The Journal of Pediatrics
Volume 160, Issue 2 , Pages 190-192, February 2012

The Last Mile: Taking the Final Steps in Preventing Pediatric Pharmaceutical Poisonings

  • Daniel S. Budnitz, MD, MPH

      Affiliations

    • Corresponding Author InformationReprint requests: Daniel S. Budnitz, MD, MPH, Division of Healthcare Quality Promotion, Centers for Disease Control and Prevention, 1600 Clifton Road, NE, Mailstop A-24, Atlanta, GA 30333.
    • ,
  • Maribeth C. Lovegrove, MPH

Division of Healthcare Quality Promotion, Centers for Disease Control and Prevention, Atlanta, Georgia

published online 07 November 2011.

Article Outline

CRC, Child-resistant closure, ED, Emergency department, OTC, Over-the-counter

 

See related article, p 265

The dramatic reduction in pediatric deaths from unintentional poisonings in the last half of the 20th century is a model of the successful application of injury prevention theory and practice. The increases in hospitalizations, emergency department (ED) visits, and persistence of deaths caused by unintentional pediatric pharmaceutical poisonings in the first decade of this century are described by Bond et al1 in this issue of The Journal and remind us that this effort is not yet complete. Hopefully the findings in this study can help catalyze targeted efforts to reverse the rise in injuries from pediatric pharmaceutical poisonings and push the number of pediatric deaths closer to zero.

Educational initiatives, engineering modifications, and enforcement actions (the “3 E’s” of injury prevention) all contributed to a decrease in pediatric poisonings in the 20th century. Educational initiatives for parents, caregivers, and children became a cornerstone of poisoning prevention activities in 1961 when the third week of March was designated as National Poison Prevention Week.2 An engineering approach to pharmaceutical poisoning prevention was introduced in the 1950s, when Dr Jay Arena convinced manufacturers to place “safety closures” on bottles of flavored children’s aspirin to prevent self-ingestion by young children.3 Unfortunately, the number of pediatric salicylate poisoning deaths continued to increase. The most popular early cap design depended on friction to keep the cap in place, and although many young children could not open these caps with their hands, they could open them using their teeth. With adoption of other types of closures, such as those which required pressure and rotation, deaths from children's aspirin began to decline.4

After studies in the late 1960s demonstrated that child-resistant closures (CRCs) on bottles of adult prescription medicines reduced unintentional poisonings in children, the Poison Prevention Packaging Act was passed in 1970.5 The US Consumer Product Safety Commission now enforces the use of CRCs on potentially toxic products, including many over-the-counter (OTC) drugs and nearly all prescription medications.6, 7

Poisoning prevention interventions of the last century also addressed each of the 3 phases of the injury process: pre-event, event, and postevent. Education to encourage safe use and storage practices seeks to alter conditions of the pre-event phase. Voluntary restrictions on the amount of medication sold in a single container limits the dose exposure in the event that a child accesses the contents of a container. Access to poison centers, now through a national toll-free number (1-800-222-1222), provides expert assistance for triage and management after an ingestion.

Poisoning morbidity and mortality did decrease significantly in the 1970s. In particular, the use of CRCs on medications has been credited with preventing more than 1000 pediatric deaths and many more injuries from nonfatal poisonings.6, 8 The most dramatic reductions have been in poisonings from nonpharmaceutical products however, and the problem of accidental pharmaceutical poisonings has persisted.9 Studies from the 1950s found that approximately two-thirds of accidental poisoning deaths among children aged <5 years in the United States involved substances other than medicines.10, 11 In the 2000s, pharmaceutical products are now the predominant cause of pediatric poisonings, accounting for 60% of accidental deaths and sending 1 of every 150 2-year-olds to an ED.12, 13

The study by Bond et al in this issue of The Journal provides additional details on the rising tide of unintentional pharmaceutical poisonings in young children. Using the National Poison Data System of the American Association of Poison Control Centers, the authors analyzed calls to poison centers for unintentional exposures of a single pharmaceutical product by a child aged <6 years for which evaluation in a healthcare facility (most commonly an ED) was sought. They found a 43% increase in the number of moderate or serious injuries, a 36% increase in number of admissions, and a 28% increase in ED visits from 2001 to 2008. Of the total 453 559 visits identified over the 8-year study period, 95% were for self-ingestions (55% involving prescription medications; 40% involving OTC products), and only 5% involved therapeutic errors. The finding that the overwhelming majority of these ED visits (as well as injuries and admissions) were due to child self-ingestions is consistent with previous studies and should lead us to conclude that preventing these self-ingestions is an important pediatric patient safety issue.14

What can be done to reduce morbidity and mortality from child self-ingestions in 2011 in addition to what has been implemented in previous decades? The limitations of CRCs were evident to their earliest proponents. In 1970, Col. Robert Scherz, who led one of the early studies of CRCs at Madigan General Hospital and McChord Air Force Base, noted that “the chief weakness of CRCs in current use is the accessibility of the entire contents of the vial to the child once it is opened. The theoretical ideal of an inexpensive practical CRC that dispenses small quantities of medicine is yet to be developed, tested, and distributed commercially.”15 Forty years later, a public–private collaboration to address pediatric pharmaceutical poisonings, the PROTECT (Preventing Overdoses and Treatment Errors in Children Taskforce) Initiative, has inspired the commercial development of packaging that seeks to approach Col. Scherz’s “theoretical ideal” for liquid medicines.16

This next-generation safety packaging is designed to provide a second, passive mechanism to limit the amount of liquid medication that can be accessed by a child when the CRC is compromised or improperly replaced. One example of this new packaging requires insertion of a needleless syringe into a valve that covers the bottle opening. Another design requires applying pressure to the bottle to extrude the liquid medication through a one-way valve. “Flow restriction” packaging to improve dosing accuracy and limit accidental exposures will soon be distributed commercially on selected liquid OTC products, including all single-ingredient infant acetaminophen products and Children’s Tylenol products.17, 18 As was the case for the early CRCs, further testing and refinement of these innovative safety packaging designs for liquid medications will be needed to confirm their effectiveness and assess for unintended consequences.

It is well known that pediatric pharmaceutical poisonings involve products other than OTC children’s liquid preparations. Are there innovative interventions to address child self-ingestion of pills? Again, early poisoning preventionists recognized this challenge. In 1981, Dr Paul Palmisano suggested a “double-barrier” approach of packaging pills in blister packs and dispensing these blister packs within a traditional child-resistant container.19 Palmisano acknowledged that additional cost and patient inconvenience may be barriers to this approach, and so suggested targeting only a few compounds with high clinical toxicity and widespread availability. High-toxicity medications that can be fatal to toddlers in small doses have been identified,20 but an even better approach than identifying which of these are highly available is to directly examine national data on the frequency and severity of actual harm to children to identify priority targets for intervention. Based on their analysis of ED visits, admissions, injuries, and deaths, Bond et al1 suggested directing attention to opioids, cardiovascular agents, and sedative-hypnotics. These are broad and widely used categories of medicines; a more focused approach could examine the intersection of high-toxicity medications and pediatric poisoning deaths to identify the specific opioid, cardiovascular, or sedative-hypnotic preparations that might maximize the impact of double-barrier approaches and minimize the cost and inconvenience to adult pill-takers.

Bond et al provide much useful information for targeting prevention activities, but a number of questions remain. First, although self-ingestion led to the greatest number of ED visits and hospitalizations, the contribution of therapeutic errors to pediatric deaths is not clearly detailed. Labeling and education also may be needed to fully address mortality.21, 22 Second, identification of the specific formulations of medications (eg, pill vs liquid, pediatric vs adult) that were responsible for the greatest proportion of ED visits, hospitalizations, and deaths could help identify target areas for intervention. Third, additional details on the circumstances of ingestions could further guide intervention priorities. Although limited, data from previous studies have shown that a fair number of self-ingestions involved a child accessing medicine from a bottle that had been left open or improperly closed or from a container, such as a bag or pillbox, to which the medication had been transferred.23, 24 Finally, as Bond et al acknowledge, their findings are based on a passive surveillance system, and such systems can be susceptible to reporting biases, incomplete data, and underreporting. All of these limitations would result in underestimates of the actual health burden, however.

The second half of the 20th century saw tremendous progress in poisoning prevention, particularly in reducing pediatric mortality. Now the baton has been passed to another generation. A new Healthy People 2020 objective aims to reduce morbidity by decreasing the number of ED visits for medication overdose in children aged <5 years by at least 10% by the end of this decade.25 Achieving this goal will require creativity, collaboration, and commitment, but working together, physicians, pharmacists, packaging professionals, pharmaceutical companies, poison preventionists, and parents can convert pediatric pharmaceutical poisonings from a reemerging risk to a historical footnote.

Back to Article Outline

References 

  1. Bond GR, Woodward RW, Ho M. The growing impact of pediatric pharmaceutical poisoning. J Pediatr. 2012;160:265–270
  2. Centers for Disease Control and Prevention. National Poison Prevention Week: 25th anniversary observance. MMWR Morb Mortal Wkly Rep. 1986;35:149–152
  3. Duke University. Transcript of an oral history interview with Jay Arena, Professor of Pediatrics and Community Health and Director of Duke Poison Control Center, 1984. Available from: http://archives.mc.duke.edu/programs/oh/oh_arena.html. Accessed August 10, 2011.
  4. Scherz RG. Safety packaging impact on childhood poisonings in the United States. Vet Hum Toxicol. 1979;21(Suppl):127–131
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  21. Tzimenatos L, Bond GR. Pediatric Therapeutic Error Study Group. Severe injury or death in young children from therapeutic errors: a summary of 238 cases from the American Association of Poison Control Centers. Clin Toxicol (Phila). 2009;47:348–354
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 The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention.

PII: S0022-3476(11)00934-6

doi:10.1016/j.jpeds.2011.09.020

Refers to article:

  • The Growing Impact of Pediatric Pharmaceutical Poisoning , 16 September 2011

    G. Randall Bond, Randall W. Woodward, Mona Ho
    The Journal of Pediatrics February 2012 (Vol. 160, Issue 2, Pages 265-270.e1)

The Journal of Pediatrics
Volume 160, Issue 2 , Pages 190-192, February 2012

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