Physicochemical stability of bortezomib solutions for subcutaneous administration.

For the majority of cytotoxic drug preparations, such as bortezomib, the unit dose information is not available. In addition, there is a lack of information on the physicochemical stability of the pharmaceutical preparation after opening; this information is crucial for its administration to patients in successive visits, and the per-patient cost can be affected. The purpose of our proposed physicochemical stability study is to determine the shelf life of the reconstituted liquid product under refrigeration and clinical practice conditions. This evaluation was extended to both vials and ready-to-use syringes prefilled with the contents of the open vial. The stability test design includes the specified storage conditions and the critical physicochemical parameters of reconstituted injectable bortezomib. Furthermore, this approach includes the determination of impurities, the monitoring of the purity of the mean peak using a photodiode array, the control of the mass balance, the monitoring of subvisible particles using a laser diffraction analyser, and the setting of stability specifications. For the chemical stability study, the amount of bortezomib and its degradation products were determined using a stability-indicating HPLC method. The physical inspection of the samples was performed throughout the stability study, and their pH values were also monitored. Bortezomib (2.5 mg/mL) in 0.9% sodium chloride remained stable for 7 days when stored in both polypropylene syringes and vials at 5 ± 3 °C (refrigeration) and shielded from light. Additionally, it exhibits stability for 24 h under storage conditions simulating clinical use (20-30 °C and protected from light). The proposed protocol provides the stability in the vials once reconstituted and in prefilled refrigerated syringes; this protocol can be used to reduce waste and increase cost savings.

Prevención de eventos adversos cardiacos relacionados con el uso de fármacos en pacientes con trastorno mental grave: a propósito de un caso / Prevention of cardiac adverse events associated with the use of drugs in patients with severe mental illness: case report

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Electrocardiographic surveillance in a psychiatric institution: avoiding iatrogenic cardiovascular death.

OBJECTIVE: To describe a new initiative developed to optimise patient safety in a mental health setting in order to prevent serious cardiac events. MATERIALS AND METHODS: A longitudinal study of all in-patients admitted at the hospital, comprised of 197 beds distributed among three units, was conducted for 12 months. All admitted patients at the hospital underwent electrocardiogram surveillance, as it was described in our new local guideline for sudden cardiac death prevention. When electrocardiographic alterations were detected, treating physicians searched for patient's risk factors and suspicious medication and communicated the adverse event to the Pharmacy Department. These data were registered in electronic medical record system. RESULTS: Over the 12-month study period, 225 patients were evaluated and 9 cases (4%) of long QT segment were detected. A multidisciplinary evaluation was done and it resulted in treatment modification and patient close monitoring. No sudden cardiac deaths occurred during the study period. Drugs more often involved in QT segment prolongation were: olanzapine, clomipramine, clozapine and risperidone. CONCLUSION: QT segment interval enlargement is a frequent clinical problem that affects patients with mental pathology. This inexpensive initiative has allowed identifying patients at risk of sudden cardiac death and has helped to avoid mayor side effects.