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DRAFT prepared 15.07.2019. Property of The Society of Hospital Pharmacists Australia 1 Standard of practice in oncology and haematology for pharmacy 1 services 2 John Coutsouvelis, BPharm, MClinPharm, MSHP 1,2 , Julie Adams, B Pharm, Grad Dip Hosp Pharm, 3 MSHP 3 , Hadley Bortz, BPharm(Hons), GradCertPharmPrac, MClinPharm, MSHP 1 , Maggie Chau, 4 BPharm(Hons), MBusMgt, MClinPharm, BCOP 4 , Karen Chiang, BSc, GradCertPublicHealth, MPharm, 5 MClinPharm, BCGP, MSHP 4,5 , Josephine Foo, BPharm(Hons), MClinPharm 6 , Karim Ibrahim BPharm, 6 DClinPharm, FSHP, AACPA 7,8 , Kimberley-Ann Kerr, BPharm(Hons), AdvPP(II), MSHP 9 , Shaun 7 O’Connor, BPharm 5,10 , Michael Powell, BPharm, DipPharmPrac, MSHP 11 , Gail Rowan, Dip Pharm, 8 BCOP, MSHP 12 , Jim Siderov AM, BPharm MClinPharm, BCOP, AdvPracPharm, FSHP 13 , Amanda Tey, 9 BPharm (Hons), GradCertPharmPrac, MPharmPrac, MSHP 14 , Jenny Tran, BPharm, MSHP 15 , Hayley 10 Vasileff, BPharm(Hons), AdvPracPharm, MSHP 16 and Courtney Munro, BPharm, GradCertPharmPrac, 11 MPharmPrac, MSHP, AACPA 17 on behalf of the Oncology and Haematology Standard Working Group. 12 13 1 Alfred Health, Melbourne, Victoria, Australia 14 2 Monash University, Centre Medication Use and Safety, Parkville, Victoria, Australia 15 3 View Health Pty Ltd; chemo@home Pty Ltd, West Perth, Western Australia, Australia 16 4 Melbourne Health, Parkville, Victoria, Australia 17 5 St Vincent’s Health, Fitzroy, Victoria, Australia 18 6 Eastern Health, Melbourne, Victoria, Australia 19 7 St Vincent’s Hospital, Darlinghurst, NSW, Australia 20 8 St Vincent’s Clinical School, UNSW, NSW, Australia 21 9 SA Pharmacy, Lyell McEwin Hospital, Elizabeth Vale, South Australia, Australia 22 10 St Vincent’s Hospital Melbourne, Victoria, Australia 23 11 Gold Coast Health, Gold Coast University Hospital, Southport, Queensland, Australia 24 12 Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia 25 13 Austin Health, Heidelberg, Victoria, Australia 26 14 Monash Health, Clayton, Victoria, Australia 27 15 Cancer Institute NSW, Eveleigh, New South Wales, Australia 28 16 SA Pharmacy, Women’s and Children’s Hospital, North Adelaide, South Australia, Australia 29 17 The Society of Hospital Pharmacists of Australia, Collingwood, Victoria, Australia 30 31 Address for correspondence: 32 John Coutsouvelis 1 , Chair, Oncology and Haematology Leadership Committee, The Society of 33 Hospital Pharmacists of Australia, Collingwood, Victoria, Australia. Email: 34 [email protected] 35

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Page 1: Standard of practice in oncology and haematology for ... · Clinical Pharmacy Services. 1, oncology and haematology pharmacists are expected to provide 148 services relevant to their

DRAFT prepared 15.07.2019. Property of The Society of Hospital Pharmacists Australia 1

Standard of practice in oncology and haematology for pharmacy 1

services 2

John Coutsouvelis, BPharm, MClinPharm, MSHP 1,2, Julie Adams, B Pharm, Grad Dip Hosp Pharm, 3

MSHP 3, Hadley Bortz, BPharm(Hons), GradCertPharmPrac, MClinPharm, MSHP 1, Maggie Chau, 4

BPharm(Hons), MBusMgt, MClinPharm, BCOP 4, Karen Chiang, BSc, GradCertPublicHealth, MPharm, 5

MClinPharm, BCGP, MSHP 4,5, Josephine Foo, BPharm(Hons), MClinPharm 6, Karim Ibrahim BPharm, 6

DClinPharm, FSHP, AACPA 7,8, Kimberley-Ann Kerr, BPharm(Hons), AdvPP(II), MSHP 9, Shaun 7

O’Connor, BPharm 5,10, Michael Powell, BPharm, DipPharmPrac, MSHP 11, Gail Rowan, Dip Pharm, 8

BCOP, MSHP 12, Jim Siderov AM, BPharm MClinPharm, BCOP, AdvPracPharm, FSHP 13, Amanda Tey, 9

BPharm (Hons), GradCertPharmPrac, MPharmPrac, MSHP 14, Jenny Tran, BPharm, MSHP 15, Hayley 10

Vasileff, BPharm(Hons), AdvPracPharm, MSHP 16 and Courtney Munro, BPharm, GradCertPharmPrac, 11

MPharmPrac, MSHP, AACPA 17 on behalf of the Oncology and Haematology Standard Working Group. 12

13

1 Alfred Health, Melbourne, Victoria, Australia 14

2 Monash University, Centre Medication Use and Safety, Parkville, Victoria, Australia 15

3 View Health Pty Ltd; chemo@home Pty Ltd, West Perth, Western Australia, Australia 16

4 Melbourne Health, Parkville, Victoria, Australia 17

5 St Vincent’s Health, Fitzroy, Victoria, Australia 18

6 Eastern Health, Melbourne, Victoria, Australia 19

7 St Vincent’s Hospital, Darlinghurst, NSW, Australia 20

8 St Vincent’s Clinical School, UNSW, NSW, Australia 21

9 SA Pharmacy, Lyell McEwin Hospital, Elizabeth Vale, South Australia, Australia 22

10 St Vincent’s Hospital Melbourne, Victoria, Australia 23

11 Gold Coast Health, Gold Coast University Hospital, Southport, Queensland, Australia 24

12 Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia 25

13 Austin Health, Heidelberg, Victoria, Australia 26

14 Monash Health, Clayton, Victoria, Australia 27

15 Cancer Institute NSW, Eveleigh, New South Wales, Australia 28

16 SA Pharmacy, Women’s and Children’s Hospital, North Adelaide, South Australia, Australia 29

17 The Society of Hospital Pharmacists of Australia, Collingwood, Victoria, Australia 30

31

Address for correspondence: 32

John Coutsouvelis1, Chair, Oncology and Haematology Leadership Committee, The Society of 33

Hospital Pharmacists of Australia, Collingwood, Victoria, Australia. Email: 34

[email protected] 35

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DRAFT prepared 15.07.2019. Property of The Society of Hospital Pharmacists Australia 2

Preface 36

This Standard references and relies upon SHPA Standards of Practice for Clinical Services 1 as the 37

foremost Standard. This Standard supersedes the previous Standard SHPA Standards of Practice for 38

the Provision of Clinical Oncology Pharmacy Services 2 and SHPA Standards of Practice for the 39

Provision of Oral Chemotherapy for the Treatment of Cancer3. 40

This Standard may overlap with others and depending on the area of specialty practice it may be 41

advisable to refer to additional Standards of Practice. For matters related to compounding, handling 42

and transport of cytotoxics refer to the SHPA Guidelines for Medicines Prepared in Australian 43

Hospital Pharmacy Departments 4, SHPA Standards of Practice for the Transportation of Cytotoxic 44

Drugs from Pharmacy Departments 5 and SHPA Standards of Practice for the Safe Handling of 45

Cytotoxic Drugs in Pharmacy Departments 6. 46

This Standard was developed prior to the release of the draft NSQHS Standard User Guide for 47

Medication Management in Cancer Care 7. Oncology and haematology pharmacists should be familiar 48

with the draft NSQHS Standards 7, Clinical Oncology Society of Australia (COSA) Guidelines 8 and this 49

Standard. 50

The use of the word ‘specialisation’ in this standard is in line with the National Competency Standards 51

Framework for Pharmacists in Australia 9 where ‘specialisation’ refers to the scope of practice rather 52

than the level of performance. ‘Specialisation’ of itself does not confer additional expertise. 53

This Standard is for professional practice and is not prepared or endorsed by Standards Australia. It 54

is not legally binding. 55

56

Introduction 57

In Australia, everyone shares a fundamental right to safe and high-quality healthcare. This is 58

enshrined in the Australian Charter of Healthcare Rights 10 by which all healthcare systems, including 59

the provision of pharmacy services, must abide. The Charter summarises the basic rights of patients 60

and consumers when accessing healthcare services including access, safety, respect, communication, 61

participation, privacy and the ability to comment. The provision of pharmacy services must 62

encompass the Charter to deliver effective, efficient, timely, and equitable patient-centred care. 63

The National Competency Standards Framework for Pharmacists in Australia 9 complements the 64

underpinnings of the Charter across five domains of competency for the pharmacy profession, 65

namely: (1) professionalism and ethics; (2) communication and collaboration; (3) medicines 66

management and patient care; (4) leadership and management; and (5) education and research. 67

Purpose and definitions 68

The purpose of this Standard is to describe best practice provision of clinical pharmacy services for 69

oncology and haematology patients (Box 1) in hospitals, outpatient and ambulatory services and in 70

the community. 71

This Standard refers to both the role of the pharmacy service and the pharmacists’ practice in 72

oncology and haematology. For consistency this Standard refers to all pharmacists who provide care 73

to people with oncology and haematology conditions as ‘oncology and haematology pharmacists’, 74

regardless of whether the pharmacist works in a specialist oncology and haematology service or 75

another setting that provides care for oncology and haematology conditions. The Standard 76

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predominantly refers to oncology and haematology pharmacists but does not intend to exclude 77

suitably qualified pharmacy technicians where appropriate 1. The SHPA supports both pharmacists 78

and pharmacy technicians to operate at their full scope of practice in order to achieve optimal 79

patient and pharmacy outcomes 80

81

82 Box 1 Oncology and haematology services 83

84

This Standard is intended to be used across hospital pharmacy services in Australia, irrespective of 85

the service type (public or private) or location (metropolitan, regional or rural). While this Standard 86

is intended for hospital pharmacy services, the principles and aspects of patient management 87

discussed herein can be applied to broader pharmacy services that provide oncology and 88

haematology care, including home cancer therapy services and teleoncology 11. It is acknowledged 89

there are significant variations in pharmacy services that are dependent on organisational capacity, 90

patient population, oncology and haematology service and pharmacy department priorities, and 91

availability of oncology and haematology pharmacists; all of which may influence the range of 92

services. 93

The Standard describes current best care for the provision of oncology and haematology pharmacy 94

services (see Box 1) by oncology and haematology pharmacists and the pharmacy department or 95

employer. Essential services relate to services that demonstrate the full scope of pharmacy practice. 96

Pharmacy are often involved in providing a coordinated multidisciplinary approach, which broadly 97

engages in activities including, but not limited to: 98

• pharmacovigilance 99

• review and development of medicine-related policies and guidelines 100

• staff education and training 101

• quality improvement initiatives to develop strategies for improving medicines utilisation 102

• collaborative research 103

Emerging services relate to services that are innovative and future-focused and are provided in 104

addition to essential services. Emerging services could include anticoagulation stewardship, 105

pharmacist-led ambulatory care or outpatient clinics, and home cancer therapy. SHPA encourages all 106

pharmacy services to strive to provide emerging services wherever possible, in addition to essential 107

services. 108

109

Evidence of pharmacist impact in oncology and haematology services 110

The American Society of Clinical Oncology (ASCO) describes oncology pharmacists as essential 111

interdisciplinary team members who have specialised knowledge of cancer therapy, help to 112

maximise the benefits of therapy and minimise toxicities 12. As integral members of interdisciplinary 113

Oncology and Haematology Services An oncology service, sometimes called a cancer service, is defined as a service caring for patients

with malignancy (both solid tumours and haematological malignancies) and may include

haematopoietic stem cell transplantation (HSCT) , palliative care and radiation therapy. The

service may also care for patients with non-malignant haematological or related conditions.

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teams, oncology and haematology pharmacists offer a variety of services as described in the 114

continuum of care flow chart (see Table 1) such as contributing to the selection of therapy, 115

prescribing, dosing, monitoring, evaluation, education, procurement and storage 13. 116

Integration of a clinical pharmacist into an outpatient clinic setting has proven to help achieve goals 117

including improved management of supportive care, enhanced education of patients receiving 118

complicated chemotherapy regimens, improved efficiency of chemotherapy infusion units and 119

provides better interacting opportunities with patients and the health care team 14. Delpeuch et al 120

have also shown the integration of clinical pharmacy services resulted in significant medicines-121

specific interventions of the prescriptions for hospitalised adult cancer patients 15. 122

Australian research has highlighted that clinical pharmacists in the specialty area of oncology and 123

haematology can improve the continuum of care during clinical handover by providing accurate 124

information in relation to cancer therapies 16. Maleki et al. reviewed the literature on the impact of 125

outpatient clinical oncology and haematology pharmacy services and conclude clinical pharmacists 126

contribute towards the assessment of medication adherence, medication understanding, symptom 127

control favouring pain, nausea and constipation, patient satisfaction and improvement in the quality 128

of life 17. 129

130

Objectives of the Service 131

The objectives of an oncology and haematology pharmacy service are to provide safe cancer and 132

supportive therapies according to current evidence-based best practice while limiting unintended 133

consequences for patients such as adverse drug events. Oncology and haematology pharmacists 134

must deliver the service as part of multidisciplinary collaboration and within the framework of 135

evidence and patient-centred healthcare ensuring optimal cancer care. 136

137

Scope 138

This Standard applies to all pharmacists providing oncology and haematology services. The service 139

provided by the oncology and haematology pharmacist may be delivered across several settings 140

including both public and private hospitals, in an inpatient, outpatient or ambulatory care setting, 141

and in community or domiciliary settings such as home cancer therapy. Broadly, the range and scope 142

of service considers activities that have a direct impact on patient care (e.g. governance, policies and 143

procedures as well as direct patient care activities) and in-direct activities such as teaching and 144

research, summarised in Table 1. 145

In addition to providing Clinical Pharmacy services as outlined in SHPA Standards of Practice for 146

Clinical Pharmacy Services 1, oncology and haematology pharmacists are expected to provide 147

services relevant to their clinical area and scope of practice. The range of services provided by 148

oncology and haematology pharmacists will be dependent on a variety of factors including: the 149

setting, patient population, the services that the hospital or health service provides, funding models, 150

governance structures for oncology and haematology services, oncology and haematology service 151

and pharmacy department priorities, organisational priorities and the scope of practice of the 152

individual pharmacist. 153

The role of the oncology and haematology pharmacist should include (i.e. essential services): 154

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• attendance on ward rounds, in outpatient consultations, at multi-disciplinary team meetings 155

and at individual patient case conferences 156

• delivery of pharmacy services that improve patient medication outcomes and adds value to 157

healthcare systems, while encouraging the financial sustainability of healthcare 158

• development of and input into policies, procedures, guidelines and resources 159

• comment on cancer therapy formulary applications and decisions 160

• provision of education and training for healthcare professionals and students 161

• quality improvement activities; and 162

• research related to cancer care. 163

It may additionally include involvement in compounding, clinical trials and emerging pharmacy 164

services. Pharmacists with specialist expertise in oncology and haematology should be a point of 165

contact and provide advice for medicines inquiries from other pharmacists and health professionals 166

within the health service. 167

Whilst the range of services provided in cancer is primarily delivered by pharmacists, it is increasingly 168

supported by pharmacy technicians in clinical and non-clinical roles. 169

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Range and scope of oncology and haematology pharmacy servicesi

Direct impact on patient care

Policies, procedures and governance Patient care activities

Prescribing

Contribute to:

• Development and review of cancer therapy protocols

• Development and review of guidelines for: o supportive care medicines o management of toxicities

• Development of prescribing procedures including for oral and intrathecal cancer therapies

• Development, implementation and maintenance of electronic medication management systems for prescribing cancer therapies

• Local cancer therapy governance committees

• Ensure safe prescribing of cancer therapies

• Ensure use of referenced and locally approved protocols

• Ensure appropriate supportive care medications are prescribed with cancer therapies

• Contributes to therapeutic decision making as part of a multi-disciplinary team

Medication reconciliation and clinical verification

• Lead on development of clinical verification procedures for cancer therapies. This could include international, national, state or local procedures

• Clinical verification of cancer therapies and supportive care according to COSA Guidelines for the Safe Prescribing, Dispensing and Administration of Systemic Cancer Therapy 8

• Regular and ongoing review of medications in the context of cancer therapy and disease, including complementary and alternative medicines (CAMs)

Compounding and dispensing

Contribute to:

• Development of cancer therapy manufacturing guidelines in collaboration with compounding pharmacists

• Development of oral cancer therapy related procedures

• Development of intrathecal cancer therapy related procedures

• Safe work environment

Facilitate safe provision of compounded cancer therapies in collaboration with compounding services (either internal, external or both) Support compounding and dispensing:

• Dispense systemic cancer therapies, including oral therapy

• Dispense supportive care medications

Involvement in the management of:

• Medication shortages

• Medicines access programs

• Special Access Scheme (SAS) medicines

• Formulary and individual patient use applications

Patient education Lead and contribute to the development

of written information and educational resources on cancer therapies

• Educate patients and/or carers on cancer therapies and supportive care medications

i N.B. The order in which items are listed does not necessarily imply the order in which they should be performed.

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• Provide written information e.g. consumer medicines information (CMIs) and medication lists

• Ensure informed patient financial consent as required

Administration of therapy

Contribute to:

• Development of administration guidelines for cancer therapies for medical and nursing staff, including oral and intrathecal cancer therapies

• Educate and support nursing and medical staff on the administration of cancer therapies

• Advise patients and/or carers on the administration of cancer therapies and supportive care medications

• Provide advice to health professionals and patients and/or carers on the safe handling of cancer therapies

Monitoring of therapy

Contribute to the development of policies and procedures regarding:

• Monitoring of patient’s therapy

• Use of electronic medication management (EMM) tools to facilitate monitoring

Monitors:

• Response and toxicities to cancer therapies

• Organ function

• Therapeutic drug levels

• Cumulative dosing

• Adherence and ensures cancer and supportive care medicines are adjusted appropriately

Indirect impact on patient care

Teaching and training

• Provide structured training and competency assessment for oncology and haematology pharmacists which may include local credentialing practices

• Education of pharmacy students, interns and pharmacists providing care to cancer patients in non-oncology settings

• Teaching of medical, nursing and allied health professionals

Research • Retrieve and critically appraise literature

• Identify evidence gaps in the treatment and pharmaceutical care of patients with cancer and non-malignant haematological conditions

• Initiate, conduct and supervise research in oncology and haematology services

• Participate in interdisciplinary and multidisciplinary research

Quality assurance and improvement

• Conduct audits to demonstrate compliance with guidelines for the provision of cancer therapies and oncology and haematology pharmacy services

• Report and investigate incidents and adverse effects, and participate in open disclosure and root cause analyses

• Monitor compliance with and variations from approved cancer therapy protocols

• Lead and contribute to quality improvement initiatives

Clinical trials • Liaise with the clinical trials pharmacists and/or personnel

• Ensure that the prescribing, preparation, dispensing and administration of clinical trial medications adheres to the trial protocol

• Order investigational agents and ensure inventory accountability

• Refer to the Standard of Practice for Pharmacy Investigational Drugs Services 18 Table 1 The range and scope of oncology and haematology pharmacy services and the role of the pharmacist in direct and 170 indirect patient care activities171

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Operation (of the service) 172

The service must be provided by oncology and haematology pharmacists whose main area of 173

specialisation should be cancer care and who demonstrates competence in such as relevant to their 174

scope of practice (refer to Training and Education). Components of the service may be delegated to 175

non-specialised pharmacists after undergoing training and demonstrating an appropriate level of 176

competence to perform their tasks. 177

178

Policies, Procedures and Governance 179

Pharmacists must have knowledge of the following documents which provide a framework within 180

which they must practice: 181

• Australian Charter of Healthcare Rights 10 182

• National Safety and Quality Health Service Standards 19 including the National Model Clinical 183

Governance Framework 20 184

• Pharmacy Board of Australia Code of Conduct 21 185

• SHPA Code of Ethics 22 186

• National Competency Standards Framework for Pharmacists in Australia 9 187

• Professional Practice Standards 23 188

• Clinical Governance Principles for Pharmacy Services 24 189

• Relevant legislation specifically State and Territory Acts and Regulations 190

Policies for the practice of clinical pharmacy provide a basis upon which cancer specific policies may 191

be developed and applied. 192

Local, institutional and state-based policies guiding practice may include consultation and/or 193

ownership by other professions or by the pharmacy department and should cover: 194

• Cancer therapy prescribing, medicines reconciliation and clinical verification, patient 195

education, compounding and dispensing, administration and monitoring of therapy, 196

including both oral and intrathecal cancer therapies 197

• Cancer-related therapies in EMM systems with electronic prescribing, or National Inpatient 198

Medication Chart (NIMC) and proformas for services with paper-based prescribing systems 199

• Cancer therapy protocol management, including protocols about complex supportive care 200

requirements e.g. tumour lysis syndrome 201

• Management of variation from standard institutional protocols 202

• Training and local authorisation of oncology and haematology pharmacists and technicians 203

• Quality and auditing in cancer (e.g. prescribing variation, protocol currency) 204

In consultation with compounding (if a separate role exists): 205

• Compounding specific guideline recommendations 4 206

• Safe handling and transport of cytotoxic and non-cytotoxic hazardous drugs 5,6,26 207

For further information to develop local policies and procedures the following resources may be of 208

use: 209

• Draft NSQHS Standards User Guide for Medication Management in Cancer Care 7 210

• COSA guidelines for the safe prescribing, dispensing and administration of systemic cancer 211

therapy 8 212

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• eviQ cancer treatments online 213

• BOPA Standards for Pharmacy Verification of Prescriptions for Cancer Medicines 214

• ASHP guidelines on preventing medication errors with chemotherapy and biotherapy. 215

The oncology and haematology pharmacist must contribute to the development of evidence-based 216

cancer therapy and supportive care protocols and actively contribute to local oncology and 217

haematology clinical governance committees. When evidence is not available to support protocols, 218

consensus-based guidelines may be considered in the development of protocols. Variation from 219

locally approved protocols in the absence of supporting evidence and/or a rational decision-making 220

process must only occur in consultation with the responsible treating physician for the patient as per 221

local policy. The use of non-approved protocols must adhere to local governance processes. 222

Protocol variations or the use of non-approved protocols must be clearly documented in the 223

patient’s health record. 224

Prescribing of treatment protocols must be done via an EMM system (where available) or an 225

institutionally approved chart. Protocols must include supportive care medications, such as 226

antiemetics and prophylactic medications 8. Development and approval of prescribing protocols 227

should include a lead or delegate oncology and haematology pharmacist as part of the 228

multidisciplinary team 8. The pharmacist should be familiar with federal, state and territory based 229

legal requirements for prescribing specific medicines e.g. retinoids, immunomodulatory medications 230

such as thalidomide and lenalidomide. 231

Direct Patient Care 232

Clinical Services 233

A clinical pharmacy service must be available to all cancer patients, which aligns to the clinical 234

activity of the health service. For example, if an inpatient service is provided and where resources 235

allow, a seven-day clinical pharmacy service should be provided with the support of an oncology and 236

haematology pharmacist (either onsite or remotely contacted for emergency call outs). For 237

outpatient or ambulatory services, and in community or domiciliary settings such as home cancer 238

therapy, clinical pharmacy services should align with patient activity. 239

The pharmacist must work as a member of the multidisciplinary team. The establishment of an 240

effective working relationship with other health professionals, patients and/or carers, as well as 241

other stakeholders, forms the basis of successful clinical practice. The oncology and haematology 242

pharmacist should regularly contribute to relevant clinical activities such as ward rounds, ward 243

meetings, case presentations, journal clubs and lectures. 244

Medicine reconciliation and Clinical verification 245

Medication reconciliation should be conducted as outlined in SHPA Standards of Practice for Clinical 246

Pharmacy Services 1. The oncology and haematology pharmacist should further consider the: 247

• impact and interaction of complementary and alternative medicines on cancer therapies and 248

disease 249

• compliance and adherence to cancer therapy 250

• impact of a patient’s personal and cultural beliefs on delivering their therapy 251

• socioeconomic situation of a patient and impact on treatment 252

Oncology and haematology pharmacists must have ready and easy access to information that is 253

detailed, documented and relevant. The information must be kept up to date and referred to prior 254

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to every dispensing of systemic cancer therapy to integrate all treatment. Pharmacists must have 255

access to information on: 256

• disease and stage of cancer or disease 257

• cancer therapies regimen including medicines and doses, and other relevant treatment 258

modalities such as radiotherapy and surgery 259

• intent or goal of treatment (i.e. curative, palliative) 260

• type of treatment relative to other modalities (e.g. adjuvant, neo-adjuvant) 261

• height, weight and body surface area 262

• relevant laboratory and clinical diagnostic measurements (e.g. renal function, pulmonary 263

function, left ventricular function, relevant mutational testing) 264

• reported signs and symptoms of toxicity 265

• preferred supportive care therapies (e.g. pre-medications, antiemetics) 266

• cumulative medicine doses where appropriate (e.g. anthracyclines, bleomycin, carmustine) 267

• past cancer-directed therapies 268

All cancer therapy orders must be verified by a locally authorised pharmacist prior to dispensing. As 269

part of the clinical verification process, the oncology and haematology pharmacist must consider the 270

following steps outlined by COSA which are summarised below: 271

1. Patient details, patient parameters and body surface area (BSA) 272

2. Prescription/medication order 273

3. Protocol and scheduling 274

4. Prescribed medication, dose calculations 275

5. Patient organ function and laboratory blood tests 27 including toxicity assessment of 276

previous cycles of therapy. 277

Refer to the COSA Guidelines for the Safe Prescribing, Dispensing and Administration of Systemic 278

Cancer Therapy for full details of these clinical verification steps 8. 279

Any clinical issues identified should be clarified with the treating registrar or consultant prior to 280

verifying and dispensing treatment. 281

Patient education 282

The oncology and haematology pharmacist should provide education to patients and/or carers 283

regarding cancer therapies, supportive care medicines and adverse effect management, with the aid 284

of patient information resources tailored to their needs. Advice on recognising and minimising 285

potential delayed adverse effects is an essential component of this counselling process. Written 286

patient information must be offered to the patient or carer. Resources are available from eviQ 287

Cancer Treatments Online, Cancer Council, the Leukaemia Foundation and local institutions 288

providing information for health professionals, patients and/or carers. If a specific information 289

resource is not readily available and needs to be developed, the pharmacist must be involved in the 290

preparation and review process. Pharmacists must assess company-printed materials and patient 291

aids to determine their applicability in oncology and haematology pharmacy practice before 292

provision to patient or carer. 293

Compounding and Dispensing (including procurement) 294

The oncology and haematology pharmacist must liaise with the compounding service responsible 295 for the provision of compounded cancer therapy doses (whether in-house or external) to coordinate 296 the supply of cancer therapies requiring manufacture. Decisions regarding compounding affected 297 by patient factors (e.g. volumes and diluents) should be made in collaboration with the 298

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compounding service. The preparation and administration of non-cytotoxic and/or hazardous 299 cancer therapies must adhere to the local policy which may be informed by consensus guidelines 300 25,28. The service should have a process of releasing compounded medicines that is compliant with 301 existing guidelines 8. 302

The pharmacist must liaise with the relevant pharmacy staff or external manufacturer to ensure 303

there are adequate medicines stock levels for the oncology and haematology service. There is 304

mandatory reporting of prescription medicines shortages in Australia with information available 305

via the Medicines Shortages Information Initiative governed by the Therapeutic Goods 306

Administration (TGA). In the event of a medicine shortage, the pharmacist should communicate 307

with relevant medical, pharmacy and/or external manufacturer staff to identify alternative 308

product or treatment protocol options and to source alternative supply to ensure treatment is 309

not delayed. Oncology and haematology pharmacists have a role in facilitating access to 310

medicines via medicines access programs, SAS, formulary and individual patient use applications . 311

Oral Cancer Therapy 312

Oral cancer therapy must be subject to the same prescribing and checking procedures as is applied 313

to cancer therapy administered by other routes 8,29,30. 314

Oral cancer therapy may present a health and safety risk to staff, patients and/or carers handling 315

them, although the risk of exposure is minimal. Health and safety precautions must be followed to 316

minimise the risk of exposure 25,8,31. 317

When a defined course of therapy is prescribed it is recommended the exact quantity for a course of 318

oral cancer therapy is issued (as opposed to whole packs). This decision must be based on the 319

judgement of pharmacists experienced in cancer therapies (cytotoxic and non-cytotoxic hazardous 320

medicines) and may depend on local/state policy. If a whole pack is issued, the patient should be 321

informed that medicine may be remaining (leftover) at the end of the course and they must be clear 322

on the start and stop dates for the course 8. 323

Where a repeat prescription is issued, the dose and intention to continue therapy should be checked 324

at each dispensing. 325

Indirect patient care activities 326

Indirect patient care activities of the oncology and haematology pharmacist may include 327

administrative activities required for the management, organisation and ongoing development of 328

the clinical service, such as: 329

• preparation and at least biennial review of a written policy and procedure manual for the 330

provision of a clinical service to oncology and haematology patients. Where possible this 331

should be done in conjunction with the pharmacist responsible for the provision of clinical 332

pharmacy services to the entire institution; 333

• development and maintenance of a quality improvement program for the provision of 334

clinical services to the patients of the oncology and haematology units; 335

• supervision of staff as well as the provision of direction and education to pharmacy 336

undergraduates, interns/trainees, and pharmacists with less experience in the provision of 337

pharmacy services to oncology and haematology patients. 338

339

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Recommended Staffing 340

As per the Clinical Pharmacy Standard 1 there are three major factors driving staffing levels for 341

clinical pharmacy services including the range of clinical pharmacy services, the complexity of care 342

required and hospital throughput. Recommended oncology and haematology pharmacist staffing 343

levels for pharmacy services are presented in Table 2 and should be interpreted with consideration 344

of the health service, activities performed by the oncology and haematology pharmacist, and those 345

that are undertaken by other pharmacists and pharmacy technicians. 346

The roles of oncology and haematology pharmacists are varied, dependent on the model of care and 347

size of the health service, and recommended staffing is, therefore, a reflection of this. Whereas the 348

traditional model has been to have ward-based pharmacists wholly responsible for an individual 349

patient, pharmacists are increasingly practising in team-based models and with specialisation, 350

consultant-type roles. As the model changes and roles are growing, providing pharmacy care for an 351

individual patient may be shared between pharmacists. 352

There should be at least one pharmacist responsible for the coordination of all aspects of the 353

oncology and haematology service. Staffing ratios should consider dedicated time for this lead 354

pharmacist to perform these coordination duties in line with the range and size of the clinical 355

service. This dedicated time is not included in the recommendations below. 356

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Type of care Medical oncology

[Inpatient]

Haematology

[Inpatient]

Haematopoietic

stem cell

transplantation

[Inpatient]

Same day admission

or home-based care

Outpatient or

Ambulatory clinic

providing care for

oncology or

haematology

Optimal FTE pharmacist:

patient ratio based on

patients/day

Adults 1:20

Paediatrics 1:15

Adults 1:15

Paediatrics 1:15

Adults 1:10 to 15*

depends on acuity

(*autograft 1:15 and

allograft 1:10)

Paediatrics 1:10

Adults 1:20

Paediatrics 1:17

Ratio cannot be

determined due to the

emerging nature of

practice in an

outpatient setting. If

this service is to be

offered, dedicated

pharmacist FTE needs

to be allocated

Optimal clinical pharmacy

service

Medication history and reconciliation on admission

Assistance with cancer therapies planning and review

Clinical verification of cancer therapies and supportive care, and coordination of compounding and/or dispensing of cancer medications

Medication chart review and monitoring of cancer therapies

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Type of care Medical oncology

[Inpatient]

Haematology

[Inpatient]

Haematopoietic

stem cell

transplantation

[Inpatient]

Same day admission

or home-based care

Outpatient or

Ambulatory clinic

providing care for

oncology or

haematology

Monitoring of cancer therapies and optimisation of supportive care plan

Optimisation of graft-versus host-disease management

Multidisciplinary ward rounds

Multidisciplinary team meeting

Patient and/or carer education on cancer therapies and supportive care medications including appropriate administration and handling of cancer medicine

Discharge prescription review and reconciliation in the context of cancer therapies and disease

Preparation and delivery of discharge medication information for patients and/or carers

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Type of care Medical oncology

[Inpatient]

Haematology

[Inpatient]

Haematopoietic

stem cell

transplantation

[Inpatient]

Same day admission

or home-based care

Outpatient or

Ambulatory clinic

providing care for

oncology or

haematology

Provision of information about medication changes to patients and/or carers

Facilitation of post-transplant vaccines administration

Development and review of cancer therapy protocols, procedures and guidelines, and patient education materials on cancer therapy

Participation in cancer therapy governance committee and Quality Use of Medicines activities such as audits and staff education

Participation in research projects

Table 2 Recommended clinical pharmacy services and pharmacist: patient ratios for oncology and haematology services

References: 2,32-34

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Training and Education 357

It is essential to develop the pharmacy workforce enabling delivery of excellent pharmacy care in 358

cancer through training and education of pharmacists and technicians. Oncology and haematology 359

pharmacists should have a scope of practice competency profile with a Continuing Professional 360

Development (CPD) plan that covers the five domains of professional performance as per the 361

National Competency Standards Framework for Pharmacists in Australia 2016 9. Whilst the 362

framework itself is not tied to any area of specialisation, there are qualifications, educational 363

activities, knowledge and skills that are recommended for oncology and haematology pharmacists, 364

in addition to those of a clinical pharmacist. The following have been informed by the SHPA 365

Oncology and Haematology Standard of Practice Working Group. 366

In addition, pharmacists and pharmacy technicians commencing practice in oncology and 367

haematology services must undertake a relevant orientation and training program as determined by 368

the health service. This should include credentialing relative to their role as implemented by the 369

local or state-based health service. 370

Oncology and haematology pharmacists must contribute to the education and development of 371

procedures for non-specialist pharmacists caring for patients being treated with cancer therapies. 372

Credentialing and Qualificationsii 373

Desirable certification, credentialing and qualifications for oncology and haematology pharmacists 374

include: 375

• a postgraduate qualification in clinical pharmacy e.g. 376

o Graduate Diploma or Master of Clinical Pharmacy 377

• credentialing as an Advancing or Advanced Practice Pharmacist is provided by Pharmacy 378

Development Australia 35 379

• formalised certification such as that offered by the US Board of Pharmaceutical Specialties 380

• other relevant postgraduate degrees which may be available nationally or internationally. 381

Examples include: 382

o Master of Cancer Sciences administered by The University of Melbourne 383

o Oncology and Palliative Care MSc studies administered by Newcastle University UK 384

Educational Activities 385

Further to the Pharmacy Board of Australia Guidelines on Continuing Professional Development 36 it 386

is recommended that oncology and haematology pharmacists have a significant proportion of their 387

continuing professional development per year tailored to oncology and haematology services. 388

Recommended continuing education for oncology and haematology pharmacists include the 389

following: 390

Attendance at local or national courses: 391

• SHPA Oncology and Haematology Seminars and related CPD activities 392

• COSA Cancer Pharmacist Group Seminars for Cancer Pharmacists 393

• International Society of Oncology Pharmacy Practitioners (ISOPP) Australasia Regional 394

Oncology Pharmacy Symposium (AusROPS) 395

ii This is a limited list offered for general information and does not represent endorsement of any provider; new providers may emerge, and this list is current as of January 2019.

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Joining professional organisations: 396

• The Australia and New Zealand Children’s Haematology and Oncology Group (ANZCHOG) 397

• American Society for Blood and Marrow Transplantation (ASBMT) 398

• American Society of Clinical Oncology (ASCO) 399

• American Society of Hematology (ASH) 400

• British Oncology Pharmacy Association (BOPA) 401

• The Children’s Oncology Group (COG) 402

• Clinical Oncology Society of Australia (COSA) 403

• European Society of Bone Marrow Transplantation (EBMT) 404

• European Society of Medical Oncology (ESMO) 405

• The European Haematology Association (EHA) 406

• Hematology/Oncology Pharmacy Association (HOPA) 407

• Haematology Society of Australia and New Zealand (HSANZ) 408

• International Society of Oncology Pharmacy Practitioners (ISOPP) 409

• Multinational Association of Supportive Care in Cancer (MASCC) 410

• The International Society of Paediatric Oncology (SIOP) 411

412

Educational material and resources are additionally provided on the SHPA Specialty Practice 413

Oncology and Haematology stream page on the SHPA eCPD website. For oncology and haematology 414

pharmacists, joining and actively participating in the SHPA Specialty Practice Oncology and 415

Haematology stream at the Practice Group level is strongly recommended. 416

The Oncology and Haematology Standard working group considers the ability to undertake 417

preceptorships and/or site visits to health services in either geographically diverse areas or areas of 418

diverse practise to be a useful way of expanding knowledge and skills, particularly for those oncology 419

and haematology pharmacists practising alone or at smaller sites. 420

Attendance at specialist conferences and educational meetings should be supported to maintain and 421

update specialist knowledge in cancer. Relevant domestic conferences include those organised by 422

SHPA, COSA, Haematology Society of Australia and New Zealand (HAA Blood), and ANZCHOG. 423

International conferences include the ISOPP International Symposia, Multinational Association of 424

Supportive Care in Cancer (MASCC) Annual Meeting, Transplantation and Cellular Therapy (TCT) 425

Meetings, and the ASCO Annual Meeting. 426

Knowledge, Skills, Activities and Experiential Learning 427

Peer collaboration and peer-to-peer supported learning and review should be encouraged in the 428

workplace. The focus of peer engagement should be on the knowledge and skills which result in 429

clinical practices that improve patient outcomes. Informal and formal frameworks including the 430

SHPA Clinical Competency Assessment Tool (ClinCAT) could be used, ideally with assessment by a 431

senior oncology and/or haematology pharmacist. Recommendations for essential and desirable 432

knowledge, skills, activities and experiential learning follow. 433

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Essential Desirable

Knowledge • Pharmacology of cancer therapies

• Cancer therapy dosing in special situations e.g. dialysis

• The aetiology, presentation, diagnosis, monitoring and

management of common cancers

• Prevention and management of cancer therapy related

adverse effects (e.g. haematological toxicities and associated

complications such as febrile neutropenia, and infection,

gastrointestinal toxicities including nausea and vomiting,

diarrhoea, mucositis and other organ toxicities such as cardiac,

hepatic, renal etc.)

• Techniques and procedures for safe handling and disposal of

cytotoxic and hazardous agents

• Understanding of the use of complementary therapies by

cancer patients and the potential effects on treatment

• Research and clinical trial methodology

Knowledge required according to the role of the pharmacist and

range of services:

• Non-malignant haematological conditions

• The role of HSCT in the treatment of cancer and management

of toxicities

• The role of novel therapies e.g. CAR-T in the treatment of

cancer

• Paediatrics

• Therapeutic drug monitoring (TDM) for cancer therapies

• Rare cancers

• Other cancer treatments e.g. radiation oncology, palliative care

• Cancer wellness and survivorship

• Pharmacoeconomics Knowledge required according to the role of the

pharmacist and range of services:

• Compounding

• Operation of clinical trials in cancer therapies

Skills • Being able to exercise independent, responsible clinical

judgment in relation to individual scope of practice

• Competence to participate in multidisciplinary ward

rounds and meetings

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Essential Desirable

• Well-developed communication skills including the ability to

have difficult conversations

• Demonstrate confidence, competence and cultural sensitivity,

as well as empathy in dealing with patients with cancer and in

end of life care

• Ability to practice self-care principles and maintain

professional boundaries for oncology and haematology

pharmacists

• Ability to provide clinical input in the

multidisciplinary setting contributing to decision-

making at the point of care

• Capability to critically appraise evidence base

• Ability to promote and support the skills

development of oncology and haematology

pharmacists

• Demonstrating leadership to support and promote

advanced pharmacy care in cancer

Activities and experiential learning

• Completion of an evaluation of clinical skills using the ClinCAT

(version 2) which can be found in Chapter 15 of the SHPA

Standards of Practice for Clinical Pharmacy Services 1

• Effectively impart up to date cancer therapy and

other medication-related information to health

professionals and patients

• Provide expert advice to drug committees on

formulary applications relating to cancer therapies

• Mentorship of early career pharmacists, those newly

working in cancer and those caring for cancer

patients requiring specialist input

• Teaching to increase advanced capability e.g.

training and education of healthcare professionals

regarding cancer

• Engage and advocate in national health and

community policy

• Effective contribution to medication safety and

clinical governance committees

Table 3 Knowledge, Skills, Activities and Experiential Learning 434

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Training and education will predominantly be work-based education and should follow adult 435

learning principles. Further information can be found in Chapter 10 of the SHPA Standards of 436

Practice for Clinical Pharmacy Services 1. 437

438

Quality Improvement 439

Quality improvement activities should demonstrate advanced pharmacy care in cancer is delivering 440

improvements in patient care by targeting and achieving the best outcomes for all patient groups, 441

including those at greatest risk for medication misadventure. Examples of quality improvement 442

activities which may be considered within a plan, do, study, act (PDSA) cycle for quality improvement 443

activities are listed in Table 4. 444

Quality improvement activities for oncology and haematology pharmacy services

Essential • Auditing and reporting of variation from standard institutional protocols

and recommendations from national alerts on high-risk medicines e.g.

vincristine 37

• Incident analysis relating to cancer therapies

• Development and review of practice guidelines and treatment protocols

considering current evidence

Desirable • Medicines Usage Evaluations or Quality Use of Medication audits for specific agents or protocols e.g. utilisation of new agents or supportive care medicines

• Report on medicines usage and medicines expenditure within cancer

• New practice introduction and assessment

• Evaluating clinical and patient reported outcomes

• Review of pharmacist interventions resulting in a change to treatment

Table 4 Quality improvement activities for oncology and haematology pharmacy services 445

An indicator for quality use of medicines is the validated medication safety self-assessment tools for 446

oncology and antithrombotic therapy 38-40 and may be used by organisations to identify potential 447

medication risks and enable implementation of processes for managing high-risk medicines 41. 448

As part of quality improvement, the following key performance indicators (KPIs) listed in Table 5 449

should be considered. Other indicators may be measured as per local policies. 450

Key performance indicators for oncology and haematology pharmacy services

Governance, Policies and Procedures Protocol Governance

• Proportion of protocols that have been reviewed and are up to date and within in use dates

Prescribing • ‘Percentage of patients receiving cytotoxic chemotherapy whose treatment is guided by a hospital approved chemotherapy treatment protocol’ (QUM 3.6 42)

• Proportion of occasions that a variance from a hospital or accepted standard protocol or dose is ordered with no acceptable justification for the variance

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Medication reconciliation and Clinical verification

• Proportion of patients for whom a medication reconciliation is completed prior to commencing cycle one of therapy

• Proportion of cancer therapy orders clinically verified by a locally authorised pharmacist prior to dispensing to the patient

• Proportion of relevant laboratory or diagnostic results checked and confirmed prior to cancer therapy. Results checked may include full blood counts, creatinine clearance, liver function tests and any other parameter required for administration of a specific agent or protocol

Patient Education

• Proportion of patients and/or carers educated and provided written information about their cancer therapy by a pharmacist according to local practice

Teaching and training Pharmacist training and authorisation

• Proportion of pharmacists involved in the clinical verification of cancer therapies who are trained and locally authorised

Table 5 Key performance indicators for oncology and haematology services 451

Further information on quality improvement can be found in Chapter 14 of the SHPA Standards of 452

Practice for Clinical Pharmacy Services 1 and the NSQHS are developing indicators for use and an 453

auditing tool. 454

455

Research 456

Research is vital for developing the pharmacy profession and may inform pharmacy services current 457

level of, and future contributions to, advancing pharmacy and patient care. Oncology and 458

haematology pharmacists should initiate, conduct and supervise research that contributes to the 459

body of knowledge providing evidence of impact in support of optimal use of medicines and 460

advanced pharmacy care in cancer care. Cross-sector, inter-sectoral and interdisciplinary research is 461

advocated to ensure the input of key stakeholders and that research is relevant to the Australian 462

community. Collaborations with research institutes and groups are also advocated, for example, The 463

Australian Leukaemia and Lymphoma Group. 464

To undertake practice-based research in cancer, the pharmacist should understand the following: 465

• the treatment settings for patients with cancer 466

• professional practice standards and guidelines as they apply to oncology pharmacy practice, 467

research and ethics 468

• methods for handling cytotoxic medicines and related materials 469

• investigational medicine management 470

• patient-reported measures (PRMs). 471

To facilitate oncology and haematology pharmacists’ participation in research it is highly 472

recommended that pharmacists possess knowledge in the areas of epidemiology, statistical analysis, 473

and research protocol development and in the areas of: 474

• oncology literature and information retrieval systems 475

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• study design and methodology 476

• common study endpoints (e.g. treatment response, adverse events, economics, quality of 477

life, pharmacokinetics, pharmacodynamics) 478

• selective strengths and limitations of different study designs 479

• statistical methods used for data analysis 480

• clinical versus statistical significance 481

• qualitative research in the area of pharmaceutical care of cancer patients (including patients 482

and/or carers education and counselling) 483

• regulatory and ethical issues related to research in patients with cancer (including 484

confidentiality, informed consent and patient rights). 485

The research question and study design must be of benefit to patients and of interest to the 486

oncology and haematology team. Liaising with medical staff may identify medicine-related aspects 487

of existing cancer projects. Research may relate to everyday practice and include identifying 488

evidence gaps for oncological and haematological conditions, implementing evidence-based practice 489

in cancer care, evaluating novel cancer therapies, comparator studies of cancer therapies, and 490

interventions directed at reducing patient admissions for supportive care and improving patient 491

safety. 492

Data collection for any research should be achievable in a timely manner. Students, intern 493

pharmacists, early career pharmacists and oncology and haematology trainees may assist with data 494

collection and performing research. There should be clearly defined outcomes with objective 495

measures where possible. 496

External funding enables larger and feasibly multi-centre studies to be conducted. The SHPA 497

National Translational Research Collaborative (NTRC) funds research grants, practitioner grants and 498

educational grants to develop research capacity. Grants may also be available from other 499

organisations including the COSA. Presentation and publication of studies by Australian oncology 500

and haematology pharmacists are imperative to aid others in the implementation of oncology and 501

haematology services (such as anticoagulant stewardship services) and illustrate how oncology and 502

haematology pharmacists are demonstrating improvements in patient care. 503

Presentation of research at relevant conferences and seminars as referenced in Training and 504

Education, such as those organised by SHPA, COSA, ASCO, and ISOPP is highly recommended. The 505

Journal of Pharmacy Practice and Research (JPPR) has a readership of primarily Australian 506

pharmacists. Journals specific to cancer which may be appropriate are listed in Appendix 2. 507

Resources 508

Further information on research can be found in Chapter 11 of the SHPA Standards of Practice for 509

Clinical Pharmacy Services 1. 510

Acknowledgements 511

The authors additionally wish to acknowledge the work of the former SHPA Committee of Specialty 512

Practice in Oncology on previous versions of this and related Standards including Jill Davis, Stuart 513

Harsley, Robert McLauchlan, Li-ling Ng, Sheue-Ching Ooi, Jim Siderov, Angela Stefanou, Sue Kirsa, 514

Christine Carrington, Peter Gilbar and Jeanette Wintraaken. 515

516

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References 517

1. SHPA Committee of Specialty Practice in Clinical Pharmacy. SHPA Standards of Practice for 518 Clinical Pharmacy Services. Journal of Pharmacy Practice and Research 2013; 43(No. 2 519 Supplement): S1-69. 520

2. SHPA Committee of Specialty Practice in Oncology. SHPA Standards of Practice for the 521 Provision of Clinical Oncology Pharmacy Services. Journal of Pharmacy Practice and Research 522 2002; 32(2): 115-8. 523

3. SHPA Committee of Specialty Practice in Cancer Services. SHPA Standards of Practice for the 524 Provision of Oral Chemotherapy for the Treatment of Cancer. 2007; 37(2): 4. 525

4. SHPA Manufacturing Working Party. SHPA Guidelines for Medicines Prepared in Australian 526 Hospital Pharmacy Departments. 2010. 527

5. SHPA Committee of Specialty Practice in Cancer Services. SHPA Standards of Practice for the 528 Transportation of Cytotoxic Drugs from Pharmacy Departments. Journal of Pharmacy Practice 529 & Research 2007; 37(3): 234-5. 530

6. SHPA Committee of Specialty Practice in Oncology. SHPA Standards of Practice for the Safe 531 Handling of Cytotoxic Drugs in Pharmacy Departments. Journal of Pharmacy Practice & 532 Research 2005; 35(1): 44-52. 533

7. Australian Commission on Safety and Quality in Health Care. Consultation draft: National 534 Safety and Quality Health Service Standards User Guide for Medication Management in 535 Cancer Care. Sydney, NSW: ACSQHC; 2019. p. 75. 536

8. Clinical Oncology Society of Australia. COSA guidelines for the safe prescribing, dispensing and 537 administration of systemic cancer therapy. Clinical Oncology Society of Australia (COSA); 2018. 538

9. Pharmaceutical Society of Australia. National Competency Standards Framework for 539 Pharmacists in Australia. Deakin West ACT 2600; 2016. 540

10. The Australian Commission on Safety and Quality in Health Care. Australian Charter of 541 Healthcare Rights. 2008. 542

11. Sabesan S, COSA Teleoncology Guidelines Working Group. Clinical practice guidelines for 543 teleoncology. Sydney: Cancer Council Australia; 2016. 544

12. Bauer A. Spotlight On: Oncology Pharmacists – Part I, a Q&A. 2014. 545 https://www.cancer.net/blog/2014-06/spotlight-oncology-pharmacists-%E2%80%93-part-i-qa 546 (accessed 17/12/2018 2018). 547

13. Ma C. Role of pharmacists in optimizing the use of anticancer drugs in the clinical setting. 548 Integrated Pharmacy Research and Practice 2014; 3: 11-4. 549

14. Valgus JM, Faso A, Gregory KM, et al. Integration of a clinical pharmacist into the hematology-550 oncology clinics at an academic medical center. American Journal Of Health-System Pharmacy: 551 AJHP: Official Journal Of The American Society Of Health-System Pharmacists 2011; 68(7): 613-552 9. 553

15. Delpeuch A, Leveque D, Gourieux B, Herbrecht R. Impact of clinical pharmacy services in a 554 hematology/oncology inpatient setting. Anticancer Res 2015; 35(1): 457-60. 555

16. Coutsouvelis J, Corallo CE, Dooley MJ, Foo J, Whitfield A. Implementation of a pharmacist-556 initiated pharmaceutical handover for oncology and haematology patients being transferred 557 to critical care units. Support Care Cancer 2010; 18(7): 811-6. 558

17. Maleki S, Alexander M, Fua T, Liu C, Rischin D, Lingaratnam S. A systematic review of the 559 impact of outpatient clinical pharmacy services on medication-related outcomes in patients 560 receiving anticancer therapies. J Oncol Pharm Pract 2019; 25(1): 130-9. 561

18. SHPA Committee of Specialty Practice in Investigational Drugs. SHPA Standards of Practice for 562 Pharmacy Investigational Drugs Services. 2006. 563

19. Australian Commission on Safety and Quality in Health Care. National Safety and Quality 564 Health Service Standards. Medication Safety. Sydney: Australian Commission on Safety and 565 Quality in Health Care; 2017. p. 86. 566

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20. Australian Commission on Safety and Quality in Health Care. National Model Clinical 567 Governance Framework. Sydney, NSW; 2017. 568

21. Pharmacy Board of Australia. For Pharmacists Code of Conduct. March 2014 ed; 2014. 569 22. The Society of Hospital Pharmacists Australia. SHPA Code of Ethics. Governance. Collingwood: 570

The Society of Hospital Pharmacists of Australia; 2016. p. 1. 571 23. Pharmaceutical Society of Australia. Professional Practice Standards Version 5. Deakin West 572

ACT 2600.; 2017. p. 116. 573 24. Pharmaceutical Society of Australia. Clinical Governance Principles for Pharmacy Services 574

2018. Deakin West, ACT, Australia: Pharmaceutical Society of Australia, 2018. 575 25. Booth J, Keith C, Tanner F, Siderov J, Aminian P. Hazardous non-cytotoxic medicines: 576

uncertainty around safe handling? A new workplace guideline for hospital staff. Journal of 577 Pharmacy Practice and Research 2018. 578

26. Power LA, Polovich M. Safe Handling of Hazardous Drugs: Reviewing Standards for Worker 579 Protection. PHARMACY PRACTICE NEWS 2018; (SE2018): 16-28. 580

27. Clinical Oncology Society of Australia. What is the procedure for the Pharmacist when clinically 581 verifying cancer prescriptions? 2017. 582

28. Alexander M, King J, Bajel A, et al. Australian consensus guidelines for the safe handling of 583 monoclonal antibodies for cancer treatment by healthcare personnel. Intern Med J 2014; 584 44(10): 1018-26. 585

29. O'Neill VJ, Twelves CJ. Oral cancer treatment: developments in chemotherapy and beyond. Br 586 J Cancer 2002; 87(9): 933-7. 587

30. Gilbar P, Carrington CV. Oral Antineoplastic Chemotherapy. Journal of Pharmacy Practice and 588 Research 2005; 35(3): 4. 589

31. National Institute for Occupational Safety and Health (NIOSH). NIOSH List of Antineoplastic 590 and Other Hazardous Drugs in Healthcare Settings,: Centers for Disease Control and 591 Prevention, 2016. 592

32. Clemmons AB, Alexander M, DeGregory K, Kennedy L. The Hematopoietic Cell Transplant 593 Pharmacist: Roles, Responsibilities, and Recommendations from the ASBMT Pharmacy Special 594 Interest Group. Biol Blood Marrow Transplant 2018; 24(5): 914-22. 595

33. Association HOP. The Role of Hematology/Oncology Pharmacists. In: Association HOP, editor.; 596 2014. 597

34. Langebrake C, Admiraal R, van Maarseveen E, et al. Consensus recommendations for the role 598 and competencies of the EBMT clinical pharmacist and clinical pharmacologist involved in 599 hematopoietic stem cell transplantation. Bone Marrow Transplantation 2019. 600

35. Pharmacy Development Australia. Advancing Practice Background and Guiding Principles, 601 2018. 602

36. Pharmacy Board of Australia. Guidelines on Continuing Professional Development. 2015. 603 37. Australian Commission on Safety and Quality in Health Care. High-risk medicines. 2017. 604

https://nationalstandards.safetyandquality.gov.au/4.-medication-safety/medication-605 management-processes/high-risk-medicines (accessed 30/01/2019 2019). 606

38. The Institute for Safe Medication Practices (ISMP). ISMP International Medication Safety Self 607 Assessment® for Oncology. Pennsylvania: Institute for Safe Medication Practices; 2012. p. 56. 608

39. NSW Therapeutic Advisory Group (NSW TAG), NSW Clinical Excellence Commission (CEC). 609 Medication Safety SELF ASSESSMENT for Antithrombotic Therapy in Australian Hospitals. In: 610 Practices IfSM, editor. New South Wales: Clinical Excellence Commission; 2007. p. 46. 611

40. The Institute for Safe Medication Practices (ISMP). ISMP Medication Safety Self Assessment® 612 for Antithrombotic Therapy. Pennsylvania: Institute for Safe Medication Practices (ISMP),; 613 2017. p. 26. 614

41. Australian Commission on Safety and Quality in Health Care. NSQHS Standards. Standard 4 615 Medication Safety Safety and Quality Improvement Guide. Sydney; 2012. p. 83. 616

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42. Australian Commision on Safety and Quality in Health Care. QUM domains: Safe and effective 617 use 3.6 Percentage of patients receiving cytotoxic chemotherapy whose treatment is guided 618 by a hospital approved chemotherapy treatment protocol. Medication ordering. National 619 Quality Use of Medicines Indicators for Australian Hospitals 2014: ASSQHC; 2014. p. 70-2. 620

621

622

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Appendices 623

Appendix 1. Oncology and Haematology Glossary 624

Term Description

Approved protocols Protocols that have been ratified for routine use by a national, state or local institution governance process.

Cancer therapy/cancer therapies Includes chemotherapy, immunotherapy, biological therapy, targeted therapy and associated supportive care medications.

CAR-T therapy A type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. Also called chimeric antigen receptor T-cell therapy (see cancer.gov ).

Clinical verification

Cytotoxic An agent capable of disrupting the growth and function of both healthy and diseased cells and can be carcinogenic, genotoxic, mutagenic, teratogenic or hazardous to cells in any way. Commonly used in referring to antineoplastic drugs that selectively damage or destroy dividing cells.

Electronic medication management (EMM) Also referred to in the literature as computerised physician order entry (CPOE), oncology management information system (OMIS), electronic prescribing system (EPS)

Emerging services or skills Emerging services relate to services that are innovative and future-focused and are provided in addition to essential services; described using ‘could’ or ‘may’.

Essential services or skills Essential services relate to services that demonstrate the full scope of pharmacy practice; described using ‘should’ and ‘must’.

eviQ Cancer Treatments Online A free resource of evidence-based, consensus-driven cancer treatment protocols and resources for use at the point of care. eviQ is developed for the Australian context and supports health professionals in the delivery of cancer treatments. Maintained by the Cancer Institute NSW.

Hazardous non-cytotoxic medicine/ substance A medicine or substance that is not cytotoxic but still has the potential to cause harm, via occupational exposure, to healthcare workers and carer.

Locally authorised pharmacist Pharmacist who has been approved by the relevant governance process as component to work within the required scope of practice.

Medicines Access Programs (MAP) Includes compassionate supply, cost sharing and familiarisation programs.

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Multidisciplinary Collaborative approach to patient care including health professionals from various fields of practice including (not exclusively) medical, nursing, pharmacy and allied health.

Non-approved protocols Protocols that have not been ratified for routine use by a national, state or local institution governance process.

Scope of practice ‘A time sensitive, dynamic aspect of practice which indicates those professional activities that a pharmacist is educated, competent and authorised to perform and for which they are accountable' 9.

Variation A deviation from an approved cancer therapy protocol. This includes change in medication component, dosing regimen or treatment schedule.

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Appendix 2. Resources 626

Recommended texts for Oncology and Haematology

• Palmieri C, Bird E, Simcock R, editors. ABC of Cancer Care. BMJ Books ISBN: 978-0-470-67440-6

• Cassidy J, Bissett D, Spence R, Payne M, Morris-Stiff G, editors. Oxford Handbook of

Oncology. 4th Edition. Oxford University Press; 2015. Print ISBN-13: 9780199689842

• Chabner B, Longo D. Harrison’s Manual of Oncology. 2nd Edition. McGraw-Hill Education;

2014. ISBN 978-0-07-179325-4

• Niederhuber J. Armitage J, Doroshow J, Kastan M, Tepper J. Abeloff’s Clinical Oncology. 5th

Edition. Saunders; 2013. Hardcover ISBN: 9781455728657.

• Bower M, Waxman J. Lecture Notes: Oncology. 2nd Edition. Wiley-Blackwell; 2010. ISBN13:

9781405195133.

Key Journals for Oncology and Haematology practice and research

• Annals of Oncology

• Asia Pacific Journal of Clinical Oncology

• Biology of Bone Marrow Transplant

• Blood

• British Journal of Cancer

• Cancer

• Journal of Clinical Oncology

• Journal of the National Cancer Institute

• Journal of Oncology Pharmacy Practice

• Journal of Pain and Symptom Management

• Journal of Thrombosis and Haematology

• Lancet Oncology

• New England Journal of Medicine

• Seminars in Oncology

• Supportive Care in Cancer

• Paediatric Blood and Cancer

Useful Guidelines

• ASCO

• BC Cancer

• BOPA

• Children’s Oncology Group Care

• COSA guidelines for the safe prescribing, dispensing and administration of systemic cancer therapy available on Cancer Guidelines Wiki

• ESMO

• eviQ Cancer Treatments Online

• HOPA

• MASCC

• NCCN

Useful websites

N.B. The oncology pharmacist must critically review all information obtained from the Internet.

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American Society of Cancer cancer.org

American Society of Clinical Oncology asco.org

Macmillan Cancer Support macmillan.org.uk

Memorial Sloane Kettering Cancer Centre mskcc.org

National Cancer Institute (NCI) cancer.gov

National Comprehensive Cancer Network nccn.org

Penn Medicine Abramson Cancer Center pennmedicine.org/cancer

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