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Pharmakon 2003ESCP, Valencia
Implementing standards of practice
Hanne Herborg
Director R&D, Pharmakon
Danish College of Pharmacy Practice (DCPP)
Pharmakon 2003
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
My plan: - Case study approach: The DCPP experience
1. Introduction – my platform
2. Research types relevant for implementation of practice standards
3. Case story: A research programme for implementation of dyspepsia standards in community pharmacy
4. Taking research into practice
5. Conclusion and vision
Pharmakon 2003
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
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
DCPP – pharmacy service 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
The role of research in implementation of standards
Pharmakon 2003
DCPP research: Implementation involves several essentially different research types/purposes
1. Descriptive studies: – Drug Related Problems (DRPs), risk, consumer needs
2. Collate evidence: “Pharmacy practice documentation database”– www.pharmakon.dk
3. Randomised controlled trials (RCTs)
4. Development projects: Formative evaluation, action research, pilot studies
5. Implementation research: Document activity, study implementation process
6. Comparative research: Health Technology Assessment (HTA), comparison of alternative models of care
Pharmakon 2003
British Medical Research Council, april 2000: Framework for trials of complex interventions- a similar strategy
Health services research following phases of drug development Pre-clinical Theory
Phase 1 Modelling
Phase 2 Exploratory trial
Phase 3 Definitive RCT
Phase 4 Long-term implementation
Pharmakon 2003
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
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
Potential problems with self-care outcomes
Wrong “self-diagnose”Self-treatment not appropriate
Risk of serious illness not diagnosedRx treatment needed, not givenRisk of long-term expensive health care
Self-medication with no effectNo self-medicationNo prevention, life-style problems
Symptoms remain unsolvedPreventable problem developsUnnecessary GP contacts
Self-care inducing harm–Drugs, herbal medicines, non-drug solutions
New medical problems added
Pharmakon 2003
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
Phase 0 and 1: Theory and modelling
How do we turn standards into a patient care model?
Pharmakon 2003
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
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
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
Pharmacy Counselling about Self CareThe Two-Legged Platform
The Scientific LegKeywords: 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 LegKeywords: 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
Pharmakon 2003
Phase 1-2: Explorative research
How do we know that the care model is feasible?
Pharmakon 2003
The development and pilot project - The key to everything else!
Formative objectives – to learn
Design: Action research in 4 pharmacies, 111 customers testing
1. Implementation model: service, processes, tools, training 2. Project management model: registrations, diaries,
experience exchange groups, and telephone interviews, audits, pseudo-customers
3. Evaluation model: test of design and measurement instruments - face validity, reliability, and data collection procedures
4. Effects on process, and outcomes: registrations and questionnaires at start and 4 weeks
Pharmakon 2003
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
Yes
The customer’s descriptionof the problem and
registration of data
Alarm signals of illness
Drug related problems
Choice of drug
Product informationgeneral advice
Counselling in relationto identified problems
Collection phase:
Counselling phase
Analysis phase Referralto doctor
PharmacistYes
Possibly
identified No problems
Problems identified
User perception
Lifestyle problems
Documentationand follow up
Pharmakon 2003
Tools example 1- the interview
Who? Customer identity,age, gender
What symptoms? Why do you use this medicine?
How will you describe your symptoms?
How long? How long have you had the symptoms?
Action? What have you tried in order to get rid of your discomforts?
Medicines? What other medicine do you take for the symptoms?
Personal ideas? How do you cope with your symptoms in daily life?
Wants and needs for counselling?
Pharmakon 2003
Tools example 2- Referral criteria Dyspepsia alarm symptom algorithm
1. Black stool, vomit, strong stomach pain
2. Increased problems with physical effort
3. Shortness of breath and coughing at night
4. Swallowing difficulties
5. Symptoms almost daily > 3 weeks
6. Painkillers (NSAID)
7. Patient > 45 years without previous symptom history
8. Unexplained weight loss
Pharmakon 2003
Ja
Yes
Heavy stomach pain, repeatedvomiting, black bowel or
vomit
Increased discomfort under strain
Nightly coughdyspnoea problems
Daily discomfort for more than3 weeks
Taking painkillers
New symptoms -patient over 40 years
Refer to doctor
Refer to doctor
Refer to doctor
Refer to doctor
Refer to doctor
Refer to doctor
Self medication / self care
No
No
No
No
No
Yes
Yes
Yes
Yes
Refer to doctor
Yes
Yes
No
No
Problems in swallowing
Pharmakon 2003
Tools example 3- drug related problems Lack of effect
1. Untreated indication
2. Inappropriate drug
3. Too low dosage used
4. Inappropriate use, patient not receiving drug
Risk of adverse effect5. Too high dosage taken
6. Adverse reactions
7. Interactions
8. Drug not indicated
Pharmakon 2003
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
Have you had it before?
“The traffic light model”- Customer differentiation
No
No
Information according to
customer wish
Asks for a product
Presents a symptom
Small non-problematic useQ. How often do you take it?Q. How is the effect?
Information wantsQ. Do you have additional questions?Q. May I give you a brochure?
Assesment of treatment Information and counselling
Yes
Yes
Response to symptomsAssessment/choice of drug treatmentAssesment of life-style problems/customer demandInformation and counselling
Service
No
Yes
Light service
Attendance concluded
Sufficiently assessed by pharmacy/GPQ. Have you discussed the symptoms with the GP?Q. Has the pharmacy assessed your symptoms?Q. Are the symptoms still the same?
Pharmakon 2003
Phase 3: RCT
How do we know that the care model can produce the expected outcomes?
Pharmakon 2003
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
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
1. Hay fever: Spring 2002 ; 343 intervention/305 control patients
2. 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
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
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
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
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 modelsCompare brief and comprehensive pharmacy modelsCompare across health systems, between regions and
between countriesCompare models of integrated care
Pharmakon 2003
Phase 4: Realistic practice research
How do we know that it still works in routine practice?
Cost-effectiveness and risk in routine practiceImplementation process studiesOptimisation Comparing models of care
Pharmakon 2003
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
1. Basic drug-information
2. Self-medication and self-care
3. Pharmaceutical care at the counter
4. Health promotion services
Pharmakon 2003
Implementation support programme
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
Pharmakon 2001
Pharmacy care process
Documentationand feedback
Implementation
Establish corporation• Role of the pharmacy• Role of the coach• Resource use
Data collection
Goal-setting and establishment of success criteria
Identification and analysis of problems
Follow up and intervention in case of
new problems
Choice of plan
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Programme intensity
Pharmacy
Coaches
Pharmacy care
Permanent implementation implies that the pharmacy must take charge of the process
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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, experience exchange groups)
Process control (audit, pseudo customers, status report)
Customer and staff satisfaction questionnaires
Pharmakon 2003
Success criteria
1. Implementation on a permanent basis
2. Relevant and feasible services
3. Reasonable cost/benefit balance
4. Continuing development of services
5. Customer satisfaction with services
6. Competence development in the pharmacies
Pharmakon 2003
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
Leavitt’s model of an organisation
Environment
Impact
Technology
Task/goalActors
Structure
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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
PROFESSIONAL COMPETENCE EQUATION- R.Holland & C.Nimmo
Skills
Psychomotor
Problem Solving
- Strategic Content (WHAT)
- Procedural Knowledge (HOW)
ProfessionalSocialization Attitudes
Values
+ + =ProfessionalCompetence
ClinicalJudgment
Practicewith feedback
Reflectionon practice
Pharmakon 2003
Today’s work with DPA
How do we take research into practice?
Pharmakon 2003
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
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
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
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Conclusion and vision
Research &
Implementation in practice
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Research - conclusion
Well-designed evaluations of outcomes in controlled studies are of primary importance.
Equally important, is research in the design of services. Controlled studies of care models that are not carefully designed and
demonstrated as implementable may fail to produce the expected outcomes. Formative evaluation studies in action research designs can help develop and
test models and provide opportunities for studying organisational learning.
Research of services in routine practice needs further development. Comparative research needs development.
Acknowledgement, publication and funding of these studies Stronger dialogue between pharmacy practice researchers, practitioners,
politicians, and other partners in health care
Pharmakon 2003
Implementation barriers - conclusion Some do not share the vision of the pharmacy as a patient care facility.
– Reasons are e.g. No belief in it as sustainable business, they can live from Not their view of their professional identity Want to keep the pharmacy as a shop No confidence in own competence
New remuneration structure based on activity is essential to those who are committed to patient care.
Some important barriers are manageable– Competence, particularly clinical judgement and intervention– Organisational change and development
Condition: Danish pharmacies do not accept authoritative protocols. They pick and choose what they like, if sanctions/awards are not very strong (post-modern behaviour).
Pharmakon 2003
Vision: - A system approach – not just guidelines
The Practice Change System
PracticeEnvironment
Learning Resources
MotivationalStrategies
Holland-Nimmo Practice Change System, ASHP 1998
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Vision: Involve all levels in the chain:
- remuneration, dissemination, implementation
PRACTICE ENVIRONMENT
Society
Pharmacy Owners
PracticeSite
Holland-Nimmo Practice Change System, ASHP 1998
Pharmakon 2003
Metamorphosis to patient care- a change of culture
Pharmakon 2003
Thank you for your attention!