Analysis Of Spontaneous Reports Research Articles

Adverse events following immunization reported with COVID-19 vaccines in Burkina Faso: Analysis of spontaneous reports

The rapid deployment of COVID-19 vaccines to a large proportion of the population requires a focus on safety. However, few studies have assessed the safety of COVID-19 vaccines in Africa. In Burkina Faso, this issue has not yet been addressed. The objective of this study was to contribute to the description of the characteristics of adverse events following immunization (AEFIs) related to COVID-19 vaccines in Burkina Faso. This was a cross-sectional descriptive retrospective study of spontaneous reports of COVID-19 vaccine-related AEFIs recorded in VigiBase® between June 2021 and November 2022 in Burkina Faso. Individual case safety reports (ICSRs) were extracted from VigiBase® using the Anatomical Therapeutic Chemical level 2 (ATC2) code. The proportion of ICSRs according to the reporter’s qualification, the reporting rate, the time taken to submit and record ICSRs, and the completeness score were calculated. A total of 973 ICSRs concerned COVID-19 vaccines and represented 32.6% of all 2,988 reports in VigiBase®. Overall, 82.0% of the reporters were nurses/midwives, 7.8% were physicians, 6.7% were pharmacists, and 3.4% were patients. The median time between the onset of AEFIs and the submission of the report to the Pharmacovigilance Center was 180 days (IQR: 136; 281). The median registration time was 188 days (IQR: 149; 286). The mean ICSR completeness score was 0.8 (standard deviation = 0.1). The overall AEFI reporting rate was 27.8 per 100,000 vaccine doses. The AEFI reporting rates for the ChAdOx1-nCoV-19, JNJ 78436735, Elasomeran, Tozinameran, and HB02 vaccines were 454.2, 17.4, 11.0, 10.2, and 0.4 per 100,000 vaccine doses, respectively. The majority of AEFIs were systemic in nature (90.1%). Headache (21.2%), fever (19.4%), and myalgia (11.0%) were the most frequently reported AEFIs. Eighteen cases (1.8%) of serious AEFIs (9 hospitalizations, 4 life threatening, 3 temporary disabilities, and 2 others unspecified) were reported. The majority of AEFIs reported were systemic in nature and mild. However, there have been reports of serious AEFIs. The overall AEFI reporting rate was low. There is a need to strengthen the monitoring of these vaccines to better organize strategies to optimize the adherence of the population of Burkina Faso.

Temporal profile of adverse drug reactions and associated clinical factors: a prospective observational study in a neonatal intensive care unit

ObjectiveAlthough adverse drug reactions (ADRs) are quite common in hospitalised neonates, pharmacovigilance activities in this public are still incipient. This study aims to characterise ADRs in neonates in a neonatal...

Menstrual abnormalities after COVID-19 vaccination in the Netherlands: A description of spontaneous and longitudinal patient-reported data.

During the COVID-19 vaccination campaigns, the number of reports of menstrual abnormalities increased rapidly. Here, we describe the nature and potential risk factors associated with menstrual abnormalities based on spontaneously reporting data as well as data from a prospective cohort event monitoring (CEM) study as these are poorly studied. Reports of menstrual abnormalities received by the Netherlands Pharmacovigilance Centre Lareb in the spontaneous reporting system between February 2021 and April 2022 were summarized. In addition, logistic regression analysis was performed on the reported menstrual abnormalities in the CEM study to assess the association between person characteristics, prior SARS-CoV-2 infection and use of hormonal contraceptives and the occurrence of menstrual abnormalities after vaccination. We analysed over 24 000 spontaneous reports of menstrual abnormalities and over 500 episodes (among 16 929 included women) of menstrual abnormalities in the CEM study. The CEM study showed an incidence of 41.4 per 1000 women aged ≤54 years. Amenorrhoea/oligomenorrhoea and heavy menstrual bleeding collectively accounted for about half of all abnormalities reported. Significant associations were observed for the age group 25-34 years (odds ratio 2.18; 95% confidence interval 1.45-3.41) and the Pfizer vaccine (odds ratio 3.04; 95% confidence interval 2.36-3.93). No association was observed for body mass index and presence of most comorbidities assessed. The cohort study showed a high incidence of menstrual disorders among women aged ≤54 years, and this observation was supported by the analysis of spontaneous reports. This suggests that a relation between COVID-19 vaccination and menstrual abnormalities is plausible and should be further investigated.

Characteristics and outcomes of cases with methylphenidate abuse, dependence or withdrawal: an analysis of spontaneous reports in EudraVigilance.

Methylphenidate (MPH) is a central nervous stimulant, which is mainly used in attention deficit hyperactivity disorder (ADHD) and narcolepsy. In recent years, rising MPH prescription volumes have drawn attention to possible misuse. We analyzed data on suspected MPH abuse, dependence or withdrawal reported to the EudraVigilance database (1996-2019), comparing case characteristics (e.g. age, indications and outcome). In 1531 cases from 35 countries (median: 29 years, 57.6% male), 42.3% had been diagnosed with ADHD and 8.0% with narcolepsy. Narcolepsy cases were older than ADHD cases (mean age: 47 vs. 22 years), and used co-medications more frequently (79.4 vs. 47.8%). Intravenous MPH administration was most common among individuals not diagnosed with ADHD or narcolepsy. A history of abuse, dependence or withdrawal of any substance was more often documented in fatal than in nonfatal cases (49.0 vs. 22.5%), whereas differences regarding the route of administration were less pronounced. Minors, who presumably received MPH for ADHD treatment, presented less frequently with serious outcomes than older cases or those without an approved indication. Prescribers should exercise caution in adult MPH users and should make a thorough co-medication assessment. Finally, more research on substance abuse in narcolepsy patients is required, which should include comorbidities and co-medication.

Adverse drug reactions of macrolide therapy: analysis of spontaneous reports according to the Pharmacovigilance system

Adverse drug reactions of macrolide therapy: analysis of spontaneous reports according to the Pharmacovigilance system

Abuse, dependence and withdrawal associated with fentanyl and the role of its (designated) route of administration: an analysis of spontaneous reports from Europe

PurposeFentanyl, a highly potent synthetic opioid used in cancer and non-cancer pain, is approved for various routes of administration. In Europe, fentanyl consumption increased substantially in the last decades but information on abuse, dependence and withdrawal associated with fentanyl is scarce, especially with respect to its different formulations.MethodsWe analysed case characteristics of spontaneous reports of suspected fentanyl-associated abuse, dependence or withdrawal from European countries recorded in the EudraVigilance database up to 2018 with respect to the (designated) routes of administration and potential indications.ResultsA total of 985 reports were included (mainly from France and Germany) with 43% of cases referring to transdermal fentanyl. Median age was 45 years (48.8% female) and 21.6% had musculoskeletal disorders. Only 12.6% of those using transdermal fentanyl had a cancer diagnosis compared to 40.2% and 26.8% of those using intranasal and oral transmucosal fentanyl, respectively. Depression was common (10.7%) and highest in cases with musculoskeletal disorders (24.9%) as was the use of benzodiazepines. Overall, 39.5% of reports resulted in a prolonged hospital stay and for 23.2% a fatal outcome was recorded. The respective proportions were especially high in cases with musculoskeletal disorders (56.3% with prolonged hospitalisation) and in those using transdermal fentanyl (35.2% fatalities).ConclusionsIn suspected cases of abuse, dependence or withdrawal, fentanyl was mainly used for non-cancer pain indications and most often as transdermal formulations. Depression and prolonged hospitalisations were common, especially in patients with musculoskeletal disorders, indicating a vulnerable patient group and complex treatment situations.

Analysis of adverse reactions of anticancer drugs in the Chuvash Republic

Due to the implementation of the national program “Fight against Oncological Diseases”, a number of anticancer drugs, mainly for targeted therapy and immunotherapy, are annually registered in Russia and included in the list of vital and essential medicines [1]. Purpose: to study the structure of adverse reactions (ADR) when using anticancer drugs based on the analysis of spontaneous reports in the Chuvash Republic for the period 01.09.2008 to 31.12.2021.

Analysis of Spontaneous Reports as a Methodological Pharmacovigilance Tool

This article deals with the problem of undesirable drug reactions (UDR), having particular importance for both pharmacology and the healthcare system as a whole. Up-to-date information on the global prevalence of UDR is presented. A methodological approach to monitoring UDR based on a system of spontaneous reporting (SR) is proposed. An analysis of SR on UDR registered in the Rostov region in 2020 is conducted.

Hypernatremia During Intravenous Treatment With Fosfomycin: A Retrospective Medical Record Review Study and an Analysis of Spontaneous Reports in the EudraVigilance Database.

Background: Hypernatremia is a serious event that can occur during intravenous (IV) treatment with fosfomycin, and it can also be caused by a wrong drug preparation. Considering the clinical significance of hypernatremia, we decided to carry out two studies by using two different data sources with the aim to evaluate cases of IV fosfomycin-induced hypernatremia. Methods: A retrospective medical record review was performed from June 2017 to June 2019 using data from two hospitals in Southern Italy. The information collected was related to the patients, the antibiotic treatment regimen, type of adverse drug reaction (ADR), hypernatremia severity classification, and drug withdrawal due to ADRs. Moreover, a pharmacovigilance study was performed from the date of the European marketing authorization of fosfomycin to October 11, 2021, using data reported on the European website of suspected ADRs. Information related to the patient characteristics, treatment, hypernatremia, and type of reporter was retrieved. Results: From the retrospective medical record review, a total of 62 patients (48 men and 14 women) in treatment with fosfomycin were identified, of which 17 experienced ADRs. Specifically, 11 patients experienced hypernatremia. During the period from June 2017 to June 2018, a total of 63.7% of hypernatremia events were related to the wrong reconstitution of the drug. According to these results, a surveillance and training campaign about the correct drug reconstitution was managed. However, from June 2018 to June 2019, we still had four new hypernatremia cases. Drug withdrawal occurred in only one patient with hypernatremia. From the pharmacovigilance study, a total of 25 cases of IV fosfomycin-induced hypernatremia were retrieved. No substantial difference was found for patients’ distribution by sex. Most cases were classified as serious (68%) and reported “Recovered/resolved” as the outcome (44%). In the majority of cases, fosfomycin was the only suspected drug reported (72%). Conclusion: Our results show that training campaigns on the correct drug preparation need to be strengthened to allow a reduction of hypernatremia cases. Moreover, when close monitoring and management is performed by the infectious disease (ID) specialist and hospital pharmacist, there also is a reduction in antibiotic withdrawal due to hypernatremia.

Remdesivir in the COVID-19 Pandemic: An Analysis of Spontaneous Reports in VigiBase During 2020.

IntroductionThe safety profile of remdesivir, conditionally approved for COVID-19, was limited at its 2020 introduction. Adverse drug reactions (ADRs) for medicines are collected in VigiBase, the WHO Global Database of Individual Case Safety Reports (ICSRs).ObjectiveThis study aimed to provide a descriptive analysis of COVID-19 ICSR data focusing on remdesivir, including a disproportionality analysis (DA) of ADRs.MethodsA dedicated algorithm enabled retrieval of all COVID-19 treatment-specific ICSRs. A severity algorithm based on co-reported medicines and symptoms enabled selection of tocilizumab with its well established safety profile as comparator for remdesivir. Descriptive statistics were used for general ICSR demographics for all COVID-19-specific medicines, remdesivir and tocilizumab individually and furthermore to present treatment patterns of medicines co-reported with remdesivir. A COVID-19 indication-focused DA was deployed to minimize confounding from underlying polysymptomatic disease.Results14,574 COVID-19-related ICSRs were entered into VigiBase during 2020. Remdesivir was the most common medicine reported. Of 4944 remdesivir ICSRs, where tocilizumab was not co-reported, 93% described remdesivir as the sole suspect medicine. Sixty percent of ICSRs concerned males, median age was 63 years and the majority originated from the Americas (72%). In 1089 (21%) of remdesivir ICSRs, data indicated severe/critical disease. Co-reported medicines peaked during the first 3 days of remdesivir treatment. The DA for the established tocilizumab and the new remdesivir were mainly in line with the safety profiles for both medicines but suggested new safety concerns. The most reported ADRs for remdesivir represented liver dysfunction, kidney injury, death and bradycardia.ConclusionGlobal COVID-19-related ADR reporting proved useful in providing information on ADRs as well as on treatment patterns in this patient group. Indication-focused disproportionality analysis, together with the use of a comparator with a known safety profile, proved effective in identifying known safety information and suggested new safety concerns for remdesivir.Supplementary InformationThe online version contains supplementary material available at 10.1007/s40264-021-01091-x.

Immune Checkpoint Inhibitors and Cardiotoxicity: An Analysis of Spontaneous Reports in Eudravigilance.

IntroductionImmune checkpoint inhibitors (ICIs) are widely used in the treatment of many cancers as they improve clinical outcomes. However, ICIs have also been associated with the development of immune-related adverse drug reactions (ADRs). Among immune-related ADRs, cardiac immune-related ADRs are rare, but also associated with high mortality rates.ObjectiveThe objective of this study was to evaluate the occurrence of cardiac ADRs reported with ICIs in the European spontaneous reporting system.MethodsWe retrieved individual case safety reports on ICI-induced cardiac ADRs from the website of suspected ADR (www.adrreports.eu) of the European pharmacovigilance database (Eudravigilance). Data were retrieved from the date of marketing authorization of each ICI (ipilimumab, nivolumab, pembrolizumab, atezolizumab, durvalumab, avelumab, and cemiplimab) to 14 March, 2020. The reporting odds ratio and its 95% confidence interval were computed to assess the reporting frequency of cardiac ADRs for each ICI compared to all other ICIs.ResultsA total of 2478 individual case safety reports with at least one ICI as the suspected drug were retrieved from Eudravigilance, of which 249 (10%) reported more than one ICI. The three most reported ICIs were nivolumab (43.2%), pembrolizumab (32.5%), and the association of nivolumab/ipilimumab (9.4%). A total of 3388 cardiac ADRs were identified. Cardiac ADRs were serious (99.4%) and had a fatal outcome (30.1%). The most reported cardiac events were myocarditis, cardiac failure, atrial fibrillation, pericardial effusion, and myocardial infarction. Nivolumab was reported with a small increased reporting frequency of individual case safety reports with cardiac ADRs compared to all other ICIs (reporting odds ratio 1.09, 95% confidence interval 1.01–1.18).ConclusionsImmune checkpoint inhibitor-induced cardiac ADRs were serious and had unfavorable outcomes. In our study, nivolumab was the only ICI with a small increased reporting frequency of individual case safety reports with cardiac ADRs compared to all other ICIs. In this regard, further head-to-head studies are needed.Supplementary InformationThe online version contains supplementary material available at 10.1007/s40264-021-01086-8.

Gabapentinoid Abuse in France: Evidence on Health Consequences and New Points of Vigilance.

Introduction: Gabapentinoid drugs (gabapentin and pregabalin) are widely used worldwide for epileptic and pain disorders. First signals of gabapentinoid abuse occurred in the last decade. This study aims to describe clinical characteristics of gabapentinoid use related disorders and health consequences in France.Materials and Methods: We designed a multisource investigation reviewing data reported to the French Addictovigilance Network (FAN) with pregabalin and gabapentin from 2010 to 2019. Information was obtained through the analysis of Spontaneous Reports (SRs) notified by health professionals and the pharmacoepidemiological surveys OSIAP (suspicious prescriptions forms indicators of potential abuse), OPPIDUM (observation of illicit drugs and misuse of psychotropic medications), DRAMES (death related to prescription drugs and other substances), and DTA (toxic deaths due to analgesics).Results: Over 2010–2019 period, were collected: (i) 265 SRs (258 pregabalin; 7 gabapentin); (ii) 816 forged prescription forms (805 pregabalin, 10 gabapentin, 1 involving both drugs); (iii) 145 cases of gabapentinoid use in people who use drugs (121 pregabalin; 24 gabapentin) and (iv) 31 cases of gabapentinoid-related deaths (25 pregabalin; 6 gabapentin). Risk factors of gabapentinoid abuse were opioid use disorders or psychiatric history, but cases of primary abuse in subjects without any substance abuse history were observed. Adverse outcomes concern almost exclusively pregabalin, with coma, dyspnea, convulsion, and conduction disorders. Treatment demands increased from 10.6% in 2018 to 23.1% in 2019, with pregabalin cited as the first substance leading to addictological care in the 2019 OPPIDUM survey. Gabapentinoid-related deaths increased over time. Pregabalin has become the first drug mentioned in forged prescriptions in 2019 (23.8% of OSIAP), while it ranked at the 15th position in 2017 (2.6%).Discussion: This study shows the importance of addictovigilance monitoring for gabapentinoids. Addictovigilance data helped to make visible the gabapentinoid-abuse related health harms (hospitalization for serious neurologic, psychiatric or cardiac effects, requests for addictological support and deaths) and to confirm the intrinsic abuse potential of pregabalin. These data highlight new points of vigilance considering observed primary abuse. At this point in France, the risk of abuse and related complications is very apparent with pregabalin. Still, it is identical to that observed elsewhere with gabapentin.

Allopurinol-Induced Severe Cutaneous Adverse Drug Reactions: An Analysis of Spontaneous Reports in Malaysia (2000-2018).

Allopurinol-induced severe cutaneous adverse drug reactions (SCARs) are potentially debilitating and life-threatening reactions, which can cause a financial burden to the healthcare system. We aimed to identify risk factors for allopurinol-induced SCARs and to assess their impact on fatality. Adverse drug reaction (ADR) reports with allopurinol as suspected drug were extracted from the Malaysian pharmacovigilance database from year 2000 to 2018. Multiple logistic regression analysis was used to identify significant predictors of allopurinol-induced SCARs. We further analysed the association between covariates and SCARs-related fatality in a separate model. Level of significance was set at p value < 0.05. Out of 1747 allopurinol ADR reports, 612 involved SCARs (35%). The strongest predictors significantly associated with SCARs were underlying renal disease (odds ratio [OR] 2.02; 95% confidence interval [CI] 1.36, 3.00; p = 0.001), allopurinol-prescribed dose of 300mg/day or higher (OR 1.72; 95% CI 1.38, 2.15; p < 0.001), females (OR 1.54; 95% CI 1.24, 1.93; p < 0.001), age 65years and above (OR 1.31; 95% CI 1.04, 1.64; p = 0.020), and allopurinol-prescribed indication. SCARs cases were higher in patients who received allopurinol for unspecified hyperuricaemia (OR 1.87; 95% CI 1.29, 2.70; p = 0.001) and off-label indications (OR 3.45; 95% CI 2.20, 5.42; p < 0.001) compared to registered indications. Fatality was associated with older age and a diagnosis of Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN) overlap or TEN. Malaysian pharmacovigilance data show that predictors of allopurinol-induced SCARs were elderly females, patients with underlying renal disease and high allopurinol doses. These patients need close monitoring and must be educated to stop allopurinol at the first signs of rash.

Drug-Induced Hearing Loss in Children: An Analysis of Spontaneous Reports in the French PharmacoVigilance Database

Hearing loss can have a negative impact on communication, with significant vocational, educational, and social consequences. Drugs are one of the causes of hearing loss in children. The objective of our study was to describe drug-induced hearing loss in the pediatric population. Reports of hearing loss from 1985 to December 2019 in the pediatric population (< 18 years) were extracted from the French PharmacoVigilance Database (FPVD). We performed a retrospective and descriptive analysis of adverse drug reaction (ADR) reports. A total of 70 ADR reports were identified among the 51,216 reports registered in the FPVD, 37 involving adolescents (12-17 years, 52.9%), 28 children (2-11 years, 40.0%), and 5 infants (28 days-23 months, 7.1%). Overall, 40 reports (57.1%) involved girls. A total of 56 reports (80.0%) were "serious." The most frequent hearing disorders were deafness (n = 31, 44.3%) and hypoacusis (n = 22, 31.4%). Suspected drugs (ATC 5th level) were amikacin (n = 11, 15.7%), cisplatin (n = 11, 15.7%), doxorubicin (n = 4, 5.7%), vincristine (n = 4, 5.7%), clarithromycin (n = 4, 5.7%), ceftriaxone (n = 3, 4.3%), isotretinoin (n = 3, 4.3%), and vancomycin (n = 3, 4.3%). This study shows that about three out of four cases of drug-induced hearing loss in the pediatric population were "serious". It also underlines the under-reporting of these ADRs and the importance of strengthening hearing monitoring in children during and long after drug exposure.

Adverse drug reactions: An analysis of spontaneous reports

Background: Adverse drug reactions (ADRs) are among the top causes of morbidity and mortality in both hospitalized and ambulatory patients worldwide. The Pharmacovigilance Programme of India was initiated with the goal that the benefits of drugs should outweigh the risks. Aim and Objective: The purpose of this study was to analyze and evaluate the incidence and the patterns of ADRs from reports collected at our ADR monitoring center (AMC). Materials and Methods: A total of 187 suspected ADR forms which were submitted to our AMC were evaluated for demographics, reporting department, causative drug(s), and organ system involvement. Causality, severity, and preventability assessments were also carried out. Results: Most ADRs (43.31%) were found in the 31–60 years age group, with health centers (63) reporting the maximum number followed by the dermatology department (34). The leading causal therapeutic class of drugs was anti-infective agents (36.73%) followed by antiparasitic products (14.79%). Skin and subcutaneous tissue disorders (47.39%) and gastrointestinal disorders (26.04%) were the organ systems with most ADRs. In causality assessment, the probable cases had a higher incidence (78.57%) than the possible (21.42%) ones. Based on the severity, most of the reactions were categorized as moderate (83.95%), 14.97% were mild, and only 1.06% were severe. Most of the ADRs were not preventable (99.5%). Conclusion: Despite most ADRs being not preventable, regular awareness programs should be conducted and a system of rewarding those who consistently report ADRs may be implemented. This will increase reporting and also improve patient safety.

Agranulocytosis attributed to metamizole: An analysis of spontaneous reports in EudraVigilance 1985-2017.

Despite ongoing debates about its safety, the use of metamizole (dipyrone) is still increasing in many countries. In this study, we analysed spontaneous reports of suspected metamizole-associated agranulocytosis recorded in EudraVigilance database from 1985 to 2017 with regard to patient and treatment characteristics as well as fatal vs non-fatal outcomes and compared these findings among countries. A total of 1448 reports from 31 different countries were included (Germany 42.0%; Spain 29.6%; Switzerland 13.1%; other countries 15.3%). Mean age of patients was 53.6years (63.4% females). Differences among countries were observed, for example with respect to patient age, route of administration and daily doses. Overall, median time between starting metamizole and developing an agranulocytosis was 13days with 34.7% of cases occurring up to 7days. This time was much shorter in patients who had already received metamizole before (median: 6 vs 15days). About 16% of cases ended fatally. Patients with fatal outcomes were older and more often had also received methotrexate compared to those with non-fatal outcomes. When adjusting for age and sex in a multivariable logistic regression, methotrexate was associated with an increased risk of fatal outcomes (odds ratio: 5.18; 95% confidence interval: 3.06-8.78). In conclusion, metamizole-associated agranulocytosis is still a life-threatening condition, especially in the elderly and those also receiving methotrexate. As agranulocytosis can develop weeks after last administration and independently of dose and duration of treatment, prescribers and patients should be aware of its signs and symptoms.

Adverse events following immunisation (AEFI) reports from the Zimbabwe expanded programme on immunisation (ZEPI): an analysis of spontaneous reports in Vigibase\xae from 1997 to 2017

BackgroundVaccine safety surveillance is an essential requirement in vaccination programmes. It supports signal identification, hypothesis generation, and the identification and rectification of gaps in vaccine pharmacovigilance systems. The objectives of this study were to determine the characteristics and trends of adverse events following immunisation (AEFI) and to assess the performance of the Zimbabwe Expanded Immunisation Programme safety surveillance system.MethodsWe carried out a descriptive study of passively collected vaccine-related Individual Case Safety Report (ICSR) data submitted to the World Health Organization global adverse drug reaction database (VigiBase®) from Zimbabwe during the period 1997 to 2017. We extracted AEFI/ICSR data using VigiLyze® for analysis with respect to the demographic distribution, AEFI characteristics, reporting trends over time, ICSR timeliness and case completeness.ResultsA total of 272 vaccine-related ICSRs were included in the analyses with a median completeness score of 0.90 interquartile range, IQR (0.63; 0.90). The overall annual reporting rate was 0.58 per 100,000 vaccine doses and the AEFI reporting ratio ranged between 0 and 30.2 AEFI reports per 100,000 surviving infants. The majority of ICSRs were male (55.3%; p value = 0.641) and the median age was 12 (0–168) months. The majority of ICSRs were reported in children who had received measles (n = 133; 48.9%) and OPV/DTP-Hib-HepB (n = 107; 39.3%) vaccines. Of the 387 observed AEFIs, 301 (77.8%) were systemic events and 86 (22.2%) were local reactions. Systemic events were more frequently reported with doses containing the measles antigen (n = 190; 49.1%) while local events were associated with the multiple antigen OPV/DTP-Hib-HepB (n = 62; 16.0%). The multiple antigen OPV/DTP-Hib-HepB was associated with higher rates for injection site abscess (n = 57), pyrexia (n = 27), diarrhea (n = 15), vomiting (n = 12), and seizures (n = 6). The measles antigen was associated with higher rates for rash (n = 44), ocular disorders (n = 26), pyrexia (n = 26), urticaria (n = 22), diarrhea (n = 8), and vomiting (n = 12).ConclusionsMost of the ICSRs were associated with measles and OPV/DTP-Hib-HepB vaccines. Zimbabwe’s vaccine safety surveillance system is still developing and is not yet fully functional. However, the current system provides a reference point for the monitoring of the ongoing AEFI reporting trends and characteristics.

SAT-137-Adverse drug reactions in patients with cirrhosis: analysis of spontaneous reports from the Dutch Pharmacovigilance Centre Lareb

SAT-137-Adverse drug reactions in patients with cirrhosis: analysis of spontaneous reports from the Dutch Pharmacovigilance Centre Lareb

Classification of existing problems in the Russian pharmacovigilance system

The pharmacovigilance system currently represents as a complex of interstate, state, departmental and public institutions. This system provides the receipt and processing of information about facts and circumstances that pose a threat to life or health for person who using drugs at all stages of life cycle of drugs. In addition, in the framework of pharmacovigilance activities, a continuous evaluation benefit and risk of the use of registered and developed drugs. On the way to its formation, the Russian pharmacovigilance system is face a challenge with a spectrum of problems, including the fragmentation of the conclusions formulated and the identification of polymorphic "targets" for the subsequent appropriate managerial decisions at pharmacovigilance field. Classification of existing problems at the field of pharmacovigilance is the technique of integration variety of studied objects to several systematized groups for the subsequent high-level review of the way for optimization and the possibilities for increasing its effectiveness. The results of the studies using methods of content analysis of publications of pharmacovigilance, statistical analysis of spontaneous reports and a sociological survey made it possible to identify a number of problems in the Russian pharmacovigilance system that were grouped of five types: political, organizational, information, cultural and personal. These analyzes allow us to determine the way for further research of the possibilities for increasing the effectiveness of the pharmacovigilance system based on the integrated development of ways for optimize the activity of the leading pharmacovigilance subjects in five problem areas.

Consumer Adverse Drug Reactions (ADRs) Reporting in Malaysia: A Retrospective Analysis of Spontaneous Reports from the National Pharmacovigilance Database from 2008 to 2015

Many countries are incorporating direct patient reporting of adverse drug reactions (ADRs) into their pharmacovigilance systems as patients provide a different insight into drug safety compared to healthcare professionals. In Malaysia, consumer reporting of ADRs and issues with product qualitiesbegan in 2007. The aim of this study was to examine consumer reports in terms of ADR categoriesby System Organ Class (SOC), suspected products and the seriousness of the ADRs.