New Guidelines on Look-alike Sound-alike Names for Health Products…

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NEWGUIDELINESONLOOK-ALIKESOUND-ALIKENAMESFORHEALTH
PRODUCTS…

CatherineDaigle*
LEGERROBICRICHARD
,L.L.P.
Lawyers,PatentandTrademarkAgents
CentreCDPCapital
1001Square-Victoria–BlocE–8thFloor
Montreal,Quebec,CanadaH2Z2B7
Tel.(514)9876242–Fax(514)8457874
www.robic.ca–info@robic.com
HealthCanada’snewGuidanceDocument“DrugNameReview:Look-alike
Sound-alike(LA/SA)HealthProductNames”hasbeenineffectsinceJanuary
1st,2006asananswertovariousmedicalstakeholders’concerns.Thus,since
thebeginningof2006,alldrugsubmissionsaresubjecttotheGuidance’s
rulesandregulations.
LA/SAnameswithspellingsimilaritiesand/orsimilarphoneticstendtocreate
confusionfortheHealthProductsandFoodBranch(HPFB)initsreviewand
analysisofahealthproductname.Furthermore,suchnamesmayconstitute
atangiblerisktoCanadians’healthbyincreasingthepotentialforerrorsin
theprescription,dispensingorintheadministrationofadrug.
Healthproductnames:howtoavoidconfusion
ThenewGuidancethereforeappliestoallhealthproducts,including
pharmaceuticalandbiologicalproducts,prescribeddrugsandover-the-
counterproducts,medicaldevices,naturalhealthproductsandveterinary
drugs.
InaccordancewiththeFoodandDrugRegulations,adrug’snamemustbe
providedwiththesubmissionofadrugtotheHPFBforapprovalaspartofthe
informationrequiredtoassessthesafetyandeffectivenessofaproduct.
Additionally,theGuidancenowrequiresthatallproposedbrandnames
submittedforreviewmustbeexaminedtoensurethattheyareunlikelyto
causemedicationerrorswithotherbrandnamesand/orgenericnames.



















































©CIPS,2006.
*OfLEGERROBICRICHARD
,L.L.P.,amultidisciplinaryfirmoflawyers,andpatentand
trademarkagents.PublishedintheFall2006issue(Vol.10,No.4)issueofourNewsletter.
Publication068.077E.

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Indeed,sponsorsshouldpaycarefulattentiontoLA/SAsimilaritieswith
productsthatarecurrentlyonthemarketinordertopreventpotentialerrors.
Inshort,theGuidanceaimstopreventandcurbspecificpracticesrelatedto
LA/SAhealthproductnames,includingthefollowing:
·similarbrandnamedesignations;
·useofsimilaroridenticalabbreviationsandsuffixes;
·brandnamedesignationssimilartogenericnames;
·resortingtotheextensionofalineofproduct(i.e.whenadrugis
namedbyusingthebrandnameofanotherdrug,andsimplyadding
toormodifyingtheprefixorsuffixwiththeintentofdistinguishingthe
newproductfromtheoriginal.)
HealthCanada’sGuidanceapplication
If,duringthedrugreviewprocess,theHPFBidentifiesapotentiallyconfusing
name,itmaybedisallowedandconsequently,theproposedproductwillbe
issuedaNoticeofCompliance(NOC)oraNoticeofNon-compliance(NON),
asapplicabledependingofthefollowing:
·ifthebrandnameisatissue,aNOCwillbeissuedwithoutthebrand
name;
·iftheissueisrelatedtothepropername,whichisdefinedasthe
assignednameofaparticulardrugorthecommonname(i.e.the
usualnameunderwhichaparticulardrugisknown),thenaNONwill
beissued,sinceahealthproduct’sNoticeofConformitycannotbe
issuedwithouttherelatedproperorcommonname.
Inordertoavoidtheissuanceofan”incomplete”NOC,orworse,aNON
pursuanttoadrugreview,acautioussponsorwillprovidetheHPFBwitha
prioritizedlistofnamechoices(maximumoftwo).Shouldthefirstname
chosenberejected,thesubsequentnameonthelistwouldthenbeassessed.
Inaddition,thesponsorshouldalsosubmitariskassessmentandan
evaluationoftheproduct’sproposedbrandnamewhichwouldbe
supportedbystudies,dataandanalysis.
Inaworldofeverevolvingscientificdiscoveriesofnewtechniquesof
assessment,wecanhardlyhope,however,forthedevelopmentofa
foolprooftechnologythatwouldallowustopreventmistakeslinkedtoLA/SA
names.Nevertheless,anevaluationoftherisksmayincludebutwouldnotbe
limitedtothefollowingelements:searchforsimilarproprietaryandnon-
proprietarybrandnames;computeranalysisofbothspellingandphonetic
similarities;verbalandhandwrittenprescriptiontestingstudies;reviewof
medicationerrors(forexample,regardingdosageformoradministration);
and,finally,processflowstudies,fromthetimeofpurchasetoadministration.

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Duringthedrugnamereview,theHPFBwillmoreparticularlyconsiderthe
followingcriterion:
·themarketingstatusoftheproduct,whetheritisaprescribeddrugor
self-carehealthproduct;
·thetherapeuticcategory;
·theindicationsand/ordirectionsforuse;
·theclinicalsettingfordistributionoruseofadrug;
·thepackaging,thelabellingandthestorageofthehealthproduct;
·thestrength;
·thedosageformormethodsofadministration;
·theproposeddosageanddosinginterval;
·groupsofsimilarpatients.
Similarly,duringthereviewofanoff-the-shelfhealthproduct,theHPFBwill
alsotakeintoconsiderationtheretailplacementoftheproduct,whilegiving
lessconsiderationtoothercriteriasuchasstrengthanddosageform.
Inconclusion,HealthCanada’sapplicationofthenewGuidancewhich
considersthespecificsafetyissueslinkedtotheLA/SAnamesishenceforth
anessentialguideforprofessionalsofthehealthcareindustry,whowillnow
beabletousesuchtooltoassistthemincomplying,moreefficiently,with
applicablepoliciesandlegislation.

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