scholarly journals An analysis of seriousness, predictability and preventability of adverse drug reactions reported at a tertiary care teaching hospital in Kerala, India: a retrospective observational record based study

2018 ◽  
Vol 7 (12) ◽  
pp. 2433
Author(s):  
Jihana Shajahan ◽  
Abdul Aslam Parathoduvil ◽  
Sangeetha Purushothaman
Keyword(s):  
Health Care ◽  
Adverse Drug Reactions ◽  
Health Care Professionals ◽  
Health Care Systems ◽  
Tertiary Care ◽  
Drug Reactions ◽  
Mortality And Morbidity ◽  
Monitoring Centre ◽  
Care Systems ◽  
The Impact

Background: Adverse drug reactions (ADR) are the leading cause of mortality and morbidity in all health care systems. Hospital based ADR monitoring and reporting programmes can throw some light upon the profile of ADRs and ways to prevent them, facilitating rational drug use. An attempt has been made in this study to analyse the seriousness, predictability, preventability, severity and outcome of ADRs occurring in a tertiary care hospital.Methods: This was a retrospective observational study based on the data collected from ADRs reported to an approved ADR monitoring centre (AMC). Data collected was evaluated for seriousness, predictability, preventability, severity and outcome using appropriate scales. Simple descriptive statistics was used for analysis.Results: The total number of ADRs reported was 300. Among this 39% reactions were serious. The commonest reason for considering as serious reaction was prolongation of hospitalization. The overall predictability was 40.4%. Total preventability was found to be 18.3%. Assessment of severity showed 55.3 %, 41.7%, 3% reactions in mild, moderate and severe grades respectively. 64.3% patients had recovered from the reaction and 30% were recovering at the time of reporting ADR. Only 0.3% ADRs caused death.Conclusions: Authors hope this study will foster the culture of reporting and analysing ADRs among health care professionals and students. The findings from the study can create awareness among health care professionals regarding the impact of ADRs on the treatment course.

scholarly journals Analysis of spontaneously reported adverse drug reactions to pharmacovigilance cell of a tertiary care hospital

2018 ◽  
Vol 7 (8) ◽  
pp. 1551
Author(s):  
Kaksha J. Patel ◽  
Ashwin K. Panchasara ◽  
Manish J. Barvaliya ◽  
C. B. Tripathi
Keyword(s):  
Health Care ◽  
Adverse Drug Reactions ◽  
Health Care Professionals ◽  
Geriatric Patients ◽  
Tertiary Care ◽  
Care Hospital ◽  
Drug Reactions ◽  
Adr Reporting ◽  
Common Group ◽  
Selection Of

Background: The objective of the study was to study the clinical patterns, causality and severity of adverse drug reactions in a tertiary care hospital.Methods: Total 131 ADR forms were collected from January 2012 to December 2012 and evaluated. Patient’s characteristics, ADR and drug characteristics, causality, severity and preventability of collected ADR were analyzed.Results: Total 131 ADR forms were evaluated. Male patient experiencing ADR were more (73, 55.7%) than female (58, 44.2%). Adult patients (12-60 years) experienced 110 (84%) ADR followed by pediatric patients (< 12 years) 11 (8.4%) and geriatric patients (>60 years) 10 (7.63%). Antimicrobial were the most common group of drugs responsible for ADR followed by NSAIDs and antipsychotic group.Conclusions: Present study shows lack of awareness among health care professionals for reporting of an ADR. Training and collaboration of health care professionals are needed for improvement in ADR reporting. Appropriate feedback from ADR reporting will help in selection of drug and promotes safer use of drugs.

scholarly journals A retrospective study of adverse drug reactions in a tertiary care center

2020 ◽  
Vol 9 (4) ◽  
pp. 611
Author(s):  
Ankitha L. ◽  
Ramesh H.
Keyword(s):  
Health Care ◽  
Adverse Drug Reactions ◽  
Health Care Professionals ◽  
Causality Assessment ◽  
Care Center ◽  
Tertiary Care ◽  
General Medicine ◽  
Accurate Estimate ◽  
Care Hospital ◽  
Drug Reactions

Background: Adverse drug reactions (ADRs) are a major concern in clinical practice. Reporting of ADRs either through health care professionals or the patients themselves is of utmost importance to give an accurate estimate of the prevalence, severity and preventability of ADRs. Present study was conducted to evaluate the prevalence of adverse drug reactions in a tertiary care hospital in Hubballi, Karnataka, India.Methods: This was a retrospective observational study, extending over 6 months (May 2019 to October 2019). A total of 124 cases comprising patients of either sex and age group ranging from 1month to 72 years were studied. The data was collected using CDSCO ADR reporting form. “Naranjo’s Assessment Scale” was used for causality assessment and severity assessment was done in accordance with “Hartwig and Siegel scale”.Results: The study showed majority of ADRs were from General Medicine department and affected skin and appendages (59%). Skin rashes 44 (31.7%) were found to be the most commonly reported ADRs most of them were with antimicrobials 67 (54%).  After causality assessment 83 (66.9%) of the cases were classified as probable and 41 (33.1%) were classified as possible. Majority of serious ADRs were not preventable in our study.Conclusions: ADRs are a major cause of morbidity worldwide. Frequency of ADRs can be reduced by careful follow up and a robust hospital-based pharmacovigilance setup. Measures to improve detection and reporting of adverse drug reactions by all health care professionals is recommended.

scholarly journals A Retrospective Study on Adverse Drug Reaction Monitoring in A Tertiary Care Hospital

2021 ◽  
Vol 70 (1) ◽  
Author(s):  
Adiba Nousheen ◽  
Asra Asra ◽  
Hasnat Fatima ◽  
Nashra Nizami ◽  
Sarah Noureen ◽  
...  
Keyword(s):  
Health Care ◽  
Adverse Drug Reactions ◽  
Health Care Professionals ◽  
Tertiary Care Hospital ◽  
Tertiary Care ◽  
Age Groups ◽  
General Medicine ◽  
Care Hospital ◽  
Age Group ◽  
Drug Reactions

Adverse drug reactions (ADRs) are a major concern in clinical practice. Reporting of ADRs either through health care professionals or the patients themselves is of utmost importance to give an accurate estimate of the prevalence, severity and preventability of ADRs. Present study was conducted to evaluate the prevalence of adverse drug reactions in a tertiary care hospital in Hyderabad, Telangana, India. This was a retrospective observational study, extending over 3 months (December 2020 to February 2021). A total of 41 cases comprising patients of either sex or age group were studied. The data was collected using CDSCO ADR reporting form. A total of 41 ADRs were reported during the three months period of study. During the study period a total of 41 ADR reports were received from various departments of the hospital. We observed 25 ADRs in females and 16 ADRs in males from our study. Among the age groups, 3 ADRs in age group 0 – 19 Yrs., 28 ADRs were seen in age group 20 – 59 Yrs., and 10 ADRs were seen in age group >60 Yrs. Maximum number of ADRs came from General Medicine department 17 (41.46%). Drug therapy 41 (100%) and diseases 19 (46.34%) were the most prominent predisposing factors of ADRs seen in our hospital. Causality assessment of suspected drugs was assessed using Naranjo scale. According to Naranjo scale most of the reported ADRs were found to be probable 23 (56.9%) followed by possible 16 (39.02%) and definite 2 (4.8%). The severities of the reactions were done using Hart Wig Scale. Majority of the reactions were mild 25 (60.97%). Withdrawal of the drug 5 (12.19%) was the main line of the management of the adverse drug reactions in the present study. Majority of serious ADRs were preventable in our study. ADRs are a major cause of morbidity worldwide. Frequency of ADRs can be reduced by careful follow up and a robust hospital-based pharmacovigilance setup. A measure to improve detection and reporting of adverse drug reactions by all health care professi

scholarly journals Patterns of adverse drug reactions: a study in a tertiary care

2019 ◽  
Vol 8 (7) ◽  
pp. 1497
Author(s):  
Donepudi Pavan Kumar
Keyword(s):  
Health Care ◽  
Adverse Drug Reactions ◽  
Health Care Professionals ◽  
Tertiary Care ◽  
Accurate Estimate ◽  
Early Age ◽  
Drug Reactions ◽  
Medicine Department ◽  
Antitubercular Drugs ◽  
Definition Of

Background: Adverse drug reaction, usually reported by pharmacovigilance, either through health care professionals or the patients themselves is of utmost importance to give an accurate estimate of the severity of the drug and also if the ADRs are casual, preventable or severe.Methods: A total of 42 patients satisfied the WHO definition of ‘adverse drug reactions’ were included in the study. The demographic details were taken, and the regular physical examination and clinical examination was done for all the patients. The latest drug they were on and the dosage were analyzed and the type of reaction was assessed. The causality, severity and preventability were also assessed.Results: Majority of the ADRs were found in the medicine department, followed pulmonology, obstetrics-gynecology and paediatrics. B-lactams were the major cause of ADRs with 42.2%, followed by NSAIDs with 23.8%, fluoroquinolones with 19% and 9.5% due to antitubercular drugs. 66.7% of the ADRs were mild, 28.6% were moderate and 4.8% were severe. The most common type of ADR were skin rashes (40.5%), urticara (16.7%), headaches (26.2%), insomnia (21.4%), diarrhoea (21.4%), abdominal pain (14.3%) and vomiting (4.8%). Most of the ADRs were evaluated as probably preventable (69%), definitely preventable (26.2%), non preventable (4.8%).Conclusions: Most of the drug reactions are mild and preventable. More health care professionals as well as patients need to be aware of the drug reactions at much early age so as to prevent the condition before it becomes serious.

scholarly journals A surveillance study of cutaneous adverse drug reactions in a tertiary care teaching hospital in India

2018 ◽  
Vol 7 (12) ◽  
pp. 2439
Author(s):  
Vandana Badar ◽  
Vidisha Vivek Parulekar ◽  
Priti Garate
Keyword(s):  
Health Care ◽  
Adverse Drug Reactions ◽  
Teaching Hospital ◽  
Health Care Professionals ◽  
Tertiary Care ◽  
Common Symptom ◽  
Drug Reactions ◽  
Tertiary Care Teaching Hospital ◽  
Care Teaching ◽  
Recorded Data

Background: Skin is one of the most common targets of adverse drug reactions (ADRs) The practice of pharmacovigilance all over the world is 5% whereas in India, it is below 1%. Hence, the purpose of our study is to monitor and analyze the suspected cutaneous adverse drug reactions (ACDRs) reported at our tertiary care teaching hospital, to characterize the nature and predictability, severity and preventability of ACDRs and identify most common drugs causing cutaneous ACDRs so that they can be given cautiously and with keen surveillance.Methods: An observational study was conducted in patients attending outpatient and inpatient department for a period of 3 years. All ACDRs of patients were referred by health care professionals and the diagnosis were made by concern doctors. The recorded data was filled in the ADR form obtained from pharmacovigilance program of India (2011) and Central Drug Standard Control Organization (CDSCO) website.Results: Out of 1399 ADR reports analyzed, 564 reports (40.31%) were of ACDRs, female to male ratio was 0.85. Redness (44.32%) was most common symptom, followed by itching (44.14%) and rash (19.14%). Antimicrobials (43.97%), NSAIDS (21.63%), Anti-retroviral therapy drugs (13.65%) were common groups. As per WHO-UMC causality classification, modified Hartwig and Siegel severity scale, Thornton and Schumock preventability scale, ACDRs were probable, mild and possibly preventable respectively.Conclusions: Effective ADR monitoring plays a role in safety of medicines. So, awareness regarding early diagnosis and prompt treatment should be created among the health care professionals and reporting of ACDRs should be regularly practiced by all the departments.

scholarly journals Retrospective analysis of adverse drug reactions reported at ADR monitoring centre under PvPI in a tertiary care hospital

2018 ◽  
Vol 7 (2) ◽  
pp. 303
Author(s):  
Manodeep Sen ◽  
Arpita Singh ◽  
Mukul Misra
Keyword(s):  
Health Care ◽  
Retrospective Analysis ◽  
Adverse Drug Reactions ◽  
Health Care Professionals ◽  
Antimicrobial Agents ◽  
Tertiary Care Hospital ◽  
Tertiary Care ◽  
Care Hospital ◽  
Drug Reactions ◽  
Skin Reactions

Background: Adverse drug reactions (ADRs) are a major cause of morbidity and mortality in hospitals and pose great economic burden on the health care system. This study was conducted with the aim of creating awareness and developing a culture for proper communication and reporting of ADRs among health care professionals.Methods: This study is a retrospective analysis of total 60 reported ADRs from AMC at a tertiary care hospital during a period of 14 months from March 2015 to April 2016. These ADRs were analysed for the pattern and type of reactions, body systems involved, causative drugs, and severity of reaction, their outcome, management and causality assessment.Results: Patients in the age groups of 41-50 years were most commonly involved with slight male preponderance. Skin reactions like rashes and itching were the most commonly observed ADR. The most common causative drugs for ADR were antimicrobial agents; IV route was the most common route responsible. Majority of ADRs belonged to type B, were non serious and moderate in severity. Most of the patients recovered. On causality assessment scale, most of the ADRs were found to be probable with the causative drugs.Conclusions: Most of the ADRs were treatable by early and appropriate management. The major limitation was under-reporting of ADRs which can be overcome by creating awareness and enhancing the culture of ADR monitoring and reporting among health care professionals for safe use of drugs.

scholarly journals The Impact and Implications of The COVID-19 Pandemic on Organ Procurement Outside of an Epicenter

2021 ◽  
pp. 152692482110028
Author(s):  
Janice Jene Hudgins ◽  
Allison Jo Boyer ◽  
Kristen Danielle Orr ◽  
Clint Allen Hostetler ◽  
Jeffrey Paul Orlowski ◽  
...  
Keyword(s):  
Health Care ◽  
Initial Phase ◽  
Organ Procurement ◽  
Health Care Systems ◽  
Health Data ◽  
Organ Procurement Organization ◽  
Care Systems ◽  
The Impact ◽  
Variable Impact ◽  
Single Organ

The COVID-19 pandemic has been well-documented to have a variable impact on individual communities and health care systems. We describe the experience of a single organ procurement organization (OPO), located in an area without a large cluster of cases during the initial phase of the COVID-19 pandemic. A review of community health data describing the impact of COVID-19 nationally and in Oklahoma was conducted. Additionally, a retrospective review of available OPO data from March 2019-May 2020 was performed. While the amount of donor referrals received and organs recovered by the OPO remained stable in the initial months of the pandemic, the observed organs transplanted vs. expected organs transplanted (O:E) decreased to the lowest number in the 15-month period and organs transplanted decreased as well. Fewer organs from Oklahoma donors were accepted for transplant despite staff spending more time allocating organs.

scholarly journals Sustainability of Biosimilars in Europe: A Delphi Panel Consensus with Systematic Literature Review

2020 ◽  
Vol 13 (11) ◽  
pp. 400
Author(s):  
Arnold G. Vulto ◽  
Jackie Vanderpuye-Orgle ◽  
Martin van der Graaff ◽  
Steven R. A. Simoens ◽  
Lorenzo Dagna ◽  
...  
Keyword(s):  
Health Care ◽  
Literature Review ◽  
Systematic Literature Review ◽  
Health Care Systems ◽  
Delphi Panel ◽  
The European Union ◽  
Modified Delphi ◽  
Care Systems ◽  
Supply Risks ◽  
The Impact

Introduction: Biosimilars have the potential to enhance the sustainability of evolving health care systems. A sustainable biosimilars market requires all stakeholders to balance competition and supply chain security. However, there is significant variation in the policies for pricing, procurement, and use of biosimilars in the European Union. A modified Delphi process was conducted to achieve expert consensus on biosimilar market sustainability in Europe. Methods: The priorities of 11 stakeholders were explored in three stages: a brainstorming stage supported by a systematic literature review (SLR) and key materials identified by the participants; development and review of statements derived during brainstorming; and a facilitated roundtable discussion. Results: Participants argued that a sustainable biosimilar market must deliver tangible and transparent benefits to the health care system, while meeting the needs of all stakeholders. Key drivers of biosimilar market sustainability included: (i) competition is more effective than regulation; (ii) there should be incentives to ensure industry investment in biosimilar development and innovation; (iii) procurement processes must avoid monopolies and minimize market disruption; and (iv) principles for procurement should be defined by all stakeholders. However, findings from the SLR were limited, with significant gaps on the impact of different tender models on supply risks, savings, and sustainability. Conclusions: A sustainable biosimilar market means that all stakeholders benefit from appropriate and reliable access to biological therapies. Failure to care for biosimilar market sustainability may impoverish biosimilar development and offerings, eventually leading to increased cost for health care systems and patients, with fewer resources for innovation.

scholarly journals The impact of chronic disease and disability on the elderly

1999 ◽  
Vol 55 (3) ◽  
pp. 9-14
Author(s):  
C. J. Eales
Keyword(s):  
Health Care ◽  
Chronic Disease ◽  
Chronic Diseases ◽  
Health Care Systems ◽  
The Elderly ◽  
Therapeutic Interventions ◽  
Elderly Persons ◽  
Care Systems ◽  
And Function ◽  
The Impact

Health care systems for elderly people should aim to delay the onset of illness, reducing the final period of infirmity and illness to the shortest possible time. The most effective way to achieve this is by health education and preventative medicine to maintain mobility and function. Changes in life style even in late life may result in improved health, effectively decreasing the incidence of chronic diseases associated with advancing age. This paper presents the problems experienced by elderly persons with chronic diseases and disabilities with indications for meaningful therapeutic interventions.

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