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

scholarly journals INVESTIGATION OF MEDICALLY INDUCED SKIN REACTIONS BASED ON THE ANALYSIS OF REPORTS OF ADVERSE DRUG REACTIONS IN THE REPUBLIC OF CRIMEA (FROM 2009 TO 2016)

2019 ◽  
Vol 7 (1) ◽  
pp. 32-41 ◽  
Author(s):  
A. V. Matveev ◽  
А. E. Krasheninnikov ◽  
E. A. Egorova ◽  
Е. I. Konyaeva
Keyword(s):  
Adverse Reactions ◽  
Drug Hypersensitivity ◽  
Clinical Manifestations ◽  
World Health ◽  
Report Cards ◽  
Hypersensitivity Reactions ◽  
Drug Reactions ◽  
Skin Reactions ◽  
Drug Hypersensitivity Reactions ◽  
The Republic

Drug hypersensitivity reactions are among the most important problems that arise when using drugs. The occurrence of such reactions in the population is at least 7% and tends to a constant increase. The most frequent manifestations of drug hypersensitivity reactions are medically induced skin lesions.The aimof this research was to study and analyze the cases of development of skin drug reactions on the basis of the reports on the adverse reactions (ADRs) of the drugs, registered in the Republic of Crimea in the period from 2009 to 2016.Materials and methods.The objects of the research were report cards about the adverse reactions, registered in the regional base (registry) of spontaneous messages called ARCADe (Adverse Reactions in Crimea, Autonomic Database) for the period from 2009 to 2016. During the analysis of the report cards, 2,698 cases of the development of skin drug reactions arising in response to the use of drugs in patients were selected. The study of the frequency of occurrence of skin drug reactions in the application of various groups of drugs was carried out taking into account the codes of the Anatomical Therapeutic Chemical (ATC) Сlassification System of drugs of the World Health Organization (WHO).Results.Of the study showed that the development of skin drug reactions was most often associated with the use of antimicrobial agents for internal use, nonsteroidal anti-inflammatory drugs (NSAIDs), drugs for the treatment of diseases of the gastrointestinal tract and agents that affect the nervous system. Among the clinical manifestations of skin drug reactions, generalized and localized rashes prevailed, and itching and hyperemia of the skin were much less common in patients. The analysis of age categories showed that the most frequently medically induced reactions occurred in children from birth to 3 years, as well as in the age group of patients from 46 to 60 years. The risk factors identified in the course of the analysis, were female gender, early childhood and old age, as well as the presence of aggravated drug allergy history.Conclusion.Drug hypersensitivity reactions create certain difficulties in clinical practice related to the diagnosis, treatment and prophylaxis, and may also cause danger to health or life of patients. In this connection, the study of such adverse reactions is the most important task of practical health care and requires direct participation of doctors of all specialties.

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.

The Incidence and Nature of Adverse Reactions during Intravenous Acetylcysteine Therapy for Acetaminophen Overdose

2000 ◽  
Vol 16 (2) ◽  
pp. 47-49 ◽  
Author(s):  
Matitiahu Lifshitz ◽  
Perez Kornmehl ◽  
Haim Reuveni
Keyword(s):  
Adverse Drug Reactions ◽  
Adverse Reactions ◽  
Medical Center ◽  
Clinical Manifestations ◽  
Cost Benefit ◽  
Maculopapular Rash ◽  
Oral Formulation ◽  
Drug Reactions ◽  
Acetaminophen Overdose ◽  
History Of

Objective: To determine the incidence of adverse drug reactions in patients with acetaminophen overdose following administration of intravenous acetylcysteine, and to evaluate the cost-benefit ratio of intravenous compared with oral acetylcysteine therapy. Methods: The incidence of adverse drug reactions to intravenous acetylcysteine therapy was studied retrospectively in all patients with acetaminophen overdose who were admitted to Soroka University Medical Center, Beer-Sheva, Israel, from 1994 to 1998. Data were obtained from hospital records. All patients were treated with a 20-hour intravenous regimen according to the Prescott protocol. Special attention was paid to the clinical manifestations of adverse reactions, time of onset, and history of patient allergy and asthma. Cost of therapy (drug prices, hospital per diems) for intravenous versus oral acetylcysteine administration was evaluated in accordance with average rates prevailing in Israel in December 1998. Results: Ninety-two patients, 32 adolescents aged 12–18 years (mean ± SD 14.2 ± 1.9) and 60 adults aged 18–52 years (28.2 ± 3.2), were treated with intravenous acetylcysteine for acetaminophen overdose during the study period. Three patients (3.2%) developed adverse reactions: one adult presented with a maculopapular rash and pruritus, and two adolescents developed mild urticaria; no other adverse reactions were reported. All adverse reactions occurred during administration of the loading dose, 15–20 minutes after initiation of therapy. The reactions subsided a few hours after the acetylcysteine infusion was stopped and did not require antiallergy therapy. None of the three patients had a history of allergy. The 20-hour intravenous acetylcysteine protocol is approximately three times less expensive than the recommended oral regimen in terms of drug cost and length of hospitalization. Conclusions: Intravenous acetylcysteine is a relatively safe antidote for acetaminophen poisoning. The incidence rate of adverse reactions is low, and they are mild and easily controlled by termination of the infusion. We recommend intravenous acetylcysteine therapy, particularly for patients with vomiting caused by the acetaminophen overdose or by oral acetylcysteine therapy. The 20-hour intravenous acetylcysteine therapy has a cost-benefit advantage over oral therapy; however, the oral formulation is not approved by the FDA.

scholarly journals Pharmacovigilance programme of India: revival of the renaissance

2018 ◽  
Vol 7 (11) ◽  
pp. 2281
Author(s):  
Jyoti B. Gadhade ◽  
Rajesh S. Hiray ◽  
Rekha Y. Aherkar ◽  
Kalpana U. Shah
Keyword(s):  
Adverse Drug Reactions ◽  
Adverse Drug Reaction Reporting ◽  
World Health ◽  
Uppsala Monitoring Centre ◽  
Family Welfare ◽  
Drug Reactions ◽  
Monitoring Centre ◽  
The World ◽  
Health Organization

Adverse drug reactions (ADRs) are the fourth leading cause of morbidity in the world. In order to safeguard the health of the community, Pharmacovigilance Programme of India (PvPI) is implemented as the monitoring body by Indian Pharmacopoeia Commission (IPC). It is leading national authority. National Coordinating Centre (NCC) PvPI works as the World Health Organization (WHO) collaborating centre for pharmacovigilance. Adverse drug reactions are reported to NCC PvPI which are then directed towards WHO Uppsala Monitoring Centre (UMC) Sweden which is the global monitoring centre for worldwide data. Central Drugs Standard Control Organization (CDSCO) is the regulatory authority of India under the Ministry of Health and Family Welfare (MOHFW), Government of India. This article focusses on the various strands of pharmacovigilance at the healthcare professional and consumer level. It also discusses the pitfalls in the journey of pharmacovigilance thus helping in enhancing the quality of health safety. Even a minuscule contribution by a health care professional or a consumer can voluminously help in promotion of drug safety. Therefore, there is a need of inculcating the culture of adverse drug reaction reporting for the welfare of the vulnerable masses.

Adverse drug reactions and drug interactions

2012 ◽  
Author(s):  
Philip Wiffen ◽  
Marc Mitchell ◽  
Melanie Snelling ◽  
Nicola Stoner
Keyword(s):  
Quality Of Life ◽  
Drug Interactions ◽  
Adverse Drug Reactions ◽  
Adverse Reactions ◽  
Adverse Drug Events ◽  
Hospital Environment ◽  
Drug Reactions ◽  
Significant Cost

Introduction to ADRs 14Classification of ADRs 15Adverse reactions: drug or disease? 16Helping patients understand the risk of ADRs 17Reporting ADRs 18Drug interactions 20Managing drug interactions 23Adverse drug reactions (ADRs), also known as ‘side effects’, ‘adverse drug events’, or ‘drug misadventures’, are a frequent cause of morbidity in hospital and the community. They have a significant cost both financially and in terms of quality of life. Few studies of ADRs have been carried out in the community so the effect on primary care is harder to assess, but studies in the hospital environment have shown the following. ...

scholarly journals Cutaneous Adverse Drug Reactions / Dematološka neželjena dejstva lekova

2012 ◽  
Vol 4 (2) ◽  
pp. 61-76
Author(s):  
Lidija Kandolf-Sekulović ◽  
Tatjana Radević
Keyword(s):  
Adverse Effects ◽  
Adverse Drug Reactions ◽  
Adverse Reactions ◽  
Skin Diseases ◽  
Clinical Manifestations ◽  
Drug Intake ◽  
Drug Reactions ◽  
Drug Induced ◽  
Skin Reactions ◽  
Wide Range

Abstract Adverse drug reactions may be defined as undesirable clinical manifestations resulting from administration of a particular drug; this includes reactions due to overdose, predictable side effects, and unanticipated adverse manifestations. Adverse drug effects on the skin are among the most frequent reactions and, according to a study, account for approximately 14% of all adverse drug reactions. However, the incidence of cutaneous adverse effects in general population is unknown. Systemic drug administration results in various cutaneous adverse reactions, and medications used in the treatment of skin diseases themselves have their own adverse effects. Adverse drug reactions include a wide range of effects, from harmless exanthema of short duration, urticaria to systemic cutaneous reactions such as drug rash with eosinophilia and systemic symptoms (DRESS) or toxic epidermal necrolysis. Exanthematous eruptions and urticaria are the two most common forms of cutaneous drug reactions. Less common include fixed eruptions, lichenoid, pustular, bullous and vasculitis reactions. The most severe cutaneous and mucosal adverse drug reactions are epidermal necrolysis, which is usually drug-induced, DRESS syndrome, and acute generalized exanthematous pustulosis. Therefore, the diagnostic of adverse drug reactions requires a detailed history of drug intake and development of skin disorders, excellent knowledge of clinical presentations for a wide range of drug-induced skin reactions as well as of the very medications being taken by patients. In addition to details on drug intake, it is necessary to learn about taking herbal and alternative preparations, which may also cause adverse reactions. A drug started within 6 weeks of the development of disorders is considered the most common cause of adverse reaction, as well as drugs taken periodically but regularly. Once a reaction has occurred, it is important to prevent future similar reactions with the same drug or a cross-reacting medication. Early withdrawal of all potentially responsible drugs is essential, particularly in case of severe drug reactions.

scholarly journals ANALYSIS OF SPONTANEOUS REPORTS OF ADVERSE REACTIONS IN PATIENTS WITH CORONARY ARTERY DISEASE IN THE REPUBLIC OF CRIMEA

2018 ◽  
Vol 7 (4) ◽  
pp. 26-32
Author(s):  
O. V. Matveev ◽  
A. E. Krasheninnikov ◽  
N. M. Kiseleva ◽  
E. A. Egorova ◽  
A. G. Dormidor
Keyword(s):  
Coronary Artery Disease ◽  
Drug Reaction ◽  
Coronary Artery ◽  
Adverse Drug Reactions ◽  
Ace Inhibitors ◽  
Adverse Reactions ◽  
Drug Reactions ◽  
Spontaneous Reports ◽  
The Republic ◽  
Artery Disease

Aim. To analyze spontaneous reports of adverse drug reactions in patients with coronary artery disease in the Republic of Crimea for the fve-year period from January 2011 to August 2016.Methods. 332 reports of adverse drug reactions in patients with coronary artery disease collected in the “ARCADe” database were analyzed. Out of them, 231 reports on essential drugs affecting the cardiovascular system were selected. The age of patients who reported adverse drug reactions ranged from 37 to 90 years.Results. The rate of adverse drug reaction reports increased with patients’ aging, reaching its maximum (31.6% of all drug reaction reports) by 70–80 years. The incidence of adverse reactions was higher among women (63.6%), which is generally consistent with other studies. However, men receiving nitrates had a 3.4-fold increase in the rate of adverse drug reactions compared to women. The highest rate of adverse drug reactions was associated with ACE inhibitors (29.0%), and in particular Enalapril, which is probably explained by a higher rate of their prescriptions, compared to other drugs.Conclusion. Most of the reported adverse drug reactions were expected. The frequent development of allergic reactions (16% out of all adverse reactions in this study) in patients with coronary artery disease were associated with ACE inhibitors, betablockers and antithrombotic agents.

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 Adverse drug reactions of anti-infective drugs for systemic use in Morocco: Pharmaco-Epidemiological study 2008-2016

2021 ◽  
Vol 319 ◽  
pp. 01048
Author(s):  
Donia Kharbouch ◽  
Houda Sefiani ◽  
Zineb Nabih ◽  
Sanou Khô Coulibaly ◽  
Tidiane Diallo ◽  
...  
Keyword(s):  
Sex Ratio ◽  
Adverse Drug Reactions ◽  
Adverse Reactions ◽  
Subcutaneous Tissue ◽  
Descriptive Study ◽  
Pharmacovigilance System ◽  
Drug Reactions ◽  
Spontaneous Reports ◽  
Pharmacovigilance Center ◽  
Research Period

Analyzing the spontaneous reports of adverse drug reactions (ADRs) of anti-infective drugs for systemic use is an essential pillar in creating valuable database in pharmacovigilance.Therefore, the main of this study is to describe the epidemiological and clinical properties, as well as, the frequency and profile of ADRs generated by anti-infective treatment, declared at the Moroccan Anti-Poison and Pharmacovigilance Center (MAPPC).A retrospective descriptive study was implemented from the notifications of ADRs generated between 2008 and 2016 and recorded on VIGIBASE. Over the research period, 1161 cases of ADRs reports were declared. The average age was 37.4 years ± 19.52, it’s been noticed that the adults were the most affected in 81.89% of the total cases, with the sex ratio (Female / Male) being 1.34. Antimycobacterials and antibacterials for systemic use were responsible for 68% and 28.3% of the adverse reactions, respectively. 29.76% of the cases showcased skin and subcutaneous tissue disorders and 23.23% of the cases displayed hepatobiliary and pancreatic system disorders. Serious cases represented 30% of all noted cases, including 2 fatalities. In the interest of preventing the risk of adverse reactions originating from the taking anti-infective drugs for systemic use, reporting to the ADRs to the pharmacovigilance system should be highly encouraged.

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