scholarly journals Medication Safety in Patients under 18 Years Old; a Retrospective Study based on Iraqi Pharmacovigilance Center Database

2020 ◽  
Vol 29 (2) ◽  
pp. 152-160
Author(s):  
Hani Gh. Jawad ◽  
Eman S. Saleh ◽  
Manal M. Younus
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Medication Errors ◽  
Medication Safety ◽  
Treatment Process ◽  
Adverse Drug Events ◽  
Risk Groups ◽  
World Health ◽  
Global Challenge ◽  
Pharmacovigilance Center

Medication safety is an important part of the comprehensive patient safety term. Medication safety is gaining more attention as the World Health Organization set the goal of decreasing medication harm by (50%) for the next 5 years when launching the third global challenge. Studying medication safety in the risk groups such as young ages, children are crucial to learn more about the effect of medicines in this risk group since they are not included in the clinical trials. Adverse drug reaction is defined as any harm resulted from the drug itself during medical process journey, while medication errors are any harm resulted from the treatment process rather than the drug or it is the result of the failure in a step of the treatment process and by that it came clear that adverse drug reaction in non-preventable event while medication error is preventable one. The objectives of this study are to find the preventable medication errors from the Iraqi database of Adverse drug events in ages from neonatal to adolescent age. This study is a retrospective descriptive study conducted using the Iraqi pharmacovigilance center database. The study included reports that were received by the Iraqi pharmacovigilance center from 1st of January 2014 until the 1st of January 2020. In this study, the total number of reports included was 2344. The type of medication involved, type of adverse event, type of error and

scholarly journals Pharmacovigilance in India and its Impact in Patient Management

2017 ◽  
Vol 1 (1) ◽  
pp. 27-33 ◽  
Author(s):  
Narinder Singh ◽  
Geeta Sharma ◽  
Rahat Kumar ◽  
Vikram Bhandari
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Adverse Effects ◽  
Patient Management ◽  
Adverse Drug Events ◽  
Monitoring Program ◽  
Vital Role ◽  
World Health ◽  
Family Welfare ◽  
Health Organization

ABSTRACT Pharmacovigilance is the pharmacological science relating to the detection, assessment, understanding, and prevention of adverse effects, particularly the long-term and short-term adverse effects of drugs or treatment. The World Health Organization (WHO) established pharmacovigilance Programme for International Drug Monitoring in response to the thalidomide disaster detected in 1961. India joined the WHO adverse drug reaction (ADR) monitoring program based in Uppsala, Sweden, in 1998. The Central Drugs Standard Control Organization (CDSCO), Directorate General of Health Services, under the aegis of the Ministry of Health and Family Welfare, Government of India, in collaboration with Indian Pharmacopoeia Commission, Ghaziabad, is a National Coordinating Centre (NCC). Adverse drug reaction monitoring centers (AMCs) under the Pharmacovigilance Programme of India (PvPI) play a vital role in the collection and follow-up of ADR reports from the patients, as drug trials in animals and humans (Phase I–III) do not predict accurately the adverse drug events. Patients with chronic kidney disease (CKD)/liver disease are at risk of enhanced drug-related events. These patients should be closely monitored for any adverse events and it should be reported. Thus, inculcating the habit of ADR reporting will help in generating data specific to Indian population and will contribute toward patient safety. This will also help in modifying the treatment given to the patients, as early identification of ADRs will help in reducing morbidity and mortality in patients. How to cite this article Sharma G, Kumar R, Singh J, Bhandari V, Singh N. Pharmacovigilance in India and its Impact in Patient Management. Curr Trends Diagn Treat 2017;1(1):27-33.

Improving Medication Safety Through the Use of Metrics

2013 ◽  
Vol 27 (1) ◽  
pp. 61-64
Author(s):  
Robert D. Beckett ◽  
Marina Yazdi ◽  
Laura J. Hanson ◽  
Ross W. Thompson
Keyword(s):  
Medication Errors ◽  
Medication Safety ◽  
Adverse Drug Events ◽  
Safety Information ◽  
Medication Use ◽  
Cross Sectional Study ◽  
Survey Instrument ◽  
Sectional Study ◽  
Cross Sectional ◽  
Safety Metrics

Purpose: Describe medication safety metrics used at University HealthSystem Consortium (UHC) institutions and recommend a meaningful way to report and communicate medication safety information across an organization. Methods: A cross-sectional study was conducted using an electronically distributed, open-ended survey instrument. Results: Twenty percent of the UHC institutions responded to our survey. Seventy-seven percent of those institutions responding to our survey reported their organization has defined metrics to measure medication safety; an additional 21% of the institutions were still in the process of defining metrics. Of metrics that were reported, 33% were true medication safety metrics. Results are distributed to a wide variety of institutional venues. Conclusion: Institutions should take several actions related to medication safety including defining local metrics; building metrics addressing preventable adverse drug events, medication errors, and technology; and reporting results to a variety of venues in order to design specific interventions to improve local medication use.

scholarly journals Medication Safety: Reducing Anesthesia Medication Errors and Adverse Drug Events in Dentistry Part 2

2020 ◽  
Vol 67 (1) ◽  
pp. 48-59
Author(s):  
Daniel S. Sarasin ◽  
Jason W. Brady ◽  
Roy L. Stevens
Keyword(s):  
General Anesthesia ◽  
Medication Errors ◽  
Medication Safety ◽  
Adverse Drug Events ◽  
Contributing Factors ◽  
Full Spectrum ◽  
Dental Profession ◽  
Novel Method ◽  
Dental Providers ◽  
Preventive Methods

For decades, the dental profession has provided the full spectrum of anesthesia services ranging from local anesthesia to general anesthesia in the office-based ambulatory environment to alleviate pain and anxiety. However, despite a reported record of safety, complications occasionally occur. Two common contributing factors to general anesthesia and sedation complications are medication errors and adverse drug events. The prevention and early detection of these complications should be of paramount importance to all dental providers who administer or otherwise use anesthesia services. Unfortunately, there is a lack of literature currently available regarding medication errors and adverse drug events involving anesthesia for dentistry. As a result, the profession is forced to look to the medical literature regarding these issues not only to assess the likely severity of the problem but also to develop preventive methods specific for general anesthesia and sedation as practiced within dentistry. Part 1 of this 2-part article illuminated the problems of medication errors and adverse drug events, primarily as documented within medicine. Part 2 will focus on how these complications affect dentistry, discuss several of the methods that medical anesthesia has implemented to manage such problems that may have utility in dentistry, and introduce a novel method for addressing these issues within dentistry known as the Dental Anesthesia Medication Safety Paradigm (DAMSP).

scholarly journals ANALYSIS OF ADVERSE DRUG REACTION REPORT FORMS ON THE MEDICINES, USED FOR AIDS TREATMENT (REGISTERED IN THE REPUBLIC OF CRIMEA IN THE PERIOD FROM 2011 TO 2016)

2019 ◽  
Vol 6 (6) ◽  
pp. 568-583
Author(s):  
A. V. Matveev ◽  
A. Е. Krasheninnikov ◽  
E. A. Egorova ◽  
E. I. Konyaeva
Keyword(s):  
Quality Of Life ◽  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Antiretroviral Therapy ◽  
Adverse Reactions ◽  
Clinical Manifestations ◽  
Public Health Problem ◽  
World Health ◽  
The Republic

According to the data of the World Health Organization (WHO), human immunodeficiency virus (HIV) remains a major global public health problem.The mainmethod of treating HIV is using highly active antiretroviral therapy (HAART), which is the use of multiple medicines acting on different viral targets. The timely onset of HAART can suppress the replication of the virus in the human body and helps to strengthen its immune system and restore its ability to fight infections. At the same time, the choice of medicines to improve the quality of life and patients’ compliance during antiretroviral therapy should be based on their effectiveness and safety. The aim of this research was to analyze and study the adverse reactions that occur in patients with HIV living in the territory of the Republic of Crimea, when using HAART.Materials and methods.The objects of research were 274 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 2011 to 2016.Results.The results of the study showed that the most often adverse reactions were observed when using medicines of the group of Nucleoside Reverse Transcriptase Inhibitors (NRTI). This is explained by the inclusion of NRTI medicines as the main medicine in the method of HAART. Efavirenz (EFV) and Nevirapine (NVP) were absolute leaders among these groups of antiretroviral medicines. Among the combined antiviral medicines active against HIV, the most frequently adverse reactions were associated with the use of a combination of Lamivudine (3TC) and Zidovudine (ZDV). The main clinical manifestations of adverse reactions in the use of combination medicines for treating HIV were a decrease in the level of hemoglobin and the development of anemia. At the same time, in 85% of cases, the patients needed medication in order to correct the resulting adverse drug reaction (ADR). The combination of antiretroviral therapy has often been associated with the development of serious ADR. In case of monotherapy, the main clinical manifestations of adverse reactions were disorders of the central nervous system (dizziness, hallucinations, sleep disorders) and allergic reactions of varying severity (including 1 case of angioedema to “Eferven” (Efavirenz (EFV)),600 mg). Hereby, in almost half of the cases, the usage of antiretroviral medicines of the NRTI group and protease inhibitors caused the development of serious side effects. This confirms the necessity to study and analyze adverse reactions in order to increase the safety of patients’ pharmacotherapy and improve their quality of life.Conclusion.The study of adverse reactions to the medicines used for treatment of HIV is of a paramount importance in improving the safety and compliance of HIV patients to lifelong pharmacotherapy.

scholarly journals High-quality reports and their characteristics in the Japanese Adverse Drug Event Report database (JADER)

2021 ◽  
Vol 24 ◽  
pp. 161-173
Author(s):  
Masami Tsuchiya ◽  
Taku Obara ◽  
Makoto Miyazaki ◽  
Aoi Noda ◽  
Takamasa Sakai ◽  
...  
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Anticancer Drugs ◽  
Adverse Drug Event ◽  
Adverse Drug Reaction Reporting ◽  
World Health ◽  
Drug Event ◽  
Event Report ◽  
High Quality ◽  
Grade 3

Purpose: Spontaneous adverse drug reaction reporting is the foundation of postmarketing drug safety monitoring. The present study aimed to analyze and clarify the quality and characteristics of the Japanese Adverse Drug Event Report database (JADER) using the World Health Organization (WHO) documentation grading scheme and the vigiGrade completeness score. The characteristics of reports were described using both schemes simultaneously. The way of proper use of these two schemes was explored. Methods: The WHO documentation grading scheme and the vigiGrade completeness score were applied to the same dataset (JADER202001 dataset). Reports classified as high-quality under both assessment criteria were extracted, and the characteristics of these reports were analyzed. Results: Of the 607,361 adverse drug reaction reports analyzed, 52.8% were ‘well-documented reports’ with a vigiGrade completeness score >0.8. Under the WHO documentation grading scheme, 328,702 reports (54.1%) were Grade 2 and 5,178 (0.9%) were Grade 3 (including rechallenge information). Among well-documented Grade 3 reports, classified as the highest quality, a high proportion of the adverse drug reaction reports were related to disorders of hematopoietic function resulting from anticancer drugs. Because a high proportion of the reports with rechallenge information were for anticancer drugs as suspect drugs, the WHO documentation grading scheme tended to extract reports regarding anticancer drugs as high quality. Conclusions: We conclude that the two schemes need to be used appropriately, depending on the purpose of analysis, the target adverse drug reactions, and suspect drugs.

scholarly journals Causes for the underreporting of adverse drug events by health professionals: a systematic review

2014 ◽  
Vol 48 (4) ◽  
pp. 739-747 ◽  
Author(s):  
Fabiana Rossi Varallo ◽  
Synara de Oliveira Paim Guimarães ◽  
Samir Antonio Rodrigues Abjaude ◽  
Patricia de Carvalho Mastroianni
Keyword(s):  
Systematic Review ◽  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Drug Use ◽  
Continuing Education ◽  
Health Professionals ◽  
Adverse Drug Events

Objective: Identifying the main causes for underreporting of Adverse Drug Reaction (ADR) by health professionals. Method: A systematic review carried out in the following databases: LILACS, PAHO, SciELO, EMBASE and PubMed in the period between 1992 and 2012. Descriptors were used in the search for articles, and the identified causes of underreporting were analyzed according to the classification of Inman. Results: In total, were identified 149 articles, among which 29 were selected. Most studies were carried out in hospitals (24/29) for physicians (22/29), and pharmacists (10/29). The main causes related to underreporting were ignorance (24/29), insecurity (24/29) and indifference (23/29). Conclusion: The data show the eighth sin in underreporting, which is the lack of training in pharmacovigilance. Therefore, continuing education can increase adherence of professionals to the service and improve knowledge and communication of risks due to drug use.


scholarly journals ANALYSIS OF ADVERSE DRUG REACTION IN A TERTIARY CARE HOSPITAL: A RETROSPECTIVE STUDY

2016 ◽  
Vol 10 (1) ◽  
pp. 347
Author(s):  
Dolly Roy ◽  
Ayan Purkayastha ◽  
Rohit Tigga
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Anaphylactic Reaction ◽  
Tertiary Care Hospital ◽  
Tertiary Care ◽  
Iron Sucrose ◽  
World Health ◽  
Care Hospital ◽  
Monitoring Centre ◽  
Health Organization

ABSTRACTObjectives: Adverse drug reaction (ADR) is an important cause of morbidity, mortality, and prolonged hospitalization. The objective of this study is tomeasure the incidence, types, and nature of ADR in a tertiary care hospital located in Silchar, Assam.Methods: A retrospective noninterventional analysis of all ADRs reported by ADR Monitoring Centre, Department of Pharmacology, Silchar MedicalCollege, from March 2014 to February 2015 was performed. A total of 162 predesigned forms were used for collection of data. All forms were dulychecked for completeness, if not, they were rejected.Results: A total of 162 forms were assessed of which 96 (59%) were females and 66 (41%) were males. The distribution of ADRs in different age groupswere found to be 3 (1.85%) in 0-15 years, 71 (43.82%) in 16-30 years, 65 (40.12%) in 31-45 years, 8 (4.93%) in 46-60 years, and 15 (9.25%) in agegroup >60 years. 150 (92.6%) of the ADRs were serious and 12 (7.4%) were not serious. As per the World Health Organization causality assessmentscale, 120 (74.07%) were probable and 42 (25.92%) were possible. The most common ADR was anaphylactic reaction (AR) in 69 (42.59%) patients.The drugs which commonly caused ADR were iron sucrose infusions, nevirapine, cephalosporins, antiprotozoals, nonsteroidal anti-inflammatorydrugs, and quinolones followed by others.Conclusion: The majority of ADRs were probable. The most common ADR was AR caused by iron sucrose infusion. Different drugs caused differentADRs. ADRs thereby increase morbidity and mortality in patients as well as socioeconomic burden.Keywords: Adverse drug reaction, Anaphylactic reaction, Iron sucrose infusion, Noninterventional, Retrospective analysis.

Enoxaparin induced reactive thrombocytosis: a rare adverse drug reaction

2020 ◽  
Vol 31 (5) ◽  
Author(s):  
Saleel Salman Meenpidiyil ◽  
Shihas Azeez ◽  
Vaisakh Prasanna Kumar ◽  
Dhanush Suresh ◽  
Sareena Kalathathoduuill ◽  
...  
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
World Health ◽  
Uppsala Monitoring Centre ◽  
Close Monitoring ◽  
Reactive Thrombocytosis ◽  
Monitoring Centre ◽  
Vein Thrombosis ◽  
Coronary Syndrome ◽  
Ischemic Complications

AbstractObjectivesEnoxaparin is a low molecular weight heparin (LMWH), which belongs to the class of anticoagulants. The drug is administered as subcutaneous injection to prevent or treat deep vein thrombosis (DVT), pulmonary embolism and ischemic complications.Case PresentationA 57-year-old women diagnosed with acute coronary syndrome developed reactive thrombocytosis following the administration of enoxaparin subcutaneously. The blood test reports of the patient showed that there is a gradual elevation of platelet count day by day following enoxaparin administration. On an assessment using both World Health Organization–Uppsala Monitoring Centre (WHO–UMC) scale and Naranjo Causality Assessment Scale indicated that enoxaparin is the “probable” cause for the reaction.ConclusionsWe conclude that reactive thrombocytosis is a probable adverse drug reaction and close monitoring of blood counts is essential, following enoxaparin injection. More studies are to be conducted to identify further complications.

scholarly journals Psychotic Disorders, Definition, Sign and Symptoms, Antipsychotic Drugs, Mechanism of Action, Pharmacokinetics & Pharmacodynamics with Side Effects & Adverse Drug Reactions: Updated Systematic Review Article

2020 ◽  
Vol 10 (1) ◽  
pp. 163-172
Author(s):  
Rohit Bangwal ◽  
Shivam Bisht ◽  
Saurabh Saklani ◽  
Shobit Garg ◽  
Mohan Dhayani
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Side Effects ◽  
Adverse Drug Reactions ◽  
Common Property ◽  
Antipsychotic Drugs ◽  
Psychotic Disorders ◽  
World Health ◽  
Drug Reactions ◽  
Wide Range

Psychosis is a mental disorder characterized by a disconnection from reality. Psychosis is a group of disorder characterized by thought disorder, abnormal behaviour, defective cognition, delusion and hallucination. Adverse drug reaction is defined as any undesired or unintended effects of drugs treatment. According to the World Health Organization (WHO)- “adverse drug reaction (ADRs) has been defined one which is noxious and unintended, and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of disease, or modification of physiological function”. Adverse drug reactions are the most important causes of the mortality and morbidity. Antipsychotics are the most effective drugs which are used in the psychiatry in the maintenance therapy of mania, psychoses and schizophrenia. The antipsychotics drugs are chemically disparate but have the common property of alleviating the symptoms of organic as well as functional psychosis. But they also have a capacity to cause a wide range of potential adverse drug reactions that can lead to non-compliance that can impair quality of life, may cause the extra pyramidal symptoms which can lead to discontinuation of therapy and in extreme cases it may be fatal. Knowledge of assessment of ADRs due to different antipsychotics is necessary. It helps to choose to safe treatment and reduce the risk of occurrence of ADRs by the clinicians. ADR are often poorly identified and reported in day to day medical practice. As we collect more and more information about ADRs, we need an active surveillance system regarding identification and reporting of ADRs with antipsychotic drugs.  On many review articles are read & ward round participation experiences we find that antipsychotic drugs can have shown a various kind of ADRs. Psychiatrist and clinical pharmacist are need to be made aware of these potentially fatal adverse effects associated with antipsychotic drugs via conduction of patients counseling regarding (drugs, disease, doses & side effects), quality-based seminars, published medical literature, conferences, learning programs and health care camps. Keywords: Antipsychotic Drugs, WHO, Adverse Drug Reactions, Pharmacovigilance, Psychiatrist.

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