The Pharmacy Council in NSW – Role in Regulation


In 2010, 10 health professional councils in NSW were established under the Health Practitioner Regulation National Law (NSW) (the National Law (NSW)), including the Pharmacy Council of NSW. A further five health professions have been added since.  The Councils were established as part of the National Registration and Accreditation Scheme (NRAS).  National Boards were also established at the same time.

Prior to the commencement of the NRAS, the Ministry of Health consulted extensively with NSW stakeholders across the health professions including NSW state health professional boards, associations, colleges, universities, community groups and many others to discuss the regulation model for NSW.  There was overwhelming support to maintain the co-regulatory model with the Health Care Complaints Commission (HCCC) that already existed in NSW.  The 15 health Professional Councils share the same Law.  This means pharmacists, physiotherapists, doctors, nurses, midwives, dentists, podiatrists, psychologists and other registered health professionals who have a complaint made about them are managed under the same legislation. The Pharmacy Council needs to comply with the National Law (NSW) (as do the other 14 health professions).

The difference in complaint management in NSW from the National Boards is that all NSW Councils co-regulate with the HCCC. 

Complaints, also referred to as notifications, about health practitioners can be made by anyone, such as a patient/customer, carer, relative, member of the public, a colleague or other health professional, or employer. Regulation of health professionals in NSW is funded by a component of the annual practitioner registration fees, with the HCCC funded by the NSW Government.

Role of the Pharmacy Council and members

The Council comprises 10 members 5 of whom are directly appointed by the Minister.  These five members comprise a pharmacist from academia/education of the profession, a hospital pharmacist, 2 lay members and a legal member.  The other five members are pharmacists directly elected by their peers.  Members are independent and do not represent any agency or organisation.  

Our functions and powers are governed by the National Law (NSW).  We also comply with the health professional Council members’ Code of Conduct which includes maintaining confidentiality and privacy.

We have a unique role compared to the other NSW Councils in registering ownership of pharmacy premises under the National Law (NSW).  In this regard we are again different to other States in that some States have an independent body overseeing ownership whereas others are managed within their State/Territory Health Departments.  NSW is currently the only State with a Pharmacy Council.

We act to protect the public. Under the National Law (NSW) we must take action if a pharmacist is practising unsafely or placing the public at risk. The National Law also recognises the Public Interest, and we acknowledge the importance of maintaining the public's trust and confidence in the profession and are obliged to use our powers in cases of serious crimes and unethical conduct. The Council also plays an important role in ensuring that pharmacy students are fit to have contact with the public in NSW.

Pharmacists, community and legal members are all involved in the consideration and decision-making process when a complaint is received. Pharmacy members assess, from a professional perspective, whether the conduct or performance is below the standard reasonably expected of a pharmacist of an equivalent level of training or experience.  The perspective of the lay/legal members is invaluable in bringing to the table the view of the public in complaint matters.

Managing complaints

The Council and the HCCC assess complaints about the conduct, performance and health (impairment) of registered pharmacists. The complaint is assessed on an individual basis, considering a range of factors including the pharmacist’s response to the complaint, relevant clinical records, and the pharmacist’s complaint history.

The Council also considers performance against:

  • Policies, guides, practice standards and codes of conduct developed by the National Board and the PSA, and
  • Legislation and regulation such as the Poisons and Therapeutic Goods Act 1966, Poisons and Therapeutic Goods Regulations 2008 and Public Health Act 2010, the Therapeutic Goods Administration Act 1989. And the National Health (Pharmaceutical Benefits) Regulations) 1960

Another important factor we consider is community expectations about treatment and patient safety.

When we manage a complaint we also consider if there is an immediate and serious risk to public safety and/or what action may be appropriate in the public interest.  If there is, the pharmacist may be suspended or have restrictions placed on their practice pending an investigation by the HCCC.

In particular, complaints involve:

  • Dispensing
  • Hygiene, cross infection
  • Disposal of drugs
  • Communication
  • Breaches of legislation and professional standards, codes and guidelines underpinning the practice of pharmacy

Less serious complaints which have not put the public at risk, but nevertheless indicate that the practitioner’s practice is deficient in some way may result in an interview to garner further information, or a counselling session where advice may be provided.

Some complaints, having been investigated by the HCCC and deemed not serious enough to proceed to prosecution, may result in a Council inquiry, where the practitioner may be found guilty of unprofessional conduct.

In some circumstances, we may impose conditions on a pharmacist's registration. Conditions are designed to protect the public and enable the practitioner to continue working.  When conditions are imposed, we monitor compliance.  Examples of conditions include the restrictions on dispensing, hours working, not being the pharmacist-in-charge, not able to compound, undertake further education, be subject to direct or indirect supervision, or participate in drug or alcohol screening.  Most conditions are publicly available on the Ahpra national register of health practitioners.

Timeliness of managing complaints

Our aim is to manage cases quickly and efficiently, however the process needs to be thorough, transparent, fair and accountable in accordance with the Law.

Impact of complaints on pharmacists

We recognise the impact a complaint has on a pharmacist and understand that being subject of a complaint can be a very stressful. We recommend that the pharmacist makes contact with their professional association and/or indemnifier to ensure they receive appropriate advice and support early and throughout the process. The Pharmacists Support Service is also available to assist with support. At all times our goal is to be remedial rather than punitive whilst protecting the public.

Case manager

If we are managing a complaint about you, you will be given a case manager.  You will be advised who your case manager is and their contact details.  You can contact your case manager (usually by email) to discuss your case, at any time.

Vexatious and frivolous complaints

From our experience, a very small number of complaints may be vexatious or frivolous and we aim to have these not proceed beyond the consultation stage with the HCCC. However, in some circumstances, the information provided by the complainant may require further consideration, prior to us making this determination.

Role of the HCCC

The HCCC manages complaints that raise concerns of unsatisfactory professional conduct, or professional misconduct, of a sufficiently serious nature to justify suspension or cancellation of a practitioner’s registration.  In these instances, they investigate the complaint with the possibility of prosecution before the NSW Civil and Administrative Tribunal (NCAT).

Role of the National Board

Under the National Law (NSW), the National Board manages complaints about advertising, and holding out (claiming to be a pharmacist when not registered).  They also manage:

  • Pharmacist registration standards

  • Pharmacist registration applications and registration queries
  • Pharmacist registration decisions; overseas trained applications
  • Codes of conduct, guidelines
  • Accreditation of courses (Pharmacy degree programs, Intern Training Programs)
  • Maintenance of the Register of Health Practitioners

Health Professional Councils Authority (HPCA) and Ahpra

The HPCA provides corporate services and day to day secretariat services to the 15 health professional Councils in NSW with Ahpra providing a similar role to the National Boards.