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

12Annual Report on Lymphatic Filariasis 2003Chapter 1 Progress of the Global Programme to Eliminate Lymphatic Filariasisreactions in a sub-population of 1000–2000 individualswho are generally representative of the population tobe covered. Such monitoring consisted of interviews onday 5, day 6 or day 7 after treatment to elicit whether ornot side-effects were experienced after the drugs weretaken. A standard questionnaire was designed to recordadverse reactions in individuals who had ingested theco-administered drugs during MDA. The type of adversereaction and its severity was recorded. Data from 13 programmesin 12 countries were analysed. Out of the 27912 respondents, 18 081 took DEC plus albendazole and9831 took ivermectin plus albendazole in the first roundof MDA. Of the respondents, 25.6% reported an adversereaction after taking the drugs (26.5% who had takenDEC plus albendazole and 24% who had taken ivermectinplus albendazole). However, in only 3.5% (5.4% in theDEC plus albendazole group and 1.4% in the ivermectinplus albendazole group) was the adverse reaction of suchseverity that they were unable to function normally intheir daily activities of going to work or school. The mostcommon adverse reactions in the DEC plus albendazolegroup were dizziness, headache, nausea and fatigue; inthe ivermectin plus albendazole group they were headache,joint or muscular pains, nausea and abdominalpain.In February 2003, the WHO Safety Review Committee,consisting of programme staff and external and internalexperts on drug safety, reviewed the use of the combineddrugs. Based on the data collected, the committee cameto the following conclusions and recommendations,which were endorsed by TAG-LF at its fourth meetingin March 2003.• After reviewing the findings of the active surveillancefollowing single exposure to co-administered drugs in27 912 individuals (18 081 received DEC and albendazole,while 9831 received ivermectin and albendazoleco-administrations), the committee concluded thatthe frequency and intensity of the reported reactionswere in line with previously documented reactions.• Based on this finding, the committee decided thatthere was no need to continue with the active surveillancefor side-effects. Furthermore, because of thenature of the reactions observed, the committee didnot expect significant changes in the pattern and frequencyof these particular adverse reactions in subsequentexposure to the drugs.• The committee recommended that in future the focusshould be on the identification and management ofidiosyncratic reactions to the drugs, and in particularto the serious adverse experiences (SAEs) followingdrug administration. Programme managers shouldbe instructed to report any such reactions.• An SAE is defined as an adverse experience followingtreatment with a drug that results in any of the following:— death;— life-threatening condition;— in-patient hospitalization or prolongation of anexisting hospitalization;— persistent or significant disability or incapacity;— congenital anomaly or birth defect;— cancer;— overdose (accidental or intentional).Important medical events not resulting in death or a lifethreateningcondition or requiring hospitalization maybe considered SAEs when, based upon appropriate medicaljudgement, they jeopardize the patient or subject andmay require medical or surgical intervention to preventone of the outcomes listed in the above definition; suchevents should also be reported.The report of an SAE should be handled with utmosturgency and should initially be taken care of accordingto local regulations before immediate forwarding toWHO by the national programme manager.• The committee reinforced TAG-LF’s recommendationsto:— encourage programme managers to be vigilant andreport pregnant women who are excluded fromdrug exposure during MDA;— use the last menstrual period as an appropriatemeasure to prevent drug administration to pregnantwomen during MDA campaigns.Based on the review of the status of the national programmesand the materials presented, there was noobvious cause for concern about the continuation and