Adverse Drug Reactions and its Management Associated with Cancer Chemotherapy

Adverse Drug Reactions () are the problem that adds extra burden in the global scenario. Anticancer drugs can lead to severe negative consequences due to these . This study was conducted to assess the causality, severity and preventability of the identified of chemotherapeutic drugs among hospitalized patients diagnosed with cancer and also to analyze its management. A prospective observational study was conducted among cancer patients for a period of eight months. A total of 120 hospitalized patients who developed at least one ADR due to chemotherapy were included in this study. Data were collected and documented in a well-designed data collection form. A total of 166 were detected in 120 patients. 33(19.8%), was found as the most commonly identified ADR. Patients administered with as were found to be reported with the highest number of (36). According to Naranjo’s scale and WHO causality assessment, 110(66.2%) and 105(63.2%) were found probable. & scale of severity showed that 97(58.4%) were moderate and Modified and Thornton scale revealed that 129(77.7%) were not preventable. The patients prescribed with , , regimen should be strictly and continuously monitored for the symptoms of ADR. Early detection of ADR can decrease morbidity and mortality.

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Adverse drug reactions due to cancer chemotherapy in a tertiary care hospital in south Karnataka: a prospective observational study

International Journal of Basic & Clinical Pharmacology ◽

10.18203/2319-2003.ijbcp20195270 ◽

2019 ◽

Vol 8 (12) ◽

pp. 2635

Author(s):

Sowmya M. S. ◽

Basavanna P. L. ◽

L. Raghavendra Gupta

Keyword(s):

Observational Study ◽

Adverse Drug Reactions ◽

Cancer Chemotherapy ◽

Prospective Observational Study ◽

Adverse Reactions ◽

Tertiary Care ◽

Care Hospital ◽

Chemotherapeutic Drugs ◽

Drug Reactions ◽

Active Monitoring

Background: Cancer is a multi-cellular disease which can arise from any cell type and organs. Adverse drug reactions (ADR) are undesirable consequence of cancer chemotherapeutic drugs. A great importance has to be given for their assessment, detection, monitoring, reporting and preventing these ADR for the beneficial effects of the patients. So the present study was undertaken for the purpose of detecting and quantifying those adverse reactions which is of some importance in therapeutic setting.Methods: A prospective observational study conducted in chemotherapy ward, male and female patients of any age receiving cancer chemotherapy and presenting with ADR’s in duration of 3 months.Results: 160 patients were observed. Out of 160 patients 123 presented with ADR’s. Most common ADR’s were loss of appetite (67.6), diarrhea (61.8%), vomiting (21.5%), nausea (17.7%), anemia (24.7%). Cisplatin, paclitaxel, oxaliplatin, doxorubicin, gefitinib are common drugs causing ADR’s.Conclusions: Cancer chemotherapeutic drugs are associated with various adverse reactions. This study shows the importance of active monitoring of these reactions and measures to prevent their effects early in the treatment of cancer.

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Collection and analysis of adverse drug reactions of antiretroviral therapy in a tertiary care hospital in central India

International Journal of Basic & Clinical Pharmacology ◽

10.18203/2319-2003.ijbcp20182677 ◽

2018 ◽

Vol 7 (7) ◽

pp. 1326

Author(s):

Sandeep Kumar Adwal ◽

B. L. Bamboria ◽

Ashutosh Chourishi ◽

Aditya Bamboria

Keyword(s):

Adverse Drug Reactions ◽

Health Care Professionals ◽

Prospective Observational Study ◽

Causality Assessment ◽

Tertiary Care ◽

Central India ◽

Treatment Interruption ◽

Care Hospital ◽

Drug Reactions ◽

The Common

Background: The main objective of study is to monitor and analyze the adverse drug reactions (ADRs) of ART and to assess causality and severity of the ADRs detected.Methods: It is a prospective observational study conducted in the ART centre of a tertiary care teaching hospital in central India. The data collected were recorded on standard ADR reporting forms. Causality was assessed by Naranjo’s algorithm. Severity of ADR’s was assessed by modified Hartwig and Seigel scale. Modified Shumock and Thorton criteria used for preventability assessment.Results: In twelve months duration 351 patients on ART were observed for ADRs. Total 166 ADRs detected in 96 patients. Incidence of ADRs was slightly more in female. The common systems involved were gastrointestinal 42.77% followed by nervous system 18.07%, musculoskeletal 15.06% skin/mucous membrane 07.83%, metabolic and nutritional 04.82%, red blood cell disorders 01.20 %, endocrinal 00.60 % and others 09.64%. The causality assessment as per Naranjo’s scale showed that out of 166 ADRs, 28.92% were probable and 71.08% were possible. Severity assessment by modified Hartwig and Siegel scale showed that 83.34% ADRs were mild and 15.66% were moderate. 46.39 % ADRs were probably preventable.Conclusions: Considering the magnitude of ADR related problems, there is a need for greater awareness among health care professionals, to detect and report them. These ADRs if recognized in time and managed properly can prevent treatment interruption.

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A COMPARISON OF CAUSALITY ASSESSMENT TOOLS FOR SUSPECTED ADVERSE DRUG REACTIONS IN HOSPITALIZED PATIENTS AT A TERTIARY CARE HOSPITAL

Asian Journal of Pharmaceutical and Clinical Research ◽

10.22159/ajpcr.2020.v13i7.38067 ◽

2020 ◽

pp. 176-181

Author(s):

PARIKH CD ◽

DESAI CK ◽

KAPADIA JD ◽

SHAH MK

Keyword(s):

Adverse Drug Reactions ◽

Causality Assessment ◽

Tertiary Care Hospital ◽

Tertiary Care ◽

Hospitalized Patients ◽

Assessment Tools ◽

Care Hospital ◽

Drug Reactions ◽

Substantial Agreement ◽

Suspected Adverse Drug Reactions

Objective: The objective of the study was to compare six causality assessment (CA) tools for suspected adverse drug reactions (ADRs) reported in hospitalized patients at a tertiary care hospital in India. Methods: Intensive ADR monitoring was performed in indoor patients of two randomly selected medicine units. A detailed case report of each suspected ADR (n=120) was provided to six independent experts for CA using either visual analog scale (VAS) or WHO-UMC scale. Investigator assessed causality using Naranjo’s scale, Koh et al. scale, the French method, and Karch and Lasagna scale. Similar causality categories from these scales were coded for correlation. Agreement among experts and that between various CA tools were analyzed using Cohen’s kappa and Fleiss kappa. Reasons for disagreements among different scales were evaluated. Results: A variation was observed in the total number of drugs suspected to cause ADR by experts and investigator. “Likely” and “Plausible” causality were suggested frequently by experts using VAS whereas “Possible” causal association was frequent according to experts using the WHO-UMC scale and also by the investigator using algorithms except Koh et al. scale. None to the slight agreement was observed among experts who used VAS (k=0.117), whereas a substantial agreement was observed among experts using the WHO-UMC scale (k=0.707). A substantial agreement was observed between Karch and Lasagna scale and the French method (k=0.740). Both scales demonstrated moderate agreement with Naranjo’s scale. Disagreement among the WHO-UMC scale, the French method, and Karch and Lasagna scale were associated with polypharmacy, serious ADRs, non-availability of laboratory data, and skin and subcutaneous tissue ADRs. Conclusion: A higher inter-rater agreement with the WHO-UMC scale suggests its utility for CA of suspected ADRs in indoor patients. The French method and Karch and Lasagna scale can be used for CA in hospitalized patients as an adjunct to Naranjo’s scale. Factors associated with disagreement should be considered at the time of reporting ADRs and evaluating causality.

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Pharmacovigilance in cancer chemotherapy in regional cancer center of Eastern India: prospective observational study

International Journal of Basic & Clinical Pharmacology ◽

10.18203/2319-2003.ijbcp20173148 ◽

2017 ◽

Vol 6 (8) ◽

pp. 1910 ◽

Cited By ~ 1

Author(s):

Anima Rout ◽

Rajendra K. Panda ◽

Vedvyas Mishra ◽

Prasant Parida ◽

Srikant Mohanty

Keyword(s):

Observational Study ◽

Adverse Drug Reactions ◽

Cancer Chemotherapy ◽

Prospective Observational Study ◽

Causality Assessment ◽

Financial Burden ◽

Morbidity And Mortality ◽

Cancer Center ◽

Platinum Compound ◽

Drug Reactions

Background: Globally cancer is the leading cause of morbidity and mortality with annual death rate of 12%. According Indian Council of Medical Research, more than 1300 Indians die every day due to cancer. Chemotherapy is one of the multimodal approaches for treatment of cancer and regimens are much complex and cancer patients are more susceptible to adverse drug reaction with little tolerance due to diminished immunity. The present study was done to evaluate the prevalence of various adverse drug reactions with different cancer chemotherapy regimens, their nature and severity as well as their causality assessment as per WHO scale.Methods: This prospective observational study was conducted from July 2015 to June 2016. Patients receiving cancer chemotherapy from regional cancer centre, Cuttack were observed during the study period for the adverse drug reactions. Those ADRs were analysed for causality assessment, severity and preventability.Results: It was observed that after the initiation of chemotherapy, ADRs were observed in 92 (88.46%) patients. Among these 329 observed ADRs, during the study period, female predominance was observed in the age group 51-60yrs. Most common ADRs observed were nausea and vomiting 57 (17.37%), alopecia 46 (13.98%) and neutropenia 38 (11.55%). ADRs were most commonly seen with the haematological systems (37.68%) followed by gastrointestinal system amounting 25.22% of the total ADRs. Platinum Compound (58.35%), followed by antibiotics, antimetabolites, were the most common group of drugs causing different adverse drug reactions. On causality assessment, as per WHO-UMC criteria 68.38% were probable and 31.62% ADRs were possible. Severity assessment showed majority of the ADRs were moderate 228 (69.31%) followed by mild 67 (20.36%) and severe 34 (10.33%). It was observed that majority 212 (64.45%) of the ADRs were not preventable, 72 (21.88%) were definitely preventable and 45 (13.67%) were probably preventable.Conclusions: Cancer chemotherapy has definitely improved the quality of life, but associated ADRs need early diagnosis, prompt management and routine reporting. Thus, pharmacovigilance will definitely reduce morbidity and mortality, so also the financial burden for the patients and society.

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Analysis of adverse drug reactions in a tertiary care emergency medicine department: prevalence, preventability and reporting

International Journal of Basic & Clinical Pharmacology ◽

10.18203/2319-2003.ijbcp20183490 ◽

2018 ◽

Vol 7 (9) ◽

pp. 1787

Author(s):

Shreya R. Patel ◽

Sapna D. Gupta ◽

Kamlesh P. Patel ◽

Supriya D. Malhotra ◽

Pankaj R. Patel

Keyword(s):

Emergency Medicine ◽

Adverse Drug Reactions ◽

Drug Class ◽

Causality Assessment ◽

Tertiary Care ◽

Negative Consequences ◽

Drug Reactions ◽

Medicine Department ◽

Physician Visits ◽

Emergency Medicine Department

Background: Adverse drug reactions (ADRs) are negative consequences of drug therapy. ADR results in diminished quality of life, increased physician visits, hospitalizations, and even death. Hence a study was planned to detect and analyze ADR encountered in emergency medicine department.Methods: Data was collected over a period of 1 year after taking approval from IRB (Institutional Review Board) and written informed consent from patients. ADRs presenting as a cause of hospital admission or developed during hospitalization were analyzed.Results: A total of 229 ADRs were analyzed. Majority of ADRs were found in the age group of 40-60 Years. The M: F Ratio was 1.10:1. According to Wills and Brown Classification, majority of the ADRs belonged to Type A. According to Hartwig and Siegel classification of severity of ADRs, 18.78% of the ADRs were severe in nature. According to Schumock and Thornton preventability score, majority (64.19%) of the ADRs were not preventable, whereas 17.03% were definitely preventable. 120 (52.40%) of the ADRs were serious in nature Anti-infective were the most common drug class (30.13%) followed by CVS (24.03%) group of drugs. About (57.64%) ADRs fall in the category of probable/likely. Regarding their Outcome, 44.10% of the ADRs were recovered and 43.23% were recovering.Conclusions: Anti-infective were the most reported drug class to cause ADRs in a tertiary care emergency medicine department. Causality assessment according to WHO-UMC and Naranjo’s causality assessment criteria reported to be Probable. Whereas modified Schumock and Thornton scale preventability scale showed that majority were not preventable.

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A study on prospective monitoring of adverse drug reactions associated with hematinics at a tertiary care teaching hospital

Journal of Pharmacovigilance and Drug Research ◽

10.53411/jpadr.2021.2.1.3 ◽

2021 ◽

Vol 2 (1) ◽

pp. 16-21

Author(s):

P. Vinay ◽

P. Venkata Ramana ◽

B. Jaya Kiran ◽

K. Meghana ◽

N. Vineetha

Keyword(s):

Adverse Drug Reactions ◽

Prospective Observational Study ◽

Adverse Reactions ◽

Causality Assessment ◽

Tertiary Care ◽

General Medicine ◽

Care Hospital ◽

Drug Reactions ◽

Organ Systems ◽

Prospective Monitoring

Introduction: Adverse reactions are the documented hazards of drug treatment and they can happen with any class of drugs and several studies exposed that the incidence is increasing with blood and blood products. Objectives: The main aim of this study is to identify and analyze Adverse Drug Reactions with Hematinics in a tertiary care hospital. Methods: This prospective observational study was conducted for a period of 6 months. Results: A total of 29 ADRs were reported during the study period with a female high proportion (79.31%), more amounts of ADRs were from Obstetrics & Gynecology and General Medicine in which the mainly affected organ systems were the skin (86.20%) and the GIT (13.79%). The hematinics mostly accounted were Iron sucrose (44.82%) followed by ferric carboxy maltose (37.93%) and Iron dextran (17.24%) in which type B reactions were more compared to type A and 72.41% of them were unpredictable. The severity assessment revealed that the majority of them were moderate reactions (62.06%). Out of the reported reactions, 58.62% were definitely preventable and a causality assessment was done which showed that 68.96% of the reactions were probable, possible (20.68%) and conditional (10.34%). Most of the patients (65.51%) were treated with Antihistamines & corticosteroids, with only anti-histamines (24.13%) and no treatment (10.34%). Conclusions: The study concludes that Adverse Drug Reactions with Hematinics are increasing in recent days. Better vigilance is necessary for the implementation of safe and effective treatment with hematinics for each and individual patient.

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A study on incidence of adverse drug reactions with commonly prescribed drugs and causality assessment in Silchar Medical College and Hospital

International Journal of Basic & Clinical Pharmacology ◽

10.18203/2319-2003.ijbcp20171673 ◽

2017 ◽

Vol 6 (5) ◽

pp. 1175

Author(s):

Jahirul Islam Laskar ◽

Pinaki Chakravarty ◽

Babul Dewan

Keyword(s):

Adverse Drug Reactions ◽

Health Care Professionals ◽

Prospective Observational Study ◽

Indian Population ◽

Hospital Admissions ◽

Causality Assessment ◽

Drug Reactions ◽

Probability Scale ◽

Medical College ◽

One Year

Background: Present study was carried out to assess the incidence of adverse drug reactions (ADRs) and assessment of causality, severity with reported suspected ADRs.Methods: A prospective observational study was conducted over a period of one year in inpatients and out patients hospitalization due to ADRs, at Silchar Medical College & Hospital, Silchar, Assam. WHO–UMC Probability scale was used for causality assessment. Reported ADRs were classified according to Wills and Brown classification and assessed for severity using scale developed by Hartwig et al. All data were calculated by ‘Descriptive statistics’ analysis as percentage of patient population who encountered ADRs.Results: A total of 192 suspected ADRs were reported and Overall incidence of ADRs during the study period was found to be 0.41% of which 0.22% of ADRs had lead to hospital admissions and 0.19% of ADRs occurred during the hospital stay. Most common drug class associated with ADRs were Antimicrobials [101(52.6%)], which was found to have mostly affected the Skin system followed by NSAIDs [24(13.54%)], Haematinics [21(10.93%)]. Severity of the ADRs were found to be moderate [79(41.14%)], followed by [71 (36.97%)] ADRs which were severe and [42(21.87%)] which were mild.Conclusions: Present study revealed that, more awareness about the importance of Pharmacovigilance have to be provided among the health care professionals by way of ADR bulletins, seminars and workshops. Also, more studies need to be conducted in Indian population to know the exact prevalence of ADRs in Indian hospitals.

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