196,047 research outputs found
The management of a Y-shaped fracture of the mandibular ramus
No full textRamus fractures are extremely rare. The exact definition of this specific fracture is not uniformly accepted: in fact, some low subcondylar fractures or low coronoid fractures are sometimes, probably erroneously, considered ramus fractures. The fractures of the ramus of the mandible are usually minimally displaced, so that most surgeons manage these fractures by closed reduction. However, mandibular fracture treatment by open reduction and rigid internal fixation provides a number of advantages. Furthermore, some cases of displaced ramus fracture still need surgery. The aim of this article is to present the management of a case of a Y-shaped fracture of the mandibular ramus
Comparative assessment of dexamethasone administration routes for the management of postoperative symptoms following third molar surgery
No full textObjective: The surgical removal of third molars (3 Ms) is often associated with postoperative symptoms such as trismus, edema, and pain. The purpose of this study was to perform a comparative assessment of the effect of dexamethasone by different administration routes. Study design: A randomized, prospective study was carried out including patients undergoing the surgical removal of bilateral impacted mandibular 3 Ms. Patients were grouped according to dexamethasone administration routes Group A (intravenous); Group B (intralesional); Group C (oral administration). After surgery, pain, edema, and trismus were recorded. Postoperative symptoms severity (PoSSE) questionnaires were administered too. Results: 108 patients were allocated to group A, 101 to group B, and 106 to group C. Statistically significant differences (P <.05) with better results were observed as for edema, pain and the results of PoSSe questionnaires by groups A and B. Conclusion: A single intralesional administration of dexamethasone seems to be effective in decreasing postoperative pain, edema, and symptoms after third molar surgery
Erratum to: Deliberate Self-Poisoning: Real-Time Characterization of Suicidal Habits and Toxidromes in the Food and Drug Administration Adverse Event Reporting System (Drug Safety, (2023), 46, 3, (283-295), 10.1007/s40264-022-01269-x)
No full textDear Editor,
On May 4th 2023, the article published in Drug Safety by Fusaroli et al. [1] was presented and discussed in a journal club hosted by the Italian chapter of the International Society of Pharmacovigilance (ISoP). In this interesting article, the authors analysed an impressive series of reports on the phenomenon of deliberate self-poisoning (DSP) using the US FDA Adverse Event Reporting System (FAERS) pharmacovigilance database [1]. This study highlighted, quantified, and characterised a drug safety issue, which is the DSP phenomenon, which may not be adequately examined using other available data sources, such as those cited by the authors (forensic autopsy records, forensic toxicology databases or the Office for National Statistics).
We found it quite intriguing and somewhat surprising that a pharmacovigilance database was utilised to characterise such an event that, although closely associated with drug safety, does not seem to fit the conventional definition of an adverse event (AE) or a suspected adverse drug reaction ADR), specifically with regard to the concept of non-intentionality. An AE can happen during or after the use of a medical product, but it’s not necessarily caused by it, while an ADR is a harmful and unintended response specifically caused by the use of a medical product [2]. Both ‘adverse event’ and ‘adverse reaction’ are characterised by non-intentionality, meaning that they are not intentionally caused.
The document ‘definitions and standards for expedited reporting E2A’ by the International Conference on Harmonisation (ICH E2A), reported a definition of ADR in the post-marketing context, based on the WHO Technical Report Series 498 [1972], which already incorporates the notion of non-intentionality: ‘A response to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of disease or for modification of physiological function’ [3]. It’s important to note that the ICH E2A guidelines are reference documents of the US FDA [4]. The European Medicine Agency (EMA), the Good Pharmacovigilance Practice (GVP) Annex I—definitions state that an ADR is ‘a response to a medicinal product which is noxious and unintended’. Also, this definition emphasises that an ADR is a harmful response that is not intended or expected from the use of the medicinal product. Notably, an update of this definition states that ADRs can arise from use outside the terms of the marketing authorisation, including overdose, off-label use, misuse, abuse and medication errors and the occupational exposure [4]. About the overdose, the FDA clarifies that an AE can occur from drug overdose whether accidental or intentional [5]. However, DSP cases should not be confused with the concept of voluntary abuse or overdose in which the patient has a recreational purpose or seeks a greater therapeutic effect. Deliberate self-poisoning case is defined precisely by the voluntary search for the toxic effect of the drug, i.e., an AE of the drug for anti-conservative purposes, which would seem to be inconsistent with the definition of AE or a suspected ADR. It is also important to note that in their article, Fusaroli et al. [1] excluded from the analysis cases of suicidal ideation induced by drugs and accidental overdose, so we are essentially dealing with cases in which the drug is only the means used for self-harm.
In light of the above, one may question whether collecting DSP cases through the pharmacovigilance system makes sense. Because FAERS database (and probably other large similar repositories) contain numerous reports of DSP cases, many reporters may answer yes. Nevertheless, to address this question, it is important to consider the overall goals of pharmacovigilance, which WHO defines as ‘the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine/vaccine related problem’ [6]. Hence, pharmacovigilance should take an interest in any safety-related issues pertaining to the use of drugs, regardless of whether they align with the definition of an AE. This is especially important when it is possible to intervene through specific actions that can reduce the risks associated with the use of drugs. In our opinion, this type of event should be included in pharmacovigilance databases, because these can produce information that may support regulatory agencies and national governments to implement risk minimisation measures. For instance, restrictions (e.g., limited dispensable dose) can be placed on the ease of patient access to certain drugs that are prone to self-poisoning, with a particular caution for subjects with history of psychiatric disorders. Moreover, appropriate information campaigns can be implemented to raise awareness among health care providers and tutors about the drugs most frequently used for self-deliberated poisoning with recommendation for implementation of access restrictions at home (e.g., keeping drugs in locked drawer or boxes).
In our opinion, it would be appropriate to initiate a discussion on formulating regulatory definitions that encompass drug-related SPD as reportable events in spontaneous reporting systems. Similar to AEs resulting from abuse, misuse, overdose, or medication errors, drug-related SPDs are significant events that warrant reporting. Including them in reporting systems can help to identify and characterise emerging drug safety concerns, improve surveillance, and ultimately defend patients who voluntarily self-harm
Signals of Possibly Persistent Gustatory, Olfactory and Auditory Adverse Drug Reactions to Antibiotic Drugs: A Disproportionality Analysis Using the EudraVigilance Database
No full textOral Presentation: Signal of Hypertension Associated with COVID-19 Vaccination: VigiBase (R) Data and Evidence from Real World
No full textIntroduction: Hypertension is a serious disease that occurs when
blood pressure is persistently elevated over time1. During the COVID-
19 vaccination campaign, several reports of hypertension occurred in
plausible temporal relationship with immunization have been
reported.
Objective: To explore a possible signal of risk of hypertension
associated with COVID-19 immunization using VigiBase the World Health Organization (WHO) pharmacovigilance database and to
review the evidence available from real world.
Methods: We performed a disproportionality analysis using data on
spontaneous reports recorded in VigiBase . Data have been extract
on May 8th, 2022. We calculated reporting odds ratio (ROR) as a
measure of disproportionality for hypertension defined by the Standardized
Medical Dictionary for Regulatory Activities (MedDRA)
query (SMQ) narrow. ROR was estimated for all reports including the
MedDRA preferred term (PT) ‘‘hypertension’’, ‘‘blood pressure
increased’’ and ‘‘hypertensive crisis’’ (cases). All other reports have
been defined as non-cases. All reports in which the suspected causative
agent was a COVID-19 vaccine were used as index reports and
all other reports as reference. A signal was defined by at least three
reports of the PT of interest and ROR025[1. We reviewed the
medical literature using MEDLINE from January 2021 to May 2022
using ‘‘COVID-19 vaccines’’ AND ‘‘hypertension’’ as a search terms
to check for evidence from observational studies.
Results: As of May 8th, 2022, VigiBase included 3,746,090 reports
of adverse events following immunization for COVID-19 vaccines
and 87,653 de-duplicated reports of hypertension define by the SMQ.
We identified 34,955 reports of ‘‘hypertension’’ (ROR:1.3;
ROR025:1.2), 47,733 reports of ‘‘blood pressure increased’’ (ROR:2.6;
ROR025:2.6) and 3,741 reports of ‘‘hypertensive crisis’’ (ROR:4.0;
ROR025:3.8) in which a COVID-19 vaccine was indicated as suspected
causative agent. Most frequently co-reported symptoms
([9%) included headache (n = 16.817; 19.2%), dizziness
(n = 12,892; 14.7%), fatigue (n = 8,406; 9.6%). Overall, 75% of
cases (n = 65,761) have been classified as not serious. A meta-analysis
of observational studies that includes 357,387 individuals
reported 13,444 events of blood pressure abnormal or increased2.
These events have been often described as short periods of hypertensive
response and often observed in patients with risk factors.
Conclusion: Our results confirmed a signal of risk of events of elevated
blood pressure following immunization with COVID-19
vaccines. However, there is no evidence that these episodes could
result in serious complication typically associated with hypertension,
such as stroke, aneurysms, heart failure, myocardial infarction and
chronic kidney disease
Fat overload syndrome following intravenous lipid emulsion administration as antidote in suspected anesthetic intoxication: insights from a clinical and forensic case experience
No full text: Medication errors pose significant risks to patients' health, representing a relevant social and economic issue for the healthcare system. This study focuses on the life-threatening consequences of an overdose of intravenous lipid emulsion (ILE), used as an antidote for suspected bupivacaine intoxication in a young woman undergoing hip surgery. Shortly after administration of the local anesthetic, the woman experienced cardiac arrest and was admitted to the intensive care unit with severe respiratory failure, metabolic acidosis and deep coma. Despite medical intervention, her condition worsened, leading the medical team to administer ILE for suspected bupivacaine intoxication. The patient's condition did not improve and ultimately resulted in death. The autopsy highlighted a widespread presence of oily material in the vascular system, compatible with an overdose of ILE. At a checking, medical records reported a dose of ILE that was 4-fold higher than the recommended dose in this off-label indication. This case report highlights the important need for healthcare professionals to understand the risks of using ILE as an antidote. Adequate monitoring of these "sentinel events" and their critical evaluation can lead to the implementation of specific clinical risk management protocols to reduce the risk for the patient and contain healthcare costs
Dr. Duane M. Jackson, Morehouse College, July 2011
No full textThis video is a conversation with Dr. Duane M. Jackson. Dr. Jackson talks about his paper, "Recall and the Serial Position Effect: The Role of Primacy and Recency on Accounting Students' Performance." Jackie Daniel, AUC Woodruff Library, is the interviewer
"Reflections on the subject of Emigration from Europe with a view to Settlement in the United States" By M. Carey.
No full text"Reflections on the subject of Emigration from Europe with a view to Settlement in the United States: containing bried sketches of the moral and political character of those states.
By M. Carey, member of the American philosophical, and of the American Antiquarian Society, and author of The Olive Branch, Cindiciae Hibernicae, essays on banking, on political economy, and on internal improvement.
To which are now added the English editor's comments on the subject; together with Important Advice to Emigrants, and Cautions Against Impositions Practiced in the Outports
Dispelling the Myths Behind First-author Citation Counts
No full textWe conducted a full-scale evaluative citation analysis study of scholars in the XML research field to explore just how different from each other author rankings resulting from different citation counting methods actually are, and to demonstrate the capability of emerging data and tools on the Web in supporting more realistic citation counting methods. Our results contest some common arguments for the continued
use of first-author citation counts in the evaluation of scholars, such as high correlations between author rankings by first-author citation counts and other citation
counting methods, and high costs of using more realistic citation counting methods that are not well-supported by the ISI databases. It is argued that increasingly available digital full text research papers make it possible for citation analysis studies to go beyond what the ISI databases have directly supported and to employ more
sophisticated methods
Dr. Glendon Swarthout
No full textHosted by Roger M. Busfield, MSU Assistant Professor of Speech and Theater, Meet the Author is designed to introduce a general audience to a contemporary author and their work through in-depth interviews. This episode features a conversation between Dr. Glendon Swarthout, prolific author and English professor at MSU, and assistant professors Sam S. Baskett and Theodore B. Strandness
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