Medication Safety Information Research Articles

Predictors of Using Pharmacists as a Medication Safety Information Resource Among Women of Reproductive Age.

Medication use during pregnancy is prevalent with notable increases in the use of over-the-counter medications. In this era of information proliferation, it is important to understand where women of reproductive age obtain information on medication safety. The main objective of this study was to determine the predictive factors associated with the utilization of pharmacists as a medication information safety resource among reproductive age women. A cross-sectional evaluation of baseline characteristics, collected during an online knowledge intervention study, was conducted among women aged 18-44 who were living in the United States in 2018 to 2019. Descriptive statistics for all study variables were estimated. Logistic regression analyses were done to assess the predictors of the utilization of pharmacists as a medication safety resource. A total of 210 women of reproductive age were included in the study. The average age was 32.4 ± 6.5 years and the majority were White (69.5%), married (61.4%), and had at least a high school education level (86%). Fifty four percent of participants reported using pharmacists as a medication safety information resource. Findings from the multivariable analyses showed that women who reported difficulty understanding written medical information (p = 0.018) and those who were Black or African American (p = 0.008) had less odds of utilizing pharmacists as a medication information source. Despite pharmacists being one of the most accessible health care professionals on medication information, only 54.3% of women surveyed utilized them as medication information sources. It was also found that women who had difficulty understanding written information and those who were Black or African American were less likely to utilize pharmacists as a medication safety information resource. Findings show opportunities for pharmacists to increase perceived value as medication safety experts among women of childbearing age. Additional studies need to be conducted given the study's limited generalizability.

Drug-related problems among breastfeeding patients treated for depressive spectrum disorders.

Depressive spectrum disorders are common and can hinder breastfeeding success. While medications typically pose minimal risk, the concerns persist. This is the first study that investigates the prevalence and characteristics of drug-related problems among breastfeeding mothers with depressive spectrum disorders. We analyzed those problems to understand their nature, severity, and contributing factors. Additionally, we evaluated the outcomes of pharmacist-led interventions in reducing them. Understanding drug-related problems is crucial for informing evidence-based practices to optimize both maternal mental health and breastfeeding success. This prospective observational study was conducted at a specialized pharmacy office in Poznan, Poland, which focuses on lactation support and medication consultations. 47 breastfeeding patients were enrolled. Pharmaceutical consultations were conducted according to Joint Commission of Pharmacy Practitioners Pharmacists' Patient Care Process standards. Novel MILC Questionnaire was used for efficient and optimal pharmaceutical interview. Drug-related problems were assessed basing on PCNE Classification System version 9.1. For adverse events in lactation, MedDRA v27 nomenclature was used; for causality, Naranjo Scale and LCAT were utilized. CTCAE was used for grading. Among the 47 patients, pharmacist identified 49 medication-related problems, with inadequate treatment effect due to underdosing or not taking the medication at all being the most common (57.1%). Pharmacist interventions focused on medication safety information and counseling. Overall, 78.7% of patients accepted these interventions, resulting in problem resolution for 71.4%. Twelve mothers (25.5%) reported adverse events in their infants, but after causality evaluation, only four (8.5%) might have been linked to maternal medication. None required medical intervention beyond one hospitalization for a serious adverse event possibly connected to maternal medication. The study identified high rates of drug-related problems among breastfeeding mothers with depression, primarily due to non-adherence. Pharmacist interventions significantly improved DRP outcomes. Adverse events were reported, but most were mild and did not require intervention. Our findings suggest that lactating mothers with depressive spectrum disorders may benefit from pharmacist-led support to optimize treatment adherence and address medication safety concern.

Analysis and reflection on current situation of Chinese patent medicine for children in China

This study took Chinese patent medicine for children included in Chinese Pharmacopoeia(2020 edition and the first supplement), Medicine Catalogue for National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance(2022 edition), and National Essential Medicines List(2018 edition) as the research objects, so as to sort out the distribution situation, characteristics, and the problems of Chinese patent medicine for children(including child-specific medicines, common medicines for children and adults, and discretionary medicines for children). According to statistics and summary, Chinese patent medicine for children is mainly administered orally, and the dosage forms are mostly traditional dosage forms, such as tablets, granules, capsules, and oral liquids, with mostly bitter or sweet taste. Diseases are mainly classified into pulmonary diseases and spleen and stomach diseases, and varieties of medication without Children's medication safety information or "still unclear" account for a relatively large proportion of the medicines. There are relatively few varieties of Chinese patent medicines for children, poor compliance of child-specific medication, lack of refinement of Chinese patent medicines for children dosage, and lack of information about safe use of medication. It is recommended to update and improve the instruction manuals in a timely manner, develop new varieties of Chinese patent medicine for children, and actively carry out post-marketing evaluation and clinical comprehensive evaluation of Chinese patent medicine for children, so as to provide a reference for the supplement and improvement of the instructions, the comprehensive improvement, the formulation of the catalogue, and the research and development of new Chinese patent medicine for children and ensure the use of medicines for children.

Infant Exposure to Armodafinil Through Human Milk Following Maternal Use of Modafinil.

Narcolepsy, a condition adversely affecting psychological, social, and cognitive function, is more prevalent in females of childbearing age than the general population. Modafinil and armodafinil are central nervous system stimulants approved for treatment of narcolepsy. Infant exposure to these agents through human milk has not been investigated. Poor quality medication safety information during lactation is associated with early cessation of breastfeeding and suboptimal healthcare for the breastfeeding family. In this case study, we measured the concentration of armodafinil (the most active form of modafinil) in human milk and infant plasma to quantify infant exposure. The participant was a 30-year-old primipara with narcolepsy, taking modafinil (300 mg morning, 100 mg noon) while breastfeeding her 6-week-old infant despite the paucity of safety information. Armodafinil concentrations were measured in eight serial human milk samples collected over a 26-hr period and in single maternal and infant plasma samples using ultra performance liquid chromatography - tandem mass spectrometry. The average concentration of armodafinil in human milk was 1.96 mg/L; the relative infant dose was 4.85%; the theoretical infant dose was 0.294 mg/kg/day. Maternal and infant plasma concentrations of armodafinil were 12.02 mg/L and 0.19 mg/L, respectively. The participant continued to exclusively breastfeed the infant, who had normal growth and development. Based on these findings, relatively small amounts of armodafinil pass into human milk, with consequent limited infant exposure. Consideration can be given to the use of modafinil or armodafinil during breastfeeding, provided the infant is monitored. Further studies are needed to confirm these findings.

Publication ethics: Patient consent for publishing case reports of adverse drug reactions is important yet absent from several recent manuscripts

Case reports of adverse drug reactions (ADRs) constitute an important source of medication safety information. Detailed description of patients in such reports could potentially make subjects identifiable, thereby emphasizing the importance of consent for publication. The Committee on Publication Ethics and the International Committee of Medical Journal Editors recommend obtaining patient consent prior to publishing potentially identifiable patient information. However, this report shows absence of information regarding patient consent for publication from several recently-published ADR case reports. A sample of 100 most-recent ADR case reports with free full-text indexed in PubMed was qualitatively reviewed for information regarding publication consent and other ethical disclosures. Of the 100 most-recently-published ADR case reports, only 52 (52%) manuscripts clearly described obtaining patient consent for publication. Thirty-seven (37%) manuscripts made no mention of such consent or approval from an ethics committee. Eleven (11%) manuscripts contained ethical disclosures such as patient consent to undergo treatment and study approval from an institutional ethics committee, but without a clear statement regarding patient consent for publication. A significant number of recently-published ADR case reports do not clearly describe if patient consent for publication was obtained. This could be attributable to various factors, including lack of clarity in journals’ guidelines regarding publication consent for case reports and dilemma regarding what constitutes identifiable patient information. This report calls for diligence of all stakeholders involved in medical manuscript publishing, viz. authors, manuscript reviewers, editors, and journal publishers to ensure that information regarding patient consent for publication is properly disclosed in ADR case reports.

Classification of Skin Injury Risk Caused by Extravasation of Electrolyte Solutions or Infusions in a Rat Model.

Cytotoxic agents are classified according to the severity of skin injury after extravasation. However, injuries caused by extravasation of noncytotoxic agents have not been sufficiently investigated, although the risk of extravasation is mentioned in medical safety information published by the Japan Council for Quality Health Care. Therefore, in this study, we focused on noncytotoxic electrolyte solutions and infusions and evaluated skin injuries during leakage using extravasation model rats. Rats were anesthetized and intradermally injected with 100 µL of an electrolyte solution or infusion. Injection lesions were macroscopically and histopathologically evaluated for extravasation injuries. Each electrolyte solution and infusion were classified into three categories (vesicants, irritants, and non-tissue-damaging agents) depending on the degree of skin injury. Similar to saline, 0.3% potassium chloride and 0.6% magnesium sulfate showed almost no injury, and 3% sodium chloride and BFLUID® caused erythema and induration. Erythema, induration, and ulceration were observed with the following: 10% sodium chloride, 2% calcium chloride, 8.5% calcium gluconate, 12.3% magnesium sulfate, MAGSENT®, FESIN®, and Intralipos®. The duration of damage with these agents was markedly prolonged. Electrolyte solutions and infusions can be classified into vesicants (10% sodium chloride, 2% calcium chloride, 8.5% calcium gluconate, 12.3% magnesium sulfate, MAGSENT®, FESIN®, and Intralipos®), irritants (3% sodium chloride and BFLUID®), and non-tissue-damaging agents (0.3% potassium chloride and 0.6% magnesium sulfate) according to their composition. The characteristic symptoms and severity of each drug extravasation revealed in this study will provide basic information for preparation of guidelines for treatment of extravasation.

Assessment of medication adherence, medication safety awareness and medication practice among patients with lung cancer: A multicentre cross-sectional study.

ObjectivesWe aimed to explore the current status of medication adherence, safety awareness and practice among patients with lung cancer.MethodsWe conducted a questionnaire‐guided cross‐sectional study in Xi'an, Yulin, Hanzhong and Weinan in Shaanxi Province, China, from April to June 2021 for a period of 3 months. The study questionnaire was developed according to previous related studies reported in the literature, and includes basic demographic information and patients' medication safety questions. The data were double‐entered using EpiData 3.1 software; descriptive statistics, t‐test, analysis of variance, the Kruskal–Wallis test and the Mann–Whitney U‐test were performed to analyse the data.ResultsA total of 567 participants were included, and 409 valid questionnaires were finally completed, with an effective response rate of 72.13%. More than 80% of patients showed good medication adherence; the average adherence score was 22 ± 2.68 of 25. The average score for medication safety awareness was 16.40 ± 4.41, which was significantly lower than that of medication adherence (p < .001). Only 22.74% of patients always checked their medicines before a nurse administered them; 17.60% of patients never checked their medicines. Few patients actively consulted an health care professional to understand safety information before taking a medication. A significant difference existed in safety awareness scores among age groups (p = .039) and geographic regions (p < .001). Patients with three or more comorbidities had the lowest awareness scores (p = .027).ConclusionWe found that patients with lung cancer showed better medication adherence, but their awareness about medication safety was poor. Older patients, those with comorbidities and patients in regions with poor medical resources may have worse awareness about safety. Current medication education for patients should not only aim to improve adherence but should also encourage patients to take greater responsibility for their own safety and to actively participate in their medication safety. Greater systematic and individualized medication safety information is needed for older patients, those with more comorbidities and patients in areas with poor medical resources.Patient ContributionWe conducted a questionnaire‐guided cross‐sectional study on hospitalized lung cancer patients in Shaanxi Province to explore the patients' practices related to safety medication, including medication adherence and medication safety awareness.

The establishment of the Korean medical device safety information monitoring center: Reviewing ten years of experience

Medical devices may revolutionize healthcare delivery but can lead to serious adverse events for treated patients and users. While reporting of adverse events related to medical devices is an essential starting point for post-market surveillance, underreporting of medical device adverse events is a global problem. Korea introduced a voluntary medical device adverse event reporting system in 2010, called the Medical Device Safety Information Monitoring Center, which has led to an increase in adverse event reports. For 10 years, the Medical Device Safety Information Monitoring Center has analyzed medical device adverse events systematically and has provided active feedback to the manufacturers and education on safe use. Recently, the Medical Device Safety Information Monitoring Center contributed to harmonization of international medical device vigilance through the sharing of adverse events. This experience of Korea might contribute to improvements in medical device vigilance, which is a critical prerequisite for improving medical device policies and regulations.

Categorization of Medication Safety Errors in Ambulatory Electronic Health Records

Preventable medication errors continue to affect the quality and consistency in the delivery of care. While numerous studies on medication safety have been performed in the inpatient setting, a review of ambulatory patient safety by the American Medical Association found that medication safety errors were the most frequent safety problems in the outpatient arena. The leading cause of ambulatory safety problems, adverse drug events (ADEs), are common, with estimates of more than 2 million ADEs each year in the ambulatory Medicare population alone, and these events are frequently preventable. We conducted an environmental scan that allowed us to create our own categorization schema of medication safety errors in electronic healthcare records (EHRs) found in the outpatient setting and observed which of these were additionally supported in the literature. This study combines data from the California Hospital Patient Safety Organization (CHPSO), with several key articles in the area of medication errors in the EHR era. Method: To best utilize the various EHR ambulatory medication events submitted into CHPSO’s database, we chose to create a framework to bucket the near misses or adverse events (AEs) submitted to the database. This newly created categorization scheme was based on our own drafted categorization labels of events, after a high-level review, and from two leading articles on physician order entry. Additionally, we conducted a literature review of computerized provider order entry (CPOE) medication errors in the ambulatory setting. Within the newly created categorization scheme, we organized the articles based on issues addressed so we could see areas that were supported by the literature and what still needed to be researched. Results: We initially screened the CHPSO database for ambulatory safety events and found 25,417 events. Based on those events, an initial review was completed, and 19,242 events were found in the “Medication or Other Substance” and “Other” categories, in which the EHR appeared to have been a potential contributing factor. This review identified a subset of 2,236 events that were then reviewed. One hundred events were randomly selected for further review to identify common categories. The most common categories in which errors occurred were orders in order sets and plans (n=12) and orders crossing or not crossing encounters (n=12), incorrect order placed on correct patient (n=10), orders missing (n=8), standing orders (n=8), manual data entry errors (n=6), and future orders (n=6). Conclusion: There were several common themes seen in this analysis of ambulatory medication safety errors related to the EHR. Common among them were incorrect orders consisting of examples such as dose errors or ordering the wrong medication. The manual data entry errors consisted of height or weight being entered incorrectly or entering the wrong diagnostic codes. Lastly, different sources of medication safety information demonstrate a diversity of errors in ambulatory medication safety. This confirms the importance of considering more than one source when attempting to comprehensively describe ambulatory medication safety errors.

Prenatal medication use in a prospective pregnancy cohort by pre-pregnancy obesity status

Background The association between obesity (body mass index (BMI) ≥ 30 kg/m2) and pattern of medication use during pregnancy in the United States is not well-studied. Higher pre-pregnancy BMI may be associated with increases or decreases in medication use across pregnancy as symptoms (e.g. reflux) or comorbidities (e.g. gestational diabetes) requiring treatment that may be associated with higher BMI could also change with advancing gestation. Objectives To determine whether prenatal medication use, by the number and types of medications, varies by pre-pregnancy obesity status. Methods In a secondary data analysis of a racially/ethnically diverse prospective cohort of pregnant women with low risk for fetal abnormalities enrolled in the first trimester of pregnancy and followed to delivery (singleton, 12 United States clinical sites), free text medication data were obtained at enrollment and up to five follow-up visits and abstracted from medical records at delivery. Results In 436 women with obesity and 1750 women without obesity (pre-pregnancy BMI, 19–29.9 kg/m2), more than 70% of pregnant women (77% of women with and 73% of women without obesity) reported taking at least one medication during pregnancy, respectively (adjusted risk ratio (aRR)=1.10, 95% confidence interval (CI)=1.01, 1.20), with 81% reporting two and 69% reporting three or more. A total of 17 classes of medications were identified. Among medication classes consumed by at least 5% of all women, the only class that differed between women with and without obesity was hormones and synthetic substitutes (including steroids, progesterone, diabetes, and thyroid medications) in which women with obesity took more medications (11 vs. 5%, aRR = 1.9, 95% CI = 1.38, 2.61) compared to women without obesity. Within this class, a higher percentage of women with obesity took diabetes medications (2.3 vs. 0.7%) and progesterone (3.4 vs. 1.3%) than their non-obese counterparts. Similar percentages of women with and without obesity reported consuming medications in the remaining medication classes including central nervous system agents (50 and 46%), gastrointestinal drugs (43 and 40%), anti-infective agents (23 and 21%), antihistamines (20 and 17%), autonomic drugs (10 and 9%), and respiratory tract agents (7 and 6%), respectively (p > 0.05 for all adjusted comparisons). There were no differences in medication use by obesity status across gestation. Since the study exclusion criteria limited the non-obese group to women without thyroid disease, in a sensitivity analysis we excluded all women who reported thyroid medication intake and still a higher proportion of women with obesity took the hormones and synthetic substitutes class compared to women without obesity. Conclusion Our findings suggest that pre-pregnancy obesity in otherwise healthy women is associated with a higher use of only selected medications (such as diabetes medications and progesterone) during pregnancy, while the intake of other more common medication types such as analgesics, antibiotics, and antacids does not vary by pre-pregnancy obesity status. As medication safety information for prenatal consumption is insufficient for many medications, these findings highlight the need for a more in-depth examination of factors associated with prenatal medication use.

Obstetrician-Gynecologist Views of Pregnancy-Related Medication Safety.

Background: Medication use among pregnant women is widespread, despite limited evidence about the teratogenicity of most medications. Improved physician-patient communication about pregnancy-related medication safety has been identified as a strategy to address this critical issue; however, little is known about physicians' knowledge, attitudes, and practices that could inform tools for information access and sharing to support such communication. The primary objective of this study is to address gaps in what is known about obstetrician-gynecologist views, practices, and needs related to accessing and sharing pregnancy-related medication safety information with patients. Materials and Methods: The basis for this study is a nationally representative, randomized survey of 506 practicing obstetrician-gynecologists. The survey was completed by mail or online between October 26, 2015 and May 8, 2016 with a 52% response rate. Data were weighted to population parameters to reduce the risk of potential nonresponse biases. Analyses included univariate distributions and comparisons between physicians in different residency cohorts using all-pairs dependent t-tests. Results: Findings point to critical features of obstetrician-gynecologist access and sharing of medication safety information. Obstetrician-gynecologists often retrieve medication safety information during a clinical visit. There is widespread provision of potentially problematic "safe lists" to patients, particularly by younger cohorts, and limited counseling for reproductive-aged patients not actively planning a pregnancy. Conclusions: To improve clinical care, physician-patient communication may be enhanced with technical and policy solutions, including improved digital information tools for retrieving and discussing information in the clinical setting; evidence-based, written information for physicians to share with patients; and encouragement for counseling all women of reproductive age receiving teratogenic medications.

Statistics and Analysis of 136 Cases of Adverse Events of International Medical Devices

To explore the law and characteristics of adverse events of medical devices and to provide research methods and basis for reducing the recurrence of similar adverse events, we collect medical devices safety information from five representative countries in the world, and make statistics and analysis on the types of events, the types of management and the causes of events. The results show that among 136 serious adverse events, the top three causes of recall are product design factors, software factors, and component defects. In order to reduce the application risk of medical devices, it is suggested that product designers, operating users and medical institutions should correctly implement the monitoring and evaluation system of medical devices.

How to Identify Organizational High-Alert Medications.

High-alert medications may cause significant patient harm when used in error. Hospital-specific safety data should be used to customize high-alert medication lists to fit the local context. The aim of this study was to identify organizational high-alert medications by evaluating university hospital's data on adverse drug reaction (ADR) and medication error (ME). The Anatomical Therapeutic Chemical (ATC) codes and top active substances in ADR (n = 401) and ME (n = 11,668) reports of Helsinki University Hospital from 2015-2016 were analyzed and compared with hospitals' drug consumption and the Institute for Safe Medication Practices' (ISMP) list of high-alert medications. The top ATC groups and active substances in ADR and ME reports were not similar. The most numerous ATC groups were L, antineoplastic and immunomodulating agents (30%) in ADRs and N, nervous system (26%) in MEs. According to ADR and ME reports, several high-alert medications from Institute for Safe Medication Practices' lists, such as antineoplastic agents, antithrombotics, opioids, and insulins, should be considered high-alert medications also in Helsinki University Hospital. Although no ADR reports of amphotericin B existed, it had the highest number of MEs causing severe/moderate harm or unexpected reactions relative to its consumption. To identify organizational high-alert medications, both drug safety information and medication safety information should be used. Adverse drug reaction and ME data are needed to recognize high-alert medications, but these should also be combined with a literature search and local expert opinions.

Adherence of safety information on over‐the‐counter product labels and leaflets to the regulatory guidelines in Malaysia

AbstractAimTo evaluate the adherence of medication safety information provided on over‐the‐counter (OTC) product labels and patient information leaflets (PILs) to the Malaysian and international regulatory guidelines.MethodsA total of 133 randomly sampled OTC medications (gastrointestinal = 31, pain = 36, skin = 35, coughs and colds = 31) from 17 community pharmacies located around Klang Valley, Malaysia were evaluated. The adherence of relevant safety information provided on the OTC product labels and PILs from the manufacturing companies to the Malaysian and international regulatory guidelines was evaluated.ResultsThe majority of the products (n = 81) were locally manufactured, followed by 34 products from the European region. About 31% (n = 41) of the sampled OTC products were sold without PILs. Overall, 98% of the labels adhered to all the criteria, but none of the PILs adhered to all the parameters. Information on action to be taken in the case of a missed dose (96%), advice on consulting a doctor/pharmacist for further information (92%) and disposal instructions (98%) were generally missing. Surprisingly, none of the PILs included the compulsory statement which is essential for adverse drug reaction reporting. In addition, only 30% of the studied PILs provided information on the date of revision. Overall, imported products had slightly better adherence compared to locally manufactured products.ConclusionThe safety information stated on the OTC products marketed in Malaysia has room for improvement to ensure safe and effective use of these products. A uniform format and collective effort is needed to ensure consumers receive adequate information about OTC products.

Message Encryption in Robot Operating System: Collateral Effects of Hardening Mobile Robots

In human-robot interaction situations, robot sensors collect huge amounts of data from the environment in order to characterize the situation. Some of the gathered data ought to be treated as private, such as medical data (i.e., medication guidelines), personal and safety information (i.e., images of children, home habits, alarm codes, etc.). However, most robotic software development frameworks are not designed for securely managing this information. This paper analyzes the scenario of hardening one of the most widely used robotic middlewares, Robot Operating System (ROS). The study investigates a robot’s performance when ciphering the messages interchanged between ROS nodes under the publish/subscribe paradigm. In particular, this research focuses on the nodes which manage cameras and LIDAR sensors, which are two of the most extended sensing solutions in mobile robotics, and analyzes the collateral effects on the robot's achievement under different computing capabilities and encryption algorithms (3DES, AES and Blowfish) to robot performance. The findings present empirical evidence that simple encryption algorithms are lightweight enough to provide cyber-security even in low-powered robots when carefully designed and implemented. Nevertheless, these techniques come with a number of serious drawbacks regarding robot autonomy and performance if they are applied randomly. To avoid these issues, we define a taxonomy that links the type of ROS message, computational units, and the encryption methods. As a result, we present a model to select the optimal options for hardening a mobile robot using ROS.

Research roundup: November 2017

In brief Primary care in Wales under-using non-medical prescribing nurse resources Probiotic and peanut oral immunotherapy is associated with long-lasting peanut tolerance in children Review of nurse-led primary care interventions recommends better articulation of the role to the public High proportion of pregnant women search for medication safety information online: single reliable site needed

An assessment of pregnant women's knowledge and use of the Internet for medication safety information and purchase.

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.

Engaging Learners in Health System Quality Improvement Efforts.

In 1999, an Institute of Medicine report spurred health care organizations to implement systems-based quality improve ment efforts and tackle patient safety. Simultaneously, the Accreditation Council for Graduate Medical Education asked residency programs to address Practice-Based Learning and Systems-Based Practice competencies. Medical educators now advocate incorporation of these competencies in undergraduate medical education.The authors examine the success of these efforts both from the health care delivery and systems perspective as well as from the perspective of educators as they aspire to engage medical students and residents in these domains. The authors argue that the missing element that prevents health care systems from the full realization of the promise of quality improvement is bidirectional alignment. Included are examples from the literature to demonstrate how medical educators are moving toward alignment of learners with health system quality improvement and safety needs. Finally, the authors explore business and information technology governance literature in support of the hypothesis that bidirectional alignment should be the next step in moving from reactive to proactive systems of care.

Effects and Satisfaction of Medical Device Safety Information Reporting System Using Electronic Medical Record.

ObjectivesThis 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.MethodsMedical 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.ResultsSixty-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.ConclusionsWe 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.

Pregnant women use the internet for medication safety information

Pregnant women use the internet for medication safety information