scholarly journals Pattern of cutaneous adverse drug reactions at a tertiary care hospital in southern India

Author(s):  
Babu L. N. ◽  
Carounanidy Udayashankar ◽  
Kavita Vasudevan ◽  
Sivagnanam G.

Background: The objective of the study was to assess the pattern of cutaneous adverse drug reactions reported by active surveillance to the Pharmacovigilance center of a tertiary care hospital in southern india, and also to establish the drugs causing the same and observe the age wise and gender based incidence of such reactions.Methods: The cutaneous ADRs (CADRs) reported to the Pharmacovigilance center of the institution were analysed retrospectively during the period of March 2013 to December 2015. The various pattern of skin reactions and the most frequent drugs causing the same were established. An age wise and gender based incidence of CADRs and drugs causing them were also reported.Results: A total of 293 cases were taken for analysis. The male female ratio was 0.89-1.in our study. Among the age wise distribution of CADRs, 57(19.4%) were seen in paediatric, 194(66.2%) in adults and 33(11.2%) in geriatric age groups. The most frequent drugs to cause the CADRs were antimicrobials 183(62.4%) followed by NSAIDs 38(12.9%) and antacids 17(5.8%).Among the skin reactions urticaria/ angioedema was the most common 109(37.2%) followed by generalised pruritis 57(19.5%) and fixed drug eruption 37(12.6%). In all the age groups and both the sexes urticaria/angioedema and generalised pruritis were the leading skin reactions observed.Conclusions: As CADRs are the most common ADRs among others, it is prudent to monitor them closely, as any change in pattern with older or newer agents can alert the health care personnel in instituting the appropriate prescription patterns, which can overall impact the quality of health care positively.

Author(s):  
Adiba Nousheen ◽  
Asra Asra ◽  
Hasnat Fatima ◽  
Nashra Nizami ◽  
Sarah Noureen ◽  
...  

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


Author(s):  
Manodeep Sen ◽  
Arpita Singh ◽  
Mukul Misra

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.


Author(s):  
Jennifer R Grace ◽  
Anna K Saina ◽  
Maheswari E ◽  
Srinivasa R ◽  
Viswam Subeesh

Objective: The purpose of this study was to assess the incidence and pattern of adverse drug reactions (ADRs) reported from the department of neurology of a tertiary care hospital in Karnataka, India.Methods: It is a hospital-based prospective, observational study, conducted among the inpatients of all age groups of either sex for a period of 6 months. ADRs were reported by the clinical pharmacists and physicians of this hospital. ADRs obtained were categorized based on its causality, severity, preventability, predictability, and outcomes. Binary logistic regression was carried out to identify the predictors of ADR and Kaplan–Meier analysis was performed for survival analysis.Results: A total of 250 patients were enrolled for the study in which 108 (43%) patients were presented with at least one ADR and a total of 212 ADRs were observed. The highest rate of ADRs was observed with antiepileptics 61 (29.5%). The most commonly reported that ADRs were skin reactions 23 (10.8%). Causality was assessed using three different scales which showed that most of the ADRs were probable. Severity, preventability, and predictability were assessed, of which 125 (59%) ADRs were moderate, 192 (90.6%) ADRs were probably preventable, and 156 (73.6%) ADRs were predictable, respectively. The outcomes showed that 150 (70.1%) patients recovered from the reactions. Predictors such as polypharmacy and duration of stay were found to be significant.Conclusion: The study concluded that the prevalence of ADRs in the department of neurology is high. Thus, early detection and management of ADRs are essential to avoid further complications of the reaction.


2019 ◽  
Vol 21 (4) ◽  
pp. 276-282
Author(s):  
Apar Pokharel

Foreign bodies are frequently encountered otorhinolaryngology emergency. The objective of this research paper is to analyze different foreign bodies in terms of type, site, age, and gender distribution and methods of removal. A retrospective study was performed from March, 2018 to March, 2019 in a tertiary care hospital in the central part of Nepal. The information was obtained from hospital record books. A total of 315 patients visited the hospital with a foreign body in either of their ear, nose or throat. It comprised of approximately 12% of all the ENT emergencies in the hospital in the last one year of study. Foreign bodies in ear, nose and throat region were found in all age groups, although it was more prevalent among children of age group less than 10 years.


2021 ◽  
Vol 6 (4) ◽  
pp. 26-41
Author(s):  
Mohsina F.P ◽  
Faheem I.P ◽  
Aquil-ur-Rahim Siddiuque

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.


Author(s):  
S. Sre Akshaya Kalyani ◽  
Pendota Srihitha ◽  
Katnapally Abhinay Sharma ◽  
Porandla Dharanija ◽  
Sandeep Kumar Bheemreddy

Background: An adverse drug reaction (ADRs) is determined as response to a drug that is noxious unintended excludes therapeutic failures, overdose, drug abuse, noncompliance, and medication errors. The main aim of the study is to detect, understand and report ADR’S.Methods: This study is prospective observational study conducted for 6 months in in-patient setting in a tertiary care hospital. Naranjo’s, WHO causality scale, Siegel scale, Schumock and Thornton scale are used to assess ADR. Graph Pad Prism and SAS software’s are used.Results: Data was collected from a total of 1000 patients of which 121 (12.1%) patients were effected with 150 ADRs. Among 121 patients AdrAd was 60.66% and AdrIn was 39.33%. Of 121 patients 97 patients with single ADR, 28 patients with 2 ADRs, 10 patients were with three ADRs. ADR onset divides acute (10%), Latent (39%) and sub-acute (51%). ADR occurred are recovered (54%), Recovering (13%). Naranjos scale interprets definite (0.9%), probable (50.9%), possible (42.97%). According to WHO scale certain (2.7%), unlikely (2.7%), possible (38.84%). Hartwig and Siegel scale results are mild (12.4%), moderate (66.12%) and severe (12.4%). Schumock and Thornton preventability results are definitely (25.45%), probably (68.18%) and not preventable (6.36%).Conclusions: Every health care professional should be aware of the Pharmacovigilance principles and also should be aware of suspected ADR reporting form of PVPI. By applying the above scales it is easy for health care professionals to assess an ADR.


Author(s):  
Sujatha Sowmyanarayan ◽  
Swati Banerjee

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.


2021 ◽  
Vol 9 (12) ◽  
pp. 696-702
Author(s):  
Suhail Mansoor ◽  
◽  
Ghulam Jeelani Romshoo ◽  
Abroo Bashir ◽  
◽  
...  

Background: This study was aimed to evaluate the age and gender related mortality and outcome of covid 19 positive patients in order to further strengthen the management of covid 19 patients as the insights from these data will be useful in determining preventive measures and treatment policies of covid 19 patients. Methodology: This was a retrospective observational study done in adult covid positive patients admitted in Tertiary Care Hospital from first May 2020 to 30 June 2021.The age related mortality and outcome in these patients was analyzed. Results: A total of 816 adult covid -19 positive patients were admitted in a Tertiary care hospital,GMC Anantnag from May 2020 to June 2021. Among the patients, 53.55 % were males and 46.44 % were females. The mean of the age involved was 57.96 years. The most common presenting symptom was fever (85%) followed by cough (70%) and shortness of breath (40%). Approximately 20% of patients presented with nonspecific complaints (including generalized aches, pains, body aches, myalgias etc). All age groups were affected equally (29% in 15-50yr, 37% in 51-65yr, 33% in 66-100yr). Maximum patients (70% ) affected were more than 50 yr of age. About 73.4% were discharged, 6% were reffered, 20% expired. So, overall hospital mortality was 20%. Further, Maximum (86%) of covid positive patients expired in age group of above 50 yrs. Further, Male and Female Mortality was also same in covid positive patients. Conclusion: Males and females were affected equally by Covid -19 disease with no sex predilection.. Fever was the main presenting symptom. All age groups were affected equally but mortality was more in elderly age group. Further, mortality is same in male and female covid positive patients with no gender predilection.


Author(s):  
Hemavathy G. ◽  
Jeyalalitha Rathinam ◽  
Preethi A. ◽  
Divakar R.

Background: Adverse drug reactions (ADRs) have a major impact on public health. Pharmacovigilance has become an integral part of pharmacotherapy. This study has been undertaken to retrospectively analyze the various adverse drug reactions and to promote the reporting of ADRs among the healthcare providers.Methods: A retrospective analysis of the reported ADRs over a period of 3 years at a tertiary care hospital, in Chennai was done. Data related to the number of adverse drug reactions, the demographic particulars, details on the drugs administered, type of ADRs, serious events and prevention strategies undertaken was analyzed. ADRs were assessed for their causality, severity, and preventability as per the standard criteria.Results: A total of 128 suspected ADRs were found to be reported over a period of 3 years. 81.25% ADRs were found to be of mild severity using the Hartwigs scale of assessment, 71.09% were classified as possible using the Naranjo’s causality assessment, the outcome of 63.28% were found to be recovering from the ADR and 41.40 % were under the probably preventable category. The most common ADRs were the skin reactions. The antimicrobial agents were found to have caused the highest number (58.59%) of ADRs followed by NSAIDs (14.84%) and the antihypertensive drugs (14.06%).Conclusions: The antimicrobial agents were associated with ADRs in majority of the patients. The commonly reported ADR s were the skin reactions.


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