Pharmaceutical packaging, especially for over-the-counter (OTC) products, must meet stringent and sometimes conflicting aims.
On the one hand, manufacturers and regulators want robust, secure containers that protect the integrity of products and — crucially — provide clear visual evidence of tampering. On the other, consumers — especially those with limited strength or dexterity — want packaging that is easy to use.
A regulatory requirement for tamper-evident packaging was enacted by the US FDA in the aftermath of a 1983 incident in which seven people in the Chicago (IL, USA) area died following the ingestion of Tylenol analgesic capsules that had been maliciously contaminated with cyanide.
Those regulations require one or more barriers that provide a visual indication of packaging integrity, together with appropriate labelling to allow the end consumer to confirm prior to use that the packaging has not been compromised. To reduce the chance of tamper-indicators being fraudulently reinstated after breach, they should carry an identifying characteristic such as a distinctive pattern, logo or product name.
Following the lead of FDA, other major regulators around the world have since incorporated requirements for tamper-evident packaging into their own regulatory regimes and good manufacturing practice guidelines. Beyond regulatory requirements and the need to prevent malicious tampering, manufacturers and retailers also value tamper-evident packaging as an aid to the prevention of theft and counterfeiting in the supply chain.
Manufacturers have the choice of several different strategies to include tamper-evident features on primary and secondary packaging. They include shrink wrap films, bands or wrappers, boxes with tamper-evident security seals and breakable caps.
A key challenge for many of these technologies, however, is that they can make access to products by their legitimate consumers more difficult. The removal of breakable closures and certain seal types, for example, can require considerable physical strength or dexterity that may be challenging for certain user groups, especially the elderly or those with limited mobility.
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