Abstract

The storage, use and disposal of controlled drugs (CDs) in hospitals and other healthcare centres are governed by a combination of government legislation and local policy. In the UK, a running balance must be kept for Schedule 2 CDs and when discrepancies arise, they must be investigated and reconciled. Policies on acceptable discrepancies are varied and based on anecdotal evidence. This study was designed to simulate dosing and stock check procedures for oxycodone oral solution, as a sample CD solution, and evaluate where the volume losses that cause discrepancies could arise from. Hypromellose solutions were formulated to simulate oxycodone commercial solutions. These were used to simulate dosing and stock check practices. Quantification of volume loss during simulated routine dosing and stock check of viscous oral CD formulations were performed in triplicate. Dosing with enteral syringes via a fitted rubber bung never resulted in volume loss. Volume loss was always observed during stock checks with no statistical difference between methods used. The findings of this study support the following recommendations. Hospital pharmacy departments should provide oxycodone and other CD liquid formulation bottles pre-fitted with a bung and make sure personnel use enteral syringes that are compatible with the chosen adaptor and of the most appropriate size for the intended dose. Stock checks should be limited to the minimum required by law or local policy.

Highlights

  • In the UK, drugs defined as controlled drugs (CDs) are listed in the Misuse of Drugs Act 1971

  • Characterisation of the stock solution In order to simulate the measuring of clinically used formulations of oxycodone containing hypromellose as the suspending agent, a number of hypromellose solutions of different concentrations were prepared and their viscosity was measured (Table 2)

  • This study provides an insight into ways to improve current practice in the administration and record-keeping of oral CDs liquid formulations

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Summary

Introduction

In the UK, drugs defined as controlled drugs (CDs) are listed in the Misuse of Drugs Act 1971. The Misuse of Drugs Regulations 2001 further classifies CDs into five different schedules depending on the level of control attributed to each. Schedule 2 contains the drugs for therapeutic use with the most stringent requirements in terms of prescription, supply, storage and destruction.[1] Similar classifications are used in different countries with strict laws governing the manufacture, supply and possession of these drugs.[2] Hospitals and other healthcare settings must comply with a combination of legal requirements and local policy for the storage, prescribing, administration and destruction of these substances. Maintaining an accurate record of the quantity of liquid CDs kept is problematic, as loss of volume can

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