Workshop 4 Pharmacovigilance: What do we know? Objectives To - - PowerPoint PPT Presentation

15 July 2017 Workshop 4

Pharmacovigilance: What do we know?

Objectives

To discuss and illustrate causality assessment of ADR’s To present results from HMC pharmacovigilance study To discuss key barriers, facilitators and improvement strategies to effective and efficient pharmacovigilance in clinical practice To Understand the process of Pharmacovigilance To describe the scope and importance of Pharmacovigilance To describe the basic concepts, terms and definitions used in Pharmacovigilance To describe the history of modern Pharmacovigilance

History of Modern Pharmacovigilance

In late 1950 no much regulation of medicine Pharmaceutical companies had greater power Thalidomide disaster in 1960’s About 10,000 babies were affected In 1960, Medical literature was only source of identifying ADR’s why so many damaged babies had been born before anything had been done?

Crossword puzzle

Terms and Definitions used in Pharmacovigilance

Pharmacovigilance has been defined by the WHO as ‘The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems’. Adverse events: Medical occurrence temporally associated with the use of a medicinal product, but not necessarily causally related Adverse Drug Reactions (ADR’s): 'A response to a drug which is noxious and unintended, and which occurs at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease, or for the modifications

• f physiological function'.

Unexpected ADR’s: Not consistent with applicable product information or characteristics of drug.

Side effects: Unintended effect occurring at normal dose related to the pharmacological properties

Signal:

• Possible causal relationship adverse event and drug
• Previously unknown or incompletely documented
• More than one report is needed. Depending on: - Quality of the

informatio

• Seriousness of the event

Serious adverse event or reaction:

• Any untoward medical occurrence that at any dose; Results in

death, Life threaten, Requires inpatient hospitalization or prolongation of existing hospitalization, Results in persistent of significant disability or incapacity, Frequency of adverse drug reactions (CIOMS):

• Very common: more than 1 in 10
• Common (frequent) : 1 in 10 to 1 in 100
• Uncommon (infrequent) : 1 in 100 to 1 in 1,000
• Rare: 1 in 1,000 to 1 in 10,000
• Very Rare : less than 1 in 10,000

Definitions Related to Causality

Certain:

• Event or laboratory test abnormality, with plausible time relationship to drug intake
• Cannot be explained by disease or other drugs
• Response to withdrawal plausible (pharmacologically, pathologically)
• Event definitive pharmacologically or phenomenologically(An objective and specific

medical disorder or a recognised pharmacological phenomenon)

• Rechallenge (if necessary)

Probable:

• Event or laboratory test abnormality, with reasonable time relationship to drug intake
• Unlikely to be attributed to disease or other drugs
• Response to withdrawal clinically reasonable
• Rechallenge not necessary

Possible:

• Event or laboratory test abnormality, with reasonable time relationship to drug intake
• Could also be explained by disease or other drugs
• Information on drug withdrawal lacking or unclear

Unlikely:

• Event or laboratory test abnormality, with a time to drug that makes a relationship

improbable (but not impossible)

• Diseases or other drugs provide plausible explanations

Conditional / Unclassified:

• Event or laboratory test abnormality
• More data for proper assessment needed

Or additional data under examination

Unassessable/ Unclassifiable:

• A report suggesting an adverse reaction
• Cannot be judged because of insufficient or contradictory information
• Report cannot be supplemented or verified

Pharmacovigilance Tools and Methods

To describe the Scope and Aim of Pharmacovigilance

In the past: Pharmacovigilance was mostly focused on the detection of hitherto unknown adverse drug reactions (ADRs) of drugs approved for marketing Extended scope since 2002: Focus on activities relating to the detection, assessment, understanding and prevention of adverse drug effects or any other drug related problem’ Focus on adverse reactions that may arise from the use of the product within or

• utside the terms of the marketing authorization or from occupational exposure
• utside the terms of the marketing authorization Include: off-label use, overdose, misuse,

abuse and medication errors

The aims of pharmacovigilance program are:

• to improve patient care and safety in

relation to the use of medicines, and all medical and paramedical interventions

• to improve public health and safety in

relation to the use of medicines

• to contribute to the assessment of benefit,

harm, effectiveness and risk of medicines, encouraging their safe, rational and more effective (including cost-effective) use

• to promote understanding, education and

clinical training in pharmacovigilance and its effective communication to health professionals and the public.

The Concepts and process of Pharmacovigilance

Flow of Information

Understanding of ADR’s and its Reporting

6% hospital admissions 4% of hospital bed capacity ADRs occur in 10-20% of hospital in-patients 2% of patients admitted with an adverse drug reaction die ADRs also impacts patients quality of life and trust in healthcare professionals or system What is the extent of underreporting ?

Why to report ADR’s?

To identify safety problems of post- marketing drugs Taking appropriate risk minimizing measures Safe use of medications

• Who?

Who should report ADR’s ?

Reporters in HMC

ADR's reported by HCP (2017) Occupation Count % Physician's 27 7% Nurse's 143 37% Pharmacist's 215 56% Grand Total 385 100%

Who should report ADR’s ?

What should be reported?

For “new” drugs - report all suspected reactions, including minor

• nes. (In many countries drugs are still considered “new” up to five

years after marketing authorization); For established or well-known drugs - report all serious or unexpected (unusual) suspected ADRs; Report if an increased frequency of a given reaction is observed; Report all suspected ADRs associated with drug-drug, drug-food or drug-food supplements (including herbal and complementary products) interactions; Report ADRs in special fields of interest such as drug abuse and drug use in pregnancy and during lactation; Report when suspected ADRs are associated with drug withdrawals; Report ADRs occurring from overdose or medication error; Report when there is a lack of efficacy or when suspected pharmaceutical defects are observed.

What information is relevant to collect?

ADR’s reporting at HMC

Where will reporters find the ADR forms?

Patients??????

What is the pharmacovigilance workflow in HMC ?

Pharmacovigilance is essentially a risk management process for medicines:

Signal Detection

Methods:

• Reporting rates
• Profiling

between drugs is to use the proportions of all ADRs for a particular drug that are of a specific type

Evaluation

Signal Prioritization

• Triage by the WHO
• Impact analysis

. Evidence score . Public health score

Investigation

.Pharmacoepidemiolo gical Studies .Mechanistic studies

Taking action

• ccurrence of ADRs

• Demographics: age, sex, race
• Genetic factors: polymorphisms

• Concomitant diseases (e.g.

• History of previous ADRs (e.g.

• Compliance

• Route of administration
• Formulation (e.g. sustained vs.

• Therapeutic Index
• Mechanisms of drug metabolism

• Potential for drug interactions

Making a decision

• Implementation
• Communication

the mnemonic ‘ABOUT’

• Measuring success

key barriers, facilitators and improvement strategies to effective and efficient pharmacovigilance in clinical practice

Barriers, facilitators and improvement strategies to reporting ADRs

Can you discuss in your groups what are the barriers, facilitators and improvement strategies to reporting ADRs?

Barriers Facilitators Predictors Improvement strategies

• lack of knowledge of ADRs
• Lack of ADRs reporting

process

• Uncertainty between ADRs

and drug

• Busy schedules, time

constraints

• Adequate

awareness

• Hospital support
• Patient safety

concerns

• Professional

responsibility

• Consultant job
• Adequate

Awareness

• Ample

knowledge of ADRs, and training

• Increasing physicians awareness

and knowledge of ADR reporting.

Health system-related Barriers: Lack of access to patient Records, Fear of litigation, Lack of clear reporting guidelines, Lack

• f financial rewards/incentives

Individual pharmacist-related Barriers: Knowledge and clinical competence ; Inability to establish Causality , Lack of understanding the responsibility of reporting ADRs, How/where to report, Attitudes toward reporting ADRs: Self-guilt of harming Patients, Lack of interest, Lack of time

• Reactions of a

serious nature

• Unusual reactions

reactions to a new product

• Continuous professional

development programs and reinforcing theoretical and practical knowledge in undergraduate pharmacy curriculum.

• Access to patient’s medical record

and introducing electronic reporting systems

• Feedback from the relevant

authorities

Knowledge Skills Beliefs about consequences Motivation and goals Environmental constraints Social influence

• Lack of

knowledge of what should be reported

• Lack of

knowledge of definitions

• Lack of

knowledge of guideline

• Lack of skills

in differentiating ADRs and MEs

• Fear of

punishment and criticism

• Lack of

feedback

• Lack of

motivation

• workload
• incentives
• human

resources

• time for

reporting

• Complicated

yellow card

• Complicated

administrative reporting procedure

• Lack of

reporting facilities

• Lack of

Clinical pharmacists .

• Lack of

teamwork

• Lack of active

support by hospital management and

• ther colleague

Improvement strategies

• Information

delivery methods adopted to individual needs

• Provide

education to improve competency

• Provide

education on consequences

• Provide more

feedback such as timely alerts

• Provide

information about impact of reporting, social influence (e.g., provide a role model), time management, incentives , establish Drug safety department,

• Training to change

group processes

• Organize social

influence (provide support )

Results from the ADR studies

Research Studies and findings

Systematic review of Adverse Drug Reactions in Middle East Evaluating the Quality, Quantity and Nature of Adverse Drug Reactions using Vigigrade and VigiBase tools. Frequency and nature of Adverse Drug Reactions reported at Hamad Medical Corporation, Qatar “A study knowledge, attitude and practice characteristics of pharmacists in HMC towards Adverse Drug Reaction Reporting”

Phase1 Systematic Review Phase 2 Women's Hospital ADR study Phase 3 Corporate ADR Study Phase 4 Questionnaire. Study (HMC Pharmacists)

What is happening in Qatar & the region? In Hamad Medical Corporation? In Women's Hospital?

Qatar - WHO Programme member

Image obtained from UMC - WHO Programme members website

Systematic Review

• The review included 12 out of 581 articles.
• The incidence varied between 0.7% at a university teaching hospital to 52.8%

in medical ward of a 600-bedded hospital.

• Majority of the studies used definition from World Health Organization

(WHO).

• The most common medication to cause ADRs are Non-steroidal anti-

inflammatory drugs (NSAIDs), followed by antibiotics, vaccines and streptokinase.

• The most common reactions were GI bleeding, renal toxicity, extrapyramidal

side effects, skin rashes and itching.

• Six (6/12) studies performed severity assessment, most these reported ADRs

to be severe.

• Only three (3/12) studies have mentioned about the strategies to

reduce/prevent the ADRs

• Only one study was included from Qatar.

Findings - WH ADR study

• Retrospective
• Data collection – 4 year ADR reports (2013 – 16)
• Quality (completeness using Vigigrade), Quantity, nature (Causality, Preventability,

Severity).

• 133/187 ADRs were included.
• Antibiotics were the most common class (39%), anti-inflammatory (9%), Gastro intestinal

(7%).

• Skin and subcutaneous tissues disorders were the most commonly affected organ system

(56%), respiratory (19%).

• 84% of the reactions were MILD while 2% caused SEVERE HARM.
• Majority of the ADRs were NON PREVENTABLE (82%).
• More than half (52%) were categorized as “POSSIBLE”
• The reports achieved a cumulative score of 0.74, that shows reports were of good quality

although the numbers were low.

Questionnaire survey of Pharmacist at HMC

• A descriptive questionnaire-based methodology was used to evaluate the

knowledge, attitude and practice of pharmacists and pharmacy technicians working at HMC.

• Of 700 pharmacists and pharmacy technicians, 300 (~43%) respondents

completed the questionnaires.

• ~62% of the participants did not report an ADR over the last 12 months and more

than 90% never received a feedback after reporting an ADR.

• 78% knew how to report an ADR, while 60% said they havent reported any ADR

in the last 12 months.

• In terms of knowledge questions, respondents showed a high understanding of

the concept of pharmacovigilance. Almost three quarters (72%) responded correctly when asked about the purpose of pharmacovigilance.

• However, majority (70%) of the respondents never attended any course or

training on pharmacovigilance and almost 80% of them were not aware if there is any pharmacovigilance center existing in Qatar.

• Majority of the pharmacists and technicians were also not aware about different

scales used to analyse ADRs (eg. Naranjo, Hartwig, Schumocks).

• Although most of the respondents were aware of their important role

towards ADR reporting, only a few reported any ADR over the last 12 months.

• Several factors such as lack of training, time and feedback, and complex

reporting process were presumably associated with low reporting. Hence, the authors recommend several interventions to enhance ADR reporting including training and educational activities on pharmacovigilance, and providing appropriate feedback to ADR reporters.

ADR assessment scales

• Naranjo Causality Assessment

Hartwig’s Severity Assessment

Preventability criteria according to Schumock and Thornton scale

Hands on Training!!!

ADR Causality assessment

Way forward

• Research opportunities
• to improve HCP reporting of ADR
• to explore patients awareness of ADR’s and ADR’s

reporting

• Research opportunities to improve different patient

safety aspects.

References

• Edwards IR, Aronson JK. Adverse drug reactions: definitions, diagnosis, and management. The lancet. 2000 Oct

7;356(9237):1255-9.

• Wester K, Jönsson AK, Spigset O, Druid H, Hägg S. Incidence of fatal adverse drug reactions: a population based study.

British journal of clinical pharmacology. 2008 Apr 1;65(4):573-9.

• Bouvy JC, De Bruin ML, Koopmanschap MA. Epidemiology of adverse drug reactions in Europe: a review of recent
• bservational studies. Drug safety. 2015;38(5):437.
• Waller P, Harrison-Woolrych M. An introduction to pharmacovigilance. John Wiley & Sons; 2017.
• The Yellow Card Scheme: guidance for healthcare professionals: available at https://www.gov.uk/guidance/the-

yellow-card-scheme-guidance-for-healthcare-professionals

• Pharmacovigilance: available at http://www.who.int/medicines/areas/quality_safety/safety_efficacy/pharmvigi/en/
• World Health Organization. The use of the WHO-UMC system for standardized case causality assessment. Uppsala: The

Uppsala Monitoring Centre. 2005:2-7.

• Bakhsh TM, Al-Ghamdi MS, Bawazir SA, Qureshi NA. Barriers, Facilitators, Strategies, and Predictors for Reporting

Adverse Drug Reactions in three General Hospitals in Jeddah, 2013. British Journal Medicine & Medical Research. 2016;17(4):1-3.

• Mirbaha F, Shalviri G, Yazdizadeh B, Gholami K, Majdzadeh R. Perceived barriers to reporting adverse drug events in

hospitals: a qualitative study using theoretical domains framework approach. Implementation Science. 2015 Aug 7;10(1):110.

• Ioannidis JP, Mulrow CD, Goodman SN. Adverse Events: The More You Search, the More You FindAdverse Events: The

More You Search, the More You Find. Annals of internal medicine. 2006 Feb 21;144(4):298-300.

• Hadi MA, Neoh CF, Zin RM, Elrggal ME, Cheema E. Pharmacovigilance: pharmacists’ perspective on spontaneous

adverse drug reaction reporting. INTEGRATED PHARMACY RESEARCH AND PRACTICE. 2017 Jan 1;6:91-8.

• Mann RD, Andrews EB, editors. Pharmacovigilance. John Wiley & Sons; 2007 Feb 6.
• Edwards R, Lindquist M, editors. Pharmacovigilance: Critique and Ways Forward. Springer; 2016 Oct 27.

Patient Engagement

A strategy for Improving medication Safety

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Patient Engagement: A strategy for Improving medication Safety

Presented by : Pharmacist Mohd A/Wahid Facilitators : Pharmacist Asma A/Azziz : Pharmacist Hiba Khairy

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Objectives

 Discuss Patient Engagement (PE)/Patient activation (PA) concepts  Strategies to improve PE/PA  Roles and responsibilities of HCP/patients in promoting patient engagement (PE)  Identify patient barriers to medication adherence. •  Describe the consequences of medication non-adherence  Discuss communication strategies to improve medication adherence and medication reconciliation

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Agenda

 Introduction  Overview of Medication Errors  Patient Engagement

• Rationale
• Levels of engagement
• Benefits of patient

engagement

• Patient Activation
• Patient activation measure

(PAM)

• Implications of PAM score
• Interventions to promote

patient activation  Patient Engagement & Medication Safety

• Adherence
• Group Activity (Medication

Adherence Scenarios)

• Medication Reconciliation

 Summary  Questions

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Introduction

 Medication use has become increasingly complex in recent times  ADE’s account for 25% of all medical errors  ADE’s occur in approximately 4% of hospital admissions.  Medication Errors account for US$ 42 billion annually. (WHO)  75% of these errors are preventable.

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Introduction

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 Medication safety is defined as freedom from preventable harm with medication use (ISMP Canada, 2007). [1,2]  "A medication error is “any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer. Such events may be related to professional practice, health care products, procedures, and systems, including prescribing, order communication, product labelling, packaging, and nomenclature, compounding, dispensing, distribution, administration, education, monitoring, and use” (NCCMERP) [3]

Factors that may influence medication errors

 Factors associated with health care professionals  Factors associated with patients  Work environment factors  Factors associated with medicines  Factors associated with tasks  Factors associated with computerized information systems

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“First do no harm”

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Traditional Error Prevention Strategies

changing provider behavior encouraging inter-professional collaboration enhancing the culture of safety

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Dimensions of healthcare quality

2001 “Crossing The Quality: A New Health System For The 21st Century” [9]

 The six dimensions of healthcare quality

Safe Effective Patient centered Timely Efficient Equitable

Patient &Family Centered Care is defined as; "care that is respectful of and responsive to individual patient preferences, needs, and values and that patient values guide all clinical decisions" (Institute of Medicine, 2001).

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Patient Engagement

 Patient engagement is defined as “Actions individuals must take to obtain the greatest benefit from the health care services available to them” [10]  The patient is not just at the center of care but is part of the team.[10]  Engagement means doing things WITH patients not just for

• them. [43]

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Patient & Family Engagement

Levels of Engagement Consultation Involvement Partnership & shared decision-making

Direct patient care Patients receive information about a diagnosis Patients are asked about their preferences in treatment plan Treatment decisions are made based on patients’ preferences, medical evidence, clinical judgement. Organizational design & governance Organization surveys patients about their care experiences Hospital involves patients as advisers or as advisory council members Patients’ co-lead hospital safety & quality improvement committees Policy-making Public agency conducts focus groups with patients to ask questions about healthcare issues Patients’ recommendations about research priorities are used by public agency to make funding decisions Patients’ have equal representation on agency committee that makes decisions about how to allocate resources to health programs

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Patient Engagement continuum

Patient & Family Engagement

Levels of Engagement Consultation Involvement Partnership & shared decision-making Direct patient care Patients receive information about a diagnosis Patients are asked about their preferences in treatment plan Treatment decisions are made based on patients’ preferences, medical evidence, clinical judgement.

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Patient Engagement continuum

Rationale for Patient Engagement

 Patients who are more actively involved in their health care experience better health outcomes and incur lower costs. [11]

 15 million patients with long-term condition (LTC) in UK.  People with LTCs account for [12]:

 about 50 per cent of all GP appointments,  64 per cent of all outpatient appointments and  over 70 % of all inpatient bed days  70% of health expenditure

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Rationale for Patient Engagement

 Patients with Long Term Conditions (LTCs) spend less than 1%

• f their time with healthcare professionals

 Patients with LTCs manage their health on a daily basis. [13]  60 to 70% of premature deaths caused by health risk

• behaviors. [12]

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Patient Activation

 “An individual’s knowledge, skill, and confidence for managing their health and health care” (Hibbard et al 2005).  links to all the principles of person-centered care,  Enables the delivery of personalized care  Supports people to develop their capability to manage their own health and care.  Activated patients experience better health outcomes at lower

• costs. [13]

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Why is Patient Activation Important?

 As activation levels increase, individuals become: [14,15,16]

More adherent to medications & medical advise More likely to engage in positive health behaviors More likely to have better health outcomes More likely to engage in health information seeking behaviors Increased readiness-to-change to live a healthier lifestyle. More likely to attend screenings, regular check-ups and immunizations,

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Behaviour associated with low activation

 Feeling overwhelmed  Little confidence in their ability to have a positive impact on their health  Passive - less likely to ask questions or to offer information  Less likely to follow clinical advice or follow recommendations  Higher hospitalisation; readmissions.  More likely to delay seeking medical help. [15,17]

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Patient Activation Measure (PAM)

Patient activation measure (PAM), assesses an individual's knowledge, skill, and confidence for self- management. Appropriately designed interventions can increase patients’ levels of activation, with associated health

• benefits. [12,14]

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What is the Patient Activation Measure (PAM)?

“patient activation measure”—a validated survey that scores the degree to which someone sees himself/herself as a manager of his or her health and care. PAM questionnaire consists of 13 items Based on PAM score, patients are categorized into four levels of the individual’s likelihood of effective self-management

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13-items PAM

17/07/2017 69 Strongly agree, Agree, Disagree, Strongly disagree Source: University of Oregon, 2010

Patient Activation is Developmental

Level-1

Individuals tend to be passive and feel

• verwhelmed by

managing their own

• health. They may not

understand their role in the care process.

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Level-3

Individuals appear to be taking action but may still lack the confidence and skill to support their behaviors.

Level-2

Individuals may lack the knowledge and confidence to manage their health.

Level-4

Individuals have adopted many of the behaviors needed to support their health but may not be able to maintain them in the face of life stressors.

1 2 3 4 5 6 7 8 9 10 11 12 13

39 40 42 43 44 44 45 47

50 51 51

52 53

Why Measure Patient Activation?

To know who needs more support & tailor interventions based their needs. To track progress over time 25 and 40 percent of the population have low levels of activation (levels 1 and 2). [13]

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Patient Activation Interventions

 Effective interventions can help to increase people’s activation levels and their confidence in managing their health.[13]  Patients need to believe that they have a sense of control over events related to their health and healthcare- Partnership vs Compliance  Building confidence through small steps is the key strategy for increasing activation.  People with lower levels of activation are likely to need more in-depth one to one support  Those who are least activated make the most progress when given appropriate

• support. [18]

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Tailoring support to patient activation levels

Level1 Build knowledge– base, self- awareness, & initial confidence Level2 Increase in knowledge, initial skills development, Grow confidence Level3 Skills development, pursue guideline behaviors Level4 Achieve/exceed life style behavior guidelines, develop techniques to prevent relapse

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Patient Activation Interventions

Examples of interventions for patients at the lowest level of activation include:[12]

Focus on one change at a time Focus on what is important to the patient Reinforce the importance of patient participation Encourage small steps with encouragement Revisit behavioral goals Show empathy Build on strengths Develop problem solving skills

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Patient Engagement & Medication Safety

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Medication Adherence

"the degree to which the person's behavior corresponds with

the agreed recommendations from a health care provider.“[20]  Acceptable Adherence rate ranges from 80 -95% [21]

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X 100 ≥ 80%% No of Pills Absent in Time X No of Pills Prescribed for Time X

Magnitude of the Medication Non- Adherence Problem

20 to 30 percent of new prescriptions are never filled. 50% of prescribed medication is not taken as prescribed Adherence is lowest among patients with chronic diseases,

• Source: Centers for Disease Control and Prevention (CDC)

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Forms of Medication Non-Adherence[46]

 Medication nonadherence, either willful or inadvertent, can include:

Failing to fill/refill a prescription Omitting a dose or more Prematurely discontinuing medication Taking a dose at the wrong time Taking a medication prescribed for someone else Taking a dose with prohibited foods, liquids, and other medications Taking outdated/damaged medications Storing medications improperly Improperly using medication administration devices (e.g., inhalers).

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Health Consequences of Non- Adherence [22,23]

 Increased hospitalization-33-69% medication related admissions.  Poor health outcomes  Increased costs-$289 Billion/year  Decreased quality of life

Patient death- 125,000 Mortalities annually

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Non-Adherence increases the total cost of healthcare

17/07/2017 80 Source: Smith DL. The effect of patient non-compliance on health care costs. Medical Interface 1993:April; 74-84

Factors Contributing to Non- Adherence

Many factors may influence patients’ adherence to medication therapy regimen [24,25,29,39]

 Patient/provider communication  Cognitive impairment  Limited language proficiency  Complexity of the medication regimen  Duration of treatment  Frequent changes to medications  Adverse drug effects & Drug interactions  Comorbidities  Lack of symptoms  No perceived benefit of medicine  Cost

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Interventions to improve Adherence

 Low literacy  Homelessness  Depression  Psychiatric disease  Substance abuse  Lower cognitive function  Forgetfulness  Anger, psychological stress, anxiety  Lack of insight into illness  Lack of belief in benefit of treatment  Belief that the drug is not important or is harmful  Complexity of medication regimen  Side effects  Cost of medication,  Inadequate follow-up  Missed appointments

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Predictors of non-adherence [44]

Interventions to Improve Adherence

Patient Engagement: [25,30]

Engaged patients are 2.57 times more likely to stay adherent with their medication regimens. Basic patient engagement techniques :

sending reminders 7-10 days prior to appointments, meeting with patients face-to-face to review their medications and answer questions.

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Interventions to improve adherence [45]

Linking with daily activity Compliance-aids Specialized labels Involve caregivers Behavioural counseling Patient education Goals/systematic plan Rewards Simple regimens Formulations Prompts/reminders Medilist (medication list) Family members Alarm beepers Mixing with foods Administration aids

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Patient Engagement & Medication Safety: Medication

Adherence

There is no universal solution to improve adherence [27] Combining approaches that are tailored to address a patient’s specific adherence barriers [27] Education-based interventions that focus on teaching individuals about their medications are Less effective than interventions that focused on changing the behavior of patients. [34]

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Interventions to Improve Adherence [33]

 For short-term treatments, counselling and written information may be effective in the short term.  More complex interventions needed to improve adherence in the long term, including various combinations of:

 Convenient care,  Information,  Counselling,  Reminders,  Self-monitoring,  Reinforcement,  Family therapy,

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Group Activity

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Scenario 1:

• Ms. D, a 65-year-old woman with hypertension and diabetes,

presented to your office for a routine appointment. Her most recent hemoglobin A1C was 9.0. On examination, her vital signs were normal with the exception of BP, which was 165/85. Her medications included zestoretic and pioglitazone. On questioning, she revealed that she has not been able to buy her medications because they are too expensive.

 What are your concerns for medication compliance for this patient?  How would help Ms. D better comply with medication regimen?

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Scenario 1:

• Ms. D, a 65-year-old woman with hypertension and diabetes, presented to your
• ffice for a routine appointment. Her most recent hemoglobin A1C was 9.0. On

examination, her vital signs were normal with the exception of BP, which was 165/85. Her medications included zestoretic and pioglitazone. On questioning, she revealed that she has not been able to buy her medications because they are too expensive.  Concerns:  Cost of medications  Knowledge about the disease  Asymptomatic disease  Interventions::  Switch to generics.  Counseling about the long-term consequences of not appropriately managing her hypertension and diabetes

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Scenario 2:

An 83 year old female has multiple chronic conditions, including diabetes, iron deficiency anemia, and gastroesophageal reflux

• disorder. She is prescribed metformin (to be taken with meals,

morning and evening), glipizide (to be taken with food), ferrous sulfate (to be taken on an empty stomach), and omeprazole (to be taken 1-2 hours before the iron supplement). All of these directions about the timing of medications with meals are confusing to the patient, so she just takes them all once a day, right before breakfast.  What are your concerns for medication compliance for this patient?  How would help the patient better comply with medication regimen?

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Scenario 2: Concerns & Interventions

An 83 year old female has multiple chronic conditions, including diabetes, iron deficiency anemia, and gastroesophageal reflux disorder. She is prescribed metformin (to be taken with meals, morning and evening), glipizide (to be taken with food), ferrous sulfate (to be taken on an empty stomach), and omeprazole (to be taken 1-2 hours before the iron supplement). All of these directions about the timing of medications with meals are confusing to the patient, so she just takes them all once a day, right before breakfast.  Concerns:  Complexity of therapy  Forgetfulness  Chronic conditions  Information overload  Interventions:  Simplify the dosing regimen (e.g., switch to extended release metformin)  Use a pill box to dosing times.  Counseling about which medications can be taken together and what is an allowable window of medication administration.

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Scenario 3:

66 year old male with type II diabetes mellitus works as a business executive in a fast-paced environment. He has been taking metformin since being diagnosed with diabetes 10 months ago. At first, he had no problem remembering to take his metformin. However, recently he has begun to notice that he sometimes cannot remember whether he took his metformin amid his busy schedule.  What are your concerns for medication compliance for this patient?  How would help the patient better comply with medication regimen?

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Scenario 3: Concerns & Interventions A 66 year old male with type II diabetes mellitus works as a business executive in a fast-paced environment. He has been taking metformin since being diagnosed with diabetes 10 months ago. At first, he had no problem remembering to take his metformin. However, recently he has begun to notice that he sometimes cannot remember whether he took his metformin amid his busy schedule. Concerns:

Lack of symptoms

Interventions

Use pill-boxes, mobile apps, PC-Based software, clocks, etc.

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Scenario 4: An 82 year old female is prescribed furosemide 20mg by mouth once daily for symptomatic treatment of her heart failure. She was recently hospitalized for a CHF exacerbation and has since had monthly follow- up visits with her primary care physician (PCP). Since she does not notice any improvement in her symptoms and experiences some urinary frequency since starting the furosemide, she occasionally skips her dose. However, in the days before her clinic appointments, she takes her furosemide exactly as prescribed. When her PCP asks her is she is taking her medications appropriately at the visit, she responds affirmatively. After a couple months, she is hospitalized again for a CHF exacerbation after a period of 10 days without furosemide.  What are your concerns for medication compliance for this patient?  How would help the patient better comply with medication regimen?

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Scenario 4: Concerns & Interventions An 82 year old female is prescribed furosemide 20mg by mouth once daily for symptomatic treatment of her heart failure. She was recently hospitalized for a CHF exacerbation and has since had monthly follow-up visits with her primary care physician (PCP). Since she does not notice any improvement in her symptoms and experiences some urinary frequency since starting the furosemide, she occasionally skips her dose. However, in the days before her clinic appointments, she takes her furosemide exactly as

• prescribed. When her PCP asks her is she is taking her medications

appropriately at the visit, she responds affirmatively. After a couple months, she is hospitalized again for a CHF exacerbation after a period of 10 days without furosemide.  Concerns:

 Perceived benefit of the treatment  Knowledge about the disease

 Treatment:

 Counseling patient about the importance of taking her medications as prescribed

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Scenario 5:

• Mr. T is an 80-year-old Chinese man, wheelchair bound

with diabetes mellitus, hypertension, chronic kidney disease, peptic ulcer disease, and anemia, presents to the clinic with recurrent admissions for poor diabetes control and hyperkalemia. He is on 17 different medications and tells you that he is having difficulty managing medications at home. What are your concerns for medication compliance for this patient? How would help Mr. T better comply with medication regimen?

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Scenario 5: Concerns & Interventions

• Mr. T is an 80-year-old Chinese man, wheelchair bound with diabetes mellitus, hypertension, chronic kidney

disease, peptic ulcer disease, and anemia, presents to the clinic with recurrent admissions for poor diabetes control and hyperkalemia. He is on 17 different medications and tells you that he is having difficulty managing medications at home.  Concerns:

 Complexity of medication regimen  Cost of medications  Limited language proficiency  Cognitive impairment  Duration of treatment

 Interventions

 Assess if he is able to understand his condition and, if he has the right belief and knowledge about his medications and health.  Include the pharmacist to:  consider doing a medication reconciliation service to assist in reduction of polypharmacy  Pack his medications in suitable storage containers for ease of consumption.  Provide a medication schedule so that other clinicians will not add on to his pill burden unnecessarily.  Refer to the medical social worker to understand his financial and social conditions  Use a translator to better understand his situation.  Assign a case manager to coordinate between multiple providers 17/07/2017 100

Scenario 6:

• Mr. Lockwood , a 102y old man was admitted to the hospital

with a diagnosis of hypotension and dizziness. He lives at home with his grandson, who, Mr. lockwood says is gone most of the

• time. You notice that Mr. Lockwood takes at least 10 different

medications.  What are your concerns for medication compliance for this patient?  How would help Mr. Lockwood better comply with medication regimen?

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Scenario 6: Concerns & Interventions Mr Lockwood , a102y old man was admitted to the hospital with a diagnosis of hypotension and dizziness. He lives at home with his grandson, who, Mr. lockwood says is gone most of the time. You notice that Mr. Lockwood takes at least 10 different medications.  Concerns:

 Cognitive impairment  Unstable living conditions  Complexity of medication regimen  Drug interactions

 Interventions:

 Involve family  Compliance aids  Review medications & discontinue unnecessary medications  Complexity of therapy (reduce frequency of daily doses)

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Conclusion

Patient engagement is an increasingly important component of patient safety initiatives in hospitals. Patients are becoming engaged with local health- care organizations, nationally and globally. Care providers at the Individual & institutional levels, should advocate for patient & family

• participation. [37]

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Conclusions

Improving adherence holds great potential to contribute to better health outcomes and more effective chronic care management. Efforts to improve adherence represent win-win solutions in which patients, HCPs, employers, and the public all benefit. “Increasing the effectiveness of adherence interventions may have a far greater impact on the health of the population than any improvement in specific medical treatments”[38]

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Tell me and I

FORGET

Teach me and I

REMEMBER

Involve me and I

LEARN

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References

1. http://www.patientsafetyinstitute.ca/en/Topic/Pages/Medication-Safety.aspx 2. Medication Safety Program, CDC, https://www.cdc.gov/medicationsafety/index.html 3. http://www.nccmerp.org/about-medication-errors 4. Canadian Patient Safety Institute, Medication Safety, http://www.patientsafetyinstitute.ca/en/Topic/Pages/Medication-Safety.aspx 5. https://www.nap.edu/read/9728/chapter/2#2 6. WHO, Patient Safety Workshop LEARNING FROM ERROR http://www.who.int/patientsafety/activities/technical/vincristine_learning- from-error.pdf 7. Kohn L, Corrigan J, Donaldson M, eds. To Err Is Human: Building a Safer Health System. Institute of Medicine. National Academies Press; 1999. ISBN: 9780309068376 8. http://www.who.int/mediacentre/news/releases/2017/medication-related-errors/en/ 9. Institute of Medicine (IOM), To Err is Human: Building a Safer Health System (IOM, 2001), p.3 10. CROSSING THE QUALITY CHASM: A NEW HEALTH SYSTEM FOR THE 21ST CENTURY, Institute of Medicine, 2001, http://www.nationalacademies.org/hmd/~/media/Files/Report%20Files/2001/Crossing-the-Quality- Chasm/Quality%20Chasm%202001%20%20report%20brief.pdf 11. http://www.cfah.org/pdfs/CFAH_Engagement_Behavior_Framework_current.pdf 12. http://healthaffairs.org/healthpolicybriefs/brief_pdfs/healthpolicybrief_86.pdf 13. https://www.kingsfund.org.uk/time-to-think-differently/trends/disease-and-disability/long-term-conditions-multi-morbidity 14. https://www.england.nhs.uk/ourwork/patient-participation/self-care/patient-activation/pa-faqs/#1 15. Greene J, Hibbard JH, Overton V, Sacks R. Highly Activated Patients Have Better Care Experiences han Patients With Less Activation When Seeing The Same Clinician. Health Affairs. July 2013. 16. http://www.oregon.gov/oha/Transformation-Center/ComplexCareMeetingDocs/Keynote-Hibbard-Patient-Activation-Health- Outcomes.pdf 17. http://personcentredcare.health.org.uk/sites/default/files/resources/patientactivation-1.pdf 18. http://www.towerhamletsccg.nhs.uk/Publications/PAM/Integrated%20Care%20PLT%20PAM%20Presentation.pptx 19. http://personcentredcare.health.org.uk/sites/default/files/resources/patientactivation-1.pdf 20. http://homelesshub.ca/resource/motivational-interviewing-open-questions-affirmation-reflective-listening-and-summary 21. http://www.who.int/chp/knowledge/publications/adherence_Section1.pdf

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References

• K. Kenny, Medication Adherence and Patient Engagement in Patients with Type 2 Diabetes, Pharmacy times, February 2016, http://www.pharmacytimes.com/news/medication-

• L. Osterberg and T. Blaschke. “Adherence to Medicine,” New England Journal of Medicine, August 2005.

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