signs remained stable. The patient was observed and monitored for several hours. After remaining clinically stable during this time, he was sent home in his parent's care with specific instructions. His mother was instructed to monitor the child for any change in alertness, mental status, pallor, or onset of new symptoms (eg, lethargy, nausea, vomiting), in which case she was instructed to contact the poison control center immediately. In addition, the child's mother was reassured that the child should have a good outcome and should be encouraged to eat at his next meal time. Normal activities could be resumed the next day.
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Context |
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It is generally recognized that most unintentional exposures usually result in mild symptoms or no symptoms, and that less than 10% of unintentional exposures involving toddlers result in significant symptoms.1,9 Nonetheless, there are certain common medications and substances that may place a child at greater risk for fatality, such as antidepressants, prenatal iron supplements, and salicylates, all of which have been reported to cause severe toxicity in toddlers.1,2,10,11
From an injury-prevention perspective, children involved in unintentional toxicant exposures who present to a healthcare facility—depending on the potential risk associated with that specific incident—are at risk for additional and more serious poisonings.12
Although the causes for such exposures are multifactorial,11,13 unintentional pharmaceutical exposure suggests that the child's environment has not been properly "child-proofed." One cause of such exposures is improper storage of controlled substances, an occurrence that is regrettably common and has resulted in the creation of child-resistant containers (CRCs). Often, parents, grandparents, and other adults forget that children are natural explorers, are able to move quickly, are determined to investigate their environments, and will generally put anything and everything into their mouths that they can get their hands on.11 Finally, toddlers are well-known imitators.13 They may have observed adults taking their medications in the past, and therefore seek to imitate that "grown-up" behavior.13 Because of their stage of cognitive development, however, children—and especially those younger than 3 years—are unable to discriminate safe from unsafe products.14 In a child's eyes, pills resemble candy. A toxic amount can be ingested before taste aversion leads to discontinuing exploratory consumption.
In a study of children younger than 6 years that examined the potential for toxicity from tricyclic antidepressants, researchers had an incidental finding that demonstrated that almost half of the patients in the case series ingested medications that belonged to a non-parent adult, mostly grandmothers.15 This finding encouraged that set of investigators to conduct a new study designed to characterize the circumstances contributing to the 27,209 calls involving children younger than 6 years placed to a regional poison control center during the years 1997 and 1998.1,3,16,17 The authors' results suggested that the presence of a grandparent is a risk factor for unintentional pediatric exposure to pharmaceuticals.
To improve the efficacy of public marketing and prevention messages, in the present study, we refer to this risk factor as the "granny syndrome."16–19 An interesting and unexpected finding of these studies was that many of the substances involved in the exposure incidents were kept in CRCs, which apparently did not confer a substantial safety advantage.
To prevent unintentional pediatric exposures, and to reduce unnecessary visits to healthcare facilities—as well as the significant psychological and emotional morbidity associated with this pattern of injury—we designed the present study to characterize the circumstances that contribute to this pattern of injury.
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Methods |
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To determine subject eligibility for the study, we assessed the records for all telephone calls related to medication exposure that involved patients aged 6 years or younger. Patients were included in the study if the toxicant belonged to a grandparent. Patients were excluded from this investigation if the ingestion was determined by LIRPDIC staff to be intentional, if the child was in the care of a parent at the time of the ingestion, or if the toxicant belonged to either a parent or the child. We felt that characterizing the precursors to exposure might assist in identifying additional opportunities for prevention.
For each potential study subject, the LIRPDIC certified poison information specialist asked questions that are standard for poison control center intake. The answers to these questions assist poison information specialists in characterizing the events leading up to an exposure.
As noted, the staff at LIRPDIC who participated in this study were certified poison information specialists. All LIRPDIC staff were blinded to all study end points and objectives. Evaluation for eligibility in the present study was performed during the initial emergency telephone call to LIRPDIC. Information gathered included patient and grandparent demographics, the location of the toxicant at the time the child gained access to it, the class and name of the toxicant(s), the method of storage (CRC or non-CRC), and medication dose—though the latter variable was not an outcome measured in the present study.
This investigation was granted exempt status by the Winthrop University Hospital committee on research involving human subjects.
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End Points |
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For statistical analysis of the first study end point, we determined that a
sample size of 200 was required to provide 80% power in detecting a 10%
difference between the CRC and non-CRC groups at the 5% level of significance
(two-tailed t test; P.05). Given the epidemiology of
childhood exposures to medications, a 10% difference would represent a sizable
population and an opportunity for clinical intervention. Statistical analysis
for the study's major events (ie, medication access and storage) was performed
using regression and 2 analysis as well as Fisher exact tests
(Power and Precision; Biostat Inc, Englewood, NJ).
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Results |
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During the 4-month study period from May 2000 through August 2000, 222
patients were identified as potential subjects. Of these patients, 200 (90%)
met inclusion criteria and were not disqualified for study through exclusion
criteria. In our study, when children had pharmaceutical exposures that were
the result of access to medications belonging to their grandparents, the
average age of the grandparent was 58.7 years (range, 43–78 y). The
majority of grandparents in this group were aged between 50 and 60 years. The
pediatric patient was, on average, aged 18.8 months (range, 10–69 mo)
The majority of patients (6206 [49%]) were aged between 13 and 24 months.
Regression and 2 analysis failed to identify demographic
factors associated with this pattern of injury, however (P>.05).
Although we originally postulated that older grandparents might be more likely
to contribute to this pattern of injury by being prescribed or taking greater
numbers of medications than younger grandparents, and also that decreased
mobility among this subgroup might also predispose children to greater risk of
pharmaceutical exposures, the data did not support these postulates.
Ninety (45%) pediatric exposures involved CRCs, and 110 (55%) involved non-CRCs (Figure 1). Multiple-day medication containers and assorted pill bottles and boxes represented the majority of non–child-resistant medication containers used (Figure 2). However, there was no statistical difference between CRCs and non-CRCs in terms of safety to the child. In addition, there was no statistically significant difference in location distribution between CRC and non-CRC exposures (Figure 1 and Figure 3). In other words, a medication found in a pocketbook was as likely to be stored in a CRC as in a non-CRC.
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36 inches floor to surface).
In the remaining two (1%) incidents, children had access to transdermal
nitroglycerin patches when they were sitting on their grandparents' laps. The
children involved in these two incidents pulled the patches off of their
grandparents and began either sucking on or licking the patch.
Although individuals typically store medications in a wide variety of
containers that are not child-resistant (eg, resealable sandwich bags), the
incidents analyzed in the present study were the result of physical
accessibility (P.001), not improper storage (P=.19).
Paralleling national and regional poison control data, cardiovascular (90 [45%]), analgesic (84 [42%]), and psychotropic (32 [16%]) medications were the source of the majority of pediatric pharmaceutical exposures in our study.1–8,16,17 These agents were followed by cold and allergy (23 [11.5%]), diabetic (15 [7.5%]), and antimicrobial (12 [6%]) medications. Some exposures involved multiple medications. Ingested medications included acetaminophen, aspirin, ß-blockers, ACE inhibitors with calcium channel blockers, and digitalis. In the present study, most children exhibited only mild symptoms. Nevertheless, cardiovascular medications have the potential for significant toxicity when ingested by young children (Table).20–23
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Comment |
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As demonstrated in this study, many senior citizens carry cosmetics, potentially toxic products, and medications in a variety of containers that are not child resistant. Consistent with national data, the data in this study demonstrate that pediatric pharmaceutical exposures primarily involved cardiovascular, analgesic, and psychotropic medications—including acetaminophen, aspirin, ß-blockers, ACE inhibitors with calcium channel blockers, and digitalis—medications that pose a moderate to significant risk potential for toddlers as a result of weight-based (ie, mg/kg) prescribing guidelines.20–23
We determined that most pediatric pharmaceutical exposures in this study
were the result of proximal accessibility rather than improper storage of
medication (ie, container type). Only 16 incidents involved cabinets or higher
shelves (ie, 36 inches floor to surface), locations that are usually
considered childproof or safe. Caregivers often fail to consider the
possibility that some toddlers are very determined and are resourceful enough
to use whatever means may be necessary to obtain what they want. Such toddlers
may climb up drawer handles or may use nearby chairs as stepstools. Children
are especially susceptible to this pattern of injury because they are natural
explorers, mouth substances as a developmental behavior, cannot discriminate
safe from unsafe—and they sometimes have access to potentially dangerous
pharmaceutical
substances.13
Although transdermal delivery devices (ie, nitroglycerin patches) accounted for a small number of total exposures in this study, an increasing number of medications are being developed for transdermal delivery, including potent opioid analgesics such as fentanyl. Even discarded patches, often carelessly "disposed" in wastebaskets, can be a source of potentially toxic pharmaceutical exposures for toddlers. Prescribing clinicians need to remind patients wearing transdermal delivery devices to exercise the same preventive cautions around children with these devices as with other toxicants and medications.
Because many families rely on the income of two adults, and because there are more single-parent households than in prior generations, grandparents are increasingly being called on to help care for their grandchildren. However, for most grandparents, it has been many years since they were responsible for taking care of small children. Many of the injury-proofing practices that were previously second nature to them have long since been forgotten. In addition, many older adults find themselves taking medications that were unnecessary during their active parenting years. In the intervening years, safety concerns have given way to convenience and lessening the impact of age-related accessibility and mobility restrictions. For this reason, many older adults decline the use of CRCs, which are often not easy for them to open. In addition, many older adults take such a large and potentially confusing number of medications that they need to use organizer containers, which are easier to open, but may contain a potentially toxic, possibly fatal amount of medication, should a toddler obtain access to them.
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Study Limitations |
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While the primary study was completed in 2000, evaluation, analysis, and subset study are ongoing. From the postulation of the granny syndrome concept,18 we have compared AAPCC data annually to that reported by the LIRPDIC. We continue to monitor cases of the granny syndrome to identify any changes in this injury pattern.
One weakness in the present study is the lack of true denominator data. We do not know how many potential exposures were, in fact, prevented by CRCs. A study of aborted pharmaceutical exposures in children would be a valuable tool in assessing the true value of CRCs. Nonetheless, the results of the present study add to the attempts of researchers to characterize childhood medication exposures and patterns of preventable injury.
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Conclusion |
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Our analysis reveals that the granny syndrome appears to be mainly the result of a failure in patient education, which is, of course, a correctable condition. Patients need to be made aware that access, not choice of container, has the most impact on prevention for this pattern of injury. Seventeen percent of the pediatric pharmaceutical exposures in the present study were the result of child access to pocketbooks. It appears that pocketbooks, when left on the floor in the presence of children aged 6 years or younger, constitute a potentially lethal weapon. In addition, counters and low shelves are dangerous points of child access to pharmaceutical agents.
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Acknowledgment |
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Footnotes |
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References |
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2. Watson WA, Litovitz TL, Rodgers GC Jr, Klein-Schwartz W, Reid N, Youniss J, et al. 2004 annual report of the American Association of Poison Control Centers Toxic Exposure Surveillance System. Am J Emerg Med. 2005;23:589–666. Available at: http://www.aapcc.org/2004.htm. Accessed June 8, 2006.
3. Litovitz TL, Klein-Schwartz W, Caravati EM, Youniss J, Crouch B, Lee S. 1998 annual report of the American Association of Poison Control Centers Toxic Exposure Surveillance System. Am J Emerg Med. 1999;17:435–487. Available at: http://www.aapcc.org/1998.htm. Accessed June 9, 2006.
4. Litovitz TL, Klein-Schwartz W, White S, Cobaugh DJ, Youniss J, Drab A, et al. 1999 annual report of the American Association of Poison Control Centers Toxic Exposure Surveillance System. Am J Emerg Med. 2000;18:517–574. Available at: http://www.aapcc.org/1999.htm. Accessed June 9, 2006.
5. Litovitz TL, Klein-Schwartz W, White S, Cobaugh DJ, Youniss J, Omslaer JC, et al. 2000 annual report of the American Association of Poison Control Centers Toxic Exposure Surveillance System. Am J Emerg Med. 2001;19:337–395. Available at: http://www.aapcc.org/2000.htm. Accessed June 9, 2006.
6. Litovitz TL, Klein-Schwartz W, Rodgers GC Jr, Cobaugh DJ, Youniss J, Omslaer JC, et al. 2001 annual report of the American Association of Poison Control Centers Toxic Exposure Surveillance System. Am J Emerg Med. 2002;20:391–452. Available at: http://www.aapcc.org/2001.htm. Accessed June 9, 2006.
7. Watson WA, Litovitz TL, Rodgers GC Jr, Klein-Schwartz W, Youniss J, Rose SR, et al. 2002 annual report of the American Association of Poison Control Centers Toxic Exposure Surveillance System. Am J Emerg Med. 2003;21:353–421. Available at: http://www.aapcc.org/2002.htm. Accessed June 9, 2006.
8. Watson WA, Litovitz TL, Klein-Schwartz W, Rodgers GC Jr, Youniss J, Reid N, et al. 2003 annual report of the American Association of Poison Control Centers Toxic Exposure Surveillance System. Am J Emerg Med. 2004;22:335–404. Available at: http://www.aapcc.org/2003.htm. Accessed June 9, 2006.
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