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Welcome to our first newsletter for 2021. This edition will update you on important practice matters as well as general Board information and National Scheme news. First, the closure of the pandemic sub-register on 5 April 2021. If you are on the sub-register and would like to continue to practise after it closes, you must apply for registration through the transition pathway before 11.59pm on 5 April. See details in the article below.
We have published a summary report of an analysis of notifications involving oral methotrexate and I encourage you to read the methotrexate case studies in this newsletter.
I would also like to thank the pharmacist immunisers for completing the Board’s survey about their immunisation training in preparation for the rollout of COVID-19 vaccines. National Boards and Ahpra have published a position statement about COVID-19 vaccination for health practitioners and students, read more below.
Brett Simmonds
Chair, Pharmacy Board of Australia
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The Board recently conducted a survey of pharmacist immunisers about their immunisation training. The information was gathered to help state and territory and Commonwealth health departments prepare for a potential Australia-wide rollout of a COVID-19 vaccine.
At present Ahpra and the Board do not have any data on the number of pharmacists in Australia who have completed a recognised immunisation training program. The survey was voluntary, so the number of survey responses may not be representative of the number of pharmacists who have completed recognised immunisation training in each state or territory.
Of the survey responses, 1,776 respondents indicated that they are currently completing or have satisfactorily completed a recognised immunisation training program. Of these, 1,725 also indicated their willingness to participate in a COVID-19 vaccination program and be contacted by health departments.
The survey is now closed, and health departments have been sent the relevant data. We thank all pharmacists who took the time to complete the survey. For any further queries about the rollout of the COVID-19 vaccination program please contact your local state or territory health department or visit their websites.
The National Boards and Ahpra have published a joint statement to help registered health practitioners and students understand what’s expected of them in giving, receiving and advising on and sharing information about COVID-19 vaccination.
Registered health practitioners have led the remarkable public health response to the COVID-19 pandemic in Australia, and we commend them for this sustained public health response. As the national vaccination program gets underway, registered health practitioners and students remain critical to this success by:
The statement should be read in conjunction with the standards, codes, guidelines, position statements and other guidance. The Code of conduct explains the public health obligations of registered health practitioners, including participating in efforts to promote the health of the community and meeting obligations on disease prevention.
There is no place for anti-vaccination messages in professional health practice, and any promotion of anti-vaccination claims, including on social media and in advertising, may result in regulatory action. See the Guidelines for advertising a regulated health service for further advice.
The pandemic response sub-register (the sub-register) was established in April last year to provide a potential surge workforce during the early stages of the COVID-19 pandemic. It was intended to provide a temporary return of additional, trained and suitable health practitioners in case more registered practitioners would be needed quickly as a result of the pandemic.
More than 34,736 practitioners opted to stay on the sub-register from eight professions, including 1,935 pharmacists. The Board extends its sincere appreciation and thanks to all practitioners on the sub-register for being available to support Australia’s healthcare system and the health workforce during this very trying time.
While responding to COVID-19 is still an important focus for the Australian community and pharmacists will continue to play a vital role in the rollout of vaccines, the need for the temporary sub-register has reduced. Pharmacists on the sub-register who would like to continue to be available to practise after it closes on 5 April 2021 can now apply for registration through a transition pathway.
Pharmacists who are on the sub-register do not need to do anything to remove themselves from the sub-register as it will automatically close.
Eligible pharmacists who used to have non-practising registration before going on the sub-register will be automatically returned to non-practising registration on 6 April 2021.
Practitioners on the sub-register who would like to maintain general registration after it closes can apply for registration through a transition pathway. This also applies to those who would like to be available for any roles as part of the rollout of COVID-19 vaccines.
There is no application fee and a reduced registration fee as the remaining period of new registration will be less than 12 months.
Applicants still need to meet the National Board’s registration standards including criminal history, English language and recency of practice (time spent practising while on the sub-register can count towards the recency of practice requirements).
If you would like to apply for registration through this pathway, you must do so before 11.59pm on 5 April. If you miss the deadline, you will no longer hold registration and will need to apply through the standard registration process.
For more information, see the Ahpra FAQs.
The Board’s registration data report for 1 October to 31 December 2020 is now available. It shows that at this date, there were 34,922 registered pharmacists in Australia. Of these:
The 1,936 pharmacists that are part of the short-term pandemic response sub-register are included in the number of pharmacists holding general registration.
For more data, including registrant numbers by age, gender and principal place of practice, visit our Statistics page.
Another successful renewal of registration period has passed, marking 10 years of annual renewal under the National Registration and Accreditation Scheme (the National Scheme). Online renewal is the easiest way to renew and since 2011 the number of practitioners who renew online has risen from 82 per cent to 97 per cent. Thanks to everyone who renewed their registration on time and especially to those of you who got in early. Responding to the early email reminders to renew ensures plenty of time for your application to be assessed and for you to be contacted if follow-up is needed.
The Board understands that some practitioners had trouble meeting the continuing professional development (CPD) and recency of practice (ROP) requirements in 2020 because of the national COVID-19 emergency.
If you declared in your 2020 renewal that you didn’t meet the CPD and/or ROP requirements because of COVID-19, there is no further action you need to take.
However, as the COVID-19 emergency has now eased, the Board expects all practitioners to take the necessary action to meet the requirements of both standards ahead of renewing their registration in 2021. The Board will publish further advice if the current situation regarding COVID-19 changes. We encourage you to do CPD that is relevant to your scope of practice and your current work environment.
The Medical and Pharmacy Boards have published a reminder on methotrexate dosing. We have included case studies from coronial proceedings which illustrate the dangers of incorrect prescribing, dispensing and administration of methotrexate.
Methotrexate is an anti-inflammatory drug. It is also a cytotoxic used in cancer chemotherapy.
Methotrexate is used as a weekly dose as one of the mainstays of treatment of rheumatoid arthritis and psoriasis, with a dose range of 7.5−30mg per week. It can provide long term clinical benefit for patients with inflammatory arthritis, but has potentially fatal side effects, particularly bone marrow suppression, if given daily by mistake.
Prescribing, dispensing and administration errors continue to lead to daily instead of weekly dosing of oral methotrexate, with sometimes avoidable fatal outcomes.
Case study 1
Mr DL, aged 66, was visiting his daughter and son-in-law in Perth in 2009 when he developed an exacerbation of arthritis in his hands and feet, and was taken by his daughter to her general practitioner. The general practitioner diagnosed rheumatoid arthritis, and prescribed methotrexate at an incorrect high dosage (5mg daily for five days followed by 10mg daily for seven days).
The community pharmacist noted the high dose but dispensed the methotrexate after trying to contact the prescriber, and after informing the patient’s son-in-law that weekly dosing was more appropriate. The patient took the methotrexate at the prescribed dosage for four days and developed abdominal pain, vomiting and polyuria. He returned to the general practitioner who diagnosed a urinary tract infection and prescribed antibiotics.
Over the next four days, the patient’s symptoms persisted and he developed diarrhoea and mouth ulcers. He was admitted to hospital, where he was found to have a very low white cell count and a chest X-ray showed old apical tuberculosis. He was treated for septicaemia, tuberculosis and gastrointestinal bleeding, but developed multi-organ failure and eventually died. Review in hospital indicated that he had polyarticular tophaceous gout rather than rheumatoid arthritis, so that the methotrexate was not indicated in the first place.
The coroner considered the responsibilities of prescribing doctors and dispensing pharmacists when the type or dosage of a medication on a prescription appears to the pharmacist to be incorrect. He noted that, ‘pharmacists are expected to play a crucial checking role in ensuring, as far as possible, that patients receive appropriate medicine.’
He also found that: ‘the cause of the failure was an inexplicably incompetent error by a suitably qualified general practitioner, which … had been identified but not effectively corrected by an apparently competent pharmacist for reasons that cannot now be ascertained.’
Case study 2
Mr IG, aged 77, lived independently despite a number of chronic medical conditions, including severe chronic kidney disease (estimated Glomerular Filtration Rate (eGFR) of 11), chronic obstructive pulmonary disease and mild cardiac failure.
The patient’s general practitioner prescribed methotrexate to treat a flare-up of psoriasis. No blood tests were checked before prescribing a daily dose of methotrexate.
The dispensing pharmacist noted that the daily dose prescribed by the general practitioner was potentially dangerous and phoned him to convey her extreme concern. The general practitioner assured her that he had checked the dose and that it was correct. Although not reassured, the pharmacist felt obliged to dispense the medicine in accordance with the prescription.
Over the next few days, Mr IG developed serious symptoms of methotrexate toxicity including a skin rash, ulcers, pallor and fever. This was on the background of serious chronic medical conditions in which the use of methotrexate was contraindicated.
Mr IG was admitted to hospital, where he required haemodialysis for renal failure, and developed methotrexate-related erosive skin rash and sepsis. He died after 11 days in hospital.
Again, the coroner identified important issues about the relationship between the prescribing doctor and dispensing pharmacist. The coroner noted that it was of particular interest, ‘whether pharmacists needed to be empowered in their dealings with medical practitioners, and if so, how to facilitate it.’
Prescribing errors and dispensing errors can be made by otherwise competent practitioners. The medical and pharmacy professions need to work together to reduce the risk of serious outcomes by communicating concerns with each other about prescribing, dispensing or administration of medication.
The Pharmacy Board of Australia’s Guidelines for dispensing of medicines state that:
You should ensure that you access contemporary works of professional reference during the dispensing process. On its website, the Board provides an up–to-date list of essential references for pharmacists, Guidelines on practice-specific issues – guideline 1 (List of reference texts for pharmacists). The list includes Therapeutic Guidelines and the Australian Medicines Handbook which both provide dosing guidelines and practice points in relation to methotrexate.
We encourage you to contact prescribers with queries about prescriptions, particularly if they involve methotrexate or other drugs with potentially serious consequences due to a prescribing error. If you remain concerned after discussion with the prescriber, you are entitled to withhold the medicine to protect the patient. Support from a senior colleague may be helpful.
The Board has also published a summary report of an analysis of notifications involving oral methotrexate. The report identified that errors with dose administration aids and labelling were responsible for the majority of errors. You need to ensure your own processes and those of the pharmacy where you are practising support you to exercise your professional responsibilities in the safest way possible. Read more in the Board’s news item.
Pharmacists are authorised to administer vaccines in a state or territory if they have met the requirements set out by the local health department. States and territories may have differences in the training requirements and in the local pharmacist-administered vaccination programs including differences in the types of vaccines and the minimum age of patients who can be vaccinated.
We remind you to be aware of your obligations in relation to record keeping, including reporting the administration of the vaccine to the Australian Immunisation Register (AIR). You should also report any suspected adverse effects associated with a vaccine. In some jurisdictions, pharmacists are required under public health legislation to notify adverse events following immunisation to their state or territory health department.
You should refer to the legislation in your state or territory for specific guidance on jurisdictional requirements.
COVID-19 vaccination has now begun across Australia. The Australian Government has partnered with the Australian College of Nursing to provide training for the COVID-19 vaccination workforce. The training is free to all authorised COVID-19 vaccination providers.
The Australian Government Department of Health COVID-19 vaccines website has useful information and resources including information for COVID-19 vaccine providers and a COVID-19 vaccine eligibility checker to find out when someone can receive a COVID-19 vaccine.
To support the roll-out of COVID-19 vaccines across Australia, the Therapeutic Goods Administration (TGA) has authorised the use of specific promotional material to advertise COVID-19 vaccines. For further information please see the TGA’s Advertising COVID-19 vaccines to the Australian public page.
Cautionary advisory label D in the Australian Pharmaceutical Formulary and Handbook (APF) has been updated to specify the duration of antimicrobial therapy. The label has been changed as taking antibiotics for longer than necessary does not improve outcomes and increases the risk of acquiring resistant bacterial strains.
Antimicrobial resistance is an issue in all parts of the world and to preserve antimicrobial effectiveness steps can be taken by health professionals to prevent and control the spread of antimicrobial resistance. As outlined in Australia’s National Antimicrobial Resistance Strategy – 2020 and Beyond, the effective stewardship of antimicrobials – through appropriate and judicious manufacture, administering, dispensing, prescribing and disposal – is vital. The strategy states that where they already exist, compliance with best-practice antimicrobial prescribing guidelines must be promoted and maintained.
The Therapeutic Guidelines: Antibiotic state that appropriate antimicrobial prescribing includes prescribing the shortest possible duration of therapy, consistent with the condition being treated and the patient’s clinical response. As highlighted by an article published in Australian Prescriber, when antibiotics are indicated for treatment, short courses are as effective as standard ones for most common infections.
To align with the advice for shorter duration of antibiotic therapy, in January 2021, the Pharmaceutical Society of Australia (PSA) changed cautionary advisory label D in the 25th Edition of the APF. Label D previously stated ‘until all used/taken’ and has been changed to ‘Take for [the number of] days as advised by your prescriber’.
In addition there have been Pharmaceutical Benefits Scheme (PBS) changes to repeats for antibiotics (effective 1 April 2020). This change was to encourage clinicians to prescribe antibiotic repeats only when clinically indicated, reducing inappropriate prescribing and increasing the quality use of antibiotic medicines.
If there is confusion about the duration of therapy of a prescribed antibiotic, you may need to seek confirmation from the prescriber. You may also need to clarify the clinical appropriateness before dispensing a repeat prescription for an antibiotic, for example, if there is a large gap since the initial prescription was dispensed.
You should note that the required duration of treatment with an antibiotic may need a smaller quantity of antibiotic than the proprietary pack prescribed for the patient. To ensure safe disposal of any leftover antibiotics, advise patients to return these to the pharmacy for safe disposal.
You are required to ensure that a patient understands how to take their medication, which is achieved by counselling, correct labelling of dispensed medicines including any cautionary advisory labels as recommended in the APF and when possible, providing additional information such as consumer medication information (CMI) leaflets. You should also tell patients that the advice to take the antibiotic for the prescribed duration of therapy may be inconsistent with the advice in the current CMI leaflet for the antibiotic.
In practice, you should routinely apply relevant practice standards, associated guidelines and guidance published by the Board. More information is available in the following Board guidelines:
From 1 February 2020, revised legislation requires medicines to be identified by active ingredient names on PBS and Repatriation PBS (RPBS) prescriptions. This applies to computer generated prescriptions, and prescriptions for medicines with up to three active ingredients. Handwritten prescriptions are excluded.
Active ingredient prescribing is expected to increase understanding of active ingredients in the community and promote uptake of generic and biosimilar medicines.
Prescribers can still choose a specific brand of medicine for their patient and can include a brand name on the prescription whenever clinically necessary for treatment. When a brand name is included on a prescription, the active ingredient name(s) will appear first.
Pharmacists play an important role in explaining to consumers why their prescriptions have changed, and you should continue to give consumers information about their brand options.
Prescribing software now incorporates necessary changes to automate the active ingredient prescribing process for prescribers. However, these updates in some cases have resulted in a prescription where the intention of the prescriber is unclear.
To avoid dispensing errors, make sure you:
The Board’s Guidelines for dispensing of medicines state that the process of dispensing includes:
More information on active ingredient prescribing can be found at:
If you have questions about active ingredient prescribing you can email AIPrescribing@health.gov.au.
We regularly publish court and tribunal summaries for their educational value for the profession. Links to past and recent tribunal cases can be found on the Pharmacy regulation at work: tribunal decisions page on the Board’s website. Here are recent tribunal cases.
A pharmacist charged with a range of serious drug offences has been reprimanded and disqualified from applying for registration for three years after a tribunal finding of professional misconduct. Read more.
A pharmacist who dispensed medication in an unsafe dosage has been reprimanded by a tribunal and ordered to do more education. Read more.
A pharmacist has been suspended after a tribunal finding of professional misconduct, for conduct described as a ‘fundamental failure of responsibility’. Read more.
Did you know that all students enrolled in an approved program of study leading to registration as a pharmacist must be registered?
If you are enrolled in an approved program of study, you do not need to apply for registration. Your education provider will pass on your details to the Board for registration. No fees are required.
While you are a student, we encourage you to learn more about the regulatory requirements for the pharmacy profession and what it means to be registered as a pharmacist with the Pharmacy Board of Australia.
The Board has produced a PowerPoint – Pharmacist registration: What you need to know – to help students understand what is involved in the transition from study to a career as a pharmacist and why they must be registered. You can find the PowerPoint on the Student registration page.
Are you concerned that your student placement will be put on hold or cancelled due to the COVID-19 pandemic?
In April 2020, Ahpra and the National Boards, together with the Australian Government and the Health Professions Accreditation Collaborative Forum, set national principles for clinical education to guide decisions of professions, accreditation authorities, education providers and health services about student clinical education during the COVID-19 pandemic response. You can read the principles in the news item.
We encourage student placements to continue where safe and possible. Clinical placements can provide many benefits to both the student and the health service, although placements may need modification during the pandemic to ensure the safety of patients, students and other staff.
The Code of conduct for pharmacists has been developed to assist and support pharmacists to deliver effective regulated health services within an ethical framework. You have a duty to make the care of patients or clients your first concern and to practise safely and effectively. Maintaining a high level of professional competence and conduct is essential for good care.
The code contains important standards for practitioner behaviour in relation to:
We have also developed several guidelines to help you and to clarify our views and expectations on a range of issues. Our Quick reference guide will help you identify the appropriate guidelines to read.
The National Boards and Ahpra are seeking feedback on revised regulatory principles for the National Registration and Accreditation Scheme (National Scheme).
The regulatory principles encourage a responsive, risk-based approach to regulation across all professions within the National Scheme. They also acknowledge the importance of community confidence and working with the professions to achieve good outcomes.
The draft revised regulatory principles reflect two recent policy directions issued by the COAG Health Council which provide a clear mandate to the National Boards and Ahpra to prioritise public protection in the work of the National Scheme.
We want the public to have trust and confidence in regulated health practitioners and to know that their safety is at the heart of everything we do in the National Scheme. The revised principles reinforce that public protection is the paramount objective.
The consultation is open until 18 May 2021. Feedback is invited from practitioners, stakeholders and the community.
Find out more about how to make a submission on the Consultations page on the Ahpra website.
A key objective of the National Scheme’s Aboriginal and Torres Strait Islander Health and Cultural Safety Strategy 2020-2025 is to embed cultural safety in the National Scheme and the health system. A new, online and face-to-face education and training program for all Ahpra staff, board and committee members is rolling out state by state, starting in our Tasmanian office in Hobart.
The Moong moong-gak Cultural Safety Training Program is designed to provide members of the National Scheme with the knowledge, skills and abilities to develop and apply culturally safe work practices as these relate to their role as part of the National Scheme.
The program gives participants an opportunity to hear and learn from the perspectives of Aboriginal and Torres Strait Islander Peoples, and to reflect on their own behaviours, and their conscious and unconscious beliefs. Upon completion of the program, participants will be better prepared to engage in culturally safe practices, communication and behaviour, in order to contribute to more effective service delivery and improved health outcomes for Aboriginal and Torres Strait Islander Peoples.
The cultural safety training will contribute to Ahpra employees’, Board members’ and practitioners’ ongoing critical reflection on their knowledge, skills, attitudes, practising behaviours and power differentials in providing safe, accessible and responsive healthcare free of racism.
We want all our people to embrace the training with an open mind and the ability to learn and unlearn!
In 2017 Ahpra commissioned independent research that took the first international look at vexatious complaints. The report, Reducing, identifying and managing vexatious complaints, found that vexatious complaints account for less than one per cent of notifications received, and that there is greater risk of people not reporting concerns than of people making truly vexatious complaints. The report also noted that being on the receiving end of any notification is a distressing experience for any health practitioner. Regulators need to have good processes for dealing with unfounded complaints quickly and fairly.
Following recommendations made in the report, Ahpra developed A framework for identifying and dealing with vexatious notifications for staff and regulatory decision-makers. This will help us identify and manage potentially vexatious notifications. The framework outlines:
We understand that practitioners who feel that they may be the subject of a vexatious notification are more likely to experience stress and anxiety. Our staff are equipped to identify and support these practitioners and to implement management strategies set out in our framework when a concern about vexatiousness is raised with us.
Our staff are here to help you before, during or after the notifications process. We encourage you to visit our General support services page where you can find the contact details for additional support services. You can also listen to Episode 1: Vexatious notifications, Taking care, Ahpra’s podcast and visit our Concerns about practitioners page for more information about notifications and links to the report and framework.
Ahpra’s Taking care podcast series has a new episode. Talking to Ahpra host Susan Biggar, Victoria’s Chief Health Officer, Adjunct Professor Brett Sutton, and Queensland’s Chief Health Officer, Dr Jeannette Young, speak openly about their experience of leading during a pandemic, how they coped, and the impact on them and their families.
Brett Sutton speaks about the heavy burden of decision-making with such far-reaching consequences and the importance of his own family and other support mechanisms he relied on to handle the huge pressures. Jeannette Young discusses the fact that there was no rule book, the importance of her husband’s early retirement to support her and how she managed death threats.
Despite the intensity and seriousness of their work, both could see the lighter side of their unexpected celebrity status, a consequence of the unavoidable media spotlight.
Ahpra releases a new Taking care episode fortnightly, discussing current topics and the latest issues affecting safe healthcare in Australia. Other recent episodes include:
You can also listen and subscribe on Spotify, Apple Podcasts and by searching ‘Taking care’ in your podcast player.
L to R: Adj. Prof. Brett Sutton, Dr Jeannette Young
Ahpra will establish a new, independently chaired committee to consider key accreditation issues, in response to a new policy direction from the Health Council (formerly the COAG Health Council).
The new committee will have broad stakeholder membership to give independent and expert advice on accreditation reform issues to Ahpra’s Agency Management Committee. The new committee will replace Ahpra’s Accreditation Advisory Committee set up in 2020.
The Independent Review of Accreditation Systems (ASR) Final Report, Australia’s health workforce: strengthening the education foundation, recommended that Health Ministers issue the policy direction.
Ahpra and the National Boards welcomed the policy direction, which requires Ahpra, the National Boards and accreditation authorities to consider the new committee’s advice when exercising their functions under the National Law.
Under the policy direction, Ahpra, National Boards and accreditation authorities must document the outcome of their consideration of the new committee’s advice in meeting minutes, communiqués or other relevant formats.
Ahpra and National Boards will continue to work collaboratively with accreditation authorities through the Accreditation Liaison Group and the Health Professions Accreditation Collaborative Forum.
The policy direction can be viewed on the Ahpra website.