International Journal of Risk & Safety in Medicine - Volume Pre-press, issue Pre-press

Authors: Talreja, Pankaj | Kalra, Rosy

Article Type: Research Article

Abstract: Medicines are an integral part of the health system and the accessibility hugely depends on affordability and availability of medicines. Oral health is an integral component of overall well-being but is ironically often one of the most neglected areas of healthcare. There is paucity of data on the pharmaceutical cost components of dental disease, so this study aims to address this lacuna on the pricing of medicines. This research study can be considered a partial economic evaluation that focuses on an estimation of costs associated with medicines used in treatment of selected oral diseases to suggest policy measures to reduce …out-of-pocket expenditure on medicines. Using cost analysis research design on Pharmatrac dataset and cross-comparing it with public procurement rates of Rajasthan Medical Services Corporation (RMSC) indicates pharmaceutical cost of treating caries and periodontitis is approximately three times higher if median retail prices are considered instead of RMSC public procurement costs. Medicine cost of treating a single episode of caries or periodontitis using RMSC medicine rates at all levels of care is approximately 1.9–2.5 times lower than retail prices of the same formulations. This strongly suggests that centralized public procurement of dental medicines with an efficient monitoring and control can reduce the out-of-pocket expenditure. Show more

Keywords: Cost analysis, dental caries, periodontitis, public procurement system, pharmaceutical expenditure

DOI: 10.3233/JRS-191033

Citation: International Journal of Risk & Safety in Medicine, vol. Pre-press, no. Pre-press, pp. 1-13, 2020

Authors: de Castro, Belén Rodríguez | Sánchez, Rubén Pampín | Martinez, Sonia Tembrás | Ruiz, Aitor Ayastuy | Barbosa, Cristina Martínez-Múgica

Article Type: Research Article

Abstract: Background: Disease-modifying therapies for multiple sclerosis have been developed tremendously over the last two decades. Objective: The aim of this study was to review the short-, medium-, and long-term safety of alemtuzumab in relapsing remitting multiple sclerosis (RRMS). Method: This retrospective observational study (2015–2019) included all patients with highly active or rapidly progressing and aggressive RRMS who were treated with alemtuzumab at the Cabueñes University Hospital. The short-, medium-, and long-term adverse effects were evaluated following the risk management program of the European Medicines Agency. Results: 39 patients were included, 23 of them received …at least two cycles of treatment. Most patients showed at least one adverse event. The following adverse reactions were reported: infusional reactions (17), urinary tract infections (six), thrombopenia (five), and thyroid dysfunction (six). Conclusion: In clinical practice alemtuzumab showed an acceptable safety profile in selected patients even if all of them suffered at least one adverse effect. Thorough and prolonged follow-up is required to further confirm the safety of this drug. Show more

Keywords: Alemtuzumab, multiple sclerosis, safety, infusion-related reactions, infections, autoimmune diseases

DOI: 10.3233/JRS-191029

Citation: International Journal of Risk & Safety in Medicine, vol. Pre-press, no. Pre-press, pp. 1-7, 2020

Authors: Alves, Daiane Fernanda Brigo | Lorenzini, Elisiane | Kolankiewicz, Adriane Cristina Bernat

Article Type: Research Article

Abstract: OBJECTIVE: To measure patient safety climate and the associated factors from the perspective of the multiprofessional team. METHOD: This was an analytical cross-sectional study, developed in a medium-sized hospital in the Southern region of Brazil. The Safety Attitudes Questionnaire (SAQ) was used as the data collection tool and applied to 199 workers of the multiprofessional and support team between November 2017 and February 2018. Data analysis was descriptive and analytical. A positive score was considered when ≥75. RESULTS: The overall SAQ score was positive (75.1). The domain Satisfaction at Work was the one with the highest …score (88.7), while Stress Perception showed the worst score (59.1). It was observed that professionals without a College/University degree better evaluated the domains Satisfaction at Work, Management Perception and Working Conditions, whereas the ones with a College/University degree had better stress perception. Medical doctors showed better Stress Perception when compared to the other health professionals. CONCLUSION: There is a positive safety climate in health organizations from the perspective of the multiprofessional team. However, the domains Safety Climate, Working Conditions and Stress Perception constitute areas that need improvement, aiming to improve patient safety in the institution. Show more

Keywords: Patient safety, safety climate, multiprofessional team, hospital, safety attitudes questionnaire

DOI: 10.3233/JRS-191024

Citation: International Journal of Risk & Safety in Medicine, vol. Pre-press, no. Pre-press, pp. 1-10, 2020

Authors: Demasi, Maryanne | Gøtzsche, Peter C.

Article Type: Research Article

Abstract: BACKGROUND: Many people use the Internet for obtaining information about their medications. OBJECTIVE: To investigate whether information about antidepressants on popular websites reflects the scientific evidence and enables people to make informed choices. METHODS: Cross sectional study using a checklist with 14 predefined criteria of 39 websites from 10 countries. RESULTS: All 39 websites mentioned the benefits of antidepressants. Twenty-nine (74%) websites attributed depression to a “chemical imbalance” or claimed they could fix an imbalance. Sexual dysfunction was mentioned as a harmful effect on 23 (59%) websites while five (13%) mentioned emotional numbing. Twenty-five …(64%) stated that antidepressants may cause increased suicidal ideation, but 23 (92%) of them contained incorrect information, and only two (5%) websites noted that the suicide risk is increased in people of all ages. Twenty-eight websites (72%) warned patients about withdrawal effects but only one stated that antidepressants can be addictive. CONCLUSIONS: None of the websites met our predefined criteria. The information was generally inaccurate and unhelpful and has potential to lead to inappropriate use and overuse of antidepressants and reduce the likelihood that people will seek better options for depression like psychotherapy. Show more

DOI: 10.3233/JRS-191023

Citation: International Journal of Risk & Safety in Medicine, vol. Pre-press, no. Pre-press, pp. 1-13, 2020

Authors: Maree, Sima | Zidi, Esa Mohammadi | Yari, Saeed | Javadi, Maryam

Article Type: Research Article

Abstract: Background: Sleep health is a prerequisite for mental and physical health. The family affects the sleeping habits of the child. Objective: The purpose of this study was to investigate the theory of mothers’ planned behavior in predicting sleeping habits of toddlers. Methods: The participants of this descriptive-analytical study were 120 mothers of 12- to 36-month-old children living in Razan, Hamadan province, Iran. Data were collected in three stages in order to develop a theory-based tool. Semi-structured qualitative interviews with mothers were conducted to investigate the application of theory in predicting mothers’ intention and behavior (n …= 25). The face and content validity of the questionnaire was confirmed by a panel of experts. Test-retest method was used to determine the reliability of the questionnaire at 3 weeks interval (n = 25). Validity of Structural Convergence and Divergence with Factor Analysis, Internal Consent with Cronbach’s Alpha and predictive validity was determined by multiple regression coefficients (n = 120). Results: The mean age of the children was 22.8 ± 7.5 months, 55% (66 children) were boys, the mean score of the children’s sleep questionnaire was 49 ± 6, and the children’s sleep duration was 9 ± 1 hour. Theoretical constructs have a positive and direct correlation with each other and with children’s sleep habits, which demonstrates the validity of the theory in predicting toddler sleep habits. Regression analysis showed that perceived behavioral control was the strongest predictor of sleeping habits of toddlers (𝛽 = 0.446) (P = 0.000). The theory of planned behavior (TPB) is able to explain 30.5 to 25.7% of the variance of toddler sleep habits. Conclusion: While recommending more comprehensive studies, the findings of the study emphasize the application of the theory of planned behavior in identifying factors influencing sleep habits and designing child sleep improvement interventions. Show more

Keywords: Theory of planned behavior, toddler, sleep habits, perceived behavioral control

DOI: 10.3233/JRS-191027

Citation: International Journal of Risk & Safety in Medicine, vol. Pre-press, no. Pre-press, pp. 1-10, 2020

Authors: Gossell-Williams, Maxine | Paul, Tomlin

Article Type: Research Article

Abstract: Pharmacovigilance is an important aspect of clinical practice; however, there is limited evidence that it exists as a theme in medical education curricula. We developed and used a Basic Research Skill Special Study Module to introduce pharmacovigilance to medical students in the early years of their programme. Students completing year one or two of the Faculty of Medical Sciences, Bachelor of Medicine, Bachelor of Surgery programme at The University of the West Indies, Jamaica participated in the four week experience from May 16th to June 12th 2019 to complete structured content sessions and self-directed activity. Sessions focused on the importance …of pharmacovigilance and guided steps to complete a secondary data research project on an adverse reaction reported for a drug of personal interest. The final output was a poster mini-symposium at which each student held a five minute oral presentation. Posters were assessed for compliance with content guidelines, quality and presentation. Ten students participated in this experience and nine students produced posters of greater than 80% compliance with the content guidelines that were provided. The points awarded also reflected high scores for the required elements, relevant graphics, attractiveness/neatness and oral presentation. Students expressed overall satisfaction with the learning experience of the module. Moving forward, the authors will continue using this innovative active learning methodology to increase student exposure to pharmacovigilance, conducting and sharing research. Quantitative outcome assessment tools will be developed and long term goals will focus on its utility in curriculum improvement. Show more

Keywords: xx

DOI: 10.3233/JRS-191032

Citation: International Journal of Risk & Safety in Medicine, vol. Pre-press, no. Pre-press, pp. 1-7, 2020

Authors: Maat, Laura | Porte, Petra J. | Verweij, Lisanne M. | Wagner, Cordula

Article Type: Research Article

Abstract: BACKGROUND: The correct and safe use of electrosurgery requires medical specialists to be proficient. Minimum proficiency requirements and proficiency tests are a manner to structurally assure proficiency. The objective of this study is to explore attitudes and perceptions of medical specialists on proficiency, proficiency requirements and proficiency tests for the safe use of electrosurgery. METHODS: A qualitative study among medical specialists using semi-structured interviews. RESULTS: The participants recognized that the use of electrosurgery poses risks to the safety of patients and perioperative staff. According to some participants, increased awareness on the risks of electrosurgery is required. …Most medical specialists however thought that proficiency of users of electrosurgery is sufficiently assured. Medical specialists stated to support proficiency requirements when they are endorsed by their scientific association. Proficiency tests encountered much resistance. Medical specialists argued that electrosurgery should not be tested as a single device but should be embedded in a larger entity, for example in a broader course or proficiency test. CONCLUSIONS: When assuring proficiency of users of electrosurgery, the positive attitude towards proficiency requirements and the more negative attitude towards proficiency tests should be taken into account. Show more

Keywords: Proficiency, competency, requirements, tests, medical specialists, electrosurgery

DOI: 10.3233/JRS-191034

Citation: International Journal of Risk & Safety in Medicine, vol. Pre-press, no. Pre-press, pp. 1-11, 2020

Authors: Karimian, Mohamad | Khalighi, Ebrahim | Salimi, Ebrahim | Borji, Milad | Tarjoman, Asma | Mahmoudi, Yosof

Article Type: Research Article

Abstract: BACKGROUND: Pressure ulcers can cause disability, which can lead to a default in patients’ safety and results in frequent complications for patients. OBJECTIVES: This study aimed to determine the effect of educational intervention on nurses’ knowledge and attitude in preventing pressure ulcers. METHODS: In this study, 67 nurses of ICU wards at Ilam University of Medical Sciences were randomly assigned into the experimental or control group. Data collection tools included the questionnaires of demographic characteristics, Pieper Pressure Ulcer Knowledge test (PUKT) and Attitude toward Pressure Ulcer tool (APuP). In the experimental group, the nurses were allocated …into groups of 4–5 persons and for each group 4 face-to-face training sessions and 2 virtual training sessions by means of educational videos on bed sores were performed. Gathered data were analyzed using SPSS software version 16, and descriptive and analytical tests were performed. RESULTS: PUKT questionnaire score in the experimental group improved from 15.68 (3.42) to 29.75 (12.33) (P = 0.000), while in the control group it was 16.40 (3.13) and 17.54 (6.62) before intervention, which was not significant (P > 0.05). Furthermore, the APUP questionnaire score in the experimental group improved from 27.12 (2.13) to 39.37 (3.21) (P = 0.000), while in the control group it was 27.65 (1.71) and 28.37 (5.00) before intervention, which was not significant (P > 0.05). CONCLUSIONS: Since educational intervention improved the knowledge and attitude of nurses in preventing pressure ulcers, it is required to conduct appropriate educational interventions to improve their knowledge and attitude. Show more

Keywords: Knowledge, attitude, pressure ulcers, intensive care

DOI: 10.3233/JRS-191038

Citation: International Journal of Risk & Safety in Medicine, vol. Pre-press, no. Pre-press, pp. 1-7, 2020

Authors: Adil, Mir S. | Sultana, Ruqiya | Khulood, Daulat

Article Type: Research Article

Abstract: BACKGROUND: Medication errors may account up to one-third of all medical errors in hospitals, thereby leading to adverse outcomes such as higher mortality rate and longer hospital stay. OBJECTIVES: The primary objective of the study was to determine whether patient safety can be improved by clinical pharmacy services. The study also aimed to reveal whether medication errors can be prevented by any means. METHODS: A prospective, observational study was conducted in a multispecialty hospital in India. Prescription audit was performed for patients followed by necessary intervention by the concerned physician. Chi-squared test, paired t-test and ANOVA …were performed to test statistical significance. RESULTS: A total of 699 errors were encountered by 501 of 1149 patients enrolled. Prescription errors accounted for the majority (87.1%) of errors followed by administration (7.4%), transcription (4.3%) and dispensing (1.2%) errors. Average error per patient showed a significant gradual decline from baseline (2.08) to the final follow-up (1.06). ICU patients encountered a higher rate (52.8%) of errors than general ward group (42.8%), while geriatric population witnessed a low error rate (18.8%) compared to adults (72%). CONCLUSIONS: The study was not only successful in highlighting the impact of medication error assessment on patient safety, but it also demonstrated that medication errors can be lowered with the help of clinical pharmacy services. Findings from the study conclude that medication errors can be prevented if healthcare professionals are educated appropriately to avoid recurrence of past mistakes. Show more

Keywords: Clinical pharmacy service, inappropriate prescriptions, medication errors, medication therapy management, patient safety, prescription monitoring

DOI: 10.3233/JRS-191025

Citation: International Journal of Risk & Safety in Medicine, vol. Pre-press, no. Pre-press, pp. 1-13, 2020