Life Saving Drugs Program for pharmacists
Pharmacies must agree to participate in the Life Saving Drugs Program (LSDP) and appoint authorised persons to handle the medicines. Find out what pharmacists need to do to manage LSDP medicines correctly, prevent wastage, and keep us informed.
The Life Saving Drugs Program (LSDP) pays for specific essential medicines to treat patients with rare and life-threatening diseases. Funding for medicines on the LSDP is separate to the Pharmaceutical Benefits Scheme (PBS).
Pharmacies must agree to participate in the LSDP before they can dispense medicines through the program.
Because LSDP medicines sit outside of the PBS, they are not subject to a PBS patient co-payment.
By agreeing to provide LSDP medicines, pharmacies agree not to charge patients a co-payment or similar fee for this service.
Pharmacies may charge a fee to provide an ‘esky’ or similar transport and handling material as required. You must tell the patient about this cost up front, and they must agree to it before we send out LSDP medicines. You cannot charge any other co-payment or fee.
Becoming an LSDP pharmacy
When we approve an application that nominates your pharmacy as a patient’s pharmacy of choice, we go through these steps:
- We contact the pharmacy to confirm that you are willing to handle and supply the LSDP medicine(s).
- If you do not wish to participate in the program, you must contact the treating specialist so they can make other arrangements.
- If you have not supplied LSDP medicines before, we tell you about your obligations under the program.
- If required, the medicine’s sponsor (pharmaceutical company) can arrange training for pharmacy staff on how to handle the LSDP medicine correctly.
- You nominate a primary and secondary contact as authorised persons to receive and dispense LSDP medicines. You can add more authorised persons at any time by emailing us.
We issue a unique identifier (for example, X01) to each patient to protect the patient’s privacy. We tell suppliers the patient’s unique identifier, and not the patient’s name.
Keep a record of the unique identifier and quote it when you communicate with us about the patient.
Role of authorised persons
An authorised person is a pharmacy representative who:
- receives LSDP medicines
- carefully checks the stock to make sure it matches the order and is not damaged
- emails us the patient’s dispensing record by the 7th day of each month (we send a reminder email on the 1st of each month)
- is a contact for all matters relating to the supply of LSDP medicines to patients who attend your pharmacy.
Authorised persons should read the program requirements on this page, and in the LSDP guidelines for the specific disease the patient has.
Managing LSDP medicines
You do not need to order LSDP medicines. We order them for each eligible patient each month, direct from the supplier. We will not reimburse the cost of any stock that pharmacies order from suppliers.
Due to the high cost of LSDP medicines, we only order 1 month’s supply of medicine for each patient at a time.
We base the order quantity on the patient’s dispensing record. You must provide this record to us by the 7th of each month. The supplier will deliver LSDP medicine for the next month before the end of the preceding month.
Checking and handling deliveries
An authorised person must be available at the time of delivery to confirm delivery and check the stock.
When LSDP stock is delivered, an authorised person must check that:
- the amount and type of LSDP medicine matches what has been ordered and what is required for each patient
- the stock has arrived via appropriate cold-chain logistics, where applicable
- the stock is intact (not broken or otherwise compromised) at the time of delivery
- the expiry date matches the date stated in the proof of delivery.
The authorised person then signs the proof of delivery and faxes or emails it to the supplier. This confirms delivery of the LSDP medicine.
Storing and handling stock
The authorised person must ensure that the pharmacy handles and stores LSDP medicine in accordance with the approved product information. You can search the TGA website for current product information documents for each LSDP medicine.
The dispensing pharmacist must tell the patient how to properly transport, store and handle the LSDP medicine.
Dealing with damaged or expired stock
Please call us within 24 hours of receipt if you believe that the LSDP stock you have received is compromised or does not match what has been ordered for your patients.
Do not use stock after the expiry date on the product. Quarantine the stock and contact us.
It is the authorised person’s responsibility to:
- rotate the stock to ensure it does not expire
- ensure the stock with shorter expiry date is used before stock with longer expiry date
- notify us at least 1 month before the stock expiry date, so we can avoid wastage and transfer it to a location where it can be used before it expires.
We do not subsidise or pay to replace stock that has expired. If stock expires due to not being rotated, the pharmacy is responsible for the cost of replacing it.
The authorised person must call us immediately if any LSDP stock is damaged.
Quarantine the stock and contact the supplier directly as soon as possible if:
- there is any vial damage
- the product appears contaminated upon delivery
- the product is expired when delivered.
If the supplier deems the product to be faulty, they must replace the stock at no cost to the Australian Government or the authorised person.
The pharmacy must order and pay for replacement stock through the supplier if the stock is compromised due to:
- expiring due to not being rotated
- power outages
- improper preparation of infusions.
Contact us to get the contact details of the supplier. The supplier will arrange payment and delivery of replacement stock.
Moving or reallocating stock
We (the Department of Health’s LSDP team) are the only ones who can reallocate LSDP medicine. This includes reallocating or transferring stock between pharmacies for the same patient. Pharmacists cannot do this themselves.
If you have leftover stock due to patients no longer accessing LSDP medicines, please notify us as soon as possible. We can then reallocate stock to where it is needed, before it expires.
Dispensing LSDP medicines
Patient caregivers, guardians or contract nurses (in the case of home infusion) may pick up the medicine on behalf of the patient.
We can also tell the supplier to send the LSDP medicine directly to the hospital unit where the patient is being treated, immediately before they attend (as per hospital procedure).
The authorised person is responsible for taking reasonable steps to verify that the medicine is being dispensed for the immediate use of the LSDP patient. If you are not sure, please do not provide the LSDP medicine. Contact the patient or their treating specialist to confirm.
Authorised persons must maintain a dispensing record for each patient. You must keep the dispensing record for at least 12 months (and meet any other applicable state or territory requirements).
We order LSDP medicine for eligible patients based on the information provided on the dispensing record. It is essential that you send us the dispensing record every month to ensure that we order the correct stock for the patient.
If there is a change to the patient’s medicine after you have submitted the dispensing record, please call us as soon as possible. This includes changes such as:
- extra order
- change to existing order
- patient no longer requires their next order(s).
You do not need to keep the packing slips/proofs of delivery after you have emailed or faxed them to the supplier.
You can email us to request the cost of the medicine for insurance purposes.
We will contact the sponsor to facilitate this request. Release of this information is at the sponsor’s discretion. The sponsor may require the pharmacy to enter into a non-disclosure agreement.
If the patient wants to change their dispensing pharmacy, they must go through their treating physician. The treating physician must contact us and arrange delivery to another pharmacy.
If you become aware of any of the following, please notify both us and the treating physician:
- A patient has enrolled in a clinical trial (even if it is not for their rare disease). Patients participating in a clinical trial are not eligible for subsidised treatment through the LSDP.
- A patient’s treatment is to be on hold for any period, for any reason (including holidays). Please include the reason, and the start and end dates for the hold period, if known.
- A patient is ceasing treatment for any reason (including death).
- There is a change in a patient’s circumstances that may affect their eligibility to receive subsidised treatment.
- A patient is changing treating physicians.
- There is a change to the authorised person.
Information for patients
Print our handout for patients and give to each new patient. You can also direct them to LSDP for patients for more information.
You should also give patients the most current consumer medicines information leaflet from the TGA website when they start an LSDP medicine.