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

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

3. 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

4. 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

5. 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

6. 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

7. 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

8. 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

9. Results – Information – Licensed?

10. Results – Information – Safe?

11. Results – Suitable product?

12. 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

13. 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

14. 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