Deprescribing by Policy David Gardner Cara Tannenbaum Justin Turner Andrea Murphy Kathleen Coleman Patricia Caetano
Disclosure Each presenter declares that they have no actual or potential conflict of interest in relation to this topic or presentation.
Acknowledgements Jay Shaw Dara Gordon Zachery Bouck James Silvius 3
Plan of the Panel Cara Tannenbaum Justin Turner Andrea Murphy Kathleen Coleman Trish Caetano CaDeN, Canada, sedative-hypnotics, and policies International scan of policies to reduce BZRA use Analysis of policy context, mechanisms, and behaviour change techniques Commentary: NS policies to reduce S-H use Commentary: MB policies to reduce S-H use 4
Review Article The intended and unintended consequences of benzodiazepine monitoring programmes: a review of the literature J. Fisher* PhD, C. Sanyal* MSc, D. Frail BSc(Pharm) MSc and I. Sketris* PharmD *College of Pharmacy, Dalhousie University, Halifax, NS, Pharmaceutical Services, Nova Scotia Department of Health and Wellness 5
2012: 38 benzodiazepine prescriptions per 100 people New York Times prescribers could be encouraged or required to check their state s prescription drug monitoring program education on safe prescribing should also include information on benzodiazepines ISLAGIATT Humphries. NEJM Feb 22, 2018 6
1. I have a connective tissue disease. For some reason my specialist seemed to be pushing me to take a sleeping pill even when I told him I wasn t interested. I walked out with a prescription and never filled it. 2. I used regular sleeping pills for a while. When they didn t work I was put on amitriptyline. Within two months I was hospitalized for a blockage in my colon. 3. My mother is frail. She feels really unsteady when she takes them. She s scared to leave her home. 4. A psychiatrist put me on it for panic attacks 25 years ago. 10 years ago it took me 2 years to wean myself off. I still feel the effects. 5. My wife has been on sleeping pills for > 10 years. When I mentioned I had a bit of sleep troubles to my doctor he prescribed zopiclone for 60 days. It was my first prescription. I didn t take it. 6. She was an avid gardener. We saw her in the Emerg after starting lorazaepam. She d had a bad fall, taking large amounts of skin off her nose, lips, and chin, and her hands were a mess also. 7. He s been taking benzos for 2 decades and speaks about how wonderful they are. He has no interest in stopping them. I m worried. He is not a safe driver. 8. Oh, I m sleeping about the same. I still wake in the middle of the night.
Cara Tannenbaum, MD Co-chair, Canadian Deprescribing Network Professor, Faculties of Medicine and Pharmacy Université de Montréal 8
The Canadian Deprescribing Network Established in 2016 Our vision: A Canada where all seniors use safe and appropriate drug and non-drug therapies. Our goals: Raise awareness and decrease the use of inappropriate medications for seniors by 50% by 2020. Ensure access to safer drug and non-drug therapies. Our strategies: Policy decisionmaking Health care provider education Public awareness
Proportion of seniors who are chronic users of benzodiazepines Source: Canadian Institute for Health Information *Self report (Qc.)
Harmful effects of benzos Memory impairment Falls Fractures Automobile accidents
International policy attempts to reduce sedative-hypnotic use among seniors Prescriber monitoring Driver s license restriction Medication scheduling change Regional educational campaign on nondrug alternatives Financial incentivization to prescribers Removal of coverage
Which policies were effective?
Which policies were effective?
Which of these policies should we apply in Canada? Why not all?
Justin Turner, PhD, MClinPharm Senior Advisor, Science Strategy for the Canadian Deprescribing Network Researcher, Institut universitaire de gériatrie de Montréal 16
Financial incentivization Rat C, et al. Did the new French pay-for-performance system modify benzodiazepine prescribing practices? BMC Health Serv Res. 2014;14:301.
Financial incentivization 1.4% new prescriptions overall What happened? 4.3% treatment >12 weeks
Context Part of a Quality improvement program 4 priorities: practice organization, chronic disease management, prevention, prescribing Total incentive payment of 5000 ( 490 for prescribing component)
Removal of Coverage Chen H et al. The impact of Medicare Part D on psychotropic utilization and financial burden for community-based seniors. Psychiatr Serv. 2008;59(10):1191-7.
Removal of Coverage 5%, briefly What happened? Chen H et al. Psychiatr Serv. 2008;59(10):1191-7.
Context Medicare Part D is for low income who can t afford insurance No implementation strategy No dose tapering strategy 22
Beware of unintended consequences
Medicare Part D Consequences out of pocket expenses substitution to other sedatives nursing home hip fractures doubled Briesacher BA, et al. Medicare part D's exclusion of benzodiazepines and fracture risk in nursing homes. Arch Intern Med. 2010;170(8):693-8 24
Public Education Dollman WB, et al. Achieving a sustained reduction in benzodiazepine use through implementation of an area-wide multi-strategic approach. J Clin Pharm Ther. 2005;30(5):425-32.
Public Education What happened? 19.1%
Context Regional area Motivated multidisciplinary team Local opinion leaders and peer champions engaged 27
Thinking outside the box! Sometimes effective policy requires
Canadian seniors drivers license BC: Mandatory test at 80yrs, +2yrs AL: 75+ = medical test at every license renewal ON: 80+ medical test QC: 75yrs = physician report and at 80yrs, +2yrs Could we copy Denmark here? Published 9 th April 2018 29
Danish Drivers Licence Rules for renewal of drivers licences
Danish Drivers Licence Between 2007-2013 What happened? 54% long acting 35% short acting
Context 2003: benzodiazepine reduction a priority 2003: several interventions implemented 2007; Introduction of Driving Under the Influence of Drugs legislation 32
Medication Rescheduling Schaffer AL, et al,. JAMA Intern Med 2016;176:1223-5 2
Rescheduling of Alprazolam 28% for 65-79 yrs old What happened? 39% for 80+ yrs old 2 Schaffer AL et al JAMA Int Med 2016;176(8):1223
Context Alprazolam was already a restricted benefit for panic disorder Alprazolam diversion was high 35
Consequences? 22% in overall alprazolam prescribing 50% in poison center calls BUT, at what cost? street price benzodiazepines by 216% Overdose deaths involving 1 or more benzodiazepines from 42.2% to 52.5% (2009 2015) 2 Schaffer AL et al JAMA Int Med 2016;176(8):1223 Lloyd B et al Int J Drug Pol 2017;39:138
Prescriber Monitoring Triplicate Prescription Program implementation McNutt LA, et al. J Clin Epidemiol 1994;47:613-25 Wagner AK, et al. Int J Qual Health Care. 2003;15(5):423-31.
New York Triplicate Prescription Program Community level What happened? 35% overall 40
New York Triplicate Prescription Program Hospital discharge Triplicate Prescription Program implementation What happened? 53% 58% Proportion of patients with new benzodiazepine prescription on hospital discharge
Context 43
Context 1989: Pre Beers List of inappropriate medications Change included: Maximum 30 days supply, no refills Physicians had to order and pay for serialised prescription pads 44
Unintended consequences Greatest Benzodiazepine reduction for Younger Black Urban-dwelling people with low income Patients with chronic psychiatric and neurological disorders affected Switching was profound 45
Which policies for Canada? Political will is key Context is important But, how do we determine what works? for who? and why? 46
Andrea Murphy, BSc Pharm, ACPR, PharmD Executive Member, Canadian Deprescribing Network Associate Professor, College of Pharmacy Dalhousie University 47
Why do some policies succeed and others fail? ISLAGIATT it seemed like a good idea at the time 48
Complexity A complex adaptive system is a collection of individual agents with freedom to act in ways that are not always totally predictable, and whose actions are interconnected so that one agent's actions changes the context for other agents. Complex systems typically have fuzzy boundaries. Membership can change, and agents can simultaneously be members of several systems. This can complicate problem solving and lead to unexpected actions in response to change. Systems are embedded within other systems and co-evolve. The challenge of complexity in health care BMJ 2001;323:625 Plsek PE, Greenhalgh T 49
Complexity FIGURE 2-1 Conceptual drawing of a fourlevel health care system. From: 2, A Framework for a Systems Approach to Health Care Delivery Building a Better Delivery System: A New Engineering/Health Care Partnership. National Academy of Engineering (US) and Institute of Medicine (US) Committee on Engineering and the Health Care System; Reid PP, Compton WD, Grossman JH, et al., editors. Washington (DC): National Academies Press (US); 2005. 50
Reducing sedative-hypnotics What works? Versus What tends to work, for whom, in what circumstances? 51
Rapid realist review Focuses on program theories Explores C-M-O configurations C M O Context Mechanisms Outcomes Saul JE, et al. A time-responsive tool for informing policy making: rapid realist review. Implementation Science20138:103 https://doi.org/10.1186/1748-5908-8-103 52
Rapid realist review An intervention (I) triggers particular mechanisms (M) of change. mechanisms work either wholly or largely through the perceptions, reasoning, and actions of human actors. 53
Rapid realist review Mechanisms may be more or less effective in producing their intended outcomes (O), depending on their interaction with various contextual (C) factors. 54
Rapid realist review People s responses are supported or constrained by the social, organizational, and political circumstances in which interventions are implemented (context). 55
Greenhalgh J, Dalkin S, Gooding K, Gibbons E, Wright J, Meads D,et al. Functionality andfeedback: a realist synthesis of the collation, interpretation and utilisation of patient-reportedoutcome measures data to improve patient care.health Serv Deliv Res2017;5(2). 56
Mechanisms Behaviour change theory 57
Michie et al. The behaviour change wheel: A new method for characterising and designing behaviour change interventions. http://www.implementationscience.com/content/pdf/1748-5908-6-42.pdf
COM-B A framework of behaviour 6:42 doi:10.1186/1748-5908-6-42
COM-B component TDF domain Capability Psychological Knowledge Skills Memory, Attention and Decision Processes Behavioural regulation Physical Skills Opportunity Social Social influences Physical Environmental Context and Resources Motivation Reflective Social/Professional Role and Identity Beliefs about Capabilities Optimism Beliefs about Consequences Intentions Goals Automatic Social/professional Role and Identity Optimism Reinforcement Emotion Cane et al. http://www.implementationscience.com/content/7/1/37
Theoretical Domains Framework Theoretical Domain 1 Knowledge An awareness of the existence of something. 2 Skills An ability or proficiency acquired through practice. 3 Social/Professional Role and Identity A coherent set of behaviours and displayed personal qualities of an individual in a social or work setting. 4 Beliefs about Capabilities Acceptance of the truth, reality, or validity about an ability, talent, or facility that a person can put to constructive use. 5 Optimism The confidence that things will happen for the best or that desired goals will be attained. 6 Beliefs about Consequences Acceptance of the truth, reality, or validity about outcomes of a behaviour in a given situation. 7 Reinforcement Increasing the probability of a response by arranging a dependent relationship, or contingency, between the response and a given stimulus. 8 Intentions A conscious decision to perform a behaviour or a resolve to act in a certain way. Cane et al. Implementation Science 2012, 7:37 http://www.implementationscience.com/content/7/1/37
Theoretical Domains Framework Theoretical Domain 9 Goals Mental representations of outcomes or end states that an individual wants to achieve. 10 Memory, Attention & Decision Processes 11 Environmental Context & Resources The ability to retain information, focus selectively on aspects of the environment and choose between two or more alternatives. Any circumstance of a person's situation or environment that discourages or encourages the development of skills and abilities, independence, social competence, and adaptive behaviour. 12 Social influences Those interpersonal processes that can cause individuals to change their thoughts, feelings, or behaviours. 13 Emotion A complex reaction pattern, involving experiential, behavioural, and physiological elements, by which the individual attempts to deal with a personally significant matter or event. 14 Behavioural Regulation Anything aimed at managing or changing objectively observed or measured actions. All definitions are based on definitions from the American Psychological Associations Dictionary of Psychology from Cane s ref #36 Cane et al. Implementation Science 2012, 7:37 http://www.implementationscience.com/content/7/1/37
Prescriber Monitoring Triplicate Prescription Program implementation McNutt LA, et al. J Clin Epidemiol 1994;47:613-25 Wagner AK, et al. Int J Qual Health Care. 2003;15(5):423-31.
NY state TPP C-M-O Intervention Benzodiazepine prescription control (TPP) with monitoring (external assessment) NYS TPP 30 day supply No repeats (excluding panic disorder, epilepsy) Context 1989 New York state Era of consistent marketing of BZDs for neuroses Liberal prescribing of BZDs is a normative prescribing behaviour. Government official, BZDs are a major public health danger Patient user fees: medical visits; prescriptions TPP administrative burden to physician ordering and paying for TPP pads 64
NY state TPP C-M-O Intervention Benzodiazepine prescription control (TPP) with monitoring (external assessment) NYS TPP 30 day supply No repeats (excluding panic disorder, epilepsy) Mechanisms MD believes policy improves relationships with patients and reduces patient harms MD unwilling to lose prescribing autonomy through monitoring MD does not want to be identified as a high BZD prescriber Patient concerned of negative health consequences of BZDs Patient not willing to take a medication requiring a special prescription reserved for abused and addictive drugs Patient cannot afford (time and out of pocket expenses) increased MD visits and prescriptions 65
NY state TPP C-M-O Intervention Benzodiazepine prescription control (TPP) with monitoring (external assessment) NYS TPP 30 day supply No repeats (excluding panic disorder, epilepsy) Outcomes Reduced benzodiazepine use Reduced benzodiazepines overdoses No change in use of effective, safer alternatives CBT Increased use of other nonmonitored sedative-hypnotics Increased non-benzodiazepine overdose (higher mortality) No change in hip fracture rate 66
NY state TPP COM-B Intervention Benzodiazepine prescription control (TPP) with monitoring (external assessment) NYS TPP 30 day supply No repeats (excluding panic disorder, epilepsy) 67
NY state TPP COM-B Intervention Benzodiazepine prescription control (TPP) with monitoring (external assessment) COM-B TDF domain C Psychological Knowledge Memory, Attention and Decision Processes Behavioural regulation O Social Social influences Physical Environmental Context and Resources NYS TPP 30 day supply No repeats (excluding panic disorder, epilepsy) M Reflective Social/Professional Role and Identity Optimism Beliefs about Consequences Automatic Social/professional Role and Identity Optimism Reinforcement Emotion 68
Commentaries Overview of challenges of policy development in reducing sedative-hypnotics. Kathleen Coleman Director of Formulary and Clinical Practice, Department of Health & Wellness, Government of Nova Scotia Patricia Caetano Executive Director, Provincial Drug Programs, Government of Manitoba Chair, Drug Policy Advisory Committee (DPAC) Optimal Use Working Group, CADTH 69
Stakeholders Health Providers Health Authorities Professional/ business MD, RN, RPh, Therapist, others Care centres, authorities, and systems Regulators P/F advocacy orgs MD, RPh, RN, Therapists Community Seniors Mental health Addictions Policies to reduce use of sedative-hypnotics Government College of Physicians & Surgeons College of Pharmacy Academia Research Knowledge translation Policy Legislation Regulations Seniors, Health, Indigenous, Public Safety, Transport Police Justice 70
Deprescribing by Policy Discussion 71
Thank You Please visit the CaDeN booth Ballroom B1 72