scholarly journals Improving Pharmacovigilliance Quality Management System in the Pharmacy and Poisions Board of Kenya

2021 ◽  
Author(s):  
Eric Apiyo ◽  
Zita Ekeocha ◽  
Stephen Robert Byrn ◽  
Kari L Clase
Keyword(s):  
Adverse Drug Reactions ◽  
Evaluation System ◽  
Impact Analysis ◽  
Quality Management System ◽  
Clinical Symptoms ◽  
Poor Performance ◽  
Poor Quality ◽  
Pharmacovigilance System ◽  
Drug Reactions ◽  
Media Reports

The purpose of this study was to explore ways of improving the pharmacovigilance quality system employed by the Pharmacy and Poisons Board of Kenya. The Pharmacy and Poisons Board of Kenya employs a hybrid system of pharmacovigilance that utilizes an online system of reporting pharmacovigilance incidences and a physical system, where a yellow book is physically filled by the healthcare worker and sent to the Pharmacy and Poisons Board for onward processing. This system, even though it has been relatively effective compared to other systems employed in Africa, has one major flaw. It is a slow and delayed system that captures the data much later after the fact and the agency will always be behind the curve in controlling the adverse incidents and events. This means that the incidences might continue to arise or go out of control. This project attempts to develop a system that would be more proactive in the collection of pharmacovigilance data and more predictive of pharmacovigilance incidences. The pharmacovigilance system should have the capacity to detect and analyze subtle changes in reporting frequencies and in patterns of clinical symptoms and signs that are reported as suspected adverse drug reactions. The method involved carrying out a thorough literature review of the latest trends in pharmacovigilance employed by different regulatory agencies across the world, especially the more stringent regulatory authorities. A review of the system employed by the Pharmacy and Poisons Board of Kenya was also done. Pharmacovigilance data, both primary and secondary, were collected and reviewed. Media reports on adverse drug reactions and poor-quality medicines over the period were also collected and reviewed. An appropriate predictive pharmacovigilance tool was also researched and identified. It was found that the Pharmacy and Poisons Board had a robust system of collecting historical pharmacovigilance data both from the healthcare workers and the general public. However, a more responsive data collection and evaluation system is proposed that will help the agency achieve its pharmacovigilance objectives. On analysis of the data it was found that just above half of all the product complaints, about 55%, involved poor quality medicines; 15% poor performance, 13% presentation, 8% adverse drug reactions, 7% market authorization, 2% expired drugs and 1% adulteration complaints. A regulatory pharmacovigilance prioritization tool was identified, employing a risk impact analysis was proposed for regulatory action.

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.

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.

Adverse drug reactions in adolescents: a review of reporting to a national pharmacovigilance system

2020 ◽  
Vol 19 (7) ◽  
pp. 915-922 ◽  
Author(s):  
Eva Rebelo Gomes ◽  
Inês Ribeiro-Vaz ◽  
Cristina Costa Santos ◽  
Maria Teresa Herdeiro
Keyword(s):  
Adverse Drug Reactions ◽  
Pharmacovigilance System ◽  
Drug Reactions

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.

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