Postmarketing Spontaneous Pharmacovigilance Reporting Systems

2021 ◽  
pp. 113-135
Author(s):  
Gerald J. Dal Pan ◽  
Marie Lindquist ◽  
Kate Gelperin
Keyword(s):  
Pharmaceutics ◽  
2021 ◽  
Vol 13 (5) ◽  
pp. 684
Author(s):  
Michela Piezzo ◽  
Roberta D’Aniello ◽  
Ilaria Avallone ◽  
Bruno Barba ◽  
Daniela Cianniello ◽  
...  

Background: The introduction of trastuzumab biosimilars in clinical practice plays an important role in promoting the sustainability of healthcare systems. By contrast, the switching process can be challenging to the clinics. This survey describes the switching process at a National Cancer Institute over a period of 2 years. Methods: Data regarding all trastuzumab-based regimens for breast cancer (BC) from 1 January 2019 and 31 December 2020 were extracted from both adverse drug reactions (ADRs) reporting systems and electronic systems involved in inventory management, prescribing, dispensing, and administration. Both patients under monotherapy and combination treatment regimens were included. There were no exclusion criteria. Results and Conclusions: Overall 354 patients received at least one trastuzumab-based regimen for a total of 493 lines of treatment and 5769 administrations. Biosimilar were used in 34.3% of trastuzumab-based treatments. No differences between biosimilars and reference drug have been observed in terms of ADRs. The effective cost-saving of the first 2 years is greater than EUR 800,000 and it is estimated to increase over time.


Author(s):  
Manju Rahi ◽  
Payal Das ◽  
Amit Sharma

Abstract Malaria surveillance is weak in high malaria burden countries. Surveillance is considered as one of the core interventions for malaria elimination. Impressive reductions in malaria-associated morbidity and mortality have been achieved across the globe, but sustained efforts need to be bolstered up to achieve malaria elimination in endemic countries like India. Poor surveillance data become a hindrance in assessing the progress achieved towards malaria elimination and in channelizing focused interventions to the hotspots. A major obstacle in strengthening India’s reporting systems is that the surveillance data are captured in a fragmented manner by multiple players, in silos, and is distributed across geographic regions. In addition, the data are not reported in near real-time. Furthermore, multiplicity of malaria data resources limits interoperability between them. Here, we deliberate on the acute need of updating India’s surveillance systems from the use of aggregated data to near real-time case-based surveillance. This will help in identifying the drivers of malaria transmission in any locale and therefore will facilitate formulation of appropriate interventional responses rapidly.


Author(s):  
Andrea Borghesi ◽  
Nicola Sverzellati ◽  
Roberta Polverosi ◽  
Maurizio Balbi ◽  
Elisa Baratella ◽  
...  

Abstract Purpose Chest imaging modalities play a key role for the management of patient with coronavirus disease (COVID-19). Unfortunately, there is no consensus on the optimal chest imaging approach in the evaluation of patients with COVID-19 pneumonia, and radiology departments tend to use different approaches. Thus, the main objective of this survey was to assess how chest imaging modalities have been used during the different phases of the first COVID-19 wave in Italy, and which diagnostic technique and reporting system would have been preferred based on the experience gained during the pandemic. Material and Methods The questionnaire of the survey consisted of 26 questions. The link to participate in the survey was sent to all members of the Italian Society of Medical and Interventional Radiology (SIRM). Results The survey gathered responses from 716 SIRM members. The most notable result was that the most used and preferred chest imaging modality to assess/exclude/monitor COVID-19 pneumonia during the different phases of the first COVID-19 wave was computed tomography (51.8% to 77.1% of participants). Additionally, while the narrative report was the most used reporting system (55.6% of respondents), one-third of participants would have preferred to utilize structured reporting systems. Conclusion This survey shows that the participants’ responses did not properly align with the imaging guidelines for managing COVID-19 that have been made by several scientific, including SIRM. Therefore, there is a need for continuing education to keep radiologists up to date and aware of the advantages and limitations of the chest imaging modalities and reporting systems.


Author(s):  
Giovanni Gabutti ◽  
Erica d’Anchera ◽  
Francesco De Motoli ◽  
Marta Savio ◽  
Armando Stefanati

Starting from December 2019, SARS-CoV-2 has forcefully entered our lives and profoundly changed all the habits of the world population. The COVID-19 pandemic has violently impacted the European continent, first involving only some European countries, Italy in particular, and then spreading to all member states, albeit in different ways and times. The ways SARS-CoV-2 spreads are still partly unknown; to quantify and adequately respond to the pandemic, various parameters and reporting systems have been introduced at national and European levels to promptly recognize the most alarming epidemiological situations and therefore limit the impact of the virus on the health of the population. The relevant key points to implement adequate measures to face the epidemic include identifying the population groups most involved in terms of morbidity and mortality, identifying the events mostly related to the spreading of the virus and recognizing the various viral mutations. The main objective of this work is to summarize the epidemiological situation of the COVID-19 pandemic in Europe and Italy almost a year after the first reported case in our continent. The secondary objectives include the definition of the epidemiological parameters used to monitor the epidemic, the explanation of superspreading events and the description of how the epidemic has impacted on health and social structures, with a particular focus on Italy.


2016 ◽  
Vol 42 (2-3) ◽  
pp. 393-428
Author(s):  
Ann Marie Marciarille

The narrative of Ebola's arrival in the United States has been overwhelmed by our fear of a West African-style epidemic. The real story of Ebola's arrival is about our healthcare system's failure to identify, treat, and contain healthcare associated infections. Having long been willfully ignorant of the path of fatal infectious diseases through our healthcare facilities, this paper considers why our reimbursement and quality reporting systems made it easy for this to be so. West Africa's challenges in controlling Ebola resonate with our own struggles to standardize, centralize, and enforce infection control procedures in American healthcare facilities.


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