Evaluation of the Use and Knowledge of Unlicensed Medication Paediatric Pharmacy Team Children’s Hospital University Hospitals of Leicester

Background Children’s Hospital Leicester 115 bedded centre with respiratory, oncology, neurology and ICU specialties November 2004 - Publication of Trust policy for use of unlicensed medication No baseline data on unlicensed drug use Increased questions from clinical teams

Questions raised It must be available if it’s included in Medicines for Children? What do you mean by a “Special” product? If this medication is made specially for this patient – how do I know it’s OK to give? This doesn’t sound very safe – I’m not really very happy about giving this

Aim and Objectives Develop a module as part of the CH induction training that will inform about medication licensing Identify and quantify the licensed status of drugs used Evaluate staff knowledge of licensing issues of medication

Methodology - ULM Drug order details for all prescribed medication collected over 3 day period Drug, dose and frequency Age Weight Medication indication Prescriber Grade Prescription reviewed and classified by licensed status – L/O/U

Methodology - Understanding Questionnaire sent to all pharmacists, CH prescribers and nurses “Operational” understanding of Paediatric medication information sources Licensed status and inclusion in MfC ULM terminology Suitability of product types

Results – ULM Usage 399 prescriptions recorded 100 patients Mean age – 6 years – (7d-15yrs) 47% either “off label” or unlicensed 72 (18%) off label 116 (29%) unlicensed

Results – Questionnaire Total - 31% response rate Pharmacists - 5/30 (16%) 3 Senior Pharmacists (D/7) Medical – 12/38 (31%) 5 Registrars Nursing – 25/69 (36%) 13 Senior Staff Nurses

Results – Information – Licensed?

Results – Information – Safe?

Results – Suitable product?

Discussion – ULM Use Greater proportion of unlicensed use Turner ? Wide use of “specials” ? Unusual patient mix Oncology, ICU Turner Conroy LCH Lic 84% 54% 53% OL 16% 39% 18% UL 7% 29% Turner S. Unregistered and off-label drug use in paediatric inpatients. Aust J Hosp Pharm 1999;29:265-8 Conroy S, et al. Survey of unlicensed and off label drug use in paediatric wards in European countries. European Network for Drug Investigation in Children. BMJ 2000;320:79-82

Discussion - Understanding Some staff are aware of limitations of information sources – enough? Pharmacy signature confers “approval” Appropriate? Out of hours? Clear training requirements Basic classification of products

Conclusions Unexpected extent of off label and unlicensed drug use Action Review of products held and rationalise Diverse range of understanding of terms used within staff groups Ensure pharmacy staff understand the issues