PBS Frequently Asked Questions

Introduction to the PBS

What is the Pharmaceutical Benefits Scheme (PBS)? 
How is the PBS Schedule released? 
Who is eligible to receive benefits under the PBS? 
Can I collect PBS medicine from a pharmacy for someone else? 
I am a pharmacist, where can I check a patient’s DVA file number or Medicare number? 
What are special numbers? 
Am I a General or a Concessional Patient? And what does it mean to the cost of my medicines? 
How does the TGA classify medicines? 
What is the Pharmaceutical Benefits Advisory Committee (PBAC)? 
What are Unrestricted, Restricted, and Authority Required Items? 
What if I need an increased maximum quantity or more prescription repeats? 
What are the restrictions on PBS prescriptions? 
What are the standards when writing PBS prescriptions? 
What if my prescription is urgent? 
Can my dentist prescribe general PBS items? 
Can my optometrist prescribe general PBS items? 
Who can dispense my PBS medicine? 
How are pharmacists subsidised by the PBS? 
What are Improved Monitoring of Entitlements (IME)? 
What happens if there is a change to the PBS and I still have a current PBS prescription to be filled? 

Fees, Charges, Allowances, & Tax

How much am I required to pay for my PBS prescriptions? 
How much am I charged for non-PBS items? 
What is the Additional fee, and I am required to pay it? 
What is the Allowable Extra fee, and I am required to pay it? 
What is the brand premium policy? 
What is the Special Patient Contribution (SPC)? 
What is the Pharmaceutical Allowance? 
What is the medical expenses tax offset? 
 

The Safety Net

What is the PBS Safety Net? 
What are Safety Net thresholds? 
What medicines count towards reaching the Safety Net threshold? 
What are cross-over arrangements? 
Who is covered under Safety Net within my family? 
Who is responsible for recording the amount spent on PBS medicines? 
What is the Joint Safety Net? 
Can I get a supplementary Safety Net Card? 
What happens if I lose my card? 

Repeat Prescriptions

What is the 4/20 day rule? 
What is the Safety Net 20 rule (SN20DR)? 
What is Regulation 24? 

PBS Refunds

What happens if I forget to present my Medicare or Concession Card when I am getting my prescription? 
Can someone else collect my PBS refund for me? 

Other Information

What happens if I take my PBS medicines overseas? 
What are Emergency Drug supplies? 
What is an extemporaneously prepared medicine? 
What are Section 100 items? 
What is the Special Access Scheme? 
Is the full cost of the medicines listed on the medicine labels? 
What is considered fraud in relation to the PBS? 
What is the Home Medicines Review (HMR)? 
How do I report an adverse drug reaction? 
What is the prescription shopping information service? 
Continuation Rules for PBS-listed Drugs 

Industry Questions

What do I need to do when I want to change the manufacturer code and/or responsible person for a product? 
How do I list a new brand of an existing PBS item on the PBS? 
What do I need to do in order to delete my product from the PBS? 
Listing a product which contains the same active moiety as an existing pharmaceutical benefit but is a different salt. 
Listing a product which contains the same active moiety as an existing pharmaceutical benefit but is a different dosage form. 
Supplying a product on the PBS in a different container type to that for which I originally sought PBS listing. 

Cost Recovery, Fees and charges

What is PBS cost recovery? 
How does cost recovery operate? 
Fees and payments? 
What are the critical times associated with lodgement fees? 

Expanded and Accelerated Price Disclosure (EAPD)

Expanded and Accelerated Price Disclosure (EAPD)
EAPD for Responsible Persons
EAPD for Pharmacies and Wholesalers
EAPD for Consumers

PharmCIS - (Pharmaceutical Consolidated Information System)

What is PharmCIS and what will it do?
PharmCIS - Pharmaceutical Industry 
PharmCIS - Software Vendors 
PharmCIS - Dispensers and Prescribers 


Introduction to PBS

What is the Pharmaceutical Benefits Scheme (PBS)?

The Pharmaceutical Benefits Scheme (PBS) is an Australian Government program that benefits you and all Australians by subsidising medicines to make them more affordable. This means you can get access to lifesaving medicines when you need them most.

The PBS is governed by the National Health Act 1953 . Details about the Minister for Health  are available on the Department of Health website.

 

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How is the PBS Schedule released?

The PBS is released in the form of an online schedule and is updated on the first day of every month. You can access the schedule by visiting the PBS website. You can view the latest news on updates and changes by visiting Latest News  section on the PBS website. By subscribing to the website  you will receive an email notification of any updates to the site,

You can also access the schedule information in PDF and various other downloadable formats available from the Publications  and Downloads  sections. Printed versions  are available on demand, you can order a copy by calling CanPrint on 1300 730 236 or you can download an order form  from the PBS website.

 

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Who is eligible to receive benefits under the PBS?

If you are an Australian Resident and you hold a current Medicare card then you are eligible to receive benefits under the PBS. The Australian Government has also set up a Reciprocal Health Care Agreement (RHCA) with certain countries, designed to give visitors from particular countries the benefits of the PBS.

Australia currently has RHCAs with New Zealand, the United Kingdom, the Republic of Ireland, the Netherlands, Finland, Sweden, Norway, Malta, and Italy.

If you are visiting from one of these countries and want to claim the PBS benefits, simply show your passport when lodging a prescription. Alternatively, you can obtain a Reciprocal Health Care Agreement Card (RHCAC) from the Department of Human Services. Please note that if you are a visitor from the Republic of Ireland and New Zealand, you are not eligible for the RHCAC.

For more information please see the PBS Eligibility  section.

 

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Can I collect PBS medicine from a pharmacy for someone else?

Yes, you can collect medicine for someone else. You will need to give the pharmacist:

  • The person’s Medicare card details
  • The person’s current concession and/or Department of Veterans' Affairs (DVA) health card details if they have one
  • The person’s PBS Safety Net entitlement or concession card details if they have one.

You will need to sign a document to endorse that you are acting as an agent and to confirm that you have received the PBS medicine on their behalf.

If you are not able to show these details you may have to pay full price for the medicine.

 

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I am a pharmacist, where can I check a patient’s DVA file number or Medicare number?

You can call 1300 302 122 to check the patient’s Department of Veterans' Affairs (DVA) file number or Medicare number, but you must obtain the patient’s consent first.

 

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What are special numbers?

When a pharmacist submits a prescription, they are required to supply a valid Medicare number so they can claim reimbursement from the Department of Human Services. There are special categories where a corresponding special number is issued when you cannot provide your Medicare number. The special number is written in place of the Medicare number on the claim form.

There are six different categories that have a special number issued:

  • Emergency situations
  • Visitors covered by the Reciprocal Health Care Agreement (RHCA)
  • Patients who a doctor considers to be entitled to the PBS
  • Patients who a pharmacist considers to be entitled to the PBS
  • Urgent clinical need situations
  • Seemingly valid Medicare cards

Numbers can be obtained from the Department of Human Services

For additional information please visit the Explanatory Notes  section.

 

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Am I a General or a Concessional Patient? And what does it mean to the cost of my medicines?

You will receive medicines under the PBS as either a general or concessional patient. This status will determine which co-payment level you are required to pay for PBS prescriptions.

If you are a concessional patient you will have one of the following cards:

  • Pensioner Concession Card
  • Australian Seniors Health Card
  • Health Care Card
  • Department of Veterans' Affairs (DVA) Gold, Orange, or White Card

Please note that your Seniors Cards issued in some states and territories, are not considered to be a PBS Concession Card.

Centrelink  is responsible for the provision and administration of your Pensioner Concession Card, the Australian Seniors Health Card and Health Care Cards.

The Department of Veterans' Affairs (DVA)  is responsible for the provision and administration or the DVA Gold, White, and Orange Cards. There is also a DVA Pension Card, which entitles you to PBS medicines at a concessional rate (but not RPBS medicines).

You are a general patient if you do not hold any of the mentioned cards, and will not receive PBS or RPBS medicines at the concessional rate.

For more information on patient charges  and patient co-payments  please visit the Explanatory Notes  section.

 

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How does the TGA classify medicines?

The Therapeutic Goods Administration (TGA) classifies medicines in a scheduling system that determines where you can get your medicines:

  • Unscheduled: these items are not classified and you can purchase them without restriction (for example, at a supermarket)
  • Schedule 2 (S2): You can only purchase these medications at a pharmacy
  • Schedule 3 (S3): You can only purchase these medications from a pharmacy, where a pharmacist must personally hand you the medicine and give you an opportunity to seek advice on the medicine
  • Schedule 4 (S4): You can only purchase these medications with a prescription, this includes most items on the PBS
  • Schedule 8 (S8): These medicines are classified as drugs of dependence or addiction

S2 and S3 medicines are sometimes called ‘over-the-counter’ medicines.

S8 medications listed on the PBS have some restrictions which are different in some States and Territories; please contact your local State or Territory health authority for more information.

For more information please visit the Scheduling of Medicines & Poisons  section in the TGA website.

 

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What is the Pharmaceutical Benefits Advisory Committee (PBAC)?

The Pharmaceutical Benefits Advisory Committee (PBAC) is an independent statutory body established under the National Health Act 1953  to make recommendations and give advice to the Minister about which drugs and medicinal preparations should be subsidised on the PBS.

The PBAC considers the medical effectiveness and cost-effectiveness of a proposed benefit compared to alternative therapies. The PBAC recommends maximum quantities and repeats, and may also recommend restrictions for medicines. When recommending listings, the PBAC provides advice to the Pharmaceutical Benefits Pricing Authority (PBPA) regarding comparison of alternatives with the medicine’s cost effectiveness.

The PBAC has three cycles per year, each lasting approximately 17 weeks.

The PBAC consists of medical experts who meet several times a year and is not a permanent unit in the Department of Health. Because of its structure, the committee is best contacted by writing.

If you require information about applying for listing on the PBS; or would like to know the PBAC meeting dates, and the members of the PBAC; please see the PBAC section.

 

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What are Unrestricted, Restricted, and Authority Required Items?

Medicines are referred to as items under the PBS. These medicines are supplied as an Unrestricted, Restricted or Authority Required item:

  • Unrestricted medicines under the PBS Schedule may be prescribed by your prescriber within their scope of practice at their discretion.
  • Restricted medicines listed in the schedule, are only prescribed if your condition meets the stated restrictions.
  • Authority Required (STREAMLINED) medicines are prescribed for specific conditions and do not need prior approval from the Department of Human Services or the Department of Veterans' Affairs. Instead the process is streamlined by providing a four digit streamlined authority code.
  • Authority Required medicines are medicines that can only be prescribed by if prior approval is obtained from the Department of Human Services or the Department of Veterans' Affairs as appropriate, by calling 1800 888 333 or 1800 552 580, respectively. Since 1 August 2003, your doctor can apply for authority for the majority of PBS medicines online at the Department of Human Services.

Some items require authority in writing to be obtained from Department of Human Services. In some cases, your doctor will be required to provide further evidence in order for you to continue subsidised treatment.

Your pharmacist can check the validity of an authorised prescription by contacting the Department of Human Services on 13 22 90 for PBS prescriptions and the the Department of Veterans' Affairs on 13 32 54 for RPBS prescriptions.

The Department of Veterans' Affairs is able to approve any RPBS prescription requiring authorisation at a concessional price. Doctors can call 1800 552 580 to gain authority.

 

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What if I need an increased maximum quantity or more prescription repeats?

If your doctor needs to increase the maximum quantity or give you more repeats of your prescription, they can apply for authorisation in the normal way by contacting the Department of Human Services or the Department of Veterans' Affairs as appropriate, unless otherwise stated in the current PBS schedule .

For more information please see the Information for Prescribers  section.

 

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What are the restrictions on PBS prescriptions?

You may only have up to three PBS items on PBS prescription; and only have one Authority Required item, including STREAMLINED authority items. A PBS prescription may only contain PBS items, and cannot contain non-PBS items.

If you would like more information please visit the Information for PBS Prescribers  section.

 

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What are the standards when writing PBS prescriptions?

Your prescriber must hold a valid PBS prescriber number to write a valid PBS prescription. This number can be obtained from the Department of Human Services. The prescriptions must either be computer generated or handwritten. If handwritten, the prescription must be in an indelible form in the prescriber’s handwriting, and on standard PBS stationery.  Paper sized 18x12cm is also appropriate.

All PBS prescriptions must contain the prescriber’s name and address; the patient’s name, address, and entitlement status; and endorsed PBS or RPBS. Prescriptions should completely identify the medicine being prescribed. The following should be defined:

  • Item
  • Form
  • Quantity
  • Dose
  • Strength
  • Instruction for use
  • If brand substitution is allowed

The prescription must be signed and dated by the prescriber forward or back-dating is not permitted.

If you would like more information please visit the Writing the PBS Prescription  section.

 

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What if my prescription is urgent?

In urgent cases, your doctor can communicate with your pharmacist by telephone to get your prescription to you quickly. The prescription must be forwarded to your pharmacist within seven days.

If you would like more information, please visit the Urgent Cases  section.

 

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Can my dentist prescribe general PBS items?

Dentists are not able to prescribe you general PBS medicines; however they have a separate Dental formulary from which they can prescribe your medications.

If you would like to view the PBS Dental Schedule please see the Dental Items  section of the website. Dental items can also be found throughout the main Schedule of Pharmaceutical Benefits PDF available on the Publications page

 

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Can my optometrist prescribe general PBS items?

Optometrists can only prescribe certain medications. The Optometrical PBS Schedule details which medicines they can prescribe.

If you would like more information about the Optometrical Schedule please visit the Optometrical Items  section.

 

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Who can dispense my PBS medicine?

All suppliers of PBS medicines must be approved by the Department of Human Services. These will be pharmacists, doctors in certain remote and rural areas, Friendly Society pharmacies, or hospital authorities.

PBS medicines are dispensed under Section 90 and Section 100 of the National Health Act 1953 .

If you would like more information please go to the Eligible Suppliers  section on the PBS website, and the Approved Supplier  section in the Department of Human Services website.

 

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How are pharmacists subsidised by the PBS?

Pharmacists are paid by the Australian Government for dispensing PBS items. To claim their subsidy, pharmacists lodge claims with Department of Human Services detailing PBS prescriptions dispensed. For prescriptions issued under the RPBS, claims are submitted to the Department of Veterans' Affairs.

If you would like more information please visit How Pharmacists Claim Reimbursements: Information Required  and Documents to be Submitted  sections.

 

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What happens if there is a change to the PBS and I still have a current PBS prescription to be filled?

Your PBS prescription is valid for 12 months from the date it was written. If there is a change to the PBS before you have had the prescription, one or more of the following will apply:

  • If an item is deleted from the schedule: even if your medicine is listed on the PBS when you received the prescription, it cannot be supplied at the discounted PBS price.
  • If an item is added to the schedule: even if the item has been added the schedule, the prescription dating back to before the item was added will not entitle you to the subsidised price. You will need to get a new prescription to receive the PBS price.
  • If the maximum quantity has changed: You will be dispensed the original amount as specified on your prescription, even though this may be different to what is listed under the schedule.
  • If the restrictions have changed: If your unrestricted medicine has been made a restricted medicine, you may still get your prescription as per your original prescription.
  • If the number of repeats has changed: You will still receive the same amount of repeats as per your original prescription.
  • If the form of drug has changed: You will need to get a new prescription to receive the PBS price.

If you would like more information please go to the What to do if the Schedule changes  section.

 

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What are Improved Monitoring of Entitlements (IME)?

Improved Monitoring of Entitlements (IME) ensure that only you and other eligible Australian Residents receive PBS subsidised medicines.

If you would like more information please visit IME  section of the the Department of Human Services website.

 

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Fees, Charges, Allowances, & Tax

How much am I required to pay for my PBS prescriptions?

If you are a general patient you pay co-payment for a medicine listed on the PBS. If you are a concessional patient, you will pay a lower co-payment for your PBS medicine.

These co-payment amounts are indexed on 1 January every year in line with Consumer Price Index (CPI).

For more information please go to the What to Charge  section in the PBS website. See also Special Patient Contribution .

 

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How much am I charged for non-PBS items?

If your medicine is not listed under the PBS Schedule, you will have to pay full price as a private prescription. It is not subsidised by the Australian Government.

Pharmacies may charge differently for these non-PBS medicines, so you may want to shop around to find the best price.

Please note that the cost of private prescriptions cannot count towards the Safety Net threshold.

 

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What is the Additional fee, and I am required to pay it?

If you are a general patient and the cost of the medicine falls below the co‑payment amount your pharmacist is allowed to apply a proportion or the whole part of the Additional fee. They can only charge up to the general patient co-payment amount. If you have a non-PBS prescription, you may pay the whole amount.

The price of the medicine is based on the cost of the maximum quantity that can be dispensed. It can also be referred to as the safety net recording fee. Your pharmacist may charge for recording the cost of the medicine on the Pharmaceutical Record Form (PRF).

The Additional fee, cannot count towards the Safety Net threshold.

If you are a concessional patient, you cannot be charged the Additional fee as there are no medicines listed under the PBS that cost less than the concessional co-patient fee. The price of the medicine is based on the cost of the maximum quantity that can be dispensed.

Where a pharmaceutical item has a dispensed price for maximum quantity (usually one month’s supply) of less than $36.90, the pharmacist may charge general patients additional allowable fees. These fees, as outlined below, cannot take the cost of the prescription above $36.90.

Additional Fees for Agreed Price Benefits (Safety Net Recording Fee)

From 1 August 2014, an additional charge of up to $1.15 for ready-prepared items and $1.50 for extemporaneously-prepared items may be charged, provided this does not take the cost of a prescription above $36.90 (for general patients only). The amount of this fee can count toward the Safety Net threshold.

This fee is paid for recording prescriptions below the maximum general patient contribution of $36.90 on the Prescription Record Form. The additional fee may be part charged to take the cost up to the maximum $36.90. Only one fee is payable per item, even if there are multiple quantities.

The additional fee does not apply to pension/concession card holders, Department of Veterans Affairs’ cardholders or general patients where the dispensed price is greater than the maximum amount of $36.90.

Allowable Extra Fee under the Fifth Pharmacy Agreement

The allowable fee of $4.19 applies where the PBS dispensed price is below the general patient contribution of $36.90. The allowable extra fee may not be charged if the cost of the medicine is over $36.90. The allowable fee is added to the PBS dispensed price in lieu of charging private prescription rates and is paid by the patient.

The fee was agreed as part of the Fifith Pharmacy Agreement and introduced to contain costs to the consumer, compensate the pharmacist and ensure that prescriptions for medicines priced less than the co-payment amount of $36.90 are still recordable on the Prescription Record Form for Safety Net recording purposes.

This allowable extra fee is optional and must not exceed $4.19. The amount of this fee cannot count toward the Safety Net threshold.

If the cost of the medicine is less than $36.90, the additional fee of $1.15 or $1.50 is added first; if the cost is still less than $36.90, the allowable extra fee is then added to bring the charge up to the maximum co-payment amount of $36.90.

These are discretionary fees and pharmacists are free to discount these fees for PBS items where the cost is below the general patient contribution rate. Consumers should ask their pharmacists if they require information about any additional fees included in the costs of their PBS prescriptions.

If you would like more information please go to the Fees  section. See also the question below on Allowable Extra fee.

 

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What is the Allowable Extra fee, and I am required to pay it?

When a medicine’s price is less than the general patient co-payment, an Allowable Extra fee may be charged. The price of the medicine is based on the cost of the maximum quantity that can be dispensed. Your pharmacist may charge the fee according to the Fifth Pharmacy Agreement.

This fee cannot take the total cost of the medicine above the patient co-payment amount.

If you are a concessional patient, you cannot be charged the Allowable Extra fee as there are no medicines listed under the PBS that cost less than the concessional co-patient fee. The price of the medicine is based on the cost of the maximum quantity that can be dispensed.

If you would like more information please go to the Fees  section on the PBS website, and the Additional Fees  Section on the Department of Health website. See also the question above on the Allowable fee.

 

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What is the brand premium policy?

When there are two or more brands of the same medicine listed under the PBS, the Australian Government subsidises each brand up to the same amount. When the Government and a supplier cannot agree on the price to be paid to the supplier a surcharge may be requested by the supplier. This can only occur if a different brand of the same medicine is available on the PBS at the agreed price.  If you choose the more expensive brand, the price difference is paid by you as a brand premium.

This brand surcharge, which is paid to the supplier, is in addition to the patient co-payment amount.

At your request, your pharmacist can substitute a less expensive brand if it is indicated as a bioequivalent under the PBS, and if your prescriber has not written ‘brand substitution not permitted’ on your prescription.

Your pharmacist is legally required to charge brand premiums.

These brand premiums do not count towards the Safety Net Threshold.

Medicines listed under the PBS are classified as bioequivalent if the manufacturer has proved that the brands are bioequivalent or therapeutically equivalent; or if the supporting evidence has already been provided and accepted by the Department of Health.

In the PBS schedule, the bioequivalent brands are listed with ‘a’ or ‘b’ and can be interchanged with each other.

If you would like more information please see the Special Patient Contributions, Brand Premiums and Therapeutic Group Premiums  section.

 

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What is the Special Patient Contribution (SPC)?

The Special Patient Contribution (SPC) is a surcharge attached to certain PBS medicines. It is the difference between what the manufacturer is charging and what the Government is willing to cover.

This cost is in addition to the patient co-payment and may take the cost above the patient co-payment threshold. This premium does not count towards the Safety Net threshold.

For some SPCs, if you have medical or other reasons to prevent you from taking the lower priced medicine, your doctor may apply through the Authority Line for an exemption from paying the SPC. Your prescription will then be marked with ‘SPX’. Please note that this exemption is not available for Bleomycin sulfate (Blenamax®).

If you are a Department of Veterans' Affairs patient you do not have to pay the SPC.

If you would like more information please visit the Special Patient Contribution  and the Special Patient Contributions, Brand Premiums and Therapeutic Group Premiums  sections.

 

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What is the Pharmaceutical Allowance?

The pharmaceutical allowance is a sum of money paid by Centrelink to help you afford the cost of your medicines.

For more information please visit the Pharmaceutical Allowance  section on the Centrelink website.

 

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What is the medical expenses tax offset?

The Australian Tax Office (ATO) offers you a tax offset of 20% of your medical expenses subject to conditions.  Medical expenses include your PBS items. This is to help keep the possible high costs of your medicines more affordable.

If you would like more information please call the ATO on 132 861 or visit the Net Medical Expenses Tax Offset  section on the ATO website.

 

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The Safety Net

What is the PBS Safety Net?

The Safety Net is a system designed to protect you and your families from the high total cost of large numbers of PBS medicines. Once you or your family have reached a particular cost threshold during a calendar year, the costs of your medicines are generally reduced. If you are a general patient, you will usually receive your PBS medicines at the concessional rate; or free if you are a concessional patient. The price of your medicines is lower for the remainder of that calendar year.

If you would like more information please visit the Safety Net Scheme  section.

 

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What are Safety Net thresholds?

Once you or your family have reached a threshold of cost for your patient co-payments, you are eligible for the Safety Net. Your pharmacist can then give you a Safety Net Concession card (CN Card) that entitles you to a reduced price for PBS medicines.

If you or your family are general patients, you are usually entitled to your PBS medicines at a concessional price. The current threshold is adjusted each year in line with the Consumer Price Index. You will be entitled to this concessional price for the remainder of the calendar year.

If you or your family are concessional patients, you are entitled to your PBS medicines for free. The current threshold is the total cost of 60 prescriptions. Your pharmacist can then issue you or your family with a Safety Net entitlement card (SN Card) which is then valid for the remainder of the calendar year. This is still subject to premiums.

Both of these thresholds are indexed on 1 January every year in line with the Consumer Price Index.

If you would like more information please visit The Safety Net Scheme  section in the PBS website. Alternatively, please visit the Safety Net  section in the Department of Health website.

 

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What medicines count towards reaching the Safety Net threshold?

The total of your patient co-payment amounts from all of your PBS listed medicines count towards the Safety Net threshold. These are called qualifying prescriptions.

If the cost of one of your prescriptions takes you exactly to the threshold amount, the particular prescription will not be reduced. Only when you have exceeded the threshold will you get the reduced Safety Net price.

Each of your prescriptions dispensed will be added to the threshold amount one at a time, so that the remainder of the repeats can be dispensed at a discounted price if you exceed the threshold amount.

If you would like more information please visit the Qualifying Prescriptions  section in the PBS website.

 

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What are cross-over arrangements?

If you change between being a general patient and a concessional patient within a calendar year, cross-over arrangements apply to you.

If you change from being a general to a concessional patient you will then have your threshold lowered to the concessional patient Safety Net threshold. Any prior prescriptions filled while you were still a general patient count towards the threshold. Each prescription you had filled will count towards the 60 prescriptions required for the concessional Safety Net threshold. If you reach the Safety Net threshold, you can then be issued a SN Card.

If you change from being a concessional to a general patient, you will then have to work towards the higher general Safety Net threshold. Each prior prescription you had filled will count towards the prescriptions required for the Safety Net threshold but only to the value of the concessional co-payment amount. If you reach the Safety Net threshold, you can then be issued a CN Card.

If you would like more information please visit the Safety Net Cross-Over Arrangements  section on the PBS website.

 

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Who is covered under Safety Net within my family?

You and family members can be covered by the Safety Net, and can all work together towards the same Safety Net threshold.

Your family includes your partner or de facto partner; children under the age of 16 and in your care; and dependent full-time students under the age of 25.

There are some different options available to your family:

  • If all of your family members are general patients: then you will all work towards general Safety Net threshold, and will be eligible for the CN Card
  • If all of your family members are concessional patients: then you will all work towards the concessional Safety Net threshold, and will be eligible for the SN Card
  • If one parent in your family is a concessional patient and all other members are general patients: then your family can work towards either threshold. Your family will then be eligible for the relevant Safety Net Card.
  • If both parents in your family are general patients and one child is a concessional patient: then the child can work towards their own concessional threshold, or your whole family can work towards the general threshold.
  • If both parents in your family are general patients and two of the children are concessional patients: then your family can work towards the general threshold together, or both children can work towards separate concessional thresholds.
  • If you are a same sex couple: you may work towards the same Safety Net threshold. This is effective from 1 January 2010 with amendments made to the National Health Act 1953 .
  • If you are a couple separated due to ill health: for example, one partner is living in a nursing home, you can still work towards the same Safety Net threshold.

If you would like more information please visit the Safety Net Cross-Over Arrangements  section on the PBS website.
 

 

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Who is responsible for recording the amount spent on PBS medicines?

It is your (the patient’s) responsibility to keep a record of the amount spent on PBS medicines. This includes keeping track of your dependents’ spending. You can do this by using a Prescription Record Form (PRF) available at any pharmacy. Pharmacists will need to get supplies of these forms from the Department of Human Services.

Your medicine is usually recorded using computer generated stickers given to you by your pharmacist. You can record them by hand but must have:

  • The date of supply
  • The PBS/RPBS item code
  • The Safety Net value of the medicine
  • The pharmacist’s approval number
  • The signature of the authorised person making the entry on your PRF

Hospital PRFs require slightly different information.

At your pharmacist’s discretion, you may be supplied with a print-out of your total PBS spending which can be used as an alternative to the PRF. It is also possible to keep your PRF stored at the pharmacy.

It is possible for you as an individual or your family can have more than one PRF.

Once you or your family have reached the Safety Net threshold, and you can provide evidence of PBS spending, then you will be able to go to any community pharmacy and receive your relevant Safety Net Card.

If you would like more information please visit the Recording PBS Prescriptions  section on the PBS website. Alternatively, please visit the Safety Net section.

 

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What is the Joint Safety Net?

The Joint Safety Net allows your prescriptions filled at outpatient pharmacies at public hospitals to count towards your total spending for the PBS Safety Net.

Although these medicines are not dispensed through the PBS, they can still count towards your total spending for the PBS Safety Net.

If you would like more information please visit the Hospital Prescription Record Forms  section.

 

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Can I get a supplementary Safety Net Card?

Your pharmacist can give you a supplementary card for your dependent only when your original SN or CS Card is issued. If you would like to get a supplementary card at a later stage, you can contact the Department of Human Services.

If you would like more information please visit the Issuing Supplementary Cards  section.

 

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What happens if I lose my card?

If your SN or CN Card has been lost, damaged, stolen, or destroyed, your pharmacists will not be able to issue you a new one. You or your spouse can contact the Department of Human Services to get a new card.

For more information please visit the Lost Safety Net Entitlement/Concession Cards  section.

 

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Repeat Prescriptions

What is the 4/20 day rule?

Once you have received a PBS benefit:

  • You cannot get another PBS prescription for the same pharmaceutical benefit dispensed on the same day or within the next 20 days if the item is listed in the PBS Schedule with five or more repeats allowed (eye preparations are excluded).
  • You cannot get another prescription for the same pharmaceutical benefit dispensed under the PBS on the same day or within the next four days for all other items (that is, items listed in the PBS Schedule with less than five repeats and eye preparations).
    For this rule, the ‘same pharmaceutical benefit’ includes any brand or item which is PBS equivalent.

However, if your PBS medicine has been lost, stolen or destroyed; or if you require your medicine without delay for treatment; then your pharmacist can dispense a prescription as an early repeat supply of your PBS medicine. This must be recorded with ‘immediate supply required’ on your prescription and signed by your pharmacist.

These rules are in place to keep the PBS fair for all Australians.

If you would like more information please visit the Repeat Authorisations  section.

 

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What is the Safety Net 20 day rule (SN20DR)?

Under the Safety Net 20 day rule (SN20DR), for some PBS medicines, an early repeat supply within 20 days is not eligible for Safety Net entitlements.

If you have your SN20DR medicine dispensed early (within 20 days), the cost of the medicine will not count towards your Safety Net threshold. If you have already met your Safety Net Threshold, your medicine will be supplied at your original co-payment amount, and not the reduced Safety Net amount.

This rule generally applies to medicines used for long term therapy.

If you would like more information please visit the Patient Contributions for Early Supply of Some PBS Medicines  section.

 

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What is Regulation 24?

Regulation 24 means that a doctor can write a PBS prescription so that all the repeats are supplied at the same time, in certain circumstances.

Your doctor can approve this if:

  • The maximum quantity specified in the PBS is not sufficient for treatment
  • If you are suffering a chronic illness and live in a remote area
  • If you would suffer hardship if you were to collect your medicines on separate occasions

A prescription of this kind needs to be endorsed with Regulation 24 or Hardship conditions apply. Your usual co-patient amount will apply for the original and repeats supplied. There may also be relevant brand or therapeutic brand premiums charged. Co-payment amounts can be recorded on your PRF in the usual way.

You do not have to get all repeats on a Regulation 24 prescription dispensed. However, any repeats that are not used when the prescription is supplied are forfeited. You will need to get a new prescription from your doctor for further supply.

For more information please visit the Regulation 24 sections under Prescribing Medicines  and Supplying Medicines . Please also visit Section 24  under Patient charges.

 

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PBS Refunds

What happens if I forget to present my Medicare or Concession Card when I am getting my prescription?

If you do not to present your Medicare Card or Concession Card when having your prescription filled you may pay more than the co-payment amount at the time of purchase. You may be eligible for a refund of money if:

  • You are a general patient unable to present your Medicare Card and pay the full private prescription amount
  • You are a concessional patient unable to present your Concession Card (including SN or CN Cards) and pay the general patient amount
  • You are a concessional patient unable to present your Concession Card and Medicare Card and pay the private prescription amount

To claim a refund of the overpaid amount at any Medicare Service Centre you must take with you:

  • Your proof of eligibility to receive PBS medicines (your Medicare card)
  • Any relevant Concession Card
  • A PBS refund receipt (requested from your pharmacist)
  • A PBS patient claim for refund from (available from a Medicare Service Centre)

You will receive the difference between the amount that you paid when filling your prescription and the amount that you were entitled to pay at time of payment.

The price you were entitled to at payment is determined by adding the applicable co-payment amount with any applicable premiums.

The price you paid when filling your prescription is the dispensed price for maximum quantity price listed in the schedule.

If the difference calculated is a negative number, you will not receive a refund. This could be because the Australian Government does not subsidise your particular medicine, if you are a general patient.

Brand premiums, therapeutic group premiums, special patient contributions, the Allowable Extra fee, and the Additional fee are not refunded.

If you have exceeded the Safety Net threshold and require a refund, you can claim the overspent amount by applying in writing to the Department of Human Services. You need to include photocopies of your PRF, Medicare card, and Concession Card if you have one.

Please send to:

The Department of Human Services
GPO Box 9826
[In your State Capital]
[Your State & applicable postcode]

If you would like more information please visit the Retrospective Entitlement and Patient Refunds  section.

 

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Can someone else collect my PBS refund for me?

Yes, you will need to get a nominated agent to do this for you. You can get a patient/claimant form to authorise this from a Medicare Service Centre. The agent will need to take the PBS refund receipt from your pharmacist and a completed PBS Patient Claim for refund form.

If you would like more information please visit the Claiming and Collecting PBS for Someone Else  section on the the Department of Human Services website. Alternatively, please visit the Receipts  section.

 

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Other Information

What happens if I take my PBS medicines overseas?

It is illegal to take your PBS medicines overseas unless it is for personal use, or for the use of the person travelling with you.
For more information please call the Taking or Sending PBS Medicines Overseas inquiry line on 1800 500 147. Please also see Travelling Overseas with PBS Medicines  on the Department of Human Services website or Travelling with medicines and medical devices  on the TGA website.

 

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What are Emergency Treatment (doctor’s bag) supplies?

Certain medicines are provided free of charge to your doctor, so in time of emergency they can be provided to you with out charge.

If you would like more information, please call the Department of Human Services on 132 290. Please also see the Emergency Drug (Doctor’s Bag) Supplies  section.

 

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What is an extemporaneously prepared medicine?

An extemporaneously prepared medicine is prepared by your pharmacist with several different ingredients. Only if each ingredient is listed on the PBS Schedule, can you receive it at a reduced PBS price.

For more information please visit Pricing Extemporaneously Prepare Items  section.

 

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What are Section 100 items?

Section 100 of the National Health Act 1953  gives the Minister for Health the power to arrange an alternative method of supply of medicines to patients when supply through a community pharmacy is not appropriate or efficient for the patient. Section 100 items, are medicines that are specialised and generally cannot be obtained through your community pharmacy.
Section 100 programs include:

  • Highly Specialised Drugs Program
  • Efficient Funding of Chemotherapy
  • Botulinum Toxin Program
  • Human Growth Hormone Program
  • IVF/GIFT Program
  • Opiate Dependence Treatment
  • Special Authority Program

If you are receiving benefits through a Section 100 program you are generally required to pay a contribution for each supply at the PBS co-payment amount.

If you would like more information please visit the Section 100  section.

 

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What is the Special Access Scheme?

You can access medicines not available in Australia for personal use through the Special Access Scheme (SAS). Your doctor must apply to the Therapeutic Goods Administration (TGA) for approval to import these medicines. This is done by calling 02 6232 8111.

All costs of SAS medicines are at your expense. Prescriptions supplied under the SAS are considered to be private prescriptions and cannot count towards your Safety Net threshold.

For more information please visit the Special Access Scheme  section on the TGA website.

 

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Is the full cost of the medicines listed on the medicine labels?

Yes, from 1 August 2003 the full cost (dispensed price for maximum quantity as in the PBS schedule) of your medicine is required to be listed on the labelling of your medication packaging. The purpose of this is to show you the true cost of the medicine.

For more information please visit the New Labels for PBS Medicine  section in the Department of Health website.

 

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What is considered fraud in relation to the PBS?

It is considered fraud when someone:

  • Is using someone else’s Medicare Card
  • Is using an invalid Concession Card
  • Forges prescriptions for PBS medicines
  • Makes PBS claims for pharmaceutical benefits that were not provided
  • Swaps PBS prescription medications for other pharmacy medications or goods

If you suspect a case of PBS fraud or require more information, please call the Department of Human Services on 131 524 or visit the Report Fraud  section on their website.

 

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What is the Home Medicines Review (HMR)?

A Home Medicines Review (HMR) is a thorough check of all the medicines you are taking. This review can give you an indication of how well you are managing your medications in your home.

The review is performed by your HMR accredited pharmacist at the request of your doctor, if you choose.  If you are not sure, ask your doctor and then you can decide if it might be of benefit to you. This review then takes place in your home.

You can find an accredited pharmacist online at The Australian Association of Consultant Pharmacy  and The Society of Hospital Pharmacists of Australia .

Once your doctor recommends your review, a HMR accredited pharmacist will organise to visit you at home. They assess all the prescription medications you are taking, as well as any other healthcare products; and will discuss your treatment with you.

After the results are discussed with your doctor, you will return to see your doctor and discuss a medication plan. Both your doctor and your pharmacist will work with you to put your plan into action.

The Australian Government will pay for the pharmacist to visit your home, but you may have to pay for the two visits to your doctor. You can claim this back from the Department of Human Services.

There is also a Residential Medication Management Review (RMMR) which is similar to a HMR but is available to residents of aged care facilities. A pharmacist would review the medication management of a number of residents at the same time.

If you would like more information please visit the Domiciliary Medication Management Review (DMMR)  section in the Department of Health website, the Home Medicines Review (HMR)  section of the Department of Human Services' website, and the Medication Management Review Program  section on the Pharmacy Guild of Australia website.

 

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How do I report an adverse drug reaction?

If you are taking medication and believe you have experienced an adverse drug reaction, then you can report it to the Consumer Adverse Medication Events line on 1300 134 237.

If you are a health professional and you are a registered user of the Therapeutic Goods Administration (TGA) Australian Adverse Drug Reaction Reporting System  then you may report such reactions online, there is also a reporting card  that can be obtained from the TGA, or by calling the TGA's Adverse Medicine Events Line on 1800 044 114.

You can send completed cards to:

Office of Product Review, TGA
Reply Paid 100
Woden ACT 2602

***If you think you may be suffering an adverse drug reaction please seek immediate medical attention***

If you would like more information please visit the Report a Problem with a medicine or medical device  section on the TGA website.

 

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What is the prescription shopping information service?

The prescription shopping information service provides information to doctors regarding the types and quantities of medicines that their patient is getting from a pharmacist. The doctor may use this service if they suspect their patient is seeking to obtain medicine in excess of their medical need. The doctor will need to be registered with the Department of Human Services to access this service.

If a patient has been identified as meeting the prescription shopping project criteria, the doctor may find out the number of PBS items supplied to the patient and the number of doctors who prescribed those medications. A more in-depth report can be issued detailing the types and quantities of medicines supplied.

If you would like more information please view the Prescription Shopping Program  section on the Department of Human Services website. Doctors can also contact a 24 hour phone line on 1800 631 181 to access the service.

 

Continuation Rules for PBS-listed Drugs

When a drug is listed on the Pharmaceutical Benefits Scheme (PBS), certain restrictions or conditions may apply to ensure that the product is subsidised in situations where treatment has been proved to be both medically effective and cost-effective. This is especially the case with high-cost drugs which may only be effective in specific patient groups.

Access to PBS-subsidised drugs falls into three broad categories:

  • unrestricted benefits – where the doctor can prescribe through the PBS without restrictions on therapeutic use;
  • restricted benefits – where the doctor can prescribe through the PBS when satisfied that the patient’s clinical condition matches the approved therapeutic uses, as determined by the Pharmaceutical Benefits Advisory Committee (PBAC); and
  • authority-required benefits – where the doctor can prescribe through the PBS when satisfied that the patient’s clinical condition matches the approved therapeutic restrictions, as determined by the PBAC and prior approval from Medicare Australia has been obtained.

For some authority-required drugs available on the PBS, patients must meet continuation criteria in order to continue treatment with the subsidised drug. These restrictions are a way of ensuring that PBS drugs are used in a way that represents good value for taxpayers’ money.

 

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Industry Questions


What do I need to do when I want to change the manufacturer code and/or responsible person for a product?

You should send a letter to the Listing Unit requesting the change. Your request should include a responsible person declaration for the new PBS supplier and a copy of the ARTG Certificate showing the new Therapeutic Goods Administration (TGA) sponsor (if this also changes). If the timing of the change is such that an ARTG Certificate will not be available at the PBS deadline, copies of the correspondence to the TGA requesting the change in sponsorship from the divesting and acquiring companies should be provided. The ARTG Certificate should then be provided as soon as it is available. If TGA sponsorship does not change and the PBS supplier is different to the TGA sponsor, a letter from the TGA sponsor authorising the PBS change should also be included.

 

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How do I list a new brand of an existing PBS item on the PBS?

You should send a letter to the Listing Unit requesting the change. The letter should provide all the information detailed in the Listing Unit Requirements. The deadlines which apply can be found on the PBS Calendar page. Listing of new brands which cause a price change can only occur 3 times a year (April, August and December) and it should be noted that different deadlines apply to these products. New brands that are equivalent to existing brands must be marked as equivalent and interchangeable in the Schedule of Pharmaceutical Benefits.

 

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What do I need to do in order to delete my product from the PBS?

If your product is the only brand of an item listed in the Schedule of Pharmaceutical Benefits (the Schedule) you should send a letter to the Secretary of the Pharmaceutical Benefits Advisory Committee requesting deletion. The letter should include as much information as possible about the reason for the deletion and whether the product will continue to be sold in Australia outside the PBS. If your product is one of several brands of an item in the Schedule a similar letter should be sent to the Listing Unit (instead of to the PBAC Secretariat) within the Pharmaceutical Evaluation Branch. Suppliers of brands of pharmaceutical items need to also take account of whether there is a current Guarantee of Supply obligation for the product they are intending to discontinue. 

In both instances it is preferred that, if possible, up to three months advance notice of the deletion be given in the Schedule. The usual deadlines for publication in the Schedule apply.

 

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I have a product which contains the same active moiety as an existing pharmaceutical benefit but is a different salt. My product has been demonstrated to be bioequivalent to a product which already on the PBS although it is a different salt. Does this product have to be considered by the Pharmaceutical Benefits Advisory Committee before being able to be listed in the Schedule of Pharmaceutical Benefits?

Yes. Products containing the same active moiety but a different salt must be recommended for listing on the PBS by the PBAC. The PBAC must also make a recommendation about whether it is appropriate to mark the new product as bioequivalent to, and interchangeable with, existing pharmaceutical benefits. The PBAC must have access to advice from the Therapeutic Goods Administration (TGA) about the bioequivalence of the new product to an existing PBS listed product.

 

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I have a product which contains the same active moiety as an existing pharmaceutical benefit but is a different dosage form. My product has been demonstrated to be bioequivalent to a product which is already listed on the PBS. Does this product have to be considered by the Pharmaceutical Benefits Advisory Committee before being able to be listed in the Schedule of Pharmaceutical Benefits?

Yes. Products containing the same active moiety which are a different dosage form must be recommended for listing on the PBS by the PBAC. The PBAC must also make a recommendation about whether it is appropriate to mark the new product as bioequivalent to, and interchangeable with, existing pharmaceutical benefits. The PBAC must have access to advice from the Therapeutic Goods Administration (TGA) about the bioequivalence of the new product to existing PBS listed products.

 

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What do I need to do if I want to supply a product on the PBS in a different container type to that for which I originally sought PBS listing eg a blister pack instead of, or in addition to, a bottle.

Products packed in different container types are considered to be different products by the Therapeutic Goods Administration (TGA) and require a separate entry in the Australian Register of Therapeutic Goods. If a supplier wishes to seek authorisation to supply a product in a different, or additional, container to that for which documentation was originally provided for PBS listing, a letter should be sent to the Listing Unit requesting this and enclosing a copy of the Certificate of Medicine Registration as evidence that the "new" product has been approved by the TGA. The "new" product may not be supplied on the PBS until a letter authorising such supply is received.