A meeting organised by the Academy of Pharmaceutical Sciences focussed on the challenges of developing medicines for older adults. International experts discussed the complexity introduced by polypharmacy and multiple morbidities and how the risk–benefit ratio of a medicine changes as an individual ages. The way in which regulatory authorities are encouraging the development of age-appropriate medicines was highlighted. Examples were provided of the difficulties faced by the older population with some medicinal products and suggestions given as to how the pharmaceutical scientist can build the requirements of the older population into their development of new medicines, as well as improvements to existing ones.
Rutger de Vries & Diana van Riet-Nales are members of the European Medicines Agency (EMA) Paediatric Committee (PDCO) Formulation Working Group (FWG). Diana van Riet-Nales is also member of the EMA Quality Working Party and the Dutch Medicines Evaluation Board (MEB) Committee on Clinical Practice.Diana van Riet-Nales was rapporteur for the EMA Guideline on pharmaceutical development of medicines for paediatric use, the reflection paper on the pharmaceutical development of medicines for use in the older population and the EMA Q&A on small volumes. She was a drafting group member of the Q&A on enteral feeding and the EMA guideline on drug device combination products. Rutger de Vries supported the work on the paediatric guideline. He was a member of the drafting group on the EMA Q&A for small volumes and enteral feeding.
Aims
Tablets may be subdivided for dose adaptations or to ease swallowing. The handling is common in older patients but can be difficult and inaccurate. Currently, it is not known which hand–eye functions determine the ability of older people to break tablets by hand and to do so with acceptable ease and accuracy. The aim of this study was to develop a test battery to assess the hand–eye functions relevant in predicting easy and accurate tablet subdivision in older people.
Methods
A mixed methods study was conducted including literature reviews and a pilot experiment. The reviews were conducted in Pubmed, Google Scholar, Dutch journals and professional standards. The first review tried to identify the hand–eye functions relevant to tablet subdivision and the second the associated measuring instruments, testing protocols and normative data. A test battery was empanelled. A pilot experiment was conducted in 30 adult volunteers to optimize and evaluate the test battery.
Results
Five domains were considered relevant: hand size, hand strength, flexibility/manual dexterity, vision and coordination. Hand size could best be measured by finger circumference, hand strength by pinch‐ and grip strength, flexibility by active range of joint motion, manual dexterity (and flexibility, coordination, cognition, vision) by pegboard function, vision by near visual acuity. Older people preferred the use of tablet splitters over hand breaking.
Conclusion
Easy and accurate tablet subdivision is essential to the good use of medicines. We developed a test battery for older people, but probably of value to all age groups.
Highlights Polypharmacy has a multifactorial aetiology and, therefore, requires a multidimensional approach. Drug RTCs must overcome barriers to include older people so they can be representative and informative. Drug design must take into consideration older people's needs and preferences from its inception. Regulation will enforce patient-centric drug design. In an age of conflicting guidelines, the individual patient must remain at the centre of care. Clinical decision support systems can effectively help clinicians to tailor medication to patients' needs. Seamless communication and involving patients and their carers in the review process is central to achieve appropriate medication in older people.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.