A Study of Adverse Drug Reactions in Paediatric Age Group with Assessment of Causality, Severity and Preventabilty in a Tertiary Care Hospital

Verma, Reena; Verma, Jyotsna; Verma, Nitin; Sharma, Parag; Rai, Nitesh

doi:10.9790/0853-13554248

Cited by 3 publications

(1 citation statement)

References 29 publications

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“…However, unfavourable side effects from medications have often been linked to non-compliance, which results in therapeutic failure, additionally, a longer hospital stay and higher medical expenses. 13 Drugs used to treat diabetes are not an exception. Early detection of these ADRs and knowledge of their type and severity enable effective therapy.…”

Section: Discussionmentioning

confidence: 99%

Analysis of Adverse Drug Reactions in Patients with Diabetes Mellitus at Private clinics in Hyderabad, Pakistan

Ayub¹,

Solangi²,

Arain³

2023

PJMHS

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Background: Diabetes is characterized by hyperglycemia, a metabolic disorder resulting from defects in insulin secretion, action, or both. The traditional treatment choices available for diabetes include medications that are oral hypoglycemic agents and insulin. Due to the introduction of several medications during the past 20 years, the identification of adverse drug reactions has gained importance. Aim: The aim of this study was to evaluate the adverse drug reactions among diabetic patients and patients’ variables that were linked to the adverse drug reactions. Study Design: Cross-sectional study Place and Duration of Study: This research was done at private clinics in Hyderabad, Pakistan, from August 2021 to January 2022. Methodology: Three hundred and seventy seven participants and the data regarding baseline characteristics of participants, adverse drug reactions reported were analyzed together with the assessment of causality and severity of unwanted reactions. Results: Two hundred and forty one (63.9%) were males and 136 (36.1%) were females. Only 19 (5%) reported adverse drugs reactions. Hypoglycemia was the most commonly reported adverse drug reaction i.e.11 ((57.9%). On causality assessment, most of the adverse drug reactions fell under the category of probable adverse drug reaction i.e.15 (78.9%). Four (21.1%) of them had the doubtful relation with the medications. The majority of the adverse drug reactions that were reported by the participants were found to be moderately severe 13 (68.4%), when analyzed through severity assessment scale. Six (31.6%) were belonged to mildly severe category. Conclusion: The upper age group, male gender, and diabetes duration of more than 5 years were associated with a higher incidence of adverse drug reactions. This study gave in depth analysis of adverse drugs reactions reported in the patients of diabetes mellitus together with the nature of adverse drug reactions reported. A better patient outcome would result from the clinical pharmacist's active participation in adverse drug resistance. Keywords: Adverse drug resistance (ADR), Diabetes mellitus, Hypoglycemia, Severity

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Section: Discussionmentioning

confidence: 99%

Analysis of Adverse Drug Reactions in Patients with Diabetes Mellitus at Private clinics in Hyderabad, Pakistan

Ayub¹,

Solangi²,

Arain³

2023

PJMHS

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Pattern, severity, and preventability of adverse drug reactions from a Northern Indian tertiary care facility: A retrospective analysis

Lhamo,

Purohit,

Singh

et al. 2024

International Journal of Risk & Safety in Medicine

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Background Over the years, it has been observed that adverse drug reaction (ADR) is a major cause of mortality and morbidity and a major cause of concern for all healthcare professionals. ADR is a leading cause for hospitalisation and increases the financial burden of the patient. Thus, it is imperative that we need steps and strategies to decrease the burden of ADRs and effectively reduce the cost of therapy to treat ADR. Objective This study evaluated the pattern, severity, and preventability of ADRs in a tertiary care hospital. Methods A retrospective observational study of all the ADR reports due to medications submitted to the ADR monitoring centre in a Northern Indian tertiary care hospital from October 2017 to December 2019. Causality assessment of the ADRs was done using the WHO-UMC causality assessment scale, and the severity was assessed using the modified Hartwig scale. Furthermore, the preventability of the ADR was assessed using the Schumock and Thornton scale. Results A total of 252 ADRs were reported. A maximum number of the ADRs (33%) were due to antimicrobials followed by analgesics (16%) and antihypertensives (10%). Amongst the analgesics, a majority of ADRs were associated with Diclofenac (16 ADRs). Amlodipine was associated with maximum ADRs (10) amongst the antihypertensives. The ADRs of gastrointestinal systems (34.5%) were most common among all system organ class (SOCs) followed by skin and subcutaneous tissue disorders (32%). Majority of ADRs were probable and mild in severity. According to the Schumock and Thornton preventability scale 69% were not preventable while 12% were definitely preventable. Conclusions Antimicrobials were associated with majority of ADRs with gastrointestinal system being the most commonest organ involved. It was also observed that most of the ADRs were not preventable but some were definitely preventable. The awareness regarding preventability of ADRs needs to be emphasised and further studies to elaborate on the preventability of ADRs needs to be carried out.

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Preventability, predictability, severity and causality assessment of adverse drug reactions reported from a teaching hospital in chhattisgarh

Keche

Gaikwad

Dhaneria

2021

Journal of Family Medicine and Primary Care

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Background and Objectives: Adverse Drug Reactions (ADRs) can lead to significant morbidity, rarely mortality and financial burden over the patient. ADRs that can be prevented can be considered as form of medication error sometimes. This study assessed the preventability, predictability and severity of ADRs using different assessment scales. Methods: ADR Monitoring Centre under newly established teaching hospital in Chhattisgarh collected ADR reports from different healthcare professionals during the period from November 2016 to November 2018. Analysis of the reported ADRs was done for their causality assessment, demographic details of patients, most common drug class responsible for the ADR. Seriousness and preventability of ADRs were analysed by using WHO Causality Scale and Modified Schumock and Thornton Scale respectively. Severity of ADRs was assessed by Modified Hartwig and Siegel Scale. Results: Totally 288 ADRs were reported in a 2-year period. 92.01% ADRs were non serious. 44.8% were mild, 53.81% moderate and 1.39% were severe ADRs. Causality assessment showed: 5.21% certain, 54.86% probable, 39.24% possible and 0.69% unlikely ADRs. Around 26% ADRs were definitely and probably preventable and 27.78% ADRs were predictable. The highest number (32.29%) of ADRs were reported to antimicrobials. 11.15% ADRs were reported to NSAIDs, in that 37.5% ADRs were due to NSAIDs combination. Conclusion: Many ADRs in this study are non-serious, preventable and predictable. Management of such ADRs through therapeutic interventions would be beneficial in a better patient outcome. Multidisciplinary strategies involving physicians, pharmacists, other healthcare professionals and patient education and awareness about ADRs are needed for prevention of ADRs.

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A Study of Adverse Drug Reactions in Paediatric Age Group with Assessment of Causality, Severity and Preventabilty in a Tertiary Care Hospital

Cited by 3 publications

References 29 publications

Analysis of Adverse Drug Reactions in Patients with Diabetes Mellitus at Private clinics in Hyderabad, Pakistan

Analysis of Adverse Drug Reactions in Patients with Diabetes Mellitus at Private clinics in Hyderabad, Pakistan

Pattern, severity, and preventability of adverse drug reactions from a Northern Indian tertiary care facility: A retrospective analysis

Preventability, predictability, severity and causality assessment of adverse drug reactions reported from a teaching hospital in chhattisgarh

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