Implementing standards of practice

1. Implementing standards of practice Hanne Herborg Director R&D, Pharmakon Danish College of Pharmacy Practice (DCPP) Pharmakon 2003

2. Task given by chairperson • Provide your vision about implementation and evaluation of pharmaceutical services in the context of standards of practice • Please include: • How we can turn clinical evidence into standards of care – in particular pharmaceutical care • The need for research to design and evaluate services, which should achieve expected patient outcomes • Organisation and the process of delivery of care from a practical perspective • Education and training needs • Experience form your own work on these issues Pharmakon 2003

3. My plan: - Case study approach: The DCPP experience • Introduction – my platform • Research types relevant for implementation of practice standards • Case story: A research programme for implementation of dyspepsia standards in community pharmacy • Taking research into practice • Conclusion and vision Pharmakon 2003

4. DCPP R&D:- Strategy and profile • DCPP: An educational centre owned by the Danish Pharmaceutical Association (DPA) • R&D objective • to contribute to quality development and documentation of pharmacy services and of the role of the pharmacy in the health care system. • Profile • Research in pharmacy practice • Development of cognitive pharmacy services • Training & consultancy on implementation Pharmakon 2003

5. DCPP:Major research activities 1993-2003 PCNE collaboration • Asthma-Therapeutic Outcomes Monitoring (TOM) • Pharmaceutical care for elderly polypharmacy patients (OMA) • Self-medication and self-care • Implementation and dissemination of cognitive pharmacy services DCPP/DPA collaboration • Sustainable implementation (The Counselling Pharmacy) • Nursing home services • Pharmacy Practice Documentation Database • Prescription interventions Partnership with Danish universities • Ph.d. projects: Change management; Drug related problems, Implementation and dissemination • Pharmacy-university project • Evaluations of: Weight reduction service; Smoking cessation service;Triptan over-use service • HTA : Automated dose-dispensing Partnership with regional health administrations • Primary care clinical pharmacist • Dose-dispensing services Pharmakon 2003

6. DCPP – pharmacyservice development Cognitive community pharmacy services offered to Danish pharmacies by DPA Clinical pharmacy at individual level • Basic services: Medication review, advice-giving, ‘patient safety alert services’, ‘pharmaceutical care at the counter’ • Disease specific pharmaceutical care: Asthma, Diabetes, Rheumatic diseases, Angina • Generic pharmaceutical care: Pharmacist consultation • Automated dose dispensing & counselling Clinical pharmacy at institutional level • Nursing home services: education, quality assurance, medication review, dose dispensing Health promotion and disease prevention • Smoking cessation, weight reduction • Screening and health counselling: BP, BS, cholesterol, health risk profiles • Customer & patient health information materials Pharmakon 2003

7. The role of research in implementation of standards Pharmakon 2003

8. DCPP research: Implementation involves several essentially different research types/purposes • Descriptive studies: • Drug Related Problems (DRPs), risk, consumer needs • Collate evidence: “Pharmacy practice documentation database” • www.pharmakon.dk • Randomised controlled trials (RCTs) • Development projects: Formative evaluation, action research, pilot studies • Implementation research: Document activity, study implementation process • Comparative research: Health Technology Assessment (HTA), comparison of alternative models of care Pharmakon 2003

9. British Medical Research Council, april 2000: Framework for trials of complex interventions- a similar strategyHealth services research following phases of drug development Pharmakon 2003

10. Case: Heartburn and dyspepsia - a research programme on Improved Self-medication and Self-care • A development and pilot study with 4 pharmacies and 110 patients, 1999-2000 • A qualitative master’s project on dyspepsia patient perceptions 1999 • A controlled study with 25 pharmacies, 648 hay fever patients and 573 dyspepsia patients, 2001-03 • An long-term implementation research project, “The Counselling Pharmacy” in 2 of 8 pharmacies, 2001-02 • A masters’ project with qualitative studies of 15 patient pathways, 2003 Pharmakon 2003

11. Why have a standard based community pharmacy care model for dyspepsia? • Most dyspepsia drugs are OTC • Many patients do not get evaluated by physicians or do not get systematic follow-up • Result: Heartburn and dyspepsia is “a self-care condition”,and pharmacies may have better opportunity to catch problems of poor outcomes than GP’s. Pharmakon 2003

12. Potential problems with self-care outcomes Pharmakon 2003

13. Patient case Woman 75 year • Asks for specific medication (Cimetidine) • Reflux symptoms every day, problems with pain • Daily activity inhibited all days, no days of illness • Has had contact with GP • Medicines: • Cimetidine 300 mg, 1 daily • Antacid 1 x 1-2 • Other: Sertraline, Ibuprofen • Alarm symptoms: Daily symptoms >3 weeks, swallowing problems, NSAID • DRP’s: Inappropriate drug? Interaction? Adverse effect? • Self-care: Knows advice; Does not prevent; Dissatisfied with drugs and GP • Intervention: GP referral, Counselling on condition, drugs and prevention Pharmakon 2003

14. Phase 0 and 1: Theory and modellingHow do we turn standards into a patient care model? Pharmakon 2003

15. Defining the care model- not just reviewing literature Theory input • Clinical guidelines • B. Marklund: Referral criteria for pharmacies and GP telephone visitation functions • Response to symptoms • Drug related problems, pharmaceutical care • Self-care theory • New consumer theory, User perspectives • Concordance/compliance • Communication Pharmakon 2003

16. Self-care as the key concept Definition: • ”Actions people do themselves to solve or prevent health problems and maintain health” Lunde 1990 • ”The fundamental health resource” WHO 1987 • The core: The patient is the decision maker! • A main strategy in Good Pharmacy Practice Pharmakon 2003

17. The intervention: An extended counselling service • 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 Pharmakon 2003

18. The Scientific Leg Keywords: Evidence based, quality controlled practice Medical starting point Expert role Objective (value neutral) Focus on symptoms, drug problems, and life style problems Identify risks, errors and problems Give correct advice and treatment Network gives interference and errors The professional is in charge The Humanistic Leg Keywords: User competence, empowerment Starting point in every day life Discussion partner Personal, subjective (with values) Focus on the user’s experiences, wants, comprehension, habits, and terms Identify resources Help to tailor solutions Network are important resources The user is in charge Pharmacy Counselling about Self CareThe Two-Legged Platform

19. Phase 1-2: Explorative researchHow do we know that the care model is feasible? Pharmakon 2003

20. The development and pilot project - The key to everything else! • Formative objectives – to learn • Design: Action research in 4 pharmacies, 111 customers testing • Implementation model: service, processes, tools, training • Project management model: registrations, diaries, experience exchange groups, and telephone interviews, audits, pseudo-customers • Evaluation model: test of design and measurement instruments - face validity, reliability, and data collection procedures • Effects on process, and outcomes: registrations and questionnaires at start and 4 weeks Pharmakon 2003

21. Tools:- The means to fix the process and integrate the clinical standard • Instruction and flowchart • Interview guide (WWHAM) • Registration form • Problem identification: • Algorithms for alarm symptom and DRP’s • Lifestyle problem categories • Patient problem? • Interventions: • Referral, • Counselling categories • Checklist • Concentrated knowledge base: clinical guideline and counselling support • Written patient information Pharmakon 2003

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23. Tools example 1- the interview Pharmakon 2003

24. Tools example 2- Referral criteria Dyspepsia alarm symptom algorithm • Black stool, vomit, strong stomach pain • Increased problems with physical effort • Shortness of breath and coughing at night • Swallowing difficulties • Symptoms almost daily > 3 weeks • Painkillers (NSAID) • Patient > 45 years without previous symptom history • Unexplained weight loss Pharmakon 2003

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26. Tools example 3- drug related problems • Lack of effect • Untreated indication • Inappropriate drug • Too low dosage used • Inappropriate use, patient not receiving drug • Risk of adverse effect • Too high dosage taken • Adverse reactions • Interactions • Drug not indicated Pharmakon 2003

27. Evaluation conclusions • The service was of value for the customers. Improvements were seen on final outcomes: Dyspepsia score, self reported symptoms, days of symptoms, and satisfaction with new service. • It was feasible to get sufficient and reliable data • A controlled study is recommended • Implementation was feasible, however a differentiation is necessary in order to define customers who will benefit from the service • Minor adjustments on tools, training, evaluation instruments and design are necessary. • There is no basis for undertaking an economic evaluation of the service in a four week study. Pharmakon 2003

28. “The traffic light model”- Customer differentiation Presents a symptom Asks for a product Have you had it before? Response to symptoms Assessment/choice of drug treatment Assesment of life-style problems/customer demand Information and counselling No Yes Service Small non-problematic use Q. How often do you take it? Q. How is the effect? No No Yes Sufficiently assessed by pharmacy/GP Q. Have you discussed the symptoms with the GP? Q. Has the pharmacy assessed your symptoms? Q. Are the symptoms still the same? Information wants Q. Do you have additional questions? Q. May I give you a brochure? Yes Information according to customer wish Assesment of treatment Information and counselling Light service Attendance concluded Pharmakon 2003

29. Phase 3: RCTHow do we know that the care model can produce the expected outcomes? Pharmakon 2003

30. Objectives of the controlled study • To evaluate if systematic counselling on self-medication and self-care in the pharmacy leads to improved treatment outcomes and more rational use of resources for society and patients • Effects measured on: • Quality of counselling and referral • Drug use • Patient knowledge and behaviour • Patient satisfaction • Patient health outcomes • Use of economic resources: Drugs and health care contacts Pharmakon 2003

31. A 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 Pharmakon 2003

32. Summary of results • At 4 or 2 weeks health status 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 no difference was seen. • Symptoms improved significantly in both hay fever and dyspepsia programs. The difference between intervention and control group was significant for dyspepsia. For hay fever only satisfaction with symptoms showed significant difference. • Satisfaction was significantly higher 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. Pharmakon 2003

33. Reflections on the role of the RCT in implementation of standards • Quality problems = weak results • Stronger interventions, study designs, indicators, …… • Practice research has to compromise, cannot work without implementation • Political actors and biomedical research focus on RCT as “The golden standard” is overvalued • Reality? • RCT is a strong political strategy • RCT is still the stronger answer to efficacy questions • RCT is a research strategy with limitations • RCT limitations in pharmaceutical care as a soft health technology • Not technical hardware like a pill. “It could be otherwise” • Software: a social construction/interaction that can be implemented differently and is continuously modified. • RCT is made for controllable technical systems. In social systems it has limitations, and other evaluation strategies are equally valuable • RCT cannot alone provide the knowledge we need • Triangulation: validate with other data Pharmakon 2003

34. After the RCT?- What we need to know - examples • The realistic implementation process • Study effectiveness and negative consequences in full scale , “post marketing” • How to account for differences and relate to outcomes • Implementation barriers and facilitators • Optimisation research – not well developed • Identify target groups with more benefit • Improve and focus processes and technology • Reduce resources • Optimise total health care model and role of pharmacy in the team (integrated care) Pharmakon 2003

35. Future: Comparative research • Health Technology Assessments (HTA) • Comparing benefits for alternative solutions to health care problems in relation to: • technology/interventions • organisation, • economy • patient preferences • Examples • Compare pharmacy services to other models • Compare brief and comprehensive pharmacy models • Compare across health systems, between regions and between countries • Compare models of integrated care Pharmakon 2003

36. Phase 4: Realistic practice researchHow do we know that it still works in routine practice? Cost-effectiveness and risk in routine practice Implementation process studies Optimisation Comparing models of care Pharmakon 2003

37. Implementation research- “The counselling pharmacy” Why? • Research projects have shown that pharmaceutical care services contribute to positive patient outcomes • Implementation in daily routines is still lacking behind Objective • To develop and test a programme supporting pharmacies in implementing defined cognitive pharmacy services on a permanent basis. Services • Basic drug-information • Self-medication and self-care • Pharmaceutical care at the counter • Health promotion services Pharmakon 2003

38. Training and coaching Brief training courses Process consultants/coaches Individual feedback/ role models Additional needs based training sessions Distance learning packages Experience exchange groups Manager consultations Project management support Documentation and feedback Quality manuals and tools Basic interview Analysis of barriers Process and outcomes documentation Quality audits Pseudo-customer feedback Customer satisfaction surveys  Implementation support programme Pharmakon 2003

39. Pharmacy care process Documentation and feedback • Establish corporation • Role of the pharmacy • Role of the coach • Resource use Follow up and intervention in case of new problems Data collection Implementation Identification and analysis of problems Choice of plan Goal-setting and establishment of success criteria Pharmakon 2001

40. Programme intensity Coaches Pharmacy care Pharmacy Permanent implementation implies that the pharmacy must take charge of the process Pharmakon 2001

41. Methods of evaluation Action research design with continuous documentation and data triangulation • Basic interview (goals, success criteria, organisation, competence) • Barrier analysis (internal and external barriers) • Evaluation of implementation (continuous data collection, structured meetings with coach, log book, experienceexchange groups) • Process control (audit, pseudo customers, status report) • Customer and staff satisfaction questionnaires Pharmakon 2003

42. Success criteria • Implementation on a permanent basis • Relevant and feasible services • Reasonable cost/benefit balance • Continuing development of services • Customer satisfaction with services • Competence development in the pharmacies Pharmakon 2003

43. Results: Organisational issues • Services and processes that the pharmacies had not implemented before were delivered now • Motivation for new roles had not grasped everyone • Services were not always offered when relevant due to capacity problems, time problems, organisation of workflow, and physical premises • Pharmacies chose to tailor the instructions and documentation systems to what they found practical to ensure their usage. Ownership and simplification were a must. Protocols should provide both structure and flexibility. • Lack of relevant technology was a barrier to documentation and decision making • Pharmacy premises are designed for shop-keeping, not as patient care setting with flexible levels of privacy • Getting the support from other professionals takes time and remains a challenge Pharmakon 2003

44. Structure Actors Task/goal Technology Leavitt’s model of an organisation Environment Impact Pharmakon 2003

45. Competence issues: - pseudo customer analyses • Process elements that were in place in case simulations were not always implemented in real life. • Instruction techniques on drug use were quite impressing: correct and yet short and simple; however sometimes too technical. • Open-ended questioning in relation to symptoms, life styles and patient concerns was weaker; often counselling would start before needs were fully assessed. • Making agreements on follow-up was a weak spot • Some problems due to lack of knowledge lead to incorrect advice-giving were seen • Clinical problem analysis and -judgement of the individual patient case were performed, but were still major challenges • Business competencies were a challenge: Promoting consumer paid services actively to customers, reacting on need signals, getting started, demanding a price …. Pharmakon 2003

46. PROFESSIONAL COMPETENCE EQUATION - R.Holland & C.Nimmo Skills Psychomotor Problem Solving - Strategic Content (WHAT) - Procedural Knowledge (HOW) Professional Socialization Attitudes Values Clinical Judgment Practice with feedback Professional Competence + + = Reflection on practice Pharmakon 2003

47. Today’s work with DPAHow do we take research into practice? Pharmakon 2003

48. Implementation of standard based services • DPA: Remuneration and dissemination • Negotiation with payers • Marketing to pharmacies, public and payers – theme years • Collaboration with health care professions • Collaboration with patient and consumer organisations • Operating an ISO quality certificate, quality bench-marks • Collaboration with educators, researchers and pharmacy networks • Access to up-to-date technology • DCPP: Development, dissemination, implementation support • Standards, quality manuals, • Tools and technology support • Patient information resources • Training, learning resources • Consultancy, coaching • Optimisation and rationalisation of services Pharmakon 2003

49. The Quality Manual- a ‘sensitive’ document • Requirements: • Comply with standards, evidence, product descriptions • Pharmacy accept and adoption • Implementation feasible • Documentation of quality feasible • Sustainability in the pharmacy setting • Structure: • Description of the service on 3 levels: • “The brief overview” • “The case-story” • “The detailed technical description” Pharmakon 2003

50. Competence development- CPD trends in Danish pharmacies • Internal pharmacy training • Learning resources: “Morning meeting materials”, service manuals, web-resources, video demonstrations etc. • Patient information materials, marketing materials • Individual distance learning, WBT • Pharmacist networking groups • Short targeted courses • Diseases, pharmacotherapy • Services: Implementation process, case training, test • Staff training workshops • Quality audit • Pseudo-customer audit • Individual performance evaluation and coaching • Certified education • Long courses, practice and problem based learning • Collaboration with external partners • Counsellor educations, Smoking cessation, Internal audit • General CE & Master programme in Quality Assured Drug Use Pharmakon 2003