Background Telaprevir is one of the new drugs for chronic hepatitis C genotype 1. As it is a new drug is necessary to be aware of the emergence of new adverse reactions that may not be included in the SPC. Purpose To investigate possible severe adverse reactions not mentioned in telaprevir’s SPC. Materials and methods Descriptive and retrospective clinical case. Data were obtained by review of the patient medical history, Savac and Selene software and laboratory data. Results Fifty-seven-year-old male with HCV genotype 1a/1c. It was decided to start his first treatment for hepatitis C with ribavirin (RBV) 400 mg/12 h, Peg-interferon (P-INF) alfa 2a 180 mcg/week and telaprevir 750 mg/8 h. In week 8 of treatment he was admitted with symptomatology compatible with pancreatitis. Amylase 1888 IU/L appeared in laboratory data. Absolute diet, analgesic and antiemetic measures were established. The patient was discharged a week after admission with an amylase of 173 IU/L. The next day he was admitted with an amylase of 3406 IU/L and the same symptoms. Telaprevir was suspended (week 9 of treatment) in case it could be the cause, and he continued with P-INF and RBV. The patient was discharged 5 days later with an amylase of 365 IU/L. The Karch-Lasagna modified algorithm established as “possible” the relationship between pancreatitis and telaprevir. Conclusions A MEDLINE search was performed on 17.01.13 with the words “telaprevir” “pancreatitis” “abdominal pain” or “amylase” and we did not find any results that evidenced pancreatitis caused by telaprevir. A temporal association existed between drug use and pancreatitis symptoms as well as between telaprevir suspension and the patient’s improvement. Therefore, we concluded that telaprevir could have caused acute pancreatitis in this patient. No conflict of interest.
Background Autologous serum eye drop treatment is a common practice in the treatment of several ocular pathologies that require relatively frequent blood draws. Purpose To study the symptom improvement perceived by patients after treatment with autologous serum 20% and overall satisfaction with such treatment. Materials and methods Observational, retrospective and descriptive study in eye disease patients (GVHD, dry eye, etc.) with autologous serum 20% eye drops in 2011 and 2012. The information was compiled by the SAVAC and SELENE prescribing systems and reviewing medical records in addition to telephone surveys of patients. Reviewed symptoms were: red eye, dry eye, inflammation, rheum, foreign body, itching/burning, tearing, photophobia, blurred vision and eye heaviness. Results A total of 15 patients (53% male) with a median age of 58 years were studied, of whom 11 (73%) had red eye, 13 (87%) dry eye, 6 (40%) inflammation, 5 (33%) rheum, 11 (73%) foreign body, 14 (93%) itching/burning, 1 (7%) tearing, 13 (87%), photophobia, 10 (67%), blurred vision, 5 (33%) eye heaviness. Of patients who experienced these symptoms, 64% of patients with red eye, 46% with dry eye, 50% with inflammation, 80% with rheum, 82% with foreign body, 64% with itching/burning, 15% with photophobia, 50% with blurred vision and 40% with eye heaviness considered they had improved and the tearing-eyed patient did not improve. Conclusions Symptoms that improved in a greater number of patients were sensation of foreign body, itching/burning eye and red eye. On the other hand, some symptoms such as photophobia, tearing and dry eye improved in only a small number of patients. Furthermore, 80% of patients said the perceived subjective improvement in symptoms was worthwhile, compared to the discomfort of blood draws. No conflict of interest.
BackgroundThe ambulatory dispensation area is one of the most important sections of the hospital pharmacy. Treatment of several pathologies, such as oncology disease, hepatitis C virus, human immunodeficiency virus and more, are dispensed in this area, where the pharmacist has total responsibility for patient satisfaction.PurposeOutpatient satisfaction after implementing an improvement cycle.Material and methodsAll patients who attended the outpatient unit of pharmacy and who agreed to participate were asked to complete a satisfaction survey during the first half of 2014. After a cycle of improvement, when facilities were improved, a system of timeouts was implemented and staff training increased, the same surveys were conducted during the first half of 2015. Surveys consisted of 14 items and several aspects were scored: facilities, waiting time, kindness of staff, information explained by the pharmacist and overall satisfaction, on a scale of 1–10.Results72 surveys were conducted, 38 pre-intervention and 34 after the intervention. Regarding the average score obtained in the pre-intervention phase, the following scores were obtained: 5.7 for facilities, 6.4 for waiting times, 8.4 for kind staff, 7.5 for information explained by the pharmacist and 7.5 for overall satisfaction.After the improvement cycle, the following scores were obtained: 8.1 for facilities, 6.9 for waiting times, 9.3 for kind staff, 9 for information explained by the pharmacist and 9 for overall satisfaction.Improvements in the scores were: +2.4 (p < 0.05) for facilities, +0.3 (p > 0.05) for waiting times, +0.9 (p > 0.05) for kind staff, +1.5 (p < 0.05) for information explained by the pharmacist and +2 (p < 0.05) for overall satisfactionConclusionThe facilities obtained the lowest score in the pre-intervention surveys, but showed the greatest increase after the improvement cycle. The improvement after implementing a system of waiting time was not significant, which led to a new cycle of improvement focused on that aspect. In general, the overall satisfaction of patients was positive after implementing the improvement cycle.No conflict of interest.
BackgroundLenalidomide is one of the main drugs for the treatment of multiple myeloma, which has a high cost per patient.PurposeTo describe and analyse the use of lenalidomide in multiple myeloma.Material and methodsThis retrospective study covered the period from January 2013 to December 2015. All patients with a diagnosis of multiple myeloma who started treatment with lenalidomide from January 2013 to June 2015 were included. The collected parameters were: number of patients, age, sex, progression free survival (PFS), economic spending (€) and dose used. Data were obtained through the prescription and validation programme SAVAC, its complementary exploitation of data programme Discoverer and collected in an Excel base designed for that purpose.ResultsA total of 44 patients (54% women) were identified, with a median age of 75 years (mean 72±11; range 37–97). Median PFS to the cut-off date was 12 months. 34% of patients exceeded 18 months of PFS and 23% achieved a PFS higher than 24 months. In contrast, 9% of patients had less than 3 months of PFS. The annual cost was €1 046 963, with an average cost per patient/year of €32 718, representing 3% of the total budget of the pharmacy service. Regarding safety, 42% received at least one dose reduction, and 17% more than one dose reduction. These data are consistent with consumption of the various presentations, where more than 50% of consumption corresponds to the dose of lenalidomide 25 mg, the 10 and 5 mg doses being consumed less (<10% and 5%, respectively).ConclusionThe results of effectiveness of PFS matched the effectiveness of the pivotal studies MM-009 and MM-010 that showed a median PFS of 48.1 weeks (12 months). Almost half of patients with more than 12 months of PFS had reached 24 months of PFS. This represents a cost per patient of approximately €30 000/year, and an incremental cost per life year gained of €56 410 compared with placebo.No conflict of interest
BackgroundOndansetron is a powerful and highly selective serotonin receptor antagonist used to prevent nauseas and vomiting after surgery or chemotherapy. Sialadenitis consists in the formation of stones along the salivary duct.PurposeTo describe a case of ondansetron-induced sialadenitis and the prevention of its reappearance.Material and methodsData obtained from the medical records and direct interview with the patient, were: age, sex, pathology, concomitant drugs and resolution. Side effects and interactions of each drug were obtained from the product information and Micromedex.ResultsA 28-year-old woman in treatment with temozolomide for a low-grade astrocytoma, sought help in her third cycle of chemotherapy for obstruction of the salivary duct.The patient was taking escitalopram and levetiracetam. Temozolomide, ondansetron and dexamethasone had been recently introduced, so they were the most likely agents to have caused the event.In the list of possible adverse effects of every agent, sialadenitis is not referenced but xerostomia is described in the information about ondansetron (5%) and escitalopram (4–9%) and it could have worsened with the vomiting and dehydration.Studying the interactions between the drugs did not warn us. The mechanism of action of ondansetron over the 5-HT4 receptor can explain it. Some antidepressants block cholinergic receptors contributing to this situation but escitalopram has a very low effect over them, the reaction was unexpected.The Naranjo algorithm assigned 5 points (likely) to both as the causative agents but there are no previous notifications of this adverse event.The stone dissolved spontaneously after oral hydration and the salivary duct became milky. The pharmacist instructed the patient in correct oral hydration and the event did not occur again during the next 12 months of treatment.ConclusionHigh dose of ondansetron added to escitalopram may cause salivary duct stones in patients with other risk factors such as vomiting and dehydration. The pharmacist can prevent new stones from appearing by teaching patients good oral hydration practices during treatment.ReferenceNo conflict of interest.
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