1. Evidence based Pharmacy Practice
Charlotte Rossing
Section Manager Research
Pharmakon
Danish College of Pharmacy Practice

2. Professional activities at Pharmakon
Education of pharmaconomists
Community pharmacy/Hospital pharmacy
Courses
Distance education, e-learning
Textbooks and course materials
Continuing education for pharmaconomists
Community pharmacy
Hospital pharmacy
Education in leadership and organisational development
Training for the pharmaceutical industry
Vocational training
In-Company training
(unskilled, academic)
Continuing education for pharmacists
Pharmaceutical industry/laboratories
Research & development of community pharmacy practice
Research and documentation
Development of services and methods
Consultancy
International activities
WHO Collaborating Centre
FIP secretariat: Community Pharmacy Section
EuroPharm Forum secretariat
PCNE: conferences and research projects
Forbedret selvmedicinering og egenomsorg
Pharmakon

3. Research and development at Pharmakon
Objectives
To conduct research in pharmacy practice and use of medicines
To contribute to quality development and documentation of pharmacy services and of the role of the pharmacy in the health care system
Kirsten
Forbedret selvmedicinering og egenomsorg
Pharmakon

4. GOOD PHARMACY PRACTICE - WHO and FIP guideline 1996
Health promotion and illness prevention
Provision of prescription medicines
Distribution
Patient information
Follow up on outcomes (Pharmaceutical Care)
Self Care
Influencing prescribing and rational use of drugs

5. Agenda Danish Pharmacy Practice Evidence Database
Asthma-Therapeutic Outcomes Monitoring (TOM)
Pharmaceutical care for elderly poly-pharmacy patients (OMA)
Self-medication and self-care
Safe and effective use of medicines

6. The Danish Community Pharmacy Evidence Database
The aim of the database is to ensure that the pharmacy sector has access to updated knowledge of the effect of community pharmacy practice in society.
The database contains:
In total 412 studies (November 2007)
Evidence reports and individual datasheets for each study (in Danish)
Summaries and reference lists in English
Access at:

7. The 412 studies
252 evaluated intervention studies in community pharmacy practice ( )
59 studies on incidence of drug-related problems and adverse drug events in primary care ( )
49 studies on patient safety and medication errors ( )
31 studies on compliance and concordance ( )
21 studies on opportunistic screening in the primary health sector ( )

11. Evidence reports - Intervention studies: structure based on GPP-guideline
Distribution and prescription handling
Patient information on prescribed drugs
Follow-up on outcomes of drug therapy (Pharmaceutical Care)
Self-care activities
Health promotion and ill-health prevention
Promoting rational pharmacotherapy to other health professionals

12. Evidence reports - Medication safety, risk in drug use and screening
Incidence of drug-related problems and adverse drug events in primary care
Patient safety and medication errors
Compliance and concordance
Opportunistic screening in the primary health sector

13. Report 3 - Pharmaceutical Care
Follow-up on outcomes of drug therapy
Medicines management for individual patients
1679 abstracts evaluated for inclusion ( )
97 articles evaluated in the report
Europe 33; Canada 10; Australia 11; New Zealand 1; USA 42
A: 40 Randomized and controlled studies
B: 9 Controlled studies
C: 32 Before/after trial without control group
D: 16 Descriptive studies
Forbedret selvmedicinering og egenomsorg
Pharmakon

14. Focus on preventing and resolving drug related problems (DRP)
DRPs leading to risk of lack of effect
Untreated indication
Inappropriate drug
Too low dosage prescribed/used
Patient not receiving drug
DRPs leading to risk of adverse effects
Too high dosage prescribed/used
Adverse reactions
Interactions
Drug not indicated

15. Types of effect measures
Clinical and health-related indicators
Economic analyses
Satisfaction
Knowledge/attitude/practice
Drug-related problems
Drug use
Process indicators

16. The ECHO model “Outcomes research in pharmacy practice” Economic
Clinical
Humanistic
Outcomes
Kozma 1995

17. Report 3 – Pharmaceutical Care - the evidence for medicines management
Pharmaceutical care can improve health related quality of life in Asthma, BP, BS, Cholesterol. Weaker evidence for the elderly.
Symptoms are significantly improved in asthma and hypertension.
Pharmaceutical care can improve clinical measures (BP, BS, Cholesterol)
Some evidence for reduced hospitalisation and care contacts in elderly
Health Care costs are reduced; drug costs are unchanged or increased.
The intervention costs are covered by the cost savings in health care
The patients enrolled in pharmaceutical care studies are satisfied with the outcome and service.

18. Report 3 – Pharmaceutical Care - more evidence
There are contradicting results on effect on knowledge and compliance.
There is evidence of a more positive attitude among the patients towards the pharmacist’s role and competence in the pharmaceutical care process
There is evidence that drug related problems (DRP) are identified and solved during the pharmaceutical care process
The quality of drug therapy is improved in asthma and cholesterol, but not documented in elderly programmes
Process indicators: GP accept rates and patient accept rates are high
Process descriptors: no. of DRP, recommendations and consultations, time consumption

19. Major Danish trials - international and university collaboration
Asthma-Therapeutic Outcomes Monitoring (TOM)
Pharmaceutical care for elderly poly-pharmacy patients (OMA)
Self-medication and self-care
Safe and effective use of medicines
Forbedret selvmedicinering og egenomsorg
Pharmakon

20. Purpose for asthma and elderly projects
To evaluate if pharmaceutical care can improve patients’ health related quality of life, prevent drug related morbidity, and influence use of resources in the health care system
Forbedret selvmedicinering og egenomsorg
Pharmakon

21. Participants in asthma and elderly projects
Asthma: 12 months
16 intervention pharmacies, 15 control pharmacies
139 GPs
500 patients med moderate asthma
10,3 consultations/patient
Elderly: 18 months
14 intervention pharmacies, 14 control pharmacies
523 patients: over 65 years, minimum 4 medications
4,6 consultations/patient
Forbedret selvmedicinering og egenomsorg
Pharmakon

22. Asthma services Check of :
Peak-flow, inhaler technique, asthma symptoms and patient perceived problems
Assessment of the total drug therapy
Assessment and monitoring of drug use and compliance
Referral to GP
Counselling on problem solving in everyday life
Education on asthma, medication, and self management
Instruction in inhaler technique
Instruction in self monitoring: Peak-flow measurement and use of diary
Instruction in self regulation
Instruction in attacks management
Forbedret selvmedicinering og egenomsorg
Pharmakon

23. Results: Asthma program - Intervention group status in relation to controls
Outcome measures
Better asthma symptom status
Fewer days of illness
Better health related quality of life
Unchanged satisfaction with quality in health care and pharmacy
Great satisfaction with the program
Process measures
Unchanged peak-flow
Fewer inhalation errors
Better knowledge
More rational drug therapy
Economy
The program was documented to be more cost-effective

24. Health economy in asthma program
Expensive program, more GP contacts
Fewer days of illness, fewer other contacts (incl. Hospitals), unchanged drug expenses
Economic analysis
The same effect will cost a factor 5 times less in the intervention group
Pay-off time: The program will pay itself within a period of 9-23 months, depending on conditions
Forbedret selvmedicinering og egenomsorg
Pharmakon

25. Elderly Services Technical medication review
Home visit to assess drug storage
Assessment and monitoring of the drug therapy including simplification and rationalization of dosage regime (as appropriate) in close collaboration with the patient’s GP
Introduction of methods for home self-monitoring (diary cards)
Introduction of a medication overview
Individual patient counselling and education on medical problems and drug use
Referral to GP if needed

26. Results: Elderly program - Intervention group status in relation to controls
Outcome measures
Better symptom-scores
Fewer hospital admissions, unchanged length of stay
Better health related quality of life
Increased satisfaction with quality in health care and pharmacy in both groups
Good satisfaction with the program
Process measures
Increased knowledge in both groups – no difference
Unchanged compliance
Fewer problems with use of medicines
More rational drug therapy: number of drugs and doses, few other changes
Economy
The program was documented to be more cost-effective and leading to direct savings

27. Potential savings in the elderly program
Net saving per intervention patient in relation to controls:
2.338 DKr in 18 months
20% of elderly people above age 70 use 4 or more drugs
elderly Danes are potential patients in need of the service
Potential saving: 328 mio. DKr
Potential saving per year: 219 mio DKr

28. Self care and self medication - An extended counselling service
The intervention
A systematic counselling on self-care and self-medication in community pharmacies, aimed at empowering customers by enabling them to make self-care decisions and solve problems in order to obtain better health and well-being
Individual problem assessment and counselling in relation to 4 key elements:
Response to symptoms
Self-medication and drug related problems
Life-style problems
Patient perceived problems
We defined the intervention as:
READ SLIDE definition
The service comprised systematic problem assessment and counselling
based on 4 key elements:
READ SLIDE
Forbedret selvmedicinering og egenomsorg
Pharmakon

29. Randomised, controlled multi-centre study
25 pharmacies randomly assigned to an intervention and a control group aimed at inviting all customers presenting relevant symptoms or drug requests and recruiting 30 patients each.
Two intervention periods, cross-over design
Hay fever: Spring 2002 ; 343 intervention/305 control patients
Dyspepsia: Autumn 2002; 262 intervention/311 control patients
Evaluation after 2 respectively 4 weeks
6 month follow up in dyspepsia group; April 2003
This slide shows the design of the study.
READ SLIDE
We measured effects just after the first counselling and after 2 weeks for hay fever patients and 4 weeks for dyspepsia patients, and in addition we had a 6 moth follow up for the dyspepsia model.
This means that variables like satisfaction and knowledge were only measured as differences between intervention and control groups after 2 or 4 weeks, not before start.
Forbedret selvmedicinering og egenomsorg
Pharmakon

30. Summary of results
At 4 or 2 weeks health status and symptoms improved significantly in both groups in both dyspepsia and hay fever programs.
The difference between intervention and control group was significant for dyspepsia. For hay fever only satisfaction with symptoms showed significant difference.
Satisfaction, knowledge, medicine use, and self care behaviour was significantly better in the intervention group for both programs
Willingness to pay was significantly higher for the dyspepsia intervention group, no difference was seen for hay fever
At 6 months dyspepsia patients had significantly improved health outcomes. The difference between intervention and control patients did not persist without any follow up.
This slide gives you a summary of our results.
READ SLIDE
Forbedret selvmedicinering og egenomsorg
Pharmakon

31. Safe and Effective Use of Medicines
Two Danish research programs
“Implementation of drug therapy - Improved adherence and self-management among users of anti-hypertensive medicines”
Program development and pilot
Screening survey and controlled study as demonstration project from January 2006 to January 2007
Test in 240 patients by 12 pharmacies
Comparing a brief and a comprehensive version of the intervention.
“Safe and effective use of medicines in Type 2-Diabetes”
Program development 2006
Screening survey and controlled study as demonstration project from January to June 2007
Test in 80 patients by 5 pharmacies
Brief and comprehensive version
We developed the program at the Danish College of Pharmacy Practice as part of a larger research program.
We are currently running two research programs within this concept together with 12 Danish pharmacies and GP’s in their area
The first is a hypertension program called
READ LIDE
The second is a diabetes . Program called …
READ SLIDE
Both programs are tested in a brief and a comprehensive version provided by Pharmaconomists (the Danish pharmacy assistant) and pharmacists respectively.
Forbedret selvmedicinering og egenomsorg
Pharmakon

32. Objectives
To develop and evaluate pharmacy based primary care programs aimed at ensuring safe and effective medicine-use among users of Hypertension and Type 2-Diabetes medicines
To develop patient self management and a concordance-partnership between GPs, pharmacy staff, and non-adherent Hypertension and Type 2 Diabetes patients
To describe the nature and extent of adherence problems
The objectives of the projects are shown on this slide
READ SLIDE
Forbedret selvmedicinering og egenomsorg
Pharmakon

33. Program elements
Quick screening for non-adherence and identification of problem types
Patient story-telling as the key starting point
Assessment and possibly adjustment of drug therapy
Finding resources in the patient-system
Individual coaching, in order to tailor solutions to individual needs and resources
Offering relevant reminder technology and/or patient instruction
Follow up
Close collaboration with patient’s GP
At this stage, the elements we include in the program, are as shown in this slide:
READ SLIDE
Forbedret selvmedicinering og egenomsorg
Pharmakon

34. Effect - Hypertension Patient reported outcomes at end point
All differences between intervention- and reference group were statistically significant
No statistically significant difference was found between the patients receiving the brief or the extended intervention
 Changes in intervention and reference group
Significant improvement in BP measured by pharmacies for intervention patients
Significant difference between intervention- and reference group was seen for improvements in patients perceived outcomes on BP
Knowledge
Health related quality of life
Reduction of symptoms
Forbedret selvmedicinering og egenomsorg
Pharmakon

35. Effect - Type 2-Diabetes
Patient reported outcomes
Differences between intervention- and control group show patient reported improvement, many are statistically significant
Statistically significant difference was found between the patients receiving the brief or the extended intervention
 Changes in intervention and control groups
Significant improvement in BP measured by pharmacies for intervention patients
Improvement in bloodsugar levels measured by pharmacies for intervention patients
Significant difference between intervention- and control group was seen for both services for improvements in
Self reported blood pressure
Knowledge
Non-significant improvement in self reported adherence behavior (intentional, self-regulation) and QoL
Forbedret selvmedicinering og egenomsorg
Pharmakon

36. Conclusions - evidence for clinical pharmacy in primary care?
Implementing clinical pharmacy in primary health care has had a positive effect for users of medicines
Community pharmacies are capable of joining the health care team as partners and take a co-responsibility for a successful medication use process as a ‘patient safety filter’
Clinical pharmacy can be implemented in a cost-effective way in community pharmacies
The effect can probably be increased by focusing on specific quality problems and by stronger implementation of multidisciplinary collaboration.