scholarly journals Antiretroviral Adverse Drug Reactions Pharmacovigilance in Harare City, Zimbabwe, 2017

2018 ◽  
Author(s):  
Hamufare Mugauri ◽  
Owen Mugurungi ◽  
Tsitsi Juru ◽  
Notion Gombe ◽  
Gerald Shambira ◽  
...  
Keyword(s):  
Health Worker ◽  
Adverse Drug Reactions ◽  
Health Workers ◽  
Likert Scale ◽  
Pharmacovigilance System ◽  
Drug Reactions ◽  
Cross Sectional ◽  
Therapeutic Decisions ◽  
Clinical Records ◽  
Harare City

AbstractIntroductionKey to pharmacovigilance is spontaneously reporting all Adverse Drug Reactions (ADR) during post-market surveillance. This facilitates identification and evaluation of previously unreported ADR’s, acknowledging the trade-off between benefits and potential harm of medications. Only 41% ADR’s documented in Harare city clinical records for January to December 2016 were reported to Medicines Control Authority of Zimbabwe (MCAZ). We investigated reasons contributing to underreporting of ADR’s in Harare city.MethodsA descriptive cross-sectional study and the updated Centers for Disease Control (CDC) guided surveillance evaluation was conducted. Two hospitals were purposively included. Seventeen health facilities and 52 health workers were randomly selected. Interviewer-administered questionnaires, key informant interviews and WHO pharmacovigilance checklists were used to collect data. Likert scales were applied to draw inferences and Epi info 7 used to generate frequencies and proportions.ResultsOf the 52 participants, 32 (61.5%) distinguished the ADR defining criteria. Twenty-nine (55.8%) knew system’s purpose whilst 28 (53.8%) knew the reporting process. Knowledge scored average on the 5-point-Likert scale. Thirty-eight (73.1%) participants identified ADR’s following client complaints and nine (1.3%) enquired clients’ medication response. Forty-six (88.5%) cited non-feedback from MCAZ for underreporting. Inadequate ADR identification skills were cited by 21 (40.4%) participants. Reporting forms were available in five (26.3%) facilities and reports were generated from hospitals only. Forty-two (90.6%) clinicians made therapeutic decisions from ADR’s. Averaged usefulness score was 4, on the 5-point-Likert scale. All 642 generated signals were committed to Vigiflow by MCAZ, reflecting a case detection rate of 4/ 100 000. Data quality was 0.75–1.0 (WHO) and all reports were causally assessed.ConclusionThe pharmacovigilance system was useful, simple, and acceptable despite being unstable, not representative and not sensitive. It was threatened by suboptimal health worker knowledge, weak detection strategies and referral policy preventing ADR identification by person place and time. Revisiting local policy, advocacy, communication and health worker orientation might improve pharmacovigilance performance in Harare city.

scholarly journals Determinants of adverse drug reactions reporting in retail chemists in Nairobi County, Kenya

2020 ◽  
Vol 7 (10) ◽  
pp. 3847
Author(s):  
June W. Njiru ◽  
Eunice M. Mwangi ◽  
Musa Oluoch
Keyword(s):  
Adverse Drug Reactions ◽  
Implementation Strategies ◽  
Cross Sectional Study ◽  
Pharmacovigilance System ◽  
Regulatory Body ◽  
Drug Reactions ◽  
Cross Sectional ◽  
Motivation Factors ◽  
Adr Reporting ◽  
The Impact

Background: Reporting of adverse drug reactions remains the mainstay of a vibrant pharmacovigilance system that seeks to safeguard medicines in a health system. This study sought to establish the impact of the national medicines regulatory body, The Pharmacy and Poisons Board (PPB), the operationalization of pharmacovigilance implementation strategies in the retail chemists, the effect of the capacity and that of underlying motivation factors of the retail chemist personnel on reporting of adverse drug reactions.Methods: This was a descriptive cross-sectional study design conducted between May 2018 to June 2018.Results: 149 (60%) of the respondents stated that PPB did not engage retail chemists as stakeholders in pharmacovigilance, 127 (51%) said they had never read any PPB publication on pharmacovigilance, 151 (61%) said they had general knowledge on pharmacovigilance, receiving feedback from PPB was considered a major motivational factor towards ADR reporting by 237 (96%). Multivariate analysis of the determinants of ADR reporting in retail chemists established that the pharmacovigilance implementation strategies (p<0.026), retail chemist personnel (p<0.001) and underlying motivational factors (p<0.05) had significant influence on ADR reporting in retail chemists in Nairobi County.Conclusions: PPB has not engaged retail chemists on pharmacovigilance matters as key stakeholders and this has impacted the quality of the pharmacovigilance implementation strategies in the chemists as well as the capacity and motivation of the retail chemist personnel to report ADRs.

scholarly journals Knowledge, attitude and perception of suspected adverse drug reactions in consumers: a prospective observational study in a tertiary care hospital

2019 ◽  
Vol 8 (2) ◽  
pp. 337
Author(s):  
Leeyasid Shaik ◽  
Vasundhara Krishnaiah ◽  
Girish K.
Keyword(s):  
Adverse Drug Reactions ◽  
Health Care Professionals ◽  
Tertiary Care ◽  
Research Center ◽  
Pharmacovigilance System ◽  
Care Hospital ◽  
Drug Reactions ◽  
Cross Sectional ◽  
Adr Reporting ◽  
Consumer Reporting

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.

scholarly journals Adverse drug reactions amongst admitted advanced age Africans

2021 ◽  
Vol 12 (3) ◽  
pp. 427-433
Author(s):  
Ekechi Stella AMADI ◽  
Erinma Fortuna PEPPLE ◽  
Bolaji OTIKE-ODIBI ◽  
Hope Ilanye BELL-GAM
Keyword(s):  
Older Adults ◽  
Adverse Drug Reactions ◽  
Adverse Drug Events ◽  
Health Workers ◽  
Screening Tools ◽  
Advanced Age ◽  
Drug Reactions ◽  
Cross Sectional ◽  
The Past ◽  
Study Results

Background: Medical therapy amongst advanced age adults sometimes have its inherent significant risks such as adverse drug reactions (ADRs) resulting from the drug itself or drug-drug interactions or interactions from other substances such as alcohol. Aim: The main aim of this study is to highlight ADRs noticed by the older adult while on admission either in the past or present with the goal of preventing them and improving treatment outcomes. Methods: A purposive cross-sectional sampling of 126 elderly patients that were admitted to the different wards of the hospital within a 3-month period was carried out of which 25 older adults who met the criteria of being able to recall ADRs in the past or during current admission were included in the study. Results: ADR was reported in a ratio of M: F ratio of 1:1.08 with a prevalence of 19.8% of the total older patients evaluated. Conclusion: Self-reported ADRs amongst these advanced age in-patients were high. The actual number of adverse drug events may be higher if they actually looked out for by the physicians or other health care workers. The use of screening tools by physicians and other prescribing health workers can help in curbing adverse drug events in older adults.

ASSESSMENT OF COMMUNITY PHARMACIST AWARENESS ON ADVERSE DRUG REACTION (ADR) AND PHARMACOVIGILANCE REPORTING SYSTEM IN KHARTOUM LOCALITY, SUDAN

2021 ◽  
Author(s):  
Ali Awadallah Saeed ◽  
Osman Umballi ◽  
Namareg Ahmed ◽  
Shaza Ali ◽  
Azza Alfaki
Keyword(s):  
Peer Review ◽  
Adverse Drug Reactions ◽  
Community Pharmacists ◽  
Total Sample ◽  
Cross Sectional Study ◽  
Pharmacovigilance Centre ◽  
Drug Reactions ◽  
Cross Sectional ◽  
Positive Attitudes ◽  
National University

Introduction: Adverse drug reactions resulting from the use of a medicinal product and were harmful or unpleasant reaction. Pharmacovigilance is related pharmaceuticals product after marketing and associated with collection, detection, assessment, monitoring and prevention of adverse effects. The aim of study is to recognize the awareness of pharmacists regarding pharmacovigilance and adverse drug reactions reporting. Methodology: Descriptive cross-sectional study conducted to 237 pharmacists working in Khartoum’s locality pharmacies from August 2019 to March 2020 selected by simple randomization. The data were collected by face to face interview using self-administrated Questionnaire and analyzed by SPSS version 23. Results: 57.4% from the total sample size never seen adverse drug reactions reporting form, 76.4% never receive training on how to report it and only 10.5% from the pharmacists in the study report it to pharmacovigilance center. 79% from pharmacists in the study were not aware about existence of pharmacovigilance program in Sudan. 51.5 % from pharmacists have good attitude about adverse drug reactions and pharmacovigilance in Sudan while 48.5% had poor attitude. Difficulty in communicating with pharmacovigilance centre in Sudan and how to write the report were the factors discourage pharmacists from reporting of adverse drug reactions. Conclusion: Community pharmacists have insufficient knowledge about the concept of pharmacovigilance and spontaneous ADRs reporting while they had positive attitudes toward pharmacovigilance, despite their little experience with ADRs reporting, this can be strengthened by educational trainings and workshops.                   Peer Review History: Received: 4 September 2021; Revised: 9 October; Accepted: 29 October, Available online: 15 November 2021 Academic Editor:  Dr. Jennifer Audu-Peter, University of Jos, Nigeria, [email protected] UJPR follows the most transparent and toughest ‘Advanced OPEN peer review’ system. The identity of the authors and, reviewers will be known to each other. This transparent process will help to eradicate any possible malicious/purposeful interference by any person (publishing staff, reviewer, editor, author, etc) during peer review. As a result of this unique system, all reviewers will get their due recognition and respect, once their names are published in the papers. We expect that, by publishing peer review reports with published papers, will be helpful to many authors for drafting their article according to the specifications. Auhors will remove any error of their article and they will improve their article(s) according to the previous reports displayed with published article(s). The main purpose of it is ‘to improve the quality of a candidate manuscript’. Our reviewers check the ‘strength and weakness of a manuscript honestly’. There will increase in the perfection, and transparency.  Received file:                Reviewer's Comments: Average Peer review marks at initial stage: 5.5/10 Average Peer review marks at publication stage: 7.0/10 Reviewers: Dr. Neelam H. Zaidi, Fiji National University, Fiji, [email protected] Dr. U. S. Mahadeva Rao, Universiti Sultan Zainal Abidin, Terengganu Malaysia, [email protected] Dr. Hayriye Eda Şatana Kara, Gazi University, Turkey, [email protected] Dr. Andrzej Szymański, Poznan University of Technology, Poland, [email protected] Similar Articles: AWARENESS OF PHARMACISTS TOWARDS ASPARTAME SIDE EFFECTS IN KHARTOUM CITY, SUDAN ASSESSMENT OF THE ROLE OF COMMUNITY PHARMACISTS IN MANAGEMENT OF HIV-POSITIVE INDIVIDUALS IN THE SOUTHERN REGION OF NIGERIA

scholarly journals PATTERN OF ADVERSE DRUG REACTIONS IN A TERTIARY CARE TEACHING HOSPITAL: A CROSS-SECTIONAL STUDY

2017 ◽  
Vol 10 (3) ◽  
pp. 170 ◽  
Author(s):  
Sangeetha Raja ◽  
Jamuna Rani R ◽  
Kala P
Keyword(s):  
Adverse Drug Reactions ◽  
Teaching Hospital ◽  
Antimicrobial Agents ◽  
Tertiary Care ◽  
Cross Sectional Study ◽  
Sectional Study ◽  
Drug Reactions ◽  
Cross Sectional ◽  
Tertiary Care Teaching Hospital ◽  
Care Teaching

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.

scholarly journals PATTERN OF ADVERSE DRUG REACTIONS AND ITS MANAGEMENT IN FEMALE CANCER PATIENTS IN A PRIVATE HOSPITAL IN TELANGANA, INDIA

2018 ◽  
Vol 6 (4) ◽  
pp. 45-53
Author(s):  
Kishore P ◽  
G Meghana ◽  
B. Pratap Reddy ◽  
K V Raghavaiah ◽  
D Sudheer Kumar
Keyword(s):  
Radiation Therapy ◽  
Adverse Drug Reactions ◽  
Cancer Chemotherapy ◽  
Health Care Professionals ◽  
Private Hospital ◽  
Therapeutic Window ◽  
Pharmacovigilance System ◽  
Drug Reactions ◽  
System Use ◽  
Female Cancer Patients

ABSTRACT Chemotherapy and radiation are one of the important components of treatment for many cancers. Anti-neoplastic agents are used with caution due to their high toxicity and narrow therapeutic window. Studies describing pattern of adverse drug reactions in cancer chemotherapy and radiation therapy patients are less in India. This study aims to evaluate the pattern of ADR’s due to cancer chemotherapy and radiation therapy in hospitalized patients and to assess the causality and severity of these reactions in Telangana state, India. This was a prospective observational study conducted in a private hospital in Telangana region from January to august. Two thousand three hundred and forty two ADR’s were recorded from 254 patients. Most common ADR’s were vomiting (10.7 %), nausea (10.7 %) and fatigue (10.7 %). Majority of the ADR’s (53.5 %) were affecting the Gastro-intestinal system. Naranjo scale for causality assessment showed 54.3 % of the reaction to be “definite”, 36.8 % to be “probable”. Modified Hartwig and Siegel scale for severity showed most reaction (84.1 %) to be of “moderate level”, while 13.3 % of reactions were of “mild level”. There is an immediate need to create awareness among health care professionals regarding the importance of the pharmacovigilance system. Use of preventive measures is to be enhanced in order to reduce the incidence and severity of ADR’s. This study showed most ADR’s are preventable with effective ADR monitoring. Keywords: Adverse drug reaction (ADR), ADR monitoring, Pharmacovigilance, chemotherapy, radiation therapy.

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