NEWS from CPSC

U.S. Consumer Product Safety Commission

CPSC Reminds Public Of Exemption To Child-Resistant Packaging Regulations

WASHINGTON, D.C. (Aug. 25) -- The U.S. Consumer Product Safety Commission said today doctors, patients and pharmacists may not be aware that child-resistant packaging is not required for nitroglycerin tablets, a drug used by heart patients.

Georg Maisel, Director of the Commission's Poison Prevention Packaging Division, said manufacturers of the drug are complying with Food and Drug Administration requirements by packaging these heart patient preparations in glass containers with screw type closures and a heat overseal. Maisel said he feared some pharmacists inadvertently may be placing these bottles into child-resistant containers before dispensing them to consumers.

Commission Chairman S. John Byington said "as Chairman, and as a pharmacist, I am concerned about a lack of understanding and appreciation of the need for these regulations by some medical and pharmacy professionals as well as some of the public.

"One of the major information and education efforts of this agency will be to inform the public and the appropriate professionals about the requirements and exemptions of safety cap regulations and how well they are working," Byington said.

A story in a popular magazine brought to light the problem of the dispensing of heart preparations in child-resistant containers. According to the story, the author's father, a cardiac patient, died with an unopened child-resistant package containing nitroglycerin in his possession. The story was published in 1975, in the New York Magazine and reprinted in Readers' Digest, May 1976.

In April 1973, regulations were issued to require child-resistant packaging for prescription drugs, in oral dosage form, but nitroglycerin was specifically excluded from coverage. Since then, another compound used by heart patients, isosorbide dinitrate, also has been exempted.

In addition to the exemptions, prescription drugs are available in containers that are not child-resistant when requested by the patient or when such instructions are directed in the prescription. In this manner patients who are elderly or in some way handicapped may obtain the easier to open packages.

Child-resistant packaging requirements issued under the Poison Prevention Packaging Act of 1970 have been credited with a reduction in fatal ingestions of aspirin and other toxic substances by children. For example, the number of reported deaths of children under five from aspirin poisoning dropped 48% in the two years after the aspirin regulation went into effect, according to statistics from the Public Health Service's National Center for Health Statistics.

Aspirin was the first item for which child-resistant packaging was required (Aug. 14, 1972) . The number of aspirin ingestions by children under five toppled from 8,146 in the year before the regulations to 4,837 in 1974, the year for which the most recent data is available from Poison Prevention Control Centers.