HST 303, INTRO TO PHARMACOLOGY.pdf

HST303 I NTRODUCTI ONTOPHARMACOLGY ByOny ekaNwadi nigwe Et ymol ogy /Def ini ti...

HST303 I NTRODUCTI ONTOPHARMACOLGY ByOny ekaNwadi nigwe Et ymol ogy /Def ini ti on Thewor d"phar macol ogy "isder ivedf rom Gr eekwor d,phar makon-" drug, poi son, spel l " andl ogi a-" studyof "," knowl edgeof ". Phar macol ogyr elat est othest udyofdr ugscommonl yusedi nthet reat mentofdi sease. Phar macol ogyi sthest udyofdr ugs,t hei rsour ces,uses,pr oper ti es,act ion,ef fect sand modeofact ionont hebody.It ' sthest udyofsubst ancest hati nter actwi thl i ving sy stemsespeci all ybybi ndi ng t oregul ator ymol ecul esand act ivat ing ori nhi bit ing nor mal bodypr ocesses. HI STORY/ DEVELOPMENTOFPHARMACOLGY The or i gins ofpharmacologydate back tot he Mi ddl e Ages.I n medievalti mes, apothecaries(inawaycrudepharmacistusedtopr epareal l sor tofst rangeconcocti ons, i ncludingt hoseofherbs,nat uralsubstancesinordertotreatthei rpati ents.Thei rwork wasn'tallt hatsci enti fi cnoral lthatsuccessful.Itwasmor eoftr aditi onalmedici ne basedonbel i efs, skil l s,experi encespassedfrom onegener ati ontoanother. Crudedr ugshavebeenusedsi ncepr ehi storyasapr eparat ionofsubstancesf r om naturalsour ces.Howev er ,theacti veingredi entsofcrudedr ugsarenotpuri f i edandthe substanceisadul t erat edwi t hot hersubstances.Tr aditionalmedicinev ariesbetween cult ures and may be speci f ic t o a par ti cular culture, such as i n tr aditi onalChinese,Mongoli an,Ti betanandKor eanmedicine. Inthe16thand17thcentury, theEngl i shPhysici anNichol asCulpeper(1616–1654)al so th contri butedtowardsthegrowt hofpharmacology.Thoseti mesint he16 cent ur y,Lat i n wast heuni ver salacceptedl anguageofknowl edgeinmedicineandphar macology , i nsteadofusi ngLatin,hetranslat ed,publ ishedandwr oteinEngli sh,pharmacological textsanddetail edplantsandcondi t ionsi tcant r eat.Becauseofthis, thekings,l awy ers andpr i est satt hattimewereagainsthim.Hegav eheal erswhocoul dnotr eadLatin, accesstomedi calandPharmaceut icalknowl edge.Hisworkpopulari zedherbali sm and madeunder standingofherbsandt heiruseseasier.Hededi catedhimselftowards servi ngthesickandt hepoor. Inthe late 18t h and ear ly19t h century,Francois Magendi e( French Phy si ologi st /Pharmacol ogist1783–1855)andl aterhisstudentCl audeBer nardbegant odev elop themet hodsofexper imentalani malphy si ologyand phar macology.Hei nt roduced ani malexper i ment ati onasbasi sforknowl edgegener at i oni nscienti ficmedi cine.He i nvestigatedmanybodysy stems( eg.thehear t,venoussy stem,bloodv essels,li verand absorpti on i nt he i ntesti ne).From her e,he dev eloped hy pothesisf rom cl inical observati ons and t ested laboratoryout comes i n pati ents,pr ot ocols wer e used t o changecl inicalpr acti ce.Hi swor kon absor ption int hei nt esti nes,v enoussy stem str etchedmor et han40y ears( 1809–1850)andi thelpedi nunder st andinghowdr ugs workatt heor ganandt i ssuel evel. OswaldSchmi edebergin19t hcentury(GermanPhar macologist,1838–1921)st udied the pharmacol ogyofv arious compounds,i ncl uding chloroform,and publ i shed an i mpor tanttextcalledtheOut li neofPhar macology.Hiswor kl ar gelydeal twit hfinding thecorrel ationbetweent hechemi calstruct ureofsubstancesandt heireff ecti venessas pharmaceut i cals.Inhi smanydecadesofpr acti ceandt eachi ng, Schmi edeber gwast he personwhoal mostsingle- handedl ytrai nedt hemaj or it yofot hermenwhowoul dt hen becomel eader sinpharmacologyal loverthewor l dinthey earst ocome.Thi sincl uded Amer i canJohnJacobAbel , t hef i rstchairofpharmacologyatanyU. S.univer sit y.Duet o hiscontri butionstothefiel d,Schmi edebergwasknownas' t hef atherofpharmacology '. Thewor kofSchmiedeberg,Abel,andot hersli kethem,l eadtot her api dgr owthinthe fi eldofpharmacologyi nthe20t hand21stcent ur ies.Manydr ugs,fr om l if esav ing anti biot ics,t oimpor t anthor monalcompoundslikei nsuli n(totreatdiabetes)were devel oped.Pharmacologi stsnotonl yst udiedwhatef fectsadrugwouldhav eonan ani mal orahuman,theyalsostudiedt hedrugit sel f. Ger manyl edthewayinphar macologi calresear charoundt het imeofWor l dWarII ,it wastheUnitedStat esinpar ti cul arwhol edtheway,inmanyr espect s,af tert hewar. Her e,thepharmacol ogi cal. Now, moder n phar macologists use t echni ques f r om genetics, mol ecul ar bi ology,biochemist ry,and ot heradv anced toolst ot ransf orm informati on about molecularmechanismsandt argetsint otherapiesdi r ect edagainstdisease,defectsor pat hogens, and cr eat e met hods f or pr ev ent ati ve car e, diagnost ics, and ul ti mat elypersonal i zedmedi cine. DI VISI ONSOFPHARMACOLGY 1.Phar macoki net ics. 2.Phar macody nami cs. Ot herdi vi sions— 1.Phar macot her apeut ics. 2.Cl i nical phar macol ogy( 3.Toxi col ogy 4.Phar macogenet ics 5.Phar macoepi demi ology 6.Compar ati vePhar macol ogy 7.Posol ogy 8Ani mal Phar macol ogy Ther apeut ics:Thebr anchofphar macol ogyt hatdeal swi tht hear tandsci enceof t reat mentofdi sease.I tist heappl i cat ionofphar macol ogi cali nfor mat iont oget herwi th t heknowl edgeofdi sease, fort hepr event ionandcur eoft hedi sease. Cl i nicalPhar macol ogy :ist hesci enceofdr ugsi nhumansandt hei ropt imal cli nical use i npat ient s.I tinv olv escl i nicalcar e,t eachi ngandeducat ionf orpat ient sandr esear ch.I t i ncl udesphar macoki net icandphar macody nami cinv est igat ionsi nheal thyordi seased i ndi vi dual s.Themai nobj ect ivesar e: 1. Maxi mizet heef fectofdr ug 2. Mi nimi zet headv erseef fect s 3. Pr omot esaf etyofpr escr ipt ion. Toxi col ogy :ist hebr anchofphar macol ogywhi chi ncl udest hest udyofadv erseef fect s ofdr ugsont hebody.Itdeal swi tht hesy mpt oms, mechani sms, treat mentanddet ect ion ofpoi soni ngcausedbydi ff erentchemi calsubst ances.I tdeal swi thpoi sonousdr ugs, t hei rsour ce, proper ti es, sign- sympt omst heypr oduceandmanagementofpoi soni ng. Phar macogenet ics/ Phar amcogenomi cs:i sthest udyofhow genesaf fectaper son’ s r esponset odr ugs.Thi srel ati vel ynew f iel dcombi nesphar macol ogy( thesci enceof dr ugs)andgenomi cs( thest udyofgenesandt hei rfunct ions)t odev elopef fect ive, saf e medi cat ionsanddosest hatwi l lbet ail oredt oaper son’ sgenet icmakeup.I tdeal swi th t hegenet icv ari ati onst hatcausedi ff erencei ndr ugr esponseamongi ndi vi dual sor popul ati on. Exampl e:Abacav iri sahi ghef fect ivet reat mentf orHI V,i twasdi scov eredt hatar ound5 t o8%ofpat ient ssuf fersev eresi deef fect ssuchasr ash, fat igueanddi arr hea.I n2002, sci ent ist sident if iedapar ti cul argenev ari ant ,cal l edHLA- B*5701, asbeent hekeyf act or i nhy per sensi ti vi tyt oabacav ir.I ndi vi dual swi tht heHLA- B*5701wer efoundt obemor e l i kel yto hav e a hy per sensi ti vi tyr eact ion t o abacav ir.Hence,scr eeni ng a pat ient dr ast ical l yreducedt hesi deef fect sbei ngexper ienced. Phar macoepi demi ology :ist hest udyoft heut il izat ionandef fect sofdr ugsi nlar ge number sofpeopl e;i tpr ovi desanest imat eoft hepr obabi l ityofbenef ici alef fect sofa dr ugi napopul ati onandt hepr obabi l ityofadv erseef fect s.I tcanbecal l edabr idge sci ence spanni ng bot h cl i nical phar macol ogy and epi demi ology. Phar macoepi demi ologyconcent rat esoncl i nicalpat ientout comesf rom t her apeut icsby usi ng met hods ofcl i nicalepi demi ology and appl yi ng t hem t o under standi ng t he det ermi nant sofbenef ici alandadv ersedr ugef fect s,ef fect sofgenet icv ari ati onondr ug ef fect ,dur ati on- responser elat ionshi ps,cl i nicalef fect sofdr ug- drugi nter act ions,and t he ef fect s of medi cat ion non- adher ence. Phar macov igi l ance i s a par t of phar macoepi demi ology Phar macoepi demi ologydeal swi tht he ef fect sofdr ugson a l arge popul ati on.The ef fect smaybegoodorhar mful.Iti sconduct edi nthr eeway s: a. Obser vat ional cohor tst udi es b. Casecont rol studi es c. Phaset ri als Compar ati vePhar macol ogy :Br anchofphar macol ogydeal i ngwi tht hecompar isonof onedr ugt oanot herbel ongi ngt othesameoranot hergr oup. Posol ogy :deal swi thdoseorquant it yofdr ugswhi chcanbeadmi nist eredt othepat ient t ogetdesi redphar macol ogi calact ion.Exampl eincl udespar acet amolgi venasone t abl etof500mgt hri ceaday. Ani malPhar macol ogy :deal swi tht hedi ff erentpr oper ti esofdr ugsi nani mal s.Av ast v ari etyofani mal sar eut il izedi ncl udi ngr abbi ts, micegui neapi gs, etc.Dr ugsar egi vent o t heani mal sandal lpar amet ers( thei rbehav ior ,act ivi tes,v italsi gns,et c.)ar erecor ded. Anychangei snot eddown.I ffoundt obeusef uli nani mal s,t hent hedr ugi stest edon humans.  CONCEPTANDNATUREOFDRUGS Adr ugcanbedef inedasanyman- made,nat ural ,orendogenous( from wi thi nbody ) mol ecul ewhi chexer tsabi ochemi calorphy siol ogi calef fectont hecel l ,ti ssue, organ, or or gani sm.Hence,i tisanysubst ancet hatbr ingsaboutachangei nbi ologi cfunct ion t hroughi tschemi cal act ions. I ngr eatmaj ori tyofcases,t hedr ugmol ecul eint eract swi thaspeci fi cmol ecul eint he bi ologi csy stem t hati sar ecept ormol ecul e.I nor dert oint eractchemi cal l ywi thi ts r ecept oradr ugmol ecul emusthav eappr opr iat esi ze, shape, andat omi ccomposi ti on. Fur ther mor e,adr ugi sof tenadmi nist eredatal ocat iondi stantf rom i tsi ntendedsi teof act ion,egapi l lgi venor all ytor eli evepai norheadache.Ther efor e,ausef uldr ugmust hav enecessar ypr oper ti est obet ranspor tedf rom t hesi teofadmi nist rat iont oit ssi teof act ion. Apr act icaldr ugshoul dbei nact ivat edorexcr etedf rom t hebodyatar easonabl erat eso t hati t' sact ionwi l lbeofappr opr iat edur ati on. Phy sicalNat ure:Dr ugsmaybesol i datr oom t emper atur e(eg.Aspi ri n,par acet amol ), l i qui d(eg.et hanol ,sy rup)orgaseousoraer osol s(ni tr ousoxi de, sal but amoli nhal er).For exampl esomel i qui ddr ugscaneasi l yvapour izeandcanbei nhal edi nthatf orm eg. Hal othane.I tal sogoeswi tht her out esofadmi nist rat ion.  PHARMACOKI NETI CS&PHARMACODYNAMI CS Two maj or ar eas t hat concer n i n phar macol ogy ar e phar macoki net ics and phar macody nami cs. Phar macoki net ics:Thewor dPhar macoki net icsi sder ivedf rom t ds,Phar wowor macon meani ugandki ngdr net icsmeani ngput ti ngi nmot ion.I tcanbedef inedas:Thebr anch ofphar macol ogyt hatdeal swi tht heabsor pti on,di str ibut ion,met abol i sm andexcr eti on ofdr ugsandt hei rrel ati onshi pwi tht heonset ,dur ati onandi ntensi tyoft hedr ugef fect. Whatt hebodydoest othedr ugi sphar macoki net ics. Thi nkaboutwhathappenswhen y oueatf oodort akedr ugs.Thef oodt rav elsf rom y ourmout htot hest omachandt hen t othei ntest ines.Al ongeachst epoft hepr ocess, thef oodi sbr okendown, nut ri ent sar e absor bed and wast eisr emov ed.Phar macoki net icsi sthest udyofhow t hebody absor bs,di str ibut es,met abol i zes,andexcr etesdr ugs.Adr ugmaybeadmi nist eredv ia or al,par ent eral( suchast hroughani nject ion) ,ori ntr avenous( int othebl oodst ream, t hroughanI V). Phar macody nami cs:( whatt hedr ugdoest othebody )isabr anchofphar macol ogyt hat deal s wi tht he mechani sm of act ion,phar macol ogi calef fect s,i ndi cat ion and cont rai ndi cat ionofuseandadv erseef fect sofdr ugs. Whatt hedr ugdoest othebodyi sphar macody nami cs.Forexampl e,Opi oiddr ugs, t ypi fi edbymor phi ne,pr oducet hei rphar macol ogi calact ions,i ncl udi nganal gesi a,by act ingonr ecept orsl ocat edonneur onalcel lmembr anest heser ecept orsar ecal l ed opi oidr ecept ors.I tdeal swi thhowt hedr ugaf fect stheor gani sm t hati nvol vesr ecept or bi ndi ng, ithel pst odef inet her elat ionshi pbet weent hedoseandr esponser elat ionshi p. Dr ugswor kbyi nter act ingwi tht argetmol ecul esf oundatt hesi teofact ion, andal ter ing t hei ract ivi tyi nawayt hati sbenef ici alt oheal th.Dr ugt arget sar eusual l ybi omol ecul es suchaspr otei ns,pr otei ncompl exes,ornucl eicaci dst hatpl ayar olei napar ti cul ar di seasepr ocess.I nmostcases, thedr ugmustt empor ari l yat tach( bind)t othet argett o exer tit sact ion.Thedr ugt argetbi ndi ngcanei therst imul atet het argetorbl ockt he nor mal act ivi tyoft het arget ,resul ti ngi naphy siol ogi cal eff ect. Asi mpl eanal ogyof tenusedt odescr ibedr ugt argeti nter act ionsi sthatofal ockand keyt het argeti sal ockonadoort hatonl yacer tai ndr ug( thekey )canbi ndt oandopen. I deal l y,t hekeyshoul dnotf itanyot herl ock, anddi ff erentkey sshoul dnotopent hisl ock. Somekey smayf iti nthel ock,butnotper fect ly.Consequent ly,t hesei mper fectkey s cannotopent hedoor.Yet ,byf it ti ngi ntot hel ock, imper fectkey spr eventt heor igi nal key f rom f it ti ngi ntot hel ock; theyt her efor ebl ockt hedoorf rom openi ng. Phar macoki net icPar amet ers  Absor pti on Bi oav ail abi l ty  Di str ibut ion Vol umeofdi str ibut ion Pr otei nbi ndi ng  Met abol i sm Bi ologi cal hal fli fe, Eli minat ion. Cl ear ance Bi oav ail abi l ty:Ther ateandext entofdr ugabsor pti on.Thef ract ionoft headmi nist ered doser eachi ngt hesy stemi cci rcul ati on.ForI Vis100%, nonI.V.r angesf rom 0t o100%. Di str ibut ioni nphar macol ogyi sabr anchofphar macoki net icswhi chdescr ibest he r ever sibl etr ansf erofadr ugf rom onel ocat iont oanot herwi thi nthebody.Onceadr ug ent ersi nto sy stemi cci rcul ati onbyabsor pti onordi rectadmi nist rat ion,i tmustbe di str ibut edi ntoi nter sti ti alandi ntr acel l ularf lui ds.Eachor ganort issuecanr ecei ve di ff erentdosesoft hedr ugandt hedr ugcanr emai nint hedi ff erentor gansort issues f orav ary ingamountoft ime. Thedi str ibut ionofadr ugbet weent issuesi sdependentonv ascul arper meabi l ity , r egi onalbl oodf low, car diacout putandper fusi onr ateoft het issueandt heabi l ityoft he dr ugt obi ndt issueandpl asmapr otei nsandi tsl i pidsol ubi l ity.pH par ti ti onpl aysa maj orr oleaswel l.Thedr ugi seasi l ydi str ibut edi nhi ghl yper fusedor ganssuchast he l i ver ,hear tandki dney.Iti sdi str ibut edi nsmal lquant it iest hroughl essper fusedt issues l i kemuscl e,f atandper ipher alor gans. Dr ugmet abol i sm i sthet erm usedt odescr ibet hebi otr ansf ormat ionofphar maceut ical subst ancesi nthebodysot hatt heycanbeel i minat edmor eeasi l y.Themaj ori tyof met abol i cpr ocessest hati nvol vedr ugsoccuri nthel i ver ,ast heenzy mest hatf aci l itat e t her eact ionsar econcent rat edt her e. Dr ugscanbemet abol i zedbyoxi dat ion,r educt ion,hy drol ysi s,hy drat ion,conj ugat ion, condensat ion,ori somer izat ion;what evert hepr ocess,t hegoali stomaket hedr ug easi ert oexcr ete.Theenzy mesi nvol vedi nmet abol i sm ar epr esenti nmanyt issuesbut gener all yar e mor e concent rat ed i nthe l i ver.Dr ug met abol i sm r ates v aryamong pat ient s.Somepat ient smet abol i zeadr ugsor api dlyt hatt her apeut ical l yef fect ivebl ood andt issueconcent rat ionsar enotr eached;i not her s,met abol i sm maybesosl owt hat usualdoseshav etoxi cef fect s.I ndi vi dualdr ugmet abol i sm r atesar einf luencedby genet icf act ors,coexi sti ngdi sor der s(par ti cul arl ychr oni cli verdi sor der sandadv anced hear tfai l ure) ,anddr ugi nter act ions( especi all ythosei nvol vi ngi nduct ionori nhi bit ionof met abol i sm). Thepat ientf act orst hataf fectt her ateofmet abol i sm i ncl ude:  agenet icpr edi sposi ti on  chr oni cli verdi sor der s  adv ancedhear tfai l ure  i nter act ionswi thot herconcur rentmedi cat ions. Excr eti oni sthepr ocessofr emov ingadr ugandi tsmet abol i tesf rom t hebody.It pr edomi nant lyoccur svi aur inef ormedi ntheki dney s.Ot herr out esofexcr eti onf rom t hebodycani ncl udei nbi l e,sal i va,sweat ,tear s,f aeces,mi l kandexhal edai r.Most dr ugsar emet abol i sedf ir stpr iort obei ngexcr eted. Thr eepr ocesscanoccuri nrenalexcr eti on:gl omer ularf il tr ati on,t ubul arsecr eti onand passi ver eabsor pti on.Somedr ugsar eel i minat edbyt hel i veri nthebi l eandexcr etedi n f eces.Renal excr eti oni sthemostcommonr out eofdr ugel i minat ion. DEFI NITI ONOFTERMS Hal fli fe: Thi sist heper iodoft imer equi redf ort heconcent rat ionoramountofdr ugi n t hebodyt ober educedbyone- hal f.I tist het imei ttakesf ort hepl asmaconcent rat ion ort heamountofdr ugi nthebodyt ober educedby50%. Canal someant het imei ttakesf oranamountofacompoundt ober educedbyhal f t hroughdegr adat ioni nanenv ironment alcompar tment( wat er, soi l ,ai r,et c).I tisusedt o measur etheper sist enceofasubst ance. Medi cat ion/ Drug:Anysy nthet ic,semi synt het ic,ornat uralchemi calsubst anceusedi n t het reat ment ,pr event ion,ordi agnosi sofdi sease,orf orot hermedi calr easons.The obj ect ive ofdr ug t her apyi sto br ing pl asma concent rat ion wi thi nthe t her apeut ic wi ndow. Dosager egi men:i stheschedul eofdosesofamedi cine,i ncl udi ngt het imebet ween doses,t hedur ati onoft reat mentand t heamountt o bet akeneacht ime.Dosage r egi mensal soi ncl udehowamedi cinei stobet aken,andi nwhatf ormul ati on( dosage f orm).Iti sthemodal i tyofdr ugadmi nist rat iont hati schosent oreacht het her apeut ic obj ect ive.Thi sdependsont hedr ugused,t hecondi ti ont obet reat ed,andt hepat ient 's char act eri sti cs. Thedeci sionsdef ini ngdosager egi menar eabout : 1.Rout eofadmi nist rat ion 2.Thef ormul ati on/ dosagef orm, 3.Uni tdose 4.Fr equency 5.Loadi ngdose 6.Lengt hoft reat ment /dur ati on DRUGI NTERACTI ON Adr ugi nter act ioni sasi tuat ioni nwhi chasubst ance( usual l yanot herdr ug)af fect sthe act ivi tyofadr ugwhenbot har eadmi nist eredt oget her.Thi sact ioncanbesy ner gist ic ( when t he dr ug' s ef fecti sincr eased)OR ant agoni sti c(when t he dr ug' s ef fecti s decr eased)oranewef fectcanbepr oducedt hatnei therpr oducesoni tsown.Ty pical l y, i nter act ionsbet weendr ugscomet omi nd( drug- drugi nter act ion).Howev er, int eract ions mayal soexi stbet weendr ugsandf oods( drug- foodi nter act ions) ,aswel lasdr ugsand medi cinal plant sorher bs( drug- planti nter act ion). Out comeofI nter act ions: Enhancementi ndr ugact ion/ impr ovedt her apeut icbenef it s. Reduct ioni ndesi reddr ugef fect.  Neut ral i sat ionofdr ugef fect( ther apeut icf ail ure). I ncr easedr iskofadv erser eact ions. ESSENTI ALDRUGS Essent ial DrugsPr ogr amme( EDP) Essent ialmedi cines,asdef ined byt heWor ld Heal th Or gani zat ion ( WHO) ,ar ethe medi cinest hat" sat isf ythepr ior it yheal thcar eneedsoft hepopul ati on".Thesear ethe medi cat ionst owhi chpeopl eshoul dhav eaccessatal lti mesi nsuf fi cientamount s.The pr icesshoul dbeatgener all yaf for dabl elev els. WHO publ i shedamodell i stofessent ialmedi cines.Eachcount ryi sencour agedt o pr epar ethei rownl i stst aki ngi ntoconsi der ati onl ocalpr ior it ies.Ov er150count ri eshav e publ i shedanof fi ci alessent ialmedi cinesl i standt heyr efert oWHOr ecommendat ions whenmaki ngdeci si onsonheal thspendi ng The f ir stedi ti on ofNi gier ia EDL was publ i shed i n 1989 i n accor dance wi tht he pr ovi si onsoft heDecr ee43of1989.I nor dert ogui det her ati onaluseoft heseessent ial medi cinesi nNi ger ia,St andar dTr eat mentGui del i nes( STGs)hav ebeendev eloped.The Nat ionalEssent ialMedi cinesLi stCommi tt ee( NEMLC) ,appoi ntedbyt heMi nist erof Heal th,i sresponsi blef orf ormul ati ng and r evi sing t he Nat ionalLi stofEssent ial Medi cines. EDLwasi ntr oducedt oimpr ovesuppl y,accessofdr ugs, rat ionalpr escr ibi nganduseof dr ugscor recti mbal ancei nthesuppl yanddemandofdr ugsandal sol owercostof dr ugs,i tisbasedonpr eval entdi seases. The essent ial dr ugs concept encompasses nat ional dr ug pol i cy, sel ect ion, quant if icat ion,qual i ty assur ance,pr ocur ement ,inv ent ory cont roland di str ibut ion, f inanci ng, rat ional druguse, andt rai ning. Cr it eri aforsel ect ingEDL Forthedrugtobei ncl udedi ntheEDL,itmustsati sfyt hefol l owi ngcr it eri abasedon phi losophyofEDL.Thedrugt obeincl udedi ntheli stmust:  Sat isf ytheneedsoft hegr eatmaj ori tyofpat ient sorcl i ent satal ll evel sofheal th car edeli ver y.  Itmusthavesuf fi cientev idenceofsafet yandef fi cacyf rom cont rol l edcl i nical studi esaswel lasfr om experi encedur inguse.  I tmustbepr esent edinrelev antdosageform withreasonabl eshelfl if eby Ni geri anstandardandenv ironment alcondi ti ons.Expi rydateandbatchnumber mustbef eatured.  Itmustbe capable ofbei ng manuf act ured by accr edit ed phar maceut ical companiesusi ngl ocal lysour cedori mport edrawmat eri alsori mportedi nbul k cheapl y.  Mustbeprefer ablysel ectedingeneri cform andnoti ntradeandbrandnames. TheInt ernat ionalNon-propr iet ory(gener ic)Nomencl ature(I NN)fordrugsor phar maceuti cal substances should be used whenev er avail abl e. Eg. Metr oni dazolenotFl agyl.  Thosewi thunpr ovenordoubt ful ther apeut icef fect sar etobeexcl uded.  Pr efer enceshoul dbegi vent odr ugswi thbet terr iskr ati o.  Ther emustbev ali dcer ti fi cat ionf rom l ocal inst it uti on, count ryofor igi nandWHO.  Asmuchaspossi bl e,choosesi mplecomponentdrugl i kepar acet amolandnot with caff eine,butifcombined choose t hose t hathav e been known and acceptabl e. I MPORTANCE/ADVANTAGESOFEDL  Prol ifer ati oniscur bedsi ncef ewerdr ugsar ebeendeal twi thi ntheheal thcar e deli verysyst em.  I tiseasierf orpract it ioner stof amili ari sethemsel veswi th phar macol ogi cal pr oper ti esandnamesasgeneri crathert hantr adenames.  Dr ugut il isat ioncanbemoni tor edeasi l yatv ari ousl evel sofheal thcar e.  Iti seasi erfordr ugcont rolagencyt ofor mul atest rat egi esf orqual i tyassur ance andmonit ori ng.  I thel pst oquant if yandest imat etr