Chemotherapy-induced nausea and vomiting in patients with breast cancer: a prospective cohort study.

Breast Cancer. 2020 Jan;27(1):122-128

Authors: Naito Y, Kai Y, Ishikawa T, Fujita T, Uehara K, Doihara H, Tokunaga S, Shimokawa M, Ito Y, Saeki T

Abstract
PURPOSE: To explore the actual status of chemotherapy-induced nausea and vomiting (CINV) through a multicenter prospective cohort study.
METHODS: Patients with breast cancer treated with moderately emetogenic (MEC) or highly emetogenic (HEC) chemotherapy were eligible. A 7-day diary was provided for all patients. Acute and delayed CINV were defined as nausea and vomiting that developed ≤ 24 or > 24 h after the start of chemotherapy, respectively. The severity of nausea was evaluated with a visual analog scale (VAS). We also assessed the accuracy of estimations of CINV by medical staff.
RESULTS: In total, 426 patients were included; 352 patients (82.6%) received HEC, and 74 (17.3%) received MEC. In the acute phase, 44.9% of patients receiving HEC and 5.4% receiving MEC experienced nausea, and 12.8% receiving HEC and none receiving MEC experienced vomiting. More patients experienced nausea in both groups and vomiting in MEC during the delayed phase (nausea: 59.4% in HEC and 44.6% in MEC group; vomiting: 11.1% in HEC; and 13.5% in MEC group) than during the acute phase. Estimations of CINV by medical staff were not accurate, with a kappa coefficient of 0.10 and 0.08 for acute nausea and vomiting and 0.02 and 0.01 for delayed. The VAS scores showed that in the HEC group, the degree of nausea was worst on the first day.
CONCLUSIONS: The degree of nausea was worst in the acute phase, although delayed nausea was more in proportion in HEC. Estimation by medical staff is not accurate.

PMID: 31407150 [PubMed - indexed for MEDLINE]

Symptoms and QOL in breast cancer patients receiving hormone therapy in Japan.

Breast Cancer. 2020 Jan;27(1):62-69

Authors: Iioka Y, Iwata T, Yamauchi H

Abstract
BACKGROUND: The aim was to clarify subjective symptoms and quality of life (QOL) in breast cancer patients receiving hormone therapy.
METHODS: After obtaining approval from the research ethics committee, an observational study using a self-administered questionnaire was conducted at outpatient clinical oncology offices in 3 facilities that targeted breast cancer patients under the age of 50 who had been undergoing hormone therapy for less than 1 year. The study examined elements such as the breast cancer patients' basic information, symptoms, pain in daily life, QOL, and depression/anxiety.
RESULTS: There were 214 valid responses. The respondents had an average age of 43.6. Of them, 100% were also treated with Tamoxifen and 30% with LH-RH agonist. There were 75% who were cognizant of side effects. Difficult symptoms that occurred with high frequency were stiff shoulders/back pain, decreased physical strength, hot flashes, and sweating. Over half the respondents were uncertain as to whether the subjective symptoms were side effects. They lost confidence in their physical strength and felt distressed over weight gain. There were 51 with a HADS anxiety score of 8 or higher, and 46 who scored 8 points or higher for depression.
CONCLUSION: Breast cancer patients undergoing hormone therapy experience a variety of pains, and some also have serious psychological symptoms. Reassessing support systems to examine screening and self-care support is an issue going forward.

PMID: 31297685 [PubMed - indexed for MEDLINE]

Comprehensive Assessment of Side Effects in COVID-19 Drug Pipeline from a Network Perspective.

Food Chem Toxicol. 2020 Sep 21;:111767

Authors: Wu Q, Fan X, Hong H, Gu Y, Liu Z, Fang S, Wang Q, Cai C, Fang J

Abstract
Currently, coronavirus disease 2019 (COVID-19), has posed an imminent threat to global public health. Although some current therapeutic agents have showed potential prevention or treatment, a growing number of associated adverse events have occurred on patients with COVID-19 in the course of medical treatment. Therefore, a comprehensive assessment of the safety profile of therapeutic agents against COVID-19 is urgently needed. In this study, we proposed a network-based framework to identify the potential side effects of current COVID-19 drugs in clinical trials. We established the associations between 116 COVID-19 drugs and 30 kinds of human tissues based on network proximity and gene-set enrichment analysis (GSEA) approaches. Additionally, we focused on four types of drug-induced toxicities targeting four tissues, including hepatotoxicity, renal toxicity, lung toxicity, and neurotoxicity, and validated our network-based predictions by preclinical and clinical evidence available. Finally, we further performed pharmacovigilance analysis to validate several drug-tissue toxicities via data mining adverse event reporting data, and we identified several new drug-induced side effects without labeling in Food and Drug Administration (FDA) drug instructions. Overall, this study provides forceful approaches to assess potential side effects on COVID-19 drugs, which will be helpful for their safe use in clinical practice and promoting the discovery of antiviral therapeutics against SARS-CoV-2.

PMID: 32971210 [PubMed - as supplied by publisher]

Care complexity individual factors associated with adverse events and in-hospital mortality.

PLoS One. 2020;15(7):e0236370

Authors: Adamuz J, Juvé-Udina ME, González-Samartino M, Jiménez-Martínez E, Tapia-Pérez M, López-Jiménez MM, Romero-Garcia M, Delgado-Hito P

Abstract
INTRODUCTION: Measuring the impact of care complexity on health outcomes, based on psychosocial, biological and environmental circumstances, is important in order to detect predictors of early deterioration of inpatients. We aimed to identify care complexity individual factors associated with selected adverse events and in-hospital mortality.
METHODS: A multicenter, case-control study was carried out at eight public hospitals in Catalonia, Spain, from January 1, 2016 to December 31, 2017. All adult patients admitted to a ward or a step-down unit were evaluated. Patients were divided into the following groups based on the presence or absence of three adverse events (pressure ulcers, falls or aspiration pneumonia) and in-hospital mortality. The 28 care complexity individual factors were classified in five domains (developmental, mental-cognitive, psycho-emotional, sociocultural and comorbidity/complications). Adverse events and complexity factors were retrospectively reviewed by consulting patients' electronic health records. Multivariate logistic analysis was performed to identify factors associated with an adverse event and in-hospital mortality.
RESULTS: A total of 183,677 adult admissions were studied. Of these, 3,973 (2.2%) patients experienced an adverse event during hospitalization (1,673 [0.9%] pressure ulcers; 1,217 [0.7%] falls and 1,236 [0.7%] aspiration pneumonia). In-hospital mortality was recorded in 3,996 patients (2.2%). After adjustment for potential confounders, the risk factors independently associated with both adverse events and in-hospital mortality were: mental status impairments, impaired adaptation, lack of caregiver support, old age, major chronic disease, hemodynamic instability, communication disorders, urinary or fecal incontinence, vascular fragility, extreme weight, uncontrolled pain, male sex, length of stay and admission to a medical ward. High-tech hospital admission was associated with an increased risk of adverse events and a reduced risk of in-hospital mortality. The area under the ROC curve for both outcomes was > 0.75 (95% IC: 0.78-0.83).
CONCLUSIONS: Several care complexity individual factors were associated with adverse events and in-hospital mortality. Prior identification of complexity factors may have an important effect on the early detection of acute deterioration and on the prevention of poor outcomes.

PMID: 32702709 [PubMed - indexed for MEDLINE]

[The similarity of drug names as a possible cause of confusion: Analysis of data from outpatient care].

Z Evid Fortbild Qual Gesundhwes. 2020 Apr;150-152:29-37

Authors: Schrader T, Tetzlaff L, Beck E, Mindt S, Geiss F, Hauser K, Franken C

Abstract
BACKGROUND: The incidence of adverse drug events (ADE) described in the literature varies between 6.5 and 20 %. Furthermore, it is assumed that up to 29 % of ADE are due to medication errors as a result of confusion because of similarities in spelling (sound alike) or in name, physical appearance or packaging (look alike). Studies dealing with the so-called "LASA" issue were mostly carried out in inpatient care. As far as we know, no systematic investigations into this subject have been carried out for the outpatient sector where patients themselves take care of the application of their medication. In addition, there is no documentation about medication errors in the home setting. The aim of the present study is to describe the importance of the LASA issue in the home setting where medication errors are likely to occur due to similarity of drug names.
METHODS: In this context, the similarity of names of prescription drugs was systematically analyzed. We examined in detail how often prescription drug pairings showing orthographic and phonetic similarity were dispensed in the investigation period to an individual patient at the same time. Orthographic similarity was defined as relevant at a Levenshtein index value of ≤ 0.4. This corresponds to the similarity measures of the drugs listed in the LASA public lists and means that the similarity in the lettering of two drug names amounts to at least 60 %. Phonetic similarity was analysed using the Cologne Phonetic ("Kölner Phonetik") for the German language.
RESULTS: A total of 255,770 prescriptions were included in the analysis. In 11.4 %, drug pairings were detected that fall below the critical orthographic similarity threshold (Levenshtein index value ≤ 0.4), which represents an increased likelihood of medication error due to the critical similarity of drug names in this fraction. Within this group of "LASA drugs" different degrees of similarity were identified. Even drug pairings with very high orthographic similarity (Levenshtein index value from ≤ 0.1 and 0.1 to ≤ 0.2, 12.4 % and 3.6 % of the drug pairings, respectively) were detected. These drug pairings were mostly different in strength while active ingredients, manufacturer name and pharmaceutical form were the same. For the majority of drug pairings (84 %), the orthographic similarity was lower and showed a Levenshtein index value of ≥ 0.2 to 0.4. Despite different active ingredients, there is a degree of similarity resulting from both identical manufacturer name and pharmaceutical form appearing as part of the drug name. At the phonetic level, the analysis shows comparable frequency of similarity of drug pairings that are subject to potential medication error.
DISCUSSION: For the first time, a study was carried out in the outpatient setting recording the incidence of drug pairings that carry a risk for medication errors resulting from patients' confusion over too similar drug names. In the light of the age structure of the patients to whom these look- or sound-alike drugs are prescribed, we can assume that there is a considerable risk of ADE. The conceivable consequences of such medication errors on a pharmacological level range from relatively harmless to potentially highly dangerous.
CONCLUSION: There is a major need to fully inform patients about this risk of confusion and subsequent medication errors with certain drug combinations. The similarity structures of drug pairings identified in this study could serve as a basis for developing an appropriate information routine.

PMID: 32279980 [PubMed - indexed for MEDLINE]

Drug Repositioning and Target Finding Based on Clinical Evidence.

Biol Pharm Bull. 2020;43(3):362-365

Authors: Kaneko S, Nagashima T

Abstract
Recent pharmacological studies have been developed based on finding new disease-related genes, accompanied by the production of gene-manipulated disease model animals and high-affinity ligands for the target proteins. However, the emergence of this gene-based strategy in drug development has led to the rapid depletion of drug target molecules. To overcome this, we have attempted to utilize clinical big data to explore a novel and unexpected hypothesis of drug-drug interaction that would lead to drug repositioning. Here, we introduce our data-driven approach in which adverse event self-reports are statistically analyzed and compared in order to find and validate new drug targets. The hypotheses provided by such a data-driven approach will likely impact the style of future drug development and pharmaceutical study.

PMID: 32115497 [PubMed - indexed for MEDLINE]

Antidotal or protective effects of honey and one of its major polyphenols, chrysin, against natural and chemical toxicities.

Acta Biomed. 2019 12 23;90(4):533-550

Authors: Samarghandian S, Azimi-Nezhad M, Pourbagher Shahri AM, Farkhondeh T

Abstract
OBJECTIVE: Honey and its polyphenolic compounds are of main natural antioxidants that have been used in traditional medicine. The aim of this review was to identify the protective effects of honey and chrysin (a polyphenol available in honey) against the chemical and natural toxic agents.
METHOD: The scientific databases such as MEDLINE, PubMed, Scopus, Web of Science and Google Scholar were searched to identify studies on the antidotal effects of honey and chrysin against toxic agents.
RESULTS: This study found that honey had protective activity against toxic agents-induced organ damages by modulating oxidative stress, inflammation, and apoptosis pathways. However, clinical trial studies are needed to confirm the efficacy of honey and chrysin as antidote agents in human intoxication.
CONCLUSION: Honey and chrysin may be effective against toxic agents. (www.actabiomedica.it).

PMID: 31910181 [PubMed - indexed for MEDLINE]

The Association Between Potential Opioid-Related Adverse Drug Events and Outcomes in Total Knee Arthroplasty: A Retrospective Study.

Adv Ther. 2020 01;37(1):200-212

Authors: Jones MR, Kramer ME, Beutler SS, Kaye AD, Rao N, Brovman EY, Urman RD

Abstract
INTRODUCTION: Characterization of the clinical and economic impact of opioid-related adverse drug events (ORADEs) after total knee arthroplasty (TKA) may guide provider and hospital system approach to managing postoperative pain after TKA. Our analysis quantifies the rate of potential ORADEs after TKA, the impact of potential ORADEs on length of stay (LOS) and hospital revenue, as well as their association with specific patient risk factors and comorbid clinical conditions.
METHODS: We conducted a retrospective study using the Centers for Medicare and Medicaid Services administrative database to analyze Medicare discharges involving two knee replacement surgery diagnosis-related groups (DRGs) in order to identify potential ORADEs. The impact of potential ORADEs on mean hospital LOS and hospital revenue was analyzed.
RESULTS: The potential ORADE rate in patients who underwent TKA was 25,523 out of 316,858 records analyzed (8.0%). The mean LOS for patients who experienced a potential ORADE was 1.04 days longer than those without an ORADE. The mean hospital revenue per day with a potential ORADE was $1334 (USD) less than without an ORADE. Potential ORADEs were significantly associated with poor patient outcomes such as pneumonia, septicemia, and shock.
CONCLUSION: Potential ORADEs in TKA are associated with longer hospitalizations, decreased hospital revenue, and poor patient outcomes. Certain risk factors may predispose patients to experiencing an ORADE, and thus perioperative pain management strategies that reduce the frequency of ORADEs particularly in at-risk patients can improve patient satisfaction and increase hospital revenue following TKAs.

PMID: 31664696 [PubMed - indexed for MEDLINE]

High Prevalence of Fall-Related Medication Use in Older Veterans at Risk for Falls.

J Am Geriatr Soc. 2020 02;68(2):438-439

Authors: Elias AM, Ogunwale AN, Pepin MJ, Bailey JC, Adams AD, Colón-Emeric CS, Vognsen JD, Schmader KE, Pavon JM

PMID: 31657005 [PubMed - indexed for MEDLINE]

Treatment patterns, adverse events, healthcare resource use and costs among commercially insured patients with mantle cell lymphoma in the United States.

Cancer Med. 2019 12;8(17):7174-7185

Authors: Kabadi SM, Near A, Wada K, Burudpakdee C

Abstract
INTRODUCTION: There are limited data on treatment patterns, adverse events (AEs), and economic burden in younger, commercially insured patients treated for mantle cell lymphoma (MCL).
METHODS: Adults with ≥1 treatment for MCL between 1 November 2013-31 December 2017 were identified from IQVIA Real-World Data Adjudicated Claims-US; index date was first treatment. Patients carried ≥1 MCL diagnosis, were newly treated, and were enrolled continuously for ≥12 months prior to and ≥30 days following index. Patients receiving the four most common MCL regimens were included. Measures included frequency of incident AEs, resource use, and costs overall and by number of AEs. Adjusted logistic regression and generalized linear modeling evaluated risk of hospitalization and all-cause costs per patient per month (PPPM).
RESULTS: Two thousand five hundred and nine treated patients had a drug-specific code and were classified to a specific treatment regimen. Of those patients, 1785 patients received at least one of the four most commonly used MCL regimens (R-CHOP, rituximab monotherapy, B-R, and ibrutinib) at some point over follow-up (median 23 months). R-CHOP was the most common regimen observed in the first line (26%), followed by rituximab monotherapy (19%), B-R (15%), and ibrutinib (5%). The median age was 57 years; median Charlson Comorbidity Index was 0. Among patients receiving the four most common regimens, 63% of patients experienced ≥1 incident AE (R-CHOP 77%, B-R 58%, and ibrutinib 52%). An increasing number of incident AEs was associated with increased hospitalization risk (odds ratio = 2.4; 95% Confidence Interval [CI] 2.1-2.7) and increased mean costs PPPM (cost ratio = 1.1; 95% CI 1.1-1.2).
DISCUSSION: This is the largest study describing treatment patterns and clinical and economic impact of MCL treatment. The most common regimens were R-CHOP, rituximab monotherapy, B-R, and ibrutinib. The majority of treated patients experienced at least one incident AE, with hospitalization risk and all-cause costs increasing as the number of AEs increased.

PMID: 31595715 [PubMed - indexed for MEDLINE]

11 new pubmed citations were retrieved for your search. Click on the search hyperlink below to display the complete search results:

("drug-induced" OR "drug-related") AND ("adverse events" OR "side effects" OR "side-effects")

These pubmed results were generated on 2020/09/24

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11 new pubmed citations were retrieved for your search. Click on the search hyperlink below to display the complete search results:

("drug-induced" OR "drug-related") AND ("adverse events" OR "side effects" OR "side-effects")

These pubmed results were generated on 2020/09/24

PubMed comprises more than millions of citations for biomedical literature from MEDLINE, life science journals, and online books. Citations may include links to full-text content from PubMed Central and publisher web sites.

A Nationwide Study of Severe Cutaneous Adverse Reactions Based on the Multicenter Registry in Korea.

J Allergy Clin Immunol Pract. 2020 Sep 19;:

Authors: Kang DY, Yun J, Lee SY, Koh YI, Sim DW, Kim S, Nam YH, Park JW, Kim SH, Ye YM, Park HK, Kim MH, Jee YK, Jung JW, Yang MS, Kim SH, Lee JK, Kim CW, Hur GY, Kim MY, Park SJ, Kwon YE, Choi JH, Kim JH, Kim SH, La HO, Kang MG, Park CS, Lee SM, Jeong YY, Kim HK, Jin HJ, Jeong JW, Lee J, Lee YW, Lee SE, Kim MS, Kang HR, Korean Severe Cutaneous Adverse Reactions Consortium

Abstract
BACKGROUND: Since severe cutaneous adverse reactions (SCARs) such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS) rarely occur, clinical data based on large scale studies are still lacking.
OBJECTIVE: To provide information on culprit drugs and clinical characteristics, including morbidity and mortality of SCARs based on a nationwide registry.
METHODS: SCAR cases that occurred from 2010 to 2015 were recruited to the Korean SCAR registry from 34 tertiary referral hospitals. Demographics, causative drugs, causality, and clinical outcomes were collected by reviewing the medical record.
RESULTS: A total of 745 SCAR cases (384 SJS/TEN cases and 361 DRESS cases) due to 149 drugs were registered. The main causative drugs were allopurinol (14.0%), carbamazepine (9.5%), vancomycin (4.7%), and antituberculous agents (6.3%). A strong preference for SJS/TEN was observed in carbonic anhydrase inhibitors (100%), nonsteroidal anti-inflammatory drugs (NSAIDs) (84%), and acetaminophen (83%), while dapsone (100%), antituberculous agents (81%), and glycopeptide antibacterials (78%) were more likely to cause DRESS. The mortality rate was 6.6% (SJS/TEN 8.9%, and DRESS 4.2%). The median time to death was 19 days and 29 days in SJS/TEN and DRESS, respectively, and 89.8% of deaths occurred within 60 days after the onset of the skin symptoms.
CONCLUSION: Allopurinol, carbamazepine, vancomycin, and antituberculous agents were the leading causes of SCARs in Korea. Some drugs preferentially caused a specific phenotype. The mortality rate of SCARs was 6.6%, and most of the deaths occurred within two months.

PMID: 32961314 [PubMed - as supplied by publisher]

The role of apatinib combined with paclitaxel (aluminum binding type) in platinum-resistant ovarian cancer.

J Ovarian Res. 2020 Sep 21;13(1):113

Authors: Zhao H, Li R, Wang X, Lu X, Hu M, Zhang J, Zhao X, Song X, Liu Y

Abstract
OBJECTIVE: To assess the anti-tumor activity and side effects of different dosages of paclitaxel (albumin binding type) (hereinafter referred to as nab-P) combined with Apatinib (hereinafter referred to as AP) in platinum-resistant ovarian cancer cell line and xenograft models.
METHODS: SKOV-3/DDP cell line was selected as the research object in cytology experiment. Firstly, we divided it into three groups for experiments to explore the individual effects of nab-P and AP. a): Control group, blank control, no drug intervention; b): nab-P group, nab-P 40 μmol/l; c): AP group, AP 50 μmol/l (Drug doses were IC-50 values that detected by MTT assay). Apoptosis related protein (Bax, bcl-2), vascular related protein(p-VEGFR-2), invasion related protein (MMP-2) expression were detected by Western blot and Cellular immunofluorescence, the invasion ability of tumor cells were detected by Transwell and Cell scratch test. Based on these dates, secondly, establishing different doses of nab-P combined with Ap to explore the curative effect of combination therapy. a): Control group, blank control, no drug intervention; b): Group-1, nab-P 5 μmol/l + AP 10 μmol/l, c): Group-2, nab-P 4.5 μmol/l + AP 10 μmol/l, d): Group-3, nab-P 4 μmol/l + AP 10 μmol/l, e): nab-P group, nab-P 5 μmol/l, f): AP group, AP 10 μmol/l (MTT assay). The combination index was analyzed by Compusyn software, Western blot, Immunofluescence, Transwell and Cell scratch test also were also chose to observe of inhibition effect. Thirdly, we used xenograft models to verify the results of cytological experiments. Tumor-forming BALB/c female nude mice were randomly divided into 4 groups, a): Control group, no drug intervention, only saline injection, b): nab-P 20 mg/kg + AP 150 mg/kg, c): nab-P 18 mg/kg + AP 150 mg/kg, d): nab-P 16 mg/kg + AP 150 mg/kg (The doses were guided by the pharmaceutical manufacturers). The tumor growth curve was analyzed during the experiment. And the apoptosis related protein (Bax, bcl-2), angiogenesis related protein (CD31, p-VEGFR-2) and invasion related protein (MMP-2) were observed by Western blot, Immunofluescence and Immunohistochemistry to analysis the ant-tumor effects. The quality of life in nude mice were observed to analysed the drug-induced side effects.
RESULT: In the separate medication section, (1) The IC-50 value of nab-P was 45.53 ± 4.06 μmol/l, while the AP was 50.66 ± 4.96 umol/L (48 h). (2) The expressions of bcl-2 (nab-P group, AP group), p-VEGFR-2 (AP group), MMP-2(nab-P group, AP group) were higher than Control group, while Bax (nab-P group, AP group) lower (P < 0.01). (3) The cell invasive ability was decreased after the nab-P and AP intervation (P < 0.01). In the combination medication section, (1) Compusyn showed the Combination index (Cl) were all below 1 (Cl < 1), that means nab-P and AP are synergism. (2) The combination IC-50 value was nab-P 5.28 μmol/l + AP 10.56 μmol/l (48 h). (3) In the detection of related protein expression, the combination of drugs can improve the anti-tumor effect, otherwise, after combined with AP, when nab-P were reduced dose in proper quantity, there were no obvious different in drug effect. (4) After reducing the doses of nab-P, the average food intake of nude mice increased from 4.50 g ± 0.17 to 5.55 g ± 0.13, and the one-hour activity increased from 6.11 min ±0.16 to 6.34 min ±0.13.
CONCLUSION: nab-P, a chemotherapeutic agent, can play an anti-tumor role in platinum-resistant ovarian cancer, but it can cause adverse effects that increase with dose. When combined with AP, the two drugs have synergistic effect, which can improve the anti-tumor effects of single drug. In addition, when combined with AP, the doses of nab-P can be appropriately reduced under the standard of recommended to reduce the toxicity of chemotherapy drugs, without affecting the anti-tumor effect.

PMID: 32958014 [PubMed - in process]

A Systems Theoretic Process Analysis of the Medication Use Process in the Operating Room.

Anesthesiology. 2020 08;133(2):332-341

Authors: Samost-Williams A, Nanji KC

Abstract
BACKGROUND: While 4 to 10% of medications administered in the operating room may involve an error, few investigations have prospectively modeled how these errors might occur. Systems theoretic process analysis is a prospective risk analysis technique that uses systems theory to identify hazards. The purpose of this study was to demonstrate the use of systems theoretic process analysis in a healthcare organization to prospectively identify causal factors for medication errors in the operating room.
METHODS: The authors completed a systems theoretic process analysis for the medication use process in the operating room at their institution. First, the authors defined medication-related accidents (adverse medication events) and hazards and created a hierarchical control structure (a schematic representation of the operating room medication use system). Then the authors analyzed this structure for unsafe control actions and causal scenarios that could lead to medication errors, incorporating input from surgeons, anesthesiologists, and pharmacists. The authors studied the entire medication use process, including requesting medications, dispensing, preparing, administering, documenting, and monitoring patients for the effects. Results were reported using descriptive statistics.
RESULTS: The hierarchical control structure involved three tiers of controllers: perioperative leadership; management of patient care by the attending anesthesiologist, surgeon, and pharmacist; and execution of patient care by the anesthesia clinician in the operating room. The authors identified 66 unsafe control actions linked to 342 causal scenarios that could lead to medication errors. Eighty-two (24.0%) scenarios came from perioperative leadership, 103 (30.1%) from management of patient care, and 157 (45.9%) from execution of patient care.
CONCLUSIONS: In this study, the authors demonstrated the use of systems theoretic process analysis to describe potential causes of errors in the medication use process in the operating room. Causal scenarios were linked to controllers ranging from the frontline providers up to the highest levels of perioperative management. Systems theoretic process analysis is uniquely able to analyze management and leadership impacts on the system, making it useful for guiding quality improvement initiatives.

PMID: 32541549 [PubMed - indexed for MEDLINE]

[Roles of Basic Subjects in Pharmacist Education].

Yakugaku Zasshi. 2020;140(3):407-410

Authors: Goto S

Abstract
As a teacher of biochemistry in a school of pharmacy, a basic subject in pharmacist education, I try to include applied topics such as the biochemical mechanisms of diseases and side effects of medicines in relation to basic knowledge of biochemistry for advanced subjects that students will learn in later years. In aging societies, many people visiting community pharmacies are elderly who tend to have health concerns other than diseases diagnosed by physicians. If asked, community pharmacists should be able to give advice on potential problems patients might have, in addition to giving explanations of medicines prescribed. Basic subjects covered in university pharmacy courses should be the most useful in such community settings.

PMID: 32115561 [PubMed - indexed for MEDLINE]

The Necessity of Anti-Tuberculosis Therapy after Resection of Pulmonary Tuberculous Nodules: A Single Center Retrospective Study.

Ann Thorac Cardiovasc Surg. 2020 Aug 20;26(4):190-195

Authors: Wang C, Liu Y, Lin H, Yang L, Yan D, Gong C, Liu S

Abstract
PURPOSE: To discuss the necessity of anti-tuberculosis therapy after resection of asymptomatic pulmonary tuberculous nodules: is postoperative anti-tuberculosis therapy is over-treatment?
METHODS: This is a single-center retrospective study. Patients with solitary pulmonary nodule (SPN) and diagnosed as tuberculosis by pathology were included. Clinical features are collected. The primary end point is tuberculosis relapse and the secondary is adverse drug reactions. Patients are divided into two groups according to the acceptance of anti-tuberculosis treatment after operation (A: treated; B: untreated). Recurrence is diagnosed by multi-disciplinary discussion. The difference of recurrence rate will be compared and the incidence of adverse drug reactions in Group A will be calculated.
RESULTS: A total of 98 patients were enrolled, 66 in Group A and 32 in Group B. No significant difference between two groups was found in the past history of tuberculosis, erythrocyte sedimentation rate (ESR), T-spot positive rate, and the uptake value of 18F-glucose. No relapse of tuberculosis was found in both groups. The incidence of adverse drug reactions in Group A was 61% (40/66), and the rate of severe adverse reaction was 14% (9/66).
CONCLUSIONS: Postoperative recurrence of tuberculosis is rare, anti-tuberculosis treatment seems unnecessary for asymptomatic pulmonary tuberculous nodules. Adverse drug reactions should not be ignored.

PMID: 31776302 [PubMed - indexed for MEDLINE]

Tumor Lysis, Adverse Events, and Dose Adjustments in 297 Venetoclax-Treated CLL Patients in Routine Clinical Practice.

Clin Cancer Res. 2019 07 15;25(14):4264-4270

Authors: Roeker LE, Fox CP, Eyre TA, Brander DM, Allan JN, Schuster SJ, Nabhan C, Hill BT, Shah NN, Lansigan F, Yazdy M, Cheson BD, Lamanna N, Singavi AK, Coombs CC, Barr PM, Skarbnik AP, Shadman M, Ujjani CS, Tuncer HH, Winter AM, Rhodes J, Dorsey C, Morse H, Kabel C, Pagel JM, Williams AM, Jacobs R, Goy A, Muralikrishnan S, Pearson L, Sitlinger A, Bailey N, Schuh A, Kirkwood AA, Mato AR

Abstract
PURPOSE: Clinical trials of venetoclax reported negligible rates of clinical tumor lysis syndrome (TLS) in patients with chronic lymphocytic leukemia (CLL) when using an extended dose escalation schedule. We aimed to understand TLS prophylaxis, rates of select adverse events (AE), and impact of dosing modifications in routine clinical practice.
EXPERIMENTAL DESIGN: This retrospective cohort study included 297 CLL venetoclax-treated patients outside of clinical trials in academic and community centers. Demographics, baseline disease characteristics, venetoclax dosing, TLS risk and prophylaxis, and AEs were collected.
RESULTS: The group was 69% male, 96% had relapsed/refractory CLL, 45% had deletion chromosome 17p, 84% had unmutated IGHV, 80% received venetoclax monotherapy, and median age was 67. TLS risk was categorized as low (40%), intermediate (32%), or high (28%), and 62% had imaging prior to venetoclax initiation. Clinical TLS occurred in 2.7% of patients and laboratory TLS occurred in 5.7%. Pre-venetoclax TLS risk group and creatinine clearance independently predict TLS development in multivariable analysis. Grade 3/4 AEs included neutropenia (39.6%), thrombocytopenia (29.2%), infection (25%), neutropenic fever (7.9%), and diarrhea (6.9%). Twenty-two patients (7.4%) discontinued venetoclax due to an AE. Progression-free survival was similar regardless of number of dose interruptions, length of dose interruption, and stable venetoclax dose.
CONCLUSIONS: These data provide insights into current use of venetoclax in clinical practice, including TLS rates observed in clinical practice. We identified opportunities for improved adherence to TLS risk stratification and prophylaxis, which may improve safety.

PMID: 31004001 [PubMed - indexed for MEDLINE]

Detection of vaginal lactobacilli as probiotic candidates.

Sci Rep. 2019 03 04;9(1):3355

Authors: Pino A, Bartolo E, Caggia C, Cianci A, Randazzo CL

Abstract
The vaginal microbiota of healthy women is dominated by lactobacilli, which exerts important health-promoting effects to the host. In the present study, 261 lactobacilli isolated from vagina of healthy women were screened for their potential probiotic characteristics. Safety features (haemolytic activity, antibiotic susceptibility, bile salt hydrolase activity) and functional properties (resistance to low pH and bile salts, lysozyme tolerance, gastrointestinal survival, antagonistic activity against pathogens, hydrophobicity, auto-aggregation, and co-aggregation abilities, hydrogen peroxide production, biofilm formation, exopolysaccharide production, adhesion capacity to both normal human vagina epithelial cells and Caco-2 epithelial cells, and lactic acid production) were in depth evaluated. Seven strains, identified as Lactobacillus rhamnosus, Lactobacillus helveticus and Lactobacillus salivarius fulfilled the criteria described above. Therefore, the vaginal ecosystem represents a suitable source of probiotic candidates that could be used in new functional formulates for both gastrointestinal and vaginal eubiosis.

PMID: 30833631 [PubMed - indexed for MEDLINE]

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