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- •Pharmaceutical Practice
- •Contributors
- •Preface
- •Acknowledgements
- •About this book
- •The NHS drugs budget
- •The NHS workforce
- •The current and future roles ofpharmacists
- •Introduction
- •The changing role of pharmacy
- •The extended role
- •The profession
- •Pharmacy education
- •Conclusion
- •Introduction
- •Healthcare systems
- •Education of pharmacists
- •Registration as a pharmacist
- •Community pharmacy
- •Hospital pharmacy
- •Conclusion
- •Introduction
- •Defining health and illness
- •Dimensions of health
- •Determinants and models ofhealth
- •Process of illness
- •Health knowledge, beliefs andattitudes
- •Decision analysis andbehavioural decision theory
- •The treatment process
- •Introduction
- •Functions of medicines
- •A societal perspective onrational use of medicines
- •Use of medicines
- •Pharmacies and the pharmacyprofession
- •Outcomes of medical treatment
- •Introduction
- •What is public health pharmacy?
- •Wider determinants of health
- •Lifestyle determinants of health
- •Measuring deprivation
- •Changing habits and lifestyle
- •Conclusion
- •Introduction
- •Types of cost sharingarrangements
- •Protection mechanisms andexemptions
- •Impact of cost sharing on druguse and health outcomes
- •Impact of cost sharing onpatients and healthcareprofessionals
- •The role of communitypharmacies
- •Conclusion
- •Introduction
- •The World Health Organization
- •WHO’s work in essentialmedicines
- •The essential medicinesconcept
- •The Model List of EssentialMedicines
- •The WHO Model Formulary
- •The need for essentialmedicines for children
- •Conclusion
- •Introduction
- •Clinical governance
- •Quality
- •Clinical governance andpharmacy
- •Professional governance andregulation procedures inpharmacy
- •When things go wrong
- •Introduction
- •Human error models
- •Risk management tools
- •Risk to patients in the pharmacysetting
- •Developments in health policy
- •National Patient Safety Agency(NPSA)
- •The risk management process
- •Conclusion
- •Introduction
- •What is continuing professionaldevelopment?
- •CPD cycle
- •Recording CPD
- •Fitness to practise
- •Conclusion
- •Introduction: what is audit?
- •Relationship between practiceresearch, service evaluationand audit
- •Types of audit
- •What is measured in audit?
- •The audit cycle
- •Learning through audit
- •Introduction
- •Morals, values and ethics
- •Ethical theories
- •Principlism and the four ethicalprinciples
- •Principlist ethics and research
- •Morals and law
- •Applied and professional ethics
- •Ethical issues in health care
- •Ethics and pharmacy
- •Conclusion
- •Introduction
- •Assumptions and expectations
- •What is communication?
- •Listening skills
- •Questioning skills
- •A model for guiding thepharmacist–patient interview
- •Patterns of behaviour incommunication
- •Empathy
- •Barriers to communication
- •Confidentiality
- •Special needs
- •Difficult situations in pharmacy
- •Conclusion
- •Introduction
- •What is teamwork?
- •The healthcare team
- •The community healthcare team
- •Role of the pharmacist inteamwork
- •Conclusion
- •Introduction
- •Why keep records?
- •What to record?
- •Barriers to record keeping
- •The future of records
- •The Data Protection Act 1998
- •Confidentiality
- •Records of supply
- •Clinical governance records
- •Consultation records
- •Introduction
- •Independent prescribing
- •Supplementary prescribing
- •Patient group directions
- •Minor ailment schemes
- •Influences on prescribing
- •Clinical governance inprescribing
- •Code of Ethics
- •Introduction
- •The prescribing process
- •Evidence-based medicine
- •Different types of formularies
- •Formulary development
- •Formulary managementsystems
- •Safety, efficacy and economy
- •Pre-marketing studies
- •Post-marketing studies
- •Pharmacoeconomic evaluationof medicines
- •Drug utilization review andevaluation
- •Introduction
- •Extent of use of CAM
- •Reasons for use of CAM
- •Regulation of CAM
- •Pharmacy and provision of CAM
- •Efficacy and safety of CAMapproaches
- •The future for complementarymedicines
- •Introduction
- •Routes of administration
- •Dosage forms
- •Introduction
- •The concept and growth ofself-care
- •Getting information from thepatient
- •Drawing together information
- •Picking up on non-verbal cues
- •Outcomes from the consultation
- •Conclusion
- •Introduction
- •Where does information existand how can it be retrieved?
- •Directory of useful websites
- •Searching the Internet
- •The sequence of information
- •Information services
- •Conclusion
- •Introduction
- •Information required on aprescription
- •Types of prescription forms
- •Routine procedure fordispensing prescriptions
- •Introduction
- •The working environment andprocedures
- •Equipment
- •Manipulative techniques
- •Ingredients
- •Problem solving inextemporaneous dispensing
- •Counting devices
- •Automated dispensing systems
- •Conclusion
- •Introduction
- •Expressions of concentration
- •Calculating quantities from amaster formula
- •Changing concentrations
- •Calculations where quantity ofingredients is too small to weighor measure accurately
- •Solubilities
- •Calculations involving doses
- •Reconstitution and infusion
- •Self-assessment questions
- •Self-assessment answers
- •Introduction
- •Primary and secondarypackaging
- •Packaging materials
- •Closures
- •Collapsible tubes
- •Unit-dose packaging
- •Paper
- •Patient pack dispensing
- •Introduction
- •Standard requirements forlabelling dispensed medicines
- •Additional labellingrequirements
- •Legal requirements in certaincircumstances
- •Errors in labelling
- •Self-assessment questions
- •Self-assessment answers
- •Introduction
- •Sterile product production
- •Premises
- •Environmental control
- •Environmental monitoring
- •Aseptic preparation
- •Testing for sterility
- •Introduction
- •Solutions for oral dosage
- •Solutions for otherpharmaceutical uses
- •Expression of concentration
- •Formulation of solutions
- •Oral syringes
- •Diluents
- •Introduction
- •Pharmaceutical applications ofsuspensions
- •Properties of a goodpharmaceutical suspension
- •Formulation of suspensions
- •The dispensing of suspensions
- •Introduction
- •Pharmaceutical applications ofemulsions
- •Emulsion types
- •Formulation of emulsions
- •Dispensing emulsions
- •Introduction
- •Types of skin preparation
- •Ingredients used in skinpreparations
- •Dispensing of externalpreparations
- •Transdermal delivery systems
- •Introduction
- •Suppository bases
- •Preparation of suppositories
- •Containers for suppositories
- •Shelf life
- •Labelling for suppositories
- •Patient advice
- •Introduction
- •Powders for internal use
- •Powders for external use
- •Introduction
- •Tablets
- •Capsules
- •Other oral unit dosage forms
- •The role of the pharmacist
- •Introduction
- •The inhaled route
- •Inhaled medicines used forasthma and COPD
- •The peak flow meter
- •Types of inhaler device
- •Introduction
- •Administration procedures
- •Products for parenteral use
- •Formulation of parenteralproducts
- •Large-volume parenteralproducts
- •Introduction
- •Anatomy and physiology of theeye
- •Formulation of eye drops
- •Preparation of eye drops
- •Labelling of containers
- •Instillation of eye drops
- •Formulation of eye lotions
- •Formulation of eye ointments
- •Ophthalmic inserts
- •Contact lenses and theirsolutions
- •Contact lenses
- •Hard lens solutions
- •Soft lens solutions
- •Advice to patients
- •Introduction
- •Cancer chemotherapy
- •Classification of drugs used incancer chemotherapy
- •Targeted therapies
- •Dose and schedule ofchemotherapy
- •Occupational exposure risks
- •Provision of a pharmacy-basedchemotherapy preparationservice
- •Administration of cytotoxicmedicines
- •Provision of chemotherapyat home
- •Centralized intravenous additiveservice (CIVAS)
- •Infusion stability and shelf lifeassignment
- •Introduction
- •Provision of nutritional support
- •Indications for TPN
- •Assessment of the patient inhospital
- •The nutrition team
- •Components of a TPNformulation
- •Compounding of TPN and HPNformulations
- •Compounding of HPNformulations by commercialcompanies
- •Potential complications arisingduring compounding andadministration of TPNformulations
- •Addition of medicines to a TPNor HPN bag
- •Administration of TPN/HPNformulations
- •Potential problems for HPNpatents
- •Training for HPN patients
- •Services provided by home-carecompanies
- •The British Parenteral NutritionGroup
- •Introduction to kidney diseaseand dialysis therapy

Continuing professional development and fitness to practise CHAPTER 10
practice and planning appropriate actions, and some
entries starting at ‘Action’, which indicates the
pharmacist is receptive to new ideas and concepts
as they arise.
Recording CPD
The CPD four-stage cyclical process should be documented to demonstrate learning is being undertaken
which meets the needs of the individuals and the
organizations in which the pharmacist works. The
RPSGB has issued guidance stating the requirement
to record CPD in a specially designed format. The
RPSGB gives additional guidance stating how much
CPD a pharmacist records is dependent on personal
development needs. It is advised that a pharmacist
focus on the quality of the process and recording
rather than the quantity.
Generally a pharmacist needs to aim to record at
least one CPD entry each month, although ordinarily
most pharmacists will undertake greater CPD daily in
the course of professional work.
ThetimetakentoundertakeaCPDcyclemay
be hours, days, weeks, months or, for some learning needs, years. The length of time taken to record
a CPD cycle is about 30 minutes. This time
includes the pharmacist recording the cycle and
the thinking during the process. It is worth acknowledging that initially it may take longer than
30 minutes but as a pharmacist becomes more
familiar and e xperienced in the process this time
should reduce.
The CPD framework described is designed specifically for u se by both pharmacists and technicians registered with the RPSGB. The framework
was piloted with 500 pharmacists in all branches
of the profession. Many of these pharmacists
found that CPD was n ot an on erous burden and
in fact it increased their personal satisfaction from
work.
The RPSGB is of t he view that pharmacists will
need to submit their CPD records periodically for
review to the RPSGB or equivalent regulatory
body. This periodic review is likely to be every
3–5 years. The method of review will involve
evaluating the records against a set of evaluation
criteria.
In summary, CPD describes any activity – whether
formal course, informal query from a patient or personal study – that helps a pharmacist do their job
better, resulting in a more competent service to cus-
tomers, line manager, colleagues and the organization,
and helps the pharmacist progress faster in their career. CPD is a cyclical process. For everyone, the need
for the updating of knowledge and skills is a continuous one. Pharmacists moving from one post to another
may need new skills. Pharmacists may find job
descriptions change over time and new developments
in practice need to be implemented, which may also
require new skills and knowledge. Learning does not
stop after the first degree course, or after the preregistration year or after completing a postgraduate
qualification. Learning continues throughout life.
What CPD does is to focus that learning on the
needs of the individuals and the organizations which
employ them.
Fitness to practise
Pharmacy in the UK is in a period of regulatory
change. Regulations regarding fitness to practise in
pharmacy have recently been implemented. It is well
recognized throughout the pharmacy profession that
this form of regulation is necessary in order to maintain and develop public confidence in pharmacists and
other healthcare professions. In the past there has
been a concern over disparity between regulation of
different professions. Some professions being ‘overregulated’ and others ‘under-regulated’ has impaired
public confidence.
The UK Government in 2007 published a document entitled Trust, Assurance and Safety – The Reg-
ulation of Health Professionals in the 21st Century.
This outlined proposals to ensure patient, public and
professional confidence in the healthcare professionals’ watchdogs to improve patient safety and ensure the fair treatment of healthcare professionals.
Further proposals also suggested healthcare professionals will be required to prove their fitness to practise every 5 years. How this will impact on
pharmacists and what role CPD has to play in proving
fitness to practise and revalidation is very much in its
embryonic stages.
Within the pharmacy profession, moves for additional broader regulation have commenced through
the Pharmacists and Pharmacy Technicians Order
2007 which aims to bring pharmacist regulation into
line with other professions. The main provisions in the
order are as follows:
*
Pharmacists to undergo CPD so that registrants
keep their knowledge, skills and aptitudes up to
date as long as they continue practising
99

SECTION TWO Governance and good professional pharmaceutical practice
*
A wider range of powers and sanctions relating to
investigating and dealing with allegations of
impaired fitness to practise. These include
impairment through ill health as well as
performance and conduct, and impairment related
to criminal convictions
*
Introduction of sanctions, including the ability to
suspend registrants when necessary to protect the
public while their fitness to practise is being
investigated and adjudicated
*
The ability to restrict the practice of those unfit
practitioners to areas in which they are safe to
practise by attaching conditions to their registration
*
New powers enabling the RPSGB to disclose
fitness to practise information where that is in the
public interest
*
The requirement for others to disclose information
to the RPSGB about fitness to practise matters
*
A new duty to cooperate with other public
authorities and bodies with an interest in pharmacy
matters
*
New powers to require practising registrants to be
covered by an adequate and appropriate indemnity
arrangement.
In addition to the annual declaration pharmacists have a responsibility under the Code of Ethics
to promptly declare to relevant parties, including
the RPSGB, their employer and other rele vant
authority, any circumstances following completion
of a declaration that may call into question their
fitness to practise. The RPSGB states that pharmacists have a responsibility to notify their profession
to the police should they be charged with any
offence.
Roles of the statutory
committees in fitness to
practise
The Pharmacists and Pharmacy Technicians Order
2007 for fitness to practise has established three
new statutory committees: the Investigating Committee, the Health Committee and the Disciplinary
Committee (see Ch. 8).
In the past, the RPSGB had powers to consider
allegations of misconduct and to make decisions
and recommendations based on the misconduct.
Under the changes introduced by the Pharmacists
and Pharmacy Technicians Order 2007, the RPSGB
Declaration of fitness to
practise
is able to consider a wider range of allegations,
including those relating to a registrant’s physical
and mental health. The Pharmacists and Pharmacy
Technici ans Order 2007 provides the RPSGB’snew
Pharmacists are required to make an annual fitness to
practise declaration to the RPSGB. The declaration
signed by practising pharmacists confirms their commitment to the Code of Ethics, to work under the
standards and guidance published by the RPSGB
and to undertake CPD. The declaration also confirms
that the signatory has not been or is not the subject of
any regulatory, civil or criminal proceedings or investigations relevant to their fitness to practise. Nonpractising pharmacists sign a declaration to confirm
statutory committees with a wider range of sanctions and options for disposal. The new Investigating Committee has the power, in certain
circumstances and where the allegation is admitted,
to accept written undertakings. The Disciplinary
and Health Committees have the power to impose
conditions on registration and to suspend a person’s
name from the register for a period of up to 1 year,
as well as the power to direct removal from the
register.
they will not practise.
Pharmacists who fail to make an annual declaration
are sent a letter by the RPSGB advising them that a
Conclusion
note will be made on their file, and that until a declaration is received they will not be eligible for a letter
of good standing or a certificate of current professional statement; this includes a complete fitness to practise check for inclusion in NHS pharmaceutical
provider lists. Following the receipt of the letter the
pharmacist has 2 months to provide a declaration;
failure to do so will lead to an automatic removal of
name from the Pharmaceutical Register.
In summary, the Pharmacists and Pharmacy Technicians Order 2007 states the fitness to practise guidance for pharmacists and pharmacy technicians in
respect of standards of conduct, practice and performance, and the need to disclose information will
change from time to time. It is important for all
practising pharmacists to be engaged in regular CPD
regarding updating their knowledge of practice,
100

Continuing professional development and fitness to practise CHAPTER 10
regulation and legislative changes within their field
of work.
KEY POINTS
*
CPD is a feature of most professions
*
CPD is part of clinical governance, is required as
part of NHS contracts, and is an obligation in the
Code of Ethics for pharmacists
*
The CPD cycle involves reflection, planning, action,
evaluation
*
Entry into the cycle can be at any of the first three
stages; exit is always at evaluation, but may lead
into further cycles
*
The RPSGB requires pharmacists to record all CPD
activity, which will be reviewed periodically
*
Recent changes have introduced the concept of
fitness to practise
*
In renewing their annual membership of the
RPSGB, pharmacists make a declaration about
their fitness to practise
101

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Chapter Eleven
Audit
Janet Krska
11
STUDY POINTS
*
Audit as part of clinical governance
*
The relationship between practice research,
service evaluation and audit
*
Types of audit
*
Structures, processes and outcomes which may
be audited
*
The stages in the audit cycle: standard setting,
data collection, comparison with standards,
identifying problems, implementing change,
re-audit
*
Learning from audit
Introduction: what is audit?
Audit concerns the quality of professional activities
and services. Audit is carried out to determine whether best practice is being delivered and, equally importantly, to improve practice. Audit is part of clinical
governance (see Ch. 8) – probably the key part –
therefore it forms part of the quality improvement
work which takes place within all NHS organizations.
It can be described as ‘improving the care of patients
by looking at what you do, learning from it and if
necessary, changing practice’.
Audit is based around standards of practice. The
hallmark of a professional is that they maintain standards of professional practice, which exist to protect
the public from poor-quality services. Audit provides
a method of accountability, both to the public and
to government, which demonstrates that standards
are being met or, if not, that action is being taken to
remedy the situation. It also provides managers
with information about the quality of the services
their staff deliver. Although this may seem somewhat
threatening, ultimately the aim of audit is to improve
the efficiency and effectiveness of services, to promote higher standards and to improve the outcome
for patients. It also allows changes in practice to
be evaluated. Therefore it is an essential component
of any professional’s work and an integral part of
day-to-day practice.
Most healthcare professionals’ activities have an
impact on patients, either directly or indirectly, so
can be described as a clinical service. Audit of these
services is therefore clinical audit. Clinical audit is
defined by the National Institute for Health and Clinical Excellence (NICE) as ‘a quality improvement
process that seeks to improve patient care and outcomes through systematic review of care against explicit criteria and the implementation of change’. All
NHS trusts in the UK must support audit, so should
have a central audit office which provides training and
help in designing audits and collates the results of
clinical audits. All NHS staff are expected to participate in clinical audit. Community pharmacists are
required to participate in two clinical audits each year,
one based on their own practice and one multidisciplinary audit organized by their local primary care
organization.
There are actually few instances where pharmacists provide a clinical service to patients in isolation
from other healthcare professionals. The provision
of advice and sale of non-prescription medicines
may be one such area, but most services will impact
on or be affected by service provision by other professionals, so can be regarded as multidisciplinary.
The audit of these clinical services should ideally
also be multidisciplinary. The users of services

SECTION TWO Governance and good professional pharmaceutical practice
should also be involved in audit whenever possible,
perhaps by asking patient representatives to join the
audit team. They can provide important insight into
what aspects of a service would benefit from audit and
can help to set the criteria against which performance
will be audited.
Relationship between practice research, service evaluation and audit
It is important to understand the relationship
between practice research, service evaluation and
audit. Practice research is designed to establish what
is best practice. An example of this would be a
randomized controlled trial of pharmacists undertaking a new service compared to normal care. In a
controlled trial, patients are often carefully selected,
using inclusion and exclusion criteria, special documentation and outcome measures are used which
may differ from those used in routine practice and
all aspects of the service being studied must be standardized.
To implement a new service into routine practice
further development will be required. Many aspects
of a new service are likely to differ from those used
in a research situation and may differ between
practice settings. All new services will then need to
be evaluated, which may involve determining the
views of service providers and users, collecting data
on the outcomes for patients who use the service
and finding out if publicity is adequate. Changes
may be necessary if problems are identified in service
evaluation.
Once a service is running smoothly it should
then be subject to audit. This will involve setting
standards for the service and measuring actual practice against these standards. Findings from research
and service evaluations can contribute to standard
setting in audit.
Although there are many similarities in the methods used to obtain data for research and for audit,
there are important differences. In research, it is important to have controlled studies, to be able to extrapolate the results and to have large enough samples
to demonstrate statistical significance of any differences between groups. None of these applies to audit.
Audit compares actual practice to a predetermined
level of best practice, not to a control. The results of
audit apply to a particular situation and should not be
extrapolated. Audit can be even applied to a single
case; large numbers are not required.
Types of audit
Audit may be of three types, depending on who
undertakes it. These are:
*
Self-audit
*
Peer or group audit
*
External audit.
Self-audit is undertaken by individuals and is part of a
professional work attitude in which critical appraisal
of actions taken and of their results is constantly being
made. While anyone can do self-audit, it is most likely
to be used by pharmacists who work in isolation, such
as in single-handed community pharmacies. There
are many examples of self-audits, such as those
on availability of leaflets, facilities within the pharmacy, owing items and patient counselling, which fulfil
the requirements of the pharmacy contract. See the
Royal Pharmaceutical Society of Great Britain
(RPSGB) website for audit packs on these topics.
Peer audit is undertaken by people within the same
peer group, which usually means the same profession.
Peer audit involves joint setting of standards by an
audit team. For example, pharmacists from several
hospitals which provide similar services could get together and audit each other’s service. In primary care,
pharmacists within or between primary care trusts
(PCTs) could compare their practices. Another way
of doing this is benchmarking – a process of defining a
level of care set as a goal to be attained. Here standards are set against those identified by a leading
centre, such as a teaching hospital.
External audit is carried out by people other than
those actually providing the service and so is perceived
as threatening by those whose services are being
audited. It may be more objective in its criticisms than
self or peer audit, but there may be less enthusiasm
for corrective action to improve services. If standards
are imposed, there is a perceived threat if an individual’s performance is not of the standard required. It
is possible to involve those whose services are to be
audited in deciding what best practice should be and
in making improvements to make external audit more
acceptable. NHS services are subject to external audit
carried out by the Healthcare Commission, which
conducts national audits in England and Wales. The
data produced enable comparisons to be made between different NHS trusts and enable sharing of
good practice.
104

Audit CHAPTER 11
Multidisciplinary audit is the most common type
of group audit and is usually preferred for clinical
audit, but it is essential to ensure that one subgroup
is not auditing the activities of another subgroup. This
would lead to tensions and be counterproductive. For
example, in an audit of doctors’ prescribing errors
detected by pharmacists, pharmacists cannot set the
standard for an acceptable level of errors without
the involvement of the doctors. If they are not part
of the audit team, there is little chance of improvement. Pharmacists are often involved in carrying out
audits of clinical practice, for example audit of prescribing against NICE clinical guidelines. In this situation, it is also important that the prescribers are
involved in setting the standards.
What is measured in audit?
There are three aspects of any services and activities
which can be audited. These are:
*
The structures or resources involved
*
The processes used
*
The outcomes of the activity.
Structures are the resources available to help deliver
services or carry out activities. Examples are staff,
their expertise and knowledge, books, learning materials or training courses, drug stocks, equipment,
layout of premises.
Processes are the systems and procedures which
take place when carrying out an activity and may
include quality assurance procedures and policies
andprotocolsofalltypes.Examplesare:procedures for dealing with patients’ own medicines in
hospital, prescribing policies and disease management protocols.
Outcomes are the results of the activity and are
arguably the most important aspect of any activity. In
pharmaceutical audits such as drug procurement or
distribution or standards of premises, outcomes
should be easily identified and measurable. In many
clinical audits, some outcomes are relatively easily
measured, for example changes in parameters such
as blood pressure, INR (international normalized
ratio) control and serum biochemistry. Surrogate outcomes can also be used, such as the drugs or doses
prescribed. However, outcomes which involve a
change in health status, attitude or behaviour may
be very difficult to measure.
Any individual audit can examine structures, processes and outcomes individually or together.
The audit cycle
Audit is a continuous process, which follows a cycle
of measurement, evaluation and improvement. The
basic cycle is shown in Figure 11.1, but audit can also
be seen as a spiral in which standards are continuously
raised as practice improves.
Before starting an audit, first identify its purpose.
This will derive from the desire to improve the quality
of the service. For example, the purpose may be ‘to
improve the dispensing turnround time’ or ‘to increase the proportion of patients counselled about
their new medicines’. It may be appropriate to conduct a ‘baseline audit’ to find out if indeed there is a
need to improve service quality. A baseline audit is a
small study in which data are collected before standards are set. Once it is known that there is a need to
improve services, the audit cycle incorporates:
*
The setting of standards for practice
*
Measuring actual practice
*
Comparing the two
*
Finding out any reasons why best practice is not
being achieved
*
Changing aspects of practice to improve this.
Although the process is continuous, it is not practicable to audit all activities or services all the time. A
baseline audit may help to decide whether improvements are possible and routine monitoring may be
instituted instead of repeat audits to ensure that best
practice, once attained, is maintained.
Figure 11.1*The audit cycle.
105

SECTION TWO Governance and good professional pharmaceutical practice
Setting standards
All audits should be based on standards which are
widely accepted (i.e. best practice). The Medicines,
Ethics and Practice guide may help to set standards
for many aspects of pharmacy services. Other
documents can also be used to develop standards,
such as national service frameworks, practice guidelines or clinical guidelines for individual medical conditions. Several standards are usually set for any
individual audit, relating to resources, processes or
outcomes.
Because audit is about comparing actual practice to
standards of best practice, numerical values need to
be added which will allow this. A guideline may suggest a criterion, for example that patients receiving
warfarin should be counselled about avoiding aspirin.
For this to form a useful standard for audit, it needs to
be clarified whether this applies to all patients, i.e.
100%. This numerical value is the target, which, together with the criterion, forms the standard or ‘level
of performance’. It is then easy to measure whether
this occurs in practice. Many clinical guidelines suggest audit standards and criteria.
A target level of 100% is termed an ideal standard
but this may not be achievable. The level set may
need to be a compromise between what is desirable
and what is possible, since resources may be limited.
This would be an optimal standard. Using the previous example, it may be considered at the outset that
there are insufficient staff to ensure that 100% of
patients receiving warfarin could be counselled about
avoiding aspirin. A compromise could be that 100% of
patients prescribed warfarin for the first time receive
this advice. Another type of standard is the minimal
standard, which, as its name implies, is the minimum
acceptable level of service and is often used in external audits.
If there are no published guidelines or standards,
they will need to be devised. This may involve searching the literature, for example recent journals, textbooks or educational material. Whether devising
standards from scratch or making guidelines into standards, it is important that the whole audit team is
involved in devising them. This may include doctors,
nurses, health visitors, technical staff and non-medical
staff, such as receptionists or porters, and patients
or their carers. Inclusion avoids the potential feeling
of threat which may be created by audit. Anyone
excluded at this stage would perceive the audit as external, and refuse to help improve performance, which
could mean the whole exercise is a waste of time.
Once standards have been set, the next stage of
audit involves collecting data on actual practice.
Observing practice
Many audits require a simple form onto which data
from other sources are transferred. In audits involving
structures, checklists are often most useful; those
involving processes may use checklists or may need
space for other types of data, while auditing clinical
outcomes may require additional methods such as
questionnaires. As with any data collection, it is
important that the information obtained is able to
answer the questions asked. In the case of an audit,
the question(s) may be relatively simple, such as
‘What percentage of patients receiving warfarin are
counselled?’
It is often useful to incorporate some measure of
potential factors which may influence practice within
the data collection. So, in addition to finding out
whether local clinical guidelines are being used by
examining medical records, it is worth issuing a questionnaire to those expected to use the guidelines to
find out their views on whether the guidelines are
readily available, are in an acceptable format and meet
their needs. In an audit of warfarin counselling, it is
useful to collect data on how busy the pharmacy is
when each patient presents their prescription and
how many staff trained to provide advice were available. This may mean that the data collection procedures may need to anticipate some potential causes of
failing to provide best practice.
Before setting out to devise a data collection form,
it is always worth finding out whether a similar audit
has been done before, so you can adapt or modify the
data collection procedures used. Some useful data
collection sheets for a wide range of audits are available from the RPSGB website. These include audits
of pharmacy processes such as prescription waiting
times, responding to symptoms and referrals to GPs.
If you do need to design a new procedure, the data
collection must fulfil some basic requirements
(Box 11.1). First the data collected must be able to
address the purpose of the audit. The method of data
collection must be valid and reliable. If sampling procedures are used, they too must be appropriate, avoiding bias and, equally importantly, it must be feasible to
carry them out.
Validity is the extent to which what is measured is
actually what is supposed to be measured. To use the
warfarin counselling example again, the standard was
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Audit CHAPTER 11
Box 11.1
Requirements for data collection procedures
*
Provide information required
*
Validity
*
Reliability
*
Controlled for bias
*
Adequate sampling technique
*
Feasible
*
Quantitative or qualitative
*
Retrospective or prospective
*
Routinely or specially collected
*
Pilot study
about advice concerning aspirin. If the only data collected involved the number of patients who were
counselled and not what advice they were given about
aspirin, these data would be invalid, since they did not
measure what they set out to measure.
Reliability is a measure of the consistency or reproducibility of the data collection procedure. Good reliability can be difficult to achieve when trying to
measure outcomes in health care. It is therefore important to use recognized measures wherever possible. Reliability may also vary among individuals
collecting data, despite their using the same data collection tool. It is important to check this and ensure
that they are doing the same thing before they start to
collect data.
Sampling is important in collecting data for audit,
because the data should be unbiased and representative of actual practice. It may be that the numbers and
time involved are small enough that all examples of
the activity are included in data collection procedures. In the case of large numbers, it may be easier
to include just a proportion in the audit. If so, a plan is
needed which ensures that those selected are representative. Many different sampling methods could be
used, including random (using number tables or computer) or systematic (such as every tenth patient presenting a prescription for warfarin). Another way is to
decide in advance that a certain percentage of the
total population (a quota) will be sampled, usually
ensuring that they will be typical of the population
in important characteristics. These techniques require that the total population size within the audit
period is known. A large population may also need to
be stratified into subgroups first before sampling, for
example patients with new prescriptions and patients
with repeats.
Sampling, or even large numbers, may not always
be necessary. Since audit is about a particular service
or activity, carried out by one or more particular
individual professionals, an audit can be carried out
on a service provided to one patient. It is still the
determination of whether actual practice equates to
best practice.
Feasibility of data collection is very important. It
must be possible to collect the data required to answer the question. It is often necessary to incorporate
data collection for audit into routine work, so the time
taken is an important consideration. Some data may
already be collected on a routine basis, which can be
used to answer audit questions. Data kept on patient
medication records or on medicine use review (MUR)
records may be useful for some audits. Some pharmacies routinely log the time when prescriptions are
handed in and given out, so an audit of turnaround
time could easily be carried out using these data.
Hospitals routinely collect data on length of stay
and number of admissions, discharges and deaths,
which may be useful outcome measures. Often data
have to be specially collected for the audit, which is
where the data collection tools come in.
Data for audit can be either quantitative or qualitative in nature. Qualitative data are often useful in
obtaining opinions about services or for measuring
outcomes in patients. Large numbers are not required
for producing qualitative data. It may be useful to
undertake qualitative work which can then be used
to help design a good data collection tool to be used in
a quantitative way, using larger numbers. Quantitative
audit may generate large amounts of data, which
require subsequent analysis, usually using statistics.
These may be purely descriptive or simple comparative statistics.
Whether the data collected are retrospective or
prospective depends to a large extent on the topic
of the audit and the data available. Retrospective audit
can only be undertaken if good records of activities
have been kept. Prospective audits should ensure that
the data required are recorded, even if only for the
audit period. There is a possibility of practice changing
during the audit period simply because the audit is
being undertaken. This may not always be a problem
if practice is better than usual and if audit is continuous, since the ultimate aim is to improve services. It is
more important to be aware of this effect if practice is
measured periodically, although it is very difficult to
control for.
In large audits, piloting the data collection tool
using a sample similar to those to be included in the
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SECTION TWO Governance and good professional pharmaceutical practice
audit is a valuable way of finding out if it is suitable.
This should avoid the discovery that there were difficulties in interpretation or that vital information has
not been recorded after acquiring large amounts
of data.
Comparing practice to
standards
This is the evaluation stage of audit, in which actual
practice is compared to best practice. First the data
obtained must be analysed and presented. Most audit
data require only descriptive analysis, such as percentages, means or medians, along with ranges and standard deviations to show the spread of the data.
Comparative statistical tests are useful for looking at
one or more subgroups of quantitative data. This could
be for different data collection periods (audit cycles)
or for subgroups within one audit. Examples where
comparison may be useful are three different pharmacies’ prescription turnaround times or the counselling
frequencies for patients presenting prescriptions for
warfarin for the first time compared to those who
have taken it before. The statistical test must be appropriate for the type of data. Chi-square is used for
nonparametric data, such as frequencies. For parametric data which are normally distributed, t-tests can be
used. When statistics are used in an audit, it is important to consider the practical significance of the data.
An improvement which is statistically significant may
not always be of practical significance and vice versa.
In presenting data, graphics can be particularly useful,
as tables can be discouraging to many people. This is
particularly important in a group audit, where everyone needs to see the results. Simple graphics, such as
pie charts or bar charts, should be adequate.
Data collected for audit purposes relate to the
activities of individual professionals and to their
effects on patients. It is therefore essential to maintain confidentiality. Permission is required before any
information about one individual’s practice is given to
other members of the audit team. Managers who may
need this sort of information should be part of the
audit team anyway. The general results of an audit
should, however, be made available to others, after
ensuring that no individual practitioner or patient can
be identified. This is essential if the audit is to improve
services, as it will help others to learn and allow comparisons to be made.
When comparing the results of audits between
centres, there will most probably be differences –
perhaps in staffing levels, population served, case
mix and so on – which could account for differences
in apparent performance. Any unusual situations
which occurred during the audit and which may have
affected performance should be highlighted. Also any
errors in data collection must be identified, which
may mean data have to be excluded from analysis as
they could be unrepresentative of what should have
happened. It is most important to remember that
the results of any audit should not be extrapolated
beyond the sample audited. Audit applies to a particular activity, carried out by particular individuals and
involving particular patients.
Providing the standards for the audit have been set
appropriately, it should be relatively easy to determine whether they have been achieved. Often the
most difficult part of audit is finding out why best
practice is not being delivered and ensuring that improvement occurs.
Identifying problems
It is little use simply finding out that a service fails to
meet a given standard. The underlying causes of failure need to be established and the data collection
procedures should have attempted to identify some
of these. Suboptimal practice can arise for a variety of
reasons, such as inadequate skills or knowledge, poor
systems of work or the behaviour of individuals within
a team. Each should be examined as a possible contributory factor to disappointing results of an audit.
Simple lack of awareness, for example, about local
clinical guidelines can contribute to their lack of
use. Lack of skill may be related to infrequency of
carrying out a particular activity. Both are relatively
easily remedied. Both behaviour and the way in which
work is organized are more difficult to change. The
strategies adopted for effecting change will need to
differ depending on which of these underlying causes
is present.
Implementing changes
Achieving improvement in practice requires a change
in behaviour. Change can be threatening simply
because of its novelty. It may also involve increased
work and is often resisted. This is why everyone
whose work pattern may need to change should be
active members of the audit team from the start.
Change must be seen as leading to improvement
in performance and ultimately patient benefit.
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