Part 2 of the International Consensus Guideline on Anticancer Drug Dosing in Kidney Dysfunction (ADDIKD) offers drug-specific consensus recommendations based on both evidence and practical experience. These recommendations build upon the kidney function assessment and classification guidelines established in Part 1 of ADDIKD. Here we illustrate how dosing recommendations differ between ADDIKD and existing guidance for four commonly used drugs: methotrexate, cisplatin, carboplatin and nivolumab. We then describe how the recommendations can be distilled into practice points for methotrexate and cisplatin. While ADDIKD is a significant improvement from previous guidelines, adoption of this new guideline requires further endorsement from key external stakeholders, 'change championing' by clinicians locally and encouraging its integration into existing reference sources, clinical trial protocols and electronic prescribing systems. Funding:Development of the ADDIKD guideline is funded by the NSW Government as part of the Cancer Institute NSW and received no funding from external commercial sources.

Reduced kidney function (or kidney dysfunction) is commonly an exclusion criterion for randomised controlled trials (RCTs) in cancer. Consequently, high quality evidence for anticancer drug dosing in reduced kidney function is limited and no internationally agreed guidelines exist to inform prescribing decisions in this population. A methodology for guideline development was applied which did not require availability of RCTs but used critical appraisal of existing observational literature and group consensus. An international multidisciplinary working group (n = 38) established consensus recommendations in two parts to form the International Consensus Guideline on Anticancer Drug Dosing in Kidney Dysfunction (ADDIKD). The approach enabled virtual participation worldwide. In Part 1 we developed a standardised approach for assessment and classification of kidney function in patients with cancer using global nephrology standards and working group expertise. Part 2 involved a comprehensive literature search of 59 anticancer drugs followed by a critical appraisal of the evidence certainty through the Grading of Recommendations Assessment, Development and Evaluation (GRADE) process and development of dosing recommendations in reduced kidney function. Key external stakeholders (n = 9) invited expert contributors (n = 25), and the working group participated in virtual interactive workshops to vote on the acceptability of these recommendations. The participants were provided with evaluation of the literature, and they engaged in several rounds of virtual discussion (involving robustness of the evidence behind recommendations and their real-world application) and anonymous consensus voting. Adapting the ADDIKD guideline development process to a virtual format enabled engagement with a very broad base of specialised international experts especially during the global pandemic. Combining GRADE methodology with consensus-building approaches was an effective method of producing recommendations (in an area lacking RCTs) by merging critical review of the literature with expert opinion and clinical practice. Funding:Development of the ADDIKD guideline is funded by the Cancer Institute NSW as part of the NSW Government and received no funding from external commercial sources.

Chronic kidney disease (CKD) is a major health concern with a growing disease burden and inequalities in access to treatments. Glomerular filtration rate (GFR) is accepted as the best overall measure of kidney function and is considered the most important measure for medications cleared by the kidneys. In clinical practice, equations that estimate GFR using validated prediction equations are routinely used. This practice update was developed by a Working Group comprising clinical pharmacists representing the Society of Hospital Pharmacists of Australia (SHPA) Specialty Practice streams of Nephrology, Oncology and haematology, Critical care and Infectious diseases. It is intended to provide practical recommendations for clinical pharmacists who use equations to estimate GFR for medication dosing decisions. The limitations of the various equations in use — such as the Chronic Kidney Disease Epidemiology Collaboration (CKD‐EPI), the Cockcroft–Gault equation and Modification of Diet in Renal Disease — are summarised and compared to direct measures of kidney function using exogenous markers. The CKD‐EPI equation is recommended to be used routinely as a primary measure of kidney function. Dose adjustments should also consider medication‐specific, patient‐related, and disease‐related characteristics. Kidney function and the response to therapy should be continuously assessed by monitoring the signs, symptoms and disease outcomes, the emergence of adverse reactions or medication‐induced disorders and use therapeutic drug monitoring (if available) to adjust doses accordingly.

BackgroundProvision of a Medication Action Plan (MAP) on admission and a Discharge Medication Record (DMR) are associated with reduced medication-related harm.AimTo report factors associated with the provision of MAPs and DMRs in rural and regional hospitals in Queensland, Australia.MethodA literature search, environmental scan and department consultations were conducted to develop Clinical Pharmacy Key Performance Indicators (cpKPIs) and design a cpKPI dashboard. Two of the five KPIs included in the dashboard, relating to medication action plans on admission and medication records on discharge, were reported for all the hospitals and were included in the study. A retrospective, period-prevalence study was conducted to evaluate the coverage and equity of clinical pharmacy service provision for patients admitted for longer than 24 h. The proportions of patients who received MAPs and DMRs were stratified by age, gender, Indigeneity and hospital type. Statistical analysis used chi-squared tests and logistic regression in R. This project was exempt due to the local policy requirements that constitute research by the Far North Queensland Human Research Ethics Committee (Reference no: EX/2023/QCH/94383-1684QA). The justification for this exemption is as follows: the project was determined to be negligible risk research and involved the use of existing collection of data or records that contain only non-identifiable data about human beings.ResultsIn total, 13 818 patients (37.9% of admissions) received a MAP and 11 631 patients (32.7% of discharges) received a DMR. The proportion of MAPs and DMRs was significantly higher in rural hospitals than in regional hospitals (MAP 50.6% vs 34.6%, DMR 33.1% vs 31.3%) and for male patients than female patients (MAP 42.2% vs 33.7%, DMR 36.4% vs 29.2%). When stratified by age, First Nations patients received a higher proportion of MAPs and DMRs in each age group, except for age 85 years and over. The proportion of First Nations patients aged 50 years and over who received MAP was lower compared to that for non-Indigenous patients aged 65 years and over (56.3% vs 59.8%), whilst the proportion for DMRs was similar (50.4% vs 49.3%).ConclusionThe study defined the clinical pharmacy key performance indicators for measuring equity of clinical pharmacy service provision in Australia. When adjusted for a difference in life expectancy, the proportion of MAPs for First Nations patients was lower compared to the proportion of MAPs for non-Indigenous patients. Further improvements are required to achieve equity of service provision for First Nations patients and female patients.

Introduction Practice-based research is essential in enhancing medication knowledge, quality use of medicines, the scope of the pharmacy profession and improving patient outcomes. This systematic review aims to uncover the attitudes of hospital pharmacists towards practice-based research and their perceptions of the barriers and facilitators to undertaking practice-based research. Methods A systematic search of MEDLINE, Embase, International Pharmaceutical Abstracts and Cumulative Index to Nursing and Allied Health Literature databases from 1 January 2000 to 11 March 2021 was conducted. Peer-reviewed empirical studies exploring hospital pharmacists' perceptions of - as well as barriers and facilitators to - practice-based research were included and a descriptive synthesis used to identify common themes. Results Nine studies were included in this review. Barriers and facilitators across four broad themes were related to pharmacist capacity and capability, workplace environment, research resources, and research culture. Hospital pharmacists had a high interest in conducting research, but limited research experience. Common barriers identified were lack of time, workplace support, funding, research culture, and competing priorities. Having a post-graduate qualification and a positive attitude towards research facilitated research participation. Departmental support, designated research time and creation of research networks and forums were seen as facilitators for practice-based research. Conclusion Hospital pharmacists recognise the importance of practice-based research in improving knowledge, patient care and advancing pharmacy practice. However, large variation has been reported for their confidence and experience in practice-based research. Building research capacity and capability by supporting post-graduate research qualification, providing designated time and creating research networks may strengthen the research culture amongst hospital pharmacists.

Medicines Use Evaluation guideline Linda Velta Graudins, BPharm, DipHospPharm, DipClinPharmacoEpi, AdvPracPharm, FSHP* , Kerry Fitzsimons, BPharm, MClinPharm, MSHP, Elizabeth Manias, RN BPharm, MPharm, MNStud, PhD MSHP , Sanja Mirkov, BPharm, PGDipPH, MSHP , Nam-Anh Nguyen, BPharm(Hons), GradDipHospPharm, AdvPracPharm, MSHP, Courtney Munro, BPharm, GradCertPharmPrac, MPharmPracMSHP, AACPA, PhD 1 Medication Safety Leadership Committee, The Society of Hospital Pharmacists of Australia, Collingwood, Australia 2 Pharmacy Department, Alfred Health, Melbourne, Australia 3 Monash University, Parkville, Australia 4 Pharmacy Department, Fiona Stanley Hospital, WA Department of Health, Western Australia and Patient Safety and Clinical Quality, Perth, Australia 5 School of Nursing and Midwifery, Centre for Quality and Patient Safety Research, Institute for Health Transformation,Deakin University, Burwood, Australia 6 School of Pharmacy, The University of Auckland, Auckland, New Zealand 7 Ramsay Pharmacy Group, Melbourne, Australia 8 Sir Charles Gairdner Hospital, Perth, Australia 9 The Society of Hospital Pharmacists of Australia, Collingwood, Australia

Journal of Pharmacy Practice and ResearchVolume 50, Issue 3 p. 263-275 Practice Standards Standard of practice in nephrology for pharmacy services Carla Scuderi BPharm, MClinPharm, MSHP, Corresponding Author Carla Scuderi BPharm, MClinPharm, MSHP specialtypractice@shpa.org.au orcid.org/0000-0002-3651-8325 Nephrology Leadership Committee, The Society of Hospital Pharmacists of Australia, Collingwood, Australia Royal Brisbane and Women’s Hospital, Herston, Australia School of Pharmacy, University of Queensland, Woolloongabba, Australia Address for correspondence: Carla Scuderi, Nephrology Leadership Committee, The Society of Hospital Pharmacists of Australia, 3/65 Oxford St, Collingwood, Victoria 3066, Australia. E-mail: specialtypractice@shpa.org.auSearch for more papers by this authorMichelle Nalder BPharm(Hons), MClinPharm, MSHP, Michelle Nalder BPharm(Hons), MClinPharm, MSHP Nephrology Leadership Committee, The Society of Hospital Pharmacists of Australia, Collingwood, Australia The Royal Melbourne Hospital, Parkville, AustraliaSearch for more papers by this authorRonald Castelino BPharm, MPharm, PhD, BCGP, MSHP, Ronald Castelino BPharm, MPharm, PhD, BCGP, MSHP Nephrology Leadership Committee, The Society of Hospital Pharmacists of Australia, Collingwood, Australia Faculty of Health and Medicine, University of Sydney, Sydney, Australia Blacktown Hospital, Western Sydney Local Health District, Blacktown, AustraliaSearch for more papers by this authorMatthew Cervelli BPharm, MSHP, Matthew Cervelli BPharm, MSHP Nephrology Leadership Committee, The Society of Hospital Pharmacists of Australia, Collingwood, Australia Renal Unit, Royal Adelaide Hospital, Adelaide, Australia MJC Pharma Pty Ltd, Adelaide, AustraliaSearch for more papers by this authorDanielle Ironside BPharm(Hons), GradCertClinPharm, MSHP, Danielle Ironside BPharm(Hons), GradCertClinPharm, MSHP Nephrology Leadership Committee, The Society of Hospital Pharmacists of Australia, Collingwood, Australia Royal Brisbane and Women’s Hospital, Herston, AustraliaSearch for more papers by this authorCeridwen Jones BPharm, DHospPharm, Ceridwen Jones BPharm, DHospPharm Nephrology Leadership Committee, The Society of Hospital Pharmacists of Australia, Collingwood, Australia Royal Prince Alfred Hospital, Camperdown, AustraliaSearch for more papers by this authorJess Lloyd BPharm, GDClinPharm, MSHP, Jess Lloyd BPharm, GDClinPharm, MSHP The Princess Alexandra Hospital, Brisbane, AustraliaSearch for more papers by this authorSanja Mirkov BPharm, PGDipPH, MSHP, Sanja Mirkov BPharm, PGDipPH, MSHP Nephrology Leadership Committee, The Society of Hospital Pharmacists of Australia, Collingwood, Australia School of Pharmacy, The University of Auckland, Auckland, New Zealand Ramsay Pharmacy Group, Sydney, AustraliaSearch for more papers by this authorCourtney Munro BPharm, GradCertPharmPrac, MPharmPrac, MSHP, AACPA, PhD, Courtney Munro BPharm, GradCertPharmPrac, MPharmPrac, MSHP, AACPA, PhD orcid.org/0000-0001-6941-7670 The Society of Hospital Pharmacists of Australia, Collingwood, AustraliaSearch for more papers by this author Carla Scuderi BPharm, MClinPharm, MSHP, Corresponding Author Carla Scuderi BPharm, MClinPharm, MSHP specialtypractice@shpa.org.au orcid.org/0000-0002-3651-8325 Nephrology Leadership Committee, The Society of Hospital Pharmacists of Australia, Collingwood, Australia Royal Brisbane and Women’s Hospital, Herston, Australia School of Pharmacy, University of Queensland, Woolloongabba, Australia Address for correspondence: Carla Scuderi, Nephrology Leadership Committee, The Society of Hospital Pharmacists of Australia, 3/65 Oxford St, Collingwood, Victoria 3066, Australia. E-mail: specialtypractice@shpa.org.auSearch for more papers by this authorMichelle Nalder BPharm(Hons), MClinPharm, MSHP, Michelle Nalder BPharm(Hons), MClinPharm, MSHP Nephrology Leadership Committee, The Society of Hospital Pharmacists of Australia, Collingwood, Australia The Royal Melbourne Hospital, Parkville, AustraliaSearch for more papers by this authorRonald Castelino BPharm, MPharm, PhD, BCGP, MSHP, Ronald Castelino BPharm, MPharm, PhD, BCGP, MSHP Nephrology Leadership Committee, The Society of Hospital Pharmacists of Australia, Collingwood, Australia Faculty of Health and Medicine, University of Sydney, Sydney, Australia Blacktown Hospital, Western Sydney Local Health District, Blacktown, AustraliaSearch for more papers by this authorMatthew Cervelli BPharm, MSHP, Matthew Cervelli BPharm, MSHP Nephrology Leadership Committee, The Society of Hospital Pharmacists of Australia, Collingwood, Australia Renal Unit, Royal Adelaide Hospital, Adelaide, Australia MJC Pharma Pty Ltd, Adelaide, AustraliaSearch for more papers by this authorDanielle Ironside BPharm(Hons), GradCertClinPharm, MSHP, Danielle Ironside BPharm(Hons), GradCertClinPharm, MSHP Nephrology Leadership Committee, The Society of Hospital Pharmacists of Australia, Collingwood, Australia Royal Brisbane and Women’s Hospital, Herston, AustraliaSearch for more papers by this authorCeridwen Jones BPharm, DHospPharm, Ceridwen Jones BPharm, DHospPharm Nephrology Leadership Committee, The Society of Hospital Pharmacists of Australia, Collingwood, Australia Royal Prince Alfred Hospital, Camperdown, AustraliaSearch for more papers by this authorJess Lloyd BPharm, GDClinPharm, MSHP, Jess Lloyd BPharm, GDClinPharm, MSHP The Princess Alexandra Hospital, Brisbane, AustraliaSearch for more papers by this authorSanja Mirkov BPharm, PGDipPH, MSHP, Sanja Mirkov BPharm, PGDipPH, MSHP Nephrology Leadership Committee, The Society of Hospital Pharmacists of Australia, Collingwood, Australia School of Pharmacy, The University of Auckland, Auckland, New Zealand Ramsay Pharmacy Group, Sydney, AustraliaSearch for more papers by this authorCourtney Munro BPharm, GradCertPharmPrac, MPharmPrac, MSHP, AACPA, PhD, Courtney Munro BPharm, GradCertPharmPrac, MPharmPrac, MSHP, AACPA, PhD orcid.org/0000-0001-6941-7670 The Society of Hospital Pharmacists of Australia, Collingwood, AustraliaSearch for more papers by this author First published: 11 June 2020 https://doi.org/10.1002/jppr.1649Read the full textAboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. 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Drug dosage recommendations in obese patients are largely lacking, as data on dosages are generally derived from clinical studies conducted in healthy subjects of average body weight. As morbid obesity (i.e. body mass index ≥ 40 kg/m2) is associated with comorbidities affecting drug pharmacokinetics, relatively few obese subjects are included in clinical studies. To insure optimal drug dosages in obese patients, efficacy and safety trials should provide subgroup analysis of data in patients with varying degrees of obesity. The body-size descriptor used to determine the optimal drug dosage in obese patients should be based on the pharmacological properties of the drug, the clinical context and other factors, and should be clearly specified (including the method of conversion from total body weight to the appropriate body-size descriptor).

In response to the increasingly complex demands of contemporary clinical practice, pharmacists and other healthcare professionals organise themselves in classical and flexible teams with the aim of combining their knowledge and skills, thereby creating additional value that would not be possible without teamwork. In addition to the diversity of team members’ skills, sexes, ages and ethnic backgrounds, cognitive diversity is vital for team success, as teams with cognitive diversity outperform those without it. When fully empowered, team members have the information, skills and authority to make decisions and create new opportunities. The selection of leaders for successful teamwork in the pharmacy profession is essential, as the dominant developmental level and mindset of leaders influences interpersonal relationships, communication, collaboration and trust among team members. Pharmacy leaders who can create psychologically safe environments and engage their team members with a shared purpose can use teamwork to improve patient outcomes and employee well-being.

Biosimilars are new biological medicines that are highly similar but not identical to their reference biological medicines. As biosimilars are produced from living organisms by genetic engineering, even a small difference in their production process has the potential to alter their efficacy and safety. Therefore, prior to their approval, biosimilars are assessed to confirm therapeutic equivalence and comparable safety and efficacy to their biological reference medicines. Once approved, adverse effects of biosimilars are continuously monitored by regulatory bodies. The lower cost of biosimilars improves affordability and access to new therapies for patients with serious diseases and these medicines are increasingly being prescribed in Australia. Hence, pharmacy professionals need to be aware of the structural complexity and important aspects of the regulatory approval process, immunogenicity and safety profiling, extrapolation of indication, nomenclature and labelling, interchangeability and substitution for these novel therapies.

Pharmacological treatment of acute gout attacks includes colchicine, nonsteroidal anti-inflammatory drugs (NSAIDs) and glucocorticoids. The choice of treatment depends on comorbidities and drug–drug interactions, requiring careful patient screening. As the use of these medications is associated with increased clinical risks, they should be used at the lowest effective dose for the shortest period of time alongside ongoing urate-lowering therapy to prevent gout attacks and to minimise their use. This article discusses the major clinical risks associated with colchicine, NSAIDs and glucocorticoids and risk minimisation strategies for their safe and effective use in this patient population.

Biologics and biosimilars are biotechnology-derived proteins and have the potential to be highly immunogenic. The consequences of an immune reaction to a therapeutic protein range from transient reactions to severe life-threatening conditions. Patient-, disease- and product-related factors influence the development of immunogenicity, and assessment of immunogenicity is always required for approval of a biosimilar. Assessment of a biologic immunogenicity profile is conducted in equivalence clinical trials to confirm that the immunogenicity profile of the biosimilar is similar to that of its reference biologic. A summary of clinical trials assessing the immunogenicity of infliximab biosimilars in patients with rheumatoid arthritis and ankylosing spondylitis and the results from observational studies in patients with gastroenterology diseases are presented. Due to the small patient populations studied in the equivalence clinical trials, the immune response may not be captured prior to licencing of the biosimilar. Therefore, ongoing pharmacovigillance is required to ensure the safe use of these novel therapies.

ABSTRACTAimTo assess the outcomes of monthly pulse intravenous cyclophosphamide (IV CYC) therapy for lupus nephritis and to identify factors contributing to suboptimal outcomes.MethodHistorical study of clinical and laboratory data. Statistical analysis consisted of one sample paired 2‐tailed t‐test and qualitative analysis of textual data.Results16 patients received 17 courses of monthly pulse IV CYC from April 2004 to January 2008 (118 doses, median dose 1025 mg or 563 mg/m2, median cumulative dose 6960 mg or 3824 mg/m2). Mean urinary protein decreased from 7.35 g/24 h pre therapy to 1.17 g/24 h (p = 0.01) after completion. Mean serum albumin increased from 25 to 35 g/L (p = 0.006). Mean serum creatinine was 105 μmol/L pre‐therapy and 122 μmol/L after treatment (p = 0.3). 9 patients achieved complete remission, 4 patients achieved partial remission, 2 patients progressed to end‐stage renal failure and 1 patient did not respond to treatment. 1 patient was lost to follow‐up. 9 out of 118 (8%) nadir white blood cell counts were below 3×109/L and neutrophils were below 2×109/L. 24 hospital admissions were due to the adverse effects of IV CYC. System deficiencies were identified relating to clinical documentation, monitoring laboratory data, patient support and coordinated care.ConclusionAlthough pulse IV CYC was effective, it was associated with serious adverse effects resulting in hospital admissions. The clinical pathway designed aims to improve efficiency and safety of pulse IV CYC for lupus nephritis.

AIMS:To implement the Pharmacist Medication Review Clinic and establish a sustainable clinical pharmacy service.METHODS:Prospective clinical medication review conducted by trained clinical pharmacists using standardised tools. Pharmacists' intervention included medication recommendation and patient education.RESULTS:From December 2007 to July 2008, medication reviews were conducted with 64 haemodialysis patients. Patients were taking on average 13 medications. Drug-related problems (DRPs) were identified in 92% of medication reviews (a total of 278 DRPs). The major DRP was non-adherence with medication regimen (33%), followed by medication requiring dose decrease (9.3%) and indication requiring new medication (8.6%). The risk factors for multiple DRPs were ethnicity, length of time on dialysis and age. New Zealand (NZ) Maori and Pacific Peoples were more likely to have more than three DRPs compared to patients of European descent. (NZ Maori: OR 7.49, 95%CI 1.15-48.9, p=0.035; Pacific Peoples: OR 5.4, 95%CI 0.96-30.34, p=0.055) and patients who spent 3.5 to 6.3 years on dialysis (OR 7.48, 95%CI 1.45-38.76, p=0.016). Patients older than 55 were less likely to have more than three DRPs compared to younger patients (OR 0.14, 95%CI 0.03-0.69, p=0.016).CONCLUSIONS:Pharmacist-led medication review clinic identified drug-related problems (DRPs) and risk factors for DRPs in haemodialysis patients.