Drug cost avoidance in clinical trials of breast cancer.

BACKGROUND: The objectives of this study were to determine if clinical trials in breast cancer, with an investigational drug, created direct drug cost savings for the healthcare system related to cost avoidance of the best standard of care treatments used in these studies. The aim was to quantify this potential drug cost avoidance. METHODS: We conducted a retrospective observational study of the drug cost avoidance during the study period (2014-2016). We included clinical trials with investigational drug, managed by pharmacy department and provided by the sponsor. The patients included had a therapeutic alternative defined as standard treatment that should have been received in case of not participating in the clinical trial. Direct cost savings, to national healthcare system, associated to clinical trials were calculated. RESULTS: Thirty-seven clinical trials with a total of 89 breast cancer patients were included in the study. A total of 62.2% were phase III and 75.7% belonged to the pharmaceutical industry. They provided a total cost avoidance of 957,246€ (1,130,028$), an average cost avoidance per patient of 10,756€ (12,697$). CONCLUSIONS: Our study suggests that those clinical trials in which investigational drug are provided or refunded by the sponsor provide substantial cost savings. Due to the shortage of published articles that calculate the cost avoided in medication, we cannot compare directly the results obtained in the different institutions.

Concomitant use of sorafenib with ombitasvir/paritaprevir/ritonavir and dasabuvir: Effectiveness and safety in clinical practice.

WHAT IS KNOWN AND OBJECTIVE: No studies have evaluated the use of sorafenib with the direct-acting antiviral ombitasvir/paritaprevir/ritonavir and dasabuvir (OBV/PTV/r+DSV). CASE SUMMARY: Three hepatitis C virus genotype 1b-infected patients with well-preserved liver function were included in this prospective case series. The patients were taking sorafenib for advanced hepatocellular carcinoma and received OBV/PTV/r+DSV for 12 weeks. One patient discontinued sorafenib while concomitant treatment due to grade 2 fatigue and muscular pain. The other two patients reported only grade 1 adverse effects. Sustained virologic response at 24 weeks was achieved, and no tumour recurrences were found. WHAT IS NEW AND CONCLUSION: The concurrent use of OBV/PTV/r+DSV with sorafenib was considered safe and effective.

Pharmacotherapy follow-up of key points in the safety of oral antineoplastic agents.

We assessed the impact of a pharmacotherapy follow-up programme on key safety points [adverse events (AE) and drug administration] in outpatients treated with oral antineoplastic agents (OAA). We performed a comparative, interventional, quasi-experimental study of outpatients treated with OAA in a Spanish hospital to compare pre-intervention group patients (not monitored by pharmacists during 2011) with intervention group patients (prospectively monitored by pharmacists during 2013). AE data were collected from medical records. Follow-up was 6 months, and 249 patients were included (pre-intervention, 115; intervention, 134). After the first month, AE were detected in 86.5% of patients in the pre-intervention group and 80.6% of patients in the intervention group, P = 0.096. During the remaining months, 79.0% patients had at least one AE in the pre-intervention group compared with 78.0% in the intervention group, P = 0.431. AE were more prevalent with sorafenib and sunitinib. In total, 173 drug interactions were recorded (pre-intervention, 80; intervention, 93; P = 0.045). Drug interactions were more frequent with erlotinib and gefitinib; food interactions were more common with sorafenib and pazopanib. Our follow-up of cancer outpatients revealed a reduction in severe AE and major drug interactions, thus helping health professionals to monitor the safety of OAA.

Optimisation of antithrombotic therapy in patients with acute coronary syndrome to reduce bleeding episodes.

AIM: The aim of the study was to evaluate the effectiveness of a multidisciplinary intervention to reduce the risk of bleeding associated with antithrombotic drugs in patients with acute coronary syndrome (ACS). METHODS: We designed a pre-post quasi-experimental intervention study using retrospective cohorts. The first cohort was analysed to detect correctable measures contributing to bleeding (PRE: January-July 2010). Second, a bundle of interventions was implemented and third, a second cohort of patients was evaluated to investigate the impact of our measures in bleeding reduction (POST: September 2011-February 2012). RESULTS: A total of 677 patients were included (377 in PRE and 300 in POST). The bundle of interventions was: Overdose avoidance measures: the percentage of patients overdosed was reduced by 66.3% (p < 0.001). Institutional protocol update to include the latest recommendations regarding bleeding prevention: In POST, the percentage of patients treated with fondaparinux increased (2.4% vs. 50.7%; p < 0.001). In PRE, 11 patients were treated with the combination of abciximab and bivalirudin; whereas in POST, only one patient received the combination (p = 0.016). Mandatory measurement of body weight: the percentage of patients with unknown body weight was reduced by 35% (p = 0.0001). In POST, the total bleeding rate was reduced by 29.2% (31.6% in PRE vs. 22.4%, p < 0.05, OR: 0.62; 95% CI: 0.44-0.88). It was necessary to implement the interventions in 11 patients to prevent one bleeding episode (95% CI: 7-39). CONCLUSION: The multidisciplinary programme has been effective in reducing bleeding episodes. The interventions were effective in reducing antithrombotic drugs overdosage, incorporating the use of fondaparinux to the NSTE-ACS therapeutic arsenal, limiting the use of bivalirudin with abciximab and obtaining body weight for most patients.

Decreased INR after acenocoumarol, ombitasvir/paritaprevir/ritonavir and dasabuvir co-administration.

WHAT IS KNOWN AND OBJECTIVE: Limited data are available on co-administration of acenocoumarol with direct-acting antiviral agents for chronic hepatitis C virus infection. CASE SUMMARY: We report a case of a patient who required a significant increase in acenocoumarol weekly dose probably due to an interaction with ombitasvir/paritaprevir/ritonavir and/or dasabuvir. A causality assessment of the drug-drug interaction leading to a reduced INR was conducted according to the Naranjo algorithm. A score of 6 suggested that the adverse drug reaction was probable. WHAT IS NEW AND CONCLUSION: Because of possible INR abnormalities during the concomitant use of acenocoumarol, ombitasvir/paritaprevir/ritonavir and dasabuvir, clinicians should closely monitor INR values.

Implementation of an enhanced recovery after surgery program including a patient school: Impact on quality of life results.

INTRODUCTION: Enhanced Recovery After Surgery (ERAS) protocols and educational programmes have been shown to accelerate orthopaedic surgery recovery with fewer complications, and improve patient-reported outcomes (PROs) for different types of surgery. The objective was to evaluate the impact of an ERAS programme including a patient school on health outcomes and PROs for Total Knee Replacement (TKR) surgery. MATERIAL AND METHODS: A multidisciplinary group created the programme and the patient school (preoperative consultations where the patients' surgical processes are explained and are also given instructions for an appropriate perioperative care management). An observational, prospective study was conducted on all patients operated for TKR from March 2021 to March 2022. Main health outcomes were: hospital stay length, surgical complications and surgery cancellations due to a wrong preoperative medication management. PROs evaluated were: patient satisfaction with pain management, the school, and quality of life before and after surgery (EQ-5D). RESULTS: One hundred thirty-three patients were included. Median hospital stay length was 3 days (IQR 3-5). Rate of surgical complications was 25.6%. No surgery was cancelled. Patient satisfaction rates with pain management and with the school were 8.10/10 and 9.89/10, respectively. Concerning quality of life, mean improvement in mobility and knee pain after the surgery was 0.66 (p < 0.05) and 0.84 (p < 0.05), respectively. CONCLUSIONS: The ERAS programme including a patient school was highly successful with a fast recovery, a short hospital stay length, no surgery cancellations, and improved PROs.

[Failure mode and effects analysis to improve quality in clinical trials]. / Análisis modal de fallos y efectos para mejorar la calidad en los ensayos clínicos.

INTRODUCTION: The failure mode and effects analysis (FMEA) has been used as a tool in risk management and quality improvement. The objective of this study is to identify the weaknesses in processes in the clinical trials area, of a Pharmacy Department (PD) with great research activity, in order to improve the safety of the usual procedures. METHODS: A multidisciplinary team was created to analyse each of the critical points, identified as possible failure modes, in the development of clinical trial in the PD. For each failure mode, the possible cause and effect were identified, criticality was calculated using the risk priority number and the possible corrective actions were discussed. RESULTS: Six sub-processes were defined in the development of the clinical trials in PD. The FMEA identified 67 failure modes, being the dispensing and prescription/validation sub-processes the most likely to generate errors. All the improvement actions established in the AMFE were implemented in the Clinical Trials area. DISCUSSION: The FMEA is a useful tool in proactive risk management because it allows us to identify where we are making mistakes and analyze the causes that originate them, to prioritize and to adopt solutions to risk reduction. The FMEA improves process safety and quality in PD.

[Internal invoicing of end products manufactured by a hospital Pharmacy Department] / Facturación interna de los productos finales elaborados por el Servicio de Farmacia Hospitalaria.

OBJECTIVE: To calculate actual costs of end products manufactured by a Pharmacy Department. MATERIAL AND METHODS: Quality standards, overall production in relative value units (RVUs), and complexity degree of a pharmacy department are assessed. Actual cost of RVUs and manufactured end products is calculated. RESULTS: The Pharmacy Department is classified as quality level II. The total number of produced RVUs is 2,334,355.86, with a complexity degree of 2.20 and a cost per RVU of 0.87 euros. Pharmacy Department cost imputation per RVU has relevant discrepancies when compared to traditional shared cost systems regarding drug consumption. CONCLUSIONS: The inclusion of a product catalogue within Pharmacy Departments allows overall and department-specific activities to be acknowledged, as well as mean complexity, strengths and issues in need of improvement, in order to include them within pharmacy department planning. Furthermore, it allows for more realistic product charging to requesting departments.