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]

Generic substitution should be discussed with patients, which places an increased demand on pharmacy staff. Pharmacists are required to use professional judgment and not supply a generic brand if there is any doubt that it will be in the patient’s best interest. The patient’s health outcome should be the prime consideration in any brand substitution decision. Pharmacists could be placed in a difficult legal position if it was found that they based substitution decisions solely on cost. Other issues, such as the potential for patient confusion, must also be considered in addition to the appropriateness of non-active ingredients (such as colouring agents) for patients with specific food allergies.

In Queensland the Health (Drugs and Poisons) Regulation 1996 (Qld) has specific restrictions on generic substitution applying to Schedule 2, 3, 4, and 8 medicines. A ‘dispenser’ may only dispense a generic medicine in place of a specified medicine if a number of criteria are satisfied, including:

Queensland appears to be the only jurisdiction which specifically addresses the matter of generic substitution in its legislation.

BARCODE SCANNERS

More than 50% of dispensing errors reported to Pharmaceutical Defence Limited (PDL), the major indemnity insurer for pharmacists in Australia, relate to human error.^[10] With regard to most pharmacy dispensing errors, PDL has identified the two most frequent causes as involving the selection of the incorrect strength of a medicine, or the selection of the incorrect product.^[11] These ‘slip/lapse’ errors often occur when different products have similar packaging or names that look or sound alike.

It is believed a significant reduction in dispensing errors could be achieved through the appropriate use of barcode scanners during the dispensing process.^[12] These scan the unique barcode that appears on the outer packaging of all medicines marketed in Australia and compare the product (the barcode represents) with the product entered into the computer by the dispensing pharmacist. A discrepancy between the two data elements will trigger an alert to the pharmacist. The use of barcode scanners has indeed been identified by PDL as a risk management tool for the reduction in dispensing errors.^[10] Additionally, at the time of writing all pharmacy registering authorities, except Queensland, mandate the use of barcode scanners.

THE PROVISION OF ADVICE

The provision of pharmacist advice, also referred to as counselling, is defined in the practice standards as:

The Guidelines for Pharmacists on Providing Medicines Information to Patients aims to optimise communications between pharmacists and patients about medicines and their use. The document states in part:

THE SUPPLY OF PHARMACIST ONLY AND PHARMACY MEDICINES

Pharmacists may supply Pharmacy medicines (S2 medicines) and Pharmacist Only medicines (S3 medicines) without prescriptions. There are six S2/S3 Standards:

The S2/S3 Standards were designed to assist pharmacists meet their legal obligations and duty of care to consumers. The standards also address the role that appropriately trained pharmacy support staff can play in the provision of these services. Various pharmacy tools have been developed with the S2/S3 Standards to assist community pharmacy practices. These tools include the ‘What-Stop-Go’ and the ‘Carer’ protocols that require pharmacy support staff to use a range of questions to identify when the patient should be referred to a pharmacist.

The guidelines Professional Role of Pharmacists in Assisting Self-Medication by Consumers provides further detailed information, indicating that a pharmacist must be available for consultation when a customer requests a S2 or S3 medicine. The guidelines go on to include pharmacy premises, sales promotion, advice on treatment of symptoms, and circumstances in which a request is made for a medicine by name. Referral notes (where a customer may be referred to a medical practitioner) are also addressed and the issue of confidentiality discussed.

It is a core function of pharmacists to assist patients in the management of minor, self-limiting conditions. By making these medicines available without prescriptions, the legislature and the public have determined that the pharmacist, as the learned intermediary, can supply these products, but should provide advice and information to ensure their appropriate use. Pharmacists therefore have a responsibility and a duty of care to ensure the appropriate supply of S2 and S3 medicines.

There is a trend in Australia towards the down-scheduling of prescription (S4) medicines to S3 and S2 medicines, and, to open sellers (for example nicotine replacement therapies and ranitidine in small packs), a trend towards allowing the patient greater flexibility in access to medicines. This increases the responsibility on pharmacists to ensure the appropriate supply of these medicines, consistent with their duty of care to the patient.

The supply of S3 medicines is restricted to pharmacists to ensure consumers have the opportunity to seek and be provided with advice regarding both the appropriateness of the medication, and how best to use it. When supplying S3 medicines, pharmacists should determine and discuss the patient’s therapeutic need for the medicine and advise the patient or carer about the correct usage, contraindications, adverse effects and precautions. Pharmacists are therefore legally obliged both to ensure the product is suitable for the patient, and to provide adequate advice. Pharmacists should also be mindful of privacy and ethical issues when supplying the medication to a third party.

MEDICATION REVIEWS

Medication Management Reviews (MMRs) provide an opportunity for pharmacists to work closer with prescribers in the management of patients’ medication. MMRs involve the delivery of structured medication reviews to patients in aged care facilities, referred to as Residential Medication Management Reviews (RMMRs), or reviews involving patients in domiciliary settings, referred to as Home Medicines Review (HMRs). The payment for these services by the government to pharmacists approved under section 90 of the National Health Act 1953 (Cth) demonstrates the government’s recognition of the important role that pharmacists play in patients’ medication management. The pharmacist undertaking the review must be accredited with the Australian Association of Consultant Pharmacy (AACP) to provide the service. To become AACP accredited pharmacists need to complete specified training, a practice portfolio and pass an assessment. Once accredited, pharmacists need to undergo annual re-accreditation.^[17]

Two standards apply to the provision of medication reviews and provide the basis of pharmacists’ responsibilities in the medication management process:

The Guidelines for Pharmacists on Home Medicines Review (HMR) have been designed to further assist pharmacists providing HMRs. (It should be noted that the term ‘Home Medicines Review’ has replaced the earlier ‘Domiciliary Medication Management Review’). The guidelines include extensive sections on: objectives of HMR; the aims of HMR; consent and confidentiality issues; contractual arrangements; agreed criteria; and details of the process itself. Complementary documents include: Framework Document for Home Medicines Review and Occupational Health and Safety Issues When Conducting Home Medicines Reviews.

A separate standard covers the provision of Services to Residential Care Facilities:

Additionally, guidelines exist for the Provision of Pharmacy Services to Residential Aged Care Facilities. The guidelines include major sections on: residents’ rights, privacy and confidentiality; service contracts; communication and administration issues; and the provision of pharmacy services. Such services may include: the dispensing, distribution and supply of medicines; provision of medication management services; the provision of information and advice; and the provision of pharmaceutical care. The document also includes a sample pharmaceutical services contract. Complementary documents include Comprehensive Medication Reviews in Residential Aged Care Facilities.

Medication reviews involve accredited pharmacists making recommendations to general practitioners regarding patients’ medication management. The process not only provides commercial and professional opportunities, but also creates new responsibilities. The introduction of government remuneration for pharmacists for the provision of medication reviews represents both a significant step towards recognising the role of the pharmacist in the medication management process, and the imposition of greater professional obligations on, and thereby potential risks for, pharmacists.

COMPOUNDING/EXTEMPORANEOUS DISPENSING

Extemporaneous compounding, also referred to as extemporaneous dispensing, is the preparation of products for individual patients. The product might be prepared in response to a diagnosis by the pharmacist or according to a prescription. As pharmacists are trained in the discipline and science of drug delivery, the law authorises them to undertake extemporaneous compounding involving scheduled medicines. The compounding standard stipulates that:

Community pharmacists provide extemporaneous compounding services in response to prescriptions which mainly involve dermatological preparations where commercially available products do not exist. Some community pharmacists provide specialised compounding services and these pharmacists are often referred to as ‘compounding chemists’.

At the present time in Australia the preparation of such products may be undertaken in premises that are not accredited under the Code of Good Manufacturing Practice (CGMP) requirements. However, pharmacists have a duty of care to ensure compounded products are safe and efficacious. Premises, equipment, and raw materials must be of an accepted standard for compounding for human or veterinary use. A record must be kept of all extemporaneous compounding to provide a full history of the product. This record must be retained for up to three years from the date of compounding or as required by state or territory law. Similarly, products must be labelled in compliance with the relevant legislation. As a minimum the labels must include: the name of the patient; the date of preparation; the name and address of the place of supply; and the name and strengths of the active ingredients.

In Australia, as is the case internationally, there has been a trend by some pharmacists to focus on extemporaneous compounding and to market these services. It should be noted that some concerns have been raised regarding safety and efficacy issues involving some of the products. In the Medical Journal of Australia it was reported that there were three cases of women who developed endometrial cancer after using ‘bioidentical’ hormone replacement therapy.^[18]

The practice of ‘compounding chemists’ has caused some regulatory difficulties as the traditional differentiation between ‘compounding’ and ‘manufacturing’ began to blur. While extemporaneous dispensing is the preparation and supply of a single ‘unit of issue’ of product which is intended for immediate use by a specific patient, extemporaneous manufacturing is the production of a batch of a product which results in a number of units of use intended for supply over a period of time.^[1] In an attempt to introduce regulatory consistency, the Therapeutic Goods Administration (TGA), through the National Coordinating Committee on Therapeutic Goods (NCCTG), in April 2008 issued a discussion paper with a proposed regulatory framework.^[19] This paper suggested a three-class structure for pharmacies and pharmacists:

Class 1 and Class 2 pharmacies would be restricted in terms of dosage forms, active ingredients and advertising of the compounded products, while Class 3 pharmacies would effectively be CGMP compliant.

HARM MINIMISATION SERVICES

Australia has a harm minimisation policy which aims to reduce the adverse consequences of drug use for both the individual and society.^[1] Pharmacists can make an important contribution to harm minimisation through the provision of various educational and supply services. These include the participation in opioid substitution and needle and syringe programs. The standard applicable to participating in a needle and syringe program is defined as:

Opioid substitution therapy with methadone, buprenorphine or a buprenorphine/naloxone combination is used in the treatment of patients with heroin dependence. Methadone is responsible for more adverse effects and diversion problems than buprenorphine or the buprenorphine/naloxone combination. The Tasmanian coroner, in investigating the death of two men who died of drug overdoses involving methadone, benzodiazepines and other drugs, specifically raised concerns about the use of methadone due to its poor safety profile.^[20]

Entry into an opioid substitution program enables individuals with problems related to dependence on opioids to focus on the psychosocial side of their substance abuse problems, reducing risk behaviour and improving their health, wellbeing and functioning. Additionally, opioid programs aim to reduce illicit drug use and other social costs. Pharmacists involved with opioid substitution therapies should ensure that they follow state-specific requirements issued by the relevant health department as well as the requirements regarding Controlled Drugs (Schedule 8). Additionally, the following professional practice standard applies to an opioid substitution program:

The PSA developed guidelines for pharmacists to follow regarding the provision of opioid substitution services. Pharmacists should use professional judgment when adapting these guidelines to the specific circumstances within their community pharmacy. The guidelines address the main objectives of: providing opioid substitution services; staff requirements; necessary equipment and private dosing areas; guidelines for dispensing and dosing; record-keeping; and a contract outlining pharmacist and client responsibilities.

GUIDELINES FOR PHARMACISTS ISSUING MEDICAL CERTIFICATES

Amendments to the Workplace Relations Act 1996 (Cth) introduced the capacity for registered health practitioners, other than medical practitioners, to issue medical certificates. The definition of ‘registered health practitioner’ includes pharmacists. Medical certificates can be issued for:

The legislation limits the ability of registered health practitioners to issue certificates only in respect of the area of practice in which the practitioner is registered or licensed. Pharmacists should therefore limit the provision of medical certificates primarily in relation to:^[21]

THE SOCIETY OF HOSPITAL PHARMACISTS OF AUSTRALIA (SHPA) STANDARDS AND GUIDELINES

The SHPA has developed a number of standards and guidelines that address those aspects of pharmacy that reflect the scope of hospital practice. These include those facets of clinical pharmacy not otherwise covered in more general standards and guidelines, and aspects of oncology services typical to hospital practice.

SUPPLY PROTOCOLS

There are three PSA supply protocols addressing issues with particular medicines. These are:

These three protocols establish clear clinical and professional guidelines for the supply of these products as a Pharmacist Only medicine. The documents provide a flowchart detailing the supply process, together with supporting documentation and references.