ABSTRACT
The COVID-19 pandemic presents several challenges to the organisation and workflow of pharmacovigilance centres as a result of the massive increase in reports, the need for quick detection, processing and reporting of safety issues and the management of these within the context of lack of complete information on the disease. Pharmacovigilance centres permanently monitor the safety profile of medicines, ensuring risk management to evaluate the benefit-risk relationship. However, traditional pharmacovigilance approaches of spontaneous reporting, are not suitable in the context of a pandemic; the scientific community and regulators need information on a near real-time point. The aim of this commentary is to suggest six interrelated multidimensional guiding axes for drug safety management by pharmacovigilance centres during the COVID-19 pandemic. This working plan can increase knowledge on COVID-19 and associated therapeutic approaches, support decisions by the regulatory authorities, oppose fake news and promote more efficient public health protection.
Subject(s)
Adverse Drug Reaction Reporting Systems , Antiviral Agents/adverse effects , COVID-19 Drug Treatment , Pharmacovigilance , Adverse Drug Reaction Reporting Systems/organization & administration , Antiviral Agents/therapeutic use , COVID-19/epidemiology , Drug-Related Side Effects and Adverse Reactions/epidemiology , Drug-Related Side Effects and Adverse Reactions/etiology , Humans , Patient Safety , SARS-CoV-2/drug effectsABSTRACT
Definition of the problem: Employees in the healthcare sector are expected to deal professionally with patients and their families at all times. Accompanying them through existential crises, disease, dying, and death is highly demanding. A situation which employees can experience as particularly stressful is when a decision needs to be made and they find themselves in a moral conflict or dilemma. Arguments: Such situations range from extremely rare triage decisions to comparably "everyday" involvement in (alleged) medical error. Conclusion: In some cases the outcome for patients and their families, who had placed their trust in the institution, can be tragic, and this already burdensome situation for employees is further exacerbated when there is no credible concept established within the organization for dealing with such events in a structured manner, and when colleagues and their superiors have little to no knowledge about helpful support options.