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Journal of Public Health

, 17:155

First Online: 20 January 2009Received: 06 December 2007Accepted: 06 October 2008DOI: 10.1007-s10389-008-0233-6

Cite this article as: Weiss, S. J Public Health 2009 17: 155. doi:10.1007-s10389-008-0233-6


BackgroundIn view of the serious health risks and high costs to the health-care system of misuse and abuse of over-the-counter OTC analgesics, this article describes a rationale and prototype for new safety or compliance packaging for OTC drug products that are sold in pill form e.g., tablets, caplets and gelcaps inside blister packs. The proposed packaging is not simply promoting the use of blister packs for pills; that utility is already well known. It is an integrated system in which blister packs of pills can, themselves, be packaged, labeled and sold, offering a dose-directed unit-of-use design with enhanced warnings and directions to help prevent consumers from taking more than the instructed dose of pill-form medicines.

MethodLiterature and information searches were conducted in publicly available databases and websites to 1 assess safety problems serious adverse events and fatalities associated with OTC analgesics and 2 determine public perceptions and knowledge about their use.

ResultsEach year in the US, there are an estimated 100,000 hospitalizations and 16,500 deaths due to NSAID overdosing, and 26,000 hospitalizations and 1,600 acute liver failure cases due to acetaminophen poisoning. Many adults take more than the recommended dose and in some cases use multiple products containing acetaminophen and ibuprofen. Risk factors, such as alcohol use or pre-existing liver disease, exacerbate problems associated with acetaminophen misuse and abuse. In pediatric cases, dosing errors are often related to confusion over different product formulations, dosing strengths, and the use of inappropriate dosing devices. Consumers are often unaware of the active ingredients in, and correct doses of, drugs they are taking; they underestimate the risks associated with misuse of OTC medicines, and they frequently discard the packaging on which the drug’s directions, warnings and dosing instructions are located.

ConclusionOptimal compliance packaging should 1 keep the instructions, warnings and dosing directions attached to the blister card of pills at all times, thus avoiding the problem of cartons and package inserts being thrown away once the package is opened; 2 increase the surface area of the packaging, without adding bulk, to provide space for the use of larger font sizes and enhanced directions and warnings that are more conspicuous, explicit and memorable; 3 organize the pills into logical, unit-of-use per-dose maximum and per-day maximum sets or rows; 4 limit the number of pills in a unit-of-use package to coincide with the instructed maximum dose and maximum days of use for a specific product.

KeywordsDose compliance OTC drugs Packaging Labeling Warnings Directions The term -compliance packaging- is used for this prototype because it is packaging designed to increase consumer compliance and to distinguish it from the more commonly known child-proof safety packaging or tamper-evident packaging.

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Autor: Susanna Weiss


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