Drug-induced Adverse Events

A meta-learning framework using representation learning to predict drug-drug interaction.
A meta-learning framework using representation learning to predict drug-drug interaction.
J Biomed Inform. 2018 Jun 26;:
Authors: Deepika SS, Geetha TV
Abstract
MOTIVATION: Predicting Drug-Drug Interaction (DDI) has become a crucial step in the drug discovery and development process, owing to the rise in the number of drugs co-administered with other drugs. Consequently, the usage of computational methods for DDI prediction can greatly help in reducing the costs of in vitro experiments done during the drug development process. With lots of emergent data sources that describe the properties and relationships between drugs and drug-related entities (gene, protein, disease, and side effects), an integrated approach that uses multiple data sources would be most effective.
METHOD: We propose a semi-supervised learning framework which utilizes representation learning, positive- unlabeled (PU) learning and meta-learning efficiently to predict the drug interactions. Information from multiple data sources is used to create feature networks, which is used to learn the meta-knowledge about the DDIs. Given that DDIs have only positive labeled data, a PU learning-based classifier is used to generate meta-knowledge from feature networks. Finally, a meta-classifier that combines the predicted probability of interaction from the meta-knowledge learnt is designed.
RESULTS: Node2vec, a network representation learning method and bagging SVM, a PU learning algorithm, are used in this work. Both representation learning and PU learning algorithms improve the performance of the system by 22% and 12.7% respectively. The meta-classifier performs better and predicts more reliable DDIs than the base classifiers.
PMID: 29959033 [PubMed - as supplied by publisher]
[Bilateral uveitis associated with nivolumab therapy].
[Bilateral uveitis associated with nivolumab therapy].
J Fr Ophtalmol. 2018 Jun 26;:
Authors: Rémond AL, Barreau E, Le Hoang P, Bodaghi B
Abstract
Immune-related adverse events (IRAEs) are rare but serious adverse events that may be associated with inhibitors of few immune control points. The purpose here is to report the case of an inflammatory ocular disease, potentially linked to the immunity and use of nivolumab, a new immunological agent used for the treatment of a solid tumor. In spite of the involvement of this treatment in the onset of inflammation, we must always seek another cause. It is possible to continue this treatment by considering the benefit/risk balance for each patient. Close collaboration between oncologists and ophthalmologists is necessary in the diagnosis and rapid management of these IRAE ocular related to these new emerging therapies.
PMID: 29958705 [PubMed - as supplied by publisher]
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Efficacy and safety of the combination fluticasone propionate plus salmeterol in asthmatic preschoolers: An observational study.
Efficacy and safety of the combination fluticasone propionate plus salmeterol in asthmatic preschoolers: An observational study.
J Asthma. 2018 Jun 29;:1-8
Authors: Hatziagorou E, Kouroukli E, Galogavrou M, Papanikolaou D, Terzi DD, Anagnostopoulou P, Kirvassilis F, Panagiotakos DB, Tsanakas J
Abstract
BACKGROUND: Inhaled Corticosteroids (ICS) are the cornerstone of asthma management in pediatric patients. However, in some cases, asthma is not adequately controlled on ICS alone. Long-acting beta2-agonists (LABA) are one of the available additional therapies but their use has rarely been studied among children younger than 5 years.
OBJECTIVE: The aim of this observational study was to evaluate the efficacy and safety of the combination of fluticasone propionate and salmeterol (FP/SA) in asthmatic children younger than 5 years of age.
METHODS: A retrospective study of 796 children under the age of 5 years (2.87 ± 1.22 years, 64.2% males), who were treated with FP/SA was conducted. Hospitalization rates, frequency of wheezing, exercise induced asthma, nocturnal wheeze and drug-related side-effects were recorded through children's medical records.
RESULTS: The children had previously received short-acting β2-agonists (73%), ICS (17%), montelukast (1%), and ICS with montelukast (2%). Mean duration of therapy with FP/SA was 12.45 ± 9.14 months. After adjusting for age, gender, and duration of treatment, a 89% reduction was recorded in annual hospitalization rates (from 27.13% before treatment to 3.01% after FP/SA therapy, p < 0.001), a 71% reduction in incidence of exercise-induced asthma (36.8% vs. after 10.6%, p < 0.001), a 81% reduction in nocturnal asthma (33.7% vs. after: 6.4%, p < 0.001), as well as in frequency of wheezing (p < 0.01),. No previous treatment carry-on effect was observed. No major drug-related side-effects occurred in the study group.
CONCLUSIONS: Combination therapy (FP/SA) is well-tolerated and highly effective in asthmatic children under the age of 5 years.
PMID: 29958011 [PubMed - as supplied by publisher]
Efficacy and Safety of Estradiol Valerate/Dienogest for the Management of Heavy Menstrual Bleeding: A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Phase III Clinical Trial.
Efficacy and Safety of Estradiol Valerate/Dienogest for the Management of Heavy Menstrual Bleeding: A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Phase III Clinical Trial.
J Womens Health (Larchmt). 2018 Jun 29;:
Authors: Yu Q, Zhou Y, Suturina L, Jaisamrarn U, Lu D, Parke S
Abstract
BACKGROUND: To investigate the efficacy and safety of estradiol valerate (EV)/dienogest (DNG) for the management of heavy menstrual bleeding (HMB) in Asian and non-Asian women desiring contraception.
MATERIALS AND METHODS: In this multicenter, double-blind, phase III study, women were randomized 2:1 to receive EV/DNG or placebo tablets daily for seven 28-day cycles. The primary endpoint was the absolute change in menstrual blood loss (MBL) volume between the run-in and efficacy phases (90 days each). Secondary endpoints included the proportion of women with successful treatment (i.e., no episodes of MBL ≥80 mL and a decrease of <50% in MBL), percent change in MBL from the run-in phase, and change in hemoglobin and serum ferritin levels. Adverse events (AEs) were monitored throughout the study.
RESULTS: Of the 341 women (mean age 34.7 ± 7.7 years; 309 Asians, 32 non-Asians) randomized, 270 completed the study. Mean reduction in MBL volume from run-in phase was significantly greater with EV/DNG than placebo (366.75 mL vs. 149.14 mL; p < 0.0001), with ∼52% and 12% of women, respectively, experiencing successful treatment. Percent decrease in MBL volume from the run-in phase was significantly greater with EV/DNG than placebo (63.5% vs. 24.8%; p < 0.0001). Hemoglobin and serum ferritin levels were increased with EV/DNG compared with placebo. Study drug-related AEs were reported in 16.3% and 8.2% of women with EV/DNG and placebo, respectively, none of which were of severe intensity.
CONCLUSIONS: EV/DNG may be a safe and effective option in the treatment of HMB in Asian and non-Asian women who desire contraception.
PMID: 29957101 [PubMed - as supplied by publisher]
A randomized, open-label, crossover study evaluating bioequivalence of two N-acetylcysteine 2% oral solution formulations in healthy subjects .
A randomized, open-label, crossover study evaluating bioequivalence of two N-acetylcysteine 2% oral solution formulations in healthy subjects .
Int J Clin Pharmacol Ther. 2018 Jun 29;:
Authors: Donath F, Armogida M, Shneyer L
Abstract
OBJECTIVE: N-acetylcysteine is a mucolytic agent used to treat bronchopulmonary diseases associated with airway mucus hypersecretion. The bioequivalence of a new oral N-acetylcysteine 2% formulation was evaluated relative to an appropriate reference product.
MATERIALS AND METHODS: This open-label, randomized, crossover study assessed the bioequivalence of a new N-acetylcysteine 2% oral solution compared to an approved reference N-acetylcysteine 2% oral solution in healthy subjects in terms of pharmacokinetics, including area under the plasma concentration vs. time curve of N-acetylcysteine plasma concentrations from time 0 to the last measurable sampling time point and the maximum postdose concentration. Bioequivalence was concluded if the 90% confidence intervals for the ratio of the geometric means of the two pharmacokinetic parameters with baseline correction were entirely within the range of 80 - 125%.
RESULTS: 46 participants were randomized. The ratios of the geometric means for the test vs. reference treatment, with baseline correction, were 1.0961 (90% confidence interval: 1.0228, 1.1746) for area under the plasma concentration curve of test N-acetylcysteine plasma concentrations and 1.0938 (90% confidence interval: 1.0142, 1.1796) for maximum postdose concentration; both were within the predefined range to demonstrate bioequivalence. Most treatment-emergent adverse events were mild or moderate and not considered study drug related.
CONCLUSION: The new N-acetylcysteine 2% oral solution was found to be bioequivalent to the marketed reference formulation. Treatments were generally safe and well tolerated.
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PMID: 29956648 [PubMed - as supplied by publisher]
Reversible pancytopenia caused by severe copper deficiency in a patient with Wilson disease.
Reversible pancytopenia caused by severe copper deficiency in a patient with Wilson disease.
Med J Aust. 2018 Jun 02;209(1):1112
Authors: Mohamed M, Johnston A, Maclaine Cross A, Sharma A
PMID: 29954304 [PubMed - in process]
Adverse Event Profile of Pyrimethamine-Based Therapy in Toxoplasmosis: A Systematic Review.
Adverse Event Profile of Pyrimethamine-Based Therapy in Toxoplasmosis: A Systematic Review.
Drugs R D. 2017 Dec;17(4):523-544
Authors: Ben-Harari RR, Goodwin E, Casoy J
Abstract
INTRODUCTION: Approximately a third of the population worldwide is chronically infected with Toxoplasma gondii. Pyrimethamine-based regimens are recommended for the treatment of toxoplasmosis.
OBJECTIVE: The aim was to evaluate the safety profile of pyrimethamine-based treatment for the three main Toxoplasma manifestations: toxoplasmic encephalitis (TE), ocular toxoplasmosis, and congenital toxoplasmosis.
METHODS: PubMed, Cochrane Library, and Google Scholar databases were searched through August 1, 2016. Randomized, observational, prospective/retrospective, and cohort studies were eligible. Thirty-one studies were included with a total of 2975 patients. Of these, 13 were in congenital toxoplasmosis (n = 929), 11 in ocular toxoplasmosis (n = 1284), and seven in TE (n = 687). Across manifestations, adverse event (AE)-related treatment discontinuation and/or change in therapy involved ≤37% of patients and occurred in >55% of studies: 100% for ocular toxoplasmosis, 57.1% for TE, and 61.5% for congenital toxoplasmosis. The most commonly observed AEs were bone marrow suppression, dermatologic, and gastrointestinal (GI). The prevalence of bone marrow suppression-related AEs was ≤50% in congenital toxoplasmosis, ≤42.7% in TE, and ≤9.0% in ocular toxoplasmosis. The frequency of GI and dermatologic AEs were ≤100 and ≤11.1%, respectively, for ocular toxoplasmosis, ≤10.7 and ≤17.9% for TE, and ≤10.8 and ≤2.1% for congenital toxoplasmosis. Steven-Johnson syndrome was reported in two patients with ocular toxoplasmosis and one with TE.
CONCLUSION: The AE profile associated with pyrimethamine-based treatments differed by each manifestation of toxoplasmosis and within a given manifestation. Hematologic AEs occurred across all manifestations indicating the importance of monitoring the blood of patients administered pyrimethamine-based regimens.
PMID: 28879584 [PubMed - indexed for MEDLINE]
Benzodiazepines and Z-Drugs: An Updated Review of Major Adverse Outcomes Reported on in Epidemiologic Research.
Benzodiazepines and Z-Drugs: An Updated Review of Major Adverse Outcomes Reported on in Epidemiologic Research.
Drugs R D. 2017 Dec;17(4):493-507
Authors: Brandt J, Leong C
Abstract
Various adverse events resulting from, or associated with, benzodiazepine and/or Z-drug use have been extensively reported on and discussed in great detail within the biomedical literature. It is widely accepted that motor vehicle accidents and falls leading to fractures in older adults are major adverse events that have been shown to occur more frequently in users of sedative-hypnotic medication, especially of the benzodiazepine and related Z-drug variety. However, the last few years have seen increasing reports in the literature raising the issue of benzodiazepine and Z-drug exposure in the development of other serious medical issues including dementia, infections, respiratory disease exacerbation, pancreatitis, and cancer. This article provides an overview and interpretation on the current state of evidence regarding each of these associations and proposes what gaps in the evidence for drug-exposure-harm associations need to be addressed in the future for the purpose of evaluating causality of harm as it relates to these drugs.
PMID: 28865038 [PubMed - indexed for MEDLINE]
[Systematic review of Kudiezi injection drug safety].
[Systematic review of Kudiezi injection drug safety].
Zhongguo Zhong Yao Za Zhi. 2017 Jun;42(12):2380-2390
Authors: Gao SS, Cui RZ, Xie YM, Liao X, Gao XY, Wang JD
Abstract
To systematically evaluate the safety of Kudiezi injection. Databases such as Cochrane library, Medline, EMbase, Web of Science, Clinical Trials, CBM, CNKI, VIP, Wanfang and Chinese Clinical Trial Register were searched to collect the literature on all the study types of Kudiezi injection. Two researchers screened literature, assessed quality and extracted data according to inclusion and exclusion criteria. All studies were assessed by using internationally recognized methodological quality assessment tools or reporting quality evaluation criteria; Meta-analysis of adverse drug reaction/adverse events (ADR/AE) of Kudiezi injection was performed by using Stata 12.0 software. There were 411 clinical studies included, out of which 315 studies were analyzed finally. 18 072 patients in total used kudiezi injection, and there were 330 cases with ADRs and 13 cases with AEs. The most common ADR related system was the central and peripheral nervous system, with a weighted incidence of 2.9% [95%CI(0.022, 0.036)]. From the current evidence, the overall safety of Kudiezi injection was acceptable. Although data could be collected from all kinds of published reports, there are lack of mechanism experiments or observational studies with large samples of Kudiezi injection. Therefore, it is necessary to carry out further research on the safety of Kudiezi injection. Meanwhile, off label use of Kudiezi injection is common, so it is urgent for relevant governmental departments to formulate drug use specifications and provide better guidance for clinical drug use.
PMID: 28822197 [PubMed - indexed for MEDLINE]
Intrauterine therapy of cytomegalovirus infection with valganciclovir: review of the literature.
Intrauterine therapy of cytomegalovirus infection with valganciclovir: review of the literature.
Med Microbiol Immunol. 2017 Oct;206(5):347-354
Authors: Seidel V, Feiterna-Sperling C, Siedentopf JP, Hofmann J, Henrich W, Bührer C, Weizsäcker K
Abstract
Congenital cytomegalovirus (CMV) infection is the leading cause for sensorineural hearing loss and mental retardation in children without genetic diseases worldwide. There is little evidence guiding therapeutic strategies during pregnancy when intrauterine fetal CMV infection is confirmed. We provide a systematic review of the use of ganciclovir (GCV) or VGCV during pregnancy discussing safety of its use for mother and fetus and describe two cases of intrauterine therapy of fetal CMV infection with valganciclovir (VGCV). A PubMed database search was done up to November 16, 2016 without any restrictions of publication date or journal, using the following keywords: "valganciclovir" or "ganciclovir" and "pregnan*". Furthermore, citations were searched and expert references were obtained. Reported cases were considered if therapy was in humans and initiation of treatment of the CMV infection was during pregnancy. In total, seven case reports were retrieved which described GCV or VGCV use during pregnancy for fetal or maternal CMV infection. In the four cases of treatment for maternal CMV infection, no negative effects on the fetus were reported. Three cases of GCV administration to pregnant woman with the intention of fetal treatment after proven fetal infection were found. We additionally present two cases of VGCV treatment in pregnancy from our center of tertiary care. VGCV seems to be a safe treatment for congenital CMV infection for the mother and the fetus. Therapeutic concentrations can be achieved in the fetus by oral intake of the mother and CMV replication can be suppressed. Larger studies are needed to evaluate this therapeutic intervention and the long-term effects.
PMID: 28733760 [PubMed - indexed for MEDLINE]
Physicians' Non-Uniform Approach to Prescribing Drugs to Older Patients - A Qualitative Study.
Physicians' Non-Uniform Approach to Prescribing Drugs to Older Patients - A Qualitative Study.
Basic Clin Pharmacol Toxicol. 2017 Dec;121(6):505-511
Authors: Christensen LD, Petersen J, Andersen O, Kaae S
Abstract
Multi-morbidity and polypharmacy are common in older patients and increase their susceptibility to adverse drug events and hospitalizations. Rational drug prescription is critical; however, little is known about physicians' perspectives on how to prescribe drugs for older patients. The aim of this study was to explore physicians' approach to prescribe drugs to older patients, including identifying the drugs that physicians perceive to be risk drugs for older patients and comparing them with established lists of potentially inappropriate medications. Short semi-structured interviews were conducted with 50 medical specialists in 23 different specialities throughout Denmark who had contact with older patients. Content analysis was performed to identify the relevant themes. Regardless of their medical or surgical background and how often they prescribed drugs for older patients in daily work, all physicians expressed a cautious approach when prescribing risk drugs. Despite their shared caution, physicians had different strategies for prescribing drugs to older patients. The following strategies were identified: (1) 'Start low, go slow', (2) 'Trial and error', (3) 'Dose reduction', and (4) 'Never prescribe'. The most frequently mentioned risk drugs considered to cause hospitalization were vitamin K antagonists, opioids and diuretics; these drugs are relatively highly consistent with established lists of PIMs. Physicians were relatively knowledgeable about risk drugs. Although the physicians agreed that a cautious approach was needed when prescribing drugs for older people, there was no consensus about how to best accomplish this in practice.
PMID: 28640946 [PubMed - indexed for MEDLINE]
Reliability and Validity of the Short Version of Udvalg for Kliniske Undersogelser in Antipsychotic Treatment.
Reliability and Validity of the Short Version of Udvalg for Kliniske Undersogelser in Antipsychotic Treatment.
Psychiatr Q. 2017 Dec;88(4):787-796
Authors: Chen KP, Lung FW
Abstract
The aim of this study was to develop a reliable and valid short version of the Udvalg for Kliniske Undersogelser (UKU) to efficiently evaluate the side effects of antipsychotics in patients with schizophrenia. This multi-site study included 10 hospitals, which included 331 inpatients and outpatients diagnosed with schizophrenia. UKU, Clinical Global Impression-Severity (CGI-S), Personal and Social Performance (PSP) and dosage of paliperidone were collected. The predictive validity of the UKU-short version, as well as that of the CGI-S, PSP and paliperidone dosages, was analyzed using structural equation modeling (SEM), latent growth models (LGM), and confirmatory factor analysis to test its content and construct validity. The UKU-short included nine-items of sedation, reduced sleep, rigidity, tremor, akathisia, headache, reduced salivation, constipation and orthostatic dizziness, and has good construct and content validity over time. Confirmatory factor analysis showed good construct validity, with the psychic, neurological and autonomic side effect dimensions having correlations between 0.60 and 0.71. The predictive validity of the short-version UKU for psychiatric symptoms (CGI-S), quality of life (PSP) and dosage showed that the effects of drug dosage were negligible, and only neurological side effects were associated with psychiatric symptoms and quality of life. The UKU-short showed good content, construct and predictive validity. It is a more time-efficient instrument than the original UKU. This study only included patients treated with paliperidone, larger scale studies is needed to validate the UKU-short in detection of side effects in routine clinical practice to prevent non-adherence in patients with schizophrenia.
PMID: 28150091 [PubMed - indexed for MEDLINE]
Development of Drug-Induced Inverse Psoriasis in a Patient with Crohn's Disease.
Development of Drug-Induced Inverse Psoriasis in a Patient with Crohn's Disease.
ACG Case Rep J. 2018;5:e47
Authors: Darwin E, Deshpande A, Lev-Tov H
Abstract
Crohn's disease is difficult to manage and often requires multiple medications. While these drugs vastly improve quality of life, physicians must monitor for adverse events. We report a case of a flare of inverse psoriasis after 15 months of treatment with ustekinumab. This is the third reported case of a flare of drug-induced psoriasis with ustekinumab, and it is the first reported case with an inverse presentation; however, the clinical picture is confounded by concomitant use of hydroxychloroquine. Inverse psoriasis is a rare variant of drug-induced psoriasis of which physicians must be cognizant while treating patients with Crohn's disease.
PMID: 29951562 [PubMed]
Assessing the ability of the Drug-Associated Risk Tool (DART) questionnaire to stratify hospitalised older patients according to their risk of drug-related problems: a cross-sectional validation study.
Assessing the ability of the Drug-Associated Risk Tool (DART) questionnaire to stratify hospitalised older patients according to their risk of drug-related problems: a cross-sectional validation study.
BMJ Open. 2018 Jun 27;8(6):e021284
Authors: Stämpfli D, Boeni F, Gerber A, Bättig VAD, Weidmann R, Hersberger KE, Lampert ML
Abstract
OBJECTIVES: The Drug-Associated Risk Tool (DART) has been developed as a self-administered questionnaire for patients with the aim of stratifying patients according to their risk of drug-related problems (DRPs). We aimed to validate the ability of the questionnaire to distinguish between hospitalised patients showing lower and higher numbers of DRPs.
DESIGN: Cross-sectional study assessing the questionnaire's concurrent criterion validity.
SETTING: Five geriatric and the associated physical and neurological rehabilitation wards of a Swiss regional secondary care hospital with 617 beds.
PARTICIPANTS: We recruited 110 patients from a total of 437 admissions. Exclusion criteria were insufficient knowledge in spoken or written German, medical conditions preventing meaningful conversations and already receiving pharmacy services.
INTERVENTIONS: Comprehensive pharmacist-led clinical medication reviews were performed, including patient interviews, to identify potential and manifest DRPs. A cluster analysis was conducted to assess the discriminatory potential of the DART to group patients according to number (low and high) of identified DRPs. A subsequent discriminatory function analysis was performed to reduce the number of items. We determined which DART items may be used to trigger what type of medication review.
RESULTS: Recruited patients had a median age of 79 years and were prescribed a median of 11 drugs. Patients with a median DART score of 10 and a median of 3 DRPs represented one cluster, whereas patients with a median DART score of 15 and a median of 8 DRPs represented another cluster. Discriminatory function analysis reduced the questionnaire to five items with a moderate to strong correlation with the number of DRPs per patient (Spearman's rank correlation ρ=0.44). Additional items were associated with patients benefiting from interviews.
CONCLUSIONS: As a self-administered questionnaire for patients, the DART may be used to stratify hospitalised non-acute older patients in groups of having low and high likelihood of DRPs. The analyses showed that a short form of the DART can be used instead of the full tool to identify older inpatients at risk for DRPs. Additional eight items from the DART may be used to initiate additional clinical pharmacy services. The linkage between certain DART questions and type of medication review enables pharmacist resource allocation.
PMID: 29950469 [PubMed - in process]
Recent Developments in ADC Technology: Preclinical Studies Signal Future Clinical Trends.
Recent Developments in ADC Technology: Preclinical Studies Signal Future Clinical Trends.
BioDrugs. 2017 Dec;31(6):521-531
Authors: Drake PM, Rabuka D
Abstract
The antibody-drug conjugate (ADC) field is in a transitional period. Older approaches to conjugate composition and dosing regimens still dominate the ADC clinical pipeline, but preclinical work is driving a rapid evolution in how we strategize to improve efficacy and reduce toxicity towards better therapeutic outcomes. These advances are largely based upon a body of investigational studies that together offer a deeper understanding of the absorption, distribution, metabolism, and excretion (ADME) and drug metabolism and pharmacokinetics (DMPK) fates of both the intact conjugate and its small-molecule component. Knowing where the drug goes and how it is processed allows mechanistic connections to be drawn with commonly observed clinical toxicities. The field is also starting to consider ADC interactions with the immune system and potential synergistic therapeutic opportunities therein. In an indication of future directions for the field, antibody conjugates bearing non-cytotoxic small-molecule payloads are being developed to reduce side effects associated with treatment of chronic diseases. ADCs are not a magic bullet to cure disease. However, they will increasingly become valuable therapeutic tools to improve patient outcomes across a variety of indications.
PMID: 29119409 [PubMed - indexed for MEDLINE]
Assessment of drug-related problems in pediatric ward of Zewditu Memorial Referral Hospital, Addis Ababa, Ethiopia.
Assessment of drug-related problems in pediatric ward of Zewditu Memorial Referral Hospital, Addis Ababa, Ethiopia.
Int J Clin Pharm. 2017 Oct;39(5):1039-1046
Authors: Birarra MK, Heye TB, Shibeshi W
Abstract
Background Although medications play a vital role in the cure, palliation, and inhibition of disease, they also expose patients to drug-related problems (DRPs). DRPs are common in hospitalized patients. Specifically, pediatrics population are easily affected by DRPs, as dynamic and kinetic behaviors of drugs in this population are usually different than in adults. Objectives To assess the prevalence of DRPs and associated factors in a pediatric setting in Ethiopia. Setting Pediatric ward of Zewditu Memorial Referral Hospital, Addis Abbeba, Ethiopia. Methods A cross-sectional study was conducted on 285 randomly selected patients. Data were obtained through review of physician medication orders and patient files. The prevalence and type of DRPs were studied and documented using the Pharmaceutical Care Network Europe Foundation classification system. The results were summarized using descriptive statistics including frequency, mean, and standard deviation. To identify the independent predicators of DRPs, logistic regression analysis was run and a P value ≤0.05 was considered as statistically significant. Main outcome measure DRPs, types of DRPs, drugs that are frequently involved in DRPs, and factors associated with DRPs. Main outcome measure Number of DRPs. Results Of the 1055 medication orders reviewed, a total of 106 DRPs were identified in 90 patients. This gives an overall rate of drug-related problems of 31.57%. The most frequently identified DRPs were dosing problems, with dose too low being 34.9% and dose too high being 7.5%. This was followed by drug-drug interactions (38.67%) and adverse drug reactions (8.49%). The number of prescribed drugs (AOR 2.3, 95% CI 1.3-4.3, P = 0.007) and total number of disease conditions (AOR 4.8, 95% CI 1.9, 12.1, P = 0.001) were potential risk factors for occurrence of DRPs. Conclusion The present study demonstrated that DRPs were common at the pediatric ward of Zewditu Memorial Referral Hospital and that it needs great attention. The most frequently identified DRPs were dosing problems, followed by drug-drug interactions and adverse drug reaction. Poly-pharmacy and number of disease conditions have been identified as important risk factors for occurrence of DRPs. The investigators recommend establishing a system for reporting DRPs in the pediatric ward of the hospital as it may facilitate appropriate measures for prospective interventions, such as training the healthcare team, as well as detail precautions to be followed by the practitioners. In addition to this, improving communication between the healthcare team members such as physicians, pharmacists, nurses, and other healthcare workers in the hospital is recommended.
PMID: 28689305 [PubMed - indexed for MEDLINE]
Coding for Medication-related Poisoning and Adverse Effects.
Coding for Medication-related Poisoning and Adverse Effects.
Continuum (Minneap Minn). 2017 Jun;23(3, Neurology of Systemic Disease):e17-e19
Authors: Yu M
Abstract
Accurate coding is important for proper reimbursement and documentation of care provided. This article provides an overview of coding considerations for patient encounters associated with medication use, abuse, or poisoning.
PMID: 28570335 [PubMed - indexed for MEDLINE]
Antiresorptive drug-related osteonecrosis of the jaws, literature review and 5 years of experience.
Antiresorptive drug-related osteonecrosis of the jaws, literature review and 5 years of experience.
Musculoskelet Surg. 2018 Jun 14;:
Authors: Bernardi S, Di Girolamo M, Necozione S, Continenza MA, Cutilli T
Abstract
PURPOSE: Bisphosphonate drug therapy provides benefits in the case of osteoporosis and carcinomas metastasizing to the bones, but it exposes patients to important side effects. The aim of this study was to investigate the incidence and the appropriate surgical treatment of bone lesions and fractures due to antiresorptive drug-related osteonecrosis of the jaws (ARONJ).
METHODS: Patients presenting with osteonecrosis lesions of the jaw, who were referred to the Maxillo-Facial unit of the University of L'Aquila, were considered for inclusion. Grade of the lesion and treatment choice was recorded for each patient. Descriptive statistics were calculated and the data were analysed with Chi-squared tests. A representative case of a fracture reduction with a supra-periostal approach is reported.
RESULTS: Among the 165 patients with ARONJ lesions, 112 were female and 53 were male. In total, 115 patients received intra-venous bisphosphonate therapy and 50 received oral bisphosphonate therapy. Five stage 2 lesions, three stage 2 lesions and two stage 3 lesions were not a consequence of dental procedures. Eighteen surgical bone excisions were performed and four pathological fractures were reduced. In one case (the reported one), the combined use of platelet-rich plasma and the supra-periostal approach leads to a successful 1-year follow-up.
CONCLUSIONS: ARONJ lesions are a type of pathological bone disease affecting the jawbones. The pathology pathway remains a controversial and frequently discussed topic. A surgically conservative strategy seems to be the best way to assure a comfortable quality of life to those patients negatively affected by this condition.
PMID: 29948937 [PubMed - as supplied by publisher]
Adverse drug reaction monitoring in patients on antiretroviral therapy in a tertiary care hospital in Eastern India.
Adverse drug reaction monitoring in patients on antiretroviral therapy in a tertiary care hospital in Eastern India.
Indian J Pharmacol. 2017 May-Jun;49(3):223-228
Authors: Mukherjee S, Era N, Saha B, Tripathi SK
Abstract
BACKGROUND: Besides unparalleled benefits, highly active antiretroviral therapy is also associated with wide range of potential adverse drug reactions (ADRs), which hinders treatment adherence. The present study was thus designed to monitor and explore the pattern of occurrence of ADRs to various antiretroviral therapy (ART) regimens in a tertiary care ART setup.
MATERIALS AND METHODS: A prospective, observational clinical study was carried out in the outpatient setting of nodal ART center of Eastern India. A total of 610 patients on various ART regimens were studied for suspected ADRs over 12 months. Adverse event history, medication history, and other relevant details were captured. Causality and severity of each reported ADR were duly assessed.
RESULTS: 32.45% patients of total study participants presented with a total of 330 ADRs. Patients from zidovudine-based regimens presented with majority of ADRs such as anemia (up to 36%), central nervous system (CNS), and gastrointestinal (GI) side effects. Tenofovir-based regimens were, however, found to be mildly safer. The combination with Efavirenz was associated with majorly CNS side effects while that of nevirapine was associated with rash and pigmentation of nails. Atazanavir boosted second-line regimens were notably associated with increased serum lipid levels followed by other GI and CNS adverse effects. Increased liver enzymes were found in atazanavir-based second-line ART.
CONCLUSION: The study enables to obtain information on the incidence and pattern of ADRs associated with various antiretroviral regimens, thereby reducing its occurrence and protecting the patient population from avoidable harm. Need of intensive monitoring for ADRs in ARTs thus seems to be a mandate.
PMID: 29033481 [PubMed - indexed for MEDLINE]