Global Programme to Eliminate Lymphatic Filariasis ... - libdoc.who.int

13further scaling up of MDA provided the above-mentionedpharmacovigilance activities continued. However, thecommittee pointed out the increased possibility of idiosyncraticadverse drug reactions with successive annualdrug administrations to the same patients. This alsomeans that the occurrence of SAEs may increase and subsequentlylead to reassessment of the safety of the drugs.In all communities receiving co-administered albendazoleplus DEC as part of a programme to eliminateLF, any SAE must be identified and handled in the mostmedically responsible way possible. The SAE must thenbe reported immediately on the standard reporting form,as prescribed by the national regulatory bodies, as wellas to WHO and the drug manufacturers concerned.This reporting requirement means that there must bea defined route of communication and access from thepatient to the health-care system that is well understoodand available during at least the first week (but preferablytwo weeks) following drug administration.For other adverse drug reactions that might develop,medical care must also be available, but no specific monitoringor reporting of side-effects is required.SUPPLYING QUALITY MEDICINES FORFILARIASIS ELIMINATIONThe drugs required to interrupt LF transmission are albendazole,DEC and ivermectin. Mass treatment using thesedrugs calls for the distribution of huge numbers of tablets,which requires innovative logistics (see Table 1.3).In December 1997, GlaxoSmithKline (GSK) (then known asSmithKline Beecham) – announced it would donate albendazoleto WHO for use by national elimination programmesof LF-endemic countries and collaborating partners ofGPELF. In 1998, Merck and Co., Inc. extended its donationof ivermectin (Mectizan®) to include Yemen and the Africancountries where onchocerciasis and LF are co-endemic(39 countries in Africa are known to be LF-endemic, 28 ofwhich are co-endemic with onchocerciasis).GlaxoSmithKlineGSK is an active partner in the global effort to eliminateLF. At the second meeting of the Global Allianceto Eliminate Lymphatic Filariasis, held in New Delhi,India, in May 2002, Dr J.-P. Garnier, Chief ExecutiveOfficer, GSK, announced the donation of the first 100million albendazole tablets since the inception of the LFelimination effort four years earlier. Dr Garnier also reconfirmedGSK’s fervent dedication to working with WHO,ministries of health of LF-endemic countries, Merck &Co., Inc. and other partners of the Global Alliance to helpachieve the goal of global elimination of the disease.In 2003, GSK supplied 94 million albendazole tablets to34 countries for MDA programmes (Uganda had no MDAin 2003 and Guyana uses DEC-fortified salt).Merck & Co., Inc. — Mectizan® Donation ProgramThe role of the Mectizan® Expert Committee/AlbendazoleCoordination (MEC/AC) and its secretariat, theMectizan® Donation Program (MDP), is to ensure thesafe and appropriate co-administration of ivermectin(Mectizan®) plus albendazole for the elimination of LF.Since 2000, national elimination programmes in areaswhere LF and onchocerciasis are co-endemic have appliedto MEC/AC and to WHO for donations of the two drugs,ivermectin plus albendazole, to provide the LF-endemicpopulations with the combined drug treatment.In 2003 the MDP supplied more than 65 million ivermectintablets to eight countries for MDA programmes.Diethylcarbamazine citrateTo fulfil the mandate of eliminating LF as a publichealth problem by the year 2020, it was estimated thatsupplies of DEC would be needed for 15 years, representingapproximately 15 billion quality-assessed tablets,manufactured according to good manufacturingpractices (GMP) by reliable companies able to deliver ontime. These practices ensure that products are consistentlyproduced to the standards appropriate for theirintended use and in accordance with the product specifications.In order to identify sources of DEC, informationwas sought from:• regulatory authorities willing to supply informationon manufacturers that had registered DEC for sale incountries where LF is a public health problem;• LF programmes that had purchased DEC;Annual Report on Lymphatic Filariasis 2003Chapter 1 Progress of the Global Programme to Eliminate Lymphatic Filariasis