Adverse Drug Reaction Monitoring System Research Articles

Retrospective analysis of perioperative anaphylactic shock induced by cefuroxime

This study investigated the characteristics and frequency of perioperative anaphylactic shock induced by cefuroxime, so as to provide a reference for the safe and rational use of cefuroxime in the perioperative period. Cases of perioperative anaphylactic shock caused by cefuroxime in our hospital from 2011 to 2021 were extracted from the Adverse Drug Reaction Monitoring System. Literature reporting adverse drug reactions (ADR) including cefuroxime-induced anaphylactic shock in perioperative settings was collected from the CNKI, VIP, Wanfang, PubMed, and Web of Science databases from their respective inception to May 2022. Statistical analysis was performed for all cases of cefuroxime-induced perioperative anaphylactic shock. A total of 31 patients were included [13 men (48.1%) and 14 women (51.9%)], most of whom were over 60 years old (n=16, 59.3%); 9 (29.0%) patients had a history of drug allergy; 5 (16.1%) patients had received skin tests, but with negative results; 28 (90.3%) patients received treatment intravenously; 22 (71.0%) patients were treated after anesthesia. For 20 (64.5%) patients the ADR occurred within 10 minutes after anesthesia. The main manifestations were hypotension, dyspnea, rash, and tachycardia. For all patients, symptoms resolved after withdrawal of the drug and active rescue, and there were no deaths. A history of allergy and skin test findings may have limitations in predicting perioperative anaphylactic shock caused by cefuroxime; greater vigilance should be exercised when using cefuroxime in the perioperative period. Close monitoring is recommended for patients undergoing treatment with cefuroxime. Rescue therapy should be administered for allergic shock, and suitable response measures must be taken in a timely manner to ensure the safety of patients.

Knowledge, Attitude and Practice on Adverse Drug Reactions and its Reporting Among Nursing Students

Adverse Drug Reaction (ADR) is defined as ‘a response to a medicine which is noxious and unintended, and which occurs at doses normally used in man’. ADR reporting does not yet appear to be regarded by healthcare practitioners as an integral element of standard professional practice. This is mainly because there isn't a robust and active ADR monitoring system or a culture of reporting among medical personnel. If given sufficient knowledge and skills during their undergraduate training careers, medical students could play a significant role and shift the paradigm in the successful implementation of a Pharmacovigilance program. At the moment, they don't have any significant roles due to insufficient training they received regarding ADR reporting. Thus it can be reasoned that effective educational intervention regarding ADR reporting improves Spontaneous Reporting. This study improves the Knowledge Attitude and Practice on ADRs among nursing students as they are the next generation of healthcare workers who will be the first point of contact in case a patient develops an adverse drug reaction in hospital settings. The goal of the study is to assess and improve the Knowledge, Attitude and Practice on Adverse Drug Reactions and its reporting among nursing students. The study also aimed to identify the barriers associated with reporting of Adverse Drug Reactions among the study subjects. An educational interventional study was carried out among 150 samples in selected nursing colleges of Bengaluru. The data was collected by using self designed content validated questionnaire and responses were recorded. All data obtained was processed and analyzed by using Microsoft excel. It was found that most of the student’s knowledge towards Adverse Drug Reactions and its reporting were found to be improved after suitable intervention. Lack of training, less exposure, absence of professional confidence was identified as barriers associated with reporting of ADR. With the right coaching and guidance provided by means of educational programs, this study was able to further enhance nursing student’s knowledge, attitude and practice regarding Adverse Drug Reactions and its reporting.

Aripiprazole-induced liver injury: a spontaneous reporting database study.

Background: There have been individual case reports of aripiprazole in recent years, both domestically and internationally, but no analysis of the characteristics of the occurrence of adverse reactions/events of drug-induced liver injury with aripiprazole using spontaneous reports has been seen. Methods: Using a retrospective study approach, the 452 adverse reaction/event reports of aripiprazole-induced liver injury collected by the China Adverse Drug Reaction Monitoring System from 1 January 2012 to 31 December 2016 were analyzed and evaluated, and exploring it's the clinical characteristics and related risk factors for liver injury occurrence. Results: Among 452 cases of aripiprazole-induced liver injury ADR/ADE reports, there were 121 cases classified as serious, accounting for 26.8% of the total. There were 250 male and 202 female patients, with a male-to-female ratio of 1.24:1. The age of patients ranged from 11 to 77years old, with an average age of (34.56 ± 12.81)years old, and a high proportion of young adults in the total population. Some patients had used the drug off-label or at a higher than recommended dosage. The onset of liver injury was generally within 15-90days after continuous use, while some patients are also accompanied by nausea, vomiting, and weight gain. 70% of the combined drug instructions listed that may cause liver injury. Conclusion: In clinical practice, healthcare professionals should pay closely attention to the adverse reactions and risk factors of liver injury caused by aripiprazole. If there are potential risk factors for liver injury, early and regular monitoring of liver function should be carried out to reduce the occurrence of adverse reactions.

Active surveillance and clinical analysis of anaphylaxis based on the China Hospital Pharmacovigilance System.

Objective: This study aimed to develop active surveillance programs (ASPs) for anaphylaxis using the China Hospital Pharmacovigilance System (CHPS) and analyze the characteristics, allergens, and management strategies for anaphylaxis within a tertiary hospital setting in China. Methods: We retrospectively analyzed the anaphylaxis cases reported to the National Adverse Drug Reaction Monitoring System in our hospital from 2014 to 2021. Characteristic medical orders, progress notes, and diagnoses in these cases were recorded to identify initial anaphylaxis trigger entries. Based on these initial entries, the questionnaire was developed, and the Delphi method was used to establish consensus entries for anaphylaxis triggers. The CHPS was used to program these trigger entries and construct ASPs, which were then tested on the 238,194 discharged patients to evaluate their performance and analyze the related clinical data. Results: Ten anaphylaxis triggers and three ASPs were ultimately identified. The ASPs captured 309 cases, out of which 94 cases were confirmed as anaphylaxis following manual screening. After removing duplicates, we noted 76 patients who experienced anaphylaxis 79 times. The positive rate of triggers and the positive predictive value of the programs were 0.13% and 30.42%, respectively. The incidence of anaphylaxis in our study was 0.03%, and the number of anaphylaxis cases detected by the ASPs was 5.64 times higher than those detected by the spontaneous reporting system. Anaphylaxis was more common among female patients. Antibacterial drugs, antineoplastic drugs, and contrast media were the most prevalent allergens in clinical practice. Anaphylaxis to antineoplastic drugs had the highest incidence (0.6%) when compared with patients admitted during the same period. Our study revealed a significant underuse of epinephrine and overuse of second-line therapy (glucocorticoids and antihistamines) in the management of anaphylaxis. Furthermore, we found the use and dosage of epinephrine to be inappropriate. Conclusion: The CHPS can effectively utilize both structured and unstructured data to construct anaphylaxis ASPs, and this could counteract the under-reporting by the spontaneous reporting system, the primary adverse reaction monitoring method in China. The treatment and management of anaphylaxis are currently inadequate and require improvement to reduce mortality risk.

Landscape of DILI-related adverse drug reaction in China Mainland.

Drug-induced liver injury (DILI) is a type of bizarre adverse drug reaction (ADR) damaging liver (L-ADR) which may lead to substantial hospitalizations and mortality. Due to the general low incidence, detection of L-ADR remains an unsolved public health challenge. Therefore, we used the dataof6.673 million of ADR reports from January 1st, 2012 to December 31st, 2016 in China National ADR Monitoring System to establish a new database of L-ADR reports for future investigation. Results showed that totally 114,357 ADR reports were retrieved by keywords searching of liver-related injuries from theoriginal heterogeneous system. By cleaning and standardizing the data fields by the dictionary ofsynonyms and English translation, we resulted 94,593 ADR records reported to liver injury andthencreated anew database ready for computer mining. The reporting status of L-ADR showed a persistent 1.62-fold change over the past five years. The national population-adjusted reporting numbers of L-ADR manifested an upward trend with age increasing and more evident in men. The annual reporting rate of L-ADR in age group over 80 years old strikingly exceeded the annual DILI incidence rate in general population, despite known underreporting situation in spontaneous ADR reporting system. The percentage of herbal and traditional medicines (H/TM) L-ADR reports in the whole number was 4.5%, while 80.60% of the H/TM reports were new findings. There was great geographical disparity of reported agents, i.e. more cardiovascular and antineoplastic agents were reported in higher socio-demographic index (SDI) regions and more antimicrobials, especially antitubercular agents, were reported in lower SDI regions. In conclusion, this study presented a large-scale, unbiased, unified, and computer-minable L-ADR database for further investigation. Age-, sex- and SDI-related risks of L-ADR incidence warrant to emphasize the precise pharmacovigilance policies within China or other regions in the world.

Pharmacovigilance programme in India (PvPI): History, Current scenario, future aspects and role in COVID 19

According to WHO, Pharmacovigilance (PV) is characterized as the science and exercises identifying with the recognition, appraisal, comprehension and anticipation of unfavourable impacts or some other medication related issue. It is an important part of our medication guideline framework. As we know, India is the world's second most populated country with very nearly one billion dynamic and potential medication buyers and clients. Though our country is participating in Uppsala Monitoring Centre, its obligation to that data base is by and pretty much nothing. This issue is due to the lack of proper ADR (Adverse drug reaction) monitoring system and awareness among associates of medicines and health workers. PV program mainly aims for patient care, patient safety and monitoring of adverse drug reaction. For the accurate practice of PV in India, there are need of more clinical preliminaries and clinical examinations. For the safe and sensible use of medication, a perfectly working PV system is mandatory. PV will be invaluable in India not only for medical services experts, regulatory authorities, pharmaceutical organizations but also for the consumers to screen the medicines. This article gives a methodical audit of the pharmacovigilance program in India (PvPI) from its starting point to the current situation and furthermore examines the future parts of pharmacovigilance program in India.

Age-Associated Risk of Liver-Related Adverse Drug Reactions.

ObjectiveAging population is generally considered more sensitive to adverse drug reactions (ADRs). Yet, big data-based quantitative evidence currently does not exist to support this concept. This study aims to investigate age-associated risks of liver-related ADR (L-ADR).MethodsSpontaneous reporting data from 2012 to 2016 were retrieved from the China National ADR Monitoring System. The risk ratio (RR) was used to quantify the relative risk of L-ADR of each age group. The reporting odds ratio (ROR) was used to quantify the correlation with the risk of L-ADR of each drug category or drug in older adults.ResultsTotally, 64,702 L-ADR reports were retrieved, covering ages from 1 to 116, with a median age of 49. The RR values increased exponentially with the increase of age, which indicates that the relative risk of L-ADR increased by 33% for every 10-year increase in age. The age cutoff point for relative high risk of L-ADR was estimated at 52.0 years old (RR = 1). In 17 categories composed of 270 drugs, the top 3 drug categories with a high correlation to the risk of L-ADR in older adults were antiarrhythmic (ROR, 5.75; 95% CI: 4.45–7.42), antilipemic (ROR, 4.77; 95% CI: 4.53–5.02), and antihypertensive (ROR, 2.97; 95% CI: 2.59–3.41).ConclusionsThis research illustrates quantitatively that aging is a potential risk factor for L-ADR, with a 33% increase in relative risk for every 10-year increase in age. Risk management should be addressed for older adults when those drugs with a high correlation to the risk of L-ADR are used.

Nutritional evaluation study based on NRS 2002, OPNI, and their combined use in patients with adverse drug reactions after chemotherapy: a cross-sectional study.

BackgroundIt is important to assess the nutritional status of patients who have experienced adverse drug reactions (ADRs) after chemotherapy. We aimed to explore the nutritional status of patients who developed ADRs after chemotherapy, using the Nutritional Risk Screening 2002 (NRS 2002) tool, the Onodera Prognostic Nutrition Index (OPNI), and their combined application.MethodsNRS 2002 screening and OPNI calculation for patients before chemotherapy. Patients with ADRs after chemotherapy were grouped according to the NRS 2002, OPNI, and combined scores from both assessments. The types of ADRs were classified according to the National adverse drug reaction monitoring system (http://www.adrs.org.cn/). The impact of nutritional risk on the classification and types of ADRs in cancer chemotherapy patients was analyzed. Logistic regression was used to analyze the key influencing factors of gastrointestinal damage and bone marrow suppression. the consistency between the NRS 2002, OPNI, and their combined application analyzed.ResultsThe difference in body mass index (BMI) scores between the OPNI (P=0.041) and NRS 2002 groups was statistically significant (P=0.051). The difference in ADR type in the OPNI subgroups (P=0.04) was statistically significant. It showed that the proportion of new and severe ADRs in the low OPNI group (47.14%) was significantly higher than that in the high OPNI group (27.13%). The differences in digestive tract-associated ADRs were statistically significant among the OPNI groups (P=0.004), NRS 2002 groups (P=0.012), and combined measures groups (P=0.000), as were the differences in myelosuppressive-type ADRs in the OPNI groups (P=0.035), NRS 2002 groups (P=0.000), and combined measures groups (P=0.000). Logistic regression analysis showed that BMI was the key influencing factor for digestive tract-associated ADRs (95% CI: 1.267, 95% CI: 1.022–1.570, P=0.031) and myelosuppressive-type ADRs (95% CI: 1.213, 95% CI: 1.020–1.443, P=0.029). It had good consistency with the combined measures of nutritional risk (Kappa value =0.675).ConclusionsPatients with severe ADRs after chemotherapy showed low OPNI values, high NRS 2002 scores, and malnutrition. These patients also had a significantly increased incidence of digestive tract and myelosuppressive-type ADRs with BMI as the key influencing factor. The combined assessments showed good consistency with the NRS 2002 scores.

A synthesis of the evidence regarding safety of a Chinese herbal formula Shufeng Jiedu: A pharmacological review

Shufeng Jiedu capsule (SFJDC) is a Chinese herbal medicine formula for treating acute respiratory tract infections. This review aims to assess its potential safety for clinical setting.Systematic literature searches were conducted across multiple databases to: investigate the phytochemistry and safety data on SFJD and its constituents; and to produce a meta-analysis of RCTs reporting safety concerns (all ages) receiving SFJDC capsule (any condition). The primary outcome was the incidence of adverse events (AEs) or complications associated with taking SFJDC with/without usual care compared with placebo or usual care.Pharmacovigilance data reporting AEs to the Chinese National Adverse Drug Reaction Monitoring System in 2017/2018 was analysed.Safety information was insufficient regarding pregnancy/lactation (all herbs). Laboratory studies raised theoretical concerns regarding saikosaponins A and D elevating blood glucose; glycyrrhizin inducing hypertension and hypokalaemia; and saikosaponins/resveratrol/lignans reducing platelet activity. However, these occurred at much higher doses than used clinically.Sixty-four RCTs (7612 participants) met the meta-analysis criteria. Fourteen additional trials and two case studies were also considered. Minor AEs included nausea/vomiting, diarrhoea, unspecified gastrointestinal discomfort, dizziness and rash; these were not significantly different (statistically) to control groups.Across 2017 and 2018 sales of SFJDC packs (content 36 capsules) totalled 23.2 million. AEs recorded were 169 (2017) and 198 (2018). The majority were gastrointestinal, and improved on stopping SFJDC. None included the potential phytochemical concerns (regarding platelets, hypertension, hypokalaemia, blood glucose).No serious AEs were identified from the included trials or pharmacovigilance data.No substantive safety concerns were identified for SFJD for clinical use; excluding pregnant/lactating women.

Application of real world study and human use experience in research and development of new traditional Chinese medicine drugs

Real world study(RWS) refers to the process of collecting real world data related to the health of research subjects in the real world environment for pre-set clinical problems and obtaining the status of drug use and potential benefits/risks through analysis. The data are derived from the hospital information system(HIS), medical insurance system, disease registration system, adverse drug reaction monitoring system, etc. Human use experience of traditional Chinese medicine(TCM) is a new concept put forward by experts after summarizing the problems existing in clinical trials of new TCM drugs. The data come partially from the real world, and more importantly, such key elements as the formulated prescriptions of new TCM drugs, principles and methods, and clinical applications should be covered. RWS is mainly used for adverse drug reaction monitoring after marketing, benefit evaluation of listed drugs, decision-making of medical treatment and medical insurance, as well as supervision and approval of special medical devices and special drugs. It is complementary to randomized controlled clinical trials. Human use experience is suitable for the research and development of Chinese medicinal compound preparations and the expansion of functions and indications. There are no special provisions for clinical indications and target population. There exists a sequential relationship between the human use experience and clinical trials. Specifi-cally, the summarization of human use experience provides good support for the design and implementation of clinical trials, which is an important segment in the research and development of new TCM drugs. The correlation between real-world data and research results and their reliability should be ensured in RWS, and the unreality should be avoided. The key to summarizing the human use experience is to identify the clinical orientation, target population, course of treatment, usage and dosage of new TCM drugs, and it should be noted that human use experience does not only mean clinical experience. Experimental clinical trial(PCT), a type of study in the real world, has been commonly employed for the summary of human use experience. RWS and human use experience are different research designs targeting different clinical questions in the research and development of new TCM drugs, which can be flexibly selected depending on the actual situation.

Clinical view on adverse drug reactions, pharmacovigilance in India and role of clinical pharmacist

An Adverse Drug Reaction (ADRs) is still a challenge in modern healthcare, increasing complication of therapeutics, an elderly populace and increasing multimorbidity. Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine/vaccine related problem. This article is having objective of evaluating the pharmacist perception about Pharmacovigilance and ADRs monitoring through ample literature review. In India pharmacovigilance activity begins in 1986 with ADR monitoring system under supervision of drug controller general of India. The prescribed National Pharmacovigilance Program was commence in 2005; with unsuccessful attempt in 1998, and renamed as Pharmacovigilance Program of India (PvPI) in 2010. Adverse drug reactions monitoring has become an essential part to be executed together with other health-care services for a safe use of medicines. Pharmacist can play an important role in evaluation of ADRs. Pharmacist – drug expert- having abundant knowledge of pharmacological action, pharmaco-therapeutics, adverse reactions, and disease pathophysiology, can make the drug therapy safer.

Landscape of Hepatobiliary Adverse Drug Reactions Related to Preparations Containing Psoraleae Fructus and Its Application in Pharmacovigilance

To analyze clinical feature and information of medication to explore the risk signals of preparations containing Psoraleae Fructus (BGZP) related with hepatobiliary adverse drug reactions (ADR), in order to reinforce pharmacovigilance. A retrospective study was conducted based on hepatobiliary ADR related with BGZP from the China Adverse Drug Reaction Monitoring System in years from January 2012 to December 2016. Serious and general ADRs were analyzed and assessed. There were 355 cases of hepatobiliary ADR related to BGZP. Both the amount of cases and the proportion of serious ADR showed an increasing growth by years (P<0.05). It was found that 10.43% of 355 cases may be involved with irrational drug use, including overdose, repeated medication, and combination of multiple drugs. There were 190 cases which used BGZP (non-combination), and they were mainly for common in diseases caused by abnormal immune activation (accounting for 40.53% of the total cases). Especially at the age group with the most cases with age of 41-50 years, the cases associated with immunological diseases of female were obviously more than that of male (P<0.05). The latency of hepatobiliary ADR related to BGZP ranged from 1 to 386 days, and the median latency was 27.5 days, along with the range of cumulative dose (0.45-520.02 g) as well as the daily dose (0.09-2.64 g/d) after the conversion. Cases of hepatobiliary ADR related to BGZP showed significant individual differences, and there was no correlation between drug usage duration and dosage and the occurrence of hepatobiliary ADR. It may be similar with idiosyncratic drug-induced liver injury, and recommended that BGZP should be used with more caution under monitoring liver function, especially in female patients with immunological diseases.

Research on the adverse reactions of medicines based on deep learning models

The frequent occurrence of adverse drug reactions in medical events has become the focus of increasing attention in various countries. The quality of adverse reaction reports is the basis for medical risk assessment and analysis. Only by obtaining high-quality and valuable information can scientific treatment be carried out. Analysis, however, at present, there is no quantitative analysis on the relationship between the factors affecting adverse drug reactions and the degree of adverse reactions. There are few reasonable mathematical models. This article adopts the method of deep learning to establish a “human-machine material law ring”. “The mathematical model between the five factors and the degree of adverse drug reactions in China analyzes adverse drug reactions in China, and provides effective guidance for reducing drug accidents and improving China’s adverse drug reaction monitoring system.

Tu1171 INCIDENCE OF ADVERSE DRUG REACTIONS OF POLYETHYLENE GLYCOL ELECTROLYTES POWDER: THE ANALYSIS OF REPORTS IN CHINA

Since 2018, the National Medical Products Administration of China has issued a notice on the Direct Reporting of Adverse Drug Reactions (ADRs) by Marketing Authorization Holders (MAH), which has ushered in a new era in the reporting of ADRs in China. Objective: Niflec (Polyethylene Glycol Electrolytes Powder, PEG-ELP) is one of the most widely used oral intestinal lavage preparation agents in China. The purpose of this study is to analyze the incidence of Niflec ADRs reported in the database of ADR monitoring system in the first six months after the MAH reporting policy, and to evaluate the clinical safety of Niflec. The reports of ADRs caused by Niflec were screened out from the database of ADR monitoring system, and they were analyzed by gender, age, primary disease, concomitant drugs, occurrence time, history of allergy, ADR types, causality, and severity. From December 15, 2018 to June 15, 2019, thirty-two ADR cases were reported, including one serious adverse event. The adverse reactions were more in patients aged 60 and over (50.0%) and more in female (71.9%). Only one patient had a clear history of drug allergy. The main adverse reactions occurred in the gastrointestinal system (53.1%) or skin and mucous membrane (34.4%). The top three manifestations were vomiting, nausea and rash. Most of the ADRs were observed within 30 minutes after the first use, accounting for 37.5%. Concomitant drugs were taken by 9.4% of the patients. The one serious adverse event was intestinal obstruction with shock. According to Pharmaceutical DataBase (PDB) data, the market size of Niflec in China was approximately 2 million bags in the first and second quarter of 2019. The number of drug users was estimated to be 679,896. Based on the above analysis, the overall incidence of ADR of Niflec was relatively low, less than 5 per 100,000 patients. The total incidence of serious ADR was less than 1.5 per million, which was very rare. All patients recovered or improved after proper treatments. The safety of PEG-ELP is confirmed by this study. However, it is still necessary to pay attention to the correct preparation and proper use. The bowel preparation personnel should be alert to monitor ADRs, especially on patients aged 60 and over, and take corresponding measures if any of these reactions are encountered.

OP0208 PATIENTS REPORT FATIGUE AS AN ADVERSE DRUG REACTION OF BIOLOGICS

Background:Chronic fatigue is a well-known symptom in patients with rheumatic diseases and other immune-mediated inflammatory diseases (IMIDs). Therefore, fatigue as an adverse drug reaction (ADR) to biologics may remain unrecognised or may erroneously be attributed to the disease.Objectives:To assess patient-reported fatigue attributed to biologics for IMIDs and investigate predisposing factors of patient-reported fatigue.Methods:The Dutch Biologic Monitor is a multicenter patient-reported ADR monitoring system that surveys patients using a biologic for an IMID. Patients completed web-based questionnaires regarding ADRs attributed to biologics and the course and experienced burden (5 point Likert scale) of these ADRs. All patient-reported ADRs with MedDRA Preferred Term ‘fatigue’ were defined as biologic-associated fatigue (BA-fatigue). Basic demographics and treatment characteristics were compared between patients reporting BA-fatigue and patients not reporting BA-fatigue (reported other ADRs or no ADRs).Results:Out of 1369 participating IMID patients, 696 patients reported 1844 unique ADRs. BA-fatigue was reported by 100 patients and 48 patients described a consistent pattern of recurring fatigue after each administration. Most of these patients (88%) described recovery from BA-fatigue within one week after biologic administration and 73 patients reported health care professional (HCP) contact following BA-fatigue, with dose adjustment in 8 and discontinuation in 5 patients.Basic demographics and characteristics that differ significantly between patients reporting BA-fatigue and patients not reporting BA-fatigue are summarized in table 1. No significant difference was found for other biologics, IMIDs, combination therapy and comorbidities. BA-fatigue was reported by 27% of rituximab users (n=33), 27% of vedolizumab users (n=26), 16% of tocilizumab users (n=50), 14% of infliximab users (n=159) and 3% of etanercept users (n=418). Although 29 patients in the BA-fatigue population had RA and 29 patients had Crohn’s disease (CD), 571 patients in our overall study population had RA and 194 patients had CD, suggesting BA-fatigue was reported by CD patients more often. The mean burden of BA-fatigue was higher than the mean burden of other ADRs (p&lt;0.001).Table 1.Characteristics of patients with BA-fatigue compared to patients with other ADRs and without ADRsPatients with BA-fatigue n (%)Patients with other ADRs n (%)Patients without ADRs n (%)n100 (100%)596 (100%)673 (100%)Basic demographicsAge (years) (mean ± SD)50.0 ± 14.653.4 ± 13.6 *55.7 ± 14.2 ***Gender (Female)59 (59%)398 (67%)ns342 (51%)nsSmoking n (%)25 (25%)97 (16%) *100 (15%) *BMI (kg/m2) (mean ± SD)25.7 ± 4.425.9 ± 4.7ns26.6 ± 5.5nsBiologicInfliximab22 (22%)53 (9%) ***84 (12%) *Etanercept13 (13%)177 (30%) ***228 (34%) ***Rituximab9 (9%)18 (3%) **6 (1%) ***Tocilizumab8 (8%)29 (5%)ns13 (2%) **Vedolizumab7 (7%)12 (2%) *7 (1%) ***IMIDRheumatoid arthritis29 (29%)270 (45%) **272 (40%) *Crohn’s disease29 (29%)77 (13%) ***88 (13%) ***Other indication16 (16%)53 (9%) *39 (6%) ***Combination therapyMethotrexate23 (23%)167 (28%)ns227 (34%) *ComorbidityPsychiatric disorder11 (11%)49 (8%)ns31 (5%) *Other comorbidity30 (30%)124 (21%) *102 (15%) ***Mean burden of ADR ± SD2.9 ± 0.92.4 ± 1.1 ***Mann Whitney U, independent t-test and Fisher’s exact as appropriatens: not significant *p ≤ 0.05 **p ≤ 0.01 ***p ≤ 0.001Conclusion:HCPs should be aware that fatigue may be associated with biologic therapy and has a significant burden on patients. Evaluating the course of the symptoms might be helpful in recognizing BA-fatigue.Disclosure of Interests:Jette van Lint: None declared, Tom Bakker: None declared, Jouke Ubbink: None declared, Martijn van Doorn Grant/research support from: Unrestricted grants, advisory board, speaker fees and/or other (investigator) from Novartis, Abbvie, Janssen Cilag, Leopharma and Pfizer, Speakers bureau: Unrestricted grants, advisory board, speaker fees and/or other (investigator) from Novartis, Abbvie, Janssen Cilag, Leopharma and Pfizer, Phyllis Spuls Grant/research support from: Departmental independent research grant for TREAT NL registry LeoPharma December 2019; Contract support: I am involved in performing clinical trials with many pharmaceutical industries that manufacture drugs used for the treatment of e.g. psoriasis and atopic dermatitis for which we get financial compensation paid to the department/hospital, Consultant of: Consultancies in the past for Sanofi 111017 and AbbVie 041217 (unpaid), Sander Tas: None declared, Harald Vonkeman: None declared, Frank Hoentjen Grant/research support from: Received grants from Dr Falk, Janssen-Cilag, and AbbVie., Consultant of: Served on advisory boards, or as speaker or consultant for AbbVie, Celgene, Janssen-Cilag, MSD, Takeda, Celltrion, Teva, Sandoz, and Dr Falk, Speakers bureau: Served on advisory boards, or as speaker or consultant for AbbVie, Celgene, Janssen-Cilag, MSD, Takeda, Celltrion, Teva, Sandoz, and Dr Falk, Bart van den Bemt Grant/research support from: UCB, Pfizer and Abbvie, Consultant of: Delivered consultancy work for UCB, Novartis and Pfizer, Speakers bureau: Pfizer, AbbVie, UCB, Biogen and Sandoz., Michael Nurmohamed Grant/research support from: Not related to this research, Consultant of: Not related to this research, Speakers bureau: Not related to this research, Eugène van Puijenbroek: None declared, Naomi Jessurun: None declared

Health-care Professionals' Knowledge and Perception of Adverse Drug Reaction Reporting and Pharmacovigilance in a Tertiary Care Teaching Hospital of Nepal.

Background: Underreporting of adverse drug reactions (ADRs) is common globally, and Nepal is not an exception to this. Health-care professionals (HCPs) play a vital role in reporting ADR during routine practice. Lack of knowledge and awareness about pharmacovigilance and reporting ADRs among HCPs may contribute to underreporting. Objective: The objective of this study was to evaluate the knowledge and perception of HCPs regarding ADR reporting and pharmacovigilance in a tertiary care teaching hospital in, Nepal. Methods: A descriptive cross-sectional study was conducted. A questionnaire was distributed to 215 HCPs (medical doctors, nurses, and pharmacists) between March and September 2018. Knowledge and perception regarding ADR reporting and pharmacovigilance were studied. Data were analyzed using IBM SPSS Statistics for Windows, Version 21.0 (IBM Corp, Armonk, New York). Results: The HCPs included 75 medical doctors, 126 nurses, and 14 pharmacists. Majority of the participants were female (67%), and the majority of participants were not aware of pharmacovigilance. Among the participants, pharmacists were found to have better knowledge regarding pharmacovigilance. However, other HCPs (doctors and nurses) strongly agreed about the necessity of having adequate knowledge about pharmacovigilance. Out of 215, 57.7% agreed that the important benefit of reporting ADR was to identify safe drugs and improve patient safety. The main reasons for not reporting were - ADR reporting was not widely promoted by relevant authorities (47%), followed by not knowing where and how to report ADR (34.9%). However, other HCPs (doctors and nurses) strongly agreed about the necessity of having adequate knowledge about pharmacovigilance. Conclusions: The knowledge of HCPs on ADR reporting and pharmacovigilance was poor. Despite a low knowledge of ADR reporting and pharmacovigilance among HCPs, there was a positive perception that ADR reporting is necessary and ADR monitoring system should be established in the hospital. This study also highlights a need for future intervention studies focusing on educating HCPs about ADR and pharmacovigilance.

A study on the knowledge, attitude and practice on adverse drug reactions and pharmacovigilance among post graduate residents in Gandhi Medical College, Bhopal

Background: Resident doctors should consider adverse drug reaction (ADR) reporting as their professional obligation and should be aware of the existing pharmacovigilance mechanisms in their countries. In India, pharmacovigilance implementation is essential due to the absence of a vibrant ADR monitoring system. The present study primary objective was to evaluate the knowledge, attitude and practices (KAP) of the postgraduate students towards pharmacovigilance and ADR reporting in GMC, Bhopal as they observe and attend to the patients round the clock while the patient is admitted in the hospital.Methods: A cross-sectional-observational study was carried out using a pretested questionnaire having 17 questions in all. Data was compiled, entered in Microsoft Excel sheet and analysed by descriptive statistics.Results: A total of 127 duly filled responses were analysed. Study shows ADR is necessary and Pharmacovigilance should be taught in detail to postgraduate students is an important finding from our study. In this study there was also a wide gap between the ADR experienced in professional practice (71%) and ADR reported (23%).Conclusions: In our present study, the average knowledge score was 64% in contrast to 32% residents who didn’t answered correctly. Though majority (87%) of the residents had a positive attitude towards awareness about Pharmacovigilance and ADR reporting, however in clinical scenario even as ADR reporting was considered to be important by a large majority of the participants, the actual practices of ADR reporting was very low.

A study on pattern of adverse drug reaction in an adverse drug reaction monitoring centre of a tertiary care hospital in South Kerala, India

Background: Adverse drug reactions (ADR) are rated as fifth leading cause of death and accounts for approximately 5% of all hospital admissions. Under reporting of ADR from healthcare professional is considered as the contributing factor for increased morbidity and mortality. India has taken well appreciated step to launch Pharmacovigilance Programme of India (PvPI) to safeguard heath care of Indian population. This study looks into the detailed analysis of ADR reported to adverse drug reaction monitoring centre (AMC), Government Medical College, Trivandrum to assess its pattern, causality, severity and seriousness of ADR. Primary objectives of this study are the pattern of adverse drug reactions reported to ADR monitoring centre (AMC) and secondary objective is to assess causality, severity.Methods: A record based descriptive study was conducted in the ADR monitoring centre of government medical college, Trivandrum, Kerala from September 1st 2016 to February 2017(6 months). The data were collected from the all reported case records/ ADR report form of CDSCO. The details of the various adverse drug reactions were identified and analysed to find the pattern of adverse drug reactions including distribution of age, gender, causal drug group, system organ class. Also, an attempt is made to do causality assessment using WHO UMC scale and severity by using Heart wig Seigel Scale.Results: Out of 320 ADR cases, majority of reports were due to cutaneous manifestations. Most common ADRs were erythema, induration, and rash, itching. Females were 56% and males were 44%. Majority cases were of adult age group. Causality 91.88% were probably related, 75.6% were mild reaction. 25% of cases were serious. 77.5% were recovered. Antibacterial implicated 25(7.8%) followed by anti-epileptics 24 (7.5%) ADR.Conclusions: The pattern of adverse drug reactions reported to this AMC is comparable to the studies done in other parts of country. A strong need for streamlining of ADR monitoring system and reporting reemphasized by this study, which will promote the ADR reporting in healthcare professionals.

Patient Reporting of Adverse Drug Reactions (ADRs): Survey of Public Awareness and Predictors of Confidence to Report

Many countries incorporate direct patient reporting of adverse drug reactions (ADRs) into their pharmacovigilance systems as patients provide a different insight into drug safety compared to health care professionals. This study aimed to examine public awareness about ADR reporting in Malaysia and patients' confidence in reporting ADRs. Using a cross-sectional design and convenient sampling, data were collected in public areas within Kuala Lumpur, Malaysia, via face-to-face interview with a structured questionnaire. Multivariate logistic regression analysis was used to identify the significant predictors of patients' confidence in ADR reporting. Out of 860 consented respondents achieving a response rate of 73.5%, only 69 (8%) were aware of the Malaysian ADR monitoring system. The majority (60%) of the respondents indicated they had the confidence to report ADRs. Multivariate logistic regression analysis revealed that ease in completing the ADR reporting form was the strongest variable predictive of confidence to report ADRs (odds ratio [OR], 18.45; 95% confidence interval [CI], 10.55-32.25). Increased confidence in ADR reporting was also associated with education level. Respondents with a higher education level were more likely to be confident to report ADRs compared to those with primary or no formal education (OR, 2.49; 95% CI, 0.77-8.1). Lack of awareness of the ADR monitoring system is still prevalent among Malaysian patients. The ease of completing the ADR form and education level are predictive of patient confidence to report ADRs. These factors should be considered in designing public promotional activities to encourage patient contributions to pharmacovigilance.

Application of biclustering algorithm in adverse drug reaction monitoring system of China.

Signal evaluation is considered to be a tedious process owing to the large number of disproportional signals detected. This study aimed to apply a biclustering algorithm in the spontaneous reporting system of China and to obtain the optimal parameters. The biclustering algorithm is expected to improve the efficiency of signal evaluation by identifying similar signal groups. Information component (IC) was the method used for disproportionality analysis. By using IC thresholds of various strengths (0.05-4.00), the original quantitative data matrix was transformed into 80 different binary data matrices, where each cell contained either a 1 or 0. The biclustering results were obtained using a total of 720 Bimax algorithm parameters (minimal number of columns and rows was 3, 4, or 5). Next, the optimal parameters were determined through the comprehensive evaluation of the rank sum ration. Finally, we examined the biclustering results under the optimal parameters and evaluated the effect of biclustering analysis on adverse drug reaction (ADR) data in China. The optimal strength of the IC threshold was 0.80, and the minimum number of rows and columns was 3. After taxonomic evaluation, we also found that 1836 biclusters (42.8%) contained similar drugs or similar ADRs, which accounted for 72.3% of signals unevaluated. Applying biclustering analysis in spontaneous reporting system could provide support in confirming unrecognized ADRs, identifying rare ADRs, and screening drug-ADR pairs, which need more attention. Biclustering algorithm could improve the efficiency of signal detection and evaluation in China.