Telbivudine versus lamivudine and entecavir for treatment-naïve decompensated hepatitis B virus-related cirrhosis.

Clin Exp Med. 2017 May;17(2):233-241

Authors: Yue-Meng W, Li YH, Wu HM, Yang J, Xu Y, Yang LH, Yang JH

Abstract
The long-term effects of telbivudine (TBV) on decompensated hepatitis B virus (HBV)-related cirrhosis were still not established. This study aimed to investigate the efficacy and safety of TBV in such cohort of patients as compared to lamivudine (LAM) and entecavir (ETV). We retrospectively evaluated 130 treatment-naïve patients with HBV-related decompensated cirrhosis who started treatment with TBV (n = 31), LAM (n = 45) or ETV (n = 54). After 24 months of treatment, cumulative virological response (VR) rates (HBV DNA <500 copies/mL) were 83.7, 65.3 and 89.1 % in TBV, LAM and ETV groups, respectively (p = 0.009). Reduction in HBV DNA levels in TBV was -3.66 ± 0.56, significantly higher than LAM (-3.34 ± 0.59; p < 0.05) and lower than ETV group (-3.98 ± 0.52; p < 0.05). The rates of HBeAg loss or seroconversion and normalization of alanine aminotransferase (ALT) were similar among the groups. Child-Turcotte-Pugh (CTP) score and model for end-stage liver disease score in TBV were significantly improved compared to at baseline without difference among the groups. TBV resulted in similar cumulative rates of survival and incidence of hepatocellular carcinoma (HCC) to LAM and ETV. Frequencies of complications from cirrhosis, including variceal bleeding, hepatic encephalopathy and spontaneous bacterial peritonitis, were comparable among the groups. Four patients (16.7 %) in TBV displayed virological breakthrough, lower than LAM and higher than ETV (p = 0.004). Cox regression analysis showed that baseline HBV DNA (hazard ratio 0.743; 95 % confidence interval 0.582-949, p = 0.017) was an independent predictor for VR at 24 months. Long-term therapy with TBV was effective and safe in HBV-related decompensated cirrhosis.

PMID: 27094312 [PubMed - indexed for MEDLINE]

Assessment of Adverse Drug Reaction Due to Cancer Chemotherapy in a Teaching Oncology Hospital in Isfahan, Central of Iran.

Rev Recent Clin Trials. 2016;11(3):266-72

Authors: Vaseghi G, Abed A, Jafari E, Eslami N, Eshraghi A

Abstract
INTRODUCTION: Adverse Drug Reactions (ADRs) are common in hospitalized oncology patients. The kinds of ADRs experienced by cancer patients are varied. Therefore, the identification of appropriate manner in order to prevent ADRs may improve patient outcome.
AIMS: The present study evaluated the incidence, frequency and common types of adverse drug reactions among hospitalized oncology patients.
METHODS: Patients hospitalized at a university oncology center (children and adult) during the calendar year 2012 were randomly selected. Data were collected by reviewing of medical records. The outcome measures included the incidence of observed ADRs and ADR-related admissions and achieving strategies to prevent the emergence of chemotherapy side effects.
RESULTS: ADRs frequently occurred in the age group less than 20 years (22%). Prevalence of leukemia (27%), colon cancer (16.5%) and breast cancer (14%) was higher in our region. Most ADRs were recorded in patients receiving cisplatin (44%), doxorubicin (24%) and 5-fluouracil (20%) as chemotherapy. The most frequently observed ADRs were nauseavomiting, neutropenia and constipation in both pediatric and adult population.
CONCLUSION: This study shows that ADRs occur more frequently in the pediatric group compared to adults. Therefore, optimum use of preventative strategy program may contribute to reducing the incidence and severity of ADRs especially in this group.

PMID: 26282897 [PubMed - indexed for MEDLINE]

Biodistribution and tolerance of intravenous iodine-131-labelled hypericin in healthy dogs.

Vet Comp Oncol. 2018 Jan 04;:

Authors: Abma E, Peremans K, De Vos F, Bosmans T, Kitshoff AM, Daminet S, Ni Y, Dockx R, de Rooster H

Abstract
Hypericin (Hyp) is a necrosis-avid compound that can be efficiently labelled with radioiodine for both diagnostic and therapeutic purposes. Before 131 I-Hyp can be considered as a clinically useful drug in a combination therapy for canine cancer patients, evaluation of its toxicity is necessary. The aim of this study was to investigate the biodistribution and tolerance of a single dose administration of 131 I-Hyp. Three healthy dogs were included. 131 I-Hyp at a dose of 0.2 mg/kg and an activity of 185 MBq was intravenously injected. The effects on physical, haematological and biochemical parameters were characterized and the biodistribution and elimination pattern, the effective half-life and dose rate were assessed. Drug-related adverse events were limited to mild gastrointestinal signs, resolving within 48 hours. No significant differences were found in blood haematology and serum biochemistry before and after treatment. Following administration, highest percentage of injected dose (%ID ± SD) was found in the liver (5.5 ± 0.33), the lungs (4.17 ± 0.14) and the heart (3.11 ± 0.78). After 24 hours, highest %ID was found in colon (4.25 ± 1.45) and liver (3.45 ± 0.60). Clearance from all organs was effective within 7 days. Effective half-life was established at 80 hours, and the dose rate fell below <20 μSv/h at 1 m within 1 day. The current study reveals that single dose treatment with 131 I-Hyp at the described dose is well tolerated by healthy dogs and supports the use of radioiodinated hypericin in a combination therapy for canine cancer patients.

PMID: 29314561 [PubMed - as supplied by publisher]

Artemether-lumefantrine for the treatment of Plasmodium malariae, Plasmodium ovale, and mixed Plasmodium malaria: A prospective clinical trial assessing species-specific efficacy in Gabon.

Antimicrob Agents Chemother. 2018 Jan 08;:

Authors: Groger M, Veletzky L, Lalremruata A, Cattaneo C, Mischlinger J, Zoleko-Manego R, Endamne L, Klicpera A, Kim J, Nguyen T, Flohr L, Remppis J, Matsiegui PB, Adegnika AA, Agnandji ST, Kremsner PG, Mordmüller B, Mombo-Ngoma G, Ramharter M

Abstract
ObjectivesTreatment recommendations for Plasmodium malariae and Plasmodium ovale malaria are largely based on anecdotal evidence. The aim of this study was to systematically assess the efficacy and safety of artemether-lumefantrine for the treatment of patients with uncomplicated P.malariae or P.ovale mono-infections, or mixed Plasmodium infections.Patients and methodsThis prospective study was conducted in Gabon. Patients with microscopically confirmed P.malariae, P.ovale, or mixed species malaria with at least one of these two Plasmodium species were treated with an oral, fixed dose combination of artemether-lumefantrine for three consecutive days. The primary endpoints were per protocol PCR-corrected adequate clinical and parasitological response (ACPR) on days 28 and 42. Tolerability and safety were recorded throughout the follow-up period.Results72 participants (42 male, 30 female) were enrolled, 62.5% of them were PCR corrected mixed Plasmodium infections. Per protocol, PCR corrected ACPR was 96.6% (95%CI 91.9 - 100) on day 28 and 94.2% (95% CI 87.7-100) on day 42. Considering Plasmodium species independently from their co-infecting species, day 42 ACPR was 95.5% (95% CI 89.0-100) for P.falciparum, 100% (exact CI 84.6-100) for P.malariae, 100% (exact CI 76.8-100) for P.ovale curtisi and 90.9% (95% CI 70.7-100) for P.ovale wallikeri Study drug related adverse events were generally mild or moderate.ConclusionThis largest clinical trial assessing the efficacy of an antimalarial against non-falciparum malaria demonstrated satisfying antimalarial activity of artemether-lumefantrine against P.ovale wallikeri, P.ovale curtisi, P.malariae, and mixed Plasmodium infections with per protocol efficacies of 90%-100% without evident tolerability or safety concerns.

PMID: 29311086 [PubMed - as supplied by publisher]

No adverse safety or virological changes 2 years following vorinostat in HIV-infected individuals on antiretroviral therapy.

AIDS. 2017 May 15;31(8):1137-1141

Authors: Mota TM, Rasmussen TA, Rhodes A, Tennakoon S, Dantanarayana A, Wightman F, Hagenauer M, Roney J, Spelman T, Purcell DFJ, McMahon J, Hoy JF, Prince HM, Elliott JH, Lewin SR

Abstract
OBJECTIVE: To determine the long-term effects of vorinostat on safety and virological parameters in HIV-infected individuals on suppressive antiretroviral therapy (ART).
DESIGN: Prospective longitudinal observational extended follow-up of 20 HIV-infected individuals on ART previously enrolled in a clinical trial of daily vorinostat 400 mg for 14 days. Extended follow-up included visits at 6, 12, 18 and 24 months postenrolment in the initial clinical trial.
METHODS: Cell-associated unspliced HIV RNA, total HIV DNA and plasma HIV RNA were quantified by PCR, and CD4 and CD8 T cells quantified by flow cytometry. Changes over time in each parameter were assessed using the Wilcoxon matched pair signed-rank test and generalized estimating equations for trend modelling.
RESULTS: We recorded a total of 31 adverse events (26 grade 1 and five grade 2) in all study participants (n = 20). There were no significant changes in the number of CD4 or CD8 T cells or plasma HIV RNA over time. In 12 participants for whom baseline samples were available, there were no significant changes in total HIV DNA, cell-associated unspliced HIV RNA, plasma RNA or CD4 and CD8 T cells at 6, 12, 18 or 24 months.
CONCLUSION: Extended follow-up for 24 months did not reveal any long-term toxicity or changes in markers of HIV persistence or transcription in participants on ART who had received 14 days of vorinostat.

PMID: 28301423 [PubMed - indexed for MEDLINE]

Is Hydroxyethyl Starch Safe in Penetrating Trauma Patients?

Mil Med. 2016 May;181(5 Suppl):152-5

Authors: Allen CJ, Ruiz XD, Meizoso JP, Ray JJ, Livingstone AS, Schulman CI, Namias N, Proctor KG

Abstract
OBJECTIVES: For logistic reasons, a bolus of 6% hydroxyethyl starch (HES 450/0.7 in lactated electrolyte injection) is recommended for battlefield resuscitation even though it has risks of mortality and acute kidney injury (AKI) in certain patient populations. The purpose of this study was to test the hypothesis that victims of penetrating trauma have no increased risks of AKI and/or death when receiving a single bolus of HES during initial fluid resuscitation.
METHODS: 816 consecutive admissions with penetrating trauma were reviewed. Patients who died within 24 hours were excluded. Propensity scores and a 1:1 fixed ratio nearest neighbor matching were used to compare those who received HES to those who did not. Data were expressed as mean ± SD and significance was assessed at p < 0.05.
RESULTS: The cohort was 88% male, age 35 ± 14 years, injury severity score of 10 ± 10, with a 3.8% rate of AKI, and 3.2% rate of mortality. HES was administered to 121 (14.8%) patients. In HES and no HES propensity matched groups, the rate of AKI was 3.8% vs. 4.8% (p = 0.749) and the 90-day mortality rate was 3.8% vs. 4.8% (p = 0.749).
CONCLUSION: An increased risk of mortality or AKI was not observed in penetrating trauma patients who were resuscitated with low volume HES.

PMID: 27168566 [PubMed - indexed for MEDLINE]

En Route Use of Analgesics in Nonintubated, Critically Ill Patients Transported by U.S. Air Force Critical Care Air Transport Teams.

Mil Med. 2016 May;181(5 Suppl):145-51

Authors: Mora AG, Ganem VJ, Ervin AT, Maddry JK, Bebarta VS

Abstract
INTRODUCTION: U.S. Critical Care Air Transport Teams (CCATTs) evacuate critically ill patients with acute pain in the combat setting. Limited data have been reported on analgesic administration en route, and no study has reported analgesic use by CCATTs. Our objective was to describe analgesics used by CCATTs for nonintubated, critically ill patients during evacuation from a combat setting.
METHODS: We conducted an institutional review board-approved, retrospective review of CCATT records. We included nonintubated, critically ill patients who were administered analgesics in flight and were evacuated out of theater (2007-2012). Demographics, injury description, analgesics and anesthetics, and predefined clinical adverse events were recorded. Data were presented as mean ± standard deviation or percentage (%).
RESULTS: Of 1,128 records, we analyzed 381 subjects with the following characteristics: age 26 ± 7.0 years; 98% male; and 97% trauma (70% blast, 17% penetrating, 11% blunt, and 3% burn). The injury severity score was 19 ± 9. Fifty-one percent received morphine, 39% hydromorphone, 15% fentanyl, and 5% ketamine. Routes of delivery were 63% patient-controlled analgesia (PCA), 32% bolus intravenous (IV) administration, 24% epidural delivery, 21% continuous IV infusions, and 9% oral opioids. Patients that were administered local anesthetics (nerve block or epidural delivery) with IV opioids received a lower total dose of opioids than those who received opioids alone. No differences were associated between analgesics and frequency of complications in flight or postflight.
CONCLUSION: About half of nonintubated, critically ill subjects evacuated out of combat by CCATT received morphine and more than half had a PCA. In our study, ketamine was not frequently used and pain scores were rarely recorded. However, we detected an opioid-sparing effect associated with local anesthetics (regional nerve blocks and epidural delivery).

PMID: 27168565 [PubMed - indexed for MEDLINE]

Induction of a Tumor-Metastasis-Receptive Microenvironment as an Unwanted Side Effect After Radio/Chemotherapy and In Vitro and In Vivo Assays to Study this Phenomenon.

Methods Mol Biol. 2016;1516:347-360

Authors: Schneider G, Sellers ZP, Ratajczak MZ

Abstract
Besides surgical removal of tumor tissue, chemotherapy and radiotherapy are the most important and efficient treatment modalities employed to treat therapy-susceptible malignancies. The main aim of this treatment-to destroy tumor cells-is unfortunately usually associated with toxicity to nontumor cells and different degrees of tissue and organ damage. In damaged tissues several chemoattractants are upregulated and released that may attract tumor cells. Moreover, highly migratory radio/chemotherapy treatment may endow cells with several properties of cancer stem cells which survive and respond to these chemoattractants upregulated in collateral tissues. Based on this, one of the unwanted and underappreciated side effects of chemotherapy or radiotherapy is the creation of a metastasis-receptive microenvironment in bones as well as in other organs of the body. Herein we describe methods and assays that can be employed to study migratory properties of cancer cells in in vitro (chemotaxis) and in vivo (seeding efficiency assay) conditions in response to the induction of pro-metastatic microenvironments in various organs and tissues.

PMID: 27032941 [PubMed - indexed for MEDLINE]

13 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 2018/01/09

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.

Vedolizumab-induced acute pancreatitis: the first reported clinical case.

BMJ Case Rep. 2018 Jan 05;2018:

Authors: Picardo S, So K, Venugopal K, Chin M

Abstract
Drug-induced acute pancreatitis (DIAP) is a rare, but clinically significant diagnosis. Vedolizumab, an α4β7 integrin inhibitor, which was approved in 2015 for treatment of moderate to severe inflammatory bowel disease, is a well-tolerated medication with a favourable safety profile and minimal serious adverse events in premarketing clinical trials. We present the first reported case of acute pancreatitis directly attributable to vedolizumab.

PMID: 29305366 [PubMed - in process]

13 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 2018/01/06

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.

13 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 2018/01/06

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.

Polypharmacy in Cardiovascular Medicine: Problems and Promises!

Cardiovasc Hematol Agents Med Chem. 2017 Nov 08;15(1):31-39

Authors: Abolbashari M, Macaulay TE, Whayne TF, Mukherjee D, Saha S

Abstract
BACKGROUND: Polypharmacy is now a frequent aspect and reality of current medicine practice, driven by managing multiple comorbidities, especially in older adults. However and unfortunately, polypharmacy can expose patients to adverse drug reactions, and drug-drug or drug-disease interactions. On the other hand, clinicians are often hesitant to add new drugs to complex regimens even when recommended by evidence-based medicine and guidelines. In addition, there is frequently a failure to assess which medications might not be beneficial and may therefore be stopped.
METHOD: Cardiovascular disease prevalence is increasing despite the efforts to prevent this with pandemics of obesity and diabetes as leading causes. The healthcare system is facing an increasing number of cardiovascular diseases in older patients with multiple comorbidities. New cardiovascular guidelines encourage multiple drug use to control these conditions and improve mortality and morbidity. However, use of multiple drugs can lead to inappropriate drug interactions and increased adverse outcomes. On the other hand, the so-called polypill has been proposed as a means to decrease the burden of multiple medications as well as increase cardiovascular disease prevention.
CONCLUSION: This review discusses multiple issues of polypharmacy and its challenges, with a focus on cardiovascular diseases.

PMID: 28552061 [PubMed - indexed for MEDLINE]

Myasthenia Gravis After Nivolumab Therapy for Squamous Cell Carcinoma of the Bladder.

J Immunother. 2017 Apr;40(3):114-116

Authors: Chang E, Sabichi AL, Sada YH

Abstract
Checkpoint inhibitors have become standard therapy for multiple cancers, and their use will increase in the next year as regulatory approvals for additional indications are expected. It is essential for clinicians to be aware of the potential for rare immune-related adverse effects. Here, we report the case of a new diagnosis of myasthenia gravis (MG) after the use of nivolumab for squamous cell carcinoma of the bladder. A review the literature identified 10 cases of MG diagnosed after programmed cell death protein 1 inhibitor therapy. This is the first case, to our knowledge, reported in association with bladder cancer. The precise diagnosis of MG has important implications on management, as treatment with steroids can transiently worsen myasthenia in nearly 50% of cases.

PMID: 28234667 [PubMed - indexed for MEDLINE]

Efficacy of tenuigenin and β-asarone as augmentations for memantine in the treatment of Alzheimer's disease.

Neuroreport. 2018 Jan 02;:

Authors: Dong H, Wu S, Hu N, Xing G

Abstract
Alzheimer's disease (AD) is a progressive neurodegenerative disease that has no cure at present. This study was carried out to evaluate whether the combination of β-asarone and tenuigenin could improve the efficacy of memantine as a monotherapy in the treatment of AD. Patients with AD were recruited and assigned to two groups. Patients in the control group received memantine (5-20 mg/day) and those in the experimental group received memantine (5-20 mg/day), β-asarone (20 mg/day), and tenuigenin (20 mg/day). The Mini-Mental State Examination (MMSE), Activities of Daily Living (ADL), Clinical Dementia Rating Scale (CDR) scores and drug-related side-effects were assessed. Treatment was continued for 12 weeks. In total, 93 AD patients (45 in the control group and 48 in the experimental group) were recruited. Before treatment, both the groups had similar average MMSE scores, ADL scores, and CDR scores, whereas all the average scores improved significantly after treatment. However, compared with the control group, the experimental group had a significantly higher average MMSE score (P=0.00001) and lower average ADL (P=0.00604) and CDR (P=0.00776) scores after treatment. Moreover, the two groups had similar rates of drug-related side-effects. These results indicated that the combination of β-asarone and tenuigenin was an effective augmentation for memantine in the treatment of AD and did not cause more drug-related side-effects. This novel method is worthy of further investigation.

PMID: 29298173 [PubMed - as supplied by publisher]

A case of probable Amiodarone-induced pancreatitis in the treatment of atrial fibrillation: a literature review and case report.

J Community Hosp Intern Med Perspect. 2017;7(6):369-371

Authors: J Mercogliano C, Khan M, Ahmad M

Abstract
Amiodarone is an effective medication used in the treatment of several different arrhythmias. Its most well-known adverse effects include pulmonary fibrosis, thyroid dysfunction, and hepatotoxicity. A less common side effect is acute pancreatitis. A 67-year-old male being treated for atrial fibrillation in rapid ventricular response with Amiodarone developed acute epigastric abdominal pain 24 hours after initiation of therapy. He was diagnosed as having acute pancreatitis based on characteristic findings seen on an abdominal CT scan. Commonly encountered etiologies of pancreatitis were ruled out through a combination of the history, laboratory values, and imaging results. Based on the temporal association of the acute presentation and initiation of Amiodarone therapy, in conjunction with a lack of support for any other etiology, the diagnosis of Amiodarone-induced pancreatitis was made. Within 7 days following the cessation of Amiodarone therapy, the patient's symptoms had completely resolved. Amiodarone-induced pancreatitis is an often overlooked medication association and is one that has been infrequently reported throughout the literature. Given the substantial morbidity and mortality associated with acute pancreatitis, and the ease of treatment (withdrawing Amiodarone), this is a critical side effect that should be recognized in the appropriate clinical setting.

PMID: 29296251 [PubMed]

Adverse Drug Event Monitoring with Clinical and Laboratory Data Using Arden Syntax.

Stud Health Technol Inform. 2017;245:1123-1127

Authors: Rappelsberger A, Adlassnig KP, de Bruin JS, Plössnig M, Schuler J, Hofer-Dückelmann C

Abstract
In times of steadily increasing numbers of administered drugs, the detection of adverse drug events (ADEs) is an important aspect of improving patient safety. At present only about 1-13% of detected ADEs are reported. Raising the number of reported ADEs will result in greater and more efficient support of pharmacovigilance. Potential ADE's must be identified early. In the iMedication system, which is a rule-based application, triggers are used for computerized detection of possible ADEs. Creating a pilot system, we defined the relevant use cases hyperkalemia, hyponatremia, renal failure, and over-anticoagulation; knowledge bases were implemented in Arden Syntax for each use case. The objective of these knowledge bases is to interpret patient-specific clinical data and generate notifications based on a calculated ADE risk score, which may indicate possible ADEs. This will permit appropriate monitoring of potential ADE situations over time in the interest of patient care, quality assurance, and pharmacovigilance.

PMID: 29295277 [PubMed - in process]

Detecting Adverse Drug Event Signals from a Clinical CaseBase.

Stud Health Technol Inform. 2017;245:549-553

Authors: Qin W, Zeng X, Jia Z, Zheng X, Duan H, Lu X, Li H

Abstract
With the rapid development of medical information systems in Chinese hospitals over the last two decades, many of these organizations have accumulated astronomical amounts of structured and unstructured clinical data, including patient diagnostic data, treatment data, lab test data, etc. Secondary use of these data for research, such as Real World Evidence (RWE) studies, has the potential to improve medical quality and safety in daily clinical practice. In this study, we describe CaseBase, a Clinical Data Warehouse (CDW) that extracts structured clinical symptoms or findings and related temporal information from narrative clinical documents and integrates medication information from the CPOE system. An Adverse Drug Event (ADE) signals detection platform has also been developed based on CaseBase to analyze and visualize drug-symptom relations in clinical data. A prototype of this platform has been evaluated in a 2,000-bed hospital and some initial results are reported here.

PMID: 29295155 [PubMed - in process]

Constructing a Gene-Drug-Adverse Reactions Network and Inferring Potential Gene-Adverse Reactions Associations Using a Text Mining Approach.

Stud Health Technol Inform. 2017;245:531-535

Authors: Sui M, Cui L

Abstract
Our objective was to identify and extract gene-drug and drug-adverse drug reaction (ADR) relationships from different biomedical literature collections, and to predict the possible association between gene and ADR. The drug, ADR and gene entities were recognized by a CRF model with multiple features. Logistic regression models were constructed for each drug-ADR and drug-gene pair based on its frequency, Mesh Rule association and similarity with known association etc. Using predicted score to generate drug-ADR matrix and drug-gene matrix, and then calculating for gene-ADR matrix. Network and clustering analysis were applied to verify and interpret the relationship between them. A total of 78014 potential gene-ADR associations were predicted. Part of the predicted results can be explained by the network-clustering-pathway analysis, and verified in the literature. The gene-drug-ADR network constructed in this study can provide a reference for the possible association between the gene and ADR.

PMID: 29295151 [PubMed - in process]

Patient safety incident reports related to traditional Japanese Kampo medicines: medication errors and adverse drug events in a university hospital for a ten-year period.

BMC Complement Altern Med. 2017 Dec 21;17(1):547

Authors: Shimada Y, Fujimoto M, Nogami T, Watari H, Kitahara H, Misawa H, Kimbara Y

Abstract
BACKGROUND: Kampo medicine is traditional Japanese medicine, which originated in ancient traditional Chinese medicine, but was introduced and developed uniquely in Japan. Today, Kampo medicines are integrated into the Japanese national health care system. Incident reporting systems are currently being widely used to collect information about patient safety incidents that occur in hospitals. However, no investigations have been conducted regarding patient safety incident reports related to Kampo medicines. The aim of this study was to survey and analyse incident reports related to Kampo medicines in a Japanese university hospital to improve future patient safety.
METHODS: We selected incident reports related to Kampo medicines filed in Toyama University Hospital from May 2007 to April 2017, and investigated them in terms of medication errors and adverse drug events.
RESULTS: Out of 21,324 total incident reports filed in the 10-year survey period, we discovered 108 Kampo medicine-related incident reports. However, five cases were redundantly reported; thus, the number of actual incidents was 103. Of those, 99 incidents were classified as medication errors (77 administration errors, 15 dispensing errors, and 7 prescribing errors), and four were adverse drug events, namely Kampo medicine-induced interstitial pneumonia. The Kampo medicine (crude drug) that was thought to induce interstitial pneumonia in all four cases was Scutellariae Radix, which is consistent with past reports. According to the incident severity classification system recommended by the National University Hospital Council of Japan, of the 99 medication errors, 10 incidents were classified as level 0 (an error occurred, but the patient was not affected) and 89 incidents were level 1 (an error occurred that affected the patient, but did not cause harm). Of the four adverse drug events, two incidents were classified as level 2 (patient was transiently harmed, but required no treatment), and two incidents were level 3b (patient was transiently harmed and required substantial treatment).
CONCLUSIONS: There are many patient safety issues related to Kampo medicines. Patient safety awareness should be raised to prevent medication errors, especially administration errors, and adverse drug events in Kampo medicine.

PMID: 29268743 [PubMed - indexed for MEDLINE]