
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 Several aliquots (5 mL) from each vial were withdrawn on days 0, 14, and 28.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 No signs of microbial growth were observed in any of the 7,000 samples withdrawn (3,500 in each environment) during the 28-day test period or in the residual growth medium remaining in the vial after all transfers were performed.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.
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.
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. 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). 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. 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 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 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 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.
The recommandations for the practical stability of anticancer drugs published in 2010 by the French Society of Hospital Pharmacists (SFPO) and the European Society of Oncology Pharmacists (ESOP) have been updated. Ten new molecules have been included (asparaginase, azacitidine, bevacizumab, clofarabine, eribuline mesylate, folinate sodium, levofolinate calcium, nelarabine, rituximab, temsirolimus).
Abstract Introduction: The 2019 coronavirus pandemic has caused serious health crises around the world such as psychological reactions of health workers. The way we work (stress, anxiety, and psychological problems) and the activities assigned to pharmacists, such as vaccination, have changed. So, we conducted a survey to investigate their psychophysical well-being and the influence of vaccination on the daily work of pharmacists. Methods: The survey (translated into 9 languages and distributed online) on mental health was sent to all ESOP members in March 2021 and February 2022 and on vaccination in December 2020, March 2021, and February 2022. The data were analyzed using Excel (Microsoft Office 2016, Microsoft, Redmond, WA) and basic descriptive statistics. Results: Over 800 colleagues from different health areas and 62 countries took part in the survey. As a result of poor mental health and increased workload as a consequence of the pandemic, it was observed in 30% (2021) and 15% (2022) of respondents, while increased cooperation among healthcare workers was observed in 65% of responders. In the vaccination survey, less than half of the professionals surveyed were directly involved in the vaccination process, conducted mainly in hospitals at first and then in other centers to increase coverage, such as “Community Pharmacy.” For the first time, there have been reports of pharmacists authorized to administer vaccines in some countries. Conclusions: With the spread of the virus, the increased workload has affected the mental health of health workers. Although a slight improvement from 2022 vs 2021 was observed, there is a need now to work on improving mental health of health care workers, to protect/care about them, and also to ensure that they will not leave the profession to ensure health care for patients with cancer and COVID-19 (and in general to all patients). Vaccination was an opportunity for the pharmacist to play a more active role that reinforces the value of pharmaceutical practice.
Abstract Introduction: Metastatic breast cancer (mBC) remains incurable, with a median overall survival (OS) of approximately 3 years and a 5-year survival rate of approximately 25%, irrespective of the economic classification of the country where treatment is received. Cyclin-dependent kinase (CDK) inhibitors increase overall survival in both first and second-line settings in the treatment of hormone receptor–positive, human epidermal growth factor receptor 2–negative mBC. This retrospective cohort study investigated the progression-free survival in women with mBC receiving combination therapy with abemaciclib (CDK4/CDK6 inhibitor) and letrozole or fulvestrant as opposed to abemaciclib only. Methods: The study included all eligible women with stage IV breast cancer treated with abemaciclib at a private oncology facility in Johannesburg over the study period. Data were collected from medical records from April 1, 2019 to March 31, 2021. Analyses were conducted to assess the overall survival rate, progression-free survival probability, and safety of abemaciclib in women with stage IV breast cancer. Results: Thirty-two patients were eligible for inclusion in this study. The progression-free survival probability was 60% after a period of 17 months, irrespective of treatment options. After 17 months, the OS of women on a combination of abemaciclib and letrozole was 80%, on a combination of abemaciclib and fulvestrant was 80%, and on abemaciclib monotherapy was 70%. The most noted adverse effects were diarrhea (92.0%), neutropenia (92.0%), fatigue (48.0%), and hepatotoxicity (16.0%). Discussion: Abemaciclib with endocrine therapy or an aromatase inhibitor provided an improvement in the OS compared with abemaciclib monotherapy. These findings are representative of the use of abemaciclib in a local population and are similar to those of larger studies conducted internationally.
Abstract Introduction: At present, there is no supporting evidence-based therapy of proven efficacy to treat posterior fossa syndrome (PFS) after surgical resection of posterior fossa tumors in children where only 22% of patients may experience a full recovery. However, zolpidem, a nonbenzodiazepine hypnotics drug, seems to be a possible treatment option for PFS symptoms. Methods and Materials: This was a retrospective chart review for all children with brain tumors younger than 15 years diagnosed with confirmed PFS after surgical resection at King Abdulaziz Medical City, Jeddah, and received zolpidem to alleviate the PFS symptoms between May 2016 and April 2019. Results: A total of 6 pediatric patients who experienced PFS symptoms (median of 4 days, range 1–7 days) were included. The most commonly observed symptoms were irritability, hypotonia, swallowing deficit, unsteady walking, and delayed speech. To alleviate the PFS symptoms, zolpidem was commenced 2–5 days postoperatively. The median duration of use was 13.5 days. During the hospital course, recovery of speech was observed after 2 weeks in most patients (50%) while 83.3% of patients recovered their normal speech in 4 months although not fully ambulated. No discontinuation of zolpidem use was reported because of adverse events. Conclusion: Most of our children (83.3%) who experienced PFS postresection responded to zolpidem trials which may represent a promising research field.
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.
Abstract Tamoxifen plays a key role in hormone therapy for patients with breast cancer. However, studies have reported inconsistent responses to the drug because of different factors. Among these, allelic variants of cytochrome P450 genes are important. This study aims to determine the polymorphic variants of CYP2D6 gene in patients with breast cancer who underwent tamoxifen hormone therapy, classifying them according to their phenotypes as poor, intermediate, extensive, or ultrarapid metabolizers and describing clinical outcomes, such as time to relapse and overall survival (OS). This was a case series study conducted in 47 patients diagnosed with breast cancer, between 2015 and 2018. Whole-blood samples were collected, and DNA was extracted. CYP2D6 gene alterations were assessed. The mean age was 61 ± 11 years. Ductal carcinoma occurred in 85%, of which 42% was grade 2. The predominant stages of breast cancer were IIB in 26% and stage I in 32%. Extensive phenotype metabolizers were identified in 92%, poor in 6%, and intermediate in 2% of participants. Relapse was reported in 30% of participants, with metastatic relapse in 86%, which was more frequently identified in poor metabolizers. The OS at 5 and 10 years was 91%, regardless of phenotype. OS was 90% at 5 and 10 years for extensive metabolizers. Although the sample size was very small to make significant comparisons, it was observed that both poor and extensive metabolizing patients experienced some form of relapse. The OS of patients with the extensive metabolizer phenotype in this study is similar to that reported worldwide.
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 Introduction: A new pemetrexed salt, pemetrexed diarginine (PDA), was marketed by Mylan company. The product is a ready-to-dilute 25 mg/mL solution. The manufacturer indicates a 24-hour stability after dilution in dextrose 5% (D5W). The objectives were to study the stability of: PDA in D5W and 0.9% sodium chloride (0.9% NaCl) polyolefin bags at 3 and 12 mg/mL protected from light (PFL) between 2 to 8°C and at 25°C, and not PFL at room temperature; PDA vials at 25 mg/mL partially used perforated with a plastic spike PFL between 2 to 8°C and at 25°C and not PFL at room temperature. Methods: The stability study was performed by high-performance liquid chromatography coupled to a photodiode array detector. The method was validated according to International Council for Harmonisation guideline Q2(R1). Physical stability was evaluated by visual and subvisual inspection. pH values were measured. Results: PDA solutions PFL in D5W and in 0.9% NaCl at 3 and 12 mg/mL retained more than 95% of the initial concentration after 7 days at 25°C and after 28 days at 2 to 8°C. PDA ready-to-dilute 25 mg/mL solutions PFL retained more than 95% of the initial concentration after 28 days at 25°C and 2 to 8°C. PDA solutions in D5W and in 0.9% NaCl at 3 mg/mL and 12 mg/mL and PDA ready-to-dilute 25 mg/mL solutions not PFL retained more than 95% of the initial concentration after 7 days at room temperature. All samples had a pH in the range of 8.05 to 8.77. A light colouration, described in SPC, to an intense yellow-brown colouration, appeared depending on concentration and time. No precipitate was observed. Conclusion: According to the manufacturer's specifications and to the chemical stability defined as more than 95% of the initial concentration, PDA solutions in D5W and in 0.9% NaCl at 3 and 12 mg/mL and PDA ready-to-dilute 25 mg/mL solutions PFL at 25°C and not PFL at room temperature were stable for 7 days and for 28 days at 2 to 8°C. The absence of a color change as an acceptance criterion for the 25 mg/mL ready-to-dilute solution perforated with a plastic spike leads to a stability of 7 days at 2 to 8°C and 4 days at room temperature allowing the use of the vial for a preparation in advance with an optimal stability.
Abstract Increasing costs of cancer treatment and anticancer drugs can create a financial burden on society and the individual. Pembrolizumab is an anti-PD-1 inhibitor immunotherapy approved for use in recurrent or metastatic head and neck squamous cell carcinoma. Limited data exists on the cost-effectiveness of pembrolizumab in this setting. This study compares the costeffectiveness of pembrolizumab against traditional chemotherapy using data from KEYNOTE-040. Published data from KEYNOTE-040 were used to create a model estimating treatment costs and overall survival benefit of pembrolizumab and traditional chemotherapy. Costs of treatment of toxicity-related events were obtained from previous literature and were incorporated into the model. Derivation of survival benefit gained from treatment was measured in quality-adjusted life-years (QALYs). The incremental cost-effectiveness ratio (ICER) of pembrolizumab compared to the investigator's choice (IC) was $801,864/QALY. The average drug cost of pembrolizumab would have to approximately decrease by 63% in order to reach the cost-effective threshold of $100,000/ QALY. Pembrolizumab would have to confer a survival benefit of 0.88 QALYs per patient over the IC to reach the cost-effective threshold. Pembrolizumab is not considered cost effective at a threshold of $100,000/QALY based on survival data reported in KEYNOTE-040. Improved long-term outcomes of patients on this relatively new immunotherapy have yet to be reported. Inclusion of these data in the future would likely improve the cost-effectiveness calculations of pembrolizumab and other immunotherapies.
Abstract Introduction: The European Society of Oncology Pharmacy (ESOP) has nearly 4000 members in 66 countries. Periodically, the needs and interests of the members as well as the predictions of the members for the development of the profession of oncology pharmacy are mapped by the board of the Society. The aim of these inquiries is to help focus the Societies' advocacy works, knowledge exchange, and scientific and educational programs into those areas where the members deem this most needed. Methods: One survey into the future of oncology pharmacy was held in 12 individual countries during a national meeting on the topic of oncology pharmacy. In this survey, the forecasts of the members were researched. A second survey was held under the full membership to identify the topics of most interest within the broader field of oncology care. Results: Five hundred ninety-five colleagues responded to the future of oncology pharmacy survey and 757 to the topics of interest survey. Participating respondents came from 53 individual countries. Combined, the results show that both clinical care (in multiprofessional treatment teams) and education are important areas for the Society to continue paying attention to. The other important aspect of oncology pharmacy, which includes the practical and safety aspects of compounding, remains of great interest, especially regarding technical innovations such as robotics. Conclusion: ESOP will remain focused on its initial aim: to support optimal treatment for patients with cancer. The globally collated data from the two surveys show that both the clinical and the practical sides of the profession deserve continuing advancement.
Abstract Introduction: Pharmacists can contribute to improve prevention and management of patients treated with oral anticancer drugs. The aim of this study was to describe pharmacist interventions in drug-related problems (DRPs), medication optimization, and patient management. Methods: The pharmaceutical process allows obtaining exhaustive list of usual patient treatment, patient education, and telephonic follow-up at home. During pharmacy consultation and telephonic follow-up, the number and type of pharmacist interventions were collected and classified into 3 categories: DRPs, medication optimization, and patient management. During telephonic follow-up, pharmacists detected adverse events. Results: From February 2016 to May 2020, 224 pharmacy consultations were conducted. A total of 508 pharmacist interventions (248 for pharmacy consultation and 260 for telephonic follow-up) were conducted, with an average of 2.3 pharmacist interventions per patient. Pharmacist interventions were 44.4% for patient management, 29.6% for DRPs, and 26.0% for medication optimization. After pharmacy consultation, 36.2% of patients' usual treatments were amended. Two hundred thirteen adverse events (AEs) were reported, and 38.8% of patients had one or more AEs. AEs detected were 15 for temporary discontinuation of oral anticancer drugs, 25 for emergency consultations, and 3 for hospitalizations. Conclusion: Pharmacy consultation has shown that pharmacists can contribute to optimize medicinal care for patients with cancer.
Abstract Introduction: The SARS-CoV-2 pandemic stroke at the beginning of 2020, challenging the health systems worldwide. As hospitals became overwhelmed by the number of cases, and community pharmacies became one of the few non-stop operating services, and the work rhythm and workload of pharmacists changed importantly. Methods: To investigate which and how the changes occurred, especially among oncology pharmacists, the ESOP together with the EAHP developed a survey, translated to 9 languages, and distributed online. The questions were changed over the duration of the survey (August 2020 to March 2021), adapting to the global situation. The answers were analyzed with basic descriptive statistics. Results: Over 1000 health professionals, predominantly pharmacists (over 85%), from 64 countries participated in the monthly survey, providing information relevant to both the hospital and the community pharmacy. More than 50% of hospital pharmacists reported shortage of chemotherapeutics, while the availability of COVID-19 related medications had more fluctuations in the hospital pharmacy. Contrastingly, over 80% of community pharmacists reported medications shortages in April 2020. The survey showed the negative impact of the pandemic on chemotherapeutic preparations, with decreased productions during the first and second waves (February-May 2020, and November 2020 to January 2021). The survey also helped visualize the stress levels and workloads of pharmacists. More than 70% of participants reported in August 2020 to have needed to procure themselves with Personal Protective Equipment. Working hours increased for 43% of the respondents, and more than 60% reported to have felt emotionally stressed. Conclusions: Thus, the presented results give a broad, yet detailed overview of how the pandemic has affected health professionals both in the hospital and the community, how professionals and governments have reacted to the situation, and how the care of oncology patience and the practice of oncology pharmacy has changed and reacted during the first year of the SARS-CoV-2 pandemic.
Abstract Myeloid leukemia with Down syndrome (ML-DS) is a unique entity of acute myeloid leukemia (AML) with superior treatment response and overall survival compared with children with AML. However, despite the advances in treatment approaches, ML-DS survival rates for children in low- and middle-income countries remain poor. In this article, we describe 3 cases of ML-DS, which were treated with a novel protocol using vincristine, cytarabine, and daunorubicin plus triple intrathecal drugs. All the 3 patients successfully finished the treatment, with 2 patients in complete remission until now. One patient died because of uncontrolled bleeding for 2 days after finishing the chemotherapy regimen. Our findings indicate that using our treatment protocol, ML-DS is treatable in limited-resource settings such as that in Manado, Indonesia.