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BACKGROUND: Adverse Drug Reactions (ADRs) are of great public health concern. FDA-approved drug labeling summarizes ADRs of a drug product mainly in three sections, i.e., Boxed Warning (BW), Warnings and Precautions (WP), and Adverse Reactions (AR), where the severity of ADRs are intended to decrease in the order of BW > WP > AR. Several reported studies have extracted ADRs from labeling documents, but most, if not all, did not discriminate the severity of the ADRs by the different labeling sections. Such a practice could overstate or underestimate the impact of certain ADRs to the public health. In this study, we applied the Medical Dictionary for Regulatory Activities (MedDRA) to drug labeling and systematically analyzed and compared the ADRs from the three labeling sections with a specific emphasis on analyzing serious ADRs presented in BW, which is of most drug safety concern. RESULTS: This study investigated New Drug Application (NDA) labeling documents for 1164 single-ingredient drugs using Oracle Text search to extract MedDRA terms. We found that only a small portion of MedDRA Preferred Terms (PTs), 3819 out of 21,920 or 17.42%, were observed in a whole set of documents. In detail, 466/3819 (12.0%) PTs were in BW, 2023/3819 (53.0%) were in WP, and 2961/3819 (77.5%) were in AR sections. We also found a higher overlap of top 20 occurring BW PTs with WP sections compared to AR sections. Within the MedDRA System Organ Class levels, serious ADRs (sADRs) from BW were prevalent in Nervous System disorders and Vascular disorders. A Hierarchical Cluster Analysis (HCA) revealed that drugs within the same therapeutic category shared the same ADR patterns in BW (e.g., nervous system drug class is highly associated with drug abuse terms such as dependence, substance abuse, and respiratory depression). CONCLUSIONS: This study demonstrated that combining MedDRA standard terminologies with data mining techniques facilitated computer-aided ADR analysis of drug labeling. We also highlighted the importance of labeling sections that differ in seriousness and application in drug safety. Using sADRs primarily related to BW sections, we illustrated a prototype approach for computer-aided ADR monitoring and studies which can be applied to other public health documents.

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We undertook a randomised control led trial to evaluate the effect of a prototype device which attaches to the intravenous drug administration port, and allows injection of intravenous drugs only after the user scans the barcode on the syringe label. This requires two steps: first, that the correct drug label is generated; and second, that the syringe-with-label is scanned before administration. Ten anaesthetists, who were unaware of the primary outcome being measured, administered general anaesthesia for two simulated standardised cases each without and with our prototype (control and intervention, respectively). The primary outcome measured was compliance with a safe drug administration procedure (defined as a two-step procedure where, step one is scanning a drug ampoule to print a label for a syringe and step two is scanning of the labelled syringe before administering it intravenously). A total of 182 intravenous drug administrations occurred in the study (91 in each group). We found that the use of our prototype increased safe drug administration behaviour in experienced anaesthetists; 33 (36.3% [95% CI 26-47%]) vs. 91 (100% [95% CI 96-100%]) in the control and intervention groups, respectively (p = 0.0001).

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Background: Information in society and in health care is currently undergoing a transition from paper to digital formats, and the main source of information will probably be electronic in the future. Objective: To explore patients’ use and perceptions of the patient information leaflet included in the medication package, and their attitude towards a transition to an electronic version. Methods: The data was collected during October to November 2014 among individuals in South-Eastern Sweden, using a questionnaire (n=406, response rate 78%) and interviews (n=15). Results: The questionnaire showed that the majority of the respondents (52%) occasionally read the patient information leaflet, 37% always read it, and 11% never read it. Almost half of the patients (41%) were positive towards reading the patient information leaflet electronically while 32% were hesitant and 26% neutral. A majority of the patients would request to get the patient information leaflet printed at the pharmacy if it was not included in the package. There were differences in attitude related to age and gender. The interviews showed that patients had mixed views on a transition to an electronic patient information leaflet. The patients perceived several positive aspects with an electronic patient information leaflet but were concerned about elderly patients. Conclusion: Although many were positive towards reading the patient information leaflet electronically, the majority prefer the patient information leaflet in paper form. Providing appropriate and useful eHealth services for patients to access the patient information leaflet electronically, along with education, could prepare patients for a transition to electronic patient information leaflet (AU)

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Background: Many medications can be used safely and effectively to provide health benefits for disease state management during pregnancy with minimal risk to the fetus or mother. Today nine out of ten women take at least one medication during pregnancy, and the number of women taking four or more medications has more than doubled over the past 30 years. However, the lack of safety data combined with the generalizations of the current risk category system (A, B, C, D, X) makes risk versus benefit assessment difficult. Discussion: In response to these concerns, the U.S. Food and Drug Administration (FDA) has decided to implement a new pregnancy and lactation labeling rule designed to improve risk versus benefit assessment of drugs used in pregnant and nursing mothers; this rule is set to take effect in June of 2015. This change is designed to provide clear and detailed information for both patients and healthcare providers pertaining to three main categories: pregnancy, lactation, and females and males of reproductive potential. The new labeling rule also removes the previous letter risk categorization system. Conclusion: The upcoming changes regarding pregnancy and lactation safety labeling are going to have a vast impact on drug safety interpretation and prescribing practices. While this rule will provide practitioners with more detailed information pertaining to pregnancy, lactation, and reproduction, it will also place more responsibility on the practitioners to ensure the safety of their patients. This review will summarize these changes and discuss their potential effect on clinical practice (AU)

Antecedentes: Muchos medicamentos pueden ser utilizados con seguridad y efectividad para mejorar la salud en la gestión de enfermedades durante el embarazo con mínimo riesgo para la madre o el feto. Hoy, 9 de cada 10 mujeres toman al menos un medicamento durante el embarazo, y el número de ellas que toma 4 o más medicamentos se ha más que doblado en los últimos 30 años. Sin embargo, la falta de datos de seguridad, combinada con las generalizaciones de la actual categoría de riesgos (A, B, C, D, X) hace difícil la evaluación riesgo contra beneficio. Discusión: En respuesta a estas preocupaciones, la U.S. Food and Drug Administration (FDA) ha decidido implantar una nueva regla de información en embarazo y lactación diseñada para mejorar la evaluación riesgo contra beneficio de los medicamentos usados em madres embarazadas o lactando; esta regla entrará en vigor en junio de 2015. Este cambio está diseñado para proporcionar una información clara y detallada tanto para pacientes como para profesionales de la salud comprendiendo 3 apartados principales: embarazo, lactación, y potencial reproductivo masculino y femenino. La nueva información elimina el anterior sistema de categorización por letras. Conclusión: Los próximos cambios en la información de seguridad de embarazo y lactación van a producir un gran impacto en la interpretación de la seguridad en las prácticas de prescripción. Mientras esta regla proporcionará a los facultativos una información más detallada sobre embarazo, lactación y reproducción, también les dará más responsabilidad para asegurar la seguridad de sus pacientes. Esta revisión resume estos cambios y discute sus efectos potenciales sobre la práctica clínica (AU)

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BACKGROUND: Many anesthetic drug errors result from vial or syringe swaps. Scanning the barcodes on vials before drug preparation, creating syringe labels that include barcodes, and scanning the syringe label barcodes before drug administration may help to prevent errors. In contrast, making syringe labels by hand that comply with the recommendations of regulatory agencies and standards-setting bodies is tedious and time consuming. A computerized system that uses vial barcodes and generates barcoded syringe labels could address both safety issues and labeling recommendations. METHODS: We measured compliance of syringe labels in multiple operating rooms (ORs) with the recommendations of regulatory agencies and standards-setting bodies before and after the introduction of the Codonics Safe Label System (SLS). The Codonics SLS was then combined with Smart Anesthesia Manager software to create an anesthesia barcode drug administration system, which allowed us to measure the rate of scanning syringe label barcodes at the time of drug administration in 2 cardiothoracic ORs before and after introducing a coffee card incentive. Twelve attending cardiothoracic anesthesiologists and the OR satellite pharmacy participated. RESULTS: The use of the Codonics SLS drug labeling system resulted in >75% compliant syringe labels (95% confidence interval, 75%-98%). All syringe labels made using the Codonics SLS system were compliant. The average rate of scanning barcodes on syringe labels using Smart Anesthesia Manager was 25% (730 of 2976) over 13 weeks but increased to 58% (956 of 1645) over 8 weeks after introduction of a simple (coffee card) incentive (P < 0.001). CONCLUSIONS: An anesthesia barcode drug administration system resulted in a moderate rate of scanning syringe label barcodes at the time of drug administration. Further, adaptation of the system will be required to achieve a higher utilization rate.

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The Codonics Safe Labeling System(™) (http://www.codonics.com/Products/SLS/flash/) is a piece of equipment that is able to barcode scan medications, read aloud the medication and the concentration and print a label of the appropriate concentration in the appropriate colour code. We decided to test this system in our facility to identify risks, benefits and usability. Our project comprised a baseline survey (25 anaesthesia cases during which 212 syringes were prepared from 223 drugs), an observational study (47 cases with 330 syringes prepared) and a user acceptability survey. The baseline compliance with all labelling requirements was 58%. In the observational study the compliance using the Codonics system was 98.6% versus 63.8% with conventional labelling. In the user acceptability survey the majority agreed the Codonics machine was easy to use, more legible and adhered with better security than the conventional preprinted label. However, most were neutral when asked about the likelihood of flexibility and customisation and were dissatisfied with the increased workload. Our findings suggest that the Codonics labelling machine is user-friendly and it improved syringe labelling compliance in our study. However, staff need to be willing to follow proper labelling workflow rather than batch label during preparation. Future syringe labelling equipment developers need to concentrate on user interface issues to reduce human factor and workflow problems. Support logistics are also an important consideration prior to implementation of any new labelling system.

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Approximately one-third of all independently living elderly people are not compliant with their drug therapy. This lack of medication management results either in undermedication or overmedication, causing unnecessary and often serious health risks. This problem will worsen in the future with the change of demographics and cost constraints in the health sector. Therefore there is a need for (cost-) effective reliable approaches to compliance monitoring. To date numerous care schemes, retrospective assessment procedures and compliance supports tools have been introduced, but none of them has fully solved the problem of medication non-compliance yet. This paper will address some of the factors that need to be considered when designing such systems and will showcase DigiSpenser, a recently developed compliance monitoring and drug management system.

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BACKGROUND: The applications of radio frequency identification (RFID) technology carry a tremendous potential for pharmaceutical industry. There is a pressing need to analyze the performance of RFID tags attached to various pharmaceutical dosage forms. METHOD: The readability of RFID-tagged pharmaceutical products is, for the first time, systematically investigated by experiments. Factors considered include dosage forms, ion concentration in solution, angle of rotation, and distance between the RFID tag and the interrogator. RESULTS: Compared with empty container, the filling of any representative dosage forms causes deteriorated readability for the tag attached to container. Analysis of variance reveals that the effects of dosage forms, angle of rotation, and their interaction are statistically significant. In addition, an increase in distance (equivalent to higher RF attenuation level) and higher ion concentration in solution beyond a certain level have detrimental effect on tag readability. CONCLUSION: The analysis shows that the RFID tag readability is strongly dependent on the factors that are experimented with. The level of the factors for optimum RFID system performance should be adjusted based on the particular application.

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INTRODUCTION: Substantial evidence exists for the use of prophylactic heparin in medical inpatients with congestive heart failure and severe respiratory disease, and in surgical patients with a moderate-to-high risk of thromboembolism (Grade 1A recommendations). Despite this, many patients who would benefit from prophylaxis do not receive this treatment. METHODS: We implemented an education programme to promote the use of prophylactic enoxaparin. In addition, preprinted stickers were placed in the notes of patients to serve as a reminder, where appropriate, that the patient was a candidate for prophylaxis. To assess changes in practice, we undertook an audit of the charts of 105 medical patients and 100 surgical patients over a 3-month period before the intervention and a further 100 medical patients and 99 surgical patients over a 3-month period after the intervention. RESULTS: Before the campaign, prophylaxis with enoxaparin was used in 11% of eligible medical patients. Following the intervention, prophylaxis increased to 47% (95%CI 23-50, p<0.0001). The audit of surgical patients showed an increase in the use of enoxaparin from 36% of eligible patients to 50% (95%CI 0-28, p = 0.07) however there was no improvement in the proportion of those treated who received the appropriate dose according to guidelines. CONCLUSION: Prophylactic heparin is under-used. An education programme together with the use of a sticker led to an improvement in the use of this treatment.

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In February, the U.S. Food and Drug Administration (FDA) issued its final ruling requiring that all drug and biological products sold to hospitals incorporate bar codes on their labels. The ruling smooths the way for widespread adoption of bar-code-enabled point-of-care (BPOC) systems, which are a valuable tool for reducing medication errors. BPOC systems help ensure that the right medications reach the right patient at the right time by allowing bar codes on a patient's ID wristband to be checked against the medication packaging. But BPOC systems will only become truly effective if medications are widely available in unit-dose packaging. Right now only about a third of all medications are available in this form. Although this situation is likely to improve, hospitals wanting to take advantage of BPOC technology soon may need to do some drug repackaging themselves (or have it done by a third party), along with a lot of other groundwork. Widespread BPOC use may still be several years away, but the time to start preparing is now.

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