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Assessment of the state of pharmacovigilance in the South-South zone of Nigeria using WHO pharmacovigilance indicators.

ABSTRACT: WHO pharmacovigilance indicators have been recommended as a useful tool towards improving pharmacovigilance activities. Nigeria with a myriad of medicines related issues is encouraging the growth of pharmacovigilance at peripheral centres. This study evaluated the status of pharmacovigilance in tertiary hospitals in the South-South zone of Nigeria with a view towards improving the pharmacovigilance system in the zone.A cross-sectional descriptive survey was conducted in six randomly selected tertiary hospitals in the South-South zone of the country. The data was collected using the WHO core pharmacovigilance indicators. The language of assessment was phrased and adapted in this study for use in a tertiary hospital setting. Data is presented quantitatively and qualitatively.A total of six hospitals were visited and all institutions had a pharmacovigilance centre, only three could however be described as functional or partially functional. Only one centre had a financial provision for pharmacovigilance activities. Of note was the absence of the national adverse drug reaction reporting form in one of the hospitals. The number of adverse drug reaction reports found in the databases of the centres ranged from none to 26 for the previous year and only one centre had fully committed their reports to the National Pharmacovigilance Centre. There were few documented medicines related admissions ranging from 0.0985/1000 to 1.67/1000 and poor documentation of pharmacovigilance activities characterised all centres.This study has shown an urgent need to strengthen the pharmacovigilance systems in the South-South zone of Nigeria. Improvement in medical record documentation as well as increased institutionalization of pharmacovigilance may be the first steps to improve pharmacovigilance activities in the tertiary hospitals.

SUBMITTER: Opadeyi AO

PROVIDER: S-EPMC5984375 | biostudies-other | 2018 May

REPOSITORIES: biostudies-other

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Assessment of the state of pharmacovigilance in the South-South zone of Nigeria using WHO pharmacovigilance indicators.

Opadeyi Abimbola O AO Fourrier-Réglat Annie A Isah Ambrose O AO

BMC pharmacology & toxicology 20180531 1

<h4>Background</h4>WHO pharmacovigilance indicators have been recommended as a useful tool towards improving pharmacovigilance activities. Nigeria with a myriad of medicines related issues is encouraging the growth of pharmacovigilance at peripheral centres. This study evaluated the status of pharmacovigilance in tertiary hospitals in the South-South zone of Nigeria with a view towards improving the pharmacovigilance system in the zone.<h4>Methods</h4>A cross-sectional descriptive survey was con ...[more]

PMID: 29855348

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Project description:Objectives: Pakistan felt the need for an effective and robust pharmacovigilance (PV) system after one of the deadliest drug-related tragedies causing more than 300 deaths in 2012. The country set up its national PV center in 2015 and joined WHO's Program for International Drug Monitoring (PIDM) in 2018 as a full member. The current study was aimed to evaluate the PV system's functionality, identify the gaps, areas of improvement, and a strategy to lead a functional PV system in Pakistan. Methods: The descriptive cross-sectional study was conducted by providing an interviewer-administered questionnaire of the PV system across Pakistan by utilizing the Indicator based Pharmacovigilance assessment tool (IPAT). By a convenience sampling method 36 study participants were selected from the Drug Regulatory Authority of Pakistan (DRAP), drug administration of provincial health departments of 4 provinces and federally affiliated areas, 5 national public health programs, and 23 public and private hospitals. The assessment includes document review, interviews of the key informants by structured open-ended questions, and a review of websites of relevant organizations. Results: Drug Regulatory Authority of Pakistan (DRAP) with a national PV center received a 75% overall performance score on IPAT. To be regarded as "minimally functioning," a country's PV and drug safety system must meet all core indicators. DRAP scored 80.76% on the core indicators so cannot be deemed functional at this time. The only province with a regional PV center, Punjab, had scored 72.13% on relevant parameters. Despite receiving funding from the Global Fund, none of the National Public Health Programs (PHPs) have PV centers or associated activities. All hospitals except two private hospitals could not qualify the minimum requirements for functional PV. The absence of a legal framework for mandatory ADR reporting, lack of drug information center, budgetary constraints, no active surveillance activities, the nonexistence of pharmacovigilance risk assessment expert committee, and insufficient coordination among stakeholders were identified as major gaps. Conclusion: The results of the study reveal that Pakistan's PV system is not fully functional at all levels. A two-phased strategy encompassing the non-financial and financial interventions is proposed to improve the PV systems at the national, provincial, PHPs, and hospitals levels.

Project description:BackgroundOur aim in this study was to evaluate the effect of a combined educational intervention and year-long monthly text message reinforcements via the Short Messaging System (SMS) on the knowledge, attitude and practice (KAP) of healthcare professionals (HCPs) towards pharmacovigilance.MethodsSix randomly selected teaching hospitals in the South-South zone of Nigeria were randomized in 1:1 ratio into intervention and control groups. The educational intervention consisted of delivering a seminar followed by sending monthly texts message reinforcements via SMS over 12 months. Then a semi-structured questionnaire regarding the KAP of pharmacovigilance was completed by HCPs working in the hospitals after the intervention. Data was analysed descriptively and inferentially.ResultsA total of 931 HCPs participated in the post intervention study (596 in the intervention and 335 in the control). The M:F ratio was 1:1.5. According to the KAP questionnaire, a significant difference was observed between the intervention and control groups, regarding knowledge of the types of adverse drug reactions (ADRs). ADR resulting from pharmacological action of the drug (85.6% versus 77%, p = 0.001), the fact that ADRs can persist for a long time; (60.1% versus 53.4%, p = 0.024) and a higher awareness of the ADR reporting form (48.7% versus 18.8%, p < 0.001). Most respondents in the intervention group (68.5% versus 60.6%, p = 0.001) believed they should report ADRs even if they were unsure an ADR has occurred, a greater proportion of HCPs from the intervention group had significantly observed an ADR (82% versus 73.4%, p = 0.001). Furthermore, of the 188 who had ever reported an ADR, 41% from the intervention group used the national ADR reporting form compared with 19.8% from the controls (p < 0.001).ConclusionThis educational intervention and the use of SMS as a reinforcement tool appeared to have positively impacted on the knowledge and practice of pharmacovigilance in South-South Nigeria with a less-than-impressive change in attitude. Continuous medical education may be required to effect long-lasting changes.

Project description:BackgroundHealth systems need to be evaluated to ascertain if they are meeting their objectives. There is an increased interest in health system responsiveness (HSR) as a means to appraise health systems. This becomes vital as we put people at the centre of integrated health systems and put a premium on their rights and perspectives. Thus, this study assessed the levels, distribution and factors associated with HSR in Oyo State.MethodsThe study was a cross-sectional study with 717 adults, who had used an out-patient health facility in the preceding 12 months, interviewed using a semi-structured, interviewer-administered questionnaire. HSR was measured on a multi-domain and multi-item (7 domains and 20 items) 5-point Likert scale that was developed by the WHO to measure HSR globally. Summary scores were computed for level, distribution and the most important domains of HSR. Determinants of poor HSR were determined using binomial logistic regression. The level of statistical significance was set at 5%.ResultsThe overall level of HSR was 47%. The highest-rated domains were confidentiality (72%), dignity (64%) and choice (60%), while the least rated were prompt attention (43%) and communication (52%). The overall distribution of HSR was 0.228 (range of 0 to 1) with the domains of prompt attention (0.595) and choice (0.506) being the most unequally distributed. The most important domains were communication, prompt attention and dignity. The least important domains were choice and confidentiality. The factors associated with poor HSR (overall) were no formal education, (OR = 2.81; 95% CI: 1.35-5.86), primary education as the highest level of education (OR = 2.19; 95% CI: 1.28-3.75), poor socioeconomic class (OR = 1.86; 95% CI: 1.23-2.80), using a government-owned facility (OR = 1.56; 95% CI: 1.11-2.19) and not using the usual health facility (OR = 1.69; 95% CI: 1.13-2.53).ConclusionsThe overall level of HSR in Oyo State was low with the domains of prompt attention, communication and autonomy being the least rated domains. Therefore, concerted efforts should be targeted at improving HSR as this will improve wellbeing, health system utilization, and the overall health system.

Project description:IntroductionOnchocerciasis or river blindness constitutes a major burden to households especially in resource-poor settings, causing a significant reduction in household productivity. There has been renewed interest from policy makers to reduce the burden of Neglected Tropical Diseases (NTDs) such as onchocerciasis on individuals and households. This paper provides new information on the patient's perceptions of onchocerciasis and its economic burden on households in South-eastern Nigeria. The information will be useful to health providers and policy makers for evidence-informed resource allocation decisions.MethodsInformation was generated from a cross-sectional household survey conducted in Achi community, Oji River Local Government Area (LGA) of Enugu State, Southeast Nigeria. A pre-tested interviewer-administered questionnaire was used to collect data. A total of 747 households were visited randomly and data were collected using pre-tested interviewer administered questionnaire from 370 respondents. The respondents' knowledge of the cause of symptoms of the disease, costs incurred for seeking treatment and productivity losses were elicited. Data were analyzed using tabulations and inferential statistics. A socio-economic status (SES) index was used to disaggregate some key variables by SES quintiles for equity analysis.ResultsMany people had more than one type of manifestation of onchocerciasis. However, more than half of the respondents (57%) had no knowledge of the cause of their symptoms. Male respondents had significantly more knowledge of the cause of symptoms than females (P = 0.04) but knowledge did not differ across SES (P = 0.82). The average monthly treatment cost per respondent was US$ 14.0. Drug cost (US$10) made up about 72% of total treatment cost. The per capita productivity loss among patients was US$16 and it was higher in the poorest (Q1) (US$20) and the third SES quintiles (Q3) (US$21). The average monthly productivity loss among caregivers was US$3.5.ConclusionOnchocerciasis still constitutes considerable economic burden on patients due to the high cost of treatment and productivity loss. Prioritizing domestic resource allocation for the treatment of onchocerciasis is important for significant and sustained reduction in the burden of the disease. In addition, focused health promotion interventions such as health education campaigns should be scaled up in onchocerciasis-endemic communities.

Dataset Information

Assessment of the state of pharmacovigilance in the South-South zone of Nigeria using WHO pharmacovigilance indicators.

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Assessment of the state of pharmacovigilance in the South-South zone of Nigeria using WHO pharmacovigilance indicators.

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