Browsing by Author "Nwokike, J."
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Item A situational analysis of pharmacovigilance plans in the Global Fund Malaria and U.S. President's Malaria Initiative proposals(2010-05-30) Stergachis, A.; Bartlein, R.J.K.; Dodoo, A.; Nwokike, J.; Kachur, S. P.Abstract Background Pharmacovigilance programmes can monitor and help ensure the safe use of medicines that are critical to the success of global public health programmes. The widespread deployment of artemisinin-based combination therapy (ACT) by national malaria control programmes as part of the overall Global Malaria Action Plan for malaria control to elimination and eradication makes ACT an excellent candidate for pharmacovigilance activities. In 2008, The Roll Back Malaria partnership issued guidelines for inclusion of pharmacovigilance in Global Fund and other related proposals. In light of this recommendation and the rapid scale-up of ACT worldwide, an analysis of Global Fund Round 8 proposals and the President's Malaria Initiative (PMI) 2009 Malaria Operational Plans was conducted to assess if and how pharmacovigilance has been incorporated into countries' national malaria plans and donor budget requests. Methods The Global Fund - Malaria Round 8 proposals for the 26 countries and the PMI Malaria Operational Plans (MOPs) for fiscal year 2009 for the 15 countries that were approved and received funding from either the Global Fund - Malaria Round 8 or PMI were accessed through the programme websites. The analysis consisted of conducting word counts and key word in context analyses of each proposal and plan. Results Twelve out of 26 (46%) of the Global Fund proposals mentioned that established pharmacovigilance systems were present in their countries. Four of the fifteen PMI MOPs (27%) mentioned that established pharmacovigilance systems were present in their countries. Only seven of the 26 (27%) Global Fund proposals included a request for funding for new or current pharmacovigilance activities. Seven of 15 (47%) MOPs included a request for funding for pharmacovigilance activities. Conclusions There were relatively few requests for funding for pharmacovigilance activities, demonstrating a lack of emphasis placed on pharmacovigilance systems in recipient countries. The findings stress the need for more active direction to strengthen active surveillance and passive adverse event reporting systems to augment the issuance of guidance documents.Item Consumer reporting of suspected adverse drug reactions: modelling the acceptance of mobile phone caller tunes to raise awareness(Journal of Pharmaceutical Health Services Research, 2019-10-14) Kretchy, I.A.; Appiah, B.; Yoshikawa, A.; Asamoah-Akuoko, L.; Anum, D.A.; Samman, E.; Goulart, A.; Nwokike, J.; Dodoo, A.N.O.; Darko, D.M.; Rene, A.Objectives Our main aim was to identify the factors that may influence consumers’ acceptance of mobile phone caller tunes to increase awareness of consumer reporting of suspected adverse drug reactions (ADRs). Mobile phone caller tunes — the songs or messages callers hear — are popular in Africa and Asia but have not been used to aid reporting of adverse drug reactions (ADRs). We also aimed to evaluate the psychometric properties of a survey instrument adapted for caller tunes and ADRs. Methods A cross-sectional survey based on the technology acceptance model (TAM) was conducted among 486 non-ADR-themed caller tune users and 470 mobile phone users with no caller tunes in Accra, Ghana. Participants were purposively recruited from voluntary blood donation sites. After testing the validity and reliability of TAM constructs, a structural equation modelling approach was used to evaluate the factors that could influence the acceptance of caller tunes for increasing awareness of consumer reporting of ADRs. Key findings Perceived usefulness and perceived ease of use had significant positive effects on consumers’ acceptance of caller tunes for increasing awareness of consumer reporting of ADRs. However, whereas free of cost had significant positive effects on the acceptance of caller tunes among those with non-ADR-themed caller tunes (b = 0.15, P = 0.006), it was not so for those lacking caller tunes (b = 0.05, P = 0.229). The survey instrument met acceptable validity and reliability criteria. Conclusions Our findings show that consumers would generally accept caller tunes on ADRs — if created — to aid consumer reporting of suspected ADRs, but there are research and practice considerations.Item Global pharmacovigilance for antiretroviral drugs: Overcoming contrasting priorities(PLoS Medicine, 2011-07) Bakare, N.; Edwards, I.R.; Stergachis, A.; Pal, S.; Holmes, C.B.; Lindquist, M.; Duncombe, C.; Dodoo, A.; Novendstern, J.; Nwokike, J.; Kuchenbecker, R.; Aberg, J.A.; Miller, V.; Strobos, J.As of 2010, over 5 million peopleworldwide have access to antiretroviraldrugs (ARVs) [1]. With increased accesscomes a greater need to monitor andpromote the safety and effectiveness ofthese essential medicines. Few resource-limited countries have all the structures,systems, or resources necessary to supportmedicines safety activities [2,3]. Diverseinternational efforts to provide optimaltreatment could be compromised by theabsence of robust strategies and frame-works for monitoring of inappropriate use,toxicity, drug-drug interactions, diversion,and substandard medicines [4]. Whileisolated episodes of substandard medica-tion distribution have been identified andhandled through the involvement of theWorld Health Organization (WHO), glob-al pharmacovigilance is needed to fullyunderstand the extent of the issue. Loss ofconfidence in the safety of ARVs couldlead to poor adherence and the emergenceof drug resistance, reduced demand fortherapy, or inappropriate switching tomore toxic or expensive medicines. Asustainable pharmacovigilance system canhelp achieve comprehensive, safe, andeffective healthcare. Efforts to date haveattempted to address the need for respon-sive drug safety monitoring systems forARVs in resource-limited settings (RLS)but with varying success. The Forum forCollaborative HIV Research (Forum) wasasked to use its neutral setting for keystakeholders from the United Nations andgovernment agencies, donors, industry,academia, multilateral organizations, andimplementers to discuss the creation of asustainable global pharmacovigilance sys-tem for ARVs that would be applicable inRLS. A meeting was convened by thecovigilance systems, the need to developsystems that may differ from well-estab-lished models, and the need to assess thefeasibility of novel models offer opportu-nities for innovation. Barriers among thesechannels of funding in established systemsare not applicable in RLS. Sustainableglobal pharmacovigilance must derivesupport from operational, research,andprogrammatic funds as programs, such ashealth care delivery and pharmacovigi-lance, are inextricably intertwined in thissetting with the need for epidemiologicaland implementation researchItem A situational analysis of pharmacovigilance plans in the Global Fund Malaria and U.S. President's Malaria Initiative proposals(Malaria Journal, 2010) Stergachis, A.; Bartlein, R.J.K.; Nwokike, J.; Kachur, P.S.