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

 

The Awareness of Pharmacovigilance among Medical Doctors in a Tertiary Care Teaching Hospital | Chapter 4 | Pharmaceutical Research: Recent Advances and Trends Vol. 6

Aims: The present study aimed to assess the knowledge, attitude and practice of ADR reporting among interns and clinical post-graduates in a tertiary care teaching hospital.

 

Background: Adverse Drug Reactions (ADRs) are an important cause of morbidity and mortality worldwide. Spontaneous reporting of ADRs has played a major role in the detection of suspected, serious, and unusual ADRs previously undetected during the clinical trial phases. ADRs are a threat to the patient’s safety as well as the quality of life and they increase the health care cost considerably. Spontaneous reporting of ADRs has played a major role in the detection of suspected, serious, and unusual ADRs previously undetected during the clinical trial phases. Proper monitoring and reporting of ADRs for the prevention and management of ADRs is the need of the hour.

 

Methodology: This was an observational, questionnaire-based study. A pre-validated questionnaire (from previous studies) containing both open and close-ended items was used as the evaluation tool. One hundred and fifty-two interns and clinical post-graduates were included in the study. Participation in the study was voluntary and without any obligation.  The study was rolled out after receiving approval from the Institutional Ethics Committee. The previously validated questionnaire consisting of a total of 24 items was distributed to the health care professionals. The data was analysed using the Chi-square test, one-way ANOVA and Karl Pearson’s co-efficient of correlation tests with the help of SPPS software 20.0.

 

Results: Out of 152 participants, 48(31.6%) were year 1, 44(28.95%) were year 2 clinical post-graduate students; as compared to 60(39.47%) interns. Thirty-two (21.1%) participants out of which 20 interns, 7(14.6%) year 1 and 5(11.4%) year 2 clinical postgraduates, had knowledge of the local peripheral monitoring centre. The difference was found to be statistically significant (p<0.05). 88.2% of the total participants had never reported an ADR to the pharmacovigilance centre. There was no significant difference among the three groups of participants, in terms of mean scores of knowledge, attitude and practice (p>0.05), but there was a significant (p<0.05) and positive correlation between knowledge and practice (r=0.2110) and attitude and practice (r=0.2415). Pharmacovigilance programmes have played a major role in the detection of ADRs and the banning of several drugs from the market. However, underreporting of ADRs is one of the major problems associated with Pharmacovigilance programmes.

 

Conclusion: The training of pharmacovigilance activities should start early in the professional training of doctors and needs to be reinforced during the postgraduate course. There is a great need to create awareness regarding Pharmacovigilance and to promote the reporting of ADR amongst healthcare professionals. The health care professionals should realize that ADR reporting is an integral part of their clinical activities and this is very necessary for better patient care.

 

Author (s) Details

Sapna Patil
Department of Pharmacology, Sapthagiri Institute of Medical Sciences and Research Centre, Bangalore, Karnataka, India.

 

P. A. Patil
Department of Pharmacology, Sapthagiri Institute of Medical Sciences and Research Centre, Bangalore, Karnataka, India.

 

S. Javali
Department of Community Medicine, USM-KLE IMP, Belagavi, India.

 

Ameeta Patil
Bioclinica Safety and Regulatory Solutions, Mysore, India.

 

Heethal Jaiprakash
Department of Pharmacology, MAHSA University, Kuala Lumpur, Malaysia.

 

Please see the book here:- https://doi.org/10.9734/bpi/prrat/v6/1920

Frontline Care: The Role of Hospital Pharmacists During the COVID-19 Pandemic in North Macedonia | Chapter 1 | Pharmaceutical Science: New Insights and Developments Vol. 6

 

Background: Hospital pharmacists played a pivotal role during the COVID-19 pandemic. As part of the team alongside nurses, physicians, and respiratory therapists, hospital pharmacists contribute to COVID-19 management protocols, warranting sufficient medication supply by managing critical drug, medical devices, or personal protection equipment (PPE) shortages through the implementation of conservation strategies and sourcing alternatives.

 

Aims: The aim of this chapter is to evaluate the knowledge, attitudes, level of engagement, and the impact of the COVID-19 pandemic on the daily professional practice of hospital pharmacists in the Republic of North Macedonia, highlighting their critical role as frontline healthcare providers during the crisis.

 

Methodology: A questionnaire-based study was conducted among hospital pharmacists and pharmacy technicians. The study was conducted in the Republic of North Macedonia in July 2022. It involved hospital pharmacists of varying ages and levels of professional experience from five different cities. Among the respondents, 95.8% were female. Focus-methodology group approach was used when designing and structuring the questionnaire was carried out.

 

Results: The results highlighted the pharmacists' knowledge of COVID-19 strains, disinfectants, and current therapeutic options. The study revealed that 37.5% of participants always, 20.8% frequently, and 29.2% occasionally felt depressed or fatigued during the pandemic, though 83% never considered leaving their jobs. The survey found that 87.5% of pharmacists experienced shortages of masks, gloves, and disinfectants early in the pandemic, and 100% noted the increased cost of these supplies. Only 22.7% were not consulted for therapy advice for hospitalised COVID-19 patients. Opinions varied on the use of off-label drugs, and pharmacists played a key role in pharmacovigilance practices, with 36.4% reporting adverse events. The study confirmed the vital role of hospitals in promoting rational antibiotic use and antimicrobial resistance programs.

 

Conclusion: This study, the first of its kind conducted in the post-pandemic period in the Republic of North Macedonia, highlights the essential and multifaceted role of hospital pharmacists during the COVID-19 crisis. It underscores the need for formal inclusion of clinical pharmacists in healthcare processes through clear legal frameworks and written procedures. Furthermore, it emphasises the importance of pharmacist engagement in clinical practice and research, particularly in monitoring drug prescription, preparation, and administration, to ensure safe and effective patient care.

Author (s) Details

Zorica Naumovska
Faculty of Pharmacy, Ss. Cyril and Methodius University, Majka Tereza 47, 1000 Skopje, RN Macedonia.

 

Biljana Lazarova
Faculty of Medicinal Sciences, “Goce Delchev” University, Krste Misirkov 10-A, 2000 Shtip, RN Macedonia.

 

Maja Kovaceva
Pharmaceutical Chamber of RN Macedonia, 50 Divizija no. 34, 1000 Skopje, RN Macedonia.

 

Aleksandra Kapedanovska Nestorovska
Faculty of Pharmacy, Ss. Cyril and Methodius University, Majka Tereza 47, 1000 Skopje, RN Macedonia.

 

Maja Simonoska Crcarevska
Faculty of Medicinal Sciences, “Goce Delchev” University, Krste Misirkov 10-A, 2000 Shtip, RN Macedonia.

 

 

Evgenija Mihajlova
Faculty of Pharmacy, Ss. Cyril and Methodius University, Majka Tereza 47, 1000 Skopje, RN Macedonia.

 

Aleksandar Dimkovski
Faculty of Medicinal Sciences, “Goce Delchev” University, Krste Misirkov 10-A, 2000 Shtip, RN Macedonia.

 

 

Please see the book here:- https://doi.org/10.9734/bpi/psnid/v6/5179

Development of Pharmacovigilance Elective Module for Medical Students | Chapter 7 | Pharmaceutical Science: New Insights and Developments Vol. 2

According to the National Medical Commission, it is mandatory to conduct electives during the MBBS curriculum. An elective is a course which the students opt for on their own. Pharmacovigilance (PV) refers to the detection, assessment, understanding and prevention of adverse effects (WHO). There is a dearth of literature regarding pharmacovigilance elective programs in India. MBBS students need comprehensive training in pharmacovigilance during the undergraduate curriculum for its thorough understanding and clinical application. An effective pharmacovigilance module can help in developing Indian Medical Graduate (IMG) into better clinicians, professionals and critical thinkers.

 

Author (s) Details

Ajay Khade
Department of Pharmacology, Datta Meghe Medical College, DMIHER, India.

 

Jyoti Khade

Department of Periodontology, Government Dental College, Nagpur, India

 

Please see the book here:- https://doi.org/10.9734/bpi/psnid/v2/4196 

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

Preventing Adverse Effects of Medicines: A Knowledge Attitude and Practice Study of Leaders in the Nigerian Public Health Supply Chain | Chapter 9 | New Advances in Medicine and Medical Science Vol. 8

 Pharmacovigilance is delineated as ‘‘the science and activities having connection with the detection, estimate, understanding and prevention of adverse belongings or any additional drug-related problem.” This study checked the knowledge, stance, and practice of pharmacovigilance by leaders in the public health drug supply chain management in Nigeria. The key practice approach of pharmacovigilance includes spontaneous reporting of antagonistic drug reactions and guaranteeing continuous post-marketing following of the quality and security of medicines. The success of pharmacovigilance depends on the knowledge, attitude, and willing participation of healthcare personnel, sufferers, and institutions. A cross-divided approach was used in the survey of 209 leaders of picked public health organisations. Purposive examining technique was used to administer certified semi-organized questionnaire. Questions were drawn from the Nigerian social pharmacovigilance policy. A 55% answer  rate was received as feedback. Among the responders, healing doctors and medical workshop scientists had better knowledge and practice of pharmacovigilance than pharmacists. Factors guide practice of pharmacovigilance include knowledge of the pharmacovigilance policy (OR = 1.90; P = .11), training given by respondents' organisations (OR = 1.34; P = .48), accused' organisation receiving periodic revises from the National Pharmacovigilance Centre (OR = 1.11; P = .85) and respondents alone receiving periodic revises (OR = .83; P = .73). In conclusion, the study suggests that listening the safety and quality of cures in the public health scope of Nigeria could improve through raised awareness of the interstate pharmacovigilance policy, training in pharmacovigilance, and regular safety media by the national pharmacovigilance centre.

Author(s) Details:

Anthony Obieze,
USAID Global Health Supply Chain-Procurement and Supply Management Project, Abuja, Nigeria.

Please see the link here: https://stm.bookpi.org/NAMMS-V8/article/view/11077

Global Health Systems: Challenges amidst Trying Times | Chapter 1 | Research Highlights in Disease and Health Research Vol. 7

 This unit introduced several texts that support background, while attempting to stimulate readers' concern of a variety of issues to ponder. More study of all-encompassing health systems grant permission open greater possibilities for correct to benefit all national health orders from successes found in enhanced performance. No smooth tasks lie in our immediate future. The friendly learning from those experiences commit have aided a better global answer to the COVID-19 outbreaks but have fallen short due to lower arrangement. Several public health scholars have committed in conceptualizing worldwide health systems inside an international health foundation with attempts to make better sense of the varying paths and approaches those countries with its own government have chosen over occasion.

Author(s) Details:

J. Warren Salmon,
University of Illinois Chicago, USA.

Please see the link here: https://stm.bookpi.org/RHDHR-V7/article/view/10565

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

Drug Safety Assessment in Ayurveda Clinical Trial and Practice: An Approach towards Concepts and Issues | Chapter 1 | Current Aspects in Pharmaceutical Research and Development Vol. 5

 One of the most hotly debated topics these days is the safety of Ayurvedic medicines. In Ayurveda practise and research, the magnitude of Adverse Drug Reaction (ADR) is underreported. Ayurveda has traditionally placed a premium on safe therapy, which includes alleviating symptoms while avoiding the onset of new ones. Others are unable to acquire and understand the information and terminologies described in old books. Drug safety terms are not covered in Ayurveda's undergraduate and postgraduate curricula for detecting ADR. As a result, an attempt was made to study Ayurveda's drug safety concept and issue in the light of modern pharmacology. One of the components of Rogi surakshya is drug safety, which may be related to bhesaja dosa or abhesaja. In Ayurveda, an adverse drug reaction or incident is known as dravya Vyapad, virudha, or ahita. In the year 2008, the National Pharmacovigilance Program for reporting adverse medication reactions for Ayurveda, Siddha, and Unani (ASU) pharmaceuticals was launched. In this study, the contemporary nomenclature of medication safety was introduced, as well as the component responsible for ADR. In the notion of ADR in Ayurveda medicine, the dosha vidha parikshya (Tenfold of clinical evaluation) takes a more comprehensive approach. Heavy metals in excess of allowed limits, dangerous microorganisms, pesticide residue, and aflatoxin can all be hazardous to human health. This review discusses the predictability of adverse medication reactions to metallic and plant-based pharmaceuticals. This review also discusses drug and herb interactions. The Ayurvedic medical process Panchakarma (Detoxification therapy) has the highest reported ADR in a study. The most common presenting symptoms of ADR in Ayurvedic treatment are skin rashes, diarrhoea, and vomiting. ADR faces a hurdle in standardising Ayurvedic formulations. The ADR protocol is being presented as a research and practise tool. In current clinical practise and research, this issue may provide some insight into the prevention, diagnosis, reporting, and management of adverse drug reactions.

Author(S) Details

Ashok Kumar Panda
Central Ayurveda Research Institute for Hepatobiliary Disorders, Bhubaneswar, Central Council of Research in Ayurveda Sciences, Ministry of AYUSH, Govt. of India, India.

Sarbeswar Kar
Department of Medical, JSS Ayurveda Medical College &Hospital, Mysore, Karnataka, India.

View Book:- https://stm.bookpi.org/CAPRD-V5/article/view/4928

Clinically Oriented Pharmacology Exercises and Innovative Evaluation System | Chapter 4 | Technological Innovation in Pharmaceutical Research Vol. 11

 Medical science is a large topic that deals with human life; as a result, talents, communication, and decision-making abilities are critical components of medical knowledge. Students are under pressure from all sides of society in today's modern world. During college, common concerns include financial strain, a hostile environment, senior and peer group pressure, single parents, drug addiction, and love affairs. Job insecurity after graduation will cause financial anxiety in the future. Pharmacology is an important field of medicine with a lot of therapeutic applications. Pharmacology is the study of prescriptions and pharmacotherapy in any clinical area. This is due to the fact that we are always attached to our ancient tradition, yet times have changed and the old presentation needs to be updated. This chapter discussed some of the more advanced and inventive approaches to practical, written, and oral examinations.

Author (S) Details

Rakesh Chandra Chaurasia
Department of Pharmacology, M.L.N. Medical College, Allahabad 211002, India.

View Book :- https://stm.bookpi.org/TIPR-V11/article/view/3126

An Assessment of Educational Intervention to Improve Knowledge, Attitude and Practice of Pharmacovigilance among Nursing Staff in Tertiary Care Hospital | Chapter 4 | Technological Innovation in Pharmaceutical Research Vol. 9

The purpose of this study was to 1) examine nursing staff knowledge, attitude, and practise, as well as to evaluate the impact of educational intervention. 2) a. To address concerns about ADR reporting, such as nervousness, legal obstacles, and a lack of confidence, among other things. c. To improve ADR reporting by training nursing personnel on how to report ADRs and how to fill out the ADR reporting form. Material and Methods: Before and after an educational intervention in a tertiary care hospital, nursing staff were given a questionnaire regarding knowledge, attitude, and practise (KAP). The collected data was statistically analysed. As a result of the training delivered in numerous sessions, KAP among nursing workers has improved. In comparison to the pre-training session, they properly recognised who can report ADR 96% of the time (69 percent ). After training, 71 percent responded yes to pharmacovigilance as a means of ensuring the safe use of drugs, compared to 54 percent before. 94 percent of nursing personnel correctly identified the scale to be used for causality assessment in PvPI questions, compared to 79 percent before training. After training, the majority of them agreed that all ADRs should be reported, not only those that are unknown or harmful. In questio, there has been a substantial improvement. Conclusion: As a result of the educational intervention, KAP among nursing workers has greatly improved.

Author(s) Details

Dr. Sadhana Hingorani
Department of Pharmacology, SMIMER, Surat, India.

Dr. Chaitali Mehta
Department of Pharmacology, SMIMER, Surat, India.

Paresh Gajera
Department of Pharmacology, SMIMER, Surat, India.

S. K. Srivastava
Department of Pharmacology, SMIMER, Surat, India.

View Book :- https://stm.bookpi.org/TIPR-V9/article/view/2517