Originally Published PMPN July 2002
Regulatory Focus
CR Protocol for Nonreclosables
European standard beefs up child-resistance testing of nonreclosable packages.
by Erik Swain,
Senior Editor
The United States and Europe used to differ greatly on the issue of testing
for child-resistance features on nonreclosable pharmaceutical packaging. Traditionally,
the European position was that nonreclosable packages, such as strips and blisters,
are inherently child-resistant (CR) as long as they are opaque. This position
is based on the theory that the child won't mistake the product for candy
if he or she can't see it and is unlikely to access enough of the product
to ingest a toxic dose. The U.S. position has been that products in nonreclosable
packages pose as much poisoning risk as products in reclosable ones and requires
drug manufacturers to test all their package designs for child resistance and
senior friendliness.
But now, Europe, and the United Kingdom in particular, is getting closer to
requiring CR protocol tests for nonreclosable packages, according to Mike Murray,
technical and environmental affairs executive for the Association of the British
Pharmaceutical Industry (London). Murray made this statement to attendees at
the Healthcare Compliance Packaging Council's (HCPC; Falls Church, VA)
10th Annual National Symposium on Patient Compliance, held May 14–15, 2002,
in Philadelphia.
The impetus for the change, Murray said, came from a widely publicized incident
in 2000, in which a child in the United Kingdom died after ingesting a massive
amount of an iron product that had been in a nonreclosable package.
Before that, the U.K. Medicines Commission (the British equivalent of FDA)
had declared strip and blister packaging to be inherently CR. Furthermore, a
U.K. law requiring all aspirin and paracetamol products sold over the counter
(OTC) to be CR deemed opaque blisters and strips to be inherently CR. And an
ethical standard from the Royal Pharmaceutical Society requiring pharmacists
to use CR packaging regarded nonreclosable packages as inherently CR.
Rather than adopting the U.S. protocol, the British Standards Institute (BSI)
in 1989 passed a code of practice, BS 7236: 1989, recommending the use of tensile
stength and twist testing, opacity, and even steps to minimize the rattling
of the product inside as ways to ensure child resistance.
After the incident in 2000, Murray said, the U.K. government sought urgent
development of a standard for CR testing of nonreclosable pharmaceutical packaging.
The European Committee for Standardization (CEN) had been working on such a
standard (currently under draft as EN 14375), so BSI took the draft of the CEN
document, modified it, and published it in December 2001 as BS 8404: 2001.
The standard calls for testing using up to 200 children aged 42 to 51 months.
Like the U.S. protocol, there are two five-minute periods during which the child
tries to open the package, with a demonstration in between. Similarly, access
to eight units or more is considered a failure, unless the amount expected to
cause serious injury is less than eight, in which case the failure threshold
is the number that produces a toxic dose. One area where it diverges, however,
is that at no time does the demonstrator tell the children that they can use
their teeth.
The package passes if at least 85% of the children cannot access more than
eight units within five minutes and if at least 80% cannot access more than
eight within 10 minutes.
The standard also outlines a senior-friendly (SF) protocol that calls for the
use of 100 adults, 70% female, in four age categories ranging from 50 to 70.
They are given five minutes to read instructions and to open the package. If
they succeed, they are given another package to open and must do so within one
minute. For a package to pass, 90% of the seniors must open that second package
within one minute.
The U.K. standard will not go into effect until the U.K. Medicines Control
Agency issues a proposal for application, which at press time had not yet happened.
Murray said that his association, which is the British equivalent of the U.S.
Pharmaceutical Research and Manufacturers Association, anticipates the standard
will apply to all products containing aspirin, paracetamol, and iron compounds.
As for CEN, Murray said, a new draft of EN 14375 was published in March 2002, with comments due by September 2002. Depending on how things go at the CEN meeting in November 2002, a vote could occur in early 2003, with publication in 2004.
Copyright ©2002 Pharmaceutical & Medical Packaging News
