3. Supplying Medicines — What Pharmacists Need to Know
Pharmaceutical benefits are mainly supplied by approved pharmacists – pharmacists who comply with certain conditions. These pharmacists are approved to dispense pharmaceutical benefits from a particular pharmacy.
Other suppliers include approved doctors (usually practising in isolated areas), Friendly Society pharmacies, and approved hospitals. All suppliers are issued with approval numbers by the Department of Human Services. They should follow the procedures in these Explanatory Notes.
An approved pharmacist may only supply pharmaceutical benefits at or from premises for which they have been approved.
Unapproved pharmacists cannot supply pharmaceutical benefits.
Conditions of Approval for approved pharmacists
The National Health Act 1953 (the Act) allows for payment of a claim for the supply of a pharmaceutical benefit where the supply has been made at or from premises for which the pharmacist is approved under the Act (approved premises).
The Act also provides that payment to an approved pharmacist for the supply of a pharmaceutical benefit cannot be made if it was supplied at or from unapproved premises, or otherwise than in accordance with a condition of approval.
As part of their approval under section 90 of the Act, all approved pharmacists are subject to certain conditions. These include that the approved pharmacist will:
- not supply to anyone any pharmaceutical benefit that attracts a Commonwealth contribution for free, or for a price that is less than the relevant patient contribution;
- clearly advertise that any offer for free or cut-price medicines does not include pharmaceutical benefits which have a Commonwealth contribution; and
- not pay rebates or refunds of patient contributions.
The Act also allows the Minister to determine any other conditions with which approved pharmacists must comply. These additional conditions are set out in the National Health (Pharmaceutical Benefits) (Conditions of approval for approved pharmacists) Determination 2007 (the Conditions of Approval). The Conditions of Approval require that an approved pharmacist must, amongst other requirements:
- comply with all legal requirements for the practice of pharmacy;
- comply with the Pharmaceutical Society of Australia’s Code of Ethics and Professional Practice Standards in their dealings with each individual patient; and
- maintain the currency of his or her pharmaceutical knowledge in accordance with the Pharmaceutical Society of Australia’s Competency Standards for Pharmacists in Australia.
From 1 December 2014, a new condition of approval is being introduced which sets out the circumstances which must be met before a claim for payment from the commonwealth for the supply of a Pharmaceutical Benefit can be made.
This new condition requires that an approved pharmacist must not make a claim for payment for the supply of a pharmaceutical benefit unless it was supplied at or from approved premises for the pharmacist.
To assist approved pharmacists in understanding the intention of the proposed new condition of approval the Department has prepared a series of Frequently Asked Questions.
Approved pharmacists should be aware that a breach of a condition of approval may lead the following compliance measures:
- recovery of monies;
- reprimand, suspension or revocation of approval (following referral to the Pharmaceutical Services Committee of Inquiry); and/or
- prosecution for criminal offence under the Act or Criminal Code.
Should you have concerns about a potential breach of the Conditions of Approval for approved pharmacists, or any other compliance matter, you can report your concerns to The Australian Government Services Fraud Tip-off Line by calling 131 524 or filling out the Reporting suspected fraud (1980) form.
The Department of Human Services investigates all tip-offs related to payments that may have been made incorrectly. However, the Department is not able to provide complainants with updates due to legislated privacy and secrecy provisions. For more information on how to report your concerns, please visit the Department of Human Services website.
Other requirements for approved pharmacists
A pharmacist approved to supply medicines under the PBS:
- will publicly display a notice setting out the pharmacy's normal trading hours;
- is obliged to supply pharmaceutical benefits at the pharmacy at any hour if a PBS prescription is marked 'urgent' and initialled by the prescriber;
- will keep adequate stocks for the supply of pharmaceutical benefits;
- may be called on by the Department of Human Services to provide details of stocks of pharmaceutical benefits or preparations for pharmaceutical benefits; and
- must keep the duplicates of all old format PBS prescriptions, and the patient/pharmacist copies of all new format PBS prescriptions, with a Commonwealth contribution for at least one year from the date of supply. This includes PBS prescriptions ordering repeats when it is the final supply, and order forms for prescriber bag supplies. Please note that some State/Territory laws require these copies to be kept for longer periods.
Before supplying pharmaceutical benefits
Several steps must be taken before a pharmaceutical benefit is supplied.
Firstly, a pharmacist must endorse the PBS prescription and duplicate with his/her name and approved supplier number.
Secondly, a PBS prescription identifying number must be given to the PBS prescription item on both the PBS prescription and duplicate. Any recognised series of numbers may be used.
If more than one item is on a PBS prescription, a separate identifying number should be allocated to each item.
In the case of a repeat authorisation, the same PBS prescription identifying number(s) must be carried through for each item. A pharmacist must also allocate his/her own identifying number on the repeat authorisation. It must be written alongside the date and place of supply.
Supplying pharmaceutical benefits
Do's and Don'ts
Except in urgent cases (see details under '2. Prescribing Medicines ... Urgent cases'), pharmacists are authorised to supply pharmaceutical benefits only after they receive:
- the pharmacist/patient and the Department of Human Services or DVA copies of a valid PBS prescription which is not more than 12 months old; or
- the pharmacist/patient and the Department of Human Services or DVA copies of an approved authority PBS prescription or an authority to prescribe which is not more than 12 months old; or
- a repeat authorisation attached to a patient/pharmacist PBS prescription not more than 12 months after the date of the original PBS prescription.
A pharmacist must not supply an Authority required (STREAMLINED) item unless the prescriber has written the four digit streamlined authority code on an authority PBS/RPBS prescription.
A pharmaceutical benefit cannot be supplied more times than specified in the PBS prescription.
A pharmacist cannot add to, delete from, or alter a PBS prescription in any other way. However, there may be circumstances where after contacting a prescriber, the pharmacist can clarify the prescriber's intentions and endorse the PBS prescription accordingly.
Once a pharmaceutical benefit has been supplied to a patient, it may not be supplied to that patient again:
- on the same day or within the next 20 days, if it is a benefit (other than an eye preparation) that has five or more repeats allowed in the Schedule; or
- on the same day or within the next four days (e.g., if a pharmaceutical benefit is supplied on a Monday, it cannot be supplied again to that patient until the next Saturday) in the case of other benefits.
Exceptions to this are:
- when a PBS prescription is endorsed with the words 'Regulation 24' or 'hardship conditions apply' (see below under 'Regulation 24'); and
- If a pharmacist believes a repeat supply is needed without delay for the treatment of the person, or a previous supply has been destroyed, lost or stolen. In this case, the pharmacist can provide another supply but must write ‘immediate supply necessary’ and sign the PBS prescription.
A pharmacist can supply an alternative pharmaceutical benefit without reference to the prescriber, provided that:
- the PBS prescription does not indicate that only the pharmaceutical benefit prescribed is to be supplied (ie substitution is not permitted); and
- the Schedule states that the prescribed benefit and the substitute benefits are equivalent; and
- supply of the substitute benefit does not contravene relevant State/Territory law; and
- the substitute benefit is a listed brand in the Schedule.
Pharmacists must heed State/Territory laws when supplying drugs listed as narcotic, specified or restricted in legislation of the particular State or Territory.
If an item or brand is deleted from the Schedule, it cannot be supplied as a pharmaceutical benefit from the date the deletion takes effect – regardless of whether the PBS prescription was written before this date. This includes repeat authorisations. (Special conditions applying to RPBS prescriptions are detailed in the RPBS Explanatory Notes.)
However, if restrictions on the prescribing of a pharmaceutical benefit change, or the maximum quantity or number of repeats is altered in the Schedule, valid PBS prescriptions written before the date of effect of the change may still be supplied as pharmaceutical benefits, under the conditions applying at the date of prescribing.
Pharmacists should take all reasonable steps to satisfy themselves that all items on a PBS prescription were written by a medical practitioner, a dentist, an optometrist, a midwife or a nurse practitioner.
This regulation allows pharmacists to supply a pharmaceutical benefit and all of its repeats at the one time.
The PBS prescription must be endorsed by the medical practitioner, midwife or nurse practitioner with the words 'Regulation 24' if it is an item under the PBS, or 'hardship conditions apply' if it is being supplied under the RPBS. (For more information see under `2. Prescribing Medicines ... Regulation 24'). Regulation 24 does not apply for supply of pharmaceutical benefits on optometrist prescriptions.
When a PBS prescription calls for repeat supplies, the pharmacist shall prepare a Repeat Authorisation Form, except when the PBS prescription is marked `Regulation 24'.
The repeat may be requested on a standard PBS prescription, an authority PBS prescription or an Authority to Prescribe Form, or on an earlier repeat authorisation. In the latter case, it must come with the duplicate PBS prescription, or in the new format, the "patient/pharmacist copy".
Preparing Repeat Authorisation Forms
A Repeat Authorisation Form must show:
- the category of benefit (concession or general) – by placing a cross (x) in the relevant box;
- the patient's name and full address;
- in the case of repeats authorised on authority PBS prescriptions, the authority prescription number;
- details of the original PBS prescription stating the item, form, strength, quantity and directions;
- if substitution has occurred, the name of the brand actually supplied;
- for the first supply, the pharmacy name, address and approval number, the date of the original PBS prescription and the allotted PBS prescription identifying number;
- for subsequent supplies, the pharmacy approval number, and the date and PBS prescription number of the original prescription;
- the number of times the item is to be repeated and the number of times it has been supplied;
- the name and pharmacy approval number of the pharmacist issuing the repeat authorisation; and
- the date of supply.
When a repeat authorisation is prepared for any further repeats or deferred supply, a pharmacist must attach the duplicate copy of an old format PBS prescription, or the patient/pharmacist copy of a new format PBS prescription, and give both to the patient at the time of supply.
Repeat authorisations for deferred supply
When a PBS prescription orders a number of pharmaceutical benefit items, but the patient does not need all of the items at the same time, a separate repeat authorisation for each deferred item must be prepared. The words 'original supply deferred' should be indicated across the relevant item on the original PBS prescription, its duplicate, and on the repeat authorisation.
Deferred items must not be claimed on the original PBS prescription.
The Repeat Authorisation Form when it is used for a deferred supply, is issued in the same way as normal repeat authorisations except that:
- '0' is to be inserted in the space for 'no. of times already dispensed'; and
- if no repeats are ordered, '0' is to be inserted in the space for 'no. of repeats authorised'.
Supplying a benefit on a deferred supply repeat authorisation is to be treated as if it is the first time of supply. If repeats are directed, the normal procedure for repeat authorisations applies. Details of the pharmacy at which the deferred supply was authorised are to be written onto subsequent repeat authorisations.
Authority PBS prescriptions
If a pharmacist is presented with an authority PBS prescription and is not sure if it has been approved, he or she should contact the Department of Human Services. Please note that the Department of Human Services will not provide clinical information.
If the authority PBS/RPBS prescription is for an Authority required (STREAMLINED) item the pharmacist should ensure that the prescriber has written the four digit streamlined authority code on the prescription, this enables the pharmacist to supply the item as a PBS benefit.
The pharmacist is required to include the four digit streamlined authority code on the claim for the PBS dispensing.
In urgent cases and where State/Territory law allows, pharmacists can supply a pharmaceutical benefit to a person without a PBS prescription, provided details of the prescription are given by the prescriber via telephone or other means. The prescriber must then forward the written PBS prescription and duplicate to the pharmacist within seven days of the date of supply.
Where a pharmaceutical benefit needs prior approval from the Department of Human Services or the DVA, the prescriber must obtain approval and then advise the pharmacist of the PBS prescription and approval details. Only an original supply can be provided in this manner, not repeats.
A person receiving a pharmaceutical benefit item must sign and date a receipt for it. If the person is not the patient, that person must also endorse the PBS prescription or repeat authorisation with his/her address. A receipt cannot be obtained until supply of the benefit has been made.
If a pharmaceutical benefit has to be sent through the post, by rail, or by other means, and a receipt is not practical, the pharmacist must certify on the PBS prescription or repeat authorisation that the benefit has been supplied, and write the date of supply and details of how it was sent. For example, if a pharmaceutical benefit is mailed to a patient on 1 April 2008, the pharmacist should write: "Certified supplied – mailed to patient 1 April 2008 (name of pharmacist) (signature of pharmacist) (date of certification)".
If an item is supplied in an urgent case, or to a person who cannot read or write, the pharmacist should sign and date a statement on the PBS prescription or repeat authorisation, stating the item has been supplied and the date on which it was supplied, and explaining why there is no receipt. For example, if a pharmaceutical benefit is supplied to a patient with a broken arm on 1 May 2008, the pharmacist should write: "Certified supplied 1 May 2008 – patient has a broken arm and is unable to sign (name of pharmacist) (signature of pharmacist) (date of certification)".
Only the pharmacist approved to supply pharmaceutical benefits can certify supply.
Prescriber bag supplies
Pharmacists may supply certain pharmaceutical benefit items free of charge to a PBS prescriber if they receive a prescriber bag order form in duplicate, signed by the prescriber. Only items listed under prescriber bag provisions for the relevant prescriber type can be supplied to the prescriber.
Pharmacists must be satisfied the form was completed by a PBS prescribers and includes the prescriber’s name and address. If a pharmacist does not know the prescriber, he/she should confirm the prescriber’s registration or PBS prescriber number and endorse this on the back of the form.
For more information see '2. Prescribing Medicines ... Prescriber bag supplies'.