PBS1

2
Medicare Australia
 Medicare Australia is responsible for the
operation of the PBS.
Its functions include:
PBS  Processing pharmacists’ claims using the claims transmission
system (CTS)
 Managing the Safety Net arrangements
 Approval of Authority prescriptions
National Health Act  Approval of pharmacists to supply PBS drugs
PBS  Approval for doctors to supply PBS drugs (inadequate pharmacy
services)
 Approval of private hospitals to supply PBS meds
24 June 2010 School of Pharmacy and Molecular 1 24 June 2010 Discipline of Pharmacy and Experimental Pharmacology
School of Biomedical Sciences
Sciences
3 4
PBS Functions Background

 Encouraging appropriate prescribing by  Began in 1947
medical partitions through education  139 drugs
and practice feedback  Expert committee (precursor PBAC)
 life saving or disease-preventing drugs
 Performing prescription audits  tailored to the health needs of the country
 Detecting and investigating suspected  available for prescription free of charge
cases of fraud and inappropriate  Preceded by the RPBS
practice  Began in 1919
 Pharmaceutical Benefits Act 1947
 Opposed by the BMA
24 June 2010 Discipline of Pharmacy and Experimental Pharmacology 24 June 2010 Discipline of Pharmacy and Experimental Pharmacology
School of Biomedical Sciences School of Biomedical Sciences
5 6
Background Background
 1950’s  1970’s
 National Health Services Act  Cyclone Tracey
 Free drugs listed in BP for pensioners  Section 100
 PBAC fformed
d
 Independent statutory body
 1980’s
 National Health Act 1953  Low-income category introduced
 1960’s  Safety-net
 National Health Act 1959  1990’s
 Co-payments introduced (5 shillings)  Co-payment for pensioners
1
7
Listing process 8
PBS – 2005
 Core to ‘access’ arm of NMP  Embodied in Part VII National Health
 >600 drug substances
Act 1953
 ~1500 forms and strengths
g  Section 101
 ~2500 different brands  PBAC makes recommendations to the Minister
 ~500 are “Authority”  Minister to declare only after receiving the
 ~700 are “Restricted” recommendation of the PBAC
 >170M prescriptions
 >$5 Billion
 Growing 10%
http://www.cfses.com/pharma/documents/05-Trends_in_Pharmaceuticals_PBS.PDF
9 10
Listing process Steps in listing

 Section 101 1. Submission
 “….Committee shall give consideration to • Pharmaceutical company
the effectiveness and cost of therapy
involving the use of the drug
drug, preparation • Healthcare p
professionals
or class, including by comparing the • Must be TGA approved
effectiveness and cost of that therapy • Provide data of:
with that of alternative therapies, whether  Details of proposed dug
or not involving the use of other drugs or
 Results of comparative RCTs
preparations”
 Modelled economic evaluation
 Estimated use and financial implications
11 12
Steps in listing Steps in listing

2. External review 4. PBAC meeting
• Three centres • Considers data from
• Prepare
p expert
p commentary
y  Commentary
 ESC advice
 Response from sponsor
3. Considered by ESC (Economic Sub-
Committee)
5. PBPA
• Reports to PBAC
• Negotiates a final price
• Report sent to sponsor
2
13 14
Steps in listing Types of recommendations

6. Recommendation to Minister  Reject and resubmit
 Defer
• >$10M goes to Cabinet  List – unrestricted
 List – with restrictions
 Restricted benefit
7. Listed in next Schedule  Authority required
 Recommended quantities/repeats
 Acute : course
 Chronic : six months supply total
15 16
The Schedule
 Section 1 – explanatory notes
 Section 2
 Ready-prepared items
 Forms
 Manner of administration
 Brand and brand equivalents
 Maximum quantity and maximum repeats
 Emergency drug supplies (doctors bag)
 Palliative care
 Dentist’s and optometrists lists
 S100 items
 Section 3 – container fees, fees related to dispensing, standard packs

and prices for ready prepared preparations
 Section 4 – extemporaneous preparations
 RPBS items
17 18
How are medicines subsidized How are medicines subsidised

 Research and development  PBAC – Pharmaceutical Benefits
 Average 8 – 12 years and costs in excess of $300 Advisory Committee
million
 Listing
g onto the PBS
 TGA
 Recommendations to Minister for Health
 Assesses and monitors activities to make sure that
 Safety
and Aged Care
 Quality  Meet four times a year
 Effectiveness
 Are of appropriate standard
3
19 20
How are medicines subsidised How are medicines subsidised

 Pharmaceutical Benefits Pricing Authority  Doctors prescribe the medication
(PBPA)
 Pharmacists dispense the medication
 Recommends a price range for the medicine to
Minister for Health and Aged Care  Pharmacists make a claim
 Final price is negotiated with manufacturer  Medicare Australia process the claim
 Minister’s Approval
 Medicine listed in the Schedule of
Pharmaceutical Benefits
21 22
Legislative responsibilities Legislative responsibilities

 Pharmaceutical Benefits Scheme  Approval granted subject to:
 Fulfils requirements of the National Health Act  Benefits will only be supplied to eligible
1953 persons
 New edition is published every 3 months  Australian residents
 Approved providers have a responsibility to  Visitors with a signed reciprocal Health Care
Agreement with the Aust Govt
comply with the National Health Act (1953)
and the National Health (Pharmaceutical  Relevant patient contribution (brand price
premium and/or therapeutic group
Benefits) Regulations (1960)
premium will be charged
Who can receive PBS 23 24
prescriptions? No Medicare card?

 Act changed in 2000  Person telephones the Medicare Information line
 Gives the pharmacist consent to obtain your
 May 2002 mandatory Medicare card details over the phone
 Australian resident  Person pays the full price and claims the refund later
 Medicare Card from a Medicare office.
 Use special numbers for emergencies
 Reciprocal health arrangement  Attach photocopy or complete form
 Italy, New Zealand, the Republic of Ireland,
Finland, Malta, the Netherlands, Sweden  NOTE: pharmacist can record Medicare card details
and the United Kingdom. for future use, but consent is required to do this.
(Section 86D)
 Temporary Medicare card or passport
4
25 Regulations for valid supply of 26
Legislative responsibilities pharmaceutical benefits

 Relevant patient contributions will not be  Schedule of Pharmaceutical Benefits
waived, discounted or refunded
 Benefits will not be supplied or advertised at  Failure to comply could lead to
reduced prices  Non
Non-payment
payment of a dispensed medication
 Profession’s ethical standards will be followed  Referral to a Committee of Inquiry
 Prosecution
 IF THESE OR OTHER CONDITIONS ARE
BREACHED, APPROVAL TO SUPPLY
BENEFITS WILL BE SUSPENED OR
REVOKED
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Preparing general 28
Prescriptions prescriptions
 Eligible prescribers  Must be written by doctor, dentist or optometrist
 Registered doctors, dentists and optometrists  Must be for the treatment of the named person
who are approved to work within the PBS  Must include prescriber’s names and address as will
 Prescription forms (Doctors) as the letters PBS, RPBS or NHS as applicable
 Personalised forms (Dent and Optom)  Prescriber must only write one prescription for the
same pharmaceutical benefit for the same person
 Non-personalised forms (Dent for emergency during a single day
supply only)
 Up to three pharmaceutical benefits may be included
 Locum forms on a single prescription form, except Authority
 PBS/RPBS Authority forms required, Authority required (STREAMLINED) and
 Computer prescription forms optometrists items
prescriptions prescriptions
 Pharmaceutical Benefits and non-  If any item is restricted, but the patient
pharmaceuticals benefits should not be is not suffering from one of the
listed together on one prescription specified conditions, it can not be
 If an item has a special manner of prescribed as a PBS item
administration it may not (as a  PBS/RPBS should be crossed out and
pharmaceutical benefit) be used in any endorsed ‘Non-PBS’
other way
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Preparing general 31 32
prescriptions Writing prescriptions

 A prescription is invalid if it lists a drug  Must be written in indelible form in the
of addiction and another pharmaceutical prescriber’s own handwriting or
benefit on one form, and directs that the  On a computer form approved by the HIC
supply of either is to be repeated  Must record prescribers name and address
(dentist and optometrists need to include
 A prescriber can not prescribe a prescriber number)
narcotic drug for him/herself
 Patient’s name, address and entitlement
 Prescribers should not use other script status and whether the script is under the
pads – stops confusion PBS or RPBS
33 34
Writing prescriptions Writing prescriptions

 Completely identify the pharmaceutical  Where a ‘solvent required’ is included
benefit by detailing: after the form, the volume and number
 Item of ampoules must be specified
 Form
 Script must be signed by the prescriber
 Strength
and dated
 Quantity
 Should indicate if brand substitution is
not permitted
35
Maximum quantity and 36
Restrictions repeats
 Three categories  The maximum quantity and number of
 Unrestricted benefits repeats allowed for PBS items are
 Restricted benefits – specific therapeutic uses recommended by the PBAC or RPRC
 Authority required benefits
 Authority required benefits are restricted benefits that  Only
O l doctors
d can prescribe
ib repeats
require prior approval from Medicare Australia or the
DVA (Authority required)  Prescriptions and repeats can only be
 Authority required (STREAMLINED) benefits are for a quantity up to the maximum
restricted benefits that do not require prior approval from
Medicare Australia or the DVA, but required the  Must clearly indicate quantity (NOT
recording of a streamlines authority codes (noted as
Authority required (STREAMLINED)
MQ/MR, etc)
6
Maximum quantity and 37 38
repeats Regulation 24
 If doctors feels that the max quantity or  Original and repeat supplies of a pharmaceutical
benefit can be supplied at the one time if a doctor is
number of repeats should be increased, they satisfied the certain conditions are met
must complete an Authority Prescription Form  Max quantity is insufficient for the patient's treatment
&
 R
Repeatst can bbe iincrease up tto 5 titimes (if clinical
li i l  The patient has a chronic illness or lives in a remote area
appropriate) to provide 6 months of therapy in total &
 Approval only extends to the provision of the  The patient would suffer great hardship trying to get the
pharmaceutical benefit on separate occasions
pharmaceutical benefit for the patient  Scripts need to be endorsed Regulation 24 (RPBS
 Does not imply approval of any aspects of the scripts may be endorsed ‘hardship conditions only)
patient’s care  Regulation 24 does not allow to scripts written by
optometrists
39 40
Urgent cases Supplying Medicines

 Must comply to State/Territory laws  Only approved pharmacist
 Prescriber may telephone a pharmacist and
ask for a prescription to be supplied  Approved doctors
 Must forward script within 7 days  Friendly Societies
 Also for Authority scripts (subject to phone  Approved Hospitals
approval by HIC/DVA)
 Approval numbers (HIC)
 The follow-up prescription must include the
approval number provided over the phone by  Unapproved pharmacists can not supply
Medicare Australia pharmaceutical benefits
41 42
Supplying Medicines Supplying Medicines

 Approval conditions  Will clearing advertise that any offer for
 Can only supply benefits from the free of cut-price medicines dose not
pharmacy that he/she is operating include pharmaceutical benefits which
 Will not supply a benefit item that attracts a
have a Commonwealth contribution
Commonwealth contribution form free or a  Will not pay rebates or refunds of
price that is less than the relevant patient patient contributions
contribution  Will publicly display a notice setting out
the pharmacy’s normal trading hours
7
43 44
Supplying Medicines Supplying Medicines

 Is obliged to supply benefits at the pharmacy  Must keep duplicates of all old format
at any hour if a prescription is marked urgent pharmaceutical benefits prescriptions
and initialed by the prescriber and the patient/pharmacists copy of all
 Will kkeep adequate
d t stocks
t k ffor ththe supply
l off new format pharmaceutical benefits for
pharmaceutical benefits
at least 1 year from the date of supply
 May be called upon the Medicare Australia to
provide details of stocks of pharmaceutical  (may need to keep for longer as
benefits or preparations for pharmaceutical required by state or territory laws)
benefits
45 46
Before supplying Supplying the benefit

 Pharmacist must endorse the prescription
 Script is only valid for 12 months (including
and duplicate with his/her name and approval
number repeats)
 A prescription identifying number must be  Pharmaceutical benefit cannot be supplied
given to the prescription item on both the more time
ti than
th specified
ifi d on th
the prescription
i ti
prescription and duplicate  Pharmacist can not add to, alter, delete from
 If more than one item, a separate identifying a prescription in any way.
number should be allocated to each item  Pharmacist could clarify the prescriber’s intentions
 In the case of a authorisation, the same and endorse the prescription accordingly
prescription identifying numbers must be
carried through for each item
47 48
Supplying the benefit Quantities and repeats

 Once a benefit has been supplied to a  Request UP TO listed quantities
patient it can not be supplied to that  Can order lesser quantities
patient again for:  Broken pack/wastage table
 On the same day or within the next 20  Can order greater number only on
days, if it is a benefit (other than an eye Authority
prep) that has 5 or more repeats allowed  Treat as private prescription
 On the same day or within the next four
days in the case of other benefits
8
Quantities and repeats 49 50
 Must state number of repeats Safety Net 20 Rule

 Intervals between dispensing
 5 or more repeats allowed in schedule – 20 days
 Other – 4 days  If drug on the Safety Net 20 Rule
 Reg 25:  Will not count on PRF card
“…the supplier of the benefit:  Must be charged if on Safety Net card back at previous cost
 If on SNE – charge at $5.30, not free
(i) reasonably believes that a supply of the pharmaceutical  If on SNC – charge at up to $32
$32.90,
90 not $5
$5.30
30
benefit that was previously supplied to the person has been  Drugs include:
destroyed, lost or stolen…  Antihypertensives
(i) reasonably believes that, having regard to the person's  Cholesterol drugs
circumstances, the supply of the benefit is necessary, without
delay, for the treatment of the person…”  PPIs
 The Safety Net 20 day rule does not apply to
 Endorse `immediate supply necessary’ and sign PBS/RPBS prescriptions originating from hospitals
or day hospital facilities.
 ‘Regulation 24’
51 52
Supplying the benefit Supplying the benefit

 Exceptions  The prescription is not endorsed ’brand
 Endorsed Reg 24 substitution not permitted’
 Urgent supply or a previous supply has been  Schedule shows that the prescribed brand
destroyed lost or stolen
destroyed, and
d th
the substitute
b tit t b
brandd are equivalent
i l t
 May supply but must include the words ‘immediate
supply necessary’ and sign the prescription  Supply of the substitute brand does not
 Pharmacist can supply an alternate brand of contravene relevant state/territory laws
a benefit without reference to the prescriber  ONLY AN ALTERNATIVE BRAND CAN
provide that: BE SUBSTITUTED
53 54
Supplying the benefit Suspected forgery

 If schedule changes:  Pharmacists should take all reasonable
 An item can not be supplied from the date of the steps to satisfy themselves that all items
deletion, regardless of when the script was written
on a prescription are written by a doctor
 If restrictions on the prescribing or the maximum
quantity or number of repeats is altered, valid or dentist
prescriptions written before the date of effect may
still be supplied (as pre conditions at the date of
the prescribing)
9
55 56
Repeats Repeats
 Must show:  If brand substitution has occurred, the name
of the brand actually supplied
 That category of benefit
 For the first supply, the approval number, the
 Patient’s name and address date of the original prescription and the
 Entitlement number allotted prescription identifying number
 Authority number relating to the first supply
 For subsequent supplies, the approval
 Details of the original script
number , the date of the original prescription
 Item, brand, form, strength, quantity and and the prescription identifying number
directions relating to the first supply
57 58
Repeats Deferred supply

 The number of items to be repeated and the  Original supply deferred
number of times it has been supplied
 These items must not be claimed on the
 Name and approval number of the
g
original p
prescription
p
pharmacist
h i t iissuing
i ththe repeatt authorisation
th i ti
 Date of supply
 Must attached the duplicate copy or the
patient/pharmacist copy of the prescription
and give to the patient at time of supply
59 60
Deferring supply Emergency supply

 More than one item  Telephone or fax orders OK
on Rx
 Supply entire quantity
 Generate a repeat
 Prescription must arrive in 7/7
 There is NO ‘3 day supply’ under the

PBS
10
Prices and Charges on the 61
Pricing 62
PBS  Set by the PBRT

 Negotiation with the Guild
 Cost to pharmacist + pharmacists mark-up + dispensing fees +
 General patients other fees
 $32.90  Cost to pharmacists = the manufacture’s price + a margin of 7%
for the wholesaler
 Concessional  Dispensing fee = $6.42 (DD – $2.71, extemp $8.46)
 $5.40
 Cannot discount the base charges Example
 Discretionary charges  Wholesale price = $5.00
 Dispensed price = $5.00 + $0.75 + $ 6.42= $12.17
 Labels must now display full cost
63 64
Pricing
Type of payment Basis of payment 1 July 2009

Dispensing fee PBS or RPBS
$6.42
((readyy prepared)
p p ) medicine
Dispensing fee
PBS or RPBS
(extemporaneousl $8.46
medicine
y prepared)
Special handling Dangerous drug $2.71
fee Extemporaneousl
(no change) $2.04
y prepared
Other charges 65
 Charges only applied to ‘General’ Rx under co-payment

 Can’t take over the co-payment
 Recording on the safety net card

 $1.05 or $1.38 for extemps
 Counts towards safety net
 Discretionary fee
 $ 3.83 Does not count towards safety net
11
67 68
Example 1 Example 2
 Minocycline 100mg  GTN transdermal 10mg/hr patch
 Price charged = $34.95 + $1.05 + $3.83

= $39.83
> Co-payment  $33.30
Price charged = $9.65 +$1.05 + $3.83 = $14.53
12

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2

PBS Functions Background

Listing process Steps in listing

Steps in listing Steps in listing

Steps in listing Types of recommendations

 Section 3 – container fees, fees related to dispensing, standard packs

How are medicines subsidized How are medicines subsidised

How are medicines subsidised How are medicines subsidised

Legislative responsibilities Legislative responsibilities

Who can receive PBS 23 24

prescriptions? No Medicare card?

Legislative responsibilities pharmaceutical benefits

prescriptions Writing prescriptions

Writing prescriptions Writing prescriptions

Urgent cases Supplying Medicines

Supplying Medicines Supplying Medicines

Supplying Medicines Supplying Medicines

Before supplying Supplying the benefit

Supplying the benefit Quantities and repeats

 Must state number of repeats Safety Net 20 Rule

Supplying the benefit Supplying the benefit

Supplying the benefit Suspected forgery

Repeats Deferred supply

Deferring supply Emergency supply

 There is NO ‘3 day supply’ under the

PBS  Set by the PBRT

Type of payment Basis of payment 1 July 2009

 Charges only applied to ‘General’ Rx under co-payment

 Recording on the safety net card

 Price charged = $34.95 + $1.05 + $3.83

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