02446nas a2200361   4500000000100000008004100001260001200042653002200054100001200076700001300088700001400101700001600115700001200131700001200143700001200155700001500167700001500182700001600197700001200213700001400225700002200239700001400261700001500275700001400290700001700304700001400321245016300335856008100498300000900579490000700588520147500595022001402070       2021                            d  bMDPI AG10aPharmacovigilance1 aBarry A1 aOlsson S1 aKhaemba C1 aKabatende J1 aDires T1 aFimbo A1 aMinzi O1 aBienvenu E1 aMakonnen E1 aKamuhabwa A1 aOluka M1 aGuantai A1 avan Puijenbroek E1 aBergman U1 aNkayamba A1 aMugisha M1 aGurumurthy P1 aAklillu E00aComparative Assessment of the Pharmacovigilance Systems within the Neglected Tropical Diseases Programs in East Africa—Ethiopia, Kenya, Rwanda, and Tanzania  uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC7922898/pdf/ijerph-18-01941.pdf  a19410 v183 a<jats:p>Monitoring the safety of medicines used in public health programs (PHPs), including the neglected tropical diseases (NTD) program, is a WHO recommendation, and requires a well-established and robust pharmacovigilance system. The objective of this study was to assess the pharmacovigilance systems within the NTD programs in Ethiopia, Kenya, Rwanda, and Tanzania. The East African Community Harmonized Pharmacovigilance Indicators tool for PHPs was used to interview the staff of the national NTD programs. Data on four components, (i) systems, structures, and stakeholder coordination; (ii) data management and signal generation; (iii) risk assessment and evaluation; and (iv) risk management and communication, were collected and analyzed. The NTD programs in the four countries had a strategic master plan, with pharmacovigilance components and mechanisms to disseminate pharmacovigilance information. However, zero individual case safety reports were received in the last 12 months (2017/2018). There was either limited or no collaboration between the NTD programs and their respective national pharmacovigilance centers. None of the NTD programs had a specific budget for pharmacovigilance. The NTD program in all four countries had some safety monitoring elements. However, key elements, such as the reporting of adverse events, collaboration with national pharmacovigilance centers, and budget for pharmacovigilance activity, were limited/missing.</jats:p>  a1660-4601