Background Failure Mode and Effect Analysis (FMEA) is a tool to identify, assess and prevent possible failures that could occur in a process. Purpose To describe FMEA as a method to identify weaknesses in the process of prescription and transcription of medical orders. To isolate the key steps according to their risk priority number (RPN). To report the steps taken. Materials and MethodsA multidisciplinary study group was assembled. Possible errors in the prescription/transcription workflow were identified and classified according to their RPN score (calculated by multiplying the severity, occurrence, and detection). Strategies for improvement were established. ResultsErrors in the prescription were classified as follows: (1) Patient-and-history identification, (2) Clinical and laboratory data checkout, (3) Treatment conciliation, (4) Allergies, (5) Verbal prescription, (6) Handwritten prescription. Errors in transcription: (7) Patient identification (nurse), (8) Internally mailed prescriptions, (9) Paper transcription, (10) Check in pharmacy, (11) Patient identification (pharmacist), (12) Prescription validation, (13) Prescription printing, and (14) Acknowledgement of errors by the pharmacist. Top-ranked item (number), suggested solution, and indicator, respectively were: (5) Verbal prescription (288), storage of verbal prescriptions in pharmacy, % of verbal prescriptions; (9) Failure in paper transcription (288), computerised physician order entry (CPOE), % of electronic prescriptions; (14) Error report to the pharmacist (288), implementation of a two-way communication protocol, number of reports; (8) Paper-based prescriptions sent to pharmacy (243), CPOE, % of electronic prescriptions; (10) Check in pharmacy (216), CPOE, % of electronic prescriptions. The pharmacy, medical director, and Quality Unit were responsible for the changes undertaken in all cases. Conclusions Verbal prescription, failure in paper transcription, error report and mailed prescriptions to pharmacy were the steps with the highest risk of error. For most cases, CPOE was implemented, whereas the percentage of electronic prescriptions was the key indicator to measure the overall improvement in these processes. In conclusion, further efforts and pharmacy policies should focus on the implementation of CPOE in all inpatient areas, thus preventing failure of prescription/transcription and validation loops. No conflict of interest.

Background Gastroprotective agents are widely used in both hospital and community settings, and they are generally perceived as safe drugs. Purpose To find out whether the prescription of anti-ulcer drugs in the Emergency Room (ER) accords with their approved indications, and the financial impact of their inappropriate use. Materials and Methods Indications for use of proton pump inhibitors (PPIs) and H2 antagonists (via the Spanish Medicines Agency): gastro-duodenal ulcers (including NSAIDs and steroid-related ulcers), reflux oesophagitis, Zollinger-Ellison’s syndrome, and Helicobacter pylori eradication. Inclusion criteria: patients >65 years old on at least four home medicines and an anti-ulcer prescription in the ER. Pharmaceutical interventions were recorded and their degree of acceptance calculated. The cost resulting from drug misuse was calculated considering a mean stay in the unit of one day. Results 111 patients, 70.2% male, median age 78.9 years-old [65–94]. 94.6% of patients (92.9% PPI, 1.7% H2 antagonists) received one of these agents upon presentation (95.5% of them were prescribed de novo), with intravenous pantoprazole the agent mainly involved (82% of cases). 29.7% of prescriptions did not meet the indications, while this percentage decreased to 12.5% upon ward admission. The pharmaceutical interventions were accepted in 16.2% of cases. Monthly, the estimated cost of the off-label use was €1850. Conclusions Gastro-protection in the ER did not meet the criteria in nearly 1/3 of patients. This contrasted with the poor acceptance of the pharmaceutical recommendations of discontinuation. The rationale might be the so-perceived harmless profile of these drugs with the short-term use. The rate of off-label prescriptions dropped to half upon ward admission, likely due to thorough revision by the prescriber. Since only patients at a higher risk of suffering from a medicines-related problem were included, the cost resulting from the misuse of anti-ulcer drugs was probably underestimated. In conclusion, forthcoming pharmacy policies should focus on improving the adherence to the indications of both widely-used and expensive drugs, given their financial and health-care impact. No conflict of interest.

Background Some authors have reported reductions in health-related quality of life (HRQOL) of hepatitis C (HCV)-infected patients, but studies fail to discriminate between the effect of factors such as the antiviral regimen, the viral load (VL) or the degree of fibrosis. Purpose To evaluate HRQOL in chronically-ill HCV patients prior to, and after, treatment initiation Materials and Methods Inclusion criteria: patients >18-years old, HCV antibodies+ and HCV-RNA+, no other relevant co-morbidities. Recruitment period: 9 months. Patients were stratified according to the previous VL and their degree of fibrosis, and started on antiviral treatment based on ribavirin + peginterferon. On their follow-up visits (weeks 0, 4 and 12), subjects were given a validated questionnaire (SF36) to be completed at home and delivered on their next visit to the outpatient pharmacy. SPSS v17 was used for the statistical analysis. Results18 subjects recruited (n = 18), percentage of males 67%, mean age 47.3. 10 patients had genotype 2 or 3, and 8 patients had genotype 1 or 4. Low-grade (stage 1–2) and high-grade (3–4) fibrosis was found in 11 and 7 patients respectively. 9 patients had >800,000 RNA copies/mL at presentation. With regard to the antiviral therapy, statistically significant differences in the following items were found between week 0 and week 4: physical functioning (P = 0.046), physical role (P = 0.001), pain (P = 0.001), health (0.046), energy/fatigue (P = 0.001), and emotional wellbeing (P = 0.001). Additionally, we found statistically significant differences in the emotional component with regard to the VL (P = 0.005) and the degree of fibrosis (P = 0.03). Conclusions Antiviral therapy was associated with deterioration in HRQOL. Items involving physical health exhibited the greatest differences. Conversely, those subjects with higher VL and an advanced degree of fibrosis had worse scores in the items involving emotional wellbeing. Long-term studies are currently being conducted to determine whether the existing differences are emphasised over time, as well as the implications of these findings. No conflict of interest.

Background The diagnosis of multiple myeloma (MM) has been associated with a greater risk of thromboembolic events. At the same time, the treatment with lenalidomide, an immunomodulator authorised in 2007 by the EMA, causes a significant increase in the risk of deep vein and arterial thrombosis, and pulmonary embolism in patients with MM. PurposeTo find whether patients diagnosed with MM being treated with lenalidomide have prophylactic antithrombotic treatment with low molecular weight heparin or with acenocoumarol, as recommended in the ASCO (American Society of Clinical Oncology) guidelines. Materials and Methods A retrospective observational study was carried out in a 700-bed secondary hospital from January 2011 to February 2012. The patients included had MM and lenalidomide and dexamethasone treatment and picked up their medicines in our hospital. The data were obtained from a Diraya computer system of the Andalusian health system. The following data were obtained: sex, age, whether they had anticoagulant treatment or not and if they had, what type of anticoagulation they received. ResultsThe total number of patients was 31, 16 males and 15 females, with an average age of 61.7 years. Of these 31 patients treated with lenalidomide plus dexamethasone, only 9 patients received antithrombotic prophylactic treatment. Of the 22 who did not receive it, there were two cases of episodes of deep arterial thrombosis. Conclusions Most of the patients with multiple myeloma who come to our pharmacy service are without antithrombotic prophylactic treatment with the risk that this situation entails. As pharmacists we consider it necessary to remind haematologists of the necessity both of prescribing such treatment in order to avoid future complications, and of monitoring that these recommendations are observed, in order to guarantee the safe use of lenalidomide. No conflict of interest.

Background HER2 (ERB2, neu) is a proto-oncogene that encodes a transmembrane protein with tyrosine kinase activity. Trastuzumab (Herceptin), a humanised monoclonal antibody that binds to the HER2 extracellular domain, is used to treat HER2-positive breast cancer. Although it is well tolerated, it has a significant adverse effect: cardiotoxicity. Purpose To evaluate the possible effect of ERB2 gene polymorphism at codon 655 (ATC/isoleucine to GTC/valine) (rs1136201) in cardiac dysfunction related to trastuzumab in women diagnosed with HER2-positive breast cancer. Materials and methods 54 patients with HER2-positive breast cancer treated with trastuzumab in our hospital were evaluated prospectively from January to December 2012. Trastuzumab was administered as a loading dose of 8 mg/kg followed by 6 mg/kg every three weeks. For all patients, cardiac function (left ventricular ejection fraction, LVEF) was checked at baseline and every 3 months by echocardiogram or MUGA (multigated blood-pool imaging) scan. We considered cardiac toxicity if the LVEF dropped 10 percentage points from baseline and below 50%, as stated in the data sheet. For genotyping we used TaqMan probes and an allelic discrimination technique. Statistical analysis was performed with Statcalc software packages and significance was indicated by a p value lower than 0.05. Results The mean age of the patients was 51.11 ± 12.16 years. The distribution of genotypes was 55.56% AA, 40.74% AG and 3.7% GG. Of all patients, 12 developed cardiotoxicity during the treatment with trastuzumab: 4 with genotype AA, 8 with AG and none with GG. Significant correlation was not found between genotypes AA (vs. AA/GG) or GG (vs. AA/AG) and cardiac dysfunction. Instead, statistically significant differences were shown when comparing patients with genotype AG and AA/GG with cardiotoxicity (p = 0.046, OR = 4, 95% CI = 1.026–15.599). Conclusions The results of our study show an association of ERB2 polymorphism Ile655Val with cardiac toxicity associated with trastuzumab. Patients with genotype AG have higher risk of developing cardiac dysfunction related to trastuzumab than those with AA or GG. We need more studies on this polymorphism as well as larger sample sizes to confirm these findings. No conflict of interest.