A Study on Pharmacist Mediated Intervention in Identifying and Reporting of Adverse Drug Reactions at a Tertiary Care Hospital

Background: Adverse drug reactions are major problem in health care system due to its consequences - morbidity, mortality and health care cost. Recent epidemiologic research reveals that the total incidence rate of ADRs was 6.7%, with an overall fatality rate of 0.32%. Method: A prospective observational study was carried out for 6 months in a tertiary care hospital. Patients admitted to the department of medicine, Pediatrics, orthopedics & surgery were selected randomly and followed from date of admission to date of discharge by enrolling into the study by considering the study criteria. Results: During the research about 27 ADRs were recognized & reported. Among them 14 (51.86%) patients were male and 13(48.14%) were female patients. The system or organ most commonly involved was Blood disorders were 8 (29.62%). Type A were 16(57.25%) reactions followed by Type B were 8 (29.62%); Type C were 3 (11.11%). Study depicts drug class usually implicated with ADRs was Antibiotics and antineoplastic drugs were 6 (22.22%) followed by Anti-Tubercular were 3 (11.11%); NSAIDS and Antidiabetic drugs were 2 (7.4%); The least implicated (3.7%) drug class are Anti-Pyretic, Diuretics and Antiretroviral. Causality was assessed for all the reported reactions are found to be PROBABLE according to WHO-UMC Scale. Conclusion: The study report shows that incidence of ADRs is steadily increasing. Under reporting of ADR is a major problem in India. Clinical Pharmacist plays a vital role in surveillance and prevention of ADRs. Keywords: Adverse Drug Reactions, Pharmacovigilance, Causality.

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Monitoring of adverse drug reactions in medicine, paediatric and surgical departments of a tertiary care hospital: a prospective observational study

International Journal of Basic & Clinical Pharmacology ◽

10.18203/2319-2003.ijbcp20181186 ◽

2018 ◽

Vol 7 (4) ◽

pp. 778

Author(s):

Sujatha Sowmyanarayan ◽

Swati Banerjee

Keyword(s):

Adverse Drug Reactions ◽

Tertiary Care Hospital ◽

Tertiary Care ◽

Care Hospital ◽

Drug Reactions ◽

Monitoring Centre ◽

Hospital Patients ◽

And Gender ◽

Steven Johnson Syndrome ◽

A Prospective Study

Background: the aim of the study was to monitor all adverse drug reactions in the departments of Medicine, Paediatrics and Surgery in a Tertiary Care Hospital.Methods: It was a prospective study undertaken in a 300 bedded tertiary care hospital. Patients presenting with adverse drug reactions in Medicine, Paediatrics and Surgery Departments were studied. Causality and severity of the adverse drug reactions were analysed Other parameters such as age wise and gender wise distribution of the ADRs, types of ADRs and drugs causing ADRs were studied.Results: There were 33 cases of ADRs were enrolled for the study in the duration of Sept. 2016 to Aug. 2017. Female preponderance was seen. The largest number of ADRs were seen in the age group of 21-30 years (30.3%). The most common ADR was skin rash (30.3%) followed by periorbital edema (12%). There were two SAEs namely Anaphylaxis and Steven Johnson syndrome. The most offending class of drug was antibiotics (30.3%) followed by intravenous fluids (12.1%).Conclusions: The maximum number of cases were reported from the Medicine Department which was 11 (33.33%). The highest number of ADRs fell in the probable category (63.6%). The number of cases of mild and moderate severity were equal (42.4%). The knowledge of these adverse drug reactions is necessary while prescribing drugs to patients as patient safety is absolutely essential. Also the healthcare provided by the institution will improve. This data has been collected with a view to establish an ADR monitoring centre at our hospital.

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

International Journal of Pharmaceutical Sciences Review and Research ◽

10.47583/ijpsrr.2021.v70i01.007 ◽

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

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

International Journal of Basic & Clinical Pharmacology ◽

10.18203/2319-2003.ijbcp20180103 ◽

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.

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Adverse Drug Reactions: Trends in a Tertiary Care Hospital

Current Drug Safety ◽

10.2174/1574886311207050011 ◽

2013 ◽

Vol 7 (5) ◽

pp. 384-388

Author(s):

Harmeet S. Rehan ◽

Deepti Chopra ◽

Ravinder K. Sah ◽

Ritu Mishra

Keyword(s):

Adverse Drug Reactions ◽

Tertiary Care Hospital ◽

Tertiary Care ◽

Care Hospital ◽

Drug Reactions

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ANALYSIS OF ADVERSE DRUG REACTIONS SPONTANEOUSLY REPORTED TO ADVERSE DRUG MONITORING CENTRE OF A TERTIARY CARE HOSPITAL–PROSPECTIVE STUDY

International Journal of Current Pharmaceutical Research ◽

10.22159/ijcpr.2018v10i1.24403 ◽

2018 ◽

Vol 10 (1) ◽

pp. 23

Author(s):

Gajanan P. Kulkarni ◽

Lokesh V. Patil

Keyword(s):

Prospective Study ◽

Adverse Drug Reactions ◽

Causality Assessment ◽

Tertiary Care Hospital ◽

Tertiary Care ◽

Care Hospital ◽

Drug Reactions ◽

Monitoring Centre ◽

Organ Systems ◽

A Prospective Study

Objective: To assess ADRs with reference to causative drugs, organ systems involved and seriousness of reactions.Methods: A prospective study conducted over a period of 1 y. The spontaneous adverse drug reactions reported between July 2016 and July 2017 at AMC centre BRIMS, Bidar were analyzed using Naranjo’s scale. Causality assessment of suspected drugs involved, system affected, and seriousness of reactions was assessed.Results: GIT system was most commonly involved, followed by generalized features, skin and appendages, CNS i. e, extrapyramidal system and dizziness, hearing and vestibular systems.Conclusion: Majority of the ADRs reported were mild to moderate severity and 20% can be categorized as severe reactions, which needed to treat under hospitalization

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Cross-sectional study regarding pattern of adverse drug reactions in a tertiary care hospital, Kakinada, India

MGM Journal of Medical Sciences ◽

10.4103/mgmj.mgmj_85_20 ◽

2021 ◽

Vol 8 (1) ◽

pp. 29

Author(s):

TarunKumar Suvvari ◽

SreenivasaRao Bendi ◽

LakshmiVenkata Simhachalam Kutikuppala

Keyword(s):

Adverse Drug Reactions ◽

Tertiary Care Hospital ◽

Tertiary Care ◽

Cross Sectional Study ◽

Care Hospital ◽

Sectional Study ◽

Drug Reactions ◽

Cross Sectional

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

International Journal of Basic & Clinical Pharmacology ◽

10.18203/2319-2003.ijbcp20183022 ◽

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.

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