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Andrew Alldred is director of pharmacy at Harrogate
and District NHS Foundation Trust
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Guidance on good practice in handling Controlled Drugs in secondary care has recently been published. “Safer management of CDs — a
guide to good practice in secondary care (England)”1 has been produced
by the Department of Health and the Royal Pharmaceutical Society in response
to the legislative changes introduced by the Health Act 2006 and amendments
to the Misuse of Drugs Regulations 2001. It is essential reading for
those charged with reviewing and improving CD handling arrangements.
It is timely and is likely to be well received.
Of particular importance is that the guidance covers areas of practice
that commonly lead to problems with handling CDs — areas in which
the law is unclear and so custom and practice have developed over time.
These include handling patients’ own CDs, destruction of waste,
reconciliation at any point of patient transfer (eg, ward to ward, ward
to theatre, ward to home), handling CDs in operating theatres, key-holding
and the inclusion of CDs in self-administration schemes.
Experience in many organisations has shown that these are the areas of
practice in which problems with CD handling are often found. They should
therefore be the focus of any local review.
Another exemplary feature of the guidance is that it takes into account
modern medicines management practices such as recognising the prescribing
roles of non-medical practitioners and the supply of CDs through patient
group directions.
The guidance also addresses issues of skill mix, covering arrangements
such as CD
top-up being carried out by pharmacy technicians, senior assistant technical
officers or other trained members of pharmacy staff.
The guidance is clear about the law relating to lines of accountability.
While some tasks involving CDs may be delegated, responsibility may not.
For example, although a nurse or midwife in charge of a department may
be responsible for the safe management of CDs in that area, control of
access (ie, key-holding) can be delegated to another member of staff,
such as an operating department practitioner (ODP). An ODP may remove
CDs on the authority of the nurse or midwife in charge, but legal responsibility
remains with the nurse or midwife.
Engagement of the multidisciplinary team is key to successful medicines
management and this is especially true for the safe handling of CDs.
This remains a challenge since handling medicines is often seen as purely
a pharmacy issue.
Action required
If trusts are to be successful in improving their governance arrangements
around safe prescribing, administration and handling of CDs they must
take ownership of this agenda. The new guidance reaffirms this principle
and is clear about roles and responsibilities of staff and the requirement
for competent staff operating under approved standard operating procedures.
Internal audit looks set to be a key tool in complying with the new requirements.
This activity provides a useful resource and can generally unearth evidence
of substandard practice which then highlights an area for the trust to
focus on.
Regular incident review and robust investigation also provide useful
tools for learning. Trusts that have already decided to look under the
stone, or have done so in response to incidents, complaints or criminal
investigations, will know only too well that it is often not until one
looks that failures in systems and processes are unearthed. The new guidance
will be a useful resource in supporting such review.
It should not be forgotten that the legislative changes outlined in the
Health Act were produced in response to the Shipman Inquiry. These aim
to reduce the risk of recurrence of the events that led to the incidents
and to enhance patient protection while recognising the legitimate and
clinically appropriate use of CDs, especially opiates, in the management
of disease. There is a particular focus on the use of CDs in pain control,
anaesthesia, treating terminally ill patients, and in the treatment of
drug addiction.
There is much debate as to whether the legislative changes have achieved
the balance between access and security and whether they would stop,
or even identify, a second Harold Shipman. However, it is clear that
the inquiry and subsequent changes in the law have raised the profile
of the safe and secure handling of CDs.
The changes introduced by the Health Act and changes to the Misuse of
Drugs Regulations are substantial and require all organisations to review
fundamentally their systems and processes for handling CDs to ensure
they meet the new legal requirements and are fit for purpose. The new
guidance will be invaluable in helping them to achieve this, ensuring
that safer systems are put into place, which can only enhance patient
safety.
References
1. Department of Health and the Royal Pharmaceutical Society of Great
Britain. Safer
management of Controlled Drugs: a guide to good practice in secondary
care (England). London: the stationary office:2007.
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Hospital Pharmacist