Along with initiatives such as the World Health Organization’s (WHO) global call to action, awareness around the importance of patient safety; a fundamental principle of healthcare; has significantly increased. According to the WHO, there are around 2.6 million deaths every year that result from adverse events in patient care. Resulting from unsafe care, adverse events are likely to be in the top 10 leading causes of death and disability worldwide. According to recent evidence, around 134 million adverse events occur every year, especially in low-income countries. We are witnessing significant efforts and investments being made by governments across the Middle East to mitigate preventable deaths, such as the formation and establishment of the Saudi Patient Safety Center (SPSC) in Saudi Arabia and the recent partnership between Dubai Healthcare City (DHCC) and global body, the Patient Safety Movement Foundation (PSMF), amongst many others, to champion the cause in the region.
Ensuring patient safety is not only seen as a fundamental principle of healthcare but as an absolute obligation and cornerstone for the pharmaceutical industry. Since our work is directly linked to the safety of patients, one of our main goals is to decrease the amount of harm related to medications, while maximising the benefit we receive from them.
The pharma industry plays a dynamic role in the research, discovery and development of new medicines and patient safety standards. This process requires active engagement from all involved stakeholders (i.e. healthcare practitioners, research institutes, pharmaceutical companies, regulatory authorities, patients) in order to deliver the right medicine to the right patient, at the right time.
Safety aspects
Safety can be a relative concept, so the importance of assessing everyone’s situation is imperative. When it comes to safety aspects of the development cycle for medicine, treatment options need to be assessed against the risks and benefits of other options, the efficacy and safety of pharma products need to be thoroughly investigated during pre-clinical and clinical studies and the correct documentation needs to be submitted to relevant regulatory authorities. The cycle does not end there because pharma companies must continue to evaluate their products, even well after they have been made available to the public through product label updates and communicating directly with HCPs and patients. Employees at Takeda are always guided by company values through every stage of a product’s life cycle and work to ensure a stringent monitoring process right from the beginning, at the research and development (R&D) stage.
At Takeda, these values of integrity, honesty, perseverance and fairness are underpinned by the company’s decision-making framework of ‘Patient – Trust – Reputation – Business’ (in that same order) that acts as a clear guide and hierarchy for deciding our actions and informing our behaviours. Patient well-being is the first consideration, with business outcomes being the last.
Everybody at the company commits to putting patients first; together we all contribute within our own area of expertise, from reporting adverse events to providing patient support and guidance to healthcare providers, support in building healthcare systems, enabling medication access, developing clear labels and delivering high-quality products. We are also taking steps to ensure we never forget the tragedy of previous medication disasters and the suffering of patients who fall victim to them, as well as our social responsibility towards society as a leading pharmaceutical industry pioneer.
Apart from stakeholder alignment, comprehensive guidelines must be implemented with trained professionals who need to be alert during the entire product development cycle and able to react to any risk. When conducting research to create new drugs, we respect the fact that participants in clinical trials are volunteers and we must exercise care to ensure their safety. Takeda has also implemented robust, global quality management systems and governance models to meet the mandatory requirements and expectations of a best-in-standards global pharmaceutical company.
Possessing the scale and expertise of a values-based, research-driven biopharmaceutical company, we continue to implement and improve our pharmacovigilance activities. We are continuously collecting and monitoring safety information from the development phase of new drugs until after their launch in order to sustain high safety standards and efficacy profiles. We continue to combat the issue of counterfeit medicines, proving our commitment to patients and their safety all around the world.
Dr. Toby Shephard
