A recent Journal of Pediatrics study revealed that over the past decade increasing numbers of very young children in the U.S. have been hospitalized or injured due to accidental poisoning with prescription and over-the-counter (OTC) medications. The study, published online on Sept. 13, 2011, showed that most of these pediatric poisonings resulted from unintentional self-ingestion of a drug (e.g., the child finds and consumes pills from an open container of a drug prescribed to a parent or...
A recent Journal of Pediatrics study revealed that over the past decade increasing numbers of very young children in the U.S. have been hospitalized or injured due to accidental poisoning with prescription and over-the-counter (OTC) medications. The study, published online on Sept. 13, 2011, showed that most of these pediatric poisonings resulted from unintentional self-ingestion of a drug (e.g., the child finds and consumes pills from an open container of a drug prescribed to a parent or grandparent). A minority of cases were caused by an unintentional therapeutic error in the administration of a medication intended to treat the child (most commonly, giving the wrong dose). The severity of injuries from such pediatric poisoning has increased with the rise of Food and Drug Administration (FDA) approvals of medications with more dangerous side-effect profiles.
Journal of Pediatrics study overview
Dr. G. Randall Bond and his co-authors analyzed records from the American Association of Poison Control Centers’ National Poison Data System (NPDS), an electronic database of all calls to the 61 poison-control centers across the U.S. Their analysis included all calls for children age 5 years or younger who came into a hospital emergency department between 2001 and 2008 for either unintentional self-exposure to a single drug (prescription or OTC) or unintentional therapeutic error for a single drug (prescription or OTC).
The number of such calls during this eight-year period totaled 453,559. Of these, 430,401 (95 percent) involved self-ingestion of a drug by the child, and 23,158 (5 percent) involved a therapeutic error. Fifty-eight percent of the calls involved poisoning with a prescription medication, and the rest with an OTC drug. The largest proportion of the emergency department visits for pediatric pharmaceutical poisoning in this study were due to child self-ingestion of prescription drugs, accounting for 248,023 (55 percent) of the visits.
Table 1 provides a further breakdown of these calls by drug type (prescription versus OTC) and the age and sex of the patient. Of note, the peak age for unintentional self-ingestion was 2 but younger than 3 years old (2<3), whereas the peak age for therapeutic errors was younger than 1 year old.
|Unintentional Self-Ingestion||Therapeutic Error|
|0 < 1||14,324 (6%)||8,965 (5%)||5,301 (37%)||4,340 (49%)|
|1 < 2||75,133 (30%)||44,010 (24%)||2,146 (15%)||1,611 (18%)|
|2 < 3||100,676 (41%)||75,690 (42%)||1,753 (12%)||1,100 (12%)|
|3 < 4||36,642 (15%)||36,171 (20%)||1,684 (12%)||759 (9%)|
|4 < 5||14,276 (6%)||12,586 (7%)||1,622 (11%)||568 (6%)|
|5||6,972 (3%)||4,956 (3%)||1,832 (13%)||442 (5%)|
|96,906 (53%)||8,256 (58%)||4,818 (55%)|
|Female||116,400 (47%)||85,472 (47%)||6,082 (42%)||4,002 (45%)|
Hospitalization and injury rates for each medication class
Based upon the type of medication ingested and the reason for ingestion, Bond and his colleagues evaluated the impact of accidental drug poisoning in children. The study considered a child to have suffered an injury if the accidental poisoning resulted in any of the following:
- A moderate effect, as defined by the NPDS: As a result of the exposure, the patient exhibited signs or symptoms that were more pronounced, more prolonged or more systemic in nature than were minor symptoms. Usually, some form of treatment was indicated. Symptoms were not life-threatening, and the patient had no residual disability or disfigurement (e.g., a moderate effect would include an acid-base disturbance, high fever, disorientation, hypotension that is rapidly responsive to treatment and isolated, or brief seizures that respond readily to treatment).
- A major effect, as defined by the NPDS: As a result of the exposure, the patient exhibited signs or symptoms that were life-threatening or resulted in significant residual disability or disfigurement (e.g., a major effect would include repeated seizures or status epilepticus, respiratory compromise requiring intubation or ventricular tachycardia with hypotension and cardiac or respiratory arrest).
Among all patients in the study, 54,943 (12 percent) were hospitalized and 25,651 (6 percent) were injured. Child self-ingestion of prescription medications represented the largest impact, leading to 41,847 (76 percent) of the hospital admissions and 18,191 (71 percent) of the injuries. Child self-ingestion of OTC medications accounted for 9,657 (18 percent) of the hospitalizations and 5,075 (20 percent) of the injuries. Admission to an intensive care unit occurred in 43 percent of admissions following self-ingestion of a prescription drug and 34 percent of admissions for self-ingestion of an OTC medication.
|Exposure Type and Drug Class||Number||Percent of All Visits||Number||Rate†||Number||Rate†|
|All Unintentional Exposures||
|Analgesics: other drugs||7,751||2%||437||6%||85||1%|
|CNS: antiseizure drugs||11,254||2%||2,757||24%||1,332||12%|
|Oral hypoglycemics (diabetes) drugs||
|Other prescription drugs**||
|Analgesics: other drugs||
|Other OTC drugs***||
*CNS = central nervous system; ED = emergency department
** Other prescription drugs: antibiotic, hormone, respiratory, gastrointestinal drugs, etc.
*** Other OTC drugs: gastrointestinal drugs, minerals and salts, herbals, vitamins, topicals, etc.
†Rate = The percent of patients presenting to an ED for accidental self-ingestion of the listed drug who were hospitalized or injured.
The researchers provided a breakdown of the pediatric patients in their study by drug class (see Table 2). The most commonly self-ingested prescription medications in this study were cardiovascular agents (9 percent), sedative-hypnotics (8 percent), opioid analgesics (7 percent) and antidepressants (6 percent). The most commonly self-ingested OTC drugs were cough-and-cold medicines (10 percent) and acetaminophen (7 percent).
The researchers found that hospital admission occurred most frequently following self-ingestion of a prescription drug with oral hypoglycemic (diabetes) drugs (49 percent), antipsychotics (27 percent), antiseizure medications (24 percent), sedative-hypnotics (21 percent) and cardiovascular agents (20 percent). A similar pattern was seen for injuries, with the highest rates of injury following self-ingestion of a prescription drug occurring with diabetes drugs (20 percent), antipsychotics (15 percent), stimulants (14 percent), antiseizure medications (12 percent) and sedative-hypnotics (12 percent).
|Variable||Pecent Increase (2001-2008)|
|U.S. population of children aged ≤ 5 years||8%|
Emergency department visits for unintentional
poisoning with drugs
|Hospital admissions for unintentional poisoning with drugs||36%|
|Injuries caused by unintentional poisoning with drugs||43%|
Increasing frequency of emergency department visits, admissions and injuries
Bond and his colleagues showed that relative to the change in the U.S. population of children age 5 years or younger, the number of emergency department visits, hospital admissions and injuries for accidental pharmaceutical poisoning in this population have increased significantly between 2001 and 2008 (see Table 3).
Deaths attributed to accidental pharmaceutical poisoning
In their review of the NPDS database, Bond and his co-authors identified 66 patient deaths related to accidental pharmaceutical poisoning in children age 5 or younger. Table 4 provides a summary of these deaths, categorized by drug class, for the periods 2001-2004 and 2005-2008. Eight of these 66 deaths involved exposure to more than one medication, but only the medication considered most likely to have contributed to the death is listed in the table. The researchers found that deaths related to prescription drugs were most frequently associated with opioid analgesics and cardiovascular medications, whereas those deaths related to OTC drugs were most often associated with acetaminophen.
|Drug Class||Number of Deaths, 2001-2004||Number of deaths, 2005-2008|
|Opioid analgesics and cough drugs||10||10|
Implications of the study results
The authors of the Journal of Pediatrics study concluded that:
[T]he problem of pediatric medication poisoning is getting worse, not better. Past preventive efforts have proved to be inadequate. More children are exposed, more are seen in the [emergency department], more are admitted and more are injured each year.
The authors discuss several explanations for these troubling trends, including the following:
- The number of prescription and OTC medications in the environment of small children is increasing.
- There is an increased use of sustained-release medications and more toxic medications.
- Effective efforts at “poison proofing” may have plateaued or declined for all groups.
They offered the following solutions to the growing epidemic of pediatric pharmaceutical poisoning:
Educational efforts are important but are unlikely to make a significant improvement alone. Education interventions should readdress home storage of all medications, repackaging of medications — particularly grandparents’ medications in “pill minders” [—] and the fact that older siblings may not be as careful as parents when opening containers or taking medications. Storage devices and child-resistant closures may need to improve. Additionally, mechanical barriers to ingestion such as blister packs may be required for more substances. Preventive efforts should also address appropriate prescribing and society’s problem with opioid and sedative abuse.
What You Can Do
All pediatric poisonings from self-ingestion of prescription and OTC medications intended for other people represent preventable adverse events. If you have young children living in your home or visit the homes of relatives or friends who have young children, you should take appropriate precautions to ensure that these children cannot access and accidentally ingest your medications.
Ideally, medication bottles and containers should include child-resistant caps and should be kept in a locked container box or cabinet out of the reach of small children. If you transfer your pills into a pill-minder container to help you remember to take them, make sure the pill minder is safely secured and outside of the reach of children.
The FDA has made available on its website (at www.fda.gov/ForConsumers/ConsumerUpdates/ucm272905.htm) an educational video that reviews how to prevent harm to children by locking up your medicine.
If you see a child accidentally self-ingest a prescription or OTC medication, you should immediately contact your local poison-control center and the child’s health care provider. If the child appears to be having a serious reaction to the medication, immediately call 911.
If your child or grandchild has a serious adverse event because of unintentional poisoning with one of your prescription or OTC medications, you should report it to the FDA MedWatch Adverse Event Reporting program online or by regular mail, fax or phone.
- Online: www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm
- Regular mail: Use postage-paid, pre-addressed FDA form 3500 and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
- Fax: (800) FDA-0178
- Phone: (800) FDA-1088