Dr Darren Ashcroft
Director, Centre for Innovation in Practice
School of Pharmacy and Pharmaceutical Sciences
University of Manchester, UK darren.ashcroft@manchester.ac.uk

 Context: pharmacy and pharmacists in GB
 Evidence from CIP studies about patient safety in community pharmacy setting:
 causes
 consequences
 influence of prevailing safety culture
 Building a safety management system

Pharmacists:
 38,051 registered
 16% non-practising
 56.4% female
 33% part-time
Community pharmacies:
 10,475 registered
 62% multiple chains
 771.5 million prescription items dispensed
 71% employed in CP
 12% owners
 19% managers
 36% locums
 1.4 million Medicine Use
Reviews
 26,970 other locally commissioned (enhanced) cognitive services

Mutiple pharmacies Independent pharmacies Items dispensed (millions)
7000
6000
5000
4000
3000
2000
1000
New contract framework introduced
800
0
1997/98 1998/99 1999/2000 2000/01 2001/02 2002/03 2003/04 2004/05 2005/06 2006/07
0
700
600
500
400
300
200
100
Numbers of multiple and independent community pharmacies and items dispensed in England between 1997/98 – 2006/07

Multiple community pharmacies Independent community pharmacies
55
50
45
25
20
15
10
5
0
20 40 60 80 100 120 140 160 180 200 220 240 260 280 300 320 340 360 380 400
Number of MURs provided
Bradley F et al. (2008) Health Policy 88: 258-268

Magirr et al (2004)

 Systematic literature review and critical appraisal of existing organisational assessment tools
 Development of conceptual framework of quality in community pharmacy setting
 Development of quality indicators

 10 instruments identified from Canada (n=1), Malta (n=2),
UK (n=5) and US (n=2) focussed on:





Clinical governance systems
Organisational culture/maturity
Safety (climate and systems)
Effectiveness of pharmacy services
Stakeholders feedback on services
 All were at different stages of development, and majority not tested for feasibility, reliability or validity
Halsall D, Ashcroft D, Noyce P. IJPP 2008; 16: 137-148

• e.g. convenience, attitude of pharmacy staff
• e.g. Effectiveness
• e.g. efficiency

 Ten in all, involving 47 participants:
 Patients and/or their carers


Community pharmacists and support staff
Community pharmacy service commissioners
 Thematic analysis of transcribed discussions
 Used to explore perceptions of key attributes of quality in community pharmacy setting
Halsall D, Ashcroft DM, Noyce PR. IJPP 2008; 16(suppl 3): C17-C18

Community Pharmacy
(Structure)
Geographical/physical access
Availability and awareness of tangible structures
• Stock
• Patient information
• Staffing
• Equipment
• Services
Patient-centred care
(Process)
Availability
• providing access to medicines
• providing access to information and advice
Consequences of care
(Outcome)
Patient satisfaction/ acceptability
Technical effectiveness
Effectiveness of interpersonal care
Health Status
• Symptom relief
• Improved health
• Illness prevented

•
•
Quality of care for individuals is determined by:
Access (can the patient reach the necessary care?)
Effectiveness (how appropriate is delivered care?)


Clinical care
Interpersonal aspects of care
Campbell S, Roland M, Buetow S.
Defining Quality of Care.
Social Science & Medicine 2000; 51: 1611-1625
•
•
Quality of care for populations is determined by:
Equity
Efficiency

 Prospective study of pharmacists interventions on prescriptions
 34 pharmacies dispensing 60,525 prescription items
 Incidence & reasons for prescription interventions
 71.2 (95% CI 64.7 – 78.3) interventions per 10,000 items dispensed
 10.7% judged potentially serious
Quinlan P, Ashcroft DM and Blenkinsopp A. IJPP (2002); 10: R67

Type
Prescription not signed
Incorrect dose
Incorrect strength
Incorrect drug
Incorrect quantity
Frequency (%)
55 (12.8%)
41 (9.5%)
34 (7.9%)
32 (7.4%)
53 (12.3%)
Rate/10,000 items
(95% CI)
9.1 (6.9 – 11.8)
6.8 (4.9 – 9.2)
5.6 (3.9 – 7.9)
5.3 (3.6 – 7.5)
8.8 (6.6 – 11.5)

 Prospective study of dispensing errors and near miss events
 35 pharmacies dispensing 125,395 prescription items
 Rates per 10,000 items dispensed
 Overall: 26.3 (95% CI 23.6 – 29.3)


Near miss: 22.3 (95% CI 19.8 – 25.1)
Dispensing errors: 4.0 (95% CI 3.0 – 5.3)
Ashcroft DM, et al. Pharmacoepidemiol Drug Saf (2005); 14: 327-332

 Types of error:


Selection of wrong medicine (60.3%)
Incorrect labelling of the medicine (33.0%)
 Causes attributed to:



 misreading the prescription (24.5%) similarity of drug names (16.8%) selecting the previous drug or dose from the patient's medication record on the pharmacy computer (11.4%) similar medicine packaging (7.6%)
 Circumstances associated with errors:


Staffing issues (25.9%)
Excessive workload and distractions (34.5%)

Errors
 arise from cognitive problems
 understand in relation to the individual
 reduce by improving skill and/or information
Violations
 arise from motivational problems
 understand in social context and/or with reference to rules
 reduce by improving attitudes, morale, culture



Questionnaire containing nine patient safety incident scenarios
Completed by 223 community pharmacists
 Pharmacist’s behaviour:



Compliance: in line with a protocol
Error: not being aware of a protocol
Violation: intentional deviation from a protocol
 Patient outcome: good, poor, or bad
Ashcroft DM, et al. QSHC 2006; 15: 48 -52

Likelihood of reporting safety incident within the pharmacy

Likelihood of reporting the incident to the NPSA




Fear of blame:



“I would feel more comfortable if the information went to someone other than my line manager”
“I would be far more likely to use an anonymous system because we have still got a residual blame culture”
“Some managers don’t like errors being reported…because of that particular manager you tend to keep things to yourself”
Pressure of work:
 “We are very busy and we don’t have the time to start writing all this stuff down”
Loyalty to colleagues:
 “I told them and we talked about it, but I didn’t report it to Head
Office”

 Failure to discover latent error-provoking conditions
 Failure to identify error-traps
 Management having its eye on the wrong ball
 A blame culture and a reporting culture cannot coexist

 The shared beliefs and values of staff working in an organisation, that determine the commitment to and quality of that organisation’s health and safety management
 Alternatively….“the way we do things round here”
 Safety culture is manifested in many different aspects of an organisation
 Involves individual and group behaviours which are accepted and reinforced in the organisation

“ The organizational causes of this accident are rooted in the Space Shuttle Program’s history and culture ….
…Cultural traits and organizational practices detrimental to safety were allowed to develop, including:
• reliance on past success as a substitute for sound engineering
• organizational barriers that prevented effective communication of critical safety information and stifled professional differences of opinion …” from Exec summary of Accident Investigation Board report on Columbia

When we talk about safety culture, we are talking first and foremost about how managerial decisions are made, about the incentives and disincentives within an organization for promoting safety.
One thing I have often observed is that there is a great gap between what executives believe to be the safety culture of an organization and what it actually is on the ground.
Almost every executive believes he or she is conveying a message that safety is number one. But it is not always so in reality.
Carolyn W. Merritt - U.S. Chemical Safety and Hazard Investigation Board,
November 2005

 Growing recognition within healthcare of the importance of transforming organisational culture to improve patient safety
 Safety culture assessments developed in a range of “highrisk” industries
 Key issues for pharmacy:


What to measure in the pharmacy setting?
How to measure it?

 Leading thinkers have suggested that organisational culture is shaped through:
 leadership (Schein, 1990)
 communication (Westrum)
 informedness via reporting (Reason, 1998)
 structure, process and outcome (Donabedian, 1980)
 My conclusion:
A good measure covers several aspects of organisational functioning that contribute to the overall safety culture

Ashcroft DM, et al. QSHC 2005: 14: 417 – 21

Westrum’s classification of three types of safety culture
•
•
•
GENERATIVE
CALCULATIVE
PATHOLOGICAL
Main differences lie in the way organisations treat safety-related information. Some deny it, others are bothered by it, yet others actively seek it out and reward the messenger

A safe culture has to
‘evolve’ from one stage to the next
We have systems in place to manage all likely risks
Why waste time on safety?
We do something when we have an incident
We are always on the alert for risks that might emerge
Risk management is an integral part of everything that we do
Pathological Reactive Calculative Proactive Generative

Dimensions of safety in community pharmacy








Commitment to patient safety
Perceptions of the causes of incidents and their reporting
Investigating incidents
Learning following an incident
Communication
Staff management and safety issues
Staff education and training about risk management
Team working



“it makes you think about the whole picture of risk management.’’
‘‘It’s a breakdown of our different reactions and it makes you reflect on your work and your practice.’’
 ‘‘I kind of fitted my experience as a locum pharmacist in the community to where I find myself, and it’s quite shocking to think that you never ever reach the idea which is generative. And whilst often in pathological, not pathological in terms of myself, but in terms of the support you would get from the organisation, especially if you’re a locum pharmacist.’’

 To raise awareness and profile the strengths and weaknesses in an organisation of patient safety culture
 To highlight differences in perceptions across staff groups, organisations, regions
 To identify areas for improvement and show what a more mature patient safety culture would be like

Pharmacy Safety Climate Questionnaire (PSCQ)
 34 item safety climate survey tool
 998 community pharmacists in the UK
 Uses:
 Measurement of staff attitudes to 7 safety climate domains
 Comparison of findings between pharmacies
 Prompt interventions to improve the prevailing safety climate within the pharmacy
 Measure the effectiveness of these interventions
Ashcroft DM, Parker D. QSHC 2009; 18: 28-31

Component structure and internal reliability
Components Cronbach α
Investigating and learning from incidents
Staffing and management
Perceptions of the causes of incidents and reporting
0.9
0.8
0.9
Team working
Communication
Commitment to patient safety
Education and training about safety
0.7
0.9
0.7
0.7

Some key findings from pharmacy…..





29% felt that similar patient safety incidents tend to reoccur
25% felt that staff worked longer hours than is sensible for patient care
39% felt that there were not enough staff to handle the workload
24% reported that there were tensions between staff members in the pharmacy
25% stated that when an incident is reported, it felt like the person was being reported, not the problem

Multiple linear regression analysis: Results
Predictor Β coefficient 95% CI
-0.398 to 0.279
Age (year)
Male
Female
Work in CP (years)
Qualified (years)
Owner
Employee
Locum
Independent pharmacy
Small chain (2-5 branches)
Local/regional chain
National chain
†p<0.001
-0.0595
Reference
-0.191
0.051
0.156
Reference
-3.942
-15.413
Reference
-0.140
-4.167
-8.098
-2.932 to 2.549
-0.154 to 0.256
-0.203 to 0.515
-8.723 to 0.838
-19.866 to -10.960
†
-4.360 to 4.079
-8.988 to 0.664
-11.927 to -4.269
†

 In risky systems, standardisation is a useful tool to increase predictability
 In healthcare, rules (guidelines, procedures, protocols) are multiplying, but evidence relating to compliance is patchy
 Monitoring often difficult and/or inappropriate

 a systematic approach to the management of safety, via formal organizational structures and processes
 applies concepts from human factors and psychology
 has the aim of maintaining and enhancing organizational safety
 used extensively across high risk industries

 Develop a policy
 what you want to achieve
 Organize and plan
 how you will get there
 Measure and review your safety performance
 how you will check where you are and change direction if necessary
 Audit all of the above

 allows for the identification of safety critical issues before they give rise to an adverse event
 enables priorities to be set
 takes a proactive approach to the identification of system factors (latent failures) before they combine with active failures, resulting in an adverse event

Yes No
Does it work?
Yes
Don’t stuff around with it!
Does anyone else know?
No
Hide it!
Yes
You idiot!
You idiot!
Yes
Did you stuff around with it?
No
Will it be a problem?
No
Stand back and enjoy the chaos!
No
Can you blame someone else?
Yes
No problem!

1. Build a safety culture
2.
Lead & support staff
3. Integrated risk management
4. Promote incident reporting
5. Involve patients and the public
6. Learn and share lessons
7. Implement solutions www.npsa.nhs.uk/sevensteps

 Break free of the myth of medical infallibility
 Cease treating errors as a moral issue. Fallibility is the norm not the exception
 Recognise that you can’t change the human condition, but you can change the conditions under which people work
 Reconcile conflicting sub-cultures
 Chronic unease and requisite imagination

darren.ashcroft@manchester.ac.uk