Artificial Intelligence, real-world evidence and big data are leading Pharmacovigilance toward a more integrated Public Health activity. Multidisciplinarity will be a key element for efficiency as illustrated in ISOP ISRAEL projects in hospital and community. Industry must bring its expertise to support wide campaign and projects promoting safe medication practices.
The Israeli pharmacovigilance system was founded recently. All over the world, pharmacovigilance regulations have evolved mainly from lessons learned as a reaction to safety issues that became public health issues. This was true also for Israel which has built its regulation on the EU model, and its pharmacovigilance department six years ago, following the Eltroxin® (levothyroxin) change in the excipients; this led not only to a huge number of adverse reactions but exposed the weaknesses in pharmacovigilance organisation in Israel.
The new field of Israeli pharmacovigilance has developed quite rapidly with the obligation for pharma companies, hospitals and Health Maintenance Organisations (HMOs) to designate a Qualified Person for Pharmacovigilance (QPPV) and establish a pharmacovigilance system. Training sessions have been performed throughout the country to educate healthcare professionals on the new regulation, some of them by ISOP ISRAEL with the support of the Ministry of Health. Several programs have been created in universities in the frame of continuing education.
Today, the Ministry of Health is still focused on its priorities, which are to implement the basics of pharmacovigilance in the whole Healthcare system. The last step was the issue, only two years ago, of the risk management regulation on the European model. The pharmacovigilance department is small, with active but rather junior professionals, and pharmacovigilance inspections are still not implemented. Therefore, it cannot be expected from the Ministry of Health to both strengthen this new activity, to deal with day-to-day activities and also to be the driving force of innovation.
For historic reasons, the public health system is quite decentralised, leaving a certain degree of autonomy to hospitals and its four HMOs. Israeli citizens can freely choose and change one of the four HMOS which therefore are in competition to provide the best services.
The benefit of this decentralisation is that it leaves space to local or regional initiative.
Therefore, it is not unusual that innovations stem from a hospital, a HMO or a professional organisation.
This is the case with Sheba-Tel Hashomer Hospital, which has been rated by Newsweek as one of the ten best hospitals in the world in 2019 and is leading healthcare innovation in Israel with a significant impact abroad.
Sheba Hospital is strongly involved in drug safety with the implementation of an Artificial Intelligence (AI) solution, Medaware, monitoring and supporting the prescription through access to the Electronic Medical Record (eMR). The Institute for Health Improvement Trigger tool is currently screening the eMRs to detect potential Adverse Events through markers; for instance a sudden drop in haemoglobin in a patient with anticoagulant could mean an occult haemorrhage.
Similarly, ISOP ISRAEL, has endorsed a role of leadership since its creation, 6 years ago, which coincided with the setup of the new pharmacovigilance era in Israel.
ISOP ISRAEL, the Israeli Chapter of the ISOP (International Society of Pharmacovigilance) has the mission to foster drug safety through education and research, combining the Israeli unique assets with the new trends which are shaping pharmacovigilance of tomorrow.
Multi-disciplinarity and System approach:
pharmacovigilance has remained limited far too much to industry experts and to clinical pharmacologists or clinical pharmacists. It is a common understanding in other high-risk industries, such as aeronautics and nuclear power plants, that management of risks can only be efficient when applied by a multidisciplinary team and considered across the entire system. Healthcare systems are still lagging behind; and the healthcare professions continue to act in silos. The future of pharmacovigilance lies in its becoming truly multidisciplinary. The stakeholders involved in the whole treatment process are the healthcare professionals, the patients and caregivers, the hospital management, the HMOs, the industry, the authorities and the academy.
Learning while doing
Rather than a theoretical training, multidisciplinarity is experienced through a case study.
Anticoagulants were chosen as a first example of high-risk products with many interactions between disciplines and rated one of the main classes of products involved in medications errors and hospitalisation for adverse reactions.
ISOP ISRAEL has gathered several tools to set up its projects:
This step has been crucial to build a network representing all stakeholders in Israel and abroad:
Each of these partners have contributed to bring its own angle to drug safety and achieve a real multidisciplinary think tank.
From the creation of the Chapter, the Advisory Board, composed of international experts, has validated the vision and the projects and actively participated in the symposium program.
The research strategy was completed by the organisation of an international symposium based on the same concepts: multidisciplinary and solution-oriented. The conference, 360° of Drug Safety was held in Tel Aviv, Israel, on 3-4 June 2019 and was attended by 174 participants from all disciplines. The main topics were the prevention of medication errors, risk communication and cases studies of risk minimisation. Several initiatives have been presented and among them the results of the ISOP ISRAEL projects. ISOP ISRAEL objectives are both to provide a toolbox ready to use to participants, and to enrol more pilot centres in Israel or abroad and spread the initiative at national level. Several start ups have presented their AI and IT solutions, Sheba hospital has shared its strategy. All stakeholders have been able to interact and share their experience.
Now that the basis of the pharmacovigilance system has been founded, the next step for Israel will be to implement the new trends which are shaping the future of pharmacovigilance. In this objective Israel can benefit from key assets:
The organisation of the four Israeli HMOs can allow them to have quick and efficient dialogue with healthcare professionals and with patients. The pooling of the HMOS’ extensive and comprehensive epidaemiologic databases has started and will provide a huge amount of data .
Risk management activities are implemented in hospitals for more than 25 years.
As a leader in digital health, Israel has facilitated the emergence of many start-ups and companies dedicated to drug safety and using the most advanced technologies of Artificial Intelligence and machine learning.
ISOP ISRAEL has the ambition to play a major role in this evolution, in providing a multidisciplinary platform for experience haring, in identifying and combining new tools and platforms and in implementing innovative projects.
Israel, the Start-up nation, has the organisational, scientific, technological and cultural resources to quickly overcome the challenges and go beyond its current state to build a unique pharmacovigilance system which could serve as an example for other countries.
Ethics approval and consent to participate: not applicable
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Competing interests: The author declares that they have no competing interests
Authors' contributions: Author wrote the final manuscript
Ayalah Livneh, Pascal Grin, Dr Hesh Hershman and Yehudith Wexler for ISOP ISRAEL organization
Prof Herve Le Louet , president of CIOMS, Peter Pitts, President Center for Medicine in Public Interest, previously FDA Associate-Commissioner, Prof Mati Berkovitch, Safety Advisor to Israeli Ministry of Health, Prof Ronald Litman, ISMP Medical Director, Prof Nick Sevdalis, Director Implementation Sciences and Patient Safety.