<str<strong>on</strong>g>Guidel<strong>in</strong>es</str<strong>on</strong>g> <strong>on</strong> <strong>the</strong> Preventi<strong>on</strong> <strong>and</strong> C<strong>on</strong>trol <strong>of</strong> <strong>Tuberculosis</strong> <strong>in</strong> Irel<strong>and</strong> 2010HSE/HPSC• Management <strong>of</strong> sputum <strong>in</strong>ducti<strong>on</strong> to m<strong>in</strong>imise risk to staff <strong>and</strong> o<strong>the</strong>r patients• Reduc<strong>in</strong>g risk associated with immunosuppressed patients.Educati<strong>on</strong> <strong>of</strong> patients/family/carersSee appendices 6 <strong>and</strong> 11 for patient <strong>in</strong>formati<strong>on</strong> leaflet <strong>and</strong> hospital discharge leaflet. Some patients whoare <strong>in</strong>fectious can rema<strong>in</strong> at home <strong>in</strong> <strong>the</strong> household that has already been exposed, as it has been shownthat <strong>the</strong> risk <strong>of</strong> additi<strong>on</strong>al transmissi<strong>on</strong> <strong>of</strong> <strong>in</strong>fecti<strong>on</strong> <strong>in</strong> this sett<strong>in</strong>g is extremely low. 52The <strong>in</strong>fectious patient must be <strong>in</strong>structed to take <strong>the</strong> follow<strong>in</strong>g precauti<strong>on</strong>s until advised by <strong>the</strong>ir doctor toreturn to normal activities:• Stay at home <strong>and</strong> not go to work, school, public places or any o<strong>the</strong>r locati<strong>on</strong>s where <strong>the</strong>re willbe previously unexposed people until advised to do so by <strong>the</strong> treat<strong>in</strong>g cl<strong>in</strong>ician• No visits by previously unexposed people• No visits by children (young children liv<strong>in</strong>g at home will be assessed by public health doctorsregard<strong>in</strong>g <strong>the</strong> need for LTBI w<strong>in</strong>dow prophylaxis)• Avoid visits by relatives or friends who are immunosuppressed• Cover <strong>the</strong>ir mouth <strong>and</strong> nose with a tissue when sneez<strong>in</strong>g or cough<strong>in</strong>g.The <strong>in</strong>fectious patient must be educated regard<strong>in</strong>g:• Safe disposal <strong>of</strong> tissues <strong>and</strong> <strong>the</strong> importance <strong>of</strong> h<strong>and</strong> wash<strong>in</strong>g after cough<strong>in</strong>g/sneez<strong>in</strong>g• Disease transmissi<strong>on</strong> <strong>and</strong> disease c<strong>on</strong>trol• The importance <strong>of</strong> compliance with medicati<strong>on</strong>• Side-effects <strong>of</strong> anti-TB medicati<strong>on</strong>• C<strong>on</strong>tact trac<strong>in</strong>g.-87-
<str<strong>on</strong>g>Guidel<strong>in</strong>es</str<strong>on</strong>g> <strong>on</strong> <strong>the</strong> Preventi<strong>on</strong> <strong>and</strong> C<strong>on</strong>trol <strong>of</strong> <strong>Tuberculosis</strong> <strong>in</strong> Irel<strong>and</strong> 2010HSE/HPSC7. BCG Vacc<strong>in</strong>ati<strong>on</strong>The Bacillus Calmette-Guer<strong>in</strong> (BCG) vacc<strong>in</strong>e was derived by <strong>in</strong>-vitro attenuati<strong>on</strong> <strong>of</strong> <strong>the</strong> bov<strong>in</strong>e tuberclebacillus between <strong>the</strong> years 1908 <strong>and</strong> 1918 <strong>in</strong> France. WHO encouraged widespread use <strong>of</strong> <strong>the</strong> vacc<strong>in</strong>estart<strong>in</strong>g <strong>in</strong> <strong>the</strong> 1950s <strong>and</strong> as a result more than 70% <strong>of</strong> <strong>the</strong> world’s children now receive BCG. However,<strong>the</strong> policies <strong>on</strong> BCG vacc<strong>in</strong>ati<strong>on</strong> differ greatly both nati<strong>on</strong>ally <strong>and</strong> <strong>in</strong>ternati<strong>on</strong>ally, reflect<strong>in</strong>g differences <strong>of</strong>expert op<strong>in</strong>i<strong>on</strong> as to <strong>the</strong> mechanism <strong>of</strong> acti<strong>on</strong> <strong>and</strong> effectiveness <strong>of</strong> <strong>the</strong> vacc<strong>in</strong>e. 242 The potential loss <strong>of</strong> <strong>the</strong>tubercul<strong>in</strong> test as an <strong>in</strong>dicator <strong>of</strong> natural <strong>in</strong>fecti<strong>on</strong> with tubercle bacilli when BCG is rout<strong>in</strong>ely used may be adisadvantage that has to be weighed aga<strong>in</strong>st <strong>the</strong> benefits <strong>of</strong> <strong>the</strong> vacc<strong>in</strong>e.7.1 Cl<strong>in</strong>ical EfficacyThe cl<strong>in</strong>ical efficacy <strong>of</strong> a vacc<strong>in</strong>e is measured <strong>in</strong> terms <strong>of</strong> <strong>the</strong> percentage reducti<strong>on</strong> <strong>in</strong> disease am<strong>on</strong>gvacc<strong>in</strong>ated <strong>in</strong>dividuals that is attributed to vacc<strong>in</strong>ati<strong>on</strong> i.e. <strong>the</strong> proporti<strong>on</strong> <strong>of</strong> those vacc<strong>in</strong>ated who ga<strong>in</strong>protective immunity from <strong>the</strong> vacc<strong>in</strong>e. 243 BCG vacc<strong>in</strong>es are generally given to protect aga<strong>in</strong>st TB. BCGvacc<strong>in</strong>e does not give 100% protecti<strong>on</strong> but it does protect aga<strong>in</strong>st <strong>the</strong> more serious forms <strong>of</strong> <strong>the</strong> disease,e.g. TB men<strong>in</strong>gitis especially <strong>in</strong> <strong>the</strong> young. The NICE guidel<strong>in</strong>es cite evidence from both r<strong>and</strong>omisedc<strong>on</strong>trolled trials <strong>and</strong> case c<strong>on</strong>trol studies for <strong>the</strong> efficacy <strong>of</strong> BCG vacc<strong>in</strong>ati<strong>on</strong> <strong>in</strong> <strong>in</strong>fancy <strong>in</strong> prevent<strong>in</strong>gpulm<strong>on</strong>ary TB <strong>in</strong>fecti<strong>on</strong>, TB deaths, TB men<strong>in</strong>gitis, laboratory-c<strong>on</strong>firmed TB cases <strong>and</strong> dissem<strong>in</strong>ated TB. 26BCG vacc<strong>in</strong>e is probably most c<strong>on</strong>sistently effective aga<strong>in</strong>st tuberculous men<strong>in</strong>gitis <strong>and</strong> miliary TB withprotecti<strong>on</strong> last<strong>in</strong>g approximately 15 years. It is universally agreed that BCG vacc<strong>in</strong>e protects small childrenfrom severe forms <strong>of</strong> childhood TB especially <strong>in</strong> areas with a high risk <strong>of</strong> <strong>in</strong>fecti<strong>on</strong>. 244;245 In such areas withhigh <strong>in</strong>fecti<strong>on</strong> risk, WHO EPI programme reports a global coverage <strong>of</strong> BCG <strong>in</strong> children less than <strong>on</strong>e yearat around 85%. 246An extensive study by Tala et al. attempted to <strong>in</strong>terpret variati<strong>on</strong>s <strong>in</strong> <strong>the</strong> efficacy <strong>of</strong> BCG vacc<strong>in</strong>e. Factorsc<strong>on</strong>sidered to be important are age at adm<strong>in</strong>istrati<strong>on</strong>, prior exposure to envir<strong>on</strong>mental n<strong>on</strong>-tuberculousmycobacteria, efficacy <strong>of</strong> BCG vacc<strong>in</strong>e <strong>in</strong>clud<strong>in</strong>g vacc<strong>in</strong>e quality, host genetics <strong>and</strong> nutriti<strong>on</strong>, <strong>in</strong>fecti<strong>on</strong><strong>in</strong>cidence, <strong>the</strong> study design <strong>and</strong> <strong>the</strong> route <strong>of</strong> adm<strong>in</strong>istrati<strong>on</strong>. 247 A meta-analysis <strong>of</strong> large numbers <strong>of</strong> BCGefficacy trials revealed a protecti<strong>on</strong> rate aga<strong>in</strong>st pulm<strong>on</strong>ary TB <strong>of</strong> 86% <strong>in</strong> r<strong>and</strong>omised trials <strong>and</strong> 75% <strong>in</strong> casec<strong>on</strong>trol studies despite extensive use <strong>of</strong> <strong>the</strong> vacc<strong>in</strong>e. 40 Colditz et al. <strong>in</strong> a meta-analysis estimated <strong>the</strong> overallefficacy <strong>of</strong> BCG <strong>in</strong> prevent<strong>in</strong>g pulm<strong>on</strong>ary TB to be approximately 50%. Aga<strong>in</strong>st TB men<strong>in</strong>gitis <strong>the</strong> efficacywas 64% <strong>and</strong> aga<strong>in</strong>st TB deaths 71%. 248 In summary, <strong>the</strong>re is overall agreement that <strong>the</strong> efficacy <strong>of</strong> BCGis at its best about 80% 249 <strong>and</strong> <strong>of</strong> 15-20 years durati<strong>on</strong>. 250 Kritski et al. reported a protecti<strong>on</strong> rate <strong>of</strong> 69%aga<strong>in</strong>st MDR-TB <strong>in</strong> a recent study <strong>in</strong> 1996. 2517.2 Criteria for Disc<strong>on</strong>t<strong>in</strong>uati<strong>on</strong> <strong>of</strong> a Universal BCG Vacc<strong>in</strong>ati<strong>on</strong> ProgrammeIn 1994, <strong>the</strong> Internati<strong>on</strong>al Uni<strong>on</strong> aga<strong>in</strong>st <strong>Tuberculosis</strong> <strong>and</strong> Lung Disease (IUATLD) expert group publishedcriteria for disc<strong>on</strong>t<strong>in</strong>u<strong>in</strong>g BCG vacc<strong>in</strong>ati<strong>on</strong> programmes <strong>in</strong> countries with a low prevalence <strong>of</strong> TB. 252 Thesecriteria are outl<strong>in</strong>ed as follows:1IUATLD criteriaBefore c<strong>on</strong>siderati<strong>on</strong> is given to whe<strong>the</strong>r a country stops or modifies its BCG programme, <strong>the</strong> follow<strong>in</strong>grequirements must be met:• There is a well functi<strong>on</strong><strong>in</strong>g TB c<strong>on</strong>trol programme• There has been a reliable report<strong>in</strong>g system over <strong>the</strong> previous five or more years, enabl<strong>in</strong>g <strong>the</strong>estimati<strong>on</strong> <strong>of</strong> <strong>the</strong> annual <strong>in</strong>cidence <strong>of</strong> active TB by age <strong>and</strong> risk groups, with particular emphasis<strong>on</strong> TB men<strong>in</strong>gitis <strong>and</strong> sputum smear positive pulm<strong>on</strong>ary TB. In Irel<strong>and</strong>, nati<strong>on</strong>al data enabl<strong>in</strong>g adetailed epidemiological analysis for <strong>the</strong> country, as a whole was first produced by HPSC <strong>in</strong> <strong>the</strong>1998 Nati<strong>on</strong>al TB Report. The 2006 Nati<strong>on</strong>al TB Report is <strong>the</strong> n<strong>in</strong>th nati<strong>on</strong>al TB report.• Due c<strong>on</strong>siderati<strong>on</strong> has been given to <strong>the</strong> possibility <strong>of</strong> an <strong>in</strong>crease <strong>in</strong> <strong>the</strong> <strong>in</strong>cidence <strong>of</strong> TB result<strong>in</strong>gfrom <strong>the</strong> epidemiological situati<strong>on</strong> <strong>of</strong> AIDS <strong>in</strong> that country.15With <strong>on</strong>e <strong>of</strong> <strong>the</strong> follow<strong>in</strong>g• The average annual notificati<strong>on</strong> rate <strong>of</strong> sputum smear positive pulm<strong>on</strong>ary TB should be 5 per100,000 or less dur<strong>in</strong>g <strong>the</strong> previous three years-88-