Adverse Drug Reaction Surveillance Research Articles

Using a Patient Portal to Screen Patients for Symptoms After Starting New Medications.

Conduct systematic proactive pharmacovigilance screening for symptoms patients experienced after starting new medications using an electronic patient portal. We aimed to design and test the feasibility of the system, measure patient response rates, provide any needed support for patients experiencing potentially drug-related problems, and describe types of symptoms and problems patients report. We created an automated daily report of all new prescriptions, excluding likely non-new and various OTC meds, and sent invitations via patient portal inviting patients to inquire if they had started the medication, and if "yes," inquire if they had they experienced any new symptoms that could be potential adverse drug effects. Reported symptoms were classified by clinical pharmacists using SOC MeDra taxonomy, and patients were offered follow-up and support as desired and needed. Of 11,724 included prescriptions for 9360 unique patients, 2758 (29.4%) patients responded. Of 2616 unique medication starts, patients reported at least 1 new symptom that represented a potential adverse drug reaction (ADR) in 678/2616 (25.9%). Nearly one-third of those experiencing new symptoms (30.3%) reported 2 or more new symptoms after initiating the drug. GI disorders accounted for 30% of the total reported ADRs. Systematic portal-based surveillance for potential adverse drug reactions was feasible, had higher response rates than other methods (such as automated interactive phone calling), and uncovered rates of potential ADRs (roughly 1 in 4 patients) consistent with other methods/studies.

Clinical pharmacy and telemedicine: an opportunity to improve epilepsy management.

Clinical pharmacy, as defined by the European Society of Clinical Pharmacy, is a comprehensive professional practice encompassing all pharmacist profiles regardless of the setting. It focuses on promoting optimal drug utilization for patient-centric clinical outcomes. Telemedicine leverages information and communication technologies for remote healthcare delivery, bridging geographical gaps. The integration of clinical pharmacy and telemedicine is crucial in modern healthcare paradigms, especially for patients with chronic illnesses. In 2021, marketing authorization was granted for cenobamate as adjunctive treatment for focal-onset seizures with or without secondary generalization in adults with epilepsy who have not been adequately controlled despite a history of treatment with at least two antiepileptic medicinal products. This review emphasizes the synergistic role of clinical pharmacists and neurologists in utilizing telemedicine for patient counselling, drug information dissemination, adverse drug reaction surveillance, and personalized medication management within the context of epilepsy care. This integration could enhance patient safety, therapeutic outcomes and address socio-economic challenges faced by chronic patients.

Dual effects of Psoraleae Fructus on the liver: hepatoprotection or hepatoxicity?

Psoraleae Fructus, the dried mature fruit of the leguminous plant Psoralea corylifolia L., contains flavonoids, coumarins, monoterpene phenols, and benzofurans. It exhibits various pharmacological activities, including immune regulation, antioxidant properties, photosensitivity, and estrogen-like effects, and finds extensive use in the clinical treatment of osteoporosis, vitiligo, and psoriasis. Extensive pharmacological research has demonstrated that Psoraleae Fructus and its components improve liver function and protect hepatocytes in animal and cellular models of liver diseases. Moreover, with the increasing clinical applications of Psoraleae Fructus and its derivatives, as well as the progression in adverse drug reaction surveillance, there is an increase in clinical cases involving these preparations and the enhancement of monitoring for any adverse reactions linked to Psoraleae Fructus and its related compounds. Here, we examined the hepatoprotective effects and hepatotoxicity of the monomer components, extracts, and related preparations of Psoraleae Fructus. We aim to contribute to safety evaluation, facilitate informed clinical application, and foster advancements in Psoraleae Fructus and its derivatives.

A retrospective and observational study of the adverse drug reactions reported in a tertiary care hospital

Background: Adverse drug reaction (ADR) is considered a common cause of prolonged hospitalization and death among patients. Pharmacovigilance is essential in the surveillance of adverse drug reactions. The responsibility of a healthcare professional is to report any adverse reaction that occurs with the use of drugs. This helps in providing a database and improving the safety of patients. The aim of the study was to determine the incidence of ADR, assess causality, severity, and preventability of the submitted adverse drug reactions, increase the awareness of preventability of adverse drug reactions in health care professionals by conducting regular workshops on ADR, and document occurrence of a rare ADR. Methods: A retrospective observational study was conducted to assess the ADR reported to the ADR monitoring Centre, for the past 6 years included in the study. The data were entered into Microsoft excel and analyzed using descriptive statistics. Mean and standard deviation were calculated for the categorical data. Drugs were classified according to the class. Reactions were analyzed using scales and presented in descriptive statistics. Results: A total of 95 ADR reports were received and reported. These ADRs were associated with a total of 108 drugs that were prescribed- the occurrence of ADRs dominated among females 60% (57). Antimicrobials were causing the highest number of adverse reactions 21 (19.44%) and antituberculosis drugs and radiocontrast media were associated with the following larger number of the ADRs 19 (17.59%). Intravenous at 40% was the most common route related to the development of ADR. The most common ADR caused by antimicrobials was rash (9), antitubercular therapy commonly caused hepatitis, and chills and rigors were more common with radiocontrast media. Most of the reactions observed in the patients were moderate reactions at 52.63% with 3.16% fatal ones. Conclusions: In this study, the predominant causative drugs associated with ADR were antimicrobials, antitubercular drugs, and radiocontrast media. The number of ADRs reported though was less there was a wide range of drugs causing ADR that were reported which gave a broader spectrum for analysis. There is a requirement for active monitoring of ADRs to understand the occurrence as well as help in prevention.

Under-reporting of adverse drug reactions: Surveillance system evaluation in Ho Municipality of the Volta Region, Ghana.

Adverse Drug Reactions (ADRs) can occur with all medicines even after successful extensive clinical trials. ADRs result in more than 10% of hospital admissions worldwide. In Ghana, there has been an increase of 13 to 126 ADR reports per million population from 2012 to 2018. ADR Surveillance System (ADRSS) also known as pharmacovigilance has been put in place by the Ghana Food and Drugs Authority (FDA) to collect and manage suspected ADR reports and communicate safety issues to healthcare professionals and the general public. The ADRSS in Ho Municipality was evaluated to assess the extent of reporting of ADRs and the system's attributes; determine its usefulness, and assess if the ADRSS is achieving its objectives. We evaluated the ADRSS of the Ho Municipality from January 2015 to December 2019. Quantitative data were collected through interviews and review of records. We adapted the updated CDC guidelines to develop interview guides and a checklist for data collection. Attributes reviewed included simplicity, data quality, acceptability, representativeness, timeliness, sensitivity, predictive value positive and stability. We found a total of 1,237 suspected ADR during the period, of which only 36 (3%) were reported by healthcare professionals in the Ho Municipality to the National Pharmacovigilance Centre (NPC). Only 43.9% of health staff interviewed were familiar with the ADRSS and its reporting channel. Staff who could mention at least one objective of the ADRSS were 34.2%, and 12.2% knew the timelines for reporting ADR. Reports took a median time of 41 (IQR = 25, 81) days from reporter to NPC. Reports sent on time constituted 37.5%. Fully completed case forms constituted 77.1% and the predictive value positive (PVP) was 20%. About 53% of ADRs were reported for female patients. Up to 88.9% of ADRs were classified as drug related. Anti-tuberculosis agents and other antibiotics constituted (40.6%) and (18.8%) of all reports. The ADRSS was not integrated into the disease surveillance and response system of Ghana's Health Service and so was not flexible to changes. A dedicated ADR surveillance officer in regions helped with the system's stability. Data from Ghana feeds into a WHO database for global decision making. There was under-reporting of ADRs in the Ho Municipality from January 2015 to December 2019. The ADR surveillance system was simple, stable, acceptable, representative, had a strong PVP but was not flexible or timely. The ADRSS was found useful and partially met its objectives.

Trends in the incidence of urothelial carcinoma in Taiwan after the ban on aristolochic acid-containing Chinese herbal preparations, 2001-2018: a national population-based cohort study.

Urothelial carcinoma (UC) of the bladder (BUC) and the upper urinary tract (UTUC) are the two most common UCs. The incidence of UTUC in Taiwan is the highest worldwide. Aristolochic acid (AA) was identified as the main cause of UTUC in Taiwan. To explore trends in the incidence of UC in Taiwan after the ban on Chinese herbal preparations containing AA in 2003. We used data from the Taiwanese National Health Insurance Research Database-linked Taiwanese National Cancer Registry for 2001-2018. UC was defined in accordance with the International Classification of Disease for Oncology. The age-standardized incidence was calculated on the basis of the World Health Organization standard population. Trends in the incidence were calculated as the annual percent change (APC) by using the Joinpoint regression program. Over the investigated period, the incidence of UC decreased at an average annual percent change (AAPC) of - 1.19% (95% CI -1.47 ~ -0.91, P < 0.001). However, the incidence in UTUC significantly increased, with the AAPC being 1.47% (95% CI 1.03 ~ 1.90, P < 0.001). In contrast, the incidence of BUC significantly decreased, with the overall AAPC being - 1.92% (95% CI -2.3 ~ -1.54, P < 0. 001). From 2001 to 2018, the overall incidence of UCs and BUC decreased in Taiwan, but the incidence of UTUC significantly increased. We suggest to apply the same review standards of new drug development process to herbal preparations and incorporate them into the adverse drug reaction or poison surveillance system. Most importantly, raise public awareness of the potential toxicity of phytotherapy.

Identifying adverse drug reactions from patient reviews on social media using natural language processing.

Drugs have the potential of causing adverse reactions or side effects and prior knowledge of these reactions can help prevent hospitalizations and premature deaths. Public databases of common adverse drug reactions (ADRs) depend on individual reports from drug manufacturers and health professionals. However, this passive approach to ADR surveillance has been shown to suffer from severe under-reporting. Social media, such as online health forums where patients across the globe willingly share their drug intake experience, is a viable and rich source for detecting unreported ADRs. In this paper, we design an ADR Detection Framework (ADF) using Natural Language Processing techniques to identify ADRs in drug reviews mined from social media. We demonstrate the applicability of ADF in the domain of Diabetes by identifying ADRs associated with diabetes drugs using data extracted from three online patient-based health forums: askapatient.com, webmd.com, and iodine.com. Next, we analyze and visualize the ADRs identified and present valuable insights including prevalent and less prevalent ADRs, age and gender differences in ADRs detected, as well as the previously unknown ADRs detected by our framework. Our work could promote active (real-time) ADR surveillance and also advance pharmacovigilance research.

Trends in Adverse Drug Reactions Among Children: Evidence from Jiangsu Province of China, 2010-2019.

Medication safety among children represents an underrecognized public health concern worldwide, yet little evidence was found in China. This study aimed to examine trends in rates of pediatric adverse drug reaction (ADR) reports in Jiangsu Province of China with a catchment population of more than 11 million children. Data for children aged under 15 years were extracted from the spontaneous reporting system of ADR surveillance in Jiangsu Province. Suspected therapeutic agents for ADRs were coded using the Anatomical Therapeutic Chemical classification system. We used the Chinese modification of the International Classification of Diseases, Tenth Revision, to group primary diseases, and the Medical Dictionary for Regulatory Activities to classify the manifestation of ADRs. We used Joinpoint to estimate age-adjusted ADR rates stratified by sex from July 2010 to June 2019, and further by specific features, including patient characteristics, main suspected therapeutic medications, primary diseases, and ADRs. We used the percentage change annualized estimator to evaluate trends over time. A total of 79,903 ADR reports were identified among children aged under 15 years, which accounted for 11.4% of all ADRs reported in Jiangsu Province during the same period. The age-adjusted ADR report rates increased significantly from 66.20 to 96.76 per 100,000 children during the period July 2010-June 2019, with an annual increase of 4.9% (95% confidence interval 1.3-8.5%; p value 0.014). Of all ADR reports, there were 47,774 (59.8%) boys and 32,129 (40.2%) girls. Children aged 0-4 years accounted for more than half of the ADR reports (n=47,680, 59.7%). Skin and subcutaneous tissue disorders were the most frequently reported ADRs (45,773, 57.3%). Respiratory diseases were the most commonly observed medical conditions in relation to pediatric ADRs, accounting for 68.8% (n=54,940) of all ADR reports, and anti-infectives for systemic use consistently represented over time the most common medication group, contributing to 69.8% of all reports. A reduction in ADR report rates was observed for vaccines, with an annual decrease of 19% in children. ADRs remain a public health challenge among the vulnerable pediatric populations. Findings from the present study call for continuing efforts in ADR prevention and medication safety improvement in children.

Hydroxychloroquine: Adverse Drug Reaction Profile of an Old Drug in a New Situation.

Hydroxychloroquine (HCQ) has been extensively used during the COVID-19 pandemic both as a therapeutic and prophylactic drug. HCQ is generally well tolerated; however, adverse drug reactions (ADRs) in COVID-19 need further exploration. In this study, we have determined the type and pattern of ADRs of HCQ as a prophylactic and therapeutic drug in COVID-19. All spontaneous suspected ADR reports due to HCQ in COVID-19 patients submitted to the ADR monitoring of a tertiary care hospital were included. Additionally, a survey was designed for active surveillance of ADRs among healthcare professionals (HCPs) who were on prophylaxis with HCQ. The ADRs were analyzed to determine severity, causality, and preventability using the Hartwig Scale, World Health Organisation-Uppasala Monitoring Centre (WHO-UMC) scale, and modified Schumock and Thornton criterion respectively. Sixty-four ADR reports were received from COVID-19 patients. A total of 78 ADRs were reported by 49 HCPs who were on HCQ prophylaxis. The majority of the patients had ADRs related to skin and soft tissues (37.5%), whereas the HCPs on prophylaxis mostly had gastrointestinal complaints (42.3%). ADRs observed in HCPs on prophylaxis were mild, not requiring any intervention. However, 50% of ADRs in patients were of "moderate" category. Undiscerning and unsupervised use of HCQ can expose the general population as well as patients to serious adverse drug effects. Utmost care is necessary before using HCQ prophylactically or for treatment in COVID-19.

Short-Term Adverse Drug Reactions to Antiretroviral Therapy in Children with HIV: A Cohort Study.

To carry out an active surveillance for adverse drug reactions (ADRs) in children with HIV infection newly initiated on antiretroviral therapy (ART), determine risk factors for their occurrence, and assess their influence on adherence to ART. All children newly initiated on ART from 1st March 2014 to 30th June 2019 at a tertiary care children's hospital in New Delhi, were actively monitored for ADRs to ART for a period of 6 mo after ART initiation. The frequency, spectrum, and severity of ADRs, their influence on adherence, and risk factors for their occurrence were analyzed. Among the 174 enrolled children, ADRs were observed in 78 (44.8%) children during the first 6 mo after ART initiation. Total numbers of episodes of ADR observed were 108 (0.62 episodes of ADR/child). Sixty percent of events were of grade 1 severity, 19.4% events were of grade 2 and 3 each, while 1 (0.9%) event was of grade 4 severity. Adherence to ART was adversely affected in 21.8% of ADRs. Gastrointestinal symptoms (49.1%) were most frequent among all the events observed. Zidovudine, lopinavir/ritonavir, efavirenz and nevirapine based regimes were significantly associated with hematological, gastrointestinal, neurological, and dermatological ADRs, respectively. Children with immunological suppression were at a higher risk of developing ADRs as compared to those without it [RR 1.9 (95% CI (1.1-3.2)]. ADRs to ART are very frequent; most of them are mild and self-limiting. However, they can adversely impact adherence to ART. Anticipatory guidance, ongoing monitoring, and provision of symptomatic treatment will help tide over most ADRs and reduce their adverse impact upon ART adherence.

Perceived Adverse Drug reactions to Artemether Lumefantrine and Artesunate Amodiaquine in Lagos, Nigeria

Introduction: Medications produce a therapeutic effect that modulates a disorder and unwarranted effects that may be intrinsically harmful. Adverse drug reactions (ADRs) are undesirable effects that results from drug administration at usual doses and are the primary focus of regulatory agencies and post-marketing surveillance. Aim and objectives: To evaluate ADRs to Artemisinin-based Combination Therapies (ACTs) such as Artemether-Lumefantrine (AL) and Artesunate-Amodiaquine (AA) among adults with the objectives of (i) estimating and comparing the frequency of ADRs associated with AL and AA and (ii) developing a list of classical adverse drug reactions to both antimalarials. Materials and Methods: This cross-sectional, quantitative study was conducted from March to May 2013 at Ikorodu, a peri-urban settlement in Lagos State of Nigeria among 252 patients diagnosed with malaria and randomized into Artemether Lumefantrine (AL) arm and Artesunate Amodiaquine (AA) arm. Results: The mean age (years) of all the study subjects was 34.4 (10.6) with 58% of them who attained secondary level education. About 50% of them took other non-antimalarial medication together with prescribed ACT during their illness. Overall mean duration of illness (days) before taking ACT was 2.8 (1.14) which was significantly longer (t-est=-3.57, P-value=0.0002) in AA arm (3.1 ± 1.2) than in AL arm (2.6 ± 1.0). In all, 234 (96.4%) and 169 (67.1%) severally completed the full dose of treatment and ate pre-medication fatty meal. Overall prevalence of ADRs was 47.6% - 27.8% in the AL arm and 69.8% in the AA arm. Among those who did not take fatty meal, the risk of ADRs was higher (χ²=0.69, P-value=0.40, RR=1.26, 95% CI=0.72, 2.21) in the AA arm compared to the AL arm. Weakness, dizziness and headache were the most prevalent ADRs reported in both AL (25.9%, 13.8%, 15.5% respectively) and AA (50.0%, 10.0%, 16.4% respectively) arms. Conclusion: In general, the frequency of ADRs, though mild or moderate in severity, was significantly higher in the AA arm than in the AL arm and the frequency of serious ADR was very low. The most prevalent ADRs reported were weakness/fatigue, headache and dizziness. Pre-medication consumption of fatty meal reduced the frequency of ADRs in both arms of the study. Programmes on the management of malaria with ACT should consider this baseline information for active surveillance for ADRs in Nigeria.

Adverse Drug Reaction Monitoring of Anticancer Drugs in Hematology Department

Background: Cancer is among the leading causes of mortality in India. Studies have reported antineoplastic agents as the common class of drugs causing Adverse Drug Reactions (ADRs). The present study aimed to conduct active surveillance of ADRs of anticancer drugs in the hematology department. Methods: A prospective observational study was conducted in 136 patients with cancer and the incidence and frequency of ADRs were assessed. The study was conducted in 6 months in a multispecialty hospital. Results: Among 136 cancer patients, All was more prevalent (39.70%); CLL, Non- Hodgkin’s Lymphoma were less prevalent (0.73%). ADRs were more prevalent in the Pediatrics department, i.e., 18.53% of ADRs were observed in patients aged &lt;10 years. ADRs in male patients constituted 54.39%, whereas it was 45.60% in female patients. Cytarabine caused the highest number of ADRs (34.48%). The most prevalent ADR was anemia (25.60%). Conclusion: Multiple ADRs were detected in cancer patients. We found that hematological ADRs were more prevalent. Most of the ADRs were possible reactions according to Naranjo and the World Health Organization (WHO) scales.

Surveillance of adverse drug reactions at an adverse drug reaction monitoring centre in Central India: a 7-year surveillance study

ObjectivesTo analyse and present the occurrence and severity of spontaneous adverse drug reaction (ADR) reports prospectively registered at an ADR monitoring centre (AMC) in Central India.Setting and dataThe survey was...

Surveillance of Adverse Drug Reactions to First-line Antituberculosis Drugs Using Common Data Model

Sun-ju Byeon, MD, PhD, Hang A Park, MD, PhD, Dong Yoon Kang, MD, PhD, In Young Choi, PhD and Jeong-Hee Choi, MD, PhD. Journal of Pharmacoepidemiology and Risk Management 2021;13:78-86. https://doi.org/10.56142/2021.13.2.78

An Overview about Safety Surveillance of Adverse Drug Reactions and Pharmacovigilance in India

One pathway for more actively monitoring Adverse Drug Reactions (ADRs) and, as a result, improving patient care safety is a structured Adverse Drug Reaction Surveillance network. Multiple methods for testing and recording the efficacy of drugs in clinical use are important for avoiding or reducing patient injury and strengthening public health. This entails establishing a well-structured Pharmacovigilance programme in clinical practise. Once a prescription has been published into the "true world," pharmacovigilance is an important method of monitoring medication-related issues. Pharmacovigilance and other drug-related problems should be familiar to those whose life is impacted by prescription procedures in some way. In modern times, pharmacovigilance has gained prominence as a technology critical to sound clinical practise and public health science. Since ADRs have such a detrimental influence on patients' wellbeing and inflict too much financial strain, it's critical to carefully monitor each medication for any potential adverse effects in animal models (preclinical studies) and clinical trials until releasing it. Pharmacovigilance aims to serve a significant part in combating the dangers faced by an ever-growing number of drugs, each of which is vulnerable to unpredictably negative side effects. When adverse effects and toxicity occur, they must be recorded, analysed and the importance of the results correctly communicated to those who may understand the evidence. By ensuring that prescription drugs of high consistency, purity and effectiveness are used rationally, the risk of injury will be minimised. In this study it will briefly explore adverse drug reaction safety control and pharmacovigilance in India.

Adverse Drug Reactions among Children with Tuberculosis in Tashkent, Uzbekistan, 2019.

The treatment of childhood tuberculosis can be challenging due to the lack of pediatric drug formulations and monitoring of drug-toxicity in routine settings. There are no published studies from Uzbekistan on the adverse drug reactions (ADR) associated with anti-tuberculosis treatment in children. In this study, we aimed to investigate the ADR associated with anti-tuberculosis treatment in children. This was a cohort study using secondary program data of children treated at the city and regional tuberculosis clinics in Tashkent, Uzbekistan. Of the 302 patients evaluated, 135 (44.7%) reported ADR. New tuberculosis was registered in 277 (92%) patients and 262 (87%) had extrapulmonary tuberculosis. Factors associated with ADR included treatment at a regional hospital (adjusted odds ratio, aOR = 1.75; p = 0.026), female sex (aOR = 2.2; p = 0.004), and treatment with second-line drugs (aOR = 8.82; p < 0.001). The most common ADRs were gastrointestinal disorders (28.5%) followed by hepatitis (8.9%) and dermatologic reactions (8.6%). Most of the ADRs were mild (55.6%) or moderate (43.7%), only one child had severe ADR. Patients with the identified risk factors should be closely monitored during the treatment. We also recommend expansion of ADR surveillance throughout the country for more representative data in the future.

Progress in Immunization Safety Monitoring - Worldwide, 2010-2019.

High levels of coverage with safe and effective immunizations are critical to the successful control and prevention of vaccine-preventable diseases worldwide. In addition to stringent standards to regulate the safety of vaccines, robust postlicensure monitoring systems help ensure that the benefits of vaccines continue to outweigh the risks for the populations who receive them. National Expanded Programmes on Immunization (EPI) are typically responsible for identifying and investigating adverse events following immunization (AEFI), including assessment of causality. National regulatory authorities (NRAs) are mandated to perform postlicensure surveillance of adverse drug reactions, including those associated with receipt of vaccines. This report describes global progress toward meeting World Health Organization (WHO) indicators on minimal country capacity for vaccine safety surveillance and coordination of AEFI reporting between countries' EPI and NRAs. In 2019, among 194 countries, 129 (66.5%) reported having an operational national AEFI causality review committee, compared with 94 (48.5%) in 2010. During 2010-2019, the proportion of countries reporting ≥10 AEFI per 100,000 surviving infants per year (an indicator of country capacity to monitor immunization safety) increased, from 41.2% to 56.2%. In 2019, however, only 46 (23.7%) countries reported AEFI data from both EPI and NRAs. Although global progress has been made toward strengthening systems for vaccine safety monitoring over the past decade, new indicators for monitoring global immunization safety performance are needed to better reflect program functionality. Continued global efforts will be vital to address barriers to routine reporting of AEFI, build national capacity for AEFI investigation and data management, and improve sharing of AEFI data at national, regional, and global levels.

Lexicon Knowledge Boosted Interaction Graph Network for Adverse Drug Reaction Recognition From Social Media.

The World Health Organization underlines the significance of adverse drug reaction (ADR) reports for patients' safety. Actually, many potential ADRs tend to be under-reported in post-market ADR surveillance. Recognizing ADRs from social media is indispensably important and could complement post-market ADR surveillance for more effective pharmacovigilance studies. However, previous approaches pose two challenges: 1) ADRs show high expression variability in social media, and thus, many potential ADRs are out-of-lexicon ones, which are difficult to be recognized, and 2) most phrasal ADRs are non-standard mentions and their boundaries are difficult to identify accurately. To tackle these challenges, we design three interaction graphs and propose a neural network approach, i.e., Interaction Graph Network (IGN). Specifically, to recognize more out-of-lexicon ADRs, besides the mentions in ADR lexicon, noun phrases in the input sentence are regarded as candidate phrases and their features are taken into considerations. Moreover, in an attempt to accurately identify ADR boundaries, three word-phrase interaction graphs are designed to represent lexicon knowledge and are encoded using graph attention networks (GATs) to directly integrate various boundary and contextual information of candidate phrases into ADR recognition. Experimental results on two benchmark datasets show that IGN can recognize ADR accurately and consistently outperforms other state-of-the-art approaches.

PP162 Digital Medication Health Service Platforms Of Pharmaceutical Companies As Novel Sources Of Real-World Data For Health Technology Assessment

IntroductionDigital medication health service (DMHS) platforms are increasingly used by pharmaceutical companies to provide direct medication health services through digital methods like apps, hotlines, and web services, etcetera. However, the implications of such platforms in supporting health technology assessment (HTA) are rarely discussed in the literature. This presentation sets out the opportunities for using the DMHS platforms of pharmaceutical companies as real-world data sources for HTA.MethodsA mixed-method qualitative study combining literature review and case study was conducted. Relevant literature was identified by searching the Web of Science and PubMed databases. A case study on current DMHS platforms in China was carried out using an inductive approach to identify the key elements emerging from these platforms.ResultsDMHS platforms of pharmaceutical companies can identify multiple attributes of medication information needs regarding medical products, including effectiveness, safety, and economic factors. The platforms can respond to different stakeholders, including patients and their carers, doctors, nurses, pharmacists, etcetera. As one kind of interactive process, DMHS platforms can provide further services, including patient education, consultation, and evaluation, follow-up visits, chronic disease management, promotion of the rational use of drugs, therapeutic drug monitoring, and adverse drug reaction surveillance and reporting.ConclusionsThe DMHS platforms of pharmaceutical companies provide a unique and valuable real-world data source for HTA. These types of self-reported outcomes have not gained enough attention in HTA. Collective efforts by HTA agencies and pharmaceutical companies are needed to set strategies for integrating DMHS platforms into HTA.

Surveillance of adverse drug reactions and drug-drug interactions with pediatric oncology patients in a south Indian tertiary care hospital.

The present study was conducted to evaluate the pattern of occurrence of adverse drug reactions and drug-drug interaction in a pediatric oncology unit of a tertiary care hospital. A prospective, observational study was conducted in the Department of Pediatric Oncology, Sri Ramachandra Medical College and Hospital, India. Patients were monitored actively for the occurrences of any adverse drug reaction during the study period. Patient's demographic details, clinical, and treatment data were collected for drug-drug interaction analysis. The detected adverse drug reaction was assessed for causality, severity, and preventability. Drug-drug interaction identified was rated based on their level of urgency and the nature of actions necessary to respond to an interaction. Of 176 patients, 118 were detected for the occurrence of various adverse drug reaction. The majority of the cases were suffering with acute lymphocytic leukemia (67.9%). Vincristine was noted for a maximum number of adverse drug reaction in cytotoxic drugs. Rash is the most frequently occurred reaction. Assessment of causality showed that the majority of cases are "probable" (60.16%). In evaluating the severity of adverse drug reactions, 57.6% reactions were moderately severe and 74.5% of the reactions were preventable. Upon assessing the drug-drug interaction, 38.13% of the prescription needs to be monitored and 10 drug-drug interactions were under the risk category of "X." The majority of the adverse drug reaction was moderately severe in nature and those were preventable. Since pediatrics are vulnerable population, they must have a thorough surveillance system for adverse drug reaction and drug-drug interaction; thereby, a positive impact on the medication-use system and improved patient care can be achieved.