INTRODUCTION

As discussed in Chapter 3 pharmacy practice standards and guidelines have been developed to express certain values, goals, and aspirations about the role of pharmacists. As these documents reference contemporary practice, they provide the framework to maintain and improve the quality of pharmaceutical services, forming an important facet in the regulation of the profession. The major pharmacy organisations in Australia, the Pharmaceutical Society of Australia (PSA), the Pharmacy Guild of Australia (PGA) and the Society of Hospital Pharmacists of Australia (SHPA), have assumed critical roles in the development of these practice standards and guidelines.

While the standards and guidelines may not be legally binding, they may be recognised and acted upon by pharmacy registering authorities and other statutory bodies through a process of adoption or endorsement. Where such is the case, pharmacists who ignore, either by omission or commission, adopted or endorsed standards or guidelines may risk a registration board initiating disciplinary action against them on the grounds of unsatisfactory professional conduct. Also of note are the requirements applicable to pharmacists dispensing prescriptions to which a pharmaceutical benefit applies under the National Health Act 1953 (Cth), which specify that pharmacists must comply with the PSA Code of Professional Conduct and PSA Professional Practice Standards.

Where there is litigation, either of a disciplinary or civil nature, the first line of defence for the pharmacist would be to demonstrate that their operating procedures were current and in accordance with contemporary standards and guidelines. If the matter related to community pharmacy practice, the standards and guidelines applicable would be those included in accreditation programs, for example the PGA’s Quality Care Pharmacy Program (QCPP).

Standards and guidelines are intended to be used as tools to achieve consistency and uniformity in service delivery and to implement continuous quality improvement to reduce the risk of misadventure.^[1] Implementing the standards and guidelines enhances the development of systems to assist in the prevention of errors and improves the quality of the service provided. As the pharmacist’s role has changed significantly and pharmacists now accept a greater role in patients’ medication management, it is particularly important that pharmacists follow current standards, both to benefit the patient and to protect them against potential litigation.

It should be noted that there are differences between standards and guidelines. Standards are objective statements of the minimum requirements of a service necessary to ensure a desirable level of acceptable or intended performance; guidelines are designed to provide advice or guidance about process issues, good practice and how responsibilities may be best discharged. Therefore, standards describe those services or actions that are essential, whereas guidelines provide information about the actions intended to provide a good quality service.

PRACTICE STANDARDS

The PSA Professional Practice Standards (PSA Standards) cover both core professional services such as dispensing and counselling, and selected speciality standards such as specialised drug information services. These standards apply to all pharmacists regardless of the particular practice setting. The following is a summary of the PSA Standards:

Each standard comprises the following elements:

The PSA Standards for the Provision of Pharmacist Only and Pharmacy Medicines in Community Pharmacy (S2/S3 Standards) specifically deals with the requirements regarding the supply of Pharmacy medicines (S2 medicines) and Pharmacist Only medicines (S3 medicines) in community pharmacy.

The Society of Hospital Pharmacists of Australia (SHPA) has also developed a raft of standards and guidelines covering services with specific application to hospital pharmacy practice.

Also of note is the National Health (Pharmaceutical Benefits) (Conditions of approval for approved pharmacists) Determination 2007 (Cth). This determination is binding on a pharmacist, approved under section 90 of the National Health Act 1953 (Cth), involved in dispensing prescriptions for pharmaceutical benefits to:

In addition to the pharmacy-specific standards and guidelines, various other health service’s standards and guidelines also exist that apply to health service providers. At a national level, the Australian Commission on Safety and Quality in Health Care (ACSQHC) has the role to recommend nationally agreed standards for safety and quality improvement. Of specific relevance to pharmacists is that the ACSQHC has taken on a coordinating role in the improvement and safety of medication usage in Australia. One of the commission’s main achievements has been the development of a national inpatient medication chart to standardise medication ordering in all public hospitals. This chart has been utilised in most Australian public hospitals since June 2006.^[2]

Various state and territory bodies are also responsible for the development, implementation and monitoring of health care standards and guidelines. For example, in Queensland, the Health Quality and Complaints Commission (HQCC) has developed clinically focussed standards (review of hospital-related deaths, management of acute myocardial infarction on admission and following discharge, and surgical safety) as well as provider-related standards (hand hygiene, credentialing and scope of clinical practice, complaints management).^[3] The monitoring of the implementation of these standards is currently at a hospital level although consideration may be given to expand monitoring to other service providers in the future.

DISPENSING

Dispensing is that component of pharmacy practice related to the preparation and/or provision of medicine by a pharmacist. It is a core service provided by pharmacists with prescription medicines comprising an average of almost 75% of total community pharmacy sales.^[4] Dispensing has become more complex over the years, expanding from a mainly technical function to a process involving many cognitive aspects. The dispensing standard is defined as:

The standard requires the pharmacist to take into account all relevant information including the patient’s other prescribed medicines and any existing co-morbidities. Accordingly, the term dispensing in the Australian context includes the patient-centred care aspects that require pharmacists to use their professional knowledge to interpret and evaluate the patient’s medication needs. The Dispensing Practice Guidelines offer advice to the pharmacist regarding the process of dispensing. The guidelines include sections on: patient details, interaction with the prescriber, dispensing, the verification process, counselling, and extemporaneous preparations.

The increased scope and changed nature of dispensing places a responsibility on pharmacists to ensure that the prescribed medication is appropriate for the patient. This role is particularly important as patients may consult several prescribers in different disciplines and receive prescriptions from each with medicines that may interact and expose patients to potentially serious adverse effects. Pharmacists therefore play an active and important role in the overall management of patients’ medication.

The dispensing process comprises both cognitive and technical functions. Cognitive functions mainly involve those that require a pharmacist’s clinical interpretation of the prescription and the provision of advice to the patient or carer. The technical functions include the selection of the medication and subsequent labelling. Pharmacists often delegate these tasks to appropriately trained pharmacy support staff, usually referred to as dispensary assistants. However, pharmacists should never lose sight of the fact that even though other personnel may have delegated roles in the dispensing process, it is the pharmacist who retains the overall responsibility. For example, in the case of a dispensing error leading to disciplinary action by a regulatory authority, it is the pharmacist against whom action would be taken, and not any ancillary personnel who may have been involved.

In the legal context, instances of unintentional or inadvertent technical dispensing errors in pharmacy practice are relatively straightforward. In the case of selection or labelling errors, the product itself can be used as evidence in cases of liability or unsatisfactory professional conduct. Although it may be a complex process to determine fault, once a mistake has been identified and a pharmacist found to have been in some way negligent or guilty of unsatisfactory professional conduct, the legal outcome is relatively predictable.

Conversely, with expanded areas of pharmacy practice, the requirement to identify an interaction or to give advice regarding potential side-effects of medication provides greater scope for error. These activities are less task-oriented, and often require professional judgment specific to the individual patient’s needs.[5, 6] These cognitive functions therefore may pose a different challenge in determining a pharmacist’s liability. For example, cases involving a failure to identify clinically significant medication interactions or medication-disease interactions, or failure to detect an overdose, have a substantial discretionary element.

Pharmacists also have a responsibility to interpret and evaluate prescriptions, acting as a safeguard for prescribers. The pharmacist’s potential responsibility regarding the more cognitive functions may be open to varied interpretations of the standard of care and the identification of risks, especially as there is only limited legal precedent. Therefore pharmacists should develop and implement processes and procedures to ensure that dispensing is always undertaken with a structured approach to reduce any risk of errors.

GENERIC SUBSTITUTION

The Guidelines for Pharmacists on Pharmaceutical Benefits Scheme (PBS) Brand Substitution provide general advice in regard to brand substitution on PBS prescriptions. Substitution is permitted where a medicine is shown to have brand equivalence in the Schedule of Pharmaceutical Benefits and both the prescriber and patient have agreed to the substitution. It should be noted that there is no readily identifiable and authorised source of bioequivalence that would reliably support brand substitution involving a medicine dispensed as a private prescription.^[7]

The increased utilisation of generic medicines has the potential to increase the risk for patients unless guidelines are rigorously adhered to. This is particularly the case with medicines with a narrow therapeutic index. Additionally, the inactive ingredients or excipients, including diluents, binders, fillers, surfactants, lubricants, coatings and dyes, can differ from brand to brand and may have an impact on patient tolerability.^[8] The need to discuss generic substitution with the patient in a meaningful way is paramount, and goes far beyond merely asking the patient whether they ‘would like the cheaper brand’.

The National Prescribing Service (NPS) recommends substitution should occur only after consultation with the patient, with their informed consent, and after considering the following:^[9]

NPS also identified the following points that should be discussed and clarified with patients. These are:^[9]