1. Medication safety - the introduction and evaluation of interventions-
Bryony Dean Franklin
Professor of Medication Safety, UCL School of Pharmacy
Director, Centre for Medication Safety and Service Quality, Imperial College Healthcare NHS Trust
Chair, Imperial Centre for Patient Safety and Service Quality
Associate Editor, BMJ Quality and Safety

2. Most common healthcare intervention…
Use of medication is the most common intervention healthcare - nearly every patient admitted to hospital will be prescribed medication, and a third are prescribed anti-infectives at any one time. Two thirds of patients registered with a GP will receive at least one prescription in a year, and about 12% of these are for anti-infectives.

3. But… International systematic reviews:
median prescribing error rate: 7.0% of inpatient medication orders 1
Median medication administration error rate: 8.0% doses, excluding wrong time errors 2
Median 3.7% of unplanned hospital admissions are due to preventable adverse drug events 3
Estimate that 1-2% inpatients harmed as a result
Lewis et al (2009) Drug Safety 32:379-89
Keers et al (2013) Ann Pharmacother 47:237-56
Howard et al (2007) Br J Clin Pharmacol 63:

5. So what are we going to do about it?

6. Objectives
To highlight key issues in developing, evaluating and publishing on interventions to enhance medication safety
Mainly hospital practice but will also include some references to primary care

7. Developing interventions

8. Developing interventions
What are the problems?
Do not assume that problems (and thus solutions!) elsewhere are the same as your own
Wide variation between settings and countries…
Paper-based or electronic prescribing? Unit dose? Original packs? Medication preparation? Use of technology?
Wide variation even within countries and settings
What are the problems? - internationally a particular issue with different baseline systems for prescribing, dispensing, administering medication – different driving forces, different contexts. Eg CPOE USA vs UK
Formal studies eg observations, case note reviews
McLeod et al (2014). A national survey of inpatient medication systems in English NHS hospitals. BMC HSR
Ahmed et al (2013). The Use and Functionality of Electronic Prescribing Systems in English Acute NHS Trusts: A Cross-Sectional Survey. PLoS ONE 8(11):

9. Developing interventions
Focus groups
Audits
Incident reports
Formal studies
What are the problems? - internationally a particular issue with different baseline systems for prescribing, dispensing, administering medication – different driving forces, different contexts. Eg CPOE USA vs UK
Formal studies eg observations, case note reviews

10. Developing interventions
Who are the stakeholders?
What are the barriers, facilitators, challenges?
Plan Do Study Act (PDSA)?
What are the problems? - internationally a particular issue with different baseline systems for prescribing, dispensing, administering medication – different driving forces, different contexts. Eg CPOE USA vs UK
Also finance,
Who are the stakeholders? Eg EP systems in hospitals – everyone thinks about the prescribers and forget about nurses (who are the biggest users!). And even if they remember about the nurses, what about the dieticians who also have to prescribe dietary supplements. And what about the patients???
What are their views on feasibility, acceptability? What are the barriers likely to be?

11. EVALUATING INTERVENTIONS

12. What are the research questions?

13. What are the research questions?
How to increase patient safety?
What are the problems?
Why do they occur?
What might the solutions be?
What works?
What works best?
Which are cost-effective?

14. What are the research questions?
How to increase patient safety?
What are the problems?
How often do they occur?
Why do they occur?
What might the solutions be?
What works?
What works best?
Which are cost-effective?

15. What are the research questions?
How to increase patient safety?
What are the problems?
How often do they occur?
Why do they occur?
What might the solutions be?
What works?
What works best?
Which are cost-effective?
Developing interventions
Evaluating interventions

16. Types of question Quantitative methods Qualitative methods How many?
- Clinical outcomes
- Observations
- Surveys
- Audits
Why? How?
Qualitative methods
- Focus groups
- Interviews

17. Quantitative v qualitative characteristics
Measuring/counting
Hypothesis testing
Random sampling
Scientific empiricism
Statistical analysis
QUALITATIVE
Exploring/qualifying
Generates hypotheses
Purposive sampling
Naturalistic
Eg. Content analysis, framework analysis

18. Quantitative methods

19. Quantitative methods - important issues
Define what you are counting
Define your denominator
Choice of data collection method
Validity
Reliability
Sampling strategy
Generalisability
Study design

20. 1. Definitions Wide ranges of published error rates:
Published rates of prescribing errors in England range from 1-15% of inpatient medication orders written
Internationally, estimates of dispensing error rates in community pharmacy vary from 0.04% to 24% of dispensed items

21. 1. Definitions
What is, and what isn’t, an error? ?

22. 2. Choice of data collection method Example: detection of prescribing errors in hospital
Prospective
reporting
by pharmacists?
Retrospective
review of medical
records &
prescriptions ?
Incident
reports?
Trigger tools?

23. 2. How do methods compare. (n = 135 errors in total; 10
2. How do methods compare? (n = 135 errors in total; 10.7% of medication orders)
Retrospective Review (n = 93; 69%)
Trigger Tool (n = 0) 41 86 7
Data recorded by
ward pharmacist
(n = 48; 36%) 1
Incident Report (n = 1; 1%)
Franklin et al. Methodological variability in detecting prescribing errors and consequences for the evaluation of interventions. Pharmacoepidemiology and Drug Safety 2009; 18: 992–999

24. 3. Study design - what is the disadvantage of collecting data just once?
Medication review intervention to reduce inpatient falls
Put into place in July
56 falls logged in June
Measured again in October - only 15 falls
Success!!!

25. 3. Study design - what is the disadvantage of collecting data just once?
Mean July to Dec = 35
Mean Jan to June = 35

26. 3. Study design - what is the disadvantage of collecting data just once?
Time series analysis

27. Qualitative methods

28. Qualitative Methods Key principles of qualitative research
Types of data:
What people say they believe or do
What people actually do
What people actually believe
The context of what people say/do/believe

29. mixed methods

30. Mixed methods
Integration of qualitative and quantitative methods in the same study to answer a research question
Increase in breadth and depth
Various ways in which the two are integrated
Independent vs interactive
Equal priority vs one weighted more than the other
Timing: concurrent vs sequential vs multi-phase
Interface: data collection vs data analysis vs data interpretation
Hadi et al (2013). Int J Pharm Prac 21:

31. Some examples

32. The Prescribing Improvement Model Study (PIMs)
Improving patient safety through providing feedback to junior doctors on prescribing errors

33. First... identify root causes

34. Quotes
“Also for something like aspirin, I know most pharmacists would just add that on to the drug chart and PNC [prescriber not contacted], so not contact the prescriber because it’s so small you wouldn’t contact the doctor just to say, oh it should be enteric coated or, oh it should be dispersible and you didn’t write that on..A lot of the time we’ll change, we’ll add modified release and, without probably telling the doctor”. (Pharmacist)

35. Quotes
“And there’s another key issue here as well especially if you’re in an area where there’s a lot of doctors rotating, sometimes that phenytoin prescription is written by Doctor X, Doctor X has gone home so I have to go to Doctor Y and get them to change it and that’s fine, they learn something new, but Doctor X who wrote the prescription doesn’t know anything about it”. (Pharmacist)

36. Is this the problem?

38. Prescribing Improvement Model
Aim
To develop, test the feasibility, and evaluate a practical, low-cost intervention to provide feedback to junior doctors on prescribing errors and increase patient safety.
Three objectives:
To encourage prescribers to identify themselves when prescribing
To increase the feedback given by pharmacists to individual prescribers on their prescribing errors
To introduce group feedback to junior doctors on common prescribing errors
Prescribing errors happen. What doesn’t always happen is that prescribers get to know about them. Part of the problem is that prescribers routinely do not identify themselves when prescribing.
The pharmacists’ emphasis is often on correcting the drug chart, which only solves the problem for that particular patient. The doctor is not told when they have made an error. We wanted to change that.
Mention again the toolkit as an outcome

39. Focus group - foundation year 1 doctors (FY1s)

40. And what do our patients think?
“…it’s OK to screw up once but there ought to be a process that says you’ve screwed up once and we’re going to correct it so that it doesn’t happen again.  What’s unforgivable is if you’ve got the ability to go on screwing up time and time again”
Patient focus group participant

41. 1. Prescriber Identification
At the three intervention sites, we gave FY1s a name stamp, a set of instructions and asked them to use it.
We modified the message to identify yourself when prescribing, rather than focussing on using the name-stamp per se.
We also spoke to the doctors in person, mostly on an ad-hoc basis, and asked them to identify themselves when prescribing. At imperial, we gave a short presentation to them at their weekly education sessions.

42. PDSA cycles Ogrinc G, Shojania KG. BMJ Qual Saf 2014;23:265–267.
As a result of our PDSA cycles we added the prefix “Dr” to name-stamps, ensured we were using prescribers’ preferred names (not always the same as those held by human resources), modified our initial message from “use your name-stamp” to “state your name when prescribing”, added a label to name-stamps reminding doctors to sign their prescription, made a minor change to our inpatient drug chart and designed brief supporting information to accompany the name-stamps when distributed.

43. Fortnightly data
Percentage of inpatient medication orders written FY1s where prescriber is identifiable

44. Fortnightly data
Percentage of inpatient medication orders written by FY1s where prescriber is identifiable
Estimate increase from 7% to 40-50%

45. 2. Individual feedback Pharmacists asked to: Publicity and education
Identify individual prescriber
Contact individual prescriber
Tell them an error made
Suggest how to avoid the error
Publicity and education
Accompanied visits
Building on being able to identify the prescriber
Error v mistake

46. 3. “Prescribing tips” Sent fortnightly “Spot the error”
Discusses one or two errors in more depth
Readable
Compatible with smartphones
Links to relevant prescribing resources
Locally relevant
Referred to specialist pharmacists during development.

47. Evaluation Process measures Outcome measures
Weekly audit on identifiable prescribers
Pharmacists assessed for feedback provision
Outcome measures
Prevalence of
prescribing errors
Questionnaire
Focus groups
Prescriber identification audited on a weekly basis by the project team at Imperial, and by existing pharmacists at North West London
Prescribing errors audited weekly by ward pharmacists at all sites, inclusive of control and intervention and North West London
Intervention and
control hospitals
Intervention hospital

48. Findings
We estimate that we increased the percentage of FY1 medication orders for which the prescriber was identifiable from about 6% to 50%.
Focus groups with pharmacists and FY1s suggested real benefits of our interventions and no evidence of negative unintended consequences.
Attempts to produce a measureable reduction in prescribing errors are likely to need multi-faceted approach of which feedback should form part.

49. Hopefully...

50. The Dose-Reference Card (Dr-CARD)
Development and evaluation of a pocket card to support prescribing by junior doctors in an English hospital

51. The Dr-CARD
Focus groups held locally: foundation year 1 (FY1) doctors perceived time pressure and lack of access to information to be sources of stress, and to potentially contribute to erroneous prescribing.
Many had developed their own pocket reference guides for commonly prescribed drugs

52. Dr-CARD

56. PUBLISHING

57. Publishing this work

58. Publishing this work Choice of journal
Appropriate checklists for study design
Quality improvement work
SQUIRE guidelines
Context – what kind of setting?
Definitions
What did you count as an error / adverse drug event / adverse drug reaction?
Who or what was counted, and non-counted, in your denominator?

59. The right tools for the job