Search

SummaryWhat is known and objective Primary immune thrombocytopenia (ITP) is characterized by accelerated platelet destruction, as well as suboptimal platelet production. Thrombopoietin (TPO) receptor agonists bind to and activate human TPO receptor, and have been shown to increase platelet counts. In this study, we assessed the effectiveness and safety of long-term administration of TPO agonist romiplostim in adult and paediatric patients. Methods This is a retrospective observational study that included every ITP patient (adults and children) who received romiplostim since its inclusion in our institutional formulary. Data on patients' demographics, romiplostim doses, platelet counts, use of rescue medication and concurrent therapies were collected. Outcomes for effectiveness evaluation were proportion of patients who achieved a platelet response (platelet count >50 × 109 per litre and double the platelet count at baseline on any scheduled visit, excluding counts obtained within 8 weeks after receipt of rescue medications), proportion of patients who achieved a durable response (platelet responses during 6 or more weeks of the last 8 weeks of treatment), proportion of patients needing rescue medication, proportion of patients able to stop or reduce concurrent treatment and mean number of weekly platelet responses. Safety was assessed on the basis of the incidence of adverse events documented on the patients' medical records. Results and discussion This study enrolled ten adults and four paediatric patients. None of the paediatric patients and one adult patient had been splenectomized (contraindicated in the other adults). In the adult population, eight achieved a response at least once during treatment, and 1 achieved a durable response. Four patients needed rescue medication (mostly intravenous immunoglobulins). Three patients were able to stop concurrent ITP therapies, and the mean number of weekly platelet responses was 6. All four paediatric patients achieved a response at least once during treatment, and three achieved durable responses. Three patients needed rescue medication. The only patient who was receiving concurrent ITP medication was able to stop it, and the mean number of weekly platelet responses was 25. No serious adverse events were registered during treatment in either population. What is new and conclusion The effectiveness of romiplostim was variable with few adult patients achieving a durable response. Our paediatric patients responded better with most achieving a durable response. The treatment was safe for both groups of patients. Studies should be conducted to identify patients more likely to benefit from this treatment.

Background Oral antineoplastic agents (OAA) interact with cytochrome P450. Therefore, one of the most important objectives of pharmaceutical care in cancer patients, who are usually polymedicated, is to review and identify drug interactions. Purpose To describe drug interactions detected in a Pharmaceutical Care Programme applied to patients who are starting treatment with OAA. Materials and methods An observational study was performed in patients who started treatment with OAA during the study period (January 2012 – August 2013). At the time of starting treatment, a clinical interview was conducted by the pharmacist, in order to detect drug interactions. Subsequently, prescriptions and reports from all patients were reviewed and interactions analysed using Lexicomp. Variables recorded were: gender, age, ECOG performance status, type and dose of OAA, other chronic treatment and interactions and their severity classified according to the FDA. Results 121 patients were included (62.0% male). The mean (SD) age was 67.9 (14.3) years old and 9.9% had an ECOG ≥2. The main OAA dispensed were: abiraterone (19.0%), lenalidomide (18.2%), sunitinib (11.6%), gefitinib (10.7%), imatinib (9.1%) and sorafenib (9.1%). The mean number of chronic co-medications used was 5.0 (2.1). Seventy two interactions were identified in 49 different patients, 27.8% had category D or X. Interactions were more prevalent with abiraterone (41.7%), gefitinib (16.7%) and imatinib (13.9%). Principal groups of drugs interacting with OAA were proton pump inhibitors (25.0%), antihypertensives (24.8%), statins (15.3%) and antidepressants (8.3%). Principal drugs interacting were amlodipine (11.1%), rabeprazole (8.3%), acenocoumarol (8.3%), atorvastatin (6.9%), simvastatin (6.9%) and tramadol (5.6%). The pharmacist was involved by informing the patient and the physician and monitoring the interaction in the follow-up. Conclusions Abiraterone is the OAA with most identified interactions. It is essential to review all the chronic drugs before starting a new OAA; be careful especially with proton pump inhibitors and antihypertensives. No conflict of interest.

Background In Europe, there are currently no common enforceable standards of practice for sterile compounding in Hospital Pharmacies. Many national and international guidelines have been published, but they usually only offer practice recommendations In 2004, the United States Pharmacopoeia (USP), published its general chapter Pharmaceutical Compounding-Sterile Preparations, which set rigorous and enforceable standards for sterile compounding in the US. Purpose To evaluate the degree of compliance in a Pharmacy Service with the sterile compounding requirements in USP Chapter . Materials and methods An online survey created by a US board of experts on sterile compounding practices was completed and submitted for analysis of compliance with USP chapter standards. The survey included 166 yes-no questions about compliance with specific required elements in , grouped in 38 domains. Upon completion, a complete report and an individualised action plan was generated by the survey tool. Results 143 of the 166 questions were answered (23 deemed to be non-applicable). The overall compliance score was 79%. Various degrees of deviation from the practice recommendations were noted in 13 of the 29 evaluated domains. Low levels of compliance were most notable in the domains of Single and Multiple-Dose Vials handling (33%), Hand Washing and Garbing requirements (33%), Hazardous Drug Compounding (33%) and Gloved Fingertip Sampling (0%). A 0% score was also obtained in the domains of Sterility Testing and Filter Integrity Testing. Higher levels of compliance were noted in the domains of Inventory Storage and Handling and Delivery of compounded sterile products (CSPs) (80%), Training and Competency Measurement (80%) and Aseptic Technique (92%). Compliance with recommendations in the areas of Facility Design, Compounding Facility Management and Quality Management was almost total. Conclusions Systematically evaluating compliance with USP standards proved useful to pinpoint inappropriate sterile practices within our sterile-compounding facility and to drive corrective actions accordingly. No conflict of interest.

Background Ivabradine is authorised for the treatment of coronary artery disease and chronic heart failure with systolic dysfunction in adult patients, but there is little information on its efficacy and safety in children. Purpose To assess the use, efficacy and safety of ivabradine in paediatric patients. Materials and methods Observational study of the children treated with ivabradine in a university tertiary hospital. Patients’ clinical records were reviewed and the following data were collected: date of birth, sex, weight, diagnosis and concomitant conditions, treatment duration and ivabradine dosing. Heart rate was used to assess effectiveness. Treatment was considered effective if the heart rate decreased below 130 bpm. Safety was assessed by the occurrence of any adverse events described in the summary of product characteristics. Results Four children were treated with ivabradine in our institution, all of them for the indication of inappropriate sinus tachycardia as an off-label use. The median age at the start of treatment was 5.6 years (1.1–15.5). Three patients had undergone a heart transplant before treatment and the fourth started ivabradine before he had received a heart transplant. Median starting dose was 0.08 mg/kg/12 h (0.05–0.14). Median heart rate before treatment was 155 bpm (140–160). Ivabradine was effective for three patients, with a median of 110 bpm (110–128) after treatment, though one of them was considered a partial responder because the dose had to be doubled to maintain the desired heart rate. Treatment was ineffective for the remaining patient (median heart rate 147 bpm) and was discontinued. Overall, ivabradine was well tolerated. However, the dose had to be reduced to a half in one patient due to QT prolongation but was normalised after dose adjustment. Conclusions Ivabradine seemed to be an effective and safe treatment for inappropriate sinus tachycardia in most of our paediatric patients. Nonetheless, more studies are required to confirm these results. No conflict of interest.

Background The use of erythropoiesis-stimulating agents (ESA) in the treatment of anaemia due to chronic kidney disease (CKD) is highly variable regarding patient characteristics and doses, including the equivalence among ESAs stated in the label product. Purpose To evaluate the use of ESAs for anaemia due to CKD in a university hospital. Materials and Methods A descriptive, transversal study was performed in patients treated with ESAs for anaemia secondary to CKD in a university hospital over a month. The principle variable was monthly dose of ESA. Secondary aims were to assess: efficacy (defined in terms of haemoglobin levels [Hb]) and safety (defined in terms of percentage of patients with Hb >13 g/dl). Variables collected were: demographic characteristics, ESA type and dose, prescribing Service, Hb, serum creatinine (Cr), C-reactive protein, albumin, ferritin, transferrin saturation index, folate, vitamin B12 and parathyroid hormone (PTH). Results 333 patients were included (52.6% female; median age 75.2 years). 69.1% patients were on pre-dialysis, 27.6% on haemodialysis and 3.3% on peritoneal dialysis. The prescription profile was: 23.4% epoetin, 41.4% darbepoetin α and 35.1% CERA. 97.0% prescriptions from Nephrology Service. Median [p25, p75] dose/month was: epoetin (12857 [8571, 25714] IU), darbepoetin α (86 [43, 129] mcg), CERA (75 [50, 100] mcg). Hb levels: epoetin (11.9 [11.3, 12.5] g/dl), darbepoetin α (11.9 [11.1, 12.8] g/dl), CERA (12.1 [11.0, 12.8] g/dl); p = 0.860. Patients with Hb> 13 g/dl: 11.5% epoetin, 19.6% darbepoetin α, 22.2% CERA; p = 0.639. Patients treated with CERA had more favourable levels of Cr, albumin and PTH than those treated with epoetin and darbepoetin α (p Conclusions Efficacy and safety were similar for different types of ESAs. CERA dose was lower than the recommended equivalence stated in the label product for the doses of epoetin and darbepoetin α obtained, although patients treated with CERA had a better kidney function. No conflict of interest.