Sonya Stacey

Safety of inhaled (Tobi®) and intravenous tobramycin in young children with cystic fibrosis

BACKGROUND Use of inhaled tobramycin therapy for treatment of Pseudomonas aeruginosa infections in young children with cystic fibrosis (CF) is increasing. Safety data for pre-school children are sparse. METHODS The aim of this study was to assess the safety of tobramycin solution for inhalation (TOBI®-TSI) administered twice daily for 2 months/course concurrently to intravenous (IV) tobramycin during P. aeruginosa eradication therapy in children (0-5 years). Audiological assessment and estimation of glomerular filtration rate (GFR) was measured prior to any exposure and end of the study. RESULTS Data were available from 142 patients who were either never exposed to aminoglycosides (n=39), exposed to IV aminoglycosides only (n=36) or exposed to IV+TSI (n=67). Median exposure to TSI was 113 days [59, 119]. Comparison of effects on audiometry results and GFR, showed no detectable difference between the groups. CONCLUSIONS Use of TSI and IV tobramycin in pre-school children with CF was not associated with detectable renal toxicity or ototoxicity.

Misleading high tobramycin plasma concentrations can be caused by skin contamination of fingerprick blood following inhalation of nebulized tobramycin (TOBI): a short report.

We observed unexpected high plasma concentrations of tobramycin (48.5 and 28.1 mg/L) in fingerprick blood samples after the nebulization of tobramycin solution for inhalation (tobramycin 300 mg/5 mL, TOBI®) by 2 young children aged 3 years. To investigate whether dermal contamination could be the source of error, 3 adult volunteers were present during another nebulization by a third child (age 2 years). The volunteers had exposure to tobramycin by handling the nebulizer or the nebule and also by inhalation from holding the child and being in close proximity while TOBI® was being administered. Five blood samples by fingerprick and 2 by venipuncture were collected and assayed for tobramycin concentration. On each occasion the site was swabbed with alcohol wipes to mimic standard patient sampling methods. One site was resampled after cleaning of hands with 2% chlorhexidine gluconate and water. Tobramycin concentrations from venipuncture 1-2 hours after nebulization were all <0.2 mg/L except for 1 result of 1.2 mg/L. The tobramycin concentrations from fingerpricks before hand washing varied between 6.8 and 172 mg/L, and after hand washing between 0.3 and 17.6 mg/L. Contamination of fingers with tobramycin is likely to have caused the error in the 2 initial cases and did cause misleadingly elevated levels in the adult volunteers. We caution that therapeutic drug monitoring of nebulized tobramycin should not be done by fingerprick sampling, and care should be taken to avoid contamination of the venipuncture site.

Characteristics of adverse medication events in a children's hospital.

To compare adverse medication events (AMEs) reported in children, via the International Statistical Classification of Diseases and Related Health Problems 10th Revision (ICD‐10) coding with events reported via other data sources.

What does advanced practice mean to Australian paediatric pharmacists? A focus group study.

The aim of this study was to explore perceptions and attitudes of Australian paediatric pharmacists about advanced pharmacy practice and to identify suitable methods of assessment for this level of practice.

BD PhaSeal™ and particulate contamination

The closed system transfer device, BD PhaSeal™, is used to compound individual doses of cytotoxic medication in the Aseptic Production Unit (APU) of the Lady Cilento Childrens Hospital (LCCH) Brisbane, Queensland, Australia. The APU noted a large number of cytotoxic medications compounded using BD PhaSeal™ required remaking of the product due to visible particulate contamination. The small gray particulate contaminate was assumed to be rubber bung produced by ‘coring’ the rubber stopper of the drug vial when using the BD PhaSeal™ Protector P50 as part of the compounding process.

Using the General Level Framework to guide training and development needs of pharmacists working in paediatrics

The ‘General Level Framework’ (GLF) has been used for many years as a tool for competency evaluation and feedback using direct observation of clinical practice; however, its use in the paediatric environment has not been investigated.

USING THE “GENERAL LEVEL FRAMEWORK” TO IDENTIFY GAPS IN KNOWLEDGE AND SKILLS TO PRIORITISE PROFESSIONAL DEVELOPMENT ACTIVITIES FOR PAEDIATRIC PHARMACISTS

Aim To review competency evaluations of pharmacists working with children to determine strengths and weaknesses in practice and identify priority areas for professional development. Methods Competency evaluations were undertaken using an Australian adaptation of the “General Level Framework” (GLF).1 The format of this tool included 102 individual competency elements grouped under three main domains: “Delivery of Patient Care”, “Problem Solving” and “Professional Competencies”. Pharmacists undertook a self-assessment using ratings of “Rarely”, “Sometimes”, “Usually”, “Consistently” or “Unable to Comment”. An evaluator rated the pharmacist using the same tool and scale during a period of direct observation of approximately 2–3 hours. GLF evaluations with pharmacists working in paediatric hospital wards in Queensland, Australia were retrospectively reviewed. Each competency element was reviewed to identify areas where <80% of pharmacists completed the competency either “Usually” or “Consistently” (excluding “Unable to Comment” responses). Results from specialist paediatric hospitals were compared to regional general hospitals. Fishers Exact Test was used to assess the strength of association between the variables. This study was approved by the hospital Health Research Ethics Committee and the University of Queensland Ethics Committee. Results 50 evaluations were identified and reviewed from 2006 to 2011, including 35 from paediatric hospitals and 15 from regional hospitals. Most areas were completed well, with 78 of the 102 competency elements achieving at least 80% of the evaluations “usually” or “consistently” undertaking that competency. 21 elements had 100% result, including important elements such as complying with code of ethics and patient confidentiality, communication and effective teamwork within pharmacy and multidisciplinary teams, and ensuring prescriptions are legible, legal and an appropriate dose. Gaps were identified with communication with children and their families, particularly patient history taking which included obtaining patient/carer consent (45%), and assessment of patients understanding of illness and treatment (45%). Other gaps involved documentation issues e.g. pharmacist interventions (45%), medication action plans (37%) and signing for clinical pharmaceutical review (67%). Consideration of non-drug alternatives (24%) and providing lifestyle advice (18%) were undertaken less frequently, however these are less commonly required in the paediatric population. Comparing regional hospitals with paediatric hospitals, some competency elements were poorer, including knowledge of pathophysiology (45% vs 83%, p=0.02), medication reconciliation on admission (67% vs 97%, p=0.03), communication with patient/carer (63% vs 97%, p=0.02), aspects of patient history taking including assessment of patients experience (33% vs 80%, p=0.03) and management of medicines (17% vs 73%, p=0.02). Conclusion Analysis of competency evaluations of hospital pharmacists working with children using a standardised tool for direct observation identified gaps in practice related to communication with children and their families particularly related to patient history taking, and pathophysiology in children. Pharmacists in regional hospitals were particularly in need of support. These gaps have been used to develop face-to-face interactive workshops and online learning modules for pharmacists working in paediatrics.