STRATEGIES FOR OPTIMIZATION OF COMPLIANCE OF MEDICATION THERAPY IN PATIENTS

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STRATEGIES FOR OPTIMIZATION OF COMPLIANCE OF MEDICATION THERAPY IN PATIENTS Liza M. Castro Rosario, Pharm.D. Ileana Rodríguez Nazario, Pharm.D. Colegio de Farmacéuticos de Puerto Rico

DISCLOSURE In compliance with continuing education requirements, ACPE, our planners, our presenters, and their spouses/partners wish to disclose they have no financial interests or other relationships with the manufacturers of commercial products, suppliers of commercial services, or commercial supporters. Planners have reviewed content to ensure there is no bias. The presentation will not include any discussion of the unlabeled use of a product or a product under investigational use.

LEARNING OBJECTIVES Define the general terminology in regards of adherence and compliance. Identify and assess nonadherence in patients. Discuss available strategies to identifying causes of nonadherence. List different strategies to increase adherence in patients. Discuss how to apply strategies for the improvement of medication adherence in patients. Value the role of the Pharmacist and Pharmacy Technician in the improvement medication adherence in patients.

INTRODUCTION [3] Types of non-adherence Unintentional non-adherence occurs when the patient wants to follow the agreed treatment but is prevented from doing so by barriers that are beyond their control. Poor recall, difficulties in understanding instructions, inability to pay for the treatment, or simply forgetting to take it Intentional non-adherence occurs when the patient decides not to follow the treatment recommendations. This often takes the form of patients. Reducing the dosing frequency Number of medications down to a level that they (and not their doctor) believe is appropriate.

INTRODUCTION [4] Direct Costs According to Iuga, and McGuire, 2014: Medication non-adherence affects health outcomes and health care costs. Patient non-adherence to prescribe medications is associated with poor therapeutic outcomes, progression of disease. In US, $100 - $300 billion of avoidable health care costs Attributed to nonadherence annually 3% - 10% of total health care costs Majority of them result from avoidable hospitalizations Image obtained from: https://www.ncbi.nlm.nih.gov/pmc/articles/pmc3934668/#!po=6.00 000

Average adherence rate INTRODUCTION [1,2] 80% - patients take medications once daily 50% - patients take medications four times daily 75% - patients fail to medication adherence More than 50% of adults don t take their medications as directed. More than 20% of new prescriptions goes unfilled. Two out of five patients don t refill prescriptions for heart-related conditions. Medication-related hospitalizations 1/3 2/3 are the result of poor adherence

INTRODUCTION [4] Indirect Costs According to Iuga, and McGuire, 2014: Reduced productivity, absenteeism, increased disability. It has been estimated that indirect health care costs are 2.3 times higher than the direct health care costs. Image obtained from: https://www.ncbi.nlm.nih.gov/pmc/articles/pmc3934668/#!po=6.00000

LEVELS OF INFLUENCE [5] Referencia: Apter, A.J., Bender, B.G., Rand, C.S. Middleton s Allergy. 2014. Elsevier. Chapter 91 Adherence.

PERCENTAGE OF PATIENTS TAKING A COURSE OF ACTION ONCE A PRESCRIPTION IS WRITTEN [6] Action Percentage (%) Don t fill their prescription at all 12 Don t take medication at all after they fill the prescription Stop taking their medication before it runs out Take less of the medication than is prescribed on the label 12 29 22 Total non-adherence 75

DEFINE THE GENERAL TERMINOLOGY IN REGARDS OF ADHERENCE AND COMPLIANCE

TERMINOLOGY [5] Adherence Non-adherence Compliance Persistence To take prescribed agents at doses and times recommended by a health care provider and agreed to by the patient. The extent to which patients take medications as prescribed by their health care providers. Failing to fill the initial prescription (primary nonadherence). Underuse of therapy (secondary nonadherence), and premature discontinuation of therapy. Implies patient passivity in following the prescriber s recommendation s. The length of time from initiation to discontinuation of therapy. [Reference: http://www.nejm.org/doi/full/10.1056/nejmra050100]

ADHERENCE Right Amount Right time Right way Right duration

IDENTIFY AND ASSESS NONADHERENCE IN PATIENTS

IDENTIFYING NON-ADHERENCE Interview Pill counts Microelectronics Utilization Diaries Standardized Instruments Observation

IDENTIFYING NON-ADHERENCE A variety of medication utilization detection/measurement methods have been reported in the literature Strengths Weaknesses varying costs applicability/feasibility in medical practice

IDENTIFYING NON-ADHERENCE No gold standard exists but some methods are clearly superior to others. Choice of measure is important due to the ramifications of misclassification Misclassifications may result in: changes in medication therapy including adding medication therapies additional diagnostic testing unnecessary referral Meaning : more expenses, more time, less benefit to patients, providers and healthcare

DIRECT OBSERVED THERAPY A patient is observed consuming his/her medication(s). Where has this method been use? Clinical trial certain public health initiatives (e.g., tuberculosis, HIV, and methadone) on. DOT is considered impractical

DIRECT OBSERVED THERAPY Use is limited Therapy is typically dispensed at the site of utilization clinic, residence, place of employment, etc. Patients enrolled in DOT may attempt to fool the observer

BIOLOGICAL FLUIDS Blood or urine samples have been used to: Detect medication levels Metabolites of medications Markers/tracers Limitations to their use include: Cost Intrusiveness Impracticality

BIOLOGICAL FLUIDS These methods are sensitive to factors associated with: ADME Susceptibility to interactions Assays measure medication utilization over relatively short time intervals Fail to provide information about consistency in medication adherence over extended periods The use of serum or urine levels to detect medication utilization is highly susceptible

PATIENT SELF-REPORT Includes: Interviews Structured Instruments Diaries Easiest strategy to assess medication utilization behavior Most practical Most widely used in clinical practice Fast, inexpensive, simple

PATIENT SELF-REPORT Disadvantages Patients may not be able to recall their medication-taking behavior Patients may over estimate their medication utilization Social desirability bias Tools Morisky Scale Brief Medication Questionnaire (BMQ) ASK-12 (Adherence Starts with Knowledge) Medication diaries ( including electronic)

MORISKY SCALE [10] The Morisky scale is a validated scale designed to estimate the risk of medication nonadherence. It s used for many different diseases such as hypertension, hyperlipidemia, asthma, and HIV. Scores are based on patient responses to four questions Yes or No

MORISKY SCALE [10] Morisky Scale Questions 1. Do you ever forget to take your medicine? 2. Are you careless at times about taking your medicine? 3. When you feel better, do you sometimes stop taking your medicine? 4. Sometimes if you feel worse when you take the medicine, do you stop taking it?

MORISKY SCALE [10] Scoring the Morisky Scale Yes=0 and No=1 Patients scoring 0 or 1 would benefit most from pharmacist intervention The goal is the screening for patients in which your pharmacist time should be spent on enhancing adherence

QUESTION #1 The Morisky scale is used to identify: A. The likelihood that a patient is non adherent to medications B. The likelihood that a patient is non adherent to lifestyle modifications C. The percentage of doses a patient has missed D. The reasons why a patient is non adherent

PILL COUNT Represented the standard objective method for measuring medication utilization Straightforward Simple Feasible

MICROELECTRONIC MEDICATION MONITORING DEVICES Electronic monitoring devices that can measure medication utilization behavior. MEMS have integrated micro circuitry that records the time and date that the package is opened.

MICROELECTRONIC MEDICATION MONITORING DEVICES Types of information provided by device chronology of dose administration evidence of overuse (short-interval administration) evidence of underuse (medication holidays) Data can be downloaded from the device to a computer for subsequent analysis.

MICROELECTRONIC MEDICATION MONITORING DEVICES Advantages collects information about the utilization of medication as well as the timing of such utilization. Disadvantage Costly Does not assure that the dosages have been consumed.

QUESTIONS TO ASSESS A PATIENT S MEDICATION ADHERENCE [12] I know it must be difficult to take all your medications regularly. How often do you miss taking them? Of the medications prescribed to you, which ones are you taking? Of the medications you listed, which ones are you taking? Have you had to stop any of your medications for any reason? How often do you not take medication X? (address each medication individually) When was the last time you took medication X? (address each medication individually) Have you noticed any adverse effects from your medications?

MEDICATION ADHERENCE REPORT I forget to take these medicines sometimes I alter the dose of these medicines sometimes I stopped taking these medicines for a while I decided to miss out a dose I take less than instructed sometimes

QUESTION #2 Which of the following are strategies to identifying non-adherence? A. A patient diary B. Interview C. Pill counts D. All of the above

DISCUSS AVAILABLE STRATEGIES TO IDENTIFYING CAUSES OF NON- ADHERENCE

Reference: Iuga, A.O., McGuire, M.J. Adherence and health care costs. Risk Management and Healthcare Policy 2014:7, pp: 35-44.

Disease factor FACTORS AND BARRIERS TO ADHERENCE BEHAVIORS [11] Chronic vs acute condition Asymptomatic periods Prophylactic treatment Perception of physiologic compromise Patient factors Life distractions Stress, depression Comorbidities Limited literacy

FACTORS AND BARRIERS TO ADHERENCE BEHAVIORS [11] Treatment factors Cost Adverse effects Incomplete benefit (perception) Inconvenient treatment schedule Requirement of long-term behavior Provider factors Ability to: Communicate and educate Communicate across cultural and language differences Assess patient s literacy and knowledge Build trust

FACTORS AND BARRIERS TO ADHERENCE BEHAVIORS [11] Practice and System factors Cost and copayments Inconvenient office hours Waiting time Difficulties with pharmacy Poor communication Society related Lack of motivation Transportation difficulties Poverty Unemployment Discrimination

MEDICATION-RELATED PROBLEM: CAUSES OF NON- ADHERENCE Patient can not swallow Patient skips doses to save money Patient has no support system Patient resist being a diabetic Patients feels no symptoms Patient has an allergic reaction to a medicine and is afraid

QUESTION #3 Medications copayments, adverse effects lack of motivations, and level of patient literacy are examples of the factors and barriers to adherence behavior. A. Yes B. No

LIST DIFFERENT STRATEGIES TO INCREASE ADHERENCE IN PATIENTS

PHARMACISTS PATIENT CARE PROCESS (PPCP) IMPLEMENTATION [7]

COMMUNICATION

QUESTION Why is communication so important to identify lack of medication adherence?

The process of communication between the health professional and the patient has two main objectives: COMMUNICATION IN A HEALTH SETTING Exchange information both parties Establish a long-life relationship

PATIENT-CENTERED HEALTH CARE Understand the illness Develop auto conscience Duties of pharmacist to their patients Perceiving individual and unique experience Build therapeutic alliance Develop a relationship of equality

REASONS TO MOTIVATE THE PATIENT Unanswered questions. They have many doubts. Identify problems related to drugs. Perform an incorrect self-monitoring. Empower patient to make decisions in their own care. Patient may not reveal some information until a dialogue is initiated.

STRATEGIC COMMUNICATION CONTRIBUTES TO... Improve patient health. Good provider patient relationship. Increase exposure in the community and use of information related to health. Improve adherence to drug therapy patient. Improvement of services offered. Assuming an active role as a health professional drug expert.

MOTIVATIONAL INTERVIEWING

STRATEGIES DURING THE INTERVIEW inquire silence listen carefully Effective interview good approach

EMPATHY Verbalize understanding to patient Understand your feelings when providing care A trust relationship is established

EMPATHY AND EFFECTIVE COMMUNICATION It happens when we help the patient to: Trust the health professional. Understand and express their own feelings. Externalize their concerns. Develop the ability to solve their own problems. Explore possible solutions.

STRATEGIES FOR EFFECTIVE INTERVIEW PROCESS Talk less, listen more. Avoid or eliminate distractions. Establish and maintain eye contact. React to the ideas, not the Be alert to nonverbal messages. The tone. Provide feedback to the patient to clarify doubts. person

MOTIVATIONAL INTERVIEWING [8] Goal Combine the use of these specific strategies to guide the patient toward making the argument for why he needs to change his behavior. Definition Directive, client-centered counseling style for eliciting behavior change by helping clients to explore and resolve ambivalence.

MOTIVATIONAL INTERVIEWING PRINCIPLES [8] Express empathy Develop discrepancy Roll with the resistance Support self-efficacy Avoid argumentation

QUESTION Which is the purpose of the Motivational Interviewing?

MEDICATION THERAPY MANAGEMENT (MTM) SERVICES Recruitment Interview Follow-up

MTM PROCESS MTR CMR (Comprehensive Medication Review) TMR (Targeted Medication Review) Follow-up PMR Health professionals Intervention Referral Action Plan Patients

ADHERENCE PROGRAMS [6] Objectives Simplifying dosage regimes Patient education and communication Modifying patient behavior Establish a supportive and trusting relationship with patients

PAM PAM = Programa de Adherencia de Medicamentos Nearly 190 communities pharmacies included in Puerto Rico Insurance plans MMM Healthcare, Inc. PMC Medicare Choice, Inc.

PROVIDER STRATEGIES TO IMPROVE ADHERENCE [13] Atreja, et al (2005) grouped adherence-promoting interventions under the mnemonic SIMPLE S implify the regimen I mpart knowledge M odify patient beliefs and human behavior P rovide communication and trust L eave the bias E valuate adherence

PROVIDER STRATEGIES TO IMPROVE ADHERENCE [13] S implify the regimen Taking the medications at the same time Adjusting time or frequency Adjusting regimen with patient s daily activities Recommending use of pill reminders and alarms I mpart knowledge Clear instructions Include family, caregivers or friends Provide additional information like handout, brochure or website link Reinforce the verbal education and discussion in every visit

PROVIDER STRATEGIES TO IMPROVE ADHERENCE [13] M odify patient beliefs and human behavior Consider their needs and expectations Educate about risks of not taking their medication Perceive barriers (fears and concerns) Provide incentives like coupons, certificates, or rewards P rovide communication and trust Patients can understand before leaving the office Improve interviewing skills Be an active listener Bring emotional support

PROVIDER STRATEGIES TO IMPROVE ADHERENCE [13] L eave the bias Identify low health literacy Address ethnically and socially diversity Interventions based on cultural and linguistic differences Address cultural barriers E valuate adherence Self-reports Identify barriers and lack of receptivity Pill counting or measuring lab levels Review patient s medications containers

QUESTION #4 The following statements are objectives for an adherence program except: A. Establish a supportive and trusting relationship with patients B. Communicate and educate effectively to patients about their medications C. Not corroborate the proper use of patient medications D. Simplifying dosage regimens

QUESTION #5 Which of the following interventions is a successful adherence-enhancing strategy? A. Complicating regimen characteristics B. Imparting knowledge C. Leave the patient s belief intact D. Allow the bias

CASE 1 AR is a 56 year old male with a recent diagnosis of Thyroid disorder. His other medical conditions include DM-II, HTN, and HLP. Current medications are metformin 500 mg bid, glimepiride 4 mg bid, Ziac 10/6.25 mg qd, atorvastatin 20 mg qd, ASA 81 mg qd, and Synthroid 100 mcg qd. Patient comes to his follow up visit with Dr. Rodríguez, a community pharmacist. (Labs: FG = 110 mg/dl, TSH = 10.5 miu/l, TC = 180 mg/dl, Tg = 120 mg/dl, LDL = 80 mg/dl, HDL = 50 mg/dl, SCr = 0.85 mg/dl) How do you determine if AR is adherent to his medications? What strategies would you use in this case?

CASE 2 A female patient visits your pharmacy to bring a new prescription because she was in the emergency room overnight due to an anaphylactic reaction to a meal. When you process the prescription, you notice that the patient did not request her refills last month. You take advantage and tell the patient if she wants to request her refills. The patient says don t give me any refill because I have more than one bottle of each one at home. I ll call you later. What approach would you do to the patient? What strategies would you use?

CASE 3 You are at the pharmacy making follow-up calls to patients of the adherence program. You call John, a 70-year-old patient with the following medical conditions: HTN, HLP, and DM-II. The patient lives alone at home and you know that the patient does not know the names of medicines and can not read. How do you determine if John is adherent to his medications? What strategies would you use in this case?

ROLE OF PHARMACIST AND PHARMACY TECHNICIAN

ROLE OF PHARMACIST Be a health professional that motivates patients to be adherent with their medications. Bring pharmaceutical care as a facilitator in patients pharmacotherapy to achieve positive outcomes to improve patients quality of life. Establish a good communication bond with patients to be trusted and confident professional. Collaborate with other health professional to optimize patient s medications. ROLE OF PHARMACY TECHNICIAN Assist to the pharmacists during: Patients interviews Administrative tasks Establish a good communication bond with patients to be trusted and confident professional.

ROLE OF PHARMACISTS [14] Be the professional that motivates the patient to be adherent with their medications Unanswered questions Lots of doubts Problems related to medicines Incorrect auto-monitoring Assisting you in making health care decisions Hidden information

SUMMARY TIPS FOR PATIENTS ABOUT MEDICATION ADHERENCE Write it down Set a routine Organize medications Report side effects Build in reminders Use one pharmacy Store properly Stick with a schedule Follow up and share concerns

SUMMARY CASE

REFERENCES 1. Reference: e-pill Medication Reminders. Patient Compliance, Medication Adherence, Medication Non-Adherence, Statistics & References. (2017) Retrieve from http://www.epill.com/statistics.html on May, 2017. 2. Jean Nappi, PharmD, FCCP, BCPS, "Taking Medications the Right Way: What Women Need to Know," WomenHeart: The National Coalition for Women with Heart Disease. 2015. 3. National Institute for Health and Clinical Excellence. Medicines Adherence: Involving patients in decisions about prescribed medicines and supporting adherence. Clinical guideline 76. January 2009. 4. Iuga, A.O., McGuire, M.J. Adherence and health care costs. Risk Management and Healthcare Policy 2014:7, pp: 35-44. 5. Apter, A.J., Bender, B.G., Rand, C.S. Middleton s Allergy. 2014. Elsevier. Chapter 91 Adherence. 6. De Brincat, M. Medication adherence: patient education, communication and behaviour. Journal of the Malta College of Pharmacy Practice. Issue 18 Summer 2012. 7. Bennett, M.S., Kliethermes, M.A. How to Implement the Pharmacists Patient Care Process. 2015. American Pharmacists Association. 8. Berger, BA, Villaume, WA, Motivational Interviewing for Health Care Professionals. 2013. American Pharmacists Association. 9. Medication Therapy Management in Pharmacy Practice: Core Elements of an MTM Service Model. Mrch 2008. Retrieved from https://www.accp.com/docs/positions/misc/coreelements.pdf on May, 2017. 10. Morisky DE, Green LW, Levine DW. Concurrent and predic ve validity of a self-reported measure of medica on adherence. Medical Care 1986;24:67-74 11. Brown, M.T., Bussell, J.K. Medication Adherence: WHO Cares? Mayo Clin Proc. April 2011; 86(4): 304-314. 12. Osterberg L, Blaschke T. Adherence to medication. 2005;353(5):487-497. 13. Atreja A, Bellam N, Levy S. Strategies to enhance patient adherence: Making it simple. Medacapt Gen Med. 2005:7(1): 4. 14. Beardsley, R.S., Kimberlin, C.L., Tindall, W.N. Communication Skills in Pharmacy Practice. 5 th Edition. 2008. Lippincott Williams & Wilkins. 15. Berger, B.A. Communication Skills for Pharmacists: Building Relationships, Improving Patient Care. 2005. American Pharmacists Association. 16. Motivational Interviewing: Assessing and Assisting Patients for Meaningful Behavior Change. 2004. Pfizer, Inc 17. McCaffrey, David J., III.. "Chapter 8. Medication Utilization Patterns." Understanding Pharmacoepidemiology Eds. Yi Yang, and Donna West-Strum. New York, NY: McGraw-Hill, 2011, http://accesspharmacy.mhmedical.com/content.aspx?bookid=515&sectionid=41502858. 18. Clinical Resource, Medication Adherence Strategies. Pharmacist s Letter/Prescriber s Letter. March 2018..