These case studies have been published by the Pharmacy Board of Australia to help practitioners understand and meet their professional and legal obligations as a registered pharmacist.
Additional case studies can be found in past newsletter issues published by the Board.
Pharmacists may choose to extend their scope of practice beyond simple compounding to compound medicines of a more complex nature (‘complex compounding’) at some point in their career.
This may require or involve specific competencies, equipment, processes and facilities to manage the higher risks associated with the preparation and dispensing of these medicines.
This case study examines issues involved in a complex compounding matter involving a pharmacist in Australia, the outcome and lessons learned.
In this matter it was alleged that a pharmacist carried out complex compounding in circumstances where:
The pharmacy premises registering authority (the premises regulator) conducted an investigation into a community pharmacy which revealed that complex compounding was being carried out in a manner that was contrary to the Board’s Guidelines on compounding of medicines, Therapeutic Goods Administration (TGA) legislation and the premises regulator guidelines. The premises regulator submitted a notification to Ahpra concerning the pharmacist who undertook the compounding.
The investigation carried out by the premises regulator found that complex compounding was carried out on an open bench in the dispensary, which was also used as a staff amenity area and to store food and drinks. The compounding area did not have appropriate equipment and resources and other staff undertaking compounding were not appropriately trained.
It was found that certain complex and high potency medicines were not subject to adequate quality assurance. In some instances, melatonin capsules were compounded at the premises in bulk and delivered to another pharmacy for supply, however the premises was not a TGA-licensed facility. Records of compounding activities including worksheets were not maintained at the premises.
The pharmacist was cautioned and had conditions placed on his registration requiring him to practise under supervision when undertaking complex compounding, undertake education and provide a reflective practice report. He was also required to attend mentoring sessions.
TGA legislation sets out the exemptions that enable pharmacists to compound medicines and specifies that pharmacists cannot lawfully compound medicines at a community pharmacy or private hospital for supply by wholesale, unless their premises are licensed by the TGA for the manufacture of therapeutic goods, or licensed/registered by the relevant state or territory authority (depending on the jurisdiction). In this case, the pharmacy was located in a jurisdiction where the premises was required to be licensed by the TGA for the manufacture of therapeutic goods for wholesale supply.
As outlined in the Board’s Guidelines on compounding of medicines, when engaging the support of ancillary staff in the compounding process, it remains the pharmacist’s responsibility to ensure support staff have the appropriate education, training and/or experience for the specific compounding activities being carried out.
The Professional practice standards published by the Pharmaceutical Society of Australia (PSA) also address training and education of staff and outline the actions required to ensure that compounding staff under direct supervision are suitably trained, and maintain the essential competencies required for their duties.
There are both legal and professional requirements for facilities and equipment that must be met to support safe compounding. Facility, working environment and equipment requirements and guidance are detailed in the:
The APF states that pharmacists should not compound medicines if they do not have suitable facilities and equipment. The Board’s compounding guidelines require pharmacists and persons responsible for the operation of premises including pharmacist proprietors, to ensure that all compounding, including that done by non-pharmacist staff, takes place in premises that are adequately designed, equipped, maintained and resourced. The compounding guidelines also acknowledge the PSA practice standards.
The Board’s guidelines for proprietor pharmacists also outline the responsibilities of the proprietor, including to ensure compliance with any state or territory legislation regarding facilities and equipment required for the types of services provided at the pharmacy.
The Board’s compounding guidelines note that pharmacists should document the preparation of compounded products in accordance with state, territory and Commonwealth legislation, practice standards and guidelines, and the quality assurance information published in the current edition of the APF. Appropriate documentation is essential for every compounded product.
The Board’s compounding guidelines outline that pharmacists who compound products must have appropriate risk management processes in place to manage risks associated with the compounded product, such as quality assurance of products (including microbial testing).
The guidelines also refer pharmacists to the quality assurance information published in the current edition of the APF which requires samples of complex or high-risk compounded medicines commonly prepared to be submitted to an appropriately accredited analytical laboratory for testing according to documented testing protocols.
Pharmacists who compound medicines or oversee the compounding of medicines must always ensure that compounding practices:
There are several possible outcomes from a notification. One possible outcome is that the National Board will decide to take no further action.
There are different reasons why a National Board may decide to take no further action:
The case provided below demonstrates when the Board may decide to take no further action.
It was alleged that the pharmacist acted in a rude and aggressive manner towards the notifier and a family member who was considered an at-risk patient.
Due to miscommunication, a request for a change to a dose administration aid resulted in a verbal confrontation between the notifier and the pharmacist. The verbal confrontation adversely affected the patient as well as the notifier and the pharmacist. In this case the patient had an intellectual disability and was considered an at-risk patient.
In this case the pharmacist demonstrated insight into her actions by acknowledging how she should improve her communication. The pharmacist expressed regret for her actions and apologised, which demonstrated to the Board that by reflecting on the situation, she would avoid similar incidents in future. As the pharmacist had already taken action to improve her practice, the Board decided to take no further action in this instance.
Pharmacists have a responsibility to be courteous and respectful to their patients as outlined in the Pharmacy Board’s Code of conduct. The Code of conduct notes that an important part of the practitioner–patient/client relationship is effective communication. This includes:
Some patients or clients (including those with impaired decision-making capacity) have additional needs. As stated in the code, good practice in managing the care of these patients or clients includes:
Patients or clients have a right to complain about their care. As outlined in the code, when something goes wrong good practice involves several steps including:
When a patient makes a complaint to the pharmacist, effective communication with the person can resolve the issue and ensure that the patient’s care is not adversely affected. If a patient believes that they have not been listened to and their care has been adversely affected, they are more likely to lodge a formal notification with the Board.
It was alleged that a pharmacist practised while unregistered for approximately four months in 2019.
The pharmacist failed to renew their registration and it lapsed on 31 December 2018 following the expiration of the one-month late renewal period. During the period from 1 January to mid-May 2019, the pharmacist continued to work on a regular basis in a community pharmacy.
During February the pharmacist made enquiries with Ahpra about renewing their registration but did not lodge their application for registration until May.
The pharmacist was reprimanded and fined by a tribunal.
Anyone who uses the protected title of ‘pharmacist’ in the Health Practitioner Regulation National Law (National Law), must be registered with the Pharmacy Board of Australia.
Falsely claiming to be a registered health practitioner is an offence under the National Law. The law allows for penalties for falsely using protected titles or holding yourself out to be a registered practitioner when you are not.
The current registration status of all registered health practitioners in Australia is published on the national register of practitioners. If a person’s name does not appear on the register, they are not registered to practise in a regulated health profession in Australia.
Published: December 2020
It was alleged that the pharmacist incorrectly labelled a bottle of prednisolone liquid for an 11-month-old child with instructions to give 8mL once a day.
A prescription was presented for the patient for prednisolone 5mg/mL solution with instructions to give 8 mg once a day for two days. When the pharmacist entered the prescription into the dispense system the instructions were transcribed incorrectly as 8 mL once a day for two days. During counselling the pharmacist gave verbal instructions to give 1.6mL however did not detect the error in labelling.
The patient was subsequently given one dose of 8mL and experienced vomiting before the error was detected.
The pharmacist was cautioned.
It was alleged that the pharmacist incorrectly labelled a bottle of prednisolone liquid for a 3-month-old child with instructions to give 5mL daily.
A prescription was presented for the patient for prednisolone 5mg/mL solution with instructions to give 5 mg once a day for two days. When the pharmacist entered the prescription into the dispense system the instructions were transcribed incorrectly as 5 mL once a day for two days. This may have happened as the pharmacist entered “5” in the directions field which the computer dispensing system automatically stated as mL on the label. The error was not detected when the final check occurred, and patient counselling was not conducted.
Fortunately, the patient’s mother was provided with dosing instructions by the doctor and therefore only administered the correct one mL (5 mg) dose.
The pharmacist provided an undertaking to complete mentoring.
The two cases above are examples of dispensing errors that still periodically come to the attention of the Board. Labelling a medication incorrectly by confusing mg and mL can have serious consequences and has occurred with other medicines, such as methadone. System-based strategies may help to reduce the risk of potential patient harm and should be considered for implementation in the workplace.
The Board’s Code of conduct outlines that good practice for risk management involves several steps. This includes working in practice and within systems to reduce error and improve the safety of patients or clients, and taking all reasonable steps to address the issue if there is reason to think that the safety of patients or clients may be compromised.
Standard 3 of the Professional Practice Standards highlights that good dispensing and supply practices are required to ensure the safe provision of prescription medicines. Standard 8 outlines the importance of patient counselling to ensure that the patient has an adequate understanding of the medicine, and how to use it safely and effectively. The Board’s Guidelines for dispensing of medicines, reiterates the importance of carefully checking and re-checking all dispensing for accuracy and completeness as well as conducting patient counselling as the final step.
As well as implementing system-based strategies to minimise the risk of errors, patient counselling is a critical step. As this is the last point of contact between the patient and pharmacist in the dispensing process it is an important strategy to minimise dispensing errors. In addition, reporting errors as they occur and when they occur will help in learning from the mistakes and ultimately reduce the risk of such errors in the future.
Published: September 2020
It was alleged that the practitioner dispensed a different brand of warfarin to the patient than what they were currently taking.
The prescriptions presented by the patient were for 1mg and 3mg warfarin (no brand specified). The dispensing history revealed the patient had previously been dispensed the Coumadin brand of 1mg, 2mg and 5mg warfarin. As Coumadin is not available in a 3mg strength, the pharmacist firstly consulted with the patient to establish if they understood the potential for a change in brand. The pharmacist then attempted to contact the patient’s usual GP but was unable to establish contact. The pharmacist subsequently dispensed the Marevan brand of warfarin 3mg as Coumadin was unavailable in a 3mg strength and the patient stated that they needed the medication.
The patient was subsequently admitted to hospital with severe epistaxis and an elevated INR.
The practitioner was required to undertake education in relation to dispensing of narrow therapeutic medications.
The Professional Practice Standards (2017) outlines that the pharmacist should apply clinical judgement to minimise medication misadventure and substitute brands only when bioequivalence has been established and substitution is consistent with patient safety and optimal health outcomes. The Board’s Code of Conduct states that good practice involves practising in accordance with the current and accepted evidence base of the health profession, including clinical outcomes.
Marevan and Coumadin have not been demonstrated to be bioequivalent or therapeutically equivalent therefore caution is required. Pharmacists should be wary of generic prescriptions and check which brand the patient is currently on, and stress to the patient the importance of staying on that particular brand. In this case where warfarin 3mg is only available in the Marevan brand, one option would have been to advise the patient to take their daily dose using the 1mg Coumadin brand tablets until the patient’s GP could be contacted.
Although the pharmacist did take steps to clarify the prescription by attempting to contact the prescriber as well as counselling the patient, the steps were insufficient to ensure the safety of the medication, especially as the patient may not have understood the clinical issues relating to brand substitution of warfarin.
At the time of dispensing the pharmacist had failed to check the expiry date before supplying the insulin to the patient. The patient then used the expired insulin for approximately six months before discovering it had expired. During the six months of using the expired insulin, the patient had inadequate control of their blood glucose levels and their insulin dosage had been increased on two separate occasions which may have been due to the decreased potency of the expired insulin.
Dispensing expired insulin which could have reduced potency may also have implications for the patient, as when they recommence using insulin that has not expired, the increased dosage could result in harm to the patient.
Although there were procedures in place to conduct monthly checks of medications in the dispensary, the expired insulin had been missed. The expired medication may have not been detected as it had been dispensed to another patient and when it was not collected, the insulin was returned to stock without the expiry date being checked. The Professional Practice Standards 2017 outlines that pharmacists should implement processes to ensure optimised and safe dispensing practices.
This case highlights the importance of checking medication expiry dates as part of the final check before supply to the patient, even if processes are in place to check expiry dates of stock on a regular basis. A pharmacist must also ensure that the medicine will be in date for the expected duration of treatment.
Owing to a dispensing error resulting in incorrect labelling of a dose administration aid (DAA), it was alleged that adequate procedures may not be in place at the pharmacy to manage public risk and a notification was raised in relation to the proprietors of the pharmacy.
During the investigation into the dispensing error that was the subject of a complaint to the Board, it was unclear who was responsible for the error, who undertook the final check of the DAA and who supplied it to the patient.
The lack of documentation and appropriate records raised concerns about the DAA service and whether the appropriate procedures were in place at the community pharmacy. As a result, a notification was raised by the Board in relation to the proprietors of the pharmacy to investigate whether the supply of DAAs at the pharmacy did not comply with relevant practice standards and Board guidelines.
The Board received further information from the proprietor outlining the procedures relating to DAA’s that have been put in place since the notification. Having considered the information, the Board was satisfied that DAA procedures had been improved since the original notification and so no further regulatory action was required.
Pharmacists are expected to comply with relevant legislation as well as the profession’s standards and guidelines (including any other standards and guidelines referred to in those documents). The Board’s Guidelines on dose administration aids and staged supply of dispensed medicines outlines that the Board has regard to established practice and quality assurance standards, including the DAA service standards and guidelines issued by the Pharmaceutical Society of Australia (PSA), and the Society of Hospital Pharmacists of Australia (SHPA).
The Board’s guidelines outline information that should be included in the record of each packing into a DAA in addition to meeting state and territory legislative requirements. This includes recording who packed and checked the DAA. The Professional Practice Standards published by the PSA articulate the expected standards of professional behaviour of pharmacists in Australia. Standard 15: Dose Administration Aid Service outlines criteria including policy and procedures and documentation. The standard states that the packing date and intended start and expiry dates should be clearly documented on the DAA label. Maintaining documentation that tracks which DAA’s have been packed and supplied by whom and when is also required.
The Board’s Guidelines for proprietor pharmacists outlines that a proprietor must maintain an active interest in how the pharmacy business is conducted to ensure that the pharmacy operation is in accordance with:
Proprietors are required to maintain awareness of the practice at the pharmacy and intervene as required to ensure the pharmacy business is conducted properly.
It was alleged that a practitioner made false and misleading declarations about meeting the Board’s recency of practice requirements on their renewal of registration applications lodged annually over the previous three years.
Although the practitioner had practised as a pharmacist overseas, they had not practised as a pharmacist in Australia for several years but continued to declare that they met the Board’s recency of practice requirements. As outlined in the Board’s Registration Standard: Recency of practice, the Board considers that practise in Australia or New Zealand meets the requirements of the standard.
Had the practitioner truthfully declared that they did not meet the recency of practice requirements when renewing their registration, the Board’s Registration and Examinations Committee would have reviewed their application to determine what action the practitioner must undertake to renew their general registration and practise in Australia.
Knowingly making a false declaration is considered by the Board to be a serious professional conduct matter and may be dealt with by the Board through the disciplinary mechanisms available under the National Law1.
The Board considered the practitioner making a false and misleading declaration to be unsatisfactory professional conduct and cautioned the practitioner with respect to falsely declaring that they had met the requirements of the Board’s Registration Standard: Recency of practice.
Pharmacists are required to maintain regular practice experience as part of the process of maintaining competence to practise and providing services to the public in Australia. To meet the recency of practice standard, pharmacists are required to have practised regularly (in Australia or New Zealand) and within the previous three years in their intended scope of practice.
If you are unable to demonstrate recency of practice (more than 450 hours within the previous three years or 150 hours in the previous 12 months in Australia or New Zealand in your intended scope of practice), or are changing your scope of practice, you will be required to demonstrate to the Board that you are competent to practise. In these circumstances, the applicant would have been asked to provide the following information:
The above information would enable the Board’s Registration and Examinations Committee to determine whether the applicant would need to complete a period of supervised practice, continuing professional development and/or examinations to ensure their competence to practise in Australia.
For more information, view the full registration standard online.
1The Health Practitioner Regulation National Law, as in force in each state and territory (the National Law).
A notifier alleged that inappropriate comments published on a pharmacist’s personal Facebook page concerned the practitioner’s personal views on abortion. Although the Facebook page was a closed group, pharmacy patients were members of the group. The pharmacist’s Facebook page included photos of the practitioner at work as a pharmacist. The notifier was concerned that pharmacy patients may be subject to judgement in certain circumstances and may not receive unbiased or timely healthcare.
The allegation raised issues concerning the practitioner’s responsibilities when using social media as outlined in the Social media policy developed by the National Boards. When using social media, pharmacists should remember that the National Law, the Pharmacy Board’s Code of conduct for pharmacists, and the Guidelines for advertising regulated health services (the advertising guidelines) apply. Whether or not an online activity can be viewed by the public or is limited to a specific group of people, registered health practitioners need to maintain professional standards and be aware of the implications of their actions, as in all professional circumstances.
Registered health practitioners should only post information that is not in breach of these obligations by:
The Board’s Code of conduct states that good practice includes being aware that differences such as gender, sexuality, age, belief systems and other anti-discrimination grounds in relevant legislation may influence care needs and avoiding discrimination based on these differences. While individual practitioners have their own personal beliefs and values, there are certain professional values on which all practitioners are expected to base their practice. These professional values apply to the practitioner’s conduct regardless of the setting, including in person and electronically, e.g. social media, e-health etc.
The Board formed a reasonable belief that the practitioner displayed unprofessional conduct, with respect to inappropriate comments on social media and that the behaviour was below the standard reasonably expected of a pharmacist by the public or their professional peers.
When using social media, it is an individual's right to express their personal views. However, in this case, the Board considered the pharmacist’s use of social media to be in breach of the National Boards’ Social media policy and the Pharmacy Board's Code of conduct for pharmacists in that the practitioner:
In this case, the Board formed a reasonable belief that the pharmacist’s conduct was unsatisfactory and proposed to caution the practitioner.
Lessons to be learnt
Pharmacists who use social media need to remember that their professional obligations continue when they are active online.
The Board’s Social media policy and Code of conduct for pharmacists both apply to all digital activity, including public forums and in closed groups.
The Social media policy provides guidance on pharmacists’ responsibilities and obligations when using and communicating on social media. Anyone using social media to advertise a regulated health service needs to meet the advertising requirements of the National Law. This includes removing any testimonials from a pharmacist’s social media page.
The Code of conduct for pharmacists sets out the required standards of professional behaviour, which apply to interactions in person and online.
Some of the principles that are useful to remember when active online include:
The Social media policy, Code of conduct for pharmacists and advertising guidelines are available on the Board’s website.
A notifier alleged that a pharmacist failed to ensure patient privacy by affixing the pharmacy dispensing label to the primary container over the top of another label showing another patient’s details. The second label was easy to remove, and as a result the first patient’s details were accessible, resulting in a breach of confidentiality.
The allegation raised issues concerning privacy of patients as outlined in the Board’s Code of conduct for pharmacists and Guidelines for dispensing of medicines, which requires the practitioner to ensure the privacy of patients is assured and that the information about a person obtained through the course of professional practice is only disclosed with the patient's permission.
The initial dispensing label had not been removed from the medication when it had been labelled in error for an earlier patient. Because the medication had not left the pharmacy it was able to be reused. However, the initial dispensing label with the patient’s details should have been removed before dispensing the medicine to the next patient.
The Board formed a reasonable belief that the pharmacist’s conduct was unsatisfactory and cautioned the practitioner.
Pharmacists must ensure that all pharmacy services are provided in a manner that respects and upholds a patient's privacy requirements in accordance with the Board’s codes and guidelines, as well as relevant privacy laws applicable to health providers.
A notifer alleged that the practitioner allowed a pharmacy student to prepare and dispense a patient’s methadone dose without direct supervision and failed to check the dose before it was provided to the patient. As a result, the patient received a dose that was significantly higher than prescribed as the student had provided the dosage milligrams as millilitres.
The allegation raised issues concerning the roles and responsibilities of pharmacy staff. The Board’s Code of conduct for pharmacists outlines that good practice involves making the scope of the student’s role in patient or client care clear to the student, to patients or clients and to other members of the healthcare team. The code also states that the onus of supervision cannot be transferred and that any practitioner or student under supervision must receive adequate oversight.
The allegation also raised issues concerning proprietor responsibilities as outlined in the Board’s Guidelines for proprietor pharmacists, which includes maintaining an awareness of and responsibility for the services being provided, ensuring that the practice of pharmacy is conducted in accordance with applicable laws, standards and guidelines, that appropriate risk management procedures are in place for the operation of the pharmacy, and that business procedures, policies and protocols are routinely followed.
The practitioner demonstrated poor insight into his roles and responsibility as a supervising pharmacist. As a consequence, the Board considered it necessary to restrict the pharmacist from acting as a preceptor or supervisor of interns or students. In addition, the practitioner was required to undertake formal education and provide a reflective report demonstrating how the practitioner had incorporated the lessons learnt in this education into the practitioners practice as a pharmacist.
Lessons to be learnt
The dispensing of methadone for opioid replacement therapy (ORT) is an inherently high-risk area of pharmacy practice. The Board considered the supervision to be irresponsible, unprofessional and in the absence of safeguards (i.e. direct supervision) extremely dangerous.
Careful management of all aspects of supply of ORT is required by pharmacists in accordance with the jurisdictional legislative requirements including any policies and guidelines issued by local authorities. Pharmacists must also ensure compliance with pharmacy practice standards and codes and guidelines published by the Board.
It was alleged that a practitioner dispensed a medication to the incorrect patient. When collecting the prescription, the patient was provided with a medication belonging to another patient with the same surname but different first name by a pharmacy assistant. As a result of this error the patient took a medication that was not prescribed for them and suffered adverse effects.
The allegation raised issues about patient counselling when supplying a medicine. The Board’s Guidelines for dispensing of medicines outline that patient counselling is part of the process of dispensing medicines and provides an opportunity to elicit the necessary information from a patient, and to provide the required information to enable safe and effective use of medicines. Counselling is also the final checking process to ensure the correct medicine is supplied to the correct patient.
The practitioner's performance was considered to be unsatisfactory and the practitioner was cautioned.
The Board notes that there have been numerous similar cases like this in the last year. In this instance, the practitioner acknowledged the importance of checking that the first name and surname are correct at all times. Supply of medications to the incorrect patient can have significant health consequences. The pharmacist should make every effort to counsel, or to offer to counsel the patient whenever a medicine is supplied. Lack of counselling can be a significant contributor in failing to detect dispensing errors.
A notifier alleged that a patient was issued a repeat authorisation by a pharmacy for two additional supplies of a prescribed medicine without the authority or direction of the prescriber. For more information, please read the newsletter.
A notifier alleged that a pharmacist purchased OxyElite Pro capsules from a supplier in the United States and supplied the product to patients of the practitioner’s pharmacy. For more information, please read the newsletter.
A recent notification highlighted the importance of giving appropriate advice about medicines used during pregnancy or while breastfeeding. For more information, please read the newsletter.