Implementation of Partnered Pharmacist Medication Charting in haematology and oncology inpatients.

AIM: Partnered Pharmacist Medication Charting (PPMC) in patients admitted under general medical units has been shown to reduce medication errors. The aim of this study is to evaluate the impact of the PPMC model on medication errors in patients admitted under cancer units in Victorian hospitals. METHODS: A prospective cohort study comparing cohorts before and after the introduction of PPMC was conducted. This included a 2-month pre-intervention phase and 3-month intervention phase. PPMC was implemented during the intervention phase as new model of care that enabled credentialed pharmacists to chart all admission medications, including pre-admission or new medications and cancer therapies, in collaboration with the admitting medical officer. The proportion of medication charts with at least one error was the primary outcome measure. RESULTS: Seven health services across Victoria were included in the study. The majority of health services were using paper-based prescribing systems for oncology. Of the 547 patients who received standard medical medication charting, 331 (60.5%) had at least one medication error identified compared to 18 out of 416 patients (4.3%) using the PPMC model (p < 0.001). The median (interquartile range) inpatient length of stay was 5 (2.9-10.6) days in pre-intervention and 4.9 (2.9-11) days in intervention (p = 0.88). In the intervention arm, 42 patients had cancer therapy charted by a pharmacist with no errors. CONCLUSIONS: PPMC was successfully scaled into cancer units as a collaborative medication safety strategy. The model was associated with significantly lower rates of medication errors, including cancer therapies. PPMC should be adopted more widely in cancer units in Australia.

A survey of global biosimilar implementation practice conducted by the International Society of Oncology Pharmacy Practitioners.

Background: The International Society of Oncology Pharmacy Practitioners (ISOPP) Biosimilars Task Force was charged to develop educational activities and resources to assist members when implementing biosimilar medicines into their local practice. To facilitate the process, the task force conducted a survey in order to understand biosimilar implementation practice by ISOPP members across the world and the challenges that oncology pharmacists face when adopting biosimilars into their clinical practice. Methods: A cross-sectional survey was conducted between 20 April 2019 and 27 May 2019. Members of ISOPP and a number of national oncology pharmacy groups were invited to complete the survey. The survey contained 29 items and consisted of three sections: respondents' demographics, respondents' institutional practice relating to biosimilar implementation and post implementation practice at the respondents' institutions. Descriptive statistics were utilized to analyze the survey results. Results: A total of 265 ISOPP members were surveyed, with 50 members providing a response (response rate = 19%). In addition, 40 nonmembers participated in the survey, bringing the total to 90 respondents. The most common factors that influence the decision to implement use of a biosimilar as reported by respondents are medication costs/pricing (92%), available clinical data (73%), and product availability (63%). Respondents also commented on the barriers to biosimilar implementation at their institutions, which included a reluctance of prescribers to use biosimilars (due to the lack of familiarity or perceived inferiority), a reluctance to switch established patients from an originator to a biosimilar and the preferences of insurance companies or funding bodies. Conclusion: The results of this survey reinforce the need for greater education and training for health care professionals in the use of biosimilars, the importance of sharing good practice, and a need for standardization.

Assessing biosimilar education needs among oncology pharmacy practitioners worldwide: An ISOPP membership survey.

Background: The International Society of Oncology Pharmacy Practitioners (ISOPP) Biosimilar Task Force was charged to develop educational resources to address the learning needs related to biosimilars use of oncology pharmacy practitioners. To facilitate the process, the task force conducted a survey in order to identify unmet education needs as well as barriers for obtaining biosimilar education among oncology pharmacy practitioners. Methods: A cross sectional survey was conducted between 10 December 2018 and 18 February 2019. Members of International Society of Oncology Pharmacy Practitioners and national oncology pharmacy groups were invited to complete the survey. The survey contained 22 items and consisted of four sections. Descriptive statistics were utilized to analyze the survey results. Results: A total of 363 International Society of Oncology Pharmacy Practitioners members were surveyed, with 75 members providing a response (response rate = 21%). In addition, 11 non-International Society of Oncology Pharmacy Practitioners members also participated in the survey, bringing the total to 86 respondents. The top three areas in which respondents reported learning needs included evaluating comparative efficacy of a biosimilar to an originator's product (74.4%), managing the switchover to a biosimilar from the original product (74.4%), and understanding medication safety issues in relation to biosimilars use (73.3%). The most common challenges faced in obtaining education on biosimilars included limited financial support for education on biosimilar products (38.4%), heavy workload (31.4%), and inadequate educational resources (27.9%). Conclusion: This survey has identified numerous biosimilar learning needs as well as challenges faced in obtaining biosimilars education among oncology pharmacy practitioners. Educational activities should be created to address these learning needs, and innovative strategies should be considered to overcome practitioner's barriers in obtaining biosimilars education.

International Society of Oncology Pharmacy Practitioners global position on the use of biosimilars in cancer treatment and supportive care.

With the development of innovative cancer treatments over recent decades, the cost of cancer care has risen exponentially, limiting patient access to patented originator biotherapeutics in many countries. The introduction of biosimilars to the market has created new opportunities as well the need for changes in practice within healthcare institutions. A 'biosimilar' is a biotherapeutic product which is highly similar in terms of quality, safety and efficacy to an already licensed originator product. Although biosimilars lack clinically meaningful differences in therapeutic activity as compared to the originator product, these complex biological molecules are not considered identical chemical copies, unlike generics, and minor differences in molecular structure and inactive compounds may exist. A thorough understanding of these differences and their clinical implications is necessary for optimising medicines-use practices involving biosimilars. This position statement, developed by the International Society of Oncology Pharmacy Practitioners Biosimilars Taskforce, aims to provide the global oncology pharmacy community with guidance to support decisions around biosimilar use. The 11 statements cover the regulation and evaluation of biosimilars, practical issues around local implementation, the education of healthcare staff and patients, and the requirement for ongoing pharmacovigilance and outcome monitoring.

Clinical Oncology Society of Australia Position Statement: 2022 update to the safe handling of monoclonal antibodies in healthcare settings.

AIM: The aims were to (a) review the scientific literature on occupational risk, including exposure mechanisms and risk assessment, with regards to handling monoclonal antibodies (mABs) in healthcare settings; and (b) update the recommendations in the Clinical Oncology Society of Australia (COSA) safe handling of monoclonal antibodies in healthcare settings position statement, published in 2013. METHODS: A literature search was conducted between April 24, 2022, and July 3, 2022, to identify evidence relating to occupational exposure and handling of mABs in healthcare settings. Evidence in the literature was compared to the Position Statement published in 2013, and any potential additions, deletions, or revisions were discussed by the authors, and then agreed changes were made. RESULTS: Thirty-nine references were included in this update, comprising of the 2013 Position Statement itself and 10 of its references, as well as 28 new references. The risks to healthcare workers in the preparation and administration of mABs arise from four distinct exposure mechanisms: dermal, mucosal, inhalation, and oral. Updates included recommendations on using protective eyewear during the preparation and administration of mABs, developing a local institutional risk assessment tool and handling recommendations, considerations for using closed system transfer devices, and to have awareness of the nomenclature change from 2021 for new mABs. CONCLUSION: Practitioners should follow the 14 recommendations to lower occupational risk when handling mABs. Another Position Statement update should occur in 5-10 years to ensure the currency of recommendations.

Taxane-induced neuropathy: How serious is this problem for patients with early breast cancer?

BACKGROUND: Taxanes form the mainstay of breast cancer therapy in the curative setting. Taxane-induced peripheral neuropathy (TIPN) is a common toxicity and confers significant morbidity with no validated therapies. Literature detailing TIPN is inconsistent in reporting its frequency, severity, risk factors, impact upon treatment course, and management practices. METHODS: A retrospective chart review was performed including 348 early-stage breast cancer patients undergoing weekly paclitaxel therapy between 2010 and 2020 in the adjuvant or neoadjuvant setting. The frequency, severity, and impact on treatment from TIPN were analyzed during treatment and at one year follow-up. Clinicopathological and patient factors were collected to identify potential risk factors. RESULTS: 279 out of 348 patients (80.2%) developed TIPN of any grade. One-year follow-up was available for 232 of the original 279 TIPN patients (83.2%). Of these, 52 patients (22.4%) exhibited persisting TIPN of any grade. The presence and severity of TIPN during treatment was significantly associated with a lower median dose intensity (100% versus 82.5% for non-TIPN and all-grade TIPN respectively, p < 0.001). Neoadjuvant treatment (p = 0.038) and body surface area (BSA, p = 0.035) were independently associated with TIPN during treatment. Increased age (p < .001) and pre-treatment diabetes (p = 0.009) were associated with TIPN at one-year follow-up. CONCLUSION: TIPN is common in breast cancer patients undergoing weekly paclitaxel therapy. TIPN results in patients receiving significantly lower dose intensity due to dose reductions and premature treatment cessation. Future prospective studies in similar cohorts are warranted, with a focus on long-term outcomes.

Delivering affordable cancer care in high-income countries.

The burden of cancer is growing, and the disease is becoming a major economic expenditure for all developed countries. In 2008, the worldwide cost of cancer due to premature death and disability (not including direct medical costs) was estimated to be US$895 billion. This is not simply due to an increase in absolute numbers, but also the rate of increase of expenditure on cancer. What are the drivers and solutions to the so-called cancer-cost curve in developed countries? How are we going to afford to deliver high quality and equitable care? Here, expert opinion from health-care professionals, policy makers, and cancer survivors has been gathered to address the barriers and solutions to delivering affordable cancer care. Although many of the drivers and themes are specific to a particular field-eg, the huge development costs for cancer medicines-there is strong concordance running through each contribution. Several drivers of cost, such as over-use, rapid expansion, and shortening life cycles of cancer technologies (such as medicines and imaging modalities), and the lack of suitable clinical research and integrated health economic studies, have converged with more defensive medical practice, a less informed regulatory system, a lack of evidence-based sociopolitical debate, and a declining degree of fairness for all patients with cancer. Urgent solutions range from re-engineering of the macroeconomic basis of cancer costs (eg, value-based approaches to bend the cost curve and allow cost-saving technologies), greater education of policy makers, and an informed and transparent regulatory system. A radical shift in cancer policy is also required. Political toleration of unfairness in access to affordable cancer treatment is unacceptable. The cancer profession and industry should take responsibility and not accept a substandard evidence base and an ethos of very small benefit at whatever cost; rather, we need delivery of fair prices and real value from new technologies.

Therapeutic drug monitoring in oncology - What's out there: A bibliometric evaluation on the topic.

Pharmacological therapy is the mainstay of treatment for cancer patients. Despite wide interpatient variability in systemic drug concentrations for numerous antineoplastics, dosing based on body size remains the predominant approach. Therapeutic drug monitoring (TDM) is used for few antineoplastics in specific scenarios. We conducted a rapid bibliometric evaluation of TDM in oncology to capture a snapshot of research in this area over time and explore topics that reflect development in the field. Reports with the composite, indexed term 'therapeutic drug monitoring' in the title and abstract were extracted from MEDLINE (inception to August 2021). Reports related to applications in cancer were selected for inclusion and were tagged by study design, antineoplastic drugs and concepts related to TDM. We present a timeline from 1980 to the present indicating the year of first report of antineoplastic agents and key terms. The reports in our sample primarily reflected development and validation of analytical methods with few relating to clinical outcomes to support implementation. Our work emphasises evidence gaps that may contribute to poor uptake of TDM in oncology.

Arsenic trioxide associated toothache.

Arsenic trioxide in the treatment of acute promyelocytic leukaemia is relatively safe with minimal side effects. Dental toxicities associated with its use are uncommon. We describe the first case report of toothache associated with arsenic trioxide. A 45-year-old male with relapsed APL was commenced on a treatment schedule of all-trans-retinoic acid 20mg four times a day for 14 days concurrent with a 10mg intravenous infusion of arsenic trioxide for 28 days. After 14 doses of the 6th cycle of treatment he experienced severe acute pain in various parts of the oral cavity. Extensive examination including an orthodontic review concluded there was no indication that the pain symptoms were due to a dental or endodontic cause. Four days after completing his 6th cycle the pain completely resolved. The mechanism of this adverse event remains unclear. Physicians with patients receiving arsenic trioxide with unexplained toothache should consider the arsenic as the cause of the pain.

Reducing workplace cytotoxic surface contamination using a closed-system drug transfer device.

BACKGROUND: The potential for staff exposure to antineoplastic agents exists in the workplace despite current recommended safe handling procedures. Reliance on cytotoxic drug safety cabinets (CDSC) to provide total protection from exposure to hazardous drugs is insufficient. Preventing workplace contamination is the best strategy to minimise exposure. PhaSeal is a commercially available system for ensuring the leak-free transfer of hazardous drugs, fitting both the NIOSH and ISOPP definitions of a closed system. To date, there have been no published studies examining the use of a closed system drug transfer device (PhaSeal) under Australian conditions.The purpose of this study is to determine the impact of a closed system drug transfer device on cytotoxic surface contamination in the cytotoxic preparation areas of two Australian metropolitan public hospitals. METHOD: This was a pre- and post-intervention study in which chemical contamination was tested at baseline then at five and 12 months after the introduction of the a closed system drug transfer device. Cyclophosphamide was used as a surrogate marker for all cytotoxic drugs. Surface wipe sampling was performed at specified sites within the cytotoxic suite using a standardized technique. Commercial products of cyclophosphamide were also sampled. RESULTS: After five months, contamination was reduced in 13 of the 22 sites sampled (59%), with four of these samples showing undetectable levels of contamination. Two other site samples (9%) remained unchanged. The total contamination of surfaces tested was reduced by 24%. After five months hospital 1 withdrew from the study. After 12 months, surface contamination was reduced in 75% of sample sites. The total contamination of surfaces tested was reduced by 68%. The wipes of the external surface of commercial products detected cyclophosphamide contamination. CONCLUSION: When used inside a CDSC, the closed system drug transfer device PhaSeal further reduces surface contamination, in some instances to undetectable levels.

A consensus statement on the use of biosimilar medicines in hematology in Australia.

Despite their availability for over a decade, the exact nature of biosimilar medicines is still poorly understood with paucity of clear treatment guidelines for their use in clinical practice in Australia. Although hematologists have had experience with biosimilars in the setting of supportive care, with the approval of the first biosimilar rituximab in hematological malignancies, it is important to revisit this topic. To inform the use of biosimilar medicines in clinical practice, we have developed a consensus statement from an Expert Panel of Australian hematologists, oncologists, and cancer pharmacists. These recommendations address the approach to use of biosimilar products in place of the corresponding reference medicine in a number of different clinical contexts. Our recommendations are based on the premise that biosimilar medicines can be considered therapeutically equivalent to their reference brand and used in a similar way to the reference product in any approved indication. We advocate for local approaches to the provision of patient information, dispensing of the intended brand and pharmacovigilance, to be developed in consultation with local hematologists and aim to improve confidence in the appropriate use of biosimilar medicines and their expected outcomes among hematologists.

High prevalence of antibiotic allergies in cladribine-treated patients with hairy cell leukemia - lessons for immunopathogenesis and prescribing.

The relationship between hematological malignancy and chemotherapy on the prevalence of antibiotic allergy label (AAL) is ill-defined. We performed a multicenter retrospective case-control study comparing AAL rates among cladribine-treated hairy cell leukemia (C-HCL) cases, non-HCL cladribine-treated controls (control-1), and fludarabine-treated controls (control-2). The prevalence of AALs in C-HCL patients was 60%, compared with control-1 (14%, p < .01) and control-2 patients (25%, p < .01). The predominant phenotype was maculopapular exanthem (92%). The drugs implicated in AAL causality in C-HCL patients included beta-lactams (81%), trimethoprim-sulfamethoxazole (58%), and allopurinol (69%). C-HCL patients demonstrate high rates of AAL, potentially due to immune dysregulation, impacting beta-lactam utilization.

The Clinical Oncological Society of Australia (COSA) guidelines for the safe prescribing, dispensing and administration of cancer chemotherapy.

The issue of medication safety is highly significant when anti-cancer therapy is used as a treatment modality due to the high potential for harm from these agents and the disease context in which they are being used. These guidelines provide recommendations on the safe prescribing, dispensing and administration of chemotherapy and related agents used in the treatment of cancer. The guidelines represent a multidisciplinary collaboration to standardise the complex process of providing chemotherapy for cancer and to enhance patient safety. These are consensus guidelines based on the best available evidence and expert opinion of professionals working in cancer care. The aim of these guidelines is to assist in the prevention of medication errors and to improve patient safety with respect to the treatment of cancer. This guidance is intended for a multi-disciplinary audience and will have most relevance for medical, nursing and pharmacy staff involved in the complex processes of delivering chemotherapy and associated treatment. The scope of the guidelines includes; all patients and age groups receiving chemotherapy and targeted therapy for the treatment of cancer and cancer therapy administered by any route in both the hospital and home setting. These guidelines should be seen as point of reference for practitioners providing cancer chemotherapy services.