BackgroundNatalizumab increases the risk of progressive multifocal leukoencephalopathy (PML), a potentially lethal brain disorder caused by JC polyomavirus (JCV). The antimalarial mefloquine has shown activity against JCV in vitro, but little evidence supports its use in vivo.PurposeTo analyse the efficacy and safety of mefloquine in a case of natalizumab related PML.Material and methodsA 51-year-old Caucasian woman was admitted to the emergency department in March 2013 complaining of ongoing limb weakness and slurred speech. Relevant past medical and drug history: relapsing remitting multiple sclerosis diagnosed in 2004, receiving monthly natalizumab since July 2010 (last infusion 4 days previously). High dose corticoid therapy plus supporting measures were started immediately. 10 days after admission, PML infection was confirmed based on contrast enhanced MRI findings and positive CRP for JCV DNA in cerebrospinal fluid. Patient consent and institutional ethics committee approval were obtained and a trial of mefloquine (250 mg for 3 days, and then 250 mg weekly) plus plasmapheresis (to accelerate removal of the antibody) were initiated.ResultsEfficacy: the patient experienced progressive motor and cognitive impairment. MRI on days 15 and 30 revealed further demyelination with areas extending into the deep white matter and the splenium of the corpus callosum. The patient died on day 55. Safety: on day 45, the patient had seizures that were treated with levetiracetam 1 g twice daily.ConclusionDespite mefloquine therapy, clinical and radiological progression was observed. Moreover, mefloquine was associated with CNS toxicity. To date, only routine MRI has ameliorated the outcome of this neuropathy at the very early stages of infection (pre-symptomatic). With the lack of firstline evidence, mefloquine has been used with mixed success in the treatment of PML although larger studies are required to assess its efficacy and safety.No conflict of interest.
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.
BackgroundHypercalcaemia can cause life-threatening complications. Pharmacological treatment of severe hypercalcaemia is complicated by lack of experience with some effective medicines such as bisphosphonates in newborns.PurposeTo describe the pharmacotherapeutic management of pamidronate in severe hypercalcaemia of a premature newborn.Material and methodsWe report on a preterm infant [weight: 1.080 kg, length 38 cm] who had required total parenteral nutrition (TPN) since birth. In routine blood tests, serum calcium was 15.6 mg/dl on the seventh day of life, reaching as high as 17.2 mg/dl as a consequence of suspected adrenal insufficiency of central origin.ResultsHypercalcaemia persisted despite the conventional treatment for excessive calcium, including removal of calcium from the TPN. The patient received intravenous pamidronate (1 mg/kg) for 1 day. Pamidronate 6 mg was diluted in 30 millilitres of 5% dextrose saline solution, only 10 millilitres were infused in 4 h. His serum calcium level decreased significantly, and about 15 h later, his total calcium level normalised (10.6 mg/dl). His serum calcium concentration returned to normal without any adverse reactions.ConclusionIntravenous pamidronate appeared to be a safe and effective treatment for severe hypercalcaemia in a premature newborn.References and/or acknowledgementsTo my pharmacist colleagues.No conflict of interest.
BackgroundRefractory cancer pain is often difficult to manage. Ketamine is a drug with evidence of efficacy in the treatment of chronic cancer pain.PurposeTo evaluate the efficacy and safety of ketamine rinse solution in paediatric patients with refractory cancer pain.Material and methodsWe report on a paediatric oncology patient who presented with painful conditions refractory to conventional analgesic treatment. Intravenous ketamine was diluted to a final concentration of 10 mg/mL in sterile water to rinse. Mouth rinses with 3 mL (30 mg) once daily was prescribed, specifying two rinses daily if required. Efficacy was measured on a visual analogue scale for pain (VAS pain), the Clinical Global Impression – Global Improvement (CGI-I) Scale, and the reduction of dose or withdrawal of analgesic drug base. Safety was measured in terms of variation in some clinical parameters (blood pressure, heart rate, oxygen saturation) and onset of drug-related symptoms (feeling drunk, drowsiness, nausea, vomiting, nystagmus or hallucinations).ResultsThe case of a male patient 13 years of age [33 kg and 143 cm] is presented. The patient was receiving morphine chloride rescues until the treatment; morphine rescue was no longer needed on the second day of initiating treatment. The VAS pain score before rinsing was 9 and remained on 2 for 24 h after the rinse was applied, achieving a score of 0 on day four. CGI-I Scale at the end of the treatment score was 1 (Very much improved). The patient had no changes in clinical parameters. The total rinsing treatment time was four days, requiring two rinses the first day only. The pain stopped within 10 min of beginning the rinsing.ConclusionKetamine rinsing was effective and safe in our paediatric oncology patient with painful conditions refractory to standard analgesic treatment. Further studies are needed to strengthen our results.References and/or acknowledgementsSpecially thanks Dr Manuel CortiñasNo conflict of interest.
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