Commenced in January 2007
Frequency: Monthly
Edition: International
Paper Count: 3799

Search results for: adverse drug events

3799 The Safety Profile of Vilazodone: A Study on Post-Marketing Surveillance

Authors: Humraaz Kaja, Kofi Mensah, Frasia Oosthuizen

Abstract:

Background and Aim: Vilazodone was approved in 2011 as an antidepressant to treat the major depressive disorder. As a relatively new drug, it is not clear if all adverse effects have been identified. The aim of this study was to review the adverse effects reported to the WHO Programme for International Drug Monitoring (PIDM) in order to add to the knowledge about the safety profile and adverse effects caused by vilazodone. Method: Data on adverse effects reported for vilazodone was obtained from the database VigiAccess managed by PIDM. Data was extracted from VigiAccess using Excel® and analyzed using descriptive statistics. The data collected was compared to the patient information leaflet (PIL) of Viibryd® and the FDA documents to determine adverse drug reactions reported post-marketing. Results: A total of 9708 adverse events had been recorded on VigiAccess, of which 6054 were not recorded on the PIL and the FDA approval document. Most of the reports were received from the Americas and were for adult women aged 45-64 years (24%, n=1059). The highest number of adverse events reported were for psychiatric events (19%; n=1889), followed by gastro-intestinal effects (18%; n=1839). Specific psychiatric disorders recorded included anxiety (316), depression (208), hallucination (168) and agitation (142). The systematic review confirmed several psychiatric adverse effects associated with the use of vilazodone. The findings of this study suggested that these common psychiatric adverse effects associated with the use of vilazodone were not known during the time of FDA approval of the drug and is not currently recorded in the patient information leaflet (PIL). Conclusions: In summary, this study found several adverse drug reactions not recorded in documents emanating from clinical trials pre-marketing. This highlights the importance of continued post-marketing surveillance of a drug, as well as the need for further studies on the psychiatric adverse events associated with vilazodone in order to improve the safety profile.

Keywords: adverse drug reactions, pharmacovigilance, post-marketing surveillance, vilazodone

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3798 Using Group Concept Mapping to Identify a Pharmacy-Based Trigger Tool to Detect Adverse Drug Events

Authors: Rodchares Hanrinth, Theerapong Srisil, Peeraya Sriphong, Pawich Paktipat

Abstract:

The trigger tool is the low-cost, low-tech method to detect adverse events through clues called triggers. The Institute for Healthcare Improvement (IHI) has developed the Global Trigger Tool for measuring and preventing adverse events. However, this tool is not specific for detecting adverse drug events. The pharmacy-based trigger tool is needed to detect adverse drug events (ADEs). Group concept mapping is an effective method for conceptualizing various ideas from diverse stakeholders. This technique was used to identify a pharmacy-based trigger to detect adverse drug events (ADEs). The aim of this study was to involve the pharmacists in conceptualizing, developing, and prioritizing a feasible trigger tool to detect adverse drug events in a provincial hospital, the northeastern part of Thailand. The study was conducted during the 6-month period between April 1 and September 30, 2017. Study participants involved 20 pharmacists (17 hospital pharmacists and 3 pharmacy lecturers) engaging in three concept mapping workshops. In this meeting, the concept mapping technique created by Trochim, a highly constructed qualitative group technic for idea generating and sharing, was used to produce and construct participants' views on what triggers were potential to detect ADEs. During the workshops, participants (n = 20) were asked to individually rate the feasibility and potentiality of each trigger and to group them into relevant categories to enable multidimensional scaling and hierarchical cluster analysis. The outputs of analysis included the trigger list, cluster list, point map, point rating map, cluster map, and cluster rating map. The three workshops together resulted in 21 different triggers that were structured in a framework forming 5 clusters: drug allergy, drugs induced diseases, dosage adjustment in renal diseases, potassium concerning, and drug overdose. The first cluster is drug allergy such as the doctor’s orders for dexamethasone injection combined with chlorpheniramine injection. Later, the diagnosis of drug-induced hepatitis in a patient taking anti-tuberculosis drugs is one trigger in the ‘drugs induced diseases’ cluster. Then, for the third cluster, the doctor’s orders for enalapril combined with ibuprofen in a patient with chronic kidney disease is the example of a trigger. The doctor’s orders for digoxin in a patient with hypokalemia is a trigger in a cluster. Finally, the doctor’s orders for naloxone with narcotic overdose was classified as a trigger in a cluster. This study generated triggers that are similar to some of IHI Global trigger tool, especially in the medication module such as drug allergy and drug overdose. However, there are some specific aspects of this tool, including drug-induced diseases, dosage adjustment in renal diseases, and potassium concerning which do not contain in any trigger tools. The pharmacy-based trigger tool is suitable for pharmacists in hospitals to detect potential adverse drug events using clues of triggers.

Keywords: adverse drug events, concept mapping, hospital, pharmacy-based trigger tool

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3797 Effect on Tolerability and Adverse Events in Participants Receiving Naltrexone/Bupropion and Antidepressant Medication, Including SSRIs, in a Large Randomized Double-Blind Study

Authors: Kye Gilder, Kevin Shan, Amy Halseth, Steve Smith

Abstract:

This study assessed the effect of prolonged-release naltrexone 32 mg/bupropion 360 mg (NB) on cardiovascular (CV) events in overweight/obese participants at elevated CV risk. Participants must lose ≥2% body weight at 16 wks, without a sustained increase in blood pressure, to continue drug. Only serious adverse events (SAE) and adverse events leading to discontinuation of study drug (AELDSD) were collected. The study was terminated early after second interim analysis with 50% of all CV events. Data on CV endpoints has been published. Current analyses focused on AEs in participants on antidepressants at baseline, as these individuals were excluded from Phase 3 trials. Intent-to-treat (ITT) population (placebo [PBO] N=4450, NB N=4455) was 54.5% female, 83.5% white, mean age of 61 yrs, mean BMI 37.3 kg/m2, 22.8% with a history of depression, 23.1% on antidepressants, including 15.4% on an SSRI. SAEs in participants receiving antidepressants was similar between NB (10.7%) and PBO (9.9%) and also similar to overall population (9.5% NB, 8.1% PBO). SAEs in those on SSRIs were similar, 10.1% NB and PBO 9.4%. For those on SSRIs or other antidepressants, AELDSDs were similar to overall population and were primarily GI disorders. Obesity increases the risk of developing depression. For participants taking NB and antidepressants, including SSRIs, there is a similar AE profile as the overall population and data revealed no evidence of an additional health risk with combined use.

Keywords: antidepressant, Contrave, Mysimba, obesity, pharmacotherapy

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3796 An Assessment of Adverse Events Following Immunization Reporting Pattern of Selected Vaccines in VigiAccess

Authors: Peter Yamoah, Frasia Oosthuizen

Abstract:

Introduction: Reporting of Adverse Events Following Immunization continues to be a challenge. Pharmacovigilance centers throughout the world are mandated by the WHO to submit AEFI reports from various countries to a large pool of adverse drug reaction electronic database called Vigibase. Despite the relevant information of AEFI in Vigibase, it is unavailable to the general public. However, the WHO has an alternative website called VigiAccess which is an open access website serving as a repository of reported adverse drug reactions and AEFIs. The aim of the study was to ascertain the reporting pattern of a number of commonly used vaccines in VigiAccess. Methods: VigiAccess was thoroughly searched on the 5th of February 2018 for AEFI reports of measles vaccine, oral polio vaccine (OPV), yellow fever vaccine, pneumococcal vaccine, rotavirus vaccine, meningococcal vaccine, tetanus vaccine and tuberculosis (BCG) vaccine. These were reports from all pharmacovigilance centers in the world from the time they joined the WHO drug monitoring program. Results: After a thorough search in VigiAccess, there were 9,062 measles vaccine AEFIs, 185,829 OPV AEFIs, 24,577 yellow fever vaccine AEFIs, 317,208 pneumococcal vaccine AEFIs, 73,513 rotavirus vaccine AEFIs, 145,447 meningococcal vaccine AEFIs, 22,781 tetanus vaccine AEFIs and 35,556 BCG vaccine AEFIs. Conclusion: The study revealed that out of the eight vaccines studied, pneumococcal vaccines are associated with the highest number of AEFIs whilst measles vaccines were associated with the least AEFIs.

Keywords: vaccines, adverse reactions, VigiAccess, adverse event reporting

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3795 Pharmacovigilance in Hospitals: Retrospective Study at the Pharmacovigilance Service of UHE-Oran, Algeria

Authors: Nadjet Mekaouche, Hanane Zitouni, Fatma Boudia, Habiba Fetati, A. Saleh, A. Lardjam, H. Geniaux, A. Coubret, H. Toumi

Abstract:

Medicines have undeniably played a major role in prolonging shelf life and improving quality. The absolute efficacy of the drug remains a lever for innovation, its benefit/risk balance is not always assured and it does not always have the expected effects. Prior to marketing, knowledge about adverse drug reactions is incomplete. Once on the market, phase IV drug studies begin. For years, the drug was prescribed with less care to a large number of very heterogeneous patients and often in combination with other drugs. It is at this point that previously unknown adverse effects may appear, hence the need for the implementation of a pharmacovigilance system. Pharmacovigilance represents all methods for detecting, evaluating, informing and preventing the risks of adverse drug reactions. The most severe adverse events occur frequently in hospital and that a significant proportion of adverse events result in hospitalizations. In addition, the consequences of hospital adverse events in terms of length of stay, mortality and costs are considerable. It, therefore, appears necessary to develop ‘hospital pharmacovigilance’ aimed at reducing the incidence of adverse reactions in hospitals. The most widely used monitoring method in pharmacovigilance is spontaneous notification. However, underreporting of adverse drug reactions is common in many countries and is a major obstacle to pharmacovigilance assessment. It is in this context that this study aims to describe the experience of the pharmacovigilance service at the University Hospital of Oran (EHUO). This is a retrospective study extending from 2011 to 2017, carried out on archived records of declarations collected at the level of the EHUO Pharmacovigilance Department. Reporting was collected by two methods: ‘spontaneous notification’ and ‘active pharmacovigilance’ targeting certain clinical services. We counted 217 statements. It involved 56% female patients and 46% male patients. Age ranged from 5 to 78 years with an average of 46 years. The most common adverse reaction was drug toxidermy. For the drugs in question, they were essentially according to the ATC classification of anti-infectives followed by anticancer drugs. As regards the evolution of declarations by year, a low rate of notification was noted in 2011. That is why we decided to set up an active approach at the level of some services where a resident of reference attended the staffs every week. This has resulted in an increase in the number of reports. The declarations came essentially from the services where the active approach was installed. This highlights the need for ongoing communication between all relevant health actors to stimulate reporting and secure drug treatments.

Keywords: adverse drug reactions, hospital, pharmacovigilance, spontaneous notification

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3794 Pattern of Adverse Drug Reactions with Platinum Compounds in Cancer Chemotherapy at a Tertiary Care Hospital in South India

Authors: Meena Kumari, Ajitha Sharma, Mohan Babu Amberkar, Hasitha Manohar, Joseph Thomas, K. L. Bairy

Abstract:

Aim: To evaluate the pattern of occurrence of adverse drug reactions (ADRs) with platinum compounds in cancer chemotherapy at a tertiary care hospital. Methods: It was a retrospective, descriptive case record study done on patients admitted to the medical oncology ward of Kasturba Hospital, Manipal from July to November 2012. Inclusion criteria comprised of patients of both sexes and all ages diagnosed with cancer and were on platinum compounds, who developed at least one adverse drug reaction during or after the treatment period. CDSCO proforma was used for reporting ADRs. Causality was assessed using Naranjo Algorithm. Results: A total of 65 patients was included in the study. Females comprised of 67.69% and rest males. Around 49.23% of the ADRs were seen in the age group of 41-60 years, followed by 20 % in 21-40 years, 18.46% in patients over 60 years and 12.31% in 1-20 years age group. The anticancer agents which caused adverse drug reactions in our study were carboplatin (41.54%), cisplatin (36.92%) and oxaliplatin (21.54%). Most common adverse drug reactions observed were oral candidiasis (21.53%), vomiting (16.92%), anaemia (12.3%), diarrhoea (12.3%) and febrile neutropenia (0.08%). The results of the causality assessment of most of the cases were probable. Conclusion: The adverse effect of chemotherapeutic agents is a matter of concern in the pharmacological management of cancer as it affects the quality of life of patients. This information would be useful in identifying and minimizing preventable adverse drug reactions while generally enhancing the knowledge of the prescribers to deal with these adverse drug reactions more efficiently.

Keywords: adverse drug reactions, platinum compounds, cancer, chemotherapy

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3793 Development Of Trigger Tool To Identify Adverse Drug Events From Warfarin Administered To Patient Admitted In Medical Wards Of Chumphae Hospital

Authors: Puntarikorn Rungrattanakasin

Abstract:

Objectives: To develop the trigger tool to warn about the risk of bleeding as an adverse event from warfarin drug usage during admission in Medical Wards of Chumphae Hospital. Methods: A retrospective study was performed by reviewing the medical records for the patients admitted between June 1st,2020- May 31st, 2021. ADEs were evaluated by Naranjo’s algorithm. The international normalized ratio (INR) and events of bleeding during admissions were collected. Statistical analyses, including Chi-square test and Reciever Operating Characteristic (ROC) curve for optimal INR threshold, were used for the study. Results: Among the 139 admissions, the INR range was found to vary between 0.86-14.91, there was a total of 15 bleeding events, out of which 9 were mild, and 6 were severe. The occurrence of bleeding started whenever the INR was greater than 2.5 and reached the statistical significance (p <0.05), which was in concordance with the ROC curve and yielded 100 % sensitivity and 60% specificity in the detection of a bleeding event. In this regard, the INR greater than 2.5 was considered to be an optimal threshold to alert promptly for bleeding tendency. Conclusions: The INR value of greater than 2.5 (>2.5) would be an appropriate trigger tool to warn of the risk of bleeding for patients taking warfarin in Chumphae Hospital.

Keywords: trigger tool, warfarin, risk of bleeding, medical wards

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3792 Effect of Smartphone Applications on Patients' Knowledge of Surgery-Related Adverse Events during Hospitalization

Authors: Eunjoo Lee

Abstract:

Background: As the number of surgeries increases, the incidence of adverse events is likely to become more prevalent. Patients who are somewhat knowledgeable about surgery-related adverse events are more likely to engage in safety initiatives to prevent them. Objectives: To evaluate the impact of a smartphone application developed during the study to enhance patients’ knowledge of surgery-related adverse events during hospitalization. Design: Non-randomized, one group, measured pre- and post-intervention. Participants: Thirty-six hospitalized patients admitted to the orthopedics unit of a general hospital in South Korea. Methods. First, a smartphone application to enhance patients’ knowledge of surgery-related adverse events was developed through an iterative process, which included a literature review, expert consultation, and pilot testing. The application was installed on participants’ smartphones, and research assistants taught the participants to use it. Twenty-five true/false questions were used to assess patients’ knowledge of preoperative precautions (eight items), surgical site infection (five items), Foley catheter management (four items), drainage management (four items), and anesthesia-related complications (four items). Results: Overall, the percentage of correct answers increased significantly, from 57.02% to 73.82%, although answers related to a few specific topics did not increase that much. Although the patients’ understanding of drainage management and the Foley catheter did increase substantially after they used the smartphone application, it was still relatively low. Conclusions: The smartphone application developed during this study enhanced the patients’ knowledge of surgery-related adverse events during hospitalization. However, nurses must make an additional effort to help patients to understand certain topics, including drainage and Foley catheter management. Relevance to clinical practice: Insufficient patient knowledge increases the risk of adverse events during hospitalization. Nurses should take active steps to enhance patients’ knowledge of a range of safety issues during hospitalization, in order to decrease the number of surgery-related adverse events.

Keywords: patient education, patient participation, patient safety, smartphone application, surgical errors

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3791 Inappropriate Prescribing Defined by START and STOPP Criteria and Its Association with Adverse Drug Events among Older Hospitalized Patients

Authors: Mohd Taufiq bin Azmy, Yahaya Hassan, Shubashini Gnanasan, Loganathan Fahrni

Abstract:

Inappropriate prescribing in older patients has been associated with resource utilization and adverse drug events (ADE) such as hospitalization, morbidity and mortality. Globally, there is a lack of published data on ADE induced by inappropriate prescribing. Our study is specific to an older population and is aimed at identifying risk factors for ADE and to develop a model that will link ADE to inappropriate prescribing. The design of the study was prospective whereby computerized medical records of 302 hospitalized elderly aged 65 years and above in 3 public hospitals in Malaysia (Hospital Serdang, Hospital Selayang and Hospital Sungai Buloh) were studied over a 7 month period from September 2013 until March 2014. Potentially inappropriate medications and potential prescribing omissions were determined using the published and validated START-STOPP criteria. Patients who had at least one inappropriate medication were included in Phase II of the study where ADE were identified by local expert consensus panel based on the published and validated Naranjo ADR probability scale. The panel also assessed whether ADE were causal or contributory to current hospitalization. The association between inappropriate prescribing and ADE (hospitalization, mortality and adverse drug reactions) was determined by identifying whether or not the former was causal or contributory to the latter. Rate of ADE avoidability was also determined. Our findings revealed that the prevalence of potential inappropriate prescribing was 58.6%. A total of ADEs were detected in 31 of 105 patients (29.5%) when STOPP criteria were used to identify potentially inappropriate medication; All of the 31 ADE (100%) were considered causal or contributory to admission. Of the 31 ADEs, 28 (90.3%) were considered avoidable or potentially avoidable. After adjusting for age, sex, comorbidity, dementia, baseline activities of daily living function, and number of medications, the likelihood of a serious avoidable ADE increased significantly when a potentially inappropriate medication was prescribed (odds ratio, 11.18; 95% confidence interval [CI], 5.014 - 24.93; p < .001). The medications identified by STOPP criteria, are significantly associated with avoidable ADE in older people that cause or contribute to urgent hospitalization but contributed less towards morbidity and mortality. Findings of the study underscore the importance of preventing inappropriate prescribing.

Keywords: adverse drug events, appropriate prescribing, health services research

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3790 Safety Profile of Human Papillomavirus Vaccines: A Post-Licensure Analysis of the Vaccine Adverse Events Reporting System, 2007-2017

Authors: Giulia Bonaldo, Alberto Vaccheri, Ottavio D'Annibali, Domenico Motola

Abstract:

The Human Papilloma Virus (HPV) was shown to be the cause of different types of carcinomas, first of all of the cervical intraepithelial neoplasia. Since the early 80s to today, thanks first to the preventive screening campaigns (pap-test) and following to the introduction of HPV vaccines on the market; the number of new cases of cervical cancer has decreased significantly. The HPV vaccines currently approved are three: Cervarix® (HPV2 - virus type: 16 and 18), Gardasil® (HPV4 - 6, 11, 16, 18) and Gardasil 9® (HPV9 - 6, 11, 16, 18, 31, 33, 45, 52, 58), which all protect against the two high-risk HPVs (6, 11) that are mainly involved in cervical cancers. Despite the remarkable effectiveness of these vaccines has been demonstrated, in the recent years, there have been many complaints about their risk-benefit profile due to Adverse Events Following Immunization (AEFI). The purpose of this study is to provide a support about the ongoing discussion on the safety profile of HPV vaccines based on real life data deriving from spontaneous reports of suspected AEFIs collected in the Vaccine Adverse Events Reporting System (VAERS). VAERS is a freely-available national vaccine safety surveillance database of AEFI, co-administered by the Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA). We collected all the reports between January 2007 to December 2017 related to the HPV vaccines with a brand name (HPV2, HPV4, HPV9) or without (HPVX). A disproportionality analysis using Reporting Odds Ratio (ROR) with 95% confidence interval and p value ≤ 0.05 was performed. Over the 10-year period, 54889 reports of AEFI related to HPV vaccines reported in VAERS, corresponding to 224863 vaccine-event pairs, were retrieved. The highest number of reports was related to Gardasil (n = 42244), followed by Gardasil 9 (7212) and Cervarix (3904). The brand name of the HPV vaccine was not reported in 1529 cases. The two events more frequently reported and statistically significant for each vaccine were: dizziness (n = 5053) ROR = 1.28 (CI95% 1.24 – 1.31) and syncope (4808) ROR = 1.21 (1.17 – 1.25) for Gardasil. For Gardasil 9, injection site pain (305) ROR = 1.40 (1.25 – 1.57) and injection site erythema (297) ROR = 1.88 (1.67 – 2.10) and for Cervarix, headache (672) ROR = 1.14 (1.06 – 1.23) and loss of consciousness (528) ROR = 1.71 (1.57 – 1.87). In total, we collected 406 reports of death and 2461 cases of permanent disability in the ten-year period. The events consisting of incorrect vaccine storage or incorrect administration were not considered. The AEFI analysis showed that the most frequently reported events are non-serious and listed in the corresponding SmPCs. In addition to these, potential safety signals arose regarding less frequent and severe AEFIs that would deserve further investigation. This already happened with the referral of the European Medicines Agency (EMA) for the adverse events POTS (Postural Orthostatic Tachycardia Syndrome) and CRPS (Complex Regional Pain Syndrome) associated with anti-papillomavirus vaccines.

Keywords: adverse drug reactions, pharmacovigilance, safety, vaccines

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3789 Applying the Global Trigger Tool in German Hospitals: A Retrospective Study in Surgery and Neurosurgery

Authors: Mareen Brosterhaus, Antje Hammer, Steffen Kalina, Stefan Grau, Anjali A. Roeth, Hany Ashmawy, Thomas Gross, Marcel Binnebosel, Wolfram T. Knoefel, Tanja Manser

Abstract:

Background: The identification of critical incidents in hospitals is an essential component of improving patient safety. To date, various methods have been used to measure and characterize such critical incidents. These methods are often viewed by physicians and nurses as external quality assurance, and this creates obstacles to the reporting events and the implementation of recommendations in practice. One way to overcome this problem is to use tools that directly involve staff in measuring indicators of quality and safety of care in the department. One such instrument is the global trigger tool (GTT), which helps physicians and nurses identify adverse events by systematically reviewing randomly selected patient records. Based on so-called ‘triggers’ (warning signals), indications of adverse events can be given. While the tool is already used internationally, its implementation in German hospitals has been very limited. Objectives: This study aimed to assess the feasibility and potential of the global trigger tool for identifying adverse events in German hospitals. Methods: A total of 120 patient records were randomly selected from two surgical, and one neurosurgery, departments of three university hospitals in Germany over a period of two months per department between January and July, 2017. The records were reviewed using an adaptation of the German version of the Institute for Healthcare Improvement Global Trigger Tool to identify triggers and adverse event rates per 1000 patient days and per 100 admissions. The severity of adverse events was classified using the National Coordinating Council for Medication Error Reporting and Prevention. Results: A total of 53 adverse events were detected in the three departments. This corresponded to adverse event rates of 25.5-72.1 per 1000 patient-days and from 25.0 to 60.0 per 100 admissions across the three departments. 98.1% of identified adverse events were associated with non-permanent harm without (Category E–71.7%) or with (Category F–26.4%) the need for prolonged hospitalization. One adverse event (1.9%) was associated with potentially permanent harm to the patient. We also identified practical challenges in the implementation of the tool, such as the need for adaptation of the global trigger tool to the respective department. Conclusions: The global trigger tool is feasible and an effective instrument for quality measurement when adapted to the departmental specifics. Based on our experience, we recommend a continuous use of the tool thereby directly involving clinicians in quality improvement.

Keywords: adverse events, global trigger tool, patient safety, record review

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3788 Effects of Using a Recurrent Adverse Drug Reaction Prevention Program on Safe Use of Medicine among Patients Receiving Services at the Accident and Emergency Department of Songkhla Hospital Thailand

Authors: Thippharat Wongsilarat, Parichat tuntilanon, Chonlakan Prataksitorn

Abstract:

Recurrent adverse drug reactions are harmful to patients with mild to fatal illnesses, and affect not only patients but also their relatives, and organizations. To compare safe use of medicine among patients before and after using the recurrent adverse drug reaction prevention program . Quasi-experimental research with the target population of 598 patients with drug allergy history. Data were collected through an observation form tested for its validity by three experts (IOC = 0.87), and analyzed with a descriptive statistic (percentage). The research was conducted jointly with a multidisciplinary team to analyze and determine the weak points and strong points in the recurrent adverse drug reaction prevention system during the past three years, and 546, 329, and 498 incidences, respectively, were found. Of these, 379, 279, and 302 incidences, or 69.4; 84.80; and 60.64 percent of the patients with drug allergy history, respectively, were found to have caused by incomplete warning system. In addition, differences in practice in caring for patients with drug allergy history were found that did not cover all the steps of the patient care process, especially a lack of repeated checking, and a lack of communication between the multidisciplinary team members. Therefore, the recurrent adverse drug reaction prevention program was developed with complete warning points in the information technology system, the repeated checking step, and communication among related multidisciplinary team members starting from the hospital identity card room, patient history recording officers, nurses, physicians who prescribe the drugs, and pharmacists. Including in the system were surveillance, nursing, recording, and linking the data to referring units. There were also training concerning adverse drug reactions by pharmacists, monthly meetings to explain the process to practice personnel, creating safety culture, random checking of practice, motivational encouragement, supervising, controlling, following up, and evaluating the practice. The rate of prescribing drugs to which patients were allergic per 1,000 prescriptions was 0.08, and the incidence rate of recurrent drug reaction per 1,000 prescriptions was 0. Surveillance of recurrent adverse drug reactions covering all service providing points can ensure safe use of medicine for patients.

Keywords: recurrent drug, adverse reaction, safety, use of medicine

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3787 Clinical and Microbiologic Efficacy and Safety of Imipenem Cilastatin Relebactam in Complicated Infections: A Meta-analysis

Authors: Syeda Sahra, Abdullah Jahangir, Rachelle Hamadi, Ahmad Jahangir, Allison Glaser

Abstract:

Background: Antimicrobial resistance is on the rise. The use of redundant and inappropriate antibiotics is contributing to recurrent infections and resistance. Newer antibiotics with more robust coverage for gram-negative bacteria are in great demand for complicated urinary tract infections (cUTIs), complicated intra-abdominal infections (cIAIs), hospital-acquired bacterial pneumonia (H.A.B.P.), and ventilator-associated bacterial pneumonia (V.A.B.P.). Objective: We performed this meta-analysis to evaluate the efficacy and safety profile of a new antibiotic, Imipenem/cilastatin/relebactam, compared to other broad-spectrum antibiotics for complicated infections. Search Strategy: We conducted a systemic review search on PubMed, Embase, and Central Cochrane Registry. Selection Criteria: We included randomized clinical trials (R.C.T.s) with the standard of care as comparator arm with Imipenem/cilastatin/relebactam as intervention arm. Analysis: For continuous variables, the mean difference was used. For discrete variables, we used the odds ratio. For effect sizes, we used a confidence interval of 95%. A p-value of less than 0.05 was used for statistical significance. Analysis was done using a random-effects model irrespective of heterogeneity. Heterogeneity was evaluated using the I2 statistic. Results: The authors observed similar efficacy at clinical and microbiologic response levels on early follow-up and late follow-up compared to the established standard of care. The incidence of drug-related adverse events, serious adverse events, and drug discontinuation due to adverse events were comparable across both groups. Conclusion: Imipenem/cilastatin/relebactam has a non-inferior safety and efficacy profile compared to peer antibiotics to treat severe bacterial infections (cUTIs, cIAIs, H.A.B.P., V.A.B.P.).

Keywords: bacterial pneumonia, complicated intra-abdominal infections, complicated urinary tract infection, Imipenem, cilastatin, relebactam

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3786 Analyses of Adverse Drug Reactions Reported of Hospital in Taiwan

Authors: Yu-Hong Lin

Abstract:

Background: An adverse drug reaction (ADR) reported is an injury which caused by taking medicines. Sometimes the severity of ADR reported may be minor, but sometimes it could be a life-threatening situation. In order to provide healthcare professionals as a better reference in clinical practice, we do data collection and analysis from our hospital. Methods: This was a retrospective study of ADRs reported performed from 2014 to 2015 in our hospital in Taiwan. We collected assessment items of ADRs reported, which contain gender and age, occurring sources, Anatomical Therapeutic Chemical (ATC) classification of suspected drugs, types of adverse reactions, Naranjo score calculating by Naranjo Adverse Drug Reaction Probability Scale and so on. Results: The investigation included two hundred and seven ADRs reported. Most of ADRs reported were occurring in outpatient department (92%). The average age of ADRs reported was 65.3 years. Less than 65 years of age were in the majority in this study (54%). Majority of all ADRs reported were males (51%). According to ATC classification system, the major classification of suspected drugs was cardiovascular system (19%) and antiinfectives for systemic use (18%) respectively. Among the adverse reactions, Dermatologic Effects (35%) were the major type of ADRs. Also, the major Naranjo scores of all ADRs reported ranged from 1 to 4 points (91%), which represents a possible correlation between ADRs reported and suspected drugs. Conclusions: Definitely, ADRs reported is still an extremely important information for healthcare professionals. For that reason, we put all information of ADRs reported into our hospital's computer system, and it will improve the safety of medication use. By hospital's computer system, it can remind prescribers to think of information about patient's ADRs reported. No drugs are administered without risk. Therefore, all healthcare professionals should have a responsibility to their patients, who themselves are becoming more aware of problems associated with drug therapy.

Keywords: adverse drug reaction, Taiwan, healthcare professionals, safe use of medicines

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3785 Study of Reporting System for Adverse Events Related to Common Medical Devices at a Tertiary Care Public Sector Hospital in India

Authors: S. Kurian, S. Satpathy, S. K. Gupta, S. Arya, D. K. Sharma

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Advances in the use of health care technology have resulted in increased adverse events (AEs) related to the use of medical devices. The study focused on the existing reporting systems. This study was conducted in a tertiary care public sector hospital. Devices included Syringe infusion pumps, Cardiac monitors, Pulse oximeters, Ventilators and Defibrillators. A total of 211 respondents were recruited. Interviews were held with 30 key informants. Medical records were scrutinized. Relevant statistical tests were used. Resident doctors reported maximum frequency of AEs, followed by nurses; and least by consultants. A significant association was found between the cadre of health care personnel and awareness that the patients and bystanders have a risk of sustaining AE. Awareness regarding reporting of AEs was low, and it was generally done verbally. Other critical findings are discussed in the light of the barriers to reporting, reasons for non-compliance, recording system, and so on.

Keywords: adverse events, health care technology, medical devices, public sector hospital, reporting systems

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3784 Pharmacovigilance: An Empowerment in Safe Utilization of Pharmaceuticals

Authors: Pankaj Prashar, Bimlesh Kumar, Ankita Sood, Anamika Gautam

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Pharmacovigilance (PV) is a rapidly growing discipline in pharmaceutical industries as an integral part of clinical research and drug development over the past few decades. PV carries a breadth of scope from drug manufacturing to its regulation with safer utilization. The fundamental steps of PV not only includes data collection and verification, coding of drugs with adverse drug reactions, causality assessment and timely reporting to the authorities but also monitoring drug manufacturing, safety issues, product quality and conduction of due diligence. Standardization of adverse event information, collaboration of multiple departments in different companies, preparation of documents in accordance to both governmental as well as non-governmental organizations (FDA, EMA, GVP, ICH) are the advancements in discipline of PV. De-harmonization, lack of predictive drug safety models, improper funding by government, non-reporting, and non-acceptability of ADRs by developing countries and reports directly from patients to the monitoring centres respectively are the major road backs of PV. Mandatory pharmacovigilance reporting, frequent inspections, funding by government, educating and training medical students, pharmacists and nurses in this segment can bring about empowerment in PV. This area needs to be addressed with a sense of urgency for the safe utilization of pharmaceuticals.

Keywords: pharmacovigilance, regulatory, adverse event, drug safety

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3783 Patient-Reported Adverse Drug Reactions, Medication Adherence and Clinical Outcomes among major depression disorder Patients in Ethiopia: A Prospective Hospital Based Study.

Authors: Tadesse Melaku Abegaz

Abstract:

Background: there was paucity of data on the self-reported adverse drug reactions (ADRs), level of adherence and clinical outcomes with antidepressants among major depressive disorder (MDD) patients in Ethiopia. Hence, the present study sought to determine the level of adherence for and clinical outcome with antidepressants and the magnitude of ADRs. Methods: A prospective cross-sectional study was employed on MDD patients from September 2016 to January 2017 at Gondar university hospital psychiatry clinic. All patients who were available during the study period were included under the study population. The Naranjo adverse drug reaction probability scale was employed to assess the adverse drug reaction. The rate of medication adherence was determined using morisky medication adherence measurement scale eight. Clinical Outcome of patients was measured by using patient health questionnaire. Multivariable logistic carried out to determine factors for adherence and patient outcome. Results: two hundred seventy patients were participated in the study. More than half of the respondents were males 122(56.2%). The mean age of the participants was 30.94 ± 8.853. More than one-half of the subjects had low adherence to their medications 124(57.1%). About 186(85.7%) of patients encountered ADR. The most common ADR was weight gain 29(13.2). Around 198(92.2%) ADRs were probable and 19(8.8%) were possible. Patients with long standing MDD had high risk of non-adherence COR: 2.458[4.413-4.227], AOR: 2.424[1.185-4.961]. More than one-half 125(57.6) of respondents showed improved outcome. Optimal level of medication adherence was found to be associated with reduced risk of progression of the diseases COR: 0.37[0.110-5.379] and AOR: 0.432[0.201-0.909]. Conclusion: Patient reported adverse drug reactions were more prevalent in major depressive disorder patients. Adherence to medications was very poor in the setup. However, the clinical outcome was relatively higher. Long standing depression was associated with non-adherence. In addition, clinical outcome of patients were affected by non-adherence. Therefore, adherence enhancing interventions should be provided to improve medication adherence and patient outcome.

Keywords: adverse drug reactions, clinical outcomes, Ethiopia, prospective study, medication adherence

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3782 Prevalence of Adverse Events in Children and Adolescents on Antiretroviral Therapy: Examining the Pediatric Cohort in the Eastern Cape

Authors: Shannon Glaspy, Gerald Boon, Jack Lambert

Abstract:

Studies on AE of highly active antiretroviral therapy (HAART) in children and adolescents are rare. The aim of this study is to observe the frequency of treatment limiting adverse drug reactions against years on ARVs and specific ARV regimen. Methods: A retrospective cohort study was conducted in East London, South Africa. All patient files in the pediatric (0 – 18 years) ARV cohort were examined, selecting only those patients started on HAART. ARV regimen changes explicitly due to AE, age on ARV treatment onset, age of AE onset, and gender were extrapolated. Eligible subjects were obtained from patient folders, anonymized and cross-referenced with data obtained from electronic records. A total of 1120 patients [592 male (52.9%) and 528 female (47.1%)] were charted by incidence and year. Additional information was extrapolated in cases where the patient experienced lipodystrophy and lipoatrophy to include the number of years on ARVs prior to the onset of the AE. Results: Of the 1120 HIV infected children of the hospital cohort, a total of 105 (9.37%) AE (53.3% male) observed were deemed eligible for the study due to completeness of medical history and agreement between electronic records and paper files. The AE cited were as follows: lipoatrophy 62 (5.53% of all subjects), lipodystrophy 27 (2.41%), neuropathy 9 (0.8%), anemia 2 (0.17%), Steven Johnsons Syndrome 1 (0.08%), elevated LFTs 1 (0.8%), breast hypertrophy (0.08%), gastritis 1 (0.08%) and rash 1 (0.08%). The most prevalence ARV regimens associated with the onset of the AE are: D4T/3TC/EFV 72 cases (64.86% of all AE), D4T/3TC/LOPr 24 cases (21.62%). Lipoatrophy and lipodystrophy combined represent 84.76% (89 cases) of all adverse events documented in this cohort. Within the 60 cases of lipoatrophy, the average number of years on ARVs associated with an AE is 3.54, with 14 cases experiencing an AE between 0-2 years of HAART. Within the 29 cases of lipodystrophy, the average number of years on ARVs associated with an AE is 3.89, with 4 cases experiencing an AE between 0-2 years on HAART. The regimen D4T/3TC/EFV is associated with 43 cases (71.66%) of lipoatrophy and 21 cases (72.41%) of lipodystrophy. D4T/3TC/LOPr is associated with 15 cases (25%) of lipoatrophy and 7 cases (24.14%) of lipodystrophy. The frequency of AE associated with ARV regimens could be misrepresented due to prevalence of different 1st line regimens which were not captured in this study, particularly with the systematic change of 1st line drugs from D4T to ABC in 2010. Conclusion: In this descriptive study we found a 9.37% prevalence of AE were significant enough to be treatment limiting among our cohort. Lipoatrophy accounted for 59.04% of all documented AE. Overall, D4T/3TC/EFV was associated with 64.86% of all AE, 71.66% of lipoatrophy cases and 72.41% of lipodystrophy cases.

Keywords: ARV, adverse events, HAART, pediatric

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3781 Getting It Right Before Implementation: Using Simulation to Optimize Recommendations and Interventions After Adverse Event Review

Authors: Melissa Langevin, Natalie Ward, Colleen Fitzgibbons, Christa Ramsey, Melanie Hogue, Anna Theresa Lobos

Abstract:

Description: Root Cause Analysis (RCA) is used by health care teams to examine adverse events (AEs) to identify causes which then leads to recommendations for prevention Despite widespread use, RCA has limitations. Best practices have not been established for implementing recommendations or tracking the impact of interventions after AEs. During phase 1 of this study, we used simulation to analyze two fictionalized AEs that occurred in hospitalized paediatric patients to identify and understand how the errors occurred and generated recommendations to mitigate and prevent recurrences. Scenario A involved an error of commission (inpatient drug error), and Scenario B involved detecting an error that already occurred (critical care drug infusion error). Recommendations generated were: improved drug labeling, specialized drug kids, alert signs and clinical checklists. Aim: Use simulation to optimize interventions recommended post critical event analysis prior to implementation in the clinical environment. Methods: Suggested interventions from Phase 1 were designed and tested through scenario simulation in the clinical environment (medicine ward or pediatric intensive care unit). Each scenario was simulated 8 times. Recommendations were tested using different, voluntary teams and each scenario was debriefed to understand why the error was repeated despite interventions and how interventions could be improved. Interventions were modified with subsequent simulations until recommendations were felt to have an optimal effect and data saturation was achieved. Along with concrete suggestions for design and process change, qualitative data pertaining to employee communication and hospital standard work was collected and analyzed. Results: Each scenario had a total of three interventions to test. In, scenario 1, the error was reproduced in the initial two iterations and mitigated following key intervention changes. In scenario 2, the error was identified immediately in all cases where the intervention checklist was utilized properly. Independently of intervention changes and improvements, the simulation was beneficial to identify which of these should be prioritized for implementation and highlighted that even the potential solutions most frequently suggested by participants did not always translate into error prevention in the clinical environment. Conclusion: We conclude that interventions that help to change process (epinephrine kit or mandatory checklist) were more successful at preventing errors than passive interventions (signage, change in memory aids). Given that even the most successful interventions needed modifications and subsequent re-testing, simulation is key to optimizing suggested changes. Simulation is a safe, practice changing modality for institutions to use prior to implementing recommendations from RCA following AE reviews.

Keywords: adverse events, patient safety, pediatrics, root cause analysis, simulation

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3780 Update on Genetic Diversity for Lamotrigine Induced Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis

Authors: Natida Thongsima, Patompong Satapornpong

Abstract:

Introduction: Lamotrigine is widely used in the treatment of epilepsy and bipolar disorder. However, lamotrigine leads to adverse drug reactions (ADRs) consist of severe cutaneous adverse reactions (SCARs) include Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and drug rash with eosinophilia and systemic symptoms (DRESS). Moreover, lamotrigine-induced SCARs is usually manifested between 2 and 8 weeks after treatment initiation. A previous study, there was found the association between HLA-B*15:02 and lamotrigine-induced cutaneous adverse drug reactions in the Thai population (odds ratio 4.89; 95% CI 1.28–18.66; p-value = 0.014). Therefore, the distribution of pharmacogenetics markers that a major role in predicting the culprit drugs for SCARs in many populations. Objective: In this study, we want to investigate the prevalence of the HLA-B allele, which correlations in lamotrigine-induced SCARs in a healthy Thai population. Materials and Methods: We enrolled 350 healthy Thai individuals and were approved by the ethics committee of Rangsit University. HLA-B alleles were genotyped by the Lifecodes HLA SSO typing kits (Immucor, West Avenue, Stamford, USA). Results: The results presented HLA-B allele frequency in healthy Thai population were 14.71% (HLA-B*46:01), 8.57% (HLA-B*15:02), 6.71% (HLA-B*40:01), 5.86% (HLA-B*13:01), 5.71% (HLA-B*58:01), 5.14% (HLA-B*38:02), 4.86% (HLA-B*18:01), 4.59% (HLA-B*51:01), 3.86% (HLA-B*44:03) and 2.71% (HLA-B*07:05). Especially, the HLA-B*15:02 allele was the high frequency in the Thais (8.57%), Han Chinese (7.30%), Vietnamese (13.50%), Malaysian (6.06%) and Indonesian (11.60%). Notwithstanding, this allele was much lower in other populations, namely, Africans, Caucasians and Japanese. Conclusions: Although the samples size of the healthy Thai population in this research was limited, there were found the frequency of the HLA-B*15:02 allele could predisposition toward lamotrigine-induced SCARs in Thailand.

Keywords: lamotrigine, cutaneous adverse drug reactions, HLA-B, Thai population

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3779 Causes and Impacts of Marine Heatwaves in the Bay of Bengal Region in the Recent Period

Authors: Sudhanshu Kumar, Raghvendra Chandrakar, Arun Chakraborty

Abstract:

In the ocean, the temperature extremes have the potential to devastate marine habitats, ecosystems together with ensuing socioeconomic consequences. In recent years, these extreme events are more frequent and intense globally and their increasing trend is expected to continue in the upcoming decades. It recently attracted public interest, as well as scientific researchers, which motivates us to analyze the current marine heatwave (MHW) events in the Bay of Bengal region. we have isolated 107 MHW events (above 90th percentile threshold) in this region of the Indian Ocean and investigated the variation in duration, intensity, and frequency of MHW events during our test period (1982-2021). Our study reveals that in the study region the average of three MHW events per year with an increasing linear trend of 1.11 MHW events per decade. In the analysis, we found the longest MHW event which lasted about 99 days, which is far greater than an average MHW event duration. The maximum intensity was 5.29°C (above the climatology-mean), while the mean intensity was 2.03°C. In addition, we observed net heat flux accompanied by anticyclonic eddies to be the primary cause of these events. Moreover, we concluded that these events affect sea surface height and oceanic productivity, highlighting the adverse impact of MHWs on marine ecosystems.

Keywords: marine heatwaves, global warming, climate change, sea surface temperature, marine ecosystem

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3778 Clinical Efficacy of Nivolumab and Ipilimumab Combination Therapy for the Treatment of Advanced Melanoma: A Systematic Review and Meta-Analysis of Clinical Trials

Authors: Zhipeng Yan, Janice Wing-Tung Kwong, Ching-Lung Lai

Abstract:

Background: Advanced melanoma accounts for the majority of skin cancer death due to its poor prognosis. Nivolumab and ipilimumab are monoclonal antibodies targeting programmed cell death protein 1 (PD-1) and cytotoxic T-lymphocytes antigen 4 (CTLA-4). Nivolumab and ipilimumab combination therapy has been proven to be effective for advanced melanoma. This systematic review and meta-analysis are to evaluate its clinical efficacy and adverse events. Method: A systematic search was done on databases (Pubmed, Embase, Medline, Cochrane) on 21 June 2020. Search keywords were nivolumab, ipilimumab, melanoma, and randomised controlled trials. Clinical trials fulfilling the inclusion criteria were selected to evaluate the efficacy of combination therapy in terms of prolongation of progression-free survival (PFS), overall survival (OS), and objective response rate (ORR). The odd ratios and distributions of grade 3 or above adverse events were documented. Subgroup analysis was performed based on PD-L1 expression-status and BRAF-mutation status. Results: Compared with nivolumab monotherapy, the hazard ratios of PFS, OS and odd ratio of ORR in combination therapy were 0.64 (95% CI, 0.48-0.85; p=0.002), 0.84 (95% CI, 0.74-0.95; p=0.007) and 1.76 (95% CI, 1.51-2.06; p < 0.001), respectively. Compared with ipilimumab monotherapy, the hazard ratios of PFS, OS and odd ratio of ORR were 0.46 (95% CI, 0.37-0.57; p < 0.001), 0.54 (95% CI, 0.48-0.61; p < 0.001) and 6.18 (95% CI, 5.19-7.36; p < 0.001), respectively. In combination therapy, the odds ratios of grade 3 or above adverse events were 4.71 (95% CI, 3.57-6.22; p < 0.001) compared with nivolumab monotherapy, and 3.44 (95% CI, 2.49-4.74; p < 0.001) compared with ipilimumab monotherapy, respectively. High PD-L1 expression level and BRAF mutation were associated with better clinical outcomes in patients receiving combination therapy. Conclusion: Combination therapy is effective for the treatment of advanced melanoma. Adverse events were common but manageable. Better clinical outcomes were observed in patients with high PD-L1 expression levels and positive BRAF-mutation.

Keywords: nivolumab, ipilimumab, advanced melanoma, systematic review, meta-analysis

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3777 Establishment of an Information Platform Increases Spontaneous Reporting of Adverse Drug Reactions

Authors: Pei-Chun Chen, Chi-Ting Tseng, Lih-Chi Chen, Kai-Hsiang Yang

Abstract:

Introduction: The pharmacist is responsible for encouraging adverse drug reaction (ADR) reporting. In a local center in Northern Taiwan, promotion and rewarding of ADR reporting have continued for over six years but failed to bring significant changes. This study aims to find a solution to increase ADR reporting. Research question or hypothesis: We hypothesized that under-reporting is due to the inconvenience of the reporting system. Reports were made conventionally through printed sheets. We proposed that reports made per month will increase if they were computerized. Study design: An ADR reporting platform was established in April 2015, before which was defined as the first stage of this study (January-March, 2015) and after which the second stage. The third stage commenced in November, 2015, after adding a reporting module to physicians prescription system. ADRs could be reported simultaneously when documenting drug allergies. Methods: ADR report rates during the three stages of the study were compared. Effects of the information platform on reporting were also analyzed. Results: During the first stage, the number of ADR reports averaged 6 per month. In the second stage, the number of reports per month averaged 1.86. Introducing the information platform had little effect on the monthly number of ADR reports. The average number of reports each month during the third stage of the study was 11±3.06, with 70.43% made electronically. Reports per month increased significantly after installing the reporting module in November, 2015 (P<0.001, t-test). In the first two stages, 29.03% of ADR reports were made by physicians, as compared to 70.42% of cases in the third stage of the study. Increased physician reporting possibly account for these differences. Conclusion: Adding a reporting module to the prescription system significantly increased ADR reporting. Improved accessibility is likely the cause. The addition of similar modules to computer systems of other healthcare professions may be considered to encourage spontaneous ADR reporting.

Keywords: adverse drug reactions, adverse drug reaction reporting systems, regional hospital, prescription system

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3776 Comparison of Analgesic Efficacy of Paracetamol and Tramadol for Pain Relief in Active Labor

Authors: Krishna Dahiya

Abstract:

Introduction: Labour pain has been described as the most severe pain experienced by women in their lives. Pain management in labour is one of the most important challenges faced by the obstetrician. The opioids are the primary treatment for patients with moderate and severe pain but these drugs are not always tolerated and are associated with dose-dependent side effects. Nonsteroidal anti-inflammatory drugs, too, are associated with variable adverse effects. Considering these factors, our study compared the efficacy and side effect of intravenous tramadol and paracetamol. Objective: To evaluate the efficacy and adverse effects of an intravenous infusion of 1000 mg of paracetamol as compared with an intravenous injection of 50mg of tramadol for intrapartum analgesia. Methods: In a randomized prospective study at Pt. BDS PGIMS, 200 women in active labor were allocated to received either paracetamol (n=100) or tramadol (n=100). The primary outcome was the efficacy of the drug to supply adequate analgesia as measured by a change in the visual analog scale (VAS) pain intensity score at various times after drug administration. The secondary outcomes included the need for additional rescue analgesia and the presence of adverse maternal or fetal events. Results: The mean age of cases were 25.55 ± 3.849 years and 25.60 ± 3.655 years respectively As recorded by the VAS score, there was significant pain reduction at 30 minutes, and at 1 and 2 hours in both groups (P<0.01). In comparison, between group I and II, a significantly higher rate of nausea and vomiting in tramadol group (14% vs 8%; P < 0.03) patients. Similarly, drowsiness (0% vs 11%; P<0.01), dry mouth (0% vs 8%; P<0.04) and dizziness (0% vs 9%; P<0.02) was also significant in group II. Conclusion: Due to difficulty in administering epidural analgesia to all parturients, administration of paracetamol and tramadol infusion for analgesia is simple and less invasive alternative. In the present study, both paracetamol and tramadol were equally effective for labour analgesia but paracetamol has emerged as safe alternative as compared to tramadol due to a low incidence of side effects.

Keywords: paracetamol, tramadol, labor, analgesia

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3775 Cannabis for the Treatment of Drug Resistant Epilepsy in Children

Authors: Sarah E. Casey

Abstract:

Epilepsy is the most common neurological disorder in children and approximately one-third of children with epilepsy have seizures that are uncontrolled on anticonvulsants alone. Cannabidiol is shown to be an effective treatment at reducing the amount of breakthrough seizures experienced by children with drug resistant epilepsy. Improvements in quality of life and overall condition were noted during cannabidiol treatment. Adverse side effects were experienced and were generally mild to moderate in nature. Additional double-blind, controlled studies with a more diverse sample population and standardized dosing are needed to ensure the efficacy and safety of cannabidiol use in children with drug resistant epilepsy.

Keywords: cannabis, drug resistant epilepsy, children, epilepsy

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3774 Effect on Body Weight of Naltrexone/Bupropion in Overweight and Obese Participants with Cardiovascular Risk Factors in a Large Randomized Double-Blind Study

Authors: Amy Halseth, Kevin Shan, Kye Gilder, John Buse

Abstract:

The study assessed the effect of prolonged-release naltrexone 32 mg/bupropion 360 mg (NB) on cardiovascular (CV) events in overweight/obese participants at elevated CV risk. Participants must lose ≥ 2% body weight at 16 wks, without a sustained increase in blood pressure, to continue drug. The study was terminated early after second interim analysis with 50% of all CV events. Data on CV endpoints has been published. Current analyses focus on weight change. Intent-to-treat (ITT) population (placebo [PBO] N=4450, NB N=4455) was 54.5% female, 83.5% white, mean age 61 yrs, mean BMI 37.3 kg/m2; 85.2% had type 2 diabetes, 32.1% had CV disease, 17.4% had both. At 52 wks, ITT-LOCF analysis showed greater least squares mean percent change in weight (LSM%ΔBW) with NB (-3.1%; 95% CI -4.8, -1.4) vs PBO (-0.3%; 95% CI -1.9, 1.4). Both groups demonstrated greater weight loss while on-treatment (NB [-7.3%], PBO [-3.9%]). Odds ratios of 5% and 10% weight loss were 3.3 and 4.1 (ITT-LOCF), respectively, in NB over PBO. At 104 wks, on-treatment LSM%ΔBW was -6.3% with NB (n=1137) vs -3.5% with PBO (n=741). Major reasons for NB withdrawal were adverse events (AE, 29%) and patient decision (21%), with GI disorders being the most common. Weight loss with NB in this study, in an older population predominantly with diabetes and elevated CV risk, was somewhat lower than that observed in overweight/obese participants without diabetes and similar to participants with diabetes in Phase 3 studies.

Keywords: contrave, mysimba, obesity, pharmacotherapy, weight loss

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3773 Operationalizing the Concept of Community Resilience through Community Capitals Framework-Based Index

Authors: Warda Ajaz

Abstract:

This study uses the ‘Community Capitals Framework’ (CCF) to develop a community resilience index that can serve as a useful tool for measuring resilience of communities in diverse contexts and backgrounds. CCF is an important analytical tool to assess holistic community change. This framework identifies seven major types of community capitals: natural, cultural, human, social, political, financial and built, and claims that the communities that have been successful in supporting healthy sustainable community and economic development have paid attention to all these capitals. The framework, therefore, proposes to study the community development through identification of assets in these major capitals (stock), investment in these capitals (flow), and the interaction between these capitals. Capital based approaches have been extensively used to assess community resilience, especially in the context of natural disasters and extreme events. Therefore, this study identifies key indicators for estimating each of the seven capitals through an extensive literature review and then develops an index to calculate a community resilience score. The CCF-based community resilience index presents an innovative way of operationalizing the concept of community resilience and will contribute toward decision-relevant research regarding adaptation and mitigation of community vulnerabilities to climate change-induced, as well as other adverse events.

Keywords: adverse events, community capitals, community resilience, climate change, economic development, sustainability

Procedia PDF Downloads 179
3772 Incidence, Risk Factors and Impact of Major Adverse Events Following Paediatric Cardiac Surgery

Authors: Sandipika Gupta

Abstract:

Objective: Due to admirably low 30-day mortality rates for paediatric cardiac surgery, it is now pertinent to turn towards more intermediate-length outcomes such as morbidities closely associated with these surgeries. One such morbidity, major adverse events (MAE) comprises a group of adverse outcomes associated with paediatric cardiac surgery (e.g. cardiac arrest, major haemorrhage). Methods: This is a retrospective study that analysed the incidence and impact of MAE which was the primary outcome in the UK population. The data was collected in 5 centres between October 2015 and June 2017, amassing 3090 surgical episodes. The incidence and risk factors for MAE, were assessed through descriptive statistical analyses and multivariate logistic regression. The secondary outcomes of life status at 6 months and the length of hospital stay were also evaluated to understand the impact of MAE on patients. Results: Out of 3090 episodes, 134 (4.3%) had a postoperative MAE. The majority of the episodes were in: neonates (47%, P<0.001), high-risk cardiac diagnosis groups (20.1%, P<0.001), episodes with longer 5mes on the bypass (72.4%, P<0.001) and urgent surgeries (57.9%, P<0.001). Episodes reporting MAE also reported longer lengths of stay in hospital (29 days vs 9 days, P<0.001). Furthermore, patients experiencing MAE were at a higher risk of mortality at the 6-month life status check (mortality rates: 29.2% vs 2%, P<0.001).Conclusions: Key risk factors were identified. An important negative impact of MAE was found for patients. The identified risk factors could be used to profile and flag at-risk patients. Monitoring of MAE rates and closer investigation into the care pathway before and after individual MAEs in children’s heart units may lead to a reduction in these terrible events.

Keywords:

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3771 Management Tools for Assessment of Adverse Reactions Caused by Contrast Media at the Hospital

Authors: Pranee Suecharoen, Ratchadaporn Soontornpas, Jaturat Kanpittaya

Abstract:

Background: Contrast media has an important role for disease diagnosis through detection of pathologies. Contrast media can, however, cause adverse reactions after administration of its agents. Although non-ionic contrast media are commonly used, the incidence of adverse events is relatively low. The most common reactions found (10.5%) were mild and manageable and/or preventable. Pharmacists can play an important role in evaluating adverse reactions, including awareness of the specific preparation and the type of adverse reaction. As most common types of adverse reactions are idiosyncratic or pseudo-allergic reactions, common standards need to be established to prevent and control adverse reactions promptly and effectively. Objective: To measure the effect of using tools for symptom evaluation in order to reduce the severity, or prevent the occurrence, of adverse reactions from contrast media. Methods: Retrospective review descriptive research with data collected on adverse reactions assessment and Naranjo’s algorithm between June 2015 and May 2016. Results: 158 patients (10.53%) had adverse reactions. Of the 1,500 participants with an adverse event evaluation, 137 (9.13%) had a mild adverse reaction, including hives, nausea, vomiting, dizziness, and headache. These types of symptoms can be treated (i.e., with antihistamines, anti-emetics) and the patient recovers completely within one day. The group with moderate adverse reactions, numbering 18 cases (1.2%), had hypertension or hypotension, and shortness of breath. Severe adverse reactions numbered 3 cases (0.2%) and included swelling of the larynx, cardiac arrest, and loss of consciousness, requiring immediate treatment. No other complications under close medical supervision were recorded (i.e., corticosteroids use, epinephrine, dopamine, atropine, or life-saving devices). Using the guideline, therapies are divided into general and specific and are performed according to the severity, risk factors and ingestion of contrast media agents. Patients who have high-risk factors were screened and treated (i.e., prophylactic premedication) for prevention of severe adverse reactions, especially those with renal failure. Thus, awareness for the need for prescreening of different risk factors is necessary for early recognition and prompt treatment. Conclusion: Studying adverse reactions can be used to develop a model for reducing the level of severity and setting a guideline for a standardized, multidisciplinary approach to adverse reactions.

Keywords: role of pharmacist, management of adverse reactions, guideline for contrast media, non-ionic contrast media

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3770 Pharmacogenetics Study of Dapsone-Induced Severe Cutaneous Adverse Reactions and HLA Class I Alleles in Thai Patients

Authors: Patompong Satapornpong, Therdpong Tempark, Pawinee Rerknimitr, Jettanong Klaewsongkram, Chonlaphat Sukasem

Abstract:

Dapsone (4, 4’-diaminodiphenyl sulfone, DDS) is broadly used for the treatment of inflammatory diseases and infections such as; leprosy, Pneumocystis jiroveci pneumonia in patients with HIV infection, neutrophilic dermatoses, dermatitis herpetiformis and autoimmune bullous disease. The severe cutaneous adverse drug reactions (SCARs) including, Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and drug reaction with eosinophilia and systemic symptoms (DRESS) are rare but severe life-threatening adverse drug reactions. Dapsone is one of many culprit drugs induced SJS, TEN and DRESS. Notwithstanding, to our knowledge, there are no studies of the association of HLA class I alleles and dapsone-induced SCARs in non-leprosy Thai patients. This investigation was a prospective cohort study, which performed in a total of 45 non-leprosy patients. Fifteen patients of dapsone-induced SCARs were classified as following the RegiSCAR criteria, and 30 dapsone-tolerant controls were exposed to dapsone more than 6 months without any evidence of cutaneous reactions. The genotyping of HLA-A, -B and –C were performed using sequence-specific oligonucleotides (PCR-SSOs). The Ethics Committee of Ramathibodi hospital, Mahidol University, approved this study. Among all HLA class I alleles, HLA-A*24:07, HLA-B*13:01, HLA-B*15:02, HLA-C*03:04 and HLA-C*03:09 were significantly associated with dapsone-induced SCARs (OR = 10.55, 95% CI = 1.06 – 105.04, p = 0.0360; OR = 56.00, 95% CI = 8.27 – 379.22, p = 0.0001; OR = 7.00, 95% CI = 1.17 – 42.00, p = 0.0322; OR = 6.00, 95% CI = 1.24 – 29.07, p = 0.0425 and OR = 17.08, 95% CI = 0.82 – 355.45, p = 0.0321, respectively). Furthermore, HLA-B*13:01 allele had strong association with dapsone-induced SJS-TEN and DRESS when compared with dapsone-tolerant controls (OR = 42.00, 95% CI = 2.88 – 612.31, p = 0.0064 and OR = 63.00, 95% CI = 7.72 – 513.94 and p = 0.0001, respectively). Consequently, HLA-B*13:01 might serve as a pharmacogenetic marker for screening before initiating the therapy with dapsone for prevention of dapsone-induced SCARs.

Keywords: dapsone-induced SCARs, HLA-B*13:01, HLA class I alleles, severe cutaneous adverse reactions, Thai

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