Evidence based Pharmacy Practice

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

2. Professional activities at 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

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: www.pharmakon.com

7. The 412 studies • 252 evaluated intervention studies in community pharmacy practice (1990-2005) • 59 studies on incidence of drug-related problems and adverse drug events in primary care (1990-2005) • 49 studies on patient safety and medication errors (1990-2005) • 31 studies on compliance and concordance (1990-2005) • 21 studies on opportunistic screening in the primary health sector (1995-2005)

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 (1990-2005) • 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

14. Focus on preventing and resolvingdrug 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 patientstowards 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

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

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

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

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

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 • 140.225 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

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

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.

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 2004-05 • 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

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

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

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

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

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.