Surveillance of adverse drug reactions at an adverse drug reaction monitoring centre in Central India: a 7-year surveillance study

Sharma, Megha; Baghel, Ruchi; Thakur, Sunil; Adwal, Sandeep Kumar

doi:10.1136/bmjopen-2021-052737

Cited by 14 publications

(7 citation statements)

References 30 publications

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“…About 69.65% of the ADRs were Type B (69.649%), and one was Type F (telmisartan, aldactone), Type C (Amlodipine induced gingival hypertrophy) each. These findings were consistent with other studies that reported an increased incidence of Type B cutaneous manifestations 21,22 .…”

Section: Fig 6: Duration Involved For Recovery From the Adrsupporting

confidence: 93%

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2022

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Background: Adverse drug reaction (ADR) evaluation and monitoring is key for safe medication use. This study aimed to initiate, enhance reporting and support the Pharmacovigilance program of India. Methodology: This prospective observational study on the evaluation of adverse drug reactions was carried out for 6 months with the approval of ethics committee. Using standard tools, data was collected in the Standard suspected ADR reporting form and assessed for causality, severity, and preventability. Complete data were collected until the discharge of the patient. Results: A total of 31 cases were recorded with 33 ADRs. The incidence of ADRs was predominant among the elderly (38.7%). ADRs were more prevalent in females (54.83%) than males. Hypertension was the commonly observed co-morbidity among the patients enrolled in the study. The most common suspected drug class was antibiotics (48.48%) followed by anti-hypertensive agents (12.12%). Type B adverse reactions were predominant (69.69%) with a higher incidence of cutaneous manifestations (51.61%). On Causality assessment using the WHO-UMC scale, the majority of the ADRs were Probable (83.87 %) and 6.45% were possible. Most of the ADRs were moderate (87.09%) in severity (Hartwig's scale), and the majority of ADRs were not Preventable (96.77%). Conclusion: This study provides a database of ADRs, which will help the healthcare professionals for optimum and safe use of the drugs. INTRODUCTION:The World Health Organization (WHO) defines pharmacovigilance (PV) as the science and activities relating to detecting, understanding, and prevention of adverse effects or any other drug-related problems 1 . Medication safety monitoring is an essential element of healthcare system for high quality medical care.

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Section: Fig 6: Duration Involved For Recovery From the Adrsupporting

confidence: 93%

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2022

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“…In our study, the majority of adverse drug reactions (ADRs) were classified as Type A according to Rawlins and Thompson's classification, consistent with the established observation that approximately 80% of ADRs fall into this category, while the remaining 20% are categorized as Type B 23 . This finding is further substantiated by two additional studies 24,25 . Causality assessment using Naranjo's Algorithm 11 indicated that probable ADRs accounted for 56.36% of cases, similar to the findings of some another literature studies 24 .…”

Section: Resultssupporting

confidence: 55%

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2024

IJPSR

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The advancement of drug therapy has undoubtedly elevated patient care standards. However, it has also led to an increase in Drug-Related Problems (DRPs), which can have a significant impact on health outcomes. In an 18-month prospective observational study involving 2,000 patients, we meticulously assessed DRPs using the Hepler and Strand classification system. These DRPs encompassed a range of issues, including adverse drug reactions (ADRs), untreated medical indications, non-compliance with prescribed regimens, improper drug selection, and more. Our data collection adhered to a well-validated and pre-tested format. Among 2,000 patients, 106 (5.3%) experienced 117 DRPs, averaging 1.1 per patient. Adverse drug reactions (ADRs) accounted for 47.01% of cases, non-compliance 35.89%, and drug use without indication 11.32%. ADR incidence was 2.75%, primarily affecting the Gastrointestinal (GIT) system. Antibiotics were frequently associated with ADRs in various drug classes. Vigilant monitoring, robust reporting mechanisms, and patient education are pivotal strategies in the prevention of drugrelated issues. Pharmacovigilance, the systematic monitoring and evaluation of drug safety and efficacy, plays a fundamental role in ensuring the delivery of high-quality healthcare. Through the effective implementation of robust pharmacovigilance practices, we can successfully diminish the occurrence of DRPs, leading to safer and more efficacious outcomes in drug treatment.

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“…Antimicrobials drew attention as the class most involved in suspicions (29%). Among the relevant AEs found, "multidrug resistance" was related to ceftriaxone/tazobactam (n = 15; 0.76%; the Not Recommended category) and amikacin (n = 9; 0.45%; Access) [112].…”

Section: Pv As a Tool To Identify The Ineffectiveness Of Antibioticsmentioning

confidence: 99%

Pharmacovigilance Strategies to Address Resistance to Antibiotics and Inappropriate Use—A Narrative Review

Sandes,

Figueras,

Lima

2024

Antibiotics

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The spread of antimicrobial resistance (AMR) is a global challenge. Close and continuous surveillance for quick detection of AMR can be difficult, especially in remote places. This narrative review focuses on the contributions of pharmacovigilance (PV) as an auxiliary tool for identifying and monitoring the ineffectiveness, resistance, and inappropriate use of antibiotics (ABs). The terms “drug ineffective”, “therapeutic failure”, “drug resistance”, “pathogen resistance”, and “multidrug resistance” were found in PV databases and dictionaries, denoting ineffectiveness. These terms cover a range of problems that should be better investigated because they are useful in warning about possible causes of AMR. “Medication errors”, especially those related to dose and indication, and “Off-label use” are highlighted in the literature, suggesting inappropriate use of ABs. Hence, the included studies show that the terms of interest related to AMR and use are not only present but frequent in PV surveillance programs. This review illustrates the feasibility of using PV as a complementary tool for antimicrobial stewardship activities, especially in scenarios where other resources are scarce.

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Surveillance of adverse drug reactions at an adverse drug reaction monitoring centre in Central India: a 7-year surveillance study

Cited by 14 publications

References 30 publications

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Pharmacovigilance Strategies to Address Resistance to Antibiotics and Inappropriate Use—A Narrative Review

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