Dispensing Highly Specialised Drugs (HSD)

Dispensing requirements for Pharmaceutical Benefits Scheme (PBS) Highly Specialised Drugs (HSD).

Restrictions apply to certain pharmacies that can dispense and claim HSD.

Under the National Health Act 1953, approved suppliers include:

  • community pharmacies approved under Section 90
  • public and private hospitals approved under Section 94
  • medical practitioners approved under Section 92, applicable to HSD Community Access (CA) items only.

You must be an approved supplier of PBS to be able to dispense PBS HSD medicines. All suppliers are issued with approval numbers by the Department of Health and Aged Care. Read more about how to become a PBS approved supplier on the Department of Health and Aged Care website.

You can only claim online for dispensing HSD. You may need to update or upgrade your software.

HSD are listed under different codes depending on where they’re dispensed from. Items are approved as either a:

  • public hospital item (HSD PUB)
  • private hospital item (HSD PTE)
  • community access item (HSD CA).

Complex Authority Required (CAR) HSD items are also listed with separate public and private hospital item codes.

You can only dispense up to 2 months’ supply, or one month’s supply in the case of clozapine. Up to 5 repeats, or one month and 11 repeats - up to 12 months’ supply - will be authorised.

For Opioid Dependence Treatment Program medicines, you can authorise no more than 28 days’ supply with provision for up to 2 repeats.

When you dispense a prescription, check your patient’s:

  • full name and address - it must match the name on their Medicare card
  • Medicare card number and that it’s valid - you must record all 11 digits and the expiry date
  • entitlement number if it applies and that it’s valid, for example, their Health Care Card and PBS Safety Net card.

When you dispense a prescription, make sure you record these details in your dispensing software the:

  • item name as specified by the prescriber
  • item form as specified by the prescriber - for example, tablets, capsules, ointment, suppository
  • strength as specified by the prescriber
  • quantity and number of repeats as specified by the prescriber
  • authority prescription number for each Authority-required item.

The streamlined authority code in the case of Authority-required (STREAMLINED) items.

Certain pharmacies can dispense and claim HSD. The following table lists eligibility criteria and restrictions:

HSD ItemDispense from as. 94 public hospitalDispense from as. 94 private hospitalDispense from as. 90 community pharmacyDispense from as. 92 dispensing doctor
HSD public - non‑CAR itemYesNoNoNo
HSD public - CAR itemYesNoYesNo
HSD private - non‑CAR itemNoYesYesNo
HSD Private - CAR itemNoYesYesNo
HSD - community access arrangement itemYesYesYesYes

Hospitals not approved under Section 94 can apply for approval to prescribe and supply HSD under the National Health (Highly Specialised Drugs program) Special Arrangements Instrument 2010.

Pharmacies must only dispense and claim HSD appropriate for their pharmacy type. The patient’s eligibility determines the item code approved and the type of pharmacy that can dispense and claim the prescription. Pharmacies aren’t eligible for payment if the prescription is dispensed by the incorrect type of pharmacy. For example, a public or private hospital.

Public hospitals wanting to claim HSD require Section 94 approval, or Section 100 approval for non-dispensing public hospitals to supply and claim PBS HSD.

The public hospital needs to apply to us to use online claiming for PBS HSD.

Public hospitals participating in the Pharmaceutical Reform Arrangements and that are already using online claiming for PBS, can claim HSD through their existing online claiming system.

If the supply has been dispensed using an approved medication chart, pharmacists must certify all paperless claims when using PBS Online. This must be done for the length of the claim period.

Public hospital pharmacies who dispense and claim for HSD must keep paperwork for a minimum of 2 years from the date of dispensing.

Private hospitals must continue using existing online claiming channels for HSD.

Private hospital pharmacies who dispense and make a claim for HSD must keep paperwork for a minimum of 2 years from the date of dispensing.

Patients of approved hospitals can access their HSD items through either a community pharmacy, or a private or public hospital pharmacy.

You must only supply an Authority-required (STREAMLINED) item when the approved prescriber has written the streamlined authority code on the PBS/RPBS prescription. You will need our approval if the authority prescription is for increased quantities, increased repeats or both.

Community pharmacies and friendly societies may not have access to public hospital HSD item codes and be able to claim for these items. However, they can dispense and claim public hospital CAR HSD and PBS trastuzumab prescriptions.

Where a community pharmacy or a friendly society acts as an agent for a non-dispensing public hospital, the claim for the HSD must be lodged by the public hospital. The community pharmacy or friendly society will have private arrangements with the hospital for administration and remuneration. If a community pharmacy or friendly society attempts to claim public hospital HSD item codes through online claiming for PBS, the claim will be rejected.

Community pharmacies who dispense and claim for HSD must keep paperwork for a minimum of 2 years from the date of dispensing.

All PBS HSD dispensed under this initiative will count towards your patient’s PBS Safety Net threshold.

Under the PBS Safety Net, patients get additional PBS benefits when their annual out-of-pocket costs for prescription items exceed a specified threshold. The PBS Safety Net threshold can be reached using prescriptions filled at community pharmacies and friendly societies at public hospitals.

HSD-approved hospitals must be registered as Safety Net hospitals. This includes non-participating public hospitals supplying HSD.

Page last updated: 15 June 2024.
QC 74067