Impact Of Adverse Drug Reactions Research Articles

Impact of adverse drug reactions on the treatment pathways of early rheumatoid arthritis patients: a prospective observational cohort study

ABSTRACT Background Several patient characteristics may be of influence on treatment pathways of rheumatoid arthritis (RA) patients in clinical practice. The aim of this study is to analyze treatment pathways of early RA patients stratified for gender and adverse drug reaction (ADR) occurrence. Research design and methods Treatment pathways of patients included in the DREAM-RA treat-to-target cohort I between 16th of July 2006–30th of April 2020 were assessed. Treatment pathways were visualized in Sankey diagrams. Follow-up time, duration per treatment and the number of treatments received were stratified for gender and ADR occurrence and analyzed. Independent t-tests and chi-square tests were performed where applicable. Results Treatment pathways of 372 patients (follow-up: 2488.4 years, mean 6.7 ± 3.7 years) were analyzed. The Sankey diagrams visualize that treatment pathways became increasingly varied and complex over time. No significant differences were found when comparing female patients and male patients. However, the average treatment duration was shorter in patients with ADRs (1.8 vs. 2.7 years, p < 0.05), and the number of treatments higher (3.5 vs. 2.5, p < 0.05). Conclusions Treatment pathways increase in complexity over time. Differences were found between patients with and without ADRs, with patients that experience ADRs receiving more and shorter treatments.

A Prospective Observational Study to Evaluate the Prevalence of Adverse Drug Reactions and its Impact on Quality of life in Psychiatric Patients at a Tertiary Care Teaching Hospital

Background: In recent times, emphasis on pharmacovigilance (PV) is elevated due to increased cases of adverse drug reactions (ADRs) coming into notice. Psychotropic medications that are the mainstay of treating psychiatric patients are linked to various adverse drug reactions. The given study lays accentuation on determining the pattern of ADRs due to the use of antipsychotics and antidepressants. Objectives: In this study, we aim to determine the incidence of ADRs and their effect on the quality of life (QOL) of the patients after the ADR (s). Methodology: This is a prospective observational study of a total of 300 subjects receiving antipsychotics and/or antidepressants. They were screened for possible ADRs. Possible risk factors for the development of ADRs were also assessed. The difference in the pattern of ADRs in patients prescribed with Antidepressants (ADs) and/or Antipsychotics (APs) was observed. The average number of APs and/or ADs per prescription was calculated. The causality and severity assessment of the observed ADRs was done by the World Health Organization-Uppsala Monitoring Center (WHO-UMC) scale, Naranjo’s algorithm, and Hartwig–Siegel scale, respectively. Lastly, the impact of ADRs on the QOL of the patients receiving APs and/or ADs was evaluated. Results: The prevalence of ADRs in patients receiving APs and/or ADs is 24.33%. Olanzapine is the most commonly prescribed AP while sertraline is the most commonly prescribed AD. Olanzapine and sertraline are responsible for the highest number of ADRs as AP and AD, respectively. Females are found to be at higher risk for developing ADRs. Multiple comorbidities and polypharmacy are also considered to be possible risk factors. The average number of APs and/or antidepressants per prescription is 1.94 drugs. APs are found to be responsible for a higher number of ADRs in comparison with ADs. The maximum number of ADRs falls into the possible criteria of causality assessment by the WHO-UMC scale and Naranjo’s algorithm. All the observed ADRs fall into the mild and moderate category of severity by the Hartwig–Siegel scale. The ADRs have a significant impact on the physical health and psychological domain of QOL assessment. Conclusion: The need for PV is highlighted by the results obtained in this study. Intense monitoring and increased awareness can help improve the rate of ADR (s) occurrence in patients receiving psychotropic medications. As a result, the impact of ADRs on the QOL of the patients can also be reduced.

Clinical and economic impact of adverse drug reactions in hospitalised patients: prospective matched nested case–control study in Ethiopia

ObjectivesThe purpose of this study was to assess the clinical and economic impact of adverse drug reactions (ADRs) among patients admitted to the University of Gondar Comprehensive Specialized Hospital (UoGCSH).Design...

Impact of adverse drug reactions on the outcomes of tuberculosis treatment.

Adverse drug reactions (ADR) challenge successful anti-tuberculosis treatment (ATT). The aim of this study was to evaluate the impact of ATT-associated ADR and related factors on ATT outcomes. A prospective cohort study of persons with tuberculosis (TB) at a referral center in Rio de Janeiro, Brazil, from 2010 to 2016. Baseline information: race, sex, schooling, economic status, tobacco, drugs and alcohol abuse, HIV-infection status and comorbidities were captured during TB screening and diagnosis. Laboratory exams were performed to confirm TB diagnosis and monitor ADRs, favorable (cure and treatment completion) and unfavorable (death, loss to follow up and failure) outcomes were prospectively captured. The Kaplan-Meier curve was used to estimate the probability of ADR-free time. A logistic regression analysis (backward elimination) was performed to identify independent associations with unfavorable outcomes. 550 patients were enrolled, 35.1% were people living with HIV (PLHIV) and ADR occurred in 78.6% of all participants. Smoking (OR: 2.32; 95% CI:1.34-3.99) and illicit-drug use (OR:2.02; 95% CI:1.15-3.55) were independent risk factors for unfavorable outcomes. In PLHIV, alcohol abuse and previous ART use were associated with unfavorable outcomes. In contrast, ADR increased the odds of favorable outcomes in the overall population. PLHIV more frequently experienced grade 3/4-ADR (18.36%), especially "liver and biliary system disorders". Lower CD4 counts (<100 cells/uL) were associated with hepatotoxicity (p = 0.03). ART-naïve participants presented a higher incidence of ADR in comparison with ART-experienced patients. Substance use was associated with unfavorable outcomes, highlighting the need for better strategies to reduce this habit. In contrast, ADRs were associated with favorable outcomes. Attention to the occurrence of ADR in PLHIV is essential, especially regarding hepatotoxicity in those with high immunosuppression.

The impact of adverse drug reactions on medication adherence and outpatient treatment outcomes in female breast cancer: A review protocol.

Discover the impact of adverse drug reactions of hormonal and chemotherapy on medication adherence and outpatient treatment outcomes in the breast cancer patient population. A systematic review following the reporting guidance from the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols (PRISMA-P) guided by the Joanna Briggs Institute methodology will be conducted. A literature search will be conducted using the following databases: PubMed, CINAHL, Web of Science, Medline and Scopus. Studies published in English before 2022 that report adverse drug reactions with medication adherence and outpatient treatment outcomes as primary outcome measures, following the initiation of one or more oral hormonal, endocrine and chemotherapy agents in female patients with diagnoses of breast cancer will be identified. Observational studies will be included for review, and two reviewers will independently screen study titles, abstracts and full text for inclusion. The quality assessment will be conducted using the Joanna Briggs Institute tools. A meta-analysis will be conducted where sufficient data are available. This is a systematic review study protocol, and results are not available at the time of the submission. All results will be reported on the completion of this study. This systematic review will highlight the impact of medication non-adherence on the breast cancer patient population, support determining strategies to address this issue and identify areas for further research. This protocol article will identify the impact of adverse drug reactions on medication non-adherence and treatment outcomes in the female breast cancer patient population. A unique contribution of our study is to support determining strategies to address this ongoing public health issue and identify areas for further research. This protocol has been registered with the International Prospective Register of Systematic Reviews (PROSPERO) database (registration number CRD 42021291364).

Itraconazole Contaminated with Rilmazafone in Japan: A Retrospective Analysis Using the Japanese Adverse Drug Event Report Database.

BackgroundIn early December 2020, the antifungal medication, itraconazole (ITCZ), was mistakenly contaminated with rilmazafone in Japan. Healthcare professionals reported adverse drug reaction reports associated with ITCZ and included central nervous system-depression symptoms such as dizziness, lightheadedness, loss of consciousness, and intense drowsiness.ObjectiveWe examined ITCZ-associated suspicious cases using the Japanese Adverse Drug Event Report (JADER) database to determine the impact of adverse drug reaction reporting on post-marketing safety measures.MethodsAdverse drug reaction reports in which the suspicious or concomitant medication was ITCZ or fluconazole (FLCZ) were extracted from the JADER dataset. The number of adverse drug reaction reports associated with central nervous system-depression adverse drug reactions were counted, and chronological changes were compared with ITCZ and FLCZ.ResultsOf the 713,893 adverse drug reaction reports in the JADER database, 5048 cases were associated with ITCZ and 6007 cases with FLCZ. When ITCZ contamination occurred, the number of adverse drug reaction reports associated with ITCZ increased rapidly, while those with FLCZ did not. In addition, the proportion of central nervous system-depression adverse drug reactions increased only in the ITCZ-associated report.ConclusionsAn incident of ITCZ contamination with rilmazafone was detected on the JADER retrospectively. This case highlights the importance of spontaneous adverse drug reaction reporting, even if the causal relationship between the drug and adverse drug reaction is unknown.Supplementary InformationThe online version contains supplementary material available at 10.1007/s40801-022-00306-6.

Identifying and managing adverse drug reactions: Qualitative analysis of patient reports to the UK yellow card scheme.

IntroductionAdverse drug reactions (ADRs) can have significant negative impact on peoples' daily lives, with physical, economic, social and/or psychological effects. Patient reporting of ADRs has been facilitated by pharmacovigilance systems across Europe. However, capturing data on patients' experiences of ADRs has proved challenging. Existing patient reports to the UK Yellow Card Scheme contain free‐text comments which could be useful sources of information.ObjectivesTo investigate patients' experiences of ADRs and their impact on patients as described in free‐text data within patient Yellow Card (YC) reports submitted to the Medicines and Healthcare products Regulatory Agency.MethodsA qualitative review of narrative texts was conducted on free‐text data from 2255 patient YC reports from July to December 2015.ResultsThree key narrative themes emerged from analysis of the free‐text data in 2255 reports: (1) identification of ADRs, (2) severity and impact of ADRs, and (3) management of ADRs. Temporal associations were the most common method of identification followed by differential diagnoses and confirmation with information sources such as healthcare professionals (HCPs). A combination of explicit and implicit impacts were described: physical, psychological, economic and social effects often persisted and caused serious disruption to many patients' lives. A range of strategies were used to manage ADRs, including consultation with HCPs, stopping/reducing the medicine or taking medicines to alleviate symptoms.ConclusionFree‐text data from YC reports has been an underutilised resource to date, but this research has confirmed its potential value to pharmacovigilance and medication safety research.

A Comprehensive Review and Application of Interpretable Deep Learning Model for ADR Prediction

Drug safety is a pressing need in today's healthcare. Minimizing drug toxicity and improving the individual’s health and society is the key objective of the healthcare domain. Drugs are clinically tested in laboratories before marketing as medicines. However, the unintended and harmful effects of drugs are called Adverse Drug Reactions (ADRs). The impact of ADRs can range from mild discomfort to more severe health hazards leading to hospitalization and in some cases death. Therefore, the objective of this research paper is to design a framework based on which research papers are collected from both ADR detection and prediction domain. Around 172 research articles are collected from the sites like ResearchGate, PubMed, etc. After applying the elimination criteria the author categorized them into ADR detection and prediction themes. Further, common data sources and algorithms as well as the evaluation metrics were analyzed and their contribution to their respective domains is stated in terms of percentages. A deep learning framework is also designed and implemented based on the research gaps identified in the existing ADR detection and prediction models. The performance of the deep learning model with two hidden layers was found to be optimum for ADR prediction and further, the non-interpretability part of the model is addressed using a global surrogate model. The proposed architecture has successfully addressed multiple limitations of existing models and also highlights the importance of early detection & prediction of adverse drug reactions in the healthcare industry.

Physicians\u2019 perspectives on adverse drug reactions in pediatric routine care: a survey

BackgroundChildren and adolescents are at particular risk for adverse drug reactions (ADRs). We investigated physicians’ perceptions on ADRs in pediatric routine care.MethodsIn this exploratory study from April to November 2020, we invited physicians treating pediatric patients across Germany to complete an online questionnaire consisting mainly of closed questions.ResultsCompletion rate was 98% (127/129). Of all participants, 23% (29/127) stated they were not able to estimate how many of their pediatric patients experienced ADRs during drug therapy. The remaining physicians estimated that 7.5% (median; Q25/Q75 3%/20%) of their pediatric patients were affected by ADRs. Regarding counseling on ADRs, 61% (77/127) stated they do not ask regularly the extent to which parents want to be informed. In total, 26% (33/127) stated they avoid counseling on ADRs concerning commonly used approved therapies, whereas only 4% (5/127) did so concerning off-label use (P < 0.001). Altogether, 16% (20/127) stated they rather prescribe new medicines as they hope for better effectiveness; 72% (91/127) said they are cautious about doing so owing to yet unknown ADRs. Of all respondents, 46% (58/127) stated they do not report ADRs to the authorities. Concerning the black triangle symbol, a European pharmacovigilance measure, 11% (14/127) stated they knew it and 6% (7/127) stated they reported any suspected ADR for drugs with that symbol.ConclusionsPhysicians’ perspectives on ADRs were ambivalent: ADRs influenced their parent counseling and drug prescribing; yet, they struggled to estimate the impact of ADRs on their patients and were not aware of specific pharmacovigilance measures.

Impact of Adverse Drug Reactions in Patients with End Stage Renal Disease in Greece

Background: Patients with end-stage renal disease (ESRD) require specialized therapeutic interventions. The decreased renal function that modulates the physiology and presence of comorbidities is often associated with variations in the pharmacological response, thus increasing the risk of adverse drug events or reactions (ADE/ADRs) from co-administered drugs. Methods: A cross-sectional study to record comorbidities, drug–drug interactions (DDIs), ADE/ADRs in patients with chronic kidney disease of stage five in Greece. The study enrolled 60 patients of mean age 64.8 ± 12.9 years, undergoing hemodialysis three times a week. Demographic and social factors, comorbidities, laboratory test data, medication regimens, DDIs and the reporting of ADE/ADRs were analyzed. Results: Cardiovascular diseases and diabetes were the main comorbidities. In total, 50 different DDIs of various clinical significance were identified. CNS, GI-track, and musculoskeletal-system-related ADE/ADRs were most often reported by patients. ADE/ADRs as clinical outcome from DDIs were associated in 64% of the total identified DDIs. There was a positive trend between number of medications, ADE/ADRs report and DDIs. Conclusions: The impact of ADE/ADRs in ESRD patients should be always considered. Guidelines as well as continuous training in the context of evidence-based clinical practice by healthcare personnel on therapy administration and prevention of adverse events are important.

THU0173 DIFFERENCES BETWEEN PATIENT-REPORTED AND PHYSICIAN-REPORTED ADVERSE DRUG REACTIONS ATTRIBUTED TO BDMARDS

Background:Patient registries are a valuable tool to monitor a patient’s health status. However, these systems operate primarily from the healthcare provider (HCP) perspective, which makes it difficult to collect detailed information on the nature, frequency and personal impact of adverse drug reactions (ADRs).Objectives:Determining whether the distribution of patient-reported ADRs attributed to bDMARDs differs from ADR registrations by HCPs.Methods:Patient reported ADRs were derived from the Dutch Biologic Monitor (DBM), a multi-centre cohort event monitoring system based on web-based questionnaires for bDMARD-using patients. ADR reports of the Dutch Rheumatic Arthritis Monitoring Registry (DREAM-RA) were used to outline the HCP perspective. ADR reports from foundation up to 31 October 2019 were coded according to MedDRA terminology. Fisher-Freeman-Halton test with Monte Carlo simulation was used to measure discrepancies between the distributions of High Level Group Terms (HLGT). The prevalence of the top 15 HLGTs were compared using Chi-Square Goodness-of-Fit tests.Results:ADR reports of 404 DBM participants (1,977 ADRs) and 341 DREAM-RA patients (679 ADRs) were analysed. Patients and HCPs reported a different ADR distribution (p&lt;.001). Administration site reactions were most frequently reported by patients, followed by infections and (epi)dermal conditions. HCPs most often reported (epi)dermal conditions, infections and general system disorders. Moreover, the distribution of ADRs that patients allegedly discussed with HCPs varied considerably from the distribution of HCP-reported ADRs (p&lt;.001).Table 1.Patient characteristicsDutch Biologic Monitorn=404DREAM-RAn=341Age, median (IQR), years57.0 (49.0-65.0)56.0 (46.0-65.0)Female, n (%)279 (73.5)240 (70.4)Indication for bDMARD therapy, n (%)Rheumatoid arthritis299 (74.0)381 (89.4)Psoriatic arthritis105 (26.0)45 (10.6)bDMARD use, n (%)Etanercept164 (40.6)152 (34.9)Adalimumab134 (33.2)119 (44.6)Tocilizumab32 (7.9)48 (14.1)Other100 (24.8)107 (31.4)Table 2.Distribution of patient-and HCP-reported ADRsPatientHCPp-valueHigh Level Group TermBurden(1-5)Reports(%)HCP contact(%)Reports(%)All patient vs HCP reportsHCP contact vs HCP reportsAdministration site reactions1.7402 (20.3)93 (11.1)20 (2.9)&lt;.001&lt;.001Infections - pathogen unspecified2.9229 (11.6)130 (15.5)93 (13.7)0.1530.344Epidermal and dermal conditions2.6218 (11.0)96 (11.4)111 (16.3)&lt;.0010.007General system disorders NEC2.8175 (8.9)82 (9.8)52 (7.7)0.3820.172Gastrointestinal signs and symptoms2.481 (4.1)17 (2.0)29 (4.3)0.8240.015Respiratory disorders NEC2.477 (3.9)33 (3.9)26 (3.8)1.01.0Headaches2.955 (2.8)23 (2.7)19 (2.8)1.01.0Joint disorders3.355 (2.8)32 (3.8)3 (0.4)0.0930.006Respiratory tract signs and symptoms2.247 (2.4)22 (2.6)7 (1.0)0.0390.036Skin appendage conditions3.044 (2.2)14 (1.7)12 (1.8)0.5381.0Musculoskeletal and connective tissue disorders NEC3.140 (2.0)16 (1.9)4 (0.6)0.0090.039Oral soft tissue conditions2.433 (1.7)12 (1.4)7 (1.0)0.2770.644Gastrointestinal motility and defaecation conditions2.629 (1.5)12 (1.4)16 (2.4)0.1230.186Ocular infections, irritations and inflammations3.129 (1.5)22 (2.6)4 (0.6)0.1060.002Therapeutic and nontherapeutic effects (excl toxicity)2.927 (1.4)16 (1.9)3 (0.4)0.0570.010Other2.9436 (22.1)221 (26.3)273 (40.2)&lt;.001&lt;.001Conclusion:Patients and HCPs report a different distribution of ADRs attributed to bDMARDs. Therefore, patient-reported ADRs should ideally be combined with HCP reports, as the combination of both perspectives gives a more complete picture of a patient’s health status.Disclosure of Interests:Leanne Kosse: None declared, Naomi Jessurun: None declared, Eugène van Puijenbroek: None declared, Astrid van Tubergen Consultant of: Novartis, Harald Vonkeman: None declared

Impact of adverse drug reactions on the coding of a hospital stay in Quebec: exploratory descriptive study by simulation.

The discharge summary sheet's coding allows calculation of the severity index (SI), mortality index (MI), and resource intensity weight (RIW). These indicators help to describe the burden of care for individual cases and could potentially influence patient-based funding. This study was undertaken to simulate the impact of different adverse drug reactions (ADRs) on the hospital length of stay, thus allowing calculation of the effect of ADRs on the SI, MI, and RIW. This exploratory descriptive study was based on computer simulations. We created, by simulation, seven patient profiles of various complexities representative of our patients. Fifteen types of combination of drug and ADR manifestation comprising 15 ADR caused by eight different drug classes were identified based on the most frequently coded ADR in fiscal years 2016-2017 and 2017-2018. Those 15 combinations were applied to the patient profile to simulate the impact on the SI, MI, and RIW in eight scenarios. From these data, we measured the impact of the ADRs on these indicators. A total of 1,571 simulations were run. In general, the addition of a couple of drug and ADR manifestation contributed to increases in all three of the indicators. More specifically, the SI and RIW both increased in 30.7% (n = 482), whereas the MI increased in 14.6% (n = 229). For a same scenario, the impact on the three indicators could vary depending on the patient profile to which it was applied. This study has presented simulation data on the impact of the coding of ADRs on the hospital stay of a patient in Quebec.

Body Weight as a Determining Factor in the Predominance of Adverse Drug Reactions Induced by Fixed-Dose Adalimumab Injections in Female Patients in a Korean Hospital Setting.

Adalimumab is used at 40-mg dose to treat systemic inflammatory diseases. Given the impact of adverse drug reactions (ADRs), which particularly result in the discontinuation of adalimumab therapy in female patients, this study examined whether sex affects the frequency and type of ADRs induced by adalimumab. In this study, the prescription records and laboratory data of patients aged ≥19 years who had been admitted to the Seoul National University Hospital (SNUH) and prescribed adalimumab were analyzed using an electronic medical record database. The analysis revealed that female patients more frequently experienced adalimumab-induced ADRs compared with male patients (63.2% vs. 52.2%). The incidence of ADRs was significantly higher in female patients with ankylosing spondylitis or rheumatoid arthritis than in male patients with similar conditions (81.5% vs. 60.7% or 64.4% vs. 50.0%, respectively). The median body weight (BW) was lower in female patients than in male patients (54.0 vs. 66.0 kg). Moreover, the incidence of ADRs in patients with a BW of <54.0 kg (i.e., the median female BW) was higher than for those with a BW of ≥54.0 kg, in both males and females. Our results suggested that the predominance of ADRs induced by adalimumab in females was because of their relatively lower BW. This suggests the importance of BW as a determining factor in sex disparity of ADR occurrences.

An analysis of seriousness, predictability and preventability of adverse drug reactions reported at a tertiary care teaching hospital in Kerala, India: a retrospective observational record based study

Background: Adverse drug reactions (ADR) are the leading cause of mortality and morbidity in all health care systems. Hospital based ADR monitoring and reporting programmes can throw some light upon the profile of ADRs and ways to prevent them, facilitating rational drug use. An attempt has been made in this study to analyse the seriousness, predictability, preventability, severity and outcome of ADRs occurring in a tertiary care hospital.Methods: This was a retrospective observational study based on the data collected from ADRs reported to an approved ADR monitoring centre (AMC). Data collected was evaluated for seriousness, predictability, preventability, severity and outcome using appropriate scales. Simple descriptive statistics was used for analysis.Results: The total number of ADRs reported was 300. Among this 39% reactions were serious. The commonest reason for considering as serious reaction was prolongation of hospitalization. The overall predictability was 40.4%. Total preventability was found to be 18.3%. Assessment of severity showed 55.3 %, 41.7%, 3% reactions in mild, moderate and severe grades respectively. 64.3% patients had recovered from the reaction and 30% were recovering at the time of reporting ADR. Only 0.3% ADRs caused death.Conclusions: Authors hope this study will foster the culture of reporting and analysing ADRs among health care professionals and students. The findings from the study can create awareness among health care professionals regarding the impact of ADRs on the treatment course.

Impact of adverse drug reactions on the incremental cost-effectiveness of bedaquiline for drug-resistant tuberculosis.

Adverse drug reactions (ADRs) are common during standard, long-course treatment for multidrug-resistant and rifampicin-resistant tuberculosis (MDR-/RR-TB). In particular, second-line injectables (SLIs) are associated with permanent hearing loss, acute renal injury and electrolyte imbalance. We adapted an established Markov model for ambulatory treatment to estimate the impact of the toxicity profile on the incremental cost-effectiveness ratio (ICER) for a proposed MDR-/RR-TB regimen replacing the SLI with bedaquiline (BDQ). Treatment effectiveness was evaluated in disability-adjusted life-years (DALYs). Clinical outcomes and ingredient costs from a provider perspective were derived from the South African public-sector treatment program or extracted from the literature. Costs and effectiveness were discounted at 3% per year over 10 years. A BDQ-based MDR-/RR-TB regimen compared with the SLI regimen had a mean ICER of US$516 per DALY averted using the standard Markov model. Costs for both regimens increased and effectiveness decreased for the SLI regimen once adjusted for toxicity. The resulting ICER for the BDQ-based regimen was cost saving (US$96/patient) and more effective (0.96 DALYs averted) after adjusting for ADRs. Decision-analysis models of treatment for MDR-/RR-TB, including new drug regimens, should consider the costs of managing ADRs and their sequelae.

Impact of adverse drug reactions on quality of life in patients with schizophrenia

Impact of adverse drug reactions on quality of life in patients with schizophrenia

Evaluation of Adverse Reactions Induced by Anti-Tuberculosis Drugs in Hospital Pulau Pinang.

BackgroundThe use of multi-drug regimens in tuberculosis (TB) treatment has been associated with undesirable adverse drug reactions (ADRs). This study aims to assess the incidence and impact of ADRs on TB treatment in Hospital Pulau Pinang.MethodsThis cross-sectional study was conducted via retrospective review of outpatients’ medical records. Details regarding ADRs were identified by a pharmacist and verified by a consultant respiratory physician.ResultsA total of 91 cases, out of 210 patients enrolled in this study, were detected with 75 patients (35.7%) experienced at least one ADR. The three most common ADRs detected were cutaneous adverse drug reactions (CADRs) (21.0%), drug-induced hepatitis (DIH) (7.1%) and gastrointestinal disturbance (4.8%). Pyrazinamide was the most common causative agent and 15.7% of all TB patients required treatment modification due to ADRs. Females were shown to have a higher tendency to develop ADRs than the males in this study (P = 0.009). The development of ADRs was shown not to affect the TB treatment outcomes (P = 0.955).ConclusionThe incidence of ADRs in this study was high so it is important to identify the risk factors for ADRs and the individuals who have those risk factors when initiating anti-TB drugs. These individuals require special attention when anti-TB drugs are initiated.

Safety Concerns Reported by Patients Identified in a Collaborative Signal Detection Workshop using VigiBase: Results and Reflections from Lareb and Uppsala Monitoring Centre.

IntroductionPatient reporting in pharmacovigilance is important and contributes to signal detection. However, descriptions of methodologies for using patient reports in signal detection are scarce, and published experiences of how patient reports are used in pharmacovigilance are limited to a few individual countries.ObjectiveOur objective was to explore the contribution of patient reports to global signal detection in VigiBase.MethodsData were retrieved from VigiBase in September 2016. Drug–event-combination series were restricted to those with >50% patient reports, defined as reporter type “Consumer/non-health professional” per E2B reporting standard. vigiRank was applied to patient reports to prioritize combinations for assessment. Product information for healthcare professionals (HCPs) as well as patient information leaflets (PILs) were used as reference for information on adverse drug reactions (ADRs). Staff from the Uppsala Monitoring Centre and the Netherlands Pharmacovigilance Centre Lareb categorized the combinations. Potential signals proceeded to a more in-depth clinical review to determine whether the safety concern should be communicated as a “signal.”ResultsOf the 212 combinations assessed, 20 (9%) resulted in eight signals communicated within the World Health Organization (WHO) programme for international drug monitoring. Review of PILs revealed insufficient ADR descriptions for patients and examples of poor consistency with product information for HCPs. Patient narratives provided details regarding the experience and impact of ADRs and evidence that patients make causality and personal risk assessments.ConclusionsSafety concerns described in patient reports can be identified in a global database including previously unknown ADRs as well as new aspects of known ADRs. Patient reports provide unique information valuable in signal assessment and should be included in signal detection. Novel approaches to highlighting patient reports in statistical signal detection can further improve the contribution of patient reports to pharmacovigilance.

Impact of adverse drug reaction of first line anti - tuberculous drugs on treatment outcome of tuberculosis under revised national tuberculosis control programme

Background: Tuberculosis (TB), an infectious disease caused by Mycobacterium tuberculosis, is the major health care burden responsible for morbidity and mortality. The objective was to study the profile of adverse drug reactions (ADRs) and its outcome.Methods: It was a prospective observational study conducted in one of the RNTCP centre of Ahmedabad district. All TB patients visiting and taking short course of directly observed treatment (DOTS) were enrolled and monitored for ADRs. All the ADRs spontaneously reported or identified by the researcher were recorded and analyzed.Results: Total 974 patients screened during the study period 72 (7.79%) developed ADRs. Significantly higher occurrence of ADRs were in age group of 31- 40 years (p&lt;0.01). Out of these 72 patients, 49 (68%) were having pulmonary TB. No statistically significant association was found between gender of patient, site of TB and occurrence of ADRs (p&gt;0.05). Occurrence of ADRs was significantly more (p&lt;0.05) in patients of category I TB (31, 43%). Out of the 49 (68%) pulmonary tuberculosis patients who developed ADR, 32 patients (44%) were sputum positive showing significant association (p&lt;0.05). Gastro-intestinal side effects were most common ADRs followed by giddiness and headache. Nine patients required complete stoppage of offending agent, while 2 patients require treatment interruption and most of the patients (61) were managed with supportive medication without removing anti tubercular drug from their treatment regimen. Out of these 72 patients, majority (56) declared cured at the end of treatment.Conclusions: ADRs are major factor limiting completion of drug therapy under RNTCP and occurrence of drug resistance which requires attention of all health care professionals.

PHP268 - Economic Impact Of Adverse Drug Reactions: A Pubmed Based Study

PHP268 - Economic Impact Of Adverse Drug Reactions: A Pubmed Based Study