Case scenario
Locum pharmacist Marie is the vaccinating pharmacist on duty. Renee, an adult patient, has attended the pharmacy for a routine influenza vaccination.
Renee brings along her two-year-old son John. During the consultation, John reaches out and almost grabs the sharps container that is located on the desk. Renee swiftly grabs John’s hands and holds him tightly on her lap. The consult proceeds without further interruption.
After the consultation, Marie mentions the near miss to a pharmacy assistant and asks if there is a reporting procedure. The pharmacy assistant does not know, and Marie is concerned that next time this could result in
a needle stick injury.
After reading this article, pharmacists should be able to:
Competency standards (2016) addressed: 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 2.2, 3.6, 4.3 Accreditation number: CAP2411SYPJH Accreditation expiry: 31/10/2027 |
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Introduction
Pharmacists have navigated significant change within the profession over the last 5 years with expanded vaccination and pharmacist prescribing services, medication shortages, 60-day dispensing and other regulatory changes. Having managed these changes and challenges, pharmacists continue to be Australia’s most accessible health provider. COVID-19 saw more customers coming to see pharmacists due to their accessibility and the high level of service and expertise pharmacies provide.1 Consumers prioritise trust in healthcare providers and have come to expect more from our profession, therefore building trust has been crucial.1 People are looking for strong relationships with their healthcare providers, valuing compassion, listening ability and personal rapport.1
There is still work to be done though, with data indicating that 250,000 hospital admissions annually are a result of medication-related problems at an annual cost of $1.4 billion to taxpayers.2
As medication experts, pharmacists are well placed within our hospitals and communities to assist in preventing medication-related issues through patient education, quality use of medicines, application of clinical expertise and the provision of expanded services such as pharmacist prescribing.
Trust in pharmacists and the healthcare services they provide is essential for patients to achieve good health outcomes. To ensure safe and quality healthcare services continue to be provided, and to prevent safety and quality lapses in service provision, pharmacists must ensure that clinical governance structures are in place at their facility or pharmacy.3
The role of the pharmacist
Clinical governance is defined as ‘the set of relationships and responsibilities established by a health service organisation between its state or territory department of health, governing body, executive, clinicians, patients, consumers and other stakeholders to ensure good clinical outcomes’.3
Having strong clinical governance mechanisms in place is a necessary foundation to achieve and improve safety, quality and effectiveness in the provision of healthcare.3 While many pharmacies implement professional services that already carry some principles of clinical governance, without a deliberate process into the design and delivery of these services, it can be difficult to identify areas of improvement and how they should be addressed.
Effective clinical governance is a shared responsibility that requires everyone in the team to be accountable to patients and the community for ensuring the continuous improvement and delivery of safe, effective, integrated and high-quality health services. This accountability extends from pharmacy assistants and dispensary technicians, to pharmacists, pharmacy managers and proprietors. The Pharmaceutical Society of Australia’s Clinical Governance Principles for Pharmacy Services further outlines other stakeholders outside of the immediate pharmacy team, including allied health professionals, hospitals, general practitioners, funding bodies and consumers, who also share this common goal and its associated responsibilities.3,4
The following section discusses some of the responsibilities of the immediate pharmacy team and the roles they play in the clinical governance framework of the organisation.
Proprietor pharmacists
Proprietor pharmacists, and pharmacists who hold a pecuniary interest in a pharmacy, are required to meet the obligations outlined in the Pharmacy Board of Australia’s Guidelines for Proprietor Pharmacists.6 These guidelines stipulate that proprietor pharmacists must6:
- maintain the manner in which that pharmacy business is being conducted and be able to demonstrate an awareness of this
- intervene, where necessary, to ensure that the practice of pharmacy is conducted in accordance with applicable laws, standards, regulations and guidelines.
Developing and following a robust clinical governance framework is essential for proprietor pharmacists to meet these obligations by assessing current service provision against current legislation and best practice standards, identifying potential areas of risk or improvement and implementing service improvements to ensure safe and quality service provision.
Proprietor pharmacists should liaise with regulators and pharmacy stakeholders to assist them in staying up to date with changes and challenges within the profession. This can assist in creating safe and appropriate healthcare environments that are adequately resourced with appropriately trained staff. Creating a safe reporting culture within the organisation is also crucial to ensure any issues or concerns can be safely raised by any team members for the purposes of providing education and improving practice.6
Managing pharmacists
Pharmacists employed in management roles often work in tandem with proprietors to implement standard operating procedures (SOPs) and staff training protocols. They also play an important role in risk identification and management and developing strategies to improve service provision where required.
Managing pharmacists also play a crucial role in supporting staff in the workplace with education, training and supervision and are often a conduit for communication between staff and proprietors or upper management. Effective communication and exchange of ideas, issues or concerns is essential to ensuring effective clinical governance can be achieved for the organisation.
Pharmacists (including provisionally registered pharmacists)
Clinical governance is often thought of as the responsibility of proprietors, senior pharmacists or upper management. However, pharmacists assigned to direct service provision are often the first people within an organisation to identify potential issues, concerns and opportunities for improvement.
Individually, pharmacists are autonomous healthcare practitioners and are expected by regulators and the public to be aware of and understand legislation and best practice guidelines related to the services they provide. Pharmacists contribute to good clinical governance by ensuring they practise according to the appropriate legislation and guidelines, and should have their own systems in place to maintain their knowledge and skillset to a high standard.
All pharmacists, including locum pharmacists, can also contribute to the organisation’s clinical governance framework. They can provide feedback on SOPs and processes that could be improved, identify risks and manage services to ensure all incidents and near misses are reported to management or the proprietor as soon as possible.
Non-pharmacist staff
Clinical governance is not limited to registered healthcare practitioners. All pharmacy staff, from pharmacy assistants, third-party contractors (e.g. cleaners) to dispensary technicians, have a role to play in the patient’s health journey and are part of a robust clinical governance framework.
Non-pharmacist staff can contribute to clinical governance by understanding their roles and responsibilities, engaging with training and education opportunities, following SOPs, passing on consumer or patient feedback and raising issues or concerns.
The National Model Clinical Governance Framework
The National Model Clinical Governance Framework (the Clinical Governance Framework) has been developed by the Australian Commission on Safety and Quality in Healthcare (ACSQHC), an organisation established to lead improvements in the safety and quality of healthcare in Australia. This Clinical Governance Framework is consistent with components generally accepted globally as being fundamental to effective clinical governance systems.3
There are five essential elements required by health service organisations to develop their own clinical governance systems. Through these systems, organisations and individuals are accountable to patients and the community for continuously improving the safety and quality of their services.3,4
The Clinical Governance Framework has the following five components to provide and improve the safety and quality of healthcare for patients:
- Governance, leadership and culture – involves establishing an organisation’s corporate and clinical governance structure and outlines the roles and responsibilities of everyone within the framework, from the owner of the pharmacy through to non-health professional staff.
- Patient safety and quality improvement systems – addresses the need for safety and quality improvement processes to ensure that all services are continuously assessed to identify issues or incidents so that change can be implemented for service improvement.
- Clinical performance and effectiveness – requires systems to be in place to ensure that the staff and practitioners involved in the provision of any service have adequate qualifications and skills and that supervision requirements are recognised and met.
- Safe environment for the delivery of care – requires systems to be in place to ensure the environment for each service provided meets legislative and best practice standards to ensure safe and high-quality healthcare provision to patients.
- Partnering with consumers – is the central component of the framework. It outlines the requirement to have patient and consumer-centred care at the forefront of service provision, from service planning and design through to evaluation of the final service provided.
Governance, leadership and culture
Pharmacists are often the most senior staff members on duty and work more closely with the team directly involved in service provision. This places them in a valuable position to model professional conduct, lead by example, and provide training and education to staff.
By maintaining clinical skills and knowledge, meeting requirements and following implemented policies and SOPs, pharmacists can ensure the provision of safe and high-quality healthcare to their patients. Practising in this way also contributes to a healthy workplace culture by demonstrating to staff the standards and expectations required to provide these services.
Patient safety and quality improvement systems
As frontline workers in the provision of safe and quality healthcare, pharmacists are well positioned to engage in Continuous Quality Improvement (CQI). While services are provided according to the pharmacy’s SOPs, opportunities for improvement and any issues or concerns are more likely to be identified by pharmacists directly involved in patient care.
Incidents and procedures not aligning with legislative requirements, issues with facilities, equipment maintenance and staff training should be reported appropriately to management or the proprietor(s) along with suggestions and opportunities for improvement.
Once changes are implemented to improve the service, feedback from pharmacists providing that service is crucial. This ensures that the changes can be assessed as being effective at mitigating the risk or concern that prompted them to be raised in the first place.
Clinical performance and effectiveness
As autonomous healthcare practitioners, pharmacists are expected to maintain clinical knowledge, competency and the skills required for their individual scope of practice. Legislative requirements and best practice standards often change, and pharmacists should engage with the profession by attending conferences, staying current with industry updates from pharmacy stakeholders, and meeting annual CPD requirements.
Being accountable for individual practice and assessing personal practice against best practice standards supports the provision of safe and quality health services and places the pharmacist in a better position to support patient safety and quality improvement systems.
Safe environment for the delivery of care
Maintaining equipment, resources and premises to a standard that complies with legislation and best practice standards is not only the responsibility of proprietor pharmacists and pharmacy managers but also the individual pharmacists involved in direct service provision.
All pharmacists should ensure equipment, resources and premises are maintained to a high standard to provide safe and quality healthcare. They should report issues and opportunities for improvement with equipment, resources and premises promptly through the appropriate channels.
Partnering with consumers
Patients and consumers should be at the forefront of pharmacists’ minds in each service provided. It is essential for pharmacists to provide patient-centred care and support shared decision-making for optimal health outcomes.
Pharmacists involved in direct service provision are also ideally placed to seek and pass on feedback via appropriate channels from patients and consumers, to recognise potential barriers to care, and to work to overcome these.
Pharmacists are expected to ensure patients provide informed consent and financial consent before proceeding with a pharmacy service. They should also practise open disclosure, understand privacy obligations and support patients in navigating and accessing health information. Providing feedback on any issues or opportunities for enhancement in SOPs in these areas contributes to the continuous improvement of clinical governance of the organisation.
Workplace culture
The Clinical Governance Framework (2017) also addresses a healthy workplace culture, and this important element cannot be overlooked. ‘Culture’ describes the values, beliefs and assumptions shared by occupational groups. Common and repeated patterns of behaviour are then developed from these shared ways of thinking and are subsequently maintained and reinforced by the rituals, ceremonies and rewards of everyday organisational life.7
A workplace culture that supports a strong clinical governance framework within an organisation is one that demonstrates strong leadership, effective planning, responsible resource allocation and clear roles and responsibilities. It also includes continuous quality-improvement systems, appropriate reporting of data and service outcomes to governing bodies, and robust risk and incident reporting systems. Staff should feel safe and empowered to raise issues, concerns and opportunities for service improvement.3,4
Knowledge to practice
Strong clinical governance mechanisms are a necessary foundation to achieve and improve safety, quality and effectiveness in the provision of healthcare. A workplace culture that empowers staff and supports a strong clinical governance framework is essential to providing high-quality services, good clinical outcomes and continuous improvement of quality systems and services. While clinical governance may, at first glance, appear to be a matter for proprietor pharmacists and pharmacy managers, all pharmacists and pharmacy staff play a part in their day-to-day practice.
A pharmacist’s involvement in clinical governance can be considered by applying the components of the National Model Clinical Governance Framework.
Conclusion
Clinical governance is defined as ‘the set of relationships and responsibilities established by a health service organisation between its state or territory department of health, governing body, executive, workforce, patients, consumers and other stakeholders to ensure good clinical outcomes’.3 The National Model Clinical Governance Framework has been developed by the Australian Commission on Safety and Quality in Healthcare to support the delivery of safe and high-quality care for patients and consumers, using five key components.
Clinical governance is not only the responsibility of proprietor pharmacists and pharmacy managers. All staff play an integral role within an organisation’s clinical governance framework. Pharmacists are well placed to contribute significantly to the clinical governance of an organisation regardless of their specific role within the organisation.
Case scenario continuedMarie notifies the pharmacy owner, Chris, of the near miss. Chris is not a vaccinating pharmacist and asks for Marie’s advice. Marie suggests moving the sharps container to a shelf out of patient reach, and informing other staff and pharmacists of the incident and the improvements implemented. She mentions that staff seemed unaware of any protocol for reporting issues or providing suggestions for improvement. Chris subsequently implements a change in the positioning of the vaccination equipment, including the sharps container in the consultation room to keep it out of reach of patients. He holds a staff meeting to educate staff on the change and the new protocol for reporting issues and/or opportunities for improvement. Chris asks all vaccinating pharmacists to monitor the outcome and notify him of any future incidents so that he can assess whether the change has been effective in mitigating the risk to patients. |
Key points
- ‘Clinical governance’ is the set of relationships and responsibilities established by a health service organisation, to ensure the safe and quality provision of healthcare and services.
- Everyone in the team, from pharmacy assistants/technicians through to proprietor pharmacists, have a crucial role to play in the clinical governance framework of the organisation.
- The five components of the National Model Clinical Governance Framework are: governance, leadership and culture; patient safety and quality improvement systems; clinical performance and effectiveness; safe environment for the delivery of care; and partnering with consumers.
- Workplace culture that supports a strong clinical governance framework displays effective leadership, planning, resource allocation, clear roles and responsibilities, reporting and CQI systems.
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References
- National Australia Bank Limited NAB Health Insights Special Report Part 1: The Health Consumer. November 2022. NAB Behavioural and Industrial Economics. At: https://business.nab.com.au/nab-health-insights-2022-56900/
- Pharmaceutical Society of Australia 2019. Medicine safety: take care. Canberra PSA., January 2019. At: www.psa.org.au/wp-content/uploads/2019/01/PSA-Medicine-Safety-Report.pdf
- Australian Commission on Safety and Quality in Health Care 2017. National Model Clinical Governance Framework 2017. At: www.safetyandquality.gov.au/sites/default/files/migrated/National-Model-Clinical-Governance-Framework.pdf
- Pharmaceutical Society of Australia 2018. Clinical Governance Principles for Pharmacy Services 2018. At: https://my.psa.org.au/s/article/Clinical-Governance-Principles-for-Pharmacy-Services.
- Pharmaceutical Society of Australia. Professional Practice Standards, Version 6. 2023. At: www.psa.org.au/practice-support-industry/pps/
- Pharmacy Board of Australia 2015. Guidelines for Proprietor Pharmacists. At: www.pharmacyboard.gov.au/documents/default.aspx?record=WD15%2F17691&dbid=AP&chksum=38U9CgE45JL%2BBPCUEpSjWw%3D%3D
- Davies HTO, Mannion R. Will prescriptions for cultural change improve the NHS? BMJ 2013;346:f1305.
Our authors
Jessica Hadley BPharm (she/her) is a registered pharmacist with 15 years of extensive experience in community pharmacy. She’s a Professional Officer with PDL and a member of PDL’s Local Advisory Committee for NSW and the ACT.
Amy Minion BPharm, MPS, MBA (she/her) is a Professional Development Pharmacist
at PDL and has been a member of the PDL SA/NT Local Advisory Committee since 2017.
Our reviewer
Rose-marie Pennisi BPharm, MBA (she/her)
