Background and importancePopulation aging and the growing risk of developing cancer with age lead to an increasing number of elderly patients treated in the oncology care unit. Elderly people are ...fragile, polypathological and polymedicated. To optimise their care, oncogeriatric consultations are performed by a doctor, nurse, dietician and psychologist.Aim and objectivesThe aim of this study was to evaluate the benefit of including the hospital pharmacist in these consultations.Material and methodsA retrospective study was conducted on 17 patient files that had been reviewed in oncogeriatric consultations at our hospital centre from May 2019 to March 2020. We searched for information on each patient in the electronic medical record: medical background, usual treatments, considered cancer therapy, biological results, risk of falling, and the presence of balance and cognitive disorders. We then analysed drug interactions, identified potentially inappropriate prescriptions according to the STOPP and START criteria and the anticholinergic burden of the treatment.ResultsAverage age was 84 and the male/female ratio was 0.55. 62 pharmaceutical interventions could have been transmitted to the doctor if the pharmacist had participated in these consultations (ranging from 3 to 6 interventions per patient, average 3.65). There were 7 types: addition of treatment (21), monitoring to be programmed remotely from the consultation (10), dosage adjustments (7), treatment discontinuation (7), biological monitoring (7), adaptation of the intake plan (6) and molecule switch (4). The main interventions were: management of vitamin deficiencies (D, B9, B12), anti-pneumococcal vaccination, discontinuation of drugs with formal contraindications or belonging to the same therapeutic class, high dose PPIs without indication, benzodiazepines dose adjustment, monitoring of nephrotoxicity and serum potassium, replacement of one benzodiazepine by another with a shorter half-life and adaptation of the intake plan to limit interactions between oral chemotherapy and antacid.Conclusion and relevanceThe pharmacist has a real role to play in oncogeriatric consultations, to prevent iatrogeny and optimise patient care. The limitations of the study were the non-exhaustiveness of the treatment (self-medication and phytotherapy), ignorance of potential swallowing disorders and vaccinations carried out. However, this missing information can impact on patient care and could be collected by the hospital pharmacist.References and/or acknowledgementsConflict of interestNo conflict of interest
BackgroundVidaza (azacitidine), comes in vials of sterile lyophilised powder for reconstitution with water for injections in a controlled environment. After reconstitution, chemical and physical ...in-use stability of the finished product has been demonstrated at 25°C for 45 min; at 2–8°C for 8 hours; and at 2–8°C for 22 hours when Vidaza is reconstituted using refrigerated (2–8°C) water for injections. Our centralised reconstitution unit prepares chemotherapy for a public hospital which is located 47 km away.PurposeThe objective of our study was the conservation of the cold chain for the reconstitution of Vidaza using refrigerated water in order to assess the feasibility of preparing Vidaza off-site.Material and methodsWe created an organisational chart that illustrated the reconstitution of Vidaza to target critical points. Average temperature measurements of each step of the Vidaza reconstitution were obtained using a digital thermometer probe. Cold chain compliance was obtained when the temperatures recorded were between 2°C and 8°C.ResultsThe results showed that refrigerated water for injection introduced into the isolator through the sterilisation chamber reached an average temperature of 10.7°C. The same experiment with frozen water for injection led to an average temperature of 9.6°C. Refrigerated, sterile water for injection once in the isolator can be placed in the rapid transfer port (RTP) system. This removable system stored in a freezer and then reconnected to the isolator provides refrigerated water for injections at an average temperature of 3.4°C after complete thawing. After reconstitution, the finished products are immediately stored in the refrigerator and transported to oncology units in coolers with time/temperature recordings to monitor the temperature. Syringes are received at an average temperature of 6°C at the public hospital located 47 km away. Therefore, syringes of Vidaza can be prepared using the RTP system and should be sent to oncology units or transported to the external public hospital in coolers.ConclusionThis study confirms the feasibility of cold chain conservation in the reconstitution of Vidaza in isolators and the feasibility of the subcontracting activity. It also strengthens collaboration between hospitals in the same catchment area and encourages the development of haematology activities in the subcontracting hospital.References and/or acknowledgementsVidal.No conflict of interest
BackgroundDuring the urology device tender, a new ureteral catheter (UC) was proposed: the UROTECH’s MAGNETIC BLACK-STAR kit, which is three times more expensive than the traditional UC (non-magnetic ...rigid polyurethane double loop UC). Its bladder side magnet allows its removal thanks to a magnetic recovery device. As this new technique is faster and requires no endoscope or re-sterilisable equipment, the additional cost of purchase would be offset during the withdrawal, and the discomfort would be reduced for the patient, according to the manufacturer.PurposeWe wanted to estimate the overall cost differences for our hospital between the BLACK-STAR UC and a traditional UC, and compare our results with an estimation made by the manufacturer to another hospital.Material and methodsThe estimation is based on the time spent by the nurse and surgeon, and the exhaustive listing of the devices used during the removal procedure of the two UC, in men and women. The estimated costs of using re-sterilisable medical devices include depreciation and sterilisation. For the flexible endoscope, this was evaluated in 2015 in our hospital by also integrating the maintenance cost. As the placement technique is identical for both UC, the cost of the equipment used was not evaluated.ResultsIn men the cost is estimated at €209 for the usual UC removed by flexible cystoscopy versus €124 for the magnetic UC (gain of €85 with the magnetic UC, higher than the €63 announced). In women, the cost is estimated at €84 for the usual UC removed by rigid cystoscopy, versus €124 for the magnetic UC (€40 more expensive with the magnetic UC, contrary to the gain of €32 announced). Since the magnetic UC was placed but not yet removed, this estimation does not include the cost of hospital staff.ConclusionThe economic evaluation conducted in our hospital is largely in favour of the use of the magnetic UC in men. Although this is not the case for women, its referencing to replace the current UC could save more than €12 000 per year in our hospital, based on 2017 consumption. Patient satisfaction also remains to be assessed.References and/or acknowledgementsNo conflict of interest.
BackgroundCyclosporine is an immunosuppressive drug known for its narrow therapeutic range. The only formulation available on the market offers a concentration of 100 mg/mL. However, in our hospital, ...the paediatric department regularly requires dosages as low as 4 mg that are difficult to prepare from the pharmaceutical specialty. This may lead to inaccurate doses that can have a marked clinical impact. In this context, we developed a 10 mg/mL cyclosporine formulation.PurposeThe aim of this study was to determine the physicochemical stability of our 10 mg/mL cyclosporine formulation, to establish the shelf-life.Material and methodsInitially, we developed a stability indicating method. We assessed the accuracy, repeatability and linearity of the procedure. We also characterised the degradation products. The concentrations were assessed by high performance liquid chromatography-UV detection method using a Xterra RP18 150x4.6mm-5 µm column. The mobile phase used was acetonitrile/water, 70/30. We then prepared three batches of solution, using cyclosporine powder and olive oil, complying with the European Pharmacopoeia. We used alpha-tocopherol as an antioxidant. All three batches were packaged in amber vials to protect from light and stored at room temperature. Several parameters where monitored on different days (0, 1, 4, 10, 14, 30): physical stability (visual inspection) and chemical stability (cyclosporine residual concentration and degradation product detection).ResultsAfter 30 days, no concentration variations were observed. All three batches showed cyclosporine concentration variation of <5%, which is considered acceptable based on ICH recommendations. No degradation products were detected throughout the study. No macroscopic alteration was observed. However, microbiological stability was not assessed. This parameter will be evaluated in further studies.ConclusionThis study showed that 10 mg/mL cyclosporine oral solution in olive oil was stable for at least 30 days at room temperature and protected from light. Therefore, we can set a shelf-life of 30 days. This 10 mg/mL cyclosporine solution will provide an interesting alternative to the pharmaceutical specialty to administer more accurate cyclosporine doses to paediatric patients.References and/or acknowledgementshttp://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q1A_R2/Step4/Q1A_R2__Guideline.pdfNo conflict of interest
BackgroundChloral hydrate, used as premedication for paediatric medical imaging, is available in France under Temporary Use Authorisation. Because of its potential carcinogenicity, its use is being ...restricted to a single administration per patient. Following this re-evaluation and in the absence of consensus, the alternative choice in our hospital is intra-rectal administration of pentobarbital (PTB). However, the efficacy of PTB alone is considered variable. Therefore, a protocol associating PTB with hydroxyzine 2 mg/kg (H-PTB) has been set up.PurposeThis study evaluated whether H-PTB association offered a significant improvement in paediatric medical imaging premedication compared with PTB alone.Material and methodsThe efficacy of both premedication protocols was measured over 13 months, divided into two successive periods. During period 1, PTB was used. During period 2, H-PTB was used. The efficacy of premedication was evaluated regarding various criteria, such as the average time to fall asleep, procedure conditions, etc. Data were obtained during each procedure, using a paper grid that was then imported onto a spreadsheet for computer based analyses.Results120 patients were enrolled (period 1, 43; period 2, 77). Average age was 30 months in the H-PTB group versus 27 months in the PTB group. Average weight was identical in the two group and PTB was administered at the same dosage (4.6 mg/kg).The rate of falling asleep (96% vs 95%) and average lag time (66 vs 64 min) were identical. Absence of sleep or waking of the patient during installation was observed in 55% and 58% of patients, respectively. The rate of procedures successfully brought to an end was also equivalent in both groups. The average sleep duration was 61 min in the H-PTB group and 49 min in the PTB group.ConclusionContrary to our expectations, apart from the higher average sleep duration in the H-PTB group, sedation induced by H-PTB was similar to that of PTB on its own. The H-PTB association did not seem to improve paediatric imaging premedication in comparison with PTB alone. Regarding international guidelines, short half-life benzodiazepines seem to be suitable in this indication. Would benzodiazepine be an alternative to chloral hydrate?References and/or acknowledgementsNice Guideline CG112.No conflict of interest
BackgroundPreparing chemotherapies is a highly critical activity. Chemotherapy overdosage in paediatric units are part of the National Agency for Medicines and Health Product Safety’s ‘never events’. ...Therefore, risk management of related processes is compulsory.PurposeGiven the complexity of current local processes, including multiple re-transcriptions, no e-prescribing and ambiguous prescriptions, an a priori risk assessment was conducted. Considering the results, corrective actions were elaborated and their impact on overall risk was evaluated.Material and methodsThe failure modes and effects analysis (FMEA) method was used to quantify the risk linked to the different phases of the process, including order reception, pharmaceutical validation, software re-transcription then preparation and delivery of the bags to the care unit. Each risk was rated, from 1 to 5, regarding the probability of occurrence (P), degree of severity (S) and detection capability (D). The criticality (C) of each step was determined by multiplying the scores: C = P×S×D.ResultsGlobal risk score, linked to 29 critical steps, was 734. Preparation phases generated 27% of overall criticality. 63% was due to ‘pre-preparation’ steps: order reception, pharmaceutical validation and software re-transcription. The remaining 10% was due to raw material storage conditions and delivery modalities to the care unit.Given these results, short term improvements concerning prescription modalities such as mention of the protocol name, type and volume of the vehicle on the order, could lead to a risk reduction of 234 points. Identity monitoring enhancement could also lower the risk by 50 points.In the medium term, e-prescribing will lower the overall risk by 60% and the number of critical steps by 30%.ConclusionThis process assessment allowed us to determine which step can be easily optimised in order to improve safety and quality of care associated with paediatric chemotherapies, pending e-prescription introduction.References and/or Acknowledgementshttp://ansm.sante.fr/Dossiers/Securite-du-medicament-a-l-hopital/Les-evenements-qui-ne-devraient-jamais-arriver-Never-Events/(offset)/0No conflict of interest.
The Submillimetre Common-User Bolometer Array (SCUBA) Half-Degree Extragalactic Survey (SHADES) is a major new blank-field extragalactic submillimetre (submm) survey currently underway at the James ...Clerk Maxwell Telescope (JCMT). Ultimately, SHADES aims to cover half a square degree at 450 and 850 μm to a 4σ depth of ≃ 8 mJy at 850 μm. Two fields are being observed, the Subaru/XMM—Newton Deep Field (SXDF) (02h18m−05°) and the Lockman Hole East (10h52m+ 57°). The survey has three main aims: (i) to investigate the population of high-redshift submm galaxies and the cosmic history of massive dust-enshrouded star formation activity; (ii) to investigate the clustering properties of submm-selected galaxies in order to determine whether these objects could be progenitors of present-day massive ellipticals; and (iii) to investigate the fraction of submm-selected sources that harbour active galactic nuclei. To achieve these aims requires that the submm data be combined with co-spatial information spanning the radio-to-X-ray frequency range. Accordingly, SHADES has been designed to benefit from ultra-deep radio imaging obtained with the Very Large Array (VLA), deep mid-infrared observations from the Spitzer Space Telescope, submm mapping by the Balloon-borne Large Aperture Submillimetre Telescope (BLAST), deep near-infrared imaging with the United Kingdom Infrared Telescope, deep optical imaging with the Subaru Telescope and deep X-ray observations with the XMM—Newton observatory. It is expected that the resulting extensive multiwavelength data set will provide complete photometric redshift information accurate to as well as detailed spectral energy distributions for the vast majority of the submm-selected sources. In this paper, the first of a series on SHADES, we present an overview of the motivation for the survey, describe the SHADES survey strategy, provide a detailed description of the primary data-analysis pipeline and demonstrate the superiority of our adopted matched-filter source-extraction technique over, for example, Emerson-II style methods. We also report on the progress of the survey. As of 2004 February, 720 arcmin2 had been mapped with SCUBA (about 40 per cent of the anticipated final total area) to a median 1σ depth of 2.2 mJy per beam at 850 μm (25 mJy per beam at 450 μm), and the source-extraction routines give a source density of 650 ± 50 sources deg−2 > 3σ at 850 μm. Although uncorrected for Eddington bias, this source density is more than sufficient for providing enough sources to answer the science goals of SHADES, once half a square degree is observed. A refined reanalysis of the original 8-mJy survey Lockman hole data was carried out in order to evaluate the new data-reduction pipeline. Of the 17 most secure sources in the original sample, 12 have been reconfirmed, including 10 of the 11 for which radio identifications were previously secured.
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