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

Authors: Valladales-Restrepo, Luis Fernando | Gaviria-Mendoza, Andrés | Londoño-Serna, María José | Ospina-Cano, Juan Alberto | Giraldo-Giraldo, Claudia | Machado-Duque, Manuel Enrique | Machado-Alba, Jorge Enrique

Article Type: Research Article

Abstract: BACKGROUND: Transdermal drug delivery has contributed positively to medical practice. However, prescriptions that do not meet minimum quality criteria and medication errors are common. OBJECTIVE: The objective was to determine how transdermal patches are being prescribed to a group of patients in Colombia, the compliance with established requirements of such prescriptions and the comparisons between correct and incorrect prescriptions. METHODS: This was a cross-sectional study of prescriptions for transdermal patches using data from a population-based drug dispensing database between December 1 and 31, 2019. Medical prescriptions were randomly reviewed, establishing whether the drugs were appropriately prescribed …by the manufacturer’s indications or national regulations. Descriptive and bivariate analysis was performed. RESULTS: A total of 415 prescriptions were reviewed; the prescription was provided to 412 patients with a median age of 76.9 years, and 63.3% were women. Rivastigmine was the most prescribed transdermal patch (57.8%). 66.3% of all prescriptions did not meet the minimum appropriate prescribing standards, especially those for rivastigmine (97.1%). The 7.0% of all prescriptions had posology errors, especially prescriptions for buprenorphine (43.8%). Older patients (84.4% vs 52.5%), from the Pacific region (34.4% vs 23.7%), with manual formulations (22.1% vs 0.8%), dementia (49.0% vs 6.8%), and in management with lipid-lowering drugs (41.8% vs 30.5%), presented incorrect transdermal patch formulations more frequently (p  < 0.05). CONCLUSION: The high proportion of inappropriately prescribed transdermal patches should draw the attention of those responsible for health care to improve the training of physicians and create prescription quality verification systems. Show more

Keywords: Drug prescriptions, medication errors, transdermal patch, buprenorphine, rivastigmine, pharmacoepidemiology

DOI: 10.3233/JRS-220027

Citation: International Journal of Risk & Safety in Medicine, vol. Pre-press, no. Pre-press, pp. 1-11, 2023

Authors: Attiya, Nourdine | Fattahi, Rkia | Amarouch, Mohamed-Yassine | El-haidani, Ahmed | El Jaafari, Samir | Filali-Zegzouti, Younes

Article Type: Research Article

Abstract: BACKGROUND: Dentists using dental amalgam are chronically exposed to low doses of elemental mercury. The complex toxico-kinetics of this systemic toxicant results in polymorphic and variable clinical phenotypes. In this context, adapted statistical methods are required to highlight potential adverse effects of occupational mercury exposure on dentists’ health. OBJECTIVE: The present study aims to analyze the distribution of self-reported subjective symptoms, commonly associated with chronic mercury poisoning, according to occupational mercury exposure in a population of Moroccan liberal dentists. METHODS: In order to achieve the defined objectives, a three-step latent class regression was fitted. First a …latent class analysis was performed to cluster the studied population according to their declared symptoms. Dentists were then classified in the defined latent classes based on their posterior probabilities. Finally, a logistic regression is fitted to identify predictors associated with latent classes’ membership. RESULTS: The final obtained model showed acceptable calibration and discrimination. Its interpretation revealed that the increase of the frequency of amalgam use was associated with significant higher odds of belonging to the high risk latent class. CONCLUSIONS: The present study represents an initial step towards the development of diagnosis model that predict clinical profiles according to occupational mercury exposure. Show more

Keywords: Mercury, dental amalgam, dentist, Morocco, latent class analysis

DOI: 10.3233/JRS-210052

Citation: International Journal of Risk & Safety in Medicine, vol. Pre-press, no. Pre-press, pp. 1-11, 2023

Authors: Al-Azzawi, Shafq | Masheta, Dhafir

Article Type: Research Article

Abstract: BACKGROUND: The world has faced an unprecedented challenge since COVID-19 emerged as a pandemic, which has led to quarantine and disruptions in drug services. During the pandemic, drug use habits and availability changed, causing a shift in behaviors and, in turn, medicine misuse. In Iraq, this is a major problem because many medicines can be easily obtained. OBJECTIVE: The study aims to describe the pattern of dispensing medications during the pandemic and to evaluate the biochemical and pathological consequences. METHOD: The analytical, observational, cross-sectional study was performed via a compiled questionnaire for 400 random pharmacists, and …the analysis and interpretation of the biochemical and medical reports. RESULTS: Results revealed that dispensing of medications since the COVID-19 outbreak has increased by 74%, and the demand for medicines seems higher than required in comparison to the periods before the pandemic, while 60% of the dispensed medicines were taken just in case needed. In addition, the availability of medicines decreased by 61%, and the dispensing of common medicines increased due to the belief in their prophylactic action. Several biochemical abnormalities and pathological consequences were recorded due to the irrational use of medicines, and the highest percentage (12%) was seen in hepatic and liver enzymatic dysfunction and 8% for the endocrine and hormonal abnormalities. CONCLUSION: It can be concluded that most of the dispensed medicines were not used on a therapeutic or scientific basis during the pandemic. Show more

Keywords: COVID-19 pandemic, community pharmacy, drug misuse, drug availability, biochemical and pathological consequences

DOI: 10.3233/JRS-220061

Citation: International Journal of Risk & Safety in Medicine, vol. Pre-press, no. Pre-press, pp. 1-17, 2023

Authors: Sridharan, Kannan | Shah, Shamik

Article Type: Brief Report

Abstract: BACKGROUND: Renal transplanted patients are often prescribed non-steroidal anti-inflammatory drugs (NSAIDs) for analgesic purposes. OBJECTIVE: Considering the dearth of data, we carried out the present study to evaluate the use of various NSAIDs and the incidence of acute kidney injury (AKI) in transplant patients. METHODS: A retrospective study amongst renal transplant patients prescribed at least one dose of NSAID was carried between January and December 2020 at the Department of Nephrology, Salmaniya Medical Complex, Kingdom of Bahrain. The patients’ demographic details, serum creatinine values, and drug-related details were obtained. The Kidney Disease Improving Global Outcomes (KDIGO) …criteria were used for defining AKI. RESULTS: Eighty-seven patients were included. Forty-three patients were prescribed diclofenac, 60 received ibuprofen, six received indomethacin, 10 were administered mefenamic acid, and 11 received naproxen. Due to multiple courses of NSAID prescription, a total of 70 prescriptions were identified for diclofenac, 80 for ibuprofen, six for indomethacin, 11 for mefenamic acid, and 16 for naproxen. No significant differences were observed in the absolute (p = 0.08) and percent changes in serum creatinine (p = 0.1) between the NSAIDs. Twenty-eight (15.2%) courses of NSAID therapy met the KDIGO criteria for AKI. Age (OR: 1.1, 95% CI: 1.007, 1.2; p = 0.02), concomitant everolimus (OR: 483, 95% CI: 4.3, 54407; p = 0.01), and mycophenolate + cyclosporine + azathioprine (OR: 63.4E+006, 95% CI: 203.2157 to 19.8E+012; p = 0.005) administration were observed with significant risk of NSAID-induced AKI. CONCLUSION: We observed possible NSAID-induced AKI to an extent of around 15.2% in our renal transplant patients. No significant differences were observed in the incidence of AKI between various NSAIDs and none of them had either graft failure or death. Show more

Keywords: Diclofenac, indomethacin, ibuprofen, naproxen, mefenamic acid, kidney transplant, AKI, NSAIDs

DOI: 10.3233/JRS-220065

Citation: International Journal of Risk & Safety in Medicine, vol. Pre-press, no. Pre-press, pp. 1-8, 2023

Authors: Deshwal, Prity Rani | Fathima, Raisa | Aggarwal, Muskan | Reddy, Nalla Surender | Tiwari, Pramil

Article Type: Review Article

Abstract: BACKGROUND: Acinetobacter baumannii is a major cause of nosocomial infections and high mortality rates. Evaluation of risk factors for such resistant infections may aid surveillance and diagnostic initiatives, as well as, can be crucial in early and appropriate antibiotic therapy. OBJECTIVE: To identify the risk factors in patients with resistant A. baumannii infection with respect to controls. METHODS: Prospective or retrospective cohort and case-control studies reporting the risk factors for resistant A. baumannii infection were collected through two data sources, MEDLINE/PubMed and OVID/Embase. Studies published in the English language were included while animal …studies were excluded. The Newcastle-Ottawa Scale was used to assess the quality of studies. The odds ratio of developing antibiotic resistance in patients with A. baumannii infection was pooled using a random-effect model. RESULTS: The results are based on 38 studies with 60878 participants (6394 cases and 54484 controls). A total of 28, 14, 25, and 11 risk factors were identified for multi-drug resistant (MDRAB), extensive-drug resistant (XDRAB), carbapenem-resistant (CRAB) and imipenem resistant A. baumannii infection (IRAB), respectively. In the MDRAB infection group, exposure to carbapenem (OR 5.51; 95% CI: 3.88–7.81) and tracheostomy (OR 5.01; 95% CI: 2.12–11.84) were identified with maximal pool odd’s ratio. While previous use of amikacin (OR 4.94; 95% CI: 1.89–12.90) and exposure to carbapenem (OR 4.91; 95% CI: 2.65–9.10) were the foremost factors associated with developing CRAB infection. Further analysis revealed, mechanical ventilation (OR 7.21; 95% CI: 3.79–13.71) and ICU stay (OR 5.88; 95% CI: 3.27–10.57) as the most significant factors for XDRAB infection. CONCLUSION: The exposure of carbapenem, amikacin (previous) and mechanical ventilation were the most significant risk factors for multidrug, extensive-drug, and carbapenem resistance in patients with A. baumannii infection respectively. These findings may guide to control and prevent resistant infections by identifying the patients at higher risk of developing resistance. Show more

Keywords: Multidrug resistance, extensive-drug resistance, carbapenem resistance, Acinetobacter baumannii , risk factors

DOI: 10.3233/JRS-220037

Citation: International Journal of Risk & Safety in Medicine, vol. Pre-press, no. Pre-press, pp. 1-19, 2023

Authors: Hamadalneel, Yousif B. | Maatoug, Maha M. | Yousif, Mirghani A.

Article Type: Research Article

Abstract: BACKGROUND: Intravenous medications have greater complexity and require multiple steps in their preparation and administration, which is considered a high risk for patients. OBJECTIVE: To determine the incidence of intravenous medications preparation and administration errors in critically ill patients. METHODS: This was an observational, cross-sectional, prospective study design. The study was performed conducted in Wad Medani Emergency Hospital, Sudan on with 33 nurses. RESULTS: All nurses working at the study setting were observed over nine days. During the study period, a total number of 236 drugs were observed and evaluated. The total error rate …was 940 (33.4%), of which 136 (57.6%) errors with no harm, 93 (39.4%) errors with harm and 7 (3%) of errors associated with mortality. 17 different drug categories were involved, in which antibiotic was the highest error rate 104 (44.1%) and 39 different drugs were involved, in which metronidazole was the most drug involved 34 (14.4%). The total error rate was associated with nurse experience, OR (95% CI); 3.235 (1.834–5.706), and nurse education level, OR (95% CI); 0.125 (0.052–0.299). CONCLUSION: The study reported high frequency of IV medications preparation and administration errors. Nurse education level, and experiences were influenced the total errors. Show more

Keywords: Preparation, administration, IV medication, ICU

DOI: 10.3233/JRS-220054

Citation: International Journal of Risk & Safety in Medicine, vol. Pre-press, no. Pre-press, pp. 1-9, 2023

Authors: Kantemirova, B.I. | Bogorodskaya, E.M. | Poptsova, M.S. | Sychev, D.A. | Tsimbal, E.A. | Stepanova, N.A.

Article Type: Research Article

Abstract: BACKGROUND: There is currently no widespread implementation of pharmacogenetic testing (PGx) methods in the practice of phthisiology service. OBJECTIVE: The aim of this study is to determine how informed and prepared phthisiologists, residents, and postgraduate students of the Russian Medical Academy of Continuing Professional Education (RMACPE, Moscow) use PGx techniques in their work to improve treatment safety, predict the occurrence of adverse reactions (ADRs), and personalize therapy. METHODS: A survey was conducted among phthisiologists (n = 314) living in different regions of the Russian Federation and studying at RMACPE, such as residents and post-graduate students (n …= 185). The survey was developed on the Testograf.ru web platform and had 25 questions for physicians and 22 for residents and post-graduate students. RESULTS: More than 50% of respondents are ready to use PGx in clinical practice and thus are aware of the method’s possibilities. At the same time only a small part of participants were aware of the pharmgkb.org resource. The absence of PGx in clinical guidelines and treatment standards, according to 50.95% of phthisiologists and 55.13% of students of RMACPE, the absence of large-scale randomized clinical trials, according to 37.26% of phthisiologists and 43.33% of students, and the lack of physician knowledge on PGx, according to 41.08% of phthisiologists and 57.83% of students, are all factors that prevent the implementation of PGx in Russia. CONCLUSION: According to the survey, the overwhelming majority of participants recognize the importance of PGx and are willing to use the method in practice. However, there is a low level of awareness among all respondents about the possibilities of PGx and the pharmgkb.org resource. The implementation of this service could significantly increase patient compliance, lower ADRs, and enhance anti-tuberculosis (TB) therapy quality. Show more

Keywords: Respiratory tuberculosis-clinical practice- adverse drugs reactions-pharmacogenetics-physician opinions-survey

DOI: 10.3233/JRS-220028

Citation: International Journal of Risk & Safety in Medicine, vol. Pre-press, no. Pre-press, pp. 1-12, 2023

Authors: Panggabean, Bungaran | Suharjo, Budi | Sumarwan, Ujang | Yuliati, Lilik Noor

Article Type: Research Article

Abstract: BACKGROUND: Healthtech has become a nascent sector of the internet economy since the emergence of the COVID-19 pandemic in 2020. Telemedicine features are facilitated, such as teleconsultation, e-diagnosis, e-prescribing, and e-pharmacy. However, the intention to use digital health services in Indonesia is still underdeveloped though the sales of other risk-free e-commerce products are high enough. OBJECTIVE: This study aims to assess the human perception of perceived value and social influences regarding the intention to use digital health services. METHODS: Google Forms web link is employed to disseminate a set of 4-Point Likert scale questionnaires. In total, …364 complete responses are collected-back. A descriptive approach is employed to process the data using Microsoft Excel and SPSS software. Validity and reliability are quantified using the item total-correlation method and Cronbach’s Alpha coefficient. RESULTS: Only 87 respondents (24%) ever used digital health services, of which Halodoc (92%) is the most preferred application, and teleconsultation became the most popular service to access. Out of four, the average score is 3.16 for perceived value and 2.86 for the social influence dimension. CONCLUSION: Most respondents, not dependent on user experience, perceive more values obtained using digital health services, such as time and money savings, convenience, flexible order time, undiscovered identity, adventurous experience, and enjoyment. Another finding of this research proves that some social influences from family, friends, and mass media also bring effect to amplify the intention to use. A low level of trust is assumed to be the cause of a small number of users. Show more

Keywords: Digital health service, human perception, perceived value, social influences, telemedicine

DOI: 10.3233/JRS-220058

Citation: International Journal of Risk & Safety in Medicine, vol. Pre-press, no. Pre-press, pp. 1-11, 2023

Authors: Vittengl, Jeffrey R. | Jarrett, Robin B. | Ro, Eunyoe | Clark, Lee Anna

Article Type: Research Article

Abstract: BACKGROUND: Although antidepressant medication (ADM) has produced small advantages over pill placebo in randomized controlled trials, consuming ADM has predicted prospectively increasing depressive symptom severity in samples of community-dwelling adults. OBJECTIVE: We extended the community literature by testing ADM’s relations to changes in personality and quality of life that may underpin depression. METHOD: In this longitudinal, observational study, community-dwelling adults (N  = 601) were assessed twice, 8 months apart on average. Assessments included depressive symptoms, personality, life satisfaction and quality, and prescription medication consumption. RESULTS: Consuming ADM at time 1 predicted relative increases in depressive …symptoms (dysphoria), maladaptive traits (negative affect, negative temperament, disinhibition, low conscientiousness), personality dysfunction (non-coping, self-pathology), and decreases in life satisfaction and quality from time 1 to 2, before and after adjustment for age, gender, race, income, education, physical health problems, and use of other psychotropics. In no analysis did ADM use predict better outcomes. CONCLUSION: Among community-dwelling adults, ADM use is a risk factor for psychosocial deterioration in domains including depressive symptoms, personality pathology, and quality of life. Until mechanisms connecting ADM to poor outcomes in community samples are understood, additional caution in use of ADM and consideration of empirically supported non-pharmacologic treatments is prudent. Show more

Keywords: Antidepressant medications, personality, quality of life, risk, community

DOI: 10.3233/JRS-230016

Citation: International Journal of Risk & Safety in Medicine, vol. Pre-press, no. Pre-press, pp. 1-14, 2023

Authors: Gøtzsche, Peter C. | Demasi, Maryanne

Article Type: Review Article

Abstract: BACKGROUND: Depression drugs can be difficult to come off due to withdrawal symptoms. Gradual tapering with tapering support is needed to help patients withdraw safely. OBJECTIVE: To review the withdrawal success rates, using any intervention, and the effects on relapse/recurrence rates, symptom severity, quality of life, and withdrawal symptoms. METHODS: Systematic review based on PubMed and Embase searches (last search 4 October 2022) of randomised trials with one or more treatment arms aimed at helping patients withdraw from a depression drug, regardless of indication for treatment. We calculated the mean and median success rates and the risk …difference of depressive relapse when discontinuing or continuing depression drugs. RESULTS: We included 13 studies (2085 participants). Three compared two withdrawal interventions and ten compared drug discontinuation vs. continuation. The success rates varied hugely between the trials (9% to 80%), with a weighted mean of 47% (95% confidence interval 38% to 57%) and a median of 50% (interquartile range 29% to 65%). A meta-regression showed that the length of taper was highly predictive for the risk of relapse (P = 0.00001). All the studies we reviewed confounded withdrawal symptoms with relapse; did not use hyperbolic tapering; withdrew the depression drug too fast in a linear fashion; and stopped it entirely when receptor occupancy was still high. CONCLUSION: The true proportion of patients on depression drugs who can stop safely without relapse is likely considerably higher than the 50% we found. Show more

Keywords: Depression drugs, withdrawal symptoms, relapse, tapering

DOI: 10.3233/JRS-230011

Citation: International Journal of Risk & Safety in Medicine, vol. Pre-press, no. Pre-press, pp. 1-14, 2023