Prevention of Pediatric Pharmaceutical Poisonings

Abstract

Pediatric poisoning remains a common, preventable childhood injury and incidence is on the rise. Child-resistant packaging has been shown to prevent pharmaceutical poisoning, but must be applied and used appropriately to be effective. Prescription drug use among adults is also increasing and may be contributing to the problem through a greater number of medications in the child’s environment. Drug take back programs are designed to reduce the number of unused medications in the home. These programs are expanding and health care providers should be aware of and encourage safe drug disposal practices.

‘Child-resistant packaging and drug take back education are 2 strategies for health care providers to employ to prevent pediatric pharmaceutical poisonings’

Pediatric poisoning remains a common, preventable childhood injury. According to the 2015 Annual Report of the American Association of Poison Control Centers, children age 5 and under account for approximately half (46.9%) of all reported poison exposures and resulted in 1 017 369 calls to poison centers in the United States. ¹ Pediatric pharmaceutical poisonings are on the rise. ² Between the years of 2001 and 2008, a total of 453 559 children presented to an emergency department for ingestion of a pharmaceutical agent. ² Ninety-five percent of these visits were the result of child self-exposure and over half of these visits were the result of ingestion of a prescription product (as opposed to a pharmaceutical agent that is available over the counter).

Child-resistant packaging and drug take back education are 2 strategies for health care providers to employ to prevent pediatric pharmaceutical poisonings. Both strategies will be discussed in detail below.

Child-Resistant Packaging

To counter the rising rate of pediatric poisonings, in 1970 Congress enacted the Poison Prevention Packaging Act (PPPA). ³ The law requires special packaging on various hazardous household products, including most oral prescription medications. The packaging must be child-resistant. To be “child-resistant,” the packaging must be “designed or constructed to be significantly difficult for children under 5 years of age to open or obtain a toxic or harmful amount of the substance contained therein within a reasonable time.” ³ To test this, children aged 42 to 51 months are given 5 minutes to try to open the package. If the child is unsuccessful within that time period, the child is given a single visual demonstration and given a second attempt to open the package. The package is considered to be child-resistant if not more than 20% of the children tested could open the package.

This special packaging has been shown to save lives. ⁴ An nearly 2-decade evaluation of National Center for Health Statistics underlying cause of death files revealed that child deaths from unintentional ingestion of oral prescription drugs were reduced following enaction of the PPPA. Specifically, the child mortality rate decreased by an estimated 1.40 deaths per million children younger than 5 years, which equates to about 24 fewer deaths annually, a reduction of about 45% from levels projected without the special packaging requirements. ⁴ The author of the aforementioned study identified 2 factors that may have led to a lower than expected reduction in mortality. First, noncompliance with the special packaging regulations at the pharmacy, and second, poisonings from prescriptions originally dispensed in child-resistant packaging that were left unsecured at the time of ingestion. Evaluation of records revealed that more than 50% of all oral prescription drug-related poisonings in pediatric patients may have occurred due to disabled child-resistant packaging. ⁴ This finding led the US Consumer Product Safety Commission (CPSC) to require changes to the special packaging regulations. ⁵

Effective in 1998, child-resistant packaging must also be “adult friendly.” The CPSC hoped to decrease the incidence of consumer-driven disabling of child-resistant packaging (leaving the cap off or unsecured, transferring the contents to a nonspecial package) by ensuring the design is easier to use by adults, including the geriatric population. In order to meet new regulations, child-resistant packaging must also be able to be opened and closed by 90% of adults aged 50 to 70 within 5 minutes.

In addition to improvements in child-resistance packaging, compliance with the PPPA at the pharmacy can be increased. A study by Slagle et al found that only 89% of prescription medications were compliant with PPPA regulations on the first fill and just 86% of refills met regulations. ⁶ Noncompliance was defined as either failure to use child-resistant caps or reusing the prescription bottle or cap on subsequent refill. Reusing bottles is prohibited due to the wear associated with the plastic vials, which could compromise the package’s effectiveness. Pharmacies should establish processes to ensure child-resistant caps are used on all prescriptions unless conventional packaging is requested by the patient. Patient-requested noncompliant packaging is allowable under the PPPA. It is important to note that all prescribers who dispense drugs (including drug samples) are subject to the provisions of the PPPA.

Although strides have been made to design packaging resistant to children, but easily operable by adults, health care providers should educate patients on the risks of pediatric pharmaceutical poisoning and encourage proper use of child-resistant packaging. If conventional packaging is requested at the pharmacy, it is prudent to check with the patient to ensure that noncomplying packaging continues to be the preferred packaging choice for all refills and subsequent fills. Education on the safe storage of medications should also be provided as child-resistant packaging, even when used appropriately, is not full-proof.

Drug Take Back Programs

At the center of unintentional prescription drug ingestion in children is the presence of medication in their environment. And the prevalence of medication in the home is increasing. Data from the National Health and Nutrition Examination Survey indicate an increase in prescription drug use among US adults between 1999 and 2012. ⁷ An estimated 51% of US adults reported prescription drug use in 1999 compared with 59% in 2012. In addition, the prevalence of polypharmacy, or use of 5 or more prescription drugs, increased from 8.2% in 1999 to 15% in 2012. Drug take back programs are administered to decrease the number of unwanted medications in the home and may assist in decreasing the rate of pediatric pharmaceutical poisonings.

Since 2010, the DEA (Drug Enforcement Administration) has sanctioned National Prescription Drug Take Back Days. The events occur twice annually (usually in April and October) and allow patients to return medications, including controlled substances to law enforcement agencies and DEA-sanctioned community partners. Since 2010, these events have collected over 8 million pounds of unused prescription drugs. ⁸

In an effort to make disposal of drugs easier for patients and their caregivers, the DEA recently approved the Disposal of Controlled Substances rule, allowing pharmacies to collect and destroy unused, unwanted, or expired prescription medications. Under this regulation, pharmacies can establish and maintain drug collection receptacles and destroy on-site or mail-in medication for destruction by a third party. Unlike the National Prescription Take Back Days, drug collection at the pharmacy sites is offered on a continuous basis. This allows patients and caregivers to dispose of medications as soon as they become unnecessary, unwanted, or expire. Safety, liability, and cost of operating such programs are major barriers to widespread implementation, but more and more pharmacies are beginning to offer take-back services. Pharmacies included in the Disposal of Controlled Substances rule include retail, hospital, and clinic pharmacies, and receptacles can also be housed in the long-term care facilities the pharmacies service.

Although data evaluating the impact of drug take back programs on incidence and death from unintentional ingestion of pharmaceutical agents is not yet available, there is promise in the participation of pharmacies and in the sheer number of drugs collected through these offerings. Health care providers can encourage use of such programs and counsel on the importance of properly disposing of medications when they are no longer needed, wanted, or when they expire. Information on Drug Take Back Day events as well as locations for medication drop-off can be found on the DEA’s website: www.dea.gov.

Conclusions

Pediatric pharmaceutical poisonings are on the rise. Health care providers can combat the issue by educating patients on the inefficiencies of child-resistant packaging, especially when used improperly or disabled. Pharmacies and dispensing prescribers should be diligent in the packaging of their drug products and promote the use of child-resistant packaging whenever possible. Education should be provided to all patients regarding safe storage of medications. Reducing the number of medications in the home may also help. Many local pharmacies now provide continuous collection of unused medications through on-site receptacles and twice annually the DEA sanctions drug take back events. Health care providers should encourage patients to dispose of medications as soon as they are no longer needed or on expiration.