Adverse drug reactions of non-opioid and opioid analgesics reported to Croatian national authority from 2007 to 2014.

Acta Med Acad. 2017 Nov;46(2):94-104

Authors: Sunara P, Krnic D, Puljak L

Abstract
OBJECTIVE: Adverse drug reactions (ADRs) are commonly observed in the health services because of system weaknesses and individual errors. Analgesics are widely used and it can be expected that with the increased use one can expect increased number of ADRs of analgesics. The aim of this study was to analyze ADRs of non-opioid and opioid analgesics reported to the Croatian Agency for Medicinal Products and Medical Devices (HALMED) from 2007 to 2014.
METHODS: HALMED provided data on generic drug name, year of the ADR report, type of report, institution, reporting person, patient's age, sex and ADR type.
RESULTS: In the analyzed period 796 ADRs of analgesics were reported, of which 367 (46%) were serious ADRs. Number of ADR reports was continuously increasing during the analyzed period. There were 20 analgesics that had ≥5 reports, making 597 (75%) of all ADR reports for analgesics. The most common adverse reaction reports of those 20 analgesics referred to individual drugs (n=16; 80%). Most of the ADR reports were filed by physicians (n=257; 43%), followed by pharmacists (n=252; 42%). Most side effects (n=572; 96%) were reported spontaneously through appropriate forms by patients or health professionals. ADRs were most commonly reported in women (n=352; 59%) and most of them have occurred in adults (n=354; 59%). The most common ADRs of opioid and non-opioid analgesics have been reported on the skin and mucous membranes. Most serious ADRs were result of action of opioid analgesics.
CONCLUSION: Number of ADR reports in Croatia is continuously increasing and a considerable number of them refers to serious ADRs. To keep better track of medications and ADRs it is necessary to educate and encourage health professionals and patients in reporting side effects.

PMID: 29338273 [PubMed - indexed for MEDLINE]

Systematic review and meta-analysis of reported adverse events of long-term intranasal oxytocin treatment for autism spectrum disorder.

Psychiatry Clin Neurosci. 2018 Mar;72(3):140-151

Authors: Cai Q, Feng L, Yap KZ

Abstract
Recent studies have suggested oxytocin as a possible drug to treat social deficits caused by autism spectrum disorder (ASD), but the safety of intranasal oxytocin in autistic patients has not been established. The aim of this review was to characterize the side-effect profile of long-term intranasal oxytocin in treatment of ASD compared to placebo. All randomized controlled trials of intranasal oxytocin in the treatment of ASD published before 1 January 2017 that reported safety data were identified from databases, including PubMed, Embase, Cochrane Library, and International Pharmaceutical Abstract. Relevant data from the selected studies were then extracted for meta-analysis to estimate the pooled risk ratio for the most common adverse events. Descriptive analysis of severe adverse events was also conducted. Of the 223 participants in the five included studies, 123 were given oxytocin and 100 were given placebos. Nasal discomfort (14.3%), tiredness (7.2%), irritability (9.0%), diarrhea (4.5%), and skin irritation (4.5%) were the most common adverse events. None of these common adverse events was statistically associated with treatment allocation according to meta-analysis using pooled data (all P-values > 0.1). Five severe adverse events were reported, namely aggression (one in placebo, two in oxytocin) and seizures (one in placebo, one in oxytocin). Results from this systematic review support intranasal oxytocin as well tolerated and safe for use in the ASD population. Larger clinical trials should be conducted to establish the efficacy of intranasal oxytocin as a treatment of ASD.

PMID: 29232031 [PubMed - indexed for MEDLINE]

Effect of hydroxychloroquine on treatment and recurrence of acute brucellosis: a single-blind, randomized clinical trial.

Int J Antimicrob Agents. 2018 Mar;51(3):365-369

Authors: Majzoobi MM, Hashemi SH, Mamani M, Keramat F, Poorolajal J, Ghasemi Basir HR

Abstract
Brucellosis is associated with a high recurrence rate and requires more than one course of standard treatment; therefore, more research is required to find more effective treatments that lead to prompt recovery, and reduce the relapse of disease. This single-blind, randomized study was designed to evaluate the effect of the standard treatment for brucellosis in combination with hydroxychloroquine. A total of 177 patients with acute brucellosis were randomly assigned to one of two treatment groups: doxycycline-streptomycin (DS) and doxycycline-streptomycin-hydroxychloroquine (DSH). Clinical symptoms and signs, serological tests, and side effects of therapy were compared between the two groups during the treatment course and at three and six months after the end of drug therapy. Of the 177 patients, with a mean age of 40.5 ± 16.9 years, 66.1% were males. The mean duration of clinical signs prior to admission was 43.4 ± 41.1 days. Appropriate clinical responses, relapse, treatment failure, and adverse drug reactions were seen in 98.9%, 1.2%, 0.0%, and 12.6% of patients, respectively, in the DSH group vs. 86.7%, 11.6%, 2.3%, and 19.8% of patients, respectively, in the DS group. There were significant differences in clinical response and relapse rates between the two groups. The addition of hydroxychloroquine to a doxycycline-streptomycin regimen appears to increase the efficacy of treatment, accelerate improvement of clinical symptoms, and significantly reduce the rate of relapse of brucellosis.

PMID: 28826825 [PubMed - indexed for MEDLINE]

The Comparative Safety of TNF Inhibitors in Ankylosing Spondylitis-a Meta-Analysis Update of 14 Randomized Controlled Trials.

Clin Rev Allergy Immunol. 2018 Apr;54(2):234-243

Authors: Hou LQ, Jiang GX, Chen YF, Yang XM, Meng L, Xue M, Liu XG, Chen XC, Li X

Abstract
TNF inhibitors have been used in ankylosing spondylitis (AS). The efficacy of TNF inhibitors was already evaluated by meta-analysis of randomized controlled trials (RCTs). However, the safety of TNF inhibitors is still unclear. Therefore, we aimed to evaluate and update the safety data from RCTs of TNF inhibitors in patients treated for AS. A systematic literature search was conducted from 1990 through May 31, 2016. All studies included were randomized, double-blind, controlled trials of patients with ankylosing spondylitis that evaluated adalimumab, certolizumab pegol, etanercept, golimumab, or infliximab treatment. The overall serious adverse events, the risk of serious infection events, and the risk of malignancy and discontinuation rates were abstracted, and risk estimates were calculated by Peto odds ratios (ORs). Fourteen randomized controlled trials involving 2032 subjects receiving TNF inhibitors and 1030 subjects receiving placebo and/or traditional disease-modifying anti-rheumatic drugs (DMARDs) were included. The overall serious adverse events (OR, 1.34; 95% CI, 0.87-2.05), the risk of serious infection events (OR, 1.59; 95% CI, 0.63-4.01), the risk of malignancy (OR, 0.98; 95% CI, 0.25-3.85), and discontinuation due to adverse events (OR, 1.55; 95% CI, 0.95-2.54) in patients treated with TNF inhibitors as a group were not significantly different from those treated with placebo in the control group. TNF inhibitors were generally safe for treatment of ankylosing spondylitis. These data may help guide clinical comparative decision making in the management of AS.

PMID: 28717941 [PubMed - indexed for MEDLINE]

Trichomonas vaginalis Treated With Boric Acid in a Metronidazole Allergic Female.

Sex Transm Dis. 2017 02;44(2):120

Authors: Backus KV, Muzny CA, Beauchamps LS

PMID: 27984554 [PubMed - indexed for MEDLINE]

Activity profile of the cisplatin analogue PN149 in different tumor cell lines.

Biochem Pharmacol. 2018 Aug 20;:

Authors: Schoch S, Sen V, Gajewski S, Golubev V, Strauch B, Hartwig A, Köberle B

Abstract
The efficacy of the anticancer drug cisplatin is restricted by tumor cell resistance and occurrence of severe side effects. One strategy to overcome these limitations is the development of new, improved platinum drugs. Previous investigations showed that platinum(IV)-nitroxyl complexes are able to circumvent cisplatin resistance in bladder cancer cells. In the present study the mode of action of the platinum(IV)-nitroxyl complex PN149 was investigated in the bladder cancer cell line RT112 and the renal cell carcinoma cell line A498 on the molecular and cellular level. Gene expression analysis showed that PN149 induced genes related to DNA damage response (RRM2B, GADD45A), cell cycle regulation (CDKN1A, PLK3, PPM1D) as well as those coding for the pro-apoptotic factors PUMA and Noxa. These findings on the transcriptional level were confirmed on the functional level revealing that PN149 treatment increased levels of p53 and resulted in cell cycle arrest and drug-induced cytotoxicity via induction of apoptosis. Regarding the expression of oxidative-stress sensitive genes, PN149 induced FTH1, GCLC, HMOX1 and TXNRD1 but relevant effects were restricted to RT112 cells treated with 50 µM. The pro-inflammatory IL-8 was induced by PN149 in RT112 but not A498 cells indicating a cell-type specific activation. Taken together, PN149 possessed promising activity in different tumor cell lines rendering it an interesting alternative to cisplatin in chemotherapy.

PMID: 30138622 [PubMed - as supplied by publisher]

Treatment with montelukast and antidepressive medication-a symmetry analysis.

Pharmacoepidemiol Drug Saf. 2018 Aug 23;:

Authors: Winkel JS, Damkier P, Hallas J, Henriksen DP

Abstract
PURPOSE: Leukotriene receptor antagonists are used in asthma and rhinitis treatment. Pharmacovigilance data have suggested an association between montelukast and depression, but the association has not been established in controlled study designs. We described the association between initiation of montelukast and depression, using prescriptions of antidepressants as a surrogate marker, and assessed whether the association was related to the underlying asthma disease.
METHODS: We performed a symmetry analysis, with a study period from January 1, 2000 to December 31, 2016, using 3 nationwide Danish registers. We included all adults, who filled their first prescription of montelukast and antidepressants within an interval of 1 year. In the absence of an association between montelukast and antidepressant use, a symmetrical distribution of prescriptions is expected before and after montelukast initiation (ie, a sequence ratio [rc ] of 1.0). We subcategorized the subjects after the severity of underlying asthma disease.
RESULTS: In total, 4450 subjects filled their first prescriptions of both montelukast and antidepressants within a 1-year interval: 2434 redeemed their first prescription of montelukast before antidepressants, and 2016 redeemed the medications in the opposite order (rc 1.21 [95% CI 1.14-1.28]). We found rc above unity in groups with long-acting asthma treatment, but no increase in antidepressant prescription, when stratifying by the asthma severity.
CONCLUSION: We found a weak association between the use of montelukast and the risk of being prescribed an antidepressant, unlikely to be of clinical relevance. Stratified analyses suggest that this association may relate to asthma, rather than to montelukast.

PMID: 30136330 [PubMed - as supplied by publisher]

Pregnancy and the global disease burden.

Reprod Health. 2017 Dec 14;14(Suppl 3):170

Authors: Sina BJ

Abstract
Pregnant women experience unique physiological changes pertinent to the effective prevention and treatment of common diseases that affect their health and the health of their developing fetuses. In this paper, the impact of major communicable (HIV/AIDS, tuberculosis, malaria, helminth infections, emerging epidemic viral infections) as well as non-communicable conditions (mental illness, substance abuse, gestational diabetes, eclampsia) on pregnancy is discussed. The current state of research involving pregnant women in these areas is also described, highlighting important knowledge gaps for the management of key illnesses that impact pregnancy globally.

PMID: 29297407 [PubMed - indexed for MEDLINE]

Research with pregnant women: a call to action.

Reprod Health. 2017 Dec 14;14(Suppl 3):156

Authors: Little MO, Wickremsinhe MN

Abstract
Despite a global need for the use of medication during pregnancy, the medical research community lacks robust evidence for safety and efficacy of treatments and preventives often taken by pregnant women. Given the biological differences between pregnant women and the rest of the population, the need to gather data on the ways in which medications behave in the pregnant body is critical to the health of pregnant women and their offspring. Three ethical reasons are central to this need: 1. Pregnant women deserve access to effective treatment, 2. Pregnant women deserve access to safe treatment, and 3. Pregnant women deserve equitable access to trials carrying the prospect of direct benefit. In this paper, we introduce and frame this Supplement Issue, which presents important conference proceedings of the 2016 Global Forum on Bioethics in Research meeting held in Buenos Aires, Argentina, on the 3rd and 4th of November.

PMID: 29297373 [PubMed - indexed for MEDLINE]

The global forum on bioethics in research meeting, "ethics of research in pregnancy": emerging consensus themes and outputs.

Reprod Health. 2017 Dec 14;14(Suppl 3):158

Authors: Hunt A, Banner N, Littler K

Abstract
Research during pregnancy is affected by multiple ethical challenges which have not received sufficient international attention and consideration from the bioethics, clinical, and policymaking communities working together. Unresolved ethical questions about research in pregnancy have significant detrimental impacts on maternal and newborn health, in part because they inhibit an evidence base being developed on the efficacy and safety of medicines and health interventions for pregnant women. These problems are compounded in low- and middle-income country (LMIC) settings due to variability in regulatory provisions, the burden of maternal morbidity and mortality, and many social and cultural conventions that impact on pregnant women's ability to participate in research. Research in pregnancy was chosen as a topic for the 2016 Global Forum on Bioethics in Research (GFBR) meeting, and its timeliness was all the more apparent given the 2016 Zika outbreak, which has deeply affected the Latin American region. The meeting's emerging consensus themes and outputs epitomized the core aims of the GFBR-to give voice to LMIC perspectives as a priority in dialogue about global health research ethics and to promote collaboration. In this instance, the GFBR meeting catalyzed a strong, unified drive to push researchers and policymakers to include pregnant women in research by default: given the complex nature of the topic, this is a significant achievement in addressing an important question of social justice.

PMID: 29297364 [PubMed - indexed for MEDLINE]

Ethics, regulation, and beyond: the landscape of research with pregnant women.

Reprod Health. 2017 Dec 14;14(Suppl 3):173

Authors: Saenz C, Cheah PY, van der Graaf R, Henry LM, Mastroianni AC

Abstract
Scarce research with pregnant women has led to a dearth of evidence to guide medical decisions about safe and effective treatment and preventive interventions for pregnant women and their potential offspring. In this paper, we highlight three aspects of the landscape in which pregnant women are included or, more frequently, excluded from research: international ethics guidance, regional and national regulatory frameworks, and prevailing practices. Our paper suggests that, in some cases, regulatory frameworks can be more restrictive than international ethics guidance, and that even when regulations permit research with pregnant women, practical challenges-as well as the prevailing practices of stakeholders, such as ethics review committees and investigators-may lead to the generalized exclusion of pregnant women from research.

PMID: 29297343 [PubMed - indexed for MEDLINE]

Understanding systemic lupus erythematosus patients' desired outcomes and their perceptions of the risks and benefits of using corticosteroids.

Lupus. 2018 Mar;27(3):475-483

Authors: Ng X, dosReis S, Beardsley R, Magder L, Mullins CD, Petri M

Abstract
Introduction The use of corticosteroids in systemic lupus erythematosus (SLE) patients requires difficult trade-offs between efficacy and risk of toxicity. This qualitative study examined SLE patients' most desired outcomes and their concerns with corticosteroid use in SLE treatment. Methods SLE patients with current/past experience with using corticosteroids were recruited from the clinics at the Johns Hopkins Lupus Center and the University of Maryland Medical Center. Five in-depth interviews ( N = 5) and four focus groups ( N = 15) were conducted during which discussions were transcribed and analyzed based on a grounded theory approach. Results We identified five major themes describing SLE patients' most desired outcomes: reduction in flares, maintenance of normal activities, minimization of treatment side effects, prevention of future organ damage, and finding a cure. Further, SLE patients reported these primary concerns with the adverse effects of corticosteroids: weight gain, organ damage (particularly bone-related damage), mood swings/irritability, sleep disturbances, and dental issues. Patients appeared to be more concerned with adverse effects that immediately affected their day-to-day lives. Conclusion Knowledge gained during this study better informs how patients view the benefits and risks of corticosteroids. This can facilitate discussions between physicians and patients as they work together to determine the appropriate use of corticosteroids.

PMID: 28857718 [PubMed - indexed for MEDLINE]

A Call to Action: The Active Role Psychiatrists and the DEA Must Take to Decrease Harm from Psychotropic Drugs Acquired via the Internet.

J Clin Psychiatry. 2016 11;77(11):e1495

Authors: Goldenberg M, Hassamal S, IsHak WW, Haglund M, Miotto K, Danovitch I

PMID: 28076677 [PubMed - indexed for MEDLINE]

Period prevalence, risk factors and consequent injuries of falling among the Saudi elderly living in Riyadh, Saudi Arabia: a cross-sectional study.

BMJ Open. 2018 01 10;8(1):e019063

Authors: Almegbel FY, Alotaibi IM, Alhusain FA, Masuadi EM, Al Sulami SL, Aloushan AF, Almuqbil BI

Abstract
OBJECTIVES: Approximately 28% to 35% of people aged 65 and over fall each year. The consequent injuries of falls are considered a major public health problem. Falls account for more than half of injury-related hospitalisations among old people. The aim of this study was to measure a 1-year period prevalence of falling among old people in Riyadh, Saudi Arabia. In addition, this study described the most common risk factors and consequent injuries of falls.
SETTING AND PARTICIPANTS: A cross-sectional survey was carried out in Riyadh, using a convenient sampling. The targeted population were Saudi citizens who were 60 years or above. Over a 6-month period, 1182 individuals were sampled (545 men and 637 women).
RESULTS: The 1-year prevalence of falling among old Saudis (>=60 years) was 49.9%. Our results show that 74% of the participants who experienced falls had postfall injuries. Old participants who were uneducated and those with middle school certification were associated with falls (adjusted OR (aOR) 1.72; 95% CI 1.15 to 2.56, aOR 1.81; 95% CI 1.15 to 2.85, respectively). Those who live in rented houses had a higher risk of falls. Interestingly, having a caregiver was significantly associated with more falls (aOR 1.39; 95% CI 1.08 to 1.79). However, not using any medications was significantly related to fewer falls. In addition, old individuals using walking aids were more likely to fall than those who did not. Participants who mentioned 'not having stressors were associated with less frequent falls (aOR 0.62; 95% CI 0.39 to 0.97). Cerebrovascular accidents were strongly associated with falls with an estimated OR of 2.75 (95% CI 1.18 to 6.43). Moreover, osteoporosis, poor vision and back pain were found to be predictors for falls among the elderly.
CONCLUSION: 49.9% of elderly Saudis had experienced one or more falls during a 12-month period. Several preventable risk factors could be addressed by routine geriatric assessment. Research on the impact of these risk factors is needed.

PMID: 29326189 [PubMed - indexed for MEDLINE]

Abuse liability assessment for biologic drugs - All molecules are not created equal.

Regul Toxicol Pharmacol. 2018 Feb;92:165-172

Authors: de Zafra CLZ, Markgraf CG, Compton DR, Hudzik TJ

Abstract
The development of novel drug candidates involves the thorough evaluation of potential efficacy and safety. To facilitate the safety assessment in light of global increases in prescription drug misuse/abuse, health authorities have developed guidance documents which provide a framework for evaluating the abuse liability of candidate therapeutics. The guidances do not distinguish between small molecules and biologics/biotherapeutics; however, there are key differences between these classes of therapeutics which are important drivers of concern for abuse. An analysis of these properties, including ability to distribute to the central nervous system, pharmacokinetic properties (e.g., half-life and metabolism), potential for off-target binding, and the physiochemical characteristics of biologic drug products suggests that the potential for abuse of a biologic is limited. Many marketed antibodies and recombinant proteins have been associated with adverse effects such as headache and dizziness. However, biologics have not historically engendered the rapid-onset psychoactive effects typically present for drugs of abuse, thus further underscoring their low risk for abuse potential. The factors to be taken into consideration before conducting nonclinical abuse liability studies with biologics are described herein; importantly, the aggregate assessment of these factors leads to the conclusion that abuse liability studies are unlikely to be necessary for this class of therapeutics.

PMID: 29199066 [PubMed - indexed for MEDLINE]

Drug Interactions in Neurocritical Care.

Neurocrit Care. 2017 Oct;27(2):287-296

Authors: Spoelhof B, Farrokh S, Rivera-Lara L

Abstract
Drug-drug interactions (DDIs) are common and avoidable complications that are associated with poor patient outcomes. Neurocritical care patients may be at particular risk for DDIs due to alterations in pharmacokinetic profiles and exposure to medications with a high DDI risk. This review describes the principles of DDI pharmacology, common and severe DDIs in Neurocritical care, and recommendations to minimize adverse outcomes. A review of published literature was performed using PubMed by searching for 'Drug Interaction' and several high DDI risk and common neurocritical care medications. Key medication classes included anticoagulants, antimicrobials, antiepileptics, antihypertensives, sedatives, and selective serotonin reuptake inhibitors. Additional literature was also reviewed to determine the risk in neurocritical care and potential therapeutic alternatives. Clinicians should be aware of interactions in this setting, the long-term complications, and therapeutic alternatives.

PMID: 28054285 [PubMed - indexed for MEDLINE]

How do parents perceive adverse drug events of their children's anticonvulsant medication?

Eur J Paediatr Neurol. 2018 May;22(3):427-433

Authors: Bach VA, Neininger MP, Spindler UP, Hotopp LC, Hornemann F, Syrbe S, Merkenschlager A, Kiess W, Bernhard MK, Bertsche T, Bertsche A

Abstract
BACKGROUND: The main source of knowledge on adverse drug events (ADE) are physicians' reports in controlled clinical trials. In contrast, little is known about the parents' perception of ADE of anticonvulsants their children receive.
METHODS: After approval by the local ethics committee, we performed a survey in a neuropediatric outpatient clinic of a university hospital. Based on a structured questionnaire, we interviewed parents of children with current anticonvulsant treatment regarding (i) their fears about potential ADE, (ii) experienced ADE according to parents, and (iii) implications of ADE on the child's life.
RESULTS: Parents of 150 patients took part in the interview. (i) 95 (63.3%) parents expressed fears concerning ADE, mostly liver injury/liver failure (33 [22%]). (ii) 129 (86%) parents reported experienced ADE, mostly sedation (65 [43.3%]) and abnormal behavior (54 [36%]). (iii) Parents reported substantial implications of ADE on the child's daily life for 84 (56%) children, and 63 (42%) parents expressed a negative impact on the child's development.
CONCLUSION: We recognized a great discrepancy between those ADE that were feared and those that were experienced. Parents feared life-threatening ADE and experienced less severe ADE that nevertheless have a negative impact on the child's daily life.

PMID: 29475820 [PubMed - indexed for MEDLINE]

HLA Association with Drug-Induced Adverse Reactions.

J Immunol Res. 2017;2017:3186328

Authors: Fan WL, Shiao MS, Hui RC, Su SC, Wang CW, Chang YC, Chung WH

Abstract
Adverse drug reactions (ADRs) remain a common and major problem in healthcare. Severe cutaneous adverse drug reactions (SCARs), such as Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN) with mortality rate ranges from 10% to more than 30%, can be life threatening. A number of recent studies demonstrated that ADRs possess strong genetic predisposition. ADRs induced by several drugs have been shown to have significant associations with specific alleles of human leukocyte antigen (HLA) genes. For example, hypersensitivity to abacavir, a drug used for treating of human immunodeficiency virus (HIV) infection, has been proposed to be associated with allele 57:01 of HLA-B gene (terms HLA-B∗57:01). The incidences of abacavir hypersensitivity are much higher in Caucasians compared to other populations due to various allele frequencies in different ethnic populations. The antithyroid drug- (ATDs- ) induced agranulocytosis are strongly associated with two alleles: HLA-B∗38:02 and HLA-DRB1∗08:03. In addition, HLA-B∗15:02 allele was reported to be related to carbamazepine-induced SJS/TEN, and HLA-B∗57:01 in abacavir hypersensitivity and flucloxacillin induced drug-induced liver injury (DILI). In this review, we summarized the alleles of HLA genes which have been proposed to have association with ADRs caused by different drugs.

PMID: 29333460 [PubMed - indexed for MEDLINE]

Evaluation of a medication intensity screening tool used in malignant hematology and bone marrow transplant services to identify patients at risk for medication-related problems.

J Oncol Pharm Pract. 2018 Jun;24(4):243-252

Authors: Lucena M, Bondarenka C, Luehrs-Hayes G, Perez A

Abstract
Background In 2014, a screening tool was implemented at Medical University of South Carolina (MUSC) Health to identify patients who are at risk for medication-related events. Patients are classified as high-risk if they meet one of the following criteria: receiving anticoagulation therapy, taking more than 10 scheduled medications upon admission, or readmission within the past 30 days. The goal of this study was to determine risk criteria specific to the malignant hematology (MH) and bone marrow transplant (BMT) patients. Methods A retrospective chart review of 114 patients admitted and discharged from the MH/BMT services between 1 September 2015 and 31 October 2015 was performed. A pharmacist-conducted medication history was completed and documented, and all interventions at admission and throughout hospitalization were categorized by severity and by value of service. The primary objective was to evaluate if patients in the MH/BMT services have more medication-related interventions documented upon admission compared with patients who are not screened as high risk. The secondary objectives were to evaluate the different types and severities of interventions made by pharmacists during the entire hospital stay, and to determine if there are certain characteristics that can help identify hematology/oncology high-risk patients. Results More interventions documented upon admission in the high-risk group as a whole when compared with the not high-risk group (73 vs. 31), but when normalized per patients in each group, there was an equal number of interventions (1.0). The most common interventions were to modify regimen (36%) and discontinue therapy (16%). The patient characteristics associated with high-risk included neutropenia, lower average platelet counts on admission, and longer length of stay. Conclusion The screening tool does not further differentiate an already complex MH/BMT patient population. Pharmacists may be more useful at capturing errors or changes during a patient's hospital stay instead of upon admission. Thrombocytopenia, neutropenia, and active infections may correlate with higher-risk status.

PMID: 29284343 [PubMed - indexed for MEDLINE]

Ameliorative Effect of Gallic Acid in Doxorubicin-Induced Hepatotoxicity in Wistar Rats Through Antioxidant Defense System.

J Diet Suppl. 2018 Mar 04;15(2):183-196

Authors: Omobowale TO, Oyagbemi AA, Ajufo UE, Adejumobi OA, Ola-Davies OE, Adedapo AA, Yakubu MA

Abstract
Hepatotoxicity has been found to be one of the main side effects associated with doxorubicin (Dox) administration in cancer therapy. The aim of the present study was to examine the ameliorative effect of gallic acid (GA) in Dox-induced hepatotoxicity. Sixty male Wistar rats of 10 rats per group were used in this study and were randomly divided into 6 experimental groups (A-F). Rats in Group A served as the control group and received distilled water orally for 7 days; Group B was given Dox at 15 mg/kg body weight intraperitoneally (IP) on Day 8. Group C was given GA at 60 mg/kg body weight orally for 7 days + Dox at 15 mg/kg IP on Day 8. Group D was given GA at 120 mg/kg body weight orally for 7 days + Dox at 15 mg/kg IP on day 8. Rats in Groups E and F were administered GA alone at 60 and 120 mg/kg body weight orally for 7 days, respectively. Dox administration led to a significant reduction in hepatic reduced glutathione and nonprotein thiol (NPT) together with significant increase in hepatic malondialdehyde, hydrogen peroxide generation, superoxide dismutase, and catalase activity; hepatic glutathione peroxidase and glutathione-S-transferase activity were significantly inhibited in Dox-treated rats. The serum alanine aminotransferase (ALT), alkaline phosphatase, and total bilirubin concentrations were significantly elevated following Dox administration. Pretreatment with GA ameliorated Dox-induced hepatotoxicity and oxidative stress. The results suggest that GA may offer protection against hepatic damage in Dox cancer chemotherapy.

PMID: 28718673 [PubMed - indexed for MEDLINE]