The ongoing pandemic of coronavirus disease 2019 (COVID-19) was first confirmed to have spread in Italy on January 31, 2020. By the end of February the virus started its exponential growth from the Lombardy region. As of today, we have had 231,139 total cases, 33,072 deaths and 147,101 recovered [1]. Since March 8, the country has been in a total shutdown. Most of the Northern hospitals are still COVID-19 dedicated and close to the breakdown, while southern hospitals are managing the hit. In order to face the COVID-19 emergency, one of the priorities of the National Health System was to reduce the flow of non-COVID-19 patients to hospitals by suspending both chronic and new outpatients’ visits. The healthcare professionals (HCPs) are still working under critical conditions and a death toll that is constantly rising (160 deaths among clinicians) [2]. In this scenario, the access to hospital sites has been restricted only to the personnel.
This experience is the first time in decades that the Italian Health System and its HCPs are facing a national emergency. Numerous management problems are emerging regarding both the COVID-19 patients and those non-infected but in need of hospital care. In this scenario of disruption of the status quo and of increasing pressure, the emotional status of the physician plays an important role. Despite the situation, HCPs are still willing to have contacts with pharma companies, a clear sign that we remain their scientific advisors and they need us at their side in this battle (Figure 1). Understandably, their primary focus is not anymore just on our products but on how our knowledge, skills, and tools can support them in winning this fight.
The aim of this article is to share with you the action plan that the Medical Affairs Team of AstraZeneca (AZ) Italy adopted in order to: 1) respond to the COVID-19 emergency, 2) answer to the new needs of HCPs and 3) keep making the difference (Figure 2). We are going to do this from our point of view as MSLs, because we played a key role in implementing the plan and we witness the incredible impact that those actions had on the key opinion leaders’ (KOLs) work.
Face-to-face interactions between pharma and physicians have essentially ceased overnight during the COVID-19 pandemic, but that does not mean HCPs have stopped looking for new medical information. Veeva Engage™ is an application that allows users to plan and make calls with healthcare professionals through video conferencing and online content sharing, either by smartphones, pc or tablets. This effective tool allowed us to be close to HCPs, not only for sharing the scientific evidence concerning our portfolio, but also to grasp their mood, listen to their individual experiences, and be able to guarantee them a more complete scientific information service. The positive feedback that we received from this experience let us think that, even after the current emergency, remote personal interactions will be the new frontier of our job as MSLs.
In order to be prepared for effective interactions with the clinicians, in-house training and exchange were crucial. The Journal Club about COVID-19 was a useful opportunity to improve medical education, to enable medical team members to keep updated about the current medical literature, and to provide an occasion for social interaction. Throughout the weeks, several hot topics concerning the outbreak were discussed, such as the virus mechanism of action [3], transmission routes [4], the mathematics of the outbreak [5] and the associated clinical complications [6-8]. Both MSLs and medical advisors from different therapeutic areas were involved as speakers. The AZ medical team also attended an international webcast held by several KOLs that shared their clinical experience about the new pandemic. All these interesting opportunities provided us with new skills as advisors, and a solid background for peer to peer interactions with the HCPs.
The wealth of new scientific data has been skyrocketing during the pandemic, and an updated ad hoc Medical Information Repository about COVID-19 has been essential to keep up with the literature in a structured way. The COVID-19 repository was made up of original articles, revision papers, consensus documents, guidelines and protocols. All of the files were stored, updated, and easy to access for the medical team members. Using this system, MSLs are able to constantly answer to the HCPs requests with the latest updated material (Figure 3).
Our activity of monitoring and supporting clinical studies and Externally Sponsored Research (ESR) was deeply affected by the contingent situation. COVID-19 free hospitals were mapped in order to carry on studies according to National Pharma Agency emergency guidelines. The collaboration with the Evidence Team allowed to estimate the delay of each study site and re-adjust the milestones of the ongoing ESR studies, and the continuous communication using ad hoc newsletters, granted the drug delivery. In the case of new studies, MSLs participated in virtual site initiation visits together with the clinical operations function. This participation allowed us, as a study sponsor, to guarantee the process and to the study sites to maintain the enrollment.
Finally, as an MSL team we took part in several training sessions to reinforce our fundamental skills in finance, market access, patient safety and regulatory, and good clinical practice. Although basic skills are important, satellite skills are equally essential. Thinking outside of the box represents life skills, being able to solve problems and overcome challenges that we have not seen before. As an MSL team, we have been involved in several training sessions, from strategic marketing, medical information, real world evidence, big data, biostatistics to innovation. Investing our time in development was the best opportunity to grow from these dramatic circumstances and to enrich our support to our clients (Figure 4).
The COVID-19 pandemic threatened our working habits with unique challenges, while also offering peculiar opportunities to work in new and effective ways. Taken together, all the initiatives adopted by the Medical Affairs Team of AstraZeneca Italy have been essential in order to: 1) guarantee quality interactions with our clinicians, 2) consolidate our partnership throughout the development of new competences, 3) give the answers our partners were expecting from us, and 4) keep the projects moving in the best way possible.
References
[1] https://www.worldometers.info/coronavirus/#countries
[2] https://portale.fnomceo.it (FNOMCEO, National Federation of Orders of Doctors and Dentist)
[3] Zhang H et al. Angiotensin-converting enzyme 2 (ACE2) as a SARS-CoV-2 receptor: molecular mechanisms and potential therapeutic target. Intensive Care Med. 2020 Apr;46(4):586-59.
[4] Zhou P et al. A pneumonia outbreak associated with a new coronavirus of probable bat origin Nature volume 579, pages 270–273(2020).
[5] Bussano et al. Mathematical models of infection transmission. January 2010. Epidemiologia e prevenzione 34(1-2):56-60.
[6] Xu Z et al. Respiratory distress syndrome pathological findings of COVID-19 associated with acute respiratory distress syndrome. Lancet Respir Med. 2020 Apr;8(4):420-422.
[7] Zheng YY et al. COVID-19 and the cardiovascular system. Nat Rev Cardiol. 2020 May;17(5):259-260.
[8] Fadini GP et al. Prevalence and impact of diabetes among people infected with SARS-CoV-2. J Endocrinol Invest. 2020 Mar 28.
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