Understanding and Advancing the Culture of Safety in Community Pharmacies

1. Understanding and Advancing the Culture of Safety in Community Pharmacies Dr Darren Ashcroft Director, Centre for Innovation in Practice School of Pharmacy and Pharmaceutical Sciences University of Manchester, UK darren.ashcroft@manchester.ac.uk

2. Agenda • 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

3. Registered Pharmacists and Community Pharmacies in England (2008/09) Pharmacists: • 38,051 registered • 16% non-practising • 56.4% female • 33% part-time • 71% employed in CP • 12% owners • 19% managers • 36% locums Community pharmacies: • 10,475 registered • 62% multiple chains • 771.5 million prescription items dispensed • 1.4 million Medicine Use Reviews • 26,970 other locally commissioned (enhanced) cognitive services

4. Numbers of multiple and independent community pharmacies and items dispensed in England between 1997/98 – 2006/07

5. Bradley F et al. (2008) Health Policy 88: 258-268

6. Clinical autonomy and occupational status Magirr et al (2004)

7. Assessing quality in community pharmacy • 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

8. Approaches used to assess quality in community pharmacy Halsall D, Ashcroft D, Noyce P. IJPP 2008; 16: 137-148 • 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

9. Assessment of quality – which perspective? Patient • e.g. convenience, attitude of pharmacy staff Pharmacist • e.g. Effectiveness Department of Health • e.g. efficiency

10. Development of conceptual framework: focus groups Halsall D, Ashcroft DM, Noyce PR. IJPP 2008; 16(suppl 3): C17-C18 • 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

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

12. 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

13. Prescribing errors in primary care: evidence of the safety net Quinlan P, Ashcroft DM and Blenkinsopp A. IJPP (2002); 10: R67 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

14. Main types of interventions

15. Dispensing errors in community pharmacies Ashcroft DM, et al. Pharmacoepidemiol Drug Saf (2005); 14: 327-332 • 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)

16. Classification of dispensing errors • 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%)

17. Rule-related behaviour 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

19. What is the likelihood of reporting adverse events? Ashcroft DM, et al. QSHC 2006; 15: 48 -52 • 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

20. Likelihood of reporting safety incident within the pharmacy

21. Likelihood of reporting the incident to the NPSA

22. Why the reluctance to report? • 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”

23. Penalties of blaming individuals 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 co-exist

25. What is safety culture? 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

27. Why measure safety culture? • “ 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

29. Why measure safety culture? 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

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

31. What to measure in the pharmacy setting? 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

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

33. 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

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

35. 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

36. MaPSAF findings “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.’’

37. Uses of MaPSAF 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

38. 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

39. Component structure and internal reliability

40. 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

41. Multiple linear regression analysis: Results †p<0.001

42. A systematic approach to patient safety 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

43. What is a Safety Management System? 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

44. An idiot’s guide to SMS • 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

45. Benefits of a SMS 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

46. A bit like the Second Law of Thermodynamics …. if complex systems are not actively managed – they tend to descend into chaos

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

48. Seven Steps to Patient Safety 1. Build a safety culture • 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

49. Conclusions 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

50. Thank you darren.ashcroft@manchester.ac.uk