Heuristics for designing user‐centric drug products: Lessons learned from Human Factors and Ergonomics

Abstract

Even the most effective drug product may be used improperly and thus ultimately prove ineffective if it does not meet the perceptual, motor and cognitive capacities of its target users. Currently, no comprehensive guideline for systematically designing user‐centric drug products that would help prevent such limitations exists. We have compiled a list of approximate but nonetheless useful strategies—heuristics—for implementing a user‐centric design of drug products and drug product portfolios. First, we present a general heuristic for user‐centric design based on the framework of Human Factors and Ergonomics (HF/E). Then we demonstrate how to implement this general heuristic for older drug users (i.e., patients and caregivers aged 65 years and older) and with respect to three specific challenges (use‐cases) of medication management: (A) knowing what drug product to take/administer, (B) knowing how and when to take/administer it, and (C) actually taking/administering it. The presented heuristics can be applied prospectively to include existing knowledge about user‐centric design at every step during drug discovery, pharmaceutical drug development, and pre‐clinical and clinical trials. After a product has been released to the market, the heuristics may guide a retrospective analysis of medication errors and barriers to product usage as a basis for iteratively optimizing both the drug product and its portfolio over their life cycle.

Commentary on the EMA reflection paper on the pharmaceutical development of medicines for use in the older population

“…Future lessons may be learned from post marketing data, dedicated scientific studies and experiences from other disciplines. [47][48][49] A well-known coping strategy in older people with polypharmacy and/or impaired cognition or motor function is the use of multiple compliance aids (MCAs) and multiple drug dispensing systems (MDDs)…”

“…All such problems may be mitigated by adopting the principles of intuitive design or risk mitigation measures such as an arrow indicating that a blister is for peel‐off use and not push‐through. Future lessons may be learned from post marketing data, dedicated scientific studies and experiences from other disciplines 47–49 …”

Demographics in the 2020s—Longevity as a challenge for pharmaceutical drug development, prescribing, dispensing, patient care and quality of life

“…For medical devices, human factor design principles have already been implemented in the past 33,34 . Feufel et al provide insights into the human factor approach in the healthcare environment 35 . This approach includes several cycles of user tests to remove potential sources of errors and to optimize the ergonomics for a safe and appropriate use of devices so that adaptations can be made to support the usability of drug products.…”

Developing patient‐centric medicines for older people: Reflections from the draft EMA paper on the pharmaceutical development of medicines for use in the older population

“…Information from other stakeholder parties on the emerging issues of medication safety and efficacy in an increasing older population are important also, eg, appropriate and useful strategies to address a problem, ie. heuristics, information technology 38,39 …”