Medical Device Link.

Originally Published PMPN December 2001

OUR VIEW

The Poison Prevention Packaging Act lets the dispensing physician decide whether special packaging is needed for prescription-drug samples.

In 1970, Congress enacted the Poison Prevention Packaging Act (PPPA) to address the rising numbers of childhood deaths and serious injuries from handling or ingesting drugs or hazardous household substances. Regulations issued under the PPPA and administered by the U.S. Consumer Product Safety Commission (CPSC) require that certain household substances be packaged in special (child-resistant and senior-friendly) packaging. The regulated substances include oral prescription drugs and other drugs containing specific substances as listed in 16 CFR Sec. 1700.14.

While protecting children, CPSC also wants seniors and the handicapped to be able to access medication. The PPPA contains provisions to ensure that individuals who are unable to use special packaging can obtain conventional (non-child-resistant) packaging. Section 4(b) of the PPPA allows a regulated prescription drug that is prescribed by a physician, dentist, or other licensed medical practitioner to be dispensed in conventional packaging only when directed in the prescriber’s order or when requested by the purchaser. Because the act allows physicians to determine which type of package is appropriate for each consumer, the Commission has, as a matter of policy, decided not to require manufacturers of regulated prescription-drug samples to provide these samples in special packaging, thus leaving the decision up to the physician on a case-by-case basis. Section 4(b), however, does not apply to regulated over-the-counter (OTC) drugs. Therefore, all physician samples of regulated OTC drugs must generally be placed in special packaging.

Regardless of the type of packaging the prescription-drug-sample manufacturer supplies to the practitioner, the PPPA establishes that the dispensing practitioner is responsible for placing drugs in special packaging, unless he or she decides that special packaging is inappropriate in a particular case. Over the years, CPSC has found that many physicians are unaware of their obligations in this respect. Thus, many manufacturers of prescription-drug samples opt to provide them in special packaging, even though they are not required to do so.

The CPSC has studied the effect of requiring special packaging for oral prescription drugs and aspirin on child death rates. Findings estimate a 45% fatality-rate reduction resulting from special packaging requirements for these substances, which translates into about 800 lives saved since the early 1970s. Despite the decrease in deaths, each year accidental poisonings from medicines and household chemicals kill about 30 children and prompt more than a million calls to the nation’s poison-control centers. A recent study shows that 36% of the childhood ingestions involved a grandparent’s medication.

The above determinations are based solely on the information currently available to the CPSC staff. They could change if the facts change and could be changed or superseded by the Commission.

Geri Smith is a Compliance Officer for the U.S. Consumer Product Safety Commission. She can be reached at gsmith@cpsc.gov or 301/504-0608, ext. 1160.

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