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On 1st August 2017, the EMA (European Medicines Agency) launched a public consultation into the possible avenues via which medicines for the elderly may be developed. This reflection paper is aimed at bringing together the available evidence and to support discussion on the development of medicinal products for this key patient population. At this point in time, the EMA has indicated that this refection paper will not be a guideline on technical and regulatory requirements.
The Eurostat data on aging populations currently predicts that there will be a growth in persons aged 65 and over from around 97m to approximately 153m by 2050. This growth in the relative share of older people may be explained by increased longevity – a pattern that has been apparent for several decades as life expectancy has risen. The statistics show that the elderly population is the fastest growing subset and, as such, they present a unique set of challenges when consider drug development, as well as a growing opportunity for targeted therapies.
The following areas are worth considering when planning drug development, although these are not exhaustive. The first point of consideration is route and administration. It is well documented that elderly patients have poor compliance with regards to medication and many have medication administered by a care giver. The paper discusses the relative pros and cons of various forms and routes, and provides a useful insight into the possible design issues a developer may face.
The second aspect to consider is dosing and dosing frequency. It is well accepted that the aging population faces unique challenges such as a higher frequency of gradually declining human body and organ functions. This decline often results in one or more of the following impairments: physical, physiological, psychological or cognitive loss in functionality. They can also face higher rates of co-morbidity and frailties. This has a correlation to the potential dosing guidelines, and additional studies that may be needed to support the intended label.
Drug developers are also recommended to consider the proposed packaging and container closure system, since the main issues facing elderly patients is lack of mobility and or lack of manual dexterity. As such, the paper goes on to discuss the possible options that a manufacturer could consider when designing packaging. Naturally these options will all have pros and cons and would need thorough planning before commercialisation.
Finally, the paper explores a key element of the medicine that can often be overlooked in the initial phases – the product information leaflet. As mentioned, one of the major issues affecting the aging population is medication compliance, and a crucial part of ensuring compliance is a well thought-out and easy to comprehend product information leaflet.
As we can see from the global trends, the world patient population is changing and, as part of any company’s drug development program, some attention should be focused on the rising trend in aging population. At ELC Group we have experts on hand who can help develop your strategies to meet current and future demands. Concept papers such as this one only go to highlight the amount of thought and planning required in order to get drug development right for such a target patient population.