Search

Background In 2015, the development of well tolerated and highly effective direct acting antivirals (DAAs) for hepatitis C virus (HCV) dramatically changed the therapeutic landscape. However, data are lacking on the effectiveness and safety of these combinations in patients coinfected with human immunodeficiency virus type 1(HIV-1). Purpose To provide preliminary data on the effectiveness and safety of DAAs for the treatment of hepatitis C infection in a HIV/HCV coinfected population, under routine clinical practice. Material and methods Design: observational, descriptive, prospective study. Inclusion criteria: coinfected patients who had finished their treatment with DAAs before 9 October 2015. Variables: demographic and baseline clinical data; HCV genotype; sex; prior response to HCV treatment; grade of fibrosis; presence or absence of decompensated cirrhosis; blood count; ALT; and AST. Effectiveness analysis: viral Load (VL) at the end of treatment or sustained virologic response at week 12 if available. Safety analysis: adverse drug events (ADEs), including laboratory abnormalities. Results Of the 95 patients enrolled, 72.6% had genotype 1 infection, 14.7% genotype 4 and 12.6% genotype 3. Overall, 70.5% were men, 54.7% had been previously treated for HCV and 65.3% had cirrhosis. 15 (15.8%) patients had developed decompensated cirrhosis. The most frequent treatments were: sofosbuvir/ledipasvir (41.0%), ombitasvir/paritaprevir/ritonavir and dasabuvir (20.0%) and sofosbuvir and daclatasir (20.0%). Ribavirin was part of the treatment in 51.6% of cases. Duration of treatment was 12 weeks in 56.8% of cases. At the end of treatment, no patient had confirmed HIV-1 virologic rebound. Undetectable HCV VL was achieved in 80/83 patients (2 patients died during treatment because of other causes and 1 patient decided to stop treatment). Serum transaminases were normalised in 79.6% of patients, and 7/8 patients achieved SVR (no data for SVR still available for the remaining patients). No patient discontinued treatment because of ADEs. Only 3 ADEs of grade III were identified (insomnia in 2 patients treated with sofosbuvir and daclatasvir and in 1 patient treated with sofosbuvir/ledipasvir). Common ADEs of grade I-II identified were: headache (30.5%), fatigue (28.4%), anaemia (17.9%) prurito (17.9%), insomnia (16.8%), dry skin (15.8%), irritability (14.7%), decreased appetite (14.7%) and nausea (11.6%). Conclusion Preliminary data corroborate the high effectiveness and good safety profile of DAA regimens in HIV/HCV coinfected populations. References and/or Acknowledgements Rev Esp Quimioter 2015;28(Suppl 1):4851 No conflict of interest.

Background The recent development of highly effective interferon free drug regimens has dramatically changed the therapeutic landscape of hepatitis C virus (HCV). An intensive pharmaceutical care programme is necessary, due to their recent commercialisation, the limited available data on their effectiveness and safety in clinical practice and their high cost. Purpose Our purpose was to evaluate, in terms of safety and efficiency, pharmacists´ interventions on patients starting treatment with new antiviral drugs (NAD). Material and methods Design: observational, prospective study. Inclusion criteria: patients who began treatment with NAD between April and September 2015. Drugs were dispensed at the outpatient pharmacy after a clinical interview on a monthly basis. A pharmaceutical care programme was developed: a protocol was elaborated by a multidisciplinary team describing the selection criteria and duration of treatment according to National Health System recommendations. It includes a checklist with demographics, pharmacologic (drug schedule, drug interactions), laboratory (haematologic, hepatic, renal) and clinical data (virological response, adverse events) to be monitored at each clinical visit to the outpatient pharmacy. The primary outcome was pharmacists’ interventions classified according to Overhage et al . and severity of medication errors according to NCC MERP. Results 694 patients were included (63.4% men), mean age 56.2 years, 52.9% fibrosis F4 and 24.6% co-infected. 50.1% of patients were naive. Regarding prescription profile, 54.5% were treated with ombitasvir/paritaprevir/ritonavir with or without dasabuvir, 40.6% with sofosbuvir/ledipasvir, 3.1% with sofosbuvir+dacltasvir and 1.8% received other combinations. 31.3% followed a 24 week schedule. 194 pharmaceutical interventions were made, with 99% acceptance rate. According to the severity, 7 (3.6%) errors were severe (G/H: 1 interaction with primidone and 3 with salmeterol and 3 ribavirin high dose); 157 (80.9%) were serious D/E/F and 30 (15.5%) were classified as not causing harm (A/B/C). Medication errors detected: 75 (38.7%) drug interactions requiring close monitoring or treatment modification, 67 (34.5%) errors in the administration technique and 12 (6.2%) errors in dosage. Selection and duration were adjusted to the protocol in 99.6% of patients with 98.2% of virological response. 10 pharmacists’ interventions concerning selection and 4 concerning duration were made, resulting in cost savings of 121.194Euros. Conclusion The role of the pharmacist in HCV patients has been fundamental in detecting relevant drug interactions and in providing accurate information on drug administration, improving safety. Pharmacists have also participated in the selection of the most cost effective treatment. No conflict of interest.

Background Robotic dispensing has demonstrated improvements in patient safety and workflow. However, there are no data on staff satisfaction after implementation. Purpose Quantitative evaluation of staff satisfaction after implementation of a robotic dispensing system in an outpatient pharmacy (OP). Material and methods Setting: OP of a 1300 bed tertiary teaching hospital in Madrid (Spain). The pharmacist’s role consists of continuous centralised order validation, and patient counselling and education. Dispensing and inventory management is performed entirely by nursing assistants, using a robotic dispensing system (Rowa Vmax) with a conveyor belt system. Design: This was a cross sectional study involving 8 pharmacists and 9 nursing assistants. Overall satisfaction index and specific aspects, such as the contribution of the robotic dispensing system to safety, ease of use and stability were evaluated. In addition, the quality of the inventory control, the quality of the integration with other information systems of the OP, and installation and technical support were evaluated by the pharmacy staff. The results (0–10 points) were expressed as mean (±SD). Comparison between staff category was made using the Mann-Whitney U test. Results Overall satisfaction index was 8.63 ± 0.744 for pharmacists and 7.78 ± 0.667 for nursing assistants (p = 0.046). The greatest satisfaction was achieved for the increase in safety during dispensing (9.75 ± 0.463 for pharmacists and 8.00 ± 0.707 for nursing assistants; p Pharmacists’ satisfaction with the quality of the inventory control, quality of the integration and installation was higher than 8.5 points. Satisfaction with technical support was 7.75 ± 0.707. All staff members recommended their implementation to other OPs. Conclusion The results of pharmacists’ and nursing assistants’ satisfaction surveys have provided useful information in evaluating the quality of implementation of the robotic dispensing system. For most of the issues, satisfaction was greater in pharmacists than in nursing assistants. The only aspect in need of improvement is the dispensing speed of the system of conveyor belts. References and/or Acknowledgements Beard RJ, Smith P. Springerplus 2013;2:295 No conflict of interest.

Background Literature states the importance of medication adherence in the effectiveness of deferasirox for the treatment of transfusional iron overload in some hematologic pathologies such as β thalassemia or sickle-cell disease. However, there is no data about patients with myelodysplastic syndrome (MDS). Purpose Our objective is to evaluate the impact of medication adherence in the effectiveness of deferasirox for the treatment of transfusional iron overload in patients with MDS. Material and methods A longitudinal, retrospective, observational study was performed in a tertiary hospital. The inclusion criteria were age over 18 years, MDS diagnosis and treatment with deferasirox for transfusion-dependent iron overload from January 2011 to April 2015. Treatment effectiveness was estimated by serum ferritin (SF) and adherence was measured by medication possession ratio (MPR). Patients were deemed adherent when MPR was ≥ 90%. The correlation between deferasirox dosage, SF and adherence over time was also assessed. Results 35 patients were included. Median (p25, p75) SF at baseline was 1636 µg/L (1100, 1634), which fell to 1399 µg/L (824, 1772) during follow-up. The median rate of adherence during treatment was 92% (90, 95); although only 54.8% of the patients had a rate of adherence ≥ 90% in every follow-up measurement. A statistically significant correlation between adherence and SF was observed (r= -0.288, p = 0.004). Association between adherence and its potentially predictive variables was described in Table 1. Conclusion The found association between adherence and treatment effectiveness is especially relevant; according to our results adherent patients have lower values of SF than non-adherent patients. References and/or Acknowledgements No conflict of interest.

Background Patients who have recurrent hepatitis C virus (HCV) infection after liver transplantation (LT) have substantial rates of morbidity and mortality. Evaluation of experience with new drug regimens is critical. Purpose The aim was to describe the effectiveness and safety of second generation direct acting antivirals (DAAs) in patients with HCV recurrence after the LT regimen became critical. Material and methods Descriptive, retrospective, non-interventional study. Inclusion criteria: all HCV monoinfected patients with LT who started treatment with DAAs before April 2015. The following variables were collected from the digital medical record: demographics, fibrosis degree, clinical data (decompensated cirrhosis, hepatocellular carcinoma), response to previous HCV treatment, viral genotype, viral load and analytical data (at baseline and at the end of treatment), and adverse events (AEs). Primary effectiveness endpoint was sustained virologic response 12 weeks after the end of treatment (SVR12). Secondary endpoint was end of treatment virologic response (EOTVR) and normalisation of serum transaminases at the end of treatment. Safety was evaluated by laboratory abnormalities and AEs. Results 22 patients were included: 21 (95.4%) were male; average age was 60 (SD 7.4) years. There were 18 (81.8%) cirrhotic patients, 11 (61.1%) of these were decompensated and 5 (22.7%) had hepatocellular carcinoma. 9 (40.9%) patients were treatment naive, 9 (40.9%) had failed prior therapy with peginterferon/ribavirin and 4 (18.2%) had failed protease inhibitor. Distribution of virus genotypes were: 1a=3 (13.6%); 1b=17 (77.3%); 1 unknown=1 (2.3%); and 3=1 (2.3%). The prescribed DDAs were: sofosbovir+daclatasvir=10 (45.4%), sofosbuvir+simeprevir=7 (31.8%), sofosbuvir=3 (13.6%) and daclatasvir+simeprevir=2 (9.1%). Ribavirin was present in 14 (63.6%) patients’ treatment. Treatment duration was 12 weeks in 10 (45.4%) patients and 24 weeks in 12 (54.5%). SVR12 was achieved in 16 (80.0%) patients (data available in 90.9%). EOTVR was achieved in 100% of patients (data available in 90.9%) and 77.8% of patients had normalised serum transaminases at the end of treatment (data available in 81.8%). Most frequent AEs were: asthenia 10 (45.4%), pruritus 8 (36.4%), confusion 6 (23.3%), dry skin 5 (22.7%), insomnia 5 (22.7%), headache 5 (22.7%), reduced appetite 5 (22.7%) and ribavirin associated anaemia 4 (66.7%). Conclusion Our data showed that DAAs are effective, inducing a high SVR12 and improving hepatic function in this special population. Despite the incidence of AEs, there were no treatment discontinuations due to AEs. Most were acceptable and consistent with the disease status. References and/or Acknowledgements Viruses 2015;7:5155-68 No conflict of interest.

Background Limited data are available regarding co-administration of acenocoumarol with direct acting antiviral agents. Purpose We report a case of a patient who required a significant increase in the acenocoumarol weekly dose when co-administered with ombitasvir/paritaprevir/ritonavir. Material and methods Data on international normalised ratio (INR), acenocumarol dosing and concomitant medications were obtained from the general practitioner. Potential drug-drug interactions were checked using Lexi-Comp, SPC and www.hep-druginteractions.org Results A 61-year-old-male with treatment naive genotype 1a chronic hepatitis C was examined in the gastroenterology department. His baseline viral load was 2 893 236 IU/mL and he had compensated liver cirrhosis. His medical record included rheumatic valvulopathy that required double valve replacement and anticoagulation with acenocoumarol 8 mg/week (target INR 2.5–3.5). His INR had been stable on a dose of 8–9.5 mg/week over the past 2 years. Concomitant medications included omeprazole 20 mg/24 h, lisinopril 5 mg/24 h, digoxin 0.125 mg/24 h, bisoprolol 2.5 mg/24 h and furosemide as needed. Omeprazole interacts with acenocoumarol but increases its effect. Concomitant medications had not been modified for several months. He started antiviral treatment in April 2015 with ombitasvir/paritaprevir/ritonavir 25 mg/150 mg/100 mg/24 h, dasabuvir 250 mg/12 h and ribavirin 400 mg/12 h for 24 weeks. His baseline INR was 3. After evaluating potential interactions, the gastroenterologist recommended close digoxin and INR monitoring. At week 4, the INR became subtherapeutic at 1.4. Therefore, the acenocoumarol dose was increased to 11 mg/week and enoxaparin 100 mg/24 h was started. At week 6, the INR was 1.6 and the dose was titrated to 13 mg/week. Enoxaparin was reduced to 60 mg/24 h. At week 9, the INR was 1.9 and the dose was increased to 16.5 mg/week. At week 12, the INR was 2.1 and the dose was increased to 19.5 mg/week. Enoxaparin was withheld. At week 16, the INR was 2.3 and the dose was titrated to 20.5 mg/week. At week 24,the INR was 3.8 and the dose was decreased to 19 mg/week. At the end of treatment, the acenocoumarol dose had been increased by 137.5%. During the 24 week period, the patient reported no compliance problems, treatment modifications or dietary changes. He did not experience any thrombotic or bleeding event. A causality assessment was conducted according to the Naranjo algorithm and the score obtained was 5 (adverse drug reaction classified as probable). Conclusion There is a possibility of decreased INR after concomitant use of acenocoumarol and ombitasvir/paritaprevir/ritonavir. No conflict of interest.

Background The introduction of robotic dispensing systems in outpatient pharmacies (OP) has increased in recent years. However, there are no data available on its impact on patient safety using a prospective risk analysis. Purpose To evaluate safety after implementation of a robotic dispensing system in an OP, and stratification of residual risks to drive future developments. Material and methods Setting: OP of a 1300 bed tertiary teaching hospital provided with a computerised prescription order entry program and online pharmacy validation. Before the implementation of the robot, dispensing was performed entirely manually by nursing assistants using barcode technology. Design: Comparative risk analysis of the drug dispensing process before and after implementation of the robotic dispensing system (Rowa Vmax), according to the failure modes, effects and criticality analysis method. Measurements: The failure modes were defined and their critically index (CI) calculated on the basis of the likelihood of occurrence, potential severity for patients and detection probability. CI of manual and robotic dispensing were compared, and new measures were proposed. Results In the pre-implementation phase, the sum of CI of 17 identified failure modes was 1141. After implementation of the robot, 23 failure modes were identified and the CI was reduced to 780 (31.64% reduction). The major safety improvements were observed for the following errors during the dispensing process: incorrect drug because of barcode control omission (-100), omission of dispensing due to lack of stock (-90), insufficient quantity (-81) and expired drug (-52). Of the 6 failure modes exclusively detected after implementation of the robot, only failure to deliver the drug to the correct dispensing point achieved a significant risk (CI=48). Improvement actions identified included: (1) monitoring during robotic dispensing on a monthly basis (drug delivered to the wrong point, interruptions of robotic dispensing and stock-outs), (2) establishing periodic maintenance checks and (3) establishing a double-checking system for manual dispensing of drugs that cannot be managed by the robot. Conclusion A robotic dispensing system has increased the safety of the process. FMECA is a useful method for evaluating the impact of robotic implementation, and identifying further improvement strategies. References and/or Acknowledgements Complying with the FMEA requirements of the new patient safety standards. http://www.jointcommission.org/ No conflict of interest.

Background Long term adverse effects, expense and difficulty of adherence to antiretroviral therapy (ART) have led to the study of simpler maintenance therapies. Switching from triple therapy to dual therapy seems to be effective and safe, but few data exist in clinical practice. Purpose To assess the effectiveness and safety of simplification to a dual therapy in experienced HIV patients. Material and methods A retrospective study including experienced HIV patients switching from triple to dual therapy between August 2009 and January 2015. Demographic and clinical characteristics, viral load (VL), CD4 + T cell count, CD4/CD8 ratio, fasting lipid profile, and liver and renal function were recorded when dual therapy was started and at week 24. Previous ARTs, reason for change to dual therapy and adverse events leading to discontinuation of the new regimen were also evaluated. Results 67 patients were included, 58.2% were male with a median (IQR) age of 50 (47 to 54) years. Reasons for switching to dual therapy were: presence of adverse events (44.8%), treatment simplification (26.9%), virological failure (14.9%), immunological failure (3%) and other (25.4%). The most frequent drug combinations were: a ritonavir boosted protease inhibitor with maraviroc (43.3%), a ritonavir boosted protease inhibitor with lamivudine (40.3%) and rilpivirine and dolutegravir (5.97%). Effectiveness and safety results are shown in table 1. All values are expressed as median (IQR), unless otherwise indicated. 18 patients (26.9%) interrupted the dual therapy: 4 patients (6.0%) switched to a triple therapy and 14 (21.0%) to a different dual therapy due to drug interactions (27.8%), metabolic disorders (22.2%), simplification (16.7%), gastrointestinal intolerance (11.1%) and failure to achieve an undetectable VL (5.6%). Conclusion Switching to dual therapy for maintenance treatment is effective, safe and not inferior to triple therapy in treatment experienced HIV patients. No conflict of interest.

Background Currently, there is little uniformity in the management of the anaemia secondary to chronic kidney disease (CKD). Purpose To analyse the use profile of erythropoiesis-stimulating agents (ESA) in the treatment of anaemia due to CKD in daily clinical practice, and to evaluate their effectiveness, safety, cost and the factors that influence resistance to these drugs. Material and methods A descriptive, cross-sectional study was carried out in adult patients with anaemia due to CKD treated with ESA in the Outpatient Unit of a tertiary hospital. Patient characteristics according to the different ESAs (epoetin α/β, darbepoetin α and CERA) were analysed: effectiveness (optimal levels of Hb), safety (high levels of Hb) and cost (cost/patient-month according to dosage and ex-factory price). Equipotent doses of ESA and the factors that influence the resistance to these drugs were also evaluated. Results 333 patients (23.4% epoetin α/β, 41.5% darbepoetin α and 35.1% CERA) were included. Patients treated with CERA had better values of serum creatinine, C-reactive protein, albumin and parathyroid hormone, and 94% of them were not on dialysis. The median (p25–p75) of Hb was 11.9 (11.1–12.7) g/dl and Hb level exceeded 13 g/dl in 16.5% of patients; no statistical differences were found between different ESAs. Median doses/patient-month were: epoetin α/β 12857 (8571–21714) IU, darbepoetin α 85.7 (42.9–128.6) mcg and CERA 75.0 (50.0–100.0) mcg. The need for higher doses and, thus, the associated cost varied depending on the type of patient: predialysis Conclusion No differences in effectiveness or safety were found among different ESAs, although patients treated with CERA showed better clinical characteristics. Dialysis, renal transplantation and low TSI were the most important factors related to ESA resistance and, therefore, to its efficiency. References And/or Acknowledgements Pharmacy and Nephrology Departments No conflict of interest.

Background There are limited data that tackle safety and effectiveness of the triple treatment based on protease inhibitors (telaprevir or boceprevir) in liver transplant patients. Purpose To describe effectiveness and safety of the triple treatment used by liver transplant patients. Material and methods We performed an observational retrospective study, from November 2012 to September 2014. Transplant patients who started triple treatment before May 2013 were included. Baseline variables included demographic data, treatment and infection related data, and laboratory data. The effectiveness outcome was sustained virological response (SVR). Safety outcomes included haematological toxicity and skin toxicity. Moreover, we recorded the requirements to treat those side effects. Results Seven patients were included; 100% were male. The average age of patients was 57.5 (standard deviation 4.2). Telaprevir was used in 3 (42.9%) patients and boceprevir in 4 (57.1%). As far as grade of fibrosis was concerned, 6 (85.7%) patients were cirrhotic or F4 and 1 (14.3%) patient was F2. Median fibroscan value was 16.6 Kpa (IQR 12.1–28.6 Kpa). Two (28.6%) patients were treatment-naive, 1 (14.3%) patient was a null responder and 4 (57.1%) patients were relapsers from previous treatment. At the beginning of treatment the median haemoglobin level was 13.6 g/dL (IQR 12.1–16.4 g/dL), the median neutrophil count was 3.0/mL (1.2–4.8/mL) and the median platelet count, 164/mL (126–197/mL). Four (66.7%) patients achieved SVR. One patient died during treatment. Haematological toxicity included anaemia (85.7%), neutropenia (28.6%) and thrombocytopenia (42.9%). Skin rash was present in 2 (28.6%) patients. Five (71.4%) patients required ribavirin dose reductions, erythropoietin and blood transfusions. The median number of red blood units administered was 28 (IQR 3–31). Conclusion Despite the severe disease of the included patients, we found that response rates to triple treatment exceeded 60%. As the treatment-related anaemia was considerable, most of the patients required supportive care. References and/or acknowledgements Conflict of interest.

Background In 2012, due to a problem in manufacturing continuous erythropoietin receptor activator (CERA), the Spanish Health System issued an alert recommending not starting new treatments with this drug and replacing it by other erythropoiesis-stimulating agents (ESA) in patients already on treatment. Purpose To assess the dose and efficacy of the ESA that replaced CERA after it became unavailable. Materials and methods A longitudinal retrospective study was conducted in patients treated with CERA when it became unavailable. The follow-up period was 4 months. We recorded the type and dose of ESA that replaced CERA and compared them with the equivalent agents recommended in summary of product characteristics (SPC). Effectiveness was judged by haemoglobin levels (Hb) at 4 months of follow-up. Other variables collected: Hb, transferrin saturation index (TSI), ferritin, albumin, C-reactive protein (CRP) and parathyroid hormone (PTH). Results 187 patients were included (58.8% female, aged 67.7 [17.2] years old). CERA was replaced by epoetin β in 52.4% of cases (previous monthly dose CERA: 94.6 [59.2] mcg), darbepoetin α in 39.6% (previous monthly dose CERA: 82.4 [56.9] mcg) and ESA prescription was discontinued in 8.0% (previous monthly dose CERA: 78.0 [60.6] mcg). No differences were found between these groups in TSI, ferritin, albumin, CRP or PTH. At the time of inclusion, Hb was 11.6 (1.5) g/dl and after 4 months it was 11.7(1.6) g/dl. Mean monthly doses of epoetin β was 18389.2(16018.3) IU and darbepoetin α 98.8(78.5) mcg were similar to those recommended by SPC ( Conclusions Epoetin β and darbepoetin α were similarly effective compared to CERA. Doses were according to those recommended in SPC and most of them did not need to be adjusted. No conflict of interest.

Background In September 2011, the European Medicines Agency (EMA) approved the use of abiraterone for metastatic castration-resistant prostate cancer in men whose disease had progressed on docetaxel-based chemotherapy. Purpose To assess the effectiveness and safety of abiraterone for metastatic prostate cancer in clinical practice in a tertiary hospital. Materials and methods A retrospective longitudinal study was performed in patients who started treatment with abiraterone for metastatic prostate cancer during the study period (March 2012–March 2013). Patients were followed up for 6 months. Variables, collected from medical records, were: age, ECOG performance status, date of diagnosis, type of metastasis, the start and end date of treatment with abiraterone, prior chemotherapy, prostate-specific antigen (PSA) at the start of treatment and one month later. We recorded possible adverse events (AE) associated with abiraterone and their severity. Results 18 patients were included. The median (p25, p75) age was 76.8 (39.2, 82.3) years old. 22.2% of them had an ECOG ≥ 2. The median time since cancer diagnosis was 7.0 (4.5, 8.1) years. 100% of patients had at least bone metastases and the disease had progressed on chemical castration and docetaxel in all of them. The median PSA at initiation of treatment with abiraterone was 86.5 (24.9, 321.5) mcg/l. One month after starting treatment, PSA had decreased in 61.1% of patients. 57.9% of patients were in treatment with abiraterone after 6 months from the beginning. 44.4% of patients experienced AE. However, all of them were mild; the most frequent AE were related to gastrointestinal and skin systems. Conclusions Abiraterone was effective in 57.9% of docetaxel-experienced patients in the sixth month of treatment. In study 302, the percentage was higher (70%). However, in that study the ECOG was lower than in our patients. We did not find any moderate-severe AE related to this drug. No conflict of interest.

Background hospital pharmacists interview all outpatients with a new prescription, including medication changes, and those who are suspected of not having good compliance. However, patients sometimes voluntarily demand to talk to the pharmacist. Purpose The objective of this work was to evaluate the features of consultations made by patients in these situations. Materials and Methods observational prospective study performed in all outpatients who demanded an interview with the pharmacist from 01/03/12 to 31/05/12. Data collected: sex, age, pathology, type of question, resolution (yes/no), and whether the patient was sent to another health professional or not. Results 48 patients were included (56.25% male; mean age 47.25 years). Pathology: 29 HIV; 4 hepatitis C; 3 multiple sclerosis; 3 hepatitis B, and 9 others (one each): lung cancer, renal impairment, rheumatoid arthritis, multiple myeloma, myosarcoma, growth disorder, pulmonary hypertension, glaucoma, and aspergillus infection. Consultations were classified into 9 types showing in brackets the number of each: 1-Drug-drug interactions (14); 2-Apply for extra medication (9); 3-Side effects (8); 4-Dosage and administering(6); 5-Missed or wrong doses(6); 6-Prescription renewal(2); 7-Drug storage(1); 8-Faulty drug(1) and 9-Misunderstanding medical prescription(1). Forty-three consultations were solved by the pharmacist (89.58%). In the other 5 cases, patients were sent to the physician: two were taking the treatment incorrectly and needed a special cheque, two needed to renew the prescription and one was suffering severe side effects. Conclusions The most common consultations were related to pharmacology except for 18,75% of patients who applied for extra medication (often not possible because of the hospital policy). The pharmacist was able to solve almost 90% of consultations, sending the patients to their doctors just in cases where their health was compromised or new prescriptions were needed. 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.

Background Abciximab (ABX) is indicated as an adjunctive to percutaneous coronary intervention in patients with acute coronary syndrome (ACS). It is considered a high-alert medicine with heightened risk of causing significant patient harm when used in error. Evidence-based guidelines recommend an intravenous administration of a 0.25 mg/kg bolus dose followed by continuous infusion of a weight-adjusted infusion of 0.125 mcg/kg/min ( Purpose The purpose of this study was to investigate dosing of ABX and its association with bleeding events in patients with ACS. Materials and methods A retrospective chart review was performed in all patients hospitalised between January and July 2010 at our hospital. Inclusion criteria were: patients >18 years of age, diagnosed with ACS and treated with ABX during their hospitalisation. A database was designed to record patient demographics (age, sex) weight, loading dose, maintenance dose, duration of prescribed ABX and bleeding events. Results 73 patients diagnosed with ACS were treated with ABX. Median age was 65 (55–73) years old and 78.1% were male. 24.7% of patients were not weighed before ABX administration. All patients who received ABX infusion were treated with a fixed, body weight-independent, dose of 10 mcg/min infused for 12 h (maximum dose) meaning that 28.8% of patients received an overdose of ABX. 66.7% of them developed a bleeding event compared with 32.8% of patients receiving the correct dose (p=0.016). Conclusions Overdose of ABX seems to be associated with high risk of developing bleeding events in patients with ACS. Some new procedures have been brought in such as hoists with weighing scales and a table made available containing the appropriate dose and infusion rate for each weight. These facilities could be perfectly applicable to other hospitals. Further analysis should be carried out to determine the effect of other potential risk factors.

Background Eltrombopag is authorised by the EMA for adult chronic immune thrombocytopenic purpura (ITP) splenectomised patients who are refractory to other treatments and as second-line treatment for non-splenectomised patients for whom surgery is contraindicated. Eltrombopag was effective in 59% of patients in a randomised controlled trial (Bussel, 2009). Purpose To determine whether eltrombopag is prescribed according to the approved indications. To observe the effect on platelet levels. Materials and methods Observational study. The authors included patients treated with eltrombopag from 01/01/2011 to 31/08/2011. Variables analysed: demographics, diagnosis, previous treatments, duration, rescue medication, changes in platelet levels, and reason for suspension (where applicable). Results Seven patients were treated with eltrombopag. Median age: 65 years, 4 males. Six had ITP and 1 had multifactorial essential thrombocytopenia. All patients with ITP had received first-line treatment with corticosteroids and immunoglobulins and were refractory to at least 2 second-line treatments, as follows: immunosuppressants (3 patients), rituximab (3), Vinca alkaloids (2), tranexamic acid (3), and romiplostim (2). One patient with ITP was splenectomised, while 5 were not (old age (3), multiple comorbidities, refusal (1 each)). Four of the 7 patients discontinued treatment before the end of the study (median duration, 87 days), while 3 continued with treatment (median interval from initiation, 46 days). The 3 patients who continued with treatment maintained increased platelet levels from baseline (>50 x 103/μL). Of the 4 who stopped treatment, 3 did not have increased platelet levels at any time during the study, while 1, despite reaching and maintaining platelet levels, discontinued treatment due to uncontrolled bleeding events. All non-responders required rescue with immunoglobulins. Conclusions Eltrombopag was prescribed according to the approved indication in 6 out of 7 patients and was effective in half of the patients with ITP. Despite our small study population, the percentage of responders was similar to that found by Bussel et al.