SPECIALACCESSPROGRAMME

FORMA– PATIENT SPECIFICREQUEST

SECTIONA:PRACTITIONERINFORMATION
Practitioner’sName:
Hospitalor ClinicName:(ifapplicable)
Address: (shippingaddressonly)
City: / Province:BC / PostalCode:
ContactPerson:(ifotherthanpractitioner) / SendDrugc/o:
In-patientHospitalPharmacy
Practitioner’sOffice NuclearMedicine BloodBank
ContactTelephone#:
ContactFax#:
Contact’sEmailAddress:(optional) / Practitioner’sEmailAddress:(optional)
SECTION B:DRUGANDMANUFACTURERINFORMATION
TradeName: HERCEPTIN / OtherName: Trastuzumab
Manufacturer:Hoffmann-La Roche / PO#:
RouteofAdministration: ORALI.V.I.M.TOPICALS.C.OTHER:
DosageForm: TABCAPLIQUIDPOWDERCREAMOINT.PATCHOTHER:
SECTIONC:PATIENTINFORMATION
If you have supplyof the drug on handandwould liketo transferit to another patient,thus requiring authorizationonly, please check here and complete the table below. Specify the amountbeing transferred in thequantity section.
Patient
Initials
(e.g. A.B.C.) / DOB (DD/MM/YYYY) / Gender / IndicationforUseofDrug / Newor Repeat patientviathe SAPforthis drug? / Dosageand
Duration
(e.g.#mgbidx#days) / Strength
(e.g.#mg) / Quantity
(e.g.##tabs)
M F / N R
M F / N R
M F / N R
M F / N R
PleasespecifytheEXACTAMOUNTofdrugrequested(e.g.numberoftabs,vials,units,etc.).TheSAPwillnotcalculate quantity. / Total:
Please specifywhenthedrug will be administered/dispensed?(i.e. a date):

RevisedJanuary 20084

SECTIOND:CLINICALRATIONALE
1a) Fornew patients,provide specificinformationabout your patient(s)’s medical history including conventional therapies considered, ruledout and/orfailedorthat areunsuitableand/or unavailable to achievean adequateresponse.Whatspecifically about this drug (e.g. mechanismofaction,drug class,dosageform) makes it the best choicefor yourpatient(s)’s? Please explain.
Treatment of HER2 +ve metastatic breast cancer
b) Forrepeat patients,describe yourpatient(s)’sresponse tothe drug relative tothe initial treatment goal(s) and provide a rationale forrequestingcontinued access.
2.Please provide SPECIFIC data,references and/orresources in yourpossession,withrespect to theuse, safety and efficacy that support yourdecision to prescribe this drug. Forcitations include,journal/articletitles, author(s),volume, issue,dateand page information. Check here if reference(s) is/are attached
Canadian product monograph of HERCEPTIN®
SECTION E:PRACTITIONERATTESTATION
I,thepractitioner,amaccessingthisnon-marketeddrugfor useintheemergencytreatmentofa patientundermycareinaccordancewiththeFood andDrugRegulationsC.08.010.
I,thepractitioner,amawarethatbyaccessingthisdrugthroughtheSAP,thesaleofthedrugisexemptfromallaspectsoftheFoodandDrugs
Regulations includingthoserespectingthesafety,efficacyandquality.
I,thepractitioner,agreetoprovidea reportontheresultsofthe use ofthedrugincludinginformationonAdverseDrugReactionsand,onrequest, to accountforquantitiesofthedrugreceived.
Practitioner’sSignature: / License#:
Date:

Special AccessProgramme Therapeutic ProductsDirectorate c/o Health Canada

AL 3105 A Tunney’s Pasture Ottawa,ON

K1A0K9

FAX all requeststo (613) 941-3194

For urgentrequestsrequiring immediate attention please followup with a call tothe SAP at:

(613) 941-2108.

AUTHORIZATIONONLY VALIDWITHSIGNATURE &SAP STAMP

website: email:

RevisedJanuary 20085