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Aims: Recently, the use of selective serotonin reuptake inhibitors (SSRIs) has been associated with the occurrence or worsening of bruxism. The aim of this study was to obtain a first indication of the prevalence of SSRI-associated bruxism reported to family physicians, the main prescribers of SSRIs. Methods: A questionnaire, with questions about prescription rate, already registered adverse reactions, and bruxism-related side effects of 4 different types of SSRIs, was sent to all family physicians in greater Amsterdam (n = 391). Results: With a response rate of 42.5%, frequent observations of already registered side effects were found. In addition, 5 family physicians (3.2%) reported the occurrence of bruxism in relation to the use of SSRIs. Conclusion: The use of SSRIs might be associated with the occurrence of bruxism. A case report is provided that corroborates this suggestion. [ABSTRACT FROM AUTHOR]

Introduction: When reporting adverse drug reactions to pharmacovigilance centres, patients and consumers can describe adverse drug reactions experienced in free-text format. Recently, a patient-friendly adverse drug reaction terms list was introduced in the adverse drug reaction report form in the UK to facilitate this reporting.Objective: The objective of this study was to evaluate the actual use of the patient-friendly terms list in the adverse drug reaction report form and its association with the type of adverse drug reactions reported.Methods: We conducted a database study in which we reviewed the list's use for all reported adverse drug reactions by patients and consumers to the pharmacovigilance centre in the UK via the online report form between August and September 2017. Descriptive statistics were used. In addition, for adverse drug reactions reported more than 20 times, Chi-squared tests were used to test for differences in the number of reports in which the patient-friendly terms list was used and those in which the adverse drug reaction was entered as free text.Results: In total, 888 reports were received. In 185 reports (21%), the patient-friendly terms list was used to enter an adverse drug reaction. In total, the reports contained 3227 adverse drug reactions. Nausea, headache, diarrhoea, dizziness, insomnia, anxiety, depression, fatigue, tiredness, vomiting, appetite lost, joint pain, chest pain, constipation and pain were reported more than 20 times. Five of these adverse drug reactions (i.e. nausea, diarrhoea, dizziness, insomnia and constipation) were reported significantly more often in reports where the adverse drug reactions were selected from the patient-friendly terms list.Conclusions: Most people chose to describe adverse drug reactions in their own words rather than selecting adverse drug reactions from a patient-friendly terms list. Although the patient-friendly terms list may be a useful feature for some patients or for some adverse drug reactions, it should not replace the option for patients to describe adverse drug reactions in their own words. [ABSTRACT FROM AUTHOR]

Introduction: An ever-increasing trend in the use of social media offers a potential forum for exchanging information in developing countries. Easy access, quick dissemination and widespread use necessitate the incorporation of social media in adverse drug reactions reporting and pharmacovigilance activities. Aim: To highlight the potential role of the use of social media in pharmacovigilance activities in a developing country like Nepal. Materials and Methods: A review of all relevant literature was conducted from scholargoogle and PubMed databases using the search terms 'Social media','Pharmacovigilance','Nepal','drug safety','social network' and 'adverse drug reaction'. In addition, a general search was conducted in Google search engine using similar terminologies. The identified literature was reviewed by the authors and the most relevant ones within the scope of the topic were included. Results: Social media use is common; the number of social media users is on increasing trend even in developing countries like Nepal. There are some unique scopes of social media in pharmacovigilance, including improving awareness, reporting and signal detection. In resource-limited settings, social media can play a crucial role in disseminating drug safety and related information. Incorporating social media in pharmacovigilance has challenges, particularly the problem associated with the authenticity and validity of information available in social media platform. Conclusion: Social media may have an opportunity in the pharmacovigilance system. However, there is limited evidence about its feasibility and validity. Systematic research should be conducted to investigate the feasibility of using social media for the pharmacovigilance system. [ABSTRACT FROM AUTHOR]

Introduction: Lawyer-submitted reports may have unintended consequences on safety signal detection in spontaneous adverse event reporting systems.Objective: Our objective was to assess the impact of lawyer-submitted reports primarily for one adverse event (AE) on the ability to detect a signal of disproportional reporting for another AE for the same drug in the US FDA Adverse Event Reporting System (FAERS).Methods: FAERS reports from January 2004 to September 2015 were used to estimate yearly cumulative proportional reporting ratios (PRRs) for three known drug-AE pairs—isotretinoin-birth defects, atorvastatin-rhabdomyolysis, and rosuvastatin-rhabdomyolysis—with and without lawyer-submitted reports. Isotretinoin and atorvastatin have been the subject of high-profile tort litigation regarding other AEs. A lower bound of the 95% confidence interval (CI) of one or more based on three or more reports defined a signal.Results: Cumulative PRRs met signaling criteria in all analyses. For isotretinoin, lawyer-submitted reports increased PRRs for birth defects before 2008, with the largest increase in 2006 (2.9 [95% CI 2.4-3.5] to 3.3 [95% CI 2.8-3.9]); lawyer-submitted reports decreased PRRs for birth defects after 2011, with the largest decrease in 2013 (2.2 [95% CI 2.0-2.5] to 1.9 [95% CI 1.7-2.1]). For atorvastatin, lawyer-submitted reports reduced PRRs for rhabdomyolysis after 2013, with the largest decrease in 2015 (18.0 [95% CI 17.1-19.1] to 15.4 [95% CI 14.5-16.2]). Lawyer-submitted reports had little impact on PRRs for rosuvastatin and rhabdomyolysis.Conclusions: Inclusion of lawyer-submitted reports in FAERS did not meaningfully distort known safety signals for two drugs subject to high-profile tort litigation for other AEs. [ABSTRACT FROM AUTHOR]

Background: Erlotinib is a drug used for the treatment of non-small cell lung cancer (NSCLC) and pancreatic cancer. Severe hepatotoxicity was observed in 4% to 31% of patients receiving erlotinib treatment prompting delay or termination of treatment. Only a few factors related to hepatotoxicity of erlotinib have been reported. No study has investigated the role of concomitant medications and erlotinib-induced hepatotoxicity. The aim of this study was to investigate the association between erlotinib-induced hepatotoxicity and various factors including concomitant medications in patients with NSCLC and pancreatic cancer.Methods: From January 2014 to June 2017, a retrospective study was conducted in patients with NSCLC and pancreatic cancer, who were treated with erlotinib. Various data were reviewed, including sex, age, body weight, height, body surface area (BSA), underlying disease, Eastern Cooperative Oncology Group (ECOG) Performance Status (PS), smoking history, erlotinib dose, EGFR mutation, and concomitant drugs.Results: The incidence of grade 2 or higher hepatotoxicity in the study group of patients was 17.2%. Multivariate analysis showed a 2.7-fold increase in hepatotoxicity with the concomitant use of CYP3A4 inducers. In NSCLC patients, co-administration of H2-antagonist/PPI increased hepatotoxicity 3.5-fold. Among the demographic factors, liver metastasis and age ≥ 65 years were significant risk factors in all study patients and NSCLC patients, respectively; the attributable risks for liver metastasis and age were 46.3% and 71.8%, respectively. Subgroup analysis using pancreatic cancer patients yielded marginally significant results with CYP3A4 inducers and erlotinib-induced hepatotoxicity. Liver metastasis and CYP3A4 inducers also shortened time to hepatotoxicity 2.1 and 2.3-fold, respectively.Conclusions: Our study showed that concomitant use of CYP3A4 inducers and H2-antagonist/PPI, liver metastasis, and age ≥ 65 were associated with erlotinib-induced hepatotoxicity. Thus, close monitoring of liver function is recommended, especially in patients using CYP3A4 inducers and anti-acid secreting agents. [ABSTRACT FROM AUTHOR]

Introduction: Electronic healthcare record (EHR) databases are used within pharmacoepidemiology studies to confirm or refute safety signals arising from spontaneous adverse event reports. However, there has been limited routine use of such data earlier in the signal management process, to help rapidly contextualise signals and strengthen preliminary assessment or to inform decisions regarding action including the need for further studies. This study explores the value of EHR used in this way within a regulatory environment via an automated analysis platform.Methods: Safety signals raised at the UK Medicines and Healthcare products Regulatory Agency (MHRA) between July 2014 and June 2015 were individually reviewed by a multi-disciplinary team. They assessed the feasibility of identifying the exposure and event of interest using primary care data from the Clinical Practice Research Datalink (CPRD) within the Commonwealth Vigilance Workbench (CVW) Longitudinal Module platform, which was designed to facilitate routine descriptive analysis of signals using EHR. Three signals, where exposure and event could be well identified, were retrospectively analysed using the platform.Results: Of 69 unique new signals, 20 were for drugs prescribed predominately in secondary care or available without prescription, which would not be identified in primary care. A further 17 were brand, formulation, or dose-specific issues, were related to mortality, were relevant only to a subgroup of patients, or were drug interactions, and hence could not be reviewed using the platform given its limitations. Analyses of exposure and incidence of the adverse event could be produced using CPRD within the CMV Longitudinal Module for 32 (46%) signals. The case studies demonstrated that the data provided supporting evidence for confirming initial assessment of the signal and deciding upon the need for further action.Conclusions: CPRD can routinely provide useful early insights into clinical context when assessing a large proportion of safety signals within a regulatory environment provided that a flexible approach is adopted within the analysis platform. [ABSTRACT FROM AUTHOR]

Background Rational drug use and drug safety are becoming increasingly important concerns in China with the increasing public access to drugs and the health-care system, and this has led to the development of pharmacovigilance in China. Aim of the review To provide a brief introduction about pharmacovigilance in China in terms of system development, utilization and challenges. Method Relevant studies on pharmacovigilance related to the study aim was undertaken through literature search to synthesize the extracted data. Results The creation and evolvement of China's pharmacovigilance system spans across 30 years since 1989. The system consists of four progressing administrative layers: county, municipal, provincial and national levels. China has passed over 20 laws and regulations related to pharmacovigilance covering the processes of drug development, manufacture, distribution and use with the aim to guard drug safety. An online spontaneous self-reporting Adverse Drug Reaction (ADR) Monitoring System was established in 2003. ADRs are mainly reported by medical institutions, pharmaceutical manufacturers, and drug distributors. Currently there is no mandatory ADR reporting requirement for pharmaceutical manufacturers, and a proposed regulation under public comment will likely change this. China has started to build active pharmacovigilance surveillance programs in addition to the passive ADR reporting system. The China Food and Drug Administration has established the intensive Safety Monitoring Program and the National Adverse Drug Reaction Monitoring Sentinel Alliance Program based on electronic health records to further the efforts of ADR reporting, monitoring and analysis. Conclusion The practice of ADR monitoring and pharmacovigilance in China have made great progress. More efforts are needed both in system building, and creation of laws and regulations to strengthen the safe use of medicines. [ABSTRACT FROM AUTHOR]

Background Adverse drug reactions (ADRs) are major health problems which are of global concern. Spontaneous reporting of adverse drug reactions constitutes a crucial contribution to patient care. Objective The purpose of this study was to assess the knowledge, attitudes, and practices of healthcare professionals towards adverse drug reaction reporting. Setting Health care professionals in Gondar, Ethiopia. Methods A cross-sectional study was conducted from March to May 2017. Data were collected through self-administered questionnaires. The collected data were analyzed using SPSS version 20. Binary logistic regression analysis was performed to distinguish factors that affect adverse drug reaction reporting. A p value < 0.05 was considered as a statistically significant. Main outcome measure Factors affecting adverse drug reaction reporting of health care professionals. Results Of 102 healthcare professionals included in this study, 61 (59. 8%) were nurses, 16 (15.7%) health officers, and 25 (24.5%) pharmacy professionals. Nearly 48 (47%) study participants had an inadequate level of knowledge towards adverse drug reaction reporting. The majority of participants 88 (86.3%) had a positive attitude, while more than half (51%) of study participants did not report the adverse drug reaction they encountered. Participants who had not taken adverse drug reaction reporting training (p = 0.037), health officers (p = 0.019), and nurse professionals (p = 0.001) showed a statistically significant association with an inadequate level of knowledge. Conclusion Even though the majority of healthcare professionals had a positive attitude, they had an inadequate level of knowledge and practice towards adverse drug reaction reporting. [ABSTRACT FROM AUTHOR]

Purpose: To determine through a literature review, the current status of patients' involvement in adverse drug reactions (ADRs) reporting. Methods: Eighteen (18) studies which were published within the period from 2010 to 2016 were reviewed. The studies were extracted from seven databases, viz, Google Scholars, Medline, Academic Search Complete "EBSCO", Health and Medical Complete ProQuest, Science Direct- Elsevier, SCOPUS and Wiley Online Library. Results: The review revealed that although the reports by patients were of good quality, the patients' awareness of, and attitude towards, ADR reporting were generally poor. Conclusion: The results of this review suggest the need for patients' enlightenment on ADRs reporting. Information on how to improve ADRs reporting is provided. [ABSTRACT FROM AUTHOR]

Background: Health-care professionals across the globe are obligated to report adverse drug reactions (ADRs). The knowledge of ADRs and attitude of health-care professionals toward ADRs reporting is vital for patient safety. This study intends to investigate the knowledge of ADRs and attitude of health-care professionals toward ADRs reporting. Materials and Methods: A cross-sectional study using an anonymous questionnaire was conducted over a period of 3 months (September 2016 to November 2016) at King Saud Medical City, Riyadh, Saudi Arabia. This study included 399 questionnaires submitted by health-care professionals. Results: A total of 399 questionnaires were submitted by health-care professionals, of which only 14.8% knew the term "ADR" and 55.1% of the respondents reported ADRs during their practice. A total of 93.8% of the respondents agreed that ADR reporting should be made mandatory for health-care professionals, and 94.5% agreed that it improves the patient safety. Conclusion: The findings generally indicate that health-care professionals in a tertiary care setting have low awareness regarding the term "ADR." Lack of pharmacovigilance training, amount of workload, and legal liabilities are the main causes of underreporting. More than half of the respondents agreed that ADR reporting eventually improves patient safety. [ABSTRACT FROM AUTHOR]

Background: The effectiveness of a national post-marketing surveillance program depends directly on the active participation of all health professionals. There is no current comprehensive and active pharmacovigilance program available in Lebanon.Objectives: To assess the knowledge, attitudes, and practices (KAP) among community pharmacists in Lebanon with respect to potential pharmacovigilance and adverse-drug-reaction reporting in Lebanon.Methods: A cross-sectional descriptive study, using a self-administered KAP questionnaire and conducted between March and July 2016, included 1857 pharmacists practicing in community settings. Statistical analysis included χ2 test for dichotomous or multinomial qualitative variables, and Wilcoxon test for quantitative variables with non-homogeneous variances or non-normal distribution.Results: The majority of responders had good knowledge concerning the concept and purpose of pharmacovigilance as well as adverse drug reactions (how to report these/the importance of reporting adverse events/the definition of an adverse event and pharmacovigilance). Concerning community pharmacists' attitudes and practice towards pharmacovigilance, the majority described having a positive attitude towards their role in adverse drug reaction reporting and this activity was even seen as one of their core duties. The questionnaire revealed a lack of practice and training regarding pharmacovigilance. Nonetheless, the pharmacists agreed on the Order of Pharmacists in Lebanon and the Ministry of Health's role in promoting this practice and helping them be more involved in reporting adverse drug reactions (ADRs). The pharmacists thought that they are well positioned regarding patient-safety practice in their pharmacies and the results were not statistically different between pharmacy employers and employees.Conclusion: Lebanese pharmacists have the required knowledge and positive attitude to start reporting ADRs, were aware of ADRs occurring with various medicines post-marketing, yet were currently not able to disseminate this information widely or to record it centrally, emphasizing the importance of establishing a national ADR reporting system. [ABSTRACT FROM AUTHOR]

BACKGROUND: India is a developing country and adverse drug reactions (ADRs) influence most of the diseases in our population, and monitoring is required due to the paucity of ADRs. The present study was done to analyze the ADRs at the ADR monitoring center (AMC) of tertiary care hospital in Raipur during 1 year. MATERIALS AND METHODS: Study of ADR monitoring of outpatient and inpatient was a prospective and observational study carried out between September 2015 and August 2016. The ADRs in the form of Individual Case Safety Report (ICSR) was sent to the Indian database (Vigiflow°). RESULTS: Total ICSRs reported to Vigiflow° were 232 during 1 year. Among them, 63.79% were found to be nonserious and 36.21% were serious. Nearly 45% of ADRs were implicated only due to antimicrobials, which is highest among all other groups of drugs. A maximum number of ADRs were observed in 31-60 years of age group (52.15%). In causality assessment, the probable cases had a higher incidence (67.24%), followed by possible (27.58%) and certain (4.74%). The frequency of ADR reporting at our AMC was low (0.043%) compared to national average. Our AMC shared 0.35% of total ICSRs, which is insignificant (P < 0.001) compared to the JSS, Mysore and PGIMER, Chandigarh, AMCs, which have shared most of the ICSRs in Vigiflow°. CONCLUSIONS: The frequencies of ADRs reporting in our study are less compared to those reported with other similar studies. Underreporting is a very serious concern in Raipur, and Pharmacovigilance Programme of India must intercede to pick up ADRs across the country. [ABSTRACT FROM AUTHOR]

Introduction: Recent efforts to introduce direct patient reporting into pharmacovigilance systems have proved that patient reports contribute significantly to medicine safety, but there is a paucity of information relating to patients' perspectives regarding adverse drug reaction reporting in developing countries.Objective: The objective of this study was to explore patients' knowledge, attitudes, behaviours and opinions on spontaneous adverse drug reaction reporting in Ghana.Methods: A cross-sectional study using questionnaires administered through face-to-face interviews was carried out from 25 August, 2016 to 20 September, 2016 with 442 patients aged 18 years and above selected by convenience sampling from two community pharmacies in urban and rural Ghana. Reasons and opinions on patients' reporting on adverse drug reactions were surveyed using a 5-point Likert scale. The Pearson chi-square test was used to determine associations between background variables and responses on knowledge of adverse drug reaction reporting.Results: Responses from 434 patients (86.7%) were included in the analysis. Among those interviewed, there was a high level of awareness regarding the existence of the National Pharmacovigilance Centre (81.6%). Approximately half of the respondents (49.5%) were aware that patients were able to report adverse drug reactions associated with medicinal products directly to the National Pharmacovigilance Centre. Of the respondents, 46.3% stated that they had an adverse drug reaction to their medicines in the past; of these, 53.2% reported to healthcare professionals and 36.9% failed to report because they stopped their medication. The three main reasons for patients' reporting were desire for extra information (92.4%), desire to share experiences with other people (91.7%) and expectation for the National Pharmacovigilance Centre to inform others about the possible adverse drug reactions (88.0%). Patients' opinions were to contribute to research/knowledge (96.5%) and improvements in drug safety (96.5%). Patients' behaviour towards adverse drug reaction reporting was affected by the likely consequences of reporting, influence of others and the ease of reporting.Conclusion: Patients have a positive attitude and good knowledge on adverse drug reaction reporting to the National Pharmacovigilance Centre and report because they expect extra information and to contribute to drug safety. Patients' positive attitude towards adverse drug reaction reporting could be sustained by hosting periodic public awareness campaigns addressing the importance of adverse drug reaction reporting and by providing timely feedback to patients on regulatory decisions taken as a result of the reports that they submitted. [ABSTRACT FROM AUTHOR]

Introduction: Proton pump inhibitors (PPIs) have been implicated in the occurrence of moderate to severe myopathies in several case reports.Aim: This study was performed to assess the reporting risk of muscular adverse drug reactions (ADRs) associated with PPIs in the Italian National Network of Pharmacovigilance database.Methods: A disproportionality analysis (case/non-case) was performed using spontaneous reports collected in the database between July 1983 and May 2016. Reporting odds ratio (ROR) and 95% confidence intervals (CIs) were calculated as a measure of disproportionality. In a secondary and tertiary analysis, we explored the association of PPIs with muscular ADRs after taking into account the masking effect of statins. Moreover, the possibility of an interaction between PPIs and statins, leading to the occurrence of muscular ADRs, was also tested.Results: The study was carried out on 274,108 reports. The ROR of muscular ADRs for PPIs, adjusted for age and gender, was 1.484 (95% CI 1.204-1.829; p < 0.001), whereas the ROR for rhabdomyolysis was 0.621 (95% CI 0.258-1.499). Similar results were obtained in the secondary analysis. The tertiary analysis, where PPIs were considered regardless of whether their role was suspected or concomitant, showed a potential disproportionate reporting for the combination PPIs-rhabdomyolysis (ROR 1.667, 95% CI 1.173-2.369; p < 0.01). The PPIs-statins combination was not associated with an enhanced ROR of muscular ADRs/rhabdomyolysis compared with statins alone.Conclusions: This explorative study suggests that the class of PPIs could be involved in reports of muscular ADRs, rather than any other ADR, more frequently than any non-statin drug. Our results must be corroborated by further studies. [ABSTRACT FROM AUTHOR]

Introduction: Australia is traditionally an early adopter of vaccines, therefore comprehensive and effective post-licensure vaccine pharmacovigilance is critical to maintain confidence in immunisation, both nationally and internationally. With adverse event following immunisation (AEFI) surveillance the responsibility of Australian jurisdictions, Victoria operates an enhanced passive AEFI surveillance system integrated with clinical services, called 'SAEFVIC' (Surveillance of Adverse Events Following Vaccination In the Community).Objective: The aim of this study was to evaluate Victoria's current AEFI surveillance system 'SAEFVIC' and inform ongoing quality improvement of vaccine pharmacovigilance in Victoria and Australia.Methods: We conducted a retrospective structured desktop evaluation of AEFI reporting received by SAEFVIC from 2007 to 2014, to evaluate the system according to its stated objectives, i.e. to improve AEFI reporting; provide AEFI signal detection; and to maintain consumer confidence in vaccination.Results: AEFI reporting has tripled since SAEFVIC commenced (incidence risk ratio [IRR] 3.04, 95% confidence interval [CI] 2.35-3.93), raising Victoria to be the lead jurisdiction by AEFI reporting volume and to rank third by population reporting rate nationally. The largest increase was observed in children. Data were utilised to investigate potential signal events and inform vaccine policy. Signal detection required clinical suspicion by surveillance nurses, or prior vaccine-specific concerns. Subsequent vaccination post-AEFI was documented for 56.2% (95% CI 54.1-58.4) of reports, and the proportion of children due or overdue for vaccination was 2.3% higher for those reporting AEFI compared with the general population.Conclusion: SAEFVIC has improved AEFI surveillance, facilitates signal investigation and validation, and supports consumer confidence in immunisation. Expansion of the system nationally has the potential to improve capacity and capability of vaccine pharmacovigilance, particularly through data consistency and jurisdictional comparability in Australia. [ABSTRACT FROM AUTHOR]

FDA issues Drug Safety Communications (DSCs) to alert health care professionals and the public about emerging safety information affecting prescription and over-the-counter drugs. News media may amplify DSCs, but it is unclear how DSC messaging is transmitted through the media. We conducted a content analysis of the lay media coverage reaching the broadest audience to characterize the amount and content of media coverage of two zolpidem DSCs from 2013. After the first DSC, zolpidem news stories increased from 19 stories/week in the preceding 3 months to 153 following its release. Most (81%) appeared in the lay media, and 64% focused on the DSC content. After the second DSC, news stories increased from 24 stories/week in the preceding 3 months to 39 following. Among the 100 unique lay media news stories, at least half correctly reported three key DSC messages: next-day impairment and drowsiness as common safety hazards, lower doses for some but not all zolpidem products, and women’s higher risk for impairment. Other DSC messages were reported in fewer than one-third of stories, such as the warning that impairment can happen even when people feel fully awake. The first—but not the second—zolpidem DSC generated high-profile news coverage. The finding that some messages were widely reported but others were not emphasizes the importance of ensuring translation of key DSC content. [ABSTRACT FROM PUBLISHER]

The article presents addiction-related news briefs and a calendar of events for 2017. The U.S. Food and Drug Administration approved the removal of a black box warning regarding the possible side effects of the smoking cessation drug varenicline. The Ukrainian government's funding of an opioid substitution therapy programme is examined, along with the American Academy of Addiction Psychiatry Annual Meeting on December 7-10, 2017 in San Diego, California.

One of the principal challenges facing a toxicologic pathologist is to determine and differentiate a true adverse effect from a nonadverse or an adaptive response. Recent publications from the Society of Toxicologic Pathology (STP) and the European STP provide guidance for determining and communicating adversity in nonclinical toxicology studies. In order to provide a forum to inform and engage in a discussion on this important topic, a continuing education (CE) course was held during the 2016 STP Annual meeting in San Diego, CA. The lectures at this course provided guidance on determining and communicating adversity using case studies involving both clinical pathology and anatomic pathology. In addition, one talk also focused on data quality, study design, and interpretation of artifacts that could hinder the determination of adversity. The CE course ended with a talk on understanding adversity in preclinical studies and engaging the regulatory agencies in the decision-making process. This manuscript is designed to provide brief summaries of all the talks in this well-received CE course. [ABSTRACT FROM AUTHOR]

Pharmacovigilance is concerned with the detection, assessment, understanding, and prevention of adverse reactions to medicines. It is helpful to prevent undesired harm sustained by the patient due to inappropriate or unsafe use of medicinal agents. As the use of drugs and polypharmacy increase in prevalence, pharmacovigilance gains relevance and momentum. Practice-based research networks have the potential to enhance health research by promoting earlier detection of adverse events at a decreased level of cost. This article explores the recent evidence of an improved benefit of administering non-steroidal antiinflammatory drugs (NSAIDs) in the fasting state, and authors propose that an improved pharmacovigilance system is both needed and feasible provided records are adapted to a nationwide integration of pharmacoepidemiology data. [ABSTRACT FROM AUTHOR]

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Promoting safe use of medicines is a priority of Indian Pharmacopoeia Commission that functions as the National Coordination Center (NCC) for Pharmacovigilance Programme of India (PvPI). One hundred and seventy-nine adverse drug reactions (ADRs) monitoring centers currently report ADRs to NCC. Current India contribution to global safety database reaches 3% and the completeness score is 0.93 out of 1. NCC is taking several measures to enhance patient safety including capacity building for monitoring, surveillance, collaboration with national health programs and other organizations to increase ADR reporting and to ensure that PvPI is a vital knowledge database for Indian regulators. The Central Drugs Standard Control Organization has notified important safety label changes on drugs such as carbamazepine and piperacillin + tazobactam in the year 2015, other drugs are under monitoring for regulatory interventions. [ABSTRACT FROM AUTHOR]

Objectives: Underreporting and poor quality of adverse drug reaction (ADR) reports pose a challenge for the Pharmacovigilance Program of India. A module to impart knowledge and skills of ADR reporting to MBBS students was developed and evaluated. Materials and Methods: The module consisted of (a) e-mailing an ADR narrative and online filling of the "suspected ADR reporting form" (SARF) and (b) a week later, practical on ADR reporting was conducted followed by online filling of SARF postpractical at 1 and 6 months. SARF was an 18-item form with a total score of 36. The module was implemented in the year 2012-2013. Feedback from students and faculty was taken using 15-item prevalidated feedback questionnaires. The module was modified based on the feedback and implemented for the subsequent batch in the year 2013-2014. The evaluation consisted of recording the number of students responding and the scores achieved. Results: A total of 171 students in 2012-2013 batch and 179 in 2013-2014 batch participated. In the 2012-2013 batch, the number of students filling the SARF decreased from basal: 171; 1 month: 122; 6 months: 17. The average scores showed improvement from basal 16.2 (45%) to 26.4 (73%) at 1 month and to 27.3 (76%) at 6 months. For the 2013-2014 batch, the number (n = 179) remained constant throughout and the average score progressively increased from basal 10.5 (30%) to 27.8 (77%) at 1 month and 30.3 (84%) at 6 months. Conclusion: This module improved the accuracy of filling SARF by students and this subsequently will led to better ADR reporting. Hence, this module can be used to inculcate better ADR reporting practices in budding physicians. [ABSTRACT FROM AUTHOR]

Background and aim: Adherence to treatment is a critical component of epilepsy management. This study examines whether addressing antiepileptic drug (AED) side effects at every visit is associated with increased patient-reported medication adherence. Patients and methods: This study identified 243 adults with epilepsy who were seen at two academic outpatient neurology settings and had at least two visits over a 3-year period. Demographic and clinical characteristics were abstracted. Evidence that AED side effects were addressed was measured through 1) phone interview (patient-reported) and 2) medical records abstraction (physician-documented). Medication adherence was assessed using the validated Morisky Medication Adherence Scale-4. Complete adherence was determined as answering "no" to all questions. Results: Sixty-two (25%) patients completed the interviews. Participants and nonparticipants were comparable with respect to demographic and clinical characteristics; however, a smaller proportion of participants had a history of drug-resistant epilepsy than nonparticipants (17.7% vs 30.9%, P=0.04). Among the participants, evidence that AED side effects were addressed was present in 48 (77%) medical records and reported by 51 (82%) patients. Twenty-eight (45%) patients reported complete medication adherence. The most common reason for incomplete adherence was missed medication due to forgetfulness (n=31, 91%). There was no association between addressing AED side effects (neither physician-documented nor patient-reported) and complete medication adherence (P=0.22 and 0.20). Discussion and conclusion: Among patients with epilepsy, addressing medication side effects at every visit does not appear to increase patient-reported medication adherence. [ABSTRACT FROM AUTHOR]

Background: Public access to human drug safety or pharmacovigilance (PV) data is a matter of interest to patients as well as to researchers and prescribers. Objective: The objective of the present study was to identify databases with open access and to analyse the accessibility of relevant data in the existing databases. Methods: To identify which drug safety databases offer public access, the 31 health authority websites that enable patients to directly report adverse events to their National Competent Authority (NCA) were reviewed between September 2014 and December 2015. For each identified open-access PV database, the type of safety data that can be retrieved was examined based on E2B fields and the level of access. For each PV database, a score was attributed based on three points: the open access items/adverse drug reactions (ADR) reporting form items ratio, the ability to access ADR details, and the processability of the data. Public access to PV databases was thus classified as high (three points), medium (two points) or low (zero or one point). Results: A total of 11 PV databases providing open access were identified: nine national and two regional. Six databases grant case-level access, the others only provide aggregated data. In terms of general case information, the USA and Canada come first by sharing case ID, the type of report, the reporter and their qualification, whereas the World Health Organization (WHO) does not provide any general information. The other databases mostly provide only one of these three items: source, case ID, or type of report. At the case level, the US database offers the greatest amount of information followed by Canadian and German databases; data are available in a workable format for the US, Canadian and EudraVigilance databases. Overall, the databases from Denmark, Japan, the Netherlands, UK and VigiBase were classified as providing a low level of access to available safety information; those from Australia, EudraVigilance, Germany and New Zealand as providing a medium level of access; and those from the USA and Canada, as providing a high level of access. Conclusion: The 11 PV databases analysed, except for those in North America, provide limited information. This may be acceptable for patient use but not for research purposes. [ABSTRACT FROM AUTHOR]

Aim Adverse drug events (ADEs) are harmful and unintended consequences of medications. Their reporting is essential for drug safety monitoring and research, but it has not been standardized internationally. Our aim was to synthesize information about the type and variety of data collected within ADE reporting systems. Methods We developed a systematic search strategy, applied it to four electronic databases, and completed an electronic grey literature search. Two authors reviewed titles and abstracts, and all eligible full-texts. We extracted data using a standardized form, and discussed disagreements until reaching consensus. We synthesized data by collapsing data elements, eliminating duplicate fields and identifying relationships between reporting concepts and data fields using visual analysis software. Results We identified 108 ADE reporting systems containing 1782 unique data fields. We mapped them to 33 reporting concepts describing patient information, the ADE, concomitant and suspect drugs, and the reporter. While reporting concepts were fairly consistent, we found variability in data fields and corresponding response options. Few systems clarified the terminology used, and many used multiple drug and disease dictionaries such as the Medical Dictionary for Regulatory Activities (MedDRA). Conclusion We found substantial variability in the data fields used to report ADEs, limiting the comparability of ADE data collected using different reporting systems, and undermining efforts to aggregate data across cohorts. The development of a common standardized data set that can be evaluated with regard to data quality, comparability and reporting rates is likely to optimize ADE data and drug safety surveillance. [ABSTRACT FROM AUTHOR]

Background: Detection, monitoring and treatment of adverse drug reactions (ADRs) are paramount to patient safety. The use of a comprehensive electronic health record (EHR) system has the potential to address inadequacies in ADR documentation and to facilitate ADR reporting to health agencies. However, effective methods to maintain the quality of documented ADRs within an EHR have not been well studied. Objective: To evaluate the accuracy and effectiveness of ADR documentation transfer throughout the implementation of a comprehensive EHR system. Methods: Retrospective analysis of ADR documentation at a tertiary care pediatric hospital between January 2013 and June 2014. ADRs documented in the newly implemented ambulatory EHR, pharmacy system and hybrid health record system were extracted. Documentation inconsistencies and processes for managing ADR documentation within the EHR were reviewed. Results: A total of 115 patients with 260 unique ADRs were identified. Only 155 (60 %) of the identified ADRs were found in the ambulatory EHR system. The remaining 105 ADRs (40 %) were missing from the EHR when it was compared with the other systems. Seventy-two patients (63 %) returned for a follow-up visit, and each had their ADR documentation reviewed in the ambulatory EHR. Following the visit, 44 % of these ambulatory EHR records still included incorrect information. Conclusions: We identified discrepancies in ADR documentation within hospital systems, which need to be addressed as healthcare institutions transition to EHRs. Processes related to the transfer of ADR information into the EHR should be clearly defined. To improve the quality of ADR documentation, steps to force complete and continual ADR verification should be introduced at early stages of implementation of a new EHR, and all responsible providers should play a role. [ABSTRACT FROM AUTHOR]

Background: Based on data of clinical trials, new agents are receiving approval to the pharmaceutical market, for which information concerning safety issues under real-life conditions is not yet available. Objectives: The aim was to evaluate the tolerability of newer antiepileptic drugs (AEDs), such as topiramate, levetiracetam, zonisamide, pregabalin, extended-release oxcarbazepine, lacosamide and eslicarbazepine, under real-life conditions by means of an assessment of routine clinical data of inpatients. Method: Over 2.75 years data of all inpatients receiving one of the newer AEDs were documented. Occurring adverse drug reactions (ADRs) were classified according to the WHO-UMC Causality Assessment concerning their likely relationship to the prescribed AEDs. For each AED, the total number of patients without and with ADRs, assessed as at least possibly related to the particular drug, was calculated and corresponding incidences compared with reference data provided in the Summary of Product Characteristics (SmPC). For statistical evaluation Spearman correlation ( r), estimated relative risk and logistic regression analysis were used. Results: In total, the data of 562 patients were assessed, of which 90 % received up to six different AEDs. The proportion of off-label use with regard to dosage varied between 6.4 and 64.7 %. Levetiracetam and oxcarbazepine as an extended-release formulation were most commonly used, and levetiracetam showed the best tolerance. By using logistic regression, the occurrence of ADRs was significantly associated with the number of AEDs ( p < 0.001) as well as the defined daily doses ( p = 0.003). In total, ADRs of AEDs were documented for 318 patients (56.6 %). The most common referred to electrolyte imbalance, e.g., low sodium ( n = 79, 14.1 %) and potassium ( n = 25, 4.4 %) levels, the central nervous system, including dizziness ( n = 61, 10.9 %), disturbed vision ( n = 47, 8.4 %), fatigue ( n = 40, 7.1 %), nystagmus ( n = 36, 6.4 %) and ataxia ( n = 29, 5.2 %), or cognitive deficits, especially disturbance of speech ( n = 37, 6.6 %), memory impairment ( n = 36, 6.4 %) and mental slowing ( n = 32, 5.7 %). By comparing the assessed ADR incidences with specification data, for some ADRs, a probable underestimation by the SmPC of respective risk could be assumed. Conclusion: During inpatient treatment, valuable data are generated, which are currently rarely utilized for pharmacoepidemiologic or pharmacovigilance purposes. A systematic evaluation of these data can increase the probability of detecting ADRs and can promote real-life-related drug surveillance. [ABSTRACT FROM AUTHOR]

Aim: To investigate the frequency and characteristics of adverse drug reactions (ADRs) in hospitalised neonates to obtain a better understanding of and improvement in neonatal healthcare.Methodology: A prospective cohort study. Data were collected on 313 neonates and 2166 drug prescriptions. Clinical characteristics of patients, drugs administered and ADRs were prospectively recorded and analysed. Informed consent was obtained in all cases.Results: 116 different ADRs were detected. 17% of the neonates experienced at least one of these ADRs. Systemic antimicrobials and caffeine citrate were the drugs that most commonly caused ADRs. According to the ADR Severity Assessment Scale, 41% were mild, 42% were moderate and 17% were severe. Of the ADRs identified, 11% were classified as 'certain' by the Naranjo method and 20% were classified as 'defined' by the Karch and Lasagna modified algorithm. Most of the ADRs detected were related to feed intolerance, phlebitis and tachycardia. Most were acute (73%) and lasted between 1 and 7 days (39%). After the occurrence of an ADR, it was necessary to initiate specific treatment in 44 cases, discontinue the drugs involved in 30 cases, and reduce the drug dose in another 30 cases. An association was shown between the number of drugs prescribed and ADR onset.Conclusions: There is a high incidence of ADRs in hospitalised newborns, which increases with the number of prescriptions. [ABSTRACT FROM AUTHOR]

Background: Short-course oral corticosteroids are commonly used in children but are known to be associated with adverse drug reactions (ADRs). This review aimed to identify the most common and serious ADRs and to determine their relative risk levels.Methods: A literature search of EMBASE, MEDLINE, International Pharmaceutical Abstracts, CINAHL, Cochrane Library and PubMed was performed with no language restrictions to identify studies in which oral corticosteroids were administered to patients aged 28 days to 18 years of age for up to and including 14 days of treatment. Each database was searched from their earliest dates to December 2013. All studies providing clear information on ADRs were included.Results: Thirty-eight studies including 22 randomised controlled trials (RCTs) met the inclusion criteria. The studies involved a total of 3200 children in whom 850 ADRs were reported. The three most frequent ADRs were vomiting, behavioural changes and sleep disturbance, with respective incidence rates of 5.4%, 4.7% and 4.3% of patients assessed for these ADRs. Infection was one of the most serious ADRs; one child died after contracting varicella zoster. When measured, 144 of 369 patients showed increased blood pressure; 21 of 75 patients showed weight gain; and biochemical hypothalamic-pituitary-adrenal axis suppression was detected in 43 of 53 patients.Conclusions: Vomiting, behavioural changes and sleep disturbance were the most frequent ADRs seen when short-course oral corticosteroids were given to children. Increased susceptibility to infection was the most serious ADR.Trial Registration Number: CRD42014008774. By PROSPERO International prospective register of systematic reviews. [ABSTRACT FROM AUTHOR]

Indian Pharmacopoeia Commission is Committed for maintaining the standards of drugs including Radiopharmaceuticals (RPs) by publishing Indian Pharmacopoeia. These RPs are being used in India for diagnostic or therapeutic purpose. RPs though contain relatively small quantities of active ingredient and administered in small volumes could cause some adverse reactions to the patients. The objective of presenting this article is to introduce the system of adverse drug reaction reporting to the nuclear medicine fraternity who are dealing with RPs. [ABSTRACT FROM AUTHOR]

Introduction: Disproportionality analyses are used in many organisations to identify adverse drug reactions (ADRs) from spontaneous report data. Reporting patterns vary over time, with patient demographics, and between different geographical regions, and therefore subgroup analyses or adjustment by stratification may be beneficial.Objective: The objective of this study was to evaluate the performance of subgroup and stratified disproportionality analyses for a number of key covariates within spontaneous report databases of differing sizes and characteristics.Methods: Using a reference set of established ADRs, signal detection performance (sensitivity and precision) was compared for stratified, subgroup and crude (unadjusted) analyses within five spontaneous report databases (two company, one national and two international databases). Analyses were repeated for a range of covariates: age, sex, country/region of origin, calendar time period, event seriousness, vaccine/non-vaccine, reporter qualification and report source.Results: Subgroup analyses consistently performed better than stratified analyses in all databases. Subgroup analyses also showed benefits in both sensitivity and precision over crude analyses for the larger international databases, whilst for the smaller databases a gain in precision tended to result in some loss of sensitivity. Additionally, stratified analyses did not increase sensitivity or precision beyond that associated with analytical artefacts of the analysis. The most promising subgroup covariates were age and region/country of origin, although this varied between databases.Conclusions: Subgroup analyses perform better than stratified analyses and should be considered over the latter in routine first-pass signal detection. Subgroup analyses are also clearly beneficial over crude analyses for larger databases, but further validation is required for smaller databases. [ABSTRACT FROM AUTHOR]

Introduction: Following the start of the World Health Organization (WHO) Programme for International Drug Monitoring (PIDM) by 10 member countries in 1968, it took another 24 years for the first two African countries to join in 1992, by which time the number of member countries in the PIDM had grown to 33. Whilst pharmacovigilance (PV), including the submission of individual case safety reports (ICSR) to VigiBase(®), the WHO global ICSR database, is growing in Africa, no data have been published on the growth of ICSR reporting from Africa and how the features of ICSRs from Africa compare with the rest of the world (RoW).Objective: The objective of this paper was to provide an overview of the growth of national PV centres in Africa, the reporting of ICSRs by African countries, and the features of ICSRs from Africa, and to compare ICSRs from Africa with the RoW.Methods: The search and analysis interface of VigiBase(®)--VigiLyze(®)--was used to characterise ICSRs submitted by African countries and the RoW. The distribution of ICSRs by African countries was listed and characterised by anatomic therapeutic chemical (ATC) code, Medical Dictionary for Regulatory Activities (MedDRA(®)) system organ class (SOC) classification, and patient age and sex. The case-defining features of ICSRs between Africa and the RoW were also compared.Results: The number of African countries in the PIDM increased from 2 in 1992 to 35 at the end of September 2015, and African PIDM members have cumulatively submitted 103,499 ICSRs (0.88 % of global ICSRs) to VigiBase(®). The main class of products in African ICSRs are nucleoside and nucleotide reverse transcriptase inhibitors (14.04 %), non-nucleoside reverse transcriptase inhibitors (9.09 %), antivirals for the treatment of HIV infections (5.50 %), combinations of sulfonamides and trimethoprim (2.98 %) and angiotensin-converting enzyme (ACE) inhibitors (2.42 %). The main product classes implicated in ICSRs from the RoW are tumour necrosis factor-α (TNFα) inhibitors (5.29 %), topical nonsteroidal anti-inflammatory preparations (2.26 %), selective immunosuppressants (2.08 %), selective serotonin reuptake inhibitors (2.04 %) and HMG CoA reductase inhibitors (1.85 %). The main SOCs reported from Africa versus the RoW include skin and subcutaneous tissue disorders (31.14 % vs. 19.58 %), general disorders and administration site conditions (20.91 % vs. 30.49 %) and nervous system disorders (17.48 % vs. 19.13 %). The 18-44 years age group dominated ICSRs from Africa, while the 45-64 years age group dominated the RoW. Identical proportions of females (57 % Africa and the RoW) and males (37 % Africa and the RoW) were represented.Conclusions: As at the end of September 2015, 35 of 54 African countries were Full Member countries of the PIDM. Although the number of ICSRs from Africa has increased substantially, ICSRs from Africa still make up <1 % of the global total in VigiBase(®). The features of ICSRs from Africa differ to those from the RoW in relation to the classes of products as well as age group of patients affected. The gender of patients represented in these ICSRs are identical. [ABSTRACT FROM AUTHOR]

Introduction: The two methods for minimizing competition bias in signal of disproportionate reporting (SDR) detection--masking factor (MF) and masking ratio (MR)--have focused on the strength of disproportionality for identifying competitors and have been tested using competitors at the drug level.Objectives: The aim of this study was to develop a method that relies on identifying competitors by considering the proportion of reports of adverse events (AEs) that mention the drug class at an adequate level of drug grouping to increase sensitivity (Se) for SDR unmasking, and its comparison with MF and MR.Methods: Reports in the French spontaneous reporting database between 2000 and 2005 were selected. Five AEs were considered: myocardial infarction, pancreatitis, aplastic anemia, convulsions, and gastrointestinal bleeding; related reports were retrieved using standardized Medical Dictionary for Regulatory Activities (MedDRA(®)) queries. Potential competitors of AEs were identified using the developed method, i.e. Competition Index (ComIn), as well as MF and MR. All three methods were tested according to Anatomical Therapeutic Chemical (ATC) classification levels 2-5. For each AE, SDR detection was performed, first in the complete database, and second after removing reports mentioning competitors; SDRs only detected after the removal were unmasked. All unmasked SDRs were validated using the Summary of Product Characteristics, and constituted the reference dataset used for computing the performance for SDR unmasking (area under the curve [AUC], Se).Results: Performance of the ComIn was highest when considering competitors at ATC level 3 (AUC: 62 %; Se: 52 %); similar results were obtained with MF and MR.Conclusion: The ComIn could greatly minimize the competition bias in SDR detection. Further study using a larger dataset is needed. [ABSTRACT FROM AUTHOR]

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

Background: Databases of suspected adverse drug reactions (ADRs) are a cornerstone of pharmacovigilance. With increasing numbers of reports, additional statistical approaches are needed to better use the data. Aim: The present study was aimed at elucidating the European Medicines Agency's (EMA) use of a novel 'paediatric' query to analyse the data in its ADR database 'EudraVigilance'. Methods: The proportional reporting ratio (PRR) is a measure of disproportionality for which the underlying principle is that a drug-event pair of interest is reported more often than expected relative to an independence model. The EMA's paediatric query, based on PRRs, was applied to the data in EudraVigilance to investigate the extent to which the known association between enalapril and renal toxicity was reflected in reported ADRs comparing children with adults and with adjustment for the effect of multiplicity. Results: The comparison of PRRs for children (14.91, 95 % confidence interval [CI] 13.05-17.04) versus adults (2.66, 95 % CI 2.52-2.82) confirmed a higher risk of renal ADRs with enalapril when used in children compared with all other medicines and compared with adults. Conclusions: The EMA's paediatric query can be used to highlight an imbalance for a drug-event pair among ADRs for a medicine when used in children and as compared with adults. Applying the query in practice can help the EMA to decide on whether stand-alone paediatric medicine development is warranted, and which, if any, further studies are necessary. Ongoing evaluation of the query is contributing to the development of new methods and guidance. [ABSTRACT FROM AUTHOR]

Background: Physicians identify from 45.7 to 96.2 % of Adverse Drug Reactions (ADRs) in their patients, with under-reporting ranging from 6 to 100 %. In order to improve ADR reporting, several interventions have been evaluated in different studies, but not with regard to ADR identification. In addition, it is not known whether some patient characteristics might influence on ADR identification and reporting by physicians.Objectives: (a) To assess the effectiveness of a comprehensive intervention directed to Emergency Department physicians and coordinated by a pharmacist in a tertiary care pediatric hospital on ADR identification and reporting. (b) To assess if some of the children’s characteristics might influence on ADR identification and reporting. Setting The Emergency Department of the Hospital Infantil de México “Federico Gómez”, which is a national pediatric institute of health in México.Methods: A Quasi-experimental, pre-post test trial was designed. During the intervention, the pharmacist gave talks on Pharmacovigilance and on the program for electronic capture of data, took part in patient visits, left reminders, improved accessibility to ADR report format and performed feedback activities. To classify and quantify correctly identified ADRs and ADRs reported to the Institutional Pharmacovigilance Center (IPC), 1136 clinical records were reviewed. The models were adjusted for patient variables.Main Outcome Measures: Total ADRs, ADRs correctly identified by physicians, ADRs reported to the IPC by physicians. Results Before the intervention, 97 % of ADRs were correctly identified and 6.1 % reported by physicians. During the intervention, 99.6 % were correctly identified and 41.2 % were reported, and after the intervention, 99.6 and 41.7 %, respectively. Identification during the intervention showed a sevenfold increase with regard to preintervention and was maintained post-intervention. ADR reporting during the intervention showed a 14-fold increase with regard to pre-intervention and was maintained during post-intervention.Conclusion: Physicians do identify ADRs, but fail to report them. The intervention increased ADR correct identification and reporting. The effect was maintained after the intervention. [ABSTRACT FROM AUTHOR]

Objectives: There was increasing adverse drug reaction (ADR) reports submitted to the Health Product Vigilance Center under the Thai FDA. The Thai Signal Detection Program was developed to identify and filter the potential signals, called signals of disproportionate reporting (SDRs). A large number of SDRs cannot be in-depth assessed by the Signal Detection Advisory Working Group (SDAWG) in time. The prioritized SDRs with concentrated in-depth assessment might help find some true signals. This preliminary study aimed at developing a signal triage algorithm that can prioritize SDRs to assign an in-depth assessment. Methods: A multi-criteria decision analysis (MCDA) was chosen for a triage algorithm by generating scores for priority rankings on clinical importance of SDRs. This study had three main steps. Key attributes for a triage decision was first identified and followed by the development of a signal triage algorithm. After that, the triage algorithm was tested by comparing the triage results of the proposed algorithm with triaging by experts. Results: Six factors were selected as key attributes, i.e. fatal outcome, serious ADRs, positive rechallenge, new drug, change in reporting and sources of reports. Four attributes used in the Thai Signal Detection Program were excluded, i.e. the drug-ADR associations, WHO-ART critical term, disproportionality and volume of reports. Experts gave the weight for the six key attributes using their experiences. To test the proposed algorithm, systemic antibiotics with 86 SDRs in total were triaged by SDAWG and eight SDRs were further assessed. Six SDRs were consistent with the result of the proposed signal triage algorithm (75% agreement) that was the top of the priority ranking. The other two SDRs were selected by SDAWG because of the highly-concerned, serious ADR and unfamiliar case. These could be because of the drug or ADRs for the current interest, level of key attributes, comorbidity and concurrent medication use, and characteristics of experts’ opinions. Conclusion: The signal triage algorithm can enhance the efficiency of the triage method by experts, as it is systematic, transparent, timely, repeatable and also scientifically based. More research is necessary to evaluate and/or improve this triage algorithm. [ABSTRACT FROM AUTHOR]

Introduction: Adverse drug reactions (ADRs) are threat to the patient's safety and the quality of life, and they increase the cost of health care. Spontaneous ADR reporting system mainly relies on physicians, but also pharmacists, nurses, and even patients. The aim of this study was to explore attitudes, barriers, and possible improvements to ADR reporting practices in Bosnia and Herzegovina. Methods: A self-reported questionnaire was developed to collect data on the perception of pharmacovigilance practice and ADR reporting. The survey was conducted in the period between September, 2014 and October, 2014. Results: The response rate was 73% (44 of 60) and 93% (148 of 160) among the pharmacist and family medicine physician groups, respectively. Regarding the attitudes to pharmacovigilance practice and reporting, both the pharmacists and physicians found the practices important. The majority of pharmacists and physicians in year 2014 did not report any ADR, while 18% of the pharmacists and 12% of the physicians, who participated in this study, reported one ADR. Reporting procedure, uncertainty, and their exposure were the main barriers to reporting ADRs for the pharmacists. The physicians claimed lack of knowledge to whom to report an ADR as the main barrier. A significant number of the respondents thought that additional education in ADR reporting would have a positive impact, and would increase the ADR reporting rate. Conclusions: Despite the overall positive attitude towards ADR reporting, the reporting rate in Bosnia and Herzegovina is still low. Different barriers to the ADR reporting have been identified, and there is also the need for improvements in the traditional education in this field. [ABSTRACT FROM AUTHOR]

Introduction: Spontaneous reporting systems (SRSs) are pivotal for signal detection, especially for rare events with a high drug-attributable component, such as torsade de pointes (TdP). Use of different national SRSs is rarely attempted because of inherent difficulties, but should be considered on the assumption that rare events are diluted in international databases.Objective: The aim was to describe TdP-related events associated with antipsychotics, H1-antihistamines and anti-infectives in three national SRSs (in Italy, Germany and France) and highlight potential signals of torsadogenicity through a combined literature evaluation.Methods: A common search strategy was applied to extract TdP-related events: (1) TdP, (2) QT interval abnormalities, (3) ventricular fibrillation/tachycardia, and (4) sudden cardiac death. Signals of disproportionate reporting (SDRs) were calculated for TdP + QT interval abnormalities and defined by a lower limit of the 95 % confidence interval of the reporting odds ratio (ROR) >1. Among SDRs with at least three cases without concomitant pro-arrhythmic drugs, we defined potential new signal of torsadogenicity as drugs with no published evidence from (a) the crediblemeds(®) website ( http://www.crediblemeds.com , as of November 1st, 2014); (b) studies on the FDA Adverse Event Reporting System (FAERS); and (c) safety trials or pharmaco-epidemiological studies (as of December 16th, 2014).Results: Overall, 3505 cases were retrieved (1372, 1468, and 801 for France, Germany and Italy, respectively). Antipsychotics were mainly recorded in Germany (792 cases), whereas antibiotics peaked at 515 and 491 (France and Italy, respectively). Forty-one drugs met criteria for SDRs in at least one single source, of which 31 were detected only from one single SRS: 18, ten and three (French, German and Italian SRS, respectively). By contrast, only five SDRs were detected in all national data sources (amisulpride, aripiprazole, haloperidol, olanzapine, risperidone). Overall, five potential new signals of torsadogenicity were identified: flupentixol, ganciclovir, levocetirizine, oxatomide and tiapride.Conclusions: We found differences across and within national SRSs in the reporting of drug-induced TdP, which finally resulted in five potential new signals of torsadogenicity. These findings warrant targeted pharmacovigilance studies to formally assess the existence of actual drug-event associations. [ABSTRACT FROM AUTHOR]

Rapid developments in pharmacogenomics have been noticeable in recent years, and much of this knowledge has improved understanding of adverse drug reactions. This improved knowledge has largely been the result of improved sequencing technologies and falling costs in this area, as well as improved statistical techniques to analyse the data derived from studies. While the genetic reasons behind adverse drug reactions are becoming better understood, translation of this knowledge, particularly in terms of biomarkers that might be clinically applicable at the bedside, has been more difficult. Understanding of the technologies and their application is limited among practising clinicians. The cost of some of the technologies available may also be prohibitive in stretched healthcare economies. As education about the potential for applying pharmacogenomics improves and costs fall, understanding of adverse drug reactions and application of this knowledge in a clinical setting should improve. [ABSTRACT FROM AUTHOR]