IPU Application Form
Use this form to apply for approval for hospital use of a medicine in an individual patient.
In most circumstances, a formal formulary submission will be required if a drug is used on an IPU basis in
more than 3 patients. In such cases, the formulary submission form should be used instead of this form.
Patient details
Patient name:
MRN:
Weight:
Date of Birth:
Planned treatment commencement date:
Location (ward/clinic):
Is this patient’s area of residence outside SESLHD?
Product Profile
Australian Approved (generic) Name
Trade Name
Dosage Form(s) – provide full details
Manufacturer/Supplier
Pharmacological class and action
(summary)
Indication(s) for use
Is the drug approved by the Therapeutic Goods Administration (TGA) for marketing in Australia?
YES
NO
What are the proposed indication(s) for drug use in this patient?
Is this is a TGA approved indication?
YES
NO
Is the drug listed on the hospital formulary for other indications?
If YES, list current formulary approval (including restrictions):
YES
NO
SESLHD District Form: F020
Revision 3
TRIM: T14/33102
October 2014
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IPU Application Form
PBS Listing
Is the drug listed as a benefit under the Pharmaceutical Benefits Scheme?
If YES:
Section 85?
Yes
No
Section 100?
Is the proposed indication approved for subsidy under the PBS?
YES
YES
NO
NO
YES
NO
If no, explain implications for continuity of supply. (For example, will the drug be supplied for inpatient use,
outpatient use or both? Will the hospital be required to provide ongoing therapy after discharge?)
Outcome/date of PBAC considerations for this indication:
Reasons for request
Explain your reasons for wanting to use this drug.
Treatment details:
Dosage, administration details,
duration of treatment, concomitant
therapy, etc
Alternate therapy:
Describe previous therapy and
outcomes.
Monitoring requirements:
Describe the objective criteria that will
be used to monitor effectiveness.
Treatment end point:
Detail expected clinical outcome and
treatment period.
SESLHD District Form: F020
Revision 3
TRIM: T14/33102
October 2014
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IPU Application Form
Efficacy:
Provide a summary of the evidence for
efficacy of this drug for this indication.
Indicate level of evidence (see below)
Safety:
Provide a summary of the evidence for
safety of this drug for this indication.
Indicate level of evidence (see below)
Grading for Level of Evidence*
Level I
Level II
Level III
Level IV
Evidence obtained from systematic review of relevant randomised controlled trials
Evidence obtained from one or more well-designed, randomised controlled trials
Evidence obtained from well-designed, non-randomised controlled trials or from well
designed
cohort, case control or interrupted time series studies
Case series with either post-test or pre-test/post-test outcomes
* From NHMRC interim levels of evidence 2005:
www.nhmrc.gov.au/publications/_files/levels_grades05.pdf
Attach details of proposed protocol and/or relevant supporting documentation (published data etc).
List documentation included:
# Financial implications:
Provide an estimate of cost using the table below and/or explain the basis of the cost estimate.
a. Dose per day
b. Duration of treatment in days
c. Total number of dosage units per day
d. Cost per dosage unit
$
e. Cost per treatment course (b x c x d)
$
f. Additional costs (drugs, monitoring, etc)
$
g. Total cost of treatment course (e + f)
$
h. Total annual cost for chronic treatment
$
i. Total cost of current/alternative therapy
$
Estimate of any costs savings / further explanation
Any resource implications for other services?
(eg. Infusion lounge booking, pharmacy
manufacture)
# If >$10,000 per annum or per treatment course, approval from Head of Department AND comment
from General Manager required prior to referral to - Drug and Quality Use of Medicines Committee
SESLHD District Form: F020
Revision 3
TRIM: T14/33102
October 2014
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IPU Application Form
Conflicts of interest
Financial or other interests resulting from contact with pharmaceutical companies which may have a
bearing on this submission:
Gifts
Travel expenses
Samples
None
Other support (describe)
Industry paid food/refreshments
Honoraria
Research support
Details of applicant
Requested by
Name of Applicant
Position /
Appointment
Contact Details
(Postal address,
email, telephone)
Signature
Date
Endorsed by
Name of Unit Head
Position /
Appointment
Contact Details
(Postal address,
email, telephone)
Date
Signature
Comment from General Manager / Budget Holder (# required if cost >$10,000)
Name
Signature
Date
Now complete checklist ►
Tick
All sections of form completed (including endorsement/comment)
Supporting data attached (relevant clinical papers, consensus guidelines, etc)
Prescribing criteria / protocol / guideline attached
►Forward completed form to local Pharmacy Department
SESLHD District Form: F020
Revision 3
TRIM: T14/33102
October 2014
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IPU Application Form
For Drug and Therapeutics Committee Use Only
Reference Number:
Comparative approvals (other hospitals):
Suitable consumer product information:
Hazardous substance – risk assessment:
Outcome of application process:
Process
Date / Details / Notes
Application received
By/date
Application considered
By/date
Outcome:
Approved
Rejected
Deferred
Conditions of approval
(Specify restrictions)
or
Reason for rejection/deferral
Approval review date
(if applicable)
Applicant advised of outcome
(Date)
Copies to:
Signed on behalf of Drug Committee:
____________________________________________________
Date: ____________________
SESLHD District Form: F020
Revision 3
TRIM: T14/33102
October 2014
Page 5 of 5