Changes and new listings for four antibiotics on the PBS

• On 1 April 2020, changes were made to the PBS listings of amoxicillin, amoxicillin + clavulanic acid, cefalexin and roxithromycin
  Maximum quantities and numbers of repeats were changed to reduce inadvertent and unnecessary repeat prescribing when initiating antibiotic treatment.
• New PBS listings were added for amoxicillin, amoxicillin + clavulanic acid and cefalexin
  Authority Required (Streamlined) listings allow prescribing if there is a clinical need for increased quantity or duration.
• The PBS listings for the four antibiotics are now more closely aligned with the Therapeutic Guidelines
  They encourage best practice by supporting clinical decision making and reduce potential harms such as antibiotic resistance.

On 1 April 2020, four antibiotics listed on the PBS General Schedule (Section 85) had changes made to their listings and new listings added for the treatment of a range of infections, such as acute cystitis, streptococcal pharyngitis or tonsillitis and periorbital cellulitis.¹

The antibiotics include:¹

• amoxicillin
• amoxicillin + clavulanic acid
• cefalexin
• roxithromycin.

See the PBS website for complete details for each item, including the specific infections. These are also listed in Table 1 at the end of this article.

The listing changes and new listings aim to promote antimicrobial stewardship, by reducing inappropriate, inadvertent repeat prescribing when initiating a course of antibiotics.^2,3 

Antimicrobial stewardship in Australia

Antibiotics are overprescribed for many conditions in Australia. For example, prescribing of antibiotics may be recommended for 19%–40% of patients with acute tonsillitis, but NPS MedicineWise’s MedicineInsight program found that 94% of patients with acute tonsillitis were prescribed antibiotic treatment.⁴

Antimicrobial stewardship promotes optimal prescribing of antibiotic, antifungal, antiviral and antiparasitic agents. It helps to improve safe and appropriate use of antimicrobials, reduce patient harm and decrease the incidence of antimicrobial resistance in the Australian healthcare system.⁴

In 2017, the General Practice National Antimicrobial Prescribing Survey (GP NAPS) identified several interventions to promote antimicrobial stewardship in general practice. One suggestion was to allow prescribers to review the maximum number of repeat prescriptions during electronic prescribing.⁴

Inappropriate repeat prescriptions typically occur inadvertently because many clinical software prescribing tools used by GPs have repeats ticked as a default setting for frequently prescribed antibiotics.³

The proportion of prescriptions issued with a repeat varies between different antibiotics, which is expected as some indications may appropriately require repeats. For example, using doxycycline for the treatment of acne requires longer time frames. However, many common infections do not require repeat prescriptions and there is evidence supporting shorter antibiotic courses.⁴

Review of PBS listings

More than 26 million antibiotic prescriptions were dispensed through the PBS in Australia in 2017.⁴

In 2018, the Department of Health reviewed PBS listings of frequently used antibiotics that allowed repeat prescriptions to be issued as the default setting for computer-generated prescriptions.²

The aim of this review was to reduce antibiotic prescribing without impacting clinical decision making, by ensuring health professionals could actively decide to prescribe repeats for antibiotics where clinically indicated.²

The antibiotics selected for the review were the top five dispensed antibiotics on the PBS.² These antibiotics – amoxicillin, amoxicillin + clavulanic acid, cefalexin, doxycycline and roxithromycin – represented over 70% of all dispensed antibiotics under the PBS in 2017.⁴

The Pharmaceutical Benefits Advisory Committee (PBAC) noted that one in five repeat prescriptions of these antibiotics supplied through the PBS were dispensed more than 30 days after the dispensing date of the original prescription.²

Alignment with Therapeutic Guidelines: Antibiotic (version 16)

In April 2019, version 16 of the Therapeutic Guidelines: Antibiotic was published. The Therapeutic Guidelines: Antibiotic are a collection of guidelines published by an independent not-for-profit Australian organisation to provide clear, practical, evidence-based and up-to-date information to prescribers. They are endorsed by reputable organisations and peak bodies, and used commonly in public teaching hospitals and community medical and pharmacy practices across Australia.²

The Department of Health review used version 16 of the guidelines to ensure changes and additions to PBS listings were in alignment.²

At its August 2019 meeting, the PBAC considered the changes proposed in the PBS review of the selected antibiotics, which included:²

• implementing new Authority Required (Streamlined) listings to enable access to repeats for antibiotics prescriptions, where clinically indicated according to version 16 of Therapeutic Guidelines: Antibiotic
• amending the maximum quantity and repeats allowed for some listings to allow a patient to receive the full recommended course of antibiotic treatment for a particular indication as per Therapeutic Guidelines: Antibiotic; this is to be dispensed in one prescription for a short course of antibiotic treatment
• maintaining access to antibiotics for indications that are not listed in Therapeutic Guidelines: Antibiotic, without repeats, by maintaining or adding unrestricted listings for shorter treatment courses (with a note detailing that no repeats or increases in maximum quantity are allowed).

These listing changes (summarised in Table 1 at the end of this article) encourage health professionals to use their clinical judgement to guide prescribing and allow them to prescribe repeats when clinically indicated.²

It should be noted that while doxycycline was considered in the review, no changes were made to its PBS listings because the indications and treatment periods of the listings were already in alignment with version 16 of the Therapeutic Guidelines.²

The amendments to repeats on antibiotic listings are expected to improve antibiotic use by reducing inadvertent repeat prescriptions,² and to assist in reducing antimicrobial resistance.³

The introduction of the Authority Required (Streamlined) listings is also expected to ensure that prescribers may still prescribe appropriate treatment courses when required, without significantly increasing prescriber workload.²

If treatment courses exceed the limits of the PBS listing, prescribers may still choose to prescribe longer courses, or for different indications, outside of the PBS.²

Patients who are prescribed shorter treatment courses may have to return more frequently than previously for clinical review, rather than taking more courses of antibiotics without review. Before these changes, if patients received repeats on their antibiotic script, they could continue taking the medicine for several weeks before returning to see their doctors.³

These changes may also help improve diagnostic accuracy. If a patient’s condition is not improving despite antibiotic treatment, it may be because the diagnosis requires further assessment. For example, patients who have endocarditis, bone and joint infections, or autoimmune diseases may first present with generalised symptoms and be treated with multiple courses of the same antibiotic. The patient returning for clinical review provides an opportunity to further investigate the underlying cause.³

At the same time as these positive impacts, the PBAC acknowledged that broader changes are required to further promote antimicrobial stewardship, as this is a complex issue due to inconsistencies in pack sizes across indications and products² (which often do not conform with guidelines³).

Shared decision-making

While removing access to repeats may cause frustration for health professionals, they may also use this as an opportunity to engage in shared decision-making. Shared decision-making is important to reinforce the fact that health professionals and patients both have roles to play in reducing antibiotic resistance, while also acknowledging the patient’s values.⁵ A Cochrane review from 2017 identified shared decision-making as one of the strategies that potentially help to reduce inappropriate antibiotic prescribing in primary care.⁶

Some antibiotic listings remain the same

Some listings for antibiotics were considered in the review but were not altered. These include:²

• doxycycline 100 mg for unrestricted use
• doxycycline 50 mg for restricted use in bronchiectasis, chronic bronchitis and severe acne (in patients ≥ 8 years of age)
• doxycycline 50 mg for restricted use in severe acne
• cefalexin 250 mg Authority required (Streamlined) for prophylaxis of urinary tract infection
• cefalexin 500 mg for treatment of osteomyelitis
• amoxicillin 1 gram for restricted use in chronic bronchitis.

With changes to maximum quantities and number of repeats, patients must meet the restriction criteria to be eligible for the PBS subsidy.⁷

Prescribers should ensure they are prescribing quantities and repeats in line with the current therapeutic guidelines,⁷ even if it involves dispensers having to break the pack size.³

If a patient has a clinical need that meets the indications of a restricted listing to receive a longer treatment course, the prescriber may choose to seek authority to do so via Services Australia.² This requires completing an Authority PBS prescription form and approval will only be granted if the reason for the prescription is consistent with the indications published in the listing.⁸

All unrestricted and two restricted listings have limits on quantities and repeats which cannot be increased (as stated in an administrative note on the listing, see the PBS website for complete details),² as Services Australia does not have delegation to administer outside the listed quantities and repeats in these instances.⁷ The limits on the unrestricted items are to ensure alignment of treatment courses with Therapeutic Guidelines: Antibiotic.²

For new listings that have an Authority Required (Streamlined) restriction on repeats, prescribers must include a valid streamlined authority code on the authority prescription.⁷

Health professionals should advise patients that there have been changes to the way antibiotics are prescribed on the PBS.²

Patients may no longer have a repeat prescription at home that they can use to self-treat their condition without the advice of their doctor.³

In some cases, this might mean they have to return to see their doctor if they feel their condition has not improved, rather than returning to the pharmacy to obtain a repeat course of antibiotics without review.³

Returning to their doctor can help patients make sure they have received the right diagnosis and the best care.³ As all antibiotics can cause adverse reactions, taking them when they may not be needed is an unnecessary risk.⁹

For more information on reducing antibiotic resistance:

• NPS MedicineWise website
• Australian Government Antimicrobial Resistance website

For more information on prescribing of antibiotics:

• Therapeutic Guidelines: Antibiotics
• Antibiotic prescribing in primary care: Therapeutic Guidelines summary table 2019

Table 1. Summary of antibiotic PBS listing changes and new additions^1,2