63 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
Analysis of the Drug Related Emergency Department Admissions in Tuscany: The FARO Project
No full textIntroduction: The FARO project is an Italian multiregional project of
active surveillance of drug safety in emergency department (ED). [1]
Aim: We analyzed all the individual case safety reports (ICSRs)
collected in the FARO database in the first three years of the project
for the Tuscany region. We also analyzed the contribution of the
project to the Tuscany reports.
Methods: A total of 9 hospitals contributed to the FARO project in
Tuscany. Dedicated monitors screened everyday ED visits using key
words related to possible adverse drug reactions (ADR) (e.g., druginduced,
reaction to drug). Then, all the selected ED visits were
manually revised and only those caused by an ADR were reported as
ICSRs first in the FARO database, and finally in the national pharmacovigilance
network.
Results: In the three-year period 2020-2022, in Tuscany we reported
the following number of ICSRs: 5043, 9267 and 7133. In the same
period, the ICSRs of the FARO which contributed to the total of
yearly Tuscan reports were 1100 (22%), 474 (5%) and 1574 (22%) for
2020, 2021 and 2022, respectively. Most of the patients of the FARO
project ICSRs were in the 18-65 years group. The seriousness of
ICSRs were equally distributed between ‘‘not serious’’ (52%) and
‘‘serious’’ (48%). Among the ‘‘serious’’ ICSRs, 555 were classified as
‘‘other condition medically significant’’, 401 ‘‘hospitalization’’, 18
‘‘life-threating’’, 6 ‘‘death’’ and 1 ‘‘permanent disability’’. The most
reported outcome was ‘‘recovering’’ (58%). Acetylsalicylic acid was
the most reported suspected active substance (50.3% ‘‘serious’’ and
49.7% ‘‘not serious’’), followed by warfarin (63.4% ‘‘serious’’ and
36.6% ‘‘not serious’’), and amoxicillin-clavulanate (43.9% ‘‘serious’’
and 56.2% ‘‘not serious’’). The three most reported System Organ
Classes were ‘‘gastrointestinal disorders’’ (20%), ‘‘skin and subcutaneous
tissue disorders’’ (14%), and ‘‘nervous system disorders’’
(10%). The three most reported Preferred Term were ‘‘anemia’’ (160),
‘‘epistaxis’’ (147), and ‘‘urticaria’’ (116).
Conclusion: The ED is a privilege observatory for pharmacovigilance,
offering the possibility to intercept ADRs in an outpatient
setting that may result in hospitalization. The FARO project contributed
for more than 20% of the regional ICSRs, with a noticeable
reduction during 2021 due to the massive reporting storm of COVID-
19 vaccine ICSRs
Quality of life in oncologic patients after maxillectomy operations: clinical case series on different rehabilitation protocols
No full textObjective: The study's purpose was to compare the quality of life (QoL) in oncologic patients treated with different rehabilitation protocols following maxillary tumor resections. Patients and methods: The patients were divided into three groups. Group A: 18 Patients with maxillary obturator prosthesis. Group B: 17 Patients with simultaneous autologous tissue reconstruction. Group C: 12 Patients with prosthesis on zygomatic implants. The post-operative QoL was compared using standard questionnaires, investigating items like pain, mood, social relations, and specific functions that could potentially compromise the post-operative QoL. A secondary analysis compared reconstructed vs. non-reconstructed patients. Results: Most questionnaire items did not show significant differences among groups. Statistically significant outcomes were found in two parameters (social contact and sexuality), in which patients treated with zygomatic implants had the best satisfaction, and patients with obturator prostheses showed the lowest satisfaction. Patients belonging to the non-reconstructed group showed better moods than those in the reconstructed group, while taste problem complaints and pain were lower in the reconstructed group. Conclusions: Although the type of reconstruction procedure depends on the type of maxillectomy to be performed and on the general health situation of each patient, the impact of the rehabilitation protocol on the patients' QoL should be accounted for when planning the treatment
Eburiini
No full textEburiini Eburodacrystola pickeli Melzer, 1928: 146; Monné, 2005: 166 (cat). Specimens examined. BOLIVIA, Tarija: Vila Montes (2 km SW, 21 º 16 ’S, 63 º 29 ’W), female, 12– 16.XII. 2011, Wappes, Bonaso & Morris col. (ACMS); Eburodacrys cunusaia Martins, 1997: 66, fig. 3; Monné, 2005: 156 (cat.). Specimens examined. BOLIVIA, Tarija: Vila Montes (2 km SW, 21 º 16 ’S, 63 º 29 ’W), female, 12– 16.XII. 2011, Wappes, Bonaso & Morris col. (ACMS).Published as part of Martins, Ubirajara R. & Galileo, Maria Helena M., 2013, New species and records of Cerambycinae and Lamiinae (Coleoptera: Cerambycidae) from the Neotropical Region, pp. 571-580 in Zootaxa 3683 (5) on page 579, DOI: 10.11646/zootaxa.3683.5.5, http://zenodo.org/record/21812
Assessing disease activity of rheumatoid arthritis patients and drug-utilization patterns of biologic disease-modifying antirheumatic drugs in the Tuscany region, Italy
No full textIntroduction: The disease activity associated with the drug-utilization patterns of biologic Disease Modifying Anti-Rheumatic Drugs (DMARDs) is poorly investigated in real-world studies on rheumatoid arthritis (RA) patients. To investigate the relationship between biologic DMARD initiation/discontinuations in RA patients identified in the healthcare administrative databases of Tuscany and the Disease Activity Score 28 (DAS28) reported in the medical charts. Methods: This retrospective population-based study included RA’s first-ever biologic DMARD users of the Pisa University Hospital from 2014 to 2016. Patients were followed up until 31 December 2019. We evaluated the DAS28 recorded before (T0) and after (T1) the biologic DMARD initiation and before (TD0) and after (TD1) discontinuations. Patients were classified as “off-target” (DAS28 > 3.2) or “in-target” (DAS28 ≤ 3.2). We described the disease activity trends at initiation and discontinuation. Results: Ninety-five users were included (73 women, mean age 59.6). Among 70 patients (74%) with at least three DAS28 measures, 28 (40.0%) were off-target at T0 and 38 (54.3%) in-target at T1. Thirty-three (47%) patients had at least one discontinuation, among those with at least three DAS28 assessments. In the disease activity trend, disease stability or improvement was observed in 28 out of 37 (75.7%) patients at initiation and in 24 out of 37 (64.9%) at discontinuation. Discussion: Biologic DMARD discontinuations identified in the healthcare administrative databasese of Tuscany are frequently observed in situations of controlled RA disease. Further studies are warranted to confirm that these events can be used in studies using healthcare administrative databases as proxies of treatment effectiveness
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