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DRAFT prepared 18.04.2019. 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 , Matthew Cervelli, BPharm, MSHP 5,6 , 3 Danielle Ironside, BPharm(Hons), GradCertClinPharm, MSHP 2 , Ceridwen Jones, post nominals 7 , Jess 4 Lloyd, BPharm, GDClinPharm, MSHP 8 , Sanja Mirkov, B Pharm, PGDipPH, MSHP 9 and Courtney 5 Munro, BPharm, GradCertPharmPrac, MPharmPrac, MSHP, AACPA 10 . 6 7 1 The Royal Melbourne Hospital, Parkville, Australia 8 2 Royal Brisbane and Women’s Hospital, suburb, Queensland 9 3 School of Pharmacy, University of Queensland, suburb, Queensland 10 4 Faculty of Health and Medicine, University of Sydney, NSW; Blacktown Hospital, WSLHD, NSW 11 5 Renal Unit, Royal Adelaide Hospital, Adelaide, Australia 12 6 13 7 14 8 The Princess Alexandra Hospital, Brisbane, Australia 15 9 Gisborne Hospital, Gisborne, New Zealand 16 10 The Society of Hospital Pharmacists of Australia, Collingwood, Victoria, Australia 17 18 Address for correspondence: 19 Carla Scuderi 2 , Chair, Nephrology Leadership Committee, The Society of Hospital Pharmacists of 20 Australia, Collingwood, Victoria, Australia. Email: [email protected] 21 22 Preface 23 This Standard references and relies upon SHPA Standards of Practice for Clinical Pharmacy Services 1 24 as the foremost Standard. As kidney disease rarely occurs in isolation, this Standard may overlap with 25 others and depending on the area of specialty practice it may be advisable to refer to additional 26 Standards of Practice. 27 The use of the word ‘specialisation’ in this standard is in line with the National Competency Standards 28 Framework for Pharmacists in Australia 2 where ‘specialisation’ refers to the scope of practice rather 29 than the level of performance. ‘Specialisation’ of itself does not confer additional expertise. 30 This Standard is for professional practice and is not prepared or endorsed by Standards Australia. It is 31 not legally binding. 32 33 Introduction 34 In Australia, everyone shares a fundamental right to safe and high-quality healthcare. This is enshrined 35 in the Australian Charter of Healthcare Rights 3 by which all healthcare systems, including the provision 36 of advanced pharmacy care, must abide. The Charter summarises the basic rights that patients and 37 consumers are entitled to receive when accessing healthcare services including access, safety, respect, 38 communication, participation, privacy and comment. Additionally, Kidney Health Australia’s Charter 39

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DRAFT prepared 18.04.2019. 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, Matthew Cervelli, BPharm, MSHP 5,6, 3

Danielle Ironside, BPharm(Hons), GradCertClinPharm, MSHP 2, Ceridwen Jones, post nominals 7, Jess 4

Lloyd, BPharm, GDClinPharm, MSHP 8, Sanja Mirkov, B Pharm, PGDipPH, MSHP 9 and Courtney 5

Munro, BPharm, GradCertPharmPrac, MPharmPrac, MSHP, AACPA 10. 6

7

1 The Royal Melbourne Hospital, Parkville, Australia 8

2 Royal Brisbane and Women’s Hospital, suburb, Queensland 9

3 School of Pharmacy, University of Queensland, suburb, Queensland 10

4 Faculty of Health and Medicine, University of Sydney, NSW; Blacktown Hospital, WSLHD, NSW 11

5 Renal Unit, Royal Adelaide Hospital, Adelaide, Australia 12

6 13

7 14

8 The Princess Alexandra Hospital, Brisbane, Australia 15

9 Gisborne Hospital, Gisborne, New Zealand 16

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

18

Address for correspondence: 19

Carla Scuderi 2, Chair, Nephrology Leadership Committee, The Society of Hospital Pharmacists of 20

Australia, Collingwood, Victoria, Australia. Email: [email protected] 21

22

Preface 23

This Standard references and relies upon SHPA Standards of Practice for Clinical Pharmacy Services 1 24

as the foremost Standard. As kidney disease rarely occurs in isolation, this Standard may overlap with 25

others and depending on the area of specialty practice it may be advisable to refer to additional 26

Standards of Practice. 27

The use of the word ‘specialisation’ in this standard is in line with the National Competency Standards 28

Framework for Pharmacists in Australia 2 where ‘specialisation’ refers to the scope of practice rather 29

than the level of performance. ‘Specialisation’ of itself does not confer additional expertise. 30

This Standard is for professional practice and is not prepared or endorsed by Standards Australia. It is 31

not legally binding. 32

33

Introduction 34

In Australia, everyone shares a fundamental right to safe and high-quality healthcare. This is enshrined 35

in the Australian Charter of Healthcare Rights 3 by which all healthcare systems, including the provision 36

of advanced pharmacy care, must abide. The Charter summarises the basic rights that patients and 37

consumers are entitled to receive when accessing healthcare services including access, safety, respect, 38

communication, participation, privacy and comment. Additionally, Kidney Health Australia’s Charter 39

DRAFT prepared 18.04.2019. Property of The Society of Hospital Pharmacists Australia 2

of Home Dialysis Rights and Responsibilities 4 provides guidance for patients, their carers and health 40

professionals who provide their care. The provision of pharmacy services must encompass both 41

Charters to deliver effective, efficient, timely and equitable patient-centred care for kidney disease. 42

The National Competency Standards Framework for Pharmacists in Australia 2 complements the 43

underpinnings of the Charter across five domains of competency for the pharmacy profession. These 44

include; professionalism and ethics, communication and collaboration, medicines management and 45

patient care, leadership and management, as well as education and research. 46

This Standard, produced by The Society of Hospital Pharmacists of Australia (SHPA), refers to both the 47

role of the pharmacy service and the pharmacists’ practice in nephrology (or kidney disease). It is 48

intended for both pharmacists involved in nephrology services and pharmacists whose area of 49

specialisation is nephrology services and for consistency refers to both as nephrology pharmacists. 50

The Standard predominately refers to nephrology pharmacists but does not intend to exclude suitably 51

qualified technicians where appropriate 1. SHPA supports both pharmacists and technicians to operate 52

at their full scope of practice in order to achieve optimal patient and pharmacy outcomes. 53

This Standard is intended to be used across hospital pharmacy services in Australia, irrespective of the 54

service type (public or private) or location (metropolitan, regional or rural). While this Standard is 55

intended for hospital pharmacy services, the principles and aspects of patient management discussed 56

herein can be applied to broader pharmacy services that provide nephrology care. It is acknowledged 57

that there are significant variations in pharmacy services that are dependent on: organisational 58

capacity, patient population, nephrology service and pharmacy department priorities, and the 59

availability and scope of practice of the nephrology pharmacist; all of which may influence the scope 60

of services. 61

The Standard describes current best care for the provision of nephrology pharmacy services (see Box 62

1) by nephrology pharmacists and the pharmacy department or employer. Essential services relate to 63

services that demonstrate the full scope of current pharmacy practice. Emerging services relate to 64

services that are innovative and future focused and are provided in addition to essential services. SHPA 65

encourages all pharmacy services to strive to provide emerging services wherever possible, in addition 66

to essential services. 67

68

DRAFT prepared 18.04.2019. Property of The Society of Hospital Pharmacists Australia 3

Box 1 Nephrology Services and the Nephrology Pharmacist 69

Burden of Kidney disease in Australia 70

One in three adults is at risk of developing CKD and one in nine Australian adults will have some sign 71

of kidney disease. For those living in rural and remote areas, rates are much higher5. End stage renal 72

disease (ESRD) is more common in ethnic minority populations and in socially deprived populations. 73

In Australia, the incidence of ESRD is substantially higher in Aboriginal people than in white people 74

(420 vs 94 per million per [p.m.p.] year) 6. The incidence of ESRD increased from 110 p.m.p. in 2007 75

to 124 p.m.p. in 2017 7. There was substantial variation in incidence rates between states, with the 76

lowest rates in Tasmania (106 p.m.p in 2017) and the highest in the Northern Territory (471 p.m.p. in 77

2017) 7. 78

79

Evidence of pharmacist impact in nephrology 80

As for other specialty areas of pharmacy practice, evidence supports pharmacist involvement as part 81

of the multidisciplinary team having direct and indirect benefits on patient care. In the hospital setting 82

for patients with CKD, a pharmacist accompanying medical physicians on rounds to provide a renal 83

drug dosing service has been shown to increase the proportion of doses adjusted to account for renal 84

function, prevent adverse drug events (ADEs) and result in medication cost savings 8. A systematic 85

review of pharmacists' interventions in patients with CKD from eight controlled studies (average 86

quality score 0.57, SD = 0.10) demonstrated that pharmacists’ interventions reduced all-cause 87

hospitalisations, cumulative time hospitalised, reduced the incidence of end-stage renal disease or 88

death in patients with diabetic nephropathy, improved management of anaemia, blood pressure, 89

calcium and phosphate parameters and lipid management. On the basis of best available evidence, 90

pharmacists’ interventions may have a positive impact on outcomes of patients with chronic kidney 91

disease 9. 92

93

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 and chronic pain)

• 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.

DRAFT prepared 18.04.2019. Property of The Society of Hospital Pharmacists Australia 4

Objectives of the Service 94

The objectives of the nephrology service provided by pharmacists are to: optimise medicines 95

management for patients with kidney disease by assessment of renal function and appropriate 96

medicines recommendations to prevent acute kidney injury (AKI), slow progression of CKD, improve a 97

patient’s quality of life while limiting unintended consequences such as adverse drug events, 98

advancement of disease stage, burden of kidney disease and costs. Nephrology pharmacists must 99

deliver the service as part of a multidisciplinary collaboration and within the framework of evidence 100

and patient-centred healthcare ensuring optimal kidney health and patient outcomes. Where possible 101

pharmaceutical care for patients with kidney disease should be standardised to minimise variation 102

and provide equitable services, with lesser dependence on locality. 103

104

Scope 105

This Standard applies to all pharmacists working in nephrology services. The service provided by the 106

nephrology pharmacist may be delivered across several settings including both public and private 107

hospitals, in an inpatient, outpatient or ambulatory care setting, and in primary care (at patient's 108

home, Aboriginal and Torres Strait Islander health centres, community clinics). 109

In addition to providing Clinical Pharmacy services as outlined in SHPA Standards of Practice for Clinical 110

Pharmacy Services 1, nephrology pharmacists are expected to provide services relevant to their clinical 111

area and scope of practice. Whilst the range of services provided in nephrology is primarily delivered 112

by pharmacists, it may be supported by pharmacy technicians in clinical and non-clinical roles. 113

The role of the nephrology pharmacist should include: 114

• attendance on ward rounds, in outpatient consultations, at multi-disciplinary team meetings 115

and at individual patient case conferences 116

• delivery of pharmacy services that improve patient medication outcomes and adds value to 117

healthcare systems, while encouraging the financial sustainability of healthcare 118

• development of and input into policies, procedures, guidelines and resources 119

• comment on nephrology medication formulary applications and decisions 120

• provision of educational and training for healthcare professionals and students 121

• quality improvement activities; 122

• and research related to nephrology. 123

It may additionally include involvement in serving satellite centres, clinical trials and emerging 124

pharmacy services. The pharmacist should be a point of contact for other pharmacists and health 125

professionals, and for the hospital or health service for medicines enquiries related to nephrology. 126

127

Operation 128

The nephrology pharmacy service should be provided by pharmacists whose main area of 129

specialisation is nephrology and who demonstrates competence in nephrology pharmacy (refer to 130

Training and Education). Components of the service may be delegated to non-specialised 131

pharmacists after undergoing training and demonstrating an appropriate level of competence to 132

perform their tasks. 133

DRAFT prepared 18.04.2019. Property of The Society of Hospital Pharmacists Australia 5

134

To achieve the aforementioned objectives, nephrology pharmacists need to consider both individual 135

patient factors and service provision with regard to practice settings, as detailed below. 136

Patient Factors 137

To meet the needs of the patient, the nephrology pharmacist (as part of the multidisciplinary 138

nephrology team) should: 139

• Be familiar with tools available to estimate a patient’s current kidney function and 140

understand both the applicability and limitations of these tools and the clinical situations 141

where they may be unreliable and/or misleading 142

• Consider individual patient circumstances including renal function, goals of therapy, clinical 143

presentation and comorbidities when evaluating and recommending medications 144

• Consider the impact of the varying renal replacement therapies (RRT) on medicine choice 145

and dosing along with the optimal timing of administration 146

• Understand patient risk factors for medication non-adherence for patients with renal 147

disease (including post-transplantation) and potential strategies to address these 148

• Understand risk factors for the development and progression of CKD and associated 149

comorbidities 10. 150

151

Service Provision with regard to Practice Settings 152

Service provision will vary with regard to practice setting. In the hospital setting, nephrology 153

pharmacists providing advanced pharmacy care can facilitate quality use of medicines to improve 154

outcomes for patients with kidney disease. Due to the large number of patients with kidney disease 155

and the treatment burden, the traditional inpatient model has expanded to include care for patients 156

in outpatient, ambulatory and clinic-based services. Progressively innovative services in atypical 157

settings are arising to accommodate patient need such as satellite dialysis units, Australia’s Big Red 158

Kidney Bus and GP shared care arrangements (like that for obstetrics). An ongoing challenge is 159

delivering regular nephrology pharmacy services in an outpatient setting since models of pharmacy 160

service are traditionally inpatient focused. Regardless of the setting, nephrology pharmacists have a 161

critical role in ensuring optimal kidney health. 162

Nephrology pharmacists should assess kidney function consistent with the role of a pharmacist in a 163

patient-centred and culturally responsive manner. A collaborative approach to develop a medication 164

management plan (MMP) should promote judicious use of medicine and engage patients, to convey 165

the benefits of evidence-based treatment options and establish realistic expectations. The nephrology 166

pharmacist should refer patients to services (e.g. nurse practitioner, case managers, dieticians, social 167

workers, psychologists, palliative care, credentialed advancing and advanced practice pharmacists, 168

HMR accredited pharmacists and medical staff including general practitioners) that could assist and 169

support self-care for kidney disease and escalate to the co-ordinator of the patient's medical care 170

when required. 171

Nephrology pharmacists should facilitate communication between the hospital and primary care and 172

provide education to patients. In keeping with best practice for facilitating continuity of medication 173

management on transition between care settings, there should be robust communication systems 1. 174

DRAFT prepared 18.04.2019. Property of The Society of Hospital Pharmacists Australia 6

As detailed in the introduction, this Standard describes best care for the provision of pharmacy 175

services with essential services that relate to services that demonstrate the full scope of pharmacy 176

practice and emerging services that are innovative and future focused and are provided in addition to 177

essential services. Table 1 lists examples of services regarding practice setting and service: 178

179

DRAFT prepared 18.04.2019. Property of The Society of Hospital Pharmacists Australia 7

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

Essential Services Emerging Services

All settings • Medication history taking

• Medication review (specifically relating to assessing 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 student’s interns and pharmacists

• Quality improvement activities

• Input into Clinical Governance

• Active involvement in policy, procedure and guideline development

• Access to 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 novel or off label therapies.

Inpatient services to renal patients (including transplant)

• Medication education for newly transplanted patients

• 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 context of renal disease

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

• 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

Outpatient Clinics Outpatient dialysis unit (Home, in-centre and satellite)

• 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

DRAFT prepared 18.04.2019. Property of The Society of Hospital Pharmacists Australia 8

Outpatient -other (i.e. infusions etc)

• Telehealth medication review follow up for remote /rural patients

DRAFT prepared 18.04.2019. Property of The Society of Hospital Pharmacists Australia 9

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 11 185

• Pharmacy Board of Australia Code of Conduct 12 186

• SHPA Code of Ethics 13 187

• National Competency Standards Framework for Pharmacists in Australia 2 188

• Professional Practice Standards 14 189

• Relevant legislation specifically State and Territory Acts and Regulations 190

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

may be developed and applied. 192

Additional policies, procedures, guidelines and registries that nephrology pharmacists should be 193

familiar with include: 194

• Kidney Health Australia – Caring for Australasians with Kidney Disease (KHA – CARI) 195

• Kidney disease: Improving Global Outcomes (KDIGO) Guidelines 196

• Chronic Kidney Disease Management in General Practice 3rd Ed 2015 197

• International Society of Peritoneal Dialysis Guidelines – 198

o ISPD Peritonitis Recommendations: 2016 Update on Prevention and Treatment of 199

Peritonitis 2016 200

o ISPD Catheter-Related Infection Recommendations: 2017 Update 201

o ISPD Position Statement on Reducing the Risks of Peritoneal Dialysis-Related 202

Infections 203

• Kidney Disease Outcomes Quality Initiative 204

• International Society of Nephrology Clinical Guidelines 205

• ANZDATA Australia & New Zealand Dialysis and Transplant Registry 206

• Dialysis Outcomes and Practice Patterns Study 207

208

Local, institutional and state-based policies guiding practice may include consultation and/or 209

ownership by other professions or by the pharmacy department and should cover: 210

• Acute hypertension 211

• Anticoagulation for haemodialysis circuits including anticoagulation in the setting of heparin 212

induced thrombocytopenia 213

• Locking solutions for venous catheters for dialysis 214

• Blocked lines e.g. alteplase or urokinase administered via venous catheter (or vas cath) 215

• Calciphylaxis including use and adverse effects of sodium thiosulfate 216

• Prevention of Contrast Induced Nephropathy (CIN) 217

• Empiric and directed treatment of peritonitis 218

• Prevention and management of PD exit site infections 219

• Pharmacological management of acute hyperkalaemia 220

• Pharmacological management of anaemia in renal disease 221

DRAFT prepared 18.04.2019. Property of The Society of Hospital Pharmacists Australia 10

• Prophylactic antibiotics pre-colonoscopy and invasive gynaecologic procedures in patients 222

on peritoneal dialysis 223

• Medications requiring substantial dose adjustment in renal disease such as aminoglycosides 224

and vancomycin 225

• Treatment of bacteraemia in patients on haemodialysis 226

• Vaccination pre-dialysis including hepatitis B, influenza and pneumococcal disease 227

• Medications used for kidney transplantation and management of complications after 228

transplant (e.g. acute rejection, BK, CMV, bone disease) 229

• Advice on dosing and monitoring of chemotherapy and immunological therapy. 230

231

Recommended Staffing 232

As per the Clinical Pharmacy Standards 1 there are three major factors driving staffing levels for clinical 233

pharmacy services including: the range of clinical pharmacy services, the complexity of care required, 234

and hospital throughput. Recommended nephrology pharmacist staffing levels for pharmacy services 235

are presented in Table 2 andTable 3 and should be interpreted with consideration of the health 236

service, activities performed by the nephrology pharmacist, and those that are undertaken by other 237

pharmacists and pharmacy technicians. 238

The roles of nephrology pharmacists are varied and dependent on the model of care and size of the 239

health service and recommended staffing levels is, therefore, a reflection of this. Whereas the 240

traditional model has been that ward-based pharmacists are wholly responsible for an individual 241

patient, pharmacists are increasingly practicing in team-based models and with specialisation, 242

consultant-type roles. As the models change and roles grow, provision of advanced pharmacy care for 243

an individual patient may be shared between pharmacists. 244

There should be at least one pharmacist responsible for the coordination of all aspects of the 245

nephrology pharmacy service. Staffing ratios should consider dedicated time for the lead nephrology 246

pharmacist to perform these coordination duties. 247

Table 2 Recommended pharmacist staffing levels for provision of clinical pharmacy services based on ‘overnight beds’. 248 Adapted from Table 9.1 Staffing Levels and Structure for the Provision of Clinical Pharmacy Services 1. 249

Category Service-related group / bed

type

Beds to 1 FTEi pharmacist for

clinical pharmacy services 5

days / weekii

1

Specialist units, high

dependence on medicines

Renal Medicine,

Transplantation

15

Consideration should be given to adjustment of this ratio for sites who manage a high number of 250

patients following acute renal transplantation (refer to Appendix H, TSANZ 15). 251

i FTE = full-time equivalent. ii 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.

DRAFT prepared 18.04.2019. Property of The Society of Hospital Pharmacists Australia 11

Table 3 Recommended pharmacist staffing levels for provision of clinical pharmacy services based on the number of 252 patients per day. Adapted from Table 9.2 Staffing Levels and Structure for the Provision of Clinical Pharmacy Services 1. 253

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

pharmacist for clinical

pharmacy services per dayiii

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

254

Owing to increasing demand there have been changes in the operation of dialysis units, increasing 255

sessions provided over a seven-day week and a push towards home-based therapies. In recognition 256

of the changing model of care provision the LC recommends ratios based on actual patient numbers 257

as opposed to bed numbers or day admissions as follows: 258

• For outpatient haemodialysis patientsiv: a ratio of 200 patients to 1 FTE pharmacist (not 259

eligible for Tier 2 funding) 260

• For nephrology outpatient clinics (category 12), a ratio of 5-7 patients to 1 FTE pharmacist 261

per day (eligible for Tier 2 funding). 262

Further to these ratios, it is recommended that support is provided for pharmacist to travel to 263

satellite centres and for home visits. 264

265

Training and Education 266

It is essential to develop the pharmacy workforce enabling delivery of advanced pharmacy care in 267

nephrology through training and education of pharmacists and technicians. Nephrology pharmacists 268

should have a scope of practice competency profile with a Continuing Professional Development (CPD) 269

plan that covers the five domains of professional performance as per the National Competency 270

Standards Framework for Pharmacists in Australia 2016 2. Whilst the framework itself is not tied to 271

any area of specialisation, for nephrology pharmacists there are qualifications, educational activities, 272

knowledge and skills that are recommended in addition to those of a clinical pharmacist. These have 273

been informed by the SHPA Nephrology Leadership Committee. 274

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

DRAFT prepared 18.04.2019. Property of The Society of Hospital Pharmacists Australia 12

In addition, pharmacists and pharmacy technicians commencing practice in nephrology services must 275

undertake a relevant orientation and training program as determined by the health service. This 276

should include credentialing relative to their role as implemented by local or state-based health 277

service. 278

Nephrology pharmacists must contribute to the education and development of procedures for non-279

specialist pharmacists caring for nephrology patients. 280

Credentialing and Qualificationsv 281

Desirable certification, credentialing and qualifications for nephrology pharmacists include: 282

• a postgraduate qualification in clinical pharmacy or public health e.g. 283

o Master of Clinical Pharmacy 284

o Master of Public Health 285

• credentialing as an Advancing or Advanced Practice Pharmacist is provided by Pharmacy 286

Development Australia 16 287

• other relevant postgraduate degrees which may be available nationally or 288

internationally. Examples include: 289

o Postgraduate Diploma in Renal Medicine currently offered by University of 290

South Wales. 291

Educational Activities 292

Further to the Pharmacy Board of Australia Guidelines on Continuing Professional Development 17 it 293

is recommended that nephrology pharmacists have a significant proportion of their continuing 294

professional development per year tailored to nephrology services. There is a dearth of specific 295

pharmacist training for nephrology however any training on chronic disease e.g. cardiac disease or 296

diabetes is worthwhile for nephrology pharmacists. Recommended continuing education for 297

nephrology pharmacists include the following; 298

Attendance at local or national courses: 299

• SHPA Seminars and related CPD activities e.g. extension seminar internal medicine, state 300

branch CEs or symposiums 301

• ANZSN Kidney School online educational website 302

• Virtual simulation on AKI ‘Ready to Practice’ 18 303

• General medicine/ chronic disease training e.g. NPS webinars and CPD activities for 304

pharmacists 305

• In house journal clubs 306

• Kidney Health Australia 307

International courses: 308

• ISN Academy Online Learning 309

• University College London (UCL) renal short courses 310

Joining professional organisations: 311

• Australian and New Zealand Society of Nephrology (ANZSN) 312

v 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.

DRAFT prepared 18.04.2019. Property of The Society of Hospital Pharmacists Australia 13

• Renal Society of Australasia (RSA) 313

• International Society of Nephrology (ISN) 314

• UK Renal Pharmacy Group (UKRPG) 315

The leadership committee consider the ability to undertake preceptorships and/or site visits to health 316

services in either geographically diverse areas or areas of diverse practise to be a useful way of 317

expanding knowledge and skills, particularly for those nephrology pharmacists practising alone or at 318

smaller sites. 319

Educational material and resources are provided on the SHPA Specialty Practice Nephrology stream 320

page on the SHPA eCPD website. For nephrology pharmacists, joining and actively participating in the 321

SHPA Specialty Practice Nephrology stream at the Practice Group level is strongly recommended. 322

Attendance at specialist conferences and educational meetings should be supported to maintain and 323

update specialist knowledge in nephrology. Relevant domestic conferences include those organised 324

by SHPA, the Australian and New Zealand Society of Nephrology (ANZSN) Annual Meeting, and the 325

Renal Society of Australasia (RSA). International conferences in conferences in nephrology include the 326

American Society of Nephrology (ASN) Kidney Week, International Society of Nephrology (ISN) World 327

Congress of Nephrology (WCN), and the European Society of Paediatric Nephrology (ESPN) Annual 328

Meeting. 329

Knowledge, Skills and Experiential Learning 330

The role of a nephrology pharmacist, like any clinician with specialised expertise, is based on a high 331

level of skill in general pharmacy with the later addition of specialty specific experience. Pharmacists’ 332

working in this area should have high levels of personable skills including confidence, empathy and 333

effective patient communication skills, in order to provide personalised care. Underpinning knowledge 334

related to key areas of pharmacy practice in nephrology are the skills and application of clinical 335

pharmacy, which may be advanced by experiential learning. This Standard does not list the 336

competencies that the individual nephrology pharmacist should address as this will be dependent 337

upon their scope of practice. 338

Table 4 Essential and desirable knowledge and skills and experiential learning for nephrology pharmacists 339

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.

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 clinical picture and patient

characteristics.

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

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.

DRAFT prepared 18.04.2019. Property of The Society of Hospital Pharmacists Australia 14

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 delivery of medication education and

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 ability to

retrieve and synthesise 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 a SHPA Foundation Residency

Program

Training and education will predominantly be work-based education and should follow adult 340

learning principles. Further information can be found in Chapter 10 of the SHPA Standards of 341

Practice for Clinical Pharmacy Services 1. 342

343

Quality Improvement 344

Quality improvement activities should demonstrate that advance pharmacy care in nephrology is 345

delivering improvements to patient care by targeting and achieving the best outcomes for all patient 346

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groups, including those at greatest risk for medicines. Examples of quality improvement activities 347

which may be considered within a plan, do, study, act (PDSA) cycle for quality improvement activities 348

are listed below: 349

• Assessment of practice against CARI guidelines e.g. iron management, preventing infection 350

in peritoneal dialysis, exit site infection avoidance 351

• Assisting nursing staff with accuracy of medicines data input into ANZDATA registry 352

• Evaluation of anaemia management 19,20 353

• Proportion of guidelines (e.g. PD, HD, kidney transplant) that have been reviewed and 354

updated within designated expiry period. 355

Further information on quality improvement can be found in Chapter 14 of the SHPA Standards of 356

Practice for Clinical Pharmacy Services 1 and ACSQHC Selected best practices and suggestions for 357

improvement for clinicians and health system managers hospital-acquired complication renal failure 358 21. 359

360

Research 361

Systematic reviews of randomised controlled trials (RCTs) are commonly used in evidence-based 362 policy making.22 However, the number of RCTs is fewer in nephrology than other specialties of internal 363 medicine and low in quality.23 Furthermore, public health systematic reviews of interventions are 364 much more likely to be evaluated using observational and other study designs - the best available 365 evidence wherever this may be found.24 366

Translational research in nephrology should include pharmacogenomics studies for renal kinetics, 367 pharmacokinetic studies on drug dosing in RRT, pharmacoepidemiology studies on drug use and 368 treatment outcomes in patients in CKD, dialysis and kidney transplantation, medication adherence 369 post kidney transplantation and evaluation of the outcomes of treatments for uncommon renal 370 conditions or for novel or off label therapies. 371

Consideration should be given to research priorities from the patient and carer’s perspective such as 372 those for chronic kidney disease published by CARI 25 e.g.’ what can we do to improve individual drug 373 therapy in terms of better management of side effects?’ and ‘what interventions can improve long 374 term post-transplant outcomes?’ 375

Research is vital for developing the pharmacy profession and may inform pharmacy services current 376 level of, and future contributions to, advancing pharmacy and patient care. Nephrology pharmacists 377 should initiate, conduct and supervise research that contributes to the body of knowledge providing 378 evidence of impact in support of optimal use of medicines and advanced pharmacy care in nephrology 379 as well as evaluating novel treatments and ensuring patient safety. Research Ethics Committee 380 approval should be sought where applicable. 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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External funding enables larger and feasibly multi-centre studies to be conducted. The SHPA National 390 Translational Research Collaborative (NTRC) funds research grants, practitioner grants and 391 educational grants to develop research capacity. Grants are also available from other organisations 392 including Kidney Health Australia and the Australian and New Zealand Society of Nephrology. 393 Presentation and publication of studies by Australian pharmacists practicing in nephrology is 394 imperative, to aid others in the implementation of innovative and evidence-based nephrology 395 pharmacy services and illustrate where nephrology pharmacists are involved in research and how they 396 are improving patient care. 397

The choice of journal to publish in depends on consideration of the best audience for the study 398 results. The Journal of Pharmacy Practice and Research (JPPR) presents findings to primarily an 399 Australian pharmacy audience. Journals specific to nephrology that may be appropriate are listed in 400 Appendix 1: Resources. 401

Further information on research can be found in Chapter 11 of the SHPA Standards of Practice for 402 Clinical Pharmacy Services 1. 403

404

References 405

1. SHPA Committee of Specialty Practice in Clinical Pharmacy. SHPA Standards of Practice for 406 Clinical Pharmacy Services. Journal of Pharmacy Practice and Research 2013; 43(No. 2 407 Supplement): S1-69. 408

2. Pharmaceutical Society of Australia. National Competency Standards Framework for 409 Pharmacists in Australia. Deakin West ACT 2600; 2016. 410

3. The Australian Commission on Safety and Quality in Health Care. Australian Charter of 411 Healthcare Rights. 2008. 412

4. Home Dialysis Advisory Committee of Dialysis Nephrology and Transplant. The Australian 413 Charter of Home Dialysis Rights and Responsibilities. Australia; 2012. p. 2. 414

5. National Rural Health Alliance. Kidney disease in rural Australia. In: Australia KH, Inc. NRHA, 415 editors. Fact Sheet 35 ed. ACT: National Rural Health Alliance; 2013. 416

6. El Nahas M. The global challenge of chronic kidney disease. Kidney Int 2005; 68(6): 2918-29. 417 7. ANZDATA Registry. Chapter 1 Incidence of Renal Replacement Therapy for End Stage Kidney 418

Disease. Adelaide, Australia, 2018. 419 8. Hassan Y, Al-Ramahi RJ, Aziz NA, Ghazali R. Impact of a renal drug dosing service on dose 420

adjustment in hospitalized patients with chronic kidney disease. The Annals of 421 pharmacotherapy 2009; 43(10): 1598-605. 422

9. Salgado TM, Moles R, Benrimoj SI, Fernandez-Llimos F. Pharmacists' interventions in the 423 management of patients with chronic kidney disease: a systematic review. Nephrol Dial 424 Transplant 2012; 27(1): 276-92. 425

10. Raymond CB, Wazny LD, Sood AR. Standards of clinical practice for renal pharmacists. Can J 426 Hosp Pharm 2013; 66(6): 369-74. 427

11. Australian Commission on Safety and Quality in Health Care. National Safety and Quality 428 Health Service Standards. Medication Safety. Sydney: Australian Commission on Safety and 429 Quality in Health Care; 2017. p. 86. 430

12. Pharmacy Board of Australia. For Pharmacists Code of Conduct. March 2014 ed; 2014. 431 13. The Society of Hospital Pharmacists Australia. SHPA Code of Ethics. Governance. 432

Collingwood: The Society of Hospital Pharmacists of Australia; 2016. p. 1. 433 14. Pharmaceutical Society of Australia. Professional Practice Standards Version 5. Deakin West 434

ACT 2600.; 2017. p. 116. 435 15. The Transplantation Society of Australia and New Zealand. Clinical Guidelines for Organ 436

Transplantation from Deceased Donors, 2018. 437

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16. Pharmacy Development Australia. Advancing Practice Background and Guiding Principles, 438 2018. 439

17. Pharmacy Board of Australia. Guidelines on Continuing Professional Development. 2015. 440 18. Martini N, Farmer K, Patil S, et al. Designing and Evaluating a Virtual Patient Simulation—The 441

Journey from Uniprofessional to Interprofessional Learning. Information 2019; 10(1). 442 19. Fishbane S, Spinowitz B. Update on Anemia in ESRD and Earlier Stages of CKD: Core 443

Curriculum 2018. Am J Kidney Dis 2018; 71(3): 423-35. 444 20. Bosch JP, Walters BA. Continuous quality improvement for a hemodialysis network. Contrib 445

Nephrol 2002; (137): 300-10. 446 21. Australian Commision on Safety and Quality in Health Care. Hospital-Acquired Complication 447

8 RENAL FAILURE, 2018. 448 22. Barton S. Which clinical studies provide the best evidence? The best RCT still trumps the best 449

observational study. British Medical Journal 2000; 321: 255-6. 450 23. Strippoli GF, Craig JC, Schena FP. The number, quality, and coverage of randomized 451

controlled trials in nephrology. J Am Soc Nephrol 2004; 15(2): 411-9. 452 24. Bambra C. Real world reviews: a beginner's guide to undertaking systematic reviews of 453

public health policy interventions. J Epidemiol Community Health 2011; 65(1): 14-9. 454 25. Tong A. Exploring Research Priorities in Chronic Kidney Disease. Centre for Kidney Research; 455

2014. p. 1. 456 26. Australian and New Zealand Society of Nephrology. ANZSN Renal Supportive Care Guidelines 457

2013. Nephrology 2013; 18: 54. 458 27. McCombie SP, Thyer I, Corcoran NM, et al. The conservative management of renal trauma: a 459

literature review and practical clinical guideline from Australia and New Zealand. BJU Int 460 2014; 114 Suppl 1: 13-21. 461

462

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Appendices 463

Appendix 1: Resources 464

Recommended texts for nephrology

Renal Drug Database

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

Morlidge, Clare; Ashley, Caroline (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.

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

• 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 26

• Conservative Management of Renal Trauma 2014 27

Useful websites

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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.

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

465

466

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Appendix 2: Common Abbreviations in Nephrology 467

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

468