Underreporting Of Adverse Events Research Articles

Safety culture in maternity hospital: Perception of nurse-midwives.

To explore nurse-midwives' perceptions of safety culture in maternity hospitals. A descriptive phenomenological study was conducted using focus groups and reported following the Consolidated Criteria for Reporting Qualitative Research. Data were obtained through two online focus group sessions in June 2022 with 13 nurse-midwives from two maternity hospitals in the central region of Portugal. The first focus group comprised 6 nurse-midwives, and the second comprised 7 nurse-midwives. Qualitative data were analysed using content analysis. Two main themes emerged from the data: (i) barriers to promoting a safety culture; (ii) safety culture promotion strategies. The first theme is supported by four categories: ineffective communication, unproductive management, instability in teams and the problem of errors in care delivery. The second theme is supported by two categories: managers' commitment to safety and the promotion of effective communication. The study results show that the safety culture in maternity hospitals is compromised by ineffective communication, team instability, insufficient allocation of nurse-midwives, a prevailing punitive culture and underreporting of adverse events. These highlight the need for managers to commit to providing better working conditions, encourage training with the development of a fairer safety culture and encourage reporting and learning from mistakes. There is also a need to invest in team leaders who allow better conflict management and optimization of communication skills is essential. Disseminating these results will provide relevance to the safety culture problem, allowing greater awareness of nurse-midwives and managers about vulnerable areas, and lead to the implementation of effective changes for safe maternal and neonatal care. There was no patient or public contribution as the study only concerned service providers, that is, nurse-midwives themselves.

Enhancing Pharmacovigilance in Côte d'Ivoire: Impact of GSK's Training and Mentoring Pilot Project in the Abidjan Region.

Pharmacovigilance (PV) in sub-Saharan Africa relies on passive surveillance but underreporting of adverse events (AEs) by health care professionals (HCPs) is a major challenge. A PV enhancement project was implemented to address this in Côte d'Ivoire. To improve safety surveillance of medicines through PV training and mentoring of HCPs in selected health care facilities (HCFs). This collaborative project between national PV stakeholders, GSK, and PATH was implemented from September 2018 to February 2020 in Abidjan region, Côte d'Ivoire. Trained PV focal points provided training and regular mentoring of HCPs. Key performance indicator (KPI) categories for AE reporting were the volume of AE reports, efficiency of report transmission and data entry, quality of reports, and quality of the central (Vigilance Unit) response to AE reports. Overall, 1427 HCPs at 91 HCFs were trained. In the 8 months before implementation, 33 AE reports were received versus 85 after 3 months and 361 after 18 months of implementation (71 [83.5%] and 278 [77.0%], respectively, from Abidjan). The KPIs with the highest proportions were: AE reports received centrally (100%), complete AE reports (69.0%), AE reports entered into the local PV database within 48h (99.6%), and AE reports entered into the global database, VigiBase (86.7%). Report notification within 72h, causality assessment, and serious AE reporting had proportions below 20%; feedback to reporters was provided for only 0.4% of reports. Regular PV trainings and mentoring improved AE reporting in Côte d'Ivoire but further enhancement is required to improve passive safety surveillance.

An Evaluation of the Adverse Events Following Voluntary Medical Male Circumcision Surveillance System in Zvimba District, Zimbabwe, 2020

Background: The Adverse Events following Voluntary Medical Male Circumcision Surveillance System (VMMC AESS) serves to identify adverse events (AEs) for safe provision of VMMC. In 2019, Zvimba District reported two adverse events out of 542 circumcisions translating to a 0.4% AE rate against an acceptable threshold of 2% and this is suggestive of underreporting. We evaluated the system to verify existence of underreporting of AEs, assess the surveillance system attributes and evaluate data quality. Methods: A descriptive cross-sectional study was conducted using the updated Center for Disease Control (CDC) guidelines for surveillance system evaluation. We proportionately sampled VMMC client intake records and purposively selected health workers involved in the VMMC programme into the study. An interviewer-administered questionnaire was used to collect data from 14 - 30 December 2020 on knowledge of the VMMC AESS among health care workers and surveillance system attributes. We used a checklist to check for data quality. Data were analysed using Epi Info 7 statistical software. Results: Of the 31 health workers that participated in the study, 21 (68%) had fair knowledge of the surveillance system. Out of 384 records reviewed, 104 had missing data on AE monitoring days 7 and 42. Sixteen (52%) of participants regarded filling AE reporting forms as difficult and the process as time-consuming. The surveillance system was not representative as only two out of eight facilities were conducting outreaches in hard-to-reach areas. Conclusion: There was possible underreporting of adverse events as about a quarter of reviewed records had missing data on AE monitoring days and the system’s performance was threatened by poor data quality and unavailability of reporting forms. The system was rendered acceptable though unstable, not representative and not simple and the health workers were not making use of the surveillance system. We recommended retraining on the surveillance system for all health care workers involved in VMMC in Zvimba District.

Does Methylphenidate Work in Children and Adolescents with Attention Deficit Hyperactivity Disorder?

Objective: Attention deficit hyperactivity disorder (ADHD) is a common psychiatric disorder diagnosed in increasing proportions of children and adolescents. The psychostimulant methylphenidate has been considered the first-line pharmacological treatment for children and adolescents with ADHD for more than 60 years. Considering recent publications on methylphenidate for ADHD, we here give an overview of its effects in children and adolescents with ADHD, elicited by a well-disputed Cochrane review and narratively synthesise the evidence in the field. Method: We searched for systematic reviews and meta-analyses that investigated methylphenidate as an intervention for children and adolescence with ADHD compared with placebo or no treatment. We assessed the quality of the evidence using AMSTAR II. Results: We found 24 eligible systematic reviews and meta-analyses of which 11 were rated as high- quality evidence according to AMSTAR II. The evidence claiming that methylphenidate is beneficial in treating children and adolescents with ADHD was of very low certainty. The underreporting of adverse events in randomised clinical trials may impede an adequate depiction of the balance between benefits and harms. Conclusions: It appears that there is uncertain evidence on group-level to support the claim that methylphenidate is beneficial in treating children and adolescents with ADHD. Future randomised clinical trials and systematic reviews should include individual participant data, which would allow us to assess intervention effects across modifiers, like age, sex, ADHD subtypes, comorbidities, and dose.

Registration bias in a clinical quality register.

Background and aims The quality of medical quality registers is poorly defined and lack of trust in data due to low completeness may be a major barrier against their use in quality improvement interventions. The aim of the current observational study was to explore how selective reporting may influence adverse events registered in the Norwegian quality register for colonoscopy (Gastronet). Materials and methods Gastronet’s database includes data provided by endoscopists, nurses and patients. All outpatient colonoscopies reported to Gastronet in 2015 were included and compared to the total number of colonoscopies performed in Norway as retrieved from the National Patient Registry. Hospitals were categorized into four groups according to reporting completeness < 50 %, 50 % to 69 %, 70 % to 89 % and ≥ 90 %. The number of recorded adverse events (AEs) and procedure time were analyzed. Multivariate logistic regression models were fitted to explore independent factors for selection bias. Results A total of 22,364 colonoscopies were reported to the National Patient Register of which 15,855 (71 %) were registered in Gastronet. Feedback was received from 11,079 patients (50 %). The frequency of AEs increased from 0.6 % in completeness group < 50 % to 1.6 % in completeness group ≥ 90 % ( P < 0.001). Long colonoscopy procedure time was associated with low reporting completeness. Patient feedback was associated with older age, cecal intubation success and sedation-free colonoscopy. Conclusion Incomplete registration in a colonoscopy quality register is associated with underreporting of AEs. Longer procedure time, a surrogate marker for time constraint, is associated with low completeness.

Using a cancer registry to capture signals of adverse events following immune and targeted therapy for melanoma.

Background Toxicity of oncology treatments in real-life patients is frequently disregarded and hence underreported. Objective To characterize adverse events (AEs) of immunotherapy and targeted therapy reported in patients with locally advanced or metastatic melanoma. Setting District Hospital for Cancer treatment (Instituto Português de Oncologia de Lisboa Francisco Gentil). Method A retrospective cohort of melanoma patients was established, comprising adult patients diagnosed with malignant melanoma treated with immunotherapy or targeted therapy. Exposure was characterized by nature, time and intensity of exposure. To account for different exposure periods, person-time was used as unit of analysis. Main outcomes measure Occurrence of AEs. Results Data from 111 patients included in the cohort indicates the majority received immunotherapy regimens (CTLA-4, anti-PD-1 and combination therapy; (n = 70; 63.1%), among which anti-PD-1 were the predominant treatment. Pembrolizumab was the most frequently prescribed drug (n = 30; 45.7%). Three hundred and seventy-one AEs were extracted. The incidence of AEs was lower in the anti-PD-1 mAc group (54 AEs per 1000 person.months) and the number of AEs/patient was also lower (3.1 ± 2.0). Grade 3 to 4 AEs occurred in 15.3% (n = 17) of the cohort, being more common in the targeted therapy group. Forty-two (11.6%) of the extracted AEs were not described in the Summary of Product Characteristics of the drugs under study. Conclusion This study suggests various known and unknown AEs of immunotherapy and targeted therapy may be identified using the Cancer Registry database. These events should be considered as signals worth further investigation for assessment of causality as the underreporting of AEs in cancer may have potential implications for the patient's quality of life.

The Safety of Hemophilia Product Use: a Simulation Analysis

Background:In hemophilia patients with inhibitors, the primary safety concern associated with the administration of bypassing agents, such arecombinant factor VIIa (rFVIIa)andFactor Eight Inhibitor Bypass Activity (FEIBA)to manage bleeding episodes is the risk ofthromboembolic events (TEs). Replacement FVIII may also increase TEs in patients with hemophilia without inhibitors, although the incidence of TE is extremely rare. The low incidence of hemophilia and low rate of TE associated with current therapies in these patients provide a significant challenge to study the comparative safety of novel non-factor therapies with the current standard of care.Aims: We aimed to estimate the sample size needed to adequately power a clinical trial that would detect a reduction in TEs in hemophilia patients exposed to a hypothetical investigational agent compared to current therapies for the management of bleeding episodes (FVIII replacement, FEIBA and rFVIIa).Methods: We conducted a simulated power analysis to quantify the number of infusions that would be needed in each treatment arm (investigational therapy vs. current therapy) to detect a reduction in the rate of TE in hemophilia patients across a range of effects. Based on published data, the rate of TE was 2 per 106 infusions of replacement FVIII. We assumed conservative rates of TE of 2 per 105 infusions of replacement FVIII to account for the potential imprecise rates estimated from the low number of events observed in prior studies. In the MedWatch database, the rate of TE was 8.24 per 105 infusions of FEIBA and 24.6 per 105 infusions of NOVOSEVEN. To account for the known underreporting of adverse events in this database, we assumed conservative estimates of and, 1.34 per 103 infusions of FEIBA and 3.12 per 103 infusions of NOVOSEVEN. We applied a two-sided Z test with pooled variance and targeted the significance level of the test at 0.05 and the power at 0.8.Results: The number of infusions needed to detect a significant reduction TE rate in patients exposed to the investigational agent compared to all 3 standard of care therapies across a range of potential effects are provided in the Table. Sample sizes of 735,821 infusions per treatment group (replacement FVIII vs. investigational agent) are needed to achieve 80% power to detect a 5 fold reduction in the rate of TE among hemophilia patients exposed to the investigational agent compared to replacement FVIII. Over 1 million infusions per treatment group would be needed to detect a 2 fold reduction in rate of TE comparing an investigational agent to replacement FVIII. Sample sizes of 35,108 infusions in each treatment group would be required to detect a 2-fold decrease in TE rates in patients exposed to the investigational agent compared to FEIBA. To detect a 2 fold reduction in rate of TE in patients receiving the investigational agent compared to rFVIIa, the study would require 15,058 infusions in each treatment group.Conclusions: Current therapies to manage bleeding episodes in patients with hemophilia have demonstrated a high degree of safety.Clinical trials of alternative non-factor therapies with mechanisms of action that differ from the standard of care will require extremely large samples sizes and/or large reduction in TE risk to demonstrate significantly greater safety with respect to TE. [Display omitted] DisclosuresChiuve:Shire: Employment. Gallo:Shire: Employment. Rowan:Baxalta: Consultancy. Valentino:Shire: Employment.

Do your patients with bipolar disorder use dietary supplements?

It is increasingly evident that physicians should routinely ask patients with bipolar disorder about the use of dietary supplements. In our recent study of 348 patients with bipolar disorder, about 3 out of 10 patients used dietary supplements in addition to prescribed drugs, with 2 in 10 of these taking supplements for the long term (Bauer et al. 2015). The patients tried about 40 different supplements, with fish oil, vitamin B preparations, multivitamins, and melatonin taken most frequently. Dietary supplements have the potential to interfere with the treatment of bipolar disorder due to patient misconceptions, and the safety and quality of some products. Patients may turn to dietary supplements to counteract side effects of prescribed drugs or because of a poor outcome. The majority of dietary supplements are self-selected, rather than recommended by a physician, and product choice is primarily influenced by friends, testimonials, aggressive marketing claims, price, and traditions (OIG 2012; New York State 2005). Many patients have misconceptions about dietary supplements, such as that “natural” is synonymous for safe, that supplements are safer than prescribed drugs, that megadoses are safe, and that the products and advertisements are pre-approved by the FDA. Dietary supplements may interact with prescription drugs or with other dietary supplements (Izzo and Ernst 2009). Most interactions with dietary supplements reported in the literature involve prescription drugs that affect the central nervous system or cardiovascular system (Tsai et al. 2012). Patients with bipolar disorder may also be at increased risk of interactions because they often take multiple prescription drugs. Another concern is that some dietary supplements may potentially cause psychiatric adverse reactions such as anxiety, panic attack, confusion, hallucinations, or mania (Ernst 2003). The FDA estimates that there is extensive underreporting of adverse events from dietary supplements (GAO 2013). Many quality problems have been reported for dietary supplements, including product contamination, ingredients not matching those listed on the label, and dosage strength inconsistencies. Between 2004 and 2012, of all FDA drug recalls due to risk of serious adverse consequences or death, over half were for dietary supplements (Harel et al. 2013). Analytical testing of the ingredients in many dietary supplements manufactured in the US found the strength varied widely from that listed on the label (Lockwood 2011). In 2015, an investigation by the New York State Attorney General’s office found that 80 % of store brand herbal dietary supplements at 4 large national chain stores did not contain the herbs listed on the label (O’Connor 2015). In addition, enforcement of current good manufacturing practices by the FDA is limited, with only 11 % of the dietary supplement manufacturing facilities inspected in fiscal year 2013 (Long 2014). The evidence suggests that physicians should assume that patients will not volunteer information on the use of supplements and that this may not be included in a patient's electronic medical record. To provide optimal treatment of bipolar disorder, physicians need to understand patient use of dietary supplements.

FDA MAUDE data on complications with lasers, light sources, and energy-based devices.

It is essential for physicians to be fully informed regarding adverse events and malfunctions associated with medical devices that occur in routine practice. There is limited information on this important issue in the medical literature, and it is mostly based on initial studies and case reports. More advanced knowledge regarding device adverse events is necessary to guide physicians towards providing safe treatments. The FDA requires that manufacturers and device users submit medical device reports (MDRs) for suspected injuries from device use or malfunction. The database of MDRs, entitled Manufacturer and User Facility Device Experience (MAUDE) enables the FDA to monitor device performance and identify potential safety issues. We employed the following search strategy to identify reported adverse events. We searched the MAUDE electronic database on the FDA website in December 2013: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm We collected all reported cases between 1991 and December 2013. The search terms utilized included a comprehensive list of device manufacturers, specific product names, and the wavelengths/technology of the devices used in the field of dermatology. Our search yielded 1257 MDRs. Forty-five MDRs were excluded due to insufficient data. The data is broken down into the adverse events observed, such as, but not limited to: blistering, burns, scarring, dyschromia, fat loss, and nerve palsy. The MDRs describe the adverse event and attempt to determine if it was related to device malfunction versus operator error. Radiofrequency devices, diode lasers, and intense pulsed light devices were the most commonly reported devices related to injuries. 1257 MDRs, from a myriad of devices used in dermatology, have been reported to the FDA as of December 2013. Despite the underreporting of adverse events, the MAUDE database is an untapped resource of post-market surveillance of medical devices. The database can offer additional information, which combined with the initial device studies and published case reports from our colleagues, will help raise awareness and improve patient safety.

Pharmacovigilance as a tool for safety and monitoring: a review of general issues and the specific challenges with end-stage renal failure patients.

Pharmacovigilance is instrumental in helping to ensure patient safety for both newly released drugs and those that are well established in the market. However, while pharmacovigilance procedures are strictly regulated in the clinical trial setting, post-marketing adverse event reporting is not well implemented or enforced. As such, the underreporting of adverse events, in relation to drugs that are on the market, is estimated to be in the region of 90%. The identification of drug safety issues in patients with complex diseases and extensive comorbidities is therefore particularly challenging. Dialysis patients – those with end-stage renal disease and often other comorbidities such as diabetes, hypertension, and cardiovascular disease – are a population with significant treatment challenges. Patients receive dialysis using complex medical devices (eg, a peritoneal dialysis home cycler) and also receive a range of pharmaceutical agents as part of dialysis itself (eg, peritoneal dialysis solutions). Many of the pharmaceutical agents used to treat these patients have been developed in populations without these complications and, therefore, an extensive knowledge of potential problems and contraindications in the dialysis population is lacking. It is important that the nephrology community understands the concept of pharmacovigilance – the pharmacologic science relating to the detection, assessment, understanding, and prevention of adverse effects, particularly long-term and short-term side effects, of medicines. Health care professionals (HCPs) and providers, pharmaceutical companies, global regulatory agencies, and the patients themselves all play unique and critical roles in this process. This review defines the science of pharmacovigilance and the process of adverse event reporting, highlights the new directions that pharmacovigilance has taken, and provides insight for HCPs managing dialysis patients into the important role that they play in helping to shape the understanding of a drug’s safety profile in order to continually enhance patient safety.

Publication Bias and Outcome Reporting Bias: Agomelatine as a Case Example

Publication bias and outcome reporting bias contribute to distorted perceptions of drug efficacy and the underreporting of adverse events. To demonstrate these biases, this article describes how the clinical profile of the antidepressant agent agomelatine (Valdoxan(®)) has been presented in the literature. Agomelatine has been systematically assessed in 10 short-term placebo-controlled studies and three long-term placebo-controlled relapse prevention studies. Five published trials demonstrated clinically modest but statistically significant benefits over placebo. Five unpublished trials did not find agomelatine more effective than placebo, but in two of these studies the active comparison drug (fluoxetine [Prozac(®)] or paroxetine [Paxil(®)]) was more effective than placebo. Agomelatine was more effective than placebo in one of three relapse prevention studies, but only the positive study was published. Based on what is evident in the entire published and unpublished dataset, agomelatine does not have a tremendously superior sleep and sexual effects profile. The risk of liver toxicity is also not prominently highlighted in the published literature.

What You See Depends on Where You’re Looking and How You Look at It: Publication Bias and Outcome Reporting Bias

Study publication bias is the decision to publish or not publish a study based on its results. Compared to unpublished work, published studies are more likely to have positive or statistically significant findings. Outcome reporting bias is opting to publish only a subset of the original variables recorded for a study, such that the inclusion of the variables in the published work is selectively based on the results. Statistically significant results have a higher likelihood of being fully reported compared to nonsignificant results, and a significant proportion of published articles describe outcome variables or data analyses that differ from the pre-specified trial protocol as originally conceived. Recognition that publication bias and outcome reporting bias contribute to a distorted perception of drug effects-inflated estimates of efficacy and underreporting of adverse events-has led to the development and expansion of publicly accessible databases that contain transparent information about clinical trials and their results.

A review of the Office of Inspector General's reports on adverse event identification and reporting

The Office of Inspector General published a series of four reports from 2008 to 2010 after investigating the frequency and financial impact of "never events" on Medicare recipients. This series investigated healthcare's ability to identify the occurrence of these events and yielded a detailed analysis of data that must, or at least should, be reviewed to fully understand the clinical risks affecting organizations. These reports also shed light on the reality that there remains gross underreporting of adverse events in healthcare and begs several questions about healthcare's current efforts to fully identify and understand risk. This article summarizes the reports and considers their risk management implications, particularly regarding adverse events.

Improving the Reporting of Adverse Drug Reactions in the Hospital Setting

The US Food and Drug Administration (FDA) is perceived by the public as having a substantial responsibility to ensure drug safety; however, the FDA has limited resources for active surveillance and relies on voluntary reporting of adverse events and potential adverse drug reactions. Studies have shown that underreporting of adverse events and adverse drug reactions is widespread. Furthermore, a review of several studies demonstrates that most adverse drug reactions are reported by pharmacists and nurses, with physicians reporting the fewest. The hospital setting, with its clearly defined patient population observed around the clock, is an ideal setting in which to identify potential adverse drug reaction signals and to report them to either the drug manufacturer or the FDA. In this article we describe the present system for addressing adverse events, obstacles to reporting them, and the important role any hospital physician could play in reporting adverse events and potential adverse drug reactions.

Allergic reactions to Japanese encephalitis vaccine.

Allergic reactions to Japanese encephalitis vaccine.