• The aim today is high to put Saudi Arabia among the leading countries in medication safety practice and therefore to shape the future of pharmacovigilance for greater patient safety. 

The Kingdom of Saudi Arabia, Al Riyadh : Boehringer Ingelheim, one of the world’s leading pharmaceutical companies, participated at the 5th Scientific Meeting for Medication Safety titled “Guidelines for Good Pharmacovigilance Practice and Signal Management Update”, which was recently held in Al Riyadh, Saudi Arabia. The event, which was under the patronage of the Vice-Rector for Graduate Studies & Scientific Research Professor, Dr. Khalid Alhumaizi at King Saud University, aimed at promoting the safe use of medications via the latest updates on the practice of pharmacovigilance globally and nationally. The event included the participation of senior officials including the Vice Rectorate for Planning and Development, Dr. Yusuf Abdo Asiri and advisor to medication safety chair, as well as, Vice Dean of Research Chairs, Dr. Abdulhamid Al-Elewi along with senior healthcare policy officials, clinical leaders and researchers, medication safety officers, postgraduate researchers, as well as quality improvement professionals. The scientific program further included a range of panel discussions and workshops where participants from local companies, hospital groups as well as government authorities collaborated together on the importance of knowledge transfers and information sharing in this crucial field to benefit patients.

Dr. Ulrich Vogel, MD, Head, GPV Strategic Data Analysis, Boehringer Ingelheim and one of the main speakers of the event said, “Patient safety is of utmost importance to Boehringer Ingelheim. We actively monitor the benefit-risk profile of our products at all stages of development and marketed use, to reduce known risks to an acceptable minimum, and to define, communicate and minimize emerging risks as quickly as possible together with the concern.  We are committed to improving the patient experience through the safe and appropriate use of our medicines, supported by the diligent work of pharmacovigilance professionals around the world.” 

Professor Mohamed Meshref, Regional Medical and Regulatory Director, Middle East, Turkey and Africa (META) at Boehringer Ingelheim highlighted the importance of this event, as it coincides with World Patient Safety Day 2019. He said, “Patient safety is a global priority. At Boehringer Ingelheim, we take a proactive and thorough approach to safety monitoring, profiling and reporting. Our approach to safety monitoring, profiling, and reporting enables us to identify potential safety concerns early and ensure compliance with today’s ever-changing regulatory environment. We work with our partners in Saudi Arabia to ensure that we work collectively towards making healthcare safer through awareness programs, scientific lectures and workshops as well as activities that engage both patients and healthcare professionals.”

The pharmacovigilance system in Saudi has remarkably improved during the past few years. Several initiatives have been taken to improve the system’s performance, including the initiation of pharmacovigilance guidelines, enhancement of communication and reporting tools, training sessions for concerned staff and healthcare providers, and compliance from stakeholders.

A number of speakers from the Saudi Food & Drug Authority, The National Pharmacovigilance and Drug Safety Center also participated during the event. They noted that “Pharmacovigilance is vital to public health. That is why the SFDA adopted a robust reporting system for adverse drug events, which aims at counteracting hazards that arise from utilizing medicinal products. Signal detection in pharmacovigilance involves looking at the adverse drug reactions data for patterns that suggest new safety information. At the SFDA, the National Pharmacovigilance and Drug Safety Center encourages healthcare professionals, consumers and patients to report adverse reactions via national spontaneous reporting systems, as part of the efforts to driving a stronger awareness around patient safety.”

Pharmacovigilance is the practice of detection, assessment, understanding and prevention of adverse effects or any other drug-related problem[1]. The aim of Pharmacovigilance is to enhance patient care and patient safety in relation to the use of medicines, and to support public health programs by providing reliable, balanced information for the effective assessment of the risk-benefit profile of medicines. In this area, the field is still open for more advances and better improvements via advanced research and strict application of the good pharmacovigilance practices. 

Dr. Tariq M. Alhawassi BSc Pharm, MClin Pharm, PhD, Assistant Professor of Clinical Pharmacy, Director of Medication Safety Research Chair, Director of Clinical Trial Unit and Supervisor of Investigational Drugs and Research Unit, King Saud University and Medical City noted, “Collaborating and sharing international best practices with industry leaders is an important step in achieving a strong pharmacovigilance system in Saudi Arabia. This meeting is part of our responsibility in promoting safe use of medications as we also encourage the combined efforts between experts, leaders in the medical field as well as regulators to place patient safety as the utmost priority.”

In Saudi Arabia, Saudi Food and Drug Authority, health and research institutions, marketing authorization holders and healthcare professional are obviously involved in pharmacovigilance activities regardless of the level of the involvement. Although pharmacovigilance is well established in developed nations, it is considered as a new concept in Saudi Arabia and the region. It is a collective effort from various stakeholders to make pharmacovigilance successful toward promoting safe and effective use of medicines among the population.[2]

The aim today for all experts from the different fields of patient safety and pharmacovigilance has to be set high to put Saudi Arabia among the leading countries in medication safety practice therefore to shape the future of pharmacovigilance good practice regionally in accordance with the global practices for greater patient safety outcomes.

At the event, Dr. Ulrich Vogel, MD, Head, GPV Strategic Data Analysis, Boehringer Ingelheim, Germany participated in a panel discussion, alongside officials from the Ministry of Health, SFDA, as well as King Faisal Specialist Hospital & Research Center. During his discussion, Dr. Vogel noted that pharmacovigilance involves the collection of data on drug effects on patients from all accessible sources, including individual case reports of suspected adverse drug reactions, and an ongoing assessment if new insights change the established safety profile.

Boehringer Ingelheim enjoys a strong and mature pharmacovigilance system. The company has developed a wide range of practices and tools for patient safety, which support the identification and management of medical risks, and a transparent communication with all involved stakeholders.

-Ends-

About Boehringer Ingelheim

Improving the health of humans and animals is the goal of the research-driven pharmaceutical company Boehringer Ingelheim. The focus in doing so is on diseases for which no satisfactory treatment option exists to date. The company therefore concentrates on developing innovative therapies that can extend patients’ lives. In animal health, Boehringer Ingelheim stands for advanced prevention.

Family-owned since it was established in 1885, Boehringer Ingelheim is one of the pharmaceutical industry’s top 20 companies. Some 50,000 employees create value through innovation daily for the three business areas human pharmaceuticals, animal health and biopharmaceuticals. In 2018, Boehringer Ingelheim achieved net sales of around 17.5 billion euros. R&D expenditure of almost
3.2 billion euros corresponded to 18.1 per cent of net sales.

As a family-owned company, Boehringer Ingelheim plans in generations and focuses on long-term success. The company therefore aims at organic growth from its own resources with simultaneous openness to partnerships and strategic alliances in research. In everything it does, Boehringer Ingelheim naturally adopts responsibility towards humankind and the environment.

More information about Boehringer Ingelheim can be found on www.boehringer-ingelheim.com  or in our annual report: http://annualreport.boehringer-ingelheim.com 

[1] World Health Authority | Pharmacovigilance | https://www.who.int/medicines/areas/quality_safety/safety_efficacy/pharmvigi/en/ 

[2] Pharmacovigilance system in Saudi Arabia | Science Direct | https://www.sciencedirect.com/science/article/pii/S1319016416301001 

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