P26 Switching from unlicensed oral Midazolam liquid to a licensed product for preoperative sedation
Authors: Patterson Emma 
Published: April 2023

Background

This specialist children’s hospital used unlicensed midazolam 2.5 mg/ml oral solution for preoperative sedative. This product had various problems such as a bitter taste which often led to poor patient acceptability and a short expiry once opened. In this Trust midazolam oral solution is stored and recorded in CD registers and discrepancies in the running balance are often reported as clinical incidents and destruction of expired stock is also time-consuming. When a licensed midazolam 5 mg/ml oral solution single dose preparation became available, the Trust wanted to investigate whether a switch to this product would be beneficial. The new product is supplied as a single dose preparation and is orange flavoured.

Method

Pharmacy completed a ‘new drug risk assessment’ for the product ensuring that the excipients were appropriate for paediatric patients. The risk assessment also identified possible problems associated with the implementation of the new product across the trust (eg different strength, single use bottle, time taken for dispensing of single bottles rather than a stock bottle, storage capacity for multiple bottles, changes to documentation in CD registers) [This hospital stores and records midazolam in CD cupboards]. Any potential cost pressure was also identified and highlighted to the finance department. A pilot was undertaken with 10 patients. Nurses and anaesthetists were asked for feedback regarding a switch to this product prior to implementing a complete switch. The electronic prescribing system was updated, and communications circulated to the hospital to alert all staff of the change of product.

Results

All nurses and anaesthetists involved in the pilot were positive in their evaluation of the new product. Comments such as ‘the child took this well and then accepted other medicines’ were recorded. Since the switch occurred there have not been any clinical incidents reported of issues with running balances or patient safety incidents involving oral midazolam. All areas reported no impact upon department due to storage capacity or increased workload based upon record keeping. Since moving to the new product feedback from clinicians has continued to be positive particularly relating to improved patient compliance due to both flavouring and smaller administrative volumes. The pharmacy has also not had any requests for return for destruction of midazolam as all destructions of remaining liquid is carried out at a ward level. The additional cost was £18,300 but the Trust were happy to offset this against the reduced risk of cancelled operations due to inadequate pre-medication. The nursing staff have noted no increased workload in practice. The has been a neutral impact upon pharmacy workload as although there is increased dispensing times as more bottles are dispensed per order the pharmacy has not been required to destroy expired stocks.

Conclusion

The move to the licensed oral midazolam liquid for pre-medication has resulted in better patient compliance, there have been no clinical incidents reported and workload has not been adversely affected.