Abstract We examined whether a closed-system transfer device (CSTD) can maintain the microbiological integrity of nonpreserved single-use drug vials for an extended period beyond the approved indication for use of 7 days and 10 activations (connection–disconnection cycles) and throughout multiple withdrawals. The CSTD's ability to maintain sterility was examined in a controlled International Organization for Standardization (ISO) class 5 (European Union Good Manufacturing Practice class A) environment and a monitored but uncontrolled environment. In each environmental condition, CSTD vial adaptor units of 20-mm neck size were mounted on three hundred fifty 100-mL glass vials, each containing 100 mL of sterile tryptic soy broth growth medium. Several aliquots (5 mL) from each vial were withdrawn on days 0, 14, and 28. All syringes and the vials containing the remaining growth medium (50 mL) were incubated for 7 additional days between 20 and 25 °C, followed by 7 days between 30 and 35 °C. Incubated samples were inspected for microbial growth daily. No signs of microbial growth were observed in any of the 7,000 samples withdrawn (3,500 in each environment) during the 28-day test period or in the residual growth medium remaining in the vial after all transfers were performed. The study's findings indicate that the tested CSTD safeguards the microbiological sterility of drug preparations for up to 4 weeks after the first puncture. Once a 28-day usage period is approved by regulatory authorities, it may help avoid wasting expensive drugs.

Abstract A second update of the recommendations for the practical stability of anticancer drugs published in 2013 has been realized by the French Society of Hospital Pharmacists (SFPO); European Society of Oncology Pharmacists (ESOP); and members of the Stabilis® database (www.stabilis.org), a stability and compatibility database of drugs. Forty-six new molecules have been included. These new data make it possible to optimize anticancer drug preparations and achieve product savings. These new recommendations have to be taken into consideration only if the preparation is made according to the Good Manufacturing Practices in classified rooms.

Abstract Context: Over the course of over 20 years, trastuzumab has been a keystone in the treatment of human epidermal growth factor receptor 2–positive breast cancer. Trastuzumab administered both intravenously and subcutaneously show consistent pharmacokinetic characteristics and have been shown to have similar levels of safety and effectiveness. Objectives: Our study's main objective was to perform a thorough comparison of the medical and pharmaceutical expenses related to the two different pharmaceutical formulations. We specifically want to evaluate the financial effects of treating individuals weighing between 60 and 73 kg with trastuzumab, which was initially administered subcutaneously, in 1,474 treatment cases. Our study includes a simulation analysis that takes into account multiple scenarios and accounts for both the cost of the medication and the related medical bills. Results: From a database containing 542 patients with cancer, the study collected 4,437 therapy cases in total divided into three categories: initial dose, loading dose, and maintenance dose. 65.1% of the patients weighed less than 69 kg. In 62.9% of instances, the hospital pharmacy provided subcutaneous trastuzumab. For patients with cancer weighing between 60 and 73 kg, the simulated scenarios included the computation of overall expenses (subcutaneous [SC]: 1,370,516.60 USD and intravenous [IV]: 941,178.42 USD) and possible budget savings if the therapies were administered in IV rather than SC, totaling 428,765.60 USD. Conclusion: Beyond just taking medication costs into account, our research may help to clarify the differences between pharmaceutical formulations intended for IV and SC administration. In reality, we recognize that other variables—like the patient's weight and the financial models used by oncology institutions and health care workers—may also be quite important.

Background: Despite the use of multimodal therapy to treat high-risk neuroblastoma, the prognosis of this patient population remains poor. The addition of dinutuximab-beta to standard maintenance therapy after autologous peripheral blood stem cell transplantation (auto-PBSCT) has been found to improve survival rates. We present treatment outcome of high-risk neuroblastoma (HR NBL) before and after the introduction of dinutuximab-beta in comprehensive large cancer centers in Saudi Arabia. Materials and Methods: This is a multicenter retrospective chart review of all patients aged 1–14 years diagnosed with HR-NBL who received multimodal therapy including dinutuximab-beta during maintenance phase after auto-PBSCT compared with patients who did not receive between 2015 and 2020. Supportive therapy was administered to manage dinutuximab-beta-associated adverse events. Results: The treatment outcome was evaluated for 32 patients (21 received dinutuximab-beta and 11 patients did not receive it). Among 21 patients who received dinutuximab-beta, 12 (57.1%) patients received all planned five cycles of dinutuximab-beta (cumulative 100% of the dose) and 9 (42.9%) patients received less than 5 cycles of dinutuximab-beta maintenance mainly secondary to toxicities, which is reported in 11.1%, and progressive disease during dinutuximab-beta therapy, which is reported in 88.9%. The 5-year mean and median survival were 67.3 and 99 months, respectively, while the overall survival (OS) rate was approximately 57%. The mean and median disease-free survival (DFS) were 36.3 and 20 months, respectively, while the DFS rate was approximately 22%. There was nonsignificant difference in OS and DFS between patients who received dinutuximab-beta and patients who did not receive it (P values 0.970 and 0.113). From all examined factors, there were no statistically significant differences between patients who received dinutuximab-beta and patients who did not receive it with the baseline characteristics, except for relapse status with P = 0.013, time from PBSCT to relapse with P = 0.023, and mortality with P=0.049. Dinutuximab-beta maintenance treatment was generally well tolerated with proper use of supportive therapy, with the most prevalent toxicities being nonhematological in nature and being reported in 52%. Conclusion: There is a noticeable improvement and reduction in disease progression-free survival with manageable adverse events in patients who received dinutuximab-beta maintenance therapy, but the overall survival rate remains unchanged.

Abstract Introduction: Exposure to antineoplastic drugs can lead to adverse health effects such as fetal loss and DNA damage. Oncology pharmacy facilities should implement best pharmacy practice guidelines to protect pharmacy personnel. The objective of this study was to assess South African oncology pharmacy facility workplace and personnel work practices, guided by internationally accepted best practice guidelines. Methods: A cross-sectional pilot study was conducted in 6 oncology pharmacy facilities (one personnel member per facility) of 2 South African oncology pharmacy service providers. Using a simple checklist, comprising 7 assessment categories and 43 questions derived from best practice guidelines, work and workplace practices were scored as compliant, partially compliant, or noncompliant. Each facility and service provider were also given an overall score. Results: Overall scores for the 6 facilities ranged from 33.1% to 79.3%. Service provider 2 pharmacy facilities (which were assessed as being compliant overall) scored higher at 78.0% ± 1.5 (76.4%–79.3%) than service provider 1 pharmacy facilities, which were noncompliant overall at 40.2% ± 21.5 (33.1%–49.9%). Categories in which performance was poor included the presence of engineering controls, use of personal protective equipment, and medical monitoring. Conclusion: The complexities of South African oncology pharmacy facilities highlight the need for stricter regulation. Despite operating under the auspices of managed care organizations, some facilities' work practices were poor. It is recommended that service providers implement international best practice guidelines.

Abstract Introduction: The European Society of Oncology Pharmacy (ESOP) Global has almost 4000 members across 70 countries. Over the past few decades, the focus of oncology pharmacists has shifted, from a mostly product-based role to include a patient-centric care model, often termed clinical pharmacy. To map the advancement of the integration of clinical pharmacy into daily oncology pharmacy practice, a survey was conducted among the members of the ESOP Global in 2023. Methods: A survey comprising 28 questions was distributed across the full ESOP Global membership. Questions were grouped to obtain demographic results (first section), the practice of clinical pharmacy (second section), and barriers to providing clinical oncology pharmacy (third section). Results: Overall, 314 colleagues responded to the clinical oncology pharmacy survey from 59 individual countries in Europe, Asia, Africa, and America, yielding a response rate of 28.6%. Overall, all participants who responded to the survey reported being involved in one or more tasks associated with clinical oncology pharmacy, with the highest responses in the section's patient counseling (62.5% of participants actively counseling outpatients) and drug–drug interaction checking (performed by 58% of participants). Furthermore, almost 50% of participants indicated that their pharmaceutical interventions are always or usually accepted by doctors. Conclusions: This survey showed that there is currently an operational clinical oncology pharmacy service in all countries surveyed. This may provide a reference for policymakers, promote international communication, and shed light on the future development of clinical pharmacies in oncology settings. These survey findings may also help guide future education strategies for the ESOP Global and other providers of oncology pharmacy education.

Abstract Targeted therapies such as cyclin-dependent kinase 4 and 6 inhibitors (CDK 4/6i) have improved the prognosis of hormone receptor-positive/human epidermal growth factor receptor-2 negative (HR+)/(HER2–) advanced/metastatic breast cancer (a/mBC) by combating the resistance observed with traditional endocrine therapy. Currently, palbociclib, ribociclib, and abemaciclib are the three medicinal products authorized by the European Medicines Agency and the Food and Drug Administration. In addition to their overall similarities, related to their primary molecular mechanism of action through CDK4/6 inhibition, they also exhibit significant pharmacodynamic differences that affect their efficacy and safety profile, which may, through further research, help in understanding predicted toxicity, safety, and interactions and assist in adjusting dosing regimens in daily clinical practice. This review article will examine the pharmacodynamic profile of CDK4/6 inhibitors, their efficacy and safety in the treatment of HR+/HER2– a/mBC.

Abstract The external gastric effect of H. pylori is not restricted to the liver. In this study, we will detect this fact through the effect of this bacterial infection on the normal physiological function of the liver. The passive negative effect of Helicobacter on the liver is reflected as hepatitis. Hepatitis causes alteration in the normal physiological function of the liver on different levels, starting from the normal enzyme secretion level to the hormonal level, which is secreted by the liver to regulate the normal function of other systems. The aim of this study was to find this fact by comparing some parameters from the patient (with gastric ulcer) with those of a normal noninfected individual. The parameter is icterus in the patient as a clinical sign that reflected hepatic abnormality and hepatitis detected by a highly skilled clinician. A recent study with a case-control design connected hepatitis and its functional abnormalities in a patient with gastric ulcer who was infected by H. pylori. A total of 382 patients were included as the sample from a community of 60,000 patients in a specific area of Mosul, Iraq. The total population of this city is around 1.5 million. According to a previous study, it is estimated that 0.02% of the city population suffers from gastric ulcers caused by H. pylori. The sample was collected by highly skilled staff along with specialist clinicians. The data were analyzed using SPSS 25 by the specialized staff. We monitored the negative effect of H. pylori on different aspects of infected patients, especially hepatic inflammation and its abnormal physiological function. In this study, icterus is used as a clinical indicator for hepatic abnormalities.

Abstract Introduction: Pertuzumab is a humanized monoclonal antibody used in the treatment of human epidermal growth factor receptor 2–positive early breast cancer. Its use can lead to a type-I hypersensitivity, which can be the result of an IgE-related reaction. This case describes a successful desensitization to pertuzumab in a patient diagnosed with a breast cancer. Method: A patient without a personal history of hypersensitivity and diagnosed with a human epidermal growth factor receptor 2–positive breast cancer was started on chemotherapy with association of trastuzumab, pertuzumab, and paclitaxel. While receiving the fourth cycle of pertuzumab, the patient developed a grade 2 hypersensitivity reaction resolved by the intravenous injection of dexchlorpheniramine and methylprednisolone. A premedication protocol has been setting up with a short desensitization protocol. Results: No adverse event occurred during the desensitization, which permits to continue pertuzumab at normal dose with a low occurrence of adverse events (spontaneous and favorable resolution). On analyzing the suspected adverse drug reaction, the event scored 10 and can found to be considered definite using the Naranjo Adverse Drug Reaction Probability Scale. This successful protocol of desensitization has helped to inhibit a hypersensitivity reaction. The monitoring showed the well-tolerance of the patient. Conclusion: This desensitization avoided a too early changing line treatment, which could have been deleterious. Very few cases of pertuzumab hypersensitivity occurred in France, and none benefited from a desensitization. This case illustrated the fact that rapid drug desensitization is possible, important and a simple opportunity to pursuit effective treatments.

Abstract Background: A fundamental requirement to ensure the safety of health care workers is to reduce environmental contamination with cytotoxic medicines. Objectives: The primary objective of this collaborative project between the European Society of Oncology Pharmacy (ESOP) and the European Society for Medical Oncology (ESMO) was to evaluate cytotoxic medicine contamination on surfaces in European hospital wards. The secondary objectives were (a) to detect possible internal bodily exposure in staff members and (b) to evaluate the impact of teaching safe handling practices. Materials and methods: Surface contamination in the chemotherapy administration areas was measured in 28 hospitals from 16 European countries before (part I) and after (part II) staff training through a standardized tutorial. Contamination with four antineoplastic medicines and total platinum was assessed using wipe samples taken from four comparable surfaces in each part of the project. In addition, hospitals that showed a high level of surface contamination, collected 24-hour urine of five staff members (part III). The samples were analyzed by liquid chromatography-mass spectrometry/mass spectrometry (LC-MS/MS) and inductively coupled plasma-mass spectrometry (ICP-MS). Results: In total, 112 and 104 wipe samples (part I and part II) and 32 urine samples (part III) were collected. Surface contamination occurred in all participating hospitals. The most contaminated spot was the floor in the nurses' station. The most frequently found compound was platinum, and the medicine that showed the highest amount of contamination was cyclophosphamide (8.18 ng/cm2 in part I and 0.53 ng/cm2 in part II). Urine samples were positive for gemcitabine and cyclophosphamide in 1 and 2 nurses, respectively. The intervention by tutorial lowered the levels of contamination, both in number (from 48% to 41%) and in amount of contamination. Conclusion: The MASHA-2 study shows that contamination of surfaces with cytotoxic medicines in European hospitals is a widespread phenomenon. Bodily exposure of nurses was clearly detected. Surface contamination decreased after training on safe handling practices. Nevertheless, further optimization of occupational safety is warranted.