scholarly journals APPLICATION OF DRUG-RELATED PROBLEMS APPROACH TO ANALYSIS OF NON-STEROIDAL ANTI-INFLAMMATORY DRUGS’ SAFETY

2019 ◽  
Vol 7 (4) ◽  
pp. 215-223 ◽  
Author(s):  
A. V. Matveev ◽  
A. E. Krasheninnikov ◽  
E. A. Egorova ◽  
E. I. Konyaeva
Keyword(s):  
Adverse Drug Reactions ◽  
Adverse Reactions ◽  
Drug Reactions ◽  
Duration Of Treatment ◽  
Drug Related Problem ◽  
Nsaid Group ◽  
Spontaneous Reports ◽  
Inflammatory Drugs ◽  
Anti Inflammatory ◽  
And Control

A Drug-Related Problem is an event or circumstance involving drug therapy that actually or potentially interferes with desired health outcomes.The aim of the study was the analysis of the adverse drug reactions (ADR) associated with prescription of the non-steroidal anti-inflammatory drugs (NSAIDs) using the DRP PCNE V5.01 qualification system.Materials and methods. The objects of the study were 415 notification forms about adverse drug reactions of NSAIDs recorded in the regional database of spontaneous reports and called ARCADe (Adverse Reactions in Crimea, Autonomic Database) for the period from 1 January 2009 to 31 December of 2018. The study and analysis of the problems associated with drugs were carried out using the qualification system DRP PCNE V5.01 (Pharmaceutical Care Network Europe) 2006 in the modification of Prof. Zimenkovsky.Results. Among other representatives of the NSAID group, Ibuprofen and Diclofenac became the “leaders” in the incidence of ADR. The frequency of ADR cases for Ibuprofen was 142 reports (34.22% of the total number of ADR for NSAIDs), and for Diclofenac it was 90 cases (21.69%). The calculation of DRP values for each of the presented cases made it possible to determine that in 81 (19.51%) and 91 (21.9%) cases, the DRP value was 6 and 7, respectively. DRP values in the range of 8–10 were found in 92 reports. The highest DRPs value was observed after the administration of Parecoxib (13 problems but only one case was found in the database), the DRPs value of Dexketoprofen was 12.5 (95% CI: 7–17) and the DRPs value of Diclofenac combinations was 10 DRPs; 95% CI: 5–17 DRP). The minimum DRPs values were associated with Naproxen, Rofecoxib, and Etoricoxib prescriptions.Conclusion. Using the DRP system in the analysis of NSAIDs, ADRs allow to identify the medicines which have a high risk of causing safety problems, such as Parecoxib, Dexketoprofen and Diclofenac combinations. The prescription of these drugs should be carried out with special cautions and control to the indications and contraindications, the dose and duration of treatment, as well as to a possible interaction of them with concomitant drugs.

scholarly journals Prospective monitoring of cutaneous adverse drug reactions in a secondary care hospital, UAE

2019 ◽  
Vol 5 (2) ◽  
pp. 231
Author(s):  
Fatma Al Mulla ◽  
Sathvik B. Sridhar ◽  
Ghada Abu Al Hassan ◽  
Atiqulla Sharif
Keyword(s):  
Adverse Drug Reactions ◽  
Secondary Care ◽  
Adverse Reactions ◽  
World Health ◽  
Care Hospital ◽  
Drug Reactions ◽  
Case Files ◽  
Inflammatory Drugs ◽  
Anti Inflammatory ◽  
Health Organization

<p class="abstract"><strong>Background:</strong> Adverse drug reactions (ADRs) are one of the most important causes of morbidity, hospitalization, increased healthcare cost and even mortality. Cutaneous adverse reactions are most commonly documented for drugs. The aim of the study was to monitor the incidence and nature of cutaneous adverse drug reactions (CADRs) in the dermatology outpatients and identify the causative drugs.</p><p class="abstract"><strong>Methods:</strong> A prospective observational study was conducted at the dermatology outpatient department of a secondary care hospital, UAE. All the patients attending dermatology outpatient and satisfying the inclusion criteria were monitored for ADRs. The required data were collected from the patients, their case files, and caretakers and entered in a suitably designed ADR reporting and documentation form. The causality, severity, and preventability of cutaneous ADRs were assessed using Naranjo, WHO, Hartwig and modified Schumock and Thornton scale.<strong></strong></p><p class="abstract"><strong>Results:</strong> The prevalence of cutaneous ADRs was found to be 2.6%. Majority (43.4%) of the cutaneous ADRs were caused by nonsteroidal anti-inflammatory drugs. Majority (56.5%) of the study population reported itching as the most common cutaneous ADR. Also, 60.8% of the reported ADRs were “probable” in nature according to World Health Organization scale, whereas 56.5% reports were “probable” according to Naranjo’s algorithm. Majority (97%) of the ADRs were not preventable.</p><p class="abstract"><strong>Conclusions:</strong> Nonsteroidal anti-inflammatory drugs were the common causes of cutaneous ADRs in the study. Majority of the adverse reactions were mild in nature. The type and nature of cutaneous adverse drug reaction profile documented in this study is almost similar in many ways to other ADRs monitoring studies conducted in dermatology outpatient clinics.</p>

scholarly journals SAFETY REPORTING STUDY OF NONSTEROIDAL ANTI-INFLAMMATORY DRUGS

2021 ◽  
Vol 5 (2) ◽  
Author(s):  
Monika Mishra
Keyword(s):  
Adverse Drug Reactions ◽  
Adverse Reactions ◽  
Standard Treatment ◽  
Diclofenac Sodium ◽  
Drug Reactions ◽  
Treatment Protocols ◽  
Safety Reporting ◽  
Ankle Oedema ◽  
Inflammatory Drugs ◽  
Anti Inflammatory

Background: The nonsteroidal anti-inflammatory drugs (NSAIDs) are among the most frequently used drugs to treat pain and inflammation. Although NSAIDs are having enormous clinical use, but are not devoid of adverse drug reactions (ADRs) as peptic ulcer, gastritis, renal, neurological reactions etc. Methods: Total 500 Orthopaedic out-patients of SIMS, Hapur were enrolled in the study to observe the risk of ADRs due to NSAIDs. All the ADRs were further analysed in relation to age, sex, types of drug and its pattern etc. The causality was analysed by using Naranjo’s Algorithm and severity was analysed by using the Hartwing and Siegel scale. Results: In this study the incidence rate of the ADRs was around 5.6%. Among the 28 patients who had developed ADRs, a total 10 kinds of ADRs were observed. The reactions that affected the study subjects were gastritis, nausea, vomiting, abdominal Pain, diarrhoea, urticaria, pruritus, headache, rash, ankle oedema and dizziness. Majority (23 cases) of ADRs were mild in their severity and that 5 cases ADRs were moderate in nature. All the ADRs were treated symptomatically by using standard treatment protocols. Conclusion: In this study, incidence of adverse reactions to nonsteroidal anti-inflammatory drugs was 5.60% and the most common implicated drug for the ADRs were Diclofenac sodium. Most of the adverse effects were mild and tolerable. Keywords: Adverse drug reactions, Nonsteroidal anti-inflammatory drugs, Pharmacovigilance

scholarly journals Major Aspects of Detection and Monitoring of Adverse Reactions Associated with Cephalosporin Antibiotic Treatment

2021 ◽  
Vol 9 (1) ◽  
pp. 34-42
Author(s):  
E. Yu. Demchenkova ◽  
G. I. Gorodetskaya ◽  
I. A. Mazerkina ◽  
M. V. Zhuravleva ◽  
A. S. Kazakov ◽  
...  
Keyword(s):  
Adverse Events ◽  
Adverse Drug Reactions ◽  
Patient Information ◽  
Adverse Reactions ◽  
Stevens Johnson Syndrome ◽  
Drug Reactions ◽  
Patient Information Leaflets ◽  
Information Leaflets ◽  
Spontaneous Reports ◽  
Cephalosporin Antibiotics

Widespread use of cephalosporin antibiotics in clinical practice calls for greater attention to the risk of adverse drug reactions. Information on serious or unexpected adverse events reported during post-marketing experience is submitted to national and international pharmacovigilance databases. Analysis of these reports helps to identify new adverse drug reactions.The aim of the study was to analyse the safety profile of cephalosporin antibiotics based on spontaneous reports in the international VigiBase database.Materials and methods: the analysis of the adverse reaction profile of cephalosporin antibiotics was based on MedDRA system organ classes and included spontaneous reports submitted to VigiBase from the moment of its creation until August 2020.Results: the authors identified the most clinically significant adverse reactions for different cephalosporin generations. They compared and analysed information on adverse events in VigiBase and in patient information leaflets of medicinal products authorised in the Russian Federation. It was demonstrated that some serious events described in VigiBase spontaneous reports for V-generation cephalosporins are not included in the “Side effects” section of the patient information leaflets. According to VigiBase, the use of ceftaroline was associated with the development of generalised exfoliative dermatitis, Stevens–Johnson syndrome, tubulointerstitial nephritis, while the use of ceftolozane was associated with acute kidney injury, renal insufficiency, sepsis, pneumonia, and respiratory insufficiency.Conclusion: reporting of unexpected and serious adverse drug reactions to cephalosporin antibiotics is an important task of healthcare practitioners. Availability of information on class-specific and generation-specific serious adverse reactions will help predict and prevent their development.

Retrospective Evaluation of Adverse??Drug Reactions Induced??by??Nonsteroidal Anti-Inflammatory Drugs

2007 ◽  
Vol 27 (2) ◽  
pp. 115-122 ◽  
Author(s):  
L Gallelli ◽  
M Colosimo ◽  
D Pirritano ◽  
M Ferraro ◽  
S De Fazio ◽  
...  
Keyword(s):  
Adverse Drug Reactions ◽  
Retrospective Evaluation ◽  
Drug Reactions ◽  
Inflammatory Drugs ◽  
Anti Inflammatory

scholarly journals Adverse drug reactions in a primary care population prescribed non-steroidal anti-inflammatory drugs

2015 ◽  
Vol 33 (3) ◽  
pp. 163-169 ◽  
Author(s):  
Aafke R. Koffeman ◽  
Amanda R. Van Buul ◽  
Vera E. Valkhoff ◽  
Geert W. 'T Jong ◽  
Patrick J. E. Bindels ◽  
...  
Keyword(s):  
Primary Care ◽  
Adverse Drug Reactions ◽  
Drug Reactions ◽  
Primary Care Population ◽  
Inflammatory Drugs ◽  
Anti Inflammatory

scholarly journals Retrospective analysis of adverse drug reaction reporting forms associated with penicillin family antibiotics (pcne-drp 9.0) based on drug-related approach

2020 ◽  
Vol 8 (1) ◽  
pp. 57-64 ◽  
Author(s):  
A. V. Matveev ◽  
A. E. Krasheninnikov ◽  
E. A. Egorova ◽  
E. I. Koniaeva
Keyword(s):  
Adverse Drug Reactions ◽  
Adverse Reactions ◽  
Adverse Drug Reaction Reporting ◽  
Drug Hypersensitivity ◽  
Clinical Manifestations ◽  
Drug Related Problems ◽  
Drug Reactions ◽  
Spontaneous Reports ◽  
Amoxicillin Clavulanate

A widespread use of β-lactam antibiotics such as penicillins in practical medicine, and its authorized use in special categories of patients (e.g. children, pregnant and lactating women, the elderly) requires a critical investigation of their safety as well as the obligatory risk assessment before conducting antibacterial pharmacotherapy.The aim of the work was the conduction of a retrospective study of adverse reactions cases, the identification and analysis of drug-related problems (DRP) associated with the use of penicillin family antibiotics.Materials and methods. The objects of the study were adverse drug reactions (ADR) associated with the use of penicillin family antibiotics in inpatient and outpatient facilities, as well as the cases of self-treatment, which were recorded in the official ADR reports and then inputted in the regional (Republic of Crimea) database of spontaneous reports called ARCADe (Adverse Reactions in Crimea, Autonomic Database). The covered period is 2009–2018. The analysis of DRP was carried out using the 9.0 version of the qualification system DRP PCNE (Pharmaceutical Care Network Europe Foundation).Results. The data analysis of ADR reporting forms has revealed that Amoxicillin clavulanate and Amoxicillin were the most frequent cause of ADR. A high incidence of penicillins ADR in pediatric patients (from 0 to 18 years) – 142 cases – has been found. The clinical manifestations of reactions included drug hypersensitivity reactions (309 cases), dyspeptic disorders (28 cases) and disorders of the central nervous system (5 cases). The incidence of serious ADR was 113 cases (33% of the total number of ADR in the study), which indicates a rather high risk of developing severe ADR for penicillins, resulted in a significant decrease in the quality of patients’ lives.Conclusion. The detection of DRP using the PCNE V9.0 approach is a useful and promising tool important to improve the quality of pharmacotherapy and their adherence to treatment. The highest DRP values which were observed for Amoxicillin clavulanate and Amoxicillin, may indicate a high frequency of irrational use of these drugs.List of abbreviations: DRP – drug related problems; ADR – adverse drug reactions; INN – international non-patented name

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