Patient centricity and patient safety: Supporting special populations
By: Alexander Biedermann
The world is rapidly changing, and this has been evidenced more than ever over the past year and a half. It’s probably the first time that everyone’s attention around the world has been focused on one thing: the importance of keeping people safe and healthy.
As the new Head of Pharmacovigilance at Bayer, patient safety and health for all are my mission. That’s why this Patient Safety Day, I want to share my thoughts about how we, as an industry and a department in a pharmaceutical company, can put the patient at the center of safety discussions and considerations.
The patient experience has been found to be consistently and positively linked to patient safety and clinical effectiveness.1 It sounds simple: if we can listen to and incorporate the patient voice into all that we do, patients are more likely to adhere to their medication regimen, and thus, minimize the risks and maximize the benefits from their treatment.
However, as different populations have differing needs, a ‘one size fits all’ approach cannot be applied. We must look to address the needs of various population groups to ensure that all patients have positive experiences.
This is especially true for ‘special populations’, defined as women who are pregnant or breastfeeding, children and the elderly. That’s why this Patient Safety Day, we at Bayer are focusing on the theme of special populations; those who are often at highest risk, yet under-represented in clinical trials. It’s therefore important for all pharmaceutical companies and regulatory bodies to strive to better protect the safety of these vulnerable groups.
So, what are some of the ways in which we, as the pharmaceutical industry, can ensure that the needs of these special populations are considered in patient safety?
Developing patient centric materials to improve patient safety for special populations
The past decade has seen the emergence of a new type of patient who actively gathers information about their health conditions and expects to form a partnership with their doctor. These patients aren’t just limited to adults, however, and can include any and all special populations.
As a result, it’s important that information about medicines and their safety data is comprehensively communicated in an understandable and accessible format for these patients. For example, materials to support the correct administration of medicines for pediatric patients need to be written with the child and their parent in mind. This can include the use of simple language, colorful imagery, and descriptions of how the medicine could affect them at school.
The elderly population often experience dysphagia, or difficulties swallowing, a condition that affects 10% to 33% of older adults.2 This can result in people modifying the medicine, such as breaking it up into smaller pieces so that it can be better swallowed.3 These small alterations may appear insignificant, but can complicate treatment by potentially changing the bioavailability, toxicity and stability of the medicine. For Patient Safety Day this year, we have developed an instructional video for our older patients who experience swallowing difficulties. This video provides guidance on how to improve swallowing, in order to minimize risks and help them better adhere to their treatment regimen, so they can experience the best possible outcomes.
As an industry, if we can work to ensure that materials provided to patients about medicines and their safety data take into consideration the needs of that population, it will bring us one step closer to supporting the correct administration and reducing the risk of harm from inadvertent misuse of these medicines.
Developing patient centric formulations of medicines to improve patient safety for special populations
Patient centric medicine design is an essential tool to improve the quality of life of patients. It involves identifying and addressing the comprehensive needs of a specific population, and developing medicine formulations that provide the best overall benefit-risk profile for them.4 Patient centric medicines are of utmost importance for special populations.
Take liquid loratadine (Claritin®, an antihistamine)* as an example. By producing a liquid loratadine based product that has a suitable taste, Bayer now has a medicine that is easily administered in children over 2 years of age. This approach has also been taken with other medicines for children, as oral solutions can be less intimidating and usually come with child- and caregiver-friendly instructions, dosing devices and intuitive point-and-press syringes. Claritin® also has other formats (chewables and RediTabs®) to support use in children.
This is why it’s important that patient centric formulations of medicines are developed both with patients and caregivers, to develop age-appropriate formulations that may improve patient adherence and safety.
Patient centricity is an essential component of patient safety. It requires that we understand the needs of all groups of patients and that we address these needs when we develop medicines and materials. In this way, we can support patient safety in the long term, and give value to patients by enhancing outcomes.
At Bayer, patient safety is our greatest priority, and we are committed to putting the patient at the center of safety discussions and considerations.
*applicable for countries where it is available on the market.
References
- Doyle C, Lennox L, Bell D. BMJ Open. 2013;3(1): e001570.
- Thiyagalingam S, et al. Mayo Clin Proc. 2021;96(2):488–97.
- FDA. Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules: Guidance for Industry. Available online:
https://www.fda.gov/downloads/drugs/guidances/ucm377938.pdf. Last accessed: August 2021. - Stegemann S, et al. AAPS J. 2016;18:1047–55.
PP-OTH-ALL-0056-1
August 2021
