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From tech billionaires turned medical philanthropists to a crusader for improved drug safety, our list of newsmakers this year includes a number of hyper-ambitious individuals.

In pharmacovigilance, disproportionality analyses based on individual case safety reports are widely used to detect safety signals. Unfortunately, publishing disproportionality analyses lacks specific guidelines, often leading to incomplete and ambiguous reporting, and carries the risk of incorrect conclusions when data are not placed in the correct context. The REporting of A Disproportionality analysis for drUg Safety signal detection using individual case safety reports in PharmacoVigilance (READUS-PV) statement was developed to address this issue by promoting transparent and comprehensive reporting of disproportionality studies. While the statement paper explains in greater detail the procedure followed to develop these guidelines, with this explanation paper we present the 14 items retained for READUS-PV guidelines, together with an in-depth explanation of their rationale and bullet points to illustrate their practical implementation. Our primary objective is to foster the adoption of the READUS-PV guidelines among authors, editors, peer reviewers, and readers of disproportionality analyses. Enhancing transparency, completeness, and accuracy of reporting, as well as proper interpretation of their results, READUS-PV guidelines will ultimately facilitate evidence-based decision making in pharmacovigilance.

Background and aim Disproportionality analyses using reports of suspected adverse drug reactions are the most commonly used quantitative methods for detecting safety signals in pharmacovigilance. However, their methods and results are generally poorly reported in published articles and existing guidelines do not capture the specific features of disproportionality analyses. We here describe the development of a guideline (REporting of A Disproportionality analysis for drUg Safety signal detection using individual case safety reports in PharmacoVigilance [READUS-PV]) for reporting the results of disproportionality analyses in articles and abstracts. Methods We established a group of 34 international experts from universities, the pharmaceutical industry, and regulatory agencies, with expertise in pharmacovigilance, disproportionality analyses, and assessment of safety signals. We followed a three-step process to develop the checklist: (1) an open-text survey to generate a first list of items; (2) an online Delphi method to select and rephrase the most important items; (3) a final online consensus meeting. Results Among the panel members, 33 experts responded to round 1 and 30 to round 2 of the Delphi and 25 participated to the consensus meeting. Overall, 60 recommendations for the main body of the manuscript and 13 recommendations for the abstracts were retained by participants after the Delphi method. After merging of some items together and the online consensus meeting, the READUS-PV guidelines comprise a checklist of 32 recommendations, in 14 items, for the reporting of disproportionality analyses in the main body text and four items, comprising 12 recommendations, for abstracts. Conclusions The READUS-PV guidelines will support authors, editors, peer-reviewers, and users of disproportionality analyses using individual case safety report databases. Adopting these guidelines will lead to more transparent, comprehensive, and accurate reporting and interpretation of disproportionality analyses, facilitating the integration with other sources of evidence.

The new approach adopted by the EMA's Pharmacovigilance Risk Assessment Committee builds on existing activities in the member states and the agency, and relies on collaboration with stakeholders.

Antivenom has been the cornerstone of management for snake envenomation since its development and clinical use more than 100 years ago. Frequently used antivenoms are polyvalent antibodies, produced by immunizing animals. Like other protein drugs, antivenom has immunogenicity and may cause acute allergic reactions including ‘anaphylaxis’ ranging from mild to life threatening reactions. Premedication with subcutaneous adrenaline has clear benefit evidenced by reduction of number and extent of these events. Due to diversities of venom composition, to be maximally effective, antivenoms should ideally be produced by using the venoms from species of local origin. For ensuring the ongoing safety and effectiveness of this antivenom, routine pharmacovigilance is necessary. Pharmacovigilance is a systematic, scientific study on adverse events that can be reported to concerned authority (Directorate General of Drug Administration (DGDA) in Bangladesh) by active or passive reporting. Introduction of pharmacovigilance will help to improve the monitoring and management of the AV related risks through identification and assessment of suspected drug adverse reactions,ineffectiveness, and other drug-related problems. Bangladesh drug regulatory authority (DGDA) encourages to report adverse events by health professionals following use of AV. At the same time need based distribution of AV and other logistics to the health care facilities across the country has to be established. Health authority should prioritize the need and take necessary actions to produce AV(s) using the venom from the locally collected medically important venomous snakes. Antivenom is an essential drug for managing a community emergency, snakebite envenomation. J Bangladesh Coll Phys Surg 2024; 42: 273-281

IntroductionMethanol intoxication is a public health problem in developing countries and can be ingested accidentally or with suicidal intent, leading to intoxication in isolated or collective forms. Methanol is used as a substitute for ethyl alcohol in several adulterated alcoholic beverages such as “eau de vie”, which is a drink distilled from dried fruits, such as dates, grapes and figs. Inside the body, it is metabolised into formic acid which, if left untreated, affects brain tissue, leads to blindness and can also cause death.ObjectivesThe objective of this retrospective study of a series of cases was to describe the epidemiological characteristics of methanol “eau de vie” poisoning cases collected by the Anti-Poison and Pharmacovigilance Centre of Morocco between 2013 and 2020 and to explain these results.MethodsThis is a descriptive and retrospective cross-sectional study over a period of 7 years from 1 January 2013 to 31 December 2020, which concerned 16 cases of intoxication by methanol “eau de vie” reported to the Anti-Poison and Pharmacovigilance Centre of Morocco, the study population concerned the entire Moroccan population throughout the territory of Morocco. The analysis concerned the frequency, the distribution in time, the distribution in space, the characteristics of the intoxicated, the type and circumstances of the intoxication and its evolution.ResultsThe CAPM recorded, during the study period, 16 cases of intoxication by methanol “Eau de vie” in Morocco. These cases were reported by telephone in 93.75% of the cases and collected by studies on hospital registers in 6.25% of the cases. Men were more affected than women. The most affected age group was adults, accounting for 50%. Adolescents accounted for 37% of cases and children for 13%. Drug addiction was the most frequent circumstance, followed by accidental intoxication and voluntary intoxication. The most frequently encountered signs were gastrointestinal signs followed by central and peripheral nervous system signs and heart rate and rhythm disorders. The outcome was favourable in 62% of cases, 6% with blindness after-effects and death occurred in 19% of cases.ConclusionsMethanol poisoning can result from the consumption of illegal products containing methanol such as brandy, hence the importance of raising public awareness of this danger. It is also necessary to make health professionals aware of the clinical signs of methanol poisoning and what to do in the event of intoxication.Disclosure of InterestNone Declared

Introduction: Spontaneous reporting is crucial in pharmacovigilance [1]. In Portugal, any citizen can report an adverse drug reaction (ADR) since 2012. Patient input provides a deeper understanding of ADR impact [2]. Patient Associations (PA) are an opportunity to boost pharmacovigilance, since they assume a privileged position with patients [3]. Objective: The aim of our study was to assess the perception of PA about the process of reporting ADRs by their members. Methods: A descriptive cross-sectional study was conducted through an online questionnaire to gather information in three domains: awareness of ADR reporting importance, reporting channels, and RAM Portal. Likert-scales were used and responses were coded in an ordinal scale (\"strongly disagree\", \"disagree\", \"neutral\", \"agree\" and \"strongly agree\"). The online questionnaire was released on April, 27th and is still accepting answers. A total of 133 Portuguese PA were invited to participate in the study. Results: A total of 51 questionnaire responses were collected up to June, 1st. From the respondents, 41.1% (n=21) had more than 500 members. The majority of PA (39.2%; n=20) considered their members don't understand the importance of reporting ADRs for medication safety. Only 7.8% (n=4) assumed that their member knew it was possible to report an ADR autonomously. 66.7% of respondents (n=34) shown that members don't know where to report if they experience an ADR while 94.1% (n=48) had the perception that their members do not know what is \"Portal RAM\". When asked if PA members felt comfortable making a reporting electronically, 64.7% (n=33) expressed their disagreement. Of the PA, 33.3% (n=17) considered the phone to be the most accessible channel for reporting an ADR. Despite only 5.9% (n=3) of the PA have a link to the \"Portal RAM\" on their website, the majority (72.6%; n=37) strongly agree that their involvement it the future reformulation of the reporting form of the Portal would be important. Conclusion: Our findings suggest the need to increase awareness among patients about the importance of reporting ADRs and the available channels for doing so. To improve ADR reporting, is crucial to ensure that reporting platforms are user-friendly and meet the needs of patients. Engaging Patient Associations in this effort is particularly important, given their pivotal role for increasing awareness among patients. By partnering with PA, a reporting system that empowers patients could be developed fostering a reporting culture. This approach has the potential to transform the current landscape of ADR reporting, and ultimately improve patient safe.

Pre-marketing expectations Although in the pre-marketing stage of development, most PV requirements are harmonized across the European and US markets, there are some small, noteworthy variations-for instance FDA's particular requirements around causality assessment, affecting what's submitted in the two regions. Differences exist too between the risk management approaches-FDA's Risk Evaluation and Mitigation Strategies (REMS) versus EMA's Risk Management Plan (RMP)-and one cannot be substituted for the other. In the US, equivalent post-marketing safety requirements are much older and leave much to interpretation, so companies tend to tread a more cautious path.

Background and ImportanceRadioligand therapy, a therapeutic application of the radiotheranostic concept, is based on the use of a therapeutic radiopharmaceutical that targets a biomarker of interest in a given pathology. One example is (177Lu)Lu-DOTATATE, used in the treatment of metastatic or inoperable, well-differentiated gastroenteropancreatic neuroendocrine tumours expressing somatostatin receptors. Clinical trials used to determine the safety of the drug do not represent a ‘real-life’ population. In order to provide a comprehensive safety analysis, we have used the World Health Organization’s pharmacovigilance database, VigiBase.Aim and ObjectivesThis study aims to elucidate a comprehensive safety profile with real-life data of a therapeutic radiopharmaceutical such as (177Lu)Lu-DOTATATE using VigiBase.Material and MethodsAn extraction of individual safety reports (ICSRs) reported and associated with (177Lu)Lu-DOTATATE was performed. The general characteristics of the ICSRs were recorded. Adverse drug reactions (ADR) reporter in the ICSRs were sorted to create an ADR dictionary divided into classes and subclasses. A retrospective disproportionality analysis of ICSRs was then performed using the information component (IC, at alpha risk 0.05: IC025). The different classes of ADR were described, including the identification of overlaps between classes and the time taken for ADR to appear after initiation of the radiopharmaceutical.ResultsA total of 3,984 ICSRs related to (177Lu)Lu-DOTATATE were analysed, with the majority of reports originating from the Americas (65%) and reported by physicians (45%). The most commonly co-reported drugs were octreotide (6%), amino acids (6%), ondansetron (6%), and lanreotide (5%). Disproportionality analysis identified significant associations between (177Lu)Lu-DOTATATE and several ADR classes, including haematologic malignancies (IC025=2.48), haematologic disorders (IC025=2.15), liver disorders (IC025=1.43), renal failure (IC025=1.16), infections (IC025=0.91), alopecia (IC025=0.74), and metabolic disorders (IC025=0.17). The overlaps between classes were identified, including an overlap between haematological disorders and infections. The median time to onset of ADRs was also calculated and the longest delay was observed for haematologic malignancies.Conclusion and RelevanceThe VigiBase pharmacovigilance database, offers essential insights into the safety profile of (177Lu)Lu-DOTATATE and can be leveraged for the evaluation of the safety of other therapeutic radiopharmaceuticals.References and/or AcknowledgementsConflict of InterestNo conflict of interest