Adverse Drug Reaction Surveillance Research Articles

A Retrospective Review of Serious Adverse Drug Reaction Reports in the Nigerian VigiFlow Database from September 2004 to December 2016.

Adverse drug reactions (ADRs) are a source of concern in healthcare as they negatively affect patients. Serious adverse drug reactions (SADRs) have an even greater impact on patients and the system in terms of morbidity and financial burden. The establishment of National Pharmacovigilance Centers (NPCs) has enhanced ADR reporting in Africa. The Nigerian Pharmacovigilance Centre has been collecting ADR reports using VigiFlow since 2004. The aim of this study was to identify and analyze SADR reports in the Nigerian VigiFlow database in order to profile the patients with SADRs, the medicines most implicated, system organ classes (SOCs) affected, outcome of such reactions, including fatalities, and ADR reporting trends over the years. We also looked at the data elements provided in the reports as a proxy measure of report quality. We retrospectively assessed all individual case safety reports (ICSRs) received by the NPC in Nigeria and entered into VigiFlow as SADR reports between September 2004 and December 2016. We defined SADR as any untoward reaction to any medicine dose that resulted in death, required in-patient hospitalization or prolongation of existing hospitalization, resulted in congenital anomaly, persistent or significant disability/incapacity or was life-threatening. The suspected SADRs were analyzed at the Medical Dictionary for Regulatory Activities SOC and Preferred Term levels. A total of 11,222 ICSRs were entered into VigiFlow during the study period, of which 298 (3%) were classified as SADR reports. Adults were the most affected (244/282; 87%). The median number of medicines per report was 3 (interquartile range = 2-4.75). Nevirapine (36/336; 11%), as a single entity, was the most reported medicine. Human immunodeficiency virus (HIV) infection affected 128/232 (55%) of those with SADRs. There was no statistically significant association between the number of reactions per report and sex of the patients (p = 0.280), their age groups (p = 0.670), or the number of medicines per report (p = 0.640). Hospitalization was the most frequently cited reason for classifying a report as serious (151/276; 53%) and death was reported in 48 cases (48/283; 17%). Based on the SOC, skin and subcutaneous tissue disorders (139/550; 25%) was the most affected, while anemia (55/550; 10%) was the most reported specific reaction. A substantial number of patients (107/256; 42%) either recovered fully or were recovering from the SADRs. The number of SADR reports received varied by year with no consistent trend. There is under-reporting of ADRs in the Nigerian VigiFlow® database, particularly SADRs and those involving pediatric and geriatric age groups. Given that over half of the SADR reports involved antiretroviral drugs, it is imperative to increase the surveillance of ADRs related to this class of drugs through regular clinical assessment of reports and provision of feedback on the findings to healthcare providers. Direct consumer reporting should also be encouraged as a means of increasing ADR reporting.

Exploring adverse drug reactions of diabetes medicine using social media analytics and interactive visualizations

The aim of this study is to propose an automatic and real-time social media analytics framework with interactive data visualizations to support effective exploration of knowledge about adverse drug reaction (ADR) surveillance. This proposed framework has been prototypically implemented on the basis of social media data. A longitudinal diabetes patient online community data (AskaPatient.com) as well as FDA Adverse Event Reporting Systems (FAERS) data as a benchmark were used to evaluate our proposed approach’s performance. Based on the results, our approach significantly increases the precision and accuracy for ADR extraction. The number of ADR cases, the time when the ADRs occurred, and the rating of Glucophage have been visualized that resulted by mining a collection of 870 ADRs posted in Askapatents.com over a certain time period (from 2001 to 2015). The results have important implications for pharmaceutical companies and hospitals wishing to monitor ADRs of medicines.

A review on Adverse drug reactions monitoring and reporting

Adverse drug reactions (ADRs) are considered as one among the leading causes of morbidity and mortality. Around 10% of hospital admissions are estimated to be due to ADRs and about 5-20% of hospitalized patients experience a serious ADR. Reporting of ADRs has become an important component of monitoring and evaluation activities performed in hospitals4. Such ADR reporting programs encourage surveillance for ADRs, promote the reporting of ADRs and stimulate the education of health professionals regarding potential ADRs. This article reviews about ADR reporting and monitoring, Classification of Adverse drug reaction, Contrast between Adverse Effects and Adverse Reactions, Methods of monitoring adverse drug reactions.

Do Tuscan people adhere to meningococcal C vaccination during an emergency campaign?

SummaryObjectivesTuscany region (Italy) recorded a rise in the number of meningococcal disease cases between January 2015 and February 2016, (52 cases) compared to 2014 (16 cases). The aim of this study was to describe the emergency meningococcal C (MenC) vaccination programme in Tuscany and the population’s adherence to the activities performed in the Local Health Unit (LHU) of Florence.MethodsThe MenC vaccination programme and the planning of the prevention and communication activities were analysed in the LHU of Florence. As an indicator of population’s adherence, the vaccination coverage (VC) during the emergency campaign was investigated and adverse drug reactions (ADR) surveillance was reported.ResultsThe communication campaign included a dedicated toll-free telephone number, press releases (newspapers, radio, television, websites), and informative letters addressed to mayors, secondary schools, and sports associations. Citizens aged 11-20 years were the primary target of the campaign. Due to the high incidence of cases among older people, the vaccination was extended to subjects over 45 years. The population’s adherence to the vaccination campaign was satisfactory: VC reached 47.1% for the primary target. The ADR reporting rate (3.1/10,000) on meningococcal vaccine in our study confirmed the safety of the vaccination.ConclusionsIn 2017, only 10 cases of invasive meningococcal diseases (IMD) were reported, suggesting the effectiveness of the immunization campaign. Similar VC during emergency MenC vaccination programmes have been reached in other Italian regions and other EU countries, too. The achievement of greater vaccination coverage is restricted by a sentiment of hesitancy towards vaccines among the general population.

Active surveillance of adverse drug reactions in patients with rheumatoid arthritis in a tertiary care teaching hospital

Background: Drugs used in the treatment of rheumatoid arthritis show significant toxicity and morbidity. The objective of the study was to evaluate the nature and incidence of adverse drug reaction in patients with rheumatoid arthritis on anti-rheumatic drugs and to assess the causality and severity of the documented adverse drug reactions.Methods: The prospective observational study was done for two months in rheumatology outpatient department. All patients were interviewed for basic details, treatment history and adverse drug reactions and were recorded. Causality assessment and severity assessment of the recorded adverse drug reactions were done.Results: About 283 patients attended the rheumatology out-patient department during the two months period out of which 57 patients had one or more adverse drug reaction. The incidence of adverse drug reaction observed in rheumatology out-patient department to anti rheumatic drug was 20.14%. A total of 145 adverse drug reactions were noted in 57 patients. The most common adverse drug reaction reported was epigastric pain (6.89%) followed by headache and dyslipidemia (6.25%). The most common system associated with adverse drug reaction was gastrointestinal system (29.66%) followed by central nervous system and cardiovascular system (15.86%). Reported adverse drug reactions were assessed for causality and maximum belonged to probable (66.9%). Severity assessment revealed that most of the adverse drug reactions were mild (74.48%) in nature.Conclusions: Active surveillance for adverse drug reactions to anti rheumatic drug in patients with rheumatoid arthritis will allow early detection of adverse drug reactions and timely intervention to provide maximum benefit to the patients.

Matching safety to access: global actors and pharmacogovernance in Kenya- a case study

BackgroundThe Kenyan government has sought to address inadequacies in its National Pharmaceutical Policy and the Pharmacy and Poisons Board’s (PPB) medicines governance by engaging with global actors (e.g. the World Health Organization). Policy actors have influenced the way pharmacovigilance is defined, how challenges are understood and which norms are requisite to address drug safety issues. In this paper, we investigate the relationship between specific modes of engagement among global (exogenous) and domestic actors at the national and sub-national level to identify the positive or negative effect on pharmacovigilance and pharmacogovernance in Kenya. Pharmacogovernance is defined as the manner in which governing structures; policy instruments; institutional authority (e.g., ability to act, implement and enforce norms, policies and processes) and resources are managed to promote societal interests for patient safety and protection from adverse drug reactions (ADRs). Qualitative research methods that included key informant interviews and document analysis, were employed to investigate the relationship between global actors’ patterns of engagement with national actors and pharmacogovernance in Kenya.ResultsGlobal actors’ influence on pharmacogovernance and pharmacovigilance priorities in Kenya (e.g., legislation and adverse drug reaction surveillance) was positively perceived by key informants. We found that global actors’ engagement with state actors produced positive and negative outcomes. Engagement with the PPB and Ministry of Health (MOH) that was characterized as dependent (advocacy, empowerment, delegated) or interdependent (collaborative, cooperative, consultative) was mostly associated with positive outcomes e.g., capacity building; strengthening legislation and stakeholder coordination. Fragmentation (independent engagement) hindered risk communication between public, private, and NGO health programs.ConclusionA framework for assessing pharmacogovernance would support policy makers’ evidence-based decision making regarding investments to strengthen capacity for pharmacovigilance and guide policies regarding the state and exogenous actor relationship pertaining to pharmacogovernance. Ideally, dependency on exogenous actors should be reduced while retaining consultative, collaborative, and cooperative engagement when inter-dependency is appropriate. The use of global actors to address Kenya’s pharmacovigilance inadequacies leaves the country vulnerable to 1) ad hoc drug surveillance; 2) pharmacovigilance fragmentation; 3) shifting priorities; and 4) cross purpose interests.

A review on the advancement of internet-based public health surveillance program

Internet data is introduced into public health arena under the features of fast updating and tremendous volume. Mining and analyzing internet data, researchers can model the internet-based surveillance system to assess the distribution of health-related events. There are two main types of internet-based surveillance systems, i.e. active and passive, which are distinguished by the sources of information. Through passive surveillance system, information is collected from search engine and social media while the active system gathers information through provision of the volunteers. Except for serving as a real-time and convenient complementary approach to traditional disease, food safety and adverse drug reaction surveillance program, Internet-based surveillance system can also play a role in health-related behavior surveillance and policy evaluation. Although several techniques have been applied to filter information, the accuracy of internet-based surveillance system is still bothered by the false positive information. In this article, we have summarized the development and application of internet-based surveillance system in public health to provide reference for a better surveillance program in China.

Evaluation of the adverse drug reaction surveillance system Kadoma City, Zimbabwe 2015.

IntroductionMedicines have the potential to cause adverse drug reactions and because of this Zimbabwe monitor reactions to medicines through the Adverse Drug Reaction Surveillance System. The Medicines Control Authority of Zimbabwe monitors reactions to medicines through the Adverse Drugs Reactions Surveillance System. The system relies on health professionals to report adverse drug reactions to maximize patient safety. We report results of an evaluation of the Adverse Drugs Reactions Surveillance System in Kadoma District.MethodsA descriptive cross-sectional study was conducted using the updated CDC guidelines in six health facilities in Kadoma City. Data were collected using a pretested interviewer administered questionnaire, checklists and records review. Data was analyzed using Epi InfoTM to calculate frequencies and means. Qualitative data were analyzed manually. Written informed consent was obtained from all study participants.ResultsThe surveillance system did not meet up to its objectives as it failed to detect the adverse drug reactions and there was no monitoring of increases in known events. Fewer than half (43%) of the participants were aware of at least 2 objectives of the surveillance system but 83% of health workers willing to participate. However the system was not acceptable, 79% did not perceive the system to be necessary with the majority saying ''why should we fill in the forms when the reactions were already known or minor''. Though the system was supposed to identify potential patient risk factors for particular types of events health workers were reluctant to participate as evidenced by only one form filled out of 20 reactions experienced in the district. The system was simple as the notification form has 16 fields which require easily obtainable information from the patient records.ConclusionThe surveillance system was not useful and was not acceptable to health workers but was simple and stable. Health workers lacked knowledge. Sharing of results with the Medicines Control Authority of Zimbabwe through the Matrons facilitated training of health workers in Kadoma City. Health workers were encouraged to notify any drug reaction and to completely fill in the notification forms. Patients were also encouraged to report any drug reaction to health care workers.

Exploring New Zealand prescription data using sequence symmetry analyses for predicting adverse drug reactions.

Prescription sequence symmetry analyses (PSSA) is a ubiquitous tool employed in pharmacoepidemiological research to predict adverse drug reactions (ADRs). Several studies have reported the advantage of PSSA as a method that can be applied to a large prescription database with computational ease. The objective of this study was to validate New Zealand (NZ) prescription database as a potential source for identifying ADRs using the PSSA method. We analysed de-identified individual-level prescription data for people aged 65 years and above for the period 2005 to 2014 from the pharmaceutical collections supplied by the NZ Ministry of Health. We selected six positive controls that have been previously investigated and reported for causing ADRs. The six positive controls identified were amiodarone (repeated twice), frusemide, simvastatin, lithium and fluticasone. Amiodarone and lithium have been reported to induce thyroid dysfunction. Simvastatin reported to cause muscle cramps while fluticasone is well documented to cause oral candidiasis. Thyroxine was identified as a marker drug to treat hypothyroidism associated with amiodarone and lithium. Carbimazole was identified as a marker drug to treat hyperthyroidism associated with amiodarone use. Quinine sulphate was identified as a marker drug to treat muscle cramps associated with statins. In addition, we also analysed six negative controls that are unlikely to be associated with ADRs. The main outcome measure is to determine associations with ADRs using adjusted sequence ratios (ASR), and 95% confidence intervals RESULTS AND DISCUSSION: Our analyses confirmed a significant signal for all six positive controls. Significant positive associations were noted for amiodarone [ASR = 3·57, 95% CI (3·17-4·02)], and lithium chloride induced hypothyroidism [ASR = 3·43, 95% CI (2·55-4·70)]. Amiodarone was also strongly associated with hyperthyroidism [ASR = 8·81 95% CI (5·86-13·77)]. Simvastatin was associated with muscle cramps [ASR = 1·69, 95% CI (1·61-1·77)]. Fluticasone was positively associated with oral candidiasis [ASR = 2·34, 95% CI (2·19-2·50)]. Frusemide was associated with hypokalaemia [ASR = 2·94, 95% CI (2·83-3·05]). No strong associations were noted for the negative pairs. It is important to highlight that PSSA automatically controls for all confounding factors including unknown and unmeasured confounding variables, plus the effect of temporal trend in prescriptions, and hence allows a more robust ADR detection especially when confounding factors are difficult to determine or measure. New Zealand prescription database can be a potential source to identify ADRs engaging the PSSA method, and this could complement pharmacovigilance surveillance in NZ. The PSSA can be an important method for post-marketing surveillance and monitoring of ADRs which have relatively short latency. However, the predictive validity of PSSA will be compromised in certain scenarios, particularly when sample size is small, when new drugs are in the market and data are sparse.

Nystatin and miconazole: pharmacological and clinical evidence regarding interactions with warfarin.

A retrospective case series published in 2012 concluded that miconazole and nystatin used as topical antifungal drugs appear to interact equally strongly with warfarin. If confirmed, this finding has significant implications for clinical practice. This study evaluates the evidence. Evidence from the pharmacology literature, the medical literature and the 'yellow card' adverse drug reaction surveillance reports was analysed regarding possible interactions of nystatin and miconazole with warfarin. There is strong evidence to support the derangement of warfarin anticoagulation by miconazole oral gel in all areas of evidence studied. No postulated mechanism of interaction, no additional published reported cases and no supportive data from adverse drug reports were identified which would corroborate the case for a significant interaction between nystatin and warfarin. Miconazole and nystatin used as topical antifungal drugs do not interact equally strongly with warfarin. Miconazole oral gel can clearly interact with warfarin to cause derangement of anticoagulation. Nystatin appears unlikely to interact with warfarin.

Adverse Drug Reaction Monitoring and Reporting at H.S.K Hospital and Research Center-Bagalkot

Adverse drug reactions (ADRs) are considered as one among the leading causes of morbidity and mortality. Around 10% of hospital admissions are estimated to be due to ADRs and about 5-20% of hospitalised patients experience a serious ADR [1-3]. Reporting of ADRs has become an important component of monitoring and evaluation activities performed in hospitals [4]. Such ADR reporting programs encourage surveillance for ADRs, promote the reporting of ADRs and stimulate the education of health professionals regarding potential ADRs [5]. A productive hospital-based reporting program can be instrumental in providing valuable information regarding potential problems of drug usage in an institution. Through these efforts, problems are identified and resolved, which results in continuous improvement in patient care [6]. Spontaneous reporting program, a common method of drug surveillance is capable of recognizing ADRs in the daily medical practice, even though under reporting and absence of information on number of people actually exposed to the drug are its disadvantages [7,8].

Adverse drug reactions to ibuprofen: a case report

Ibuprofen is a commonly used drug available by prescription and over the counter for treatment of fever, joint pain, headache, migraine, inflammatory states. It is available in combination with paracetamol and various other drugs. Side effects associated with aspirin & non-steroidal anti-inflammatory drugs (NSAIDs) are rash, gastrointestinal ulcers, hepatic toxicity, Steven Johnson syndrome, respiratory skin rashes, acute exacerbation of asthma and anaphylaxis. We have reported here severe distress hypersensitive reaction with ibuprofen induced hypersensitivity syndrome. Within two hours of consumption of ibuprofen patient developed severe bronchospasm, throat & laryngeal oedema leading to respiratory distress. He was treated with salbutamol, hydrocortisone, deriphylline and supportive oxygen, but did not respond and went into coma. Unlike acetaminophen, ibuprofen does not have any antidote hence managing adverse drug reactions (ADR) due to ibuprofen is big challenge. Therefore understanding pathophysiology of ADR to Ibuprofen is necessary to manage the patient. Literature in the field of allergic drug reaction shows that epinephrine, a physiological antagonist of histamine is the first drug of choice for the treatment of allergic or drug induced angioedema, laryngeal oedema and bronchospasm due to its direct action on target organs. Such reactions should therefore be managed by epinephrine without loss of time. ADR due to ibuprofen could be prevented by (a) avoiding unnecessary intake of drug, (b) educating patients / families and public about adverse drug reactions (c) surveillance and monitoring of drug reactions (d) record keeping (e) drug audit and (f) reporting of ADR to state/central pharmacovigilance agency. We do observe doctors having misconception about adrenaline, its actions, usage & side effects especially cardio-vascular, hence are reluctant to use. But in severe violent adverse drug reaction we have to use our wisdom and judgement and see whether usage of adrenaline overweighs the ADR or not. In acute drug reaction like this where respiratory system is compromised use adrenaline could have been helpful. We therefore suggest adequate teaching of the field of adverse drug reactions, early diagnosis of drug reactions and judicious use of epinephrine if warranted.

Clinical implication of adverse drug reaction surveillance in children

Clinical implication of adverse drug reaction surveillance in children

Common data model for decision support system of adverse drug reaction to extract knowledge from multi-center database

An adverse drug reaction (ADR) surveillance system integrated with various electronic medical record (EMR) systems has been suggested as an effective way to collect more data and analyze ADRs earlier than the spontaneous reporting of ADRs. Because Korean hospitals have heterogeneous EMR databases, a common data model (CDM) should first be defined to develop the multi-center EMR-based drug surveillance system. We investigated the data models from two prominent drug safety surveillance studies, the Mini-Sentinel program and the Observational Medical Outcomes Partnership, and developed an EMR-based ADR common data model (EADR CDM). The EADR CDM has eight tables, including a demographic table, drug table, visit table, procedure table, diagnosis table, death table, laboratory table and organization table. Each table consists of 5---12 fields. Among a total of 2,931,060 patients from January 2008 to December 2012 in clinical data warehouse of the S hospital, we extracted the data from 135,745 patients who were prescribed below drugs to determine whether the exported data were sufficient to detect ADRs of six drugs. After validation, we found that the transformed data based on EADR CDM is helpful to understand the prescription pattern and explore feasible medication list for adverse drug signal detection. The collection of diverse data using the CDM is an effective method of early decision of ADRs. This study provides guidelines for developing the CDM and plans to develop the drug safety surveillance system based on multi-center EMR.

Strategy support for the Post‐Market Monitoring (PMM) of GM plants: Review of existing PMM strategies developed for the safety assessment of human and animal health

Strategy support for the Post‐Market Monitoring (PMM) of GM plants: Review of existing PMM strategies developed for the safety assessment of human and animal health

Clinical coding of prospectively identified paediatric adverse drug reactions--a retrospective review of patient records.

BackgroundNational Health Service (NHS) hospitals in the UK use a system of coding for patient episodes. The coding system used is the International Classification of Disease (ICD-10). There are ICD-10 codes which may be associated with adverse drug reactions (ADRs) and there is a possibility of using these codes for ADR surveillance. This study aimed to determine whether ADRs prospectively identified in children admitted to a paediatric hospital were coded appropriately using ICD-10.MethodsThe electronic admission abstract for each patient with at least one ADR was reviewed. A record was made of whether the ADR(s) had been coded using ICD-10.ResultsOf 241 ADRs, 76 (31.5%) were coded using at least one ICD-10 ADR code. Of the oncology ADRs, 70/115 (61%) were coded using an ICD-10 ADR code compared with 6/126 (4.8%) non-oncology ADRs (difference in proportions 56%, 95% CI 46.2% to 65.8%; p < 0.001).ConclusionsThe majority of ADRs detected in a prospective study at a paediatric centre would not have been identified if the study had relied on ICD-10 codes as a single means of detection. Data derived from administrative healthcare databases are not reliable for identifying ADRs by themselves, but may complement other methods of detection.Electronic supplementary materialThe online version of this article (doi:10.1186/2050-6511-15-72) contains supplementary material, which is available to authorized users.

Adverse drug reactions monitoring: prospects and impending challenges for pharmacovigilance.

Pharmacovigilance plays a consequential role in the surveillance of adverse drug reactions, which is provoked by the drugs used to cure diseases. Adverse drug reactions (ADRs) produce detrimental or undesirable effects to the body after administration of drugs. It has been reported that the number of patients dying because of contrary effects of drugs per year increased upto 2.6-fold. Moreover, rates of hospitalization of patients are increasing owing to adverse effects of drugs. Thus, it becomes challengeable for physician, health care providers, WHO and pharmaceutical industries to resolve the associated problem of ADRs. During the clinical trial of a novel drug, it is prominent to explore the dependability of drug. In this review, we documented the details required to identify the ADRs in patients along with reported banned drugs.

Signal detection for Thai traditional medicine: Examination of national pharmacovigilance data using reporting odds ratio and reported population attributable risk

Herbal containing medicine consumption has increased while the awareness of adverse drug reaction (ADR) was less than conventional medicine. Early detection of unexpected numbers of ADRs from herbal medicines’ reports which are abnormal from the whole database needs quantification. Disproportionality analysis has been performed for signal detection by using reporting odds ratio (ROR) as measurement. The impact of having medicine as exposures in each ADR should be measured by using reported population attributable risks (RPAR). This study aimed to quantify the contribution of Thai traditional medicine (TTM) to ADR reports and to assess the association between TTMs and serious adverse drug reactions. Data were retrieved from the adverse drug reaction surveillance database, Thai-Food and Drug Administration from 2002 to 2013. Crude and adjusted RORs for each drug–ADR pair and RPARs were computed. TTM contributed only 0.001% of all serious ADRs reported. Out of 4208 TTM-ADR pairs were examined, three had the statistically significant RORs, namely Andrographis paniculata and anaphylactic shock (ROR 2.32, 95% CI 1.03, 5.21); green traditional medicine and Stevens-Johnson syndrome (ROR 13.04, 95% CI 5.4–31.51) and Derris scandens Benth and angioedema (ROR 2.71, 95% CI 1.05–6.95). Their RPARs ranged from 0.05% to 0.16%. We conclude that TTMs need more intensive surveillance.

Methylprednisolone-induced hepatotoxicity: experiences from global adverse drug reaction surveillance

Joint evaluation of drugs’ beneficial and adverse effects is required in many situations, in particular to inform decisions on initial or sustained marketing of drugs, or to guide the treatment of individual patients. This synthesis, known as benefit-risk assessment, is without doubt important: timely decisions supported by transparent and sound assessments can reduce mortality and morbidity in potentially large groups of patients. At the same time, it can be hugely complex: drug effects are generally disparate in nature and likelihood, and the information that needs to be processed is diverse, uncertain, deficient, or even unavailable. Hence there is a clear need for methods that can reliably and efficiently support the benefit-risk assessment process. For already marketed drugs, this process often starts with the detection of previously unknown risks that are subsequently integrated with all other relevant information for joint analysis.In this thesis, quantitative methods are devised to support different aspects of drug benefit-risk assessment, and the practical usefulness of these methods is demonstrated in clinically relevant case studies. Shrinkage regression is adapted and implemented for large-scale screening in collections of individual case reports, leading to the discovery of a link between methylprednisolone and hepatotoxicity. This adverse effect is then considered as part of a complete benefit-risk assessment of methylpredniso­lone in multiple sclerosis relapses, set in a general framework of probabilistic decision analysis. Two methods devised in the thesis substantively contribute to this assessment: one for efficient generation of utility distributions for the considered clinical outcomes, driven by modelling of qualitative information; and one for computing risk limits for rare and otherwise non-quantifiable adverse effects, based on collections of individual case reports.

Urticarial vasculitis in association with imatinib: Case report and literature review

We present a case report of a 49-year-old female with recently diagnosed chronic myeloid leukaemia, in chronic phase (CML-CP), presenting 10 days following commencement of imatinib with fevers, generalised rash, oedema, and systemic inflammatory response syndrome (SIRS) mimicking severe sepsis. Skin punch biopsy was compatible with drug reaction, with findings consistent with urticarial vasculitis. Although dermatological toxicities have been associated with imatinib, isolated cutaneous urticarial vasculitis with associated severe SIRS has never been reported in the literature. Rapid clinical resolution following the use of corticosteroid and cessation of imatinib in this patient strongly suggests the causative role of imatinib. Her higher initiation dose of 600 mg daily may have been a contributory factor. Ongoing adverse drug reaction surveillance is important to monitor serious and rare complications.