Adoption of new technologies needed around the handing of controlled drugs to modernise processes and drive patient safety in hospitals

Handling of controlled drugs (CDs) within the hospital setting requires skill and attention to detail. In fact, the entire legal framework has been designed to minimise patient harm and drive safety.

However, over the last 10 years developments have moved apace and now there are many specific processes involved with the administering of these medicines which take up considerable staff resource and require regular training which need updating in terms of procedures and an overarching umbrella policy.

Automated dispensing systems across pharmacies, wards and departments linked to digital systems have made significant progress with the handling of CDs. But now within a newly launched advisory report, experts say that these technologies should be recognised within a new legal framework with guidance to promote a more secure and efficient means for the ordering, storing, dispensing and administration of controlled drugs.

Currently, the legal framework for managing CDs in the hospital setting is a minimum standard, with the Home Office enforcing the legislation via the police to minimise patient harm, misuse and criminality.  The CQC and the GPhC also have roles to play within this framework, as well as those healthcare practitioners on the ground handling and administering controlled drugs to patients.

The current processes include time-intensive record keeping practices and manual physical reconciliation of stock, often securely locked away in outdated storage facilities with limited capacity and accessibility issues.

UK pharmacies have sought to increase the use of technology to streamline the sorting and administration of medications with impressive outcome data and evidence and now, when new hospitals are planned or remodelling is being made to existing facilities, such is the success of this technology, that it will form the centrepiece to any new building concept.

However, automated systems have only been used with CDs on a limited basis in a relatively small number of UK hospitals due to difficulties with compliance, along with legislative storage and record-keeping requirements.  As such, most controlled drugs are still managed via traditional ‘lock and key’ medication cupboards supported by a paper ledger. But changes to this process are being made and now the recently published Health Building Note provides new best practice guidance on storage facilities for medications (including controlled drugs) to clarify the legislative and regulatory requirement including updated advice on automated drug storage cupboards.

It is hoped that the adoption of this updated guidance will reduce waste and improve consistency in the handling and administration of medications.  A framework and standard operating procedures to ensure that this is statutory, now needs to follow.

Within the newly launched advisory report, which invited and interviewed a number of leading experts to input into the review and final document, the current legal framework for handling controlled drugs in hospitals was closely analysed. Equally, the principles relating to the handling of controlled drugs including the administration, supply process, the benefits of prescribing via the Electronic Prescription Service (EPS), the need for ‘wet’ signatures, as well as the principles of the safe custody and storage of CDs were also reviewed. The report also details an analysis of a series of principles with relation to CDs such as access, ordering, authorised staff, record keeping, as well as those related to stock checks, transportation and finally the disposal of unused controlled drugs. 

The report found that the current problems in handling CDs within the hospital setting were both numerous and complex.  These were largely driven and bought about by a time-intensive and complex mandatory record keeping process which included the manual reconciliation of stock involving people at every stage of the process, supported by inadequate storage facilities that by now are not fit for purpose.  To manage this current process, hospitals introduce their own mandatory strategy and policy underpinned by a set of risk-assessed standard operating procedures (SOPs).  These SOPs are introduced to cover the training of pharmacy professionals and nurses, storage of CDs, the ordering and supply, prescribing, recording (via a ledger/paper record book), as well as the transportation and destruction and disposal of CDs.  The SOPs are complex and fraught with the risk of error, from the need to find authorised staff on a busy ward to record newly arrived stock in a record book, to requirements to find an appropriate witnesses for counter-recording data. Variations across hospitals is widespread.

As such, the detailed, consistent record keeping of issues and problems with associated outcomes of incidents nationwide is also sparse and often anecdotal. Comprehensive data linked to incidents reported to NHS England is subject to variation, making it almost impossible to gain a complete overall and accurate national picture.  According to data from 2018/9, the number of incidents reported to NHS England and published by the CQC for the first time included 2,899 unaccounted losses of CDs, with nearly half of these being either lost, stolen or missing. Due to the staggered roll-out of a new reporting tool and the interpretation of risk by individual organisations, there was an average of 8 daily unaccounted for losses recorded in England alone. No-one believes this is an informative or accurate reflection on what is happening at a grass root level.

The report went on to recommend the optimal way to order, store and manage controlled drugs using a closed loop digital system.  A greater use of technological systems and automated drug cabinets will improve the audit trail and create a consistency in processes.  While this programme has without doubt started – to become truly widespread, , it requires a greater degree of support in reference sources such as a ‘Medicines, Ethics & Practice Guide’ is called for to drive real progress.

The benefits of automation and digitalisation were analysed within the advisory document.  These included the fact that a digital recording system provides an audit trail showing who has handled what, when.  A cabinet can secure stock from access to all but authorised HCPs (via fingerprint technology), with each CD supplied having a unique code associated with it.  CD cabinets in clinical areas are linked to pharmacy cabinets creating a unique order process with a full paper trail. The digital system also allows for end-to-end tracking, ordering and restocking negating the need for a timely, arduous manual stock take.  Finally, the automated system can connect to the ePMA and determine which drugs are needed for which patients on the ward.

There are currently a variety of automated systems available in the hospital setting – some in pharmacy, some on wards and in operating theatres.  A few use an integrated system where the pharmacy and clinical settings are fully automated.  The report calls on the Home Office to set a legal framework supported by the GPhC and the CQC. Agreeing governance arrangements for CDs with clear lines of responsibility and accountability should include harnessing technology to digitalise and automate processes. It is also believed that local and national systems for reporting CD incidents should be used in organisations and CDAW must be kept informed – especially true during the changeover from paper, lock and key based systems.

The clear set of recommendations are set out in the report include the following:

1. New technologies, including automated dispensing systems should be included within a legal framework for handling controlled drugs
2. Ordering, storing, dispensing and administering CDs in hospitals should be through automated dispensing systems
3. The need for a ‘wet’ signature from a prescriber on electronic patient discharge and outpatient prescriptions should be reviewed
4. The paper-less CD record book should be replaced with electronic registers
5. A digital system to record the movement of the messenger transporting CDs from pharmacy to a clinical area should be used
6. The ‘messenger’ to put the CDs into the automated dispensing system to verify stock quantity with authorised user in the clinical area
7. A nationally recognised, consistent approach to automation and digitalisation in the handling of CDs, underpinned by a CD policy and standardised operating procedures (SOPs) needs to be introduced
8. An inclusive training programme for the handling of CDs using automation and digitalisation should be provided to all HCPs

For a full copy of the advisory document click here 

Case study examples of the benefits of using automated systems for handling CDs

Leeds Teaching Hospitals NHS Trust was an early adopter of a pharmacy-based robot, an automated dispensing cabinet (ADC) and reported a reduction in time to dispense CDs of 50%

Belfast Health and Social Care Trust; prior to the installation of the cabinet there had been a 20% increase in CD activity from 2013 to 2018 affecting working conditions, causing staff anxieties and naturally an increase in medication errors due to volume pressures.  Automation reduced the time taken to supply CDs by 63% and the error rate was reduced from 24 per 1000 to 9 per 1000. 

University Hospital Coventry & Warwickshire; following the introduction of automated medicines cabinets including AMCs for the pharmacy CD room, transaction time for CDs was reduced by an average of 1 minute 48 seconds.  This equates to a time saving of over 15 hours per week for a pharmacy technician.

Chesterfield Royal Hospital; the audit of controlled drugs in the clinical area involved a daily stock count. With the implementation of automation this activity was reported to take less than 50% of the time previously taken.