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Conclusion: Computerized determination of CBA was helpful in preventing adverse reactions, identifying which drugs are responsible for adverse reactions and modifying therapy to avoid the occurrence of adverse events. However, these patterns might be insightful for decision-makers and regulatory authorities—like the EMCDDA—to prognosticate and prevent addiction catastrophes. The views and opinions of authors expressed herein do not necessarily state or reflect those of EDCTP. Conclusion: In clinical practice, a significantly better benefit profile has been demonstrated for kidney recipients treated with TAC compared to CsA. Surveillance of toxic exposures: the pilot experience of the Poison Control Centers of Milan, Pavia and Bergamo in

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Conclusion: The vigiGroup animated explainer video was effective in communicating cluster analysis of adverse event reports to an audience of both pharmacovigilance and non-pharmacovigilance professionals.

Increasing the use of such videos, to complement scientific literature, could be an effective way of building knowledge of complex statistical methodology and scientific developments more broadly. The power of storytelling and video: a visual rhetoric for science communication. Bredbenner K, Simon SM. Video abstracts and plain language summaries are more effective than graphical abstracts and published abstracts.

PLoS One. Consensus clustering for case series identification and adverse event profiles in pharmacovigilance. Artif Intell Med. Introduction: Data from ongoing open-label clinical studies are assessed for safety signals on a set cadence, complying with regulatory requirements. One challenge is the need to contextualize safety when individual subjects have different exposure times rolling enrollment.

Such issues resolve at the end of the study. However, during the study, visualizations add considerable value to the multidisciplinary discussion of incoming safety data. The tool produces a column x-axis for each subject with a height y-axis corresponding to exposed time. Subjects are grouped by exposure in open-label or completed studies , and AEs are displayed relative to start of exposure by symbols on each subject-column.

The entire population can be displayed, or the display can be limited to the patients with the event s of interest. This allows viewing of AEs in the context of total study population number of columns and total exposed time area of the graph as a whole , or to narrow the focus to affected patients. Although the tool is capable of calculating AE incidence rates, its real value for the assessment of ongoing studies lies in the ability to display events and patient time in an adaptive and intuitive way that allows for meaningful discussion of safety data.

Conclusion: Interactive data visualizations can enhance internal risk communication and clinical decision-making during ongoing clinical trials. Introduction: In , European pregnancy prevention program for oral retinoids, i. Objective: To measure the impact of the RMMs on utilization patterns of oral retinoids, alternative medications, contraceptives, and on rates of pregnancies occurring concurrently with retinoid prescriptions.

Common analysis scripts were implemented by study sites. An interrupted time series analysis was performed to assess immediate changes after the implementation level change and over time trend change. Results: The study population comprised 11,, females of childbearing age 12—55 years , 88, persons used an oral retinoid at any point during the study period. Monthly incidence and prevalence rates showed that retinoid prescriptions have a strong seasonal pattern with peaks of use in winter months.

The low level of recording of pregnancy tests did not allow for trend analysis. Pregnancy rates varied between 0. Conclusion: Based on the findings, there is very limited measurable impact of the RMMs among females of childbearing age in the included databases.

Moreover, pregnancies still happen during oral retinoid treatment after the implementation. Updated measures for pregnancy prevention during retinoid use. Compliance with pregnancy prevention programmes of isotretinoin in Europe: a systematic review. Br J Dermatol. Isotretinoin exposure during pregnancy: a population-based study in the Netherlands.

BMJ Open ;4:e Clin Pharmacol Ther. Introduction: During the recent covid vaccination campaign, the number of ICSRs reported by patients and professionals has dramatically increased, reaching up to almost 1 M declarations only in Europe EMA numbers. Before the covid pandemic, this system was successful in detecting ADRs from the patient reports declared through the French web national reporting system 1, 2. However, how it behaves in conditions of higher reporting flow rate is unknown at present.

The encoding of regional pharmacovigilance centers was employed as the reference ground truth to train the algorithm in a supervised manner.

Moreover, a panel of three pharmacologists, with significant experience in ADRs encoding, was set-up to perform a case-by-case analysis of hundreds reports for which the algorithm provided improper encoding. Results: Overall, Of this, Because the percentage of newly reported ADRs increased over time and was higher for vaccine than not-vaccine related reports, we split the training and validation sets in batches with similar ADRs distribution.

Performance evaluation is currently under process. Initial feedbacks from the analysis performed by the experts are showing an uneven distribution of false positive and false negative across samples. Results from the other experts are needed to confirm this finding. Conclusion: The core findings of this study will be gathered in the forthcoming weeks and be ready for the ISoP meeting in September. This work will provide new insights about the effectiveness of deploying AI as a support to treat real world data in a context of sanitary crisis.

Validation of an artificial intelligence pipeline to support the automatic coding of patient adverse drug reaction reports, using nationwide pharmacovigilance data. Drug Safety. Introduction: The analysis of spontaneous reporting systems aims to identify potential adverse drug reactions in a timely and cost-effective manner. For their apparent simplicity, disproportionality analyses assessing the disproportionate presence of single drug-adverse event associations in spontaneous reports are rapidly expanding as a source of safety evidence complementary to clinical trials.

However, the world and spontaneous reports is more complex than that: events occur in syndromes, drugs are taken in polytherapy, and patients are mosaics of multiple comorbidities.

Network science is one of the most promising approaches to tackle such complexity. Objective: To investigate the applications and promises of network science to spontaneous reporting data. Methods: We identified four key examples to highlight the potentiality of network approaches to pharmacosurveillance: multiple drug intake in suicidal attempts, iatrogenic syndromes i.

Entities e. We used co-reporting frequencies to describe cooccurrence patterns for example, polytherapy and iatrogenic syndromes. We used marginal and partial correlations to investigate the associations between entities and their direction: for example, to identify biases and secondary adverse events. We used multilevel algorithms to identify clusters of interest, and network measures to identify trends of co-reporting. Results: The multiple drug intake network showed paracetamol at the center, as a drug of choice both alone and in combinations, and common combinations separated by therapeutic area, plausibly because of availability The Covid adversome identified a cluster of drug-induced hepatic injury and arrhythmia, and a disease-related cluster with Covid infection and respiratory conditions 1.

The immunotherapy adversome identified not only the known overlap syndrome cooccurrence of myocarditis, myasthenia, and myositis , but also another cluster with hepatitis, colitis and thyroiditis. Finally, investigating reactions to oxycodone, we observed that the reporting of crime and psychosocial reactions was secondary to the reporting of drug dependence. Conclusion: Networks allow to visualize and compare individual relations, identify clusters, and gather insights into the direction of correlation e.

Networks can complement traditional descriptive and disproportionality analyses characterizing the complexity of spontaneous reporting data. Frontiers in Pharmacology.

Introduction: The spontaneous reporting system SRS has proven to be a cornerstone in the early and cost-effective detection of adverse drug reactions ADRs []. Electronic Health Records EHRs are relatively untapped sources of real-world information that can be used in order to facilitate signal detection in pharmacovigilance PV.

However, utilizing the EHR for PV involves a number of critical challenges including the efficient extraction of valuable pieces of information from unstructured bulk of free-text. Objective: To explore whether targeted searches in structured and unstructured fields in EHRs can be used as a method to detect possible cases in addition to spontaneous reports to strenghten a potential safety signal.

Suspected ADRs refer to potential signals based on the analysis of spontaneous reports with insufficient evidence insight into a possible relationship between the ADR and the drug. Per potential signal, a search with a validated text-mining software tool Ctcue was performed via combined queries on both structured and unstructured data [4].

In order to perform the process of case detection systematically, a step-by step search plan was developed and applied to each signal based on:. Results: The search retrieved 27 cases with flucloxacillin induced hypokalemia. After five confirmed cases via manual validation, no further validation was performed for the established ADRs. For each suspected ADR potential signal , one validated case was detected.

Conclusion: A targeted search on structured and unstructured fields in EHRs using text-mining can be used as a method to detect additional cases next to spontaneous reports for a potential safety signal. It is recommend to implement this as a complementary method in the current pharmacovigilance system.

Evaluation of FDA safety-related drug label changes in Pharmacoepidemiol Drug Saf ;22 3 — A description of signals during the first 18 months of the EMA pharmacovigilance risk assessment committee. Drug Saf ;37 12 — Raine J. Risk management: a European Regulatory view. Clinical pharmacology and therapeutics, 3 , — Research has proven that when patients are admitted to hospital, there are often changes to medication regimens 2, 3.

Further research is necessary to establish if pharmacists’ interventions on ensuring safety during patients’ healthcare journey from hospital admission to discharge, differs between MDS using patients and non-MDS using patients. Objective: The aim of this study was to analyse hospital pharmacists’ interventions for patients’ healthcare journeys for MDS using and non-MDS using patients. The study took place over four months from 1st July to 31st October There were initially admission episodes included in the study, and for each adult patient their healthcare journey from hospital admission to discharge was analysed for interventions and workforce input.

Interventions were ranked using the validated Eadon Scale 4. Results: A total of patients’ healthcare journeys were analysed. Patients whom did not have complete healthcare journeys from hospital admission to discharge were excluded. These patients had either died, had been transferred to another hospital, or were still inpatients when the study ended.

There were Of the total MDS using patient journeys, Of the total non-MDS using patient journeys, Conclusion: This study has identified that the use of MDS increase the burden to pharmacist workforce input. It is evident from the findings, that interventions may be needed for the majority of MDS using patients. It has highlighted that more significant interventions, Eadon Scale 5, are more prevalent for MDS using patients in comparison to non-MDS using patients.

Relationship of in-hospital medication modifications of elderly patients to postdischarge medications, adherence, and mortality. Ann Pharmacother. Drug changes at the interface between primary and secondary care.

Int J Clin Pharmacol Ther. Eadon H. Assessing the quality of ward pharmacists’ intervention. International Journal of Pharmacy Practice. Validation of a hospital clinical pharmacy workforce calculator: a methodology for pharmacy? International Journal of Clinical Practice. Introduction: Hypertension is a serious disease that occurs when blood pressure is persistently elevated over time 1. During the COVID vaccination campaign, several reports of hypertension occurred in plausible temporal relationship with immunization have been reported.

Data have been extract on May 8th, All other reports have been defined as non-cases. All reports in which the suspected causative agent was a COVID vaccine were used as index reports and all other reports as reference.

A meta-analysis of observational studies that includes , individuals reported 13, events of blood pressure abnormal or increased 2. 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 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. Introduction: Intravitreal drugs such as bevacizumab, ranibizumab, and aflibercept are widely used to treat a wide range of retinal diseases.

Several studies suggest that repeated injections of these drugs may lead to a sustained rising of intraocular pressure increasing risk for glaucoma. To date, a comparative safety study of these three drugs with respect to the incidence of glaucoma diagnosis has not been done. Objective: The objective of this study was to evaluate the risk of glaucoma diagnosis compared among new users of bevacizumab, ranibizumab, and aflibercept in Tuscany.

Methods: A retrospective cohort study using the Tuscan regional administrative database was conducted. Subjects with a first intravitreal injection index date between January —June were identified and followed to the first occurrence of glaucoma diagnosis. Patients with less than a five-year look-back period, those with less than one year of follow-up, and those with previous use of intravitreal dexamethasone, diagnosis of diabetes or glaucoma were excluded.

We also excluded patients for whom we could not track the first injection to bevacizumab, ranibizumab or aflibercept. Glaucoma diagnosis was identified from exemptions, diagnosis in hospital discharge records or drug dispensations. An intention-to-treat analysis was conducted to analyze risk of glaucoma diagnosis between the three drugs. A Cox model was constructed to compute hazard ratios adjusting for age, sex comorbidities, corticosteroid use and binocularity. The risk of incident glaucoma diagnosis compared to aflibercept was significantly higher among non-anticoagulant users who had received ranibizumab HR 2.

Among anticoagulant users no statistically significant difference was observed. Moreover, we found an increase in the risk of glaucoma with ranibizumab and bevacizumab compared to aflibercept among non-anticoagulant users. A time dependent exposure analysis is ongoing to confirm these results. Introduction: A method of time-to-onset TTO signal detection for screening unexpected temporal patterns from vaccine spontaneous report data has been published in [1].

Due to the large number of spontaneous reports associated to covid vaccines, highly significant TTO signals could be detected whereas there are no clinically relevant unexpected temporal patterns.

Methods: The revised method used only the most predictive measure [3] of the two Kolmogorov-Smirnov KS tests originally designed: the p-value of the KS test of the TTO distribution of a given event post a given vaccine against the TTO distribution of the same event post other vaccines.

A threshold on the Kolmogorov-Smirnov distance, that can have values between 0 and for no difference between time-to-onset distributions and 1 for extreme differences—was set at 0. A threshold on the p-value of the KS test was set at 0.

The Vaccine Adverse Event Reporting System was prospectively frozen every week of the first quarter and the revised TTO signal detection method was prospectively applied on the two covid vaccines.

The performance in detecting events that were posteriori determined as causally related to the exposure of the covid vaccines, namely Pericarditis and Myocarditis, was retrospectively assessed. Conclusion: The revised TTO method allowed early detection of unexpected TTO patterns post exposure to covid vaccines by controlling both the level of significance and the magnitude of difference between the TTO distributions in a context of mass vaccination where individual case review is challenging.

Van Holle L et al. Using time-to-onset for detecting safety signals in spontaneous reports of adverse events following immunization: a proof-of-concept study, PDS 21 6 , — Use of logistic regression to combine two causality criteria for signal detection in vaccine spontaneous report data, Drug Safety 37 12 , — With the fast-tracked development and concurrent introduction of vaccines in all countries, there is a need for equitable safety surveillance to monitor adverse events following immunization AEFIs in high-income and low- and middle-income countries LMICs.

Reports from females made up The highest number of reports came from persons 18—44 years. Sputnik V contributed the highest percentage of AEs per vaccine for Africa. Headache, pyrexia, injection site pain, dizziness, and chills were the top 5 reported AEs for Africa and RoW. Qualitative findings revealed decisions of many funding organizations to fund safety surveillance in LMICs were influenced by considerations about country priorities, the perceived utility of the evidence generated for local decision making, and the contributions to global health by safety surveillance systems.

Funding decisions by donor organizations were influenced by country priorities and the perceived value added by data generated from safety surveillance systems in LMICs to local and global decision making.

Coronavirus Vaccine Tracker. The New York Times [Internet]. Introduction: Therapeutic advances have reduced morbidity and mortality, but have led to an increase in adverse drug events ADE. This is a case-control type study, with the original information from the administrative data from the hospital information system of the public health system in Brazil-SIH-SUS, in the period from to After applying the exclusion criteria, , hospital admissions associated with at least one ADE were included in the study.

The proportion of patients with ADE in hospitalizations was 0. Drug poisoning and drug abuse are the adverse event classes most associated with increased risk of death.

This study, confirm that the SIH-SUS is a robust source of data for the field of pharmacovigilance, enabling the identification of risk factors for death and facilitating the monitoring of ADEs in the hospital environment. Mortality among patients due to adverse drug reactions that occur following hospitalisation: a meta-analysis. Prospective identification versus administrative coding of adverse drug reaction-related hospitalizations in the elderly: A comparative analysis.

Pharmacoepidemiol Drug Saf. Evaluating adverse drug event reporting in administrative data from emergency departments: a validation study. Stausberg J, Hasford J. Drug-related admissions and hospital-acquired adverse drug events in Germany: a longitudinal analysis from to of ICDcoded routine data.

Introduction: Transplant recipients are chronically ill patients, who require lifelong drug therapies to prevent reject and graft loss. To date, there is no consensus on the optimal immunosuppressive strategy [].

Objective: The aim of the study was to assess the effectiveness and safety of maintenance immunosuppressive drug therapies in kidney transplant. Methods: A retrospective multicentre observational study, involving 4 Italian regions, was conducted based on the national transplant Information system and regional healthcare claims data.

Specifically, the regional analytical datasets regarding incident patients underwent to kidney transplant in the years —19 were created using an open-source tool for distributed analysis. Results: Overall, 3, kidney recipients were considered, of which During a median follow-up period of 4. Among safety outcomes, serious infections had the highest incidence 9.

Conclusion: In clinical practice, a significantly better benefit profile has been demonstrated for kidney recipients treated with TAC compared to CsA. In particular, the combination of TAC and mTOR appears to be the optimal strategy reducing the incidence of severe infections.

Our findings on long term risk-benefit profile of immunosuppressive therapy may be helpful to define the optimal drug therapy in kidney recipients. Comparison of tacrolimus and cyclosporine for immunosuppression after renal transplantation: An updated systematic review and meta-analysis. Saudi J Kidney Dis Transpl.

Target of rapamycin inhibitors TOR-I; sirolimus and everolimus for primary immunosuppression in kidney transplant recipients. Cochrane Database Syst Rev. Timing of mTORI usage and outcomes in kidney transplant recipients. Int J Med Sci. Published Jan 9. Due to the small sample size of pivotal trials in pediatrics, real-world evidence on the safety of those vaccines in the pediatric population is urgently required. Objective: i To investigate the safety of COVID vaccines by measuring frequencies of solicited and serious adverse events following immunization AEFIs with the first and the second doses of vaccines through active surveillance and, ii to compare the results with the published clinicaltrials in children and adolescents.

Of them, only Overall, Conclusion: This study confirmed safety profile of COVID vaccines in the pediatric population as already documented in the pivotal trials, with a high frequency of local solicited adverse events and an extremely low rate of serious adverse events. Introduction: Advances in the treatment of cancer in young patients have led to great improvements in life expectancy. However, treatment with chemo or radiotherapy causes reduction of sperm counts often to azoospermic levels that may persist for several years or be permanent.

Oligospermia or azoospermia and long-lasting testicular atrophy are common adverse consequences of cancer treatment 1. Cases of oligospermia and azoospermia were identified using MedDRA v No Dis-Rep was found for any of the 14 AA TKIs: acalabrutinib, axitinib, cabozantinib, dacomitinib, lenvatinib, neratinib, nintedanib, pazopanib, ponatinib, regorafenib, sorafenib, sunitinib, tivozanib and vandetanib.

The analysis in VigiBase database yielded similar results. Our results however, should be interpreted with caution as disproportionality analyses are hypothesis generating rather than hypothesis testing.

Meistrich, M. Clinical drug investigation. Bate A, Evans S. Quantitative signal detection using spontaneous ADR reporting. A comparison of measures of disproportionality for signal detection in spontaneous reporting systems for adverse drug reactions.

Skin lightening products contain high concentrations of harmful ingredients such as hydroquinone, mercurials, and corticosteroids, and are reported to cause serious complications such as hyperpigmentation, exogenous ochronosis, wound dehiscence, nephropathy, steroid addiction syndrome, predisposition to infections, and other endocrinologic complications. Despite all these public health risks, they have been used in many countries without regulation and consultation of healthcare professionals 3.

Similarly, in Eritrea, there is uncontrolled marketing and use of SLAs even those with banned harmful ingredients. Objective: This study was conducted to assess the perception and utilization of SLAs among females of Asmara, the capital city of Eritrea. Methods: A cross-sectional descriptive study was conducted in representative samples of all beauty salons available in Asmara between May and July The study participants were selected using two-stage stratified cluster sampling technique. The data collected through face-to-face interview was entered and analyzed using CSPro 7.

Results: The study enrolled females. The majority of the respondents agreed that SLAs can make someone white About two-third Of those who ever used SLAs, About half of the respondents With the use of SLAs, Employed females AOR: 1.

Conclusion: Utilization of SLAs among females was prevalent. They were satisfied with its use despite experiencing adverse effects which urges coordinated efforts in tightening the regulation of cosmetics in general and establishment of cosmetovigilance systems in particular. Widespread use of toxic skin lightening compounds: medical and psychosocial aspects. Dermatologic Clinics, Afr Health Sci. The global prevalence and correlates of skin bleaching: a meta-analysis and meta-regression analysis.

Int J Dermatol. Introduction: Drug therapy in paediatrics is often associated with uncertainties due to lack of data from clinical trials. Due to this off-label use, missing paediatric dosage forms and complex dose calculations, medication errors ME occur up to three times more frequently compared to adults [3]. Objective: The aim of the study was to investigate the nature, characteristics and preventability of drug-related hospital admissions in paediatrics.

If parents had given consent for data transfer and further analysis, the suspected ADRs resp. MEs were subsequently validated by a blinded, independent expert team [6]. All ADRs and MEs were assessed with regard to their nature, preventability, severity and drug association. Results: Of Consent for further analysis was obtained for 9. Allergic conditions, seizures incl. Treatment noncompliance, accidental exposure to product and dosing problems mainly underdosing were primarily identified as MEs in connection with the use of antiepileptic drugs, insulins and analogues and other beta-lactam-antibacterials.

Conclusion: Drug-related hospital admissions play a significant role in paediatrics. Moreover, almost half of them are considered preventable and therefore result in unnecessary harm and treatment costs. Dosing databases, training, and systematic screening for ADRs and MEs have great potential to increase the safety of drug therapy in children. Kimland, E. Odlind, Off-label drug use in pediatric patients.

Clin Pharmacol Ther, Magalhaes, J. Eur J Clin Pharmacol, Kaushal, R. JAMA, Smyth, R. PLoS One, Gallagher, R. Schulze, C. J Patient Saf, The lack of staff trained in PV is one of the most serious limiting factors affecting the development of PV in resource-constrained settings. Previous experiences suggest that blending learning programmes can be implemented in resource-limited countries to train health care professionals HCP with remarkable gains in terms of knowledge acquisition.

Methods: We developed the blended-courses integrated with a Train of Trainers scheme [1]. Two e-learning courses were made available on a web-based application, together with a manual on how to combine the e-learning courses together with face-to-face interactions.

The blended course were given in Tanzania, Eswatini and Nigeria. Results: In the three countries 95 participants were trained Table 1. All participants completed the two courses and the mean score of the post-test was significantly greater than on the pre-test Table 1.

In the second level, the participants from the first training were training others. The majority of respondents to questionnaires have been satisfied, declared they felt more involved in PV and reported at least an ADR after the training both in the first and second level.

The trends of reporting increased in the twelve months after the training if compared to the previous twelve months: vs and vs ICSRs were reported to Vigibase for Tanzania and Eswatini National Agency respectively. Conclusion: Our results demonstrated that a blended course can reach an important number of participants and improve their knowledge. It is difficult to establish how much of the increase of reports was attributed to the blended learning training. Alammary A. Blended learning models for introductory programming courses: a systematic review.

Plos one. The views and opinions of authors expressed herein do not necessarily state or reflect those of EDCTP. Introduction: Considering data from the literature in favor of active educational intervention to teach pharmacovigilance, we describe an innovative model of distance learning clinical reasoning sessions CRS of pharmacovigilance with 3rd year medical French students. Objective: The three main objectives were to identify the elements necessary for the diagnosis of an adverse drug reaction, report an adverse drug reaction and perform drug causality assessment.

Methods: The training was organized in 3 stages. First, students practiced clinical reasoning CRS by conducting fictive pharmacovigilance telehealth consultations. Second, students wrote a medical letter summarizing the telehealth consultation and analyzing the drug causality assessment. This letter was sent to the teacher for a graded evaluation.

In the third stage was a debriefing course with all the students. Results: Of the third-year medical students enrolled in this course, participated in the distance learning CRS. The evaluation received feedback from students, with an average score of 8. The qualitative evaluation had only positive feedback. The students appreciated the different format of the teaching, with the possibility to be active. Conclusion: Through distance CRS of pharmacovigilance, medical students’ competences to identify and report adverse drug reactions were tested.

The students experienced the pharmacovigilance skills necessary to detect adverse drug reactions in a manner directly relevant to patient care. The overall evaluation of the students is in favor of this type of method. Methods: This research used a qualitative inductive methodology through thematic analysis.

The first step was to identify, through a literature review, current practices for herbal pharmacovigilance. Based on the findings a semi-structured interview guide was designed, and purposive sampling was used to recruit the interview participants.

By using a snowballing technique more potential participants were reached. Most of these recommendations are applicable worldwide, while some are limited to certain regions.

Tong, A. Consolidated criteria for reporting qualitative research COREQ : a item checklist for interviews and focus groups. International Journal for Quality in Health Care, 19 6 , — Introduction: Although medical cannabis MC has been available in Canada since , lack of recognition of MC as a drug has restricted patient access. The Quebec College of Physicians, between and , authorized MC use only within a research framework. Follow-up ended due to either MC discontinuation, loss to follow-up, 3 years follow-up, or end of data collection May , 6 months after the last patient in.

Data were collected at inclusion and at follow-up visits every 3 months for the first 2 years, then at least once per year in the third year. MC mode of administration ingestion, inhalation, other , and cannabinoid content ratio tetrahydrocannabinol THC -dominant, cannabidiol CBD -dominant, or balanced were documented.

Results: 2, patients were enrolled in the registry mean age Over follow-up, 3. Reports included a total of AEs average 1. The most common PTs were dizziness Conclusion: There were no new safety concerns identified in the Registry, although notable differences in AE profile between modes of administration and cannabinoid content ratios should be considered by health professionals.

Further work identifying and managing risk factors for AEs is warranted to maintain a favorable risk-benefit ratio for MC. Introduction: Dengue is one of top ten global health threats and is a serious burden in the Philippines. Dengvaxia immunization program was launched on April for children 9—year-olds in three regions with high statistics of dengue, hospitalization, and deaths. This was coincidentally the campaign period for national elections.

Use of vaccine, once available, was part of a strategy to control epidemic. Current measures were inadequate. What started as vaccine-vigilance information sparked a public outcry. This led to a series of parliamentary investigations, traditional and social media misinformation and disinformation vilifying the health decision makers and the company, and criminal charges filed against over 20 individuals by the state over alleged unproven vaccine caused deaths.

Despite attempts to correct these narratives by a few health professionals, the damage to institution, the program, the product, and individuals have been done. The consequences of such actions of emotional approach without understanding the science have resulted in creating general vaccine rejection, hesitancy, other outbreaks such as measles, lowered confidence even with recent COVID vaccines.

Objective: This abstract aim to describe the situation at that time in the Philippines and extract lessons that will inform better risk communications during crisis.

Results: Some of the important lessons learned are in risk management and communications. Adverse health product information should be announced with circumspect considering the level of health literacy and risk appreciation in a country.

Partisan politics interfered with poorly understood science, fueled by imprudent comments by officials and health professionals who spoke out of turn, amplified by the media and created chaos. The fear was so palpable that enlightened health professionals refused to provide countervailing facts.

Reinstating the vaccine would be perceived as the government had back-pedaled on a mistake. In the meantime, the drama contributed to vaccination hesitancy and outbreaks.

Conclusion: Public health decisions are policy and regulatory decisions anchored in ethical and utilitarian principles. Edillo et al. Economic Cost and Burden of Dengue in the Philippines. Vannice, et al Mendoza, Dayrit, Valenzuela. Dengue researcher faces charges in vaccine fiasco. Lasco et. Medical populism and immunisation programmes: Illustrative examples and consequences for public health.

Trolleyology and the Dengue Vaccine Dilemma. Dayrit, Mendoza, Valenzuela The importance of effective risk communication and transparency: lessons from the dengue vaccine controversy in the Philippines. Dengue vaccination: a more balanced approach is needed. Introduction: Vaccines are vital tools to control epidemic and pandemic diseases, such as COVID, demonstrating safety and effectiveness. However, rare adverse events of special interest AESIs following vaccination arise with every new emerging pathogen vaccine program.

Adversomics, a set of technologies that measure the inventory of molecules e. The International Network of Special Immunization Services INSIS brings together vaccine safety, public health, and systems biology experts in middle- and high-income countries to investigate the causes of, and identify strategies to mitigate AESIs following vaccination insisvaccine. Brighton Collaboration case definitions and harmonized protocols will be employed to collect detailed clinical data and serial blood samples suitable for adversomics e.

Integration of clinical and biological data will enable comparisons of analyte levels and immune responses within groups over time and between cases and controls. Global collaboration across five continents will ensure adequate sample size. Conclusion: INSIS-led studies will provide insight into pathways triggered in these AESIs and susceptible populations to inform vaccine development strategies to reduce the potential to trigger pathways involved in AESIs, risk-benefit assessment, and personalized vaccination strategies.

Introduction: During the covid 19 period, several countries needed to set up or develop their pharmacovigilance systems, unfortunately containment and the closure of borders prevented the organisation of classic training sessions. Objective: The objective of this work is to present the pharmacovigilance simulation game developed by CAPM, RCC and the results of its pilot use with pharmacovigilants from 10 French-speaking African countries.

The game is based on good practices in Pharmacovigilance PV , and inspired by the different WHO guidelines, the experience of the Moroccan PV center, and behaviors consensually considered as the norm in PV. In fact, they are put in a real-life situation to choose actions and strategies for the development of a PV center and must be able to optimize the human and material resources at their disposal to make their center shine within their national health system but also at the level of the international PV network.

Better understand the challenges and outlooks linked to the creation and management of a PV center. Put into practice the theoretical concepts in causality assessment, signal detection and risk minimization actions.

During the game, within 10 levels, participants have to set up a PV center following WHO pharmacovigilance indicators: a practical manual for the assessment of pharmacovigilance systems as structural indicators, process indicators and outcome indicators, and following the pharmacovigilance process from collecting data, analyzing them, detecting signals, and setting up national technical pharmacovigilance committee to discuss about safety signals and risk minimization actions to put in place.

Conclusion: The use of the game by the pharmacovigilantes during the pilot phase gave good feedback on the ease of use and the effectiveness of the game in capacity building in pharmacovigilance. University of Huddersfield, Huddersfield, pp. Introduction: Pharmacovigilance has traditionally been a reactive science with a significant dependence on spontaneous adverse event reporting. The pandemic on the other hand has accelerated application of novel technologies and approaches to engaging with the patient, remote connected care at their home and dependence on technologies to supplement regular communication channels.

Telemedicine is evolving rapidly and playing a key role in clinical interventions. Objective: Digital Health and novel technologies offer a significant opportunity to enhance pharmacovigilance thru proactive patient monitoring, risk communication, personalized care plans and access to real world data. Leveraging such approaches will not only lead to early detection of risks but also to personalized interventions and improved patient outcomes.

Educational material which is more interactive, visual and multi-dimensional can replace paper or text based risk communication material. This could provide early signal detection in individual patients and enable proactive patient level pharmacovigilance.

Educational and risk related material can be dynamically updated based on patient preferences, interactions and profiles. Machine learning approaches which link material with outcome can enhance impact of pharmacovigilance methods and tools. In order to utilize the full potential of such options it is critical that the regulatory framework is updated to enable such approaches which complement traditional PV and can drive efficiencies and higher effectiveness in the risk communication process.

Collaboration within the network of industry and regulators is essential to further such research and maximize the impact on value for patients, HCPs and sponsors. Introduction: Large amounts of data associated with safety issues are generated along the entire lifetime of drugs, from its infancy as preclinical leads, through its adolescence as clinical candidates, all the way up to its adulthood as marketed drugs exposed to the human population.

Across the different stages in the life of a drug, some of the data collected initially may be confirmed and consolidated with data at an advanced stage, whereas other data may not be translated, and in some cases may even contradict, those safety signals that are ultimately observed in the human population. Collecting and properly integrating such an heterogenous pool of data is a complex and tedious task.

But even if one manages to put all data together, the construction of useful models to anticipate and detect drug safety signals remains a challenge. Objective: The presentation will cover our efforts to connect data from in vitro safety pharmacology, preclinical toxicology, clinical safety and post-marketing spontaneous reports for over 9, small molecule drugs, combination drugs, and biologics. A novel consensus approach using various statistical and machine learning methods to anticipate side effects of potential safety concern, detect adverse drug reaction signals and perform pharmacovigilance analyses will be introduced.

Use case application examples to individual drugs and drug classes will be discussed. Methods: Our consensus approach to post-marketing surveillance integrates four different methodologies based on detection of prior safety markers, identification of class reactions, statistical projection of disproportionalities based on reporting frequencies and velocities, and machine learning models of translational safety data.

Results: Results on the validation of our approach to anticipating adverse drug reactions of safety concern to the population at the postmarketing stage based on i in vitro safety pharmacology data, ii preclinical toxicology data, iii clinical safety data and iv the first sample of 25 postmarketing spontaneous reports will be presented.

Based on data available in each case, the performance of the different methods varies for different drugs, drug classes, and side effects. A discussion on performances in selected use cases will be included.

As an example, the analysis of long-term PARP inhibition on circadian patterns and its dependence on the reporting bias by consumers will be discussed. Conclusion: Integration and modelling of the large amount of translational safety data currently available from all phases of drug discovery, development and post-marketing to anticipate and follow adverse drug reactions opens an avenue to a whole new perspective in pharmacovigilance.

Introduction: Psychedelics are unique psychoactive chemicals that can change consciousness by acting on 5-HT2A receptors []. There is limited knowledge concerning the online interest in psychedelics that we can extrapolate via trends websites. Objective: We aim to examine the online information-seeking behavior concerning the most popular psychedelics, including cannabis—a quasi-psychedelic—in the European Union EU members of interest and the UK before and during the pandemic.

Methods: We designed a “dictionary” of terms to extract online search data from Google Trends concerning psychedelics and cannabis from Jan to 1-Jan We conducted a triple Holt-Winters exponential smoothing—additive model—for time series analysis to infer seasonality [4, 5].

We utilized hierarchical clustering—an unsupervised machine learning method—to explore clusters of countries concerning the spatial geographic mapping of these chemicals.

We also implemented—a t-test—for comparing the slope difference of two trends before versus during the pandemic. Results: There was an evident seasonal pattern for cannabis, NBOMe, and psilocybin in almost all nations of interest. Similar patterns existed in France and the UK, while those in Germany, Sweden, and Romania had relatively shorter periodicity. Analysis of slopes and hierarchical clustering conveyed differentiated patterns concerning the temporal and spatial mapping, respectively, while contrasting the two periods before versus during the pandemic.

Conclusion: Cannabis and psychedelics follow somewhat a consistent pattern concerning seasonality across Europe; some correlate with the seasonal harvesting of mushrooms, and others with public holidays, including Christmas, the new year holiday, or school breaks. The pandemic influenced some significant changes concerning the online interest in the EU and the UK; nonetheless, we should rely on more rigorous longitudinal and experimental study designs—possessing a superior level of evidence—to confirm the causal relationship.

However, these patterns might be insightful for decision-makers and regulatory authorities—like the EMCDDA—to prognosticate and prevent addiction catastrophes. Understanding and using time series analyses in addiction research.

Carhart-Harris RL. How do psychedelics work?. Current Opinion in Psychiatry. Novel psychoactive substances: types, mechanisms of action, and effects. British Medical Journal. Robust forecasting with exponential and Holt—Winters smoothing. Journal of Forecasting. Gardner Jr ES. Exponential smoothing: The state of the art—Part II. International Journal of Forecasting. Introduction: Continuous monitoring of the safety profile of drugs is one of the critical processes of pharmacovigilance.

As medical literature might be valuable source of safety data, especially for rare, unlisted, serious cases, all MAHs are obliged to medical literature monitoring MLM in all marketing countries [1].

This approach can be changed through modern automation techniques. Objective: To develop and test a tool for automated monitoring of local literature and enhance drug safety data identification. Methods: Modern programming approaches were used to create PV platform, intended for automated literature screening.

GAMP 5 recommendations were used to prove the validation status. Results: We developed a tool—DrugCard PV platform which screens local medical sources for updates on a weekly basis. Till May we added around local journals originated from 10 countries that cover different therapeutic areas.

Our tool automatically searches for defined keywords drug trade names, active substances in published articles. Different file formats can be screened including text, pdfs, images etc. In case a new issue of a journal is published—a PV specialist will receive an email notification. The mandatory features of a validated computerized system, like audit trail, logs, reports are also present here.

Instead of manual reading of the whole journal issue the user only should read a separate article, analyze whether there is a valuable safety data and label it depending on the content. PV specialists may work together inside the platform and provide a quality check for labeled articles. Our pilot study of how a new tool may improve the efficiency revealed interesting results. Despite the dramatically decreased amount of time needed, the number of identified ICRSs from literature increased.

During the abovementioned pilot study of automated local literature monitoring lasting 2 months, 31 safety cases were identified valid and non-valid ICSRs. This is much more than usual rate of safety cases finding. It offers increasing efficiency in safety information identification with less time spent on routine activities.

Certificate of copyright in Ukraine. Hyperacute toxicity is a recent newly described entity, albeit incompletely characterized [3]. We selected reports with available information to calculate a plausible time-to-onset. Events of interest were classified into fulminant within 7 days and hyper-acute cases within 21 days, i.

Cases were described in terms of demographic and clinical features: age, gender, anticancer regimen combination vs monotherapy , therapeutic indications, seriousness hospitalization , case fatality rate CFR, namely the proportion of cases where death was reported as outcome , co-reported symptoms, co-reported irAEs. The Immune-Adversome was estimated considering events as nodes and co-reporting as links.

Hyperacute cases 18, represented Monotherapy was reported in the majority of cases Pyrexia, diarrhea, fatigue, dyspnea were the most frequently reported symptoms. Hyperacute myocarditis was reported in Among fulminant cases, most frequent irAEs were interstitial lung disease , colitis , hypothyroidism , and myocarditis Other co-occurring irAEs were colitis-hepatitis-thyroiditis, and arthritis and psoriasis.

Our network approach may complement traditional disproportionality analyses in pharmacovigilance for a more effective signal detection technique, thus supporting regulatory and clinical monitoring, especially in complex scenario such as oncology. Target Oncol ; — Oncologist ; — Hyperacute toxicity with combination ipilimumab and anti-PD1 immunotherapy.

Eur J Cancer ; — Introduction: The prolongation of the QT interval is a serious and potentially fatal adverse reaction that has led to the discontinuation of many drugs including some opioids. Data mining on pharmacovigilance databases can detect signals that identify early the risk associated with some drugs. Results: A total of drug-reaction pairs was found in opioid reports.

Analysis of individual opioids show significant signals for QT prolongation for each drug. The temporal evolution of the different signals according to the number of reports included from to shows early significant positivization of signals in the first 6 to 12 months.

Underlying mechanism is unknown, but it seems to be linked to hERG channel blocking. We propose the evaluation of the trend of change in the confidence intervals of the disproportionality parameters as a measure that can predict the occurrence of clinical events at the population level and a posible usefull strategy to minimize adverse reactions.

Introduction: Language and speech are increasingly debated as potential markers for diagnosing and monitoring patients with affective and psychotic disorders 1—3. However, many neglected factors may confound communicative atypicalities. A comprehensive list of potential confounding drugs will support the design of robust communicative marker studies.


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