scholarly journals Pharmacovigilance Study of Anticancer Drugs in a Tertiary Care Rural Hospital in Central India

2021 ◽  
Vol 14 (2) ◽  
pp. 597-606
Author(s):  
Dipankar Chakraborty ◽  
Ranjana S Kale ◽  
Lakshman Das ◽  
Mousumi Das ◽  
Sonali Kirde

The present study has been undertaken to evaluate the pattern of adverse drug reactions (ADRs) of intravenous anticancer (i.v.) drugs with their causality and severity in a tertiary health care set up. The study was an observational cross-sectional survey over a period of 18 months. The indoor patients who were diagnosed to have cancer and receiving i.v. anticancer drugs were included in the study. The details of the patients and ADRs were recorded at the time of visit or within one-month of occurrence of ADRs using case record form and ADR reporting form. A total of 374 patients on cancer chemotherapy were included in the study and ADR was seen in 293(78.34%) patients. Out of total 812 number of ADRs, most ADRs (51.60%) were G.I. system related, followed by skin and appendages related ADRs (23.88%). The association of females in developing haematological ADRs is statistically significant (p<0.05). Most common (19.80%) cause of ADRs was the use of combination of Cisplatin, Paclitaxel and 5 Fluorouracil. Most (90.02%) of the ADRs were categorized as ‘possible’ and the remaining (9.98%) as ‘probable/likely’. The maximum number of the ADRs were classified as ‘mild’(87.68%) followed by moderate (11.45%) and severe (0.86%). The mild reactions were more common as compare to moderate & severe category in G.I & haematology related ADRs (p<0.05).

2018 ◽  
Vol 08 (04) ◽  
pp. 250-253
Author(s):  
Anum Baqar ◽  
Saman Hakeem ◽  
Farnaz Ilyas ◽  
Abid Mohsin ◽  
Fatima Hassan ◽  
...  

Objective: This research was aimed to assess the awareness and attitude regarding implant-retained prosthesis as the most advanced option for tooth replacement amongst residents of Karachi visiting tertiary care centre. Methodology: This cross-sectional survey was conducted in the department of Prosthodontics at Bahria University Dental Hospital, Karachi. Undertaking the demographic characteristics of patients, the objective was to determine the awareness and attitude toward implant supported prosthesis. Results: Amongst 380 responses retrieved, 9.8% of respondents were aware about the dental implant treatment. While correlating awareness with demographics features, awareness statistically increased with educational level (p= 0.00) and occupational category(p=0.01) of the participants. The friends and relative s(40.5%) were the main source of information regarding dental implant treatment modality. 54.1% were unwilling to undergo treatment with dental implant whereas high cost (55.2%)was the major limiting factor for implant treatment. 64.9% demanded dental insurance for getting the treatment. 45.9% had no knowledge regarding maintenance of implant supported prosthesis .73.0% had no idea regarding longevity of dental implant where as 86.5% were unaware of it’s impact on systemic health. Conclusion: The overall awareness regarding implant supported prosthesis was found to be minimal. This underlines the need of efforts and measures that should be made to raise the awareness and thus alter attitude towards dental implant therapy. Expensive rates (55.2%) was found to be the major limiting factor that should be relieved in the form of health insurance policies, especially in the developing countries like ours.


Author(s):  
Aparna S. Chincholkar ◽  
Alisha Naik

Background: Adverse Drug Reactions (ADRs) are a major cause of morbidity and mortality. Under reporting of ADRs by health care professionals is a very common problem worldwide. So, the present study was planned to assess the knowledge, attitude and practices of postgraduate (PG) students towards ADR reporting and suggest possible ways for improvement.Methods: It was a cross sectional questionnaire-based study conducted among 44 PG students using a questionnaire with questions on knowledge (21), attitude (13) and practices (15) of ADR reporting. The questionnaire was analyzed question wise and the percentage was calculated using Microsoft Excel spreadsheet in Microsoft Office 2010 software.Results: Most of them were aware of the term pharmacovigilance (PV) (95.45%). 54.55% agreed to be trained on how to report an ADR. 88.63% knew about the existence of pharmacovigilance committee in the institute.93% of participants knew that Central Drug Standard Control Organization (CDSCO) is responsible for monitoring of ADRs. 56.82% were aware about VIGIBASE an online software to report ADR. 81.82% of participants had agreed to witness ADRs in patients but only 38.64% reported them. The main reason behind it was non – availability of ADR forms. 42.55% opine that mobile based app would be the most preferred method to send ADR information to an ADR reporting center.Conclusions: There exists a huge gap between ADR experienced and ADR reported by PG students. Participants agreed upon necessity of reporting ADR and periodic briefing about PV.


Author(s):  
Leeyasid Shaik ◽  
Vasundhara Krishnaiah ◽  
Girish K.

Background: Adverse drug reactions (ADRs) are the main leading causes of hospitalization which leads to morbidity and mortality worldwide. Reporting of ADRs to national databases is necessary. To strengthen this system, consumers apart from health-care professionals have also been empowered to report any ADRs directly to the regulatory agencies. Direct and spontaneous patient or consumer reporting offers various benefits beyond pharmacovigilance (PV). Consumer reporting of ADRs has existed in several countries for decades, but in India, with the inclusion of consumer reporting of ADR, the data on the same is valuable and limited. Hence the present study is taken up. The aim of this study was to explore the knowledge, perceptions and practice of ADR reporting among consumers in KIMS hospital and research center, Bangalore.Methods: The data was collected from Patients attending OPD’s, admitted in wards and at pharmacy in KIMS Hospital and Research Center, Bangalore. It is a cross sectional descriptive study. Study period is for six months from 1st April to 31st September 2018 and sample size is 200. A structured questionnaire in English and Kannada was used as a tool.Results: Of the 200 patients from the surveyed, in males the knowledge scores were better when compared to females and attitude, perception scores were same (statistically not significant). Most of the patients opined for the establishment of consumer pharmacovigilance system at hospitals and local pharmacies.Conclusions: Knowledge about ADR reporting and pharmacovigilance is less in consumers. So that there is a need to increase awareness in consumers.


2021 ◽  
Vol 8 (04) ◽  
pp. 230-235
Author(s):  
Avinash Vikram Turankar ◽  
Shankar Bhusari ◽  
Manish Thakre ◽  
Ashwita Uday Shetty ◽  
Pramoda N. ◽  
...  

BACKGROUND Emotional intelligence and temperament are important parts of medical practice in good clinical history taking, diagnosis, effective treatment, and in managing the extreme situations in the workplace. This is more important in young resident doctors who lack the experience in handling patients. The primary objective of this study is to evaluate the four different aspects of emotional intelligence and their correlation with different temperamental factors in medical resident doctors. METHODS This is a cross sectional study. Students pursuing higher medical education were assessed for temperament and emotional intelligence. Purposefully selected participants were given temperament scale and emotional intelligence scale for their assessment. The four components of emotional intelligence were correlated with the 15 temperamental factors. RESULTS In this study medical residents were found to be low / very low on temperamental scale on all 15 parameters and are average on emotional intelligence score on all four parameters. There is a positive correlation between all temperamental factors and emotional intelligence factors except secretiveness and aggressiveness, which show negative correlation. When various subfactors of temperament were correlated with grand emotional intelligence, sociability, vigorous, cooperative, persistence and tolerance showed moderate strength of correlation ranging from 0.36 to 0.5. In comparison between male and female residents, factors like acceptability, responsibility and persistence were predominant in males while sociability, ascendant, placid, vigorous and tolerance were predominant in female resident doctors. CONCLUSIONS In this study medical residents were found to be are low / very low on temperamental scale and average on emotional intelligence. There is moderate correlation between grand emotional intelligence and grand temperamental score. There is no gender factor influence when head-to-head comparison was done but individual gender wise correlation analysis has shown that emotional intelligence correlates differently to temperamental factors in both genders. KEYWORDS Emotional Intelligence, Temperament, Correlation, Medical Residents, Gender Correlation


2020 ◽  
pp. 001857872091040
Author(s):  
Iftikhar Ali ◽  
Wiqar Ahmad ◽  
Arslan Rahat Ullah ◽  
Faheemullah Khan ◽  
Muhammad Ijaz ◽  
...  

Background: Underreporting of adverse drug reactions (ADRs) is considered a major determinant of poor ADR signal detection in Pakistan. Considering this, the study was proposed to evaluate healthcare professionals’ (HCPs) knowledge attitude toward and the barriers that discourse ADRs reporting. Methods: A cross-sectional survey was distributed among HCPs in 3 major tertiary care facilities of Peshawar. A self-administered, 31 items questionnaire was circulated online to collect the required information. Relative index ranking was used to identify the top barriers to the ADR reporting process. Results: HCPs (n = 322) were requested, and over one-third (n = 122) responded. Of the total, 97 (79.5%) were males, and by designation, 59(48.4%) were resident medical officers. About 45% of the HCPs did not identify the appropriate pharmacovigilance (PV) definition. More than half of the HCPs (52.2%) distinguished the appropriate PV purpose. Nearly 80% HCPs did not know the acceptable reporting time frame, while 22.1% HCPs knew that regulatory body for ADRs does not exist in Pakistan. The majority (95.08%) of the HCPs either strongly agreed or agreed that reporting an ADRs is a professional obligation and all the HCPs were of the opinion that PV should be taught in detail to HCPs. Exploring the barriers, it was identified that the key barriers to ADRs reporting were “unavailability of professional environment to discuss ADRs,” Relative Importance Index (RII) = 0.813, “lack of incentives for reporting” (RII = 0.774), “lack of knowledge regarding reporting” (RII = 0.693), and “insufficient knowledge of pharmacotherapy in detecting ADRs” (RII = 0.662). In addition to these, “complicated reporting forms” (RII = 0.616), “lack of motivation for reporting ADRs” (RII = 0.610), and “absence of professional confidence” were seen as major hindrances in effective reporting of ADRs (RII = 0.598). Conclusion: Concerning PV and ADR reporting poor knowledge was noted. However, the majority of the HCPs showed an explicit attitude regarding ADRs reporting. The majority of the HCPs disclosed unavailability of professional environment to discuss about ADRs, lack of incentives, and how to report the main factors hindering the ADRs reporting. It is emphasized that health authorities carve out a niche for a well purposeful PV center and pledge educational activities and trainings for increasing understanding and approaches regarding reporting of ADR.


2012 ◽  
Vol 3 (5) ◽  
pp. 1-3
Author(s):  
* Avinash Borkar ◽  
◽  
Namita Deshmukh ◽  
Deepak Lone ◽  
Mohan Khamgaonkar

2021 ◽  
Vol 11 (5) ◽  
pp. 399
Author(s):  
Casey Overby Taylor ◽  
Natalie Flaks Manov ◽  
Katherine D. Crew ◽  
Chunhua Weng ◽  
John J. Connolly ◽  
...  

There is a need for multimodal strategies to keep research participants informed about study results. Our aim was to characterize preferences of genomic research participants from two institutions along four dimensions of general research result updates: content, timing, mechanism, and frequency. Methods: We conducted a web-based cross-sectional survey that was administered from 25 June 2018 to 5 December 2018. Results: 397 participants completed the survey, most of whom (96%) expressed a desire to receive research updates. Preferences with high endorsement included: update content (brief descriptions of major findings, descriptions of purpose and goals, and educational material); update timing (when the research is completed, when findings are reviewed, when findings are published, and when the study status changes); update mechanism (email with updates, and email newsletter); and update frequency (every three months). Hierarchical cluster analyses based on the four update preferences identified four profiles of participants with similar preference patterns. Very few participants in the largest profile were comfortable with budgeting less money for research activities so that researchers have money to set up services to send research result updates to study participants. Conclusion: Future studies may benefit from exploring preferences for research result updates, as we have in our study. In addition, this work provides evidence of a need for funders to incentivize researchers to communicate results to participants.


2021 ◽  
Vol 79 (1) ◽  
Author(s):  
Azizah AL-Mutairi ◽  
Isamme AlFayyad ◽  
Youssef Altannir ◽  
Mohamad Al-Tannir

Abstract Background Pharmacovigilance (PV) demarcates all actions involving the detection and prevention of adverse drug reactions (ADR) for marketed drugs. However, ADRs are considerably underreported worldwide and continue to be a major concern to health care systems. This study aims to assess the knowledge, attitude, and perception of hospital pharmacists regarding medication safety concerning PV and ADRs across multiple tertiary care centers around Saudi Arabia. Methods This cross-sectional study was conducted between July 2019 and January 2020. Pharmacists working in the tertiary care centers of Riyadh City, Saudi Arabia were asked to participate in the study. A self-administered questionnaire was used to conduct this study, it consisted of: 63 questions out of which 19 questions were knowledge-based, 15 were attitude-based, and 29 were practice-based questions. Results A total of 350 pharmacists were distributed and 289 agreed to participate, giving a response rate of 82.6%. Most pharmacists were aware of the concept of VP and its functions (96.5%) and (87.2%), respectively. Moreover, 90% said that ADR can be preventable and non-preventable. However, the findings revealed inadequate knowledge about the overall PV field, where the majority of the pharmacists failed to correctly answer questions related to independent ADRs treatment, Augmented drug reaction, the international location of ADR, and the World Health Organization “online database” for reporting ADRs. Moreover, incomplete and/or wrong answers were recorded for questions that included single or multiple correct answers. Regarding the participants” attitude, 96.9% were interested in ADR reporting, agreeing that ADR is important to enable safe drug usage. Although a general positive attitude was recorded, pharmacists have stated that the three main barriers that hinder reporting ADRs are: unavailability of information about ADRs, lack of awareness about the need to report ADRs, and lack of time. Concerning practice, 69.2% said they received training in ADRs reporting, and 70% have reported ADRs more than once a week. Conclusion Surveyed pharmacists from Riyadh hospitals showed narrow knowledge of the PV field. However, a positive attitude and satisfactory practice was observed among pharmacists. These findings warrant the need for educational programs and an encouraging environment for ADR reporting to increase ADR reporting rates and support PV activities in Saudi Arabia.


Author(s):  
Sangeetha Raja ◽  
Jamuna Rani R ◽  
Kala P

ABSTRACTObjective: The aim of this study was to carry out adverse drug reactions (ADRs) monitoring in various departments of a tertiary care teaching hospital.Methods: A cross-sectional study was conducted on ADRs reported in the hospital from December 2012 to May 2013 after obtaining InstitutionalEthics Committee approval.Results: A total of 40 ADRs were reported, 47.50% were males and 52.50% were females. The female adult population was 45%. The majority of ADRswere due to antimicrobial agents especially beta-lactam antibiotics (42.5%) followed by NSAIDs (7.50%). A maximum number of patients (75%)were reported with dermatological manifestations. The department of medicine reported the highest number of ADRs (37.5%). As per Naranjo’sprobability scale, 62.5% reports were assessed as probable. 62.5% reports were documented as mild according to Modified Hartwig’s criteria forseverity assessment.Conclusion: This study was done to sensitize the practicing physicians on the importance of adverse drug monitoring and reporting.Keywords: Pharmacovigilance, Adverse drug reactions, Tertiary care teaching hospital, Antimicrobial agents.


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