QUALITY ASSURANCE IN

PHARMACY PRACTICE
HOSPITAL PHARMACY -2.54910

LECTURE I

PRESENTED BY: B.SIPANA

SMHS_UPNG

Bpharm V

Acknowledgment: Dr. Stella Pihau-Tulo

 OBJECTIVES
 Bythe end of this topic, you should be
able to:
– Define QA with respect to Pharmacy practice
– Know the importance of QA in pharmacy
practice
– Describe the different types of audit
– Describe the methods and tools used in
continuous quality improvement programs

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 DEFINING “QUALITY”
 Definitionof “quality” (one of the definitions) as it
applies to health care
– “Meeting or exceeding valid customer
requirements” when providing a product or
service1

This definition is implying that to provide quality services

we must know who our customers are and what they
need or require of us

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 DEFINING “QUALITY”
 Quality can be transparent
– It may not be easily recognised
 This is especially true in pharmacy where there is
a lack of established standards or thresholds
against which to measure performance
– E.g. Is there a safe number of prescriptions
to be filled per hour?

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 DEFINITION OF QUALITY ASSURANCE
 Quality Assurance (QA):
– any systematic process of checking to see whether a
product or service is meeting specified requirements
 QA in pharmacy practice
– Ensuring that the practice of pharmacy is at a high
or appropriate standard.
 That is, whatever activities and service the
pharmacists undertake or provide in their
practice, must be at a high or appropriate
standard.
– Public should be able to have confidence in
the services we provide
– We must be confident that we are providing
services at a high or appropriate standard 5
 IMPORTANCE OF QA
 Activities pharmacists undertake are to serve
patients and the community
– Pharmacists have the obligation of ensuring that
service provided is of appropriate quality
 To ensure patient safety

– Errors arising in the pharmacy can directly

affect the patients & the provision of poor
advice to prescribers or patients can cause
similar harm
 To ensure patients get the outcomes expected
from for e.g. medications, medical devices, drug
information
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 IMPORTANCE OF QA
AQA program provides a structure in
which problems can be:
– identified
– documented for pattern recognition
– analysed for better understanding
 What is learned through the process can
then be:
– Shared and used to propose strategies or
methods to prevent future occurrences

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 IMPORTANCE OF QA
A QA program process
– Ideally this should be a continuous process or
effort and it requires commitment from all of
the participants in a given service in a way
which will see any system flaws transformed
into improvement opportunities
– Allows us to reflect on what was
experienced, conceptualise what happened,
and put the lessons learned into practice to
prevent future problems

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 IMPORTANCE OF QA
 QA procedures can determine the
learning needs of pharmacists
 Public & other professions will judge the
pharmacy profession on how its members
conduct themselves in their settings

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 The QA Cycle
Desire for improvement
Or Evidence of poor quality
service

Set or improve
standards

Identify problems Observe

and implement practice
changes

Compare practice
to standards

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 QA – PHARMACY PROFESSION
 Questions to answer
– What activities are undertaken & are they of
a high standard?
– Are there documented SOPs for the
activities?
– Resources, equipment & facilities; are they
appropriate?
– Are personnel qualified to do what they are
doing?

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 QA – PHARMACY PROFESSION
 How to get the answers!

AUDITING THE PROFESSION

AND SERVICES PROVIDED

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 AUDIT OF SERVICES/ACTIVITIES
 An audit of services/activities
Examination of the quality of
services provided
– Comparison of actual practice with
best practice to protect the public
from poor-quality service

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 WHAT IS MEASURED IN QA
 The structures or resources involved
– Resources available to help deliver services or
carry out activities
E.g. staff, their expertise & knowledge,
books, learning materials etc
 The processes used

– Systems and procedures which take place

when carrying out an activity
 The outcomes of the activity

– Results of an activity
Arguably the most important aspect of any
activity 14
 TYPES OF AUDIT/QA
 Self audit
– Undertaken by individuals
– May be seen as the development of a
professional attitude to work, in which
critical appraisal of actions taken and of
their results is constantly being made
 Peer or group audit
– Undertaken by people within the same peer
group which usually means the same
profession

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 TYPES OF AUDIT/QA
 External audit
– Carried out by people other than those
actually providing the service
– Because the audit is carried out by people
outside of the profession, this is perceived as
threatening by those whose service is being
audited.

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 WHERE DO WE START?
 1. Designate a process improvement
team
 2. Create a culture of safety

 3. Think in terms of systems, not

individuals

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 WHERE DO WE START?
 Designate a process improvement team
– 1st thing is to identify individuals who will
participate
Ideally should be everyone who plays a
role in a process
– Bring everyone together regularly to discuss
problems that have occurred & brainstorm
solutions that are likely to be effective
– Select staff to be responsible for further
analysis and implementation of process
changes 18
 WHERE DO WE START?
 Designate a process improvement team
– People involved in all the stages of the
process need to understand how important
their contributions are to the whole effort
– All members of the team should understand
the entire workflow process
E.g. all participants in dispensing or drug
distribution must understand the process

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 WHERE DO WE START?
 Create a culture of safety
– Do not blame each other for errors
 Blaming is not productive
 Employees will feel more inclined to report errors
& participate in resolving problems if the
environment is non-punitive
– No one makes an error on purpose, but health
professionals are human beings
– Create an environment of trust & a
willingness to learn from mistakes, either our
own or those of others.
 This is important to prevent the same types of
errors from reoccurring
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 WHERE DO WE START?
 Think in terms of systems and not
individuals
– Focus on the process or system design & look
for ways to improve it
– Look for steps that can be eliminated or
simplified & ways that procedures can be
standardised
– Where possible, implement protocols &
checklists to minimise or avoid relying on
one’s memory
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 WHERE DO WE START?
 Think in terms of systems and not
individuals
– Improve access to important info & take
advantage of warnings/alerts on computer
databases
IMPORTANT THINGS TO REMEMBER!!!
There are multiple Systematically A multi-disciplinary
causes that collect data & base approach to problem-
contribute to any decisions on that solving or process
error data, not on opinions redesign is often
necessary

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 METHODS & TOOLS FOR QA
 General key steps for QA process

The process is described & sources of variation from the

intended outcomes are identified

The team conducts an in-depth analysis to clarify the sources

of variation & extent of problems

The team weighs alternatives & makes decisions about how to

reduce variations

The team implements one or more of these alternatives &

measures how that affects the process
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 METHODS & TOOLS FOR QA
 SEVEN (7) QUALITY TOOLS
– Flow charts
– Cause & effect diagrams Most commonly used

– Check sheets
– Histograms
– Pareto charts
– Control charts
– Correlation analysis

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 METHODS & TOOLS FOR QA
 Quality improvement tools
– Flow charts & diagrams
 Help members of the team visualise all the steps
in a given process
– E.g. if error occurs, convene meeting & look
at possible causes & solutions
 The main steps leading up to the error can
be diagramed in the order in which they
occur
– Cause-and-effect diagrams
 Useful when brainstorming the underlying causes
of an event

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 Technique begins
with identifying
the problem &
drawing it as the
end result as if
backbone of fish

Once main stem

has been identified,
contributing factors
leading up to the
end result can be
added as branches
off the main stem
This type of schematic enables a group to For each of these, root
visualise multiple contributing factors Causes can be
& underlying root causes in one identified
diagram

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 METHODS & TOOLS FOR QA
 Quality improvement tools
– Check sheets
 Used to record data in a way that facilitates
analysis
 Number or frequency of an occurrence can be
tabulated, for example by time of day or day of
week, to identify peak periods when an event
occurs
 Example of a check sheet
– Form used to document process errors

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 METHODS & TOOLS FOR QA
 Quality improvement methods
– Methods selected may be simple or complex
 Choice of method depends on the size and
resources available for the pharmacy or pharmacy
organisation
– Whatever method it is, the important thing is
that focus is on what is manageable for a
given pharmacy
 Avoid getting bogged down in the process!!

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 METHODS & TOOLS FOR QA
 Quality improvement methods
– FOCUS-PDCA Model

Find a process to improve

Organise a team that knows the process
Clarify current knowledge of the process
Uncover/understand causes of process variation
Select the process improvement

Plan the action aimed at the problem

Do perform a test or pilot study (small scale)
Check/study analysing the impact/effect of the action
Act to fully implement & continue to improve 29
 METHODS & TOOLS FOR QA
 Quality improvement methods
– Root Cause Analysis (RCA)
For identifying the basic or causal factors that
underlie variations in performance including
the occurrence or possible occurrence of a
sentinel event
Focuses primarily on systems & processes, not
on individual performance
Identifies potential improvements in
processes or systems that would tend to
decrease the likelihood of such events in the
future or determines after analysis, that no
such improvement opportunities exist
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 METHODS & TOOLS FOR QA
 Quality improvement methods
– Failure Mode and Effects Analysis (FMEA)
A systematic assessment of a system or process
that enables one to determine the location & the
mechanism of potential failures
– Imadim
 Parallels
the FOCUS-PDCA and meets the intent of
performance improvement

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 The IMADIM Method
Identify Identify the process for improvement
Develop your problem statement using clear,
concise, and measurable terms
Identify the team
Identify individuals involved in the project

Measure Measure current performance

Identify data sources for measurement of the
problem
Benchmark
Use comparative data when possible

Analyse Analyse current processes

Look at all steps in the process

Include input from a cross section of project

members
Analyse the data using Quality improvement
tools 32
 THE IMADIM METHOD
Design Design the improvement
Using your data, analyse & design a
specific course of action

Implement Implement process improvement

What are the implementation steps?

Who will be involved?

*What are the milestones?

Measure Measure Performance

What will be the methods for monitoring
progress?
How will you make conclusions as to
whether the implementation actions were
effective
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 Conclusion
 QA is a continuous process or effort and it requires
commitment from all of the participants in a given
service in a way which will see any system flaws
transformed into improvement opportunities
 Continuous quality improvement is vital in measuring
quality of the services provided to patient/clients,
usually in terms of medication errors; determine what
causes the errors; implement changes to reduce errors;
measure; repeat.

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 References
 1. Gaucher EJ, Coffey RJ. Total quality
in health care: from theory to practice.
San Francisco, CA: Jossey Bass Publishers,
1993
 Shahkarami M. The Quest for Quality: A
basic review. In: Health Notes: Quality
Assurance. California State Board of
Pharmacy; 2002 p.31-35

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 Activity
 Identify the possible secondary causes for the main
problem which is dispensing errors

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