Presence Of Adverse Drug Reactions Research Articles

Prediction of adverse drug reactions using demographic and non-clinical drug characteristics in FAERS data

The presence of adverse drug reactions (ADRs) is an ongoing public health concern. While traditional methods to discover ADRs are very costly and limited, it is prudent to predict ADRs through non-invasive methods such as machine learning based on existing data. Although various studies exist regarding ADR prediction using non-clinical data, a process that leverages both demographic and non-clinical data for ADR prediction is missing. In addition, the importance of individual features in ADR prediction has yet to be fully explored. This study aims to develop an ADR prediction model based on demographic and non-clinical data, where we identify the highest contributing factors. We focus our efforts on 30 common and severe ADRs reported to the Food and Drug Administration (FDA) between 2012 and 2023. We have developed a random forest (RF) and deep learning (DL) machine learning model that ingests demographic data (e.g., Age and Gender of patients) and non-clinical data, which includes chemical, molecular, and biological drug characteristics. We successfully unified both demographic and non-clinical data sources within a complete dataset regarding ADR prediction. Model performances were assessed via the area under the receiver operating characteristic curve (AUC) and the mean average precision (MAP). We demonstrated that our parsimonious models, which include only the top 20 most important features comprising 5 demographic features and 15 non-clinical features (13 molecular and 2 biological), achieve ADR prediction performance comparable to a less practical, feature-rich model consisting of all 2,315 features. Specifically, our models achieved an AUC of 0.611 and 0.674 for RF and DL algorithms, respectively. We hope our research provides researchers and clinicians with valuable insights and facilitates future research designs by identifying top ADR predictors (including demographic information) and practical parsimonious models.

Pharmaco-Therapeutic Factors Influencing the Quality of Life in Patients on Anti-Glaucoma Medications for the Treatment of Primary Open-angle Glaucoma: A Cross-Sectional Study

Abstract Purpose: Vision significantly affects a person’s quality of life (QOL). This study aims to determine the pharmaco-therapeutic factors influencing it among patients on anti-glaucoma medications. Materials and Methods: A total of 100 patients diagnosed with primary open-angle glaucoma (POAG) on medications for six weeks were included in this cross-sectional study. QOL was assessed using a pre-validated Glaucoma Quality of Life-15 (GQOL-15) Questionnaire. Adverse drug reactions (ADRs) to the anti-glaucoma medications were determined using the pre-validated Comparison of Ophthalmic Medications for Tolerability (COMTOL) checklist. The Chi-square test, Fisher’s exact test and multiple logistic regression analysis were performed to test the statistical significance of the data. A P value of < 0.05 was considered statistically significant. Results: Out of the 100 patients, 76 had good QOL and 24 had poor QOL. Among them, 67 patients were on a single drug, 27 were on a two-drug combination and six were on a three-drug combination for the management of glaucoma. Patients receiving multiple drugs for the management of POAG were associated with poor QOL (P = 0.006). Out of the other variables tested for association, the presence of ADRs, patients having a positive family history of POAG, patients with a duration of illness of more than three years, hypertensives and diabetics had a statistically significant association with poor QOL. Conclusion: POAG patients on multiple anti-glaucoma medications had poor QOL compared to those on a single drug. Multiple drug combinations caused a greater number of ADRs compared to single drug use. Patients with ADRs had poor QOL. The presence of co-morbidities like diabetes, hypertension and positive family history were associated with poor QOL.

The clinical, sociodemographic, and pharmacotherapeutic characteristics influencing quality of life in patients with epilepsy

Background: It is becoming widely understood that evaluating a patient’s quality of life (QOL) is crucial to managing their epilepsy. The study aimed to explore the impact of sociodemographic, clinical, and pharmacotherapy factors on QOL in patients with epilepsy. Methods: This was a cross-sectional study conducted over 2 years at the outpatient and inpatient Department of Medicine (Neurology Division) of SMHS Hospital, affiliated with Government Medical College, Srinagar. The patients with epilepsy with a definite diagnosis of epilepsy as per the International League Against Epilepsy (ILAE) guidelines were included. Results: Patients on polytherapy had significantly lower scores for overall QOL, energy/fatigue, medication effects, social functioning, and overall score. Patients on monotherapy scored significantly lower for the said domains, including the seizure worry domain, compared to those patients with epilepsy who were antiepileptic drugs (AEDs) naive. Conclusion: Individuals who were receiving monotherapy had greater QOL scores than those who were receiving traditional AEDs and had focal epilepsy. Furthermore, in patient with epilepsy, all QOL domains were significantly predicted by increased seizure frequency and the presence of adverse drug reactions (ADRs).

Adverse drug reactions in children and adolescents on daily antitubercular regimen: An observational longitudinal study

ObjectivesSubsequent to introduction of daily fixed dose combination (FDC) regimen with increased dosages and inclusion of ethambutol in continuation phase of antitubercular therapy (ATT) in India, this study was done to evaluate adverse drug reactions (ADRs) in children and adolescents. MethodsLongitudinal observational study conducted in tertiary teaching hospital. Children (1 month–18 year), with newly diagnosed drug sensitive tuberculosis, started on daily FDC regimen of ATT, were included. Participants were followed up at 2 weeks, 8 weeks and 6 months. Division of AIDS (DAIDS) severity grading and World Health Organization-Uppsala Monitoring Centre (WHO-UMC) causality assessment was done. ResultsIn 99 participants, 29 experienced ADRs. Most commonly ADRs involved hepatobiliary (11.1%) and gastrointestinal (8.1%) systems. Grade 3 severity noted in 35.5% ADRs. Certain causality classified in 19.3%. Presence of ADRs was significantly higher in participants with vs without malnutrition [40.5% vs 21.1% (p = 0.036)]. Tendency for more severe ADRs noted in participants with vs without malnutrition [Grade 3 ADRs out of all ADRs: 64.7% vs 0% (p < 0.001)]. ConclusionIncidence and severity of ADRs has increased after introduction of daily FDC of ATT. Most common ADR observed were hepatobiliary. Malnutrition and less weight for age were risk factors for occurrence and severity of ADRs.

Personalized therapy: the crucial role of the DPYD c.2194G&gt;A (V732I) allele in the treatment of colorectal cancer patients candidates for therapy with fluoropyrimidines

5-Fluorouracil (5FU) is a chemotherapeutic agent belonging to the class of antimetabolite drugs, which exert a toxic action causing death of neoplastic cells. 5FU is mostly used as a standard treatment for colorectal cancer; the development of toxicity phenomena is related to the partial or complete deficiency of the enzyme dihydropyrimidine dehydrogenase (DPD), limiting factor of the catabolism of fluoropyrimidines. Only 3-5% of 5-FU is converted to an active metabolite, while 85% of the drug is inactivated by DPD to 5-fluoro-dihydrouracil (5-FDHU). A reduced enzymatic activity of the DPD can be the cause for the presence of adverse drug reactions and toxicity in the patient, with multiorgan involvement, which can sometimes lead to death. The variants of the DPYD gene recommended by the AIOM (Associazione Italiana di Oncologia Medica)guidelines are: DPYD*2A (IVS14+1G&gt;A, c.1905+1G&gt;A); DPYD*13 (c.1679T&gt;G); DPYD c.2846A&gt;T, D949V; DPYD c.1236G&gt;A (HapB3); DPYD c.2194G&gt;A (V732I).Patients with complete DPD deficiency are at high risk of life-threatening or fatal toxicity and should not be treated with fluoropyrimidines, but this is a rare condition; while patients with partial deficiency should be treated with a reduced dose of the drug. Before starting treatment it’s crucial to determine the genetic profile of the patients candidates to therapy with fluoropyrimidines. In our cohort of the 370 samples analyzed by Real Time PCR, 294(~80%) are wild type for each variant screened. : DPYD c.2194G&gt;A (V732I) alleleis significantly represented in the population examinated: considering the 15% reduction in drug administration imposed by this genotype, molecular profiling is essential before starting therapy with 5FU.In our study we also found a rare variant DPYD F632F rs17376848 c.1896 T&gt; C in a patient, whose relevancefor therapeutic purposes is currently of uncertain significance.

AN OBSERVATIONAL STUDY TO ASSESS THE ADVERSE DRUG REACTION OF ANTI-ASTHMATIC DRUGS AMONG ADULTS IN WESTERN RAJASTHAN

Background: Asthma is one of the most common chronic illness worldwide. For prevention of exacerbations, patients of bronchial asthma are kept on long-term treatment that is why they are amenable for adverse drug reactions (ADRs). The study was planned to monitor ADRs with intervention of anti-asthmatic drugs in adults visited in medicine outpatient or admitted in inpatient department of a tertiary care teaching hospital. Methods: A cross-sectional study was conducted among 340 asthma patients in collaboration with Department of Medicine for duration of 12 months. Information of patients was collected with the help of semi-structured case record form ADRs along with interventions given that were also recorded. Results: Data analysis was done with the help of SPSS version20.0. Fisher exact test was applied. A total of 340 patients were enrolled in the study. The highest numbers of ADRs were observed with Salbutamol (34.78%). The highest ADRs were noted with Beta2 agonists class of drugs. The main ADRs noted were headache followed by tremors and oral thrush. Statistically significant association was found between presence of ADRs and severity of asthma. Conclusion: Identifying any possible connection between a presenting complaint and drug used is crucial to reduce the risk of ADRs in the future. Appropriate monitoring of ADRs is a key for this. Reduction in ADRs will improve the compliance of patient and ultimately their clinical outcome.

ОЛЬ ПОЛИМОРФИЗМА ГЕНА MDR1 ДЛЯ НАЗНАЧЕНИЯ НЕСТЕРОИДНЫХ ПРОТИВОВОСПАЛИТЕЛЬНЫХ ПРЕПАРАТОВ ПРИ БОЛЕВОМ СИНДРОМЕ

Introduction. One of the key roles in the excretion of a number of drugs, in particular nonsteroidal anti- inflammatory drugs, has a transport protein glycoprotein P, encoded by the MDR1 gene. In this connection, the influence of genetic polymorphism of glycoprotein P on the pharmacokinetics of these drugs contributes to the prediction of clinical consequences. Aim. The aim of the current study was to study the associations of polymorphic markers C1236T and C3435T of the MDR1 gene encoding glycoprotein P with the development of undesirable drug reactions in patients with pain syndrome. Material and methods. The study included 69 patients with pain syndrome and were divided into 2 groups depending on the presence of adverse drug reactions: NLR+ - 20 patients and NLR - - 49 patients with pain syndrome. The association of the polymorphic marker C3435T of the MDR1 gene was also studied among 22 patients with adverse drug reactions (ADR+) and 47 patients with pain syndrome without the presence of adverse drug reactions (ADR-). Molecular genetic studies were carried out on the basis of the Laboratory of medical genetics of NIIG and the PC of the Ministry of Health of the Republic of Uzbekistan. Results and discussion. During the genotyping, it was found that the occurrence of alleles and genotypes of the polymorphic marker C3435T of the MDR1 gene had significantly significant differences among the patients of the examined groups, depending on adverse drug reactions. Conclusion. The association of the polymorphic marker C3435T of the MDR1 gene with the development of undesirable drug reactions in pain syndrome, the TT genotype and the T allele may be genetic risk factors (OR=4.0 and 8.25; 95% CI 1.78-9.09 and 2.56-26.57, respectively) predisposing to the development of undesirable drug reactions in patients with pain syndrome. Therefore, further study is necessary in order to carry out genotyping of the polymorphic marker C3435T of the MDR1 gene to increase the effectiveness and safety of therapy of nonsteroidal anti-inflammatory drugs.

Between Curing and Torturing: Burden of Adverse Reaction in Drug-Resistant Tuberculosis Therapy.

Drug-resistant tuberculosis (DR-TB) requires prolonged and complex therapy which is associated with several adverse drug reactions (ADR). The burden of ADR can affect the quality of life (QoL) of patients that consists of physical, mental, and social well-being, and influences the beliefs and behaviors of patient related to treatment. This article reviews the burden of ADR and its association with QoL and adherence. We used PubMed to retrieve the relevant original research articles written in English from 2011 to 2021. We combined the following keywords: “tuberculosis,” “Drug-resistant tuberculosis,” “Side Effect,” “Adverse Drug Reactions,” “Adverse Event,” “Quality of Life,” “Adherence,” “Non-adherence,” “Default,” and “Loss to follow-up.” Article selection process was unsystematic. We included 12 relevant main articles and summarized into two main topics, namely, 1) ADR and QoL (3 articles), and 2) ADR and therapy adherence (9 articles). The result showed that patients with ADR tend to have low QoL, even in the end of treatment. Although it was torturing, the presence of ADR does not always result in non-adherence. It is probably because the perception about the benefit of the treatment dominates the perceived barrier. In conclusion, burden of ADR generally tends to degrade QoL of patients and potentially influence the adherence. A comprehensive support from family, community, and healthcare provider is required to help patients in coping with the burden of ADR. Nevertheless, the regimen safety and efficacy improvement are highly needed.

Optimising Medications for Patients With Cancer and Multimorbidity: The Case for Deprescribing

The majority of patients diagnosed with cancer are aged over 65 years and have two or more chronic conditions in addition to cancer and the risk of chronic conditions increases further after cancer. The presence of multimorbidity adds complexity to care, as patients' goals of care and the focus of treatment can change with a diagnosis of cancer. Multimorbidity is frequently associated with polypharmacy, the use of potentially inappropriate medications, the presence of adverse drug reactions and potential drug–drug interactions: all of which impact on health outcomes and the cost of care. Consequently, it is vital that a systematic approach is taken to regularly review cancer patients' medication regimens to ensure that they support an optimal balance of benefits with acceptable levels of harm. Several patient and clinician resources are presented to guide the process of medication review and deprescribing.

Multimorbidity patterns in chronic older patients, potentially inappropriate prescribing and adverse drug reactions: protocol of the multicentre prospective cohort study MoPIM

IntroductionMultimorbidity is a major challenge for current healthcare systems and professionals. From the different approaches that have been proposed to analyse this issue, the hypothesis of the existence of association...

Study of self-reported adverse drug reactions and factors influencing it among human immunodeficiency virus/acquired immunodeficiency syndrome patients on antiretroviral therapy

Background: Human immunodeficiency virus (HIV) is the causative agent of acquired immunodeficiency syndrome (AIDS). HIV/AIDS is a significant worldwide medical issue. Patients on highly active antiretroviral therapy (HAART) generally encounter adverse drug reactions (ADRs). Various aspects of HAART such as adherence of the patient to the therapy, results of the therapy, and their treatment alternatives are considerably influenced by the presence of ADRs. Aim and Objectives: To estimate the commonly encountered self-reported ADRs among the patient on HAART, to know the various factors which influence the ADRs, the reasons behind missing ART doses and to know the relationship among ADRs and different factors to HAART. Materials and Methods: The present study was conducted in HIV/AIDS patients on HAART attending ART center at Raichur Institute of Medical Sciences, Raichur, after getting the ethical clearance. This was a cross-sectional, observational study conducted among the two hundred and seventy HIV/AIDS patients on HAART during the 12-month study period from December 2013 to November 2014. After obtaining the informed consent, the information pertaining to the sociodemographic profile of the patient, ADRs to HAART, and explanations behind missing ART dose were collected using a semi-structured interview questionnaire. The patient treatment record was used to collect the information regarding variables related to HAART and the laboratory values. Data were interpreted by applying descriptive analysis after collecting in Microsoft Excel sheet. The relationships of dependent variables to ADRs were determined by logistic regression analysis. Results: Of 270 enrolled patients, 135 (50%) patients aged less than 40 years, 190 (70.4%) were literate, 142 (52.6%) were male, and 194 (71.9%) were from rural background. Zidovudine based regimens 117 (43.3%) were the most commonly prescribed regimen in this study. The most frequently self-reported ADRs were burning sensation in stomach 40 (14.8%). The two most normal explanations behind missing ART dosages were simply forgot 35 (70%) trailed by ADRs 17 (34%) to HAART. Two variables were found to have a significant relationship to the self-reported ADRs on bivariate analysis. These were patients on HAART who aged more than or equal to 40 years (24.4%, P = 0.04) and when the duration of HAART was under 2 years (17.8%, P = 0.028). Conclusions: The most common self-reported ADR was a burning sensation in stomach. The ADR encounter was more common when the duration of HAART was lesser than 2 years. Aside from the age of the patient, no other sociodemographic variable has an impact on ADR occurrence. Therefore, it is the responsibility of the health care service providers to have the knowledge of frequently occurring ADRs and the factors influencing it to enhance the effectiveness of HAART.

Association of adverse drug reaction to anti-tuberculosis medication with quality of life in patients in a tertiary referral hospital.

INTRODUCTION: Adverse drug reactions can develop when using anti-tuberculosis medication, and the effects of the drugs can also significantly hinder the treatment of patients.METHODS:A cross-sectional survey was conducted in 73 patients using two standardized questionnaires and the World Health Organization Quality of Life-Bref.RESULTS:All patients reported the presence of adverse drug reactions, 71.6% of which are minor and 28.3% both major and minor. The global quality of life analysis showed that patients with tuberculosis have a good average (67.3%). CONCLUSIONS:There is an association between quality of life and adverse drug reaction, educational level, and vulnerability.

Genetic risk factors for behavioral adverse reactions in epileptic patients taking levetiracetam

Levetiracetam (LEV) is an effective antiepileptic drug. Nevertheless, when the drug is used, its behavioral adverse drug reactions (ADRs), such as aggressivity, irritability, hyperexcitability, and anxiety, occur in almost 30% of cases. Recent studies show that personality traits can predispose to LEV-induced ARs.Objective: to establish genetic risk factors for behavioral ADRs in epileptic patients taking LEV. Patients and methods. Single nucleotide variants (SNVs) were chosen according to their importance for the development of impulsivity and aggressivity. At Stage 1, the dose-dependent effect of LEV, which was responsible for behavioral ADRs, was studied in 179 epileptic patients taking this drug, who were divided into four groups according to age and the presence of ADRs. Molecular genetic testing of SNVs DRD2 rs1800497 (DRD2/ANKK1 Taq1A), COMT rs4680, and DBH rs1611115 was done at Stage 2. Results and discussion. The ADR and non-ADR groups showed no statistically significant differences in the daily dose of LEV in both children (696.1 and 500.0 mg/day, respectively; p=0.087) and adults (750.9 and 750.9 mg/day, respectively; p=0.13). The similar data were obtained for blood LEV concentrations in children (31.6 and 27.3 μg/ml, p=0.12) and in adults (23.1 and 17.6 μg/ml, respectively; p=0.12). There was a statistically significant association between the carriage of the heterozygous CT genotype of SNV rs1611115 and the rate of both behavioral (OR, 3.38; 95% CI, 1.25–9.14; p=0.042) and CNS ADRs in general (OR, 3.29; 95% CI, 1.29–8.44; p=0.036). Higher impulsivity values were recorded in the carriers of the CT + TT genotypes of SNV rs1800497 (p&lt;0.05) and rs1611115 (p&lt;0.01) compared with those of the CC genotype. No statistically significant intergroup differences were obtained for SNV COMP rs4680. Conclusion. The dose-dependent effect of behavioral ADRs is absent in both pediatric and adult patients taking LEV. Increased impulsiveness in epileptic patients taking LEV is associated with the carriage of SNV rs1800497 and rs1611115. The LEV-induced behavioral ADRs are related to SNV DBH rs1611115 that can be considered as one of the potential genetic predictors for behavioral ADRs and impulsivity.

Factors associated with health care seeking behavior for musculoskeletal pain in Indonesia: A cross-sectional study.

To assess the factors defining healthcare-seeking behavior of people with musculoskeletal pain in the urban community of Malang City, East Java, Indonesia. A cross-sectional survey was performed in Malang City, East Java, Indonesia. In total, 2067 participants aged 16-93years were interviewed. The sociodemographic and socioeconomic factors of healthcare seeking behavior, musculoskeletal pain, disability, and adverse drug reactions were assessed using the validated Indonesian version of Community Oriented Program for the Control of Rheumatic Disease (COPCORD) protocol by International League of Associations for Rheumatology and the World Health Organization core questionnaire. Chi-square test was applied to assess the determinants of health-seeking behavior for musculoskeletal pain. Slightly more than one-third of the respondents (36%) with musculoskeletal pain, described as osteoarthritis, low back pain, gouty arthritis, soft tissue rheumatism, and autoimmune arthritis, were assessed for their health-seeking behavior. About 73% of all those participants sought treatment for their musculoskeletal symptoms. Treatment modality used was modern healthcare, traditional healthcare, self-treatment using traditional medication, self-treatment using modern medication with the proportions of 20.94%, 25.23%, 33.95%, 25.77%, respectively. Disability significantly affected health-seeking behavior as the major determinant (prevalence ratio [PR] 1.087, 95% CI 1.031-1.146, P=0.002), followed by age (PR 1.043, 95% CI 1.000-1.087, P=0.049). Healthcare-seeking behavior was associated with the presence of adverse drug reactions (P<0.001). Factors associated with musculoskeletal pain health-seeking behavior were disability and age. Self and traditional healthcare treatment were further associated with an adverse drug reaction.

A systematic approach for developing a corpus of patient reported adverse drug events: A case study for SSRI and SNRI medications.

"Psychiatric Treatment Adverse Reactions" (PsyTAR) corpus is an annotated corpus that has been developed using patients narrative data for psychiatric medications, particularly SSRIs (Selective Serotonin Reuptake Inhibitor) and SNRIs (Serotonin Norepinephrine Reuptake Inhibitor) medications. This corpus consists of three main components: sentence classification, entity identification, and entity normalization. We split the review posts into sentences and labeled them for presence of adverse drug reactions (ADRs) (2168 sentences), withdrawal symptoms (WDs) (438 sentences), sign/symptoms/illness (SSIs) (789 sentences), drug indications (517), drug effectiveness (EF) (1087 sentences), and drug infectiveness (INF) (337 sentences). In the entity identification phase, we identified and extracted ADRs (4813 mentions), WDs (590 mentions), SSIs (1219 mentions), and DIs (792). In the entity normalization phase, we mapped the identified entities to the corresponding concepts in both UMLS (918 unique concepts) and SNOMED CT (755 unique concepts). Four annotators double coded the sentences and the span of identified entities by strictly following guidelines rules developed for this study. We used the PsyTAR sentence classification component to automatically train a range of supervised machine learning classifiers to identifying text segments with the mentions of ADRs, WDs, DIs, SSIs, EF, and INF. SVMs classifiers had the highest performance with F-Score 0.90. We also measured performance of the cTAKES (clinical Text Analysis and Knowledge Extraction System) in identifying patients' expressions of ADRs and WDs with and without adding PsyTAR dictionary to the core dictionary of cTAKES. Augmenting cTAKES dictionary with PsyTAR improved the F-score cTAKES by 25%. The findings imply that PsyTAR has significant implications for text mining algorithms aimed to identify information about adverse drug events and drug effectiveness from patients' narratives data, by linking the patients' expressions of adverse drug events to medical standard vocabularies. The corpus is publicly available at Zolnoori et al. [30].

Economic burden of adverse drug reactions and potential for pharmacogenomic testing in Singaporean adults.

Adverse drug reactions (ADRs) contribute to hospitalization but data on its economic burden is scant. Pre-emptive pharmacogenetic (PGx) testing can potentially reduce ADRs and its associated costs. The objectives of this study were to quantify the economic burden of ADRs and to estimate the breakeven cost of pre-emptive PGx testing in Singapore. We collected itemized costs for 1000 random non-elective hospitalizations of adults admitted to a tertiary-care general hospital in Singapore. The presence of ADRs at admission and their clinical characteristics were reported previously. The economic burden of ADRs was assessed from two perspectives: (1) Total cost and (2) incremental costs. The breakeven cost of PGx testing was estimated by dividing avoidable hospitalization costs for ADRs due to selected drugs by the number of patients taking those drugs. The total cost of 81 admissions caused by ADRs was US$570,404. Costs were significantly higher for bleeding/elevated international normalized ratio (US$9906 vs. US$2251, p = 6.58 × 10-3) compared to other ADRs, and for drugs acting on the blood coagulation system (US$9884 vs. US$2229, p = 4.41 × 10-3) compared to other drug classes. There were higher incremental laboratory costs due to ADRs causing or being present at admission. The estimated breakeven cost of a pre-emptive PGx test for patients taking warfarin, clopidogrel, chemotherapeutic and neuropsychiatric drugs was US$114 per patient. These results suggest that future studies designed to directly measure the clinical and cost impact of a pre-emptive genotyping program will help inform clinical practice and health policy decisions.

Potential drug-drug interactions and their risk factors in pediatric patients admitted to the emergency department of a tertiary care hospital in Mexico.

BackgroundDrug-drug interactions (DDIs) detected in a patient may not be clinically apparent (potential DDIs), and when they occur, they produce adverse drug reactions (ADRs), toxicity or loss of treatment efficacy. In pediatrics, there are only few publications assessing potential DDIs and their risk factors. There are no studies in children admitted to emergency departments (ED). The present study estimates the prevalence and describes the characteristics of potential DDIs in patients admitted to an ED from a tertiary care hospital in Mexico; in addition, potential DDI-associated risk factors are investigated.MethodsA secondary analysis of data from 915 patients admitted to the ED of the Hospital Infantil de México “Federico Gómez” was conducted. The Medscape Drug Interaction Checker software was used to identify potential DDIs. The results are expressed as number of cases (%), means (95% CI) and medians (25-75th percentiles). Count data regressions for number of total and severity-stratified potential DDIs were performed adjusting for patient characteristics, number of administered drugs, days of stay, presence of ADRs and diagnoses.ResultsThe prevalence of potential DDIs was 61%, with a median of 4 (2–8). A proportion of 0.2% of potential DDIs was “Contraindicated”, 7.5% were classified as “Serious”, 62.8% as “Significant” and 29.5% as “Minor”. Female gender, age, days of stay, number of administered drugs and diagnoses of Neoplasms (C00-D48), Congenital malformations (Q00-Q99), Diseases of the Blood, Blood-forming Organs and Immunity (D50-D89) and Diseases of the nervous system (G00-G99) were significantly associated with potential DDIs.ConclusionThe prevalence of potential DDIs in the ED is high, and strategies should therefore be established to monitor patients’ safety during their stay, in addition to conducting investigations to estimate the real harm potential DDIs inflict on patients.

Factors Affecting Polypharmacy in Elderly Patients with Diabetes in Greece

To determine prevalence and factors affecting polypharmacy amongelderly diabetic patients in Greece. A prospective multi-center cross-sectional study was carried out in the regions of Attica and Western Greece. Data were collected via personal interviews at the outpatients’ and specialized diabetes units of the public, private and university hospitals. A random sample of 702 patients was selected out of 1.134 patients followed up from March to May 2016. A questionnaire was prepared based on the EU SIMPATHY experience including questions on patients’ characteristics, medication use and adherence, adverse drug reactions (ADRs) and self-assessment of health status. The criterion for polypharmacy was defined as the concomitant use of 5 or more medications.Descriptive and multiple regression analyses were performed to examine the impact of studied independent variables on polypharmacy. Data analysis was carried out using SPSS-21. 644outpatients filled out the questionnaire (RR=91.7%) witha mean age of 67.8 (SD 13) years and disease duration of11 (SD 8) years. The prevalence of polypharmacy among the sample is 22.5%.Mean number of medications used by each elder was 4.2 (SD 2.5). Approximately 6/10 patients received antidiabetic drug as monotherapy, and 4/10 receivedat least one more medication for other chronic diseases. The majority of the sample suffered from cardiovascular diseases. The findings showed that polypharmacy isaffected significantly by gender (P≤ 0.01; β= 2,093), age (P = 0.005; β=0,026), presence of ADRs (P = 0.085; β=0,778), caregiver’ help in taking medicines (P = 0.025; β=-0.491), increased drug dosage in order to feel better (P = 0.028; β=0.403) and self-assessment of health status (P ≤ 0.01; β=-0.451). Change management practices and integrated healthcare networks are needed to be introduced in Greece in order to support health providers to medication decision making as well as to educate elderly about the consequences of polypharmacy.

Resident and nurse reports of potential adverse drug reactions.

Nursing home residents are at high risk for adverse drug reactions (ADR). To improve pharmacotherapeutic care for individual residents, healthcare professionals need to be aware of ADRs. In nursing homes, nurses have a central role in monitoring residents' health and informing physicians on the presence of ADRs. The aim of this study was to evaluate the value of nursing home residents' ADR reports. Residents of a convenient sample of two nursing homes were included if their mental status and understanding of Dutch enabled them to report ADRs. In a cross-sectional design, residents and nurses were questioned about 17 potential ADRs. Reports of residents and nurses were consequently compared. Medication use was studied to describe the risk for ADRs per resident. Residents had a mean of eight different chronic medication prescriptions. Over 90% of the residents used medications which increase the risk of feeling somnolent/tired/sedated, arrhythmias and abdominal pain. The median number of potential ADRs reported by nurses was significantly lower compared to the number of resident reports (median [range], respectively, 1 [1-10] and 4 [1-10]). In general, residents reported the presence of more ADRs than nurses, except for confusion. The correspondence between nurse and resident reports ranged from 43% (dry mouth) till 88% (arrhythmia). Nurses and patients reported a lot of potential ADRs. The type of ADRs they reported was different and complementary. Questioning residents about specific potential ADRs may increase the awareness of ADRs.

CHARACTERIZATION OF POLYPHARMACY IN THE ELDERLY IN THREE UNITS OF HEALTH SERVICES IN PACHUCA, HIDALGO

The aim of this study is to determine the characteristics of poly pharmacy in the elderly in three units of Health Services in the state of Hidalgo, Mexico. A cross-sectional study of 282 patients treated at three units of the Health Services of Hidalgo during July-August 2014. A questionnaire was applied to collect the variables age, gender, diagnosis, drugs (prescription or self-medication) and the presence of adverse drug reactions. Descriptive statistics were performed using SPSS version 18 and the freely available software Drug Interaction Checker was used for identifying drug interactions. Mean age was 72 ± 11 years and 74.46 % were women (ratio 3:1); the most frequent illnesses were hypertension (30.1 %) and type 2 diabetes mellitus (17 %); regarding co-morbidities, 43.61 % had two concomitant pathologies followed by 25.9 % who presented three. Of the patients studied, 66 % consumed 3-5 drugs (median 4). The longest administration of a drug was 38 years (glibenclamide). The predominant route of administration was oral (93 %) with tablets (83.8) being the most prescribed pharmaceutical form. The ratio for self-medication was 10:100 with herbal products (57 %) being the most consumed by self-medication. Patients felt unwell after administration of a drug in 22.3 % with the main reaction referred being dyspepsia. Losartan, naproxen and sertraline were the main drugs associated with a suspected adverse reaction. At least one drug interaction was identified in 60 % of patients, with a median of 2 interactions; 63 % were classified as clinically significant, 33.7 % as minor, and 3.3 % as severe. The drug most often involved in an interaction was metformin; however, the most frequent interaction was aspirin-losartan. The characterization of poly pharmacy in the elderly sets the tone for developing interventions aimed at the prevention of drug interactions and promoting the rational use of drugs.