Compliance packaging for over-the-counter drug products

Abstract

Background In view of the serious health risks and high costs to the health-care system of misuse and abuse of overthe-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 dosedirected unit-of-use design with enhanced warnings and directions to help prevent consumers from taking more than the instructed dose of pill-form medicines. Method Literature 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. Results Each 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. Conclusion Optimal 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 perday 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.

Package Design Affects Accuracy Recognition for Medications

“…This user group also elicited the largest number of errors ( Fraeyman et al, 2015 ; Mira, Lorenzo, et al, 2015 ; Weiss, 2009 ). The elderly population is particularly at risk for consequences of medication errors ( Estock et al, 2015 ; Fraeyman et al, 2015 ; Weiss, 2009 ), because it both uses more medications and is more vulnerable to adverse drug events. According to Holden, Schubert, and Mickelson (2015) , in the United States, 80% of older adults have at least one chronic disease and 50% have two or more, accounting for 75% of health care expenditures.…”

“…In a recent review, Mira, Lorenzo, Guilabert, Navarro, and Pérez-Jover (2015) found that medication error rates were between 19% and 59% in studies from different countries. Even if many of the errors do not lead to life-threatening situations, such errors are the principle cause of adverse events, especially among the elderly ( Weiss, 2009 ). This user group also elicited the largest number of errors ( Fraeyman et al, 2015 ; Mira, Lorenzo, et al, 2015 ; Weiss, 2009 ).…”

“…Even if many of the errors do not lead to life-threatening situations, such errors are the principle cause of adverse events, especially among the elderly ( Weiss, 2009 ). This user group also elicited the largest number of errors ( Fraeyman et al, 2015 ; Mira, Lorenzo, et al, 2015 ; Weiss, 2009 ). The elderly population is particularly at risk for consequences of medication errors ( Estock et al, 2015 ; Fraeyman et al, 2015 ; Weiss, 2009 ), because it both uses more medications and is more vulnerable to adverse drug events.…”

Amorphisation of Free Acid Ibuprofen and Other Profens in Mixtures with Nanocellulose: Dry Powder Formulation Strategy for Enhanced Solubility

“…In the USA alone, there are annually ca. 100,000 hospitalizations and 16,500 deaths due to NSAID overdosing [ 2 ]. The US Food and Drug Administration (FDA) and the European Medical Products Agency (EMA) recommend that NSAIDs should be prescribed with the lowest effective dose and for the shortest duration in order to avoid drug abuse [ 3 ].…”

Creating Consumer Loyalty in the Field of Using Over-the-Counter Products

“…Still, considering typically lower concentration of certain bad substances and the possibility to use them of one's own choice, the risk is lowered with the proper implementation of marketing strategies, the transfer of an adequate and true message, as well as the packaging which adequately points out all the benefits, as well as the dangers of their use. In relation to that, certain suggestions are pointed out in order to increase the consumers' perceived safety when purchasing OTC products (Weiss, 2009): increasing the font that will point out the facts about an OTC product, explicitly pointing out why it is important to follow proper instructions and what will happen if that is not done. Starting from the perceived risk, for the needs of the research the following hypothesis is formulated:…”