New drugs, new adverse drug reactions, and bibliographic databases

The Lancet ◽  
1999 ◽  
Vol 353 (9162) ◽  
pp. 1447-1448 ◽  
Author(s):  
A Figueras ◽  
F Estévez ◽  
J-R Laporte
Keyword(s):  
Adverse Drug Reactions ◽  
New Drugs ◽  
Bibliographic Databases ◽  
Drug Reactions

scholarly journals Nurse knowledge about potentially inappropriate medications for elderly

2021 ◽  
Vol 37 ◽  
pp. e37037
Author(s):  
Gabriela Garcia Soares ◽  
Ana Luisa Zanardo Buso ◽  
Bruna Stephanie Sousa Malaquias ◽  
Rodrigo Rodrigues Silva ◽  
Juliana Maria Soares ◽  
...  
Keyword(s):  
Adverse Drug Reactions ◽  
Population Aging ◽  
The Elderly ◽  
New Drugs ◽  
Potentially Inappropriate Medications ◽  
Drug Reactions ◽  
Cross Sectional ◽  
Elderly Health ◽  
The Individual ◽  
Inappropriate Medications

Due to the consequences of changes in fertility and mortality rates, there is an increase in population aging. In this context, the use of potentially inappropriate medications in this population makes nurses important agents in the identification of adverse reactions, requiring their knowledge about these drugs and their effects. The study aimed to verify nurses knowledge about the 2015 AGS BeersCriteria, regarding the potentially inappropriate medications for the elderly, and their adverse effects. It is a cross-sectional, descriptive, and analytical study with a quantitative and qualitative approach performed in a teaching hospital in the Triângulo Mineiro, Minas Gerais. Of the 80 professionals, 74.1% reported attending the elderly frequently, and only 3.8% had a specialization course in elderly health. Only 13.8% reported knowing the Beers Criteria. And 69% believe that adverse drug reactions can be confused as a new symptom and because of this, new drugs can be inserted into the therapeutic plan. Three categories emerged: The importance of assertive knowledge about PIMs, The nurse as a fundamental character in ADR, and Knowledge as a reinforcer of care. There is evidence of the need to train nurses to better identify adverse drug reactions so that they can act on these events avoiding the worsening of the individual.

scholarly journals Fuzzy Comprehensive Evaluation Assistant 3D-QSAR of Environmentally Friendly FQs to Reduce ADRs

2019 ◽  
Vol 16 (17) ◽  
pp. 3161 ◽  
Author(s):  
Ren ◽  
Wang ◽  
Xu ◽  
Li ◽  
Han
Keyword(s):  
Adverse Drug Reactions ◽  
Comprehensive Evaluation ◽  
Metabolic Activation ◽  
Fuzzy Comprehensive Evaluation ◽  
3D Qsar ◽  
New Drugs ◽  
Drug Reactions ◽  
Improved Method ◽  
Biological Studies

Most studies on adverse drug reactions (ADRs) of fluoroquinolones (FQs) have focused on the mechanisms of single ADRs, and no quantitative structure–activity relationship (QSAR) method studies have been carried out that combine several ADRs of FQs. In this study, an improved three-dimensional (3D) QSAR method was established using fuzzy comprehensive evaluation. This method could simultaneously consider three common ADRs of FQs using molecular parameters. The improved method could comprehensively predict three ADRs of FQs and provide direction for the development of new drugs with lower ADRs than the originals. According to the improved method, 48 derivatives with lower ADRs (decreased by 4.86% to 50.92%) were designed from pazufloxacin. Three derivatives with a higher genotoxicity, higher photodegradation, and lower bioconcentration than pazufloxacin were selected using the constructed QSAR methods of the FQs. Finally, three traditional 3D-QSAR methods of single ADR were constructed to validate the improved method. The improved method was reasonable, with a relative error range of 0.96% to 4.30%. This study provides valuable reference data and will be useful for the development of strategies to produce new drugs with few ADRs. In the absence of complementary biological studies of these adverse drug reactions, the results reported here may be quite divergent from those found in humans or experimental animals in vivo. One major reason for this is that many adverse drug reactions are dependent upon enzyme-catalyzed metabolic activation (toxication) or on non-enzymatic conversion to toxic products and are not due to the parent drug moiety.

The Influence of Primary Care Prescribing Rates for New Drugs on Spontaneous Reporting of Adverse Drug Reactions

Drug Safety ◽  
2007 ◽  
Vol 30 (4) ◽  
pp. 357-366 ◽  
Author(s):  
Richard C Clark ◽  
Simon R J Maxwell ◽  
Sheena Kerr ◽  
Melinda Cuthbert ◽  
Duncan Buchanan ◽  
...  
Keyword(s):  
Primary Care ◽  
Adverse Drug Reactions ◽  
Spontaneous Reporting ◽  
New Drugs ◽  
Drug Reactions

scholarly journals Detection of Unknown Ototoxic Adverse Drug Reactions: An Electronic Healthcare Record-Based Longitudinal Nationwide Cohort Analysis

2021 ◽  
Author(s):  
Suehyun Lee ◽  
Jaehun Cha ◽  
Jong-Yeup Kim ◽  
Gil Myeong Son ◽  
Dong-Kyu Kim
Keyword(s):  
Hearing Loss ◽  
Adverse Drug Reactions ◽  
Proportional Hazards ◽  
Cohort Analysis ◽  
Cox Proportional Hazards ◽  
Hazard Ratio ◽  
New Drugs ◽  
Rank Test ◽  
Drug Reactions ◽  
Bilateral Hearing Loss

Abstract Ototoxic medications can lead to significant morbidity. Thus, pre-marketing clinical trials have assessed new drugs that have ototoxic potential. Nevertheless, several ototoxic side effects of drugs may remain undetected. Hence, we sought to retrospectively investigate the potential risk of ototoxic adverse drug reactions among commonly used drugs via a longitudinal cohort study. An electronic health records-based data analysis with a propensity-matched comparator group was carried out. This study was conducted using the MetaNurse algorithm for standard nursing statements on electronic healthcare records and the National Sample Cohort obtained from the South Korea National Health Insurance Service. Five target drugs capable of causing ototoxic adverse drug reactions were identified using MetaNurse; two drugs were excluded after database-based analysis because of the absence of bilateral hearing loss events in patients. Survival analysis, log-rank test, and Cox proportional hazards regression models were used to calculate the incidence, survival rate, and hazard ratio of bilateral hearing loss among patients who were prescribed candidate ototoxic drugs. The adjusted hazard ratio of bilateral hearing loss was 1.31 (1.03–1.68), 2.20 (1.05–4.60), and 2.26 (1.18–4.33) in cimetidine, hydroxyzine, and sucralfate users, respectively. Our results indicated that hydroxyzine and sucralfate may cause ototoxic adverse drug reactions in patients. Thus, clinicians should consider the risk of ototoxicity when prescribing these drugs.

scholarly journals Detection of unknown ototoxic adverse drug reactions: an electronic healthcare record-based longitudinal nationwide cohort analysis

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Suehyun Lee ◽  
Jaehun Cha ◽  
Jong-Yeup Kim ◽  
Gil Myeong Son ◽  
Dong-Kyu Kim
Keyword(s):  
Hearing Loss ◽  
Adverse Drug Reactions ◽  
Cohort Analysis ◽  
Cox Proportional Hazards ◽  
Hazard Ratio ◽  
New Drugs ◽  
Rank Test ◽  
Drug Reactions ◽  
Bilateral Hearing Loss ◽  
Ototoxic Drugs

AbstractOtotoxic medications can lead to significant morbidity. Thus, pre-marketing clinical trials have assessed new drugs that have ototoxic potential. Nevertheless, several ototoxic side effects of drugs may remain undetected. Hence, we sought to retrospectively investigate the potential risk of ototoxic adverse drug reactions among commonly used drugs via a longitudinal cohort study. An electronic health records-based data analysis with a propensity-matched comparator group was carried out. This study was conducted using the MetaNurse algorithm for standard nursing statements on electronic healthcare records and the National Sample Cohort obtained from the South Korea National Health Insurance Service. Five target drugs capable of causing ototoxic adverse drug reactions were identified using MetaNurse; two drugs were excluded after database-based analysis because of the absence of bilateral hearing loss events in patients. Survival analysis, log-rank test, and Cox proportional hazards regression models were used to calculate the incidence, survival rate, and hazard ratio of bilateral hearing loss among patients who were prescribed candidate ototoxic drugs. The adjusted hazard ratio of bilateral hearing loss was 1.31 (1.03–1.68), 2.20 (1.05–4.60), and 2.26 (1.18–4.33) in cimetidine, hydroxyzine, and sucralfate users, respectively. Our results indicated that hydroxyzine and sucralfate may cause ototoxic adverse drug reactions in patients. Thus, clinicians should consider avoiding co-administration of these drugs with other well-confirmed ototoxic drugs should be emphasized.

scholarly journals Adverse drug reactions related to drug interactions

2014 ◽  
Vol 1 (2) ◽  
pp. 111-115
Author(s):  
Lylia Kheddouci ◽  
Keyword(s):  
Adverse Events ◽  
Drug Interactions ◽  
Adverse Drug Reactions ◽  
New Drugs ◽  
Morbidity And Mortality ◽  
Drug Reactions ◽  
The Cost

Adverse drug reactions are numerous and steadily increasing as the emergence of new drugs on the market, the wide use within the population, and/or polypharmacy. Even if many drug interactions have an insignificant impact on the patient, others are causing an increase in hospitalization, morbidity, and mortality and therefore the cost. This article is a non-exhaustive review of published literature regarding adverse events related to drug interactions: their impacts, the factors favoring their occurrence, and the problematic around this theme. Most published studies are pharmaco-epidemiological and results vary depending on various factors.

Increased Prescribing of Valium, Librium, and other Drugs—An Example of the Influence of Economic and Social Factors on the Practice of Medicine

1977 ◽  
Vol 7 (1) ◽  
pp. 37-62 ◽  
Author(s):  
Ingrid Waldron
Keyword(s):  
Adverse Drug Reactions ◽  
Social Stress ◽  
The United States ◽  
Therapeutic Benefit ◽  
Early Years ◽  
New Drugs ◽  
Drug Reactions ◽  
Therapeutic Benefits ◽  
Drug Companies ◽  
Clinical Conditions

Drug prescriptions per capita in the United States have more than doubled since 1950 without a commensurate improvement in health. Drugs are often prescribed for clinical conditions in which therapeutic benefits do not outweigh the risk of adverse drug reactions. Deaths due to adverse drug reactions are roughly as frequent as deaths due to automobile accidents. Valium and Librium are the first and fourth most commonly prescribed drugs in the U.S., used by one in ten adults each year. The rapid rise in use of these drugs has occurred during a period of rising social stress, as indicated by increases in alcohol consumption, suicide, and homicide. Valium and Librium are frequently prescribed for patients who go to doctors with social or other nonmedical problems, often in lieu of attempts to resolve these underlying problems. Overprescribing occurs because the decision to prescribe is influenced not only by consideration of therapeutic benefit, but also by nonmedical factors, for example the widespread expectation by both patient and doctor that the doctor will provide a drug or some other technological treatment. Prescribing decisions are also influenced by the profit-motivated activities of drug companies, including the expenditure of almost one-quarter of every sales dollar on drug promotion. The most widely used source of drug information for doctors is the industry-sponsored Physicians' Desk Reference, which overrates the therapeutic value of Valium and Librium as compared to disinterested medical sources. Drug companies also contribute to overprescribing by introducing numerous minor variants of existing drugs. The therapeutic benefits of such new drugs are often overestimated in the early years of use when adverse side effects are not well known and apparent efficacy is enhanced by placebo effects in uncontrolled observations.

Comparison and Evaluation of Nine Bibliographic Databases concerning Adverse Drug Reactions

DICP ◽  
1991 ◽  
Vol 25 (10) ◽  
pp. 1062-1065 ◽  
Author(s):  
Odile Biarez ◽  
Bernard Sarrut ◽  
Christian G. Doreau ◽  
Jean Etienne
Keyword(s):  
Adverse Drug Reactions ◽  
Bibliographic Databases ◽  
Drug Reactions

scholarly journals CUTANEOUS ADVERSE DRUG REACTIONS IN GENERAL PRACTICE - AN ANALYSIS

2016 ◽  
Author(s):  
*G. Rajaram ◽  
P. Sugirda ◽  
R. Lenin
Keyword(s):  
Urban Area ◽  
General Practitioners ◽  
Adverse Drug Reactions ◽  
Maculopapular Rash ◽  
New Drugs ◽  
Drug Reactions ◽  
Fixed Drug Eruption ◽  
Fixed Drug ◽  
The Common ◽  
Reported Data

Aim: To study the pattern of cutaneous adverse drug reactions presenting to general practitioners in a semi urban area.  Methodology and Results: This study was conducted among general practitioners of Villupuram, a semi urban area in Tamilnadu State. During the study, a total of 60 CADRs were reported. Data were collected using standard CDSCO ADR form. The majority of CADRs were observed in the age group of 20-40 years. According to WHO causality assessment, 48 were probable and 12 were possible. The severity assessment using modified hartwig and seigel revealed 18 mild, 41 moderate and one severe CADRs. The common drug groups implicated are antibiotics followed by NSAIDS and anticonvulsants. Maculopapular rash was the most common presentation of CADRs.Conclusion: Among the various types of CADRs seen in this study, Maculopapular rash was the most common followed by fixed drug eruption. studies antimicrobials were the most common causative agent followed by NSAIDs and anti- convulsants. This study on CADRs gains importance as the pattern of drug use is changing periodically and everyday many new drugs enter the market.

scholarly journals Detecting Potential Adverse Drug Reactions Using a Deep Neural Network Model (Preprint)

2018 ◽  
Author(s):  
Chi-Shiang Wang ◽  
Pei-Ju Lin ◽  
Ching-Lan Cheng ◽  
Shu-Hua Tai ◽  
Yea-Huei Kao Yang ◽  
...  
Keyword(s):  
Neural Network ◽  
Adverse Drug Reactions ◽  
Deep Neural Network ◽  
Characteristic Curve ◽  
Reporting Rate ◽  
Biomedical Literature ◽  
New Drugs ◽  
Drug Reactions ◽  
New Drug ◽  
Spontaneous Reports

BACKGROUND Adverse drug reactions (ADRs) are common and are the underlying cause of over a million serious injuries and deaths each year. The most familiar method to detect ADRs is relying on spontaneous reports. Unfortunately, the low reporting rate of spontaneous reports is a serious limitation of pharmacovigilance. OBJECTIVE The objective of this study was to identify a method to detect potential ADRs of drugs automatically using a deep neural network (DNN). METHODS We designed a DNN model that utilizes the chemical, biological, and biomedical information of drugs to detect ADRs. This model aimed to fulfill two main purposes: identifying the potential ADRs of drugs and predicting the possible ADRs of a new drug. For improving the detection performance, we distributed representations of the target drugs in a vector space to capture the drug relationships using the word-embedding approach to process substantial biomedical literature. Moreover, we built a mapping function to address new drugs that do not appear in the dataset. RESULTS Using the drug information and the ADRs reported up to 2009, we predicted the ADRs of drugs recorded up to 2012. There were 746 drugs and 232 new drugs, which were only recorded in 2012 with 1325 ADRs. The experimental results showed that the overall performance of our model with mean average precision at top-10 achieved is 0.523 and the rea under the receiver operating characteristic curve (AUC) score achieved is 0.844 for ADR prediction on the dataset. CONCLUSIONS Our model is effective in identifying the potential ADRs of a drug and the possible ADRs of a new drug. Most importantly, it can detect potential ADRs irrespective of whether they have been reported in the past.

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