Carriage of Neisseria meningitidis in newly enlisted young military professionals during the COVID-19 pandemic

Aim: Invasive meningococcal disease (IMD) is still a major threat not only to the youngest age group of children but also to adolescents and young adults. Higher rates of meningococcal disease have also been reported in specific at-risk groups, such as secondary and tertiary students and members of the military. Infection occurs after close contact with a clinically ill individual, but most often with an asymptomatic carrier. The aim of our study was to determine the prevalence of carriage of N. meningitidis in young persons newly enlisted in the Army of the Czech Republic (ACR). Material and methods: During August 2021, persons entering the service in the ACR were asked to participate in the presented study approved by the Ethics Committee. Nasopharyngeal and oropharyngeal swabs were collected from the study participants in August. A questionnaire survey was administered to each of them after signing an informed consent form. The biological samples were cultured on the day of collection and analysed for N. meningitidis. In case of meningococcal detection, the serogroup of N. meningitidis was determined. For most of the study participants, swabs were repeated after 2-3 months, in October and November. Swabs were also collected from additional participants, namely students entering the first year of bachelor and master studies at a military college. Results: A total of 252 newly recruited young military professionals, 201 males and 51 females, were included in the study. Carriage of N. meningitidis was found in 13 study participants, i.e., 5.2 % of all tested subjects, with a predominance of positive findings in the summer period. All carriers were males while in females, meningococcal carriage was not detected. In carriers, serogroup B was predominant over non-groupable isolates (NG). There was no evidence of carriage of meningococcal groups A, C, W, X, or Y. Meningococcal isolation was significantly more successful from oropharyngeal compared to nasopharyngeal swabs. Only in five of 17 positive findings, meningococci were detected from both the oropharynx and nasopharynx. No isolation was made from the nasopharynx alone. Conclusion: The lower percentage of meningococcal carriage in young military professionals in the Czech Republic in the study period 2021 as compared to similar reports on military collectives from other countries can be attributed to the current epidemic situation, where the measures taken in connection with the efforts to prevent the spread of COVID-19 resulted in the loss of seasonality of respiratory diseases and also their significantly lower incidence. This correlates with a reduction in carriage in the monitored age category.

Establishing Patient Safety Monitoring in the Benefit-Risk Paradigm for Off-Label and Emergency Use of Medications for COVID-19: A Pharmacovigilance Perspective

Introduction: With the massive widespread impact of COVID-19 [1, 2], before the accelerated development timelines for vaccines, one of the options to help mitigate disease impact was in repurposing already approved drugs [3-6]. In the race to discover/implement an already approved agent, which may also be effective in treating COVID-19, we have learned lessons to form a pharmacovigilance perspective that is central to the conscientious approach one is required to employ to ensure patient safety and continued assessment. This work was written under the umbrella of NASoP and represents learnings/recommendations for safety monitoring relating to off-label use in future pandemics or other emergency scenarios after an appropriate benefitrisk assessment, it does not represent an official view of our respective companies/institutions. Objective(s): Within the lens of optimizing pharmacovigilance through both the planning and the implementation phases of drug repurposing, we outline a strategy and provide suggestions to ensure optimal drug rollout and patient safety. Method(s): An international, multi-institutional expert panel provides a review of lessons learned through a descriptive narrative. Result(s): All drug repurposing should be pursued through a systems approach insuring institutional/regional collaboration, innovation, and data-driven decision making. The roll-out of any repurposed drug should occur in two phases: the planning and implementation. Institutional responses in drug repurposing requires identification of key stakeholders, establishment of local expert working groups tasked with continuous assessment and critical review of emerging literature. The off-label use is at the discretion of the healthcare provider, in collaboration with institutional/regional authorities after an appropriate benefit-risk assessment, and we are not recommending or promoting off-label use. A shared decision making strategy is central to ensure patient involvement and understanding of not just the available evidence, but the rationale and acceptance of the repurposed drug. Pharmacovigilance plays a crucial role in the expedient evaluation of new uses for existing therapies and can rely on already established institutional monitoring modalities. A close institutional partnership with regional/national drug regulatory agencies, healthcare professionals, and pharmaceutical companies allows for a wider breadth of information and experience dissemination for the purposes of patient safety and continuation of a drug's repurposed indication. Conclusion(s): As more data emerges during the COVID-19 pandemic, one can presume other medications for off-label use in COVID-19 will have been identified. Therefore, it is important that increased attention and awareness is created regarding drug safety and the potential harm these medications may have on an individual and reaffirm the critical role of pharmacovigilance expertise.

Am2P: A New Accredited Academic Training Program in Pharmacovigilance and Pharmacoepidemiology Designed for US, Canadian and Caribbean Healthcare Professionals: An International Journal of Medical Toxicology and Drug Experience

Introduction: Pharmacovigilance (PV) is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine/vaccine related problem. Objective: In November 2021, the North American Society of Pharmacovigilance (NASoP), a Chapter of the International Society of Pharmacovigilance (ISoP), launched PV courses for the education of North American stakeholders, in collaboration with Eu2P academic institutions. Methods: The Am2P program (Am2P) follows WHO-ISoP Core Elements of a Comprehensive Modular Curriculum and subscribes to the Innovative Medicines Initiative (IMI) Education and Training quality standards, jointly developed by Eu2P and other IMI Education and Training projects to foster quality in lifelong learning and continuing professional development. Convenient online education in PV supports the mission of ISoP to foster PV scientifically and educationally and enhance the safe and proper use of medicines worldwide. Am2P was designed by experienced PV experts from multiple institutions within NASoP, in partnership with Eu2P instructors, to comprise North America-focused online courses that benefit from existing Eu2P material, education technology, and academic accreditation. Results: Am2P offers two academic options: the Certificate degree and the Short Course certificate of achievement in PV. Four modular course programs are available on the Am2P website (https://www. am2p-courses.com) providing education on core and specialized PV topics with a focus on North America: Basic Pharmacovigilance (PV) & PV regulations;PV for Biologics;External databases/Real World Data/Real World Evidence;Benefit-Risk assessment. Program approval is ensured by the Eu2P Executive Board including academic representatives of the 6 Eu2P degree-awarding universities. Am2P and Eu2P Certificate Courses hold the same academic value. A regular Certificate course involves 75h student workload over three months, recognized as 3 ECTS (European-Credit Transfer and Accumulation System) credits, equivalent to 1.5 American credits. Am2P Short Courses are bite-sized courses to provide or reinforce solid, current knowledge in PV focused on North America. Conclusion: Am2P is a partnership between NASoP and Eu2P to build a set of North America-focused online courses offered in PV. Am2P offers accredited PV training of the highest standard, focused on North America, as an extension of the Eu2P program. Online PV training addresses needs of new entrants to PV, and seasoned personnel.

Establishing Patient Safety Monitoring in the Benefit-Risk Paradigm for Off-Label and Emergency Use of Medications for COVID-19: A Pharmacovigilance Perspective: An International Journal of Medical Toxicology and Drug Experience

Introduction: With the massive widespread impact of COVID-19 [1, 2], before the accelerated development timelines for vaccines, one of the options to help mitigate disease impact was in repurposing already approved drugs [3-6]. In the race to discover/implement an already approved agent, which may also be effective in treating COVID-19, we have learned lessons to form a pharmacovigilance perspective that is central to the conscientious approach one is required to employ to ensure patient safety and continued assessment. This work was written under the umbrella of NASoP and represents learnings/recommendations for safety monitoring relating to off-label use in future pandemics or other emergency scenarios after an appropriate benefitrisk assessment, it does not represent an official view of our respective companies/institutions. Objective: Within the lens of optimizing pharmacovigilance through both the planning and the implementation phases of drug repurposing, we outline a strategy and provide suggestions to ensure optimal drug rollout and patient safety. Methods: An international, multi-institutional expert panel provides a review of lessons learned through a descriptive narrative. Results: All drug repurposing should be pursued through a systems approach insuring institutional/regional collaboration, innovation, and data-driven decision making. The roll-out of any repurposed drug should occur in two phases: the planning and implementation. Institutional responses in drug repurposing requires identification of key stakeholders, establishment of local expert working groups tasked with continuous assessment and critical review of emerging literature. The off-label use is at the discretion of the healthcare provider, in collaboration with institutional/regional authorities after an appropriate benefit-risk assessment, and we are not recommending or promoting off-label use. A shared decision making strategy is central to ensure patient involvement and understanding of not just the available evidence, but the rationale and acceptance of the repurposed drug. Pharmacovigilance plays a crucial role in the expedient evaluation of new uses for existing therapies and can rely on already established institutional monitoring modalities. A close institutional partnership with regional/national drug regulatory agencies, healthcare professionals, and pharmaceutical companies allows for a wider breadth of information and experience dissemination for the purposes of patient safety and continuation of a drug's repurposed indication.