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| home > pmps > spring 2002 > ensuring children's safety with child-resistant clinical trial packaging |
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Pharmaceutical Manufacturing and Packing Sourcer
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As a growing number of clinical trials - some using potent agents - are conducted on outpatients or in the community, the risk of children accidentally consuming potentially toxic drugs increases. As a result, clinical trials' traditional exception in the US from the requirement to dispense drugs in child-resistant packaging no longer applies. Moreover, the desire to protect all children from hazardous material around the home means that the requirement for child-resistant clinical trial packaging is set to spread worldwide. Fortunately, a number of companies have developed innovative new child-resistant packaging for clinical trials.
At one time, most clinical trials were performed on hospitalised patients, especially if the study drugs were potentially toxic. However, there is an increasing trend towards conducting studies either on outpatients or those in primary care. Using a community-based population brings a new set of problems - not least of these is ensuring that the patient can get to the medication, while their children and grandchildren cannot. Indeed, over the last 30 years or so, governments worldwide have introduced legislation to protect children from consuming hazardous household materials.
The commonplace 'child-proof' medicine and household chemical bottles - that all too often prove elderly-proof as well, especially for patients suffering from arthritis - is one response to the legal and moral responsibility to protect children from inadvertently consuming potentially toxic products. In the US, the primary legislation, the Poison Prevention Packaging Act, was passed in 1970 and amended in 1974. The act aims to protect children from hazardous materials at home and it seems to have been a success.
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