Design of pharmaceutical products to meet future patient needs requires modification of current development paradigms and business models

Abstract

Drugs represent the most common intervention strategy for managing acute and chronic medical conditions. In light of demographic change and the increasing age of patients, the classic model of drug research and development by the pharmaceutical industry and drug prescription by physicians is reaching its limits. Different stakeholders, e.g. industry, regulatory authorities, health insurance systems, physicians etc., have at least partially differing interests regarding the process of healthcare provision. The primary responsibility for the correct handling of medication and adherence to treatment schedules lies with the recipient of a drug-based therapy, i.e. the patient. It is thus necessary to interactively involve elderly patients, as well as the other stakeholders, in the development of medication and medication application devices, and in clinical trials. This approach will provide the basis for developing a strategy that better meets patients' needs, thus resulting in improved adherence to treatment schedules and better therapeutic outcomes.

Towards better understanding of patient centric drug product development in an increasingly older patient population

“…In particular, there is a growing number of drug products that are marketed with claims of being more age appropriate for older adults even though neither scientific methodology nor scientific data could be identified that would support such claims (Messina et al, 2015). This challenge need to be addressed already during the pharmaceutical development phase and need to be considered during drug product prescribing (Stegemann et al, 2014). The objective of this publication is to review important specific clinical and therapeutic characteristics of older adult patients and challenges to be considered during drug product development.…”

Medication Packaging and Older Patients: A Systematic Review

“…The studies were mostly from Europe (23) and North America (U.S. and Canada) (11) probably because they are the world's two main hubs of medicine production. 27 In Europe, the majority of papers were from the United Kingdom (6) and Germany (5). Nine studies came from the United States, and two were from Canada.…”

“…The location, as reported by the authors, also seemed relevant. Single and multiple locations were identified, with the recurrent places being domiciles (14), hospitals, healthcare facilities or sheltered accommodations (13), ambulatory care (9) and community pharmacies (5). Only two studies were found involving a number of patients exceeding 1000 subjects.…”

“…Such challenges exist in terms of not only the drugs that are developed but also the presentation of and means by which these drugs are provided, especially to senior patients. According to Stegemann, this ‘(…) means designing, developing and delivering drug products that patients can understand from the perspective of their health and wellbeing, as well as being able to manage and administer them properly’. In contrast, ranging from the social inclusivity of the aged adults to economic aspects related to healthcare costs, the older population will require more healthcare expenditures, including chronic disease therapies at the domiciliary level …”

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

“…Increased global longevity necessitates a re‐evaluation of the way societies are organised to adapt to the social, economic, environmental and healthcare consequences of the associated demographic shift 1–3 . Where an optimal strategy in the provision of healthcare services would be characterised by a holistic vision and multi‐, inter‐ and transdisciplinary work between, for example, medical and pharmaceutical care, drug development, accessibility, human factors, housing or social security, such a strategy cannot mature without domain‐specific understanding of expected challenges, potential solutions and useful interim measures 4,5 …”