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.
BackgroundNon-adherence in patients with multiple chronic conditions (PMCC) is associated with poor disease control, reduced quality of life and increased risk of morbidity and mortalityPurposeTo assess the available scientific evidence regarding the efficacy of interventions aimed to improve medicines adherence that are applicable to PMCC.Material and methodsOverview of systematic reviews (SRs). The following databases were consulted (September 2013): PubMed, EMBASE, the Cochrane Library, CRD and WoS to identify SRs of clinical trials focused on PMCC, or otherwise, patients with chronic diseases common in the PMCC, or polypharmacy. SRs that compared the efficacy of any intervention aiming to improve compliance with medicines with clinical practice or other interventions were included. For every SR and type of intervention (behavioural, educational and combined) the percentage of clinical trials in which adherence improved was estimated. Rates were combined between SRs by means and ranges. Meta-analysis could not be conducted because of the heterogeneity of the data. This analysis was also applied to the components from those interventions described in ≥1 SR.Results566 articles were retrieved of which 9 SRs were included. None was specifically focused on PMCC but considered patients with chronic diseases common in PMCC, patients with more than one chronic disease and polypharmacy.Seven, three and six SRs reported behavioural, educational and combined interventions, respectively. The mean efficacy rates were 49% [0–100], 51% [0–100%] and 53% [44–75]. The components from those interventions which reported higher efficacy were: counselling about the patients’ target disease, the importance of treatment and compliance with treatment (5 SR, 79% [47–100]), reminders (4 SR, 70% [50–100]), simplified dosing (3 SR, 90% [75–100]) and special pill packaging (2 SR, 83% [66–100]).ConclusionThere is a large heterogeneity in the efficacy of interventions aimed to improve medicines adherence that are applicable to PMCC. Nevertheless, they seem to have a modest impact on adherence. Some components of the interventions appear to have greater efficacy.References and/or AcknowledgementsArch Intern Med 2007;167:540–50No conflict of interest.
BackgroundReport of a case of a patient allergic to albumin. In the absence of therapeutic alternatives we proposed an albumin desensitisation protocol.PurposeTo describe how the samples were prepared and the technique administered. To evaluate the effectiveness and safety of the desensitisation protocol for albumin in a patient who developed a hypersensitivity reaction to it.Material and methodsReview of the clinical history of a 72 year-old female diagnosed with liver cirrhosis HCV that had developed over 8 years, portal hypertension, ascites, oesophageal varices and splenomegaly. She was thought to have suffered an allergic reaction to intravenous albumin, based on symptoms after administration including neck rash, facial flushing and chest tightness, after we had eliminated allergy to any of the product excipients.Alternatives such as administering albumin with premedication (corticosteroids and antihistamines), diuretics and plasma expanders were evaluated without getting the desired result.After an unsuccessful literature review in which we could not find an albumin desensitisation protocol or a similar case, a protocol was suggested that involved the administration of increasing doses of albumin until a total cumulative dose achieved therapeutic levels.ResultsThree albumin preparations were devised: 0.6 grams of albumin diluted in 250 ml of physiological saline to give a concentration of 0.0024 g/ml, a second one with 6 grams in 250 ml for a concentration of 0.024 g/ml and a third preparation with 60 grams of undiluted albumin, which were administered at infusion rates of 5, 10, 20 and 40 ml/h every 15 min.After four sessions of paracentesis, with subsequent return of 60 grams of albumin infusion as per the desensitisation protocol, the patient did not have a further anaphylactic reaction. The regimen was well tolerated, achieving a final infusion rate of 50 ml/h.ConclusionThe protocol and formulation have proved to be effective and safe for desensitisation to albumin in the clinical case described.Multidisciplinary collaboration of the professionals involved has enabled treatment with post-paracentesis albumin to be considered a valid therapeutic strategy for patients in the same clinical situation.References and/or acknowledgementsNo conflict of interest.
BackgroundThe high economic impact of biologic therapy justifies the need of supervising and monitoring patients treated by the requesting department (Dermatology) and service responsible of dispensing (Pharmacy).PurposeTo analyse biological therapy resolutions submitted by a commission formed by dermatologic experts.Material and methodsDescriptive, retrospective study. Applications emitted by a local commission were reviewed between September 2013 and March 2014.The variables collected were: treatment suggestion, diagnosis, resolution, therapeutic alternative in case of refusal, PASI (>10 as initial criterium) and BSA (%) at the beginning.Treatment adherence’s was also checked, using dispensations made by pharmacists.Results43 applications were collected from 38 patients. 5 were evaluated twice after a previous rejection.Regarding to applications, 54% were Adalimumab, 19% Ustekinumab, 14% Infliximab, 7% Etanercept, 4% Metotrexate and 2% Infliximab + Metotrexate. Diagnosis included: serious plaque psoriasis (9), moderate-severe (4), severe (21); psoriasis with artropathy (4) severe hidradenitis suppurative (2). This last two requiered an Adalimumab’s use which were “off-label”.Nine proposal were rejected: 4 with Adalimumab in serious plaque psoriasis (1), moderate-sever (1), severe (1) and with artropathy (1), 2 with Etanercept in psoriasis and artropathy and 1 Infliximab in serious plaque psoriasis.In 89% of refusal, a therapeutic alternative was proposed: cyclosporine (2), methotrexate (4) or phototherapy (2). In another one no treatment was proposed.From the 34 approvals, 25 patients accomplished the PASI criteria greater than 10, 3 did not and 7 did not reveal that information. Checking adherence treatment, 88% of patients continue with their treatment, 6% did not collect medication and another 6% have discontinued therapy due to incompatibility with other pathology.ConclusionThe work made by these experts can help to regulate the use of biological therapies, restricting them to patients for whom there is solid evidence to support its use, and offering a therapeutic alternative in case of refusal. The Pharmacy Service reviews patient progress and adherence treatment, thus promoting rational drug use.References and/or AcknowledgementsNo conflict of interest.
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