Semple, Susan J; Roughead, Elizabeth E
Background This paper presents Part 2 of a literature review examining medication safety in the Australian acute care setting. This review was undertaken for the Australian Commission on Safety and Quality in Health Care, updating the 2002 national report on medication safety. Part 2 of the review examined the Australian evidence base for approaches to build safer medication systems in acute care. Methods A literature search was conducted to identify Australian studies and programs published from 2002 to 2008 which examined strategies and activities for improving medication safety in acute care. Results and conclusion Since 2002 there has been significant progress in strategies to improve prescription writing in hospitals with the introduction of a National Inpatient Medication Chart. There are also systems in place to ensure a nationally coordinated approach to the ongoing optimisation of the chart. Progress has been made with Australian research examining the implementation of computerised prescribing systems with clinical decision support. These studies have highlighted barriers and facilitators to the introduction of such systems that can inform wider implementation. However, Australian studies assessing outcomes of this strategy on medication incidents or patient outcomes are still lacking. In studies assessing education for reducing medication errors, academic detailing has been demonstrated to reduce errors in prescriptions for Schedule 8 medicines and a program was shown to be effective in reducing error prone prescribing abbreviations. Published studies continue to support the role of clinical pharmacist services in improving medication safety. Studies on strategies to improve communication between different care settings, such as liaison pharmacist services, have focussed on implementation issues now that funding is available for community-based services. Double checking versus single-checking by nurses and patient self-administration in hospital has been
Keohane, Carol A; Bates, David W
Patient safety is a state of mind, not a technology. The technologies used in the medical setting represent tools that must be properly designed, used well, and assessed on an on-going basis. Moreover, in all settings, building a culture of safety is pivotal for improving safety, and many nontechnologic approaches, such as medication reconciliation and teaching patients about their medications, are also essential. This article addresses the topic of medication safety and examines specific strategies being used to decrease the incidence of medication errors across various clinical settings.
... More Medical Device Recalls Recent Medical Device Safety Communications FDA analyses and recommendations for patients and health ... about ongoing medical device safety issues. FDA Safety Communication Date FDA Warns Of Potentially Contaminated SPS-1 ...
Medication error and adverse drug reactions occur frequently, leading to a high burden of patient harm in the hospital setting. Many Irish hospitals have established medication safety initiatives, designed to encourage reporting and learning to improve medication use processes and therefore patient safety. Eight Irish hospitals or hospital networks provided data from voluntary medication safety incident and near miss reporting programmes for pooled analysis of events occurring between 1st January 2006 and 30th June 2007. 6179 reports were received in total (mean 772 per hospital; range 96-1855). 95% of reports did not involve patient harm. Forty seven percent of reports related to the prescribing stage of the medication use process, 40% to the administration stage and 9% to the pharmacy dispensing stage. This data is published to increase awareness of this key patient safety issue, to share learning from these incidents and near misses and to encourage a more open patient safety culture.
Sleinitz, Annett; Heyde, Christian; Kloft, Charlotte
Drug therapy is one of the most common therapeutic interventions in the medical care of in-patients. It is a complex risk-associated procedure, which is why risk prevention is of top priority in medication safety. Medical care in hospitals is organised via various forms of distribution, e.g. the traditional distribution on the ward or as computerised unit dose drug dispensing system. In order to improve medication safety, the computerised unit dose drug dispensing system was introduced in the Ruppiner Kliniken in 2009. The implementation of the system to the clinic was scientifically evaluated within the scope of a diploma thesis which focused on the examination and analysis of medication safety and its evolvement. Amongst others, medication errors were detected and classified (via DokuPIK). The thesis showed that the implementation of the computerised unit dose system had a positive impact on the reduction of consequences of common and clinically relevant medication errors, thereby enhancing medication safety for the patient.
The use of robots in medicine is increasing, leading to the call for specific safety standards. This is a challenging endeavor, however, because the patient must usually be placed in the robot's workspace and the medical staff must frequently interact with the robot. Although specific safety standards for medical robots do not yet exist, there are several medical device standards and well-established principles of risk analysis and safety design that can and should be applied. This paper presents a tutorial overview of safety design for medical robots, starting with a discussion of high-level safety requirements, followed by methods for risk assessment (or hazard analysis) and a brief discussion of some sample safety strategies.
Five-rights - medication; Medication administration - hospital; Medical errors - medication; Patient safety - medication safety ... right dose, at the right times. During your hospital stay, your health care team needs to follow ...
A medical device is any product used to diagnose, cure, or treat a condition, or to prevent disease. They range ... may need one in a hospital. To use medical devices safely Know how your device works. Keep instructions ...
... feet fires, injuries and deaths. from a heat source, open flames or electrical devices. KKK Body oil, hand ... near the oxygen. Post No Smoking and No Open Flames signs in and outside the home to remind people not to smoke. Your Source for SAFETY Information NFPA Public Education Division • 1 ...
Verster, Joris C.; Mets, Monique A.J.
Driving a car is important to maintain independence and participate in society. Many of those who use psychoactive medication are outpatients and are thus likely to drive a vehicle. Most common adverse effects that impair driving are reduced alertness, affected psychomotor functioning and impaired vision. This review discusses the effects on driving ability of most commonly prescribed psychoactive drugs, including hypnotics, antidepressants, antihistamines, analgesics and stimulant drugs. Within these categories of medicines significant differences concerning their impact on driving ability are evident. The International Council on Alcohol, Drugs and Traffic Safety (ICADTS) categorization can help physicians to make a choice between treatments when patients want to drive a car. PMID:19440432
Kriewall, Timothy J
How safe is safe? The design intent of a medical device is to off er maximum flexibility, and low-cost and fail-safe features. Easily said, these requirements are difficult to deliver in a litigious society where performance standards are uncommon. Medical device manufacturers face challenges as they strive to offer the ultimate in product safety and keep the price affordable for the technology deployed, while making the usability of typically complex products common sense for the operator. As microprocessors are able to assist designers in providing intelligent, multifunctional systems, care must be taken during the design process to balance technological ability with intuitive use. The medical device development process requires rigor that is not often taught to biomedical engineers. Ethical product development requires a process that will be described in this paper using as an example the development of a recent cardiopulmonary perfusion system. However, the same techniques are germane to implantable devices such as cochlear implants. All engineering product development requires trade-off decisions considering how much is too much and how much is too little. Biomedical engineering faculty need to present this ethical dilemma to their students and give them the tools to help decide. However, in the final analysis, the operator of any medical product or installer of any medical device holds the primary responsibility for understanding how to use the system or install the implant in normal use as well as emergent or special situations; the technology is his or her backup in performing the medical professionals primary job.
... For Consumers Home For Consumers Consumer Updates 4 Medication Safety Tips for Older Adults Share Tweet Linkedin ... t select a dose yourself. 2. Keep a Medication List Write down what you’re taking and ...
LeBlanc, Raeanne Genevieve; Choi, Jeungok
Medication safety among community-dwelling older adults in the United States is an ongoing health issue impacting health outcomes, chronic disease management, and aging in place at home. This article describes a medication safety improvement project that aimed to: (1) Increase the ability of participants to manage medications, (2) Identify and make necessary medication changes, (3) Create an accurate up-to-date medication list to be available in the home, and (4) Provide communication between the primary care provider, participant, and case manager. An in-home medication assessment was completed for 25 participants using an evidence-based medication management software system. This process was used to review medications; identify medication-related problems; create a shared medication list; and convey this information to the primary care provider, case manager, and client while addressing needed medication changes. Educational interventions on management and understanding of medications were provided to participants to emphasize the correct use of medications and use of a personal medication record. Outcome improvements included provision of an accurate medication list, early identification of medication-related problems, identification of drug duplication, and identification of medication self-management challenges that can be useful for optimizing medication safety-related home healthcare and inform future interventions.
Durand, Lizette Olga; Cheng, Po-Yung; Palekar, Rakhee; Clara, Wilfrido; Jara, Jorge; Cerpa, Mauricio; El Omeiri, Nathalie; Ropero-Alvarez, Alba Maria; Ramirez, Juliana Barbosa; Araya, Jenny Lara; Acosta, Belsy; Bruno, Alfredo; Calderon de Lozano, Celina; Castillo Signor, Leticia Del Carmen; Matute, Maria Luisa; Jackson-Betty, Sandra; Mung, Kam Suan; Díaz-Quiñonez, José Alberto; López-Martinez, Irma; Balmaseda, Angel; Arévalo, Brechla Morneo; Vazquez, Cynthia; Gutierrez, Victoria; Garten, Rebecca; Widdowson, Marc-Alain; Azziz-Baumgartner, Eduardo
Influenza-associated illness results in increased morbidity and mortality in the Americas. These effects can be mitigated with an appropriately chosen and timed influenza vaccination campaign. To provide guidance in choosing the most suitable vaccine formulation and timing of administration, it is necessary to understand the timing of influenza seasonal epidemics. Our main objective was to determine whether influenza occurs in seasonal patterns in the American tropics and when these patterns occurred. Publicly available, monthly seasonal influenza data from the Pan American Health Organization and WHO, from countries in the American tropics, were obtained during 2002-2008 and 2011-2014 (excluding unseasonal pandemic activity during 2009-2010). For each country, we calculated the monthly proportion of samples that tested positive for influenza. We applied the monthly proportion data to a logistic regression model for each country. We analyzed 2002-2008 and 2011-2014 influenza surveillance data from the American tropics and identified 13 (81%) of 16 countries with influenza epidemics that, on average, started during May and lasted 4 months. The majority of countries in the American tropics have seasonal epidemics that start in May. Officials in these countries should consider the impact of vaccinating persons during April with the Southern Hemisphere formulation. © 2015 The Authors. Influenza and Other Respiratory Viruses Published by John Wiley & Sons Ltd.
Pradhan, A; Tincello, D G; Kearney, R
To report the numbers of patients having childbirth after pelvic floor surgery in England. Retrospective analysis of Hospital Episode Statistics data. Hospital Episode Statistics database. Women, aged 20-44 years, undergoing childbirth after pelvic floor surgery between the years 2002 and 2008. Analysis of the Hospital Episode Statistics database using Office of Population, Censuses and Surveys: Classification of Interventions and Procedures, 4th Revision (OPCS-4) code at the four-character level for pelvic floor surgery and delivery, in women aged 20-44 years, between the years 2002 and 2008. Numbers of women having delivery episodes after previous pelvic floor surgery, and numbers having further pelvic floor surgery after delivery. Six hundred and three women had a delivery episode after previous pelvic floor surgery in the time period 2002-2008. In this group of 603 women, 42 had a further pelvic floor surgery episode following delivery in the same time period. The incidence of repeat surgery episode following delivery was higher in the group delivered vaginally than in those delivered by caesarean (13.6 versus 4.4%; odds ratio, 3.38; 95% confidence interval, 1.87-6.10). There were 603 women having childbirth after pelvic floor surgery in the time period 2002-2008. The incidence of further pelvic floor surgery after childbirth was lower after caesarean delivery than after vaginal delivery, and this may indicate a protective effect of abdominal delivery. © 2012 The Authors BJOG An International Journal of Obstetrics and Gynaecology © 2012 RCOG.
Medical safety has been one of the most important issues addressed by the Japan Surgical Society (JSS), and the topic has been discussed at every annual meeting of the JSS since 2004. In 2008, the Medical Safety Committee was established under the JSS. The JSS is one of the principal founding members of the Japan Council for Quality Health Care (JCQHR) and has placed many members on evaluation committees for a majority of malpractice cases. In cooperation with the Japanese Society of Internal Medicine and JCQHR, the JSS is trying to lead the Japanese medical community to create an official third-party organization for medical safety.
Brémond, Philippe; Roca, Yelin; Brenière, Simone Frédérique; Walter, Annie; Barja-Simon, Zaira; Fernández, Roberto Torres; Vargas, Jorge
In the context of a rapid increase of dengue cases in the Americas, a monitoring system based on systematic serological control (IgM) of patients consulting for suspected dengue was developed in Bolivia at the end of the 1990s. In the most affected city of Santa Cruz, this system was complemented by an entomological surveillance program based on periodical search for immature stages of Aedes aegypti in dwelling water-holding containers. Here, we analyze these data and describe dengue patterns over 6 years (2002-2008), highlighting the spatial distribution of patients and vectors. Data mining concerned six annual epidemic cycles (2002-2008), with continuous serological and clinical results and entomological data from 16 surveys, examined at the scales of 36 urban areas and four concentric areas covering the entire city. Annual incidence varied from 0.28‰ to 0.95‰; overall incidence was higher in women and adults, and dengue dynamics followed successive periods of high (January-June) and low (July-December) transmission. Lower numbers of cases from the city center to the periphery were observed, poorly related to the more homogeneous and permanent distribution of A. aegypti. "Plant pots" were a major vector source in the city center, and "Tires" and "Odds and ends" beyond the second ring of the city. Over the years, the increasing trend of dengue cases has been highlighted as well as its widespread distribution over the entire city, but an underestimation of the number of cases is strongly suspected. Contrary to popular belief, the city center appears more affected than the periphery, and dengue is not particularly related to waste. Interestingly, the clinical diagnosis of dengue by physicians improved over the years, whatever the gender, age and residential area of suspected cases.
Patterson, P. Daniel; Anderson, Michelle S.; Zionts, Nancy D.; Paris, Paul M.
The overarching mission of prehospital Emergency Medical Services (EMS) is to deliver life-saving care for people when their needs are greatest. Fulfilling this mission is challenged by threats to patient and provider safety. The EMS setting is high-risk because care is delivered rapidly in the out-of-hospital setting where patient-benefiting resources are limited. There is growing evidence that safety culture varies widely across EMS agencies. A poor safety culture may manifest as error in medication, back injuries, and other poor outcomes for patient and provider. Recently, federal and national leaders of EMS (i.e., the National Highway Traffic Safety Administration) have made improving EMS safety culture a national priority. Unfortunately, there are few initiatives that can help local EMS leaders achieve that priority. We describe the successful EMS Champs Fellowship program supported by the Jewish Healthcare Foundation (JHF) designed to train EMS leaders to improve safety for patients and providers. PMID:23150883
According to the background of the age of big data, the medical devices are informatized, we analyze the safety and efficiency for the information and data of digital medical devices or medical systems, also discussed some test methods. Lack of a suitable standard system of digital medical devices is a big problem both for domain standard and international standard. GB25000.51 is too ambiguous and free for testing, also not very operational. So this paper suggested some test advices and some prospective method. These test methods are helpful for finding the problem and performing the standards. What's more, these methods are famous in the world and used widely in the 3C region but just start in the medical region, which can promote the development of the medical devices.
Fontanella, Cynthia A; Warner, Lynn A; Phillips, Gary S; Bridge, Jeffrey A; Campo, John V
This study examined polypharmacy patterns and rates over time among Medicaid-enrolled youths by comparing three enrollment groups (youths in foster care, with a disability, or from a family with low income). Serial cross-sectional trend analyses of Medicaid claims data were conducted for youths age 17 and younger who were continuously enrolled in Ohio Medicaid for a one-year period and prescribed one or more psychotropic medications during fiscal years 2002 (N=26,252) through 2008 (N=50,311). Outcome measures were any polypharmacy (three or more psychotropic medications from any drug class) and multiclass polypharmacy (three or more psychotropic medications from different drug classes). Both types of polypharmacy increased across all three eligibility groups. Any polypharmacy increased from 8.8% to 11.5% for low-income youths (adjusted odds ratio [AOR]=1.12, 99% confidence interval [CI]=1.10-1.13), from 18.0% to 24.9% for youths with a disability (AOR=1.11, CI=1.09-1.13), and from 19.8% to 27.3% for youths in foster care (AOR=1.09, CI=1.07-1.11). Combinations associated with positive increases were two or more antipsychotics, two or more stimulants, and antipsychotics with stimulants. Polypharmacy increased across all enrollment groups, with the highest absolute rates for youths in foster care. Both the overall prevalence and increases in prescriptions for drug combinations with limited evidence of safety and efficacy, such as the prescription of two or more antipsychotics, underscore the need for targeted quality improvement efforts. System oversight and monitoring of psychotropic medication use appears to be warranted, especially for higher-risk groups, such as youths in foster care and those from low-income households who were prescribed multiple antipsychotics.
Most applications of lasers in medicine are based on the producing of a controlled thermal damage into a preferably tissue location. Laser safety deals with non controlled damage (thermal or other) that could be randomly produced into a non preferable tissue locations. This kind of damage is not allowed and the laser safety material is designed to provide the user with a knowledge and with sufficient safety instructions and means to prevent such damage. Following the laser safety instructions is especially important for the medical applications because in these applications the laser beam is brought in a close proximity to the patient's body and non-desired damage can be easily produced. Most medical lasers are classified as Class 4 laser products, the highest hazard class. Direct laser beam of class 4 is capable to produce skin burns and to ignite flammable materials, and even its scattered beam may produce severe eye damage. The paper presents the nature of the skin and eye damage for different spectral range, and the state of the art rules in preventing such damage. The safety means that should be implemented in, and around, the laser clinique and in the laser surgery room will also be highlighted.
Resić, Halima; Mešić, Enisa
Renal Registry (RR) of Bosnia and Herzegovina was established in 2002, with aim to follow up the trends of Renal Replacement Therapy in Bosnia and Herzegovina. The prevalence of Renal Replacement Therapy (RRT) in Bosnia and Herzegovina is rising steadily. One reason for this is an increasing number of patients starting RRT. The aim is to present the epidemiology and treatment of all aspects of RRT in Bosnia and Herzegovina in period 2002-2008. Centre-related and patient-related questionnaires were sent to all 25 dialysis centres in Bosnia and Herzegovina. The demographic data, prevalence and incidence, type of renal replacement therapy, cause of ESRD, erythropoietin administration, cause of death, and type of vascular access were obtained from the questionnaires. Collected data were analysed using SPSS statistics. The number of patients treated by Renal Replacement Therapy (RRT) increased steadily from 1,531 patients in 2002 to the 2,206 at the 2008 (43%). The prevalence has increased from 399 pmp in 2002 to 696 pmp. in 2008. Incidence (new patients) in 2002 was 110 pmp and incidence rate in 2008 was 163, and there were 249 new patients (day 1). The mean age for new patients increased from 60 years in 2002 to 63.5 years in 2008 and the population over 75 years rate from 8.79% to 11.3%. Most ESRD patients in Bosnia and Herzegovina are undergoing intermittent hemodialysis (92%), while some patients (8%) are treated by peritoneal dialysis and transplantation. The most significant cause of ESRD in 2008 was chronic glomerulonephritis (421 patients, 19.2%), followed by pyelonephritis (414 patients, 18.9%), BEN (14.7%) and Diabetes mellitus (12.2%). Hepatitis B and C virus infections had 397 (16.3%) patients, out of them 22 had both type of infections and 98 patients had B type infection. Only 10.5% of patients were tested on MRSA and 3 patients were positive on MRSA. There were no HIV-positive patients on RRT. The most common type of vascular access was AV fistula in 85
Yip, Luke; Farmer, Brenna
High reliability organizations (HROs), such as the aviation industry, successfully engage in high-risk endeavors and have low incidence of adverse events. HROs have a preoccupation with failure and errors. They analyze each event to effect system wide change in an attempt to mitigate the occurrence of similar errors. The healthcare industry can adapt HRO practices, specifically with regard to teamwork and communication. Crew resource management concepts can be adapted to healthcare with the use of certain tools such as checklists and the sterile cockpit to reduce medication errors. HROs also use The Swiss Cheese Model to evaluate risk and look for vulnerabilities in multiple protective barriers, instead of focusing on one failure. This model can be used in medication safety to evaluate medication management in addition to using the teamwork and communication tools of HROs.
Patel, Viral M; Schwartz, Robert A; Lambert, W Clark
Dermatologic drugs should be employed with caution in women of childbearing age who are pregnant or considering pregnancy. Topical drugs have little systemic absorption. Therefore, they are deemed safer than oral or parenteral agents and less likely to harm the fetus. However, their safety profile must be assessed cautiously, as there is limited available data. In this article, we aggregate human and animal studies and provide recommendations on using topical dermatologic medications in pregnancy.
J Drugs Dermatol. 2016;15(7):830-834.
Dickson, Geri L; Flynn, Linda
In this article, we describe the depth of knowledge and skill nurses used in making decisions regarding the safe processes and practices of medication administration. Using grounded theory, we identified the essence of medication safety by nurses as the theme of clinical reasoning. Nurses used two medication safety processes within the clinical reasoning theme-maintaining medication safety and managing the environment-together with six categories of patient-focused medication safety practices in the first process and four categories of environmental-focused safety practices within the second process. These processes and practices present an emerging model of safe medication administration developed from the narratives of 50 medical-surgical nurses. This model provides researchers with the basis for the development of systemic policies for safer medication administration for patients. Health care professional educators might also find the results useful in developing curricula focused on patient safety as the foundation of quality care.
Sammet, Steffen; Sammet, Christina L.
This article proposes the design of an educational MR safety module using an available comprehensive multiple-choice exam for instructing medical students about basic MR and patient related safety. The MR safety course material can be implemented as a traditional didactic or interactive lecture in combination with hands-on safety demonstrations. The goal of the course is to ensure that medical students receive a basic understanding of MR principles and safety considerations. This course should prepare medical students for consideration of patient screening and safety when ordering MR studies. A multiple-choice exam can be used to document the proficiency in MR safety of the medical students. The course can be used by various medical school programs and may help to ensure consistent quality of teaching materials and MR safety standards. PMID:26172156
Saha, A. K.; Price, R. M.; Fitz, H.; Engel, V.
A monthly and annual water budget has been created for Shark River Slough (SRS) within the Everglades National Park (ENP) over 2002-2008. Inputs considered are surface water inflows via water delivery structures (S12s and S333) and precipitation, while outputs consist of evapotranspiration, discharge to the Gulf of Mexico (Lostman, Shark, Broad, Harney and North rivers) and seepage losses from the eastern part of the slough under levee L31. Using a mass balance approach, monthly change in volume of SRS (from water level changes) is equated to the sum of inputs, outputs and a residual term, that includes error in each of the inputs and outputs as well as net groundwater exchange. Results for 2002-2008 indicate that precipitation is the largest input to the SRS, while ET is the largest output, with ET being equal to or greater than precipitation. A net groundwater discharge to freshwater flow is predicted that is also lag correlated with surface water salinity by 1 month, thereby supporting earlier hydrological and geochemical findings of coastal groundwater discharge in the mangrove zone. The small quantity of inflows relative to precipitation and ET highlights the necessity of gradually increasing surface water inflows to restore ecosystem processes in terrestrial, freshwater and marine portions of the ENP. Water flow measurement data and the Ecological Landscape Model (ELM) is used in conjunction with Phosphorus concentration data to calculate phosphorus residence times in different parts of SRS that has been found to vary seasonally.
National Highway Traffic Safety Administration (DOT), Washington, DC.
Volume 11 of the 19-volume Highway Safety Program Manual (which provides guidance to State and local governments on preferred highway safety practices) concentrates on emergency medical services. The purpose of the program, Federal authority in the area of medical services, and policies related to an emergency medical services (EMS) program are…
Liao, Joshua M; Etchegaray, Jason M; Williams, S Tyler; Berger, David H; Bell, Sigall K; Thomas, Eric J
To develop and test the psychometric properties of a survey to measure students' perceptions about patient safety as observed on clinical rotations. In 2012, the authors surveyed 367 graduating fourth-year medical students at three U.S. MD-granting medical schools. They assessed the survey's reliability and construct and concurrent validity. They examined correlations between students' perceptions of organizational cultural factors, organizational patient safety measures, and students' intended safety behaviors. They also calculated percent positive scores for cultural factors. Two hundred twenty-eight students (62%) responded. Analyses identified five cultural factors (teamwork culture, safety culture, error disclosure culture, experiences with professionalism, and comfort expressing professional concerns) that had construct validity, concurrent validity, and good reliability (Cronbach alphas > 0.70). Across schools, percent positive scores for safety culture ranged from 28% (95% confidence interval [CI], 13%-43%) to 64% (30%-98%), while those for teamwork culture ranged from 47% (32%-62%) to 74% (66%-81%). They were low for error disclosure culture (range: 10% [0%-20%] to 27% [20%-35%]), experiences with professionalism (range: 7% [0%-15%] to 23% [16%-30%]), and comfort expressing professional concerns (range: 17% [5%-29%] to 38% [8%-69%]). Each cultural factor correlated positively with perceptions of overall patient safety as observed in clinical rotations (r = 0.37-0.69, P < .05) and at least one safety behavioral intent item. This study provided initial evidence for the survey's reliability and validity and illustrated its applicability for determining whether students' clinical experiences exemplify positive patient safety environments.
Beyea, Suzanne C
Registered nurses in perioperative settings and managers of perioperative departments must work together to implement policies and procedures to ensure compliance with these very important federal regulations. If the information is not recorded in the proper manner and shared with the manufacturer, patients' safety is at risk. Without the ability to contact physicians and patients, manufacturers cannot alert individuals appropriately if problems arise with a certain device. Tracking devices in the correct manner ensures that patients can be notified expediently. Nurses and managers should examine their current practices to ensure that they are consistent with federal regulations. A regular assessment should be conducted to ensure that tracking forms are completed in an accurate, timely manner, that permission to release a patient's social security number is obtained, and that the hospital is compliant with the FDA's most up-to-date list of devices that must be tracked. All perioperative staff members must receive education about the tracking process in their particular institution and receive updates when the process or FDA regulations change. Maintain patient safety by ensuring that the medical device tracking process is followed accurately and meets federal regulations.
Li, Gang; Tao, Hong-Bing; Liao, Jia-Zhi; Tang, Jin-Hui; Peng, Fang; Shu, Qin; Li, Wen-Gang; Tu, Shun-Gui; Chen, Zhuo
Patient safety education is conducive to medical students' cognition on patient safety and to improvement of medical quality and safety. Developing patient safety education for medical students is more and more widely recognized by World Health Organization and countries all over the world. However, in China, patient safety courses aiming at medical students are relatively few, and there are few reports about the effect of patient safety courses. This paper explored the influence of patient safety curriculum on medical students' attitude to and knowledge of patient safety. The patient safety curriculum was carried out for 2011-grade undergraduates of Tongji Medical College, Huazhong University of Science and Technology. The students participated in the class according to free choice. After the curriculum, the information of gender, major, attended course, attitude toward patient safety, and knowledge of laws and regulations of the 2011-grade undergraduates were collected. After rejecting invalid questionnaires, the number of undergraduates that participated in the survey was 112 (61 students did not take part in the curriculum; 51 took part in). Chi-square test was applied to analyze patient safety education's influence on medical students' attitude to patient safety and their knowledge mastery situation. The influence of patient safety education on the attitude of medical students to patient safety was not significant, but that on their knowledge of patient safety was remarkable. No matter male or female, as compared with medical students who had not accepted patient safety education, they both had a better acquisition of knowledge after having this education (for male students: 95% CI, 4.556-106.238, P<0.001; for female students: 95% CI, 3.183-33.238, P<0.001). Students majoring in Western Medicine had a relatively better mastery of knowledge of patient safety after receiving patient safety education (95% CI, 6.267-76.271, P<0.001). Short-term patient safety
Bush, Peggy A; Hueckel, Rémi M; Robinson, Dana; Seelinger, Terry A; Molloy, Margory A
Safety education in nursing has traditionally focused at the level of individual nurse-patient interactions. Students and novice clinicians lack clinical experience to create context and understand the complexity of the health care system and safety science. Using the Quality and Safety Education for Nurses quality and safety competency as a framework, the objective of this education project was to design comprehensive, engaging, learner-centered, online modules that increase knowledge, skills, and attitudes about medication safety.
Veeranki, Sreenivas P; Zheng, Shimin
Screening rates for colorectal cancer (CRC) are increasing nationwide including Tennessee (TN); however, their up-to-date status is unknown. The objective of this study is to determine the trends and characteristics of TN adults who are up-to-date status with CRC screening during 2002-2008. We examined data from the TN Behavioral Risk Factor Surveillance System for 2002, 2004, 2006 and 2008 to estimate the proportion of respondents aged 50 years and above who were up-to-date status with CRC screening, defined as an annual home fecal occult blood test and/or sigmoidoscopy or colonoscopy in the past 5 years. We identified trends in up-to-status in all eligible respondents. Using multivariable logistic regression models, we delineated key characteristics of respondents who were up-to-date status. During 2002-2008, the proportion of respondents with up-to-date status for CRC screening increased from 49% in 2002- 55% in 2006 and then decreased to 46% in 2008. The screening rates were higher among adults aged 65-74 years, those with some college education, those with annual household income ≥$35,000 and those with health-care access. In 2008, the respondents who were not up-to-date status with CRC screening included those with no health-care coverage (adjusted odds ratio [OR] 0.46, 95% confidence interval [CI] 0.33-0.63), those aged 50-54 years (OR 0.62, 95% CI 0.46-0.82) and those with annual household income <$25,000 (OR 0.65, 95% CI 0.52-0.82). TN adults who are up-to-date status with CRC screening are increasing, but not across all socio-demographic subgroups. The results identified specific subgroups to be targeted by screening programs, along with continued efforts to educate public and providers about the importance of CRC screening.
Veeranki, Sreenivas P; Zheng, Shimin
Background: Screening rates for colorectal cancer (CRC) are increasing nationwide including Tennessee (TN); however, their up-to-date status is unknown. The objective of this study is to determine the trends and characteristics of TN adults who are up-to-date status with CRC screening during 2002-2008. Methods: We examined data from the TN Behavioral Risk Factor Surveillance System for 2002, 2004, 2006 and 2008 to estimate the proportion of respondents aged 50 years and above who were up-to-date status with CRC screening, defined as an annual home fecal occult blood test and/or sigmoidoscopy or colonoscopy in the past 5 years. We identified trends in up-to-status in all eligible respondents. Using multivariable logistic regression models, we delineated key characteristics of respondents who were up-to-date status. Results: During 2002-2008, the proportion of respondents with up-to-date status for CRC screening increased from 49% in 2002- 55% in 2006 and then decreased to 46% in 2008. The screening rates were higher among adults aged 65-74 years, those with some college education, those with annual household income ≥$35,000 and those with health-care access. In 2008, the respondents who were not up-to-date status with CRC screening included those with no health-care coverage (adjusted odds ratio [OR] 0.46, 95% confidence interval [CI] 0.33-0.63), those aged 50-54 years (OR 0.62, 95% CI 0.46-0.82) and those with annual household income <$25,000 (OR 0.65, 95% CI 0.52-0.82). Conclusions: TN adults who are up-to-date status with CRC screening are increasing, but not across all socio-demographic subgroups. The results identified specific subgroups to be targeted by screening programs, along with continued efforts to educate public and providers about the importance of CRC screening. PMID:25104998
Wholey, Douglas; Moscovice, Ira; Hietpas, Terry; Holtzman, Jeremy
The environmental context of patient safety and medical errors was explored with specific interest in rural settings. Special attention was paid to unique features of rural health care organizations and their environment that relate to the patient safety issue and medical errors (including the distribution of patients, types of adverse events…
Wholey, Douglas; Moscovice, Ira; Hietpas, Terry; Holtzman, Jeremy
The environmental context of patient safety and medical errors was explored with specific interest in rural settings. Special attention was paid to unique features of rural health care organizations and their environment that relate to the patient safety issue and medical errors (including the distribution of patients, types of adverse events…
Reiner, Bruce I
Medical analytics relating to quality and safety measures have become particularly timely and of high importance in contemporary medical practice. In medical imaging, the dynamic relationship between medical imaging quality and radiation safety creates challenges in quantifying quality or safety independently. By creating a standardized measurement which simultaneously accounts for quality and safety measures (i.e., quality safety index), one can in theory create a standardized method for combined quality and safety analysis, which in turn can be analyzed in the context of individual patient, exam, and clinical profiles. The derived index measures can be entered into a centralized database, which in turn can be used for comparative performance of individual and institutional service providers. In addition, data analytics can be used to create customizable educational resources for providers and patients, clinical decision support tools, technology performance analysis, and clinical/economic outcomes research.
Nabilou, Bahram; Feizi, Aram; Seyedin, Hesam
Patient safety is a new and challenging discipline in the Iranian health care industry. Among the challenges for patient safety improvement, education of medical and paramedical students is intimidating. The present study was designed to assess students’ perceptions of patient safety, and their knowledge and attitudes to patient safety education. This cross-sectional analytical study was conducted in 2012 at Urmia University of Medical Sciences, West Azerbaijan province, Iran. 134 students studying medicine, nursing, and midwifery were recruited through census for the study. A questionnaire was used for collecting data, which were then analyzed through SPSS statistical software (version 16.0), using Chi-square test, Spearman correlation coefficient, F and LSD tests. A total of 121 questionnaires were completed, and 50% of the students demonstrated good knowledge about patient safety. The relationships between students’ attitudes to patient safety and years of study, sex and course were significant (0.003, 0.001 and 0.017, respectively). F and LSD tests indicated that regarding the difference between the mean scores of perceptions of patient safety and attitudes to patient safety education, there was a significant difference among medical and nursing/midwifery students. Little knowledge of students regarding patient safety indicates the inefficiency of informal education to fill the gap; therefore, it is recommended to consider patient safety in the curriculums of all medical and paramedical sciences and formulate better policies for patient safety. PMID:26322897
Kaul, Sonam Devgan; Awasthi, Amit K
Medication errors can cause substantial harm to patients. Automated patient medication system with RFID technology is purposely used to reduce the medication error, to improve the patient safety, to provide personalized patient medication and identification and also to provide counterfeit protection to the patients. In order to enhance medication safety for patients we propose a new dynamic ID based lightweight RFID authentication protocol. Due to low storage capacity and limited computational and communicational capacity of tags, only pseudo random number generator function, one way hash function and bitwise Xor operation are used in our authentication protocol. The proposed protocol is practical, secure and efficient for health care domain.
Background Air ambulance service in Norway has been upgraded during the last years. European regulations concerning pilots' working time and new treatment guidelines/strategies have called for more resources. Aims The objective was to describe and analyse the two supplementary air ambulance [fixed wing (FW) and rotor wing (RW)] alternatives' activity during the study period (2002-2008). Furthermore we aimed to compare our findings with reports from other north European regions. Methods A retrospective analysis. The air ambulance fleet's activity according to the electronic patient record database of "Luftambulansetjenesten ANS" (LABAS) was analysed. The subject was the fleet's operations in northern Norway, logistics, and patients handled. Type of flight, distances, frequency, and patients served were the main outcome measures. Results A significant increase (45%) in the use of RW and a shift in FW operations (less primary and more secondary) were revealed. The shift in FW operations reflected the centralisation of several health care services [i.e. percutaneous cardiac intervention (PCI), trauma, and cancer surgery] during the study period. Cardiovascular disease (CVD) and injuries were the main diagnoses and constituted half of all operations. CVD was the most common cause of FW operations and injuries of the RW ones. The number of air ambulance operations was 16 per 1,000 inhabitants. This was more frequent than in other north European regions. Conclusions The use of air ambulances and especially RW was significantly increased during the study period. The change in secondary FW operations reflected centralisation of medical care. When health care services are centralised, air ambulance services must be adjusted to the new settings. PMID:21878107
Chaneliere, M; Jacquet, F; Occelli, P; Touzet, S; Siranyan, V; Colin, C
The assessment of patient safety culture refers mainly to surveys exploring the perceptions of health professionals in hospitals. These surveys have less relevance when considering the assessment of the patient safety culture of medical students, especially at university or medical school. They are indeed not fully integrated in care units and constitute a heterogeneous population. This work aimed to find appropriate assessment tools of the patient safety culture of medical students. Systematic review of the literature. Surveys related to a care unit were excluded. A typology of the patient safety culture of medical students was built from the included surveys. Eighteen surveys were included. In our typology of patient safety culture of medical students (15 dimensions), the number of dimensions explored by survey (n) ranged from 1 to 12, with 6 "specialized" tools (n ≤ 4) and 12 "global" tools (N ≥ 5). These surveys have explored: knowledge about patient safety, acknowledgment of the inevitability of human error, the lack of skills as the main source of errors, the errors reporting systems, disclosure of medical errors to others health professionals or patients, teamwork and patient involvement to improve safety in care. We recommend using Wetzel's survey for making an overall assessment of the patient safety culture of medical students at university. In a specific purpose-e.g. to assess an educational program on medical error disclosure-the authors recommend to determine which dimensions of patient safety will be taught, to select the best assessment tool. Learning on patient safety should however be considered beyond the university. International translations of tools are required to create databases allowing comparative studies.
What Works Clearinghouse, 2010
"Impact of For-Profit and Nonprofit Management on Student Achievement: The Philadelphia Intervention, 2002-2008" examined whether shifting from traditional district management to management by a for-profit or nonprofit organization improves student achievement. The study analyzed data on six cohorts of elementary and middle school…
Sinclair, Susan M; Miller, Richard K; Chambers, Christina; Cooper, Elizabeth M
Nearly 90% of women in the United States have taken medications during pregnancy. Medication exposures during pregnancy can result in adverse pregnancy and neonatal outcomes including birth defects, fetal loss, intrauterine growth restriction, prematurity, and longer-term neurodevelopmental outcomes. Advising pregnant women about the safety of medication use during pregnancy is complicated by a lack of data necessary to engage the woman in an informed discussion. Routinely, health care providers turn to the package insert, yet this information can be incomplete and can be based entirely on animal studies. Often, adequate safety data are not available. In a busy clinical setting, health care providers need to be able to quickly locate the most up-to-date information in order to counsel pregnant women concerned about medication exposure. Deciding where to locate the best available information is difficult, particularly when the needed information does not exist. Pregnancy registries are initiated to obtain more data about the safety of specific medication exposures during pregnancy; however, these studies are slow to produce meaningful information, and when they do, the information may not be readily available in a published form. Health care providers have valuable data in their everyday practice that can expand the knowledge base about medication safety during pregnancy. This review aims to discuss the limitations of the package insert regarding medication safety during pregnancy, highlight additional resources available to health care providers to inform practice, and communicate the importance of pregnancy registries for expanding knowledge about medication safety during pregnancy.
Knight, John C.
There are many computer-based medical applications in which safety and not reliability is the overriding concern. Reduced, altered, or no functionality of such systems is acceptable as long as no harm is done. A precise, formal definition of what software safety means is essential, however, before any attempt can be made to achieve it. Without this definition, it is not possible to determine whether a specific software entity is safe. A set of definitions pertaining to software safety will be presented and a case study involving an experimental medical device will be described. Some new techniques aimed at improving software safety will also be discussed.
Meleshko, Alexander N; Savva, Natalia N; Fedasenka, Uladzimir U; Romancova, Alexandra S; Krasko, Olga V; Eckert, Cornelia; von Stackelberg, Arend; Aleinikova, Olga V
Detection of minimal residual disease (MRD) during the treatment of acute lymphoblastic leukemia (ALL) by RQ-PCR analysis of clonal Ig/TCR rearrangements is used for risk group stratification in European treatment protocols. In Belarus patients with childhood ALL are treated according to ALL-MB protocols, which do not use MRD-based risk stratification. To evaluate the prognostic significance of MRD for ALL-MB-2002/2008 protocols, MRD was quantified by RQ-PCR in 68 ALL patients at four time points: on day 15, on day 36, before and after maintenance therapy (MT). MRD positivity, as well as quantitative level of MRD were analyzed and compared between patients who stayed in remission and relapsed. Relapse-free survival revealed to be significantly associated with MRD levels at different time points. Unfavorable prognosis was shown for MRD≥10(-3) on day 36 (p<0.001), and any positive MRD before (p<0.001) and after (p=0.001) MT. Multivariate Cox regression analysis proved MRD as independent significant prognosis factor at day 36 (p=0.005) and before MT (p=0.001). We conclude, that MRD quantified by RQ-PCR in children with ALL treated with ALL-MB protocols is feasible and independently associated with outcome. MRD may be a suitable parameter for treatment stratification in MB protocols in future.
Hertig, John B.; Hultgren, Kyle E.; Weber, Robert J.
The discipline of studying medication errors and implementing medication safety programs in hospitals dates to the 1970s. These initial programs to prevent errors focused only on pharmacy operation changes – and not the broad medication use system. In the late 1990s, research showed that faulty systems, and not faulty people, are responsible for errors and require a multidisciplinary approach. The 2013 ASHP Statement on the Role of the Medication Safety Leader recommended that medication safety leaders be integrated team members rather than a single point of contact. Successful medication safety programs must employ a new approach – one that embraces the skills of all health care team members and positions many leaders to improve safety. This approach requires a new set of leadership skills based on contemporary management principles, including followership, team-building, tracking and assessing progress, storytelling and communication, and cultivating innovation, all of which promote transformational change. The application of these skills in developing or changing a medication safety program is reviewed in this article. PMID:27303083
Abbing, Henriette Roscam
Medical confidentiality is of individual and of general interest. Medical confidentiality is not absolute. European countries differ in their legislative approaches of consent for data-sharing and lawful breaches of medical confidentiality. An increase of interference by the legislator with medical confidentiality is noticeable. In The Netherlands for instance this takes the form of new mandatory duties to report resp. of legislation providing for a release of medical confidentiality in specific situations, often under the condition that reporting takes place on the basis of a professional code that includes elements imposed by the legislator (e.g. (suspicion of) child abuse, domestic violence). Legislative interference must not result in the patient loosing trust in healthcare. To avoid erosion of medical confidentiality, (comparative) effectiveness studies and privacy impact assessments are necessary (European and national level). Medical confidentiality should be a subject of permanent education of health personnel.
Chien, Hung-Yu; Yang, Chia-Chuan; Wu, Tzong-Chen; Lee, Chin-Feng
Owing to the low cost and convenience of identifying an object without physical contact, Radio Frequency Identification (RFID) systems provide innovative, promising and efficient applications in many domains. An RFID grouping protocol is a protocol that allows an off-line verifier to collect and verify the evidence of two or more tags simultaneously present. Recently, Huang and Ku (J. Med. Syst, 2009) proposed an efficient grouping protocol to enhance medication safety for inpatients based on low-cost tags. However, the Huang-Ku scheme is not secure; an attacker can easily make up fake grouping records to cheat the verifier. This weakness would seriously endanger the safety of inpatient medication safety. This paper will show the weaknesses, and then propose two RFID-based solutions to enhance medication safety for two different scenarios. The proposed schemes are practical, secure and efficient for medication applications.
Conlin, Paul R.; Travison, Thomas; McMahon, Graham T.
Background Patient safety is a core educational topic for medical trainees. Objectives To determine the current level and determinants of patient safety knowledge in medical trainees. Design Multi-institutional cross-sectional assessment of patient safety knowledge. Participants Residents and medical students from seven Harvard-affiliated residencies and two Harvard Medical School courses. Measurements Participants were administered a 14-item validated test instrument developed based on the patient safety curriculum of the Risk Management Foundation (Cambridge, MA). The primary outcome measure was the amount of patient safety knowledge demonstrated by trainees on the validated test instrument. The secondary outcome measure was their subjective perceptions as to their baseline knowledge level in this domain. Results Ninety-two percent (640/693) of residents and medical students completed the patient safety test. Participants correctly answered a mean 58.4% of test items (SD 15.5%). Univariate analyses show that patient safety knowledge levels varied significantly by year of training (p = 0.001), degree program (p < 0.001), specialty (p < 0.001), country of medical school (p = 0.006), age (p < 0.001), and gender (p = 0.050); all but the latter two determinants remained statistically significant in multivariate models. In addition, trainees were unable to assess their own knowledge deficiencies in this domain. Conclusions Patient safety knowledge is limited among medical trainees across a broad range of training levels, degrees, and specialties. Effective educational interventions that target deficiencies in patient safety knowledge are greatly needed. PMID:17551796
Pape, Theresa M
Medication administration errors (MAE) continue as major problems for health care institutions, nurses, and patients. However, MAEs are often the result of system failures leading to patient injury, increased hospital costs, and blaming. Costs include those related to increased hospital length of stay and legal expenses. Contributing factors include distractions, lack of focus, poor communication, and failure to follow standard protocols during medication administration.
Pitkänen, Anneli; Teuho, Susanna; Uusitalo, Marjo; Kaunonen, Marja
In recent years, patient safety has been a serious concern internationally. Medication in particular is a significant area in improving patient safety because medication errors are a crucial clinical problem. This study aimed to explore suggestions to improve medication safety reported via computerized patient safety systems in hospitals. The research data were retrospectively collected from the computerized patient safety incident reporting systems in one university hospital and two regional hospitals in Finland. Open-ended records concerning prescribing medicines (n = 136), dispensing medicines (n = 362), administering medicines to patients (n = 538), and documenting medication (n = 434) were included in the analysis. The data were analyzed by using inductive content analysis. Based on the study findings, there is a need to develop and standardize procedures related to all four parts of medication management process. Moreover, working environment, multiprofessional collaboration, and knowledge and skills of the professionals should be developed. Promoting medication safety in hospitals is an urgent challenge. The study results indicated that computerized patient safety incident reporting systems can provide important qualitative information to improve medication process to be safer.
Patterson, P Daniel; Huang, David T; Fairbanks, Rollin J; Simeone, Scott; Weaver, Matthew; Wang, Henry E
Workplace attitude, beliefs, and culture may impact the safety of patient care. This study characterized perceptions of safety culture in a nationwide sample of emergency medical services (EMS) agencies. We conducted a cross-sectional survey involving 61 advanced life support EMS agencies in North America. We administered a modified version of the Safety Attitudes Questionnaire (SAQ), a survey instrument measuring dimensions of workplace safety culture (Safety Climate, Teamwork Climate, Perceptions of Management, Job Satisfaction, Working Conditions, and Stress Recognition). We included full-time and part-time paramedics and emergency medical technicians. We determined the variation in safety culture scores across EMS agencies. Using hierarchical linear models, we determined associations between safety culture scores and individual and EMS agency characteristics. We received 1,715 completed surveys from 61 EMS agencies (mean agency response rate 47%; 95% confidence interval [CI] 10%, 83%). There was wide variation in safety culture scores across EMS agencies [mean (minimum, maximum)]: Safety Climate 74.5 (min 49.9, max 89.7), Teamwork Climate 71.2 (min 45.1, max 90.1), Perceptions of Management 67.2 (min 31.1, max 92.2), Job Satisfaction 75.4 (min 47.5, max 93.8), Working Conditions 66.9 (min 36.6, max 91.4), and Stress Recognition 55.1 (min 31.3, max 70.6). Air medical EMS agencies tended to score higher across all safety culture domains. Lower safety culture scores were associated with increased annual patient contacts. Safety Climate domain scores were not associated with other individual or EMS agency characteristics. In this sample, workplace safety culture varies between EMS agencies.
Sharma, Sangeeta; Tabassum, Fauzia; Khurana, Sarbjeet; Kapoor, Kaveri
Background: To explore interprofessionals’ perceptions about patient safety, particularly medication safety and associated factors and barriers. Methods: A total of 389 respondents were recruited using convenience sample in the cross sectional survey. Results: Medication safety was perceived as somewhat safe (60%). One-third of respondents witnessed 3–4 or more medication errors (MEs) within the past 1 year. Out of that, one quarter were reportedly, sentinel events. More sentinel events were witnessed in public hospitals and solo practice clinics compared with corporate hospitals and nursing homes (p < 0.02). No difference was observed in the occurrence of sentinel events in accredited and nonaccredited facilities (p = 0.30). Younger respondents witnessed more MEs, whereas accredited hospitals (mostly corporate hospitals) witnessed significantly fewer MEs and graded overall safety as ‘better’. However, most MEs go unreported particularly in solo practice clinics (88%) followed by nursing homes (67%), public hospitals (54%), and corporate hospitals (42%). Error identification and subsequent disclosure was inhibited by several system factors: fear of punitive action and lack of reporting systems. General surgical (46%), medical (42%), and paediatric units (36%), were the most error-prone places. Documentation diverted all healthcare workers from direct patient care. Many doctors and pharmacists from nursing homes, solo clinics and public hospitals reported working overtime. Staff shortages and poor training were overwhelming concerns to all healthcare workers and in public hospitals. Solo clinics and nursing homes perceived more barriers; lack of reporting systems, standard protocol, and resources for patient safety and unfamiliarity with prescribed medications was their overwhelming concern. Other factors threatening MEs were a lack of team approach and openness in interdisciplinary communications, illegible medical orders, and medicines prescribed by brand
Toennessen, B; Swart, E; Marx, Y
Ten years after the publication of "To Err is Human" in November1999, the development of patient safety efforts has been summa-rised in the statement "Ten years later, a million lives lost, billions of dollars wasted." This leads to the question why, despite evidence-based mea-sures for greater patient safety, they are not implemented or only implemented on a small scale. One approach to promote patient safety is the implementation of a safety culture. Such a safety culture is based on knowledge of employees about safe behaviour and their willingness to implement it. In this context it is interesting to explore the knowledge and the needs of medical students concerning patient safety. At the University of -Magdeburg 354 medical students in their clinical semesters were asked about their knowledge of specific recommendations on patient safety and about their attitude to patient safety and risk man-agement as well as their subjective need for knowledge on this subject. Only 16.7 % of the PJ (practical year) students and 11.7 % of students in all other clinical semester indicated to know the recommenda-tions for patient safety. This correlated with the answers to questions about single recommenda-tions. The importance of risk management during medical education was considered to be important by 53.3 % of the students of all clinical semesters and in particular 80.6 % of the surveyed PJ students. The answers to most questions showed a high demand for general information on patient safety. This is seen throughout all questions, especially with increasing clinical experience, and the need for information on single recommendations, such as critical incident reporting systems (CIRS), or Team Time Out. The establishment of a safety culture is described as a useful way to fewer patient injuries. This includes knowledge on recommendations for patient safety, which may contribute to the implementation of a safety culture to reduce medical errors. Our survey shows the
Dell, Evelyn M; Varpio, Lara; Petrosoniak, Andrew; Gajaria, Amy; McMcarthy, Anne E
To explore and characterize the ethical and safety challenges of global health experiences as they affect medical students in order to better prepare trainees to face them. Semi-structured interviews were conducted with 23 Canadian medical trainees who had participated in global health experiences during medical school. Convenience and snowball sampling were utilized. Using Moustakas's transcendental phenomenological approach, participant descriptions of ethical dilemmas and patient/trainee safety problems were analyzed. This generated an aggregate that illustrates the essential meanings of global health experience ethical and safety issues faced. We interviewed 23 participants who had completed 38 electives (71%, n=27, during pre-clinical years) spending a mean 6.9 weeks abroad, and having visited 23 countries. Sixty percent (n=23) had pre-departure training while 36% (n=14) had post-experience debriefing. Three macro-level themes were identified: resource disparities and provision of care; navigating clinical ethical dilemmas; and threats to trainee safety. Medical schools have a responsibility to ensure ethical and safe global health experiences. However, our findings suggest that medical students are often poorly prepared for the ethical and safety dilemmas they encounter during these electives. Medical students require intensive pre-departure training that will prepare them emotionally to deal with these dilemmas. Such training should include discussions of how to comply with clinical limitations.
Dell, Evelyn M.; Varpio, Lara; Petrosoniak, Andrew; Gajaria, Amy
Objectives To explore and characterize the ethical and safety challenges of global health experiences as they affect medical students in order to better prepare trainees to face them. Methods Semi-structured interviews were conducted with 23 Canadian medical trainees who had participated in global health experiences during medical school. Convenience and snowball sampling were utilized. Using Moustakas’s transcendental phenomenological approach, participant descriptions of ethical dilemmas and patient/trainee safety problems were analyzed. This generated an aggregate that illustrates the essential meanings of global health experience ethical and safety issues faced. Results We interviewed 23 participants who had completed 38 electives (71%, n=27, during pre-clinical years) spend-ing a mean 6.9 weeks abroad, and having visited 23 countries. Sixty percent (n=23) had pre-departure training while 36% (n=14) had post-experience debriefing. Three macro-level themes were identified: resource disparities and provision of care; navigating clinical ethical dilemmas; and threats to trainee safety. Conclusions Medical schools have a responsibility to ensure ethical and safe global health experiences. However, our findings suggest that medical students are often poorly prepared for the ethical and safety dilemmas they encounter during these electives. Medical students require intensive pre-departure training that will prepare them emotionally to deal with these dilemmas. Such training should include discussions of how to comply with clinical limitations. PMID:25341214
Risch, Martin R; Gay, David A; Fowler, Kathleen K; Keeler, Gerard J; Backus, Sean M; Blanchard, Pierrette; Barres, James A; Dvonch, J Timothy
Annual and weekly mercury (Hg) concentrations, precipitation depths, and Hg wet deposition in the Great Lakes region were analyzed by using data from 5 monitoring networks in the USA and Canada for a 2002-2008 study period. High-resolution maps of calculated annual data, 7-year mean data, and net interannual change for the study period were prepared to assess spatial patterns. Areas with 7-year mean annual Hg concentrations higher than the 12 ng per liter water-quality criterion were mapped in 4 states. Temporal trends in measured weekly data were determined statistically. Monitoring sites with significant 7-year trends in weekly Hg wet deposition were spatially separated and were not sites with trends in weekly Hg concentration. During 2002-2008, Hg wet deposition was found to be unchanged in the Great Lakes region and its subregions. Any small decreases in Hg concentration apparently were offset by increases in precipitation. Published by Elsevier Ltd.
Risch, Martin R.; Gay, David A.; Fowler, Kathleen K.; Keeler, Gerard J.; Backus, Sean M.; Blanchard, Pierrette; Barres, James A.; Dvonch, J. Timothy
Annual and weekly mercury (Hg) concentrations, precipitation depths, and Hg wet deposition in the Great Lakes region were analyzed by using data from 5 monitoring networks in the USA and Canada for a 2002-2008 study period. High-resolution maps of calculated annual data, 7-year mean data, and net interannual change for the study period were prepared to assess spatial patterns. Areas with 7-year mean annual Hg concentrations higher than the 12 ng per liter water-quality criterion were mapped in 4 states. Temporal trends in measured weekly data were determined statistically. Monitoring sites with significant 7-year trends in weekly Hg wet deposition were spatially separated and were not sites with trends in weekly Hg concentration. During 2002-2008, Hg wet deposition was found to be unchanged in the Great Lakes region and its subregions. Any small decreases in Hg concentration apparently were offset by increases in precipitation.
Hoover, Eddie L.; Cole-Hoover, Gwendolyn; Berry, Paula K.; Hoover, Evan T.; Harris, Betsy; Rageh, Deman; Weaver, W. Lynn
Many African Americans from a variety of medical specialties are interested in satisfying a life-long dream of visiting Africa by volunteering their services to faith-based and private volunteer organizations doing missionary work on the continent. While this can be an extremely rewarding experience in which measurable good can be accomplished, this path can also be strewn with many obstacles that will affect both the success of the mission and the personal well-being of the volunteer. The American Medical Team for Africa is a nonprofit, tax-exempt, volunteer organization that has been doing medical missionary work in Africa since 1993. This manuscript is a compilation of this 10-year experience that has established some very useful guidelines for insuring a successful and safe mission if you are fortunate enough to have this opportunity. PMID:15719877
POLAR WINTER CONDITIONS IN 2009; COMPARISONS WITH YEARS 2002-2008 Peter P. Wintersteiner ARCON Corporation 260 Bear Hill Road Waltham...NUMBER ARCON Corporation 260 Bear Hill Rd. Waltham, MA 02451-1080 AFRL/RVBYM 9. SPONSORING... ARCON Corporation according to the provisions of contract #FA8718-04-C-0031. Much of this work was done during the fifth year in which it was in effect
Kagan, Ilya; Barnoy, Sivia
To investigate the association between patient safety culture (PSC) and the incidence and reporting rate of medical errors by Israeli nurses. Self-administered structured questionnaires were distributed to a convenience sample of 247 registered nurses enrolled in training programs at Tel Aviv University (response rate = 91%). The questionnaire's three sections examined the incidence of medication mistakes in clinical practice, the reporting rate for these errors, and the participants' views and perceptions of the safety culture in their workplace at three levels (organizational, departmental, and individual performance). Pearson correlation coefficients, t tests, and multiple regression analysis were used to analyze the data. Most nurses encountered medical errors from a daily to a weekly basis. Six percent of the sample never reported their own errors, while half reported their own errors "rarely or sometimes." The level of PSC was positively and significantly correlated with the error reporting rate. PSC, place of birth, error incidence, and not having an academic nursing degree were significant predictors of error reporting, together explaining 28% of variance. This study confirms the influence of an organizational safety climate on readiness to report errors. Senior healthcare executives and managers can make a major impact on safety culture development by creating and promoting a vision and strategy for quality and safety and fostering their employees' motivation to implement improvement programs at the departmental and individual level. A positive, carefully designed organizational safety culture can encourage error reporting by staff and so improve patient safety. © 2013 Sigma Theta Tau International.
Background To reduce harm caused by health care is a global priority. Medical students should be able to recognize unsafe conditions, systematically report errors and near misses, investigate and improve such systems with a thorough understanding of human fallibility, and disclose errors to patients. Incorporating the knowledge of how to do this into the medical student curriculum is an urgent necessity. This paper aims to systematically review the literature about patient safety education for undergraduate medical students in terms of its content, teaching strategies, faculty availability and resources provided so as to identify evidence on how to promote patient safety in the curriculum for medical schools. This paper includes a perspective from the faculty of a medical school, a major hospital and an Evidence Based Medicine Centre in Sichuan Province, China. Methods We searched MEDLINE, ERIC, Academic Source Premier(ASP), EMBASE and three Chinese Databases (Chinese Biomedical Literature Database, CBM; China National Knowledge Infrastructure, CNKI; Wangfang Data) from 1980 to Dec. 2009. The pre-specified form of inclusion and exclusion criteria were developed for literature screening. The quality of included studies was assessed using Darcy Reed and Gemma Flores-Mateo criteria. Two reviewers selected the studies, undertook quality assessment, and data extraction independently. Differing opinions were resolved by consensus or with help from the third person. Results This was a descriptive study of a total of seven studies that met the selection criteria. There were no relevant Chinese studies to be included. Only one study included patient safety education in the medical curriculum and the remaining studies integrated patient safety into clinical rotations or medical clerkships. Seven studies were of a pre and post study design, of which there was only one controlled study. There was considerable variation in relation to contents, teaching strategies, faculty
Leahy, Laura G
"Safety first" has always been a nursing priority-just as medication education has been an essential nursing function. Approximately 79 million individuals of all ages, birth-to-death, were prescribed psychotropic medications in 2013. Nurses of all disciplines and who work in all practice settings must be aware of the potential safety concerns related to medications patients may be taking. Black Box Warnings (BBWs) are the strictest labeling requirements that the U.S. Food and Drug Administration can mandate. Risks of increased suicidality, mortality in older adults, potential for abuse and drug dependence, and life-threatening hepatic failure are among the most significant BBWs attributed to psychotropic medications. As such, nurses must be aware of not only how medications will benefit patients in relieving symptoms of or preventing their disease but also the potential risks, adverse reactions, and BBWs. [Journal of Psychosocial Nursing and Mental Health Services, 55(6), 11-15.]. Copyright 2017, SLACK Incorporated.
Gerhart, Donald; O'Shea, Kristen; Muller, Sharon
Adverse drug events resulting from errors in prescribing or administering medications are preventable. Within a hospital system, numerous technologies are employed to address the common sources of medication error, including the use of electronic medical records, physician order entry, smart infusion pumps, and barcode medication administration systems. Infusion safety is inherently risky because of the high-risk medications administered and the lack of integration among the stand-alone systems in most institutions. Intravenous clinical integration (IVCI) is a technology that connects electronic medical records, physician order entry, smart infusion pumps, and barcode medication administration systems. It combines the safety features of an automatically programmed infusion pump (drug, concentration, infusion rate, and patient weight, all auto-programmed into the device) with software that provides visibility to real-time clinical infusion data. Our article describes the characteristics of IVCI at WellSpan Health and its impact on patient safety. The integrated infusion system has the capability of reducing medication errors, improving patient care, reducing in-facility costs, and supporting asset management. It can enhance continuous quality improvement efforts and efficiency of clinical work flow. After implementing IVCI, the institution realized a safer patient environment and a more streamlined work flow for pharmacy and nursing.
Mickelson, Robin Sue; Holden, Richard J
An important domain of patient safety is the management of medications in home and community settings by patients and their caregiving network. This study applied human factors/ergonomics theories and methods to data about medication adherence collected from 61 patients with heart failure accompanied by 31 informal caregivers living in the US. Seventy non-adherence events were identified, described, and analysed for performance shaping factors. Half were classified as errors and half as violations. Performance shaping factors included elements of the person or team (e.g. patient limitations), task (e.g. complexity), tools and technologies (e.g. tool quality) and organisational, physical, and social context (e.g. resources, support, social influence). Study findings resulted in a dynamic systems model of medication safety applicable to patient medication adherence and the medication management process. Findings and the resulting model offer implications for future research on medication adherence, medication safety interventions, and resilience in home and community settings. Practitioner Summary: We describe situational and habitual errors and violations in medication use among older patients and their family members. Multiple factors pushed performance towards risk and harm. These factors can be the target for redesign or various forms of support, such as education, changes to the plan of care, and technology design.
Rattanarojsakul, Phichai; Thawesaengskulthai, Natcha
Reaching zero defects is vital in medication service. Medication error can be reduced if the causes are recognized. The purpose of this study is to search for a conceptual framework of the causes of medication error in Thailand and to examine relationship between these factors and its importance. The study was carried out upon an in-depth case study and survey of hospital personals who were involved in the drug use process. The structured survey was based on Emergency Care Research Institute (ECRI) (2008) questionnaires focusing on the important factors that affect the medication safety. Additional questionnaires included content to the context of Thailand's private hospital, validated by five-hospital qualified experts. By correlation Pearson analysis, the result revealed 14 important factors showing a linear relationship with drug administration error except the medication reconciliation. By independent sample t-test, the administration error in the hospital was significantly related to external impact. The multiple regression analysis of the detail of medication administration also indicated the patient identification before administration of medication, detection of the risk of medication adverse effects and assurance of medication administration at the right time, dosage and route were statistically significant at 0.05 level. The major implication of the study is to propose a medication safety model in a Thai private hospital. PMID:23985110
Harrington, J. M.
There has been a large increase in the number of persons employed in medical laboratories in the last 25 years. These workers are exposed to a variety of infective agents in the course of their work, the most important being Mycobacterium tuberculosis, Salmonella typhi, Brucella spp., and serum hepatitis virus. Chemical and physical hazards include toxic chemicals, lacerations, skin disease, and possibly cancer. Current knowledge of safe working practice in laboratories leaves much to be desired and there is an urgent need for both internationally agreed codes of safe practice and the development of guidelines for the medical surveillance of laboratory workers. The World Health Organization is developing such guidelines in an attempt to protect the health of workers employed in the investigation of ill health in others. PMID:6979421
Kravchenko, O K
The medical personnel operating currently available medical equipment can be exposed to physical factors. To prevent the adverse consequences of these exposures, medical equipment undergoes sanitary-and-epidemiological examination, resulting in the drawing up of a sanitary-and-epidemiological report. For regulation of this procedure, a management directive has been worked out, which determines an examination procedure, a hygienic classification of medical equipment, allowable values for controlled safety indices during operation, etc. Introduction of the directive makes it possible to upgrade the quality of sanitary-and-epidemiological equipment audit, to improve working conditions, and to keep health in the personnel operating the present-day high-technology equipment.
Soldatenko, N A; Karmanov, V V; Vaisman, Ya I; Samutin, N M
In the article the issues of environmental, sanitary and hygienic safety of medical waste management are considered. Recently, for the treatment of certain types of medical waste thermal methods using small plants not equipped with a proper flue gas cleaning system are widely used. In this article the potential danger of supertoxicants generation when applying thermal methods of neutralization of medical waste that contains polyvinyl chloride (PVC) is justified by thermogravimetric and mass spectrometric studies. This research shows the necessity of introducing technologies of separate collection of PVC medical waste and its' thermal recycling in compliance with special requirements.
Carpenter, Delesha; Gonzalez, Daniel; Retsch-Bogart, George; Sleath, Betsy; Wilfond, Benjamin
In May 2016, the Eshelman School of Pharmacy at The University of North Carolina at Chapel Hill convened the PharmSci conference to address the topic of "methodological and ethical issues in pediatric medication safety research." A multidisciplinary group of experts representing a diverse array of perspectives, including those of the US Food and Drug Administration, children's hospitals, and academia, identified important considerations for pediatric medication safety research and opportunities to advance the field. This executive summary describes current challenges that clinicians and researchers encounter related to pediatric medication safety research and identifies innovative and ethically sound methodologies to address these challenges to improve children's health. This article addresses 5 areas: (1) pediatric drug development and drug trials; (2) conducting comparative effectiveness research in pediatric populations; (3) child and parent engagement on study teams; (4) improving communication with children and parents; and (5) assessing child-reported outcomes and adverse drug events. Copyright © 2017 by the American Academy of Pediatrics.
McTier, Lauren; Botti, Mari; Duke, Maxine
Patient participation in medication management during hospitalization is thought to reduce medication errors and, following discharge, improve adherence and therapeutic use of medications. There is, however, limited understanding of how patients participate in their medication management while hospitalized. To explore patient participation in the context of medication management during a hospital admission for a cardiac surgical intervention of patients with cardiovascular disease. Single institution, case study design. The unit of analysis was a cardiothoracic ward of a major metropolitan, tertiary referral hospital in Melbourne, Australia. Multiple methods of data collection were used including pre-admission and pre-discharge patient interviews (n = 98), naturalistic observations (n = 48) and focus group interviews (n = 2). All patients had changes made to their pre-operative cardiovascular medications as a consequence of surgery. More patients were able to list and state the purpose and side-effects of their cardiovascular medications at pre-admission than prior to discharge from hospital. There was very little evidence that nurses used opportunities such as medication administration times to engage patients in medication management during hospital admission. Failure to engage patients in medication management and provide opportunities for patients to learn about changes to their medications has implications for the quality and safety of care patients receive in hospital and when managing their medications once discharged. To increase the opportunity for patients to participate in medication management, a fundamental shift in the way nurses currently provide care is required. © 2013 John Wiley & Sons Ltd.
Jang, Hye Jung; Choi, Young Deuk; Kim, Nam Hyun
This paper describes an evaluation study on the effectiveness of developing an in-hospital medical device safety information reporting system for managing safety information, including adverse incident data related to medical devices, following the enactment of the Medical Device Act in Korea. Medical device safety information reports were analyzed for 190 cases that took place prior to the application of a medical device safety information reporting system and during a period when the reporting system was used. Also, questionnaires were used to measure the effectiveness of the medical device safety information reporting system. The analysis was based on the questionnaire responses of 15 reporters who submitted reports in both the pre- and post-reporting system periods. Sixty-two reports were submitted in paper form, but after the system was set up, this number more than doubled to 128 reports in electronic form. In terms of itemized reporting, a total of 45 items were reported. Before the system was used, 23 items had been reported, but this increased to 32 items after the system was put to use. All survey variables of satisfaction received a mean of over 3 points, while positive attitude, potential benefits, and positive benefits all exceeded 4 points, each receiving 4.20, 4.20, and 4.13, respectively. Among the variables, time-consuming and decision-making had the lowest mean values, each receiving 3.53. Satisfaction was found to be high for system quality and user satisfaction, but relatively low for time-consuming and decision-making. We were able to verify that effective reporting and monitoring of adverse incidents and the safety of medical devices can be implemented through the establishment of an in-hospital medical device safety information reporting system that can enhance patient safety and medical device risk management.
Jang, Hye Jung; Choi, Young Deuk
Objectives This paper describes an evaluation study on the effectiveness of developing an in-hospital medical device safety information reporting system for managing safety information, including adverse incident data related to medical devices, following the enactment of the Medical Device Act in Korea. Methods Medical device safety information reports were analyzed for 190 cases that took place prior to the application of a medical device safety information reporting system and during a period when the reporting system was used. Also, questionnaires were used to measure the effectiveness of the medical device safety information reporting system. The analysis was based on the questionnaire responses of 15 reporters who submitted reports in both the pre- and post-reporting system periods. Results Sixty-two reports were submitted in paper form, but after the system was set up, this number more than doubled to 128 reports in electronic form. In terms of itemized reporting, a total of 45 items were reported. Before the system was used, 23 items had been reported, but this increased to 32 items after the system was put to use. All survey variables of satisfaction received a mean of over 3 points, while positive attitude, potential benefits, and positive benefits all exceeded 4 points, each receiving 4.20, 4.20, and 4.13, respectively. Among the variables, time-consuming and decision-making had the lowest mean values, each receiving 3.53. Satisfaction was found to be high for system quality and user satisfaction, but relatively low for time-consuming and decision-making. Conclusions We were able to verify that effective reporting and monitoring of adverse incidents and the safety of medical devices can be implemented through the establishment of an in-hospital medical device safety information reporting system that can enhance patient safety and medical device risk management. PMID:28523207
Pires, Aline de Oliveira Meireles; Ferreira, Maria Beatriz Guimarães; do Nascimento, Kleiton Gonçalves; Felix, Márcia Marques dos Santos; Pires, Patrícia da Silva; Barbosa, Maria Helena
ABSTRACT Objective: to elaborate and validate a checklist to identify compliance with the recommendations for the structure of medication prescriptions, based on the Protocol of the Ministry of Health and the Brazilian Health Surveillance Agency. Method: methodological research, conducted through the validation and reliability analysis process, using a sample of 27 electronic prescriptions. Results: the analyses confirmed the content validity and reliability of the tool. The content validity, obtained by expert assessment, was considered satisfactory as it covered items that represent the compliance with the recommendations regarding the structure of the medication prescriptions. The reliability, assessed through interrater agreement, was excellent (ICC=1.00) and showed perfect agreement (K=1.00). Conclusion: the Medication Prescription Safety Checklist showed to be a valid and reliable tool for the group studied. We hope that this study can contribute to the prevention of adverse events, as well as to the improvement of care quality and safety in medication use. PMID:28793128
Huang, Hsieh-Hong; Ku, Cheng-Yuan
In order to provide enhanced medication safety for inpatients, the medical mechanism which adopts the modified grouping proof protocol is proposed in this paper. By using the grouping proof protocol, the medical staffs could confirm the authentication and integrity of a group of Radio-Frequency Identification (RFID) tags which are embedded on inpatient bracelets and the containers of drugs. This mechanism is designed to be compatible with EPCglobal Class-1 Generation-2 standard which is the most popular specification of RFID tags. Due to the light-weight computational capacity of passive tags, only the pseudo-random number generator (PRNG) and cyclic redundancy code (CRC) are allowed to be used in the communication protocol. Furthermore, a practical scenario of using this proposed mechanism in hospital to examine the medication safety is also presented.
Patel, Viral M; Lambert, W Clark; Schwartz, Robert A
Medications should be employed with caution in women of childbearing age. Topical medications have little systemic absorption. Therefore, they are considered safer than oral or parenteral agents and less likely to be embryotoxic or fetotoxic. However, their safety profile must be assessed cautiously as the available data are limited. In this article, we aggregate human and animal studies to provide recommendations on using topical anti-scabies and anti-lice therapy in pregnancy. PMID:27904173
Patel, Viral M; Lambert, W Clark; Schwartz, Robert A
Medications should be employed with caution in women of childbearing age. Topical medications have little systemic absorption. Therefore, they are considered safer than oral or parenteral agents and less likely to be embryotoxic or fetotoxic. However, their safety profile must be assessed cautiously as the available data are limited. In this article, we aggregate human and animal studies to provide recommendations on using topical anti-scabies and anti-lice therapy in pregnancy.
Dudas, Robert A; Bundy, David G; Miller, Marlene R; Barone, Michael
The purpose of this study was to evaluate the impact of a patient-safety curriculum administered during a paediatric clerkship on medical students' attitudes towards patient safety. Medical students viewed an online video introducing them to systems-based analyses of medical errors. Faculty presented an example of a medication administration error and demonstrated use of the Learning From Defects tool to investigate the defect. Student groups identified and then analysed medication errors during their clinical rotation using the Learning From Defects framework to organise and present their findings. Outcomes included patient safety attitudinal changes, as measured by questions derived from the Safety Attitudes Questionnaire. 108 students completed the curriculum between July 2008 and July 2009. All student groups (25 total) identified, analysed and presented patient safety concerns. Curriculum effectiveness was demonstrated by significant changes on questionnaire items related to patient safety attitudes. The majority of students felt that the curriculum was relevant to their clinical rotation and should remain part of the clerkship. An active learning curriculum integrated into a clinical clerkship can change learners' attitudes towards patient safety. Students found the curriculum relevant and recommended its continuation.
Yoo, J H; Broderick, W A
Although hospital electrical safety is receiving increased attention in the literature of engineers, it is not, at present, reflected in the curricula of medical schools. A possible reason for this omission is that biomedical and/or clinical engineers knowledgeable in electrical safety are not usually trained to teach. One remedy for this problem is to combine the knowledge of engineers with that of instructional developers to design a systematic curriculum for a course in hospital electrical safety. This paper describes such an effort at the University of Texas Health Science Center at San Antonio (UTHSCSA). A biomedical engineer and an instructional developer designed an instructional module in hospital electrical safety; the engineer taught the module, and both evaluated the results. The process and outcome of their collaboration are described. This model was effectively applied in the classroom as a four-hour segment in hospital electrical safety for first-year medical students at UTHSCSA. It is hoped that an additional benefit of this system will be that it offers an opportunity for continuing improvement in this kind of instruction at other medical schools and hospitals.
IMPROVING PATIENT SAFETY has become one of the driving forces in health care delivery. Honest, accurate disclosure of medical errors and close calls is crucial to gain a better grasp of problems, make effective changes, and evaluate progress. ALTHOUGH FEAR OF MALPRACTICE litigation remains a major deterrent to medical-error reporting, disclosure allows organizations to benefit from one another's experiences. Accountability necessitates mandatory reporting to external organizations, but a wide variety of reporting systems exist, each with its own advantages and shortcomings. National standardized reporting is a major objective for the patient safety movement. STAFF MEMBER INVESTMENT is a key factor in the safety process and needs to extend beyond the reporting procedure.
Ford, Eric C; Nyflot, Matthew; Spraker, Matthew B; Kane, Gabrielle; Hendrickson, Kristi R G
Education in patient safety and quality of care is a requirement for radiation oncology residency programs according to accrediting agencies. However, recent surveys indicate that most programs lack a formal program to support this learning. The aim of this report was to address this gap and share experiences with a structured educational program on quality and safety designed specifically for medical physics therapy residencies. Five key topic areas were identified, drawn from published recommendations on safety and quality. A didactic component was developed, which includes an extensive reading list supported by a series of lectures. This was coupled with practice-based learning which includes one project, for example, failure modes and effect analysis exercise, and also continued participation in the departmental incident learning system including a root-cause analysis exercise. Performance was evaluated through quizzes, presentations, and reports. Over the period of 2014-2016, five medical physics residents successfully completed the program. Evaluations indicated that the residents had a positive experience. In addition to educating physics residents this program may be adapted for medical physics graduate programs or certificate programs, radiation oncology residencies, or as a self-directed educational project for practicing physicists. Future directions might include a system that coordinates between medical training centers such as a resident exchange program. © 2017 The Authors. Journal of Applied Clinical Medical Physics published by Wiley Periodicals, Inc. on behalf of American Association of Physicists in Medicine.
Peris-Lopez, Pedro; Orfila, Agustin; Mitrokotsa, Aikaterini; van der Lubbe, Jan C A
Errors involving medication administration can be costly, both in financial and in human terms. Indeed, there is much potential for errors due to the complexity of the medication administration process. Nurses are often singled out as the only responsible of these errors because they are in charge of drug administration. Nevertheless, the interventions of every actor involved in the process and the system design itself contribute to errors (Wakefield et al. (1998). Proper inpatient medication safety systems can help to reduce such errors in hospitals. In this paper, we review in depth two recent proposals (Chien et al. (2010); Huang and Ku (2009)) that pursue the aforementioned objective. Unfortunately, they fail in their attempt mainly due to their security faults but interesting ideas can be drawn from both. These security faults refer to impersonation and replay attacks that could produce the generation of a forged proof stating that certain medication was administered to an inpatient when it was not. We propose a leading-edge solution to enhance inpatient medication safety based on RFID technology that overcomes these weaknesses. Our solution, named Inpatient Safety RFID system (IS-RFID), takes into account the Information Technology (IT) infrastructure of a hospital and covers every phase of the drug administration process. From a practical perspective, our system can be easily integrated within hospital IT infrastructures, has a moderate cost, is very ease to use and deals with security aspects as a key point.
Ugur, Esra; Kara, Sevim; Yildirim, Songul; Akbal, Elif
To investigate medical errors in the operating room, attitudes of healthcare professionals in case of errors and educational needs of professionals. The descriptive study was conducted at a university hospital in Turkey from January 25 to February 14, 2011, and comprised operating room staff, including physicians, nurses, anaesthesia technicians and perfusion technicians. Data was obtained using a questionnaire. Of the 69 respondents, 45(65.2%) had experienced medical errors and 29(42%) had verbally warned the person who caused the error. The main cause of the medical errors was a lack of healthcare professionals and their inadequate qualifications, 51(73.9%); and insufficient communication, 41(59.4%). Coping with stress and communication 45(65.2%) and radiation safety 28(40.6%) were the most common educational needs. Patient safety applications in the operating room can be improved by offering educational programmes, designing an easy reporting system, encouraging reporting of medical errors and active participation of healthcare professionals in decisions that might affect patient safety.
Anathhanam, Sujo; Powis, Rachel A.; Robson, Jeremy
Appropriate prescribing for older adults presents unique challenges to the prescriber. An understanding of the scale of the problems and contributing factors is essential when designing interventions to improve patient safety. The altered pharmacology of ageing, the existence of multiple medical conditions and the exclusion of elderly patients from many trials render this subgroup of the population particularly vulnerable to underprescribing and overprescribing. Adverse drug events are common, causing significant morbidity and mortality as well as having economic implications. ‘High-risk’ medications such as opioids, anticoagulants and antipsychotics can have benefits in this group of patients but strategies to optimize their safety are required. Tools exist that help to identify those at risk of adverse drug reactions and to screen for inappropriate prescribing. Developments in information technology are ongoing, and it is hoped that these may enhance the process of medication reconciliation across healthcare transitions and alert the prescriber to potential adverse drug events. This review addresses commonly encountered issues when prescribing for older people, considers strategies to improve medication safety and offers a list of ‘top tips’ to aid the clinician. PMID:25083234
Alomari, Albara; Wilson, Val; Solman, Annette; Bajorek, Beata; Tinsley, Patricia
This study aims to outline the current workplace culture of medication practice in a pediatric medical ward. The objective is to explore the perceptions of nurses in a pediatric clinical setting as to why medication administration errors occur. As nurses have a central role in the medication process, it is essential to explore nurses' perceptions of the factors influencing the medication process. Without this understanding, it is difficult to develop effective prevention strategies aimed at reducing medication administration errors. Previous studies were limited to exploring a single and specific aspect of medication safety. The methods used in these studies were limited to survey designs which may lead to incomplete or inadequate information being provided. This study is phase 1 on an action research project. Data collection included a direct observation of nurses during medication preparation and administration, audit based on the medication policy, and guidelines and focus groups with nursing staff. A thematic analysis was undertaken by each author independently to analyze the observation notes and focus group transcripts. Simple descriptive statistics were used to analyze the audit data. The study was conducted in a specialized pediatric medical ward. Four key themes were identified from the combined quantitative and qualitative data: (1) understanding medication errors, (2) the busy-ness of nurses, (3) the physical environment, and (4) compliance with medication policy and practice guidelines. Workload, frequent interruptions to process, poor physical environment design, lack of preparation space, and impractical medication policies are identified as barriers to safe medication practice. Overcoming these barriers requires organizations to review medication process policies and engage nurses more in medication safety research and in designing clinical guidelines for their own practice.
Chandy, Sujith John
Objective: A rising number of medicines and minimal emphasis on rational prescribing in the medical curriculum may compromise medication safety. There is no focused module in the curriculum dealing with factors affecting safety such as quality, medicines management, rational use, and approach to adverse effects. Creating awareness of these issues would hopefully plant a seed of safe prescribing and encourage pharmacovigilance. A study was therefore done to determine the need for such a module. Method: A quasi-experimental pre-post module study. Medical students (n = 88) completing pharmacology term were recruited after informed consent. A questionnaire containing 20 questions on various themes was administered and scored. Subsequently a module was developed and relevant safety themes taught to the students. After one month, the questionnaire was re-administered. Results: The pre module score was 9.52/20. Knowledge about the various themes, adverse effects, medication management, quality issues and rational use were similar though poor knowledge was evident in specific areas such as clinical trials, look alike-sound alike medicines (LASA) and medicine storage. The post module score was 12.24/20. The improvement of score was statistically significant suggesting the effectiveness of the module. Conclusion: The relatively poor knowledge and improvement with a specific educational module emphasizes the need of such a module within the medical curriculum to encourage safe use of medicines by Indian Medical Graduates (IMG). It is hoped that the policy makers in medical education will introduce such a module within the medical curriculum. PMID:28031610
Chen, Chin-Ling; Wu, Chun-Yi
The low birth rate has led to an aging society; the burgeoning number of elderly patients may affect the medical quality and result in negative medical incidents. There are many factors that lead to medical errors, such as similar medication names, erroneous labels and packaging, as well as staff shortages, fatigue and carelessness. Determining how to reduce medical errors has become an important issue. As RFID exhibits powerful identification characteristics, it can help nurses to quickly identify patients and their corresponding medicine. Currently, there are numerous practical applications for improving the efficiency of Radio Frequency Identification (RFID) systems. In this paper, we use an RFID yoking proof mechanism which conforms to EPCglobal Class 1 Generation 2 standards to improve patient safety and reduce medical errors. Our scheme can achieve different goals such as resist numerous known attacks, achieve mutual authentication, anonymity and non-repudiation. It also provides a practical medical care and offer higher quality of medical care. The pharmacist cannot deny that this prescription was confirmed for the patient and the nurse cannot also deny he or she dispensed this medicine to the patient for protecting the patients' interests.
Neto, José Augusto; Figueiredo Damásio, Jemerson; Monthaler, Paul; Morais, Misael
Worldwide medical device embedded software certification practices are currently focused on manufacturing best practices. In Brazil, the national regulatory agency does not hold a local certification process for software-intensive medical devices and admits international certification (e.g. FDA and CE) from local and international industry to operate in the Brazilian health care market. We present here a product-based certification process as a candidate process to support the Brazilian regulatory agency ANVISA in medical device software regulation. Center of Strategic Technology for Healthcare (NUTES) medical device embedded software certification is based on a solid safety quality model and has been tested with reasonable success against the Class I risk device Generic Infusion Pump (GIP).
Progress in patient safety, or lack thereof, is a cause for great concern. In this article, we argue that the patient safety movement has failed to reach its goals of eradicating or, at least, significantly reducing errors because of an inappropriate focus on provider and patient-level factors with no real attention to the organizational factors that affect patient safety. We describe an organizational approach to patient safety using different organizational theory perspectives and make several propositions to push patient safety research and practice in a direction that is more likely to improve care processes and outcomes. From a Contingency Theory perspective, we suggest that health care organizations, in general, operate under a misfit between contingencies and structures. This misfit is mainly due to lack of flexibility, cost containment, and lack of regulations, thus explaining the high level of errors committed in these organizations. From an organizational culture perspective, we argue that health care organizations must change their assumptions, beliefs, values, and artifacts to change their culture from a culture of blame to a culture of safety and thus reduce medical errors. From an organizational learning perspective, we discuss how reporting, analyzing, and acting on error information can result in reduced errors in health care organizations.
Mahler, Cornelia; Freund, Tobias; Baldauf, Annika; Jank, Susanne; Ludt, Sabine; Peters-Klimm, Frank; Haefeli, Walter Emil; Szecsenyi, Joachim
Patients with chronic disease usually need to take multiple medications. Drug-related interactions, adverse events, suboptimal adherence, and self-medication are components that can affect medication safety and lead to serious consequences for the patient. At present, regular medication reviews to check what medicines have been prescribed and what medicines are actually taken by the patient or the structured evaluation of drug-related problems rarely take place in Germany. The process of "medication reconciliation" or "medication review" as developed in the USA and the UK aim at increasing medication safety and therefore represent an instrument of quality assurance. Within the HeiCare(®) project a structured medication management was developed for general practice, with medical assistants playing a major role in the implementation of the process. Both the structured medication management and the tools developed for the medication check and medication counselling will be outlined in this article; also, findings on feasibility and acceptance in various projects and experiences from a total of 200 general practices (56 HeiCare(®), 29 HiCMan,115 PraCMan) will be described. The results were obtained from questionnaires and focus group discussions. The implementation of a structured medication management intervention into daily routine was seen as a challenge. Due to the high relevance of medication reconciliation for daily clinical practice, however, the checklists - once implemented successfully - have been applied even after the end of the project. They have led to the regular review and reconciliation of the physicians' documentation of the medicines prescribed (medication chart) with the medicines actually taken by the patient.
Mekonnen, Alemayehu B; McLachlan, Andrew J; Brien, Jo-anne E; Mekonnen, Desalew; Abay, Zenahebezu
Introduction Medication related adverse events are common, particularly during transitions of care, and have a significant impact on patient outcomes and healthcare costs. Medication reconciliation (MedRec) is an important initiative to achieve the Quality Use of Medicines, and has been adopted as a standard practice in many developed countries. However, the impact of this strategy is rarely described in Ethiopia. The aims of this study are to explore patient safety culture, and to develop, implement and evaluate a theory informed MedRec intervention, with the aim of minimising the incidence of medication errors during hospital admission. Methods and analyses The study will be conducted in a resource limited setting. There are three phases to this project. The first phase is a mixed methods study of healthcare professionals' perspectives of patient safety culture and patients' experiences of medication related adverse events. In this phase, the Hospital Survey on Patient Safety Culture will be used along with semi-structured indepth interviews to investigate patient safety culture and experiences of medication related adverse events. The second phase will use a semi-structured interview guide, designed according to the 12 domains of the Theoretical Domains Framework, to explore the barriers and facilitators to medication safety activities delivered by hospital pharmacists. The third phase will be a single centre, before and after study, that will evaluate the impact of pharmacist conducted admission MedRec in an emergency department (ED). The main outcome measure is the incidence and potential clinical severity of medication errors. We will then analyse the differences in the incidence and severity of medication errors before and after initiation of an ED pharmacy service. PMID:27884844
Mekonnen, Alemayehu B; McLachlan, Andrew J; Brien, Jo-Anne E; Mekonnen, Desalew; Abay, Zenahebezu
Medication related adverse events are common, particularly during transitions of care, and have a significant impact on patient outcomes and healthcare costs. Medication reconciliation (MedRec) is an important initiative to achieve the Quality Use of Medicines, and has been adopted as a standard practice in many developed countries. However, the impact of this strategy is rarely described in Ethiopia. The aims of this study are to explore patient safety culture, and to develop, implement and evaluate a theory informed MedRec intervention, with the aim of minimising the incidence of medication errors during hospital admission. The study will be conducted in a resource limited setting. There are three phases to this project. The first phase is a mixed methods study of healthcare professionals' perspectives of patient safety culture and patients' experiences of medication related adverse events. In this phase, the Hospital Survey on Patient Safety Culture will be used along with semi-structured indepth interviews to investigate patient safety culture and experiences of medication related adverse events. The second phase will use a semi-structured interview guide, designed according to the 12 domains of the Theoretical Domains Framework, to explore the barriers and facilitators to medication safety activities delivered by hospital pharmacists. The third phase will be a single centre, before and after study, that will evaluate the impact of pharmacist conducted admission MedRec in an emergency department (ED). The main outcome measure is the incidence and potential clinical severity of medication errors. We will then analyse the differences in the incidence and severity of medication errors before and after initiation of an ED pharmacy service. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.
Over-the-counter (OTC) medications are among the most commonly used products in pregnancy. Similar to prescription medications, for many products there is a lack of adequate data on safety of use in pregnancy. Assumptions of safety for these products based on long experience and OTC status, in the absence of data, may be ill founded. Examples of four OTC products used to treat common conditions in pregnancy are described. Potential links to adverse short- and long-term infant outcomes for these products are reviewed, and the strengths and limitations of data to support these. Research to detect or rule out these risks is essential. Copyright © 2015 Elsevier Inc. All rights reserved.
Harrington, J M; Shannon, H S
A retrospective postal survey of 24 000 medical laboratory workers in England, Wales, and Scotland showed highly variable standards of safety and health care. Pre-employment health screening was offered to two-thirds of employees, the physicians being the least likely to be examined (15%). Scottish laboratories provided better safety control than English and Welsh laboratories, while Public Health Service Laboratories had a better record than National Health Service establishments. Mouth pipetting is still practised in 65% of English and Welsh laboratories, and the use of protective clothing is rarely compulsory. The servicing of safety cabinets is often inadequate. Known and suspected carcinogens are still apparently used in a few laboratories (2-10%). In view of the wide variation in standards among laboratories, urgent consideration should be given to establishing regulations for codes of safe practice rather than relying merely on recommendations as at present. PMID:843842
Savely, Susanne M; Hamilton, Winifred J; Degani, Farah; Weinberg, Armin D; Muraca, Paul
In the study described in this article, the authors performed safety walk-throughs or inspections for 20 clinics located both inside a major medical center clinic (onsite) and away from the main clinic site (offsite). A checklist was used to evaluate compliance with institutional, local, state, and federal guidelines and regulations. The results obtained at onsite clinics were compared with the results from offsite clinics. Findings suggested no overall difference in the number of yes (desirable) answers. A marginally significant difference, however, was observed between the onsite and offsite clinics with regard to knowledge of infection control and waste/infection control questions. The walk-throughs helped create an improved working relationship between clinic personnel and environmental safety personnel, allowed for correction of safety issues, enabled an informal training opportunity, and increased institutional compliance with guidelines and regulations.
Mira, J J; Guilabert, M; Vitaller, J; Ignacio, E
To compare the information on patient safety received by students of medicine and nursing. Cross-sectional study was conducted using a convenience sample of medical and nursing students of 3 Universities. The Latin Patient Safety Student Information and a test of 5 questions with 5 options were used. A sample of 79 students in each group was enrolled to detect differences of .3 units (bilateral estimation), considering 80% statistical power and 95% confidence interval. A total of 144 students replied (74 nursing and 70 medicine students). Nursing students achieved higher scores in the communication with patients factor (3.8 vs 3.2, P<.001) and proactive attitude to identify risks for patient safety (4.3 vs 3.8, P<.001). Medical students were more aware of the inevitability of adverse events (2.3 vs 3.1, P<.001). Ten (7%) students had only one fault in the test, and only one (1%) answered all questions correctly. The training in patient safety should be improved both in nursing and medicine, although nursing students receive more information. Copyright © 2015 SECA. Published by Elsevier Espana. All rights reserved.
Neuenschwander, Mark; Cohen, Michael R; Vaida, Allen J; Patchett, Jeffrey A; Kelly, Jamie; Trohimovich, Barbara
Bar coding for the medication administration step of the drug-use process is discussed. FDA will propose a rule in 2003 that would require bar-code labels on all human drugs and biologicals. Even with an FDA mandate, manufacturer procrastination and possible shifts in product availability are likely to slow progress. Such delays should not preclude health systems from adopting bar-code-enabled point-of-care (BPOC) systems to achieve gains in patient safety. Bar-code technology is a replacement for traditional keyboard data entry. The elements of bar coding are content, which determines the meaning; data format, which refers to the embedded data and symbology, which describes the "font" in which the machine-readable code is written. For a BPOC system to deliver an acceptable level of patient protection, the hospital must first establish reliable processes for a patient identification band, caregiver badge, and medication bar coding. Medications can have either drug-specific or patient-specific bar codes. Both varieties result in the desired code that supports patient's five rights of drug administration. When medications are not available from the manufacturer in immediate-container bar-coded packaging, other means of applying the bar code must be devised, including the use of repackaging equipment, overwrapping, manual bar coding, and outsourcing. Virtually all medications should be bar coded, the bar code on the label should be easily readable, and appropriate policies, procedures, and checks should be in place. Bar coding has the potential to be not only cost-effective but to produce a return on investment. By bar coding patient identification tags, caregiver badges, and immediate-container medications, health systems can substantially increase patient safety during medication administration.
Wilson, Amanda Jane; Palmer, Lorinda; Levett-Jones, Tracy; Gilligan, Conor; Outram, Sue
Medication errors are the second most prevalent cause of adverse patient incidents in Australian hospital settings. Although numerous strategies to address this patient safety issue have been implemented, the impact of interprofessional collaborative practice (IPCP) on medication safety has received limited attention. The aim of this article is to report the perspectives and experiences of recently graduated, currently practicing Australian nurses, pharmacists, and doctors in relation to IPCP and medication safety. Sixty-eight graduates from three Australian states participated in focus groups. Thematic analysis of transcripts was conducted using an iterative process. The findings from this study illustrate how knowing about and valuing the skills and responsibilities of other team members and respecting each person's unique contribution to the work of the team can lead to more effective communication and collaboration in the context of medication safety. Although collaborative practice is critical to safe medication prescribing, dispensing, and administration, there are recurring and pervasive challenges to its achievement. This study indicated the need for improved preparation of graduates to equip them with the knowledge and skills needed to participate in an interprofessional team; and we advocate that deliberate, structured, and meaningful interprofessional clinical education initiatives are required.
Nurses can protect patients receiving intravenous (IV) medication by using medication safety software to program "smart" pumps to administer IV medications. After a patient safety event identified inconsistent use of medication safety software by nurses, a performance improvement team implemented the Deming Cycle performance improvement methodology. The combined use of improved direct care nurse communication, programming strategies, staff education, medication safety champions, adherence monitoring, and technology acquisition resulted in a statistically significant (p < .001) increase in nurse adherence to using medication safety software from 28% to above 85%, exceeding national benchmark adherence rates (Cohen, Cooke, Husch & Woodley, 2007; Carefusion, 2011).
Özcanhan, Mehmet Hilal; Dalkılıç, Gökhan; Utku, Semih
Reliable sources report that errors in drug administration are increasing the number of harmed or killed inpatients, during healthcare. This development is in contradiction to patient safety norms. A correctly designed hospital-wide ubiquitous system, using advanced inpatient identification and matching techniques, should provide correct medicine and dosage at the right time. Researchers are still making grouping proof protocol proposals based on the EPC Global Class 1 Generation 2 ver. 1.2 standard tags, for drug administration. Analyses show that such protocols make medication unsecure and hence fail to guarantee inpatient safety. Thus, the original goal of patient safety still remains. In this paper, a very recent proposal (EKATE) upgraded by a cryptographic function is shown to fall short of expectations. Then, an alternative proposal IMS-NFC which uses a more suitable and newer technology; namely Near Field Communication (NFC), is described. The proposed protocol has the additional support of stronger security primitives and it is compliant to ISO communication and security standards. Unlike previous works, the proposal is a complete ubiquitous system that guarantees full patient safety; and it is based on off-the-shelf, new technology products available in every corner of the world. To prove the claims the performance, cost, security and scope of IMS-NFC are compared with previous proposals. Evaluation shows that the proposed system has stronger security, increased patient safety and equal efficiency, at little extra cost.
Aljadhey, Hisham; Mahmoud, Mansour Adam; Hassali, Mohamed Azmi; Alrasheedy, Alian; Alahmad, Amjad; Saleem, Fahad; Sheikh, Aziz; Murray, Michael; Bates, David W.
Background Medication safety is a global concern among healthcare providers. However, the challenges to and the future of medication safety in Saudi Arabia have not been explored. Objectives We explored the perspectives of healthcare practitioners on current issues about medication safety in hospitals and community settings in Saudi Arabia in order to identify challenges to improving it and explore the future of medication safety practice. Methods A total of 65 physicians, pharmacists, academics and nurses attended a one-day meeting in March 2010, designed especially for the purpose of this study. The participants were divided into nine round-table discussion sessions. Three major themes were explored in these sessions, including: major factors contributing to medication safety problems, challenges to improving medication safety practice, and participants’ suggestions for improving medication safety. The round-table discussion sessions were videotaped and transcribed verbatim and analyzed by two independent researchers. Results The round-table discussions revealed that major factors contributing to medication safety problems included unrestricted public access to medications from various hospitals and community pharmacies, communication gaps between healthcare institutions, limited use of important technologies such as computerized provider order entry, and the lack of medication safety programs in hospitals. Challenges to current medication safety practice identified by participants included underreporting of medication errors and adverse drug reactions, multilingualism and differing backgrounds of healthcare professionals, lack of communication between healthcare providers and patients, and high workloads. Suggestions for improving medication safety practices in Saudi Arabia included continuous education for healthcare professionals and competency assessment focusing on medication safety, development of a culture that encourages medication error and adverse
Aljadhey, Hisham; Mahmoud, Mansour Adam; Hassali, Mohamed Azmi; Alrasheedy, Alian; Alahmad, Amjad; Saleem, Fahad; Sheikh, Aziz; Murray, Michael; Bates, David W
Medication safety is a global concern among healthcare providers. However, the challenges to and the future of medication safety in Saudi Arabia have not been explored. We explored the perspectives of healthcare practitioners on current issues about medication safety in hospitals and community settings in Saudi Arabia in order to identify challenges to improving it and explore the future of medication safety practice. A total of 65 physicians, pharmacists, academics and nurses attended a one-day meeting in March 2010, designed especially for the purpose of this study. The participants were divided into nine round-table discussion sessions. Three major themes were explored in these sessions, including: major factors contributing to medication safety problems, challenges to improving medication safety practice, and participants' suggestions for improving medication safety. The round-table discussion sessions were videotaped and transcribed verbatim and analyzed by two independent researchers. The round-table discussions revealed that major factors contributing to medication safety problems included unrestricted public access to medications from various hospitals and community pharmacies, communication gaps between healthcare institutions, limited use of important technologies such as computerized provider order entry, and the lack of medication safety programs in hospitals. Challenges to current medication safety practice identified by participants included underreporting of medication errors and adverse drug reactions, multilingualism and differing backgrounds of healthcare professionals, lack of communication between healthcare providers and patients, and high workloads. Suggestions for improving medication safety practices in Saudi Arabia included continuous education for healthcare professionals and competency assessment focusing on medication safety, development of a culture that encourages medication error and adverse drug reactions reporting, use of technology
An Inventory and Safety Stock Analysis of Air Force Medical Service Pharmaceuticals THESIS Blake...Department of Defense, or the United States Government. AFIT-ENS-MS-15-M-133 An Inventory and Safety Stock Analysis of Air Force Medical...APPROVED FOR PUBLIC RELEASE; DISTRIBUTION UNLIMITED. AFIT-ENS-MS-15-M-133 AN INVENTORY AND SAFETY STOCK ANALYSIS OF AIR FORCE MEDICAL
Schmitz, K; Lenssen, R; Rosentreter, M; Gross, D; Eisert, A
In medicine today, future doctors are expected to ensure patient safety. Yet medical students often feel uncertain if they can meet these high expectations. This study aims to quantify the perceptions of medical students regarding the actual quality of their education in the fields of patient safety and, in particular, medication safety. A questionnaire was designed and distributed to about 100 upper-level medical students. The students had to respond to 12 questions regarding the following categories: 1) familiarity with patient safety and/or medication safety; 2) personal experience in high-risk clinical situations; and 3) perceived relevance of knowledge in the area of patient and medication Safety for clinical practice. Of the respondents 42.1% and 36.8% had delved into the topic patient safety and medication safety, respectively. In clinical practice 88.2% of respondents had experienced a high-risk situation for patients. Regarding patient safety and medication safety, respectively, 82.9% and 85.3% of the respondents found these topics to be particularly relevant to their clinical practice. This study has shown that there is a measurable discrepancy between the students' perceived quality of their medical education and their feelings that they are well prepared to cope with severe clinical challenges.
Cottrell, Erika K.; O’Brien, Kerth; Curry, Merlin; Meckler, Garth D.; Engle, Philip P.; Jui, Jonathan; Summers, Caitlin; Lambert, William; Guise, Jeanne-Marie
Objective For over a decade, the field of medicine has recognized the importance of studying and designing strategies to prevent safety issues in hospitals and clinics. However, there has been less focus on understanding safety in prehospital emergency medical services, particularly in regard to children. Roughly 27.7 million (or 27%) of the annual ED visits are by children under the age of 19, and about 2 million of these children reach the hospital via EMS. This paper adds to our qualitative understanding of the nature and contributors to safety events in the prehospital emergency care of children. Methods We conducted four 8–12 person focus groups among paid and volunteer Emergency Medical Services providers to understand: 1) patient safety issues that occur in the prehospital care of children, and 2) factors that contribute to these safety issues (e.g. patient, family, systems, environmental, or individual provider factors). Focus groups were conducted in rural and urban settings. Interview transcripts were coded for overarching themes. Results Key factors and themes identified in the analysis were grouped into categories using an ecological approach that distinguishes between systems, team, child and family, and individual provider level contributors. At the systems level, focus group participants cited challenges such as lack of appropriately sized equipment or standardized pediatric medication dosages, insufficient human resources, limited pediatric training and experience, and aspects of emergency medical services culture. EMS team level factors centered on communication with other EMS providers (both prehospital and hospital). Family and child factors included communication barriers and challenging clinical situations or scene characteristics. Finally, focus group participants highlighted a range of provider level factors including heightened levels of anxiety, insufficient experience and training with children and errors in assessment and decision
... HUMAN SERVICES Agency for Healthcare Research and Quality Patient Safety Organizations: Voluntary... Quality (AHRQ), HHS. ACTION: Notice of Delisting. SUMMARY: Community Medical Foundation for Patient Safety... Patient Safety, of its status as a Patient Safety Organization (PSO). The Patient Safety and Quality...
Maro, Judith C; Brown, Jeffrey S; Kulldorff, Martin
Large linked database networks, like the US Food and Drug Administration's Sentinel System, are being built for medical product surveillance. One use of these networks is for "near real-time" sequential database surveillance of prespecified medical product-adverse event pairs, which may result in a "safety signal" when a statistical excess risk is detected. Sequential database surveillance requires the investigator to manage surveillance in both information time (ie, how sample size accrues) and calendar time. Calendar time is important because people external to the surveillance population may be affected by the speed with which a safety signal is detected or ruled out. Optimal design and analysis aspects of sequential database surveillance are not well developed, but are gaining in importance as observational database networks grow. Using information time concepts, we show how to calculate sample sizes when performing sequential database surveillance, illustrating the relationships between statistical power, the time to detect a signal, and the maximum sample size for various true effect sizes. Then, using a vaccine example, we demonstrate a four-step planning process that allows investigators to translate information time into calendar time. Given the calendar time for surveillance, the process focuses on choosing observational database configurations consistent with the investigator's preferences for timeliness and statistical power. Although the planning process emphasizes sample size considerations, the influence of secondary database attributes such as delay times, measurement error, and cost are also discussed. Appropriate planning allows the most efficient use of public health dollars dedicated to medical product surveillance efforts.
Reducing the number of preventable adverse events has become a public health issue. The paper discusses in which ways the law can contribute to that goal, especially by encouraging a culture of safety among healthcare professionals. It assesses the need or the usefulness to pass so-called disclosure laws and apology laws, to adopt mandatory but strictly confidential Critical Incidents Reporting Systems in hospitals, to change the fault-based system of medical liability or to amend the rules on criminal liability. The paper eventually calls for adding the law to the present agenda of patient safety. Significance for public health The extent of preventable adverse events and the correlative need to improve patient safety are recognized today as a public health issue. In order to lower the toll associated with preventable adverse events, the former culture of professionalism (based on the premise that a good physician doesn’t make mistakes) must be replaced by a culture of safety, which requires a multi-pronged approach that includes all the main stakeholders within the healthcare system. A number of legal reforms could help in prompting such a change. This contribution stresses the need to include legal aspects when trying to find appropriate responses to public health issues. PMID:25170502
Bardou, Marc; Fortinsky, Kyle J
The management of gastro-esophageal reflux and esophagitis in infants and children is challenging, and there are currently no clear practice guidelines. Given a paucity of evidence in the treatment of pediatric esophagitis, there are concerns over both the efficacy and safety of proton-pump inhibitors, histamine type 2 receptor antagonists, and prokinetics. Comprehensive data from randomized-controlled trials, meta-analyses and observational studies have helped to illustrate the efficacy and safety of various pharmacologic and non-pharmacologic treatments in pediatric esophagitis. We review the evidence on the risks of antacid therapy including bone mineral density, respiratory infections and enteric infections including necrotizing enterocolitis. Evidence pertaining to the safety of proton-pump inhibitors and histamine 2 receptor antagonists in pediatric populations is lacking. Largely based on small observational and randomized controlled trials, it does appear both antacids pose an increased risk of respiratory and enteric infections, which can occur even with a short course of treatment. The benefits of treatment, especially in pediatric esophagitis, must be weighed against the potential risks. More large-scale studies are needed to better quantify short-term and long-term risks of treatment. Anti-secretory medications, mostly proton pump inhibitors, have substantially improved the management of pediatric esophagitis. Nevertheless, because of possible infectious safety concerns, their use must be restricted to validated indications only.
Kravchenko, O K; Prokopenko, L V
The article covered observance of sanitary legal requirements in special technical regulations "On requirements to medical equipment and medical products safety". The authors discussed problems of applied terminology, classification of medical products, occupational risk, control over observance of safety requirements on all stages of medical products circulation--design, production, usage.
... Product Design To Minimize Medication Errors; Availability AGENCY: Food and Drug Administration, HHS... guidance for industry entitled ``Safety Considerations for Product Design to Minimize Medication Errors... using a systems approach to minimize medication errors relating to product design. The draft...
Given the unique nature of pregnancy with respect to obtaining safety data regarding medication exposures, developing comprehensive information on the wide variety of medications that might be of clinical benefit during pregnancy is a challenging and on-going task. For many of the most commonly used asthma and allergy medications that were covered in this article, there is at least limited human data are available. Even for relatively well-studied medications, there are many unanswered questions, and few studies exist that are large enough to rule out at least a doubling of risk for specific outcomes, particularly congenital anomalies. This challenge becomes even more daunting when evaluating risks of individual products is considered the optimal goal, as opposed to "lumping" all medication exposures within a class. All of these issues call for more human pregnancy data that are collected more efficiently so that the answers that clinicians and pregnant women need are available more readily. In the meantime, health care providers and pregnant women must work with the information that is available to evaluate the risks and benefits of a particular medication and alternative choices for treatment of asthma or allergy during pregnancy, while considering the potential for adverse effects if the woman with severe or uncontrolled asthma is under-treated. To assist in making a risk/benefit assessment, the clinician can draw on existing resources that provide systematic periodic review of new data on medications in pregnancy as it becomes available, and synthesize the entire body of data on a particular drug into concise summary statements. Two such resources are TERIS (TeratogenInformation System)  and Reprotox ; both on-line services are managed by experts in the field of teratology. An additional resource for clinicians and pregnant women is the Organization of Teratology Information Specialists , a network of risk-assessment counselors in the United States
Malirat, Viviana; Bergmann, Ingrid Evelyn; Campos, Renata de Mendonça; Salgado, Gustavo; Sánchez, Camilo; Conde, Florangel; Quiroga, José Luis; Ortiz, Salomón
At present, Foot-and-Mouth Disease (FMD) has been successfully controlled in most territories of South America, where only Ecuador and Venezuela remain as endemic countries. In this context, the precise characterization of circulating viruses is of utmost importance. This work describes the first molecular epidemiology study performed with the complete VP(1)-coding region of 114 field isolates of FMD virus (FMDV) type O, collected in the Andean countries mainly during 2002-2008. Sequences were aligned and compared to isolates responsible for emergencies in the Southern Cone of the continent between the years 2000 and 2006, and to other representative type O viruses worldwide. The results showed that FMD type O viruses isolated in South America and analyzed up to date are placed in 11 different lineages within the Euro SA topotype. Five of these lineages included viruses circulating in Ecuador and Venezuela during 2002-2008. The last emergencies reported in already-free areas in the Andean region, showed close relationships with viruses circulating in these endemic countries. Andean lineages showed a clear separation from the unique lineage containing viruses responsible for the emergencies in the Southern Cone, reflecting the different livestock circuits and providing evidence that support the ecosystem dynamics in the region. A wide geographical dissemination of the same strain in short time intervals has been observed, pointing to animal movements as the most significant risk parameter. This fact, together with an important generation of viral variants in areas under weak control strategies, reinforce the need of stronger official controls, as well as for establishing multinational cooperative measures in the border areas. Copyright © 2011 Elsevier B.V. All rights reserved.
Weingart, Saul N.; Spencer, Justin; Buia, Stephanie; Duncombe, Deborah; Singh, Prabhjyot; Gadkari, Mrinalini; Connor, Maureen
Purpose: Oral chemotherapies represent an emerging risk area in ambulatory oncology practice. To examine the hazards associated with five oral chemotherapies, we performed a proactive risk assessment. Methods: We convened interdisciplinary teams and conducted failure mode and effects analyses (FMEAs) for five oral chemotherapy agents: capecitabine, imatinib, temozolomide, 6-mercaptopurine, and an investigational agent. This involved the creation of process maps for each medication, identification of failure modes, selection of high-risk failure modes, and development of recommendations to mitigate these risks. We analyzed the number of steps and types of failure modes and compared this information across the study drugs. Results: Key vulnerabilities include patient education about drug handling and adverse effects, prescription writing, patient self-administration and medication adherence, and failure to monitor and manage toxicities. Many of these failure modes were common across the five oral chemotherapies, suggesting the presence of common targets for improvement. Streamlining the FMEA itself may promote the dissemination of this method. Conclusion: Each stage of the medication process poses risks to the safe use of oral chemotherapies. FMEAs may identify opportunities to improve medication safety and reduce the risk of patient harm. PMID:21532801
Popescu, Andrea; Currey, Judy; Botti, Mari
Although numerous factors influence medication administration, our understanding of the interplay of these factors on medication quality and safety is limited. The aim of this study was to explore the multifactorial influences on medication quality and safety in the context of a single checking policy for medication administration in acute care. An exploratory/descriptive study using non-participant observation and follow-up interview was used to identify factors influencing medication quality and safety in medication administration episodes (n=30). Observations focused on nurses' interactions with patients during medication administration, and the characteristics of the environment in which these took place. Confirmation of observed data occurred on completion of the observation period during short semi-structured interviews with participant nurses. Findings showed nurses developed therapeutic relationships with patients in terms of assessing patients before administering medications and educating patients about drugs during medication administration. Nurses experienced more frequent distractions when medications were stored and prepared in a communal drug room according to ward design. Nurses deviated from best-practice guidelines during medication administration. Nurses' abilities and readiness to develop therapeutic relationships with patients increased medication quality and safety, thereby protecting patients from potential adverse events. Deviations from best-practice medication administration had the potential to decrease medication safety. System factors such as ward design determining medication storage areas can be readily addressed to minimise potential error. Nurses displayed behaviours that increased medication administration quality and safety; however, violations of practice standards were observed. These findings will inform future intervention studies to improve medication quality and safety. Copyright ©2011 Sigma Theta Tau International.
Employees in Critical Safety or Security Positions and Positions with Safety Sensitive Duties . 1. REFERENCES. A. Army Regulation 40-5, Preventive... duties . C. The employee is considered unfit for safety sensitive duties until such a time when he or she is no longer taking opioid pain...Aeromedical Policy Letters, Medication Waivers, January 2002 Revision. 2. BACKGROUND. Employees who work in safety-sensitive occupations or handle
Hainer, Vojtech; Aldhoon-Hainerová, Irena
Worldwide obesity prevalence has nearly doubled since 1980. Due to numerous co-morbidities, obesity represents a serious health and socioeconomic problem worldwide. Pharmacotherapy should be an integral part of comprehensive obesity management. Drug therapy can assist in weight loss and its maintenance in those individuals who do not achieve appropriate weight loss through lifestyle interventions alone. After the withdrawal of sibutramine from the market in 2010, orlistat, a lipase inhibitor, was the only remaining prescription drug approved for the long-term treatment of obesity. In 2012, phentermine/topiramate extended-release (PHEN/TPM ER) combination and lorcaserin were approved by the US FDA as novel medications for long-term weight management. Three major phase III trials conducted with each drug confirmed their efficacy in terms of weight loss/maintenance and improvement of cardiometabolic risks. No head-to-head studies between the two new anti-obesity drugs have been carried out. However, in the existing studies PHEN/TPM ER had a superior weight loss profile to lorcaserin but the incidence of adverse effects was lower with lorcaserin. Both drugs were well-tolerated, and adverse events were modest in intensity, dose dependent, rather rare, and tended to decrease with the duration of treatment. Major safety concerns regarding PHEN/TPM ER include elevations in resting pulse rate, teratogenicity, mild metabolic acidosis, and psychiatric and cognitive adverse events. Valvulopathy, cognitive impairment, psychiatric disorders, and hypoglycemia represent major safety concerns for lorcaserin. Although existing trials have not demonstrated any significant issues with PHEN/TPM ER-induced heart rate elevation and lorcaserin-induced valvulopathy, all safety concerns should be seriously taken into account in patients treated with either of these novel anti-obesity medications.
Demaria, Thomas; Barrett, Minna; Ryan, Diane
Emotional distress appears to be a component of the medical screening process for 9/11 Public Safety Workers. A significant number of Public Safety Workers have found the anticipation of the medical examination process and actual examination to trigger reexperiencing and problems of emotional regulation. Selective Case examples are presented to illustrate how Public Safety Workers might be better prepared for this process.
Padmavathi, V; Prasad, PS Vishnu; Kundra, Pankaj
A tertiary care 1000 bedded hospital contains more than 10,000 pieces of equipment worth approximately 41 million USD, while the power cords supplied along with the imported equipment do not comply with country-specific norms. Moreover, the local vendors procure power cords with type D/M plug to complete installation and also on-site electrical safety test is not performed. Hence, this project was undertaken to evaluate the electrical safety of all life-saving equipment purchased in the year 2013, referring to the guidelines of International Electrotechnical Commission 62353, the Association for the Advancement of Medical Instrumentation (AAMI) and National Fire Protection Association (NFPA)-99 hospital standard for the analysis of protective earth resistance and chassis leakage current. This study was done with a measuring device namely electrical safety analyser 612 model from Fluke Biomedical. PMID:26903668
O'Beirne, Maeve; Sterling, Pam D
A safety learning system (SLS) is a system that monitors patient safety incident information and analyzes it to develop and implement improvement strategies to increase patient safety. The purpose of this paper is to discuss the necessary elements of a community-based family medicine practice SLS in Alberta Health Services - Calgary zone, and barriers to, and facilitators of, the implementation of this system. An SLS was developed in the research program Medical Safety in Community Practice. To determine the elements necessary to implement an SLS in community-based family medicine practice, we performed a comprehensive literature review, internal investigator discussions and internal investigator and external stakeholder reviews of key design elements. The system is currently being implemented and tested in community-based family practices as part of the program. Steps identified for implementation: included determining key design elements including creating a website and ascertaining a classification system or taxonomy; developing recruitment strategies; establishing an incident analysis methodology; building a knowledge translation strategy; and pursuing sustainability. These elements produced an SLS that is easily incorporated into community-based family medicine clinics.
Bepko, Robert J; Moore, John R; Coleman, John R
This article reports an intervention to improve the quality and safety of hospital patient care by introducing the use of pharmacy robotics into the medication distribution process. Medication safety is vitally important. The integration of pharmacy robotics with computerized practitioner order entry and bedside medication bar coding produces a significant reduction in medication errors. The creation of a safe medication-from initial ordering to bedside administration-provides enormous benefits to patients, to health care providers, and to the organization as well.
Casey, Michelle M.; Moscovice, Ira S.; Davidson, Gestur
Context: Medication safety is clearly an important quality issue for rural hospitals. However, rural hospitals face special challenges implementing medication safety practices in terms of their staffing and financial and technical resources. Purpose: This study assessed the capacity of small rural hospitals to implement medication safety…
Casey, Michelle M.; Moscovice, Ira S.; Davidson, Gestur
Context: Medication safety is clearly an important quality issue for rural hospitals. However, rural hospitals face special challenges implementing medication safety practices in terms of their staffing and financial and technical resources. Purpose: This study assessed the capacity of small rural hospitals to implement medication safety…
Holmberg, Michael J.
The U.S. Geological Survey in cooperation with the Lower Arkansas Valley Water Conservancy District measures groundwater levels periodically in about 100 wells completed in the alluvial material of the Arkansas River Valley in Pueblo, Crowley, Otero, Bent, and Prowers Counties in southeastern Colorado, of which 95 are used for the analysis in this report. The purpose of this report is to provide information to water-resource administrators, managers, planners, and users about groundwater characteristics in the alluvium of the lower Arkansas Valley extending roughly 150 miles between Pueblo Reservoir and the Colorado-Kansas State line. This report includes three map sheets showing (1) bedrock altitude at the base of the alluvium of the lower Arkansas Valley; (2) estimated spring-to-spring and fall-to-fall changes in water-table altitude between 2002, 2008, and 2015; and (3) estimated saturated thickness in the alluvium during spring and fall of 2002, 2008, and 2015, and thickness of the alluvium in the lower Arkansas Valley. Water-level changes were analyzed by geospatial interpolation methods.Available data included all water-level measurements made between January 1, 2001, and December 31, 2015; however, only data from fall and spring of 2002, 2008, and 2015 are mapped in this report. To account for the effect of John Martin Reservoir in Bent County, Colorado, lake levels at the reservoir were assigned to points along the approximate shoreline and were included in the water-level dataset. After combining the water-level measurements and lake levels, inverse distance weighting was used to interpolate between points and calculate the altitude of the water table for fall and spring of each year for comparisons. Saturated thickness was calculated by subtracting the bedrock surface from the water-table surface. Thickness of the alluvium was calculated by subtracting the bedrock surface from land surface using a digital elevation model.In order to analyze the response
Carrasco, Oscar; Gomez, Richard B.; Chainani, Arun; Roper, William E.
This paper analyzes the feasibility and performance of HSI systems for medical diagnosis as well as for food safety. Illness prevention and early disease detection are key elements for maintaining good health. Health care practitioners worldwide rely on innovative electronic devices to accurately identify disease. Hyperspectral imaging (HSI) is an emerging technique that may provide a less invasive procedure than conventional diagnostic imaging. By analyzing reflected and fluorescent light applied to the human body, a HSI system serves as a diagnostic tool as well as a method for evaluating the effectiveness of applied therapies. The safe supply and production of food is also of paramount importance to public health illness prevention. Although this paper will focus on imaging and spectroscopy in food inspection procedures -- the detection of contaminated food sources -- to ensure food quality, HSI also shows promise in detecting pesticide levels in food production (agriculture.)
The estimates of the contribution of drowsiness and fatigue to the number of road crashes is often neglected considerably, due both to under-reporting of these factors by drivers, and technical difficulty in investigating the problem. Preventing and treating the reasons for falling asleep behind the wheel may have considerable contribution in traffic safety. Therefore the licensing authorities in co-operation with the medical profession should attend more closely to the issue of sleep related disorders and their implications for driving in cases with notoriously high risk. The police and other enforcement authorities need appropriate knowledge and procedures to detect drivers at risk of falling asleep while driving. Considering the increasing number of road traffic accidents day per day, it is a need of the hour to detect drivers possibly at risk, and to take appropriate precautions in terms of education, advice and treatment regimes, as well as restrictions on licensing.
Green, Jody L; Wang, George Sam; Reynolds, Kate M; Banner, William; Bond, G Randall; Kauffman, Ralph E; Palmer, Robert B; Paul, Ian M; Dart, Richard C
The safety of cough and cold medication (CCM) use in children has been questioned. We describe the safety profile of CCMs in children <12 years of age from a multisystem surveillance program. Cases with adverse events (AEs) after ingestion of at least 1 index CCM ingredient (brompheniramine, chlorpheniramine, dextromethorphan, diphenhydramine, doxylamine, guaifenesin, phenylephrine, and pseudoephedrine) in children <12 years of age were collected from 5 data sources. An expert panel determined relatedness, dose, intent, and risk factors. Case characteristics and AEs are described. Of the 4202 cases reviewed, 3251 (77.4%) were determined to be at least potentially related to a CCM, with accidental unsupervised ingestions (67.1%) and medication errors (13.0%) the most common exposure types. Liquid (67.3%), pediatric (75.5%), and single-ingredient (77.5%) formulations were most commonly involved. AEs occurring in >20% of all cases included tachycardia, somnolence, hallucinations, ataxia, mydriasis, and agitation. Twenty cases (0.6%) resulted in death; most were in children <2 years of age (70.0%) and none involved a therapeutic dose. The overall reported AE rate was 0.573 cases per 1 million units (ie, tablets, gelatin capsules, or liquid equivalent) sold (95% confidence interval, 0.553-0.593) or 1 case per 1.75 million units. The rate of AEs associated with CCMs in children was low. Fatalities occurred even less frequently. No fatality involved a therapeutic dose. Accidental unsupervised ingestions were the most common exposure types and single-ingredient, pediatric liquid formulations were the most commonly reported products. These characteristics present an opportunity for targeted prevention efforts. Copyright © 2017 by the American Academy of Pediatrics.
Hinrichs, Saba; Dickerson, Terry; Clarkson, John
This study identifies the stakeholders who have a role in medical device purchasing within the wider system of health-care delivery and reports on their particular challenges to promote patient safety during purchasing decisions. Data was collected through observational work, participatory workshops, and semi-structured qualitative interviews, which were analyzed and coded. The study takes a systems-based and engineering design approach to the study. Five hospitals took part in this study, and the participants included maintenance, training, clinical end-users, finance, and risk departments. The main stakeholders for purchasing were identified to be staff from clinical engineering (Maintenance), device users (Clinical), device trainers (Training), and clinical governance for analyzing incidents involving devices (Risk). These stakeholders display varied characteristics in terms of interpretation of their own roles, competencies for selecting devices, awareness and use of resources for purchasing devices, and attitudes toward the purchasing process. The role of "clinical engineering" is seen by these stakeholders to be critical in mediating between training, technical, and financial stakeholders but not always recognized in practice. The findings show that many device purchasing decisions are tackled in isolation, which is not optimal for decisions requiring knowledge that is currently distributed among different people within different departments. The challenges expressed relate to the wider system of care and equipment management, calling for a more systemic view of purchasing for medical devices.
... December 23, 2010. SYSTEM. FDA-2011-M-0035 P100028 Cook Medical, Inc.. FORMULA BALLOON- January 14, 2011...-0132, FDA-2011-M-0170, FDA-2011-M-0175, and FDA-2011-M-0198] Medical Devices; Availability of Safety...
Burns, Brian J; Habig, Karel; Reid, Cliff; Kernick, Paul; Wilkinson, Chris; Tall, Gary; Coombes, Sarah; Manning, Ron
This article reviews the logistics and safety of extracorporeal membrane oxygenation (ECMO) medical retrieval in New South Wales, Australia. We describe the logistics involved in ECMO road and rotary-wing retrieval by a multidisciplinary team during the H1N1 influenza epidemic in winter 2009 (i.e., June 1 to August 31, 2009). Basic patient demographics and key retrieval time lines were analyzed. There were 17 patients retrieved on ECMO, with their ages ranging from 22 to 55 years. The median weight was 110 kg. Four critical events were recorded during retrieval, with no adverse outcomes. The retrieval distance varied from 20.8 to 430 km. There were delays in times from retrieval booking to both retrieval tasking and retrieval team departure in 88% of retrievals. The most common reasons cited were "patient not ready" 23.5% (4/17); "vehicle not available," 23.5% (4/17); and "complex retrieval," 41.2% (7/17). The median time (hours:minutes) from booking with the medical retrieval unit (MRU) to tasking was 4:35 (interquartile range [IQR] 3:27-6:15). The median time lag from tasking to departure was 1:00 (IQR 00:10-2:20). The median stabilization time was 1:30 (IQR 1:20-1:55). The median retrieval duration was 7:35 (IQR 5:50-10:15). The process of development of ECMO retrieval was enabled by the preexistence of a high-volume experienced medical retrieval service. Although ECMO retrieval is not a new concept, we describe an entire process for ECMO retrieval that we believe will benefit other retrieval service providers. The increased workload of ECMO retrieval during the swine flu pandemic has led to refinement in the system and process for the future.
Costello, Jennifer L; Torowicz, Deborah Lloyd; Yeh, Timothy S
The effects of a pharmacist-led pediatrics medication safety team (PMST) on the frequency and severity of medication errors reported were studied. This study was conducted in a pediatric critical care center (PCCC) in three phases. Phase 1 consisted of retrospective collection of medication-error reports before any interventions were made. Phases 2 and 3 included prospective collection of medication-error reports after several interventions. Phase 2 introduced a pediatrics clinical pharmacist to the PCCC. A pediatrics clinical pharmacist-led PMST (including a pediatrics critical care nurse and pediatrics intensivist), a new reporting form, and educational forums were added during phase 3 of the study. In addition, education focus groups were held for all intensive care unit staff. Outcomes for all phases were measured by the number of medication-error reports processed, the number of incidents, error severity, and the specialty of the reporter. Medication-error reporting increased twofold, threefold, and sixfold between phases 1 and 2, phases 2 and 3, and phases 1 and 3, respectively. Error severity decreased over the three time periods. In phases 1, 2, and 3, 46%, 8%, and 0% of the errors were classified as category D or E, respectively. Conversely, the reporting of near-miss errors increased from 9% in phase 1 to 38% in phase 2 and to 51% in phase 3. An increase in the number of medication errors reported and a decrease in the severity of errors reported were observed in a PCCC after implementation of a PMST, provision of education to health care providers, and addition of a clinical pharmacist.
Marugg Mary; Erceg, Linda Ebner; Weinberg, Stuart
Staff medications, except for time-critical medications, should be kept at the camp health center, separate from camper medications. Medication use should be documented, with efforts to insure confidentiality. Staff should be able to access their own medications unless they are controlled substances. Medication policies should be explained to…
The contribution is concerned with the correlations between risk information, patient safety, responsibility and liability, in particular in terms of liability law. These correlations have an impact on safety culture in healthcare, which can be evaluated positively if--in addition to good quality of medical care--as many sources of error as possible can be identified, analysed, and minimised or eliminated by corresponding measures (safety or risk management). Liability influences the conduct of individuals and enterprises; safety is (probably) also a function of liability; this should also apply to safety culture. The standard of safety culture does not only depend on individual liability for damages, but first of all on strict enterprise liability (system responsibility) and its preventive effects. Patient safety through quality and risk management is therefore also an organisational programme of considerable relevance in terms of liability law.
Pires, Aline de Oliveira Meireles; Ferreira, Maria Beatriz Guimarães; Nascimento, Kleiton Gonçalves do; Felix, Márcia Marques Dos Santos; Pires, Patrícia da Silva; Barbosa, Maria Helena
to elaborate and validate a checklist to identify compliance with the recommendations for the structure of medication prescriptions, based on the Protocol of the Ministry of Health and the Brazilian Health Surveillance Agency. methodological research, conducted through the validation and reliability analysis process, using a sample of 27 electronic prescriptions. the analyses confirmed the content validity and reliability of the tool. The content validity, obtained by expert assessment, was considered satisfactory as it covered items that represent the compliance with the recommendations regarding the structure of the medication prescriptions. The reliability, assessed through interrater agreement, was excellent (ICC=1.00) and showed perfect agreement (K=1.00). the Medication Prescription Safety Checklist showed to be a valid and reliable tool for the group studied. We hope that this study can contribute to the prevention of adverse events, as well as to the improvement of care quality and safety in medication use. elaborar e validar um instrumento tipo checklist para identificar a adesão às recomendações na estrutura das prescrições de medicamentos, a partir do Protocolo do Ministério da Saúde e Agência Nacional de Vigilância Sanitária. pesquisa metodológica, conduzida por meio do processo de validade e análise de confiabilidade, com amostra de 27 prescrições eletrônicas. análises realizadas confirmaram a validade de conteúdo e a confiabilidade da versão do instrumento. A validade de conteúdo, obtida por meio da avaliação de juízes, foi considerada satisfatória por contemplar itens que representam a adesão às recomendações na estrutura das prescrições de medicamentos. A confiabilidade, avaliada por interobservadores, apresentou-se excelente (ICC=1,00) e de concordância perfeita (K=1,00). o instrumento Lista de Verificação de Segurança na Prescrição de Medicamentos demonstrou-se válido e confiável para o grupo estudado. Espera
Merritt, K; Hitchins, V M; Brown, S A
A study was undertaken to evaluate different procedures to safely remove microorganisms, protein, and mammalian cells from materials and provide a suitable method for cleaning and assessing effectiveness of cleaning medical devices for reuse or for analysis of failure. Safety considerations for the personnel performing the cleaning or handling the device after cleaning are important issues. Polystyrene plates (96 well) were used to simulate device surfaces not amenable to manual scrubbing. Staphylococcus epidermidis, Candida albicans, Escherichia coli, Pseudomonas aeruginosa, and oral flora were grown in the plates. The plates were stained with crystal violet and the optical densities recorded. The results indicated that E. coli did not adhere well and Pseudomonas formed clumps that were easily detached from the surface of the plates. However, S. epi, C. albicans, and the oral organisms formed adherent biofilms that were difficult to remove from the plates. Detergents with enzymes and sodium hypochlorite (NaOCl) bleach were both effective in removing the biofilm. Other detergents and surfactants were not effective. The aldehyde agents did not remove the organisms and made further cleaning difficult. Allowing the biofilm to dry first made cleaning very difficult. Only the NaOCl bleach could subsequently remove the dried or aldehyde fixed organisms from the wells. The same 96-well polystyrene plate format was used to measure the amount of protein and cell adherence as well as the effectiveness of subsequent cleaning. Bradford reagent was used to detect protein as a measure of the cleaning efficacy. As with the bacteria, NaOCl bleach was effective at removing the protein and cells that had been dried or fixed by formalin or alcohol, whereas detergent with enzymes was not very effective. This study confirmed that used medical devices, contaminated with microorganisms, protein, and/or mammalian cells, should not be allowed to dry before cleaning and that a thorough
Saxton, James W; Finkelstein, Maggie M; Marles, Adam F
Physician practices can enhance their economics by taking patient safety to a new level within their practices. Patient safety has a lot to do with systems and processes that occur not only at the hospital but also within a physician's practice. Historically, patient safety measures have been hospital-focused and -driven, largely due to available resources; however, physician practices can impact patient safety, efficiently and effectively, with a methodical plan involving assessment, prioritization, and compliance. With the ever-increasing focus of reimbursement on quality and patient safety, physician practices that implement a true culture of safety now could see future economic benefits using this business strategy.
... HUMAN SERVICES Agency for Healthcare Research and Quality Patient Safety Organizations: Delisting for...: Notice of Delisting. SUMMARY: AHRQ has delisted Medical Informatics as a Patient Safety Organization (PSO... (Patient Safety Act) authorizes the listing of PSOs, which are entities or component organizations...
An estimated 108,000 people die each year from potentially preventable iatrogenic injury. One in 50 hospitalized patients experiences a preventable adverse event. Up to 3% of these injuries and events take place in emergency departments. With long and detailed training, morbidity and mortality conferences, and an emphasis on practitioner responsibility, medicine has traditionally faced the challenges of medical error and patient safety through an approach focused almost exclusively on individual practitioners. Yet no matter how well trained and how careful health care providers are, individuals will make mistakes because they are human. In general medicine, the study of adverse drug events has led the way to new methods of error detection and error prevention. A combination of chart reviews, incident logs, observation, and peer solicitation has provided a quantitative tool to demonstrate the effectiveness of interventions such as computer order entry and pharmacist order review. In emergency medicine (EM), error detection has focused on subjects of high liability: missed myocardial infarctions, missed appendicitis, and misreading of radiographs. Some system-level efforts in error prevention have focused on teamwork, on strengthening communication between pharmacists and emergency physicians, on automating drug dosing and distribution, and on rationalizing shifts. This article reviews the definitions, detection, and presentation of error in medicine and EM. Based on review of the current literature, recommendations are offered to enhance the likelihood of reduction of error in EM practice.
Liddle, Stephanie; Grover, Lata; Zhang, Rachel; Khitrov, Maxim; Brown, Joan C; Cobb, J Perren; Goldman, Julian; Chou, Joseph; Yagoda, Daniel; Westover, Brandon; Reisner, Andrew T
Our hospital became interested in the extraction of electronic data from our bedside monitor network to enrich clinical care, and enable various quality improvement projects, research projects, and future applications involving advanced decision-support. We conducted a range of tests to confirm the safety of deploying BedMaster (Excel Medical Electronics, Jupiter FL, USA), which is third-party software sold expressly to provide electronic data extraction and storage from networked General Electric Healthcare bedside patient monitors. We conducted a series of tests examining the changes in network performance when the BedMaster system was on our isolated patient monitor network. We found that use of BedMaster led to measurable, but trivial increases in network traffic and latency. We did not identify any failure scenarios in our analysis and testing. The major value of this report is to highlight potential challenges inherent in data and electronic device integration within the healthcare setting. In describing our strategy for testing the BedMaster system, it is our intention to present one testing protocol and to generate thought and discussion in the broader community about what types of problems can arise with inter-operability, and what types of testing are necessary to mitigate against these risks. Standards for inter-operability would surely reduce the inherent risks.
Duke, Jon; Friedlin, Jeff; Li, Xiaochun
Bioequivalent medications are required by the Food and Drug Administration to have identical warnings on their labels. This requirement has both clinical and legal importance, yet has never been validated. We sought to determine the real-world consistency of electronic labeling for bioequivalent drugs from different manufacturers. Using natural language processing, we indexed the adverse drug reactions (ADRs) found in the Adverse Reactions and Post-Marketing sections of 9105 structured product labels. We calculated the standard deviation in ADR labeling for each bioequivalent drug and the percent deviation of each generic label from its corresponding brand. We also analyzed the performance of individual generic manufacturers. For the 25 drugs with the greatest discrepancy in labeled ADRs, we performed manual review to identify causes of inconsistency. 68% of multi-manufacturer drugs had discrepancies in ADR labeling. For a given drug, the mean deviation in number of labeled ADRs was 4.4, and the median was 0.8 (IQR 0 to 3.2). The mean range in number of labeled ADRs was 12 +/- 0.9, and the median was 2 (IQR 0 to 9). Overall, 77.9% of generic manufacturers produced labels differing from brand. Causes of inconsistency included missing tables, outdated post-marketing reports, and formatting issues. Despite FDA mandate, bioequivalent drugs often differ in their safety labeling. Physicians should be aware of such differences and regulators should consider new strategies for harmonizing bioequivalent labels. Copyright © 2012 John Wiley & Sons, Ltd.
Sujan, Mark A; Koornneef, Floor; Chozos, Nick; Pozzi, Simone; Kelly, Tim
In the United Kingdom, there are more than 9000 reports of adverse events involving medical devices annually. The regulatory processes in Europe and in the United States have been challenged as to their ability to protect patients effectively from unreasonable risk and harm. Two of the major shortcomings of current practice include the lack of transparency in the safety certification process and the lack of involvement of service providers. We reviewed recent international standardisation activities in this area, and we reviewed regulatory practices in other safety-critical industries. The review showed that the use of safety cases is an accepted practice in UK safety-critical industries, but at present, there is little awareness of this concept in health care. Safety cases have the potential to provide greater transparency and confidence in safety certification and to act as a communication tool between manufacturers, service providers, regulators and patients.
Blasiak, Rachel C; Stokes, Claire L; Meyerhoff, Karen L; Hines, Rachel E; Wilson, Lindsay A; Viera, Anthony J
The Association of American Medical Colleges and the World Health Organization have endorsed formal patient safety and quality improvement (QI) education for medical students. We surveyed medical students to assess their current level of patient safety and QI knowledge and to identify factors associated with increased knowledge. A literature review, focus groups with medical students, and local expert interviews were used to develop an electronic survey, which was distributed to all medical students at a single medical school in the spring of 2012. Fifty-seven percent of the medical school student body (N = 790) participated in the survey. A greater proportion of students reported previous exposure to patient safety education than to QI education (79% vs 47%). Students scored an average of 56% and 58% on the patient safety and QI knowledge tests, respectively. Having or pursuing an advanced degree (P = .02) and previous exposure to patient safety education (P = .02) were associated with higher knowledge scores. After adjusting for confounding variables, only previous exposure to QI education (P = .02) was associated with higher QI knowledge scores. There is a risk of measurement bias due to the use of an unvalidated instrument. Students who have greater knowledge of patient safety or QI might recall exposure at a greater frequency, inflating the association between exposure and knowledge. Also, this is a cross-sectional study, so we cannot draw conclusions about causality. Medical students' knowledge of patient safety and QI is low. Previous formal or informal education about these topics is associated with increased knowledge.
Hagopian, Benjamin; Singer, Mendel E; Curry-Smith, Anne C; Nottingham, Kelly; Hickner, John
A strong safety culture is an essential element of safe medical practice. Few studies, however, have studied the link between safety culture and clinical quality outcomes. In this study, we examined the association between safety culture and quality measures in primary care offices. A total of 24 primary care offices in Cleveland, Ohio. The Medical Office Survey on Patient Safety was administered to clinicians and support staff to rate 12 dimensions of safety culture and a single overall patient safety rating. An average of the 12 safety culture dimension scores was calculated to produce an aggregated patient safety score. Using linear correlation, we calculated the association between the 2 summary safety measures (overall patient safety rating and aggregated patient safety score) and 2 composite quality measures, a chronic disease score, and a prevention score. The survey response rate was 79% (387/492). There was considerable variation in both safety culture scores and quality scores from office to office. There was no association between the chronic disease score and either summary measure of safety culture. There were small but statistically significant negative associations between the prevention score and the overall patient safety rating (β = -0.087, P = 0.002) as well as the aggregated patient safety score (β = -0.004, P = 0.007). Although safety theory predicts a positive association between safety culture and quality, we found no meaningful associations between safety culture and currently accepted measures of primary care clinical quality. Larger studies across several health care organizations are needed to determine whether these findings are reproducible. If so, it may be necessary to reconsider the dimensions of safety culture in primary care as well as the relationship between safety culture and primary care clinical quality.
Gagne, Joshua J; Fireman, Bruce; Ryan, Patrick B; Maclure, Malcolm; Gerhard, Tobias; Toh, Sengwee; Rassen, Jeremy A; Nelson, Jennifer C; Schneeweiss, Sebastian
Active medical product monitoring systems, such as the Sentinel System, will utilize electronic healthcare data captured during routine health care. Safety signals that arise from these data may be spurious because of chance or bias, particularly confounding bias, given the observational nature of the data. Applying appropriate monitoring designs can filter out many false-positive and false-negative associations from the outset. Designs can be classified by whether they produce estimates based on between-person or within-person comparisons. In deciding which approach is more suitable for a given monitoring scenario, stakeholders must consider the characteristics of the monitored product, characteristics of the health outcome of interest (HOI), and characteristics of the potential link between these. Specifically, three factors drive design decisions: (i) strength of within-person and between-person confounding; (ii) whether circumstances exist that may predispose to misclassification of exposure or misclassification of the timing of the HOI; and (iii) whether the exposure of interest is predominantly transient or sustained. Additional design considerations include whether to focus on new users, the availability of appropriate active comparators, the presence of an exposure time trend, and the measure of association of interest. When the key assumptions of self-controlled designs are fulfilled (i.e., lack of within-person, time-varying confounding; abrupt HOI onset; and transient exposure), within-person comparisons are preferred because they inherently avoid confounding by fixed factors. The cohort approach generally is preferred in other situations and particularly when timing of exposure or outcome is uncertain because cohort approaches are less vulnerable to biases resulting from misclassification.
... its Motor Carrier Safety Advisory Committee (MCSAC) and Medical Review Board (MRB) on September 9-10... information about Schedule II medications and their effect on CMV drivers' ability to operate safely. Meetings... Transportation, with the advice of the MRB and the chief medical examiner, to establish, review, and revise...
Jin, Chunhua; Xu, Chunxiang; Zhang, Xiaojun; Li, Fagen
Patient medication safety is an important issue in patient medication systems. In order to prevent medication errors, integrating Radio Frequency Identification (RFID) technology into automated patient medication systems is required in hospitals. Based on RFID technology, such systems can provide medical evidence for patients' prescriptions and medicine doses, etc. Due to the mutual authentication between the medication server and the tag, RFID authentication scheme is the best choice for automated patient medication systems. In this paper, we present a RFID mutual authentication scheme based on elliptic curve cryptography (ECC) to enhance patient medication safety. Our scheme can achieve security requirements and overcome various attacks existing in other schemes. In addition, our scheme has better performance in terms of computational cost and communication overhead. Therefore, the proposed scheme is well suitable for patient medication systems.
Owen, Michael C; Chang, Nancy M; Chong, David H; Vawdrey, David K
Clinical documents frequently contain a list of a patient's medications. Missing information about the dosage, route, or frequency of a medication impairs clinical communication and may harm patients. We examined 253 medication lists. There were 181 lists (72%) with at least one medication missing a dose, route, or frequency. Missing information was judged to be potentially harmful in 47 of the lists (19% of 253) by three physician reviewers (kappa=0.69). We also observed that many lists contained additional information included as annotations, prompting a secondary thematic analysis of the annotations. Fifty-five of the 253 lists (22%) contained one or more annotations. The most frequent types of annotations were comments about the patient's medical history, the clinician's treatment plan changes, and the patient's adherence to a medication. Future development of electronic medication reconciliation tools to improve medication list completeness should also support annotating the medication list in a flexible manner.
Thomas, A N; Panchagnula, U
We reviewed all patient safety incidents reported to the UK National Patient Safety Agency between 1st August 2006 and 28th February 2007 from intensive care or high dependency units. Incidents involving medications were then categorised. 12 084 incidents were submitted from 151 organisations (median 40, range 1-634/organisation). 2428 incidents were associated with medication use involving 355 different drugs, most commonly morphine (207 incidents), gentamicin (190 incidents) and noradrenaline (133 incidents). Noradrenaline (55 incidents of harm) and insulin (48 incidents of harm) were most commonly associated with patient harm. Sixty-one percent of medication incidents were associated with drug administration and 26% with prescription. Two hundred and eighty-seven medication incidents caused temporary harm and 43 more than temporary harm. Five per cent of medication incidents were associated with staff communication during transfer from theatre or recovery. Categorisation of medication-associated incidents has allowed us to suggest changes to improve the reporting of incidents and to improve medication safety.
Gilley, Debbie Bray; Holmberg, Ola
Patient safety should be considered in the use of ionising radiation equipment in medicine. The International Atomic Energy Agency (IAEA) establishes standards of safety and provides for the application of these standards, also in the area of medical use of radiation. Equipment acceptability, as it relates to radiation in medicine, is the need to satisfy the requirements or standards prior to the use of the device in patient imaging or treatment. Through IAEA activities in establishing and developing Safety Standards, Safety Reports and recommendations to regulatory authorities and end-users, it encourages the adoption of acceptability criteria that are relevant to the medical equipment and its use.
Friday, Nancy A.; Zerbini, Alexandre N.; Waite, Janice M.; Moore, Sue E.; Clapham, Phillip J.
As part of the Bering Sea Project, cetacean surveys were conducted to describe distribution and estimate abundance on the eastern Bering Sea shelf. Three marine mammal observers conducted visual surveys along transect lines sampled during the Alaska Fisheries Science Center walleye pollock assessment survey in June and July of 2008 and 2010. Distribution and abundance in 2008 and 2010 (cold years) are compared with results from a similar survey conducted in 2002 (a warm year), as the only three years that the entire survey area was sampled; patterns largely match those previously observed. Abundance estimates for comparable areas in 2002, 2008 and 2010 were as follows: humpback whales (Megaptera novaeangliae): 231 (CV=0.63), 436 (CV=0.45), and 675 (CV=0.80); fin whales (Balaenoptera physalus): 419 (CV=0.33), 1368 (CV=0.34), and 1061 (CV=0.38); minke whales (Balaenoptera acutorostrata): 389 (CV=0.52), 517 (CV=0.69), and 2020 (CV=0.73); Dall's porpoise (Phocoenoides dalli): 35,303 (CV=0.53), 14,543 (CV=0.32), and 11,143 (CV=0.32); and harbor porpoise (Phocoena phocoena): 1971 (CV=0.46), 4056 (CV=0.40), and 833 (CV=0.66). It should be noted that these abundance estimates are not corrected for biases due to perception, availability, or responsive movement. Estimates for humpback, fin and minke whales increased from 2002 to 2010, while those for harbor and Dall's porpoise decreased; trends were significant for fin whales. It is likely that changes in estimated abundance are due at least in part to shifts in distribution and not just changes in overall population size. Annual abundance estimates were examined by oceanographic domain. Humpback whales were consistently concentrated in coastal waters north of Unimak Pass. Fin whales were broadly distributed in the outer domain and slope in 2008 and 2010, but sightings were sparse in 2002. Minke whales were distributed throughout the study area in 2002 and 2008, but in 2010 they were concentrated in the outer domain and
Kuo, Grace M; Steinbauer, Jeffrey R; Spann, Stephen J
To describe a roadmap for developing a practice-based research network (PBRN) through the experience of conducting medication safety research projects in a primary care physician PBRN. Southern Primary-care Urban Research Network (SPUR-Net) in Houston, Tex., from 2000 to 2007. SPUR-Net is a partnership of six health care organizations in Houston and includes 32 clinics with 313 primary care clinicians (50% family physicians, 25% general internists, and 25% pediatricians) who provide care for approximately 1 million patient encounters annually. The pharmacist principal investigator collaborates with physicians and researchers in primary care clinics to investigate medication safety practice in SPUR-Net. (1) A roadmap for PBRN research and (2) initiation of a research program focusing on medication safety through the PBRN. A roadmap with 10 steps for conducting practice-based research is recommended: (1) form collaborative partnership, (2) develop research infrastructure, (3) formulate research questions, (4) design study methods, (5) obtain funding support, (6) develop study instruments, (7) implement the study, (8) manage and analyze data, (9) disseminate results, and (10) translate research into practice. Four research projects focusing on medication safety were conducted in SPUR-Net from 2002 to 2007. Medication outcomes include improved medication use, increased awareness for medication counseling, decreased medication errors, and identification of best practices for medication reconciliation. Practice-based research conducted in primary care settings identifies, studies, and evaluates common problems encountered in busy clinic practice. With feedback from stakeholders, best practices and improved practice can be identified and "translated" back to practice. Grant funding for research projects helps sustain PBRNs. The implementation of medication safety research projects has helped primary care clinics, clinicians, and patients increase appropriate medication
Yu, K; Nation, R; Dooley, M
Objectives: To identify the terms and definitions used by organisations involved in medication safety and to examine differences in functional meaning using a novel scenario assignment method. Methods: Medication safety related terms and definitions were sought from websites of organisations associated with medication safety. The functional meanings of terms and definitions were analysed and compared using a scenario assignment method where each definition found was assessed against four scenarios with a central theme. Main outcome measures: Medication safety related terms and definitions currently in use, similarities and differences in their functional meanings, and practical implications of the use of these terms and definitions. Results: Thirty three of 160 websites searched were found to have one or more definitions for medication safety related terms. Twenty five different terms with 119 definitions were found. The most frequently defined groups of terms were "adverse event" (8 different definitions), "error" (n = 9), "near miss" (n = 12), "adverse reaction" (n = 8), and "incident" (n = 4). Substantial diversity of functional meanings of definitions was demonstrated using the scenario-assignment method. Of the five groups of frequently defined terms, definitions within the "adverse event", "near miss", and "incident" groups resulted in three functional meanings each, while two functional meanings resulted for "error" and "adverse reaction". Conclusion: The multiplicity of terms, definitions and, most importantly, functional meanings demonstrates the urgent need for agreement on standardisation of nomenclature describing medication related occurrences. This is an essential prerequisite to enable meaningful analysis of incidence data and development of medication safety improvement strategies. PMID:16195570
How to prevent medical adverse events and augment the public's confidence in healthcare has become an urgent and one of the highest-priority medical policy issues in Japan. All parties involved in healthcare, such as medical institutions, companies that sell medical supplies and devices, educational institutions, and medical societies, are asked to work together cooperatively in their respective roles to ensure medical safety. Medical institutions, as the facilities that actually provide healthcare, are responsible for improving the safety and reliability of medical treatment. They must do this through appropriate supervision of their organizations and maintenance of their systems under the sound leadership of their management, and they must tackle safety measures by improving their organizations. Medical societies are expected not only to make scientific contributions but also to collect and evaluate information on the risks in their specialties and disseminate the information widely to their members. The national government must clarify the short- and long-term goals for promoting medical safety. At the same time, it must maintain the appropriate environment and coordinate the involvement of concerned parties in the achievement of those goals.
Gmuer, N.F.; Thomlinson, W.
This report contains a safety analysis for the X17B2 beamline synchrotron medical research facility. Health hazards, risk assessment and building systems are discussed. Reference is made to transvenous coronary angiography. (LSP)
Adhikari, Radha; Tocher, Jennifer; Smith, Pam; Corcoran, Janet; MacArthur, Juliet
Medication management is a complex multi-stage and multi-disciplinary process, involving doctors, pharmacists, nurses and patients. Errors can occur at any stage from prescribing, dispensing and administering, to recording and reporting. There are a number of safety mechanisms built into the medication management system and it is recognised that nurses are the final stage of defence. However, medication error still remains a major challenge to patient safety globally. This paper aims to illustrate two main aspects of medication safety practices that have been elicited from an action research study in a Scottish Health Board and three local Higher Education Institutions: firstly current medication safety practices in two clinical settings; and secondly pre and post-registration nursing education and teaching on medication safety. This paper is based on Phase One and Two of an Action Research project. An ethnography-style observational method, influenced by an Appreciative Inquiry (AI) approach was adapted to study the everyday medication management systems and practices of two hospital wards. This was supplemented by seven in-depth interviews with nursing staff, numerous informal discussions with healthcare professionals, two focus-groups, one peer-interview and two in-depth individual interviews with final year nursing students from three Higher Education Institutions in Scotland. This paper highlights the current positive practical efforts in medication safety practices in the chosen clinical areas. Nursing staff do employ the traditional 'five right' principles - right patient, right medication, right dose, right route and right time - for safe administration. Nursing students are taught these principles in their pre-registration nursing education. However, there are some other challenges remaining: these include the establishment of a complete medication history (reconciliation) when patients come to hospital, the provision of an in-depth training in
Hughes, Linda C; Chang, Yunkyung; Mark, Barbara A
Describing the safety climate in hospitals is an important first step in creating work environments where safety is a priority. Yet, little is known about the patient safety climate on medical-surgical units. Study purposes were to describe quality and strength of the patient safety climate on medical-surgical units and explore hospital and unit characteristics associated with this climate. Data came from a larger organizational study to investigate hospital and unit characteristics associated with organizational, nurse, and patient outcomes. The sample for this study was 3,689 RNs on 286 medical-surgical units in 146 hospitals. Nursing workgroup and managerial commitment to safety were the two most strongly positive attributes of the patient safety climate. However, issues surrounding the balance between job duties and safety compliance and nurses' reluctance to reveal errors continue to be problematic. Nurses in Magnet hospitals were more likely to communicate about errors and participate in error-related problem solving. Nurses on smaller units and units with lower work complexity reported greater safety compliance and were more likely to communicate about and reveal errors. Nurses on smaller units also reported greater commitment to patient safety and participation in error-related problem solving. Nursing workgroup commitment to safety is a valuable resource that can be leveraged to promote a sense of personal responsibility for and shared ownership of patient safety. Managers can capitalize on this commitment by promoting a work environment in which control over nursing practice and active participation in unit decisions are encouraged and by developing channels of communication that increase staff nurse involvement in identifying patient safety issues, prioritizing unit-level safety goals, and resolving day-to-day operational problems the have the potential to jeopardize patient safety.
Wallack, Madeline Carpinelli; Loafman, Mark; Sorensen, Todd D
The Patient Safety and Clinical Pharmacy Services Collaborative (PSPC) is demonstrating improvements in the quality of care delivered by safety-net organizations through integration of clinical pharmacy services. This article describes how the PSPC is leading meaningful change in the arena of medication use in management of chronic disease.
Orbæk, Janne; Gaard, Mette; Fabricius, Pia; Lefevre, Rikke S; Møller, Tom
The technology-driven medication process is complex, involving advanced technologies, patient participation and increased safety measures. Medication administration errors are frequently reported, with nurses implicated in 26-38% of in-hospital cases. This points to the need for new ways of educating nursing students in today's medication administration. To explore nursing students' experiences and competences with the technology-driven medication administration process. 16 pre-graduate nursing students were included in two focus group interviews which were recorded, transcribed and analyzed using the systematic horizontal phenomenological-hermeneutic template methodology. The interviews uncovered that understanding the technologies; professionalism and patient safety are three crucial elements in the medication process. The students expressed positivity and confidence in using technology, but were fearful of committing serious medication errors. From the nursing students' perspective, experienced nurses deviate from existing guidelines, leaving them feeling isolated in practical learning situations. Having an unclear nursing role model for the technology-driven medication process, nursing students face difficulties in identifying and adopting best practices. The impact of using technology on the frequency, type and severity of medication errors; the technologies implications on nursing professionalism and the nurses ability to secure patient adherence to the medication process, still remains to be studied. Copyright © 2014 Elsevier Ltd. All rights reserved.
Koronkowski, Michael; Eisenhower, Christine; Marcum, Zachary
The prescribing of drug therapies in older adults presents a number of safety challenges. The increased complexity of chronic care for older adults has led to polypharmacy and potentially inappropriate medication use, which can contribute to drug-induced diseases, adverse drug reactions, drug interactions, cognitive impairment, falls, hospitalization, and mortality. In this review, the authors discuss recent medication safety literature pertaining to the classes of medications commonly prescribed to older adults: anticholinergics, psychiatric medications, and antibiotics. Safety concerns associated with the use of these medications and the implications for long-term care practitioners are reviewed. The information provided can be used to inform and improve geriatric care delivered by practitioners across health care environments. PMID:27340375
Vaismoradi, Mojtaba; Griffiths, Pauline; Turunen, Hannele; Jordan, Sue
This paper discusses the application of transformational leadership to the teaching and learning of safe medication management. The prevalence of adverse drug events (ADEs) and medication-related hospitalisations (one hundred thousand each year in the USA) are of concern. This discussion is based on a narrative literature review and scrutiny of international nursing research to synthesise pedagogical strategies for the application of transformational leadership to teaching medication safety. The four elements relating transformational leadership to medication safety education are: 'Idealised influence' or role modelling, both actual and exemplary, 'Inspirational motivation' providing students with commitment to medication safety, 'Intellectual stimulation' encouraging students to value improvement and change, and 'Individualised consideration' of individual students' educational goals, practice development and patient outcomes. The model lends itself to experiential learning and a case-study approach to teaching, offering an opportunity to reduce nursing's theory-practice gap. Transformational leadership for medication safety education is characterised by a focus on the role of nurse educators and mentors in the development of students' abilities, creation of a supportive culture, and enhancement of students' creativity, motivation and ethical behaviour. This will prepare nursing graduates with the competencies necessary to be diligent about medication safety and the prevention of errors. Teaching medication safety through transformational leadership requires the close collaboration of educators, managers and policy makers. Investigation of strategies to reduced medication errors and consequent patient harm should include exploration of the application of transformational leadership to education and its impact on the number and severity of medication errors. © 2016 John Wiley & Sons Ltd.
Graudins, Linda V; Ingram, Catherine; Smith, Brodie T; Ewing, Wendy J; Vandevreede, Melita
Omitting time-critical medications leads to delays in treatment and may result in patient harm. Published studies show that omission of prescribed medication doses is common. Although most are inconsequential, up to 86% of omitted medications place patients at some risk of harm. Funding was obtained to develop a medication safety package to facilitate decreasing omitted dose incidents by audit, education and feedback. A panel of nursing and pharmacy hospital staff in Victoria, Australia, reviewed existing audit tools and published studies to develop a critical medication list and audit tool. The tool, definitions and instructions were tested in 11 rural, urban and teaching hospitals. Qualitative feedback was sought to refine the tool using a Plan-Do-Study-Act model. An educational presentation was developed using reported incidents. Staff in 11 hospitals tested the audit tool in 321 patients receiving 17 361 doses of medication. Feedback indicated audit data were useful for informing improvements in practice and for accreditation. The educational material consists of the User Guide, plus a presentation for nursing staff illustrated by six cases with questions, with instructions on how to decrease harm from omitted doses by ensuring correct documentation and prioritising time-critical medications. A medication safety package using standard definitions and a critical medication list was successfully tested. It is now used by nursing and pharmacy staff across the state. Several interstate hospitals are using the tools as part of their hospital medication safety programmes. © The Author 2014. Published by Oxford University Press in association with the International Society for Quality in Health Care; all rights reserved.
LEISS, Jack K.
Abstract: Use of personal protective equipment (PPE) and safety medical devices is mandated for healthcare workers to reduce the risk of infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV) from exposure to patients’ blood. Research has shown that a strong safety climate may promote increased use of PPE. Therefore, the objective of this study was to examine the association between safety climate and use of PPE among homecare/hospice nurses in North Carolina. To this end, a mail survey was conducted in 2006. The response rate, adjusted on the assumption that the proportion of eligible nurses from among those who did not return the questionnaire or could not be contacted was similar to the proportion among those who did return the questionnaire, was 69% (n=833 eligibles). The percentage of nurses who used the specified PPE was two to three times greater among nurses who had a strong safety climate. Safety climate was only weakly associated with using safety devices. These results suggest that improving safety climate may be a powerful tool for increasing use of PPE. PMID:25055845
Xu, Jie; Reale, Carrie; Slagle, Jason M; Anders, Shilo; Shotwell, Matthew S; Dresselhaus, Timothy; Weinger, Matthew B
Medication safety presents an ongoing challenge for nurses working in complex, fast-paced, intensive care unit (ICU) environments. Studying ICU nurse's medication management-especially medication-related events (MREs)-provides an approach to analyze and improve medication safety and quality. The goal of this study was to explore the utility of facilitated MRE reporting in identifying system deficiencies and the relationship between MREs and nurses' work in the ICUs. We conducted 124 structured 4-hour observations of nurses in three different ICUs. Each observation included measurement of nurse's moment-to-moment activity and self-reports of workload and negative mood. The observer then obtained MRE reports from the nurse using a structured tool. The MREs were analyzed by three experts. MREs were reported in 35% of observations. The 60 total MREs included four medication errors and seven adverse drug events. Of the 49 remaining MREs, 65% were associated with negative patient impact. Task/process deficiencies were the most common contributory factor for MREs. MRE occurrence was correlated with increased total task volume. MREs also correlated with increased workload, especially during night shifts. Most of these MREs would not be captured by traditional event reporting systems. Facilitated MRE reporting provides a robust information source about potential breakdowns in medication management safety and opportunities for system improvement.
Maeda, Shoichi; Kamishiraki, Etsuko; Starkey, Jay
Patient safety education, including error prevention strategies and management of adverse events, has become a topic of worldwide concern. The importance of the patient safety is also recognized in Japan following two serious medical accidents in 1999. Furthermore, educational curriculum guideline revisions in 2008 by relevant the Ministry of Education includes patient safety as part of the core medical curriculum. However, little is known about the patient safety education in Japanese medical schools partly because a comprehensive study has not yet been conducted in this field. Therefore, we have conducted a nationwide survey in order to clarify the current status of patient safety education at medical schools in Japan. Response rate was 60.0% (n = 48/80). Ninety-eight-percent of respondents (n = 47/48) reported integration of patient safety education into their curricula. Thirty-nine percent reported devoting less than five hours to the topic. All schools that teach patient safety reported use of lecture based teaching methods while few used alternative methods, such as role-playing or in-hospital training. Topics related to medical error theory and legal ramifications of error are widely taught while practical topics related to error analysis such as root cause analysis are less often covered. Based on responses to our survey, most Japanese medical schools have incorporated the topic of patient safety into their curricula. However, the number of hours devoted to the patient safety education is far from the sufficient level with forty percent of medical schools that devote five hours or less to it. In addition, most medical schools employ only the lecture based learning, lacking diversity in teaching methods. Although most medical schools cover basic error theory, error analysis is taught at fewer schools. We still need to make improvements to our medical safety curricula. We believe that this study has the implications for the rest of the world as a
Background Patient safety education, including error prevention strategies and management of adverse events, has become a topic of worldwide concern. The importance of the patient safety is also recognized in Japan following two serious medical accidents in 1999. Furthermore, educational curriculum guideline revisions in 2008 by relevant the Ministry of Education includes patient safety as part of the core medical curriculum. However, little is known about the patient safety education in Japanese medical schools partly because a comprehensive study has not yet been conducted in this field. Therefore, we have conducted a nationwide survey in order to clarify the current status of patient safety education at medical schools in Japan. Results Response rate was 60.0% (n = 48/80). Ninety-eight-percent of respondents (n = 47/48) reported integration of patient safety education into their curricula. Thirty-nine percent reported devoting less than five hours to the topic. All schools that teach patient safety reported use of lecture based teaching methods while few used alternative methods, such as role-playing or in-hospital training. Topics related to medical error theory and legal ramifications of error are widely taught while practical topics related to error analysis such as root cause analysis are less often covered. Conclusions Based on responses to our survey, most Japanese medical schools have incorporated the topic of patient safety into their curricula. However, the number of hours devoted to the patient safety education is far from the sufficient level with forty percent of medical schools that devote five hours or less to it. In addition, most medical schools employ only the lecture based learning, lacking diversity in teaching methods. Although most medical schools cover basic error theory, error analysis is taught at fewer schools. We still need to make improvements to our medical safety curricula. We believe that this study has the implications for
Pajic, Miroslav; Mangharam, Rahul; Sokolsky, Oleg; Arney, David; Goldman, Julian; Lee, Insup
In modern hospitals, patients are treated using a wide array of medical devices that are increasingly interacting with each other over the network, thus offering a perfect example of a cyber-physical system. We study the safety of a medical device system for the physiologic closed-loop control of drug infusion. The main contribution of the paper is the verification approach for the safety properties of closed-loop medical device systems. We demonstrate, using a case study, that the approach can be applied to a system of clinical importance. Our method combines simulation-based analysis of a detailed model of the system that contains continuous patient dynamics with model checking of a more abstract timed automata model. We show that the relationship between the two models preserves the crucial aspect of the timing behavior that ensures the conservativeness of the safety analysis. We also describe system design that can provide open-loop safety under network failure.
Pajic, Miroslav; Mangharam, Rahul; Sokolsky, Oleg; Arney, David; Goldman, Julian; Lee, Insup
In modern hospitals, patients are treated using a wide array of medical devices that are increasingly interacting with each other over the network, thus offering a perfect example of a cyber-physical system. We study the safety of a medical device system for the physiologic closed-loop control of drug infusion. The main contribution of the paper is the verification approach for the safety properties of closed-loop medical device systems. We demonstrate, using a case study, that the approach can be applied to a system of clinical importance. Our method combines simulation-based analysis of a detailed model of the system that contains continuous patient dynamics with model checking of a more abstract timed automata model. We show that the relationship between the two models preserves the crucial aspect of the timing behavior that ensures the conservativeness of the safety analysis. We also describe system design that can provide open-loop safety under network failure. PMID:24177176
Phipps, Denham L; Noyce, Peter R; Parker, Dianne; Ashcroft, Darren M
Background While much research has been conducted on medication safety, few of these studies have addressed primary care, despite the high volume of prescribing and dispensing of medicines that occurs in this setting. Those studies that have examined primary care dispensing emphasised the need to understand the role of sociotechnical factors (that is, the interactions between people, tasks, equipment and organisational structures) in promoting or preventing medication incidents. The aim of this study was to identify sociotechnical factors that community pharmacy staff encounter in practice, and suggest how these factors might impact on medication safety. Methods Sixty-seven practitioners, working in the North West of England, took part in ten focus groups on risk management in community pharmacy. The data obtained from these groups was subjected to a qualitative analysis to identify recurrent themes pertaining to sociotechnical aspects of medication safety. Results The findings indicated several characteristics of participants' work settings that were potentially related to medication safety. These were broadly classified as relationships involving the pharmacist, demands on the pharmacist and management and governance of pharmacists. Conclusion It is recommended that the issues raised in this study be considered in future work examining medication safety in primary care. PMID:19735550
Pfaf, V F; Gorokhova, S G; Kotenko, V A
The article covers hi-tech cardiologic care model in system of medical support of train operation safety, with definition of structure blocks in this model. Discussion covers peculiarities of the model functioning in comparison with the governmental system of hi-tech medical care, including its closed cycle principle characteristics, wide patients selection among railway workers, continuous and close cooperation between various medical speicalities, with active involvement of occupational fitness specialists (medical examination committees of various levels, including Central Medical Examination Committee), major extent of interventional rentgenosurgical technologies applied in diseases without significant functional failure.
Gershman, Jennifer A
The Institute for Safe Medication Practices encourages pharmacists to assist in preventing medication misuse. The purpose of this article is to discuss a medication-safety education session conducted by a pharmacy professor, the faculty advisor to the American Society of Consultant Pharmacists university student chapter and students in a pharmacovigilance rotation, which was conducted at a local senior center. The author attended a train-the-trainer Webinar and then educated the pharmacy students. Participants at the senior center were taught about poison prevention, drug interactions, and appropriate drug disposal through an interactive format. We plan to continue the medication safety program at the senior center as a longitudinal project to promote patient safety. Pharmacists should be encouraged to play an active role in community outreach programs.
Formea, Christine M.; Picha, Andrew F.; Griffin, Monica G.; Schaller, Jane A.; Lee, Mary R.
Abstract While clinical medicine is often well supported by health system information technology infrastructure, clinical research may need to create strategies to use clinical‐medicine informational technology tools. The authors describe a medication‐safety initiative that was carried out in a National Institutes of Health Clinical and Translational Science Award (CTSA)‐sponsored clinical research environment. A web based, medical informatics application was designed and implemented that allowed research groups to build protocol specific, electronic medication templates that were subsequently used to create participant‐specific medication order sets for conductance of clinical research activities in the CTSA‐sponsored clinical research environment. The medical informatics initiative eliminated typewritten or handwritten medication orders, created research protocol‐specific templates meeting institutional order‐writing requirements, and formalized a rigorous review and approval process. Enhancing safety in medication ordering and prescribing practices in a clinical research environment provided the background for multidisciplinary cooperation in medical informatics. Clin Trans Sci 2010; Volume 3: 312–315 PMID:21167008
Navas, H; Graffi Moltrasio, L; Ares, F; Strumia, G; Dourado, E; Alvarez, M
Within preventable medical errors, those related to medications are frequent in every stage of the prescribing cycle. Nursing is responsible for maintaining each patients safety and care quality. Moreover, nurses are the last people who can detect an error in medication before its administration. Medication administration is one of the riskiest tasks in nursing. The use of information and communication technologies is related to a decrease in these errors. Including mobile devices related to 2D code reading of patients and medication will decrease the possibility of error when preparing and administering medication by nurses. A cross-platform software (iOS and Android) was developed to ensure the five Rights of the medication administration process (patient, medication, dose, route and schedule). Deployment in November showed 39% use.
The focus of work of medical physicists in 1980’s was on quality control and quality assurance. Radiation safety was important but was dominated by occupational radiation protection. A series of over exposures of patients in radiotherapy, nuclear medicine and observation of skin injuries among patients undergoing interventional procedures in 1990’s started creating the need for focus on patient protection. It gave medical physicists new directions to develop expertise in patient dosimetry and dose management. Publications creating awareness on cancer risks from CT in early part of the current century and over exposures in CT in 2008 brought radiation risks in public domain and created challenging situations for medical physicists. Increasing multiple exposures of individual patient and patient doses of few tens of mSv or exceeding 100 mSv are increasing the role of medical physicists. Expansion of usage of fluoroscopy in the hands of clinical professionals with hardly any training in radiation protection shall require further role for medical physicists. The increasing publications in journals, recent changes in Safety Standards, California law, all increase responsibilities of medical physicists in patient protection. Newer technological developments in dose efficiency and protective devices increase percentage of time devoted by medical physicists on radiation protection activities. Without radiation protection, the roles, responsibilities and day-to-day involvement of medical physicists in diagnostic radiology becomes questionable. In coming years either medical radiation protection may emerge as a specialty or medical physicists will have to keep major part of day-to-day work on radiation protection. Learning Objectives: To understand how radiation protection has been increasing its role in day-to-day activities of medical physicist To be aware about international safety Standards, national and State regulations that require higher attention to radiation
Iscoe, Louise; And Others
This manual for child care personnel in day care homes and centers provides guidelines and information on the detection, treatment, and control of medical problems of children. Introductory materials focus on signs of illness which carepersons can recognize. Section II concentrates on insect, animal and human bites. Section III discusses skin…
Evans, Anthony D; Watson, Dougal B; Evans, Sally A; Hastings, John; Singh, Jarnail; Thibeault, Claude
The different interpretations by States (countries) of the aeromedical standards established by the International Civil Aviation Organization has resulted in a variety of approaches to the development of national aeromedical policy, and consequently a relative lack of harmonization. However, in many areas of aviation, safety management systems have been recently introduced and may represent a way forward. A safety management system can be defined as "A systematic approach to managing safety, including the necessary organizational structures, accountabilities, policies, and procedures" (1). There are four main areas where, by applying safety management principles, it may be possible to better use aeromedical data to enhance flight safety. These are: 1) adjustment of the periodicity and content of routine medical examinations to more accurately reflect aeromedical risk; 2) improvement in reporting and analysis of routine medical examination data; 3) improvement in reporting and analysis of in-flight medical events; and 4) support for improved reporting of relevant aeromedical events through the promotion of an appropriate culture by companies and regulatory authorities. This paper explores how the principles of safety management may be applied to aeromedical systems to improve their contribution to safety.
Daumit, Gail L.; McGinty, Emma E.; Pronovost, Peter; Dixon, Lisa B.; Guallar, Eliseo; Ford, Daniel E.; Cahoon, Elizabeth K.; Boonyasai, Romsai T.; Thompson, David
Objective This study explored the risk of patient safety events and associated nonfatal physical harms and mortality in a cohort of persons with serious mental illness. This group experiences high rates of medical comorbidity and premature mortality and may be at high risk of adverse patient safety events. Methods Medical record review was conducted for medical-surgical hospitalizations occurring during 1994–2004 in a community-based cohort of Maryland adults with serious mental illness. Individuals were eligible if they died within 30 days of a medical-surgical hospitalization and if they also had at least one prior medical-surgical hospitalization within five years of death. All admissions took place at Maryland general hospitals. A case-crossover analysis examined the relationships among patient safety events, physical harms, and elevated likelihood of death within 30 days of hospitalization. Results A total of 790 hospitalizations among 253 adults were reviewed. The mean number of patient safety events per hospitalization was 5.8, and the rate of physical harms was 142 per 100 hospitalizations. The odds of physical harm were elevated in hospitalizations in which 22 of the 34 patient safety events occurred (p<.05), including medical events (odds ratio [OR]=1.5, 95% confidence interval [CI]=1.3–1.7) and procedure-related events (OR=1.6, CI=1.2–2.0). Adjusted odds of death within 30 days of hospitalization were elevated for individuals with any patient safety event, compared with those with no event (OR=3.7, CI=1.4–10.3). Conclusions Patient safety events were positively associated with physical harm and 30-day mortality in nonpsychiatric hospitalizations for persons with serious mental illness. PMID:27181736
Acheampong, Franklin; Bruce, Elizabeth; Anto, Berko Panyin
Pharmacists by their training have the competences and skills to promote safe use of medicines which is an essential component of patient safety. This study explored the perceptions of hospital pharmacists' role in medication safety in Ghana, identified their attendant challenges and ways of enhancing such roles in the future. A self-administered questionnaire was delivered to 200 pharmacists selected conveniently from the 10 regions of Ghana. Questions in the questionnaire were based on a systematic literature review that had catalogued and summarised all the activities of hospital pharmacists related to medication safety. A total of 176 (88% response rate) questionnaires were completed and returned. Almost all pharmacists (97.7%) believed that they were involved in medication safety activities in their daily routine. The frequently performed activities were counselling of out-patient (91.8%), training pharmacy and other clinical students (72.2%), reporting on medication errors (70%), and reconciling medications (69.2%). The mean weekly time spent on the activities ranged from 6.5 to 19.8 hours. Participants who had clinical pharmacy related additional qualifications (χ2 = 37.749; p = 0.049) and worked in tertiary care hospitals (χ2 = 26.6; p = 0.377) undertook more medication safety activities than those without. The cited challenges faced by participants included inadequate time available (62.7%), spending most time in managerial activities (47.3%), lack of formal structures of engagement (43.8%), lack of motivation by superiors (34.9%), and no formal schedule by supervisor (32%). Only 7.7% stated they lack interest in performing those activities. Pharmacists undertake many medication safety activities routinely that they perceive to have impact on patient care outcomes. Restructuring of their managerial roles will contribute to freeing time for pharmacists to engage more in those activities.
Power, Maxine; Harrison, Abigail; Bramfitt, Kurt; Williams, Steve D.; Jani, Yogini; Ashcroft, Darren M.; Tully, Mary P.
Abstract Quality issue Approximately 10% of patients are harmed by healthcare, and of this harm 15% is thought to be medication related. Despite this, medication safety data used for improvement purposes are not often routinely collected by healthcare organizations over time. Initial assessment A need for a prospective medication safety measurement tool was identified. Choice of solution The aim was to develop a tool to allow measurement and aid improvement of medication safety over time. The methodology used for the National Health Service (NHS) Safety Thermometer was identified as an approach. The resulting tool was named the ‘Medication Safety Thermometer’. Implementation The development of the Medication Safety Thermometer was facilitated by a multidisciplinary steering group using a Plan, Do, Study, Act (PDSA) method. Alpha and beta testing occurred over a period of 9 months. The tool was officially launched in October 2013 and continued to be improved until May 2016 using ongoing user feedback. Evaluation Feedback was gained through paper and online forms, and was discussed at regular steering group meetings. This resulted in 16 versions of the tool. The tool is now used nationally, with over 230 000 patients surveyed in over 100 NHS organizations. Data from these organizations are openly accessible on a dedicated website. Lessons learned Measuring harm from medication errors is complex and requires steps to measure individual errors, triggers of harm and actual harm. PDSA methodology can be effectively used to develop measurement systems. Measurement at the point of care is beneficial and a multidisciplinary approach is vital. PMID:28035039
Stuijt, Clementine C M; Klopotowska, Joanna E; Kluft-van Driel, Chantal; Le, Nhut; Binnekade, Jan; van der Kleij, Bea; van der Schors, Tjalling; van den Bemt, Patricia; Lie-A-Huen, Loraine
Crushing solid oral dosage forms is an important risk factor for medication administration errors (MAEs) in patients with swallowing difficulties. Nursing home (NH) residents, especially those on psychogeriatric wards, have a high prevalence of such difficulties. Six different psychogeriatric wards in two Dutch NH facilities, participating over a total period of 1 year divided into preintervention, implementation, and the first and second evaluation period. Number of MAEs per number of observed medication administrations calculated for all and three subtypes of MAEs: crushing-uncrushable-medication, inappropriate-technique, and food-drug interactions. The intervention included (i) education for nursing staff about crushing medication safely, (ii) a medication administration protocol for patients with swallowing difficulties, (iii) a 'do-not-crush-medication' pocket card for the nursing staff, (iv) screening of medication charts by pharmacy technicians on potential crushing problems, and (v) advices on medication charts on safe medication administration to residents with swallowing problems. The number of crushing uncrushable medication errors, an MAE subtype with the highest potential risk for patient harm, was reduced significantly from 19 (9.6%) to 7 (3.0%; first evaluation period), adjusted odds ratio 0.20 (OR = 95%CI, 0.07-0.55). During the second evaluation period, the proportion crushing uncrushable medications errors was the only outcome that remained significantly lower in comparison with the preintervention period (p = 0.045). Introduction of a multifaceted medication safety programme in NH facilities by a pharmacy team is a tool towards safer medication administration practice in residents with swallowing difficulties. Commitment on organisational level is, however, vital to achieve sustainable improvements. Copyright © 2012 John Wiley & Sons, Ltd.
Murase, Jenny E; Heller, Misha M; Butler, Daniel C
Dermatologists are frequently faced with questions about the safety of commonly prescribed topical and systemic medications during pregnancy and lactation from women of childbearing age who are pregnant, considering pregnancy, or breastfeeding. Safety data, particularly regarding medications that are unique to dermatology, can be difficult to locate and are not consolidated in a single reference guide for clinicians. Parts I and II of this continuing medical education article provide a capsule summary of key points for the most commonly prescribed dermatologic medications to facilitate patient medication risk counseling in pregnancy. A summary table details safety classification data for 3 primary international classification systems: the US Food and Drug Administration, the Swedish Catalogue of Approved Drugs, and the Australian Drug Evaluation Committee. In addition, this table includes an alternative pregnancy classification system developed by a consortium of active members of teratology societies in the US and Europe detailed in Drugs during Pregnancy and Lactation: Treatment Options and Risk Assessment and a safety classification system developed for breastfeeding mothers detailed in Medications and Mother's Milk. Copyright © 2013 American Academy of Dermatology, Inc. Published by Mosby, Inc. All rights reserved.
Botsis, Taxiarchis; Jankosky, Christopher; Arya, Deepa; Kreimeyer, Kory; Foster, Matthew; Pandey, Abhishek; Wang, Wei; Zhang, Guangfan; Forshee, Richard; Goud, Ravi; Menschik, David; Walderhaug, Mark; Woo, Emily Jane; Scott, John
We have developed a Decision Support Environment (DSE) for medical experts at the US Food and Drug Administration (FDA). The DSE contains two integrated systems: The Event-based Text-mining of Health Electronic Records (ETHER) and the Pattern-based and Advanced Network Analyzer for Clinical Evaluation and Assessment (PANACEA). These systems assist medical experts in reviewing reports submitted to the Vaccine Adverse Event Reporting System (VAERS) and the FDA Adverse Event Reporting System (FAERS). In this manuscript, we describe the DSE architecture and key functionalities, and examine its potential contributions to the signal management process by focusing on four use cases: the identification of missing cases from a case series, the identification of duplicate case reports, retrieving cases for a case series analysis, and community detection for signal identification and characterization.
Rath, Barbara; Muhlhans, Susann; Gaedicke, Gerhard
Not only the general public, but also those studying to become health professionals, are struggling to keep up with a growing body of evidence and increasingly complex information about the many different types of vaccines available to date. At the same time, a number of increasingly complex subjects of study are competing for their attention during undergraduate and graduate education. In many medical school curricula in German-speaking countries, the subject of vaccines has been entirely omitted, or is regarded a minor subtopic. During the studies, most medical school curricula in German-speaking countries do not offer obligatory courses and/ or hands-on training vaccinology in vaccination. In Germany, private pediatricians administer the majority of immunizations. Even during postgraduate training programs in pediatrics, which are largely hospital-based, vaccinations are rarely a topic, and vaccinology remains a "hobby" and a "field without lobby" lacking specific certification requirements. Studies of acceptance of vaccines among health professionals and medical students have shown that many may still have their own doubts and uncertainties about vaccines revealing a number of unanswered questions during their studies and postgraduate training.
High, Kevin; Brywczynski, Jeremy; Guillamondegui, Oscar
The use of thoracostomy to treat tension pneumothorax is a core skill for prehospital providers. Tension pneumothoraces are potentially lethal and are often encountered in the prehospital environment. The authors reviewed the prehospital electronic medical records of patients who had undergone finger thoracostomy (FT) or tube thoracostomy (TT) while under the care of air medical crewmembers. Demographic data were obtained along with survival and complications. During the 90-month data period, 250 patients (18 years of age or older) underwent FT/TT, with a total of 421 procedures performed. The mean age of patients was 44.8 years, with 78.4% being male and 21.6% being female; 98.4% of patients had traumatic injuries. Cardiopulmonary resuscitation was required in 65.2% of patients undergoing FT/TT; 34.8% did not require cardiopulmonary resuscitation. Thirty percent of patients exhibited clinical improvement such as increasing systolic blood pressure, oxygen saturation, improved lung compliance, or a release of blood or air under tension. Patients who experienced complications such as tube dislodgement or empyema made up 3.4% of the cohort. The results of this study suggest that flight crews can use FT/TT in their practice on patients with actual or potential pneumothoraces with limited complications and generate clinical improvement in a subset of patients. Copyright © 2016 Air Medical Journal Associates. Published by Elsevier Inc. All rights reserved.
Scanlon, Matthew C.; Karsh, Ben-Tzion
Conventional wisdom suggests that the “human factor” in critical care environments is reason for inadequate medication and patient safety. Human factors (or human factors engineering (HFE)) is the science and practice of improving human performance. Using decades of HFE research, this paper evaluates a range of common beliefs about patient safety through a human factors lens. This evaluation demonstrates that HFE provides a framework for understanding safety failures in critical care settings, offers insights in to how to improve medication and patient safety, and reminds us that the “human factor” in critical care units is what allows these time pressured, information intense, mentally challenging, interruption-laden, and life-or-death environments to function so safely so much of the time. PMID:20502180
Zhang, Zezhong; Qi, Qingqing
Medication errors are very dangerous even fatal since it could cause serious even fatal harm to patients. In order to reduce medication errors, automated patient medication systems using the Radio Frequency Identification (RFID) technology have been used in many hospitals. The data transmitted in those medication systems is very important and sensitive. In the past decade, many security protocols have been proposed to ensure its secure transition attracted wide attention. Due to providing mutual authentication between the medication server and the tag, the RFID authentication protocol is considered as the most important security protocols in those systems. In this paper, we propose a RFID authentication protocol to enhance patient medication safety using elliptic curve cryptography (ECC). The analysis shows the proposed protocol could overcome security weaknesses in previous protocols and has better performance. Therefore, the proposed protocol is very suitable for automated patient medication systems.
Macdonald, Marilyn T; Heilemann, MarySue V; MacKinnon, Neil J; Lang, Ariella; Gregory, David; Gurnham, Mary Ellen; Fillatre, Theresa
The purpose of our study was to gain an understanding of current patient involvement in medication administration safety from the perspectives of both patients and nursing staff members. Administering medication is taken for granted and therefore suited to the development of theory to enhance its understanding. We conducted a constructivist, grounded theory study involving 24 patients and 26 nursing staff members and found that patients had the role of confirming delivery in the administration of medication. Confirming delivery was characterized by three interdependent subprocesses: engaging in the medication administration process, being "half out of it" (patient mental status), and perceiving time. We believe that ours is one of the first qualitative studies on the role of hospitalized patients in administering medication. Medication administration and nursing care systems, as well as patient mental status, impose limitations on patient involvement in safe medication administration.
either a fibric acid derivative or niacin . (4) A final analysis looked at therapeutic selection, whether treatment incorporated the Pharmacoeconomic...with simvastatin doses that exceed FDA safety recommendations (simvastatin dose more than 10mg/day in combination with fibrates or niacin ). A...no greater than 10 mg of simvastatin when used with fibrates or niacin .1 An assessment of medication safety from this labeling change was evaluated
Miller, Robert H; Bovbjerg, Randall R
Medical care should be safer. Inpatient problems and solutions have received the most attention; this outpatient qualitative case study addresses a gap in knowledge. We describe safety improvements among large physician groups, model the key influences on their behavior, and identify beneficial public and private policies. All groups were trying to reduce medical injury, which was part of the sample design. The most commonly targeted problems are those that are similar across groups: shortcomings in diagnosis, abnormal tests follow-up, scope of practice and referral patterns, and continuity of care. Medical group innovators vary greatly, however, in implementation of improvements, that is, in the extent to which they implement process changes that identify events/problems, analyze and track incidents, decide how to change clinical and administrative practices, and monitor impacts of the changes. Our conceptual model identifies key determinants: (1) demand for safety comes from external factors: legal, market, and professional; (2) organizational responses depend on internal factors: group size, scope, and integration; leadership and governance; professional culture; information-system assets; and financial and intellectual capital. Further, safety is an aspect of quality (the same tools, decision making, interventions, and monitoring apply), and safety management benefits from prior efficiency management (similar skills and culture of innovation). Observed variation in even simple safeguards shows that existing safety incentives are too weak. Our model suggests that the biggest improvement would come from boosting the demand for quality and safety from both private and public larger group purchasers. Current policy relies too much on litigation and discipline, which have sometimes helped, but not solved, problems because they are inefficient, tend to drive needed information underground, and complicate needed cultural change. Patients' safety demand is also weak
Virtually all health care organizations have goals of improving patient safety, but despite clear goals and considerable investments, gains have been limited. This article explores a community hospital's resounding success using Lean methodology to improve medication administration safety with process changes designed by engaged employees and leaders with the knowledge and skill to effect improvements. This article inspires an interdisciplinary approach to quality improvement using reproducible strategies.
Amenta, Valeria; Aschberger, Karin
Carbon nanotubes (CNTs) have unique atomic structure, as well as outstanding thermal, mechanical, and electronic properties, making them extremely attractive materials for several different applications. Many research groups are focusing on biomedical applications of carbon-based nanomaterials, however the application of CNTs to the biomedical field is not developing as fast as in other areas. While CNTs-based products are already being used in textiles, polymer matrices to strengthen materials, sports articles, microelectronics, energy storage, etc., medicinal products and medical devices for in vivo application based on CNTs have not been commercialized yet. However, CNTs for biomedical application, i.e., CNTs conjugated to siRNA for cancer therapy, or CNTs for imaging of colorectal cancer and many other products may enter clinical trials in the next years. Concerns related to the toxicity of CNTs must be overcome in order to have these products commercialized in a near future. This article reviews emerging biomedical applications of CNTs, specifically for therapy. It also deals with challenges associated with possible medical applications of CNTs, such as their not fully understood toxicological profile in the human body. © 2014 Wiley Periodicals, Inc.
Concern about the safety of the US food supply has stimulated criticism of the present system for assuring safe food in American markets. This report was prepared in response to resolutions introduced at the American Medical Association House of Delegates' December 1990 Interim Meeting. The resolutions requested the AMA to study the plans and procedures needed to improve the federal inspection of meat, poultry, and shellfish. To put these issues into perspective, an overview of food safety is presented. This report is not intended, however, to be a broad review of the Food and Drug Administration's and the US Department of Agriculture's responsibilities for food safety.
Blegen, M A; Sehgal, N L; Alldredge, B K; Gearhart, S; Auerbach, A A; Wachter, R M
The goal of this project was to improve unit-based safety culture through implementation of a multidisciplinary (pharmacy, nursing, medicine) teamwork and communication intervention. The Agency for Healthcare Research and Quality Hospital Survey on Patient Safety Culture was used to determine the impact of the training with a before-after design. Surveys were returned from 454 healthcare staff before the training and 368 staff 1 year later. Five of eleven safety culture subscales showed significant improvement. Nurses perceived a stronger safety culture than physicians or pharmacists. While it is difficult to isolate the effects of the team training intervention from other events occurring during the year between training and postevaluation, overall the intervention seems to have improved the safety culture on these medical units.
Lang, Ariella; Macdonald, Marilyn; Marck, Patricia; Toon, Lynn; Griffin, Melissa; Easty, Tony; Fraser, Kimberly; MacKinnon, Neil; Mitchell, Jonathan; Lang, Eddy; Goodwin, Sharon
Patient safety is a national and international priority with medication safety earmarked as both a prevalent and high-risk area of concern. To date, medication safety research has focused overwhelmingly on institutional based care provided by paid healthcare professionals, which often has little applicability to the home care setting. This critical gap in our current understanding of medication safety in the home care sector is particularly evident with the elderly who often manage more than one chronic illness and a complex palette of medications, along with other care needs. This study addresses the medication management issues faced by seniors with chronic illnesses, their family, caregivers, and paid providers within Canadian publicly funded home care programs in Alberta (AB), Ontario (ON), Quebec (QC) and Nova Scotia (NS). Informed by a socio-ecological perspective, this study utilized Interpretive Description (ID) methodology and participatory photographic methods to capture and analyze a range of visual and textual data. Three successive phases of data collection and analysis were conducted in a concurrent, iterative fashion in eight urban and/or rural households in each province. A total of 94 participants (i.e., seniors receiving home care services, their family/caregivers, and paid providers) were interviewed individually. In addition, 69 providers took part in focus groups. Analysis was iterative and concurrent with data collection in that each interview was compared with subsequent interviews for converging as well as diverging patterns. Six patterns were identified that provide a rich portrayal of the complexity of medication management safety in home care: vulnerabilities that impact the safe management and storage of medication, sustaining adequate supports, degrees of shared accountability for care, systems of variable effectiveness, poly-literacy required to navigate the system, and systemic challenges to maintaining medication safety in the home
Rhodes, Penny; McDonald, Ruth; Campbell, Stephen; Daker-White, Gavin; Sanders, Caroline
This study explores the ways in which patients make sense of 'safety' in the context of primary medical care. Drawing on qualitative interviews with primary care patients, we reveal patients' conceptualisation of safety as fluid, contingent, multi-dimensional, and negotiated. Participant accounts drew attention to a largely invisible and inaccessible (but taken for granted) architecture of safety, the importance of psycho-social as well as physical dimensions and the interactions between them, informal strategies for negotiating safety, and the moral dimension of safety. Participants reported being proactive in taking action to protect themselves from potential harm. The somewhat routinised and predictable nature of the primary medical care consultation, which is very different from 'one off' inpatient spells, meant that patients were not passive recipients of care. Instead they had a stock of accumulated knowledge and experience to inform their actions. In addition to highlighting the differences and similarities between hospital and primary care settings, the study suggests that a broad conceptualisation of patient safety is required, which encompasses the safety concerns of patients in primary care settings.
Blaginin, A A; Lizogub, I N
Issues of medical supply of aviation operations, that is part of general system of flight safety are analyzed in this article. One of the main issues is development of the system of vocational preparation of medical personnel, taking part in organization and carrying flights. This issue consists of several themes: formation of united system of education from primary to post graduate; formation of modern training facility; assurance of high potential in academic and teaching staff and providing of good basic training and high learning motivation of applicants, who wants to become a air medical officer. Fundamental principles of developed concept of medical supply of flight safety are presented. It is shown that the essential condition of good implementation of the given concept is informaltion support of all its structures.
Stahl, Kenneth; Augenstein, Jeffrey; Schulman, Carl I; Wilson, Katherine; McKenney, Mark; Livingstone, Alan
A critical aspect of enhancing patient safety is modifying the healthcare safety culture. We hypothesize that students who participate in safety curricula are knowledgeable regarding patient safety and likely to intervene to avoid patient errors. A two-part patient safety curriculum was taught: introductory theories (first year) and a clinically oriented course during surgery rotations (third year). All students participated in the first year introduction and a random cohort of students (62.6%, N = 67) participated in the third year program. Multiple choice tests and web-based surveys were administered. Statistical analysis was carried out using Student's t-test for comparisons of test mean scores and z-test for comparison of the survey data. Students who participated in both years' curricula scored higher on didactic test than those who participated in only the first year course (82.9% versus 75.5%, P < 0.001). More students participating in both portions of the curricula intervened during at least one clinical encounter to avoid a patient error (77% versus 61%, P < 0.05). Students rated junior house-staff more receptive to patient safety suggestions than surgical fellows and faculty (84% versus 66%, P < 0.05); 75% of students rated their surgical clerkship exposure to patient safety somewhat/extremely valuable compared with 54% students who rated the first year exposure as somewhat/extremely valuable (P < 0.05). Medical students who have practical applications of patient safety education reinforced during surgery rotations are knowledgeable and willing to intervene in patient safety concerns. Teaching clinically relevant patient safety skills influences positive behavioral changes in medical students' performance on surgical teams. Copyright © 2011 Elsevier Inc. All rights reserved.
Tudor Car, Lorainne; Papachristou, Nikolaos; Gallagher, Joseph; Samra, Rajvinder; Wazny, Kerri; El-Khatib, Mona; Bull, Adrian; Majeed, Azeem; Aylin, Paul; Atun, Rifat; Rudan, Igor; Car, Josip; Bell, Helen; Vincent, Charles; Franklin, Bryony Dean
Medication error is a frequent, harmful and costly patient safety incident. Research to date has mostly focused on medication errors in hospitals. In this study, we aimed to identify the main causes of, and solutions to, medication error in primary care. We used a novel priority-setting method for identifying and ranking patient safety problems and solutions called PRIORITIZE. We invited 500 North West London primary care clinicians to complete an open-ended questionnaire to identify three main problems and solutions relating to medication error in primary care. 113 clinicians submitted responses, which we thematically synthesized into a composite list of 48 distinct problems and 45 solutions. A group of 57 clinicians randomly selected from the initial cohort scored these and an overall ranking was derived. The agreement between the clinicians' scores was presented using the average expert agreement (AEA). The study was conducted between September 2013 and November 2014. The top three problems were incomplete reconciliation of medication during patient 'hand-overs', inadequate patient education about their medication use and poor discharge summaries. The highest ranked solutions included development of a standardized discharge summary template, reduction of unnecessary prescribing, and minimisation of polypharmacy. Overall, better communication between the healthcare provider and patient, quality assurance approaches during medication prescribing and monitoring, and patient education on how to use their medication were considered the top priorities. The highest ranked suggestions received the strongest agreement among the clinicians, i.e. the highest AEA score. Clinicians identified a range of suggestions for better medication management, quality assurance procedures and patient education. According to clinicians, medication errors can be largely prevented with feasible and affordable interventions. PRIORITIZE is a new, convenient, systematic, and replicable method
Weingart, Saul N; Hamrick, Hope E; Tutkus, Sharon; Carbo, Alexander; Sands, Daniel Z; Tess, Anjala; Davis, Roger B; Bates, David W; Phillips, Russell S
Communication failures account for many adverse drug events (ADEs) in adult primary care. Improving patient-physician communication may improve medication safety. Accordingly, the goal of this study was to learn whether electronic medication safety messages directed to patients can improve communication about medications and identify ADEs. We studied adult patients enrolled in a patient Internet portal at three primary care practices affiliated with a teaching hospital. MedCheck, a medication safety application, sent patients a secure electronic message 10 days after they received a new or changed prescription. MedCheck asked if the patient had filled the prescription or experienced medication-related problems, and then forwarded the patient's response to their primary care physician. We selected a stratified random sample of 267 subjects from 1821 patients who received and opened a MedCheck message from April 2001 to June 2002. We reviewed subjects' medical records for three months following their first MedCheck message. We analyzed patient and clinician response rates and times, examined patient-clinician communication about medications, and identified ADEs. Patients opened 79% of MedCheck messages and responded to 12%; 77% responded within 1 day. Patients often identified problems filling their prescriptions (48%), problems with drug effectiveness (12%), and medication symptoms (10%). Clinicians responded to 68% of patients' messages; 93% answered within 1 week. Clinicians often supplied or requested information (19%), or made multiple recommendations (15%). Patients experienced 21 total ADEs; they reported 17 electronically. Patients and physicians responded promptly to patient-directed electronic medication messages, identifying and addressing medication-related problems including ADEs.
Connor, Jean Anne; Ahern, Jeanne P; Cuccovia, Barbara; Porter, Courtney L; Arnold, Alana; Dionne, Roger E; Hickey, Patricia A
The incidence of medication errors remains a continued concern across the spectrum of health care. Approaches to averting medication errors and implementing a culture of safety are key areas of focus for most institutions. We describe our experience of implementing a distraction-free medication safety practice across a large free-standing children's hospital. A nurse-led interprofessional group was convened to develop a program-wide quality improvement process for the practice of medication safety. A key driver diagram was developed to guide the Red Zone Medication Safety initiative. Change acceleration process was used to evaluate the implementation and impact of the initiative. Since implementation in 2010, there has been a significant reduction in medication events of 79.2% (P = .00184) and 65.3% (P = .035) (in the cardiac intensive care unit and acute care cardiac unit, respectively), including months with unprecedented zero reportable medication events. There also has been a sustained decrease in the number of events reaching the patient (33.3% in the cardiac intensive care unit and 57.1% in the acute care cardiac unit). The implementation of a distraction-free practice was found to be feasible and effective, demonstrating a sustained decrease in the overall number of medication events, event rate, and number of events reaching patients. This interprofessional approach was successful in a large inpatient cardiovascular program and then effectively transferred across all hospital inpatient units. Additional sites of implementation include other high-risk patient care areas such as procedure/operative units.
Steyrer, Johannes; Schiffinger, Michael; Huber, Clemens; Valentin, Andreas; Strunk, Guido
Hospitals face an increasing pressure toward efficiency and cost reduction while ensuring patient safety. This warrants a closer examination of the trade-off between production and protection posited in the literature for a high-risk hospital setting (intensive care). On the basis of extant literature and concepts on both safety management and organizational/safety culture, this study investigates to which extent production pressure (i.e., increased staff workload and capacity utilization) and safety culture (consisting of safety climate among staff and safety tools implemented by management) influence the occurrence of medical errors and if/how safety climate and safety tools interact. A prospective, observational, 48-hour cross-sectional study was conducted in 57 intensive care units. The dependent variable is the incidence of errors affecting those 378 patients treated throughout the entire observation period. Capacity utilization and workload were measured by indicators such as unit occupancy, nurse-to-patient/physician-to-patient ratios, levels of care, or NEMS scores. The safety tools considered include Critical Incidence Reporting Systems, audits, training, mission statements, SOPs/checklists, and the use of barcodes. Safety climate was assessed using a psychometrically validated four-dimensional questionnaire.Linear regression was employed to identify the effects of the predictor variables on error rate as well as interaction effects between safety tools and safety climate. Higher workload has a detrimental effect on safety, whereas safety climate-unlike the examined safety tools-has a virtually equal opposite effect. Correlations between safety tools and safety climate as well as their interaction effects on error rate are mostly nonsignificant. Increased workload and capacity utilization increase the occurrence of medical error, an effect that can be offset by a positive safety climate but not by formally implemented safety procedures and policies.
Lainer, Miriam; Mann, Eva; Sönnichsen, Andreas
Improving medication safety has become a major topic in all clinical settings. Information technology (IT) can play an important role to prevent adverse drug events (ADEs), but data on the effectiveness of IT interventions are controversial. The objective of this paper is to provide a systematic review about the effects of IT interventions on medication safety in primary care. PubMed, International Pharmaceutical Abstracts, EMBASE, Cochrane Database of Systematic Reviews, handsearching reference lists from full-text articles. Randomized controlled trials (RCTs), if interventions based on IT, performed in primary care and outcomes reported on medication safety. Data extraction Study characteristics and outcome data independently extracted by two reviewers. Disagreement resolved by discussion with a third reviewer. Out of 3918 studies retrieved, 10 RCTs met the inclusion criteria. Of the six studies evaluating computerized provider order entry (CPOE) with clinical decision support (CDS) only 3 studies effectively reduced unsafe prescribing. Both pharmacist-led IT interventions decreased the prescription of potentially inappropriate medication or unsafe prescribing in pregnancy. No reduction of ADEs was achieved by a web program or a TeleWatch system intervention. Only 5 of 10 RCTs revealed a reduction of medication errors. CPOE with CDS was effective if targeted at a limited number of potentially inappropriate medications. The positive results of pharmacist-led IT interventions indicate that IT interventions with inter-professional communication appear to be effective. The unequivocal results of the included RCTs stress the necessity of rigorous evaluation prior to large-scale implementation.
Yu, Hongxing; Hu, Zhenglu; Zhang, Xifan; Li, Bin; Zhou, Shangcheng
Background & Objective: In recent years there have been many cases of violence against healthcare professionals (HCPs) in China leading to the death of some doctors as well as nurses by patient’s relatives. Our objective was to identify the causative factors for these violent acts and address these isssues which is vital to ensure patient safety. Methods: A multidisciplinary research task force was formed to do a root cause analysis of the violent acts against the healthcare professionals. A flowchart was developed to identify the steps in the process and discover the potential links. Results: There are complex reasons behind the violence against HCPs. However, the main reasons were found to be poor quality of medical services and increased awareness of patients’ rights and their willingness to knock at the doors of courts to seek justice. The feasible counter measures includes stimulating hospital directors to improve patient safety, aligning incentives with quality of service provided in healthcare facilities, monitoring educational quality of HCPs, making necessary changes in medical education programmes besides setting up a reasonable academic promotion mechanism for health professionals based on merit and competence. Conclusion: Poor quality of medical services, increased awareness among patients about their rights has resulted in increase in medical disputes and at times violence against healthcare professionals. A number of effective measures can be undertaken by the government, hospitals, and medical schools ensuring patient safety. However, it is essential to sensitize the hospital directors to elevate their quality of medical services. PMID:25878605
Tamuz, M; Thomas, E; Franchois, K
Background: It is important for healthcare providers to report safety related events, but little attention has been paid to how the definition and classification of events affects a hospital's ability to learn from its experience. Objectives: To examine how the definition and classification of safety related events influences key organizational routines for gathering information, allocating incentives, and analyzing event reporting data. Methods: In semi-structured interviews, professional staff and administrators in a tertiary care teaching hospital and its pharmacy were asked to describe the existing programs designed to monitor medication safety, including the reporting systems. With a focus primarily on the pharmacy staff, interviews were audio recorded, transcribed, and analyzed using qualitative research methods. Results: Eighty six interviews were conducted, including 36 in the hospital pharmacy. Examples are presented which show that: (1) the definition of an event could lead to under-reporting; (2) the classification of a medication error into alternative categories can influence the perceived incentives and disincentives for incident reporting; (3) event classification can enhance or impede organizational routines for data analysis and learning; and (4) routines that promote organizational learning within the pharmacy can reduce the flow of medication error data to the hospital. Discussion: These findings from one hospital raise important practical and research questions about how reporting systems are influenced by the definition and classification of safety related events. By understanding more clearly how hospitals define and classify their experience, we may improve our capacity to learn and ultimately improve patient safety. PMID:14757794
Miri, Ali; Poursadeghiyan, Mohsen; Baneshi, Mohammad Mehdi; Biglari, Hamed; Yari, Ahmad Reza; Khammar, Alireza
Given the importance of high-quality healthy food for humans, contamination control is the most important concern for healthy staff. To determine the attitudes of students at Islamic Azad University (Tehran Medical Branch) toward food safety. This cross-sectional and analytic-descriptive study was conducted on 326 students of Azad University of Medical Sciences in 2016. A self-made questionnaire consisting of 40 questions was used. The reliability of the questionnaire was confirmed using internal consistency method (Cronbach's alpha coefficient of 0.80). After collecting data, we use descriptive statistical indexes (mean and standard deviation) among demographic variables and the level of knowledge to describe and analyze the data. The participants' attitudes and operation are measured by Spearman tests, and the analytical results are given using SPSS version 20. According to the findings, 55.3, 30 and 14.7 percent of students had high, moderate and low attitude scores toward food safety, respectively. In addition, male and female students had equal attitudes toward food safety, and no significant relationship between sex and attitude was observed a significant difference (p>0.05), but between educational levels (p=0.008) and ages (p=0.001) of students significance was a positive correlation. Due to the low attitudes score of about half of the students of Islamic Azad University Tehran Medical Branch toward food safety, it can be claimed, food safety training in this community is required.
Pane, Josep; Coloma, Preciosa M; Verhamme, Katia M C; Sturkenboom, Miriam C J M; Rebollo, Irene
Recent safety issues involving non-active implantable medical devices (NAIMDs) have highlighted the need for better pre-market and post-market evaluation. Some stakeholders have argued that certain features of medicine safety evaluation should also be applied to medical devices. Our objectives were to compare the current processes and methodologies for the assessment of NAIMD safety profiles with those for medicines, identify potential gaps, and make recommendations for the adoption of new methodologies for the ongoing benefit-risk monitoring of these devices throughout their entire life cycle. A literature review served to examine the current tools for the safety evaluation of NAIMDs and those for medicines. We searched MEDLINE using these two categories. We supplemented this search with Google searches using the same key terms used in the MEDLINE search. Using a comparative approach, we summarized the new product design, development cycle (preclinical and clinical phases), and post-market phases for NAIMDs and drugs. We also evaluated and compared the respective processes to integrate and assess safety data during the life cycle of the products, including signal detection, signal management, and subsequent potential regulatory actions. The search identified a gap in NAIMD safety signal generation: no global program exists that collects and analyzes adverse events and product quality issues. Data sources in real-world settings, such as electronic health records, need to be effectively identified and explored as additional sources of safety information, particularly in some areas such as the EU and USA where there are plans to implement the unique device identifier (UDI). The UDI and other initiatives will enable more robust follow-up and assessment of long-term patient outcomes. The safety evaluation system for NAIMDs differs in many ways from those for drugs, but both systems face analogous challenges with respect to monitoring real-world usage. Certain features
... HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2010-M-0519, FDA-2010-M-0556, FDA-2010-M-0558, FDA- 2010-M-0557, and FDA-2010-M-0591] Medical Devices; Availability of Safety and Effectiveness..., 2010 PMA No. Docket No. Applicant Trade name Date of action P100016 FDA-2010-M-0556.........
... HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2011-M-0735, FDA-2011-M-0736, FDA-2011-M...-2011-M-0917] Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug...
..., Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg... HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2012-M-0712, FDA-2012-M-0713, FDA-2012-M...-0968, FDA-2012-M-1011, and FDA-2012-M-1013] Medical Devices; Availability of Safety and Effectiveness...
... HUMAN SERVICES Food and Drug Administration Medical Devices; Availability of Safety and Effectiveness..., Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg... 18, 2010. Nancy K. Stade, Deputy Director for Policy, Center for Devices and Radiological...
Katzis, Konstantinos; Jones, Richard W; Despotou, George
Modern Implantable Medical Devices (IMDs), implement capabilities that have contributed significantly to patient outcomes, as well as quality of life. The ever increasing connectivity of IMD's does raise security concerns though there are instances where implemented security measures might impact on patient safety. The paper discusses challenges of addressing both of these attributes in parallel.
Dorpema, J. W.
Safety assessment of medical devices includes sterilization and biological evaluation or biocompatibility testing. Sterilization by ETO gas is critised for their carcinogenic potency or even banned. Mutual acceptance of biological evaluation test results is promoted by a laboratory accreditation and qualification program.
... Psychiatric Residential Treatment Facilities Providing Inpatient Psychiatric Services for Individuals Under Age 21 § 483.372 Medical treatment for injuries resulting from an emergency safety intervention. (a... participation under the Medicaid program that reasonably ensure that— (1) A resident will be transferred from...
... Psychiatric Residential Treatment Facilities Providing Inpatient Psychiatric Services for Individuals Under Age 21 § 483.372 Medical treatment for injuries resulting from an emergency safety intervention. (a... participation under the Medicaid program that reasonably ensure that— (1) A resident will be transferred from...
... Psychiatric Residential Treatment Facilities Providing Inpatient Psychiatric Services for Individuals Under Age 21 § 483.372 Medical treatment for injuries resulting from an emergency safety intervention. (a... participation under the Medicaid program that reasonably ensure that— (1) A resident will be transferred from...
Pirrallo, Ronald G; Cady, Charles E
The authors conducted a pilot study, finding that many households that experienced fires had received prior emergency medical services (EMS) visits, but few had operational smoke alarms. The study hypothesis is that dwellings that received smoke alarms and/or batteries during an EMS call were more likely to have an operational alarm, less property dollar loss, and decreased morbidity and mortality at the time of a subsequent fire. Smoke detectors and batteries were provided to an urban fire department for placement in unprotected homes at the time of an EMS call from March 1, 1999, through January 31, 2001. After addressing the reason for the 911 EMS call, verification or installation of an operational smoke alarm was performed. The authors examined records for dwellings that had a subsequent fire for outcomes of smoke alarm status, estimated property dollar loss, and number of injuries and fatalities. This program placed 1,335 smoke detectors. Of these, 99 dwellings were found to have a fire or smoke condition with 20 exclusions. Our final number was 79; 28 (35%) still had an operating smoke alarm. In homes with operational alarms, the mean dollar loss was 2,870 dollars (U.S. 2001) (95% confidence interval [CI], 143-5,596). In homes without operational alarms, mean loss was 10,468 dollars (U.S. 2001) (95% CI, 5,875-15,061). No injuries or fatalities occurred in either group. This program was successful in placing 1,335 smoke alarms in at-risk dwellings and reaffirmed that an operational smoke alarm significantly decreases property dollar loss. However, if the goal is to have all homes protected by smoke alarms, this program has long-term effectiveness limitations.
Lin, Qiping; Zhang, Fangguo
Several papers were proposed in which symmetric cryptography was used to design RFID grouping-proof for medication safety in the Journal of Medical Systems. However, if we want to ensure privacy, authentication and protection against the tracking of RFID-tags without losing system scalability, we must design an asymmetric cryptography-based RFID. This paper will propose a new ECC-based grouping-proof for RFID. Our ECC-based grouping-proof reduces the computation of tags and prevents timeout problems from occurring in n-party grouping-proof protocol. Based on asymmetric cryptography, the proposed scheme is practical, secure and efficient for medication applications.
Keohane, Carol A; Hayes, Judy; Saniuk, Catherine; Rothschild, Jeffrey M; Bates, David W
The Institute of Medicine report To Err Is Human: Building a Safe Health System greatly increased national awareness of the need to improve patient safety in general and medication safety in particular. Infusion-related errors are associated with the greatest risk of harm, and "smart" (computerized) infusion systems are currently available that can avert high-risk errors and provide previously unavailable data for continuous quality improvement (CQI) efforts. As healthcare organizations consider how to invest scarce dollars, infusion nurses have a key role to play in assessing need, evaluating technology, and selecting and implementing specific products. This article reviews the need to improve intravenous medication safety. It describes smart infusion systems and the results they have achieved. Finally, it details the lessons learned and the opportunities identified through the use of smart infusion technology at Brigham and Women's Hospital in Boston, Massachusetts.
Ishida, Kai; Hirose, Minoru; Fujiwara, Kousaku; Tsuruta, Harukazu; Ikeda, Noriaki
Half a decade has passed since the fifth revision of the medical law and mandatory appointment of a medical equipment safety manager (MESM) in hospitals in Japan. During this period, circumstances have changed regarding maintenance of medical equipment (ME). We conducted a survey to examine these changes and the current situation in ME management. Maintenance of ME and related work were found to have increased in many hospitals, but the number of clinical engineering technologists (CETs) has only slightly increased. The appointed MESM was a CET or physician in most hospitals. In hospitals where physicians were appointed as the MESM, 81% had operation managers. Many respondents commented that it was difficult for one person to cover all the tasks required by the MESM, due to a lack of knowledge, too much work, or other reasons. This suggests the importance of an operation manager for ME to work under the MESM.
The aim of this article is to highlight some of the methodological and ethical challenges that the researcher faced when conducting a study of the safety of medication administration. Investigating a sensitive topic, such as the safety of medication administration, can be methodologically demanding, time-consuming and ethically challenging. Moreover, it can be particularly difficult to balance methodological with ethical and legal challenges. This article presents the considerations involved in the sampling, recruitment and ethical issues related to participants' involvement in a medication safety study. The article draws on the methodological and ethical approaches related to one qualitative study that investigated the nurse's views of the organisational contributions toward the safety of medication administration in adult critical care. The study was completed in 2009. The study used a questionnaire to recruit the paticipants and this gave the researcher the advantage of being able to select critical care nurses from particular backgrounds, enriching the views and perspectives relating to the topic under investigation. Approaching the participants for 'expert' opinions, rather than 'error-makers', helped to established early rapport with the participants. Research rigour and data trustworthiness were demonstrated by several operational techniques, including providing a detailed account and justification for the research process. Research into patient safety may have particular methodological and ethical challenges and therefore needs an appropriate research approach to balance practicality, the participants' integrity and research rigour. IMPLICATIONS FOR PRACTICE AND RESEARCH It is anticipated that this approach will provide an insight into some challenges that may arise in conducting patient safety research, providing a useful guide for others to consider in their future research.
Schwind, Cathy J; Boehler, Margaret L; Markwell, Stephen J; Williams, Reed G; Brenner, Michael J
During the transition from medical school to internship, trainees experience high levels of stress related to pages on the inpatient wards. The steep learning curve during this period may also affect patient safety. The authors piloted the use of simulated pages to improve medical student preparedness, decrease stress related to pages, and familiarize medical students with common patient problems. A multidisciplinary team at Southern Illinois University School of Medicine developed simulated pages that were tested among senior medical students. Sixteen medical students were presented with 11 common patient scenarios. Data on assessment, management, and global performance were collected. Mean confidence levels were evaluated pre- and postintervention. Students were also surveyed on how the simulated pages program influenced their perceived comfort in managing patient care needs and the usefulness of the exercise in preparing them to handle inpatient pages. Mean scores on the assessment and management portions of the scenarios varied widely depending on the scenario (range -15.6 ± 41.6 to 95.7 ± 9.5). Pass rates based on global performance ranged from 12% to 93%. Interrater agreement was high (mean kappa = 0.88). Students' confidence ratings on a six-point scale increased from 1.87 preintervention to 3.53 postintervention (P < .0001). Simulated pages engage medical students and may foster medical student preparedness for internship. Students valued the opportunity to simulate "on call" responsibilities, and exposure to simulated pages significantly increased their confidence levels. Further studies are needed to determine effects on patient safety outcomes.
Newell, Terry L; Steinmetz-Malato, Laura L; Van Dyke, Deborah L
The inpatient medication delivery system used at a large regional acute care hospital in the Midwest had become antiquated and inefficient. The existing 24-hr medication cart-fill exchange process with delivery to the patients' bedside did not always provide ordered medications to the nursing units when they were needed. In 2007 the principles of the Toyota Production System (TPS) were applied to the system. Project objectives were to improve medication safety and reduce the time needed for nurses to retrieve patient medications. A multidisciplinary team was formed that included representatives from nursing, pharmacy, informatics, quality, and various operational support departments. Team members were educated and trained in the tools and techniques of TPS, and then designed and implemented a new pull system benchmarking the TPS Ideal State model. The newly installed process, providing just-in-time medication availability, has measurably improved delivery processes as well as patient safety and satisfaction. Other positive outcomes have included improved nursing satisfaction, reduced nursing wait time for delivered medications, and improved efficiency in the pharmacy. After a successful pilot on two nursing units, the system is being extended to the rest of the hospital.
Vidi, Venkatesan D.; Matheny, Michael E.; Donnelly, Sharon; Resnic, Frederic S.
Background Post-market medical product safety surveillance is a complex task requiring standardized data collection, prompt adverse event reporting mechanisms and appropriate methodologies to identify low frequency safety threats and risk communication. Purpose To review the design of the DELTA (Data Extraction and Longitudinal Trend Analysis) network study of the medical device safety surveillance. Methods This is a multicenter prospective observational study designed to evaluate the safety of new cardiovascular devices used during percutaneous coronary intervention (PCI) performed through continuous analysis of the routinely collected American College of Cardiology- National Cardiovascular Data Registry (ACC-NCDR) data elements. The primary endpoint of the study is detection of adverse event rates specific to several classes of new medical devices, including drug eluting coronary stents, embolic protection devices, and vascular closure devices in patients undergoing PCI. Secondary endpoints include the time-savings between the DELTA network detection of a true device safety alert and the time taken to detect the same outcome using conventional retrospective data analysis, overall sensitivity, specificity, positive predictive value and negative predictive value of the DELTA network surveillance system. Results The details of the study are described including system design, eligibility criteria, methods and components of data collection, data security and statistical methods. In addition, the methods of adjudication and verification following an adverse event alert, overall study outcomes, end points, limitations and potential advantages are discussed. Conclusion This report describes the first multicenter prospective study of a computerized safety surveillance system to monitor and evaluate the safety of new cardiovascular devices. PMID:21356331
Ridgely, M Susan; Greenberg, Michael D; Pillen, Michelle B; Bell, James
To identify lessons learned from the experience of the Agency for Healthcare Research and Quality (AHRQ) Patient Safety and Medical Liability (PSML) Demonstration Program. On September 9, 2009, President Obama directed the Secretary of Health and Human Services to authorize demonstration projects that put "patient safety first" with the intent of reducing preventable adverse outcomes and stemming liability costs. Seven demonstration projects received 3 years of funding from AHRQ in the summer of 2010, and the program formally came to a close in June 2015. The seven grantees implemented complex, broad-ranging innovations addressing both patient safety and medical liability in "real-world" contexts. Some projects featured novel approaches, while others implemented adaptations of existing models. Each project was funded by AHRQ to collect data on the impact of its interventions. In addition, AHRQ funded a cross-cutting qualitative evaluation focused on lessons learned in implementing PSML interventions. Site visits and follow-up interviews supplemented with material abstracted from formal project reports to AHRQ. The PSML demonstration projects focused on three broad approaches: (1) improving communication around adverse events through disclosure and resolution programs; (2) preventing harm through implementation of clinical "best practices"; and (3) exploring alternative methods of settling claims. Although the demonstration contributed to accumulating evidence that these kinds of interventions can positively affect outcomes, there is also evidence to suggest that these interventions can be difficult to scale. In addition to producing at least preliminary positive outcomes, the demonstration also lends credence to the idea that targeted interventions that improve some aspect of patient safety or malpractice performance may also contribute more broadly to institutional culture and the alignment of all parties around reducing risk and preventing harm. However, more
Koutkias, V G; McNair, P; Kilintzis, V; Skovhus Andersen, K; Niès, J; Sarfati, J-C; Ammenwerth, E; Chazard, E; Jensen, S; Beuscart, R; Maglaveras, N
Errors related to medication seriously affect patient safety and the quality of healthcare. It has been widely argued that various types of such errors may be prevented by introducing Clinical Decision Support Systems (CDSSs) at the point of care. Although significant research has been conducted in the field, still medication safety is a crucial issue, while few research outcomes are mature enough to be considered for use in actual clinical settings. In this paper, we present a clinical decision support framework targeting medication safety with major focus on adverse drug event (ADE) prevention. The novelty of the framework lies in its design that approaches the problem holistically, i.e., starting from knowledge discovery to provide reliable numbers about ADEs per hospital or medical unit to describe their consequences and probable causes, and next employing the acquired knowledge for decision support services development and deployment. Major design features of the framework's services are: a) their adaptation to the context of care (i.e. patient characteristics, place of care, and significance of ADEs), and b) their straightforward integration in the healthcare information technologies (IT) infrastructure thanks to the adoption of a service-oriented architecture (SOA) and relevant standards. Our results illustrate the successful interoperability of the framework with two commercially available IT products, i.e., a Computerized Physician Order Entry (CPOE) and an Electronic Health Record (EHR) system, respectively, along with a Web prototype that is independent of existing healthcare IT products. The conducted clinical validation with domain experts and test cases illustrates that the impact of the framework is expected to be major, with respect to patient safety, and towards introducing the CDSS functionality in practical use. This study illustrates an important potential for the applicability of the presented framework in delivering contextualized decision
DesHarnais, Susan I; Nash, David B
The purpose of this article is to briefly review the history of how quality and safety have been addressed in the United States by those who have been teaching medical students and residents, and then discuss why and how this training must change in the future to more effectively address the problems of improving healthcare quality and safety. Although it has become clear that the curriculum in medical schools should encompass quality and safety training, medical schools have been very slow to implement the reforms that are necessary to accomplish such a goal. These changes, although desirable from a rational perspective, involve basic changes in the culture of medical schools and teaching hospitals. Moreover, the cost of implementing these changes would be very large, and, if imposed by outside agencies, would likely constitute an unfunded mandate. It should also be noted that at the present time there are very few people who are well trained to develop and teach these classes. In order to accomplish the goal of improving patient safety, it is essential that we provide much more training and knowledge regarding patient safety to medical students, including knowledge of interventions known to be effective in preventing errors; education in technical performance; information about organizational and team issues; and training in disclosing errors to patients. This training should occur early in the training of professionals, preferably while they are still in school, if such training is to change the culture of medicine. Some suggestions and plans for implementation are discussed, using some innovative programs as examples. © 2011 Mount Sinai School of Medicine.
Lee, A M; Lee, M J
European recommendations suggest that medical students should be taught radiation safety before entering clinical practice. The aim of this study was to produce a summative assessment of radiation protection training in medical school in Ireland. A web-based questionnaire was distributed to the 2014 intern population (n = 683) via network intern-coordinators. The survey encompassed knowledge of radiation dose in X-ray investigations, laws governing the prescribing of radiation and complications of radiation exposure to staff and patients. Response rate was 14.2% (97/683) with all Irish medical schools represented. 64% of interns reported no formal training in radiation safety. 80% correctly identified MRI and 94% US as not posing a radiation risk. 54% identified CT PET as emitting the highest radiation dose to patients. Only 32% correctly identified one CT abdomen/pelvis as equivalent to the dose from 300 to 500 chest X-rays and 22% correctly identified the theoretical lifetime risk of cancer induction from CT abdomen/pelvis as 1 in 2000. While 71% thought it was very important that prescribers should be aware of patient radiation dose and 28% thought it was moderately important, 74% were not aware of any laws governing the prescribing of radiology investigations. Currently, there is little formal radiation safety training in Irish medical schools. Knowledge of radiation dose and the laws governing prescribing is limited among qualifying interns. Implementation of a formal radiation safety curriculum in Irish Medical Schools would adhere to EU guidelines and improve prescriber knowledge, patient, and personal radiation safety.
Natafgi, Nabil; Saliba, Miriam; Daya, Rami; El-Jardali, Fadi
Hospital accreditation places emphasis on the role of health professionals in quality of patient care. Training physicians in quality and patient safety influences quality improvement efforts in healthcare. Little is known about the attitudes and knowledge of medical students towards the concepts of quality of care, patient safety and accreditation. The objective of this study was to determine the extent to which Lebanese medical students are aware of and familiar with these aforementioned concepts. The study adopted a cross-sectional research design on a sample of (148 participants) graduating medical students from four major universities in Lebanon. A semi-structured self-completion questionnaire was developed to assess students' knowledge towards: (A) quality concepts; (B) quality tools ; (C) patient safety & risk management; (D) accreditation ; and (E) policies & procedures/guidelines. Two statistical tests, MANOVA (parametric) and Kruskal-Wallis (nonparametric) were used to analyze the data. Study results showed that 85% of medical students did not receive any course about quality and patient safety, although 93% considered them to be important and called for their integration into curricula. Lowest mean scores were recorded for the theme on quality concepts and tools (1.60 +/- 0.81 and 1A.49 +/- 0.71 respectively). Respondents from sampled universities showed a general lack of knowledge of the themes studied. Quality, patient safety and accreditation are important disciplines that need to be incorporated into medical curricula. This would be a positive step towards enabling future physicians to meet the changing needs of the constantly evolving healthcare system.
Fahrni, Mathumalar Loganathan; Franklin, Bryony Dean; Rawaf, Salman; Majeed, Azeem
In the UK, there are policy and regulatory concerns regarding the governance of care homes and healthcare provision within these homes. From a public health perspective, these issues can pose significant challenges to the provision of safe and quality medication use services to care home residents. The objective of this paper is to highlight an important and neglected issue for the growing population of institutionalized older adults. We reviewed relevant literature for the years 2000 to present and identified recent efforts undertaken to improve medication safety standards in UK care homes. We consider the limitations and reasons for the National Health Service's restricted role and lack of leadership in providing medical services for this institutionalized population. The efforts taken by the Department of Health and other healthcare authorities targeting medication safety in care homes are also highlighted. In order to improve the quality of healthcare, specifically in areas related to medication safety and quality use of medicines, interventions need to be taken by the national government and similarly by local authorities and NHS commissioners.
Chen, Yu-Yi; Tsai, Meng-Lin
The occurrence of a medication error can threaten patient safety. The medication administration process is complex and cumbersome, and nursing staffs are prone to error when they are tired. Proper Information Technology (IT) can assist the nurse in correct medication administration. We review a recent proposal regarding a leading-edge solution to enhance inpatient medication safety by using RFID technology. The proof mechanism is the kernel concept in their design and worth studying to develop a well-designed grouping-proof scheme. Other RFID grouping-proof protocols could be similarly applied in administering physician orders. We improve on the weaknesses of previous works and develop a reading-order independent RFID grouping-proof scheme in this paper. In our scheme, tags are queried and verified under the direct control of the authorized reader without connecting to the back-end database server. Immediate verification in our design makes this application more portable and efficient and critical security issues have been analyzed by the threat model. Our scheme is suitable for the safe drug administration scenario and the drug package scenario in a hospital environment to enhance inpatient medication safety. It automatically checks for correct drug unit-dose and appropriate inpatient treatments. Copyright © 2013. Published by Elsevier Ireland Ltd.
Fujita, Katsuhide; Akiyama, Masanori; Park, Keunsik; Yamaguchi, Etsuko Nakagami; Furukawa, Hiroyuki
The analysis of medical incident reports is indispensable for patient safety. The cycles between analysis of incident reports and proposals to medical staffs are a key point for improving the patient safety in the hospital. Most incident reports are composed from freely written descriptions, but an analysis of such free descriptions is not sufficient in the medical field. In this study, we aim to accumulate and reinterpret findings using structured incident information, to clarify improvements that should be made to solve the root cause of the accident, and to ensure safe medical treatment through such improvements. We employ natural language processing (NLP) and network analysis to identify effective categories of medical incident reports. Network analysis can find various relationships that are not only direct but also indirect. In addition, we compare bottom-up results obtained by NLP with existing categories based on experts' judgment. By the bottom-up analysis, the class of patient managements regarding patients' fallings and medicines in top-down analysis is created clearly. Finally, we present new perspectives on ways of improving patient safety.
Galvin, Shannon; Robertson, Russell; Hargarten, Stephen
The number of medical students traveling to nations outside the United States is steadily increasing. The Association of American Medical Colleges graduation questionnaire notes an increase from 2,838 students in 2001 to 3,799 students in 2009, the last year for which information is available. The risk of having any type of illness during international travel approaches 50%. Up to 19% of students will seek medical care on their return to the United States for illnesses. Most illnesses are benign and self limited. However, when deaths do occur, the leading causes are motor vehicle crashes and drownings. If air medical evacuation occurs, the most likely cause is an injury event. The authors review the literature to determine the risk of and type of illnesses and injuries suffered by travelers while overseas, especially medical volunteers. We describe the major categories of illness and injury risk and propose reasonable risk reduction and prevention strategies for prevention for injury, a relatively neglected area. We recommend that medical schools provide pre-travel training that includes injury prevention so that students are prepared not only for illness prevention but also for injury prevention. A focus on injury prevention, especially from motor vehicle crashes and drowning, is warranted given their role in causing death and serious injury to traveling students.
Wilby, K J; Hazi, H M; Ashour, M A
The objectives of this study were to assess the needs of schoolchildren relating to medication safety and to develop and implement a health promotion programme in Qatar. Semi-structured interviews were completed with teachers, nurses and school administrators at 2 primary schools in Doha. Two main themes were identified from these interviews, namely medication basics and medication safety. Subsequently, a 25-minute health promotion programme was developed and delivered to 11 groups of schoolchildren aged 6-10 years. The student groups contained both expatriate and local Qatari students. The programme was evaluated based on perceptions of site representatives, investigators and peer reviewers using a standardized evaluation form. All the evaluators agreed that the programme was beneficial and should be recommended to other schools in Qatar. This study can serve as a prototype for future programmes in the Eastern Mediterranean Region and elsewhere.
The implications arising from the Inquiry into the Waterfall train crash for medical examinations of safety-critical workers are discussed. Examinations need to be appropriate for the level of risk in the job and apply current medical thinking. A careful balance is required between the various legal obligations, including duty of care, disability discrimination and privacy. The frequency of examinations depends on a combination of medical, economic and logistical factors. Health professionals who conduct examinations should be familiar with the occupation of the person being examined. Ethical relationships with the worker's general practitioner or specialist(s) must be observed. The procedures associated with the examinations are as important in achieving safety as the actual examinations. These include complying with relevant standards; providing all relevant documentation with a referral for an examination; acting on the doctor's report appropriately; and auditing the process.
Ohba, Hisateru; Ogasawara, Katsuhiko; Aburano, Tamio
In this study, a questionnaire survey was carried out to determine the actual situation of radiation safety management systems in Japanese medical institutions with nuclear medicine facilities. The questionnaire consisted of questions concerning the Radiation Protection Supervisor license, safety management organizations, and problems related to education and training in safety management. Analysis was conducted according to region, type of establishment, and number of beds. The overall response rate was 60%, and no significant difference in response rate was found among regions. Medical institutions that performed nuclear medicine practices without a radiologist participating accounted for 10% of the total. Medical institutions where nurses gave patients intravenous injections of radiopharmaceuticals as part of the nuclear medicine practices accounted for 28% of the total. Of these medical institutions, 59% provided education and training in safety management for nurses. The rate of acquisition of Radiation Protection Supervisor licenses was approximately 70% for radiological technologists and approximately 20% for physicians (regional difference, p=0.02). The rate of medical institutions with safety management organizations was 71% of the total. Among the medical institutions (n=208) without safety management organizations, approximately 56% had 300 beds or fewer. In addition, it became clear that 35% of quasi-public organizations and 44% of private organizations did not provide education and training in safety management (p<0.001, according to establishment).
Camper, L.W.; Schlueter, J.; Woods, S.
A Task Force, comprising eight US Nuclear Regulatory Commission and two Agreement State program staff members, developed the guidance contained in this report. This report describes a systematic approach for effectively managing radiation safety programs at medical facilities. This is accomplished by defining and emphasizing the roles of an institution`s executive management, radiation safety committee, and radiation safety officer. Various aspects of program management are discussed and guidance is offered on selecting the radiation safety officer, determining adequate resources for the program, using such contractual services as consultants and service companies, conducting audits, and establishing the roles of authorized users and supervised individuals; NRC`s reporting and notification requirements are discussed, and a general description is given of how NRC`s licensing, inspection and enforcement programs work.
... ``Global Quality Systems--An Integrated Approach to Improving Medical Product Safety.'' This 2-day public... HUMAN SERVICES Food and Drug Administration Global Quality Systems--An Integrated Approach To Improving Medical Product Safety; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of...
Gallagher Gordon, Mary
This dissertation examines nurses' perceptions of the impacts of systems and technology utilized during the medication administration process on patient safety and the culture of medication error reporting. This exploratory research study was grounded in a model of patient safety based on Patricia Benner's Novice to Expert Skill Acquisition model,…
Gallagher Gordon, Mary
This dissertation examines nurses' perceptions of the impacts of systems and technology utilized during the medication administration process on patient safety and the culture of medication error reporting. This exploratory research study was grounded in a model of patient safety based on Patricia Benner's Novice to Expert Skill Acquisition model,…
Beeftink, Martine M A; van der Sande, Nicolette G C; Bots, Michiel L; Doevendans, Pieter A; Blankestijn, Peter J; Visseren, Frank L J; Voskuil, Michiel; Spiering, Wilko
Successful control of blood pressure relies on identification of secondary causes and contributing factors of hypertension. As antihypertensive medication can interfere with diagnostic investigations, temporary discontinuation of medication is advised. However, there are concerns about the safety of temporary discontinuation of antihypertensive medication in patients with difficult-to-control hypertension. We assessed the occurrence of adverse cardiovascular and cerebrovascular events potentially attributable to temporary discontinuation of antihypertensive medication between February 2010 and March 2016 (n=604) in our Analysis of Complicated Hypertension screening program. A reference group (n=604) was extracted from the SMART study (Second Manifestations of Arterial Disease) cohort (comprising a similar cohort at our hospital in whom medication was not stopped) and individually matched for blood pressure, age, sex, and history of cardiovascular disease. Discontinuation of medication was well tolerated; 62% reported no complaints, 24% had mild discomfort that could be left untreated, and 14% experienced complaints that required prescription of antihypertensive escape medication. Three major adverse events were observed in the Analysis of Complicated Hypertension group between discontinuation of medication and 30 days after restart of medication (event rate=31.2 events per 1000 patient-year). In the reference cohort, 5 cardiovascular events were observed during a similar follow-up period (event rate=51.2 events per 1000 patient-year). In conclusion, discontinuation of antihypertensive medication for the diagnostic evaluation of hypertension does not increase the acute risk of cardiovascular events when performed in a well-controlled setting in specialized hospitals with appropriate protocols for monitoring safety. © 2017 American Heart Association, Inc.
Krzyzaniak, Natalia; Bajorek, Beata
Objective: The objective of this study was to describe the medication errors in hospitalized patients, comparing those in neonates with medication errors across the age spectrum. Method: In tier 1, PubMed, Embase and Google Scholar were searched, using selected MeSH terms relating to hospitalized paediatric, adult and elderly populations. Tier 2 involved a search of the same electronic databases for literature relating to hospitalized neonatal patients. Results: A total of 58 articles were reviewed. Medication errors were well documented in each patient group. Overall, prescribing and administration errors were most commonly identified across each population, and mostly related to errors in dosing. Errors due to patient misidentification and overdosing were particularly prevalent in neonates, with 47% of administration errors involving at least tenfold overdoses. Unique errors were identified in elderly patients, comprising duplication of therapy and unnecessary prescribing of medicines. Overall, the medicines most frequently identified with error across each patient group included: heparin, antibiotics, insulin, morphine and parenteral nutrition. While neonatal patients experience the same types of medication errors as other hospitalized patients, the medication-use process within this group is more complex and has greater consequences resulting from error. Suggested strategies to help overcome medication error most commonly involved the integration of a clinical pharmacist into the treating team. Conclusion: This review highlights that each step of the medication-use process is prone to error across the age spectrum. Further research is required to develop targeted strategies relevant to specific patient groups that integrate key pharmacy services into wards. PMID:27298721
Brown, Jamie N; Britnell, Sara R; Stivers, Andrew P; Cruz, Jennifer L
Standardized safety practices for investigational drugs in clinical research protocols are limited and the vast majority of research pharmacists have concerns regarding its safety. Identified areas for medication safety risks include protocol complexity, medication ordering, and the processes for packaging, storage, and dispensing investigational medications. Inclusion of a pharmacist creates multiple mechanisms to promote safety and improve the quality of clinical research. This is accomplished through collaborating in the development of a research protocol, reviewing as a member of an advisory committee, developing mechanisms that contribute to safety, and assuring compliance with local and national regulations and standards. Ultimately, the profession of pharmacy has foundational responsibility for assuring the safe and effective use of medications, including investigational drugs in clinical research. It is through multidisciplinary collaboration that a research study will attain the highest standards for safety and maximize the quality and effectiveness of the data obtained in the clinical trial.
Brown, Jamie N.; Britnell, Sara R.; Stivers, Andrew P.; Cruz, Jennifer L.
Standardized safety practices for investigational drugs in clinical research protocols are limited and the vast majority of research pharmacists have concerns regarding its safety. Identified areas for medication safety risks include protocol complexity, medication ordering, and the processes for packaging, storage, and dispensing investigational medications. Inclusion of a pharmacist creates multiple mechanisms to promote safety and improve the quality of clinical research. This is accomplished through collaborating in the development of a research protocol, reviewing as a member of an advisory committee, developing mechanisms that contribute to safety, and assuring compliance with local and national regulations and standards. Ultimately, the profession of pharmacy has foundational responsibility for assuring the safe and effective use of medications, including investigational drugs in clinical research. It is through multidisciplinary collaboration that a research study will attain the highest standards for safety and maximize the quality and effectiveness of the data obtained in the clinical trial. PMID:28356900
Cochran, Gary L; Barrett, Ryan S; Horn, Susan D
The role of pharmacist transcription, onsite pharmacist dispensing, use of automated dispensing cabinets (ADCs), nurse-nurse double checks, or barcode-assisted medication administration (BCMA) in reducing medication error rates in critical access hospitals (CAHs) was evaluated. Investigators used the practice-based evidence methodology to identify predictors of medication errors in 12 Nebraska CAHs. Detailed information about each medication administered was recorded through direct observation. Errors were identified by comparing the observed medication administered with the physician's order. Chi-square analysis and Fisher's exact test were used to measure differences between groups of medication-dispensing procedures. Nurses observed 6497 medications being administered to 1374 patients. The overall error rate was 1.2%. The transcription error rates for orders transcribed by an onsite pharmacist were slightly lower than for orders transcribed by a telepharmacy service (0.10% and 0.33%, respectively). Fewer dispensing errors occurred when medications were dispensed by an onsite pharmacist versus any other method of medication acquisition (0.10% versus 0.44%, p = 0.0085). The rates of dispensing errors for medications that were retrieved from a single-cell ADC (0.19%), a multicell ADC (0.45%), or a drug closet or general supply (0.77%) did not differ significantly. BCMA was associated with a higher proportion of dispensing and administration errors intercepted before reaching the patient (66.7%) compared with either manual double checks (10%) or no BCMA or double check (30.4%) of the medication before administration (p = 0.0167). Onsite pharmacist dispensing and BCMA were associated with fewer medication errors and are important components of a medication safety strategy in CAHs. Copyright © 2016 by the American Society of Health-System Pharmacists, Inc. All rights reserved.
Ching, Joan M; Long, Christina; Williams, Barbara L; Blackmore, C Craig
At Virginia Mason Medical Center (Seattle), the Collaborative Alliance for Nursing Outcomes (CALNOC) Medication Administration Accuracy Quality Study was used in combination with Lean quality improvement efforts to address medication administration safety. Lean interventions were targeted at improving the medication room layout, applying visual controls, and implementing nursing standard work. The interventions were designed to prevent medication administration errors through improving six safe practices: (1) comparing medication with medication administration record, (2) labeling medication, (3) checking two forms of patient identification, (4) explaining medication to patient, (5) charting medication immediately, and (6) protecting the process from distractions/interruptions. Trained nurse auditors observed 9,244 doses for 2,139 patients. Following the intervention, the number of safe-practice violations decreased from 83 violations/100 doses at baseline (January 2010-March 2010) to 42 violations/100 doses at final follow-up (July 2011-September 2011), resulting in an absolute risk reduction of 42 violations/100 doses (95% confidence interval [CI]: 35-48), p < .001). The number of medication administration errors decreased from 10.3 errors/100 doses at baseline to 2.8 errors/100 doses at final follow-up (absolute risk reduction: 7 violations/100 doses [95% CI: 5-10, p < .001]). The "perfect dose" score, reflecting compliance with all six safe practices and absence of any of the eight medication administration errors, improved from 37 in compliance/100 doses at baseline to 68 in compliance/100 doses at the final follow-up. Lean process improvements coupled with direct observation can contribute to substantial decreases in errors in nursing medication administration.
Greenall, Julie; Shastay, Ann; Vaida, Allen J; U, David; Johnson, Philip E; O'Leary, Joe; Chambers, Carole
In 2012, the Institute for Safe Medication Practices (ISMP) and the Institute for Safe Medication Practices Canada (ISMP Canada) collaborated with an international panel of oncology practitioners to develop the ISMP International Medication Safety Self Assessment® for Oncology. This self-assessment was designed to assist oncology practitioners in hospitals, ambulatory care centers, and office practice settings throughout the world to evaluate safe practices related to medication use in the oncology setting and to identify opportunities for improvement. The self-assessment consists of 175 items organized into 10 key elements subdivided into 18 core characteristics of safe medication use. Assessment results were submitted via a secure online portal. The online program allows participants to print and graph their results and to compare their findings with those of similar organizations both nationally and internationally. Complimentary access to the self-assessment was made available for a seven-month "snapshot" period in 2012. A total of 352 organizations from 13 countries submitted assessment results. Key opportunities for improvement were identified in five areas: implementation of the World Health Organization recommendations for management of vinCRIStine and other vinca alkaloids, safe management of oral chemotherapy, labeling of distal ends of intravenous tubing, implementation of technology-based safeguards, and patient education. This international snapshot provides important data about the level of implementation of system-based safeguards in oncology practice, key improvement opportunities, and represents a baseline for future improvement efforts. A collaborative approach to identifying vulnerabilities and developing solutions for safe medication use in oncology will enhance the care of patients with cancer internationally. © The Author(s) 2014 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.
The Learning Objective Catalogue for Patient Safety in Undergraduate Medical Education – A Position Statement of the Committee for Patient Safety and Error Management of the German Association for Medical Education
Kiesewetter, Jan; Gutmann, Johanna; Drossard, Sabine; Gurrea Salas, David; Prodinger, Wolfgang; Mc Dermott, Fiona; Urban, Bert; Staender, Sven; Baschnegger, Heiko; Hoffmann, Gordon; Hübsch, Grit; Scholz, Christoph; Meier, Anke; Wegscheider, Mirko; Hoffmann, Nicolas; Ohlenbusch-Harke, Theda; Keil, Stephanie; Schirlo, Christian; Kühne-Eversmann, Lisa; Heitzmann, Nicole; Busemann, Alexandra; Koechel, Ansgar; Manser, Tanja; Welbergen, Lena; Kiesewetter, Isabel
Background: Since the report “To err is human” was published by the Institute of Medicine in the year 2000, topics regarding patient safety and error management are in the focal point of interest of science and politics. Despite international attention, a structured and comprehensive medical education regarding these topics remains to be missing. Goals: The Learning Objective Catalogue for Patient Safety described below the Committee for Patient Safety and Error Management of the German Association for Medical Education (GMA) has aimed to establish a common foundation for the structured implementation of patient safety curricula at the medical faculties in German-speaking countries. Methods: The development the Learning Objective Catalogue resulted via the participation of 13 faculties in two committee meetings, two multi-day workshops, and additional judgments of external specialists. Results: The Committee of Patient Safety and Error Management of GMA developed the present Learning Objective Catalogue for Patient Safety in Undergraduate Medical Education, structured in three chapters: Basics, Recognize Causes as Foundation for Proactive Behavior, and Approaches for Solutions. The learning objectives within the chapters are organized on three levels with a hierarchical organization of the topics. Overall, the Learning Objective Catalogue consists of 38 learning objectives. All learning objectives are referenced with the National Competency-based Catalogue of Learning Objectives for Undergraduate Medical Education. Discussion: The Learning Objective Catalogue for Patient Safety in Undergraduate Medical Education is a product that was developed through collaboration of members from 13 medical faculties. In the German-speaking countries, the Learning Objective Catalogue should advance discussion regarding the topics of patient safety and error management and help develop subsequent educational structures. The Learning Objective Catalogue for Patient Safety can
The Learning Objective Catalogue for Patient Safety in Undergraduate Medical Education--A Position Statement of the Committee for Patient Safety and Error Management of the German Association for Medical Education.
Kiesewetter, Jan; Gutmann, Johanna; Drossard, Sabine; Gurrea Salas, David; Prodinger, Wolfgang; Mc Dermott, Fiona; Urban, Bert; Staender, Sven; Baschnegger, Heiko; Hoffmann, Gordon; Hübsch, Grit; Scholz, Christoph; Meier, Anke; Wegscheider, Mirko; Hoffmann, Nicolas; Ohlenbusch-Harke, Theda; Keil, Stephanie; Schirlo, Christian; Kühne-Eversmann, Lisa; Heitzmann, Nicole; Busemann, Alexandra; Koechel, Ansgar; Manser, Tanja; Welbergen, Lena; Kiesewetter, Isabel
Since the report "To err is human" was published by the Institute of Medicine in the year 2000, topics regarding patient safety and error management are in the focal point of interest of science and politics. Despite international attention, a structured and comprehensive medical education regarding these topics remains to be missing. The Learning Objective Catalogue for Patient Safety described below the Committee for Patient Safety and Error Management of the German Association for Medical Education (GMA) has aimed to establish a common foundation for the structured implementation of patient safety curricula at the medical faculties in German-speaking countries. The development the Learning Objective Catalogue resulted via the participation of 13 faculties in two committee meetings, two multi-day workshops, and additional judgments of external specialists. The Committee of Patient Safety and Error Management of GMA developed the present Learning Objective Catalogue for Patient Safety in Undergraduate Medical Education, structured in three chapters: Basics, Recognize Causes as Foundation for Proactive Behavior, and Approaches for Solutions. The learning objectives within the chapters are organized on three levels with a hierarchical organization of the topics. Overall, the Learning Objective Catalogue consists of 38 learning objectives. All learning objectives are referenced with the National Competency-based Catalogue of Learning Objectives for Undergraduate Medical Education. The Learning Objective Catalogue for Patient Safety in Undergraduate Medical Education is a product that was developed through collaboration of members from 13 medical faculties. In the German-speaking countries, the Learning Objective Catalogue should advance discussion regarding the topics of patient safety and error management and help develop subsequent educational structures. The Learning Objective Catalogue for Patient Safety can serve as a common ground for an intensified
Otero López, M J; Bermejo Vicedo, T; Moreno Gómez, A M; Aparicio Fernández, M A; Palomo Cobos, L
To determine the degree of implementation of recommended safety practices in the design and use of automated medication dispensing cabinets (ADCs) in Spanish hospitals. A descriptive study based on completion of the "Self- Evaluation Survey on the Safety of Automated Medication Dispensing Systems" from 10/10/2012 to 4/10/2013, at voluntarily participating hospitals. The survey contained 93 items grouped into 14 core processes. In the 36 participating hospitals the average score for the completed survey was 307.8 points (66.2% of the highest possible score [LC 95% CI: 63.2-69.2]). The lowest scores were obtained for core processes 9, 12, 13, 8, 3, 4 and 11 referring to the establishment of guidelines for medication removed using the override function (28.4%), training for healthcare professionals (52%), risk management (53%), defining removal procedures (55.3%), use of ADCs in connection with electronic prescribing (60.9%), information that appears on ADC screens (61.8%) and eliminating medications being returned to ADCs (63.9%), respectively. The hospitals that used ADCs in connection with electronic prescribing as their principal system for distribution presented a higher level of implantation of safety practices than those that used ADCs as a complementary distribution system. ADC installation has been accompanied by the implementation of various safety practices, but there are still numerous areas of risk for which technical, organizational, and system monitoring safety practices must be added in order to minimize errors with this technology. Copyright © 2013 SEFH. Published by AULA MEDICA. All rights reserved.
Kabil, J; Belguerras, L; Trattnig, S; Pasquier, C; Felblinger, J; Missoffe, A
To review past and present challenges and ongoing trends in numerical simulation for MRI (Magnetic Resonance Imaging) safety evaluation of medical devices. A wide literature review on numerical and analytical simulation on simple or complex medical devices in MRI electromagnetic fields shows the evolutions through time and a growing concern for MRI safety over the years. Major issues and achievements are described, as well as current trends and perspectives in this research field. Numerical simulation of medical devices is constantly evolving, supported by calculation methods now well-established. Implants with simple geometry can often be simulated in a computational human model, but one issue remaining today is the experimental validation of these human models. A great concern is to assess RF heating on implants too complex to be traditionally simulated, like pacemaker leads. Thus, ongoing researches focus on alternative hybrids methods, both numerical and experimental, with for example a transfer function method. For the static field and gradient fields, analytical models can be used for dimensioning simple implants shapes, but limited for complex geometries that cannot be studied with simplifying assumptions. Numerical simulation is an essential tool for MRI safety testing of medical devices. The main issues remain the accuracy of simulations compared to real life and the studies of complex devices; but as the research field is constantly evolving, some promising ideas are now under investigation to take up the challenges.
Dauer, Lawrence T; St Germain, Jean
This paper examines the educational philosophy of radiation safety education programs at medical institutions. The regulatory mandates for radiation safety training have traditionally emphasized competency-based training. This emphasis led to the adoption of a behaviorist philosophy that requires predetermined responses to certain situations. The behaviorist approach determines the roles of teacher and learner as well as the methods to be used. This paper examines these roles and methods and the influence of a highly regulated environment on the adoption of the behaviorist model. The paper also suggests that other educational philosophies, such as the progressive philosophy, should be examined to provide a rich foundation for improving the educational experience and outcomes.
Valentin, Andreas; Schiffinger, Michael; Steyrer, Johannes; Huber, Clemens; Strunk, Guido
To assess the frequency and contributing factors of medication and dislodgement errors attributable to common routine processes in a cohort of intensive care units, with a special focus on the potential impact of safety climate. A prospective, observational, 48 h cross sectional study in 57 intensive care units (ICUs) in Austria, Germany, and Switzerland, with self-reporting of medical errors by ICU staff and concurrent assessment of safety climate, workload and level of care. For 795 observed patients, a total of 641 errors affecting 269 patients were reported. This corresponds to a rate of 49.8 errors per 100 patient days related to the administration of medication, loss of artificial airways, and unplanned dislodgement of lines, catheters and drains. In a multilevel model predicting error occurrence at the patient level, odds ratios (OR) per unit increase for the occurrence of at least one medical error were raised for a higher Nine Equivalents of Nursing Manpower Use Score (NEMS) (OR 1.04, 95 % CI 1.02-1.05, p < 0.01) and a higher number of tubes/lines/catheters/drains (OR 1.02, 95 % CI 1.01-1.03, p < 0.01) at the patient level and lowered by a better safety climate at the ICU level (OR per standard deviation 0.67, 95 % CI 0.51-0.89, p < 0.01). Safety climate apparently contributes to a reduction of medical errors that represent a particularly error-prone aspect of frontline staff performance during typical routine processes in intensive care.
Mygind, Anna; El-Souri, Mira; Rossing, Charlotte; Thomsen, Linda Aagaard
To develop and test an educational programme on quality and safety in medication handling for staff in residential facilities for the disabled. The continuing pharmacy education instructional design model was used to develop the programme with 22 learning objectives on disease and medicines, quality and safety, communication and coordination. The programme was a flexible, modular seven + two days' course addressing quality and safety in medication handling, disease and medicines, and medication supervision and reconciliation. The programme was tested in five Danish municipalities. Municipalities were selected based on their application for participation; each independently selected a facility for residents with mental and intellectual disabilities, and a facility for residents with severe mental illnesses. Perceived effects were measured based on a questionnaire completed by participants before and after the programme. Effects on motivation and confidence as well as perceived effects on knowledge, skills and competences related to medication handling, patient empowerment, communication, role clarification and safety culture were analysed conducting bivariate, stratified analyses and test for independence. Of the 114 participants completing the programme, 75 participants returned both questionnaires (response rate = 66%). Motivation and confidence regarding quality and safety in medication handling significantly improved, as did perceived knowledge, skills and competences on 20 learning objectives on role clarification, safety culture, medication handling, patient empowerment and communication. The programme improved staffs' motivation and confidence and their perceived ability to handle residents' medication safely through improved role clarification, safety culture, medication handling and patient empowerment and communication skills. © 2017 Royal Pharmaceutical Society.
Car, Lorainne Tudor; Papachristou, Nikolaos; Urch, Catherine; Majeed, Azeem; Atun, Rifat; Car, Josip; Vincent, Charles
Cancer care is liable to medication errors due to the complex nature of cancer treatment, the common presence of comorbidities and the involvement of a number of clinicians in cancer care. While the frequency of medication errors in cancer care has been reported, little is known about their causal factors and effective prevention strategies. With a unique insight into the main safety issues in cancer treatment, frontline staff can help close this gap. In this study, we aimed to identify medication safety priorities in cancer patient care according to clinicians in North West London using PRIORITIZE, a novel priority-setting approach. The project steering group determined the scope, the context and the criteria for prioritization. We then invited North West London cancer care clinicians to identify and prioritize main causes for, and solutions to, medication errors in cancer care. Forty cancer care providers submitted their suggestions which were thematically synthesized into a composite list of 20 distinct problems and 22 solutions. A group of 26 clinicians from the initial cohort ranked the composite list of suggestions using predetermined criteria. The top ranked problems focused on patients' poor understanding of treatments due to language or education difficulties, clinicians' insufficient attention to patients' psychological distress, and inadequate information sharing among health care providers. The top ranked solutions were provision of guidance to patients and their carers on what to do when unwell, pre-chemotherapy work-up for all patients and better staff training. Overall, clinicians considered improved communication between health care providers, quality assurance procedures (during prescription and monitoring stages) and patient education as key strategies for improving cancer medication safety. Prescribing stage was identified as the most vulnerable to medication safety threats. The highest ranked suggestions received the strongest agreement among
Car, Lorainne Tudor; Papachristou, Nikolaos; Urch, Catherine; Majeed, Azeem; Atun, Rifat; Car, Josip; Vincent, Charles
Background Cancer care is liable to medication errors due to the complex nature of cancer treatment, the common presence of comorbidities and the involvement of a number of clinicians in cancer care. While the frequency of medication errors in cancer care has been reported, little is known about their causal factors and effective prevention strategies. With a unique insight into the main safety issues in cancer treatment, frontline staff can help close this gap. In this study, we aimed to identify medication safety priorities in cancer patient care according to clinicians in North West London using PRIORITIZE, a novel priority–setting approach. Methods The project steering group determined the scope, the context and the criteria for prioritization. We then invited North West London cancer care clinicians to identify and prioritize main causes for, and solutions to, medication errors in cancer care. Forty cancer care providers submitted their suggestions which were thematically synthesized into a composite list of 20 distinct problems and 22 solutions. A group of 26 clinicians from the initial cohort ranked the composite list of suggestions using predetermined criteria. Results The top ranked problems focused on patients’ poor understanding of treatments due to language or education difficulties, clinicians’ insufficient attention to patients’ psychological distress, and inadequate information sharing among health care providers. The top ranked solutions were provision of guidance to patients and their carers on what to do when unwell, pre–chemotherapy work–up for all patients and better staff training. Overall, clinicians considered improved communication between health care providers, quality assurance procedures (during prescription and monitoring stages) and patient education as key strategies for improving cancer medication safety. Prescribing stage was identified as the most vulnerable to medication safety threats. The highest ranked suggestions
Tomazoni, Andréia; Rocha, Patrícia Kuerten; de Souza, Sabrina; Anders, Jane Cristina; de Malfussi, Hamilton Filipe Correia
To verify the assessment of the patient safety culture according to the function and length of experience of the nursing and medical teams at Neonatal Intensive Care Units. Quantitative survey undertaken at four Neonatal Intensive Care Units in Florianópolis, Brazil. The sample totaled 141 subjects. The data were collected between February and April 2013 through the application of the Hospital Survey on Patient Safety Culture. For analysis, the Kruskal-Wallis and Chi-Square tests and Cronbach's Alpha coefficient were used. Approval for the research project was obtained from the Ethics Committee, CAAE: 05274612.7.0000.0121. Differences in the number of positive answers to the Hospital Survey on Patient Safety Culture, the safety grade and the number of reported events were found according to the professional characteristics. A significant association was found between a shorter Length of work at the hospital and Length of work at the unit and a larger number of positive answers; longer length of experience in the profession represented higher grades and less reported events. The physicians and nursing technicians assessed the patient safety culture more positively. Cronbach's alpha demonstrated the reliability of the instrument. The differences found reveal a possible relation between the assessment of the safety culture and the subjects' professional characteristics at the Neonatal Intensive Care Units.
Stordeur, S; Vinck, I; Neyt, M; Van Brabandt, H; Hulstaert, F
Innovative high-risk medical devices, such as new types of heart valves or hip prostheses, become available on the European market more rapidly than in USA. This is due to the European legislation allowing early marketing of innovative high-risk medical devices before high-quality clinical evidence is obtained from randomized controlled trials. We studied the premarket clinical evaluation of innovative high-risk medical devices in Europe compared with the USA. We also discussed patient safety and the transparency of information. The literature and regulatory documents were checked. Representatives from industry, competent authorities, notified bodies, ethics committees, and health technology assessment agencies were consulted. In contrast to the US, there is no requirement in Europe to demonstrate the clinical efficacy of high-risk devices in the premarket phase. For the patient, this implies earlier access to innovative technology, but at the risk of potential safety issues. At this moment, European requirements for clinical studies are lower for medical devices than for drugs, and data from premarket clinical trials are scarce or remain unpublished. The European Medical Device Directives are currently being reworked. For innovative high-risk devices, and while awaiting a reworked Medical Device Directive, patient risk should be minimized by limiting the market introduction of novel high-risk devices with minimal clinical data to physicians with the necessary training and expertise. The new European legislation should require the premarket demonstration of clinical efficacy and safety, using a randomized controlled trial if possible, and a transparent clinical review, preferably centralized. Copyright © 2013 Elsevier Masson SAS. All rights reserved.
Vogus, Timothy J; Sutcliffe, Kathleen M
Prior research has found that safety organizing behaviors of registered nurses (RNs) positively impact patient safety. However, little research exists on the joint benefits of safety organizing and other contextual factors that help foster safety. Although we know that organizational practices often have more powerful effects when combined with other mutually reinforcing practices, little research exists on the joint benefits of safety organizing and other contextual factors believed to foster safety. Specifically, we examined the benefits of bundling safety organizing with leadership (trust in manager) and design (use of care pathways) factors on reported medication errors. A total of 1033 RNs and 78 nurse managers in 78 emergency, internal medicine, intensive care, and surgery nursing units in 10 acute-care hospitals in Indiana, Iowa, Maryland, Michigan, and Ohio who completed questionnaires between December 2003 and June 2004. Cross-sectional analysis of medication errors reported to the hospital incident reporting system for the 6 months after the administration of the survey linked to survey data on safety organizing, trust in manager, use of care pathways, and RN characteristics and staffing. Multilevel Poisson regression analyses indicated that the benefits of safety organizing on reported medication errors were amplified when paired with high levels of trust in manager or the use of care pathways. Safety organizing plays a key role in improving patient safety on hospital nursing units especially when bundled with other organizational components of a safety supportive system.
Ammenwerth, E; Aly, A-F; Bürkle, T; Christ, P; Dormann, H; Friesdorf, W; Haas, C; Haefeli, W E; Jeske, M; Kaltschmidt, J; Menges, K; Möller, H; Neubert, A; Rascher, W; Reichert, H; Schuler, J; Schreier, G; Schulz, S; Seidling, H M; Stühlinger, W; Criegee-Rieck, M
Information technology in health care has a clear potential to improve the quality and efficiency of health care, especially in the area of medication processes. On the other hand, existing studies show possible adverse effects on patient safety when IT for medication-related processes is developed, introduced or used inappropriately. To summarize definitions and observations on IT usage in pharmacotherapy and to derive recommendations and future research priorities for decision makers and domain experts. This memorandum was developed in a consensus-based iterative process that included workshops and e-mail discussions among 21 experts coordinated by the Drug Information Systems Working Group of the German Society for Medical Informatics, Biometry and Epidemiology (GMDS). The recommendations address, among other things, a stepwise and comprehensive strategy for IT usage in medication processes, the integration of contextual information for alert generation, the involvement of patients, the semantic integration of information resources, usability and adaptability of IT solutions, and the need for their continuous evaluation. Information technology can help to improve medication safety. However, challenges remain regarding access to information, quality of information, and measurable benefits.
Degnan, Daniel D; Hertig, John B; Peters, Michael J; Stevenson, James G
State boards of pharmacy are generally responsible for the governance of the practice of pharmacy. While the regulatory process and methods for accomplishing this task may vary by state, all boards of pharmacy must address medication errors committed by pharmacists. The National Association of Boards of Pharmacy (NABP) has recommended that state boards of pharmacy implement best practices and enforcement actions that are aimed to promote patient safety and reduce medication errors. The current study was designed to identify and compare current corrective action practices among boards of pharmacy in response to medication errors. An electronic survey regarding board policies and anticipated board actions in response to hypothetical medication error scenarios was sent to boards of pharmacy for completion. Approximately 45% of pharmacy boards responded. Survey responses demonstrated that corrective actions and consequences were levied against pharmacists inconsistently among state boards. Corrective action plans and process improvement components were lacking in a majority of state board of pharmacy practices. Medication safety education for pharmacists and for members on boards of pharmacy was insufficient in many states. Responses to hypothetical error scenarios indicated that most board actions are educational and punitive in nature, rather than focusing on systems improvement.
Koppel, Ross; Wetterneck, Tosha; Telles, Joel Leon; Karsh, Ben-Tzion
The authors develop a typology of clinicians' workarounds when using barcoded medication administration (BCMA) systems. Authors then identify the causes and possible consequences of each workaround. The BCMAs usually consist of handheld devices for scanning machine-readable barcodes on patients and medications. They also interface with electronic medication administration records. Ideally, BCMAs help confirm the five "rights" of medication administration: right patient, drug, dose, route, and time. While BCMAs are reported to reduce medication administration errors--the least likely medication error to be intercepted--these claims have not been clearly demonstrated. The authors studied BCMA use at five hospitals by: (1) observing and shadowing nurses using BCMAs at two hospitals, (2) interviewing staff and hospital leaders at five hospitals, (3) participating in BCMA staff meetings, (4) participating in one hospital's failure-mode-and-effects analyses, (5) analyzing BCMA override log data. The authors identified 15 types of workarounds, including, for example, affixing patient identification barcodes to computer carts, scanners, doorjambs, or nurses' belt rings; carrying several patients' prescanned medications on carts. The authors identified 31 types of causes of workarounds, such as unreadable medication barcodes (crinkled, smudged, torn, missing, covered by another label); malfunctioning scanners; unreadable or missing patient identification wristbands (chewed, soaked, missing); nonbarcoded medications; failing batteries; uncertain wireless connectivity; emergencies. The authors found nurses overrode BCMA alerts for 4.2% of patients charted and for 10.3% of medications charted. Possible consequences of the workarounds include wrong administration of medications, wrong doses, wrong times, and wrong formulations. Shortcomings in BCMAs' design, implementation, and workflow integration encourage workarounds. Integrating BCMAs within real-world clinical workflows
Koppel, Ross; Wetterneck, Tosha; Telles, Joel Leon; Karsh, Ben-Tzion
The authors develop a typology of clinicians' workarounds when using barcoded medication administration (BCMA) systems. Authors then identify the causes and possible consequences of each workaround. The BCMAs usually consist of handheld devices for scanning machine-readable barcodes on patients and medications. They also interface with electronic medication administration records. Ideally, BCMAs help confirm the five “rights” of medication administration: right patient, drug, dose, route, and time. While BCMAs are reported to reduce medication administration errors—the least likely medication error to be intercepted— these claims have not been clearly demonstrated. The authors studied BCMA use at five hospitals by: (1) observing and shadowing nurses using BCMAs at two hospitals, (2) interviewing staff and hospital leaders at five hospitals, (3) participating in BCMA staff meetings, (4) participating in one hospital's failure-mode-and-effects analyses, (5) analyzing BCMA override log data. The authors identified 15 types of workarounds, including, for example, affixing patient identification barcodes to computer carts, scanners, doorjambs, or nurses' belt rings; carrying several patients' prescanned medications on carts. The authors identified 31 types of causes of workarounds, such as unreadable medication barcodes (crinkled, smudged, torn, missing, covered by another label); malfunctioning scanners; unreadable or missing patient identification wristbands (chewed, soaked, missing); nonbarcoded medications; failing batteries; uncertain wireless connectivity; emergencies. The authors found nurses overrode BCMA alerts for 4.2% of patients charted and for 10.3% of medications charted. Possible consequences of the workarounds include wrong administration of medications, wrong doses, wrong times, and wrong formulations. Shortcomings in BCMAs' design, implementation, and workflow integration encourage workarounds. Integrating BCMAs within real-world clinical
This final occupational safety and health standard, promulgated today as a revised 29 CFR 1910.20, provides for employee, designated representative, and OSHA access to employer-maintained exposure and medical records relevant to employees exposed to toxic substances and harmful physical agents. Access is also assured to employer analyses using exposure and medical records. The final standard requires long term preservation of these records, contains provisions concerning informing employees of their rights under the standard, and includes provisions protective of trade secret information.
Ko, Wen-Tsai; Chiou, Shin-Yan; Lu, Erl-Huei; Chang, Henry Ker-Chang
RFID technology is increasingly used in applications that require tracking, identification, and authentication. It attaches RFID-readable tags to objects for identification and execution of specific RFID-enabled applications. Recently, research has focused on the use of grouping-proofs for preserving privacy in RFID applications, wherein a proof of two or more tags must be simultaneously scanned. In 2010, a privacy-preserving grouping proof protocol for RFID based on ECC in public-key cryptosystem was proposed but was shown to be vulnerable to tracking attacks. A proposed enhancement protocol was also shown to have defects which prevented proper execution. In 2012, Lin et al. proposed a more efficient RFID ECC-based grouping proof protocol to promote inpatient medication safety. However, we found this protocol is also vulnerable to tracking and impersonation attacks. We then propose a secure privacy-preserving RFID grouping proof protocol for inpatient medication safety and demonstrate its resistance to such attacks.
Kulkarni, Vaman; Kanchan, Tanuj; Palanivel, C; Papanna, M K; Kumar, Nithin; Unnikrishnan, B
The UN general assembly has declared 2011-2020 as the "Decade of Action for Road Safety". The declaration holds significance because road traffic accidents (RTAs) have become a major cause of morbidity and mortality, especially among the adults and middle aged individuals who constitute economically most productive age groups of society. The importance of knowledge and practice of road safety measures needs to be emphasized in the prevention of RTAs. The present study is aimed to assess the knowledge and practice of road safety measures among the students of a medical college in coastal, South India. A total of 260 medical students were included in this cross-sectional study. A semi-structured questionnaire was used to collect the relevant information from the participants. The data collected was analyzed using SPSS version 11.5. Out of the 260 participants, 149 (57.3%) were females and 111 (42.7%) were males. The overall awareness on road safety measures was slightly higher among females (20.6%) than males (19.9%). The participants had significantly low awareness with regard to alcohol and driving (4.2%), use of seat belts (20%) and use of mobile phones without hands free device (6.1%). The participants had a better knowledge about traffic signs and more than half of them identified all the signs correctly. With regard to the road safety practices, 25% were involved in drunken driving in the past one year. The practice of using mobile phones with hands free devices while driving was admitted by 20% of them. Nearly two-third participants (68%) admitted to have crossed speed limits on multiple occasions. Observations of the study emphasize on the need to generate awareness among medical students through training and IEC activities to curb the epidemic of RTAs. Copyright © 2012 Elsevier Ltd and Faculty of Forensic and Legal Medicine. All rights reserved.
Gaertner, Jan; Vent, Julia; Greinwald, Ralf; Rothschild, Markus A; Ostgathe, Christoph; Kessel, Rene; Voltz, Raymond
Especially when caring for patients approaching the end of life, physicians and nursing staff feel committed to fulfilling as many patient desires as possible. However, sometimes a patient's "final will" may threaten public safety. This can lead to severe conflicts, outweighing the physician's obligation and dedication to care for the patient and to respect his autonomy. Yet, public safety can be threatened if confidentiality is not broken. This article provides a concise summary of the medicolegal and ethical fundamentals concerning this difficult situation. If the patient's and others' health and safety are at risk, physicians may (and in some countries must) break medical confidentiality and disclose confidential patient information to the police and other authorities. Physicians should be able to professionally deal with such a conflict in all patients, not only in patients with advanced illness. Copyright © 2011 U.S. Cancer Pain Relief Committee. Published by Elsevier Inc. All rights reserved.
Garfield, Sara; Jheeta, Seetal; Husson, Fran; Lloyd, Jill; Taylor, Alex; Boucher, Charles; Jacklin, Ann; Bischler, Anna; Norton, Christine; Hayles, Rob; Dean Franklin, Bryony
Background Inpatient medication errors are a significant concern. An approach not yet widely studied is to facilitate greater involvement of inpatients with their medication. At the same time, electronic prescribing is becoming increasingly prevalent in the hospital setting. In this study we aimed to explore hospital inpatients’ involvement with medication safety-related behaviours, facilitators and barriers to this involvement, and the impact of electronic prescribing. Methods We conducted ethnographic observations and interviews in two UK hospital organisations, one with established electronic prescribing and one that changed from paper to electronic prescribing during our study. Researchers and lay volunteers observed nurses’ medication administration rounds, pharmacists’ ward rounds, doctor-led ward rounds and drug history taking. We also conducted interviews with healthcare professionals, patients and carers. Interviews were audio-recorded and transcribed. Observation notes and transcripts were coded thematically. Results Paper or electronic medication records were shown to patients in only 4 (2%) of 247 cases. However, where they were available during patient-healthcare professional interactions, healthcare professionals often viewed them in order to inform patients about their medicines and answer any questions. Interprofessional discussions about medicines seemed more likely to happen in front of the patient where paper or electronic drug charts were available near the bedside. Patients and carers had more access to paper-based drug charts than electronic equivalents. However, interviews and observations suggest there are potentially more significant factors that affect patient involvement with their inpatient medication. These include patient and healthcare professional beliefs concerning patient involvement, the way in which healthcare professionals operate as a team, and the underlying culture. Conclusion Patients appear to have more access to
Garfield, Sara; Jheeta, Seetal; Husson, Fran; Lloyd, Jill; Taylor, Alex; Boucher, Charles; Jacklin, Ann; Bischler, Anna; Norton, Christine; Hayles, Rob; Franklin, Bryony Dean
Inpatient medication errors are a significant concern. An approach not yet widely studied is to facilitate greater involvement of inpatients with their medication. At the same time, electronic prescribing is becoming increasingly prevalent in the hospital setting. In this study we aimed to explore hospital inpatients' involvement with medication safety-related behaviours, facilitators and barriers to this involvement, and the impact of electronic prescribing. We conducted ethnographic observations and interviews in two UK hospital organisations, one with established electronic prescribing and one that changed from paper to electronic prescribing during our study. Researchers and lay volunteers observed nurses' medication administration rounds, pharmacists' ward rounds, doctor-led ward rounds and drug history taking. We also conducted interviews with healthcare professionals, patients and carers. Interviews were audio-recorded and transcribed. Observation notes and transcripts were coded thematically. Paper or electronic medication records were shown to patients in only 4 (2%) of 247 cases. However, where they were available during patient-healthcare professional interactions, healthcare professionals often viewed them in order to inform patients about their medicines and answer any questions. Interprofessional discussions about medicines seemed more likely to happen in front of the patient where paper or electronic drug charts were available near the bedside. Patients and carers had more access to paper-based drug charts than electronic equivalents. However, interviews and observations suggest there are potentially more significant factors that affect patient involvement with their inpatient medication. These include patient and healthcare professional beliefs concerning patient involvement, the way in which healthcare professionals operate as a team, and the underlying culture. Patients appear to have more access to paper-based records than electronic equivalents
Martinez-Raga, Jose; Ferreros, Amparo; Knecht, Carlos; de Alvaro, Raquel; Carabal, Eloisa
While treatment of patients with attention-deficit hyperactivity disorder (ADHD) is based on a multimodal approach that combines medication with specific psychological interventions, pharmacotherapy alone is generally considered an essential and cost-effective element. This paper aims to comprehensively and critically review factors involved in prescribing and medication use in individuals diagnosed with ADHD, focusing on the difficulties facing patients with ADHD seeking treatment, as well as the safety and tolerability aspects of ADHD pharmacotherapies, with particular attention on the cardiovascular adverse events and the potential risk of misuse or diversion of ADHD medications. A comprehensive and systematic literature search of PubMed/MEDLINE database was conducted to identify studies published in peer-reviewed journals until 1 August 2016. Children, adolescents and adults often encounter significant difficulties in the process of accessing specialist assessment and treatment for ADHD as a consequence of disparities in service organization and available treatment provision. Despite the well-established efficacy and overall safety profile, ADHD medications are not exempt from adverse events. The cardiovascular safety of pharmacotherapies used for treating individuals with ADHD has raised particular concerns; however there is little evidence of serious cardiovascular adverse events, including no serious corrected QT (QTc) abnormalities associated with stimulants, atomoxetine or α2-adrenergic receptor agonists. Although the abuse of prescription stimulant drugs, particularly, short-acting stimulants is a prevalent and growing problem, nonmedical use of prescription stimulants within the clinical context is very limited. In addition, nonstimulant ADHD medications lack any reinforcing effects and consequently any abuse potential. PMID:28382197
Bubalo, Joseph; Warden, Bruce A; Wiegel, Joshua J; Nishida, Tess; Handel, Evelyn; Svoboda, Leanne M; Nguyen, Lam; Edillo, P Neil
Medical errors, in particular medication errors, continue to be a troublesome factor in the delivery of safe and effective patient care. Antineoplastic agents represent a group of medications highly susceptible to medication errors due to their complex regimens and narrow therapeutic indices. As the majority of these medication errors are frequently associated with breakdowns in poorly defined systems, developing technologies and evolving workflows seem to be a logical approach to provide added safeguards against medication errors. This article will review both the pros and cons of today's technologies and their ability to simplify the medication use process, reduce medication errors, improve documentation, improve healthcare costs and increase provider efficiency as relates to the use of antineoplastic therapy throughout the medication use process. Several technologies, mainly computerized provider order entry (CPOE), barcode medication administration (BCMA), smart pumps, electronic medication administration record (eMAR), and telepharmacy, have been well described and proven to reduce medication errors, improve adherence to quality metrics, and/or improve healthcare costs in a broad scope of patients. The utilization of these technologies during antineoplastic therapy is weak at best and lacking for most. Specific to the antineoplastic medication use system, the only technology with data to adequately support a claim of reduced medication errors is CPOE. In addition to the benefits these technologies can provide, it is also important to recognize their potential to induce new types of errors and inefficiencies which can negatively impact patient care. The utilization of technology reduces but does not eliminate the potential for error. The evidence base to support technology in preventing medication errors is limited in general but even more deficient in the realm of antineoplastic therapy. Though CPOE has the best evidence to support its use in the
Akbarov, Artur; Kontopantelis, Evangelos; Sperrin, Matthew; Stocks, Susan J; Williams, Richard; Rodgers, Sarah; Avery, Anthony; Buchan, Iain; Ashcroft, Darren M
The extent of preventable medication-related hospital admissions and medication-related issues in primary care is significant enough to justify developing decision support systems for medication safety surveillance. The prerequisite for such systems is defining a relevant set of medication safety-related indicators and understanding the influence of both patient and general practice characteristics on medication prescribing and monitoring. The aim of the study was to investigate the feasibility of linked primary and secondary care electronic health record data for surveillance of medication safety, examining not only prescribing but also monitoring, and associations with patient- and general practice-level characteristics. A cross-sectional study was conducted using linked records of patients served by one hospital and over 50 general practices in Salford, UK. Statistical analysis consisted of mixed-effects logistic models, relating prescribing safety indicators to potential determinants. The overall prevalence (proportion of patients with at least one medication safety hazard) was 5.45 % for prescribing indicators and 7.65 % for monitoring indicators. Older patients and those on multiple medications were at higher risk of prescribing hazards, but at lower risk of missed monitoring. The odds of missed monitoring among all patients were 25 % less for males, 50 % less for patients in practices that provide general practitioner training, and threefold higher in practices serving the most deprived compared with the least deprived areas. Practices with more prescribing hazards did not tend to show more monitoring issues. Systematic collection, collation, and analysis of linked primary and secondary care records produce plausible and useful information about medication safety for a health system. Medication safety surveillance systems should pay close attention to patient age and polypharmacy with respect to both prescribing and monitoring failures; treat prescribing and
ARAB, Mohammad; AKBARI SARI, Ali; MOVAHED KOR, Elham; HOSSEINI, Mostafa; TOLOUI RAKHSHAN, Shiva; EZATI, Mohammad
Background It is important to focus on creating opportunities for patients’ participation at all levels of health systems in order to promote their ability to improve patient safety and quality of services. The general aim of this study was to determine patient safety level in Tehran University of Medical Sciences’ (TUMS) general hospitals, Tehran, Iran from patients’ perspective and to determine the contributory factors on their perspective. Methods: This was a cross-sectional study. In the spring 2011, the list of clinical departments of the six general hospitals affiliated to TUMS was obtained through the Website of TUMS. By using stratified random sampling, the sample size was calculated 300 patients. Data were collected by using a structured questionnaire and its validity and reliability were acceptable. Descriptive statistics, linear regression and logistic regression were used for analyzing the data. Results: Totally, 60% of patients were female. Patient safety was evaluated high by 60% of respondents. The unmarried or educated or employed individuals tend to score lower than others. Conclusion: TUMS’s general hospitals are enough safe from patients’ perspective, patient safety should be improved. In clinical governance, contributing patients’ perspective to the improvement of patient safety reforms is critical in generating new models of good practice. PMID:23641408
Marinos, D.; Leonidas, F.; Vlissidis, N.; Giovanis, C.; Pagiatakis, G.; Aidinis, C.; Vassilopoulos, C.; Pistner, T.; Schmitt, N.; Klaue, J.
An integrated health and safety monitoring system for aircraft environments using commercially available medical sensor modules and custom made safety sensors in conjunction with an appropriate database supervised through a human-machine interface is implemented. The application described aims at preventing critical health- or safety-related situations during the flight. The health monitoring part of the system is capable of collecting all relevant data, essential in analysing a passenger's health profile. These data, comprising of body temperature, blood pressure, pulse oximetry and electrocardiogram, are throughput and transmitted over a wireless optical intra-cabin link to a server. Furthermore, and in order to reduce the cabin crew workload, along with the health data from a specific passenger group, seat-embedded safety sensors provide information for all passengers' flight safety parameters (such as table upright, seat-belt closed, etc.). The data gathered by the system in a central server can, in its entirety, be stored, processed or acted upon in real time.
Arab, Mohammad; Akbari Sari, Ali; Movahed Kor, Elham; Hosseini, Mostafa; Toloui Rakhshan, Shiva; Ezati, Mohammad
It is important to focus on creating opportunities for patients' participation at all levels of health systems in order to promote their ability to improve patient safety and quality of services. The general aim of this study was to determine patient safety level in Tehran University of Medical Sciences' (TUMS) general hospitals, Tehran, Iran from patients' perspective and to determine the contributory factors on their perspective. This was a cross-sectional study. In the spring 2011, the list of clinical departments of the six general hospitals affiliated to TUMS was obtained through the Website of TUMS. By using stratified random sampling, the sample size was calculated 300 patients. Data were collected by using a structured questionnaire and its validity and reliability were acceptable. Descriptive statistics, linear regression and logistic regression were used for analyzing the data. Totally, 60% of patients were female. Patient safety was evaluated high by 60% of respondents. The unmarried or educated or employed individuals tend to score lower than others. TUMS's general hospitals are enough safe from patients' perspective, patient safety should be improved. In clinical governance, contributing patients' perspective to the improvement of patient safety reforms is critical in generating new models of good practice.
Resnic, Frederic S.; Gross, Thomas P.; Marinac-Dabic, Danica; Loyo-Berrios, Nilsa; Donnelly, Sharon; Normand, Sharon-Lise T.; Matheny, Michael E.
Context Assuring the safety of medical devices challenges current surveillance approaches which rely heavily on voluntary reporting of adverse events. Automated surveillance of clinical registries may provide early warnings in the post-market evaluation of medical device safety. Objective To determine whether automated safety surveillance of clinical registries using a computerized tool can provide early warnings regarding the safety of new cardiovascular devices. Design Prospective propensity matched cohort analysis of seven newly introduced cardiovascular devices, utilizing data from patients undergoing percutaneous coronary intervention (PCI) in Massachusetts between April 2003 and October 2007. Setting and Patients All adults undergoing PCI in Massachusetts licensed hospitals utilizing clinical data captured in the Massachusetts implementation of the National Cardiovascular Data Repository CathPCI Registry. Main Outcome Measure The presence of any safety alert, triggered if the cumulative observed risk for a given device exceeded the upper 95% confidence interval (CI) of comparator control device. Predefined sensitivity analyses assessed robustness of alerts when triggered. Results We evaluated 74,427 consecutive interventional coronary procedures. Three of 21 safety analyses triggered sustained alerts in two implantable devices. Patients receiving Taxus Express2® drug eluting stents (DES) experienced a 1.28 fold (2.87% versus 2.25%, absolute risk increase of 0.62%, CI: 0.25-0.99%) increased risk of post-procedural myocardial infarction and a 1.21 fold increase major adverse cardiac events relative to alternative DES (4.24% vs. 3.50%, absolute increase of 0.74%, CI: 0.29-1.19%). Patients receiving the Angio-Seal STS® vascular closure device (VCD) experienced a 1.51 fold increased risk (1.09% vs. 0.72%, absolute increased risk 0.37%, CI: 0.03-0.71%) increased risk of major vascular complications compared with alternative VCD. Sensitivity analyses confirmed
Mori, Kazuhiko; Watanabe, Meguru; Horiuchi, Naoya; Tamura, Atsushi; Kutsumi, Hiromu
The development of drugs and medical devices is necessary for medical progress; however, safety measures need to be put in place to protect the health of the population. In order to ensure the safety of drugs and medical devices, it is important to determine measures for appropriate management of risks at any time during the development phase, the regulatory review and the post-marketing phase. Adverse events detected in clinical trials are limited due to the restricted numbers of patients enrolled in the trials. Therefore, it is almost impossible to predict rare serious adverse events during the post-marketing phase. The revised Pharmaceutical Affairs Act was established in Japan in November 20, 2013. The new act focuses on increased safety of drugs and medical devices. The Pharmaceuticals and Medical Devices Agency (PMDA) is the regulatory authority in Japan that promotes safety measures from the development phase through to the post-marketing phase. In the post-marketing phase, the PMDA collects information from the medical product companies and healthcare professionals, as well as instructing and advising them with regard to post-marketing safety measures for each drug and medical device. Since Japan has a national health insurance system, a new drug or a medical device is available throughout the country when the drug price or medical fee is listed in the National Health Insurance price list. Healthcare professionals in medical institutions must learn about the drugs and medical devices they handle, and should make an effort to maintain patient safety. The PMDA medi-navi is a very useful electronic mail delivery service that provides critical information for protecting patients from health hazards caused by adverse events. The 'risk management plan' is also important as it contains important information about safety profile and post-marketing measures of a new drug.
Bakhireva, Ludmila N; Young, Bonnie N; Dalen, Jeanne; Phelan, Sharon T; Rayburn, William F
To examine information sources about the safety of medications during pregnancy among predominantly Latina pregnant women. Consecutively chosen pregnant women (n = 404) attending the University of New Mexico clinics were offered participation and interviewed by a bilingual interviewer. Patient-initiated questions about the safety of medications in pregnancy were addressed most frequently to prenatal care providers (62.1%) and family members (25.2%). The Internet, books and clinic pamphlets/brochures were the most frequent self-identified sources of information. Among the 181 women with medical conditions (44.8%), education, marital status and parity were important predictors of information-seeking behavior. Specifically, women with higher education were 3.0 times (95% CI 1.2-7.5) more likely to seek advice than women with less than a high school education. Single (OR = 0.3; 95% CI 0.1-0.7) and multiparous (OR = 0.4; 95% CI 0.1-0.9) women were less likely to seek advice than married and nulliparous patients, respectively. Prenatal care providers need to more actively engage pregnant women in a decision-making process and discuss risks and benefits of medication management during pregnancy.
Medicinal products are associated with risks as well as potential therapeutic benefits. This is reflected by the legal requirements for patient information on drug therapy which can be differentiated into general product information, regulated by pharmaceutical (i. e. product safety) law, and individual patient information on the treatment with the product, which is subject to medical malpractice law. The physician's duty to inform the patient comprises therapeutic information as well as information required for informed consent. Therapeutic information intends to empower the patient to comply with the requirements of treatment and to protect him/her against preventable danger and risk; it is part of the medical treatment, aimed at the individual patient and his/her personal situation. Information required for informed consent enables the patient to a self-determined decision on the treatment offered; it can be divided into information on the course of treatment and risk information. Product information and treatment information complement each other; the former should be the basis of individual information on the concrete treatment, provided by the physician in a mandatory oral conversation with the patient. Product information cannot replace the physician's individual information about the treatment.
Chrischilles, Elizabeth A; Hourcade, Juan Pablo; Doucette, William; Eichmann, David; Gryzlak, Brian; Lorentzen, Ryan; Wright, Kara; Letuchy, Elena; Mueller, Michael; Farris, Karen; Levy, Barcey
To examine the impact of a personal health record (PHR) on medication-use safety among older adults. Online PHRs have potential as tools to manage health information. We know little about how to make PHRs accessible for older adults and what effects this will have. A PHR was designed and pretested with older adults and tested in a 6-month randomized controlled trial. After completing mailed baseline questionnaires, eligible computer users aged 65 and over were randomized 3:1 to be given access to a PHR (n=802) or serve as a standard care control group (n=273). Follow-up questionnaires measured change from baseline medication use, medication reconciliation behaviors, and medication management problems. Older adults were interested in keeping track of their health and medication information. A majority (55.2%) logged into the PHR and used it, but only 16.1% used it frequently. At follow-up, those randomized to the PHR group were significantly less likely to use multiple non-steroidal anti-inflammatory drugs-the most common warning generated by the system (viewed by 23% of participants). Compared with low/non-users, high users reported significantly more changes in medication use and improved medication reconciliation behaviors, and recognized significantly more side effects, but there was no difference in use of inappropriate medications or adherence measures. PHRs can engage older adults for better medication self-management; however, features that motivate continued use will be needed. Longer-term studies of continued users will be required to evaluate the impact of these changes in behavior on patient health outcomes. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
Smetzer, Judy L; Vaida, Allen J; Cohen, Michael R; Tranum, Diane; Pittman, Mary A; Armstrong, Carl W
Hospital medication practices should be assessed, awareness of the characteristics of a safe medication system heightened, and baseline data to identify national priorities established. A cross-sectional survey of U.S. hospitals (N = 6,180) was conducted in May 2000. The survey instrument contained 194 self-assessment items organized into 20 core characteristics and 10 larger domains. Hospitals were asked to voluntarily submit their confidential assessment data to the Institute for Safe Medication Practices (ISMP) for aggregate analysis. A weighting structure was applied to the individual items and used to calculate core characteristic scores, domain scores, and overall self-assessment scores. These scores were then compared to identify areas most in need of improvement. The 1,435 participating hospitals scored highest in domains related to drug storage and distribution; environmental factors; infusion pumps; and medication labeling, packaging, and nomenclature issues. These hospitals scored lowest in domains related to accessible patient information, communication of medication orders, patient education, and quality processes such as double-check systems and organizational culture. Enormous opportunities exist to improve medication safety, especially in domains related to culture, information management, and communication.
Hayes, Adrian J; Roberts, Poppy; Figgins, Adam; Pool, Rosalind; Reilly, Siobhan; Roughley, Christopher; Salter, Thomas; Scott, Jessica; Watson, Sarah; Woodside, Rebecca; Patel, Vinod
Patient safety is becoming an important but under-emphasised topic in medical education. Despite high-profile recommendations, it has not yet been ingrained in the medical undergraduate curriculum. We designed and evaluated an educational intervention on patient safety to pre-clinical undergraduate medical students, devised and run entirely by medical students in their clinical years. The aim was to raise awareness of patient safety, and provide the opportunity to practice specific skills useful as medical students and junior doctors. We designed a two hour seminar consisting of a brief lecture on the principles of patient safety, followed by a carousel of interactive activities in small groups. Attendance was voluntary. The effects were evaluated by questionnaires addressing satisfaction, attitudes and self-efficacy completed before, after and six months following the seminar. A total of 86 students attended, with a reserve list of interested students in place. A total of 92% completed the pre- and post-evaluation, of whom 100% enjoyed the seminar, 99% recommended other students to take part and 92% thought it should be a mandatory part of the curriculum. A total of 64% completed follow-up questionnaires at six months and showed significant maintenance of skills taught. Student tutors can deliver effective and engaging teaching on patient safety and should be utilised as part of the existing medical curriculum. Patient safety should be taught at medical schools using interactive methodologies to promote interest.
Haslam, C; Atkinson, S; Brown, S; Haslam, R
Background: The number of people taking prescribed medication for anxiety and depression has increased greatly, but little is known of how this medication impacts on safety at work. Aims: To examine the relation between anxiety and depression, prescribed medication, performance, and safety in the workplace. Methods: The research involved nine focus groups with sufferers of anxiety and depression to investigate experiences of mental health problems and the impact of psychotropic drugs. A further three focus groups were conducted with staff in human resources, personnel, occupational health, and health and safety departments, to explore organisational perspectives. The sample comprised 74 individuals drawn from a wide range of occupational sectors. Finally, the results were presented to a panel of experts from occupational medicine, general practice, psychology, health and safety, and psychiatry, to consider the implications for practice. Results: Workers reported that both the symptoms and the medication impaired work performance. Participants described accidents which they attributed to their condition or to the medication. Workers with responsibilities for others, such as teachers, healthcare workers, and managers appeared to present a particular safety risk. Healthcare workers believed that they placed themselves and their patients at risk when carrying out medical procedures. Conclusions: Respondents in this study felt that their symptoms of anxiety and depression and the medication they took to treat these conditions placed them at risk with respect to safety in the workplace. Drawing on the results, the authors outline areas for improvement in the management of mental health problems at work. PMID:16046606
Escher, Cecilia; Creutzfeldt, Johan; Meurling, Lisbet; Hedman, Leif; Kjellin, Ann; Felländer-Tsai, Li
Patient safety education, as well as the safety climate at clinical rotations, has an impact on students' attitudes. We explored medical students' self-reported motivation to participate in simulation-based teamwork training (SBTT), with the hypothesis that high scores in patient safety attitudes would promote motivation to SBTT and that intrinsic motivation would increase after training. In a prospective cohort study we explored Swedish medical students' attitudes to patient safety, their motivation to participate in SBTT and how motivation was affected by the training. The setting was an integrated SBTT course during the surgical semester that focused on non-technical skills and safe treatment of surgical emergencies. Data was collected using the Situational Motivation Scale (SIMS) and the Attitudes to Patient Safety Questionnaire (APSQ). We found a positive correlation between students' individual patient safety attitudes and self-reported motivation (identified regulation) to participate in SBTT. We also found that intrinsic motivation increased after training. Female students in our study scored higher than males regarding some of the APSQ sub-scores and the entire group scored higher or on par with comparable international samples. In order to enable safe practice and professionalism in healthcare, students' engagement in patient safety education is important. Our finding that students' patient safety attitudes show a positive correlation to motivation and that intrinsic motivation increases after training underpins patient safety climate and integrated teaching of patient safety issues at medical schools in order to help students develop the knowledge, skills and attitudes required for safe practice.
Azuma, Kentaro; Iseki, Hiroshi
Regulatory convergence in safety reporting requirements for medical device clinical trials has not yet been achieved. The Global Harmonization Task Force (GHTF) issued new guidance, GHTF/SG5/N5, on this topic in August 2012. First, we compared current reporting requirements for drug and medical devices in Japan with the international guidelines International Conference on Harmonization (ICH)-E2A/E2F and GHTF/SG5/N5. As a result, we confirmed that Japan's expedited reporting requirements are nearly the same for drugs and medical devices and that these requirements are similar to those described in ICH-E2A. We also found that GHTF/SG5/N5 differs from the ICH-E2A in several ways. We sorted these differences into three categories: reportable events, reporting time frame, and definitions of terms. Although there are several equivalent terms between the ICH and GHTF guidelines, the terms Serious Health Threat and Device Deficiency are only defined in GHTF/SG5/N5. The reporting time frame for a Serious Adverse Event is either 10 or 30 days for medical devices; expedited reporting is not required according to ICH-E2A, but it is covered in the annual Development Safety Update Report in ICH-E2F. GHTF/SG5/N5 recommends substantially stricter requirements than the current requirements in Japan. Therefore, the Ministry of Health, Labour and Welfare (MHLW) seemed to have prioritized the introduction of consistent definitions of terms while maintaining the current reporting time frame, rather than introducing GHTF guidance as it is. This policy is in accordance with the draft proposal on the revision of safety reporting requirements issued by MHLW in October 2012.
Klieger, Sarah B; Gutman, Abraham; Allen, Leslie; Pacula, Rosalie Liccardo; Ibrahim, Jennifer K; Burris, Scott
(1) To describe open source legal data sets, created for research use, that capture the key provisions of US state medical marijuana laws. The data document how state lawmakers have regulated a medicine that remains, under federal law, a Schedule I illegal drug with no legitimate medical use. (2) To demonstrate the variability that exists across states in rules governing patient access, product safety and dispensary practice. Two legal researchers collected and coded state laws governing marijuana patients, product safety and dispensaries in effect on 1 February 2017, creating three empirical legal data sets. We used summary tables to identify the variation in specific statutory provisions specified in each state's medical marijuana law as it existed on 1 February 2017. We compared aspects of these laws to the traditional Federal approach to regulating medicine. Full data sets, codebooks and protocols are available through the Prescription Drug Abuse Policy System (http://www.pdaps.org/; Archived at http://www.webcitation.org/6qv5CZNaZ on 2 June 2017). Twenty-eight states (including the District of Columbia) have authorized medical marijuana. Twenty-seven specify qualifying diseases, which differ across states. All states protect patient privacy; only 14 protect patients against discrimination. Eighteen states have mandatory product safety testing before any sale. While the majority have package/label regulations, states have a wide range of specific requirements. Most regulate dispensaries (25 states), with considerable variation in specific provisions such as permitted product supply sources number of dispensaries per state and restricting proximity to various types of location. The federal ban in the United States on marijuana has resulted in a patchwork of regulatory strategies that are not uniformly consistent with the approach usually taken by the Federal government and whose effectiveness remains unknown. © 2017 Society for the Study of Addiction.
Jia, Pengli; Zhang, Longhao; Chen, Jingjing; Zhao, Pujing; Zhang, Mingming
Background The clinical decision support system(CDSS) has potential to improving medication safety. However, the effects of the intervention were conflicting and uncertain. Meanwhile, the reporting and methodological quality of this field were unknown. Objective The aim of this overview is to evaluate the effects of CDSS on medication safety and to examine the methodological and reporting quality. Methods PubMed, Embase and Cochrane Library were searched to August 2015. Systematic reviews (SRs) investigating the effects of CDSS on medication safety were included. Outcomes were determined in advance and assessed separately for process of care and patient outcomes. The methodological quality was assessed by Assessment of Multiple Systematic Reviews (AMSTAR) and the reporting quality was examined by Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). Results Twenty systematic reviews, consisting of 237 unique randomized controlled trials(RCTs) and 176 non-RCTs were included. Evidence that CDSS significantly impacted process of care was found in 108 out of 143 unique studies of the 16 SRs examining this effect (75%). Only 18 out of 90 unique studies of the 13 SRs reported significantly evidence that CDSS positively impacted patient outcomes (20%). Ratings for the overall scores of AMSTAR resulted in a mean score of 8.3 with a range of scores from 7.5 to 10.5. The reporting quality was varied. Some contents were particularly strong. However, some contents were poor. Conclusions CDSS reduces medication error by obviously improving process of care and inconsistently improving patient outcomes. Larger samples and longer-term studies are required to ensure more reliable evidence base on the effects of CDSS on patient outcomes. The methodological and reporting quality were varied and some realms need to be improved. PMID:27977697
Background Medication incident reporting (MIR) is a key safety critical care process in residential aged care facilities (RACFs). Retrospective studies of medication incident reports in aged care have identified the inability of existing MIR processes to generate information that can be used to enhance residents’ safety. However, there is little existing research that investigates the limitations of the existing information exchange process that underpins MIR, despite the considerable resources that RACFs’ devote to the MIR process. The aim of this study was to undertake an in-depth exploration of the information exchange process involved in MIR and identify factors that inhibit the collection of meaningful information in RACFs. Methods The study was undertaken in three RACFs (part of a large non-profit organisation) in NSW, Australia. A total of 23 semi-structured interviews and 62 hours of observation sessions were conducted between May to July 2011. The qualitative data was iteratively analysed using a grounded theory approach. Results The findings highlight significant gaps in the design of the MIR artefacts as well as information exchange issues in MIR process execution. Study results emphasized the need to: a) design MIR artefacts that facilitate identification of the root causes of medication incidents, b) integrate the MIR process within existing information systems to overcome key gaps in information exchange execution, and c) support exchange of information that can facilitate a multi-disciplinary approach to medication incident management in RACFs. Conclusions This study highlights the advantages of viewing MIR process holistically rather than as segregated tasks, as a means to identify gaps in information exchange that need to be addressed in practice to improve safety critical processes. PMID:23122411
Zuckerman, Diana; Brown, Paul; Das, Aditi
Under the 510(k) process, the US Food and Drug Administration (FDA) clears about 400 implanted medical devices that are considered moderate to high risk for market each year without requiring clinical testing. Instead, the FDA requires the applicant to provide scientific evidence that the new device is "substantially equivalent" to a device or devices already on the market (predicate devices). Companies are legally required to submit the evidence to the FDA and to make publicly available at least a summary of the evidence. To assess the types of scientific evidence used to determine substantial equivalence, safety, or effectiveness for a representative sample of implanted medical devices; the number of predicates for each implant; and whether this evidence was publicly available. Using FDA databases, we determined the device categories of the first 5 implanted medical devices cleared through the 510(k) process in 2008: cardiovascular, dental, general and plastic surgery, neurological, and orthopedic. We then identified the first 2 implanted medical devices approved in each of the 5 categories for each year from 2008 through 2012. The sample of 50 devices included, for example, total hip implants, vascular embolization devices, and surgical mesh. We also identified the 1105 predicates the manufacturers listed for these devices. For each implanted medical device and its predicates, we determined whether clinical or nonclinical scientific evidence was provided to the FDA to support the claim of substantial equivalence and whether this evidence was publicly available. We also determined if safety or effectiveness data were provided. Scientific data to support the claim of substantial equivalence were publicly available for 8 of the 50 newly cleared implants (16%) and 31 of their 1105 listed predicates (3%). Most of the evidence was nonclinical data; some of the data also evaluated safety or effectiveness. Despite the legal requirement that scientific evidence of
This report is about planning, developing, and implementing the automated alert system for the Hospital infection control and the safety of medical staffs about information on patients exposed to infection based on EMR Data in a tertiary hospital in Korea.
Kertesz, Stefan G; McNeil, Whitney; Cash, Julie J; Desmond, Renee; McGwin, Gerald; Kelly, Jason; Baggett, Travis P
Although homeless individuals often experience health problems requiring care, there are limitations to available research concerning the scale of their needs and the accessibility of safety net agencies to meet them. Traditional access-to-care surveys calculate unmet need among all persons queried (rather than persons needing care), making it difficult to calculate what percentage of persons requiring care actually obtain it. Additionally, no research has compared the relative accessibility of safety net programs to homeless persons in need. This cross-sectional, community-based survey assessed the prevalence of unmet need for several specific types of health care and compared the accessibility of agencies in Birmingham, AL. Substantial proportions of respondents reported unmet needs for general medical care (46 %), specialty care (51 %), mental health care (51 %), dental care (62 %), medications (57 %), and care of a child (23 %). The most commonly mentioned sites where care was sought included a federally funded Health Care for the Homeless (HCH) program (59 %), a religious free clinic (31 %), and a public hospital emergency department (51 %). The HCH program was most commonly cited as the location where care, once sought, could not be obtained (15 %), followed by the county hospital primary care clinics (13 %). In this survey, unmet need was common for all types of care queried, including primary care. Key components of the safety net, including a federally funded homeless health care program, had suboptimum accessibility.
Polisena, Julie; Jutai, Jeffrey; Chreyh, Rana
Purpose Medical devices are used to monitor, replace, or modify anatomy or physiological processes. They are important health care innovations that enable effective treatment using less invasive techniques, and they improve health care delivery and patient outcomes. Devices can also introduce risk of harm to patients. Our objective was to propose a surveillance system framework to improve the safety associated with the use of medical devices in a hospital. Materials and methods The proposed medical device surveillance system incorporates multiple components to accurately document and assess the appropriate actions to reduce the risk of incidents, adverse events, and patient harm. The assumptions on which the framework is based are highlighted. The surveillance system was designed from the perspective of a tertiary teaching hospital that includes dedicated hospital staff whose mandate is to provide safe patient care to inpatients and outpatients and biomedical engineering services. Results The main components of the surveillance system would include an adverse medical device events database, a medical device/equipment library, education and training, and an open communication and feedback strategy. Close linkages among these components and with external medical device/equipment networks to the hospital must be established and maintained. A feedback mechanism on medical device-related incidents, as well as implementation and evaluation strategies for the surveillance system are described to ensure a seamless transition and a high satisfactory level among the hospital staff. The direct cost items of the proposed surveillance system for consideration, and its potential benefits are outlined. Conclusion The effectiveness of the proposed medical device surveillance system framework can be measured after it has been implemented in a Canadian hospital facility. PMID:24876796
Hickner, John; Smith, Scott A; Yount, Naomi; Sorra, Joann
Experts in patient safety stress the importance of a shared culture of safety. Lack of consensus may be detrimental to patient safety. This study examines differences in patient safety culture perceptions among providers, management and staff in a large national survey of safety culture in ambulatory practices in the USA. The US Agency for Healthcare Research and Quality Medical Office Survey on Patient Safety Culture (SOPS) assesses perceptions about patient safety issues and event reporting in medical offices (ie, ambulatory practices). Using the 2014 data, we analysed responses from medical offices with at least five respondents. We calculated differences in perceptions of patient safety culture across six job positions (physicians, management, nurse practitioners (NPs)/physician assistants (PAs), nurses, clinical support staff and administrative/clerical staff) for 10 survey composites, the average of the 10 composites and an overall patient safety rating using multivariate hierarchical linear regressions. We analysed data from 828 medical offices with responses from 15 523 providers and staff, with an average 20 completed surveys per medical office (range: 5-367) and an average medical office response rate of 65% (range: 3%-100%). Management had significantly more positive patient safety culture perceptions on nine of 10 composite scores compared with all other job positions, including physicians. The composite that showed the largest difference was Communication Openness; Management (85% positive) was 22% points more positive than other clinical and support staff and administrative/clerical staff. Physicians were significantly more positive than PAs/NPs, nursing staff, other clinical and support staff and administrative/clerical staff on four composites: Communication About Error, Communication Openness, Staff Training and Teamwork, ranging from 3% to 20% points more positive. These findings suggest that managers need to pay attention to the training needs
The European Federation of Organisations for Medical Physics policy statement No. 13: recommended guidelines on the development of safety and quality management systems for medical physics departments.
This EFOMP Policy Statement outlines the way in which a Safety and Quality Management System can be developed for Medical Physics Departments. The Policy Statement can help Medical Physicists to eliminate or at least minimize accidents or incidences due to improper use or application of medical technology on one hand and on the other to guarantee a safe, effective and efficient usage of new highly complicated and sophisticated technologies and procedures.
Medical librarians supporting information systems project lifecycles toward improved patient safety. Medical librarians possess expertise to navigate various search resources and can investigate inquiries during IS project lifecycles.
Saimbert, Marie K; Zhang, Yingting; Pierce, Jenny; Moncrief, Erica S; O'Hagan, Keydi Boss; Cole, Peter
Health information systems (HIS) have progressed from being used to manage billing to impacting patient safety and health professionals' job satisfaction. Many decisions are made during project management and the information system lifecycle of a HIS. Medical librarians are underutilized in HIS lifecycles; it may not be clear to stakeholders what they can provide and where their services fit. Medical librarians possess expertise to navigate various search resources and can investigate inquiries during information systems project lifecycles. Librarians can market specific skills to project lifecycle teams such as those involved in computerized provider order entry (CPOE), electronic medication administration record (eMAR) and root cause analysis (RCA). HIS project personnel, including patient safety team members, should make use of medical librarians in phases of health information systems project management. This will help them meet institutional and global objectives for evidence-based use of technology towards improved patient safety.
Fong, Allan; Harriott, Nicole; Walters, Donna M; Foley, Hanan; Morrissey, Richard; Ratwani, Raj R
Many healthcare providers have implemented patient safety event reporting systems to better understand and improve patient safety. Reviewing and analyzing these reports is often time consuming and resource intensive because of both the quantity of reports and length of free-text descriptions in the reports. Natural language processing (NLP) experts collaborated with clinical experts on a patient safety committee to assist in the identification and analysis of medication related patient safety events. Different NLP algorithmic approaches were developed to identify four types of medication related patient safety events and the models were compared. Well performing NLP models were generated to categorize medication related events into pharmacy delivery delays, dispensing errors, Pyxis discrepancies, and prescriber errors with receiver operating characteristic areas under the curve of 0.96, 0.87, 0.96, and 0.81 respectively. We also found that modeling the brief without the resolution text generally improved model performance. These models were integrated into a dashboard visualization to support the patient safety committee review process. We demonstrate the capabilities of various NLP models and the use of two text inclusion strategies at categorizing medication related patient safety events. The NLP models and visualization could be used to improve the efficiency of patient safety event data review and analysis. Copyright © 2017 Elsevier B.V. All rights reserved.
Ladas, P; Giatagatzidis, P; Anogianakis, G; Maglavera, S
Telemedicine dates to the days of "wireless telegraphy". As an "extraordinary" arrangement for medical services delivered at time of need, telemedicine has thus far escaped the developments that have taken place over the last 50 years in the areas of medical liability, safety and confidentiality. Today, however, telemedicine is also used to increase quality and cost effectiveness of healthcare provision. This trend is set by the U.S. where the U.S. federal government funds telemedicine at an annual rate of more than $100 million i.e., at a rate 30 times or more than what the EU does while state and local agency support and private business investment in telemedicine is 3 to 4 times larger than that of the U.S. federal government. In this respect it must be stressed that technology tends to satisfy the relevant demand for telecommunications. Telemedicine is used in diverse areas such as pathology, surgery, physical therapy, and psychiatry. It is expected to revolutionise health care in the coming decade and, therefore, it will certainly take into account requirements for medical liability, safety and confidentiality in the same way as traditional "establishment" medicine does.
Rajkomar, Atish; Mayer, Astrid; Blandford, Ann
As healthcare shifts from the hospital to the home, it is becoming increasingly important to understand how patients interact with home medical devices, to inform the safe and patient-friendly design of these devices. Distributed Cognition (DCog) has been a useful theoretical framework for understanding situated interactions in the healthcare domain. However, it has not previously been applied to study interactions with home medical devices. In this study, DCog was applied to understand renal patients' interactions with Home Hemodialysis Technology (HHT), as an example of a home medical device. Data was gathered through ethnographic observations and interviews with 19 renal patients and interviews with seven professionals. Data was analyzed through the principles summarized in the Distributed Cognition for Teamwork methodology. In this paper we focus on the analysis of system activities, information flows, social structures, physical layouts, and artefacts. By explicitly considering different ways in which cognitive processes are distributed, the DCog approach helped to understand patients' interaction strategies, and pointed to design opportunities that could improve patients' experiences of using HHT. The findings highlight the need to design HHT taking into consideration likely scenarios of use in the home and of the broader home context. A setting such as home hemodialysis has the characteristics of a complex and safety-critical socio-technical system, and a DCog approach effectively helps to understand how safety is achieved or compromised in such a system.
In 2014, Prescrire examined the packaging quality of about 250 drugs. A few advances stand out, mainly involving recent drugs, but on the whole, the situation is worrisome in terms of medication safety. Although pharmaceutical companies and drug regulatory agencies seem to be taking more account of the risk of accidental poisoning in children, the level of protection remains low overall in the absence of stringent measures on the part of the authorities. New drugs too often have poor-quality or even dangerous packaging at the time of their market introduction. And the packaging quality of older drugs is disturbing. Pharmaceutical companies no longer invest in the packaging of these products, and agencies often fail to take advantage of the opportunities provided by their reassessment to improve the situation. The inappropriate labelling of certain injectable drugs remains a source of medication errors, sometimes resulting in very serious consequences. In 2014, signs of progress in the packaging of several drugs show that its role in medication safety is better appreciated. But the persistence of dangers in the pharmaceuticals market, created by "unfinished", overly complex or poor-quality packaging, raises the question of the responsibility of pharmaceutical companies and agencies for past and present accidents.
Santos, A L R; Wauben, L S G L; Guilavogui, S; Brezet, J C; Goossens, R; Rosseel, P M J
Safety challenges related to the use of medical equipment were investigated during the training of nurse anaesthetists in Haiti, using a systems approach to Human Factors and Ergonomics (HFE). The Observable Performance Obstacles tool, based on the Systems Engineering Initiative for Patient Safety (SEIPS) model, was used in combination with exploratory observations during 13 surgical procedures, to identify performance obstacles created by the systemic interrelationships of medical equipment. The identification of performance obstacles is an effective way to study the accumulation of latent factors and risk hazards, and understand its implications in practice and behaviour of healthcare practitioners. In total, 123 performance obstacles were identified, of which the majority was related to environmental and organizational aspects. These findings show how the performance of nurse anaesthetists and their relation to medical equipment is continuously affected by more than user-related aspects. The contribution of systemic performance obstacles and coping strategies to enrich system design interventions and improve healthcare system is highlighted. In addition, methodological challenges of HFE research in low-resource settings related to professional culture and habits, and the potential of community ergonomics as a problem-managing approach are described. Copyright © 2015 Elsevier Ltd and The Ergonomics Society. All rights reserved.
Nelson, Lewis S; Loh, Meredith; Perrone, Jeanmarie
The decision to approve a drug for clinical use is based on an understanding of its benefits versus the risks. Although efficacy is generally understood at the time of submission to the FDA for approval, the risks are more difficult to assess. Both PubMed (from 2000 to 2012) and the FDA website (www.fda.gov) were searched using the search terms "risk evaluation and mitigation strategy" (REMS). Articles for review were selected by relevance to topic, and their references were searched as well for additional relevant resources. Since the search results were not expected to contain research studies, formal quality assessment and inclusion and exclusion criteria were not utilized resulting in a narrative review. Few directly relevant research studies exist, although supporting documents such as government reports were available. For effective drugs with unclear or concerning safety records, the FDA has the option of requiring a risk evaluation and mitigation strategy, which allows a systematic approach to track and assure safe medication use. Over 100 different medications are currently covered by REMS, and each REMS is developed individually based on the needs of the specific drug or class. Although likely associated with improvements in medication safety, the potential benefit, limitations, and consequences of REMS are not yet fully understood.
Robb, Melissa A; Racoosin, Judith A; Worrall, Chris; Chapman, Summer; Coster, Trinka; Cunningham, Francesca E
After half a century of monitoring voluntary reports of medical product adverse events, the Food and Drug Administration (FDA) has launched a long-term project to build an adverse events monitoring system, the Sentinel System, which can access and evaluate electronic health care data to help monitor the safety of regulated medical products once they are marketed. On the basis of experience gathered through a number of collaborative efforts, the Federal Partners' Collaboration pilot project, involving FDA, the Centers for Medicare & Medicaid Services, the Department of Veteran Affairs, and the Department of Defense, is already enabling FDA to leverage the power of large public health care databases to assess, in near real time, the utility of analytical tools and methodologies that are being developed for use in the Sentinel System. Active medical product safety surveillance is enhanced by use of these large public health databases because specific populations of exposed patients can be identified and analyzed, and can be further stratified by key variables such as age, sex, race, socioeconomic status, and basis for eligibility to examine important subgroups.
Sinclair, Marlene; Lagan, B M; Dolk, Helen; McCullough, Julie E M
The aim of this study was to assess pregnant women's Internet searching activity about medication safety, knowledge and perceptions of medication risk and willingness to take prescribed and non-prescribed medication or make online medication purchases. Online medication advice for pregnant women is complex. The quality and veracity of this data is increasingly important as more midwives report women are bringing retrieved online information to clinical appointments. Pregnant women's use of the Internet for seeking medication advice and purchasing medications has not yet been fully investigated. Online survey conducted from January - March 2013. Of the 284 respondents, 39% were taking a medication when they became pregnant and 76% had searched the Internet for medication safety information. Analgesics were the most commonly searched category (41%). Health service sites were the most common online source and regarded as the most helpful and trusted. Regardless of age and education level, 90% of women agreed that if trying to become pregnant they would reconsider taking any medications because of the potential risk to their unborn baby. Forty-six percent of women with higher levels of education consider buying medication online as safe, a greater proportion than those of lower education. Five percent of women reported buying medication online. The lack of specific recommendations for medication use during pregnancy is challenging for healthcare staff and pregnant women who need robust evidence to make informed treatment decisions. The Internet is a recognized, commonly accessed, source of medication information for pregnant women. © 2017 John Wiley & Sons Ltd.
Coppens, Greet; Stalmans, Ingeborg; Zeyen, Thierry; Casteels, Ingele
Topical glaucoma medications are widely used for childhood glaucoma, although little is known concerning the use of the newer glaucoma medications in this population. The majority of the references cited were extracted from PubMed. A literature review of all English language reports related to glaucoma medication in the pediatric population since 1980 was performed. Medical therapy of pediatric glaucoma contains four groups of drugs: beta-blockers (timolol and betaxolol), carbonic anhydrase inhibitors (dorzolamide), alpha2-agonists (brimonidine), and prostaglandin analogs (latanoprost). Timolol is the first choice in pediatric glaucoma. In cases with insufficient reduction of the intraocular pressure (IOP), the combination of timolol once a day and dorzolamide twice a day brings about a good control of the IOP. Both medications are effective and well tolerated. The alpha2-agonists have more and potentially serious adverse effects in children and are contraindicated for children younger than 2 years of age. Latanoprost tends to be less effective in lowering IOP in children than in adults. However, no studies are reported where latanoprost is used in monotherapy. Additional study may further delineate this drug's role in treating pediatric glaucoma. The safety profile of latanoprost in children appears excellent.
Bhardwaj, M; Arteta, M; Batmunkh, T; Briceno Leonardo, L; Caraballo, Y; Carvalho, D; Dan, W; Erdogan, S; Brborovic, H; Gudrun, K; Ilse, U; Ingle, G K; Joshi, S K; Kishore, J; Khan, Z; Retneswari, M; Menses, C; Moraga, D; Njan, A; Okonkwo, F O; Ozlem, K; Ravichandran, S; Rosales, J; Rybacki, M; Sainnyambuu, M; Shathanapriya, K; Radon, K
Work-related diseases contribute immensely to the global burden of diseases. Better understanding of attitudes of health care workers towards occupational safety and health (OSH) is important for planning. To assess the attitude of medical students towards OSH around the globe. A questionnaire assessing the attitude towards OSH was administered to medical and paramedical students of 21 Medical Universities across the globe. In the current study 1895 students, aged 18-36 years, from 17 countries were included. After having performed a principal components analysis, the associations of interest between the identified components and other socio demographic characteristics were assessed by multivariate linear regression. Principal component analysis revealed 3 components. Students from lower and lower-middle-income countries had a more positive attitude towards OSH, but the importance of OSH was still rated higher by students from upper-income countries. Although students from Asian and African continents showed high interest for OSH, European and South-Central American students comparatively rated importance of OSH to be higher. Paramedical students had more positive attitude towards OSH than medical students. The attitude of students from lower-income and lower-middle-income towards importance of OSH is negative. This attitude could be changed by recommending modifications to OSH courses that reflect the importance of OSH. Since paramedical students showed more interest in OSH than medical students, modifications in existing health care system with major role of paramedics in OSH service delivery is recommended.
Battaglia, Jessica N; Lis, Jennifer E; Chui, Michelle A
To develop and evaluate the impact of a module discussing the patient's perspective on medication errors in a required medication safety course at a college of pharmacy. Students were required to read Josie's Story, a true story written by a mother after her daughter died from a medical error, and attend an in-class discussion regarding the book. A questionnaire, which employed a pre-post retrospective method and extracted items from the Caring Ability Inventory, was then administered to measure the change in students' perceptions of patient care. Additional questions gathered students' perceptions of the assignment, their personal experiences with the topic, and the importance of medication safety. 120 out of 138 students (response rate = 87%) completed the questionnaire. 56% of students indicated they would be more likely to speak with a patient directly about a medication error after reading the book, whereas only 3% were less likely, and 42% indicated they were just as likely. Most students (59%) reported that they felt more motivated to learn about medication safety after reading Josie's Story. This course previously addressed strategies to prevent medication errors. Successfully adding a component that introduces how a medication error impacted a patient and her family may help motivate students to recognize the importance and need for a culture of safety, personalize how medication errors impact patients, and provide a venue for students to gain patient centeredness and caring skills.
Benjamin, David M
Today, reducing medication errors and improving patient safety have become common topics of discussion for the president of the United States, federal and state legislators, the insurance industry, pharmaceutical companies, health care professionals, and patients. But this is not news to clinical pharmacologists. Improving the judicious use of medications and minimizing adverse drug reactions have always been key areas of research and study for those working in clinical pharmacology. However, added to the older terms of adverse drug reactions and rational therapeutics, the now politically correct expression of medication error has emerged. Focusing on the word error has drawn attention to "prevention" and what can be done to minimize mistakes and improve patient safety. Webster's New Collegiate Dictionary has several definitions of error, but the one that seems to be most appropriate in the context of medication errors is "an act that through ingnorance, deficiency, or accident departs from or fails to achieve what should be done." What should be done is generally known as "the five rights": the right drug, right dose, right route, right time, and right patient. One can make an error of omission (failure to act correctly) or an error of commission (acted incorrectly). This article now summarizes what is currently known about medication errors and translates the information into case studies illustrating common scenarios leading to medication errors. Each case is analyzed to provide insight into how the medication error could have been prevented. "System errors" are described, and the application of failure mode effect analysis (FMEA) is presented to determine the part of the "safety net" that failed. Examples of reengineering the system to make it more "error proof" are presented. An error can be prevented. However, the practice of medicine, pharmacy, and nursing in the hospital setting is very complicated, and so many steps occur from "pen to patient" that there
Sonawane, A U; Singh, Meghraj; Sunil Kumar, J V K; Kulkarni, Arti; Shirva, V K; Pradhan, A S
We conducted a radiological safety and quality assurance (QA) audit of 118 medical X-ray diagnostic machines installed in 45 major hospitals in India. The main objective of the audit was to verify compliance with the regulatory requirements stipulated by the national regulatory body. The audit mainly covered accuracy check of accelerating potential (kVp), linearity of tube current (mA station) and timer, congruence of radiation and optical field, and total filtration; in addition, we also reviewed medical X-ray diagnostic installations with reference to room layout of X-ray machines and conduct of radiological protection survey. A QA kit consisting of a kVp Test-O-Meter (ToM) (Model RAD/FLU-9001), dose Test-O-Meter (ToM) (Model 6001), ionization chamber-based radiation survey meter model Gun Monitor and other standard accessories were used for the required measurements. The important areas where there was noncompliance with the national safety code were: inaccuracy of kVp calibration (23%), lack of congruence of radiation and optical field (23%), nonlinearity of mA station (16%) and timer (9%), improper collimator/diaphragm (19.6%), faulty adjustor knob for alignment of field size (4%), nonavailability of warning light (red light) at the entrance of the X-ray room (29%), and use of mobile protective barriers without lead glass viewing window (14%). The present study on the radiological safety status of diagnostic X-ray installations may be a reasonably good representation of the situation in the country as a whole. The study contributes significantly to the improvement of radiological safety by the way of the steps already taken and by providing a vital feed back to the national regulatory body.
Covvey, J R; Al-Balushi, A; Boyter, A C; Gourlay, Y
Medication-related incidents are an important consideration in enhancing patient safety in hospital care. The wide use of antimicrobial therapy in this population renders these medications particularly vulnerable to errors and adverse events. To analyse the characteristics of antimicrobial-related incident reports across a group of secondary care hospitals. Reports for antimicrobial-related incidents from April 2010 to December 2013 were obtained from a regional area of hospitals in National Health Service Scotland. Reports were analysed as a full set, and with subset analyses of incidents resulting in patient harm/injury and those included in a multi-variable regression adjusted by occupied bed-days and defined daily doses to better ascertain areas to target for antimicrobial safety. In total, 1345 incidents were reported at a crude rate of 0.98 reports/day [95% confidence interval (CI) 0.93-1.03 reports/day]. Penicillins (371 reports; 27.6%), aminoglycosides (358; 26.6%) and glycopeptides (210; 15.6%) were the most commonly involved classes of medications. Most incidents involved no injury/harm (514; 38.2%), but 72 reports (5.4%) did result in patient harm. The rehabilitation/assessment [relative rate (RR) 2.61, 95% CI 1.70-4.03] and women/childrens (RR 2.04, 95% CI 1.39-2.99) directorates had higher incident reporting rates compared with other directorates, likely as a function of at-risk patient populations. Among the types of incidents reported, those involving issues with administration/supply were most common (RR 2.07, 95% CI 1.51-2.84). Incident reporting for antimicrobials identified several key areas for quality improvement in the hospital setting, which can guide safety efforts. Copyright © 2015 The Healthcare Infection Society. Published by Elsevier Ltd. All rights reserved.
Gatter, Mary; Cleland, Kelly; Nucatola, Deborah L
The aim of this study was to report on the safety and efficacy of an evidence-based medical abortion regimen utilizing 200 mg of mifepristone orally followed by home use of 800 mcg misoprostol buccally 24-48 h later through 63 days estimated gestational age. We analyzed outcomes in women presenting for medical abortion between April 1, 2006, and May 31, 2011, using an evidence-based alternative to the United States Food and Drug Administration (FDA)-approved regimen. Cases were identified for this descriptive study from our electronic practice management (EPM) database, and our electronic database on adverse events was queried for information on efficacy and safety. The primary outcome was successful abortion. Logistic regression was used to identify predictors of successful abortion. Among the 13,373 women who completed follow-up, efficacy of the regimen was 97.7%. Efficacy was highest at 29 to 35 days (98.8%) and 36 to 42 days (98.8%) of gestation and lowest at 57 to 63 days (95.5%). The odds of needing aspiration for any reason were greatest at higher gestational ages. Rates of infection requiring hospitalization and rates of transfusion were 0.01 and 0.03%, respectively. An evidence-based regimen of 200 mg of mifepristone orally followed by home use of 800 mcg of buccal misoprostol 24-48 h later is safe and effective through 63 days estimated gestational age. Further, the need for aspiration for any reason was low, and hospitalization was rare. This study reinforces the safety and efficacy of the evidence-based regimen for medical abortion (200 mg mifepristone orally followed by home use of 800 mcg of misoprostol buccally 24-48 h later) through 63 days estimated gestational age, and contributes to the existing evidence against restrictions requiring use of the FDA-approved regimen. Copyright © 2015 Elsevier Inc. All rights reserved.
Mansouri, Mohammad; Aran, Shima; Harvey, Harlan B; Shaqdan, Khalid W; Abujudeh, Hani H
To describe our multiyear experience in incident reporting related to magnetic resonance imaging (MRI) in a large academic medical center. This was an Institutional Review Board (IRB)-approved, Health Insurance Portability and Accountability Act (HIPAA)-compliant study. Incident report data were collected during the study period from April 2006 to September 2012. The incident reports filed during the study period were searched for all reports related to MRI. Incident reports were classified with regard to the patient type (inpatient vs. outpatient), primary reason for the incident report, and the severity of patient harm resulting from the incident. A total of 362,090 MRI exams were performed during the study period, resulting in 1290 MRI-related incident reports. The rate of incident reporting was 0.35% (1290/362,090). MRI-related incident reporting was significantly higher in inpatients compared to outpatients (0.74% [369/49,801] vs. 0.29% [921/312,288], P < 0.001). The most common reason for incident reporting was diagnostic test orders (31.5%, 406/1290), followed by adverse drug reactions (19.1%, 247/1290) and medication/IV safety (14.3%, 185/1290). Approximately 39.6% (509/1290) of reports were associated with no patient harm and did not affect the patient, followed by no patient harm but did affect the patient (35.8%, 460/1290), temporary or minor patient harm (23.9%, 307/1290), permanent or major patient harm (0.6%, 8/1290) and patient death (0.2%, 2/1290). MRI-related incident reports are relatively infrequent, occur at significantly higher rates in inpatients, and usually do not result in patient harm. Diagnostic test orders, adverse drug reactions, and medication/IV safety were the most frequent safety incidents. © 2015 Wiley Periodicals, Inc.
Turchaninova, V F; Alferova, I V
The paper considers key methodical, logistics and tactical aspects of enhancing cosmonaut's medical monitoring to ensure crew safety in long-duration space mission. Activities toward extension of the diagnostic capabilities included hardware development, choice of examination procedures and defining the content of physiological information that would be necessary and sufficient for evaluation, including in real-time, of the cardiovascular system function and capacity, planning functional tests procedures as close as possible to the generally accepted clinical protocols used in selection of candidates for cosmonauts, and pre- and post-flight examination; refining the objective criteria of test tolerance and termination, and end-of-mission LBNP training tolerance and effectiveness; constructing a fundamentally new structure for medical telemetry data acquisition and processing at the Moscow Mission Control Center (MCC-M).
Peter, K; Dieterich, H J
In January 1986, West German legislators enacted the Medical Equipment Ordinance (MedGV) to define specific regulations for both manufacturers and operators of medical equipment and to offer a measure of safety to patients. We describe the history of MedGV, its regulations, and the mechanisms developed to enforce those regulations. We also evaluate its impact on clinical practice in light of the current staff shortages in anesthesia practice and research in Germany. Finally, we focus our discussion on the distinction between improved equipment as a minor factor in critical-incidents and the inadequate manpower as a major factor in anesthesia mishaps. It is unclear what will develop after 1993, when the national states in Europe form a common market.
Liewer, Susanne; Huddleston, Ashley N
The advent of newer, targeted oral chemotherapy medications such as small molecule kinase inhibitors, ibrutinib and idelalisib, has created additional options for the treatment of lymphoma. The targeted nature of these agents offers many patient-identified advantages over older, intravenously administered chemotherapy regimens such as ease of self-administration and an increased sense of independence. However, newer oral agents also present unique challenges not previously experienced with older therapies that may affect safety, efficacy and patient adherence. In this article, we review oral agents for the treatment of lymphoma, how to evaluate and manage drug-drug and drug-food interactions with concomitant oral medications, and issues with patient adherence as well as methods to determine adherence for oral chemotherapy.
Davoodi, Rozita; Mohammadzadeh Shabestari, Mahmoud; Takbiri, Afsaneh; Soltanifar, Azadeh; Sabouri, Golnaz; Rahmani, Shaghayegh; Moghiman, Toktam
Since establishing a safety culture in an organization is considered as the first step in patient safety improvement, there is always a need for updated field evaluation to better plan future decisions. We performed a cross-sectional, analytic-descriptive study in 25 hospitals related to Mashhad University of Medical Sciences (MUMS) during a 3-month period from April to June 2012. A questionnaire, designed by previous patient safety culture studies with confirmed validity and reliability, was used and distributed among a sample of 922 staff, chosen randomly from the mentioned hospitals. Data were analyzed by SPSS software version 16. "Organizational learning - continuous improvement" and "teamwork within unit" had the highest percentage of positive results as 79.85 ± 12.03% and 71.92 ± 17.08%, respectively; whereas "non-punitive response" to errors (21.57 ± 6.42) and "staffing" (26.36 ± 16.84) came out as the least important factors. There were no meaningful statistical relation between general features of the understudy hospitals including the number of beds, educational level or proficiency status with the general safety culture score. Most of the safety culture aspects were reported as low to moderate in terms of importance. If something needs to be modified interventionally in this respect, "the approach to confront errors" would be a wise choice. This could be achieved by establishing an atmosphere of open communication and continuous learning through elimination of the fear for reporting errors and installing a more acceptable approach in hospitals.
... Swimming and Water Apply Swimming and Water filter Toy Safety Apply Toy Safety filter TV and Furniture Tip-Overs Apply ... Laundry Packets Medication Poison Sleep Safety and Suffocation Toy Safety TV and Furniture Tip-Overs Water and ...
Yousef, Nadin; Yousef, Farah
medication doses to less than the global standard; as a result, it enhances patient safety. However, we hope other studies will be made later in hospitals to practically evaluate how much effective our proposed systematic strategy really is in comparison with other suggested remedies in this field.
Joslin, Jeremy; Mularella, Joshua; Bail, Allison; Wojcik, Susan; Cooney, Derek R
Provisions of medical direction and clinical services for ultramarathons require specific attention to heat illness. Heat stress can affect athlete performance negatively, and heat accumulation without acclimatization is associated with the development of exertional heat stroke (EHS). In order to potentially mitigate the risk of this safety concern, the Jungle Marathon (Para, Brazil) instituted mandatory rest periods during the first two days of this 7-day, staged, Brazilian ultramarathon. Race records were reviewed retrospectively to determine the number of runners that suffered an emergency medical complication related to heat stress and did not finish (DNF) the race. Review of records included three years before and three years after the institution of these mandatory rest periods. A total of 326 runners competed in the Jungle Marathon during the 2008-2013 period of study. During the pre-intervention years, a total of 46 athletes (21%) DNF the full race with 25 (54.3%) cases attributed to heat-related factors. During the post-intervention years, a total of 26 athletes (24.3%) DNF the full race with four (15.4%) cases attributed to heat-related factors. Mandatory rest stops during extreme running events in hot or tropical environments, like the Jungle Marathon, are likely to improve athlete safety and improve the heat acclimatization process.
Lambert, Bruce L; Centomani, Nichola M; Smith, Kelly M; Helmchen, Lorens A; Bhaumik, Dulal K; Jalundhwala, Yash J; McDonald, Timothy B
To determine whether a communication and resolution approach to patient harm is associated with changes in medical liability processes and outcomes. Administrative, safety, and risk management data from the University of Illinois Hospital and Health Sciences System, from 2002 to 2014. Single health system, interrupted time series design. Using Mann-Whitney U tests and segmented regression models, we compared means and trends in incident reports, claims, event analyses, patient communication consults, legal fees, costs per claim, settlements, and self-insurance expenses before and after the implementation of the "Seven Pillars" communication and resolution intervention. Queried databases maintained by Department of Safety and Risk Management and the Department of Administrative Services at UIH. Extracted data from risk module of the Midas incident reporting system. The intervention nearly doubled the number of incident reports, halved the number of claims, and reduced legal fees and costs as well as total costs per claim, settlement amounts, and self-insurance costs. A communication and optimal resolution (CANDOR) approach to adverse events was associated with long-lasting, clinically and financially significant changes in a large set of core medical liability process and outcome measures. © Health Research and Educational Trust.
Hannig, Jürgen; Siekmeier, Rüdiger
The current European system for medical devices is governed by three EC directives: the Medical Device Directive 93/42/EEC, the In-Vitro Diagnostic Directive 98/79/EC and the Active Implantable Medical Device Directive 90/385/EEC and regulates marketing and post-market surveillance of medical devices in the European Economic Area. In cases of incidents and field safety corrective actions (FSCA) manufacturers have to inform the responsible Competent Authority, which is the Federal Institute for Drugs and Medical Devices (BfArM) and the public by field safety notices (FSN). In this study we analyzed FSN of medical devices exclusively serving for diagnostics or treatment in pulmonology (e.g. nebulizers, oxygen concentrators, pulse oximeters, lung function analyzers, and non-active devices for treatment). FSCA and FSN publicized by BfArM in 2005-2013 were analyzed in respect to the MEDDEV 2.12-1 rev 8. In total 41 FSCA were publicized for the included products. German and English FSN were found in 36/35 cases, respectively. FSN were clearly characterized as FSN in 22/20 cases and declaration of the type of action was found in 27/26 cases, respectively. Product names were provided in all cases. Lot numbers or other information for product characterization were available in 7/8 and 26/24 cases, respectively. Detailed information regarding FSCA and product malfunction were found in 27/33 and 36/35 cases, respectively. Information on product related risks with previous use of the affected product was provided in 24/23 cases. In 34/34 cases manufacturers provided information to mitigate product related risks. Requests to pass FSN to persons needing awareness were found in 10/14 cases. Contact data were provided in 30/30 cases. Confirmation that the Competent Authority was informed was found in 12/14 cases and in 19/18 cases a customer confirmation was included. The obtained data suggest that there is an increasing annual number of FSCA and most FSN fulfill the criteria of
Sun, Pei Ran; Wang, Bo Han; Wu, Fan
Since life is invaluable, the patient safety is always an important issue. How to reduce the malpractices and advance the patient safety is the primary goal of many countries. The current problem is that the hospitals cannot quickly and precisely identify the name of medicine, the position of patient and staff and the servicing time and dosage taken by patients. The application of Radio Frequency Identification (RFID) is rocketing in popularity as varieties of expanded uses. However, due to the investment consideration, there are few cases that practically implement such a technology in healthcare industries. This paper presents a Wisely Aware RFID Dosage (WARD) system, which based on an integration of barcodes and RFID tags, to demonstrate effective and safe patient care environment, for preventing the risk of medication error. Finally, through an evaluation of users' satisfaction, a reliability of 0.92 and a criterion-related validity of 0.82 show that this system is able to effectively construct the patient-safety-centric environment.
Patapovas, Andrius; Dormann, Harald; Sedlmayr, Brita; Kirchner, Melanie; Sonst, Anja; Müller, Fabian; Pfistermeister, Barbara; Plank-Kiegele, Bettina; Vogler, Renate; Maas, Renke; Criegee-Rieck, Manfred; Prokosch, Hans-Ulrich; Bürkle, Thomas
The aim was to improve medication safety in an emergency department (ED) by enhancing the integration and presentation of safety information for drug therapy. Based on an evaluation of safety of drug therapy issues in the ED and a review of computer-assisted intervention technologies we redesigned an electronic case sheet and implemented computer-assisted interventions into the routine work flow. We devised a four step system of alerts, and facilitated access to different levels of drug information. System use was analyzed over a period of 6 months. In addition, physicians answered a survey based on the technology acceptance model TAM2. The new application was implemented in an informal manner to avoid work flow disruption. Log files demonstrated that step I, 'valid indication' was utilized for 3% of the recorded drugs and step II 'tooltip for well-known drug risks' for 48% of the drugs. In the questionnaire, the computer-assisted interventions were rated better than previous paper based measures (checklists, posters) with regard to usefulness, support of work and information quality. A stepwise assisting intervention received positive user acceptance. Some intervention steps have been seldom used, others quite often. We think that we were able to avoid over-alerting and work flow intrusion in a critical ED environment. © 2013 The Authors. British Journal of Clinical Pharmacology © 2013 The British Pharmacological Society.
Silvestre-Busto, C; Torijano-Casalengua, M L; Olivera-Cañadas, G; Astier-Peña, M P; Maderuelo-Fernández, J A; Rubio-Aguado, E A
To adapt the Medical Office Survey on Patient Safety Culture (MOSPSC) Excel(®) tool for its use by Primary Care Teams of the Spanish National Public Health System. The process of translation and adaptation of MOSPSC from the Agency for Healthcare and Research in Quality (AHRQ) was performed in five steps: Original version translation, Conceptual equivalence evaluation, Acceptability and viability assessment, Content validity and Questionnaire test and response analysis, and psychometric properties assessment. After confirming MOSPSC as a valid, reliable, consistent and useful tool for assessing patient safety culture in our setting, an Excel(®) worksheet was translated and adapted in the same way. It was decided to develop a tool to analyze the "Spanish survey" and to keep it linked to the "Original version" tool. The "Spanish survey" comparison data are those obtained in a 2011 nationwide Spanish survey, while the "Original version" comparison data are those provided by the AHRQ in 2012. The translated and adapted tool and the analysis of the results from a 2011 nationwide Spanish survey are available on the website of the Ministry of Health, Social Services and Equality. It allows the questions which are decisive in the different dimensions to be determined, and it provides a comparison of the results with graphical representation. Translation and adaptation of this tool enables a patient safety culture in Primary Care in Spain to be more effectively applied. Copyright © 2014 SECA. Published by Elsevier Espana. All rights reserved.
Pierce, Carrie E; Bouri, Khaled; Pamer, Carol; Proestel, Scott; Rodriguez, Harold W; Van Le, Hoa; Freifeld, Clark C; Brownstein, John S; Walderhaug, Mark; Edwards, I Ralph; Dasgupta, Nabarun
The rapid expansion of the Internet and computing power in recent years has opened up the possibility of using social media for pharmacovigilance. While this general concept has been proposed by many, central questions remain as to whether social media can provide earlier warnings for rare and serious events than traditional signal detection from spontaneous report data. Our objective was to examine whether specific product-adverse event pairs were reported via social media before being reported to the US FDA Adverse Event Reporting System (FAERS). A retrospective analysis of public Facebook and Twitter data was conducted for 10 recent FDA postmarketing safety signals at the drug-event pair level with six negative controls. Social media data corresponding to two years prior to signal detection of each product-event pair were compiled. Automated classifiers were used to identify each 'post with resemblance to an adverse event' (Proto-AE), among English language posts. A custom dictionary was used to translate Internet vernacular into Medical Dictionary for Regulatory Activities (MedDRA(®)) Preferred Terms. Drug safety physicians conducted a manual review to determine causality using World Health Organization-Uppsala Monitoring Centre (WHO-UMC) assessment criteria. Cases were also compared with those reported in FAERS. A total of 935,246 posts were harvested from Facebook and Twitter, from March 2009 through October 2014. The automated classifier identified 98,252 Proto-AEs. Of these, 13 posts were selected for causality assessment of product-event pairs. Clinical assessment revealed that posts had sufficient information to warrant further investigation for two possible product-event associations: dronedarone-vasculitis and Banana Boat Sunscreen--skin burns. No product-event associations were found among the negative controls. In one of the positive cases, the first report occurred in social media prior to signal detection from FAERS, whereas the other case
Hansen, Matthew; Meckler, Garth; Dickinson, Caitlyn; Dickenson, Kathryn; Jui, Jonathan; Lambert, William; Guise, Jeanne-Marie
Emergency medical services (EMS) providers may have critical knowledge gaps in pediatric care due to lack of exposure and training. There is currently little evidence to guide educators to the knowledge gaps that most need to be addressed to improve patient safety. The objective of this study was to identify educational needs of EMS providers related to pediatric care in various domains in order to inform development of curricula. The Children's Safety Initiative-EMS performed a three-phase Delphi survey on patient safety in pediatric emergencies among providers and content experts in pediatric emergency care, including physicians, nurses, and prehospital providers of all levels. Each round included questions related to educational needs of providers or the effect of training on patient safety events. We identified knowledge gaps in the following domains: case exposure, competency and knowledge, assessment and decision making, and critical thinking and proficiency. Individual knowledge gaps were ranked by portion of respondents who ranked them "highly likely" (Likert-type score 7-10 out of 10) to contribute to safety events. There were 737 respondents who were included in analysis of the first phase of the survey. Paramedics were 50.8% of respondents, EMT-basics/first responders were 22%, and physicians 11.4%. The top educational priorities identified in the final round of the survey include pediatric airway management, responder anxiety when working with children, and general pediatric skills among providers. The top three needs in decision-making include knowing when to alter plans mid-course, knowing when to perform an advanced airway, and assessing pain in children. The top 3 technical or procedural skills needs were pediatric advanced airway, neonatal resuscitation, and intravenous/intraosseous access. For neonates, specific educational needs identified included knowing appropriate vital signs and preventing hypothermia. This is the first large-scale Delphi
Gagne, Joshua J.; Rassen, Jeremy A.; Walker, Alexander M.; Glynn, Robert J.; Schneeweiss, Sebastian
BACKGROUND Active medical-product-safety surveillance systems are being developed to monitor many products and outcomes simultaneously in routinely collected longitudinal electronic healthcare data. These systems will rely on algorithms to generate alerts about potential safety concerns. METHODS We compared the performance of five classes of algorithms in simulated data using a sequential matched-cohort framework, and applied the results to two electronic healthcare databases to replicate monitoring of cerivastatin-induced rhabdomyolysis. We generated 600,000 simulated scenarios with varying expected event frequency in the unexposed, alerting threshold, and outcome risk in the exposed, and compared the alerting algorithms in each scenario type using an event-based performance metric. RESULTS We observed substantial variation in algorithm performance across the groups of scenarios. Relative performance varied by the event frequency and by user-defined preferences for sensitivity versus specificity. Type I error-based statistical testing procedures achieved higher event-based performance than other approaches in scenarios with few events, whereas statistical process control and disproportionality measures performed relatively better with frequent events. In the empirical data, we observed 6 cases of rhabdomyolysis among 4,294 person-years of follow-up, with all events occurring among cerivastatin-treated patients. All selected algorithms generated alerts before the drug was withdrawn from the market. CONCLUSION For active medical-product-safety monitoring in a sequential matched cohort framework, no single algorithm performed best in all scenarios. Alerting algorithm selection should be tailored to particular features of a product-outcome pair, including the expected event frequencies and trade-offs between false-positive and false-negative alerting. PMID:22266893
Zwierzchowska, Aneta; Głuszak, Michał; Jabiry-Zieniewicz, Zoulikha; Banaszek-Wysoczańska, Agnieszka; Dziadecki, Wojciech; Barcz, Ewa
The aim of our study was to assess the efficacy and safety of medical treatment of non-viable first trimester pregnancy. We analyzed 50 cases of women diagnosed with non-viable first trimester pregnancy: missed abortion (79.6%) or anembryonic pregnancy (20.4%), who were admitted and treated at the First Clinic of Obstetrics and Gynecology Medical University of Warsaw, between June 2011 and February 2012. The diagnosis was made after two ultrasound examinations, performed at least one week apart. None of the patients manifested symptoms of imminent miscarriage. All women received medical treatment - misoprostol administered vaginally or in cases of excessive bleeding in the course of the procedure, sublingually - according to our own scheme. The patients were informed that any moment they could decide to discontinue medical treatment and ask for surgery Initially, 4 tablets containing misoprostol (800 mcg) were administered vaginally A control ultrasound examination was performed 6 hours later. If expulsion of the gestational sac was completed, the patient was discharged. If the gestational sac was still present in the uterus, an additional dose of misoprostol was administered: 4 tablets vaginally or if excessive bleeding occurred, 3 tablets (600 mcg) sublingually. Another ultrasound examination was performed after 6 hours from the second dose and the patient was discharged if the expulsion of the gestational sac was completed. If the procedure failed, it was repeated in the same manner the next day. D&C was performed in cases of excessive bleeding, failure of medical treatment after 48 hours, patient decision to discontinue medical treatment or suspected incomplete abortion after menstrual bleeding. For women who completed the medical treatment, control visits were scheduled 14 days after hospital discharge and after menstrual bleeding, if incomplete abortion was suspected. D&C was performed in 12% of patients because of failure of medical treatment after 48 hours
Do User-Applied Safety Labels on Medication Syringes Reduce the Incidence of Medication Errors During Rapid Medical Response Intervention for Deteriorating Patients on Wards? A Systematic Search and Review.
Mikhail, John; Grantham, Hugh; King, Lindy
Intravenous medication errors (MEs) occur during medical emergency situations. An initiative, not yet in common practice, that could address these errors is safety labeling. The aim of this review was to identify and appraise research evidence related to the impact of user-applied medication safety labeling on reducing the incidence of MEs during rapid medical response intervention for patient deterioration in the ward setting. A systematic search and review framework was used to conduct the review. A comprehensive database search was conducted of BioMed Central, Clinical Trials, Cumulative Index to Nursing and Allied Health Literature, Expanded Academic ASAP, Joanna Briggs Institute, MEDLINE, OVID, ProQuest Central, PubMed, Wiley Online Library, and World Health Organization Library. The Young and Solomon (2009) critical appraisal tool was used to critically appraise the identified research articles. Each article was then analyzed using a thematic network strategy to identify commonality. Four primary themes were identified; they were as follows: MEs occur during medical emergency responses (MERs); MEs occur throughout the medication administration process; MERs are stressful and are associated with MEs; and role of medication labeling in reducing MEs during MERs. Greater vigilance is required by health professionals during the medication administration process. The implementation of specific medication safety labeling into the MER could be beneficial in reducing the overall incidence of MEs. Further research is required to validate the merits of a MER medication safety labeling system.
Rodriguez-Gonzalez, Carmen Guadalupe; Martin-Barbero, Maria Luisa; Herranz-Alonso, Ana; Durango-Limarquez, Maria Isabel; Hernandez-Sampelayo, Paloma; Sanjurjo-Saez, Maria
To critically evaluate the causes of preventable adverse drug events during the nurse medication administration process in inpatient units with computerized prescription order entry and profiled automated dispensing cabinets in order to prioritize interventions that need to be implemented and to evaluate the impact of specific interventions on the criticality index. This is a failure mode, effects and criticality analysis (FMECA) study. A multidisciplinary consensus committee composed of pharmacists, nurses and doctors evaluated the process of administering medications in a hospital setting in Spain. By analysing the process, all failure modes were identified and criticality was determined by rating severity, frequency and likelihood of failure detection on a scale of 1 to 10, using adapted versions of already published scales. Safety strategies were identified and prioritized. Through consensus, the committee identified eight processes and 40 failure modes, of which 20 were classified as high risk. The sum of the criticality indices was 5254. For the potential high-risk failure modes, 21 different potential causes were found resulting in 24 recommendations. Thirteen recommendations were prioritized and developed over a 24-month period, reducing total criticality from 5254 to 3572 (a 32.0% reduction). The recommendations with a greater impact on criticality were the development of an electronic medication administration record (-582) and the standardization of intravenous drug compounding in the unit (-168). Other improvements, such as barcode medication administration technology (-1033), were scheduled for a longer period of time because of lower feasibility. FMECA is a useful approach that can improve the medication administration process. © 2015 John Wiley & Sons, Ltd.
Resnic, Frederic S; Majithia, Arjun; Marinac-Dabic, Danica; Robbins, Susan; Ssemaganda, Henry; Hewitt, Kathleen; Ponirakis, Angelo; Loyo-Berrios, Nilsa; Moussa, Issam; Drozda, Joseph; Normand, Sharon-Lise; Matheny, Michael E
Background The process of assuring the safety of medical devices is constrained by reliance on voluntary reporting of adverse events. We evaluated a strategy of prospective, active surveillance of a national clinical registry to monitor the safety of an implantable vascular-closure device that had a suspected association with increased adverse events after percutaneous coronary intervention (PCI). Methods We used an integrated clinical-data surveillance system to conduct a prospective, propensity-matched analysis of the safety of the Mynx vascular-closure device, as compared with alternative approved vascular-closure devices, with data from the CathPCI Registry of the National Cardiovascular Data Registry. The primary outcome was any vascular complication, which was a composite of access-site bleeding, access-site hematoma, retroperitoneal bleeding, or any vascular complication requiring intervention. Secondary safety end points were access-site bleeding requiring treatment and postprocedural blood transfusion. Results We analyzed data from 73,124 patients who had received Mynx devices after PCI procedures with femoral access from January 1, 2011, to September 30, 2013. The Mynx device was associated with a significantly greater risk of any vascular complication than were alternative vascular-closure devices (absolute risk, 1.2% vs. 0.8%; relative risk, 1.59; 95% confidence interval [CI], 1.42 to 1.78; P<0.001); there was also a significantly greater risk of access-site bleeding (absolute risk, 0.4% vs. 0.3%; relative risk, 1.34; 95% CI, 1.10 to 1.62; P=0.001) and transfusion (absolute risk, 1.8% vs. 1.5%; relative risk, 1.23; 95% CI, 1.13 to 1.34; P<0.001). The initial alerts occurred within the first 12 months of monitoring. Relative risks were greater in three prespecified high-risk subgroups: patients with diabetes, those 70 years of age or older, and women. All safety alerts were confirmed in an independent sample of 48,992 patients from April 1, 2014, to
Vath, Richard J; Musso, Mandi W; Rabalais, Lauren S; Dunbar, Alston; Hosea, Stephen; Johnson, Angela C; Bolton, Michael; Rhynes, Vernon K; Caffery, Terrell S; Tynes, L Lee; Mantzor, Savarra; Miller, Bahnsen; Calongne, Laurinda L
The 2013 closure of a public hospital in Baton Rouge, LA transformed graduate medical education (GME) at Our Lady of the Lake Regional Medical Center (OLOL). Administrators were tasked with incorporating residents into patient safety and quality improvement initiatives to fulfill regulatory obligations. This report outlines our experiences as we built these patient safety and quality improvement initiatives in a rapidly expanding independent academic medical center. We joined the Alliance of Independent Academic Medical Centers (AIAMC) to meet and learn from national peers. To fulfill the scholarly activity requirement of the AIAMC's National Initiative IV, we formed a multidisciplinary team to develop a patient safety education project. Prioritized monthly team meetings allowed for project successes to be celebrated and circulated within the organization. The public-private partnership that more than quadrupled the historic size of GME at OLOL has, in the past 2 years, led to the development of an interdisciplinary team. This team has expanded to accommodate residency program leadership from across the campus. Our National Initiative IV project won a national award and inspired several follow-up initiatives. In addition, this work led to the formation of a Patient Safety and Clinical Quality Improvement fellowship that matched its first fellow in 2015. Through the commitment and support of hospital and medical education leaders, as well as a focus on promoting cultural change through scholarly activity, we were able to greatly expand patient safety and quality improvement efforts in our institution.
Ross, Joseph S.; Bernheim, Susannah M.; Lin, Zhenqiu; Drye, Elizabeth E.; Chen, Jersey; Normand, Sharon-Lise T.; Krumholz, Harlan M.
Safety net hospitals remain under financial strain, possibly affecting quality of care, and face uncertain financial consequences under the Patient Protection and Affordable Care Act. We compared risk-standardized mortality and readmission rates among fee-for-service Medicare beneficiaries admitted for acute myocardial infarction, heart failure, or pneumonia to urban hospitals within metropolitan statistical areas containing at least one safety net and non-safety net hospital. There was substantial variation in both mortality and readmission rates among safety-net and non-safety net hospitals for all three conditions, although safety-net hospitals had marginally worse outcomes. Herein we discuss the clinical and policy implications of these findings. PMID:22869652
Yu, Yao-Chang; Hou, Ting-Wei; Chiang, Tzu-Chiang
An Institute of Medicine Report stated there are 98,000 people annually who die due to medication related errors in the United States, and hospitals and other medical institutions are thus being pressed to use technologies to reduce such errors. One approach is to provide a suitable protocol that can cooperate with low cost RFID tags in order to identify patients. However, existing low cost RFID tags lack computational power and it is almost impossible to equip them with security functions, such as keyed hash function. To address this issue, a so a real lightweight binding proof protocol is proposed in this paper. The proposed protocol uses only logic gates (e.g. AND, XOR, ADD) to achieve the goal of proving that two tags exist in the field simultaneously, without the need for any complicated security algorithms. In addition, various scenarios are provider to explain the process of adopting this binding proof protocol with regard to guarding patient safety and preventing medication errors.
Hansen, Matthew; O'Brien, Kerth; Meckler, Garth; Chang, Anna Marie; Guise, Jeanne-Marie
Mixed methods research has significant potential to broaden the scope of emergency care and specifically emergency medical services investigation. Mixed methods studies involve the coordinated use of qualitative and quantitative research approaches to gain a fuller understanding of practice. By combining what is learnt from multiple methods, these approaches can help to characterise complex healthcare systems, identify the mechanisms of complex problems such as medical errors and understand aspects of human interaction such as communication, behaviour and team performance. Mixed methods approaches may be particularly useful for out-of-hospital care researchers because care is provided in complex systems where equipment, interpersonal interactions, societal norms, environment and other factors influence patient outcomes. The overall objectives of this paper are to (1) introduce the fundamental concepts and approaches of mixed methods research and (2) describe the interrelation and complementary features of the quantitative and qualitative components of mixed methods studies using specific examples from the Children's Safety Initiative-Emergency Medical Services (CSI-EMS), a large National Institutes of Health-funded research project conducted in the USA.
Iserson, K V; Kastre, T Y
referral. In contrast to most private primary care practitioners, EDs are at least willing to serve as a triage point for the medically indigent and are often the primary-care "safety net" for the medically indigent.
Alsweed, Fatimah; Alshaikh, Anwar; Ahmed, Anwar; Yunus, Faisel; Househ, Mowafa
There is a paucity of research on the impact of computerised provider order entry (CPOE) system on the front line staff. We assessed nurses perspectives of the impact of CPOE system implementation on their workflow, patient safety and medication errors in a Saudi Arabian hospital. We conducted a cross-sectional survey involving 112 nurses between April and May 2012. The workflow was easy to manage for nurses who rated CPOE training as of good quality (p = 0.001) and they found that CPOE helped in reducing medication errors (p = 0.001). The nurses who rated CPOE training as of good quality also stated that patient safety was better with CPOE implementation and its use (p < 0.05). Provision of adequate CPOE training improves nurses' perception of the system's role in their workflow, patient safety and medication errors, and is critical in the success of CPOE use and its long-term adoption.
Bustami, Rami; Albekairy, Abdulkareem M.; Almodaimegh, Hind; Alghamdi, Sahar; Alharbi, Shemylan; Khalidi, Nabil; Murphy, John E.
Objective. To assess pharmacy educators’ knowledge of medication safety and their perception toward its integration into the PharmD curriculum in Saudi Arabia. Methods. A survey was administered to pharmacy educators at a college of pharmacy and its affiliate hospital. Knowledge, training, and perception toward integrating medication safety into the PharmD curriculum were evaluated. Results. More than 50% of respondents indicated that medication safety should be covered within selected courses, and 65% indicated that such courses should be mandatory. Pharmacy practice educators had significantly higher levels of knowledge about medication safety than their nonpractice counterparts. Perceptions toward medication safety integration into the curriculum varied significantly by general discipline, academic degree, years of experience, and gender. Conclusion. Pharmacy educators in Saudi Arabia understand the importance of medication safety and its integration into the curriculum. Further studies are needed to guide curricular change to achieve this integration. PMID:28381890
... address broader product safety issues. FDA Drug Safety Communications for Drug Products Associated with Medication Errors FDA Drug Safety Communication: FDA approves brand name change for antidepressant drug ...
Reichley, Richard M; Seaton, Terry L; Resetar, Ervina; Micek, Scott T; Scott, Karen L; Fraser, Victoria J; Dunagan, W Claiborne; Bailey, Thomas C
A commercial rule base (Cerner Multum) was used to identify medication orders exceeding recommended dosage limits at five hospitals within BJC HealthCare, an integrated health care system. During initial testing, clinical pharmacists determined that there was an excessive number of nuisance and clinically insignificant alerts, with an overall alert rate of 9.2%. A method for customizing the commercial rule base was implemented to increase rule specificity for problematic rules. The system was subsequently deployed at two facilities and achieved alert rates of less than 1%. Pharmacists screened these alerts and contacted ordering physicians in 21% of cases. Physicians made therapeutic changes in response to 38% of alerts presented to them. By applying simple techniques to customize rules, commercial rule bases can be used to rapidly deploy a safety net to screen drug orders for excessive dosages, while preserving the rule architecture for later implementations of more finely tuned clinical decision support.
Dunn-Lombard, Donisha; Harden-Barrios, Jewel; Lefante, John J.
Abstract Little is known about how to integrate primary care with mental/behavioral services outside of clinical trials. The authors implemented a collaborative care model (CCM) for depression in a safety net patient-centered medical home. The model focused on universal screening for symptoms, risk stratification based on symptom severity, care management for intensive follow-up, and psychiatry consultation. CCM increased rates of primary care physician encounters, timely follow-up for monitoring symptoms of depression, and documentation of treatment response. Contextual factors that facilitated or hindered practice redesign included clinic leadership, quality improvement culture, staffing, technology infrastructure, and external incentives/disincentives for organizational change. (Population Health Management 2016;19:46–55) PMID:26087153
Navez, Marie Louise; Monella, Christopher; Bösl, Irmgard; Sommer, Daniela; Delorme, Claire
Postherpetic neuralgia (PHN) is a common, very painful, and often long-lasting complication of herpes zoster which is frequently underdiagnosed and undertreated. It mainly affects the elderly, many of whom are already treated for comorbidities with a variety of systemic medications and are thus at high risk of drug-drug interactions. An efficacious and safe treatment with a low interaction potential is therefore of high importance. This review focuses on the safety and tolerability of the 5% lidocaine medicated plaster, a topical analgesic indicated for the treatment of PHN. The available literature (up to June 2014) was searched for publications containing safety data regarding the use of the 5% lidocaine medicated plaster in PHN treatment; unpublished clinical safety data were also included in this review. The 5% lidocaine medicated plaster demonstrated good short- and long-term tolerability with low systemic uptake (3 ± 2%) and minimal risk for systemic adverse drug reactions (ADRs). ADRs related to topical lidocaine treatment were mainly application site reactions of mild to moderate intensity. The treatment discontinuation rate was generally below 5% of patients. In one trial, the 5% lidocaine medicated plaster was better tolerated than systemic treatment with pregabalin. The 5% lidocaine medicated plaster provides a safe alternative to systemic medications for PHN treatment, including long-term pain treatment.
Barer, A S
Participating in the comprehensive development of the system for safe emergency landing in space vehicles Voskhod and Soyuz, enterprise "Zvezda" undertook an extensive program of technical and physiological experiments with volunteers, including a group of physicians, in the interest of designing personal protection means for space crew. Over 130 physiological pile-engine experiments with the impact velocity of up to 9 m/s were performed between 1963 and 1967. The article presents medical and biomechanical analysis of the experimental data. The central part of the crew safety system in the event of emergency landing is a shock-absorbing seat with an individually molded support surface. This support surface ensures a uniform load distribution and also attenuates shock hardness by dint of own deformation. The Voskhod seat was outfitted with a pendulum hanger bracket on two shock-absorbers. The Soyuz seat has only one shock-absorber at the head end. The shock-absorber allows seat turns at high angular velocities and, consequently, appearance of additional mechanic and biomechanical reactions. The article attempts to analyze this phenomenon as well as the whole aggregate of human body responses onto the spacecraft impact with ground. To give readers the opportunity of independent conclusions from the data of the unlikely to be replicated experiments, the article is supplemented with graphs visualizing a larger part of the tests data, and their interpretations. It is aimed to help young specialists fill up the gap in knowledge about this medical aspect which remains of high topicality in many fields including safety of future piloted space programs.
Kirkman, Matthew A; Sevdalis, Nick; Arora, Sonal; Baker, Paul; Vincent, Charles; Ahmed, Maria
Objective To systematically review the latest evidence for patient safety education for physicians in training and medical students, updating, extending and improving on a previous systematic review on this topic. Design A systematic review. Data sources Embase, Ovid Medline and PsycINFO databases. Study selection Studies including an evaluation of patient safety training interventions delivered to trainees/residents and medical students published between January 2009 and May 2014. Data extraction The review was performed using a structured data capture tool. Thematic analysis also identified factors influencing successful implementation of interventions. Results We identified 26 studies reporting patient safety interventions: 11 involving students and 15 involving trainees/residents. Common educational content included a general overview of patient safety, root cause/systems-based analysis, communication and teamwork skills, and quality improvement principles and methodologies. The majority of courses were well received by learners, and improved patient safety knowledge, skills and attitudes. Moreover, some interventions were shown to result in positive behaviours, notably subsequent engagement in quality improvement projects. No studies demonstrated patient benefit. Availability of expert faculty, competing curricular/service demands and institutional culture were important factors affecting implementation. Conclusions There is an increasing trend for developing educational interventions in patient safety delivered to trainees/residents and medical students. However, significant methodological shortcomings remain and additional evidence of impact on patient outcomes is needed. While there is some evidence of enhanced efforts to promote sustainability of such interventions, further work is needed to encourage their wider adoption and spread. PMID:25995240
Blegen, M A; Sehgal, N L; Alldredge, B K; Gearhart, S; Auerbach, A A; Wachter, R M
The goal of this project was to improve unit-based safety culture through implementation of a multidisciplinary (pharmacy, nursing, medicine) teamwork and communication intervention. The Agency for Healthcare Research and Quality Hospital Survey on Patient Safety Culture was used to determine the impact of the training with a before-after design. Surveys were returned from 454 healthcare staff before the training and 368 staff 1 year later. Five of eleven safety culture subscales showed significant improvement. Nurses perceived a stronger safety culture than physicians or pharmacists. While it is difficult to isolate the effects of the team training intervention from other events occurring during the year between training and postevaluation, overall the intervention seems to have improved the safety culture on these medical units.
The rapid uptake of the hypodermic syringe as a medical technology by physicians in Europe and America since its introduction in the middle of the 19th century has led to a level of medical and public acceptance seldom reached by other therapeutic techniques. Presently, the developed world has clear guidelines regarding injection use and safety; in contrast, developing countries are facing the brunt of risks associated with the use of this technology, which was introduced into their societies during the early 20th century. There is now a popular demand for injections, and an alarming number of unnecessary and unsafe injections are being administered. The problem of unsafe injections is not restricted to curative injections, but includes immunizations too. The association of unsafe injections and infection transmission is quite clear, and there is an urgent need to reduce the number of required injections and make them safe. An understanding of the determinants of current injection practices in the socio-cultural-economic context is necessary in order to plan relevant and effective interventions.
The use of radiation sources, namely radioactive sealed or unsealed sources and particle accelerators and beams is ubiquitous in the industrial and medical applications of ionizing radiation. Besides radiological protection of the workers, members of the public and patients in routine situations, the use of radiation sources involves several aspects associated to the mitigation of radiological or nuclear accidents and associated emergency situations. On the other hand, during the last decade security issues became burning issues due to the potential malevolent uses of radioactive sources for the perpetration of terrorist acts using RDD (Radiological Dispersal Devices), RED (Radiation Exposure Devices) or IND (Improvised Nuclear Devices). A stringent set of international legally and non-legally binding instruments, regulations, conventions and treaties regulate nowadays the use of radioactive sources. In this paper, a review of the radiological protection issues associated to the use of radiation sources in the industrial and medical applications of ionizing radiation is performed. The associated radiation safety issues and the prevention and mitigation of incidents and accidents are discussed. A comprehensive discussion of the security issues associated to the global use of radiation sources for the aforementioned applications and the inherent radiation detection requirements will be presented. Scientific, technical, legal, ethical, socio-economic issues are put forward and discussed.
Hodgson, M; Brodt, W; Henderson, D; Loftness, V; Rosenfeld, A; Woods, J; Wright, R
Medical research facilities, indeed all the nation's constructed facilities, must be designed, operated, and maintained in a manner that supports the health, safety, and productivity of the occupants. The National Construction Goals, established by the National Science and Technology Council, envision substantial improvements in occupant health and worker productivity. The existing research and best practices case studies support this conclusion, but too frequently building industry professionals lack the knowledge to design, construct, operate, and maintain facilities at these optimum levels. There is a need for more research and more collaborative efforts between medical and facilities engineering researchers and practitioners in order to attain the National Construction Goals. Such collaborative efforts will simultaneously support attainment of the National Health Goals. This article is the summary report of the Healthy Buildings Committee for the Leadership Conference: Biomedical Facilities and the Environment sponsored by the National Institutes of Health, the National Association of Physicians for the Environment, and the Association of Higher Education Facilities Officers on 1--2 November 1999 in Bethesda, Maryland, USA. PMID:11124125
This article aims to improve the understandings of safety and risk in childbirth in Morocco from a critical medical anthropological perspective. It is based upon nine weeks' of fieldwork undertaken in the town of Ifli,(1) an oasis in Eastern Morocco, on the border with Algeria. Ethnographic material stemmed mainly from participant observation and semi-structured interviews conducted between April and July 2009. This research sheds light on the interplay between the socio-cultural context and the broader political economy of health in shaping the knowledge and practices of childbirth. The core issues emerging from the fieldwork are the local concepts of risk in the birthing process through mothers' and birth attendants' experiences within medical pluralistic frames of reference. This article shall argue that ethnographic insights can play a crucial role not only in understanding socio-cultural dimensions of childbirth, but also in implementing novel approaches to reproductive health care in this area, such as the exchange of experiences between trained and local, non-trained midwives.(2).
Hamre, Harald J.; Glockmann, Anja; Fischer, Michael; Riley, David S.; Baars, Erik; Kiene, Helmut
Objective Anthroposophic medications (AMED) are widely used, but safety data on AMED from large prospective studies are sparse. The objective of this analysis was to determine the frequency of adverse drug reactions (ADR) to AMED in outpatients using AMED for acute respiratory and ear infections. Methods A prospective four-week observational cohort study was conducted in 21 primary care practices in Europe and the U.S.A. The cohort comprised 715 consecutive outpatients aged ≥1 month, treated by anthroposophic physicians for acute otitis and respiratory infections. Physicians’ prescription data and patient reports of adverse events were analyzed. Main outcome measures were use of AMED and ADR to AMED. Results Two patients had confirmed ADR to AMED: 1) swelling and redness at the injection site after subcutaneous injections of Prunus spinosa 5%, 2) sleeplessness after intake of Pneumodoron® 2 liquid. These ADR lasted one and two days respectively; both subsided after dose reduction; none were unexpected; none were serious. The frequency of confirmed ADR to AMED was 0.61% (2/327) of all different AMED used, 0.28% (2/715) of patients, and 0.004% (3/73,443) of applications. Conclusion In this prospective study, anthroposophic medications used by primary care patients with acute respiratory or ear infections were well tolerated. PMID:21901075
Patapovas, Andrius; Pfistermeister, Barbara; Tarkhov, Aleksey; Terfloth, Lothar; Maas, Renke; Fromm, Martin F; Kornhuber, Johannes; Prokosch, Hans-Ulrich; Bürkle, Thomas
In many countries, officially approved drug information known as summary of product characteristics (SPC) is mostly available in text form, which cannot be used for Clinical Decision Support Systems (CDSS). It may be essential however to substantiate CDSS advice with such legally binding text snippets. In an attempt to link various drug data sources including SPC towards a CDSS to support medication safety in psychiatric patients we arrived at the notion of an effect object. A requirements analysis revealed data items and data structure which are needed from the patient and from the drug information source for the CDSS functionality. Published drug data modelling approaches were analyzed and found unsuitable. A conceptional database modeling approach using top down and bottom up modeling was performed. The schema based data model implemented within the django framework centered on SPC "effect objects" which comprise all SPC data required for the respective CDSS function such as search for contraindications in the proposed medication. Today six effect objects have been defined for contraindications and warnings, missing indications, adverse effects, drug-drug interactions, dosing and pharmacokinetics. The transformation of SPC data to a database-driven "effect objects" structure permits decoupling between the CDSS functions and different underlying data sources and supports the design of reusable, stable and verified CDSS functions.
Biswal, Manisha; Khurana, Sumeeta; Taneja, Neelam; Kaur, Tripta; Samanta, Palash; Malla, Nancy; Sharma, Meera
Nosocomial food outbreaks due to infected food handlers is primarily due to inadequate knowledge and faulty practices of food handlers during diarrhoeal episodes. The aim of this study was to assess: 1) prevalence of enteropathogen infection among food handlers working in our hospital during 2007 to 2011 and 2) adequacy of precautions taken by them during gastroenteritis episodes. Stool samples submitted by food handlers during 2007 to 2011 were examined for the presence of enteropathogens by standard methodology. For the second part of the study, a questionnaire regarding practices during episodes of diarrhoea in food handlers or their family members was handed out to willing participants. During the years 2007, 2008, 2010 and 2011 respectively, 3.9%, 9.8%, 5.1% and 9.4% food handlers were found infected with enteropathogens. The most common parasite detected was Entamoeba histolytica. Bacterial enteropathogens prevalence was very low during these years. There was high awareness (78.8%) among the food handlers regarding routine testing of faeces. Only 64.7% knew that it was important to report for purpose of treatment and leave. While 9.4% had suffered from diarrhoeal episodes in between intervals of annual microbiological testing, only 4.7% took appropriate treatment and availed medical leave. A regular training programme on food safety should be established and emphasis should be laid on mandatory reporting and stool testing of kitchen personnel as well as abstaining from work till they are medically fit.
Background Medication safety in patients with chronic kidney disease (CKD) is a growing concern. This is particularly relevant in older adults due to underlying CKD. Metformin use is contraindicated in patients with abnormal kidney function; however, many patients are potentially prescribed metformin inappropriately. We evaluated the prevalence of CKD among older adults prescribed metformin for type 2 diabetes mellitus using available equations to estimate kidney function and examined demographic characteristics of patients who were potentially inappropriately prescribed metformin. Methods We conducted a cross-sectional analysis of older adults aged ≥65 years prescribed metformin from March 2008-March 2009 at an urban tertiary-care facility in Seattle, Washington, USA. CKD was defined using National Kidney Foundation-Kidney Disease Outcomes Quality Initiative criteria. Creatinine clearance was calculated using the Cockcroft-Gault equation; estimated glomerular filtration rate was calculated using the abbreviated Modification of Diet in Renal Disease (MDRD) and CKD-Epidemiology (EPI) Collaboration equations. Regression analyses were used to determine the associations between demographic characteristics and prevalent CKD. Results Among 356 subjects (median age 69 years, 52.5% female, 39.4% non-Hispanic black), prevalence of stage 3 or greater CKD calculated by any of the equations was 31.4%. The Cockcroft-Gault equation identified more subjects as having CKD (23.7%) than the abbreviated MDRD (21.1%) or CKD-EPI (21.7%) equations (P < 0.001). Older age (OR = 1.13, 95% CI 1.08-1.19) and female sex (OR = 2.51, 95% CI 1.44-4.38) were associated with increased odds of potentially inappropriate metformin prescription due to CKD; non-Hispanic black race was associated with decreased odds of potentially inappropriate metformin prescription due to CKD (OR = 0.41, 95% CI 0.23-0.71). Conclusions CKD is common in older adults prescribed metformin for type 2
Buckner, Steven A.
The Helicopter Emergency Medical Service (HEMS) industry has a significant role in the transportation of injured patients, but has experienced more accidents than all other segments of the aviation industry combined. With the objective of addressing this discrepancy, this study assesses the effect of safety management systems implementation and aviation technologies utilization on the reduction of HEMS accident rates. Participating were 147 pilots from Federal Aviation Regulations Part 135 HEMS operators, who completed a survey questionnaire based on the Safety Culture and Safety Management System Survey (SCSMSS). The study assessed the predictor value of SMS implementation and aviation technologies to the frequency of HEMS accident rates with correlation and multiple linear regression. The correlation analysis identified three significant positive relationships. HEMS years of experience had a high significant positive relationship with accident rate (r=.90; p<.05); SMS had a moderate significant positive relationship to Night Vision Goggles (NVG) (r=.38; p<.05); and SMS had a slight significant positive relationship with Terrain Avoidance Warning System (TAWS) (r=.234; p<.05). Multiple regression analysis suggested that when combined with NVG, TAWS, and SMS, HEMS years of experience explained 81.4% of the variance in accident rate scores (p<.05), and HEMS years of experience was found to be a significant predictor of accident rates (p<.05). Additional quantitative regression analysis was recommended to replicate the results of this study and to consider the influence of these variables for continued reduction of HEMS accidents, and to induce execution of SMS and aviation technologies from a systems engineering application. Recommendations for practice included the adoption of existing regulatory guidance for a SMS program. A qualitative analysis was also recommended for future study SMS implementation and HEMS accident rate from the pilot's perspective. A
Teigland, Claire L; Blasiak, Rachel C; Wilson, Lindsay A; Hines, Rachel E; Meyerhoff, Karen L; Viera, Anthony J
Recent educational initiatives by both the World Health Organization and the American Association of Medical Colleges have endorsed integrating teaching of patient safety and quality improvement (QI) to medical students. Curriculum development should take into account learners' attitudes and preferences. We surveyed students to assess preferences and attitudes about QI and patient safety education. An electronic survey was developed through focus groups, literature review, and local expert opinion and distributed via email to all medical students at a single medical school in the spring of 2012. A greater proportion of students reported previous exposure to patient safety than to quality improvement topics (79% vs. 47%). More than 80% of students thought patient safety was of the same or greater importance than basic science or clinical skills whereas quality improvement was rated as the same or more important by about 70% of students. Students rated real life examples of quality improvement projects and participation in these projects with actual patients as potentially the most helpful (mean scores 4.2/5 and 3.9/5 respectively). For learning about patient safety, real life examples of mistakes were again rated most highly (mean scores 4.5/5 for MD presented mistakes and 4.1/5 for patient presented mistakes). Students rated QI as very important to their future career regardless of intended specialty (mean score 4.5/5). Teaching of patient safety and quality improvement to medical students will be best received if it is integrated into clinical education rather than solely taught in pre-clinical lectures or through independent computer modules. Students recognize that these topics are important to their careers as future physicians regardless of intended specialty.
Bryan, Rachel; Aronson, Jeffrey K.; ten Hacken, Pius; Williams, Alison; Jordan, Sue
Background Confusion between look-alike and sound-alike (LASA) medication names (such as mercaptamine and mercaptopurine) accounts for up to one in four medication errors, threatening patient safety. Error reduction strategies include computerized physician order entry interventions, and ‘Tall Man’ lettering. The purpose of this study is to explore the medication name designation process, to elucidate properties that may prime the risk of confusion. Methods and Findings We analysed the formal and semantic properties of 7,987 International Non-proprietary Names (INNs), in relation to naming guidelines of the World Health Organization (WHO) INN programme, and have identified potential for errors. We explored: their linguistic properties, the underlying taxonomy of stems to indicate pharmacological interrelationships, and similarities between INNs. We used Microsoft Excel for analysis, including calculation of Levenshtein edit distance (LED). Compliance with WHO naming guidelines was inconsistent. Since the 1970s there has been a trend towards compliance in formal properties, such as word length, but longer names published in the 1950s and 1960s are still in use. The stems used to show pharmacological interrelationships are not spelled consistently and the guidelines do not impose an unequivocal order on them, making the meanings of INNs difficult to understand. Pairs of INNs sharing a stem (appropriately or not) often have high levels of similarity (<5 LED), and thus have greater potential for confusion. Conclusions We have revealed a tension between WHO guidelines stipulating use of stems to denote meaning, and the aim of reducing similarities in nomenclature. To mitigate this tension and reduce the risk of confusion, the stem system should be made clear and well ordered, so as to avoid compounding the risk of confusion at the clinical level. The interplay between the different WHO INN naming principles should be further examined, to better understand their
Knowing and applying standards is an opportunity of the years 2007-2008 in any kind of field where a successful activity is intended and this assures a certain way towards competence and quality. The most recent German studies highlighted, to the surprise of the specialists, that standardization holds the second place, after the material means, in the row of the elements considered to be decisive for the success of a business. The existence of standards and the concern for their implementation in the activity provides a high technical and quality level of the products services offered to the clients and the increase in the level of competence of the personnel, who will be able to cope with all the challenges. This need comes from the process of Romania’s accession to the European Union. There are a lot of reasons why standards represent a fundamental part of our daily life. Practically, we are surrounded by standards. Everything is „working” well and it is efficient if the standards used as a base for manufacturing „things” have been correctly developed and applied. Standards open communication channels and commercial channels, promote the understanding of technical products, the compatibility of products and services, facilitate mass production and, most importantly, they are the necessary base for the achievement of the objectives in the fields of health and safety and a better quality of life. The transition towards the global market needs an instrument for the removal of the barriers to the application of the latest discoveries in the field of medical instruments, materials and manual labor. Each medical device, equipment and material used in the Dental and General Medicine is standardized, in fact that leads to their better knowing and provides controllable treatment for manual labor with predictable and repeatable results. This presentation intends to make a survey of some general aspects on standardization as well as a review of the standards in
Pannick, Samuel; Beveridge, Iain; Wachter, Robert M; Sevdalis, Nick
Despite its place at the heart of inpatient medicine, the evidence base underpinning the effective delivery of medical ward care is highly fragmented. Clinicians familiar with the selection of evidence-supported treatments for specific diseases may be less aware of the evolving literature surrounding the organisation of care on the medical ward. This review is the first synthesis of that disparate literature. An iterative search identified relevant publications, using terms pertaining to medical ward environments, and objective and subjective patient outcomes. Articles (including reviews) were selected on the basis of their focus on medical wards, and their relevance to the quality and safety of ward-based care. Responses to medical ward failings are grouped into five common themes: staffing levels and team composition; interdisciplinary communication and collaboration; standardisation of care; early recognition and treatment of the deteriorating patient; and local safety climate. Interventions in these categories are likely to improve the quality and safety of care in medical wards, although the evidence supporting them is constrained by methodological limitations and inadequate investment in multicentre trials. Nonetheless, with infrequent opportunities to redefine their services, institutions are increasingly adopting multifaceted strategies that encompass groups of these themes. As the literature on the quality of inpatient care moves beyond its initial focus on the intensive care unit and operating theatre, physicians should be mindful of opportunities to incorporate evidence-based practice at a ward level. Copyright © 2014 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved.
Hansen, Matthew; Meckler, Garth; OʼBrien, Kerth; Engle, Phillip; Dickinson, Caitlin; Dickinson, Kathryn; Jui, Jonathan; Lambert, William; Cottrell, Erika; Guise, Jeanne-Marie
The objective of this study was to determine what aspects of prehospital pediatric airway management may contribute to patient safety events. We conducted a 3-phase Delphi survey in prehospital professionals across the United States to identify potential contributors to patient safety events. Respondents ranked how likely factors were to contribute on a 9-point Likert-type scale and were allowed to elaborate through open-ended questions. Analysis was conducted using a mixed-methods approach, including Likert-type responses and open-ended questions which were analyzed for specific themes. All 3 phases of the survey were completed by 492 participants; 50.8% of respondents were paramedics, 22% were emergency medical technician-basics/first responders, and 11.4% were physicians. Seventy-five percent identified lack of experience with advanced airway management, and 44% identified medical decision making regarding airway interventions as highly likely to lead to safety events. Within the domain of technical skills, advanced airway management was ranked in the top 3 contributors to safety events by 71% of participants, and bag-mask ventilation by 18%. Qualitative analysis of questions within the domains of equipment and technical skills identified endotracheal intubation as the top contributor to safety events, with bag-mask ventilation second. In the domains of assessment and decision making, respiratory assessment and knowing when to perform an advanced airway were ranked most highly. This national Delphi survey identified lack of experience with pediatric airway management and challenges in decision making in advanced airway management as high risk for safety events, with endotracheal intubation as the most likely of these.
Education in Science, 1996
Discusses safety issues in science, including: allergic reactions to peanuts used in experiments; explosions in lead/acid batteries; and inspection of pressure vessels, such as pressure cookers or model steam engines. (MKR)
Education in Science, 1996
Discusses safety issues in science, including: allergic reactions to peanuts used in experiments; explosions in lead/acid batteries; and inspection of pressure vessels, such as pressure cookers or model steam engines. (MKR)
Puttagunta, R; Coverdale, T R; Coverdale, J
Because there have been no published formal reviews on teaching of firearm safety, we set out to systematically locate and review the literature on curricula that educated physicians and other health care providers, residents across specialties, and medical students on how to counsel on firearm safety. We searched for all papers with outcomes that described firearm safety training programs for healthcare providers and trainees. Studies were identified through PubMed, Scopus, Google Scholar, PsychInfo, EMBASE, and MedEdPortal databases and electronically searched using combinations of words from general topic areas of firearms, learners, and education. We found four programs that met inclusion criteria. These targeted a narrow range of learners including medical students, pediatric residents, practicing pediatricians, and nurse practitioners. Teaching methods included lectures, case-based learning, group discussions, and audiotape training. There were two randomized controlled trials, one cohort design, and one posttest design. One of the randomized controlled trials was an office-based high quality multisite national study, although the focus of teaching was not on firearm safety alone. All studies used different outcomes, and only one study validated the outcome measures. There were no studies targeting psychiatrists or psychiatry residents. These results underscore a priority for developing firearm safety education programs in undergraduate, graduate, and continuing medical education settings.
Tregunno, Deborah; Ginsburg, Liane; Clarke, Beth; Norton, Peter
As efforts to integrate patient safety into health professional curricula increase, there is growing recognition that the rate of curricular change is very slow, and there is a shortage of research that addresses critical perspectives of faculty who are on the 'front-lines' of curricular innovation. This study reports on medical, nursing and pharmacy teaching faculty perspectives about factors that influence curricular integration and the preparation of safe practitioners. Qualitative methods were used to collect data from 20 faculty members (n=6 medical from three universities; n=6 pharmacy from two universities; n=8 nursing from four universities) engaged in medical, nursing and pharmacy education. Thematic analysis generated a comprehensive account of faculty perspectives. Faculty perspectives on key challenges to safe practice vary across the three disciplines, and these different perspectives lead to different priorities for curricular innovation. Additionally, accreditation and regulatory requirements are driving curricular change in medicine and pharmacy. Key challenges exist for health professional students in clinical teaching environments where the culture of patient safety may thwart the preparation of safe practitioners. Patient safety curricular innovation depends on the interests of individual faculty members and the leveraging of accreditation and regulatory requirements. Building on existing curricular frameworks, opportunities now need to be created for faculty members to act as champions of curricular change, and patient safety educational opportunities need to be harmonises across all health professional training programmes. Faculty champions and practice setting leaders can collaborate to improve the culture of patient safety in clinical teaching and learning settings.
Pronovost, P J; Weast, B; Holzmueller, C G; Rosenstein, B J; Kidwell, R P; Haller, K B; Feroli, E R; Sexton, J B; Rubin, H R
Despite the emphasis on patient safety in health care, few organizations have evaluated the extent to which safety is a strategic priority or their culture supports patient safety. In response to the Institute of Medicine's report and to an organizational commitment to patient safety, we conducted a systematic assessment of safety at the Johns Hopkins Hospital (JHH) and, from this, developed a strategic plan to improve safety. The specific aims of this study were to evaluate the extent to which the culture supports patient safety at JHH and the extent to which safety is a strategic priority. During July and August 2001 we implemented two surveys in disparate populations to assess patient safety. The Safety Climate Scale (SCS) was administered to a sample of physicians, nurses, pharmacists, and other ICU staff. SCS assesses perceptions of a strong and proactive organizational commitment to patient safety. The second survey instrument, called Strategies for Leadership (SLS), evaluated the extent to which safety was a strategic priority for the organization. This survey was administered to clinical and administrative leaders. We received 395 completed SCS surveys from 82% of the departments and 86% of the nursing units. Staff perceived that supervisors had a greater commitment to safety than senior leaders. Nurses had higher scores than physicians for perceptions of safety. Twenty three completed SLS surveys were received from 77% of the JHH Patient Safety Committee members and 50% of the JHH Management Committee members. Management Committee responses were more positive than Patient Safety Committee, indicating that management perceived safety efforts to be further developed. Strategic planning received the lowest scores from both committees. We believe this is one of the first large scale efforts to measure institutional culture of safety and then design improvements in health care. The survey results suggest that strategic planning of patient safety needs
Whittaker, Chanel F.; Tom, Sarah E.; Bivens, Angel; Klein-Schwartz, Wendy
Background: Older adults with low health literacy are at increased risk of nonadherence, accidental drug exposure, and adverse events. Purpose: This study evaluated older adults' knowledge and awareness of medication safety and poison prevention resources using an interactive educational game compared to a less intensive intervention involving…
Frakes, Michael A; Van Voorhis, Samantha
Checklists are a frequently recommended strategy for minimizing human error in both the aviation and medical industries, yet checklist noncompliance is sometimes cited as a factor in untoward incidents. We evaluate the use of a challenge-and-respond checklist designed to ensure compliance with basic pre-departure safety preparations by medical personnel at a helicopter air medical program. The studied helicopter air medical transport program uses an interactive, challenge-and-respond checklist prior to departure to verify completion of four operational safety items. This is a prospective, convenience sample evaluation of 33 observations in which a checklist violation was created artificially and detection of that violation by the transport team was measured by direct observation. Characteristics of the transport by time, site of origin, and patient acuity were also recorded. Undetected violations were corrected by the investigator prior to departure, ensuring operational safety. Seven of the violations (21.2%) were detected by the transport team during routine completion of the checklist. Team members with less than 3 years of experience in the program had a 10% detection rate (95% confidence interval [CI], 1.5-23.1), whereas those with greater than 3 years experience in the program had a 38.5% detection rate (95% CI, 12.0-65.0). In this sample, no other observed variable suggested an association with detection rates. Routine completion of an interactive challenge-and-respond checklist by medical personnel had a low rate of detecting operational safety omissions in the studied helicopter critical care transport program. There was some difference in results by crew tenure.
Safkhani, Masoumeh; Bagheri, Nasour; Naderi, Majid
In this paper we investigate the security level of a comprehensive RFID solution to enhance inpatient medication safety, named IS-RFID, which has been recently proposed by Peris-Lopez et al. We analyses the security of the protocol against the known attacks in the context. The main target of this paper is to determine whether the new protocol provides the confidentiality property, which is expected to be provided by such a protocol. It was found that IS-RFID has critical weaknesses. The presented security investigations show that a passive adversary can retrieve secret parameters of patient's tag in cost of O(2(16)) off-line PRNG evaluations. Given the tag's secret parameters, any security claims are ruined. In this paper we presented an efficient passive secret disclosure attack which retrieves the main secret parameters related to the patient which shows that IS-RFID may put the patient safety on risk. The proposed attacking technique is in light of two vulnerabilities of the protocol: (1) the short length of the used PRNG, which is urged by the target technology, EPC C1 Gen2 ; (2) the message-generating mechanism utilizing PRNG was not carefully scrutinized. While the later point can be fixed by careful designing of the transferred messages between the protocol's party, the earlier point, i.e., the short length of the available PRNG for EPC C1 Gen2 tags, is a limitation which is forced by the technology. In addition, over the last years, schemes based solely on using simple operations or short PRNG (such as IS-RFID) have been shown to offer very low or no security at all. Recent advances in lightweight ciphers, such as PRESENT or Grain , seem a much more appropriate solution rather than relying on short PRNGs. However, such solutions breaks the EPC C1 Gen2 compatibility. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.
Sirois, Patricia A; Huo, Yanling; Williams, Paige L; Malee, Kathleen; Garvie, Patricia A; Kammerer, Betsy; Rich, Kenneth; Van Dyke, Russell B; Nozyce, Molly L
This study evaluated effects of perinatal exposure to antiretroviral (ARV) medications on neurodevelopment of HIV-exposed, uninfected infants. HIV-exposed, uninfected infants (age 9-15 months) enrolled in Surveillance Monitoring for Antiretroviral Therapy Toxicities, a multisite prospective surveillance study, completed the Bayley Scales of Infant and Toddler Development-Third Edition (Bayley-III), assessing cognition, language, motor skills, social-emotional development and adaptive behavior. Linear regression models were used to evaluate associations between Bayley-III outcomes in infants with and without perinatal and neonatal ARV exposure, by regimen (combination ARV [cARV] versus non-cARV), type of regimen (defined by drug class) and individual ARVs (for infants with cARV exposure), adjusting for maternal and infant health and demographic covariates. As of May 2010, 374 infants had valid Bayley-III evaluations. Median age at testing was 12.7 months; 49% male, 79% black and 16% Hispanic. Seventy-nine percent were exposed to regimens containing protease inhibitors (9% of protease inhibitor-containing regimens also included non-nucleoside reverse transcriptase inhibitors), 5% to regimens containing non-nucleoside reverse transcriptase inhibitors (without protease inhibitor) and 14% to regimens containing only nucleoside reverse transcriptase inhibitors. Overall, 83% were exposed to cARV. No Bayley-III outcome was significantly associated with overall exposure to cARV, ARV regimen or neonatal prophylaxis. For individual ARVs, following sensitivity analyses, the adjusted group mean on the Language domain was within age expectations but significantly lower for infants with perinatal exposure to atazanavir (P = 0.01). These results support the safety of perinatal ARV use. Continued monitoring for adverse neurodevelopmental outcomes in older children is warranted, and the safety of atazanavir merits further study.
Hider, Phil; Parker, Karl; von Randow, Martin; Milne, Barry; Lay-Yee, Roy; Davis, Peter
Increasing interest has focused on the safety of hospital care. The AusPSIs are a set of indicators developed from Australian administrative data to reliably identify inpatient adverse events in hospitals. The main aim of this study was to explore the application of the AHRQ/AusPSIs to New Zealand administrative hospital data related to medical and surgical care. Variation over time and across hospitals were also considered for a subset of the more common indicators. AHRQ/AusPSIs were adapted for use with New Zealand National Minimum Dataset administrative data for the period 2001-9. Crude positive event rates for each of the 16 indicators were assessed across New Zealand public hospitals. Variation over time for six more common indicators is presented using statistical control charts. Variation between hospitals was explored using rates adjusted for differences in patient variables including age, sex, ethnicity, rurality of residence, NZDep score and comorbidities. The AHRQ/AusPSIs were applied to New Zealand administrative hospital data and some 99,366 admissions were associated with a positive indicator event. However rates for some indicators were low (<1% of denominator admissions). Over the study period considerable variation in the rate of positive events was evident for the six most common indicators. Likewise there was substantial variation between hospitals in relation to risk adjusted positive event rates Patient safety indicators can be applied to New Zealand administrative hospital data. While infrequent rates hinder the use of some of the indicators, several could now be readily employed as warning flags to help monitor rates of adverse events at particular hospitals. In conjunction with other established or emerging tools, such as audit and trigger tools, the PSIs are now available to promote ongoing quality improvement activities in New Zealand hospitals.
Huynh, Chi; Wong, Ian C K; Correa-West, Jo; Terry, David; McCarthy, Suzanne
Since the publication of To Err Is Human: Building a Safer Health System in 1999, there has been much research conducted into the epidemiology, nature and causes of medication errors in children, from prescribing and supply to administration. It is reassuring to see growing evidence of improving medication safety in children; however, based on media reports, it can be seen that serious and fatal medication errors still occur. This critical opinion article examines the problem of medication errors in children and provides recommendations for research, training of healthcare professionals and a culture shift towards dealing with medication errors. There are three factors that we need to consider to unravel what is missing and why fatal medication errors still occur. (1) Who is involved and affected by the medication error? (2) What factors hinder staff and organisations from learning from mistakes? Does the fear of litigation and criminal charges deter healthcare professionals from voluntarily reporting medication errors? (3) What are the educational needs required to prevent medication errors? It is important to educate future healthcare professionals about medication errors and human factors to prevent these from happening. Further research is required to apply aviation's 'black box' principles in healthcare to record and learn from near misses and errors to prevent future events. There is an urgent need for the black box investigations to be published and made public for the benefit of other organisations that may have similar potential risks for adverse events. International sharing of investigations and learning is also needed.
Farre, Albert; Heath, Gemma; Shaw, Karen; Jordan, Teresa; Cummins, Carole
Objectives To explore paediatric nurses' experiences and perspectives of their role in the medication process and how this role is enacted in everyday practice. Methods A qualitative case study on a general surgical ward of a paediatric hospital in England, one year prior to the planned implementation of ePrescribing. Three focus groups and six individual semi-structured interviews were conducted, involving 24 nurses. Focus groups and interviews were audio-recorded, transcribed, anonymized and subjected to thematic analysis. Results Two overarching analytical themes were identified: the centrality of risk management in nurses' role in the medication process and the distributed nature of nurses' medication risk management practices. Nurses' contribution to medication safety was seen as an intrinsic feature of a role that extended beyond just preparing and administering medications as prescribed and placed nurses at the heart of a dynamic set of interactions, practices and situations through which medication risks were managed. These findings also illustrate the collective nature of patient safety. Conclusions Both the recognized and the unrecognized contributions of nurses to the management of medications needs to be considered in the design and implementation of ePrescribing systems.
Lawani, Lucky Osaheni; Eze, Justus Ndulue; Mamah, Emmanuel Johnbosco; Onoh, Robinson Chukwudi; Ogah, Emeka Onwe; Umezurike, Daniel Akuma; Anozie, Rita Onyinyechi
Introduction Awareness of appropriate waste management procedures and occupational safety measures is fundamental to achieving a safe work environment, and ensuring patient and staff safety. Aim This study was conducted to assess the attitude of healthcare managers to medical waste management and occupational safety practices. Materials and Methods This was a cross-sectional study conducted among 54 hospital administrators in Ebonyi state. Semi-structured questionnaires were used for qualitative data collection and analyzed with SPSS statistics for windows (2011), version 20.0 statistical software (Armonk, NY: IBM Corp). Results Two-fifth (40%) of healthcare managers had received training on medical waste management and occupational safety. Standard operating procedure of waste disposal was practiced by only one hospital (1.9%), while 98.1% (53/54) practiced indiscriminate waste disposal. Injection safety boxes were widely available in all health facilities, nevertheless, the use of incinerators and waste treatment was practiced by 1.9% (1/54) facility. However, 40.7% (22/54) and 59.3% (32/54) of respondents trained their staff and organize safety orientation courses respectively. Staff insurance cover was offered by just one hospital (1.9%), while none of the hospitals had compensation package for occupational hazard victims. Over half (55.6%; 30/54) of the respondents provided both personal protective equipment and post exposure prophylaxis for HIV. Conclusion There was high level of non-compliance to standard medical waste management procedures, and lack of training on occupational safety measures. Relevant regulating agencies should step up efforts at monitoring and regulation of healthcare activities and ensure staff training on safe handling and disposal of hospital waste. PMID:28511409
While FDA gathers vast amounts of data about prescription drugs prior to their marketing approval, important information about the relative effectiveness and long term safety of products is not required for approval, and often is never collected. Increased postmarket research on the safety and comparative effectiveness of products would improve medical decisionmaking and lead to better clinical outcomes. Fortunately, Congress has recognized the value of this information for healthcare professionals. In response to a congressional mandate in the FDA Amendments Act (FDAAA), FDA is developing the Sentinel Initiative, an active surveillance system for monitoring postmarket drug safety issues. FDAAA also authorized FDA to require a drug sponsor to conduct postmarket safety studies or clinical trials to address a specific safety concern. To increase the repository of comparative effectiveness information, Congress established the Patient-Centered Outcomes Research Institute (PCORI) in the Patient Protection and Affordable Care Act (PPACA), directing it to manage comparative effectiveness research (CER). This article discusses the need for better safety and comparative effectiveness information and outlines methods to efficiently conduct the research and communicate it effectively to healthcare professionals. Coordination between FDA and the PCORI in gathering and communicating postmarket information is recommended. Medical source data collected by the Sentinel Initiative should be used for CER in addition to postmarket safety surveillance, and FDA and the PCORI should adopt identical standards for the distribution and communication of CER. Coordination between the two entities is recommended to save costs, reduce duplication of efforts, and to generate and communicate more information on prescription drugs for medical decisionmakers.
Hochman, Michael E; Asch, Steven; Jibilian, Arek; Chaudry, Bharat; Ben-Ari, Ron; Hsieh, Eric; Berumen, Margaret; Mokhtari, Shahrod; Raad, Mohamad; Hicks, Elisabeth; Sanford, Crystal; Aguirre, Norma; Tseng, Chi-hong; Vangala, Sitaram; Mangione, Carol M; Goldstein, David A
The patient-centered medical home (PCMH) model holds promise for improving primary care delivery, but it has not been adequately tested in teaching settings. We implemented an intervention guided by PCMH principles at a safety-net teaching clinic with resident physician providers. Two similar clinics served as controls. Using a cross-sectional design, we measured the effect on patient and resident satisfaction using the Consumer Assessment of Healthcare Providers and Systems survey and a validated teaching clinic survey, respectively. Both surveys were conducted at baseline and 1 year after the intervention. We also measured the effect on emergency department and hospital utilization. Following implementation of our intervention, the clinic’s score on the National Committee for Quality Assurance’s PCMH certification tool improved from 35 to 53 of 100 possible points, although our clinic did not achieve all must-pass elements to qualify as a PCMH. During the 1-year study period, 4676 patients were exposed to the intervention; 39.9% of these used at least 1 program component. Compared with baseline, patient-reported access and overall satisfaction improved to a greater extent in the intervention clinic, and the composite satisfaction rating increased from 48% to 65% in the intervention clinic vs from 50% to 59% in the control sites (P = .04). The improvements were particularly notable for questions relating to access. For example, satisfaction with urgent appointment scheduling increased from 12% to 53% in the intervention clinic vs from 14% to 18% in the control clinics (P < .001). Resident satisfaction also improved in the intervention clinic: the composite satisfaction score increased from 39% to 51% in the intervention clinic vs a decrease from 46% to 42% in the control clinics (P = .01). Emergency department utilization did not differ significantly between the intervention and control clinics, and hospitalizations increased from 26 to 27 visits
Hochman, Michael E.; Asch, Steven; Jibilian, Arek; Chaudry, Bharat; Ben-Ari, Ron; Hsieh, Eric; Berumen, Margaret; Mokhtari, Shahrod; Raad, Mohamad; Hicks, Elisabeth; Sanford, Crystal; Aguirre, Norma; Tseng, Chi-hong; Vangala, Sitaram; Mangione, Carol M.; Goldstein, David A.
IMPORTANCE The patient-centered medical home (PCMH) model holds promise for improving primary care delivery, but it has not been adequately tested in teaching settings. DESIGN, SETTING, AND PARTICIPANTS We implemented an intervention guided by PCMH principles at a safety-net teaching clinic with resident physician providers. Two similar clinics served as controls. MAIN OUTCOMES AND MEASURES Using a cross-sectional design, we measured the effect on patient and resident satisfaction using the Consumer Assessment of Healthcare Providers and Systems survey and a validated teaching clinic survey, respectively. Both surveys were conducted at baseline and 1 year after the intervention. We also measured the effect on emergency department and hospital utilization. RESULTS Following implementation of our intervention, the clinic’s score on the National Committee for Quality Assurance’s PCMH certification tool improved from 35 to 53 of 100 possible points, although our clinic did not achieve all must-pass elements to qualify as a PCMH. During the 1-year study period, 4676 patients were exposed to the intervention; 39.9% of these used at least 1 program component. Compared with baseline, patient-reported access and overall satisfaction improved to a greater extent in the intervention clinic, and the composite satisfaction rating increased from 48% to 65% in the intervention clinic vs from 50% to 59% in the control sites (P = .04). The improvements were particularly notable for questions relating to access. For example, satisfaction with urgent appointment scheduling increased from 12% to 53% in the intervention clinic vs from 14% to 18% in the control clinics (P < .001). Resident satisfaction also improved in the intervention clinic: the composite satisfaction score increased from 39% to 51% in the intervention clinic vs a decrease from 46%to 42% in the control clinics (P = .01). Emergency department utilization did not differ significantly between the intervention and
Morris, Susan; Otto, Catherine N; Golemboski, Karen
Healthcare quality has yet to meet the aims of the Institute of Medicine (IOM) with respect to safety, effectiveness, patient-centeredness, efficiency, timeliness and equity. No professional curricula adequately prepare future healthcare practitioners-including medical laboratory science professionals-with all competencies necessary to deliver quality healthcare. Practicing evidence-based medicine, focusing on quality improvement, using information technology, delivering patient-centered care and working as part of interdisciplinary teams are identified by the IOM as the five core competencies that every healthcare practitioner needs to effectively provide healthcare. Medical laboratory science educators need to incorporate patient safety concepts into the curricula and include assignments to develop the IOM competencies in order to adequately prepare future practitioners to effectively practice medical laboratory science in the healthcare system of the 21st century.
Baril, Chantal; Gascon, Viviane; Brouillette, Christel
Despite the fact that since 1985 the government of Québec increased by 5.75 % on average the amount of money spent on healthcare per year, little improvement was noted. It is obvious that an optimal use of resources is essential to reduce waiting times and provide safer and faster services to patients. The use of new technology can contribute to improve the healthcare system efficiency. Our study aims to assess the impact of a medication distribution technology on 1) the performance of a health and social services center's pharmacy, 2) the performance of one care unit in a nursing home and on 3) the medication-use process safety. To measure performance we were inspired by the Lean approach. The results show that medication distribution technology is considered as an effective way to significantly detect medication errors, to allow nurses to focus more on patients and pharmacy to react more rapidly to changes in patient medications.
Petersen, Amy J.; Karliner, Leah S.; Tice, Jeffrey A.
Introduction The global medical technology industry brings thousands of devices to market every year. However, significant gaps persist in the scientific literature, in the medical device approval process, and in the realm of postmarketing surveillance. Although thousands of drugs obtain approval only after review in randomized controlled trials, relatively few new medical devices are subject to comparable scrutiny. Objective To improve health outcomes, we must enhance our scrutiny of medical devices, and, without simply deferring to the Food and Drug Administration, we must ask ourselves: Who is responsible for evaluating the safety and effectiveness of medical devices? Conclusions Technology assessments by independent organizations are a part of the solution to this challenge and may motivate further research focused on patient outcomes. PMID:18095046
Star, Kristina; Watson, Sarah; Sandberg, Lovisa; Johansson, Jeanette; Edwards, I Ralph
To explore whether and how longitudinal medical records could be used as a source of reference in the early phases of signal detection and analysis of novel adverse drug reactions (ADRs) in a global pharmacovigilance database. Drug and ADR combinations from the routine signal detection process of VigiBase® in 2011 were matched to combinations in The Health Improvement Network (THIN). The number and type of drugs and ADRs from the data sets were investigated. For unlabelled combinations, graphical display of longitudinal event patterns (chronographs) in THIN was inspected to determine if the pattern supported the VigiBase combination. Of 458 combinations in the VigiBase data set, 190 matched to corresponding combinations in THIN (after excluding drugs with less than 100 prescriptions in THIN). Eighteen percent of the VigiBase and 9% of the matched THIN combinations referred to new drugs reported with serious reactions. Of the 112 unlabelled combinations matched to THIN, 52 chronographs were inconclusive mainly because of lack of data; 34 lacked any outstanding pattern around the time of prescription; 24 had an elevation of events in the pre-prescription period, hence weakened the suspicion of a drug relationship; two had an elevated pattern of events exclusively in the post-prescription period that, after review of individual patient histories, did not support an association. Longitudinal medical records were useful in understanding the clinical context around a drug and suspected ADR combination and the probability of a causal relationship. A drawback was the paucity of data for newly marketed drugs with serious reactions. © 2015 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons, Ltd.
Watson, Sarah; Sandberg, Lovisa; Johansson, Jeanette; Edwards, I. Ralph
Abstract Purpose To explore whether and how longitudinal medical records could be used as a source of reference in the early phases of signal detection and analysis of novel adverse drug reactions (ADRs) in a global pharmacovigilance database. Methods Drug and ADR combinations from the routine signal detection process of VigiBase® in 2011 were matched to combinations in The Health Improvement Network (THIN). The number and type of drugs and ADRs from the data sets were investigated. For unlabelled combinations, graphical display of longitudinal event patterns (chronographs) in THIN was inspected to determine if the pattern supported the VigiBase combination. Results Of 458 combinations in the VigiBase data set, 190 matched to corresponding combinations in THIN (after excluding drugs with less than 100 prescriptions in THIN). Eighteen percent of the VigiBase and 9% of the matched THIN combinations referred to new drugs reported with serious reactions. Of the 112 unlabelled combinations matched to THIN, 52 chronographs were inconclusive mainly because of lack of data; 34 lacked any outstanding pattern around the time of prescription; 24 had an elevation of events in the pre‐prescription period, hence weakened the suspicion of a drug relationship; two had an elevated pattern of events exclusively in the post‐prescription period that, after review of individual patient histories, did not support an association. Conclusions Longitudinal medical records were useful in understanding the clinical context around a drug and suspected ADR combination and the probability of a causal relationship. A drawback was the paucity of data for newly marketed drugs with serious reactions. © 2015 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons, Ltd. PMID:25623045
Background Patient safety is a fundamental component of good quality health care. Checklists have been proposed as a method of improving patient safety. This systematic review, asked "In acute hospital settings, would the use of safety checklists applied by medical care teams, compared to not using checklists, improve patient safety?" Methods We searched the Cochrane Library, MEDLINE, CINAHL, and EMBASE for randomised controlled trials published in English before September 2009. Studies were selected and appraised by two reviewers independently in consultation with colleagues, using inclusion, exclusion and appraisal criteria established a priori. Results Nine cohort studies with historical controls studies from four hospital care settings were included-intensive care unit, emergency department, surgery, and acute care. The studies used a variety of designs of safety checklists, and implemented them in different ways, however most incorporated an educational component to teach the staff how to use the checklist. The studies assessed outcomes occurring a few weeks to a maximum of 12 months post-implementation, and these outcomes were diverse. The studies were generally of low to moderate quality and of low levels of evidence, with all but one of the studies containing a high risk of bias. The results of these studies suggest some improvements in patient safety arising from use of safety checklists, but these were not consistent across all studies or for all outcomes. Some studies showed no difference in outcomes between checklist use and standard care without a checklist. Due to the variations in setting, checklist design, educational training given, and outcomes measured, it was unfeasible to accurately summarise any trends across all studies. Conclusions The included studies suggest some benefits of using safety checklists to improve protocol adherence and patient safety, but due to the risk of bias in these studies, their results should be interpreted with
Sarnquist, Clea; Sawyer, Mark; Calvin, Kris; Mason, Wilbert; Blumberg, Dean; Luther, Jeffrey; Maldonado, Yvonne
Physicians spend significant amounts of time discussing vaccine safety concerns with patients and parents. This study aimed to better understand the educational needs of US residents regarding vaccine safety communication, primarily by quantifying the vaccine safety communication training that residents currently receive and elucidating residents' preferences around education about vaccines and vaccine safety communication. A mixed-methods needs assessment consisting of focus groups and a survey. A convenience sample of 303 medical residents in pediatrics, family medicine, and internal medicine from across the United States participated in an online, anonymous survey from March through June 2010. In addition, 9 focus groups with 47 resident participants were held. The sample included residents in pediatrics (239, 80.2%), internal or family medicine (30, 10.1%), and dual medicine-pediatrics (29, 9.7%); 20.6% of the residents reported "not learning" about vaccine safety communication in their residency programs. Preferred learning methods, which were also the most commonly used methods, included didactic lectures and role-modeling/cases. Electronic teaching method were not only less desired but also very rarely utilized. More than 95% of residents reported thinking that vaccine safety communication would be very or somewhat important in their careers. Improving education on vaccine safety communication within US residency programs, as well as offering self-learning opportunities, can better prepare physicians for their careers.
O'Leary, Kevin J; Creden, Amanda J; Slade, Maureen E; Landler, Matthew P; Kulkarni, Nita; Lee, Jungwha; Vozenilek, John A; Pfeifer, Pamela; Eller, Susan; Wayne, Diane B; Williams, Mark V
In a prior study involving 2 medical units, Structured Interdisciplinary Rounds (SIDRs) improved teamwork and reduced adverse events (AEs). SIDR was implemented on 5 additional units, and a pre- versus postintervention comparison was performed. SIDR combined a structured format for communication with daily interprofessional meetings. Teamwork was assessed using the Safety Attitudes Questionnaire (score range = 0-100), and AEs were identified using queries of information systems confirmed by 2 physician researchers. Paired analyses for 82 professionals completing surveys both pre and post implementation revealed improved teamwork (mean 76.8 ± 14.3 vs 80.5 ± 11.6; P = .02), which was driven mainly by nurses (76.4 ± 14.1 vs 80.8 ± 10.4; P = .009). The AE rate was similar across study periods (3.90 vs 4.07 per 100 patient days; adjusted IRR = 1.08; P = .60). SIDR improved teamwork yet did not reduce AEs. Higher baseline teamwork scores and lower AE rates than the prior study may reflect a positive cultural shift that began prior to the current study.
da Silva, Mônica Valero; Ribeiro, Alberto de Freitas; Pinto, Terezinha de Jesus A
Pyrogenic and toxic reactions, especially in immunologically compromised patients, are among the risks associated with reuse of single-use medical devices (SUDs) with recurrent damaged surfaces. These drawbacks have raised serious doubts about the true benefits of the reprocessing practice. Taking into consideration prolonged patients' stay in hospitals due to adverse reactions provoked by recycled SUDs, the safety of these reprocessed materials was evaluated. The reprocessing cycles were simulated after intentional contamination of selected test material such as intravenous catheters, 3-way stopcocks, and tracheostomy tubes with Bacillus subtilis var. niger ATCC 9372 spores (10(7) CFU/unit). The repeated reprocessing cycles consisted of subsequent wash with enzymatic detergent followed by drying and sterilization with ethylene oxide-CFC (12 + 88), 600 mg/L at 55 degrees C, relative humidity 60%, for 3 h. After each reprocessing cycle, specimen samples were evaluated by pour plate microbial counts, direct and indirect inoculation sterility tests, cytotoxicity evaluation, and scanning electron microscopy (SEM). Microbial counts as high as 10(3) CFU were evident even after the 10th reprocessing cycle, besides scratched and damaged surfaces observed by SEM. Risk-benefit viewpoints are discussed.
Casella, Erica; Capozzi, Donna; McGettigan, Suzanne; Gangadhar, Tara C.; Schuchter, Lynn; Myers, Jennifer S.
Purpose: Over the last decade, the use of oral chemotherapy (OC) for the treatment of cancer has dramatically increased. Despite their route of administration, OCs pose many of the same risks as intravenous agents. In this quality improvement project, we sought to examine our current process for the prescription of OC at the Abramson Cancer Center of the University of Pennsylvania and to improve on its safety. Methods: A multidisciplinary team that included oncologists, advanced-practice providers, and pharmacists was formed to analyze the current state of our OC practice. Using Lean Six Sigma quality improvement tools, we identified a lack of pharmacist review of the OC prescription as an area for improvement. To address these deficiencies, we used our electronic medical system to route OC orders placed by treating providers to an oncology-specific outpatient pharmacist at the Abramson Cancer Center for review. Results: Over 7 months, 63 orders for OC were placed for 45 individual patients. Of the 63 orders, all were reviewed by pharmacists, and, as a result, 22 interventions were made (35%). Types of interventions included dosage adjustment (one of 22), identification of an interacting drug (nine of 22), and recommendations for additional drug monitoring (12 of 22). Conclusion: OC poses many of the same risks as intravenous chemotherapy and should be prescribed and reviewed with the same oversight. At our institution, involvement of an oncology-trained pharmacist in the review of OC led to meaningful interventions in one third of the orders. PMID:26733627
Fore, Amanda M; Sculli, Gary L; Albee, Doreen; Neily, Julia
To implement the sterile cockpit principle to decrease interruptions and distractions during high volume medication administration and reduce the number of medication errors. While some studies have described the importance of reducing interruptions as a tactic to reduce medication errors, work is needed to assess the impact on patient outcomes. Data regarding the type and frequency of distractions were collected during the first 11 weeks of implementation. Medication error rates were tracked 1 year before and after 1 year implementation. Simple regression analysis showed a decrease in the mean number of distractions, (β = -0.193, P = 0.02) over time. The medication error rate decreased by 42.78% (P = 0.04) after implementation of the sterile cockpit principle. The use of crew resource management techniques, including the sterile cockpit principle, applied to medication administration has a significant impact on patient safety. Applying the sterile cockpit principle to inpatient medical units is a feasible approach to reduce the number of distractions during the administration of medication, thus, reducing the likelihood of medication error. 'Do Not Disturb' signs and vests are inexpensive, simple interventions that can be used as reminders to decrease distractions. © 2012 Blackwell Publishing Ltd.
Bohomol, Elena; Cunha, Isabel Cristina Kowal Olm
Objective To analyze the Educational Project of the undergraduate medical course to verify what is taught regarding Patient Safety and to enable reflections on the educational practice. Methods A descriptive study, using document research as strategy. The document of investigation was the Educational Project of the medical course, in 2006, at the Escola Paulista de Medicina of the Universidade Federal de São Paulo. The theoretical framework adopted was the Multi-Professional Patient Safety Curriculum Guide of the World Health Organization, which led to the preparation of a list with 153 tracking terms. Results We identified 65 syllabus units in the Educational Project of the course, in which 40 (61.5%) addressed topics related to Patient Safety. Themes on the topic “Infection prevention and control” were found in 19 (47.5%) units and teaching of “Interaction with patients and caregivers” in 12 (32.5%); however content related to “Learning from errors to prevent harm” were not found. None of the framework topics had their proposed themes entirely taught during the period of education of the future physicians. Conclusion Patient safety is taught in a fragmented manner, which values clinical skills such as the diagnosis and treatment of diseases, post-treatment, surgical procedures, and follow-up. Since it is a recent movement, the teaching of patient safety confronts informative proposals based on traditional structures centered on subjects and on specific education, and it is still poorly valued. PMID:25993062
Frakes, Michael A; Kelly, John G
Operational safety, both crash prevention and improved crash survival, is a central concern in the air medical community. Professional organizations have published operational safety guidelines, but the extent to which those guidelines are followed is unclear. We report the results of a survey of adherence with selected safe practice recommendations. An anonymous survey of adherence with 8 individual and 11 program safety guidelines was distributed to flight team members at 10 Association of Air Medical Services-member rotor-wing air medical programs selected by stratified random sample to ensure geographic diversity. Descriptive statistics are reported and relationships are evaluated with the chi-square test. The sample size provided 80% power at a .05 significance level for the comparisons. Data were analyzed from 126 of the 200 surveys distributed. Adherence with program-wide safety behaviors ranged from 41.3% (complete a pre-departure checklist) to 99.2% (program has an annual safety review). Adherence to individual behaviors ranged from 15.1% (wear fire-resistant gloves) to 99.2% (wear seatbelts and shoulder harnesses on approach and departure). There was 100% adherence to wearing helmets by the respondents whose program provided a helmet at no cost to the staff member. There were no associations between job description and any individual behavior. Hospital-operated programs were less likely to have a daily briefing (P < .05), less likely to have a written policy allowing flight refusal for fatigue (P < .01), and tended toward lower rates of having a written policy allowing flight refusal for fatigue (P = .07). Non-hospital-operated programs were less likely to provide helmets (P < .001), to operate in an airframe with a clear headstrike area (P < .001), and to wear long-sleeved fire-resistant flight suits (P = .01). Both organizational and individual adherence to community safety recommendations are variable and not universal. There is variability by
Hansen, Matthew; Meckler, Garth; O’Brien, Kerth; Engle, Phillip; Dickinson, Caitlin; Dickinson, Kathryn; Jui, Jonathan; Lambert, William; Cottrell, Erika; Guise, Jeanne-Marie
Objective The objective of this study was to determine what aspects of prehospital pediatric airway management may contribute to patient safety events. Methods We conducted a 3-phase Delphi survey in prehospital professionals across the US to identify potential contributors to patient safety events. Respondents ranked how likely factors were to contribute on a 9-point Likert-type scale and were allowed to elaborate through open-ended questions. Analysis was conducted using a mixed-methods approach including Likert-type responses and open ended questions which were analyzed for specific themes. Results All 3 phases of the survey were completed by 492 participants; 50.8% of respondents were paramedics, 22% were EMT-Basics/first responders, and 11.4% were physicians. Seventy-five percent identified lack of experience with advanced airway management and 44% identified medical decision making regarding airway interventions as highly likely to lead to safety events. Within the domain of technical skills, advanced airway management was ranked in the top 3 contributors to safety events by 71% of participants, and bag mask ventilation by 18%. Qualitative analysis of questions within the domains of equipment and technical skills identified endotracheal intubation as the top contributor to safety events, with bag-mask-ventilation second. In the domains of assessment and decision making respiratory assessment and knowing when to perform and advanced airway were ranked most highly. Conclusion This national Delphi survey identified lack of experience with pediatric airway management and challenges in decision making in advanced airway management as high risk for safety events with endotracheal intubation as the most likely of these. PMID:27253653
... 10 Energy 1 2013-01-01 2013-01-01 false Training for experienced Radiation Safety Officer... BYPRODUCT MATERIAL General Administrative Requirements § 35.57 Training for experienced Radiation Safety... pharmacist, and authorized nuclear pharmacist. (a)(1) An individual identified as a Radiation Safety Officer...
... 10 Energy 1 2011-01-01 2011-01-01 false Training for experienced Radiation Safety Officer... BYPRODUCT MATERIAL General Administrative Requirements § 35.57 Training for experienced Radiation Safety... pharmacist, and authorized nuclear pharmacist. (a)(1) An individual identified as a Radiation Safety Officer...
... 10 Energy 1 2012-01-01 2012-01-01 false Training for experienced Radiation Safety Officer... BYPRODUCT MATERIAL General Administrative Requirements § 35.57 Training for experienced Radiation Safety... pharmacist, and authorized nuclear pharmacist. (a)(1) An individual identified as a Radiation Safety Officer...
... 10 Energy 1 2014-01-01 2014-01-01 false Training for experienced Radiation Safety Officer... BYPRODUCT MATERIAL General Administrative Requirements § 35.57 Training for experienced Radiation Safety... pharmacist, and authorized nuclear pharmacist. (a)(1) An individual identified as a Radiation Safety Officer...
... 10 Energy 1 2010-01-01 2010-01-01 false Training for experienced Radiation Safety Officer... BYPRODUCT MATERIAL General Administrative Requirements § 35.57 Training for experienced Radiation Safety... pharmacist, and authorized nuclear pharmacist. (a)(1) An individual identified as a Radiation Safety Officer...
SMITH, C. C.; BENNETT, P. M.; PEARCE, H. M.; HARRISON, P. I.; REYNOLDS, D. J. M.; ARONSON, J. K.; GRAHAME-SMITH, D. G.
1We have retrospectively analysed data collected by a local adverse drug reactions reporting scheme in an acute hospital medical setting and have determined the numbers and types of reactions that would have merited notification as yellow card reports according to the guidelines of the Committee on Safety of Medicines. 2The data related to 20 695 consecutive acute general medical admissions on seven general medical wards (140 beds) and were collected over 3 years, from April 1990 to March 1993. 3Over 3 years there were 1420 reports of suspected adverse drug reactions, a rate of 68.7 per 1000 admissions. 4If the guidelines for reporting issued by the Committee on Safety of Medicines had been strictly followed, 477 yellow cards would have been sent (23.1 per 1000 admissions). In 357 of these reports (74.8%), the reaction had caused admission to hospital. Only 31 of the 477 potential cards (6.5%) involved black triangle drugs and 10 of these were for minor reactions. 5Only 30 of the 477 potential yellow cards (6.3%) were known to have been sent. The majority of those reactions not reported were for drug-related admissions, most of which were for well-known reactions to established drugs. 6We have confirmed and quantified the extent of under-reporting of serious suspected adverse drug reactions to the Committee on Safety of Medicines from our hospital medical unit. PMID:8904613
Smith, C C; Bennett, P M; Pearce, H M; Harrison, P I; Reynolds, D J; Aronson, J K; Grahame-Smith, D G
1. We have retrospectively analysed data collected by a local adverse drug reactions reporting scheme in an acute hospital medical setting and have determined the numbers and types of reactions that would have merited notification as yellow card reports according to the guidelines of the Committee on Safety of Medicines. 2. The data related to 20,695 consecutive acute general medical admissions on seven general medical wards (140 beds) and were collected over 3 years, from April 1990 to March 1993. 3. Over 3 years there were 1420 reports of suspected adverse drug reactions, a rate of 68.7 per 1000 admissions. 4. If the guidelines for reporting issued by the Committee on Safety of Medicines had been strictly followed, 477 yellow cards would have been sent (23.1 per 1000 admissions). In 357 of these reports (74.8%), the reaction had caused admission to hospital. Only 31 of the 477 potential cards (6.5%) involved black triangle drugs and 10 of these were for minor reactions. 5. Only 30 of the 477 potential yellow cards (6.3%) were known to have been sent. The majority of those reactions not reported were for drug-related admissions, most of which were for well-known reactions to established drugs. 6. We have confirmed and quantified the extent of under-reporting of serious suspected adverse drug reactions to the Committee on Safety of Medicines from our hospital medical unit.
He, Aijie; Song, Dehua; Zhang, Lei; Li, Chen
A large number patients struggle with migraine which is classified as a chronic disorder. The relative efficacy, safety and tolerability of prophylactic medications for migraine play a key role in managing this disease. We conducted an extensive literature search for popular prophylactic medications that are used for migraine patients. Pairwise meta-analysis and network meta-analysis (NMA) were carried out sequentially for determining the relative efficacy, safety and tolerability of prophylactic medications. Summary effect for migraine headache days, headache frequency, at least 50% reduction in headache attacks, all-adverse events, nausea, somnolence, dizziness, withdrawal and withdrawal due to adverse events were produced by synthesizing both direct and indirect evidence. Patients with three interventions exhibited significantly less average migraine headache days compared with those treated by placebo (topiramate, propranolol, divalproex). Moreover, topiramate and valproate exhibited a significantly increased likelihood of at least 50% reduction in migraine headache attacks compared to placebo. Patients with topiramate and propranolol also exhibited significantly reduced headache frequency compared to those with placebo. On the other hand, patients with divalproex exhibited significantly higher risk of nausea compared to those with placebo, topiramate, propranolol, gabapentin and amitriptyline. Finally, divalproex was associated with an increased risk of withdrawal compared to placebo and propranolol. Topiramate, propranolol and divalproex may be more efficacious than other prophylactic medications. Besides, the safety and tolerability of divalproex should be further verified by future studies.
Hills, Laura Sachs
This article offers 30 practical strategies that will keep a medical practice safe and secure. These strategies can serve as the core knowledge base for staff safety instruction programs and can be included in employee procedure manuals. Specifically, the article presents easy-to-follow and affordable strategies for deterring professional burglars and petty thieves, for preventing or responding tofires, for avoiding falls and other common office mishaps, and for securing office keys. It suggests 10 additional safety do's and don'ts for your staff; including several pertaining to their dress and work habits. It also offers guidelines for planning and rehearsing an effective office evacuation procedure.
Pirrallo, R G; Rubin, J M; Murawsky, G A
To determine how often house fires occur at 1- and 2-family dwellings visited previously by emergency medical services (EMS) personnel and whether these visits were missed opportunities for a point-of-contact home fire safety intervention. A retrospective, consecutive, case series analysis of all Milwaukee Fire Department alarm responses during 1994 was performed. Measurements included date of service, type of response, property type, dollar loss estimate, number of injuries and fatalities, cause of alarm, and presence of an operational smoke detector. Descriptive, chi2, and relative risk statistics were used to describe the relationship between EMS responses and fire responses at 1- and 2-family dwellings. The Milwaukee Fire Department dispatched 94,378 requests for service to 43,556 addresses. 16,150 addresses generated multiple requests; 7.2% (1,162/16,150) were for an "alarm of fire" response [relative risk 1.83 (95% CI: 1.69-1.99) for addresses with multiple requests vs those with a single request for service]. Most [62% (721/1,162)] of the addresses were visited by EMS personnel prior to the alarm; 28% (205/721) were 1- and 2-family dwellings. A mean of 1.8 (376/205) EMS responses occurred prior to the "alarm of fire" response; 121 addresses received 1 response, 46 received 2, 18 received 3, and 20 received > or = 4 responses. Of 169 addresses with complete data, there was a total fire dollar loss of $1,963,020 (1994) along with 32 injuries and 0 fatalities. While 47% (80/169) of the 1- and 2-family dwellings had a smoke detector present, only 17% (29/169) of the dwellings had an operational smoke detector. A point-of-contact home fire safety intervention appears of potential benefit for frequent users of EMS care. Determination of the presence of an operational smoke detector in 1- and 2-family dwellings may be a useful injury prevention act during such EMS calls.
Every scheduled treatment at a radiation therapy clinic involves a series of safety protocol to ensure the utmost patient care. Despite safety protocol, on a rare occasion an entirely preventable medical event, an accident, may occur. Delivering a treatment plan to the wrong patient is preventable, yet still is a clinically documented error. This research describes a computational method to identify patients with a novel machine learning technique to combat misadministration. The patient identification program stores face and fingerprint data for each patient. New, unlabeled data from those patients are categorized according to the library. The categorization of data by this face-fingerprint detector is accomplished with new machine learning algorithms based on Sparse Modeling that have already begun transforming the foundation of Computer Vision. Previous patient recognition software required special subroutines for faces and different tailored subroutines for fingerprints. In this research, the same exact model is used for both fingerprints and faces, without any additional subroutines and even without adjusting the two hyperparameters. Sparse modeling is a powerful tool, already shown utility in the areas of super-resolution, denoising, inpainting, demosaicing, and sub-nyquist sampling, i.e. compressed sensing. Sparse Modeling is possible because natural images are inherently sparse in some bases, due to their inherent structure. This research chooses datasets of face and fingerprint images to test the patient identification model. The model stores the images of each dataset as a basis (library). One image at a time is removed from the library, and is classified by a sparse code in terms of the remaining library. The Locally Competitive Algorithm, a truly neural inspired Artificial Neural Network, solves the computationally difficult task of finding the sparse code for the test image. The components of the sparse representation vector are summed by ℓ1 pooling
Ohashi, Kumiko; Dykes, Patricia; Mcintosh, Kathleen; Buckley, Elizabeth; Yoon, Catherine; Luppi, Carol; Bane, Anne; Bates, David W
Patient controlled analgesia (PCA) and Patient-controlled epidural analgesia (PCEA) pumps are methods of pain control with complex smart infusion devices and are widely used in hospitals. Smart PCA/PCEA pumps can be programmed with the dose and rate of medications within pre-set ranges. However, adverse effects have been reported associated with these pumps' use. In this paper, we describe a prevalence observational study where observers used an electronic data collection tool to record pump settings and medications with PCA pumps, corresponding medication orders to identify errors. The results showed that there were many labeling and tubing change tag errors, which were a violation of hospital policy. A few potential harmful medication errors were identified but no critical errors. Study results suggest the importance of a standard process of PCA pump use. Next steps include implementing a safety bundle for improving PCA practice to support safe and effective pain management.
Ramsay, Angus I G; Turner, Simon; Cavell, Gillian; Oborne, C Alice; Thomas, Rebecca E; Cookson, Graham; Fulop, Naomi J
Background Relatively little is known about how scorecards presenting performance indicators influence medication safety. We evaluated the effects of implementing a ward-level medication safety scorecard piloted in two English NHS hospitals and factors influencing these. Methods We used a mixed methods, controlled before and after design. At baseline, wards were audited on medication safety indicators; during the ‘feedback’ phase scorecard results were presented to intervention wards on a weekly basis over 7 weeks. We interviewed 49 staff, including clinicians and managers, about scorecard implementation. Results At baseline, 18.7% of patients (total n=630) had incomplete allergy documentation; 53.4% of patients (n=574) experienced a drug omission in the preceding 24 h; 22.5% of omitted doses were classified as ‘critical’; 22.1% of patients (n=482) either had ID wristbands not reflecting their allergy status or no ID wristband; and 45.3% of patients (n=237) had drugs that were either unlabelled or labelled for another patient in their drug lockers. The quantitative analysis found no significant improvement in intervention wards following scorecard feedback. Interviews suggested staff were interested in scorecard feedback and described process and culture changes. Factors influencing scorecard implementation included ‘normalisation’ of errors, study duration, ward leadership, capacity to engage and learning preferences. Discussion Presenting evidence-based performance indicators may potentially influence staff behaviour. Several practical and cultural factors may limit feedback effectiveness and should be considered when developing improvement interventions. Quality scorecards should be designed with care, attending to evidence of indicators’ effectiveness and how indicators and overall scorecard composition fit the intended audience. PMID:24029440
Davis, Stephen Jerome; Hurtado, Josephine; Nguyen, Rosemary; Huynh, Tran; Lindon, Ivan; Hudnall, Cedric; Bork, Sara
. The error rate after the implementation of the workflow management system averaged 8.4%, which was a 1.6% reduction. After the implementation of the workflow management system, the average number of reported oral liquid medication and injectable medication errors decreased to 0.4 and 0.2 times per week, respectively. Conclusion: The organization was able to achieve its purpose and goal of improving the provision of quality pharmacy care through optimal medication use and safety by reducing medication preparation errors. Error rates decreased and the workflow processes were streamlined, which has led to seamless operations within the pharmacy department. There has been significant cost avoidance and waste reduction and enhanced interdepartmental satisfaction due to the reduction of reported medication errors.
Harvey, Richard P
Based on anecdotal evidence and networking with colleagues at other facilities, it has become evident that some radiation safety departments are not adequately staffed and radiation safety professionals need to increase their staffing levels. Discussions with management regarding radiation safety department staffing often lead to similar conclusions. Management acknowledges the Radiation Safety Officer (RSO) or Director of Radiation Safety's concern but asks the RSO to provide benchmarking and justification for additional full-time equivalents (FTEs). The RSO must determine a method to benchmark and justify additional staffing needs while struggling to maintain a safe and compliant radiation safety program. Benchmarking and justification are extremely important tools that are commonly used to demonstrate the need for increased staffing in other disciplines and are tools that can be used by radiation safety professionals. Parameters that most RSOs would expect to be positive predictors of radiation safety staff size generally are and can be emphasized in benchmarking and justification report summaries. Facilities with large radiation safety departments tend to have large numbers of authorized users, be broad-scope programs, be subject to increased controls regulations, have large clinical operations, have significant numbers of academic radiation-producing machines, and have laser safety responsibilities.
Flood, Ann Barry; Wood, Victoria A; Swartz, Harold M
Clinical EPR spectroscopy is emerging as an important modality, with the potential to be used in standard clinical practice to determine the extent of hypoxia in tissues and whether hypoxic tissues respond to breathing enriched oxygen during therapy. Oximetry can provide important information useful for prognosis and to improve patient outcomes. EPR oximetry has many potential advantages over other ways to measure oxygen in tissues, including directly measuring oxygen in tissues and being particularly sensitive to low oxygen, repeatable, and non-invasive after an initial injection of the EPR-sensing material is placed in the tumor. The most immediately available oxygen sensor is India ink, where two classes of carbon (carbon black and charcoal) have been identified as having acceptable paramagnetic properties for oximetry. While India ink has a long history of safe use in tattoos, a systematic research search regarding its safety for marking tissues for medical uses and an examination of the evidence that differentiates between ink based on charcoal or carbon black has not been conducted. Using systematic literature search techniques, we searched the PubMed and Food and Drug Administration databases, finding ~1000 publications reporting on adverse events associated with India/carbon based inks. The detailed review of outcomes was based on studies involving >16 patients, where the ink was identifiable as carbon black or charcoal. Fifty-six studies met these criteria. There were few reports of complications other than transient and usually mild discomfort and bleeding at injection, and there was no difference in charcoal vs. carbon black India ink. India ink was generally well tolerated by patients and physicians reported that it was easy to use in practice and used few resources. The risk is low enough to justify its use as an oxygen sensor in clinical practice.
MacDonald, Russell D; Thomas, Laura; Rusk, Frederick C; Marques, Shauna D; McGuire, Dan
Transport medicine personnel are potentially exposed to jet fuel combustion products. Setting-specific data are required to determine whether this poses a risk. This study assessed exposure to jet fuel combustion products, compared various engine ignition scenarios, and determined methods to minimize exposure. The Beechcraft King Air B200 turboprop aircraft equipped with twin turbine engines, using a kerosene-based jet fuel (Jet A-1), was used to measure products of combustion during boarding, engine startup, and flight in three separate engine start scenarios ("shielded": internal engine start, door closed; "exposed": ground power unit start, door open; and "minimized": ground power unit right engine start, door open). Real-time continuous monitoring equipment was used for oxygen, carbon dioxide, carbon monoxide, nitrogen dioxide, hydrogen sulfide, sulfur dioxide, volatile organic compounds, and particulate matter. Integrated methods were used for aldehydes, polycyclic aromatic hydrocarbons, volatile organic compounds, and aliphatic hydrocarbons. Samples were taken in the paramedic breathing zone for approximately 60 minutes, starting just before the paramedics boarded the aircraft. Data were compared against regulated time-weighted exposure thresholds to determine the presence of potentially harmful products of combustion. Polycyclic aromatic hydrocarbons, aldehydes, volatile organic compounds, and aliphatic hydrocarbons were found at very low concentrations or beneath the limits of detection. There were significant differences in exposures to particulates, carbon monoxide, and total volatile organic compound between the "exposed" and "minimized" scenarios. Elevated concentrations of carbon monoxide and total volatile organic compounds were present during the ground power unit-assisted dual-engine start. There were no appreciable exposures during the "minimized" or "shielded" scenarios. Air medical personnel exposures to jet fuel combustion products were
Bandari, Jathin; Schumacher, Kathy; Simon, Michelle; Cameron, Danielle; Goeschel, Christine A; Holzmueller, Christine G; Makary, Martin A; Welsh, Robert J; Berenholtz, Sean M
Briefings and debriefings, previously shown to be a practical and feasible strategy to improve interdisciplinary communication and teamwork in the operating room (OR), was then assessed as a strategy to prospectively surface clinical and operational defects in surgical care--and thereby prevent patient harm. A one-page, double-sided briefing and debriefing tool was used by surgical teams during cases at the William Beaumont Hospital Royal Oak (Royal Oak, Michigan) campus to surface clinical and operational defects during the study period (October 2006-May 2010). Defects were coded into six categories (with each category stratified by briefing or debriefing period) during the first six months, and refinement of coding resulted in expansion to 16 defect categories and no further stratification. A provider survey was used in January 2008 to interview a sample of 40 caregivers regarding the perceived effectiveness of the tool in surfacing defects. The teams identified a total of 6,202 defects--an average of 141 defects per month--during the entire study period. Of 2,760 defects identified during the six-defect coding period, 1,265 (46%) surfaced during briefings, and the remaining 1,495 (54%) during debriefings. Equipment (48%) and communication (31%) issues were most prominent. Of 3,442 defects identified during the 16-defect coding period, the most common were Central Processing Department (CPD) instrumentation (22%) and Communication/Safety (15%). Overall, 70 (87%) of the 80 responses were in agreement that briefings were effective for surfacing defects, as were 59 (76%) of the 78 responses for debriefings. Briefings and debriefings were a practical and effective strategy to surface potential surgical defects in the operating rooms of a large medical center.
Ojeleye, Oluwagbemileke; Avery, Anthony J; Boyd, Matthew J
To evaluate the ability of electronic patient medication record (ePMR) systems used in community pharmacies in England to detect and alert users about clinical hazards, errors and other safety problems. Between September 2012 and November 2012, direct on-site observational data about the performance of ePMR systems were collected from nine sites. Twenty-eight scenarios were developed by consensus agreement between a general practitioner and two community pharmacists. Each scenario was entered into the ePMR system, and the results obtained from the assessment of six unique systems in nine sites, in terms of the presence or absence of an alert, were recorded onto a prespecified form. None of the systems produced the correct responses for all of the 28 scenarios tested. Only two systems provided an alert to penicillin sensitivity. No dose or frequency check was observed when processing a prescription for methotrexate. One system did not warn about nonsuitability of aspirin prescribed to a child of 14 years of age. In another system, it was not possible to record a patient's pregnancy status. None of the six systems provided any warning for diclofenac overdose, high initiation dose of morphine sulfate or significant dose increase. Only one of the systems did not produce any spurious alerts. The performance of the ePMR systems tested was variable and suboptimal. The findings suggest the need for minimum specifications and standards for ePMR systems to ensure consistency of performance. © 2014 The Authors. British Journal of Clinical Pharmacology published by John Wiley & Sons Ltd on behalf of The British Pharmacological Society.
Sawada, Rumi; Ito, Tomomi; Tsuchiya, Toshie
Several recent studies demonstrated the potential of bioengineering using somatic stem cells in regenerative medicine. Adult human mesenchymal stem cells (hMSCs) derived from bone marrow have the pluripotency to differentiate into cells of mesodermal origin, e.g., bone, cartilage, adipose, and muscle cells; they, therefore, have many potential clinical applications. On the other hand, stem cells possess a self-renewal capability similar to cancer cells. For safety evaluation of tissue engineered medical devices using normal hMSCs, in this study, we investigated the expression levels of several genes that affect cell proliferation in hMSCs during in vitro culture. We focused on the relationship between the hMSC proliferation and their transforming growth factor beta (TGFbeta) signaling during in vitro culture. The proliferation rate of hMSCs gradually decreased and cellular senescence was observed for about 3 months. The mRNA expressions of TGFbeta1, TGFbeta2, and TGFbeta receptor type I (TGFbetaRI) in hMSCs increased with the length of cell culture. The mRNA expressions of Smad3 increased, but those of c-myc and nucleostemin decreased with the length hMSCs were in in vitro culture. In addition, the expression profiles of the genes which regulate cellular proliferation in hMSCs were significantly different from those of cancer cells. In conclusion, hMSCs derived from bone marrow seldom underwent spontaneous transformation during 1-2 months in vitro culture for use in clinical applications. In hMSCs as well as in epithelial cells, growth might be controlled by the TGFbeta family signaling.
Tregunno, Deborah; Ginsburg, Liane; Clarke, Beth; Norton, Peter
Background As efforts to integrate patient safety into health professional curricula increase, there is growing recognition that the rate of curricular change is very slow, and there is a shortage of research that addresses critical perspectives of faculty who are on the ‘front-lines’ of curricular innovation. This study reports on medical, nursing and pharmacy teaching faculty perspectives about factors that influence curricular integration and the preparation of safe practitioners. Methods Qualitative methods were used to collect data from 20 faculty members (n=6 medical from three universities; n=6 pharmacy from two universities; n=8 nursing from four universities) engaged in medical, nursing and pharmacy education. Thematic analysis generated a comprehensive account of faculty perspectives. Results Faculty perspectives on key challenges to safe practice vary across the three disciplines, and these different perspectives lead to different priorities for curricular innovation. Additionally, accreditation and regulatory requirements are driving curricular change in medicine and pharmacy. Key challenges exist for health professional students in clinical teaching environments where the culture of patient safety may thwart the preparation of safe practitioners. Conclusions Patient safety curricular innovation depends on the interests of individual faculty members and the leveraging of accreditation and regulatory requirements. Building on existing curricular frameworks, opportunities now need to be created for faculty members to act as champions of curricular change, and patient safety educational opportunities need to be harmonises across all health professional training programmes. Faculty champions and practice setting leaders can collaborate to improve the culture of patient safety in clinical teaching and learning settings. PMID:24299734
Watkins, Terri; Whisman, Lynn; Booker, Pamela
Evaluate continuous vital sign surveillance as a tool to improve patient safety in the medical/surgical unit. Failure-to-rescue is an important measure of hospital quality. Patient deterioration is often preceded by changes in vital signs. However, continuous multi-parameter vital sign monitoring may decrease patient safety with an abundance of unnecessary alarms. Prospective observational study at two geographically disperse hospitals in a single hospital system. A multi-parameter vital sign monitoring system was installed in a medical/surgical unit in Utah and one in Alabama providing continuous display of SpO2, heart rate, blood pressure and respiration rate on a central station. Alarm thresholds and time to alert annunciations were set based on prior analysis of the distribution of each vital sign. At the end of 4 weeks, nurses completed a survey on their experience. An average alert per patient, per day was determined retrospectively from the saved vital signs data and knowledge of the alarm settings. Ninety-two per cent of the nurses agreed that the number of alarms and alerts were appropriate; 54% strongly agreed. On average, both units experienced 10·8 alarms per patient, per day. One hundred per cent agreed the monitor provided valuable patient data that increased patient safety; 79% strongly agreed. Continuous, multi-parameter patient monitoring could be performed on medical/surgical units with a small and appropriate level of alarms. Continuous vital sign assessment may have initiated nursing interventions that prevented failure-to-rescue events. Nurses surveyed unanimously agreed that continuous vital sign surveillance will help enhance patient safety. Nursing response to abnormal vital signs is one of the most important levers in patient safety, by providing timely recognition of early clinical deterioration. This occurs through diligent nursing surveillance, involving assessment, interpretation of data, recognition of a problem and meaningful
Myers, Jennifer S; Nash, David B
The Accreditation Council for Graduate Medical Education recently announced its Clinical Learning Environment Review (CLER) program, which is designed to catalyze and promote the engagement of physician trainees in health care quality and patient safety activities that are essential to the delivery of high-quality patient care in U.S. teaching hospitals. In this Commentary, the authors argue that a strong organizational culture in quality improvement and patient safety is a necessary foundation for resident engagement in these areas. They describe residents' influence via their social networks on the behaviors and attitudes of peers and other health care providers and highlight this as a powerful driver for culture change in teaching hospitals. They also consider some of the potential unintended consequences of the CLER program and offer strategies to avoid them. The authors suggest that the CLER program provides an opportunity for health care and graduate medical education leaders to closely examine organizational quality and safety culture and the degree to which their residents are integrated in these efforts. They highlight the importance of developing collaborative interprofessional strategies to reach common goals to improve patient care. By sharpening the focus on patient safety, supervision, professionalism, patient care transitions, and the overall quality of health care delivery in the clinical learning environment during residents' formative training years, the hope is that the CLER program will inspire a new generation of physicians who possess and value these skills.
... Preventing Strangulation and Entrapment Household Safety: Preventing Suffocation Internet Safety Kitchen: Household Safety Checklist Knowing Your Child's Medical History Lead Poisoning Leaving Your Child Home Alone Making ...
Jian, Hao; Fan, Zhang; Li-nong, Yu; Jie, Wang; Jun, Fei; Ping, Hao; Ya-wei, Shen; Yue-jin, Chang
Objective-Explore and research the application effect of medical security information engineering in the hospital. Methods-Based on the real examples of the medical security hidden danger, the transportation module system of medical security is set up. By the all survival cycle's theory and IOP modeling method, four modules of structure model are developed, which are disposal of medical hidden danger. Results-The medical information system is developed, which includes four-in-one modules of structure model of integrated medical security transportation system, disputes evaluation system, protocol handling system, medical case analysis and handling system. And it is applied in the implementation of hospital management. Conclusions-The application of the research in the implementation of hospital management can find security hidden danger of hospital timely, the objective existence of medical disputes problems timely. And it can solve medical disputes timely and appropriately, and achieve ideal result, which is worth popularizing and applying in the hospital management.
Ipatov, P L; Sorokin, A V; Basov, V I
The article deals with 15-year experience of medical and psychophysiologic service in Medical and Sanitary Establishment No. 156 and Balakovo nuclear power station on providing reliability of occupational activities for the station personnel.
Vasudevan, Vinod; Singh, Preeti; Basu, Samyajit
India has been slow in implementing a central emergency medical services (EMS) system across the country. "108 services" is one of the most popular services that is functional under the public-private partnership model. Limited available literature shows that despite access to services, many traffic crash victims are transported using private vehicles. The objective of this study is to understand the effectiveness of 108 services from a traffic safety perspective. A questionnaire survey is conducted to understand the awareness of EMS and their function. Using traffic-related fatalities as the dependent variable, a fixed effect panel data model is developed to analyze the effectiveness of the 108 services in improving the traffic safety. The results from the survey show that, in general, people are not aware of the 108 services. A majority of the population prefers taking victims to the hospital using their personal vehicles or any other vehicles available compared to calling an ambulance. Results from panel data analysis show that despite having an efficient system, these services failed to make significant improvement in the safety of road users in the states in which their services were subscribed. The lack of awareness of an important safety service is alarming. This could be a major reason for lower utilization of 108 services for transporting victims of traffic crashes. This article shows the importance of having efficient awareness campaigns to improve the efficiency of any similar programs that are aimed to enhance the safety of a region.
17a-Methyltestosterone (17MT) is used in U.S. aquaculture under an Investigational New Animal Drug exemption to produce male populations of tilapia. Efforts to gain FDA-approval include this Target Animal Safety study. A study was designed to determine its histological safety to tilapia when fed a...
Faulkner, Michele A
Parkinson's disease (PD) is among the most common of the neurodegenerative disorders. Treatment is primarily focused on correcting neurotransmitter imbalances. Several classes of medication are available for this purpose. A Medline search was performed to gather information about the safety of the medications approved for the treatment of the motor symptoms of PD. This was supplemented with additional articles obtained from online sources and information provided by the FDA and the manufacturers. The focus of this review is the side-effect and safety profiles of carbidopa/levodopa, dopamine agonists, selective monoamine oxidase inhibitors, catechol-o-methyltransferase inhibitors, anticholinergics and amantadine. Though serious side-effects may occur, as a group, the medications used for the treatment of PD motor symptoms tend to produce side-effects that are mild to moderate in nature, and that primarily reflect the focus on dopaminergic therapies. Care plans for Parkinson's patients should be approached based on the needs of the individual as disease presentation, lifestyle, level of disability, concurrent disease states and the presence of non-motor symptoms make each case unique. Patients and caregivers must have realistic expectations about the use of PD medications.
Van Dyk, J; Meghzifene, A
Purpose: The last few years have seen a significant growth of interest in the global radiation therapy crisis. Various organizations are quantifying the need and providing aid in support of addressing the shortfall existing in many low-to-middle income countries (LMICs). The Lancet Oncology Commission report (Lancet Oncol. Sep;16(10):1153-86, 2015) projects a need of 22,000 new medical physicists in LMICs by 2035 if there is to be equal access globally. With the tremendous demand for new facilities, equipment and personnel, it is very important to recognize quality and safety considerations and to address them directly. Methods: A detailed examination of quality and safety publications was undertaken. A paper by Dunscombe (Front. Oncol. 2: 129, 2012) reviewed the recommendations of 7 authoritative reports on safety in radiation therapy and found the 12 most cited recommendations, summarized in order of most to least cited: training, staffing, documentation/standard operating procedures, incident learning, communication/questioning, check lists, QC/PM, dosimetric audit, accreditation, minimizing interruptions, prospective risk assessment, and safety culture. However, these authoritative reports were generally based on input from high income contexts. In this work, the recommendations were analyzed with a special emphasis on issues that are significant in LMICs. Results: The review indicated that there are significant challenges in LMICs with training and staffing ranking at the top in terms quality and safety. Conclusion: With the recognized need for expanding global access to radiation therapy, especially in LMICs, and the backing by multiple support organizations, quality and safety considerations must be overtly addressed. While multidimensional, training and staffing are top priorities. The use of outdated systems with poor interconnectivity, coupled with a lack of systematic QA in high patient load settings are additional concerns. Any support provided to lower
Fogarty, G J; McKeon, C M
Medication errors are a leading cause of unintended harm to patients, both in Australia and internationally, and there is now a concerted attempt to identify and correct individual and workplace factors that encourage medication errors. The current study used structural equation modelling to measure organizational climate and to test a model with hypothesized links between climate and unsafe medication administration behaviours. The study also examined the possible mediating role of stress and morale. Data were collected from 176 nurses working in rural areas in Australia. The model provided a reasonable fit to the data with organizational climate accounting for 39% of the variance in individual distress, which in turn explained 7% of the variance in self-reported violations. The only variable that made a direct contribution to errors was violations, which accounted for 24% of the variance in medication errors. These findings highlight the importance of monitoring the state of the whole health system. Deficiencies at the organizational level affect the psychological well-being of hospital employees, and distressed employees are more likely to engage in substandard work practices that ultimately endanger the patients under their care.
The application of strong cryptography secures the integrity of medical data and their confidentiality during transmission. Encryption allows to use the Internet for the transmission of confidential medical data rendering an expensive specialised Internet like the DGN superfluous. By signing and timestamping medical records electronically their probative force is substantially improved in case of a law-suit.
Bamford, Thomas; Haindl, Cornelia; Cracknell, Alison
Problem Significant deficiencies exist in the knowledge and skills of medical students and residents around health care quality and safety. The theory and practice of quality and safety should be embedded into undergraduate medical practice so that health care professionals are capable of developing interventions and innovations to effectively anticipate and mitigate errors. Approach Since 2011, Leeds Medical School in the United Kingdom has used case study examples of nasogastric (NG) tube patient safety incidents within the undergraduate patient safety curriculum. In 2012, a medical undergraduate student approached a clinician with an innovative idea after undertaking an NG tubes root cause analysis case study. Simultaneously, a separate local project demonstrated low compliance (11.6%) with the United Kingdom’s National Patient Safety Agency NG tubes guideline for use of the correct method to check tube position. These separate endeavors led to interdisciplinary collaboration between a medical student, health care professionals, researchers, and industry to develop the Initial Placement Nasogastric Tube Safety Pack. Outcomes Human factors engineering was used to inform pack design to allow guideline recommendations to be accessible and easy to follow. A timeline of product development, mapped against key human factors and medical device design principles used throughout the process, is presented. The safety pack has since been launched in five UK National Health Service (NHS) hospitals, and the pack has been introduced into health care professional staff training for NG tubes. Next Steps A mixed-methods evaluation is currently under way in five NHS organizations. PMID:26579792
Taylor, Natalie; Bamford, Thomas; Haindl, Cornelia; Cracknell, Alison
Significant deficiencies exist in the knowledge and skills of medical students and residents around health care quality and safety. The theory and practice of quality and safety should be embedded into undergraduate medical practice so that health care professionals are capable of developing interventions and innovations to effectively anticipate and mitigate errors. Since 2011, Leeds Medical School in the United Kingdom has used case study examples of nasogastric (NG) tube patient safety incidents within the undergraduate patient safety curriculum. In 2012, a medical undergraduate student approached a clinician with an innovative idea after undertaking an NG tubes root cause analysis case study. Simultaneously, a separate local project demonstrated low compliance (11.6%) with the United Kingdom's National Patient Safety Agency NG tubes guideline for use of the correct method to check tube position. These separate endeavors led to interdisciplinary collaboration between a medical student, health care professionals, researchers, and industry to develop the Initial Placement Nasogastric Tube Safety Pack. Human factors engineering was used to inform pack design to allow guideline recommendations to be accessible and easy to follow. A timeline of product development, mapped against key human factors and medical device design principles used throughout the process, is presented. The safety pack has since been launched in five UK National Health Service (NHS) hospitals, and the pack has been introduced into health care professional staff training for NG tubes. A mixed-methods evaluation is currently under way in five NHS organizations.
Karl, Edward H.; Curro, Frederick A.
Introduction Antibiotics are a class of medications widely used by dentists. The class of agents has a number of listed side effects. This case report details an unusual adverse effect of tetracycline-induced psychosis recognized due to the diligence of a practitioner. To our knowledge, this is the first reported case by a dentist. Case Presentation A 44-year-old patient was started on tetracycline therapy for prophylaxis before a periodontal procedure. The patient began having paranoid and psychotic experiences. The patient sought psychiatric medical care and was diagnosed with tetracycline-induced psychosis. He was treated with an antipsychotic drug, which resolved his symptoms. Conclusion Dental medical histories are a resource that is underused and can often be of value in the continual assessment of drug safety and pharmacovigilance. PMID:26146592
Jiménez Ruiz, Carlos A; Ramos Pinedo, Angela; Cicero Guerrero, Ana; Mayayo Ulibarri, Marisa; Cristobal Fernández, Maribel; Lopez Gonzalez, Gema
Smoking is the main cause of chronic obstructive pulmonary disease (COPD), and smoking cessation is the only treatment shown to be effective in arresting the progression of COPD. Different epidemiological and population-based studies have shown smokers with COPD to have specific smoking characteristics that differentiate them from the rest of smokers and which complicate smoking cessation. The main objective of this study is to analyze the effectiveness and safety of drug treatments for smoking cessation in smokers with severe or very severe COPD. Smokers with severe or very severe COPD (Global Initiative for Chronic Obstructive Lung Disease stages III and IV) received treatment for smoking cessation. The treatment program consisted of a combination of behavioral therapy and drug treatment. Patients were followed up at 1, 2, 4, 6, 8, 10, 12, 18, and 24 weeks after the quit date. Four hundred seventy-two patients were seen, 65% were male, and their mean age was 58.3 (9.8). They smoked an average of 29.7 (13.4) cigarettes/day, and their mean Fagerström test for nicotine dependence score was 7.4 (2.1). Continuous abstinence rate from 9 to 24 weeks (CAR 9-24) was 48.5%. According to type of treatment used, CAR 9-24 for nicotine replacement therapy (NRT), bupropion, and varenicline were 38.2%, 55.6%, and 58.3%, respectively. Varenicline was more effective than nicotine patches: 61% versus 44.1% (odds ratio: 1.98; 95% CI: 1.25-3.12; p = .003). NRT was the treatment producing the fewest adverse effects. The onset of psychiatric symptoms due to medication was rare and evenly distributed across groups. This study shows that smokers with severe or very severe COPD are predominantly males with a high degree of physical dependence upon nicotine. CAR 9-24 was 48.5%. Varenicline and bupropion yielded higher abstinence rates than NRT. Varenicline was more effective than nicotine patches: all types of treatments were safe.
Hamad, Anas; Cavell, Gillian; Wade, Paul; Hinton, James; Whittlesea, Cate
Medication incidents (MIs) account for 11.3 % of all reported patient-safety incidents in England and Wales. Approximately one-third of inpatients are prescribed an antibiotic at some point during their hospital stay. The WHO has identified incident reporting as one solution to reduce the recurrence of adverse incidents. The aim of this study was to determine the number and nature of reported antibiotic-associated MIs occurring in inpatients and to use defined daily doses (DDDs) to calculate the incident rate for the antibiotics most commonly associated with MIs at each hospital. Two UK acute NHS teaching hospitals. Retrospective quantitative analysis was performed on antibiotic-associated MIs reported to the risk management system over a 2-year period. Quality-assurance measures were undertaken before analysis. The study was approved by the clinical audit departments at both hospitals. Drug consumption data from each hospital were used to calculate the DDD for each antibiotic. The number of antibiotic-related MIs reported and the incident rate for the 10 antibiotics most commonly associated with MIs at each hospital. Healthcare staff submitted 6,756 reports, of which 885 (13.1 %) included antibiotics. This resulted in a total of 959 MIs. Most MIs occurred during prescribing (42.4 %, n = 407) and administration (40.0 %, n = 384) stages. Most common types of MIs were omission/delay (26.3 %, n = 252), and dose/frequency (17.9 %, n = 172). Penicillins (34.5 %, n = 331) and aminoglycosides (16.6 %, n = 159) were the most frequently reported groups with co-amoxiclav (16.8 %, n = 161) and gentamicin (14.1 %, n = 135) the most frequently reported drugs. Using DDDs to assess the incident rate showed that cefotaxime (105.4/10,000 DDDs), gentamicin (25.7/10,000 DDDs) and vancomycin (23.7/10,000 DDDs) had the highest rates. This study highlights that detailed analysis of data from reports is essential in understanding MIs and developing strategies to prevent their recurrence
Hughes, Allen A.
Public safety can be enhanced through the development of a comprehensive medical device risk management. This can be accomplished through case studies using a framework that incorporates cost-benefit analysis in the evaluation of risk management attributes. This paper presents a framework for evaluating the risk management system for regulatory Class III medical devices. The framework consists of the following sixteen attributes of a comprehensive medical device risk management system: fault/failure analysis, premarket testing/clinical trials, post-approval studies, manufacturer sponsored hospital studies, product labeling, establishment inspections, problem reporting program, mandatory hospital reporting, medical literature surveillance, device/patient registries, device performance monitoring, returned product analysis, autopsy program, emergency treatment funds/interim compensation, product liability, and alternative compensation mechanisms. Review of performance histories for several medical devices can reveal the value of information for many attributes, and also the inter-dependencies of the attributes in generating risk information flow. Such an information flow network is presented as a starting point for enhancing medical device risk management by focusing on attributes with high net benefit values and potential to spur information dissemination.
Lunardi-Maia, Tânia; Schuelter-Trevisol, Fabiana; Galato, Dayani
To identify the profile of use of medication during the first trimester of pregnancy with emphasis on safety assessment and on the adoption of folic acid and ferrous sulfate by pregnant women attended at a Basic Health Unit in Brazil. This was a cross-sectional study nested in a cohort of pregnant women. Medications were classified according to the Anatomical Therapeutic Chemical (ATC), and their safety was evaluated according to the Food and Drug Administration (FDA) and the Brazilian Health Surveillance Agency (ANVISA). The adoption of ferrous sulfate and folic acid was investigated according to the protocol set forth by the Brazilian Ministry of Health. The survey included 212 pregnant women, 46.7% of whom were taking medications at the time of pregnancy diagnosis, and 97.6% used medication during the first trimester after diagnosis. The highest percentage of self-medication occurred before the beginning of prenatal care (64.9%). According to the FDA criteria, there was a high level of exposure to D and X risk drugs before the beginning of prenatal care (23.0%), which was also observed for drugs not recommended by ANVISA (36.5%). Of the surveyed sample, 32.5% did not follow the protocol of the Brazilian Ministry of Health. In all, 67.9% of pregnant women had inadequate drug exposure. There was a difference between the proportions of drugs used according to the ATC, and the main anatomical groups identified were the drugs that act on blood and blood-forming organs, and anti-infective medications for systemic use. When pregnancy was diagnosed, the use of a large number of medications that act on the genitourinary system and sex hormones (16.2%) was identified, such as oral contraceptives, a fact probably related to the percentage of unplanned pregnancies (67.0%), on the same occasion 4 pregnant women used folic acid and 3 used ferrous sulphate. The present results show that a large number of medications are used during pregnancy. Even if there was little exposure
Härkänen, Marja; Voutilainen, Ari; Turunen, Elina; Vehviläinen-Julkunen, Katri
The aim of this study is to evaluate the nature, quality and effectiveness of educational interventions designed to increase the medication administration skills and safety of registered nurses working in hospitals. A systematic review with meta-analysis. Intervention studies designed to increase the medication administration skills and safety of nurses, indexed in one or more databases (CINAHL, PubMed, Scopus, Cochrane, PsycInfo, or Medic), and published in peer-reviewed journals between January 2000 and April 2015. The nature of the interventions was evaluated by narrative analysis, the quality of studies was assessed using the Effective Public Health Practise Project Quality Assessment Tool and the effectiveness of the interventions was ascertained by calculating effect sizes and conducting a meta-analysis. A total of 755 studies were identified and 14 intervention studies were reviewed. Interventions differed by their nature, including traditional classroom training, simulation, e-learning, slide show presentations, interactive CD-ROM programme, and the use of posters and pamphlets. All interventions appeared to improve medication administration safety and skills based on original p-values. Only five studies reached strong (n=1) or moderate (n=4) quality ratings and one of them had to be omitted from the meta-analysis due unclear measures of dispersion. The meta-analysis favoured the interventions, the pooled effect size (Hedges' g) was large, 1.06. The most effective interventions were a blended learning programme including e-learning and a 60-min PowerPoint presentation. The least effective educational intervention, an interactive internet-based e-learning course, was reported in the study that achieved the only strong quality rating. It is challenging to recommend any specific intervention, because all educational interventions seem to have a positive effect, although the size of the effect greatly varies. In the future, studies sharing similar contents and
... Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications AGENCY... CONTACT: Nicole Wolanski, Center for Devices and Radiological Health, Food and Drug Administration, 10903......... Synapse NEURX DPS DIAPHRAGM PACING September 28, 2011. Biomedical, Inc.. SYSTEM. II. Electronic Access...
Holden, Richard J.
According to the human factors paradigm for patient safety, health care work systems and innovations such as electronic medical records do not have direct effects on patient safety. Instead, their effects are contingent on how the clinical work system, whether computerized or not, shapes health care providers' performance of cognitive work processes. An application of the human factors paradigm to interview data from two hospitals in the Midwest United States yielded numerous examples of the performance-altering effects of electronic medical records, electronic clinical documentation, and computerized provider order entry. Findings describe both improvements and decrements in the ease and quality of cognitive performance, both for interviewed clinicians and for their colleagues and patients. Changes in cognitive performance appear to have desirable and undesirable implications for patient safety as well as for quality of care and other important outcomes. Cognitive performance can also be traced to interactions between work system elements, including new technology, allowing for the discovery of problems with “fit” to be addressed through design interventions. PMID:21479125
Quinn, Michael T; Gunter, Kathryn E; Nocon, Robert S; Lewis, Sarah E; Vable, Anusha M; Tang, Hui; Park, Seo-Young; Casalino, Lawrence P; Huang, Elbert S; Birnberg, Jonathan; Burnet, Deborah L; Summerfelt, W Thomas; Chin, Marshall H
Safety net health centers (SNHCs), which include federally qualified health centers (FQHCs) provide primary care for underserved, minority and low income patients. SNHCs across the country are in the process of adopting the patient centered medical home (PCMH) model, based on promising early implementation data from demonstration projects. However, previous demonstration projects have not focused on the safety net and we know little about PCMH transformation in SNHCs. This qualitative study characterizes early PCMH adoption experiences at SNHCs. We interviewed 98 staff (administrators, providers, and clinical staff) at 20 of 65 SNHCs, from five states, who were participating in the first of a five-year PCMH collaborative, the Safety Net Medical Home Initiative. We conducted 30-45 minute, semi-structured telephone interviews. Interview questions addressed benefits anticipated, obstacles encountered, and lessons learned in transition to PCMH. Anticipated benefits for participating in the PCMH included improved staff satisfaction and patient care and outcomes. Obstacles included staff resistance and lack of financial support for PCMH functions. Lessons learned included involving a range of staff, anticipating resistance, and using data as frequent feedback. SNHCs encounter unique challenges to PCMH implementation, including staff turnover and providing care for patients with complex needs. Staff resistance and turnover may be ameliorated through improved health care delivery strategies associated with the PCMH. Creating predictable and continuous funding streams may be more fundamental challenges to PCMH transformation.
Liang, Bryan A; Mackey, Tim
The rapid changes in health care policy, embracing quality and safety mandates, have culminated in programs and initiatives under the Patient Protection and Affordable Care Act. To review the context of, and anticipated quality and patient safety mandates for, delivery systems, incentives under health care reform, and models for future accountability for outcomes of care. Assessment of the provisions of Patient Protection and Affordable Care Act, other reform efforts, and reform initiatives focusing on future quality and safety provisions for health care providers. Health care reform and other efforts focus on consumerism in the context of price. Quality and safety efforts will be structured using financial incentives, best-practices research, and new delivery models that focus on reaching benchmarks while reducing costs. In addition, patient experience will be a key component of reimbursement, and a move toward "retail" approaches directed at the individual patient may supplant traditional "wholesale" efforts at attracting employers. Quality and safety have always been of prime importance in medicine. However, in the future, under health care reform and associated initiatives, a shift in the paradigm of medicine will integrate quality and safety measurement with financial incentives and a new emphasis on consumerism.
Carling, Cheryl L L; Kirkehei, Ingvild; Dalsbø, Therese Kristine; Paulsen, Elizabeth
The objective was to find evidence to substantiate assertions that electronic applications for medication management in ambulatory care (electronic prescribing, clinical decision support (CDSS), electronic health record, and computer generated paper prescriptions), while intended to reduce prescribing errors, can themselves result in errors that might harm patients or increase risks to patient safety. Because a scoping search for adverse events in randomized controlled trials (RCTs) yielded few relevant results, we systematically searched nine databases, including MEDLINE, EMBASE, and The Cochrane Database of Systematic Reviews for systematic reviews and studies of a wide variety of designs that reported on implementation of the interventions. Studies that had safety and adverse events as outcomes, monitored for them, reported anecdotally adverse events or other events that might indicate a threat to patient safety were included. We found no systematic reviews that examined adverse events or patient harm caused by organizational interventions. Of the 4056 titles and abstracts screened, 176 full-text articles were assessed for inclusion. Sixty-one studies with appropriate interventions, settings and participants but without patient safety, adverse event outcomes or monitoring for risks were excluded, along with 77 other non-eligible studies. Eighteen randomized controlled trials (RCTs), 5 non-randomized controlled trials (non-R,CTs) and 15 observational studies were included. The most common electronic intervention studied was CDSS and the most frequent clinical area was cardio-vascular, including anti-coagulants. No RCTS or non-R,CTS reported adverse event. Adverse events reported in observational studies occurred less frequently after implementation of CDSS. One RCT and one observational study reported an increase in problematic prescriptions with electronic prescribing The safety implications of electronic medication management in ambulatory care have not been
Keller, James P
Before hospitals embrace new technologies, it's important that medical personnel agree on how best to use them. Likewise, hospitals must provide the support to operate these sophisticated devices safely. With this in mind, it's wise for hospitals to include medical device training in the procurement process. Moreover, purchasing professionals can play a key role in helping to increase the amount of user training for medical devices and systems. What steps should you take to help ensure that new medical devices are implemented safely? Here are some tips.
Faunce, Thomas Alured
• Expert evaluations of the safety, efficacy and cost-effectiveness of pharmaceutical and medical devices, prior to marketing approval or reimbursement listing, collectively represent a globally important public good. The scientific processes involved play a major role in protecting the public from product risks such as unintended or adverse events, sub-standard production and unnecessary burdens on individual and governmental healthcare budgets. • Most States now have an increasing policy interest in this area, though institutional arrangements, particularly in the area of cost-effectiveness analysis of medical devices, are not uniformly advanced and are fragile in the face of opposing multinational industry pressure to recoup investment and maintain profit margins. • This paper examines the possibility, in this context, of States commencing negotiations toward bilateral trade agreement provisions, and ultimately perhaps a multilateral Treaty, on safety, efficacy and cost-effectiveness analysis of pharmaceuticals and medical devices. Such obligations may robustly facilitate a conceptually interlinked, but endangered, global public good, without compromising the capacity of intellectual property laws to facilitate local product innovations. PMID:16569240
Thaçi, Diamant; Weisenseel, Peter; Philipp, Sandra; Rosenbach, Thomas; Rotterdam, Sebastian; Augustin, Matthias; Neureither, Marcus; Reich, Kristian
Safety and efficacy of fumaric acid esters (FAE) in patients with psoriasis requiring treated comorbidit condition were investigated. Data collected from 7 dermatology centers were used for a retrospective analysis of patients treated continuously with FAE for at least 6 weeks who required at least one medication for a comorbid condition. The records were analyzed at baseline and after 1, 3, 6, 12 and 24 months of therapy. Safety parameters were monitored and the severity of skin symptoms was assessed by 'Physician's Global Assessment' (PGA). A total of 69 patients with moderate to severe psoriasis and a mean duration of 27.4 months of continuous treatment were included in the study. In less than 5% were interactions between FAE and co-medications observed. Changes of hepatic, renal or hematological laboratory parameters were usually insignificant and required a modification of FAE treatment in less than 12% of the cases. The percentage of patients documented as markedly improved or clear was 61% after 6 months, 77% after 12 months, and 75% after 24 months of therapy. In patients with moderate to severe psoriasis on co-medications, FAE were effective and safe without any noteworthy drug interactions. © The Authors • Journal compilation © Blackwell Verlag GmbH, Berlin.
Faunce, Thomas Alured
Expert evaluations of the safety, efficacy and cost-effectiveness of pharmaceutical and medical devices, prior to marketing approval or reimbursement listing, collectively represent a globally important public good. The scientific processes involved play a major role in protecting the public from product risks such as unintended or adverse events, sub-standard production and unnecessary burdens on individual and governmental healthcare budgets. Most States now have an increasing policy interest in this area, though institutional arrangements, particularly in the area of cost-effectiveness analysis of medical devices, are not uniformly advanced and are fragile in the face of opposing multinational industry pressure to recoup investment and maintain profit margins. This paper examines the possibility, in this context, of States commencing negotiations toward bilateral trade agreement provisions, and ultimately perhaps a multilateral Treaty, on safety, efficacy and cost-effectiveness analysis of pharmaceuticals and medical devices. Such obligations may robustly facilitate a conceptually interlinked, but endangered, global public good, without compromising the capacity of intellectual property laws to facilitate local product innovations.
Rassen, Jeremy A; Schneeweiss, Sebastian
Distributed medical product safety monitoring systems such as the Sentinel System, to be developed as a part of Food and Drug Administration's Sentinel Initiative, will require automation of large parts of the safety evaluation process to achieve the necessary speed and scale at reasonable cost without sacrificing validity. Although certain functions will require investigator intervention, confounding control is one area that can largely be automated. The high-dimensional propensity score (hd-PS) algorithm is one option for automated confounding control in longitudinal healthcare databases. In this article, we discuss the use of hd-PS for automating confounding control in sequential database cohort studies, as applied to safety monitoring systems. In particular, we discuss the robustness of the covariate selection process, the potential for over- or under-selection of variables including the possibilities of M-bias and Z-bias, the computation requirements, the practical considerations in a federated database network, and the cases where automated confounding adjustment may not function optimally. We also outline recent improvements to the algorithm and show how the algorithm has performed in several published studies. We conclude that despite certain limitations, hd-PS offers substantial advantages over non-automated alternatives in active product safety monitoring systems.
Zahabi, Maryam; Kaber, David B; Swangnetr, Manida
The objectives of this study were to (a) review electronic medical record (EMR) and related electronic health record (EHR) interface usability issues, (b) review how EMRs have been evaluated with safety analysis techniques along with any hazard recognition, and (c) formulate design guidelines and a concept for enhanced EMR interfaces with a focus on diagnosis and documentation processes. A major impact of information technology in health care has been the introduction of EMRs. Although numerous studies indicate use of EMRs to increase health care quality, there remain concerns with usability issues and safety. A literature search was conducted using Compendex, PubMed, CINAHL, and Web of Science databases to find EMR research published since 2000. Inclusion criteria included relevant English-language papers with subsets of keywords and any studies (manually) identified with a focus on EMR usability. Fifty studies met the inclusion criteria. Results revealed EMR and EHR usability problems to include violations of natural dialog, control consistency, effective use of language, effective information presentation, and customization principles as well as a lack of error prevention, minimization of cognitive load, and feedback. Studies focusing on EMR system safety made no objective assessments and applied only inductive reasoning methods for hazard recognition. On the basis of the identified usability problems and structure of safety analysis techniques, we provide EMR design guidelines and a design concept focused on the diagnosis process and documentation. The design guidelines and new interface concept can be used for prototyping and testing enhanced EMRs. © 2015, Human Factors and Ergonomics Society.
Kozak, Mary Ann; Melton, Johnna R; Gernant, Stephanie A; Snyder, Margie E
Access and availability of unused and expired medication (UEM) due to improper disposal and storage is a serious issue, potentially leading to abuse and environmental concerns. To describe the extent of the UEM issue in Indiana (U.S. State), identify patient beliefs about UEM, and determine any association between those beliefs and various personal/demographic characteristics. A needs assessment was conducted among community pharmacy patients. A convenience sample of 200 patients from 15 community pharmacies that are part of a practice-based research network (PBRN) in Indiana completed a survey concerning UEM beliefs and behaviors from Feb-March, 2014. Approximately 40% of patients were aware of a UEM take-back location in their community, although only 15% had utilized a UEM take-back location. Seventy-seven percent of patients were willing to drive to a take-back location to return UEM. Particularly vulnerable populations lacking knowledge regarding UEM and access to proper disposal were identified. While states have made efforts to increase accessibility for UEM return, there remains a need for more disposal locations for both non-controlled and controlled medication. Copyright © 2016 Elsevier Inc. All rights reserved.
Crooks, Valorie A; Turner, Leigh; Cohen, I Glenn; Bristeir, Janet; Snyder, Jeremy; Casey, Victoria; Whitmore, Rebecca
Medical tourism involves patients' intentional travel to privately obtain medical care in another country. Empirical evidence regarding health and safety risks facing medical tourists is limited. Consideration of this issue is dominated by speculation and lacks meaningful input from people with specific expertise in patient health and safety. We consulted with patient health and safety experts in the Canadian province of British Columbia to explore their views concerning risks that medical tourists may be exposed to. Herein, we report on the findings, linking them to existing ethical and legal issues associated with medical tourism. We held a focus group in September 2011 in Vancouver, British Columbia with professionals representing different domains of patient health and safety expertise. The focus group was transcribed verbatim and analysed thematically. Seven professionals representing the domains of tissue banking, blood safety, health records, organ transplantation, dental care, clinical ethics and infection control participated. Five dominant health and safety risks for outbound medical tourists were identified by participants: (1) complications; (2) specific concerns regarding organ transplantation; (3) transmission of antibiotic-resistant organisms; (4) (dis)continuity of medical documentation and (5) (un)informed decision-making. Concern was expressed that medical tourism might have unintended and undesired effects upon patients' home healthcare systems. The individual choices of medical tourists could have significant public consequences if healthcare facilities in their home countries must expend resources treating postoperative complications. Participants also expressed concern that medical tourists returning home with infections, particularly antibiotic-resistant infections, could place others at risk of exposure to infections that are refractory to standard treatment regimens and thereby pose significant public health risks.
Crooks, Valorie A; Turner, Leigh; Cohen, I Glenn; Bristeir, Janet; Snyder, Jeremy; Casey, Victoria; Whitmore, Rebecca
Objectives Medical tourism involves patients’ intentional travel to privately obtain medical care in another country. Empirical evidence regarding health and safety risks facing medical tourists is limited. Consideration of this issue is dominated by speculation and lacks meaningful input from people with specific expertise in patient health and safety. We consulted with patient health and safety experts in the Canadian province of British Columbia to explore their views concerning risks that medical tourists may be exposed to. Herein, we report on the findings, linking them to existing ethical and legal issues associated with medical tourism. Design We held a focus group in September 2011 in Vancouver, British Columbia with professionals representing different domains of patient health and safety expertise. The focus group was transcribed verbatim and analysed thematically. Participants Seven professionals representing the domains of tissue banking, blood safety, health records, organ transplantation, dental care, clinical ethics and infection control participated. Results Five dominant health and safety risks for outbound medical tourists were identified by participants: (1) complications; (2) specific concerns regarding organ transplantation; (3) transmission of antibiotic-resistant organisms; (4) (dis)continuity of medical documentation and (5) (un)informed decision-making. Conclusions Concern was expressed that medical tourism might have unintended and undesired effects upon patients’ home healthcare systems. The individual choices of medical tourists could have significant public consequences if healthcare facilities in their home countries must expend resources treating postoperative complications. Participants also expressed concern that medical tourists returning home with infections, particularly antibiotic-resistant infections, could place others at risk of exposure to infections that are refractory to standard treatment regimens and thereby pose
Ilev, Ilko K.; Walker, Bennett; Calhoun, William; Hassan, Moinuddin
Biophotonics is an emerging field in modern biomedical technology that has opened up new horizons for transfer of state-of-the-art techniques from the areas of lasers, fiber optics and biomedical optics to the life sciences and medicine. This field continues to vastly expand with advanced developments across the entire spectrum of biomedical applications ranging from fundamental "bench" laboratory studies to clinical patient "bedside" diagnostics and therapeutics. However, in order to translate these technologies to clinical device applications, the scientific and industrial community, and FDA are facing the requirement for a thorough evaluation and review of laser radiation safety and efficacy concerns. In many cases, however, the review process is complicated due the lack of effective means and standard test methods to precisely analyze safety and effectiveness of some of the newly developed biophotonics techniques and devices. There is, therefore, an immediate public health need for new test protocols, guidance documents and standard test methods to precisely evaluate fundamental characteristics, performance quality and safety of these technologies and devices. Here, we will overview our recent developments of novel test methodologies for safety and efficacy evaluation of some emerging biophotonics technologies and medical devices. These methodologies are based on integrating the advanced features of state-of-the-art optical sensor technologies and approaches such as high-resolution fiber-optic sensing, confocal and optical coherence tomography imaging, and infrared spectroscopy. The presentation will also illustrate some methodologies developed and implemented for testing intraocular lens implants, biochemical contaminations of medical devices, ultrahigh-resolution nanoscopy, and femtosecond laser therapeutics.
de Feijter, Jeantine M; de Grave, Willem S; Hopmans, Esther M; Koopmans, Richard P; Scherpbier, Albert J J A
Patient safety has become an important topic over the last decade and has also been increasingly implemented in the undergraduate curriculum. However, the best timing and method of teaching still remains to be decided. To develop and evaluate a patient safety course for final-year students. The course is based on reflective learning and personal experiences to improve the transfer of theory into practice. We performed a mixed method evaluation study of the course. An evaluation questionnaire and the number of completed incident report cards were analyzed using descriptive statistics. Focus groups, organized two and four weeks after the course, were analyzed using template analysis; the Theory of Planned Behaviour (TPB) was used to interpret the results. Students found the course overall instructive and reacted positively towards many elements of the course. Focus group analysis showed that an increase in knowledge about patient safety topics resulted in a change of attitudes towards these subjects and in an increase in awareness of patient safety. This influenced students' behavioral intention and their behavior. A course based on students' personal experiences enables them to transfer theory on patient safety issues into their own practice and has an effect on their awareness, attitudes and behavior. This could have a large impact on their future role as resident.
Williams, Steven David; Phipps, Denham L; Ashcroft, Darren
To assess the effect of factors within hospital pharmacists' practice on the likelihood of their reporting a medication safety incident. Theory of planned behaviour (TPB) survey. Twenty-one general and teaching hospitals in the North West of England. Two hundred and seventy hospital pharmacists (response rate = 45%). Hospital pharmacists were invited to complete a TPB survey, based on a prescribing error scenario that had resulted in serious patient harm. Multiple regression was used to determine the relative influence of different TPB variables, and participant demographics, on the pharmacists' self-reported intention to report the medication safety incident. The TPB variables predicting intention to report: attitude towards behaviour, subjective norm, perceived behavioural control and descriptive norm. Overall, the hospital pharmacists held strong intentions to report the error, with senior pharmacists being more likely to report. Perceived behavioural control (ease or difficulty of reporting), Descriptive Norms (belief that other pharmacists would report) and Attitudes towards Behaviour (expected benefits of reporting) showed good correlation with, and were statistically significant predictors of, intention to report the error [R = 0.568, R(2) = 0.323, adjusted R(2) = 0.293, P < 0.001]. This study suggests that efforts to improve medication safety incident reporting by hospital pharmacists should focus on their behavioural and control beliefs about the reporting process. This should include instilling greater confidence about the benefits of reporting and not harming professional relationships with doctors, greater clarity about what/not to report and a simpler reporting system. © The Author 2015. Published by Oxford University Press in association with the International Society for Quality in Health Care; all rights reserved.
Gatter, Mary; Cleland, Kelly; Nucatola, Deborah L.
Objective The aim of this study was to report on the safety and efficacy of an evidence-based medical abortion regimen utilizing 200 mg of mifepristone orally followed by home use of 800 mcg misoprostol buccally 24–48 h later through 63 days estimated gestational age. Study design We analyzed outcomes in women presenting for medical abortion between April 1, 2006, and May 31, 2011, using an evidence-based alternative to the United States Food and Drug Administration (FDA)-approved regimen. Cases were identified for this descriptive study from our electronic practice management (EPM) database, and our electronic database on adverse events was queried for information on efficacy and safety. The primary outcome was successful abortion. Logistic regression was used to identify predictors of successful abortion. Results Among the 13,373 women who completed follow-up, efficacy of the regimen was 97.7%. Efficacy was highest at 29 to 35 days (98.8%) and 36 to 42 days (98.8%) of gestation and lowest at 57 to 63 days (95.5%). The odds of needing aspiration for any reason were greatest at higher gestational ages. Rates of infection requiring hospitalization and rates of transfusion were 0.01 and 0.03%, respectively. Conclusions An evidence-based regimen of 200 mg of mifepristone orally followed by home use of 800 mcg of buccal misoprostol 24–48 h later is safe and effective through 63 days estimated gestational age. Further, the need for aspiration for any reason was low, and hospitalization was rare. Implications This study reinforces the safety and efficacy of the evidence-based regimen for medical abortion (200 mg mifepristone orally followed by home use of 800 mcg of misoprostol buccally 24–48 h later) through 63 days estimated gestational age, and contributes to the existing evidence against restrictions requiring use of the FDA-approved regimen. PMID:25592080
Farnan, Jeanne M; Gaffney, Sean; Poston, Jason T; Slawinski, Kris; Cappaert, Melissa; Kamin, Barry; Arora, Vineet M
Patient safety curricula in undergraduate medical education (UME) are often didactic format with little focus on skills training. Despite recent focus on safety, practical training in residency education is also lacking. Assessments of safety skills in UME and graduate medical education (GME) are generally knowledge, and not application-focused. We aimed to develop and pilot a safety-focused simulation with medical students and interns to assess knowledge regarding hazards of hospitalisation. A simulation demonstrating common hospital-based safety threats was designed. A case scenario was created including salient patient information and simulated safety threats such as the use of upper-extremity restraints and medication errors. After entering the room and reviewing the mock chart, learners were timed and asked to identify and document as many safety hazards as possible. Learner satisfaction was assessed using constructed-response evaluation. Descriptive statistics, including per cent correct and mean correct hazards, were performed. All 86 third-year medical students completed the encounter. Some hazards were identified by a majority of students (fall risk, 83% of students) while others were rarely identified (absence of deep venous thrombosis prophylaxis, 13% of students). Only 5% of students correctly identified pressure ulcer risk. 128 of 131 interns representing 49 medical schools participated in the GME implementation. Incoming interns were able to identify a mean of 5.1 hazards out of the 9 displayed (SD 1.4) with 40% identifying restraints as a hazard, and 20% identifying the inappropriate urinary catheter as a hazard. A simulation showcasing safety hazards was a feasible and effective way to introduce trainees to safety-focused content. Both students and interns had difficulty identifying common hazards of hospitalisation. Despite poor performance, learners appreciated the interactive experience and its clinical utility. Published by the BMJ Publishing
Zhang, Jian; Zhang, Min-Zhou; Kong, Xiang-Zhao
Along with the development of Chinese medicine and pharmacy (CMP), Chinese materia medica (CMM) has been used more and more widely at home and abroad. But we have to confront worsening problems such as lack of safety evidence, immature self -formulation technologies, lack of knowledge about their toxicities, and public misunderstanding, especially for patients with cardiovascular disease (CVD). Therefore, we cardiovascular physicians are requested improve knowledge for CMM preparations and their effects and side effects, supervise and identify the interactions between CMM and Westem medicine. Meanwhile, the researchers are also requested to assess the safety and efficacy of CMM through rigorous experimental des