Scientists and practitioners two species, same mission?

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1 Scientists and practitioners two species, same mission? Prof. Dr. Kurt E. Hersberger Pharmaceutical Care Research Group Klingelbergstrasse 50 CH-4056 Basel Tel (1426) Fax Apotheke Hersberger am Spalebärg, CH-4051 Basel Tel.: Scientists and practitioners two species, same mission? Disclosure statement: no relevant financial or nonfinancial relationships JANUS Roman god of beginnings, gates, transitions, time, duality, doorways, passages, and ending. Symbol for change and transitions, for looking into the past with one face and into the future with the other. Janus, a symbol for integration of science and practice («Science meets practice») 1

2 Crilly Philip et al. Pharmacy 2017, 5, 48; doi: /pharmacy General perceptions of community pharmacists (n = 104) towards practice research. Universität Basel 3 Agenda. 1 Introduction 2 PCNE contributions of researchers and practitioners 3 DRPs cornerstone of pharmaceutical care 4 Examples of valuable research 5 Pharmacogenomics and Clinical Pharmacy 6 Adherence 7 Interprofessional Education and Patient Engagement Universität Basel 4 2

3 Turner P. The Nuffield report: a signpost for pharmacy. BMJ 1986; 292(6527): Of its 96 recommendations, 26 related to community pharmacy. Very influential conclusions, the pharmacy profession has a distinctive and indispensable contribution to make to healthcare that is capable of still further development. pharmacists and medical practitioners should collaborate to improve the effectiveness and efficiency of prescribing Etc. A more recent Nuffield Trust report in 2014 goes further, highlighting the need for pharmacists to work in integrated local care provider networks, and embracing new models of care. Universität Basel 5 Prof. Ch. D. Hepler Pharmaceutical care is the responsible provision of drug therapy for the purpose of achieving definite outcomes that improve a patient s quality of life. (Hepler and Strand, 1990)? Pharmaceutical Care = practice / philosophy Clinical pharmacy = science? Universität Basel 6 3

4 Pharmaceutical Care Network Europe (PCNE) The Pharmaceutical Care Network Europe (PCNE) was established in 1994 by a number of European pharmaceutical care researchers. the aim of PCNE is to help to develop pharmacy along the lines of pharmaceutical care in the involved European countries through: stimulating pharmaceutical care and pharmacy related outcome research in Europe; stimulating research and implementation projects carried out in more countries simultaneously; organising a bi-annual working conference around pharmaceutical care and pharmacy practice research; all other possible activities that serve the aim of the association. PCNE definition of Pharmaceutical Care 1 Invitational Conference 5th February 2013, Berlin «The pharmacist s contribution to the care of individuals in order to optimize medicines use and improve health outcomes.» 1) Allemann S, Mil JWF, Botermann L, Berger K, Griese N, Hersberger K. Pharmaceutical Care: the PCNE definition Int J Clin Pharm 2014:1-12 4

5 Three main topics (= 3 Working groups): The aim of the working group is to bring experts together in order to create a set of guidelines for conducting medication review. Drug-related problems are one of the cornerstones of pharmaceutical care. Therefore the working group develops and evaluates a DRP-classification. To make pharmaceutical care effective and efficient in practice, guidelines are needed. Such guidelines need to be based on health -care standards. Science & Practice Universität Basel 9 PCNE Definition of Medication Review 2016 Medication review is a structured evaluation of a patient s medicines with the aim of optimising medicines use and improving health outcomes. This entails detecting drug related problems and recommending interventions. PCNE classification of medication reviews Universität Basel 10 5

6 The PRACTISE Project The PRACTISE project (PhaRmAcist-led CogniTIve Services in Europe - a survey on remuneration of pharmacist-led cognitive services with a focus on medication review) By the end of March 2017, the survey was closed and we had a response rate of 72.9% (n=35) with 2.5 Respondents/country (three stakeholders per country). We developed a consensus document to resolve inconsistencies within country responses. We achieved full response from 13 countries and partial response (2/3 or 1/2 participants) from 10 countries. Soon we expect to begin the evaluation of the consensus process towards the final data analysis. Tamara Imfeld-Isenegger, Urska Nabergoj Makovec, Inês Branco Soares, Nejc,Horvat, Mitja Kos, Kurt E Hersberger, Filipa A. Costa and the PCNE PRACTISE team 11 Universität Basel 12 6

7 Ann Pharmacother 2004;38: Drug related problems the cornerstone 0f pharmaceutical care What are the major requirements for a DRP classifications? Universität Basel 13 Drug related problems classification which one is the best? The PCNE classification od DRP Is a one-size-fits-all classification achievable? Universität Basel 14 7

8 Questions What does matter most? The mass of all potential and manifest DRPs OR only those DRPs, which triggered an intervention in practice? Do we need different classifications in the hospital and in the community pharmacy? What is the best classification (=documentation) at transition of care? Universität Basel 15 Classification of DRPs or only of the according intervention(s)? A case with multiple potential DRPs: Patient A., female, 81 years, 167cm, 59kg. Living alone ALDOMET TABL 250 MG 100 STK AMLODIPIN MEPHA TABL 5 MG 100 STK CIPRALEX FILMTABL 20 MG 98 STK ESIDREX TABL 25 MG 100 STK ESOMEP MUPS TABL 40 MG 98 STK For a while she is complaining insomnia The pharmacist asks the patient why the drug was prescribed in the evening. There was no plausible reason for the evening dose intake. Therefore, the pharmacist suggests a morning dose. Patient A. agrees. Universität Basel 16 8

9 An alternative approach to classification of DRPs in ambulatory care Focus on interventions AND seamless care Maximise similarity between the system used in hospitals (GSASA classification) and the new pharmdisc classification for community pharmacies (very similar structure, maximum number of equal items, all items specific for the setting) Both systems fully validated Patient file H Intervention initiated in the hospital P Intervention initiated by a community pharmacist Universität Basel 17 The PharmDISC system. 6 categories, 53 subcategories (Version 2.0) Problem Type of problem Cause of intervention Intervention Communication: Individuals involved Outcome of intervention Available in German, French and English Maes et al. J Eval Clin Pract. 2017;1 8 PharmDISC, Maes Karen, University of Basel 18 9

10 Lessson learned from this project Two very similar classifications for hospital and ambulatory settings could ease seamless care and promote mutual information sharing Validation is crucial, thus close collaboration of academia with practice We strongly believe that an intervention actually performed in practice is the much better trigger than the observation of a manifest or potential DRP For practice, the classification itself only becomes attractive for practitioners if it is also a documentation system. Key elements for user acceptance are minimal time consumption and ease of use Optimally, the paper version is only one page in length Integration into IT-systems is essential Thus, For «practice» we prefer a focus on the intervention For «science» comprehensive assessment of the whole range of DRPs remains the standard Universität Basel 19 Rare species: some animals and clinical pharmacists In Switzerland, clinical pharmacy services (CPS) were offered by 65% of the hospitals and only 40 % offer daily or weekly interprofessional ward rounds. 1 Thus, identifying patients with a high risk for drug-related problems might optimise the allocation of targeted pharmaceutical care during the hospital stay and upon discharge. Ideally this identification of patients at risk is without additional workload for the rare clinical pharmacists. 1) Studer H et al. Poster HP-PC126 Universität Basel 20 10

11 DART (Drug-Associated Risk Tool) Self assessment questionnaire 35 items (from literature, nominal group technique, Delphi survey) 1,2 Clinical information (eg renal function) Patient opinions (handling, swallowing difficulty Patient sorrows (questions from BMQ) After validation, 5 items of discriminatory power 3 1) Kaufmann C et al. BMJ Open 5(3): e ) Kaufmann C & Stämpfli D et al. BMJ Quality & Safety, 2017 in press 3) Stämpfli D et al. In preparation Universität Basel 21 Swameco SWAllowing difficulties with MEdication intake and COping strategies Messerli M et al. Patient Preference and Adherence 2017: Uncovered coping strategies among 20 patients: 40% modified the dosage form (splitting, dissolving, crushing) and 10% stopped medication Through self-report questionnaires, patients can efficiently provide individual information that can be used for relevant counseling and tailored interventions. Swameco-2 Study in preparation in collaboration with University College Cork (IR) Universität Basel 22 11

12 QTc-Prolongation An observational study from Belgium reports: 1 Out of 928 patients receiving a QTc-prolonging antibiotic, 33.7% were synchronously treated with another QTc-prolonging drug and the GP was only contacted in one case. One intervention after 313 alerts for potential DRPs! 1) Vandael et al. Archives of Public Health 2015, 73(Suppl 1):P42 Universität Basel 23 Circ Cardiovasc Qual Outcomes. 2014;7: Eline Vandael, Chantal Leirs, Margaux Claes, Amelie Matheve, Elien Verbeeck, Delphine Demeyer, Veerle Foulon Int J Clin Pharm (2017) 39: reduced risk of QT-c prolongation (adjusted OR 0.65; 95% CI ; P<0.0001) reduced prescribing of noncardiac medications known to cause torsades de pointes This RISQ-PATH score is able to rule out low-risk patients with a negative predictive value of 98.0% and is promising to exclude patients from further follow-up when starting QTc-prolonging drugs. Universität Basel 24 12

13 Conclusions regarding attempts to reduce risks for the Qtc-prolongation Disclosure: This conclusion is not based on a systematic review However, we could see: Diversity of risk-scores used (complexity, weighting of risk factors etc) Diversity in methods used (setting, patient inclusion criteria etc.) Integration in a CDS system is indispensable Usability of the score in practice? which data available in both settings (hospital & community pharmacy)? We need 2 distinguished scores, validated in each setting. Universität Basel 25 to Pharmacogenomic and personalised drug therapy From traditional DDI management Universität Basel 26 13

14 Why integrate Pharmacogenomics into Clinical practice? Prevention of DRPs in 1 out of 6 prescriptions! Nature 2015; 526: Universität Basel 27 Dosing guidelines CPIC (Clinical Pharmacogenetics Implementation Consortium) DPWG (Dutch Association for the Advancement of Pharmacy - Pharmacogenetics Working Group CPNDS (Canadian Pharmacogenomics Network for Drug Safety) Other Universität Basel 28 14

15 A dramatic gap between science and practice 98.5 % of whites and 99.1% of blacks in the US have at least one high-risk diplotype in 2016 Ubiquitous Pharmacogenomics (U-PGx): Making actionable pharmacogenomic data and effective treatment optimization accessible to every European citizen. Project ID: : 15 Mio; Horizon 2020 HM Dunneberger Annu Rev Pharmacol Toxicol. 2015; 55: Universität Basel 29 And in Clinical Pharmacy?? in 2006 PWS 2006;28: in 2011 J Am Pharm Assoc. 2011;51:e64 e74. in 2015 Am J Health-Syst Pharm. 2015; 72: Universität Basel 30 15

16 accessed Universität Basel 31 Abstract of study design. The study is ongoing Future perspective: Pre-emptive genotyping is more effective than reactive genotyping? Dunnenberger HM et al. Annu Rev Pharmacol Toxicol. 2015; 55: Universität Basel 32 16

17 Conclusions regarding pharmacogenomics Genomic medicine is going mainstream and pharmacists need to be prepared Because implementation of pharmacogenetic testing in clinical care has been slow, important opportunities for clinical pharmacists exist in all settings. ESCP should start at least with a SIG The good news is that a given genotype needs to be determined only once, unlike a measure of renal function. Universität Basel 33 The Pharmacogenomics Journal 2013; 13, Abstract Poor medication adherence is a well-known problem, particularly in patients with chronic conditions, and is associated with significant morbidity, mortality and health-care costs. Multi-faceted and personalized interventions have shown the greatest success. Pharmacogenetic (PGx) testing may serve as another tool to boost patients confidence in the safety and efficacy of prescribed medications. Universität Basel 34 17

18 Adherence research and pratice of supporting patients in achieving better adherence Nieuwlaat R, et al. Interventions for enhancing medication adherence. Cochrane Database Syst Rev 2014; 11 Current methods of improving medication adherence for chronic health problems are mostly complex and not very effective, so that the full benefits of treatment cannot be realized. Although present in only 6 out of 190 studies available in the Cochrane database, the inclusion of nonadherent patients was the single feature significantly associated with effective adherence interventions (P = 0.003). In order to obtain clinical benefits from effective adherence interventions, we encourage researchers to focus on the inclusion of nonadherent patients. Universität Basel 35 Targeting and/or Tailoring of interventions? An important lesson learned form a specific literature review:. Front Pharmacol. 2016; 7: 429 Valid for any intervention! In research and in practice Genotypes are unmodifiable, could be an important confounder in evaluation of adherence data Universität Basel 36 18

19 Other factors for successful interventions Universität Basel 37 19

20 From Interprofessional Education (IPE) to Interprofessional Clinical Practice (IPCP): The Framework for Action on Interprofessional Education and Collaborative Practice (2010, WHO/HRH/HPN/10.3). Interprofessional education is a necessary step in preparing a collaborative practice-ready health workforce that is better prepared to respond to local health needs A collaborative practice-ready health worker is someone who has learned how to work in an interprofessional team and is competent to do so Escorted by research Project IPE Pharmacy-Medicine UNI BS Results from the pilot project 2017 reveals high impact of only 2 consecutive half-day workshops. Students reported increased knowledge of their own role in an interprofessional team, of each other s role and compentencies and how to contribute with their competencies. In 2019 and in collaboration with the chair for family medicine, this IPE workshop will be implemented in both curricula with a total of 270 students of the University of Basel. We will use the Inverted/Flipped Classroom Model in order to achieve balanced knowledge among medical and pharmacy students before the workshops See Poster by Fabienne Böni Tolks D et al. An Introduction to the Inverted/Flipped Classroom Model in Education and Advanced Training in Medicine and in the Healthcare Professions. GMS J Med Educ. 2016; 33(3): Doc46. 20

21 Participatory action research (PAR) «reflection without action is sheer verbalism or armchair revolution and action without reflection is pure activism, or action for action s sake» Paulo Freire ( ) In PAR, knowledge is created in the interplay between research and practice, PAR involves the people who, in turn, take actions PAR aims to achieve empowerment of those involved PAR includes action, reflection and partnership Baum F et al. Epidemiol Community Health 2006;60: Further Reading: Bradley H. (2015) Participatory Action Research in Pharmacy Practice. In: Babar ZUD. (eds) Pharmacy Practice Research Methods. Adis, Cham Universität Basel 41 Patient engagement is key! Patient Engagement: Technical Series on Safer Primary Care. Geneva: World Health Organization; Licence: CC BY-NC-SA 3.0 IGO. Participants agreed that the time is now to involve people and patients in their health and their care through: More intelligent use of technology and electronic data Measuring more of what people want from their health systems Policies and regulation that promote team-based care designed around needs and preferences of individuals and communities. Universität Basel 42 21

22 Discovery Skills that Distinguish Great Innovators Gubbins PO et al. ACCP commentary: Innovation in Clinical Pharmacy Practice and Opportunities for Academic Practice Partnership Pharmacotherapy 2014;34(5):e45 e54) doi: /phar.1427 Universität Basel 43 Academic Practice Partnership Universität Basel 44 22

23 Take home Shared terminology /definitions Interventions should target the current modifiable determinants and be tailored to the unmodifiable determinants A call for Precision Pharmacy Consider e-health and digital health as great opportunities Academic Practice Partnership And, keep endurance: Two Steps Forward, One Step Back still results in at least one step of progress! Universität Basel 45 23