Medication Profiles Research Articles

The burden and predisposing factors of non-communicable diseases in Mashhad University of Medical Sciences personnel: a prospective 15-year organizational cohort study protocol and baseline assessment

BackgroundThe rising burden of premature mortality for Non-Communicable Diseases (NCDs) in developing countries necessitates the institutionalization of a comprehensive surveillance framework to track trends and provide evidence to design, implement, and evaluate preventive strategies. This study aims to conduct an organization-based prospective cohort study on the NCDs and NCD-related secondary outcomes in adult personnel of the Mashhad University of Medical Sciences (MUMS) as main target population.MethodsThis study was designed to recruit 12,000 adults aged between 30 and 70 years for 15 years. Baseline assessment includes a wide range of established NCD risk factors obtaining by face-to-face interview or examination. The questionnaires consist of demographic and socioeconomic characteristics, lifestyle pattern, fuel consumption and pesticide exposures, occupational history and hazards, personal and familial medical history, medication profile, oral hygiene, reproduction history, dietary intake, and psychological conditions. Examinations include body size and composition test, abdominopelvic and thyroid ultrasonography, orthopedic evaluation, pulse wave velocity test, electrocardiography, blood pressure measurement, smell-taste evaluation, spirometry, mammography, and preferred tea temperature assessment. Routine biochemical, cell count, and fecal occult blood tests are also performed, and the biological samples (i.e., blood, urine, hair, and nail) are stored in preserving temperature. Annual telephone interviews and repeated examinations at 5-year intervals are planned to update information on health status and its determinants.ResultsA total of 5287 individuals (mean age of 43.9 ± 7.6 and 45.9% male) were included in the study thus far. About 18.5% were nurses and midwives and 44.2% had at least bachelor’s degree. Fatty liver (15.4%), thyroid disorders (11.2%), hypertension (8.8%), and diabetes (4.9%) were the most prevalent NCDs. A large proportion of the population had some degree of anxiety (64.2%). Low physical activity (13 ± 22.4 min per day), high calorie intake (3079 ± 1252), and poor pulse-wave velocity (7.2 ± 1.6 m/s) highlight the need for strategies to improve lifestyle behaviors.ConclusionThe PERSIAN Organizational Cohort study in Mashhad University of Medical Sciences is the first organizational cohort study in a metropolitan city of Iran aiming to provide a large data repository on the prevalence and risk factors of the NCDs in a developing country for future national and international research cooperation.

Real world experience from 1000 patients. Preprocedural DOAC interruption impacts detectable DOAC serum levels but not adverse events after catheter ablation of atrial fibrillation

Abstract Introduction Direct oral anticoagulation (DOAC) therapy represents the standard of care in patients with atrial fibrillation (AF) and increased stroke risk. In a real world setting withholding DOAC medication before elective AF ablation is considered to reduce procedural bleeding risks. The aim of this study was to determine the individual DOAC level prior to the ablation procedure, to identify predisposing factors affecting traceable DOAC levels and to screen for associated severe adverse events. Methods Between September 2016 and March 2019 blood samples were obtained from patients on DOAC before an elective AF ablation. Per institutional standard all patients have been instructed to pause DOAC medication prior ablation for one or two doses depending on the patient profile and type of medication. The time interval between ablation and last DOAC intake was calculated in hours. Patient characteristics, procedural data and in-hospital complications were noted from all patients. Results A total of 1000 patients (60% male, age: 68y, GFR 83.25: BMI: 28, CHADSVASC score 3) undergoing AF ablation were included. Two groups were defined. Group A (n=416, 41.6%): patients treated with “single pill” DOAC (Rivaroxaban (n=288, 28.8%) and Edoxaban (n=128, 12.8%)). Group B (n=584, 58.4%): patients treated with twice a day DOAC (Apixaban (n=505, 50.5%) and Dabigatran (n=79, 7.9%)). The only difference in patient characteristics was an increased prior bleeding history in group B. The DOAC pause was significantly longer in group A (mean 40h) compared to group B (mean 32h), p=0.026. In a total of 217 patients (21.7%) DOAC levels where traceable prior to AF ablation. Traceable DOAC levels were significantly more common in group B (n=144/584, 24.7%) compared to group A (n=73/416, 17.5%). Adverse events occurred in 5.7% of patients (0.4% stroke, 0.3% tamponade, 2.5% hematoma, 1.9% AV-fistel, 0.7% pseudoaneurysma). T-Test analysis showed no significant difference in the occurrence of adverse events between both groups. Conclusion Despite of interrupting DOACs before an elective AF ablation therapeutic substance levels can be detected in >20% of patients. The rate of adverse events was not different between “single pill” vs. twice a day DOAC intake. Funding Acknowledgement Type of funding source: None

Assessment of Prescription Medications for Indoor Patients and Effect of Interventions in a Medical College Hospital.

Bharati Vidyapeeth University Medical College Hospital and Research Centre in Pune, India has been a pioneer institute with 831 beds, with learned faculty, residents, and trained nursing and supportive staff. Top management decided to further improve quality and safety in patient care and accordingly felt the need to acquire accreditation under the banner of National Accreditation Board for Hospitals and Healthcare Providers (NABH). As a first step toward this, a quality assurance department was established and entrusted with the task to identify areas needing improvement. "Prescription profile of medications" was identified as one of the core areas needing improvement as medication errors are mostly due to faulty prescriptions. The aim of this study was to measure the compliance of indoor patient prescriptions towards standard guidelines. Top management of the hospital envisaged that preparing for NABH accreditations would be one of the tools for improving patient safety and quality. Hence, in addition to a quality assurance department, a separate department of clinical pharmacy and pharmacovigilance was also established, specifically to take care of medication safety, including prescription profile. Interventions were designed based on observations in the preintervention phase. Interventions included regular monitoring of prescriptions, medication safety, and repeated training sessions for physicians by the department of clinical pharmacy and quality assurance. Compliance by physicians regarding most of the components of prescriptions showed improvement. There has been a substantial reduction in medication errors (in patient days). The improvement in compliance of components of prescriptions and reduction in medication errors was attributable to applied interventions.

Residual functional SYNTAX score by quantitative flow ratio and improvement of exercise capacity after revascularization in patients with stable ischemic heart disease

Abstract Background In patients with stable ischemic heart disease (SIHD), the efficacy of percutaneous coronary intervention (PCI) in improving exercise capacity has been under debate and the differential effect of PCI for exercise capacity, according to functional completeness of revascularization, has not been evaluated. Purpose This study aimed to evaluate the association between improvement in exercise capacity and functional completeness of revascularization, determined by residual functional SYNTAX score (rFSS), which is the sum of residual SYNTAX score of the vessels with post-PCI quantitative flow ratio (QFR)≤0.80. Methods Among patients enrolled in the QFR multicenter registry, 110 patients who underwent prespecified routine exercise treadmill tests before and after PCI were analyzed. Patients were classified into functional complete revascularization (CR) group (rFSS=0) and functional incomplete revascularization (IR) group (rFSS≥1). Increase of exercise time after PCI was compared between the 2 groups. Improvement of exercise capacity was defined as ≥10% increase of exercise time after PCI. Results Functional CR was achieved in 79 patients (71.8%), otherwise classified as functional IR in 31 patients (18.2%). There were no significant differences in baseline characteristics including medication profiles. Increase of exercise time was significantly associated with increase of 3-vessel QFR (r=0.198, P=0.038) and rFSS (r=−0.312, P<0.001), but not with decrease of SYNTAX score (r=0.097, P=0.313). The rFSS showed significantly higher c-index to predict the improvement of exercise capacity after PCI than increase of 3-vessel QFR or decrease of SYNTAX score (0.722 vs. 0.627 vs. 0.492, respectively, P<0.001). Patients with functional CR, defined by rFSS, showed significantly higher increase of exercise time than those with functional IR (97.7 sec vs. 12.5 sec, P<0.001). Functional CR was an independent predictor of the improvement of exercise capacity after PCI (adjusted odds ratio 4.656, 95% CI 1.678–12.920, P=0.002). Conclusions Integrated anatomic and functional scoring system (rFSS) was significantly associated with improvement of exercise capacity after PCI. SIHD patients with functional CR, defined by rFSS, showed significantly higher exercise capacity after PCI than those with functional IR. Summarizing Figure Funding Acknowledgement Type of funding source: Private company. Main funding source(s): SaeHan NK & D and Medis Corporation

Análise do perfil sociodemográfico e de utilização de medicamentos de idosos atendidos em ambulatório universitário

Estima-se que em 2020 13,6% da população será idosa, estes pacientes geralmente são acometidos por doenças crônicas, tornando-se prioridade nos cuidados de saúde. O objetivo desta pesquisa foi caracterizar o perfil sociodemográfico e de utilização de medicamentos de 200 pacientes tratados em um ambulatório de uma universidade privada em São Paulo. Foram analisados prontuários de pacientes atendidos pelo ambulatório da universidade de 2012 a 2016, autorizado pelo Comitê de Ética com o parecer nº 1.587.320. Os medicamentos foram classificados de acordo com a Anatomical Therapeutic Chemical (ATC) e os Critérios de Beers da Sociedade Americana de Geriatria de 2015 serviram como base para a classificação dos medicamentos inapropriados para idosos. Com relação a amostra, 70% da população era feminina, a média de idade foi 71±8 anos, 40,5% dos usuários não possuíam o ensino fundamental completo ou eram analfabetos. Observou-se 36% de pacientes polimedicados e mais da metade acometidos por comorbidades. As classes de medicamentos mais utilizadas foram inibidores da bomba de prótons e benzodiazepínicos. É pertinente nas pesquisas o uso irracional de omeprazol e os benzodiazepínicos são caracterizados como inseguros para idosos de acordo com os critérios de Beers. Conclui-se com essa pesquisa a importância de analisar o perfil da população atendida e consequentemente ofertar serviços mais qualificados, bem como a relevante atuação do farmacêutico no que se refere ao uso racional de medicamentos nos atendimentos de idosos.

Potentially inappropriate medication in older psychiatric patients.

Many psychotropic drugs are listed as potentially inappropriate medication (PIM) in the older population. Potentially inappropriate means that prescription of those drugs in older adults may cause significant harm. The objective of this study was to analyze the prevalence and sort of PIM prescribing in a naturalistic, real-world psychiatric setting. The retrospective analysis gathered data from a large pharmacovigilance study, conducted at 10 psychiatric hospitals. Data from inpatients aged ≥ 65years were included for the analysis. The number and sort of PIM, as defined by the German PRISCUS list, were controlled by analyzing the patients' medication profile. In total, 4760 patient cases (59.2% female) with a mean (mean ± standard deviation (SD)) age of 77.33 ± 7.77years were included into the study. Altogether, 1615 cases (33.9%) received at least 1 PRISCUS-PIM per day (regular and as-needed medication included). The most frequently prescribed PRISCUS-PIM (n = 2144) were zopiclone > 3.75mg/day (n = 310), lorazepam > 2mg/day (n = 269), haloperidol > 2mg/day (n = 252), and diazepam (n = 182). Cases with PRISCUS-PIM were younger (75.7 vs. 78.2years, p < 0.001) and had a longer (26 vs. 22days, p < 0.001) hospital length of stay. Replacing benzodiazepines and z-substances, haloperidol > 2mg, tricyclic antidepressants, first generation antihistaminergic drugs, and clonidine by non-PIM could reduce 69.9% of PRISCUS-PIM-prescribing. The prevalence of PRISCUS-PIM is high in the hospitalized psychiatric setting. Rational deprescribing of inappropriate anticholinergics, benzodiazepines, and antipsychotics in the older population is a key component to reduce the risk of adverse drug reactions. More tolerable medications should be prescribed.

Student Pharmacist Perceptions of the Utility of a Medication Therapy Management-Based, Medication-Related, Falls Risk-Assessment Tool

OBJECTIVE: To evaluate student pharmacists' perceptions of the Medication Fall Risk-Assessment Tool (MFRAT), a novel medication therapy management (MTM)-based clinical decision support tool.<br/> DESIGN: A cross-sectional study<br/> SETTING: One school of pharmacy<br/> PARTICIPANTS: Participants were eligible if they had used the MFRAT as part of a wellness clinic or as part of required coursework prior to April 2016.<br/> INTERVENTIONS: An online, author developed survey was distributed to assess previous MFRAT use, perceptions of the tool on a 5-point Likert-type scale, and qualitative feedback related in the areas of pharmacy workflow, clinical utility, and perceived patient acceptance.<br/> MAIN OUTCOME MEASURE(S): Positive agreement to survey items served as the main outcome measure. A chi-square test was used to test for a difference in positive response between naive and experienced MFRAT users. Cronbach's alpha was calculated to assess internal consistency of items in each domain.<br/> RESULTS: Of the 127 potential participants surveyed, 110 completed the survey for an overall response rate of 87%. Greater than 85% of participants found the MFRAT's report clinically useful. Eighty-seven percent of respondents agreed or strongly agreed that the information provided by the tool could easily be understood by patients. The most significant limitation to the use if the MFRAT in existing workflow was time required to enter a patient's medication profile.<br/> CONCLUSION: The MFRAT was viewed positively in terms of clinical utility and perceived patient acceptance. Improvements will need to be made to make using the tool more time efficient in pharmacy MTM workflow.

Student Pharmacist Perceptions of the Utility of a Medication Therapy Management-Based, Medication-Related, Falls Risk-Assessment Tool.

OBJECTIVE: To evaluate student pharmacists' perceptions of the Medication Fall Risk-Assessment Tool (MFRAT), a novel medication therapy management (MTM)-based clinical decision support tool.<br/> DESIGN: A cross-sectional study<br/> SETTING: One school of pharmacy<br/> PARTICIPANTS: Participants were eligible if they had used the MFRAT as part of a wellness clinic or as part of required coursework prior to April 2016.<br/> INTERVENTIONS: An online, author developed survey was distributed to assess previous MFRAT use, perceptions of the tool on a 5-point Likert-type scale, and qualitative feedback related in the areas of pharmacy workflow, clinical utility, and perceived patient acceptance.<br/> MAIN OUTCOME MEASURE(S): Positive agreement to survey items served as the main outcome measure. A chi-square test was used to test for a difference in positive response between naive and experienced MFRAT users. Cronbach's alpha was calculated to assess internal consistency of items in each domain.<br/> RESULTS: Of the 127 potential participants surveyed, 110 completed the survey for an overall response rate of 87%. Greater than 85% of participants found the MFRAT's report clinically useful. Eighty-seven percent of respondents agreed or strongly agreed that the information provided by the tool could easily be understood by patients. The most significant limitation to the use if the MFRAT in existing workflow was time required to enter a patient's medication profile.<br/> CONCLUSION: The MFRAT was viewed positively in terms of clinical utility and perceived patient acceptance. Improvements will need to be made to make using the tool more time efficient in pharmacy MTM workflow.

The Toxicity Evaluation of Salvia rhytidea and Glycine Max Extracts versus the Biochemical and Histological Indices of Liver and Kidney Functions in Mice

Background: The safety of the use of medicinal plants is a general challenge among consumers. To improve the use, it is necessary to provide complete profiles of the natural medications for quality control and the therapeutic and toxicity effects. This study was conducted to evaluate the structural and functional toxicity of the methanolic extracts of Salvia rhytidea and Glycine max plants in mice. Methods: After determining the LD50, NMRI mice with mean weight of 25-30 g were treated intraperitoneally with 100, 200 and 400 mg/kg, and orally with 800 mg/kg of the extracts for 7 consecutive days. After the last treatment, the serum samples were prepared and used for the biochemical assays. The liver and left kidney were removed from the animals and fixed in 10% formalin for histopathological examinations. Results: The results indicated that the biochemical parameters of liver and kidneys were not significantly different among the experimental and control groups (P&gt;0.05). Mild degenerative changes in the liver and kidneys were observed at the IP dose of 400 mg/kg and oral dose of 800 mg/kg of both extracts. Conclusion: The use of these plants’ extracts did not induce severe toxicity in the short-term; however, caution should be exercised with the long-term use.

Impact of pharmacy technicians as part of an integrated health-system pharmacy team on improvement of medication access in the care of cystic fibrosis patients.

Cystic fibrosis (CF) is a genetic disease requiring patients to take multiple medications per day. Multiple barriers exist affecting access and adherence. Studies have demonstrated the positive outcomes of pharmacist involvement in CF care. The purpose of this study is to characterize the impact of pharmacy technicians on medication access in the care of CF patients. A retrospective review and analysis of patient medication profiles for patients followed by the integrated pharmacy care process model was performed. Two electronic prescription pathways with pharmacy technician involvement were analyzed. One pathway using a specialty pharmacy CF pharmacy technician (SP technician) examined CF specialty medication delivery times. The other pathway examined the impact of the clinic-based CF pharmacy technician (CB technician) on the number of filling pharmacies for patients. One-hundred and fifty-three patients met inclusion criteria in the CF specialty medication delivery analysis, and 56 patients met inclusion criteria filling pharmacy analysis. The median delivery time for dornase alfa decreased from 8 days to 3 days, p < .00001. The number of patients utilizing one filling pharmacy increased from 8 (14%) to 21 (38%)(p = .005); and utilizing three filling pharmacies decreased from 14 (25%) to 1 (2%)(p = .003). The study demonstrated that pharmacy technicians as part of an integrated health-system pharmacy care process model improve medication access in the care of CF patients.

Intrauterine Exposure to Biologics in Inflammatory Autoimmune Diseases: A Systematic Review.

BackgroundInflammatory autoimmune diseases are chronic diseases that often affect women of childbearing age. Therefore, detailed knowledge of the safety profile of medications used for management of inflammatory autoimmune diseases during pregnancy is important. However, in many cases the potential harmful effects of medications (especially biologics) during pregnancy (and lactation) on mother and child have not been fully identified.ObjectiveOur aim was to update the data on the occurrence of miscarriages and (major) congenital malformations when using biologics during pregnancy based on newly published articles. Additionally, we selected several different secondary outcomes that may be of interest for clinicians, especially information on adverse events in the use of a specific biologic during pregnancy.Material and MethodsA search was conducted from 1 January 2015 until 4 July 2019 in Embase.com, Medline Ovid, Web of Science, Cochrane CENTRAL, and Google Scholar with specific search terms for each database. Selection of publications was based on title/abstract and followed by full text (double blinded, two researchers). An overview was made based on outcomes of interest. References of the included publications were reviewed to include and minimize the missing publications.ResultsA total of 143 publications were included. The total number of cases ranged from nine for canakinumab to 4276 for infliximab. The rates of miscarriages and major congenital malformations did not show relevant differences from those rates in the general population.ConclusionDespite limitations to our study, no major safety issues were reported and no trend could be identified in the reported malformations.Electronic supplementary materialThe online version of this article (10.1007/s40265-020-01376-y) contains supplementary material, which is available to authorized users.

Treatment of psoriasis in pregnancy.

Many women report improvement in psoriasis during pregnancy; others report that psoriasis becomes worse during pregnancy. Balancing effective management of psoriasis against potential risk in pregnancy is important, especially because the severity of psoriasis can have an impact on the pregnancy experience and possibly the outcome. This article discusses current understanding of pregnancy risk profiles of medications used to treat psoriasis.

Patient and caregiver benefit-risk preferences for nonmetastatic castration-resistant prostate cancer treatment.

BackgroundRecently approved second‐generation androgen receptor inhibitors (SGARIs) for non‐metastatic castration‐resistant prostate cancer (nmCRPC) have similar efficacy but differ in safety profiles. We used a discrete choice experiment (DCE) to examine how nmCRPC patients and caregivers perceive the benefits versus risks of these new treatments.MethodsAn online DCE survey with 14 treatment choice questions was administered to nmCRPC patients and caregivers. Each choice question compared two hypothetical medication profiles varying in terms of 5 safety attributes (risk or severity of adverse events [AEs]: fatigue, skin rash, cognitive problems, serious fall, and serious fracture) and two efficacy attributes (duration of overall survival [OS] and time to pain progression). Random parameters logit models were used to estimate each attribute's relative importance. We also estimated the amounts of OS that respondents were willing to forego for a reduction in AEs.ResultsIn total, 143 nmCRPC patients and 149 caregivers viewed the AEs in following order of importance (most to least): serious fracture, serious fall, cognitive problems, fatigue, and skin rash. On average, patients were willing to trade 5.8 and 4.0 months of OS to reduce the risk of serious fracture and fall, respectively, from 3% to 0%; caregivers were willing to trade 6.6 and 5.4 months of OS.ConclusionsnmCRPC patients and caregivers preferred treatments with lower AE burdens and were willing to forego OS to reduce the risk and severity of AEs. Our results highlight the importance of carefully balancing risks and benefits when selecting treatments in this relatively asymptomatic population.

Effects of cardiovascular medications on primary patency of hemodialysis arteriovenous fistula

While the patency of vascular access is essential for hemodialysis patients, optimal pharmaceutical treatment to maintain arteriovenous fistula (AVF) patency remains lacking. As cardiovascular diseases are highly prevalent in patients with end-stage renal disease, various cardiovascular medications have also been used to maintain AVF patency. However, previous studies revealed inconsistent therapeutic effects and a comprehensive evaluation of this issue is needed. The present retrospective, longitudinal cohort study included patients receiving successful AVF creation. The evaluated cardiovascular medications included antiplatelet agents, antihypertensive agents, nitrates and nitrites, statins, dipyridamole, and pentoxifylline. The outcome was AVF primary patency. All laboratory data and medication profiles were recorded at baseline and followed at 3-month interval, until the end of the 2-year study period. Cox proportional regression model with time-dependent covariates was used to evaluate the risk for AVF patency loss. A total of 349 patients were included in the present study, in which 57% were men and the mean age was 65 ± 14 years. Among the included patients, 40% used antiplatelet agents, 27% used dipyridamole and 36% used statins at baseline. Of all the evaluated cardiovascular medications, only dipyridamole showed significant association with a higher risk for loss of AVF patency. To evaluate the effect of combination of antiplatelet agents and dipyridamole, the patients were classified into four groups, I: combine use of antiplatelet agents and dipyridamole, II: antiplatelet only, III: dipyridamole only; IV: none of both were used. Of the four groups, group IV exhibited highest AVF patency (52.4%), which was followed by group III (42.7%), group II (40%), and group I (28.6%), respectively. Compared with group IV, only group I showed a significantly higher risk for AVF patency loss. None of the cardiovascular medications evaluated in the present study showed a beneficial effect on AVF patency. Furthermore, dipyridamole showed an association with a higher risk of AVF patency loss. We do not suggest a beneficial effect of dipyridamole on maintaining AVF patency, particularly in combination with antiplatelet agents.

Baseline Prevalence of Polypharmacy in Older Hypertensive Study Subjects with Elevated Dementia Risk: Findings from the Risk Reduction for Alzheimer's Disease Study (rrAD).

Little is known about the prevalence of polypharmacy, the taking of five or more medications a day, in older adults with specific dementia risk factors. To examine the prevalence of polypharmacy in participants at baseline in a vascular risk reduction focused Alzheimer's disease (rrAD) trial targeting older patients with hypertension and elevated dementia risk. We conducted a detailed review of medications in a cross-sectional study of community-dwelling older adults with hypertension and elevated dementia risk. Medications were identified in a structured interview process with an onsite pharmacist or qualified designee. Polypharmacy was defined as use of five or more medications on a regular basis. Descriptive analyses were conducted on the sample as well as direct comparisons of subgroups of individuals with hypertension, diabetes, and hyperlipidemia. The 514 rrAD participants, mean age 68.8 (standard deviation [sd] 6), reported taking different combinations of 472 unique medications at their baseline visit. The median number of medications taken by participants was eight [Range 0-21], with 79.2% exhibiting polypharmacy (n = 407). Sites differed in their prevalence of polypharmacy, χ2(3) = 56.0, p < 0.001. A nearly identical percentage of the 2,077 prescribed (51.8%) and over the counter (48.2%) medications were present in the overall medication profile. The presence of diabetes (87.5%), hyperlipidemia (88.2%), or both (97.7%) was associated with a higher prevalence of polypharmacy than participants who exhibited hypertension in the absence of either of these conditions (63.2%), χ2(3) = 35.8, p < 0.001. Participants in a dementia risk study had high levels of polypharmacy, with the co-existence of diabetes or hyperlipidemia associated with a greater prevalence of polypharmacy as compared to having hypertension alone.

Differences in safety profiles of newly approved medications for multiple myeloma in real-world settings versus randomized controlled trials

Four new agents (elotuzumab, ixazomib, panobinostat, and daratumumab) were approved by the US Food and Drug Administration (FDA) in 2015 for the treatment of multiple myeloma. Our objective was to compare the safety profiles of these new medications in real-world settings and their randomized controlled trial(s). An analysis was conducted of the FDA Adverse Event Reporting System (FAERS) for each drug consisting of the quarter that the drug received its FDA approval and the eight subsequent quarters. Reporting odds ratios and corresponding 95% confidence intervals were then calculated for each drug for each of the 10 most frequent adverse drug reactions. The randomized controlled trials that led to initial FDA approval for these medications were subsequently reviewed to assess the 10 most frequently reported adverse drug reactions in these trials. There were only two adverse drug reactions in the top 10 of both FAERS and its randomized controlled trials for elotuzumab (anaemia, diarrhoea) and for daratumumab (cough, back pain), five for ixazomib (diarrhoea, constipation, fatigue, nausea, peripheral neuropathy), and four panobinostat (diarrhoea, fatigue, nausea, constipation). Ixazomib had two adverse drug reactions with a significant reporting odds ratios greater than a 10-fold increased risk (plasma cell myeloma, peripheral neuropathy); elotuzumab had three adverse drug reactions (infusion site reaction, malignant neoplasm progression, deep vein thrombosis); daratumumab had three adverse drug reactions (infusion site reaction, bronchospasm, chills), while panobinostat had four (malignant neoplasm progression, decreased platelet count, diarrhoea, increased blood creatinine). This analysis helps to highlight the importance of conducting postmarketing pharmacovigilance studies to better understand the potential adverse reactions of these medications.

Potentially inappropriate medications in elderly patients with heart failure: Beers Criteria-based study.

Primary objectives were to evaluate the use of potentially inappropriate medication (PIM) use in elderly heart failure (HF) patients and the factors associated with the number of PIMs. Secondary objectives were to test for the correlation between PIMs and quality of life (QOL) and depression. A cross-sectional study was conducted among 125 elderly Lebanese HF patients with left ventricular ejection fraction <50%. Data on socio-demographics, clinical data and medications were collected. Patients were interviewed with Minnesota living with Heart Failure Questionnaire (MLHFQ) and Patient Health Questionnaire-9 (PHQ-9). Medication profile per patient was evaluated for PIMs using Beers Criteria. The correlations between the number of PIMs and the MLHFQ, PHQ-9 and the number of medications were tested using Pearson's correlation. Linear regression was done to predict the factors associated with the number of PIMs. Patients were taking a total of 1035 medications with a mean of 8.28±3.14 medications. In total, 80.0% of patients were taking at least one PIM. Diuretics (55.2%) and proton pump inhibitors (41.6%) were most commonly prescribed PIMs. The number of PIMs was moderately correlated with the number of medications and the MLHFQ score. Linear regression showed that the number of medications, age ≥85years, chronic kidney disease and HF with New York Heart Association III were associated with more PIMs. A high percentage of PIMs was found among a sample of elderly Lebanese HF patients. HF multidisciplinary team is needed to control the prescription of PIMs in this vulnerable population.

Residual functional SYNTAX score by quantitative flow ratio and improvement of exercise capacity after revascularization.

This study aimed to evaluate the association between improvement in exercise capacity and functional completeness of revascularization, determined by residual functional SYNTAX score (rFSS), which is the sum of residual SYNTAX score of the vessels with post- percutaneous coronary intervention (PCI) quantitative flow ratio (QFR) ≤0.80. In patients with stable ischemic heart disease (SIHD), the efficacy of PCI in improving exercise capacity has been under debate and the differential effect of PCI for exercise capacity, according to functional completeness of revascularization, has not been evaluated. Among patients enrolled in the QFR multicenter registry, 110 patients who underwent routine exercise treadmill tests before and after PCI were analyzed. Patients were classified into functional complete revascularization (CR) group (rFSS = 0) and functional incomplete revascularization (IR) group (rFSS ≥ 1). Increase of exercise time after PCI was compared between the two groups. Improvement of exercise capacity was defined as ≥10% increase of exercise time after PCI. Functional CR was achieved in 79 patients (71.8%), otherwise classified as functional IR in 31 patients (28.2%) without differences in baseline characteristics including medication profiles. Increase of exercise time was significantly associated with increase of 3-vessel QFR (sum of QFRs in all three vessels; r = .198, p = .038) and rFSS (r = -.312, p < .001), but not with decrease of SYNTAX score (r = .097, p = .313). The rFSS showed significantly higher c-index to predict the improvement of exercise capacity after PCI than increase of 3-vessel QFR or decrease of SYNTAX score (0.722 vs. 0.627 vs. 0.492, respectively, p < 0.001). Patients with functional CR, defined by rFSS, showed significantly higher absolute and relative increase in exercise time than those with functional IR (97.7 s vs. 12.5 s, p < .001; 25.4% vs. 3.6%, p = .001). Functional CR was an independent predictor for improvement of exercise capacity after PCI (adjusted OR 4.656, 95% CI 1.678-12.920, p = .002). Integrated anatomic and functional scoring system (rFSS) was significantly associated with improvement of exercise capacity after PCI. SIHD patients with functional CR, defined by rFSS, showed significantly higher exercise capacity after PCI than those with functional IR.

Florfenicol 경구 투여에 따른 조피볼락 혈액의 약동학적 특성

The pharmacokinetics characterization of florfenicol(FF) after single oral medication was studied in the cultured korean rockfish, Sebastes schlegelii, using high performance liquid chromatography(HPLC). After single oral medication of FF(20 ㎎/㎏ body weight) in the cultured Korean rockfish(590±50 g, 23±1.5℃), the FF concentration in the serum was determined at different period(1, 5, 10, 15, 24, 30, 50 and 168 h post dose). The pharmacokinetics profile of FF oral medication in serum were analyzed to a one- or two-compartment model by WinNonlin program, respectively. Under the one-compartment model, the area under the concentration-time curve(AUC), maximum concentration(Cmax) and time for maximum concentration(Tmax) were 31.84 ㎍·h/㎖, 1.14 ㎍/㎖, and 9.3 h, respectively. Under the two-compartment model, the AUC, Cmax and Tmax were 45.52 ㎍·h/㎖, 1.14 ㎍/㎖ and 9.43 h, respectively. The results of this study could be used for determining efficacy dosage and withdrawal times of FF for the therapy of bacterial diseases in korean rockfish.

Associations of Maternal Use of Benzodiazepines or Benzodiazepine-like Hypnotics During Pregnancy With Immediate Pregnancy Outcomes in Norway

Understanding the safety profile of medications used in pregnancy is crucial for clinical decision-making. Few studies exist on the associations of exposure to benzodiazepines and benzodiazepine-like hypnotic drugs (z-hypnotics) in pregnancy with pregnancy outcomes. To determine whether exposure to benzodiazepines or z-hypnotics in pregnancy is associated with greater risk of negative immediate pregnancy outcomes compared with nonexposure. This questionnaire-based cohort study used data from the Norwegian Mother, Father and Child cohort study (MoBa), which also includes data from the Medical Birth Registry of Norway. Pregnant women were recruited from all over Norway from 1999 and 2008. The first child was born in October 1999 and the last in July 2009. This analysis included women who completed 3 questionnaires, twice during pregnancy and once 6 months after delivery. Data analyses were conducted from September to November 2019. Self-reported exposure to benzodiazepines or z-hypnotics during pregnancy, characterized in terms of any exposure, timing (ie, early, middle, or late), and duration of exposure. The main outcomes were gestational age at delivery, risk of preterm delivery, birth weight, birth weight relative to gestational age and sex, risk of being small for gestational age, head circumference, Apgar score less than 7 at 5 minutes, and risk of neonatal respiratory distress. Continuous outcomes are reported using effect estimates as mean differences, and binary outcomes are reported using risk ratios. The MoBa study included 114 234 mother-child dyads. This analysis of MoBa data includes 82 038 singleton pregnancies among 69 434 unique women. Mean (SD) maternal age was 30.2 (4.5) years, and 37 641 pregnancies (45.9%) were in primiparous women. Exposure to benzodiazepines or z-hypnotics was reported in 679 pregnancies (0.8%). After adjusting for all measured baseline and postbaseline confounders, benzodiazepine or z-hypnotic use during pregnancy was associated with lower birth weight (mean difference, -79.3 [95% CI, -126.7 to -31.9] g), lower gestational age at birth (mean difference, -2.1 [95% CI, -3.3 to -0.9] days), and higher risk of preterm birth (risk ratio, 1.41 [95% CI, 1.03 to 1.94]). We found no significant association of exposure to benzodiazepines or z-hypnotics with the child's birth weight relative to gestational age and sex (z score), or any of the other immediate birth outcomes. These findings suggest that the magnitude of the association of exposure to benzodiazepines or z-hypnotics with gestational age is not necessarily clinically significant. The absence of an association of exposure to benzodiazepines or z-hypnotics with z score for birth weight relative to gestational age and sex suggests that association of exposure to benzodiazepines or z-hypnotics with birth weight could be explained by earlier delivery rather than impaired intrauterine growth.