Key points
1. Clinical governance is an essential
service in the new contract and is built around seven components:
patient and public involvement,
clinical audit, risk management, clinical
effectiveness, staff management, training and development, and use
of information
2. All pharmacies will be expected to participate in two clinical
audits each year
3. Patient safety incidents (not just dispensing errors) will need
to be recorded, reported, monitored, analysed and learnt from
4. Standard operating procedures will be needed for many of the pharmacy’s
functions
5. All staff should be trained or be undergoing training, and pharmacists
should undertake continuing professional development |
Complying with clinical governance requirements is an essential service
in the new pharmacy contract. The clinical governance service is built
around seven components: patient and public involvement, clinical audit,
risk management, clinical effectiveness, staff management, training and
development, and use of information.
An explanation of these seven components was given in last week’s
Contract 2005 (PJ, 9 October, p519). The new contract sets out the requirements
for pharmacy for each of these components. One, patient and public involvement,
was covered in last week’s article. This article describes the requirements
of the other six components.
Clinical audit
In order to comply with the clinical audit section of the clinical governance
service, contractors will be expected to participate in two clinical
audits each year. One is likely to be a practice-based audit. The other
will be a multidisciplinary audit, determined by primary care trusts,
through which it is hoped team working will be developed. Both must
have a clear outcome so that they can be used to help develop patient care.
Although details of how long the audits will be expected to take are
yet to be finalised, it will be necessary for PCTs to give contractors
reasonable
notice of any meetings required for the multidisciplinary audit. Risk management
To meet risk management requirements, contractors will need to ensure
that procedures are in place to guarantee that stock is procured and handled
properly and that equipment is maintained appropriately.
Maintaining a log of patient safety incidents at all stages of the medication
process, not just dispensing errors, will be a requirement of the new contract.
The information collected will be used to fill the mandatory fields of
the reporting form in the National Patient Safety Agency’s national
reporting and learning system.
The national reporting and learning
system will allow any NHS staff to report
patient safety incidents and near misses anonymously. The information will
be analysed by the NPSA so that patterns can be identified and solutions
developed. The system was explained in a series
of articles last year (PJ,
22 November 2003, p719).
The NPSA is currently exploring how it can provide anonymised feedback
to the PCT in which the pharmacy is located. It is also hoped that, in
future, pharmacists will report incidents directly to PCTs. In order for
this to happen, reporting systems will need to be non-punitive, confidential
and be based on open disclosure, ie, on telling patients when something
has gone wrong.
Contractors will have to demonstrate that they are not only recording incidents
but also monitoring, analysing and learning from them. Critical incidents
should be analysed by the whole pharmacy team to inform both individuals
and the organisation. To assist with this, pharmacists should be competent
in risk management, including root cause analysis. The Centre for Pharmacy
Postgraduate Education is planning to produce a distance learning pack
on risk management next year.
Case study
Brian Jolley, of Park Pharmacy in Lowestoft,
has successfully written and implemented a number of standard operating
procedures. “The
key message is keep it simple, keep it flexible and review it regularly,” he
says.
To write a SOP, he suggests writing a step-by-step
description of the process and then asking a member of staff to test
it. “When
you adopt a SOP, monitor it monthly initially and alter it if you
identify a problem.” |
Contractors should have standard operating
procedures in place, covering the areas specified by the Royal Pharmaceutical
Society as a minimum. SOPs
should also be produced for advanced and enhanced services.
Waste disposal systems will need to be
developed for clinical and confidential waste. All confidential paper
waste should be considered, from paperwork associated with services to
unused
labels which state patients’ names.
Contractors will have to comply with other guidance, including health
and safety legislation, and local and national guidance relating to child
protection
procedures.
Finally, each pharmacy will need one member of staff to become its clinical
governance lead. This person does not necessarily have to be a pharmacist. Clinical effectiveness
To ensure that standards of clinical effectiveness are met in the provision
of self-care
advice, SOPs or other protocols will have to be put in place. Another
way in which pharmacists will contribute to improving clinical effectiveness
is through the medicines use
review service. Staff management
The first requirement of the staff management section is for contractors
to ensure that all staff and locums are given appropriate induction training
on issues such as confidentiality, health and safety, and security. Furthermore,
all staff should be trained or be undergoing training, and contractors
should identify and support the ongoing developmental needs of staff.
The qualifications of all staff should be checked and references taken.
For pharmacists, this will be supported by the introduction of PCT-held
lists. This list will be called a “supplementary list” and
will be in addition to the main pharmaceutical list which contains the
names of contractors and company directors. All employed pharmacists and
locums will have to register on one PCT’s supplementary list in order
to work in pharmacies providing NHS services in England. Training and development
To fulfil training and development requirements, pharmacists will have
to be able to demonstrate a commitment to continuing professional development
using a CPD record. They will also have to obtain any
necessary accreditation before providing
enhanced or advanced services. Use of information
In terms of information requirements, contractors will have to provide
access to up-to-date reference sources (such as the BNF and the Drug
Tariff) and appropriate IT links to electronic reference sources.
To protect patient data, confidentiality policies will need to be in
place for all staff. Records should be made of interventions and advice
given,
as well as basic recording of medication supplied.
Contractors will also have to ensure that the PCT and NHS Direct are aware
of the pharmacy’s actual working hours so that these organisations
can provide accurate
information to the public. |
The
Pharmaceutical Journal