There is no pharmacovigilance centre in my state, which is a malaria endemic zone. I want to get one on board. I would need to develop some hands-on training, as well as learn how to relate with and manage the personnel that are involved in the hospital setting.
Hi Thank you very much for your question. Pharmacovigilance is not my topic. I am specialised in malaria surveillance and we use WOOZANOO.
link to: https://portal.voozanoo.net/
Regards
You may follow 1.- A pasive register method through a designed format with key questions at the rural medical facilities and hospitals, so you can build a data base for basical satistical analysis. 2.- An active method with trained personal that will conduct field work with a previous designed format with the key question related to survillance variables, it may be a deign for the instrument to collect the information and also for the sampling method to cover your study universe, also the way you wil used to analyzed results has to be poredesigned.. 3.- a combination of the two already described but you must care a bout the way you will use to statistically extracte and interpret results.
Kind regards,
Santiago Ramos.
Pharmacovigilance is Phase IV Clinical Trials if you are engaged in Regulated Research on Malaria; Our (ZETA-12) CT Site Training for Phase IV studies is mainly on GPvP. But for Routine Clinical/Hospital practice in Nigeria, just use the NAFDAC Yellow forms to document your findings and report back to the Regulator. Ask Doctors and Head Nurses about the forms. I am aware some hospitals may not have them, but you can get them by contacting NAFDAC via their website, or at their regional office in Agulu. You will also see the draft regulation on Good Pharmacovigilance Practice (GPvP) on the NAFDAC website. http://www.nafdac.gov.ng/
Try to contact P. Caduff at Uppsala Monitoring Center. She worked on establishing PV in Tanzania.
May I suggest some helpful sources
1. Levine JG, 1. Tonning JM, Szarfman A. Reply: The evaluation of data mining methods for the simultaneous and systematic detection of safety signals in large databases: lessons to be learned. Br J Clin Pharmacol 2005; 61 (1):105-113.
2. ICTDR (International Centre for Tropical Diseases). Investigator manual.
Monitoring and reporting adverse events. 2005 Available from: www.icssc.org/.../ICTDR_AE_Manual_February_6_2003_final.pdf.
3. Talisuna AO, Staedke SG, D'Alessandro U. Pharmacovigilance of antimalarial treatment in Africa: is it possible? Malar J. 2006;5:50.
4. World Health Organization: The importance of pharmacovigilance: safety
monitoring of medicinal products. WHO, Geneva; 2002.
5. Kuemmerle A, Dodoo AN, Olsson S, Van Erps J, Burri C, Lalvani PS. Assessment of global reporting of adverse drug reactions for anti-malarials, including artemisinin-based combination therapy, to the WHO programme for international drug monitoring. Malar J. 2011; 9;10:57.
6. WHO. Introductory Guide MedDRA Version 14.0. 2011. MSSO-DI-6003-14.0.0 . http://www.who.int/medical_devices/innovation/MedDRAintroguide_version14
_0_March2011.pdf
Thank you.
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