Evaluation on Safety of Non-steroidal Anti-inflammatory Drugs in a Tertiary Care Hospital in India: A Prospective Observational Study | Chapter 5 | Pharmaceutical Research - Recent Advances and Trends Vol. 4

 

Background: The nonsteroidal anti-inflammatory drugs (NSAIDs) are among the most frequently used drugs to treat pain and inflammation. NSAIDs constitute the largest single group of drugs used worldwide, constituting more than 20% of all drug prescriptions. Although NSAIDs have enormous clinical use, but are not devoid of adverse drug reactions (ADRs) such as peptic ulcer, gastritis, renal, neurological reactions, etc. Therefore, this pilot study is intended to assess the incidence and pattern of ADRs of NSAIDs in a tertiary care teaching hospital.

 

Methods: This is a prospective observational study, which was executed in the department of Orthopaedics with association of the department of Pharmacology, SIMS Medical College, Hapur, UP, India. A total of 600 Orthopaedic outpatients were enrolled in the study to observe the risk of ADRs due to NSAIDs. All the ADRs were further analysed in relation to age, sex, types of drug and its pattern, etc. The causality was analysed by using Naranjo’s Algorithm and severity was analysed by using the Hartwing and Siegel scale.

 

Results: Out of the 600 patients with NSAID therapy, 35 patients (5.83%) experienced a total of 10 types of ADRs. The adverse drug reactions observed by the patients were gastric symptoms, headache, urticaria, oedema etc. The most frequently observed ADR was gastritis. Out of 35 patients who had ADRs, 62.86% were male and 37.14% were female. The study found that Gender and age did not show any statistical significance in relation to the occurrence of adverse drug reactions due to prescribed NSAIDs. Among all the prescribed drugs, Tab Diclofenac sodium accounted for 57.14% and Paracetamol for 11.42% of all the ADRs. According to Naranjo’s Algorithm, 62.87% of ADRs were possible’ and 37.14% were of probable type and ADRs were mostly mild in severity.

 

Conclusion: In this study, the incidence of adverse reactions to nonsteroidal anti-inflammatory drugs was 5.83 and the most commonly implicated drug for the ADRs was Diclofenac sodium. Most of the adverse effects were mild and tolerable.

 

 

Author(s) Details

Saborni Dey
Department of Pharmacology, Saraswathi Institute of Medical Sciences, Hapur, Uttar Pradesh, India.

Harsh Kumar
Department of Orthopedics, Saraswathi Institute of Medical Sciences, Hapur, Uttar Pradesh, India.

Anand Kumar Shukla
Department of Pharmacology, Saraswathi Institute of Medical Sciences, Hapur, Uttar Pradesh, India

Please see the book here:- https://doi.org/10.9734/bpi/prrat/v4/1120

 

Pharmacovigilance Practice in AYUSH Drugs: Present Status and Future Prospective | Chapter 9 | Advanced Concepts in Pharmaceutical Research Vol. 4

 This division focuses on requirement of Pharmacovigilance in AYUSH Drugs. Because centuries Ayurveda and other established systems of cure are practised in this continent. They are believed as the safest healing systems. However accompanying the scientific philosophy everything is rejected or sanctioned in the light of available dispassionate data only. Hence, to form pharmacovigilance, program for AYUSH drugs become essential for bestowing them credibility. Feature of the ASU drugs may be restricted by poor quality raw material, plant readinesses and not prepared following distinguishing procedures. Good administering practices ensure that an effective form of the correct cure is delivered to the right patient, in the correct portion of drug or other consumable and quantity, with clear commands, and in a package that asserts the potency of the medicine. Dispassionate use should be contingent adopting Good Clinical Practice of ASU system to prevent the Adverse drug Responses. Cooperation and sharing of news among the accompanying drug regulating agencies concede possibility also progress in business.

Author(s) Details:

M. G. Rajanandh,
Department of Pharmacy Practice, SRM College of Pharmacy, SRM Institute of Science and Technology, Kattankulathur, Tamil Nadu 603203, India.

D. Chamundeeswari,
Meenakshi Faculty of Pharmacy, Meenakshi Academy of Higher Education and Research (DU), Chennai 602 105, India.

Please see the link here: https://stm.bookpi.org/ACPR-V4/article/view/13004

Monitoring and Reporting Adverse Drug Reactions (ADRs) and Their Significance in Healthcare | Chapter 8 | Advanced Concepts in Pharmaceutical Research Vol. 3

 Listening and reporting Adverse Drug Backlashes (ADRs) is crucial for patient safety, supervisory compliance, and advancing pharmacovigilance. It helps identify and control medication-related risks, guaranteeing safe and effective drug use. Hospital-based following in healthcare settings involves differing reporting channels, including Electronic Strength Records, Incident Reporting Methods, and Pharmacy Surveillance, accompanying healthcare professionals playing a main role. Collaboration between healthcare stakeholders is essential to protect inmates, improve healthcare quality, and assert public trust. Addressing ADRs is both a professional assignment and a moral imperative, resulting in more reliable and more efficient healthcare for individuals and institution.

Author(s) Details:

Rajesh Hadia,
Department of Pharmacy, Sumandeep Vidyapeeth (Deemed to be University), Vadodara-391760, Gujarat, India.

Cyril Sajan,
Department of Pharmacy, Sumandeep Vidyapeeth (Deemed to be University), Vadodara-391760, Gujarat, India.

Hemraj Singh Rajput,
Department of Pharmacy, Sumandeep Vidyapeeth (Deemed to be University), Vadodara-391760, Gujarat, India.

Rahul Trivedi ,
Department of Pharmacy, Sumandeep Vidyapeeth (Deemed to be University), Vadodara-391760, Gujarat, India.

Sunil Bhaurao Baile,
Department of Pharmacy, Sumandeep Vidyapeeth (Deemed to be University), Vadodara-391760, Gujarat, India.

Sunilkumar Laxmidas Kardani,
Department of Pharmacy, Sumandeep Vidyapeeth (Deemed to be University), Vadodara-391760, Gujarat, India.

Varunsingh Saggu,
Department of Pharmacy, Sumandeep Vidyapeeth (Deemed to be University), Vadodara-391760, Gujarat, India.

Please see the link here: https://stm.bookpi.org/ACPR-V3/article/view/12701

A Novel Rapid IL-6 Release Assay Using Blood Mononuclear Cells in the Differential Diagnostics of Patients after Skin Localized Hypersensitivity Reactions to Drugs | Chapter 10 | Perspective of Recent Advances in Medical Research Vol. 10

 Interleukin-6 (IL-6) has a main role in the musical arrangement of immune response. It is showed to have a key role in the change from innate to adjusting immune reaction. It has two together pro and antagonistic-inflammatory features. Normal values in antitoxin are below 7 pg/ml. Its effects are mostly dependent on the demeanor of its receptor (IL-6R) that is bound either on the cell surface or exists in free dissolved form (sIL-6R). The binding of a small microscopic weight fragment (i.e a drug) to its receptor and to HLA fragments on T-memory containers does not involve certainly hapten presentation but can proceed very immediately by pharmacologic interaction (p-i) mobilizing immune means (Pichler). This in turn can mobilize pro-inflammatory means and start through the IL-6 release a response order both artificial and in vivo. Our aim was to measure secreted IL-6 from the mononuclear containers’ supernatants after 20 proceedings incubation in a big cohort of patients following in position or time both of early and late skin sensitivity (HS) reactions to differing common drugs (43) arising from the record and compare the results accompanying those of an appropriate control group and validate bureaucracy by in vivo tests. Together 213 patients accompanying the history of adverse belongings to drugs and 48 control subjects were complicated. The majority of cases (159) and all the controls’ mononuclear cells were divided and after readiness with a standard order of 0.15-0.5 µmol solutions of various drugs for 20’ in addition to negative and positive controls, IL-6 announced into the cell free supernatants was calculated by ELISA assay. The tests were correlated to the former diagnostic method expanded to measure nuclear rearrangements afterwards similarly short development with drugs named chromatin incitement test. The exact conditions unavoidable for reproducible and clinically relevant results were settled by comparing two groups of similar dispassionate phenotype composition. The form offering extreme sensitivity was selected out.   Sensitivity of 85.4% and particularity of 82.4% of the IL-6 release assay was found against the in vivo tests. In the microscopic mass range of 76-4000 Da, IL-6 release was helpless on the clinical phenotype but gone the evoking drug(s). Reactivity of mononuclear cells at rude or at multiple drug test concentrations mirrored clinical asperity per diagnoses, or in HS cases with varying skin difficulty the area, complicated. The largest pharmacological subgroup provoking positive test results was of nonsteroidal anti-angering drugs (NSAID). Consisting of 51 patients and 9 controls, individually was tested by 9 various non-steroidal anti-inflammatory drugs and distinguished with another group of subjects (56 with next or early HS reaction in their record) using determination of particular IgE against NSAID from their sera within individual year following in position or time the event. In vivo tests (patch, intradermal and oral provocations) were acted in parallel to artificial testing. The zeal ratio of validated test results was almost double within the IL-6 release-proven group after antagonistic reactions due to NSAID compounds as distinguished to specific IgE proven patients’ positiveness in their sera (65.4% vs. 36.5%). The mechanism of IL-6 transsignaling that is behind the life threatening “Cytokine Release Syndrome” is trusted to account for this novel demonstrative test.

Author(s) Details:

Baló-Banga Joseph Mathias,
Department of Dermatology, Central Hospital of the Hungarian Defense Forces, Hungary.

Please see the link here: https://stm.bookpi.org/PRAMR-V10/article/view/9650

Safety and Tolerability of Some Second Generation of Antipsychotics | Chapter 4 | Novel Aspects on Pharmaceutical Research Vol. 1

 To monitor ADRs of second production antipsychotics and find out the origin and severity of ADRs had connection with the second generation antipsychotics. An antipsychotic drug is a insane tranquillizer typically arbitrary to treat psychosis, emotional disorder, bipolar disorder, misconceptions, paranoid disorder, mental handicap, depression, and added mental strength conditions. These cures are also used to treat non-unhinged disorders. The drugs in the second generation came later and are popular as atypical antipsychotics. The first creation of antipsychotics, also known as conventional antipsychotics, were discovered in the 1950s. In the study 100 patients were secluded, of whom 91 (91.00%) were suspected to contract an illness adverse drug responses (ADRs). Four atypical antipsychotic drugs were most frequently secondhand such as olanzapine (5mg, 10mg), risperidone (2mg, 1mg), clozapine (0.5mg) and quetiapine (50 mg). Information about ADRs was assembled simultaneously from victims' guardians and patients themselves. The plan created for one Department of Clinical and Experimental Pharmacology, Calcutta School of Tropical Medicine, Kolkata, allowed for the access of information concerning the study of prescribed medications, differing adverse backlashes, the management of ADR, in addition to reports of laboratory examinations. Total 171 adverse occurrences were investigated and figured. Causality of adverse occurrences was assessed by Naranjo's invention and World Health Organization-Uppsala Monitoring Centre (WHO-UMC) criteria. The results of the current study and the documented ADR reports concede possibility be useful for future analysts to conduct additional research or in general area and to inform clinicians about the ADR description of the otherwise widely arbitrary class of antipsychotic drugs.

Author(s) Details:

Nilanjan Pahari,
Department of Pharmacology, Calcutta Institute of Pharmaceutical Technology and AHS, Uluberia, Howrah-711316, West Bengal, India.

Koyel Mandal,
Department of Pharmacy, Kshudiram Bose College of Pharmacy, Tajpur, Mahishadal, Purba Medinipur-721628, West Bengal, India.

Biprojit Bhowmick,
Department of Pharmacology, Seacom Pharmacy College, Jaladhulagori, Sankrail, Howrah-711302, West Bengal, India.

Please see the link here: https://stm.bookpi.org/NAPR-V1/article/view/10302

Determination of Gastrointestinal Toxicity of Selective COX-2 Inhibitors in Comparison with Conventional NSAIDs | Chapter 12 | Current Aspects in Pharmaceutical Research and Development Vol. 6

 Background: The most prevalent side effects of NSAIDs are adverse gastrointestinal events, which are thought to be caused by the suppression of gastric COX-1, which is responsible for the manufacture of prostaglandins that typically regulate acid secretion and protect the mucosa. According to previous research, selective COX-2 inhibitors are safer than non-selective cyclooxygenase inhibitors when it comes to gastrointestinal side effects. However, current research shows that the gastrointestinal safety of these selective COX-2 inhibitors is comparable to that of traditional NSAIDs.

Aims: Given the increased use of selective COX-2 inhibitors, the goal of this study is to determine if selective COX-2 inhibitors offer any advantages over traditional NSAIDs in terms of gastrointestinal adverse effects.

Patients were separated into eight groups, each with fifteen patients. For 15 days, each group was given one of the eight NSAIDs that had been chosen for the study. Along with the symptomatic assessment of stomach toxicity, both pre and post-treatment Hb percent values are determined, tabulated, and statistically analysed in the selected group.

On symptomatic assessment, both diclofenac and meloxicam showed significant changes in Hb percent values ('p' value 0.02 each), although selective COX-2 inhibitors like nimesulide and celecoxib showed no less stomach toxicity than diclofenac. Diclofenac and meloxicam showed a significant shift in the 'p' value in the assessment of Hb percent change both before and after therapy, indicating that gastric bleeding erosions must have caused such alterations and therefore anaemia, despite the absence of any warning symptoms.

Conclusions: When it came to gastrointestinal toxicity, selective COX-2 inhibitors had no advantage over non-selective NSAIDs in our short-term trial.

Author(S) Details

K. Hima Bindu
Department of Pharmacology, Kakatiya Medical College, Warangal-506007, Telangana, India.

G. Venkat Rao
Department of Orthopaedics, Kakatiya Medical College, Warangal-506007, Telangana, India.

View Book:- https://stm.bookpi.org/CAPRD-V6/article/view/5164

Determination of Knowledge, Attitude and Practice in Pharmacovigilance among Clinical Post Graduate Students in a Teaching Hospital, Vizianagaram, Andhra Pradesh, India | Chapter 12 | Issues and Developments in Medicine and Medical Research Vol. 1

 Background: Adverse drug reactions (ADRs) are a leading cause of morbidity and mortality globally. A good pharmacovigilance (PV) programme can help with this problem. Underreporting of ADR is one of the obstacles to good PV. To do so, health professionals must have adequate ADR knowledge, attitude, and practise (KAP).

The goal of this study was to determine KAP about PV among postgraduate (PG) students.

Methods: PG students in MIMS College's clinical departments were given a self-administered questionnaire with 22 items assessing PV knowledge, attitude, and practise. During the completion of the surveys, direct supervision was provided. A Microsoft Excel spreadsheet was used to examine the findings of the completed questionnaires.

Results: The average understanding of ADRs and PV was 52.3 percent correct and 47.7% erroneous, according to the evaluation. Fifty percent of pupils are unsure whether or not ADR occurs. 90% of students have never been educated on how to report ADRs.

While PG students had a more favourable attitude toward PV, our research found that they lack information and awareness about the matter. In addition, we observed that the pupils lacked experience.

Conclusions: Regular educational intervention can transfer PV knowledge and awareness among PG students, resulting in better practise among PG students.

Author(S) Details

Sindhura Nagisetty
Department of Pharmacology, GITAM Institute of Medical Sciences and Research, Rushikonda, Visakhapatnam, Andhra Pradesh, India.

Jillella Naga Sreenivasulu
Department of General Medicine, GITAM Institute of Medical Sciences and Research, Rushikonda, Visakhapatnam, Andhra Pradesh, India.

Vijaya Bhaskara Rao Janapareddi
Department of General Medicine, GITAM Institute of Medical Sciences and Research, Rushikonda, Visakhapatnam, Andhra Pradesh, India.

Tulasi M. Thotakura
Department of Pharmacology, GITAM Institute of Medical Sciences and Research, Rushikonda, Visakhapatnam, Andhra Pradesh, India.

View Book:- https://stm.bookpi.org/IDMMR-V1/article/view/5050

Determination of Knowledge, Attitude and Practice in Pharmacovigilance among Clinical Post Graduate Students in a Teaching Hospital, Vizianagaram, Andhra Pradesh, India | Chapter 12 | Recent Developments in Medicine and Medical Research Vol. 13

 Background: Adverse drug reactions (ADRs) are a leading cause of morbidity and mortality globally. A good pharmacovigilance (PV) programme can help with this problem. Underreporting of ADR is one of the obstacles to good PV. To do so, health professionals must have adequate ADR knowledge, attitude, and practise (KAP).

The goal of this study was to determine KAP about PV among postgraduate (PG) students.

Methods: PG students in MIMS College's clinical departments were given a self-administered questionnaire with 22 items assessing PV knowledge, attitude, and practise. During the completion of the surveys, direct supervision was provided. A Microsoft Excel spreadsheet was used to examine the findings of the completed questionnaires.

Results: The average understanding of ADRs and PV was 52.3 percent correct and 47.7% erroneous, according to the evaluation. Fifty percent of pupils are unsure whether or not ADR occurs. 90% of students have never been educated on how to report ADRs.

While PG students had a more favourable attitude toward PV, our research found that they lack information and awareness about the matter. In addition, we observed that the pupils lacked experience.

Conclusions: Regular educational intervention can transfer PV knowledge and awareness among PG students, resulting in better practise among PG students.

Author(S) Details

Sindhura Nagisetty
Department of Pharmacology, GITAM Institute of Medical Sciences and Research, Rushikonda, Visakhapatnam, Andhra Pradesh, India.

Jillella Naga Sreenivasulu
Department of General Medicine, GITAM Institute of Medical Sciences and Research, Rushikonda, Visakhapatnam, Andhra Pradesh, India.

Vijaya Bhaskara Rao Janapareddi
Department of General Medicine, GITAM Institute of Medical Sciences and Research, Rushikonda, Visakhapatnam, Andhra Pradesh, India.

Tulasi M. Thotakura
Department of Pharmacology, GITAM Institute of Medical Sciences and Research, Rushikonda, Visakhapatnam, Andhra Pradesh, India.

View Book:- https://stm.bookpi.org/IDMMR-V1/article/view/5050