Child resistant packaging: USA vs Europe

Child-resistant packaging in the USA is a result of the Poison Prevention Act (PPA) passed by the US Congress in 1970. Congress gave the Consumer Products Safety Commission (CPSC) the responsibility and authority to administer and enforce the statutes. The purpose of the law is to decrease the opportunity for children to gain access to substances, resulting in accidental poisoning.

The PPA, a mandatory statute, includes all potentially harmful products to children that may be ingested, including drugs and nutritional supplements with an iron content of 30mg or more. The European standard only mandates those packages that contain drugs containing paracetamol, aspirin and medicines containing 24mg of iron. In addition, the PPA extends to all states or localities in the USA and is the one standard applied for all applicable products. In Europe there are efforts to develop a unified standard that can be adopted by all the countries in Europe.

In the USA, protocol testing methods were developed primarily to address cap-and-vial closures as this was the preferred packaging format in the 1970s with unit dose formats being virtually non-existent. Today, there is a significant bias towards unit dose formats such a blister and strip packaging. During the protocol development era, it has been estimated that blister use and unit of use packaging formats represented less than 20 per cent of US drug packaging. This compares to over 80 per cent blister usage in Europe during the same time frame. Only in later years have blisters become more common in the US with Rx and OTC products. As a result, there is intense lobbying to get the CPSC to update the protocol to consider the existence of blisters as the highest compliance package that is currently being used.

Several different types of unit dose formats are capable of passing the CPSC protocol yet pharmaceutical companies, laboratories and contract packagers always consider unit-of-use packaging as their primary choice, because this format offers significant benefits to drug manufacturers and consumers alike. Unit-of-use formats can be relied upon to:

provide tamper evidence
increase shelf life
facilitate distribution
increase brand awareness
facilitate compliance with pharmaceutical regimens
prevent counterfeiting and diversion
protect each dosage unit from the time it is manufactured until the time it is ingested.

These are attributes that have been appreciated in Europe for decades. For consumers, unit dose formats:

reduce the likelihood of medication errors
enhance portability
ensure product protection
offer superior child-resistance

Generally speaking, CPSC regulations require that the following drug products be dispensed by the manufacturer in primary packaging deemed child-resistant:

Anything that requires a doctor's prescription (unless it has been specifically exempted from CR requirements)
Certain OTC products including those that contain specific amounts of aspirin, acetaminophen, ibuprofen, iron, fluoride and several other listed substances
Any solid oral dosage product approved for OTC sale by FDA after 29 January 2002 which contains an active ingredient that had previously been available by prescription only
Investigational substances being used in clinical trials dispensed on an out-patient basis, and containing a substance that could be expected to cause serious injury or illness to a small child.

US and European testing methodologies are not very different but there are substantial differences in the additional requirements and criteria that US drugs must meet to be labelled Child-resistant, including determination that if ingested by a child, the drug toxicity level would cause harm or injury. This is not a consideration in determining the type of package used in Europe.

A final point is that CPSC does not require manufacturers to test their packages. Instead, the Commission monitors data such as emergency-room admissions and calls to poison control centres in an effort to identify packaging that could be dangerous. When CPSC identifies such packaging, which is extremely rare, the Commission has the ability to penalise the manufacturer and recall any product contained in those packages.

Author

Dr William A Nelson is director of marketing and business development for Alcoa Flexible Packaging

Further information

Alcoa Inc
Website: www.alcoa.com

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