Safety Alerts Research Articles

PRM79 - WEBER EFFECT: AN EXTENDED ANALYSIS FOR TEN YEARS OF REPORTING TRENDS IN FDA ADVERSE EVENT REPORTING SYSTEM (FAERS)

The Weber effect, a peak in adverse event (AE) reporting of a drug at the end of second year and continuous decline thereafter, has been considered an important bias for a long time. The aim of this study was to analyze the temporal reporting patterns of fourteen drugs (approved in 2006) for ten years in FAERS database. A retrospective analysis was executed on the fourteen drugs approved in 2006. The drugs were selected according to the following conditions. Drugs should be approved in 2006 so that the Adverse Event (AE) reports will be available for at least ten years and the drug should not have acclaimed any major safety alerts. Reports of all drugs were normalized for ease of analysis in such a way that the highest count in the reports of any of the 40 quadrants of the drug in question was considered as 100 and remaining count of reports of that particular drug was normalized accordingly. The reporting pattern were analyzed by quarterly and yearly basis. The data set for analysis was retrieved from FAERS database between 2006 and 2016. The analysis was performed by using 19,539 primary suspected reports associated with the fourteen drugs approved in 2006. Four different types of reporting patterns were observed on analysis according to quarterly basis, namely, transitory decline, plateau prior to the rise in AE reports resumes, Weber effect, M-type pattern. Significant Weber pattern was observed when the reports were analyzed yearly basis. The present analysis showed that FAERS reporting is pertinent to Weber effect. It is advisable to address Weber effect in all studies which utilize FAERS database and quantification of such effects are required as it may affect the results drawn from the database.

Future Information Technology Tools for Fighting Substandard and Falsified Medicines in Low- and Middle-Income Countries.

Substandard and falsified (SF) medicines have emerged as a global public health issue within the last two decades especially in low- and middle-income countries (LMICs). Serious consequences of this problem include a loss of trust and increased financial costs due to less disease control and more frequent complications during therapy. Of note, antimicrobial resistance is an additional long-term implication of poor-quality antimicrobials. This review covers information technology tools including medicines authentication tools (MAT) as mobile apps and messaging service, 2D barcoding approaches with drug safety alert systems, web based drug safety alerts, radiofrequency identification tags, databases to support visual inspection, digital aids to enhance the performance of quality evaluation kits, reference libraries for identification of falsified and substandard medicines, and quality evaluation kits based on machine learning for field testing. While being easy to access and simple to use, these initiatives are gaining acceptance in LMICs. Implementing 2D barcoding based on end-to-end verification and “Track and Trace” systems has emerged as a step toward global security in the supply chain. A breakthrough in web-based drug safety alert systems and data bases was the establishment of the Global Surveillance and Monitoring System by the World Health Organization in 2013. Future applications include concepts including “lab on a chip” and “paper analytical devices” and are claimed to be convenient and simple to use as well as affordable. The principles discussed herein are making profound impact in the fight against substandard and falsified medicines, offering cheap and accessible solutions.

Effect of European Medicines Agency's restrictions on trimetazidine utilization in Portugal.

Following safety concerns regarding trimetazidine, the European Medicines Agency (EMA) recommended restrictions on its use. Our objective was to determine the impact of regulatory actions on trimetazidine utilization in Portugal. Retrospective interrupted time-series analysis of monthly ambulatory pharmacy reimbursement records for the Portuguese National Health Service between January 2006 and December 2015. Regulatory actions were identified by searching the EMA, Portuguese Medicines Authority, and European Commission's websites. Concurrent factors in the same period were also identified. The main outcome was the dispensing of trimetazidine-containing products per month in Portugal. Two interruption periods were defined in the series: May 2011, when EMA announced it would review trimetazidine safety, and June 2012 to January 2013, when EMA announced it had reached a final opinion recommending restrictions; the European Commission approved EMA's recommendation; the Portuguese Medicines Authority issued safety alerts, changed the summary of product characteristics, and approved a direct health-care professional letter; and a regional bulletin was issued. Interruption 1 had no effect on trimetazidine use, but interruption 2 resulted in decreases in level and trend-from 8.3million defined daily doses in 2010 to 2.8million in 2015. After interruption 2, trimetazidine use tended towards a lower steady state. There was a significant decrease in trimetazidine use in Portugal following a complex intervention that included safety alerts, changes to the summary of product characteristics, a direct health-care professional letter, and a regional drug bulletin. No effect was seen when EMA announced its review of trimetazidine safety.

Accidental dual humidification in intensive care units: Repeated alerts and system changes are not enough

PurposeThe inadvertent, simultaneous use of heat and moisture exchangers (HMEs) and heated humidifiers (HHs) can result in waterlogging of the filter and sudden ventilation tube occlusion, with potentially fatal consequences. Following an NHS England Safety Alert, a near miss and educational reminders in our institution, we introduced new guidelines to solely use HHs in the intensive care unit and HMEs only for patient transfers. No further incidents have occurred, however this solution is potentially fallible. Two years later, we sought to assess staff knowledge and likelihood of recognising this error should it occur. Materials and methodsIn a simulation study, a tracheally intubated and ventilated mannequin had a breathing circuit containing both a HME and a HH. Participants were asked to assess the circuit, identify errors and undertake corrective measures. ResultsOnly 30% (6/20) recognised and undertook corrective measures. ConclusionsDespite educational efforts and system changes, recognition of this error remained poor. System changes may reduce the likelihood of the error occurring, but when it does, recognition may not occur. Substantial reductions or elimination of this error may be achieved through a safety-engineered fail-safe within the equipment, which alerts staff to improve recognition and prevent the mistake.

Safety Alert System in Automobiles

Safety Alert System in Automobiles

A UK clinical audit addressing the quality of prescribing of sodium valproate for bipolar disorder in women of childbearing age

ObjectivesTo review prescribing practice concerning valproate, an established human teratogen, for the management of bipolar disorder in women of childbearing age.DesignThe Prescribing Observatory for Mental Health conducted a baseline clinical...

Developing a Shared Patient-Centered, Web-Based Medication Platform for Type 2 Diabetes Patients and Their Health Care Providers: Qualitative Study on User Requirements.

BackgroundInformation technology tools such as shared patient-centered, Web-based medication platforms hold promise to support safe medication use by strengthening patient participation, enhancing patients’ knowledge, helping patients to improve self-management of their medications, and improving communication on medications among patients and health care professionals (HCPs). However, the uptake of such platforms remains a challenge also due to inadequate user involvement in the development process. Employing a user-centered design (UCD) approach is therefore critical to ensure that user’ adoption is optimal.ObjectiveThe purpose of this study was to identify what patients with type 2 diabetes mellitus (T2DM) and their HCPs regard necessary requirements in terms of functionalities and usability of a shared patient-centered, Web-based medication platform for patients with T2DM.MethodsThis qualitative study included focus groups with purposeful samples of patients with T2DM (n=25), general practitioners (n=13), and health care assistants (n=10) recruited from regional health care settings in southwestern Germany. In total, 8 semistructured focus groups were conducted. Sessions were audio- and video-recorded, transcribed verbatim, and subjected to a computer-aided qualitative content analysis.ResultsAppropriate security and access methods, supported data entry, printing, and sending information electronically, and tracking medication history were perceived as the essential functionalities. Although patients wanted automatic interaction checks and safety alerts, HCPs on the contrary were concerned that unspecific alerts confuse patients and lead to nonadherence. Furthermore, HCPs were opposed to patients’ ability to withhold or restrict access to information in the platform. To optimize usability, there was consensus among participants to display information in a structured, chronological format, to provide information in lay language, to use visual aids and customize information content, and align the platform to users’ workflow.ConclusionsBy employing a UCD, this study provides insight into the desired functionalities and usability of patients and HCPs regarding a shared patient-centered, Web-based medication platform, thus increasing the likelihood to achieve a functional and useful system. Substantial and ongoing engagement by all intended user groups is necessary to reconcile differences in requirements of patients and HCPs, especially regarding medication safety alerts and access control. Moreover, effective training of patients and HCPs on medication self-management (support) and optimal use of the tool will be a prerequisite to unfold the platform’s full potential.

Enrolling Underserved Women in mHealth Programs: Results From Text4baby Outreach Campaigns.

Public health practitioners have increasingly leveraged technology-based communication to get health information into the hands of hard-to-reach populations; however, best practices for outreach and enrollment into mobile health (mHealth) programs are lacking. This article describes enrollment results from campaigns focused on enrolling underserved pregnant women and mothers in Text4baby-a free, mHealth service-to inform outreach strategies for mHealth programs. Text4baby participants receive health and safety information, interactive surveys, alerts, and appointment reminders through at least three weekly texts and a free app-timed to users' due date or babies' birth date. Text4baby worked with partners to implement national, state, and community-based enrollment campaigns. Descriptive statistics were used to compare baseline enrollment prior to a campaign with enrollment during a campaign to generate enrollment estimates. Enrollment rates were calculated for campaigns for which the number targeted/reached was available. National television campaigns resulted in more than 10,000 estimated enrollments. Campaigns that were integrated with an existing program and text-based recruitment had the highest enrollment rates, ranging from 7% to 24%. Facebook advertisements and traditional media targeting providers and consumers were least effective. mHealth programs should consider text-based recruitment and outreach via existing programs; additional research is needed on return on investment for different outreach strategies and on the effectiveness of different outreach strategies at reaching and enrolling specific target populations.

Alignment with the ISMP 2018–2019 Targeted Medication Safety Best Practices for Hospitals

Despite the great strides in medication safety and the plethora of new medication-related technologies and devices in the United States over the last few decades, thousands of medication errors are still occurring each year. 1 Institute for Safe Medication Practices (ISMP) National Medication Error Reporting Database. in: Confidential Access. 2017 Google Scholar Unfortunately, with new innovation also come new sources of error. 2 Institute for Safe Medication Practices Understanding human over-reliance on technology. in: ISMP Medication Safety Alert!21 (18). 2016: 1-4 Google Scholar , 3 Lawes S Grissinger M Medication errors attributed to health information technology. PA-PSRS Patient Saf Advis. 2017; 14: 1-8 Google Scholar Although it is unreasonable to believe that any complex process involving human interaction with systems (such as medication use), will ever be error free, we can feel fortunate that not all errors result in patient harm. What is regrettable, however, is the portion of these events each year that are both harmful and preventable. 1 Institute for Safe Medication Practices (ISMP) National Medication Error Reporting Database. in: Confidential Access. 2017 Google Scholar Although national reporting of medication-related events to federally recognized patient safety organizations, such as the Institute for Safe Medication Practices (ISMP), has resulted in numerous documented changes to patient safety, 4 Institute for Safe Medication Practices Historical Timeline. http://www.ismp.org/about/timeline.aspDate accessed: November 5, 2017 Google Scholar in the continued analysis of medication-related events, ISMP has found that specific preventable medication-related events resurface and continue to result in serious outcomes and even patient deaths. 1 Institute for Safe Medication Practices (ISMP) National Medication Error Reporting Database. in: Confidential Access. 2017 Google Scholar Susan F. Paparella, Member, Bux-Mont Chapter, is Vice President at the Institute for Safe Medication Practices (ISMP ⁎ISMP is a nonprofit organization that works closely with health care practitioners, consumers, hospitals, regulatory agencies, and professional organizations to educate caregivers about preventing medication errors. ISMP is the premier international resource on safe medication practices in health care institutions. If you would like to report medication errors to help others, E-mail us at: [email protected] or call (800)FAIL-SAF(e). This Medication Error Reporting Program keeps information confidential and secure. We will include only the level of detail that the reporter wishes in our publication.ISMP is a nonprofit organization that works closely with health care practitioners, consumers, hospitals, regulatory agencies, and professional organizations to educate caregivers about preventing medication errors. ISMP is the premier international resource on safe medication practices in health care institutions. If you would like to report medication errors to help others, E-mail us at: [email protected] or call (800)FAIL-SAF(e). This Medication Error Reporting Program keeps information confidential and secure. We will include only the level of detail that the reporter wishes in our publication.), Horsham, PA.

The Pharmaceuticals and Medical Devices Agency's Approach to Facilitate Risk Communication and Its Challenges

The issue of drug lag in Japan has been rapidly reduced in recent years, and newly approved drugs now become available on Japanese and international markets at the same time. In this context, the risk management plan (RMP) system was introduced in 2012. RMPs describe important safety concerns recognized by Japan's Pharmaceuticals and Medical Devices Agency (PMDA) and marketing authorization holders (MAHs), as well as safety measures that MAHs request healthcare professionals (HCPs) to follow. The publication of RMPs is expected to support the sharing of drug risk management among HCPs during the postmarketing phase. In addition, to encourage risk communication between HCPs and patients, the PMDA website provides drug guides for patients and other information to promote proper understanding of drugs by patients and their families and enable them to identify serious adverse drug reactions at an early stage. However, the results of surveys conducted by the PMDA in FY2014 and FY2015 revealed low levels of awareness of RMPs and drug guides for patients in hospitals and other healthcare institutions. The surveys also showed that information regarding the proper use of drugs from MAHs and the PMDA was not incorporated into practice at healthcare institutions, resulting in the repeated release of identical safety alerts. To facilitate the increased utilization of risk communication tools, the PMDA has been providing and disseminating these tools through its website. This study addresses those efforts and the associated challenges.

Analysis of Safety Alerts Associated with Dietary Supplements from Japan and Overseas

The prevalence of dietary supplement use has increased in Japan, and consumers can purchase supplements from foreign countries through the internet. Therefore, it is important to consider both domestic and overseas safety alerts to prevent adverse events associated with dietary supplement use. We have been collecting global safety alerts associated with dietary supplements and providing this information to the public via the "Information system on safety and effectiveness for health foods (HFNet)" website. In this study, we analyzed the characteristics of safety alerts from 2010 to 2016 in HFNet (total: 2,124 alerts). The most common reason for alerts was illegal adulteration with pharmaceutical substances (85%), and sexual enhancement or weight loss products accounted for 68% of all alerts. Most alerts were based on market surveillance reports or recall information. However, 181 adverse event reports were identified, and most of them were related to weight loss or disease treatment in patients. In Japan, a majority of the adverse events was caused by products intended for weight loss or purchased online, and young female users were commonly involved. These findings should be helpful for prevention of adverse events associated with dietary supplement use.

Drug safety alerts of pharmacovigilance programme of India: A scope for targeted spontaneous reporting in India.

Background:The National Coordination Centre-Pharmacovigilance Programme of India (NCC-PvPI), Indian Pharmacopoeia Commission works under the aegis of Ministry of Health and Family Welfare, Government of India. It promotes patient safety in India and also supports postmarketing surveillance programs. Currently, almost hundred thousand case reports are submitted to NCC-PvPI each year through its 250 ADR Monitoring Centers (AMCs) located across India, and India is the one of the top ten contributor countries under WHO-Uppsala Monitoring Centre since 2012 and start issuing drug safety alerts from March 2016.Aim:This study aims to highlight the drug safety alerts issued by NCC-PvPI from March 2016 to June 2017 and urgent need for further monitoring by adopting targeted spontaneous reporting (TSR) methodology at AMCs and its impact on the NCC's drug safety database, i.e., VigiFlow in India.Methodology:A retrospective analysis was done for the reported unlisted ADRs by various AMCs to PvPI through VigiFlow, i.e., individual case safety report (ICSR) management system at NCC, where these unlisted drug-ADR combinations considered and issued as drug safety alerts for further reporting these to NCC, if any detected at healthcare settings during routine clinical practice by healthcare professionals.Results:From July 2011 to June 2017, NCC-PvPI was collated 250,787 ICSRs and contributed to WHO international drug safety database, i.e., VigiBase, from these ICSRs; NCC-PvPI was issued 56 drug safety alerts from March 2016 to June 2017.Conclusion:In India, spontaneous reporting of ADRs existed since 1998 under passive surveillance method, but there is an urgent need to initiate TSR, which is a complementary method to spontaneous reporting on these drug safety alerts for further regulatory action by Central Drugs Standard Control Organization.

Obstacle Detection as a Safety Alert in Augmented Reality Models by the Use of Deep Learning Techniques.

Augmented reality (AR) is becoming increasingly popular due to its numerous applications. This is especially evident in games, medicine, education, and other areas that support our everyday activities. Moreover, this kind of computer system not only improves our vision and our perception of the world that surrounds us, but also adds additional elements, modifies existing ones, and gives additional guidance. In this article, we focus on interpreting a reality-based real-time environment evaluation for informing the user about impending obstacles. The proposed solution is based on a hybrid architecture that is capable of estimating as much incoming information as possible. The proposed solution has been tested and discussed with respect to the advantages and disadvantages of different possibilities using this type of vision.

Time to STOP Acute Kidney Injury (AKI)

Acute kidney injury (AKI) is a serious condition that is often unrecognized leading to delays in treatment. AKI is an independent risk factor for mortality, intensive care admission and length of stay in hospital. In the UK a National Patient Safety Alert was issued around the recognition and response to AKI as a preventable cause of death and an estimated annual cost of £ 500 million per year to the NHS. A UK BAPN audit in 2012 of 6 centers showed > 60% of AKI cases were unrecognized. Studies in adults on electronic alerts (e-alerts) for AKI have shown an improvement in recognition but not subsequent response with fluid resuscitation and timely antibiotics. A Quality Improvement Project was devised in a large tertiary children's hospital in the UK to improve response and recognition to AKI. The project was based on the children's oncology unit, which is an area of high incidence of AKI with high-risk patients, often in high-risk scenarios. The project utilised Plan Do Study Act (PDSA) cycles and the improvement model. The stages are: initiation of e-alerts on the blood results server, raising awareness of e-alerts, education package on AKI response and recognition which is now informing the development of a AKI care bundle. The overall incidence of AKI is low, mean 8–10 per week since the interventions there has been an increase in recognition and a decrease in the number of AKI stage 1 that progressed. There has been no increase in the number of blood tests being requested (balancing measure). Interestingly false positive alerts have been seen in children on hyperhydration for risk of tumour lysis syndrome. A multidisciplinary approach can achieve improvements in recognition & response to AKI.

55 ‘Mini Sim’ – innovative bite sized simulation teaching in a busy children’s emergency department

Emergency Medicine requires a highly skilled workforce who are passionate about delivering excellent patient care. Shift patterns linked with the ever increasing numbers of patients who attend Emergency Departments puts...

A broadcast scheme for vehicle-to-pedestrian safety message dissemination

Ensuring cooperative awareness by periodic message beaconing in vehicular environments is necessary to address pedestrian safety. However, high periodic basic safety message broadcasting in dense vehicular environments makes accessing the communication channel very competitive. Furthermore, high-frequency periodic broadcasting causes fast device energy dissipation which is a key issue for small computing devices used in wireless sensor and mobile communications. Therefore, in order to achieve reliable message dissemination for vehicle-to-pedestrian safety, energy loss minimization mechanisms for pedestrian mobile devices should be developed. This article proposes controlling the number of broadcasts by eliminating periodic safety message broadcasts from pedestrian nodes; these nodes only receive broadcasts from vehicles and then conditionally communicate with the vehicles when safety alerts are raised. When the pedestrian nodes do not receive messages from any vehicle for a specified period, pedestrian no...

Assessing for Cardiotoxicity from Metal-on-Metal Hip Implants with Advanced Multimodality Imaging Techniques.

High failure rates of metal-on-metal (MoM) hip implants prompted regulatory authorities to issue worldwide safety alerts. Circulating cobalt from these implants causes rare but fatal autopsy-diagnosed cardiotoxicity. There is concern that milder cardiotoxicity may be common and underrecognized. Although blood metal ion levels are easily measured and can be used to track local toxicity, there are no noninvasive tests for organ deposition. We sought to detect correlation between blood metal ions and a comprehensive panel of established markers of early cardiotoxicity. Ninety patients were recruited into this prospective single-center blinded study. Patients were divided into 3 age and sex-matched groups according to implant type and whole-blood metal ion levels. Group-A patients had a ceramic-on-ceramic [CoC] bearing; Group B, an MoM bearing and low blood metal ion levels; and Group C, an MoM bearing and high blood metal-ion levels. All patients underwent detailed cardiovascular phenotyping using cardiac magnetic resonance imaging (CMR) with T2*, T1, and extracellular volume mapping; echocardiography; and cardiac blood biomarker sampling. T2* is a novel CMR biomarker of tissue metal loading. Blood cobalt levels differed significantly among groups A, B, and C (mean and standard deviation [SD], 0.17 ± 0.08, 2.47 ± 1.81, and 30.0 ± 29.1 ppb, respectively) and between group A and groups B and C combined. No significant between-group differences were found in the left atrial or ventricle size, ejection fraction (on CMR or echocardiography), T1 or T2* values, extracellular volume, B-type natriuretic peptide level, or troponin level, and all values were within normal ranges. There was no relationship between cobalt levels and ejection fraction (R = 0.022, 95% confidence interval [CI] = -0.185 to 0.229) or T2* values (R = 0.108, 95% CI = -0.105 to 0.312). Using the best available technologies, we did not find that high (but not extreme) blood cobalt and chromium levels had any significant cardiotoxic effect on patients with an MoM hip implant. There were negligible-to-weak correlations between elevated blood metal ion levels and ejection fraction even at the extremes of the 95% CI, which excludes any clinically important association. Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.

How do I . . . . implement patient safety alerts for adrenal insufficiency across my institution

Searchable abstracts of presentations at key conferences in endocrinology ISSN 1470-3947 (print) | ISSN 1479-6848 (online)

Survey of guidelines and current practices for safe handling of antineoplastic and other hazardous drugs used in 24 countries.

A survey of guidelines and current practices was conducted to examine the safe handling procedures for antineoplastic and other hazardous drugs that are used in 24 countries including the Americas, Europe, the Mideast, Far East, and Australia. Subject experts were asked to complete a brief survey regarding safe handling guidelines and practices for hazardous drugs in their countries. Questions addressed practices for handling monoclonal antibodies, the use of closed-system transfer devices, medical surveillance practices, and measurements of compliance with existing guidelines. Responses from 37 subject experts representing 24 countries revealed considerable variation in the content and scope of safe handling guidelines and pharmacy practices among the participating countries. Guidelines in the majority of countries used the term "cytotoxics," while others referred to "hazardous" or "antineoplastic" drugs. The International Society of Oncology Pharmacy Practice standard was cited by six countries, and five cited the National Institute for Occupational Safety and Health Alert. Others cited international guidelines other than International Society of Oncology Pharmacy Practice, or they have created their own guidelines. Approximately half reported that their guidelines were mandatory under federal, state, or provincial legislation. Only 11 countries reported that monoclonal antibodies were covered in their guidelines. Closed-system drug-transfer devices are widely used, but were not specifically recommended in four countries, while one country required their use. Medical surveillance programs are in place in 20 countries, but only in The Netherlands is surveillance mandatory. Nine countries reported that they have completed recent updates or revisions of guidelines, and the measures for their adoption have been initiated. Although the overall goals in the participating countries were similar, the approaches taken to assure safe handling of hazardous drugs varied considerably in some cases.

Biases Can Get in the Way of Important Shared Safety Lessons

Most professionals have read many tragic tales about medication errors published in various media sources, including in this column and in the Institute for Safe Medication Practice’s (ISMP’s) Medication Safety Alert! and Nurse Advise-ERR publications. These examples have included events from acute care locations and emergency departments across the United States. As with most serious events, these errors were the result of the intersection between faulty organizational systems and risky human behaviors, as demonstrated by the following examples: Susan Paparella, Member, Bux-Mont Chapter, is Vice President at the Institute for Safe Medication Practices (ISMP ⁎ISMP is a nonprofit organization that works closely with health care practitioners, consumers, hospitals, regulatory agencies, and professional organizations to educate caregivers about preventing medication errors. ISMP is the premier international resource on safe medication practices in health care institutions. If you would like to report medication errors to help others, E-mail us at: [email protected] or call (800)FAIL-SAF(e). This Medication Error Reporting Program keeps information confidential and secure. We will include only the level of detail that the reporter wishes in our publications.ISMP is a nonprofit organization that works closely with health care practitioners, consumers, hospitals, regulatory agencies, and professional organizations to educate caregivers about preventing medication errors. ISMP is the premier international resource on safe medication practices in health care institutions. If you would like to report medication errors to help others, E-mail us at: [email protected] or call (800)FAIL-SAF(e). This Medication Error Reporting Program keeps information confidential and secure. We will include only the level of detail that the reporter wishes in our publications.), Horsham, PA.