At the end of 2019, humanity faced a new coronavirus infection that swept across all continents and became a pandemic in a short period. This circumstance has led to forced restrictions on human contact and decreased productivity in many industries. Changes have also occurred in the provision of pharmacovigilance processes.
Regardless of the world situation, a company’s routine pharmacovigilance processes include interacting with health care providers and patients, collecting information about adverse reactions, maintaining a database of those reactions, determining the signal, analyzing information, reporting data, providing periodic reports, and more. Internally, these functions are regulated by regulations, job descriptions, and standard operating procedures. If the pharmacovigilance system processes are well structured, there should be no difficulties in collecting information and reporting data in a pandemic environment. For X7 Research, we decided to increase our vigilance in handling incoming reports and pay special attention to those adverse reactions that are similar to the symptoms of COVID-19 infection. We also effectively ensure continuity of pharmacovigilance processes even in the face of emerging constraints. All incoming adverse reactions are coded with a MedDRA medical dictionary, which allows processing large amounts of data and quickly identifying emerging “trends” among the received information. There is also a convenient system of interaction with regulatory authorities for reporting adverse reactions through the Pharmacovigilance Automated Information System online in Russia.
Globally, ensuring the safe use of medicines is a priority for modern healthcare. During an outbreak of viral infection, anyone will try to protect themselves and their loved ones by following preventive measures. These include frequent hand washing, use of antiseptics and disinfectants, taking vitamins, etc. In this case, pharmacovigilance specialists must be prepared for a possible increase in reports of adverse reactions. This hypothesis can be easily tested. The World Health Organization recommends the use of alcohol-based hand sanitizers, which rarely cause adverse reactions when used routinely. This is confirmed by previously published data in the FAERS (The FDA Adverse Event Reporting System) open database, where all “alcohol-based sanitizer” queries have hardly 20 adverse reactions. However, a recently published study from the epicenter of China, in which healthcare workers treated their hands with alcohol-based antiseptics more than 10 times a day, reported that of 321 healthcare workers, 76.6% developed hand skin lesions and dermatitis symptoms. The high incidence of skin adverse reactions is at least of scientific interest and provides new information about the safety of these agents. And for manufacturers, these data can serve as a reason to change precautions in the use of skin antiseptics.
If in the previous example we cannot draw any conclusions and the data were provided only for thought, the following information is already a scientifically documented fact. For previously unknown diseases, taking any medication is “off-label,” that is, not for the indications given in the instructions for medical use. Due to the high incidence of COVID-19, the Solidarity clinical trial (more than 3,500 patients from 35 countries) was launched to find drugs to treat this infection. One of the objectives was to study the therapeutic efficacy of a hydroxychloroquine-based drug. After some time in the study, on May 23, 2020, the Solidarity executive team made an official announcement of its decision to suspend the study of hydroxychloroquine due to negative safety data on the drug. The Data Monitoring and Analysis Committee (this is the role of pharmacovigilance in clinical trials) conducted an analysis and reacted instantly in a way that would minimize risks and keep trial participants safe . Each report of a suspected adverse reaction contributes to an up-to-date view of a drug’s safety profile. By the way, after a thorough evaluation of all adverse events and deaths, the hydroxychloroquine study has resumed, and the safety data monitoring and analysis committee continues to closely monitor the study.
Each of these examples involves huge resources, ensuring continuity of pharmacovigilance both at the global level and at the level of pharmacovigilance of a specific company. The performance of any system is determined by its ability to adapt to current conditions. Maintaining a heightened focus on reported adverse reactions and doing their job well are some of the key requirements for pharmacovigilance in a pandemic.