Beyond Child-Resistant Packaging for Drugs: F Value Determination for Added Child Safety

American Medical Writers Association
December 2018
Author: Chinmayee Joshi – Sciformix, A Covance Company

Background
According to the World Health Organization (WHO), acute poisoning is the third leading cause of unintentional deaths in children up to the age of 14 years. WHO estimates that each year, these episodes of acute poisoning are fatal in approximately 3,000 children and that 90% of those poisonings take place in the home.1

According to the 2016 annual report of the American Association of Poison Control Centers’ National Poison Data
System, the top 5 substance classes most frequently involved in all human exposures are analgesics (11.2%), household cleaning substances (7.54%), cosmetics/personal care products (7.20%), sedatives/hypnotics/antipsychotics (5.84%), and antidepressants (4.74%). The top 5 most common exposures in children 5 years of age or younger are cosmetics/personal care products (13.3%), household cleaning substances
(11.1%), analgesics (9.21%), foreign bodies/toys/miscellaneous (6.48%), and topical preparations (5.07%). The overall rate of poison exposures is 660/100,000 population, with the highest rates in children of ages 1 year (8,083/100,000 population) and 2 years (7,675/100,000 population).2

Various regulatory requirements exist to prevent unintentional drug poisoning in children. The United States Food
and Drug Administration (US FDA)’s Consumer Product Safety Commission’s special packaging standards, also
known as child-resistant packaging (CRP) standards, are applicable for most oral prescription drugs, many nonprescription drugs, and various household products. Under the Poison Prevention Packaging Act (PPPA), one of the bestdocumented successes in preventing unintentional poisoning in children,1 any package (including blisters or pouches) containing a substance regulated under the PPPA must meet CRP standards. Otherwise, the product could be misbranded or recalled and the marketing authorization holder penalized.3

The US FDA also recommends including a labeling statement declaring the compliance of the product to the
CRP standards.3 Since the PPPA has been in effect, reported deaths of children from ingestion of toxic household products, including medications, have declined remarkably.4 The International Organization for Standardization also published an internationally agreed standard test procedure for reclosable CRP.5 In Europe, several regulatory requirements have been introduced that complement the International Organization for Standardization’s standard.6,7

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