WHO Drug Information Vol. 25, No. 2, 2011

WHO Drug Information Vol. 25, No. 2, 2011Safety and Efficacy Issuesment of oral clefts in infants of womentreated with topiramate (Topamax® andgeneric products) during pregnancy.Topiramate is an anticonvulsant used totreat epilepsy. It is approved for use toprevent migraine headaches. Topiramateis being placed in Pregnancy Category Dindicating positive evidence of humanfetal risk but with potential benefits thatmay be acceptable in certain situationsdespite its risks.Reference: FDA Drug Safety Communication,4 March 2011 at http://www.fda.gov/Drugs/DrugSafetyWHO training course onpharmacovigilanceA recent survey by the WHO Programmefor International Drug Monitoring identifiedserious gaps in technical capacity forpharmacovigilance (PV) in resourcelimited settings. The Inter-regionalPharmacovigilance Training Course, heldin February 2011 in New Delhi, India, waspart of the WHO strategy to help establishminimum standards for PV as identifiedby WHO and the Global Fund during aconsensus meeting in 2010.The course identified leveraging opportunitiesoffered by liaison and sharingresources with lymphatic filariasis publichealth programmes. By introducing PVwithin mass preventive treatment campaigns,the quality of care and patientsafety within such programmes could besignificantly improved.The specific objectives of the trainingcourse were to:• Raise awareness about public healthissues and patient safety in relation tothe use of medicines.• Demonstrate the importance of PVactivities in improving patient safety andtreatment outcomes.• Provide training on the latest tools inbasic adverse drug reaction (ADR)reporting, to enhance reporting withincountries and to the WHO Programmefor International Drug Monitoring.• Build or reinforce capacity of nationalPV centres.• Share experiences and challengesfaced in establishing or strengtheningPV programmes.• Establish networking among regulatoryagencies, PV centres, national neglectedtropical diseases (NTD) controlprogrammes and WHO for informationsharing and providing assistance indetecting signals and making judgmentsbased on sound science.Two participants per country attendedfrom Cambodia, Lao PDR, Maldives,Nepal and Viet Nam, with six participantsfrom India. Others represented thenational PV centre or the NTD controlprogramme.The five-day course covered the followingtopics:• WHO Programme for International DrugMonitoring.• Establishing a PV centre; how to promotereporting.• Vigibase (a WHO global database ofindividual case reports), VigiFlow (aweb-based case report managementsystem), WHO Adverse ReactionTerminology and WHO Drug Dictionary.• Causality assessment.• Collaboration with public health programmesand NTD control programmesin particular.• Risk management and the prevention ofADRs.111