Prescription Of Anticancer Drugs Research Articles

#1187 Acute kidney injury and tubulointerstitial nephritis following prescription of anticancer drugs: VigiBase analysis

Abstract Background and Aims Anticancer drugs can have varying effects on the kidneys, depending on their characteristics. Various anticancer drugs may be nephrotoxic and can potentially cause renal impairment. We aimed to analyze the risk of renal adverse reactions according to different types of anticancer drugs using a global reporting system. Method We conducted an analysis on VigiBase, the World Health Organization pharmacovigilance database from Dec 1967 to Jul 2023 via disproportionate Bayesian reporting method. We further categorized the anticancer drugs into four groups: cytotoxic therapy, hormone therapy, immunotherapy, and targeted therapy. Reporting odds ratio (ROR) compares observed and expected values to find the associations of each category of anticancer drugs with acute kidney injury (AKI) and tubulointerstitial nephritis (TIN). Results We observed 32,722 AKI and 2,056 TIN reports which were reported as anticancer drug-related renal adverse reactions. Noteworthy trends emerged in AKI reports following anticancer drugs: cytotoxic therapies consistently dominated with 13,925 cases, while AKI cases related to targeted therapies and immunotherapies surged to 14,236 and 3,816 cases over three decades, respectively. Notably, TIN exhibited a significant increase, particularly after the popular usage of immunotherapy between 2015 and 2020, surpassing other categories of anticancer drugs. The highest disproportionality signal for AKI was associated with immunotherapies (ROR, 8.92; confidence interval [CI], 8.63–9.21, followed by cytotoxic therapies (ROR, 7.14; 95% CI, 7.01–7.26), targeted therapies (ROR, 5.83; 95% CI, 5.73–5.93), and hormone therapies (ROR, 2.59; 95% CI, 2.41–2.79). In the case of TIN, a significantly higher disproportionality signal was found for immunotherapies (ROR, 21.74; 95% CI, 20.39–23.18), followed by cytotoxic therapies (ROR, 2.60; 95% CI, 2.40–2.82), and targeted therapies (ROR, 1.54; 95% CI, 1.40–1.69). Hormone therapies did not exhibit a significant disproportionality signal. Separate analyses were also conducted for the ROR of AKI and TIN for each individual anticancer drug. Conclusion AKI and TIN were substantially observed following the administration of anticancer drugs. Noticeably, renal adverse reactions following immunotherapy, which have been experiencing an increase in utilization, were more prominent than other types of anticancer drugs. Clinicians should consider the increased risk of renal adverse reactions after specific anticancer drugs.

Adverse Event Signal Detection Using Patients' Concerns in Pharmaceutical Care Records: Evaluation of Deep Learning Models.

Early detection of adverse events and their management are crucial to improving anticancer treatment outcomes, and listening to patients' subjective opinions (patients' voices) can make a major contribution to improving safety management. Recent progress in deep learning technologies has enabled various new approaches for the evaluation of safety-related events based on patient-generated text data, but few studies have focused on the improvement of real-time safety monitoring for individual patients. In addition, no study has yet been performed to validate deep learning models for screening patients' narratives for clinically important adverse event signals that require medical intervention. In our previous work, novel deep learning models have been developed to detect adverse event signals for hand-foot syndrome or adverse events limiting patients' daily lives from the authored narratives of patients with cancer, aiming ultimately to use them as safety monitoring support tools for individual patients. This study was designed to evaluate whether our deep learning models can screen clinically important adverse event signals that require intervention by health care professionals. The applicability of our deep learning models to data on patients' concerns at pharmacies was also assessed. Pharmaceutical care records at community pharmacies were used for the evaluation of our deep learning models. The records followed the SOAP format, consisting of subjective (S), objective (O), assessment (A), and plan (P) columns. Because of the unique combination of patients' concerns in the S column and the professional records of the pharmacists, this was considered a suitable data for the present purpose. Our deep learning models were applied to the S records of patients with cancer, and the extracted adverse event signals were assessed in relation to medical actions and prescribed drugs. From 30,784 S records of 2479 patients with at least 1 prescription of anticancer drugs, our deep learning models extracted true adverse event signals with more than 80% accuracy for both hand-foot syndrome (n=152, 91%) and adverse events limiting patients' daily lives (n=157, 80.1%). The deep learning models were also able to screen adverse event signals that require medical intervention by health care providers. The extracted adverse event signals could reflect the side effects of anticancer drugs used by the patients based on analysis of prescribed anticancer drugs. "Pain or numbness" (n=57, 36.3%), "fever" (n=46, 29.3%), and "nausea" (n=40, 25.5%) were common symptoms out of the true adverse event signals identified by the model for adverse events limiting patients' daily lives. Our deep learning models were able to screen clinically important adverse event signals that require intervention for symptoms. It was also confirmed that these deep learning models could be applied to patients' subjective information recorded in pharmaceutical care records accumulated during pharmacists' daily work.

Osteoporosis Associated with Breast Cancer Treatments Based on Types of Hormonal Therapy: A Cross-Sectional Study Using Korean National Sample Data.

Background and Objectives: This study aimed to investigate osteoporosis-related treatments and the overall anticancer drug treatment tendencies, with a focus on selective estrogen receptor modulators (SERMs) and aromatase inhibitors (AIs), in Korean patients with breast cancer from 2010 to 2019. Materials and Methods: Data were obtained from the Health Insurance Review and Assessment Service. Patients with breast cancer (International Classification of Diseases, 10th Revision code: C50) as a principal diagnosis at least once from 2010 to 2019 were included. Those with osteoporosis (M80, M81, or M82) as a principal or sub-diagnosis or those who received osteoporosis treatment at least once were categorized as the osteoporosis-related treatment group, and others as the non-osteoporosis-related treatment group. The trends of drug prescriptions and treatment costs in patient groups were evaluated using descriptive statistics. Results: Among all included patients, those aged 45-54 years (40.20%) without osteoporosis treatment and those aged 55-64 years (34.11%) with osteoporosis treatment were the most common. SERM was the most commonly prescribed anticancer drug (29.20%) in the entire patient group, followed by AIs (20.83%). Patients without osteoporosis treatment had the highest prescription rate of SERM (31.48%), and those with osteoporosis treatment had a higher prescription rate of AIs (34.28%). Additionally, SERM and AIs were prescribed most frequently before and after the age of 55 years, respectively, regardless of the presence of treatment. Conclusions: This study found that osteoporosis-related treatment and patient age were associated with anticancer drug prescriptions. The present findings would help clinicians and researchers in the clinical diagnosis and treatment of breast cancer.

Birth Outcomes of Anticancer Drug Prescriptions during Pregnancy: A Case Series from a Japanese Claims Database

We aimed to evaluate the adverse birth outcomes of anticancer drug prescription during pregnancy using a Japanese claims database from 2005 to 2019. We applied validated claims-based algorithms to identify pregnant women with birth outcomes, and evaluated drug prescription during pregnancy. The causal relationship between anticancer drugs and adverse birth outcomes was evaluated using the Council for International Organizations of Medical Sciences Working Group VI criteria. Thirteen women with anticancer drugs prescription during pregnancy were identified (mean age: 34.6 years). Atrial/ventricular septal defect was observed in one infant after exposure to cyclophosphamide and doxorubicin for breast cancer in the second and third trimesters. One woman on several anticancer drugs (cyclophosphamide, cytarabine, daunorubicin, l-asparaginase, methotrexate, nelarabine, and vincristine) for acute lymphoblastic leukemia, one on imatinib for chronic myeloid leukemia, and one on cisplatin and fluorouracil for cervical cancer had miscarriages after exposure in the first trimester. A relationship between those anticancer drugs and miscarriage could not be ruled out, while no relationship was identified regarding the atrial/ventricular septal defect considering the period of exposure and organogenesis. Our results suggest increased risk of miscarriage with the use of several anticancer drugs such as methotrexate, imatinib, cisplatin, and fluorouracil in the first trimester.

Case report on Reversal of Field Cancerization using Nutraceuticals mapped to the aberrant pathways deciphered via NGS analysis of the neoplastic oral mucosa

Head and neck cancer, particularly oral cancer, presents a significant health concern in Southeast Asia with a high incidence rate, advanced stage of presentation and poor treatment outcomes. The high failure rate is due to recurrence of primary tumor and emergence of second primary tumors (SPTs) due to field cancerization. This case report focuses on a 79-year-old male with a long history of tobacco exposure, resulting in extensive field cancerization within the oral mucosa. This led to sequential development of six primaries both malignant and pre-malignant over the period of 8 years for which the patient underwent multiple surgical resections over these years. The last surgical resection specimen was subjected to Next Generation Sequencing (NGS), genetic and epigenetic alterations were identified causing dysregulation of Janus kinase/signal transducers and activators of transcription signaling pathway (JAK-STAT), Toll-like receptor signalling (TLR) and Extracellular signal regulated kinase (ERK) signalling pathways. The patient post-surgical resection is labelled as disease free; the treatment guidelines do not recommend further prescription of anticancer drugs to prevent another primary and reverse field cancerization. Also, there is lack of approved drugs targeting these pathways, a novel approach was taken using natural supplements (nutraceuticals) to modulate these dysregulated pathways. Curcumin, Epigallocatechin Gallate (EGCG) and Genistein were prescribed to downregulate TLR expression, Boswellia extracts were used to antagonize ERK activation, and Methylsulfonylmethane (MSM), Honokiol, and Berberine were employed to inhibit the JAK-STAT pathway. The patient exhibited good compliance and experienced no adverse effects. Over a span of 24 months, the patient displayed a disease-free status, and the characteristic field cancerization changes within the oral mucosa began to reverse. This unique therapeutic strategy underscores the potential of natural supplements in targeting genetic aberrations and reverting neoplastic processes, ultimately preventing the development of second primary tumors. The study highlights the significance of NGS in unravelling genomic abnormalities underlying neoplasia and supports the exploration of nutraceuticals as a viable option for correcting these aberrations. The successful application of this approach in a real-world case provides a compelling basis for further research and clinical investigation into personalized and integrative approaches for managing oral cancer and potentially other malignancies.

Out-of-pocket costs of oral anticancer drugs for Medicare beneficiaries vary by strength and formulation

Medicare beneficiaries filling oral anticancer drug prescriptions often have expected annual out-of-pocket costs exceeding $10,000 [1]. Cost-related prescription non-initiation affects almost 1 in 3 Medicare beneficiaries (without low-income subsidies) prescribed high-cost specialty anticancer drugs [2]. While longer-term policy solutions are implemented, there is an urgent need to explore “on-the-ground” affordability solutions. It is unknown how altering medication prescribing could reduce out-of-pocket costs.

Assessment of drug utilization pattern in patients undergoing chemotherapy for various types of metastatic cancers in a tertiary care government hospital

Background: Cancer is one among main causes of morbidity and mortality in developing and developed countries. The World Cancer Report 2014 of World Health Organization’s (WHO’s) International Agency for Research on Cancer (IARC), states that in 2012 the global incidence of cancer increased to a 14 million new cases, the figure expected to rise to an annual 19.3 million by 2025. The prescription pattern of anticancer drugs has evolved considerably in recent years because of better understanding of underlying pathophysiology of carcinomas as well as introduction of newer drugs. Methods: It was a hospital-based prospective, cross-sectional study conducted in Department of Oncology, GGH, Kakinada for a period of twelve months from February 2017 to January 2018. A total of 100 patients were enrolled using convenience sampling technique. Patient demographics like age, gender, educational level, employment status, marital status, smoking category, alcohol consumption, stage of cancer was collected. Drug utilization pattern was obtained from inpatient case reports, prescriptions and medication charts used during a chemotherapy cycle.Results: Among all anticancer drugs, cisplatin and 5-flurouracil were most commonly prescribed followed by Adriamycin. The most commonly used adjuvant drugs were B-complex, diclofenac, granisetron, ranitidine, dexamethasone. Antibiotic use was found to be very limited.Conclusions: Various anticancer drug prescription patterns are being used for treatment of patient with metastatic cancers. In this study, cisplatin and 5-flurouracil were commonly used. Injudicious antibiotic prescribing was not observed.

Use of nonclinical staff to coordinate oral anticancer drug prescriptions.

72 Background: In September 2018, Herbert Irving Comprehensive Cancer Center (HICCC) began using non-clinical pharmacy liaisons to oversee coordination of oral anticancer drug (OACD) prescriptions (RXs), a task previously performed by clinical staff. Liaisons interact with payers, specialty pharmacies and financial assistance (FA) groups. We assessed the impact of this strategy on time to receipt of OACDs. Methods: We collected prospective data on all new OACD RXs from HICCC’s medical oncology practice from 1/1/2018 to 9/17/2018 (pre-liaisons) and 9/17/2018 to 5/1/2019 (post-liaisons). We collected patient demographic and insurance data; date of prescription; date of drug delivery; and interactions with payers and FA groups. Federal Drug Association labels were reviewed for drug approval dates and indications. Daily drug cost was defined according to average wholesale price. We define time to receipt (TTR) as days from RX to OACD delivery and used multivariable linear regression to determine factors associated with TTR (log transformed). Results: Over the study period, we evaluated 707 RXs; 93 (13%) were never filled. Of 614 filled RXs, 350 (57%) were placed in the pre-liaison period and 264 (43%) in the post-liaison period. After introduction of liaisons, FA was pursued for more RXs (17% vs 25%, p = 0.007); there was no difference pre- and post-liaisons in patient demographics, distribution of payers, RXs needing prior authorization (PA) (76% vs 77%), off-label RXs (14% vs 16%), RXs for drugs approved < 2 years earlier (5% vs 3%) or mean daily cost ($471 vs $470). Mean TTR before and after liaisons were 11.9 and 11.6 days, respectively. Linear regression showed longer TTR was associated with commercial payers (p = 0.02), need for PA (p = 0.03), FA pursuit (p ≤ 0.0001) and daily OACD cost (p = 0.03); no association was seen with use of liaisons, patient age, off-label use or OACDs approved < 2 years earlier. Conclusions: Implementation of pharmacy liaisons to coordinate OACD prescriptions did not impact the time to OACD receipt, though liaisons were able to pursue financial assistance for more patients. Insurance and cost factors had the greatest impact on time to drug receipt. Task shifting may reduce the clerical workload for providers.

Anticancer Drug Prescription Patterns in Japan: Future Directions in Cancer Therapy.

Despite their benefits, the rapid development of new cancer treatments has been a significant driver of increasing health care expenditures in the face of limited health care budgets. In this study, we analyzed the prescribing trends for anticancer drugs from 2010 through 2016 in Japan and sought to identify unique trends that could provide a basis for future medical economic research aiming to develop more efficacious and cost-effective cancer therapies. We used publicly available marketing data for anticancer drugs in Japan for 2010-2016. The drugs selected for this research were categorized according to the Anatomical Therapeutic Chemical Classification System. We investigated the overall anticancer drug market size, the number of anticancer drugs, the top 30 selling anticancer categories, sales and prescription volumes, and changes in sales and prescription volumes between 2010 and 2016 in the country. The anticancer agent market expanded each year from 2010 to 2016, with sales exceeding 1 trillion yen in 2015. The proportion of molecular targeted drugs (antineoplastic mAbs and protein kinase inhibitors) among the top 30 selling anticancer categories has continued to increase, and both the sales and prescription volumes of these drugs exceeded those of drugs in other categories, suggesting that these treatments play a dominant role in cancer pharmacotherapy. The availability and increasing use of innovative but more expensive targeted therapies were major drivers of increases in pharmaceutical expenditures for cancer treatment in Japan. Therefore, the effective use of genetic testing can mitigate these rising costs.

Cancer referral and treatment activity 2010-2015: a population-based study from Vancouver Island.

The years since 2005 have seen major changes in cancer treatment and significant increases in the number of anticancer drugs available. However, there are relatively few published data to reflect how those changes are affecting the activity and workload of oncology services. To explore the effects of those changes, we reviewed the population-based cancer treatment activity on Vancouver Island for the period 2010-2015. Information about new patient referrals, radiation courses, new chemotherapy cycles commenced, total intravenous (IV) chemotherapy treatment visits, and pharmacy activity for oral anticancer drug prescriptions was obtained from BC Cancer Agency databases. During the 5-year study period, the Vancouver Island population increased by 2.8% and the number of new referrals to the BC Cancer Agency increased by 17.7%. The overall number of radiation courses increased by 6.1%. In contrast, IV chemotherapy activity increased by 52.1% for new courses commenced and by 62% for total IV chemotherapy attendances. Oral anticancer drug prescriptions rose by 22.9% during the 5-year period. Our study documents substantial recent increases in cancer therapy activity in terms of patient referrals and particularly IV chemotherapy and oral anticancer therapy. The data reported here could be of value in planning for future care provision.

Abstract A1-45: In silico prescription of anticancer drugs to cohorts of 28 tumor types reveals novel targeting opportunities

Abstract The development of targeted therapies against altered driver proteins holds the promise of selectively and efficiently eliminating cancer cells. However, high intertumor heterogeneity is a major obstacle to develop and apply therapeutic targeted agents to treat most cancer patients. Here, we present the first large-scale therapeutic landscape of cancer as it stands today in a 6.792 sample cohort covering 28 tumor types. To pursue this goal, we developed a three-step in silico drug prescription strategy. 1) To discover actionable driver events, we first comprehensively identified mutational cancer driver genes by detecting complementary signals of positive selection in the pattern of their mutations across the tumor cohorts. We also identified actionable copy number alteration (CNA) and fusion cancer driver genes. Second, we detected which of these driver genes would have an oncogenic role in the tumor and which ones would lose their function. With these two steps we generated the Drivers Database. 2) Next, we systematically gathered all information available on therapeutic agents; FDA approved and in clinical or pre-clinical stages. We considered three different types of targeting strategies for the cancer driver genes: direct targeting, indirect targeting and gene therapies in clinical trials. Moreover, we designed a set of rules for assigning therapeutic agents to specific genomic alterations beard for the driver genes. By doing this last step, we generated the Drivers Actionability Database. 3) Finally, by combining data of Drivers Database, Drivers Actionability Database and sample data, we developed in silico drug prescription, a novel approach to determine which of the drugs could benefit each of the tumor individuals. In all, in the Driver Database we identified 460 mutational cancer driver genes acting in one or more of the tumor types along with 39 driver genes acting via CNAs or fusions. Fifty of these cancer driver genes are targeted by FDA approved agents, 63 by molecules currently in clinical trials and 74 are bound by pre-clinical ligands. We also identified 81 therapeutically unexploited targetable cancer genes. Lastly, by applying in silico drug prescription we found that only 6.7% of the patients could be treated following clinical guidelines, and were concentrated in only 6 tumor types. Moreover, considering repurposing strategies the fraction of patients that could benefit from FDA approved drugs would increase up to 40%, increasing remarkably the fraction of targetable patients in some tumor types like glioblastoma and thyroid cancer, and up to 72% if considering targeted therapies in clinical trials. In summary, the in silico drug prescription based on Drivers and Drivers Actionability Databases was tested on one of the largest cohorts of tumor samples currently collected for research. The main result highlights the current scope of targeted anti-cancer therapies and its prospects for growth in view of the drugs that are currently in clinical trials or at pre-clinical stages. Additionally, another important output of this work is a ranked list of novel target opportunities for anticancer drug development. Continuous update of drug-target interactions information, and the application of the strategy to larger cohorts, will improve the in silico prescription rules contained within the two databases, thus enhancing its usefulness within personalized cancer medicine. Citation Format: Carlota Rubio-Perez, David Tamborero, Michael P. Schroeder, Albert A. Antolín, Jordi Deu-Pons, Christian Perez-Llamas, Jordi Mestres, Abel Gonzalez-Perez, Nuria Lopez-Bigas. In silico prescription of anticancer drugs to cohorts of 28 tumor types reveals novel targeting opportunities. [abstract]. In: Proceedings of the AACR Special Conference on Translation of the Cancer Genome; Feb 7-9, 2015; San Francisco, CA. Philadelphia (PA): AACR; Cancer Res 2015;75(22 Suppl 1):Abstract nr A1-45.

Abstract 2983: In silico prescription of anticancer drugs to cohorts of 28 tumor types reveals novel targeting opportunities

Abstract Recent advances in DNA sequencing technologies provide unprecedented capacity to comprehensively identify the alterations, genes, and pathways involved in the tumorigenic process, raising the hope of extending targeted therapies against the drivers of cancer from a few successful examples to a broader personalized medicine strategy. However, high intertumor heterogeneity is a major obstacle to develop and apply therapeutic targeted agents to treat most cancer patient. In addition, advances in our ability to precisely assign the most effective targeted therapy to each patient based on the genome events driving the tumor are urgently needed. The present study offers the first comprehensive assessment of the scope of targeted drugs in a large pan-cancer cohort. To pursue this goal, we developed a three-step in silico drug prescription strategy. We first identified the driver genes acting across 6792 tumor samples from 28 different cancer types via an integrated analysis of their mutations, copy number alterations and gene fusions. All information pertaining these driver genes has been compiled in a publicly available Drivers Database. Next, following the rationale that targeted therapies are effective only if they are administered to treat tumors driven by the alterations they are aimed at, we collected all therapeutic agents capable of targeting altered driver genes either directly, indirectly or through gene therapies. The catalog of available therapeutic agents and ancillary information on their application, referred here as Drivers Actionability Database, included FDA (Foods and Drugs Administration Agency) approved drugs, agents undergoing clinical trials, and ligands in pre-clinical stages. Finally, based on the driver alterations in each tumor in the cohort and the rules in the Drivers Actionability Database, we connected each patient to all targeted therapies that could benefit them, thus producing the landscape of utility of targeted therapeutic agents in the cohort. We found that only a minority of patients could benefit from approved targeted therapy interventions following clinical guidelines (5.9%), while up to 40% could benefit from different types of repurposing opportunities of approve drugs, and up to 78% considering treatments currently under investigation. In addition, we identified 16 therapeutically unexploited cancer genes targeted by small molecules currently in pre-clinical stages, and 66 others structurally suitable for small molecule binding or accessible by antibody targeting. These results highlight the current scope of targeted anti-cancer therapies and its prospects for growth. The application of the strategy to larger cohorts and the continuous update of drug-target interactions information, will improve the in silico prescription rules contained within the two databases, thus enhancing its usefulness within personalized cancer medicine. Citation Format: Carlota Rubio-Perez, David Tamborero, Michael P. Schroeder, Albert A. Antolin, Jordi Deu-Pons, Christian Perez-Llamas, Jordi Mestres, Abel Gonzalez-Perez, Nuria Lopez-Bigas. In silico prescription of anticancer drugs to cohorts of 28 tumor types reveals novel targeting opportunities. [abstract]. In: Proceedings of the 106th Annual Meeting of the American Association for Cancer Research; 2015 Apr 18-22; Philadelphia, PA. Philadelphia (PA): AACR; Cancer Res 2015;75(15 Suppl):Abstract nr 2983. doi:10.1158/1538-7445.AM2015-2983

Managing a research hospital at the time of a global economics crisis: Cruising between Scylla and Charybdis

Managing a research hospital at the time of a global economics crisis: Cruising between Scylla and Charybdis

Personalized cancer medicines

An in silico prescription strategy targets genes driving tumorigenesis.

In Silico Prescription of Anticancer Drugs to Cohorts of 28 Tumor Types Reveals Targeting Opportunities

Large efforts dedicated to detect somatic alterations across tumor genomes/exomes are expected to produce significant improvements in precision cancer medicine. However, high inter-tumor heterogeneity is a major obstacle to developing and applying therapeutic targeted agents to treat most cancer patients. Here, we offer a comprehensive assessment of the scope of targeted therapeutic agents in a large pan-cancer cohort. We developed an in silico prescription strategy based on identification of the driver alterations in each tumor and their druggability options. Although relatively few tumors are tractable by approved agents following clinical guidelines (5.9%), up to 40.2% could benefit from different repurposing options, and up to 73.3% considering treatments currently under clinical investigation. We also identified 80 therapeutically targetable cancer genes.

Rising cost of anticancer drugs in Australia

Anticancer drugs are often expensive and are contributing to the growing cost of cancer care. Concerns have been raised about the effect rising costs may have on availability of new anticancer drugs. This study aims to determine the recent changes in the costs of anticancer drugs in Australia. Publicly available expenditure and prices paid by the Australian Pharmaceutical Benefits Scheme (PBS) for anticancer drugs from 2000 to 2012 were reviewed. The measures used to determine changes in cost were total PBS expenditure and average price paid by the PBS per prescription for anticancer drugs and for all PBS listed drugs. An estimated monthly price paid for newly listed anticancer drugs was also calculated. Annual PBS expenditure on anticancer drugs rose from A$65 million in 1999-2000 to A$466 million in 2011-2012; an average increase of 19% per annum. The average price paid by the PBS per anticancer drug prescription, adjusted for inflation, increased 133% from A$337 to A$786. The real average annual increase in the price per anticancer drug prescription was more than double that for all other PBS drugs combined (7.6% vs 2.8%, difference 4.8%, 95% confidence interval -0.4% to 10.1%, P = 0.07). The median price for a month's treatment of the new anticancer drugs listed was A$4919 (range A$1003 to A$12 578, 2012 prices). PBS expenditure and the price of anticancer drugs in Australia rose substantially from 2000 to 2012. Dealing with these burgeoning costs will be a major challenge for our health system and for those affected by cancer.

P0092 The rising cost of anti-cancer drugs

Background Anti-cancer drugs are often expensive and are contributing to the growing cost of cancer care. Concerns have been raised about the effect rising costs may have on availability of new anti-cancer drugs. The aim of this study was to determine recent changes in the costs of anti-cancer drugs in Australia. Methods Publicly available expenditure and prices paid by the Australian Pharmaceutical Benefits Scheme (PBS) for anti-cancer drugs from 2000 to 2012 were reviewed. The measures used to determine changes in cost were total PBS expenditure and average price paid per prescription for anti-cancer drugs and for all PBS listed drugs. An estimated monthly price paid for newly listed anti-cancer drugs was also calculated. Findings Annual PBS expenditure on anti-cancer drugs rose from $65 million in 1999–2000 to $466 million in 2011–2012; an average increase of 19% per annum compared with 9% per annum for total PBS expenditure. The average price paid by the PBS per anti-cancer drug prescription, adjusted for health prices inflation, increased 133% from $337 to $786. The real average annual increase in the price per anti-cancer drug prescription was more than double that for all other PBS drugs combined (7.6% versus 2.8%, difference 4.8%, 95% confidence interval −0.4 to 10.1, p = 0.07). The median price for a month’s treatment of the new anti-cancer drugs listed during the study period was $4919 (range $1003 to $12578, 2012 prices). Interpretation PBS expenditure and the price of anti-cancer drugs in Australia climbed substantially over the study period. Dealing with these burgeoning costs is a major challenge for health systems worldwide and for those affected by cancer.

Off-Label Prescription of Anticancer Drugs in Italy: What Responsibilities?

Off-Label Prescription of Anticancer Drugs in Italy: What Responsibilities?

経口抗がん剤の調剤に関する実態調査

In this study, a questionnaire survey was conducted among pharmacists to determine the actual dispensing conditions of anti-cancer drugs and problems associated with dispensing drugs, especially after the drugs are taken out of individual packaging. Responses were obtained from 163 pharmacists who had experience in handling oral anticancer drugs. Of these, 76 answered that they had filled oral anti-cancer drug prescriptions, which involved single dose packaging, pulverization of the drug, capsule opening, or preparation of a simple suspension. A total of 107 specific cases involving 26 oral anti-cancer drugs were collected. The drugs were dispensed in accordance with prescriptions in 85 cases (the percentage of prescription questions asked in these cases was 13%) and not in accordance with prescriptions in 16 cases (69%), a prescription was canceled in one case (100%), and details were unknown in 5 cases. Matters noted by the respondents included being careful not to cross-contaminate drugs with other drugs and not to expose dispensers to powdered anti-cancer drugs, which are characteristically easily scattered. The respondents also requested the development of new formulations that do not need special preparation, are easy to dispense and are easy to take for the patients. In conclusion, the following is needed for pharmacists to dispense oral anti-cancer drugs safely and properly: 1) an environment that allows pharmacists to ask physicians about their prescriptions and to cooperate with health professionals by sharing information about anti-cancer regimens; and 2) improvement of the procedures and environment for dispensing such drugs.

Drug Management of Prostate Cancer: Prevalence and Consequences of Renal Insufficiency

Background The Renal Insufficiency and Anticancer Medications (IRMA) study reported a renal insufficiency (RI) prevalence of 50%–60% in a population of almost 5000 patients with solid tumors, 80% of whom were being treated with anticancer drugs that either necessitated dosage adjustment or were potentially nephrotoxic drugs. A national multicenter study from 15 cancer centers in France analyzed IRMA data on patients with prostate cancer. Patients and Methods Data on patients with prostate cancer from the IRMA study were analyzed. Renal function was calculated using Cockcroft-Gault and abbreviated Modification of Diet in Renal Disease (aMDRD) formulas to estimate the prevalence of RI. Anticancer drugs' potential renal toxicity and need for dosage adjustment were detailed. Results Of the 222 IRMA patients with prostate cancer, 14.9% had a serum creatinine (SCr) level of > 110 μmol/L. When using Cockcroft-Gault and aMDRD formulas, 62.6% and 55.9%, respectively, of the patients had RI. Of the 228 anticancer drug prescriptions, 82.9% required dose adjustments for RI or were drugs with no available data on their administration in patients with RI. Of the patients treated, 86.9% received ≤ 1 such drug, but only 29.1% received nephrotoxic drugs. Conclusion The prevalence of RI in patients with prostate cancer was very high in spite of a normal SCr level in most cases. Some anticancer drugs, particularly some bisphosphonates and platinum salts, might be nephrotoxic and/or need dosage adjustment. However, other important drugs in prostate cancer, such as docetaxel, neither require dose reduction nor present with potential nephrotoxicity. Both issues were significantly more important in the patients with bone metastases compared with those with nonmetastatic disease.