Supporting Patient Safety Day
World Patient Safety Day was established in 2019 by the World Health Organization, to enhance the global understanding of patient safety, increase public engagement in the safety of health care, promote global actions and reduce patient harm.1
At Bayer, we take great pride in always putting patient safety and well-being first, ahead of everything else. It is at the core of all that we do and more than just an obligation. That’s why we are proud to have supported World Patient Safety Day since 2019, developing various tools and supportive materials to educate and inform the public about patient safety.
Patient safety in special populations
The COVID-19 pandemic has put patient safety and decisions about managing health at the forefront of everyone’s mind. Every day, we make decisions based on our perceived risk of catching or spreading the virus and protecting ourselves and the health of those around us.
For special populations, such as people over the age of 65, children, or women who are pregnant or breastfeeding, extra considerations need to be taken to keep these groups safe.
These risk-based decisions are also at the heart of medicine development. Treatments are approved if the data show that they are both safe and effective.2 However, all medicines come with potential side effects.3 It is the responsibility of the prescribing doctor and patient to discuss the benefits and risks together and make decisions on what’s best for the individual.
The COVID-19 vaccine story helps bring to life the benefit versus risk assessment while highlighting the need to include special populations in the equation
The initial COVID-19 vaccine trials were mainly conducted in adults, with few special populations participating.4,5
However, due to the impact of the virus, it became apparent that those over the age of 65 should be the vaccination priority. As there was limited safety or efficacy data on the vaccines for this population, it was challenging to predict the benefits and potential risks they would bring.5
Once a vaccine was approved for adults, it was rolled out to those over the age of 65, as it was assessed based on the data available that the risk of serious illness from COVID-19 in this population was greater than that of the vaccine side effects.
Furthermore, when side effects started occurring as the vector vaccines were administered to millions of people globally, focus of the public media was put on their potential fatality without considering the wider context about the proportion of the population in which they were occurring.6
Because of this, there was a misalignment between the perceived risk of harm from vaccination, which was communicated widely in the news, and the actual risk of serious side effects.7
A person’s perceived risk can be described as their own evaluation of how likely a harmful event will happen. However, this may differ from the actual risk, which is a statistical evaluation based on data and evidence.8
By closely monitoring benefit-risk data, regulatory bodies, government scientists and the pharmaceutical industry were able to conclude that the benefits of the vaccine for public health outweighed the potential risks of side effects in all populations.
Look at our infographic on what we have learned from the Smallpox vaccine and how the risk of COVID-19 vaccination side effects may be perceived:
What is the role of Pharmacovigilance in monitoring the benefits and risks of medicines?
At every pharmaceutical company, pharmacovigilance teams work to protect the safety of patients by ensuring that the expected benefits of a medicine outweigh the risks. This occurs both during clinical trials whilst treatments are being evaluated, but also throughout the whole lifecycle of a medicine, even after it’s been approved.
Pharmacovigilance is always there to monitor the safety and the balance of benefit and risk of a medicine at every stage.
The importance of conducting medical research in special populations
Clinical trials are usually conducted in adults aged 18-64,9 which is why there are limitations in generating safety data for special populations. Because of this, the risk of potential side effects in special populations is usually estimated based on the available data or from experience with similar products.10
However, as the needs of these special populations can differ from those of adults, it is important that trials are also conducted in these groups, to find new ways to treat, manage or prevent disease.10
How pharmaceutical companies are using medical research to address the needs of special populations
Pharmaceutical companies are innovating to find new treatment formulations and providing comprehensive training materials for special populations, so that they are also able to benefit from medical advances.
Find out more about how this research can help to provide new innovations for children:
Developing new medicine formulations
The pharmaceutical industry is investing in innovative medicinal products to address the needs of patients, including new formulations of existing treatments such as liquid syrups or dispersible tablets, to ensure they can be administered with minimal risk.
For example, pharmaceutical companies have developed liquid paracetamol-based products for children, as oral solutions are less intimidating and usually come with child- and caregiver-friendly instructions, dosing devices and syringes.
Providing informative materials to support patients
Another way that pharmaceutical companies can support special populations is to provide informative materials about the disease or medicine.
For example, some patients – especially older populations – may have trouble swallowing tablets because of their age, neurological or physical disorders.11 Pharmaceutical companies can support these patients by offering informative materials that provide techniques to make taking their medicines easier.
Click below to watch an instructional video, created by Bayer, that shares tips, tricks and techniques, on how to overcome challenges with swallowing:
As another example, children and adolescents are now more involved than ever before in decisions related to their health and want to be able to take their medicines with minimal support from an adult.
As such, it is important that informative materials are age-appropriate and clearly address how their medicine can interfere with school and sports, interacts with food and other substances, the risks of sharing their medicine with friends, and advice on the right storage and administration of the medicine.
One example of this is in hemophilia, where Bayer has created informative videos to help patients to learn more about their condition and how it can be managed by their treatments.
By conducting clinical trials with special populations, licensing new medicine formulations, and developing informative materials that support them in managing their treatments, the pharmaceutical industry can help these special populations to feel more empowered in their healthcare, and have access to new innovations.
The importance of open and honest conversations about side effects
Patients who discuss side effects with their physicians are less likely to prematurely discontinue their medicines.12 However, there are also ways to communicate information about side effects to patients outside the four walls of the doctor’s office. Improvements that make this information more accessible, engaging and informative can empower patients to improve the quality of their conversations with their healthcare provider.
A series of videos, developed for patients and with patients, aims to support the patient self-management of the common side effects associated with cancer treatments. These videos aim to empower patients to speak openly and honestly with their doctor about the side effects they may experience, whilst providing simple tips and advice for how to cope.
High quality conversations between patients and healthcare professionals about the side effects and impact of medicines are of great benefit to the patient, their family, health systems and those of us who strive to make medications that make a difference. Bayer Pharmacovigilance is committed to supporting and empowering patients with well-tolerated and appropriate use of our products.
The importance of reporting side effects
As patient safety is one of Bayer’s core values, enabling patients and caregivers to report potential side effects is essential.
Patients are best placed to share their experiences about how the medicines they are taking have impacted them, particularly their quality of life. By reporting side effects, patients can contribute to the overall knowledge about the safety profile of a medicine, allowing pharmaceutical companies to initiate action and effect positive changes for the future. Reporting also allows pharmaceutical companies to learn from patient experiences and provide advice to empower patients to use their medicines appropriately and effectively. These side effect reports provide invaluable data that aid drug discovery in new indications, sustain market authorization through safe and effective use, and ultimately mean that patients can continue to benefit from their treatments.
Bayer developed “The Sonifex Mystery: Three Curious Cases” online game, which aims to educate and inform on why and when to report side effects. Players enter the fictitious world of the Roseville Retirement Home, where they are led through a series of curious cases affecting patients. By selecting the most appropriate responses to a series of questions, mysteries are solved and the residents of Roseville Retirement home are protected.
- WHO. World Patient Safety Day 2021. Available from: https://www.who.int/news-room/events/detail/2021/09/17/default-calendar/world-patient-safety-day-2021. Last accessed: August 2021. Return to content
- FDA. The FDA’s Drug Review Process: Ensuring Drugs are Safe and Effective. Available from: https://www.fda.gov/drugs/information-consumers-and-patients-drugs/fdas-drug-review-process-ensuring-drugs-are-safe-and-effective. Last accessed: August 2021. Return to content
- NICE. Adverse Reactions to Drugs – Yellow Card Scheme. Available from: https://bnf.nice.org.uk/guidance/adverse-reactions-to-drugs.html. Last accessed: August 2021. Return to content
- EMA. COVID-19 Vaccines: Studies for Approval. Available from: https://www.ema.europa.eu/en/human-regulatory/overview/public-health-threats/coronavirus-disease-covid-19/treatments-vaccines/vaccines-covid-19/covid-19-vaccines-studies-approval#what-types-of-studies-are-needed-to-approve-a-covid-19-vaccine?-section. Last accessed: August 2021. Return to content
- Helfand BKI, Webb M, Gartaganis SL, Fuller L, Kwoon C, Inouye SK. (2020). The Exclusion of Older Persons From Vaccine and Treatment Trials for Coronavirus Disease 2019—Missing the Target. JAMA Int Med. 180(11):1546-8. Return to content
- OECD. OECD Policy Response to Coronavirus (COVID-19): Enhancing public trust in COVID-19 vaccination: The role of governments. Available from: https://www.oecd.org/coronavirus/policy-responses/enhancing-public-trust-in-covid-19-vaccination-the-role-of-governments-eae0ec5a/. Last accessed: August 2021. Return to content
- WIRED. Vaccines are Here. We Have to Talk About Side Effects. Available from: https://www.wired.com/story/vaccines-are-here-we-have-to-talk-about-side-effects/. Last accessed: August 2021. Return to content
- Wolff K, Larsen S, Ogaard T. (2019). How to define and measure risk perceptions. Ann Tour Res. 79. Return to content
- Shenoy P, Harugeri A. (2015). Elderly patients’ participation in clinical trials. Perspect Clin Res. 6(4):184-9. Return to content
- Grimsrud KN, Sherwin CMT, Constance JE, Tak C, Zuppa AF, Spigarelli MG, Mihalopoulous NL. (2015). Special population considerations and regulatory affairs for clinical research. Clin Res Regul Aff. 32(2):47-56. Return to content
- Thiyagalingam S, Kulinski AE, Thorsteinsdottir B, Shindelar KL, Takahashi PY. (2021). Dysphagia in Older Adults. Return to content
- Bull SA, Hu XH, Hunkeler EM, et al. (2002). Discontinuation of use and switching of antidepressants: influence of patient-physician communication. JAMA. 288(11):1403-9. Return to content
Date of preparation: September 2021