standard of practice in nephrology for pharmacy services · 54 full scope of practice in order to...

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DRAFT prepared 6.06.2019. Property of The Society of Hospital Pharmacists Australia 1 Standard of practice in nephrology for pharmacy services 1 Michelle Nalder, BPharm(Hons), MClinPharm, MSHP 1 , Carla Scuderi, BPharm, MClinPharm, MSHP 2,3 , 2 Ronald Castelino, BPharm, MPharm, PhD, BCGP, MSHP 4,5 , Matthew Cervelli, BPharm, MSHP 6,7 , 3 Danielle Ironside, BPharm(Hons), GradCertClinPharm, MSHP 2 , Ceridwen Jones, BPharm, 4 DHospPharm 8 , Jess Lloyd, BPharm, GDClinPharm, MSHP 9 , Sanja Mirkov, B Pharm, PGDipPH, MSHP 10 5 and Courtney Munro, BPharm, GradCertPharmPrac, MPharmPrac, MSHP, AACPA 11 . 6 7 1 The Royal Melbourne Hospital, Parkville, Victoria, Australia 8 2 Royal Brisbane and Women’s Hospital, Herston, Queensland, Australia 9 3 School of Pharmacy, University of Queensland, Woolloongabba, Queensland, Australia 10 4 Faculty of Health and Medicine, University of Sydney, New South Wales, Australia 11 5 Blacktown Hospital, Western Sydney Local Health District, New South Wales, Australia 12 6 Renal Unit, Royal Adelaide Hospital, Adelaide, Australia 13 7 MJC Pharma Pty Ltd, Adelaide, Australia 14 8 Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia 15 9 The Princess Alexandra Hospital, Brisbane, Australia 16 10 Gisborne Hospital, Gisborne, New Zealand 17 11 The Society of Hospital Pharmacists of Australia, Collingwood, Victoria, Australia 18 19 Address for correspondence: 20 Carla Scuderi 2 , Chair, Nephrology Leadership Committee, The Society of Hospital Pharmacists of 21 Australia, Collingwood, Victoria, Australia. Email: [email protected] 22 23 Preface 24 This Standard references and relies upon SHPA Standards of Practice for Clinical Pharmacy Services 1 25 as the foremost Standard. As kidney disease rarely occurs in isolation, this Standard may overlap with 26 others and depending on the area of specialty practice it may be advisable to refer to additional 27 Standards of Practice. 28 The use of the word ‘specialisation’ in this standard is in line with the National Competency Standards 29 Framework for Pharmacists in Australia 2 where ‘specialisation’ refers to the scope of practice rather 30 than the level of performance. ‘Specialisation’ of itself does not confer additional expertise. 31 This Standard is for professional practice and is not prepared or endorsed by Standards Australia. It is 32 not legally binding. 33 34 Introduction 35 In Australia, everyone shares a fundamental right to safe and high-quality healthcare. This is enshrined 36 in the Australian Charter of Healthcare Rights 3 by which all healthcare systems, including the provision 37 of advanced pharmacy care, must abide. The Charter summarises the basic rights that patients and 38 consumers are entitled to receive when accessing healthcare services including access, safety, respect, 39

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Page 1: Standard of practice in nephrology for pharmacy services · 54 full scope of practice in order to achieve optimal patient and pharmacy outcomes. 55 This Standard is intended to be

DRAFT prepared 6.06.2019. Property of The Society of Hospital Pharmacists Australia 1

Standard of practice in nephrology for pharmacy services 1

Michelle Nalder, BPharm(Hons), MClinPharm, MSHP 1, Carla Scuderi, BPharm, MClinPharm, MSHP 2,3, 2

Ronald Castelino, BPharm, MPharm, PhD, BCGP, MSHP 4,5, Matthew Cervelli, BPharm, MSHP 6,7, 3

Danielle Ironside, BPharm(Hons), GradCertClinPharm, MSHP 2, Ceridwen Jones, BPharm, 4

DHospPharm 8, Jess Lloyd, BPharm, GDClinPharm, MSHP 9, Sanja Mirkov, B Pharm, PGDipPH, MSHP 10 5

and Courtney Munro, BPharm, GradCertPharmPrac, MPharmPrac, MSHP, AACPA 11. 6

7

1 The Royal Melbourne Hospital, Parkville, Victoria, Australia 8

2 Royal Brisbane and Women’s Hospital, Herston, Queensland, Australia 9

3 School of Pharmacy, University of Queensland, Woolloongabba, Queensland, Australia 10

4 Faculty of Health and Medicine, University of Sydney, New South Wales, Australia 11

5 Blacktown Hospital, Western Sydney Local Health District, New South Wales, Australia 12

6 Renal Unit, Royal Adelaide Hospital, Adelaide, Australia 13

7 MJC Pharma Pty Ltd, Adelaide, Australia 14

8 Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia 15

9 The Princess Alexandra Hospital, Brisbane, Australia 16

10 Gisborne Hospital, Gisborne, New Zealand 17

11 The Society of Hospital Pharmacists of Australia, Collingwood, Victoria, Australia 18

19

Address for correspondence: 20

Carla Scuderi 2, Chair, Nephrology Leadership Committee, The Society of Hospital Pharmacists of 21

Australia, Collingwood, Victoria, Australia. Email: [email protected] 22

23

Preface 24

This Standard references and relies upon SHPA Standards of Practice for Clinical Pharmacy Services 1 25

as the foremost Standard. As kidney disease rarely occurs in isolation, this Standard may overlap with 26

others and depending on the area of specialty practice it may be advisable to refer to additional 27

Standards of Practice. 28

The use of the word ‘specialisation’ in this standard is in line with the National Competency Standards 29

Framework for Pharmacists in Australia 2 where ‘specialisation’ refers to the scope of practice rather 30

than the level of performance. ‘Specialisation’ of itself does not confer additional expertise. 31

This Standard is for professional practice and is not prepared or endorsed by Standards Australia. It is 32

not legally binding. 33

34

Introduction 35

In Australia, everyone shares a fundamental right to safe and high-quality healthcare. This is enshrined 36

in the Australian Charter of Healthcare Rights 3 by which all healthcare systems, including the provision 37

of advanced pharmacy care, must abide. The Charter summarises the basic rights that patients and 38

consumers are entitled to receive when accessing healthcare services including access, safety, respect, 39

Page 2: Standard of practice in nephrology for pharmacy services · 54 full scope of practice in order to achieve optimal patient and pharmacy outcomes. 55 This Standard is intended to be

DRAFT prepared 6.06.2019. Property of The Society of Hospital Pharmacists Australia 2

communication, participation, privacy, and comment. Additionally, Kidney Health Australia’s Charter 40

of Home Dialysis Rights and Responsibilities 4 provides guidance for patients, their carers and health 41

professionals who provide their care. The provision of pharmacy services must encompass both 42

Charters to deliver effective, efficient, timely and equitable patient-centred care for kidney disease. 43

The National Competency Standards Framework for Pharmacists in Australia 2 complements the 44

underpinnings of the Charter across five domains of competency for the pharmacy profession. These 45

include; professionalism and ethics, communication and collaboration, medicines management and 46

patient care, leadership and management, as well as education and research. 47

This Standard, produced by The Society of Hospital Pharmacists of Australia (SHPA), refers to both the 48

role of the pharmacy service and the pharmacists’ practice in nephrology (or kidney disease). It is 49

intended for both pharmacists involved in nephrology services and pharmacists whose area of 50

specialisation is nephrology services and for consistency refers to both as nephrology pharmacists. 51

The Standard predominately refers to pharmacists but does not intend to exclude suitably qualified 52

technicians where appropriate 1. SHPA supports both pharmacists and technicians to operate at their 53

full scope of practice in order to achieve optimal patient and pharmacy outcomes. 54

This Standard is intended to be used across hospital pharmacy services in Australia, irrespective of the 55

service type (public or private) or location (metropolitan, regional or rural). While this Standard is 56

intended for hospital pharmacy services, the principles and aspects of patient management discussed 57

herein can be applied to broader pharmacy services that provide nephrology pharmacy services. It is 58

acknowledged that there are significant variations in pharmacy services that are dependent on 59

organisational capacity, patient population, nephrology service and pharmacy department priorities, 60

and the availability and scope of practice of the nephrology pharmacist; all of which may influence the 61

scope of services. 62

The Standard describes current best care for the provision of nephrology pharmacy services (see Box 63

1) by nephrology pharmacists and the pharmacy department or employer. Essential services relate to 64

services that demonstrate the full scope of current pharmacy practice. Emerging services relate to 65

services that are innovative and future-focused and are provided in addition to essential services. 66

SHPA encourages all pharmacy services to strive to provide emerging services wherever possible, in 67

addition to essential services. 68

69

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Box 1 Nephrology Services and the Nephrology Pharmacist 70

Burden of kidney disease in Australia and globally 71

One in three adults is at risk of developing CKD and one in nine Australian adults will have some sign 72

of kidney disease. For those living in rural and remote areas, rates are much higher5. End-stage renal 73

disease (ESRD) is more common in ethnic minority populations and in socially deprived populations. 74

In Australia, the incidence of ESRD is substantially higher in Aboriginal people than in white people 75

(420 vs 94 per million population [p.m.p.] per year) 6. The incidence of ESRD increased from 110 p.m.p. 76

in 2007 to 124 p.m.p. in 2017 7. There was substantial variation in incidence rates between states, with 77

the lowest rates in Tasmania (106 p.m.p in 2017) and the highest in the Northern Territory (471 p.m.p. 78

in 2017) 7. Furthermore, for Indigenous people, the likelihood of receiving a kidney transplant is 79

substantially lower and post-transplant outcomes worse than that of non-Indigenous patients 8. 80

Globally, the International Society of Nephrology (ISN) Global Kidney Health Atlas, highlights the 81

growing burden of kidney disease and significant inequities in access to treatment across world 82

countries and regions 9. 83

84

Evidence of pharmacist impact in nephrology 85

As for other specialty areas of pharmacy practice, evidence supports pharmacist involvement as part 86

of the multidisciplinary team having direct and indirect benefits on patient care. In the hospital setting 87

for patients with CKD, a pharmacist accompanying medical physicians on rounds to provide a renal 88

drug dosing service has been shown to increase the proportion of doses adjusted to account for renal 89

function, prevent adverse drug events (ADEs) and result in medication cost savings 10. A systematic 90

review of pharmacists' interventions in patients with CKD from eight controlled studies significantly 91

demonstrated that pharmacists’ interventions reduced all-cause hospitalisations, cumulative time 92

hospitalised, reduced the incidence of end-stage renal disease or death in patients with diabetic 93

nephropathy, improved management of anaemia, blood pressure, calcium and phosphate 94

Nephrology Services and the Nephrology Pharmacist

Nephrology or renal pharmacists provide services across the spectrum of kidney disease which includes:

• acute kidney injury (AKI)

• chronic kidney disease (CKD)

• renal replacement therapies, including dialysis and transplantation; and

• supportive care for end-stage renal disease (ESRD).

Due to the high burden of chronic diseases, such as cardiac disease and diabetes, the nephrology pharmacist should have a broad working knowledge of other chronic disease states.

The nephology pharmacist provides a service including, but not limited to:

• dose adjustment of medicines in kidney impairment, disease and renal replacement therapy

• management of complications of CKD (e.g. vascular access complications, infection, electrolyte

disturbances, mineral bone disorder (MBD), anaemia, restless leg syndrome, cardiovascular disease and hypertension, diabetes mellitus, gout, chronic pain psychiatric illnesses)

• patient education, adherence and rejection management following transplantation; and

• that works towards closing the gap in disparities in kidney disease in the Aboriginal and Torres Strait Islander population.

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parameters, and lipid management. On the basis of the best available evidence, pharmacists’ 95

interventions may have a positive impact on the outcomes of patients with chronic kidney disease 11. 96

97

Objectives of the Service 98

The objectives of the nephrology pharmacy service are to: optimise medicines management for 99

patients with kidney disease by assessment of renal function and appropriate medicines 100

recommendations to prevent acute kidney injury (AKI), slow progression of CKD, improve a patient’s 101

quality of life while limiting unintended consequences such as adverse drug events, advancement of 102

disease stage, burden of kidney disease and costs. Nephrology pharmacists must deliver the service 103

as part of multidisciplinary collaboration and within the framework of evidence and patient-centred 104

healthcare ensuring optimal kidney health and patient outcomes. Where possible pharmaceutical care 105

for patients with kidney disease should be standardised to minimise variation and provide equitable 106

services, with lesser dependence on locality. 107

108

Scope 109

This Standard applies to all pharmacists working in nephrology services. The service provided by the 110

nephrology pharmacist may be delivered across several settings including both public and private 111

hospitals, in an inpatient, outpatient or ambulatory care setting, and in primary care (at patient's 112

home, Aboriginal and Torres Strait Islander health centres, community clinics). 113

In addition to providing Clinical Pharmacy services as outlined in SHPA Standards of Practice for Clinical 114

Pharmacy Services 1, nephrology pharmacists are expected to provide services relevant to their clinical 115

area and scope of practice. Whilst the range of services provided in nephrology is primarily delivered 116

by pharmacists, it may be supported by pharmacy technicians in clinical and non-clinical roles. 117

The role of the nephrology pharmacist should include: 118

• attendance on ward rounds, in outpatient consultations, at multi-disciplinary team 119

meetings, and at individual patient case conferences 120

• delivery of pharmacy services that improve patient medication outcomes and adds value to 121

healthcare systems, while encouraging the financial sustainability of healthcare 122

• development of and input into policies, procedures, guidelines, and resources 123

• comment on nephrology medication formulary applications and decisions 124

• provision of educational and training for healthcare professionals and students 125

• quality improvement activities; 126

• and research related to nephrology. 127

It may additionally include involvement in serving satellite centres, clinical trials, and emerging 128

pharmacy services. The pharmacist should be a point of contact for other pharmacists and health 129

professionals, and for the hospital or health service for medicines enquiries related to nephrology. 130

131

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Operation 132

The nephrology pharmacy service should be provided by pharmacists whose main area of 133

specialisation is nephrology and who demonstrates competence in nephrology pharmacy (refer to 134

Training and Education). Components of the service may be delegated to non-specialised 135

pharmacists after undergoing training and demonstrating an appropriate level of competence to 136

perform their tasks. 137

138

To achieve the aforementioned objectives, nephrology pharmacists need to consider both individual 139

patient factors and service provision with regard to practice settings, as detailed below. 140

Patient Factors 141

To meet the needs of the patient, the nephrology pharmacist (as part of the multidisciplinary 142

nephrology team) should: 143

• Be familiar with tools available to estimate a patient’s current kidney function and 144

understand both the applicability and limitations of these tools and the clinical situations 145

where they may be unreliable and/or misleading 146

• Consider individual patient circumstances including renal function, goals of therapy, clinical 147

presentation and comorbidities when evaluating and recommending medications 148

• Consider the impact of the varying renal replacement therapies (RRT) on medicine choice 149

and dosing along with the optimal timing of administration 150

• Understand patient risk factors for medication non-adherence for patients with renal 151

disease (including post-transplantation) and potential strategies to address these 152

• Understand risk factors for the development and progression of CKD and associated 153

comorbidities 12. 154

155

Service Provision with regard to Practice Settings 156

Service provision will vary with regard to the practice setting. In the hospital setting, nephrology 157

pharmacists providing pharmacy care can facilitate quality use of medicines to improve outcomes for 158

patients with kidney disease. Due to a large number of patients with kidney disease and the treatment 159

burden, the traditional inpatient model has expanded to include care for patients in outpatient, 160

ambulatory and clinic-based services. Progressively innovative services in atypical settings are arising 161

to accommodate patient need such as satellite dialysis units, Australia’s Big Red Kidney Bus and GP 162

shared care arrangements (like that for obstetrics). An ongoing challenge is delivering regular 163

nephrology pharmacy services in an outpatient setting since models of pharmacy service are 164

traditionally inpatient focused. Regardless of the setting, nephrology pharmacists have a critical role 165

in ensuring optimal kidney health. 166

Nephrology pharmacists should assess kidney function consistent with the role of a pharmacist in a 167

patient-centred and culturally responsive manner. A collaborative approach to develop a medication 168

management plan (MMP) should promote the judicious use of medicine and engage patients, to 169

convey the benefits of evidence-based treatment options and establish realistic expectations. The 170

nephrology pharmacist should refer patients to services (e.g. nurse practitioner, case managers, 171

dieticians, social workers, psychologists, palliative care, credentialed advancing and advanced practice 172

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pharmacists, HMR accredited pharmacists and medical staff including general practitioners) that could 173

assist and support self-care for kidney disease and escalate to the coordinator of the patient's medical 174

care when required. 175

Nephrology pharmacists should facilitate communication between the hospital and primary care and 176

provide education to patients. Communication and education should be patient-centred and culturally 177

appropriate, to ensure patient understanding and adherence. In keeping with best practice for 178

facilitating continuity of medication management on the transition between care settings, there 179

should be robust communication systems 1. 180

As detailed in the introduction, this Standard describes the best care for the provision of pharmacy 181

services with essential services that relate to services that demonstrate the full scope of pharmacy 182

practice and emerging services that are innovative and future-focused and are provided in addition to 183

essential services. Table 1 lists examples of services regarding practice setting and service: 184

185

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Table 1 Examples of services provided by nephrology pharmacists with regard to practice setting and service (essential and emerging)

Essential Services Emerging Servicesi

All settings • Medication history taking

• Medication review (specifically relating to assessing the suitability of medication and doses in relation to the patient’s degree of kidney disease or timing of dialysis)

▪ on commencement of dialysis ▪ at least every 3/12 while on dialysis or when a significant

event occurs

• Provision of medicines information to patients

• Clear communication with care facilities including dialysis units at times of transfer of care

• Rationalise formulary; respond to legislative requirements; medicines shortages and medication safety alerts/concerns for medicines used in renal

• Adherence assessments

• Provide education to staff (nursing / medical and allied health) regarding pharmacological treatment of kidney disease and associated comorbidities

• Clinical teaching to students interns and pharmacists

• Quality improvement activities

• Input into Clinical Governance

• Active involvement in policy, procedure and guideline development

• Access to a pharmacist with specialist knowledge in nephrology / advanced practice nephrology pharmacist

• Lead development of medication-related patient education materials for nephrology services

• Clinical teaching in post-graduate pharmacy programs

• Development of virtual teaching tools

• Teaching at patient conferences

• Participation in Nephrology network-wide audit and medicines use review projects

• Translational research

• Evaluation of the outcomes of treatments for uncommon renal conditions or for a novel or off label therapies.

Inpatient services to renal patients (including transplant)

• Medication education for newly transplanted patients and patients starting dialysis

• Management of complications post-transplant

• Management of complex drug interactions

• Contribute to ward rounds

• Peri-operative medication management

• Advice on therapy for disorders outside of renal specialty e.g. treatment of comorbidities in the context of renal disease

• Clinical advice on therapeutic drug monitoring (TDM) for immunosuppressants

• The transition of care to the primary care teams at discharge

• Auditing of prescribing in nephrology

• Monitoring and analysis of adverse drug events to recommend system changes where appropriate

i Some of the emerging services listed here may be considered essential, depending on the pharmacy service resources and ability of to provide such.

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Outpatient Clinics Outpatient dialysis unit (Home, in-centre and satellite) Outpatient -other (i.e. infusions etc)

• Patient education

• Overseeing supply and storage of medication given with dialysis e.g. erythropoiesis-stimulating agent (ESA), iron and heparin

• Review and supply of medications for infusion. e.g. rituximab, iron

• Reviewing monthly blood results of dialysis patients and medications in conjunction as part of a multidisciplinary team

• Outpatient clinics with GPs and palliative care

• Development of clinical pathways

• Telehealth medication review follow up for remote /rural patients

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Policies, Procedures, and Governance 181

Pharmacists must have knowledge of the following documents which provide a framework within 182

which they must practice: 183

• Australian Charter of Healthcare Rights 3 184

• National Safety and Quality Health Service Standards 13 including the National Model Clinical 185

Governance Framework 14 186

• Pharmacy Board of Australia Code of Conduct 15 187

• SHPA Code of Ethics 16 188

• National Competency Standards Framework for Pharmacists in Australia 2 189

• Professional Practice Standards 17 190

• Clinical Governance Principles for Pharmacy Services 18 191

• Relevant legislation specifically State and Territory Acts and Regulations 192

Policies for the practice of clinical pharmacy provide a basis upon which nephrology-specific policies 193

may be developed and applied. 194

Additional policies, procedures, guidelines, and registries that nephrology pharmacists should be 195

familiar with include: 196

• Kidney Health Australia – Caring for Australasians with Kidney Disease (KHA – CARI) 197

• Kidney disease: Improving Global Outcomes (KDIGO) Guidelines 198

• Chronic Kidney Disease Management in General Practice 3rd Ed 2015 199

• International Society of Peritoneal Dialysis Guidelines – 200

o ISPD Peritonitis Recommendations: 2016 Update on Prevention and Treatment of 201

Peritonitis 2016 202

o ISPD Catheter-Related Infection Recommendations: 2017 Update 203

o ISPD Position Statement on Reducing the Risks of Peritoneal Dialysis-Related 204

Infections 205

• Kidney Disease Outcomes Quality Initiative 206

• International Society of Nephrology Clinical Guidelines 207

• ANZDATA Australia & New Zealand Dialysis and Transplant Registry 208

• Dialysis Outcomes and Practice Patterns Study 209

210

Local, institutional and state-based policies guiding practice may include consultation and/or 211

ownership by other professions or by the pharmacy department and should cover: 212

• Acute hypertension 213

• Anticoagulation for haemodialysis circuits including anticoagulation in the setting of heparin-214

induced thrombocytopenia 215

• Locking solutions for venous catheters for dialysis 216

• Blocked lines e.g. alteplase or urokinase administered via a venous catheter (or vas cath) 217

• Calciphylaxis including the use and adverse effects of sodium thiosulfate 218

• Prevention of Contrast-Induced Nephropathy (CIN) 219

• Empiric and directed treatment of peritonitis 220

• Prevention and management of PD exit site infections 221

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• Pharmacological management of acute hyperkalaemia 222

• Pharmacological management of anaemia in renal disease 223

• Prophylactic antibiotics pre-colonoscopy and invasive gynaecologic procedures in patients 224

on peritoneal dialysis 225

• Medications requiring substantial dose adjustment in renal diseases such as aminoglycosides 226

and vancomycin 227

• Treatment of bacteraemia in patients on haemodialysis 228

• Vaccination pre-dialysis including hepatitis B, influenza and pneumococcal disease 229

• Medications used for kidney transplantation and management of complications after 230

transplant (e.g. acute rejection, BK, CMV, bone disease) 231

• Advice on dosing and monitoring of chemotherapy and immunological therapy. 232

• Policy guiding management of vasculitis or glomerular nephritis 233

234

Recommended Staffing 235

As per the Clinical Pharmacy Standards 1 there are three major factors driving staffing levels for clinical 236

pharmacy services including the range of clinical pharmacy services, the complexity of care required, 237

and hospital throughput. Recommended nephrology pharmacist staffing levels for pharmacy services 238

are presented in Table 2 and Table 3 and should be interpreted with consideration of the health 239

service, activities performed by the nephrology pharmacist, and those that are undertaken by other 240

pharmacists and pharmacy technicians. 241

The roles of nephrology pharmacists are varied and dependent on the model of care and size of the 242

health service and recommended staffing levels is, therefore, a reflection of this. Whereas the 243

traditional model has been that ward-based pharmacists are wholly responsible for an individual 244

patient, pharmacists are increasingly practicing in team-based models and with specialisation, 245

consultant-type roles. As the models change and roles grow, provision of advanced pharmacy care for 246

an individual patient may be shared between pharmacists. 247

There should be at least one pharmacist responsible for the coordination of all aspects of the 248

nephrology pharmacy service. Staffing ratios should consider dedicated time for the lead nephrology 249

pharmacist to perform these coordination duties. 250

Table 2 Recommended pharmacist staffing levels for the provision of clinical pharmacy services based on ‘overnight beds’. 251 Adapted from Table 9.1 Staffing Levels and Structure for the Provision of Clinical Pharmacy Services 1. 252

Category Service-related group/bed

type

Beds to 1 FTEii pharmacist for

clinical pharmacy services 5

days/weekiii

1

Specialist units, high

dependence on medicines

Renal Medicine,

Transplantation

15

ii FTE = full-time equivalent. iii Service on a weekend (assuming few admissions and discharges and medication chart review only) would require an additional 2 to 2.5 hours per day.

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Consideration should be given to adjustment of this ratio for sites who manage a high number of 253

patients following acute renal transplantation (refer to Appendix H, TSANZ 19). 254

Table 3 Recommended pharmacist staffing levels for the provision of clinical pharmacy services based on the number of 255 patients per day. Adapted from Table 9.2 Staffing Levels and Structure for the Provision of Clinical Pharmacy Services 1. 256

Category Patient/service type No. of patients to 1 FTE

pharmacist for clinical

pharmacy services per dayiv

9

Review and advice on

medicine usage – ambulatory

Pharmacists providing review

and advice on medicine usage

in Allied Health and/or Clinical

Nurse Specialist Interventions

clinics – Tier 2 Non-admitted

Service 40.04

5

10

Review and advice on

medicine usage – outreach

services

Pharmacists providing review

and advice on medicine usage

in Allied Health and/or Clinical

Nurse Specialist Interventions

clinics – Tier 2 Non-admitted

Service 40.04 as an outreach

service or in the patient’s

home

3

257

Owing to increasing demand there have been changes in the operation of dialysis units, increasing 258

sessions provided over a seven-day week and a push towards home-based therapies. In recognition 259

of the changing model of care provision the LC recommends ratios based on actual patient numbers 260

as opposed to bed numbers or day admissions as follows: 261

• For outpatient haemodialysis patientsv: a ratio of 200 patients to 1 FTE pharmacist (not 262

eligible for Tier 2 funding) 263

• For nephrology outpatient clinics (category 12), a ratio of 5-7 patients to 1 FTE pharmacist 264

per day (eligible for Tier 2 funding). 265

Further to these ratios, it is recommended that support is provided for the pharmacist to travel to 266

satellite centres and for home visits. 267

268

Training and Education 269

It is essential to develop the pharmacy workforce enabling the delivery of advanced pharmacy care in 270

nephrology through training and education of pharmacists and technicians. Nephrology pharmacists 271

should have a scope of practice competency profile with a Continuing Professional Development (CPD) 272

plan that covers the five domains of professional performance as per the National Competency 273

Standards Framework for Pharmacists in Australia 2016 2. Whilst the framework itself is not tied to 274

any area of specialisation, for nephrology pharmacists there are qualifications, educational activities, 275

iv Includes services on weekdays and weekends. v Described previously in Clinical Pharmacy Standards 1 as category 11 same day admission, renal dialysis.

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knowledge, and skills that are recommended in addition to those of a clinical pharmacist. These have 276

been informed by the SHPA Nephrology Leadership Committee. 277

In addition, pharmacists and pharmacy technicians commencing practice in nephrology services must 278

undertake a relevant orientation and training program as determined by the health service. This 279

should include credentialing relative to their role as implemented by local or state-based health 280

service. 281

Nephrology pharmacists must contribute to the education and development of procedures for non-282

specialist pharmacists caring for nephrology patients. 283

Credentialing and Qualificationsvi 284

Desirable certification, credentialing and qualifications for nephrology pharmacists include: 285

• a postgraduate qualification in clinical pharmacy or public health e.g. 286

o Master of Clinical Pharmacy 287

o Master of Public Health 288

• credentialing as an Advancing or Advanced Practice Pharmacist is provided by Pharmacy 289

Development Australia 20 290

• other relevant postgraduate degrees which may be available nationally or 291

internationally. Examples include: 292

o Postgraduate Diploma in Renal Medicine currently offered by the University of 293

South Wales. 294

Educational Activities 295

Further to the Pharmacy Board of Australia Guidelines on Continuing Professional Development 21 it 296

is recommended that nephrology pharmacists have a significant proportion of their continuing 297

professional development per year tailored to nephrology services. There is a dearth of specific 298

pharmacist training for nephrology however any training on chronic disease e.g. cardiac disease or 299

diabetes is worthwhile for nephrology pharmacists. Recommended continuing education for 300

nephrology pharmacists include the following; 301

Attendance at local or national courses: 302

• SHPA Seminars and related CPD activities e.g. extension seminar internal medicine, state 303

branch CEs or symposiums 304

• ANZSN Kidney School online educational website 305

• Virtual simulation on AKI ‘Ready to Practice’ 22 306

• General medicine/ chronic disease training e.g. NPS webinars and CPD activities for 307

pharmacists 308

• In house journal clubs 309

• Kidney Health Australia 310

International courses: 311

• ISN Academy Online Learning 312

• University College London (UCL) renal short courses 313

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

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Joining professional organisations: 314

• Australian and New Zealand Society of Nephrology (ANZSN) 315

• Renal Society of Australasia (RSA) 316

• International Society of Nephrology (ISN) 317

• UK Renal Pharmacy Group (UKRPG) 318

The leadership committee considers the ability to undertake preceptorships and/or site visits to health 319

services in either geographically diverse areas or areas of diverse practice to be a useful way of 320

expanding knowledge and skills, particularly for those nephrology pharmacists practising alone or at 321

smaller sites. 322

Educational material and resources are provided on the SHPA Specialty Practice Nephrology stream 323

page on the SHPA eCPD website. For nephrology pharmacists, joining and actively participating in the 324

SHPA Specialty Practice Nephrology stream at the Practice Group level is strongly recommended. 325

Attendance at specialist conferences and educational meetings should be supported to maintain and 326

update specialist knowledge in nephrology. Relevant domestic conferences include those organised 327

by SHPA, the Australian and New Zealand Society of Nephrology (ANZSN) Annual Meeting, and the 328

Renal Society of Australasia (RSA). International conferences in conferences in nephrology include the 329

American Society of Nephrology (ASN) Kidney Week, International Society of Nephrology (ISN) World 330

Congress of Nephrology (WCN), and the European Society of Paediatric Nephrology (ESPN) Annual 331

Meeting. 332

Knowledge, Skills and Experiential Learning 333

The role of a nephrology pharmacist, like any clinician with specialised expertise, is based on a high 334

level of skill in general pharmacy with the later addition of specialty-specific experience. Pharmacists’ 335

working in this area should have high levels of personable skills including confidence, empathy, and 336

effective patient communication skills, in order to provide personalised care. Underpinning knowledge 337

related to key areas of pharmacy practice in nephrology is the skills and application of clinical 338

pharmacy, which may be advanced by experiential learning. This Standard does not list the 339

competencies that the individual nephrology pharmacist should address as this will be dependent 340

upon their scope of practice. 341

Table 4 Essential and desirable knowledge and skills and experiential learning for nephrology pharmacists 342

Knowledge and Skills

Essential Desirable

Understanding of the various equations and

method used to estimate kidney function

and the limitations associated with these

equations and methods.

The specialist knowledge of pharmacotherapeutics

to support comprehensive medicines use e.g. drug

dosing in CRRT, TDM post-transplantation

Ability to identify medicines that need dose

adjustment in kidney disease and be able to

recommend appropriate dose adjustments

considering the clinical picture and patient

characteristics.

Ability to select dose regimens for medicines in renal disease in the absence of published recommendations.

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Understanding of drug removal by

haemodialysis and peritoneal dialysis and

implications for drug dosing.

Motivational interviewing to support changes in

medication adherence for transplant medications.

Knowledge of acute kidney injury, chronic

kidney disease, transplantation, and renal

replacement therapies.

Interdisciplinary clinical decision-making at the

point of care

Ability to identify and manage clinically

significant drug interactions in patients with

CKD including those post kidney transplant.

Mentorship for early career pharmacists, those

newly working in nephrology and those caring for

complex patients requiring specialist input.

Delivery of medication education and

management plans, tailored to the patient's

literacy, language and understanding.

Ability to develop novel patient education materials

to facilitate the delivery of medication education

and the importance of medication adherence

Well-developed clinical reasoning skills and

ability to evaluate treatment approaches in

complicated patients.

Ability to promote and support the skills

development of nephrology pharmacists

Education of other health professionals

(medical, nursing, pharmacy and allied

health staff), with respect to medicines in

kidney disease.

Leadership to support and promote advanced pharmacy practice in nephrology

Undertaking quality improvement projects

within the chronic kidney disease and

transplantation setting.

Teaching to increase advanced capability e.g. training and education of healthcare professionals regarding nephrology

In-depth understanding of risk factors for

medication non-adherence and strategies to

address them.

Psychological support and end-of-life education and training

Well-developed written skills and the ability

to retrieve and synthesize evidence in order

to contribute to guideline development.

Skills in research, clinical epidemiology, medical

statistics

Engagement in National health and community

policy

Experiential Learning (includes training)

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

Completion of an SHPA Foundation Residency

Program

Training and education will predominantly be work-based education and should follow adult 343

learning principles. Further information can be found in Chapter 10 of the SHPA Standards of 344

Practice for Clinical Pharmacy Services 1. 345

346

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Quality Improvement 347

Quality improvement activities should demonstrate that advance pharmacy care in nephrology is 348

delivering improvements to patient care by targeting and achieving the best outcomes for all patient 349

groups, including those at greatest risk for medicines. Examples of quality improvement activities 350

which may be considered within a plan, do, study, act (PDSA) cycle for quality improvement activities 351

are listed below: 352

• Assessment of practice against CARI guidelines e.g. iron management, preventing infection 353

in peritoneal dialysis, exit site infection avoidance 354

• Assisting nursing staff with the accuracy of medicines data input into ANZDATA registry 355

• Evaluation of anaemia management 23,24 356

• The proportion of guidelines (e.g. PD, HD, kidney transplant) that have been reviewed and 357

updated within the designated expiry period. 358

Further information on quality improvement can be found in Chapter 14 of the SHPA Standards of 359

Practice for Clinical Pharmacy Services 1 and ACSQHC Selected best practices and suggestions for 360

improvement for clinicians and health system managers hospital-acquired complication renal failure 361 25. 362

363

Research 364

Research is vital for developing the pharmacy profession and may inform pharmacy services current 365 level of, and future contributions to, advancing pharmacy and patient care. Nephrology pharmacists 366 should initiate, conduct and supervise research that contributes to the body of knowledge providing 367 evidence of impact in support of optimal use of medicines and advanced pharmacy care in nephrology 368 as well as evaluating novel treatments and ensuring patient safety. Research Ethics Committee 369 approval should be sought where applicable. 370 371 Systematic reviews of randomised controlled trials (RCTs) are commonly used in evidence-based 372 policymaking.26 However, the number of RCTs is fewer in nephrology than other specialties of internal 373 medicine and low in quality.27 Furthermore, public health systematic reviews of interventions are 374 much more likely to be evaluated using observational and other study designs - the best available 375 evidence wherever this may be found 28. 376

Translational research in nephrology should include pharmacogenomics studies for renal kinetics, 377 pharmacokinetic studies on drug dosing in RRT, pharmacoepidemiology studies on drug use and 378 treatment outcomes in patients in CKD, dialysis and kidney transplantation, medication adherence 379 post kidney transplantation and evaluation of the outcomes of treatments for uncommon renal 380 conditions or for novel or off label therapies. 381

Cross-sector, inter-sectoral and interdisciplinary research is advocated to ensure the input of key 382 stakeholders and that research is relevant to the Australian community. Medical teams external to 383 nephrology may be involved, depending on subject choice. Liaising with medical staff may identify 384 medicine-related aspects of existing nephrology projects. Students, pre-registration pharmacists or 385 doctors in training may assist with data collection. To improve the chance of project success, the data 386 collection should be achievable in a timely manner and the topic should be of interest to the 387 nephrology team. Collaborations with research institutes and groups such as the Australian Kidney 388 Trials Network (AKTN) and CKD-Centre for Research Excellence are also advocated. 389

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Consideration should be given to research priorities from the patient and carer’s perspective such as 390 those for chronic kidney disease published by CARI e.g.’ what can we do to improve individual drug 391 therapy in terms of better management of side effects?’ and ‘what interventions can improve long 392 term post-transplant outcomes?’ 393

External funding enables larger and feasibly multi-centre studies to be conducted. The SHPA National 394 Translational Research Collaborative (NTRC) funds research grants, practitioner grants, and 395 educational grants to develop research capacity. Grants are also available from other organisations 396 including Kidney Health Australia and the Australian and New Zealand Society of Nephrology. 397 Presentation and publication of studies by Australian pharmacists practicing in nephrology are 398 imperative, to aid others in the implementation of innovative and evidence-based nephrology 399 pharmacy services and illustrate where nephrology pharmacists are involved in research and how they 400 are improving patient care. 401

The choice of the journal to publish in depends on consideration of the best audience for the study 402 results. The Journal of Pharmacy Practice and Research (JPPR) presents findings to primarily an 403 Australian pharmacy audience. Journals specific to nephrology that may be appropriate are listed in 404 Appendix 1: Resources. 405

Further information on research can be found in Chapter 11 of the SHPA Standards of Practice for 406 Clinical Pharmacy Services 1. 407

408

References 409

1. SHPA Committee of Specialty Practice in Clinical Pharmacy. SHPA Standards of Practice for 410 Clinical Pharmacy Services. Journal of Pharmacy Practice and Research 2013; 43(No. 2 411 Supplement): S1-69. 412

2. Pharmaceutical Society of Australia. National Competency Standards Framework for 413 Pharmacists in Australia. Deakin West ACT 2600; 2016. 414

3. The Australian Commission on Safety and Quality in Health Care. Australian Charter of 415 Healthcare Rights. 2008. 416

4. Home Dialysis Advisory Committee of Dialysis Nephrology and Transplant. The Australian 417 Charter of Home Dialysis Rights and Responsibilities. Australia; 2012. p. 2. 418

5. National Rural Health Alliance. Kidney disease in rural Australia. In: Australia KH, Inc. NRHA, 419 editors. Fact Sheet 35 ed. ACT: National Rural Health Alliance; 2013. 420

6. El Nahas M. The global challenge of chronic kidney disease. Kidney Int 2005; 68(6): 2918-29. 421 7. ANZDATA Registry. Chapter 1 Incidence of Renal Replacement Therapy for End Stage Kidney 422

Disease. Adelaide, Australia, 2018. 423 8. E G, S M. Improving Access to and Outcomes of Kidney Transplantation for Aboriginal and 424

Torres Strait Islander People in Australia. Sydney: The Transplantation Society of Australia and 425 New Zealand, 2019. 426

9. AK B, A L, M T, et al. Global Kidney Health Atlas: A report by the International Society of 427 Nephrology on the current state of organization and structures for kidney care across the 428 globe. Brussels, Belgium: International Society of Nephrology, 2017. 429

10. Hassan Y, Al-Ramahi RJ, Aziz NA, Ghazali R. Impact of a renal drug dosing service on dose 430 adjustment in hospitalized patients with chronic kidney disease. The Annals of 431 pharmacotherapy 2009; 43(10): 1598-605. 432

11. Salgado TM, Moles R, Benrimoj SI, Fernandez-Llimos F. Pharmacists' interventions in the 433 management of patients with chronic kidney disease: a systematic review. Nephrol Dial 434 Transplant 2012; 27(1): 276-92. 435

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12. Raymond CB, Wazny LD, Sood AR. Standards of clinical practice for renal pharmacists. Can J 436 Hosp Pharm 2013; 66(6): 369-74. 437

13. Australian Commission on Safety and Quality in Health Care. National Safety and Quality 438 Health Service Standards. Medication Safety. Sydney: Australian Commission on Safety and 439 Quality in Health Care; 2017. p. 86. 440

14. Australian Commission on Safety and Quality in Health Care. National Model Clinical 441 Governance Framework. Sydney, NSW; 2017. 442

15. Pharmacy Board of Australia. For Pharmacists Code of Conduct. March 2014 ed; 2014. 443 16. The Society of Hospital Pharmacists Australia. SHPA Code of Ethics. Governance. Collingwood: 444

The Society of Hospital Pharmacists of Australia; 2016. p. 1. 445 17. Pharmaceutical Society of Australia. Professional Practice Standards Version 5. Deakin West 446

ACT 2600.; 2017. p. 116. 447 18. Pharmaceutical Society of Australia. Clinical Governance Principles for Pharmacy Services 448

2018. Deakin West, ACT, Australia: Pharmaceutical Society of Australia, 2018. 449 19. The Transplantation Society of Australia and New Zealand. Clinical Guidelines for Organ 450

Transplantation from Deceased Donors, 2018. 451 20. Pharmacy Development Australia. Advancing Practice Background and Guiding Principles, 452

2018. 453 21. Pharmacy Board of Australia. Guidelines on Continuing Professional Development. 2015. 454 22. Martini N, Farmer K, Patil S, et al. Designing and Evaluating a Virtual Patient Simulation—The 455

Journey from Uniprofessional to Interprofessional Learning. Information 2019; 10(1). 456 23. Fishbane S, Spinowitz B. Update on Anemia in ESRD and Earlier Stages of CKD: Core Curriculum 457

2018. Am J Kidney Dis 2018; 71(3): 423-35. 458 24. Bosch JP, Walters BA. Continuous quality improvement for a hemodialysis network. Contrib 459

Nephrol 2002; (137): 300-10. 460 25. Australian Commision on Safety and Quality in Health Care. Hospital-Acquired Complication 8 461

RENAL FAILURE, 2018. 462 26. Barton S. Which clinical studies provide the best evidence? The best RCT still trumps the best 463

observational study. British Medical Journal 2000; 321: 255-6. 464 27. Strippoli GF, Craig JC, Schena FP. The number, quality, and coverage of randomized controlled 465

trials in nephrology. J Am Soc Nephrol 2004; 15(2): 411-9. 466 28. Bambra C. Real world reviews: a beginner's guide to undertaking systematic reviews of public 467

health policy interventions. J Epidemiol Community Health 2011; 65(1): 14-9. 468 29. Australian and New Zealand Society of Nephrology. ANZSN Renal Supportive Care Guidelines 469

2013. Nephrology 2013; 18: 54. 470 30. McCombie SP, Thyer I, Corcoran NM, et al. The conservative management of renal trauma: a 471

literature review and practical clinical guideline from Australia and New Zealand. BJU Int 2014; 472 114 Suppl 1: 13-21. 473

474

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Appendices 475

Appendix 1: Resources 476

Recommended texts for nephrology

Renal Drug Database

Discretionary texts (at least one would be available in most nephrology departments)

Morlidge, C; Ashley, C (2008) Introduction to Renal Therapeutics. Pharmaceutical Press London.

Available as eBook via EBSCOhost for SHPA members

American College of Physicians (2007) Drug Prescribing in Renal Failure. 5th Edition. ISBN:978-1-

930513-76-1

Seyffart G (2011) Seyffart’s Directory of Drug Dosage in Kidney Disease . Dustri-Verlag.

Therapeutic Guidelines Limited (2019) electronic Therapeutic Guidelines (eTG). Therapeutic

Guidelines Ltd. Melbourne. In particular, Antimicrobial dosages for adults with impaired renal

function (Table 2.80)

Gilbert, D; Chambers H; Eliopoulos, G; Saag, M; Pavia, A et al. (2019) The Sanford Guide to

Antimicrobial Therapy 2019. 49th edition. ISBN: 978-1-944272-09-8

Useful journals specific to nephrology

American Journal of Nephrology

American Journal of Kidney Diseases

Kidney

Kidney Diseases

Kidney International

Kidney Research and Clinical Practice

BMC Nephrology

Case Reports in Nephrology

Clinical Nephrology

Current Opinion in Nephrology & Hypertension

European Medical Journal: Nephrology

International Journal of Nephrology

Journal of Nephrology

Journal of Pediatric Nephrology

Journal of the American Society of Nephrology (JASN)

Kidney International

Nature Reviews Nephrology (formerly Nature Clinical Practice Nephrology)

Nephrology

Nephrology, dialysis, transplantation

Seminars in Nephrology

American Journal of Transplantation

Peritoneal Dialysis International

Transplantation

Clinical Guidelines

• KHA-CARI Guidelines e.g. KHA-CARI Chronic Kidney Disease Guidelines, KHA-CARI Dialysis

Guidelines, KHA-CARI Transplantation Guidelines

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• KDIGO Guidelines e.g. Acute Kidney Injury (AKI), Anemia in CKD, Blood Pressure in CKD,

CKD Evaluation and Management

• ANZSN Renal Supportive Care Guidelines 2013 29

• Conservative Management of Renal Trauma 2014 30

Useful websites

Kidney Health Australia Patient information, GP practice guide,

professional information

National Kidney Foundation US based health organisation focussed on kidney

disease. Publishes resources for health

professionals and patients.

ANZData Statistics relating to the outcomes of treatment

for end stage renal failure

Global Kidney Health Atlas Global report on kidney disease in all countries

BC Renal Agency Multidisciplinary collective, focused on improving

care for the kidney community in British

Columbia

Think Kidneys UK program dedicated to raising awareness

about kidney disease. Includes resources for

health professionals and patients.

Conservative Kidney Management (CKM) Care A resource for patients and healthcare

professionals with a focus on quality of life,

symptom management, and living well without

dialysis.

The Lancet Kidney Campaign Raises awareness about acute and chronic kidney

diseases and collates evidence to inform

strategies to reduce national, regional and global

burden of the disease and its risk factors.

University of Louisville Division of Nephrology

& Hypertension Kidney Disease Program

Adult & Pediatric Drug Book

Provides pharmacokinetic data, dose adjustment

for renal failure and information on use in

dialysis.

Societies

International Society of Nephrology

Renal Society of Australasia

UK Renal Pharmacist Group

Useful Apps

eGFR Calculators National Kidney Foundation

Transplant Hero

CKD Go KHA

My Kidneys My Health – KHA

477

478

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Appendix 2: Common Abbreviations in Nephrology 479

Abbreviation Description

AKI Acute Kidney Injury

ANCA Anti-neutrophil cytoplasmic antibody

APD Automated Peritoneal Dialysis

AVF Arteriovenous Fistula

CARI Caring for Australians with Renal Impairment

CKD Chronic Kidney Disease

CKD -MBD Mineral Bone Disorder

CrCl Creatinine Clearance

CVVH Continuous Veno-Venous Hemofiltration

CVVHDF Continuous Veno-Venous Hemodiafiltration

eGFR Estimated Glomerular Filtration Rate

ESRD End Stage Renal Disease

HD Haemodialysis

HHD Home Haemodialysis

HUS Haemolytic Uraemic Syndrome

KDIGO Kidney Disease Improving Global Outcomes

KHA Kidney Health Australia

MDRD Modification of Diet in Renal Disease

MDT Multidisciplinary Team

NKF KDOQI The National Kidney Foundation Kidney Disease

Outcomes Quality Initiative (KDOQI)

PD Peritoneal dialysis

RRT Renal Replacement Therapy

TMA Thrombotic Microangiopathy

480