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

Stegemann, Sven; Riet–Nales, Diana van; Boer, Anthonius de

doi:10.1111/bcp.14511

Cited by 8 publications

(4 citation statements)

References 42 publications

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“…When it comes to older patients with dysphagia, nowadays SODF administration still remains an unresolved challenge within the subject of pharmaceutical technology. Besides the development of technical approaches and solutions, clinical data in the concerned patient populations will be required to confirm the theoretical models underlying the scientific and technical rationales for drug products claiming enhanced swallowability or appropriateness for older patient populations [215][216][217][218].…”

Section: Discussionmentioning

confidence: 99%

Better Medicines for Older Patients: Considerations between Patient Characteristics and Solid Oral Dosage Form Designs to Improve Swallowing Experience

Drumond

Stegemann

2020

Pharmaceutics

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Oral drug administration provided as solid oral dosage forms (SODF) remains the major route of drug therapy in primary and secondary care. There is clear evidence for a growing number of clinically relevant swallowing issues (e.g., dysphagia) in the older patient population, especially when considering the multimorbid, frail, and polymedicated patients. Swallowing impairments have a negative impact on SODF administration, which leads to poor adherence and inappropriate alterations (e.g., crushing, splitting). Different strategies have been proposed over the years in order to enhance the swallowing experience with SODF, by using conventional administration techniques or applying swallowing aids and devices. Nevertheless, new formulation designs must be considered by implementing a patient centric approach in order to efficiently improve SODF administration by older patient populations. Together with appropriate SODF size reductions, innovative film coating materials that can be applied to SODF and provide swallowing safety and efficacy with little effort being required by the patients are still needed. With that in mind, a literature review was conducted in order to identify the availability of patient centric coating materials claiming to shorten esophageal transit times and improve the overall SODF swallowing experience for older patients. The majority of coating technologies were identified in patent applications, and they mainly included well-known water soluble polymers that are commonly applied into pharmaceutical coatings. Nevertheless, scientific evidence demonstrating the benefits of given SODF coating materials in the concerned patient populations are still very limited. Consequently, the availability for safe, effective, and clinically proven solutions to address the increasing prevalence of swallowing issues in the older patient population is still limited.

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Section: Discussionmentioning

confidence: 99%

Better Medicines for Older Patients: Considerations between Patient Characteristics and Solid Oral Dosage Form Designs to Improve Swallowing Experience

Drumond

Stegemann

2020

Pharmaceutics

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“…Second, regulation benefits from regulatory science and transdisciplinary work such as literature reviews, qualitative research, tailored experiments, post marketing database evaluations and multidisciplinary expert conferences. 35 The ultimate value of this RP for older people can only be determined once the RP is actually in use. Therefore, the EMA continues to seek active feedback from the public in working with the RP (comments can be send to qwp@ema.…”

Section: What This Study Addsmentioning

confidence: 99%

“…First, active contributions by EMA stakeholder parties, national pharmaceutical organisations and (multidisciplinary) experts at conferences fostered concise and valuable feedback from different regions and disciplines. Second, regulation benefits from regulatory science and transdisciplinary work such as literature reviews, qualitative research, tailored experiments, post marketing database evaluations and multidisciplinary expert conferences 35 . The ultimate value of this RP for older people can only be determined once the RP is actually in use.…”

Section: The Final Reflection Papermentioning

confidence: 99%

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

Riet‐Nales

Bemt

Bodegom

et al. 2022

Brit J Clinical Pharma

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Funding information Medicines Evaluation BoardOlder people are often affected by impaired organ and bodily functions resulting in multimorbidity and polypharmacy, turning them into the main user group of many medicines. Very often, medicines have not specifically been developed for older people, causing practical medication problems for them like limited availability of easy to swallow formulations, easy to open packaging and dosing instructions for enteral administration. In 2020, the European Medicines Agency (EMA) published a reflection paper 'Pharmaceutical development of medicines for use in the older population', which discusses how the emerging needs of an ageing European population can be addressed by medicines regulation. The paper intends to help industry to better consider the needs of older people during pharmaceutical/clinical medicines development by summarising data on the most relevant topics, providing early suggestions on how to move forward and prompting expert discussions and studies into knowledge gaps. Topics include patient acceptability, (dis)advantages of an administration route, formulation, dosage form, packaging, dosing device and user instruction. While the paper is directed at older people and the pharmaceutical industry, the reflections

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“…In addition to these environmental factors, a spike in birth rates following World War II into the early 1960s has also contributed to the high proportion of individuals aged over 60 years currently living in the United States [ 4 ]. With the growth of the older population in the United States and abroad [ 5 ], the development of efficacious drugs and treatments for an aging population is becoming increasingly important [ 6 ].…”

Section: Introductionmentioning

confidence: 99%

Best Practices in Evolving Privacy Frameworks for Patient Age Data: Census Data Study

Moffatt,

Leshin

2024

JMIR Form Res

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Background Over the previous 4 decennial censuses, the population of the United States has grown older, with the proportion of individuals aged at least 90 years old in the 2010 census being more than 2 and a half times what it was in the 1980 census. This suggests that the threshold for constraining age introduced in the Safe Harbor method of the HIPAA (Health Insurance Portability and Accountability Act) in 1996 may be increased without exceeding the original levels of risk. This is desirable to maintain or even increase the utility of affected data sets without compromising privacy. Objective In light of the upcoming release of 2020 census data, this study presents a straightforward recipe for updating age-constrained thresholds in the context of new census data and derives recommendations for new thresholds from the 2010 census. Methods Using census data dating back to 1980, we used group size considerations to analyze the risk associated with various maximum age thresholds over time. We inferred the level of risk of the age cutoff of 90 years at the time of HIPAA’s inception in 1996 and used this as a baseline from which to recommend updated cutoffs. Results The maximum age threshold may be increased by at least 2 years without exceeding the levels of risk conferred in HIPAA’s original recommendations. Moreover, in the presence of additional information that restricts the population in question to a known subgroup with increased longevity (for example, restricting to female patients), the threshold may be increased further. Conclusions Increasing the maximum age threshold would enable the data user to gain more utility from the data without introducing risk beyond what was originally envisioned with the enactment of HIPAA. Going forward, a recurring update of such thresholds is advised, in line with the considerations detailed in the paper.

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

Cited by 8 publications

References 42 publications

Better Medicines for Older Patients: Considerations between Patient Characteristics and Solid Oral Dosage Form Designs to Improve Swallowing Experience

Better Medicines for Older Patients: Considerations between Patient Characteristics and Solid Oral Dosage Form Designs to Improve Swallowing Experience

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

Best Practices in Evolving Privacy Frameworks for Patient Age Data: Census Data Study

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