Injectable Anticancer Drugs Research Articles

Gravimetric-based technology-assisted workflow system for injectable anticancer drugs compounding: Design and qualification of an original weighing scale anchored inside an isolator.

Technology-assisted manufacturing such as computer-assisted gravimetric control (CAGC) is a well-established method for injectable anticancer drugs (AD) compounding. The aim of this study was to validate an innovative weighing scale (WS) anchored inside an isolator for in-process gravimetric control (GC) of injectable AD compounding in a French Comprehensive Cancer Centre. The weighing scale studied Cyto-TopControl® was designed by hospital pharmacists and the manufacturer LDI. Operational and performance qualification were carried out using weights ranging from 1 to 2000 g to assess fidelity, accuracy, linearity, eccentricity, precision and inter-test precision. The performance of the Cyto-TopControl® were compared to the standard WS model Cytocontrol® (LDI) by using a Bland-Altman plot. Infusion bags of four drugs (paclitaxel, docetaxel, epirubicin and trastuzumab) were then compounded by using CAGC associated with this new WS. For each preparation, an analytical control (AC) was carried out to validate the GC as a reference method. A total of 1530 weighings were performed. The maximum tolerated deviation and the accuracy deviations were not exceeded for each of the weights studied (<0.1 g for weights up to 100 g; <0.2 g for weight up to 2000 g). The standard deviations remained less than 5x 0.02 g and the linearity coefficients were above 0.9999. Eccentric weights coefficients of variation were less than 0.05%. The measurements obtained between Cyto-TopControl® and CytoControl® were consistent. Sixty bags were manufactured with the accuracy of 0.19% for GC and 5.07% for AC. This work confirms the reliability of this innovative WS for the in-process GC of injectable AD compounding.

Advanced prescription of injectable anticancer drugs: Safety assessment in a European Comprehensive Cancer Centre using the risk matrix approach.

The purpose of this work was to assess failures in the advanced prescription of parenteral anticancer agents in an adult day oncology care unit with more than 100 patients per day. An a priori descriptive analysis was carried out by using the risk matrix approach. After defining the scope in a multidisciplinary meeting, we determined at each step the failure modes (FMs), their effects (E) and their associated causes (C). A severity score (S) was assigned to all effects and a probability of occurrence (O) to all causes. These S and O indicators, were used to obtain a criticality index (CI) matrix. We assessed the risk control (RC) of each failure in order to define a residual criticality index (rCI) matrix. During risk analysis, 14 FMs were detected, and 61 scenarios were identified considering all possible effects and causes. Nine situations (15%) were highlighted with the maximum CI, 18 (30%) with a medium CI, and 34 (55%) with a negligible CI. Nevertheless, among all these critical situations, only three (5%) had an rCI to process (i.e., missed dose adjustment, multiple prescriptions and abnormal biology data); the others required monitoring only. Clinicians' and pharmacists' knowledge of these critical situations enables them to manage the associated risks. Advanced prescription of injectable anticancer drugs appears to be a safe practice for patients when combined with risk management. The major risks identified concerned missed dose adjustment, prescription duplication and lack of consideration for abnormal biology data.

Survey of community and hospital pharmacist involvement in outpatient chemotherapy using Japanese health information data.

In this study, information on injectable anticancer drug use and additional fee for enhanced collaboration (AEC) and additional fee for specific drug management guidance 2 (ASD2) claims from the NDB Open Data Japan (NODJ) dataset and the number of patients with cancer according to sex and age from the National Cancer Registry (NCR) dataset were integrated and evaluated to determine the current status and challenges in pharmacist interventions for patients receiving cancer treatment. The NODJ data, including receipt data billed from 2020 to 2021, were obtained from the Ministry of Health, Labour and Welfare website. The use of injectable anticancer drugs decreased relative to the number of cancer patients aged ≥ 75 years compared to those aged < 75 years. Regarding injectable anticancer drug use, the number of AEC claims was similar between men and women, but the number of ASD2 claims was lower in men than in women. The number of times community pharmacists claimed their ASD2 was approximately 5% of the number of times hospital pharmacists claimed their AEC. This study revealed that several patients did not receive sufficient guidance from community pharmacists compared to hospital pharmacists, suggesting a potential insufficiency in the collaboration between the two groups.

A Method for Risk Assessment Evaluating the Safety, Stability and Efficacy in Clinical Practice of Anticancer Drug Preparations in the Centralized Compounding Unit of the Veneto Institute of Oncology-IRCCS.

Preparation of injectable anticancer drugs in hospital pharmacies is a high-risk activity that requires a proper risk assessment (RA) and quality assurance system (QAS) to ensure both a decrease in risk associated with chemotherapy compounding and high quality of the final product, especially in terms of its microbiological stability. At the centralized compounding unit (UFA) of the Italian Hospital IOV-IRCCS, a quick and deductive method was applied to evaluate the "added value" provided by each prescribed preparation, and its RA was calculated applying a formula that integrates different pharmacological, technological and organizational aspects. According to specific RA range values, the preparations were divided into different risk levels, in order to determine the QAS to be adopted, according to the Italian Ministry of Health guidelines, whose adherence was meticulously evaluated through a specific self-assessment procedure. A review of the scientific literature was carried out to integrate the risk-based predictive extended stability (RBPES) of drugs with data concerning their physiochemical and biological stability. Based on the self-assessment comprising all microbiological validations of the working area, personnel and products, the microbiological risk level within the IOV-IRCCS' UFA was defined through the creation of a transcoding matrix, conferring a microbiological stability to preparations and vial leftovers of a maximum of 7 days. The calculated RBPES were successfully integrated with stability data from the literature, leading to the drafting of a stability table of drugs and preparations in use in our UFA. Our methods allowed us to perform an in-depth analysis of the highly specific and technical process of anticancer drug compounding in our UFA, ensuring a certain grade of quality and safety to preparations, especially in terms of microbiological stability. The resulting RBPES table represents an invaluable tool with positive repercussions at organizational and economic levels.

Clinical and economic impact of clinical oncology pharmacy in cancer patients receiving injectable anticancer treatments: a systematic review.

Clinical pharmacy can reduce drug-related iatrogenesis by improving the management of adverse effects of drugs, limiting drug-drug interactions, and improving patient adherence. Given the vulnerability of cancer patients and the toxicity of injectable anticancer drugs, clinical pharmacy service (CPS) could provide a significant clinical benefit in cancer care. This review aims to synthesize existing evidence on clinical pharmacy's impact on patients treated with intravenous anticancer drugs. A comprehensive search was performed in the PubMed/Medline database from January 2000 to December 2021, associating the keywords: clinical pharmacy, pharmaceutical care, pharmacist, oncology, and chemotherapy. To be eligible for inclusion, studies have to report clinical pharmaceutical services for patients treated with intravenous chemotherapy with a clinical and/or economic impact. Forty-one studies met the selection criteria. Various CPS were reported: medication reconciliation, medication review, and pharmaceutical interview with patient. There was a lack of randomized study (n = 3; 7.3%). In one randomized controlled trial, pharmaceutical intervention significantly improved quality of life of patients receiving pharmaceutical care during injectable anticancer drugs courses. Economical results appear to show positive impact of clinical pharmacy with cost savings reported from 3112.87$ to 249844€. Although most studies were non-comparative, they highlighted that clinical pharmacy tend to limit chemotherapy side effects and drug-related problems, improve quality of life and satisfaction of patients and healthcare professional, and a positive economic impact. Clinical pharmacy can reduce adverse drug events in cancer patients. More robust and economic evaluations are still required to support its development in everyday practice.

A pharmacist check of patients’ infection-related condition prior to drug preparation reduces anticancer drug wastage after mixing: a retrospective study

BackgroundWe previously reported that a standardized pharmacist check of medical orders related to the administration criteria of anticancer drugs prior to preparation of injectable anticancer drugs was useful for reducing drug wastage after mixing. To further reduce anticancer drug wastage after preparation, we added a pharmacist check of patients' infection-related condition to the previous protocol and assessed the effectiveness of the modified protocol for reducing injectable anticancer drug wastage.MethodsIn addition to the administration criteria of anticancer drugs, patients’ infection-related condition, which was based on a body temperature ≥ 37.5 °C or elevated C-reactive protein (CRP) or white blood cell (WBC) count from baseline, was added to pharmacists’ checklist of items used previously to prepare injectable anticancer drugs. We retrospectively compared the number, type and cost of anticancer drugs discarded after preparation and the reasons for discarding these drugs between pre- and post-protocol modification.ResultsThe rate at which anticancer drugs were discarded after preparation was significantly reduced after introducing the modified protocol compared to the original protocol (0.288% [18/6253] vs. 0.095% [6/6331], P = 0.013). Furthermore, the number of cases for which mixed anticancer agents were discarded because of infection decreased from 11 (fever: n = 8; elevated CRP or WBC: n = 3) to one (elevated CRP: n = 1) a year.ConclusionsIn addition to the standard administration criteria of anticancer drugs, checking patients’ infection-related condition, defined by a body temperature ≥ 37.5 °C or elevated CRP or WBC from baseline, before mixing by the pharmacist is useful for reducing anticancer drug wastage after preparation.

Comparing different robots available in the European market for the preparation of injectable chemotherapy and recommendations to users.

Recent advances in technology have made it possible to develop robots for preparing injectable anticancer drugs. This study aims to compare characteristics between robots available in the European market in 2022 and to help future pharmacy users in their choices. Three sources of data were used: (1) a review of published articles in the MEDLINE database from November 2017 to end of June 2021 on chemotherapy-compounding robots used in hospital; (2) all manufacturers' documentation, and (3) demonstrations of robot operations in real hospital conditions and discussions with users and manufacturers. Robot characteristics included number of robots installed, general technical characteristics, type of injectable chemotherapy produced and compatible materials, productivity data, preparation control methods, residual manual tasks, chemical and microbiological risk management, cleaning method, software, and implementation time. Seven robots commercialized were studied. Several technical characteristics have to be taken into account in selecting the robot whose match the specific needs of a particular hospital, and which often require rethinking the current production workflow as well as the organization of the pharmacy unit. In addition to increasing productivity, the robots improve the quality of production thanks to better traceability, reproducibility, and precision of sampling. They also improve user protection against chemical risk, musculoskeletal disorders, and needle wounds. Nevertheless, when robotization is being planned, there are still numerous residual manual tasks to keep in mind. Robotization of the production of injectable anticancer drugs is booming within anticancer chemotherapy preparation pharmacy units. Feedback from this experience needs to be further shared with the pharmacy community regarding this significant investment.

Quantitative comparison of anticancer drug dispersal before and after introducing appropriate preparation procedures during anticancer drug preparation

BackgroundIn Japan, engineering controls for preparing injectable anticancer drugs are inadequate and compliance with appropriate preparation procedures is vital. In this study, we evaluated the effects of adherence to appropriate anticancer drug formulation and packaging procedures on reducing anticancer drug dispersal in clinical practice, especially in Japan.MethodsWe quantitatively evaluated the effectiveness of implementing procedures that were experimentally verified to help reduce the amount of anticancer drug dispersed during preparation based on procedures described in the “Anticancer Drug Preparation Manual.” The target facilities were four regional hub hospitals in the Kanto area. Contamination of sheets and gloves with 5-fluorouracil (5-FU) and gemcitabine (GEM) in a safety cabinet during formulation was evaluated using wipe tests. Subsequently, the proper preparation procedure was shown on a video, training was provided, and the wipe tests were repeated.ResultsForty-one and 39 pharmacists were engaged in drug preparation before and after intervention, respectively. 5-FU had the highest dispersal per prepared vial on the sheet before intervention. The dispersal amount per prepared vial decreased significantly (P = 0.01) after intervention. The amount of GEM dispersed before and after intervention did not differ significantly. However, the percentage of sheets below the detection limit after intervention was 62%, increasing from 46% before intervention. The amount dispersed on gloves was not significantly reduced by proper preparation technique. Although not explicitly noticeable and quantifiable, pharmacists must consider that a significant amount of anticancer drug is dispersed on gloves despite following appropriate preparation procedures.ConclusionsQuantitative amounts of anticancer drugs dispersed in the preparations of 5-FU and GEM were found in our study. The difference in the amount of contamination before and after intervention was significantly reduced only for the contamination of sheets with 5-FU. There was no decrease in the amount of glove contamination. There was also no difference between medical facilities. Despite following appropriate preparation procedures, dispersed amounts cannot be maintained below the detection limit, indicating the need for a combination of education and engineering controls.

Risk management in an anticancer drug preparation unit: use of Preliminary Risk Analysis method and application to the preparation process

Abstract Objectives Preparation of injectable anticancer drugs in hospital pharmacies, in particular of cytotoxics, is a high-risk activity. We used Preliminary Risk Analysis (PRA) to analyse the risks in the different steps of our anticancer drug circuit, including the preparation step (PRA1). Then, to prepare an important change in management of the circuit with the software Chimio® (pooling of three databases for subcontracting), we repeated the analysis of preparation step (PRA2). PRA is known to be time and resource consuming. To overcome this, we developed a strict organisational framework to perform the analysis within a reasonable amount of time. We present the PRA method including its practical implementation, and its application to the anticancer drug preparation process, before and after pooling of Chimio® databases. Methods PRA has two main stages, PRA “system” and PRA “scenario”. A multidisciplinary working group is created for the entire PRA process. PRA “system” is an exploratory and qualitative stage. PRA “scenario” requires the creation of risk assessment tools and decision tools before actually developing, analysing and treating scenarios, with risk reduction actions structured in an action plan. For PRA2 we used the same working group, assessment and decision tools as for PRA1 and we only analysed dangerous situations (DS) that appeared or changed towards more risk, requiring a new action plan. The different PRA only required four 2 h meetings thanks to the investment of a coordinator who is expert in the method. Results In PRA1, the riskiest phase was production while it was the verification and delivery of the finished product in PRA2. The risks were mainly related to management, human and technical dangers in PRA1. Human danger was found to be the main danger in PRA2, followed by organisational danger. Among the 264 scenarios described in PRA1, six of criticality 3 and 69 of criticality 2 have been associated with risk reduction actions. These actions mainly involved managing the risk of human error, with the control system Drugcam® and the standardisation of the pharmaceutical assistants’ training program. In PRA2, 11 scenarios were analysed, including three of criticality 3 and 4 of criticality 2 for which risk reduction measures were taken. Conclusions PRA allowed us to perform an in depth analysis of the highly specific and technical process of anticancer drug preparation. Human danger was one of the most important dangers identified, and it should always be taken into consideration, whatever the measures taken to prevent it. PRA2 was extremely useful to plan the organisation that would result from the new Chimio® database, while involving the team and winning its commitment. It allowed an exhaustive and structured anticipation of this major change. Practical aspects of PRA method implementation we have adopted facilitate its application and can help to deploy it on many areas in our hospitals. Indeed, besides an exhaustive analysis of the risks, this approach promotes collaboration, develops a quality culture and is an excellent tool for team and project management, as well as communication.

Estimating the effect of optimizing anticancer drug vials on medical costs in Japan based on the data from a cancer hospital

BackgroundThe substantial increase in the use of expensive anticancer drugs has been accompanied by an increase in the amount of disposing residual liquid from drug preparations. Many Western countries, including the United States, have implemented drug vial optimization (DVO) to prevent the waste of anticancer drugs and have reported the reductions in the total drug costs. This study was designed to estimate the expected reduction in spending on anticancer drugs by Japanese cancer hospitals when DVO was implemented instead of individual preparations and to test the effectiveness of this approach.MethodsWe investigated the doses of drugs used and quantity specifications for individually prepared vials for patients who received anticancer drug treatment in December 2017 at the Outpatient Treatment Center of the National Cancer Center Hospital East. Based on these findings, we calculated the total quantity of each drug used on a given day, and the minimum cost for preparation of the number of specified combinations corresponding to the total cost (DVO preparation). Based on the differences in these two costs, we estimated the economic impact of implementing DVO.ResultsWhile the cost for anticancer drugs for the 1-month study period was US$3,305,595 (US$1 = \\110) for individual preparations, the estimated cost for DVO preparations was US$3,092,955, equivalent to a reduction of US$212,640.ConclusionsBased on these study results, implementation of DVO-based preparation of injectable anticancer drugs in Japan in 2017 would have resulted in saving approximately US$460 million. This calculation revealed the need for the Japanese government to modify the methods employed to calculate drug costs in the insurance system and develop policies for the proper and optimal use of medical resources.

Implementation of a standardised pharmacist check of medical orders prior to preparation of anticancer drugs to reduce drug wastage.

The increasing cost of anticancer drugs is now being recognised as a global problem, and measures against drug wastage are among the most important cost containment strategies for anticancer drugs. When blood examination results or changes to a patient's condition necessitate dose reduction or discontinuation of anticancer drugs after their preparation, the compounded anticancer drugs are discarded. To reduce anticancer drug wastage after preparation, we developed a protocol that set the eligibility, start of treatment, dose reduction and discontinuation criteria for injectable anticancer drugs and assessed the effect of pharmacists' checks of these criteria based on the present protocol prior to preparation of injectable anticancer drugs. Observations before and after introduction of the protocol were conducted at Gifu University Hospital. We recorded the number, type and cost of anticancer drugs discarded after preparation and the reason for discarding these drugs in our dedicated database. Checking the criteria for anticancer drug administration before preparation significantly reduced the rate at which anticancer drugs within a chemotherapy cycle were discarded after preparation compared with that prior to the protocol's introduction (0.367% [18/4909] vs 0.032% [2/6248], P<.001). Additionally, the total cost of anticancer drugs discarded after preparation was reduced from JPY 2041786 (USD 18562) to JPY 398414 (USD 3622). Pharmacists' checks of the eligibility, start of treatment, dose reduction and discontinuation criteria for anticancer drugs based on the present protocol prior to preparation of injectable anticancer drugs was useful for reducing drug wastage after preparation.

A real-world analysis of cancer drug wastage due to oversized vials

A real-world analysis of cancer drug wastage due to oversized vials

Interactions between injectable anticancer drugs and polyvinyl chloride bags: Evaluation of the adsorption phenomenon after reconstitution.

During the reconstitution of a drug and during its storage, there are risks of interactions between the drug and the bag used for the preparation. Polyvinyl chloride is a material used in the manufacture of a large part of chemotherapy infusion bags. It is subject to many interactions like sorption of drugs and release of phthalate additives. Seven anticancer drugs used in pediatric oncology were involved in our study. After reconstitution of the anticancer agents in polyvinyl chloride bags, the adsorption phenomenon between the container and the contents is evaluated by infrared spectroscopy by analyzing the inner surface of the polyvinyl chloride. Subsequently, for the anticancer agents which exhibited an adsorption-container-content, the analysis was carried out by ultraviolet-visible spectrophotometry in order to examine the kinetics of the concentration of reconstituted anticancer drugs. All the polyvinyl chloride bags gave a spectrum identical to the spectrum of the reference bag, except the bags used to reconstitute etoposide whose spectra showed 12 additional peaks. With the absorbances measured by ultraviolet-visible spectrophotometry at different times, the analysis of variance statistical analysis shows that there is a significant difference in absorbances between t0 and all the other measurement times. This study testifies to the existence of a container-content interaction between etoposide and polyvinyl chloride. Thus, reconstitution of etoposide for intravenous infusion into a polyvinyl chloride bag should be used immediately. For etoposide preparations intended for storage beyond 24 h, it is recommended to use a container other than the polyvinyl chloride bag.

Trajectories of Injectable Cancer Drug Costs After Launch in the United States.

Purpose Cancer drug prices at launch have increased in recent years. It is unclear how individual drug prices change over time after launch and what market determinants influence these changes. We measured the price trajectories of a cohort of cancer drugs after their launch into the US market and assessed the influence of market structure on price changes. Methods We studied the changes in mean monthly costs for a cohort of 24 patented, injectable anticancer drugs that were approved by the US Food and Drug Administration between 1996 and 2012. To account for discounts and rebates, we used the average sales prices published by the Centers for Medicare and Medicaid Services. Costs were adjusted to US general and health-related inflation rates. For each drug, we calculated the cumulative and annual drug cost changes. We then used a multivariable regression model to evaluate the association between market and cost changes over time. Results With a mean follow-up period of 8 years, the mean percent change in cost for all drugs was +25% (range, -14% to +96%). After adjusting for inflation, the mean cost change was +18% (range, -16% to +59%). Rituximab and trastuzumab followed a similar pattern in cost increases over time, and the inflation-adjusted monthly costs rose since approval by 49% and 44%, respectively. New supplemental US Food and Drug Administration approvals, new off-label indications, and new competitors did not influence the annual cost change rates. Conclusion Anticancer drug costs may change substantially after launch. Regardless of competition or supplemental indications, there is a steady increase in costs of patented anticancer agents over time. New regulations may be needed to prevent additional increases in drug costs after launch.

Performance evaluation of the compounding robot, APOTECAchemo, for injectable anticancer drugs in a Japanese hospital

BackgroundThe accuracy, safety and feasibility of, the compounding robot APOTECAchemo were evaluated in the clinical practice of Japan.MethodsAccuracy and precision of robotic preparations by APOTECAchemo was evaluated in 20 preparations of fluorouracil (FU) and cyclophosphamide (CPA) infusions by four pharmacists. Environmental and product contaminations with FU and CPA were evaluated by wipe testing. Robotic performance was compared with manual preparation in a biological safety cabinet. The number of robotic products, total compounding time and total pre-reconstitution time of lyophilized drugs between January 1, 2014 to December 31, 2015 were investigated.ResultsRobotic preparation resulted more accurate and precise (mean absolute dose error and coefficient of variation were 0.83 and 1.04% for FU and 0.52 and 0.59% for CPA) than those of manual preparation (respective values were 1.20 and 1.46% for FU and 1.70 and 2.20% for CPA). Drug residue was not detected from any of the prepared infusion bags with the robotic preparation, whereas FU was detected in two of four analyzed infusion bags with manual preparation. Average total time to make single anticancer drug preparation (compounding plus reconstitution of lyophilized drugs) was 6.11 min in the second half of 2015. During the study period, the highest percentage of production covered by APOTECAchemo was 70.4% of the total inpatient pharmacy activity.ConclusionRobotic preparation using APOTECAchemo should give substantial advantages in drug compounding for accuracy and safety and was able to be successfully worked in Mie university hospital.

Évolution du remboursement des anticancéreux inscrits sur la liste en sus : impact financier au sein d’un centre hospitalo-universitaire

Évolution du remboursement des anticancéreux inscrits sur la liste en sus : impact financier au sein d’un centre hospitalo-universitaire

Sustainable me – a pharmacist’s role in reducing the carbon footprint of healthcare delivery

Sustainable me – a pharmacist’s role in reducing the carbon footprint of healthcare delivery

SIMMEON-Prep study: SIMulation of Medication Errors in ONcology: prevention of antineoplastic preparation errors.

Medication errors (ME) in oncology are known to cause serious iatrogenic complications. However, MEs still occur at each step in the anticancer chemotherapy process, particularly when injections are prepared in the hospital pharmacy. This study assessed whether a ME simulation program would help prevent ME-associated iatrogenic complications. The 5-month prospective study, consisting of three phases, was undertaken in the centralized pharmaceutical unit of a university hospital of Lyon, France. During the first simulation phase, 25 instruction sheets each containing one simulated error were inserted among various instruction sheets issued to blinded technicians. The second phase consisted of activity aimed at raising pharmacy technicians' awareness of risk of medication errors associated with antineoplastic drugs. The third phase consisted of re-enacting the error simulation process 3 months after the awareness campaign. The rate and severity of undetected medication errors were measured during the two simulation (first and third) phases. The potential seriousness of the ME was assessed using the NCC MERP(®) index. The rate of undetected medication errors decreased from 12 in the first simulation phase (48%) to five in the second simulation phase (20%, P = 0.04). The number of potential deaths due to administration of a faulty preparation decreased from three to zero. Awareness of iatrogenic risk through error simulation allowed pharmacy technicians to improve their ability to identify errors. This study is the first demonstration of the successful application of a simulation-based learning tool for reducing errors in the preparation of injectable anticancer drugs. Such a program should form part of the continuous quality improvement of risk management strategies for cancer patients.

Impact of the healthcare payment system on patient access to oral anticancer drugs: an illustration from the French and United States contexts.

BackgroundOral anticancer drugs (OADs) allow treating a growing range of cancers. Despite their convenience, their acceptance by healthcare professionals and patients may be affected by medical, economical and organizational factors. The way the healthcare payment system (HPS) reimburses OADs or finances hospital activities may impact patients’ access to such drugs. We discuss how the HPS in France and USA may generate disincentives to the use of OADs in certain circumstances.DiscussionFrench public and private hospitals are financed by National Health Insurance (NHI) according to the nature and volume of medical services provided annually. Patients receiving intravenous anticancer drugs (IADs) in a hospital setting generate services, while those receiving OADs shift a part of service provision from the hospital to the community. In 2013, two million outpatient IADs sessions were performed, representing a cost of €815 million to the NHI, but positive contribution margin of €86 million to hospitals. Substitution of IADs by OADs mechanically induces a shortfall in hospital income related to hospitalizations. Such economic constraints may partially contribute to making physicians reluctant to prescribe OADs. In the US healthcare system, coverage for OADs is less favorable than coverage for injectable anticancer drugs. In 2006, a Cancer Drug Coverage Parity Act was adopted by several states in order to provide patients with better coverage for OADs. Nonetheless, the complexity of reimbursement systems and multiple reimbursement channels from private insurance represent real economic barriers which may prevent patients with low income being treated with OADs. From an organizational perspective, in both countries the use of OADs generates additional activities related to physician consultations, therapeutic education and healthcare coordination between hospitals and community settings, which are not considered in the funding of hospitals activities so far.SummaryFunding of healthcare services is a critical factor influencing in part the choice of cancer treatments and this is expected to become increasingly important as economic constraints grow. Drug reimbursement systems and hospital financing changes, coupled with other accompanying measures, should contribute to improve equal and safe patient access to appropriate anticancer drugs and improve the management and care pathway of cancer patients.

外来患者に対する経口抗がん剤の薬歴管理導入の有用性

Medication history management has been conducted for all patients in Kitasato Institute Hospital, Kitasato University, who were administered with injectable anticancer drugs; however, the medication history management of oral anticancer drugs was not adequately addressed. In this study, we started the medication history management for oral anticancer drugs that were administered, and investigated the usefulness of this practice. The medication history management of S1 and Capecitabine was started from May 2010, and in January 2011, the medication history management of all oral anticancer drugs, whose washout period was specified on the package, was started. The number and details of inquiries on the prescription of oral anticancer drugs between May 2009 and April 2011 were investigated. The number of the prescription inquiries after the introduction of the medication history management was 129, which was 6.5 times higher than that observed before the introduction. With respect to the details of inquiries, most inquiries were related to the “date of administration commencement” (61.2％), followed by the “duration of prescription,” “administration schedule,” and “dose” (9.3％, 8.5％, and 7.8％, respectively). These results suggest that introducing the medication history management can contribute greatly to assuring the efficacy and safety of drug treatment for cancer.