The issues surrounding controls assurance were discussed at the British Pharmaceutical Conference on September 11.The session was organised in conjunction with the Guild of Healthcare Pharmacists and the Hospital Pharmacists Group and was chaired by Mr Keith Farrar (chairman, Hospital Pharmacists Group)
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| Keith Ridge: a zero risk society is not achievable |
The requirements for controls assurance in the National Health Service had
been extended into areas such as the safe and secure handling of medicines,
Mr KEITH RIDGE (principal pharmacist, Office of the Chief Pharmacist) told Conference
participants. It was no longer just financial controls that the chief executive
of NHS trusts had to be confident in, but a range of organisational controls
as well. Since March, chief executives had had to make a statement accepting
responsibility for maintaining a sound system of internal control, including
risk management.
The risk management and organisational controls included a core standard —
the Risk Management Standard. Its aim was to ensure that all NHS organisations
had in place basic building blocks for managing risk and that risk management
should be recognised as an integral part of good practice. It had set out a
formal process for risks to be identified, assessed, prioritised, and acted
upon and offered standard documentation for a register of risks.
For example, if a switch to dispensing for discharge was being considered, the
standard might offer a way systematically to go through the development, implementation
and monitoring of the system and highlight from a risk management point of view
the clinical, financial and perhaps legal advantages of doing this.
Mr Ridge hoped that pharmacists would not consider this to be just another level
of bureaucracy distracting them from work and pointed out that risk was not
only about bad things happening but also about good things not happening. Risk
could deflect an organisation from its core objectives, he said.
Scope for development
There was no doubt that this tool could be used to help foster change. It offered
an opportunity for staff at all levels to be involved and to create a risk management
culture at all levels. It helped prioritise areas of work and offered scope
for development of early warning systems to help detect and prevent or minimise
future problems. It also offered scope for learning and sharing from other colleagues
through benchmarking activities — something the newly established controls
assurance support unit at Keele university would be fostering.
There were no totally new hurdles or barriers or performance indicators. Essentially
the standards had assembled together all the laws and regulations and some best
practice issues that applied to the NHS and had cross-referred to all relevant
guidance issued by the Department of Health. The standards had rationalised
and consolidated existing requirements and they were presented in such a way
as to be authoritative, achievable, measurable and auditable.
Mr Ridge commented that, as a potential patient, he would want to know that
the organisation that he was exposing himself or his family to had in place
systems which minimised the risk of something going wrong.
Hospital pharmacy services had come a long way over the past 20 years. While
remaining the focus for the efficient procurement, distribution and safe and
secure handling of medicines around the hospital, clinical pharmacy services
had become an established part of hospital health care.
Key area
However, major studies had shown that patients admitted to Australian or United
States hospitals were reasonably likely to suffer an adverse event and at the
top of the list, in terms of numbers and severity, was adverse events caused
by drugs. Together with the fact that about 25 per cent of litigation claims
that the Medical Defence Union was aware of involved medication, it was not
suprising that the safe and secure handling of medicines had been identified
as one of the key areas in risk management.
The aim had been to develop a succinct document which brought together some
of the key pieces of guidance and legislation. The standard stated: “The
organisation handles medicines safely and securely, in accordance with legislative
requirements and best practice.” It also spelt out the commitment of the
organisation in terms of the level at which this would be addressed.
The standard also referred to 18 criteria in the areas of accountability, processes,
capability and outcomes. The guidance underpinning the criteria stated that
the chief pharmacist should be responsible for all aspects of the safe and secure
handling of medicines, not just in the pharmacy department, but across the whole
organisation.
Pharmacists had been doing their best to make sure that medicines were used
as they should be for many years, but now it was publicly acknowledged, which
was a commitment and signal not only to other colleagues, but also to the public.
Controls assurance had required English trusts to carry out a baseline assessment
against the standards to develop a prioritised action plan. The methodology
was based on self assessment and resulted in a score for each criterion and
an overall score.
There had to be a willingness and openness to carry out the self assessment
honestly to help get a fair reflection of the level of risk the organisation
was running with the use of medicines. The exercise was not, for example, about
securing unnecessary resources, but was about identifying risks, assessing them,
prioritising them so that resource could be allocated in the most important
areas, and then making an appropriate plan to deal with them. This was an important
part of the process as the NHS had to target its resources as best it could
to get the most out of limited resources.
Aseptic dispensing was one of the riskiest activities undertaken by hospital
pharmacy departments. A suggestion that risk assessment of ward level aseptic
preparation should be undertaken had been added to the verification section
of the criteria. This had not been added lightly and offered the opportunity
to build on the improvements seen since the introduction of the inspection system
to bring to the attention of senior management the risks associated with that
activity.
Criterion updated
The criterion dealing with prescription, supply and administration of medicines
was likely to be updated soon to reflect changes to legislation that specified
requirements for the use of patient group directions. The criterion would be
changed to ensure that the requirements were signed off by a senior doctor or
pharmacist. Mr Ridge hoped that this would reinforce the need for existing group
protocols to be reviewed.
Mr Ridge pointed out that most people accepted that a zero-risk society was
not achievable. There would always be some residual risk, even in hospitals,
and the Risk Management Standard offered a way for that risk to be acknowledged
and recorded at board level.