BackgroundGabapentin and pregabalin are two GABA analogues, example of an evergreening strategy. Both have been associated with a markedly off-label use.PurposeTo describe the extent and nature of the off-label use of gabapentin and pregabalin.Material and methodsProspective observational study performed in a tertiary hospital. We included patients being treated with gabapentin or pregabalin at any time between June and August 2014. The variables collected were: sex, age, drug, therapeutic indication, dose and cost per patient-month (according to retail prices). These data were used to describe the rate and nature of the overall use and off-label use by drug. Data were collected through review of medical records and by electronic pharmacy refill records. Statistical analysis was performed using SPSS Statistics 20.0.ResultsSixty-five patients (54% male, mean age 60 ± 14 years) were included. Eighteen (28%) were being treated with gabapentin and 47 (28%) with pregabalin. The overall off-label use was 43% (28 patients), with no differences between the drugs (44% gabapentin and 43% pregabalin). The off-label use was related to the therapeutic indication (25 patients) or the dose (3 patients). The off-label indications for gabapentin were: central neuropathic pain (6), subacute or chronic low back pain (3), generalised anxiety disorder (3) and refractory visceral pain (1). The off-label indications for pregabalin were: subacute or chronic low back pain (6 patients), fibromyalgia (5), and essential tremor (1). The average cost per patient-month was €25 ± 11 for gabapentin and €156 ± 65 for pregabalin.ConclusionGabapentin and pregabalin are often prescribed for off-label use. Despite having failed to demonstrate clinically relevant differences over gabapentin, pregabalin holds a high prescription rate with consequent extra costs for the hospital, representing an area in which rational drug use could be promoted.ReferenceRadley DC, Finkelstein SN, Stafford RS. Off-label prescribing among office-based physicians. Arch Intern Med 2006;166:1021–6No conflict of interest.
ObjectiveWe aimed to compare the response rates between two different hepatitis B virus vaccination schedules for cirrhotic subjects who were non-responders to the first three 40 µg doses (month 0-1-2), and identify factors associated with the final response.DesignA total of 120 cirrhotic patients (72.5% decompensated) were randomised at a 1:1 ratio to receive a single 40 µg booster vaccination at month 6 (classical arm) versus an additional round of three new 40 µg doses administered at monthly intervals (experimental arm). The main outcome was the rate of postvaccinal anti-hepatitis B surface antibodies levels ≥10 mIU/mL.ResultsEfficacy by ITT analysis was higher in the experimental arm (46.7%) than in the classical one (25%); OR 2.63, p=0.013. The experimental arm increased response rates compared with the classical one from 31% to 68% (OR 4.72; p=0.007), from 24.4% to 50% (OR 3.09; p=0.012) and from 24.4% to 53.8% (OR 3.62; p=0.007), in Child A, Model for End-Stage Liver Disease (MELD) <15 and MELD-Na<15 patients, respectively. Patients with more advanced liver disease did not benefit from the reinforced scheme. Both regimens showed similar safety profiles. Multivariable analysis showed that the experimental treatment was independently response associated when adjusted across three logistic regression models indicating equivalent cirrhosis severity.ConclusionFor cirrhotic patients, the revaccination of non-responders to the first three dose cycle, with three additional 40 µg doses, achieved significantly better response rates to those obtained with an isolated 40 µg booster dose.Trial registration numberNCT01884415.
Background Boceprevir has been linked with high rates of anaemia in patients with HCV infection. Anaemia management strategies (AMS) are strongly recommended in order to achieve therapeutic success. Purpose To describe AMS in HCV-infected patients who are on triple therapy that includes boceprevir. Materials and methods We conducted a retrospective observational study. Medical records of patients on boceprevir between 01/2012–05/2013 in a tertiary hospital were reviewed. Patients were included if they were ≥18 years and had already finished their HCV treatment. Demographic and laboratory data were recorded from the start of the HCV treatment. The following data related to AMS were collected during the HCV treatment: number of ribavirin dose reductions, minimum ribavirin dose prescribed, use of recombinant human erythropoietin (rh-EPO) and/or granulocyte colony-stimulating factor (G-CSF). The chi-squared test was performed to examine the role of AMS on the incidence of therapeutic failure due to adverse events (AE). Statistical analysis was performed using SPSS 19.0. Results 64 patients were included. 44 (69%) required AMS vs. 19 (31%) who did not. No statistically significant differences were observed for the variables age [56 ± 7.4 years vs. 51 ± 8.8]; sex [65% male vs. 79%]; liver fibrosis [31 (70%) F4 stage vs. 12 (63%)]; HIV-HCV co-infection [14% vs. 16%]; baseline haemoglobin [145 ± 18 mg/dl vs. 154 ± 15]; AST [74 ± 50 mU/ml vs. 78 ± 46] and ALT levels [66 ± 44 mU/ml vs. 68 ± 32]. Regarding the AMS used, 22 (34%) received at least one dose of rh-EPO, 4 (6%) of G-CSF and 37 (58%) required a ribavirin dose adjustment with a median of one dose adjustment [1–6]. The minimum ribavirin dose prescribed was 400 mg in 6 (9%) patients, followed by 600 mg [12 (19%)] 800 mg [13 (20%)] and 1000 mg [6 (9%)]. A statistically significant difference (p < 0.05) was found between the use of AMS and failure due to AE [3 (7%) vs. 7 (37%)]. Conclusions Regarding the safety profile of boceprevir, AMS such as ribavirin dose adjustments or the use of rh-EPO are effective in improving treatment outcomes in HCV-infected patients. No conflict of interest.
BackgroundPatient safety is a key factor in the quality of care and it is the object of public attention.Improvement strategies have stimulated the development of models that allow a better understanding of the adverse effects related to health care. The most common adverse effects are related to drug use and often are preventable. Therefore, they have to develop strategies to reduce and detect them.PurposeTo describe the development of a strategy designed to improve drug’s storage and dispensing in a pharmacy service to ensure patient safety.Material and methodsLiterature review about drugs that are confused: drugs that must be stored and dispensed in special conditions because of their photosensitivity, drugs whose active generic or trade name are written or pronounced in the same way (look-alike, sound-alike: LASA) or drugs that bear a heightened risk when used in error (high alert medication).Design a colour labelled to avoid the possible confusions. Photosensitive drugs were labelled with yellow point, “LASA” with green and high alert medication with red point. Then, it has been set some posters with the colour code to teach the pharmacist and technicians. After that, we evaluated the results and checked with a survey among the technicians, that this strategy was useful.ResultsOf 2,490 drugs that are stored, 89 (3.57%) were categorised as photosensitive drugs, 6 (0.24%) as “LASA” and 66 (2.65%) as high alert medication.Four error related with dispensation were registered along three months before intervention, however any error has occurred the quarter after that. In addition, after an audit, all the photosensitivity drug’s are stored in optimal conditions.From 15 technicians surveyed, 90% say to know the strategy implemented and consider it like useful.ConclusionThis strategy has helped the pharmacy service to improve the storage and dispensing quality, avoiding medication error and providing the drugs in optimal conditions to the patients, increasing their safety.References and/or acknowledgementsNo conflict of interest.
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