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Medicines Acceptability Matters: A Chance at Independence

Posted by Neel Desai 1 month ago

Living longer has become commonplace globally. A longer life provides opportunities for people to take part and contribute in many ways towards their families and communities: taking up a new career, a long-ignored passion or education. However, the freedom to explore these things in old age and maintain a level of independence depends on one thing: health.

Despite being of the same age, older people, aged over 65 [1], can appear remarkably different to one another because of differences in both physical and mental health [2]. An increased life expectancy doesn’t automatically mean good health and quality of life. Ill health may require increased medical or social care. Older people are the most common users of medication [3]. Many are prescribed multiple medicines to manage their conditions, which in a smaller number of cases, can have a greater potential for harm than benefit [4,5], since many medicines aren’t designed for this population.

Before a medicine is licensed, pharmaceutical companies must demonstrate the safety and efficacy of medicines to local healthcare regulatory authorities [in the UK, Medicines and Healthcare products Regulatory Agency (MHRA), in Europe, the European Medicines Agency (EMA) and in the US, the Food and Drug Administration (FDA)]. Collecting this evidence requires multiple stages of design, development, and many mechanical, animal, and human tests, all of which have significant time and monetary costs. Medicines with regulatory approval, whilst safe and effective for the conditions they are licensed for, do not always address the challenges faced by patients in the real-world, as many medicines are not designed explicitly for use in older people. This can result in patients taking medicines the wrong way – such as chewing or crushing them – which can have an impact on how well the medicine works which can affect overall treatment outcomes.

So, what about acceptability?By definition, medicines acceptability is ‘the ability and willingness of a patient to self-administer, and also of any of their lay or professional caregivers, to administer a medicinal product as intended’ [2]. The acceptability of medicinal products plays a fundamental role in overall adherence to prescribed treatment, since, by encouraging self-administration and management of medicines, all patients could have greater independence [6]. Understanding medicines acceptability requires considering:

  • Patient factors (for instance age, health status, disease state and ability to swallow),
  • Drug therapy-associated factors (including length of treatment and taking other medicines), and
  • Socio-cultural factors (such as how the medicine is taken, the availability of carers and where the person stays) [7].

In 2020, the EMA published a reflection paper [2], recognising the importance of medicines acceptability data and its requirement when submitting documents for market approval of medicines for older people. Importantly, the EMA position on acceptability data isn’t limited to just medicines for older people, but follows separate guidance published on medicines for children almost a decade beforehand [8]. The guidance provides hope that the newest generation of medicines will be assessed for acceptability and appropriateness in the final patient cohort, leading to reduced use of unlicensed medicines in older people.

How can I help? – A question synonymous with my duty as a healthcare professional and life as a researcher.

Pharmaceutical companies involved in the design and development of age-appropriate medicines now need new or alternative ways to assess medicines acceptability. Research projects at UCL School of Pharmacy are modifying existing equipment and developing new age-appropriate tests to help reduce time and monetary costs of collecting and analysing medicines acceptability data.

For older adults, these collaborations could provide some degree of autonomy, promoting older people living at their own homes to self-administer and self-manage medicines without informal (i.e., family and friends) or formal (i.e., registered carers) assistance. As the next generation of medicines are assessed for acceptability and appropriateness, we will see a reduction in unlicensed medicines use, further enabling independence in the medicines taking process in older people.

The newest guidance from regulatory authorities demonstrates the value of medicines acceptability data in the design, development, and administration of medicinal products in older people. The latest research developments and partnerships will help to reduce real-world challenges faced by older people. Promoting independence through medicines self-management is just a matter of time.

1             NHS. (2020) Improving Care for Older People.

2             European Medicines, A. (2020) Reflection paper on the pharmaceutical development of medicines for use in the older population. EMA 44 (October), 6-23

3             World Healthcare, O. (2019) Toolkit for Research and Development of Paediatric Antiretroviral Drugs and Formulations. WHO, 84-109

4             Hajjar, E.R. et al. (2007) Polypharmacy in elderly patients. Am J Geriatr Pharmacother 5 (4), 345-351

5             World Healthcare, O. (2017) Medication Without Harm - Global Patient Safety Challenge on Medication Safety. World Health Organization, 16-16

6             Squires, L.A. et al. (2013) A Systematic Literature Review on the Assessment of Palatability and Swallowability in the Development of Oral Dosage Forms for Pediatric Patients.

7             Liu, F. et al. (2014) Patient-centred pharmaceutical design to improve acceptability of medicines: similarities and differences in paediatric and geriatric populations. Drugs 74 (16), 1871-1889

8             European Medicines, A. (2013) Guideline on Pharmaceutical Development of Medicines for Paediatric Use Guideline on Pharmaceutical Development of Medicines for Paediatric Use. EMA

This post was edited on May 20, 2021 by Alice Hardy

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