Quality of Adverse Drug Reaction (QADRA) reports: an algorithm to appraise the efficiency of spontaneous reporting systems in pharmacovigilance

2013 ◽  
Vol 21 (4) ◽  
pp. 365-372 ◽  
Author(s):  
Marco Tuccori ◽  
Giulio Giustarini ◽  
Corrado Blandizzi ◽  
Alice Capogrosso-Sansone ◽  
Marco Rossi ◽  
...  
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Spontaneous Reporting ◽  
Reporting Systems

scholarly journals ANTIMICROBIAL-RELATED ADVERSE DRUG REACTION IN A TERTIARY CARE HOSPITAL

2017 ◽  
Vol 10 (8) ◽  
pp. 229
Author(s):  
Jindal M ◽  
Sharma Rk
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Spontaneous Reporting ◽  
Tertiary Care Hospital ◽  
Past History ◽  
Tertiary Care ◽  
Care Hospital ◽  
Beta Lactam ◽  
Active Monitoring ◽  
Beta Lactam Antibiotics

  Objective: The objective of the study was to evaluate the adverse drug reaction (ADR) related to commonly used antimicrobials in a tertiary care hospital.Methods: A prospective spontaneous reporting study involving, active methods (pharmacist actively looking for suspected ADRs) and passive methods (stimulating prescribers to report suspected ADRs) was carried out in all departments of a tertiary care hospital, for 1 year. Patients of all age groups were included in the study. The data for the study were taken from case sheets, investigation reports of patients who had experienced an ADR, personal interviews with reporting persons or clinicians, personal interviews with patient or patient’s attendant, past history of medication use, which were generally obtained from, prescriptions from the past, reports of medical and surgical interventions, referral letters, ADR reporting forms. Collected data were then analyze for causality assessment by Naranjo’s scale and severity assessment by Hartwig and Siegel’s scale.Result: During 1 year of study period, 75 ADRs related to antimicrobial were reported among 1354 patients who were given antibiotic for the treatment. The incidence rate of antibiotic was found to be 5.53%. The department that reported ADR was medicine (10.16%), ENT (4.6%), pediatric (8.12%), orthopedics (06.9%), surgery (06.9%), chest and tuberculosis (04.6%), obstetrics and gynecology (06.9%), dentistry (02.3%), and skin (10.16%). The most common ADRs were related to gastrointestinal tract; dermatological reactions were second in the list of antimicrobial drugs causing ADR. In this study, among antimicrobials, fluoroquinolones, and beta-lactam antibiotics were the most common drugs causing gastrointestinal and dermatological ADRs. There was no unknown ADR reported that may need to be further investigated through active monitoring. All patients recovered from ADRs without any complications. The causality was assessed by Naranjo’s scale and it revealed that out of 75 antibiotics related ADR 48 (64%) were possible, 27 (36%) were probable, 3 (4.00%) were definate, and 0% were unlikely. According to the Hartwig and Siegel’s scale, most of ADR were mild 45 (60%) and moderate 30 (40%) in nature.Conclusion: ADRs related to antimicrobials occurs frequently. Among antimicrobials, fluoroquinolones, and beta-lactam antibiotics were the most common drugs causing gastrointestinal and dermatological ADRs. The health-care system can promote the spontaneous reporting of antimicrobial ADR to pharmacovigilance center for ensuring safe drug use and patient care.

SPONTANEOUS ADVERSE DRUG REACTION REPORTS FOR NEONATES AND INFANTS IN THE UK 2001–2010

2015 ◽  
Vol 101 (1) ◽  
pp. e1.43-e1
Author(s):  
Dan Hawcutt ◽  
Hannah Maqsood ◽  
Simon Gomberg ◽  
Andrew Riordan ◽  
Mark Turner
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Gestational Age ◽  
Spontaneous Reporting ◽  
Swine Flu ◽  
Yellow Card ◽  
Neisseria Meningitides ◽  
Spontaneous Adverse Drug Reaction ◽  
The Uk ◽  
Neonates And Infants

AimsThe UK Medicines and Healthcare products Regulatory Agency (MHRA) runs a national spontaneous reporting system (Yellow Card Scheme [YCS]) to collect ‘suspected' adverse drug reaction (ADR) data. We aim to describe the Yellow card reports received for patients aged ≤1 year for a 10 year period and assess their utility.MethodsData on all ADRs reported via the YCS in Infants aged ≤1 years from the years 2001–10 were supplied by the MHRA.ResultsIn total, 3217 suspected ADRs were reported to the YCS between 2001–10 for infants age ≤1 year (Neonates n=97, vaccinations n=2673, infant [neither neonate nor vaccine] n=477). Overall only 0.88 YC per day were received by the MHRA with a male preponderance (Male 50.3%, Female 45.7%); only 25 (0.8%) YC reports stated a gestational age for the affected infant. The medications most frequently reported as suspected of causing an ADR were Swine Flu Vaccine (neonates n=8), Neisseria meningitides (vaccinations n=693) and oseltamivir (infants n=37). Reports associated with vaccinations followed the expected trends. ADRs highlighted by regulators for neonatal and infant populations are not represented in the YCs received by the regulator.Conclusions The frequency of YCS reports for those ≤1 year is low, with less than 1 per day overall. Neonates are poorly represented, and recording of gestational age is very limited. The YCS appears to be more effective for spontaneous reporting of vaccination-related ADRs in infants than for other medications. Action is required to improve reporting of suspected ADRs that affect neonates and infants.

scholarly journals Study on the Classification, Causality, Preventability and Severity of Adverse Drug Reaction Using Spontaneous Reporting System in Hospitalized Patients

Pharmacy ◽  
2018 ◽  
Vol 6 (4) ◽  
pp. 108 ◽  
Author(s):  
Siraj Sundaran ◽  
Anjali Udayan ◽  
Keerthi Hareendranath ◽  
Basil Eliyas ◽  
Babu Ganesan ◽  
...  
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Spontaneous Reporting ◽  
Reporting System ◽  
Causality Assessment ◽  
Hospital Setting ◽  
Adr Reporting ◽  
Reporting Programs ◽  
Monitoring Service ◽  
Assessment Scales

Hospital-based adverse drug reaction (ADR) monitoring and reporting programs intend to identify and quantify the risks associated with the use of medicines. To examine the causality, preventability and severity of ADR in a hospital setting; a prospective cohort study on spontaneous ADR reporting was conducted from December 2015 to May 2016. Incidence of ADRs, causality, type, severity and preventability were assessed using necessary assessment scales. The study included 3157 hospitalized individuals, in whom 51 ADRs were detected among 49 patients. The overall incidence of suspected ADRs was found to be 1.6%. According to the causality assessment, most of the ADRs reported were probable (n = 26, 51.0%), and type A (augmented/pharmacological) reactions (n = 39, 76%) were the most common type of ADR found. The majority of ADRs were moderate to severe (n = 35, 68.6%), of which 37.3% were found to be potentially preventable. Predictability was observed in 28 (54.9%) reported ADRs. The prescribed medicines most frequently associated with ADRs were antibiotics, antiepileptics and antihypertensives. This feasibility study was able to highlight the clinical pharmacist’s role in ADR monitoring service and create awareness about the way it could be done to promote safer medication use. Similar ADR reporting programs are necessary to educate and to improve awareness among healthcare professionals in some countries.

Can causality assessment fulfill the new European definition of adverse drug reaction? A review of methods used in spontaneous reporting

2017 ◽  
Vol 123 ◽  
pp. 122-129 ◽  
Author(s):  
Annamaria Mascolo ◽  
Cristina Scavone ◽  
Maurizio Sessa ◽  
Gabriella di Mauro ◽  
Daniela Cimmaruta ◽  
...  
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Spontaneous Reporting ◽  
Causality Assessment ◽  
Definition Of

scholarly journals Characteristics and quality of adverse drug reaction reporting among healthcare providers at Rumailah Hospital in Qatar

2017 ◽  
Vol 2017 (3) ◽  
pp. 2
Author(s):  
Noor Alsalimy ◽  
Moammed Magdy ◽  
Dana Elkhalifa ◽  
Aya Al Shammaa ◽  
Ahmed Awaisu
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Adverse Drug Reaction Reporting ◽  
Healthcare Providers ◽  
Reaction Reporting

scholarly journals Impact of adverse drug reaction and predictivity of quality of life status in tuberculosis

2010 ◽  
Vol 36 (1) ◽  
pp. 206-208 ◽  
Author(s):  
N. Guo ◽  
F. Marra ◽  
J. M. Fitzgerald ◽  
R. K. Elwood ◽  
C. A. Marra
Keyword(s):  
Quality Of Life ◽  
Adverse Drug Reaction ◽  
Drug Reaction

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.

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