CLINICAL OUTCOMES AND ADVERSE DRUG REACTIONS IN COVID-19 PATIENTS TREATED WITH HYDROXYCHLOROQUINE AND AZITHROMYCIN ALONE OR COMBINED

Background. Use of Hydroxychloroquine with or without Azithromycin is repurposed in SARS-CoV-2 in the absence of definitive treatment. Objective. To evaluate the association between the use of Hydroxychloroquine and Azithromycin when given alone or in combination on clinical outcomes and adverse drug reactions among lab confirmed SARS CoV-2 positive patients admitted in a COVID tertiary care hospital of a University Medical college. Methods. a retrospective observational comparative study was conducted. COVID-19 positive patients admitted in study hospital for management of COVID-19 were enrolled into the study. The patients were categorized into 4 treatment groups based on having received the following treatment during hospitalization: (A) Hydroxychloroquine with Azithromycin, (B) Hydroxychloroquine without Azithromycin (Hydroxychloroquine alone), (C) Azithromycin alone, and (D) Neither drug, defined as no receipt of either Hydroxychloroquine or Azithromycin in the record; other medications may have been dispensed. Results. 800 patients were enrolled. Mean±Standard deviation of duration of hospital stay (in days) for study Group A was 11.37±7.11, for Group B was 8.37±4.77, for Group C was 18.22 ± 5.69 and for Group D was 6.12±2.97. Mortality in Group A was 29.74%, Group B – 33.16%, Group C – 0% and in Group D – 1.32%. Conclusion. Among hospitalized patients with COVID-19 treatment, Group C was associated with good clinical outcome. However, the interpretation of these findings may be limited by the observational design.

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EFFICACY AND TOLERABILITY OF FLUPIRTINE VERSUS TRAMADOL IN THE TREATMENT OF MODERATE CHRONIC LOW BACK PAIN

Asian Journal of Pharmaceutical and Clinical Research ◽

10.22159/ajpcr.2019.v12i4.31699 ◽

2019 ◽

pp. 84-87

Author(s):

VINEELA KARTHIK NAGURI ◽

RAVI BABU KOMARAM ◽

TAMILISETTI VIDYA SAGAR

Keyword(s):

Low Back Pain ◽

Back Pain ◽

Adverse Drug Reactions ◽

Tertiary Care ◽

Care Hospital ◽

Low Back ◽

Drug Reactions ◽

Study Results ◽

Group A ◽

Group B

Objective: The objective of the study was to assess and compare the efficacy and tolerability of flupirtine versus tramadol in patients with chronic moderate low back pain (LBP). Materials and Methods: A prospective study was conducted in the outpatient department of orthopaedics at tertiary care hospital, Rajamahendravarm. After meeting the inclusion criteria, a total of 60 patients were randomly allocated to tablet flupirtine 100 mg in Group A and tablet tramadol 50 mg in Group B. The efficacy of the study drugs was assessed at baseline and the end of treatment by numerical rating scale11, visual analog scale-100 mm, physician’s, and patient’s global assessment. Statistical analysis was done using paired and unpaired t-test and data were presented as mean±standard deviation. Adverse drug reactions were monitored during the treatment. Results: The study results showed that 90% of the patients in Group A and 78% of the patients in Group B had shown a good response to their respective drugs. 30% of flupirtine group patients reported adverse drug reactions which were mild. Conclusion: Both the drugs are effective in the treatment of moderate chronic LBP, but the advantage of flupirtine was, the incidence of adverse drug reactions was less when compared to tramadol group.

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A prospective observational pharmacovigilance study of adverse drug reaction monitoring in patients of MDR-TB at tertiary care hospital

International Journal of Basic & Clinical Pharmacology ◽

10.18203/2319-2003.ijbcp20182671 ◽

2018 ◽

Vol 7 (7) ◽

pp. 1291

Author(s):

Mirza Shiraz Baig ◽

Monali Raghunath Kale ◽

Avinash Lamb

Keyword(s):

Adverse Drug Reactions ◽

Health Care Professionals ◽

Tertiary Care Hospital ◽

Tertiary Care ◽

Public Health Problem ◽

Treatment Withdrawal ◽

Care Hospital ◽

Drug Reactions ◽

Medical College ◽

Mdr Tb

Background: The emergence of drug resistant mycobacteria has become a significant public health problem world over creating an obstacle to effective TB control. ADRs are common in patients of MDR-TB on DOTs-Plus drug regimen. Present study was carried out in tertiary care hospital. Identification of types and frequency of adverse drug reactions in Intensive and continuation phase of MDR-TB Patients.Methods: It was a prospective observational study conducted in Department of TB- Chest and Medicine, Govt. Medical College, Aurangabad, Maharashtra, India. All the MDR-TB patients admitted at the directly observed treatment, short course plus (DOTS plus) Center at Medical College Hospital were enrolled and were monitored for ADRs. The causality and severity of the reactions were determined using Naranjo algorithm and Hartwig questionnaire, respectively.Results: A total of 121 tuberculosis patients of MDR-TB on DOTS therapy were enrolled for the study. Out of 121 patients, 13 were dropouts, 6 died, 7 defaulted so 108 patients assessed for ADRs, 48 patients developed 61 (56.48%) adverse drug reactions. The higher numbers of ADRs were observed in age group 31-40yrs followed by 21-30yrs which were more common in men. Majority of adverse drug reactions were Gastrointestinal (GI) problems 32 (52.45%), followed by Ototoxicity 7 (11.48%) and Psychiatric Manifestations 6 (9.84%) and skin problems 3 (4.92%). On evaluation of the causality of ADRs, majority were found to be Possible (59.02%). The severity assessment showed that most of the patients ADRs were of moderate level (50.82%).Some patients required treatment withdrawal and replacement with other drug and most of the patients were managed with supportive medication without removing anti-tubercular drug from their treatment regimen.Conclusions: ADRs are major factor limiting completion of drug therapy under RNTCP and occurrence of drug resistance which requires attention of all health care professionals.

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An observational study of adverse drug reactions reported in a rural tertiary care hospital

International Journal of Basic & Clinical Pharmacology ◽

10.18203/2319-2003.ijbcp20194638 ◽

2019 ◽

Vol 8 (11) ◽

pp. 2367

Author(s):

Ravi D. Mala ◽

D. M. Ravichand ◽

B. V. Patil ◽

B. S. Payghan ◽

Anurag Yadav

Keyword(s):

Adverse Drug Reactions ◽

Antimicrobial Agents ◽

Tertiary Care ◽

Cross Sectional Study ◽

Care Hospital ◽

Unintended Effects ◽

Drug Reactions ◽

Cross Sectional ◽

Physician Visits ◽

Medical College

Background: Adverse drug reactions (ADRs) are noxious and unintended effects of a drug that occurs at doses normally used in humans. ADRs may also result in diminished quality of life, increased physician visits, hospitalizations, and even death. The objectives of this study are to analyze and assess the causality and severity of reported ADRs.Methods: A cross sectional study of ADRs reported to Pharmacovigilance cell of MNR Medical College and Hospital Sangareddy in a year. The details of the various ADRs were statistically analyzed to find out pattern of ADRs. The WHO-UMC causality category and Hartwig-Seigel Scale were used to assess causality and severity of ADRs respectively.Results: The study shows, out of 60 suspected ADRs, the majority of ADRs were adults (68.3%) and out of whom 56% were females. According to the WHO-UMC Causality categories, 43.3% of the ADRs were categorized under Probable/likely, followed by possible (35%). The Hartwig-Siegel severity assessment scale shows that the majority (90%) of suspected ADRs were of mild category.Conclusions: The pattern of ADRs reported in our study is comparable to other studies. The commonest organ system affected was gastrointestinal tract, nervous and cutaneous system. Antimicrobial agents were causing maximum ADRs and medicine and allied departments have more number of ADRs. This study provides a valuable database for ADRs due to all commonly used drugs at hospitals and also helps in creating awareness regarding safe & judicious use of drugs to prevent ADRs.

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Pharmacovigilance study in geriatric patients of a tertiary care hospital

Journal of Pharmacovigilance and Drug Research ◽

10.53411/jpadr.2021.2.2.7 ◽

2021 ◽

Vol 2 (2) ◽

pp. 33-38

Author(s):

Rajalakshmi Rukmangathen ◽

Vasundara Devi Brahmanapalli

Keyword(s):

Adverse Drug Reactions ◽

Geriatric Patients ◽

Causality Assessment ◽

Tertiary Care Hospital ◽

Tertiary Care ◽

Care Hospital ◽

Drug Reactions ◽

Adverse Drug Reaction Monitoring ◽

Medical College ◽

Organ Systems

Introduction: The aim was to assess, categorize and analyze the adverse drug reactions among geriatric patients in a tertiary care hospital. Methods: All adverse drug reactions of geriatric patients reported at the Adverse Drug Reaction Monitoring Center, Sri Venkateswara Medical College, Tirupati, under the Pharmacovigilance programme of India, during September 2016 and January 2018 were identified and evaluated. A retrospective analysis was carried out for ADR pattern, drug groups, organ systems implicated in suspect ADR, demographic profile, causality (as per the WHO–UMC scale), severity (Hartwig and Seigel scale), and preventability (Schumock and Thornton criteria) of a said drug. Results: A total of 120 ADRs were received among geriatric patients. Most of the ADRs occurred in male geriatrics (55.83 %) and (34.2 %) occurred in the age group of 60- 64 years. Antibiotics comprised the major group of drugs causing ADRs (18.3 %). ADRs related to gastrointestinal systems were most common with 31.7 % followed by skin disorders (15 %) and central nervous system disorders (13.3 %). As per the causality assessment scale, the majority of adverse drug reactions were found to be possible (51.7 %). Conclusions: There were 60.8 % of reactions being mild and 39.2 % were moderate reactions as per severity scale. The majority of the adverse drug reactions were non-serious (33 %) and in the serious category, 27.5 % of ADRs required intervention to prevent permanent damage.

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A PROSPECTIVE STUDY OF ADVERSE DRUG REACTIONS DUE TO PLATINUM ANALOGS - CHEMOTHERAPY IN A TERTIARY CARE HOSPITAL

Asian Journal of Pharmaceutical and Clinical Research ◽

10.22159/ajpcr.2018.v11i6.24849 ◽

2018 ◽

Vol 11 (6) ◽

pp. 215

Author(s):

Sumit Kumar ◽

Badruddeen Badruddeen ◽

Singh S P ◽

Mohammad Irfan Khan

Keyword(s):

Adverse Drug Reactions ◽

Tertiary Care Hospital ◽

Tertiary Care ◽

World Health ◽

Care Hospital ◽

Drug Reactions ◽

Medical College ◽

Health Organization ◽

A Prospective Study ◽

Platinum Analogs

Objective: The objective of this study was to analyze the types of adverse drug reactions (ADRs) associated with platinum analogs (cisplatin, carboplatin and oxaliplatin) used for cancer chemotherapy in a tertiary care hospital and determine their causal relationship with the offending drug.Methods: This prospective, observational, non-interventional study was conducted in a tertiary care hospital at GSVM Medical College Kanpur, India, for 4 months. Patients of all age and either sex were included in the study. ADRs were reported by the physicians of oncology department of the hospital and ADRs were assessed for different parameters -causality, outcome, and seriousness of ADR as per the World Health Organization (WHO), type of ADRs as per expanded Rawlins and Thompson’s classification, predictability using council for international organization of medical sciences guidelines and severity using modified Hartwig’s scale. Descriptive statistics were used for data analysis.Results: A total of 140 ADRs were reported from platinum analogs following treatment of different types of cancer in hospital. The burden of ADRs in each patient was 2.41. Most of the ADRs were observed in the age group of 40–60 years. Vomiting (27 ADRs) was commonly reported reaction. Among platinum analogs, cisplatin leads to 82 ADRs (58.57%) followed by carboplatin with 53 ADRs (37.86%) and least with oxaliplatin 5 ADRs (3.57%). Most of the ADRs on causality assessment were possible (104, 74.29%) and probable (36, 25.71%) in nature. Type -A ADRs account for 4/5th of the total reported ADRs, followed by Type-B and C. Severity of 90.71% ADRs was found to be mild followed by moderate, with no case of severe and serious nature. Nearly, most of the ADRs were of predictable type (97.14%).Conclusion: The potential of platinum analogs to cause ADRs is high; thus, the need of effective ADRs monitoring is highly emphasized.

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A STUDY ON CUTANEOUS ADVERSE DRUG REACTIONS REPORTED IN A TERTIARY CARE HOSPITAL, KANCHIPURAM

Asian Journal of Pharmaceutical and Clinical Research ◽

10.22159/ajpcr.2020.v13i1.36090 ◽

2019 ◽

pp. 74-76

Author(s):

NITHYA PANNEERSELVAM ◽

PARIMALA KADHIRVELU ◽

REVATHI SOMASUNDARAM ◽

SOUNDARRAJAN JAYAPRAKASH

Keyword(s):

Adverse Drug Reactions ◽

Therapeutic Agent ◽

Tertiary Care ◽

Care Hospital ◽

Drug Reactions ◽

Inclusion Criteria ◽

College Hospital ◽

Cutaneous Manifestations ◽

Medical College ◽

Inflammatory Drugs

Objective: The objective of the study was to study the pattern of various types of cutaneous adverse drug reactions (CADRs) and its relation to therapeutic agents. Methods: A retrospective study was carried out in the Department of Pharmacology, Meenakshi Medical College Hospital and Research Institute. Pharmacovigilance reports collected from 2017 to 2019 which were probable and certain by the WHO causality assessment were included in the study. Descriptive statistics were used. Values were expressed in numbers and percentage. Results: Adverse drug reactions (ADRs) of 40 patients were selected based on the inclusion criteria, of which 22 were female (55%) and 18 males (45%). Patients aged <50 years had more incidence (77.5%) of ADRs. Cutaneous manifestations contributed to major ADRs (67.5%). CADRs were more common with antibiotics (55.5%) followed by nonsteroidal anti-inflammatory drugs (14.6%). Conclusion: The most common therapeutic agent of CADRs were antibiotics (fluoroquinolones and cephalosporins) and the frequent cutaneous manifestation was urticaria.

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Role of tamsulosin in the management of lower ureteric stone at tertiary care hospital in Western Rajasthan, India

International Surgery Journal ◽

10.18203/2349-2902.isj20171628 ◽

2017 ◽

Vol 4 (5) ◽

pp. 1721

Author(s):

Parikshit Singh Chandawat ◽

Ashok Kumar ◽

Mahendra Kumar ◽

Lalit Kumar ◽

Sunder Kishore ◽

...

Keyword(s):

Tertiary Care ◽

Care Hospital ◽

Ureteric Stone ◽

Expulsion Rate ◽

Medical College ◽

Experienced Pain ◽

Group A ◽

Extracorporeal Lithotripsy ◽

Group B

Background: Many minimally invasive interventional techniques as well as expectant treatments exist for the management of lower ureteric calculi.Methods: 100 patients [group A (50 patients) patients given capsule tamsulosin 0.4mg, 1 daily up to 4 weeks while group B (50 patients) patients given regularly practiced treatment without Tamsulosin] with distal ureteric stone included in the study. Study duration was 6 months and study performed at S.P. Medical College. Bikaner, Rajasthan, India.Results: Group A showed a statistically significant advantage in terms of the stone expulsion rate. 41 patients (82%) in group A and 30 patients (60%) in group B expelled stones. Overall patients in group A had mean expulsion time of 7.86 days, whereas in group B mean expulsion time was 18.64 days. In group A stone expulsion rate was higher as compared to group B. In group A only 12 (24%) patients experienced pain relapses whereas in group B 32 (64%) patients reported pain relapses. The diclofenac dosage required in group A was observed to be 1.62 tablets whereas in group B it was 2.6 tablets.Conclusions: It is concluded that tamsulosin should be considered for uncomplicated distal ureteral calculi before ureteroscopy or extracorporeal lithotripsy. Tamsulosin has been found to increase and hasten stone expulsion rates, decrease acute attacks by acting as a spasmolytic, reduces mean days to stone expulsion and decreases analgesic dose usage.

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A pattern of serious adverse drug reactions reported in a tertiary care hospital, Rangaraya Medical College, Kakinada, Andhra Pradesh

International Journal of Basic & Clinical Pharmacology ◽

10.18203/2319-2003.ijbcp20201178 ◽

2020 ◽

Vol 9 (4) ◽

pp. 566

Author(s):

Sweta Bindu Mendu ◽

K. V. Siva Prasad

Keyword(s):

Adverse Drug Reactions ◽

Andhra Pradesh ◽

Tertiary Care Hospital ◽

Tertiary Care ◽

Kidney Injury ◽

Close Monitoring ◽

Care Hospital ◽

Social Inhibition ◽

Drug Reactions ◽

Medical College

Background: Serious adverse drug reactions (ADRs) constitute a major limitation in clinical development of a drug thus necessitating close monitoring. Studies regarding the pattern of serious ADRs are limited in southern India. The present study was conducted in tertiary care hospital in Andhra Pradesh with an objective to evaluate the pattern of severe cutaneous and non-cutaneous ADRs in our hospital and to assess the causality, severity, and preventability of these reactions.Methods: A retrospective observational study was conducted over two years, from January 2016 till January 2018 in our ADR monitoring center. The pattern of serious adverse drug reactions, the nature of ADR, suspected drug, the outcome and preventability were analyzed using Modified Hartwig and Siegel scale, and modified Schumock and Thorton scale.Results: Out of 734 ADRs reported, 42 were serious, while 692 were non-serious. Out of 42, 22 were dermatological in origin while the others were acute kidney injury, acute psychosis, febrile neutropenia, gynecomastia, and lipodystrophy. According to WHO causality assessment scale, 27 were probable while 15 were possible. The majority were reported in the age group of 16 to 65 years with female (34) preponderance. The most common drug category responsible was antimicrobials, followed by antiretrovirals, anti-epileptics, and analgesics.Conclusions: Antimicrobial, anti-epileptics, and analgesics contributed to serious ADRs. Although non-cutaneous ADRs did not result in hospitalization, they caused social inhibition and mental stress in the patient.

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Pattern of adverse drug reactions occurring at department of neurology of a tertiary care hospital in India

International Journal of Basic & Clinical Pharmacology ◽

10.18203/2319-2003.ijbcp20201756 ◽

2020 ◽

Vol 9 (5) ◽

pp. 772

Author(s):

Virendra Kushwaha ◽

Pooja Agrawal ◽

Ruchi Srivastava ◽

Alok Verma

Keyword(s):

Adverse Drug Reactions ◽

Joint Pain ◽

Prospective Observational Study ◽

Tertiary Care Hospital ◽

Tertiary Care ◽

Relevant Information ◽

Care Hospital ◽

Drug Reactions ◽

Medical College ◽

Antiparkinsonian Drugs

Background: The objective of the study was to study the pattern and trends of adverse effects of drugs used in department of neurology in a tertiary care hospital.Methods: A prospective, observational study was carried out for a duration of 12 months from November 2018 to October 2019 at Department of Neurology and Department of Pharmacology and Therapeutics, G.S.V.M. Medical College, Kanpur after getting an approval from institutional ethical committee. Data was collected by analyzing OPD prescription slip, treatment charts and investigation reports. All relevant information regarding adverse drug reactions (ADRs) were collected as per norms of Indian Pharmacopoeia commission (IPC).Results: During the study period, a total of 130 ADRs reported. Most of the ADRs were reported due to antiepileptic drugs followed by antiparkinsonian drugs. Dizziness was the most frequent ADR reported. Most of the ADRs were reported due to phenytoin. Other ADRs observed were drowsiness, nausea/vomiting, weakness, joint pain, dyskinesia.Conclusions: Most of the ADRs were due to anti-epileptic drugs. Most of the reactions were of mild severity.

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