The patient and medicine use: Safety and rational use

Discusses patient safety in the use of medicines as well as rational use of medicines.

1. The patient & medicine use PART ONE

2. Drugs Definition: Substances that produce a change in cellular or physiological functioning of humans. Manufacturers focus on a drug’s therapeutic effect with the goals of Optimizing biochemical activity Increasing specificity Limiting negative effects Prescription Drug – medication requiring a prescription by an authorized licensed healthcare provider.

3. Drugs (cont’d) Non-prescription – medication available to the general public without a prescription May have some restrictions Also known as OTC (over-the-counter) Approved use – medication or indication officially recognized by the FDA or other international regulatory agency, e.g., EMA, MHRA, Health Canada, for marketing Unapproved use – medication or indication without regulatory agency permission for marketing

4. Drugs (cont’d) Medicalization: redefining or relabeling of a personal or social problem as a medical condition, thus necessitating treatment in the health care system Conditions with physical pathologies that also have complex mental, emotional, and social processes: Anxiety/Depression ADD/ADHD Eating disorders Obesity

5. Prescribers’ Perspectives Drug therapy is a mainstay of prescribed treatments by physicians. Right or wrong, prescribing has a ritualistic component between physicians and patients. Enhances and solidifies the interaction as a symbolic component to healing. Provides a sense of satisfaction to the patient. Reduces uncertainty and frustration by reinforcing the physician’s power to cure. Fulfills an ingrained need (habit) to take action against illness.

6. Prescribers’ Perspectives (cont’d) Factors influencing prescribing behaviour: Education Training in pharmacotherapeutics Preceptors’ prescribing habits Colleagues or other health care providers Control and regulatory mechanisms Demands by consumers and society Promotional activities by drug manufacturers

7. Dispensers’ Perspectives As volume and regulatory pressures have mounted, pharmacists have had less time to perform patient-centered services other than dispensing. Dissatisfaction with this situation is partly responsible for the rapid changes seen in the profession. Pharmacy technicians Robotics Increased clinical activities Computerized monitoring of therapies Patient counseling

8. Consumers’ Perspectives on Health Consumer beliefs are often very different from the beliefs held by healthcare professionals. Perceptions of current or potential symptoms along with their social knowledge of health may suggest whether a health problem exists. Possible actions taken for a perceived health problem: Do nothing Take action Begin self-care Seek care from physician

9. Consumers’ Perspectives (cont’d) Pharmacies are the source of most drug products for consumers OTCs (2017): Pharmacy = 83% Grocery store/supermarket = 8% Gas station/internet < 1% Reasons often cited for choosing a particular pharmacy: Habit The counseling The range of products The confidence of the staff Accessibility Opening hours Quality of products (Source: Westerlund, Barzi & Bernsten, 2017 – Sweden)

10. Consumers’ Perspectives (cont’d) (Source: Westerlund , Barzi & Bernsten , 2017 – Sweden)

11. Consumers’ Perspectives (cont’d) (Source: Westerlund , Barzi & Bernsten , 2017 – Sweden)

12. Patients’ Expectations: Consumerism Access to information is improving for both patients and practitioners: Facilitates “self-care” Internet Health information websites Outcomes data Research Popular media (TV, magazines, etc.) May increase demand for goods and services Direct-to-consumer advertising Popular media and images

13. Consumerism: How far is too far?

14. Patient safety

15. TUTORIAL PRESENTATION

16. The patient & models of care

17. The Patient A “patient” used to be considered someone under the care of a physician, but now it is anyone under the care of any healthcare provider.

18. Patients and the Health Care Environment With improved public health measures, technology (including medicines), and longer life expectancies, health care needs have shifted towards managing chronic disease and disability. Despite efforts to emphasize prevention, the healthcare system is still primarily designed to care for the sick (i.e., a “sick care system”).

19. Models of Care (physician-patient relations)

20. Szasz and Hollender’s Three Models Activity-Passivity Patient is a passive recipient of care Little communication (e.g., emergencies) Likened to a parent-infant relationship Guidance-Cooperation Patient defers to medical expertise Communication and more independence/input Likened to parent-adolescent relationship Mutual Participation Patient and physician are interdependent Must communicate

21. Consumer Model

22. Patient-Centred Model

23. Biopsychosocial Model Health and illness is a product of a person’s: Behavioural and psychosocial data incorporated into the analysis of the biochemical understanding of illness

24. patient ADHERENCE

25. Adherence Compliance Patient following or “complying” with a health professional’s recommendations Adherence implies patient choice in making the decision to follow health professional’s recommendations

26. COMPLIANCE Initially, “the extent to which the patient follows medical instructions” BUT “Medical” felt to be insufficient to describe the range of interventions used to treat chronic diseases AND Term “instructions” implies that the patient is a passive, acquiescent recipient of expert advice AND The idea of non-compliance is associated too closely with blame

27. FROM COMPLIANCE TO ADHERENCE Compliance is uni -dimensional , focusing on patient-related factors Strong emphasis was placed on the need to differentiate adherence from compliance Main difference is that adherence requires the patient’s agreement to the recommendations

28. ADHERENCE DEFINED “The extent to which a person’s behaviour – taking medication, following a diet, and/or executing lifestyle changes – corresponds with agreed recommendations from a health care provider”. (WHO)

29. MEDICATION NON-ADHERENCE The failure or refusal of a patient to take the correct amount of the prescribed medicine at the proper time. Failure to alter diet + other lifestyle modifications essential for successful treatment Extends to the incorrect use of pharmaceutical delivery systems, such as inhalers.

30. CONCORDANCE “ Agreement between the patient and the health care professional, reached after negotiation , that respects the beliefs and wishes of the patient in determining whether, when and how their medicine is taken…and the primacy of the patient’s decision (is recognised).” (RPSGB, 1997)

31. CONCORDANCE (cont’d) Working group of the Royal Pharmaceutical Society of Great Britain (1995-1997) explored reasons for non-compliance. Findings published in an influential report entitled “From compliance to concordance”. International Journal of Pharmacy Practice (IJPP) volume 9, issue 2, June 2001 devoted to this theme. https://academic.oup.com/ijpp/article/9/2/65/6138999 Fosters joint decision making between professionals and patients Allows patients to reject what may be considered to be best clinical practice even when fully informed as to the nature and consequences of this decision Patient empowerment

32. Concordance is not a synonym for compliance or adherence Concordance is a process while adherence is a behaviour or outcome Concordance may or may not lead to adherence Challenges us to find out the real concerns patients have about taking medicines and working with patients to discover imaginative solutions on how they can make best use of their medicines CONCORDANCE (cont’d)

33. DIMENSIONS OF NON-ADHERENCE

34. Multiple classification systems Paladino (1993) – 7 non-complier categories Becker (1995) Perri (1998) - 3 dimensions University of Missouri – 3 non-complier categories NONCOMPLIANCE: TYPES & DIMENSIONS

35. Paladino (1993) The consistent underdoser - routinely misses, or skips doses The overdoser - consistently takes medicine more often, or in higher dosage than prescribed The individual who abruptly takes a “drug holiday”, often resulting in withdrawal and rebound adverse effects. “ Perivisit ” compliant patients - take their medication just before a scheduled medical visit NONCOMPLIANCE: TYPES & DIMENSIONS

36. Paladino (1993) (cont’d) Random compliers - take medicine whenever they remember Patients whose compliance with a treatment regimen falls in proportion to the time since the last medical visit Those who comply with treatment only as long as they have symptoms as a reminder NONCOMPLIANCE: TYPES & DIMENSIONS

37. “RATIONAL NONCOMPLIANCE” Defined as the refusal to take medication with unpleasant side effects as the apparent long-term rewards are outweighed by the obvious short-term costs. (Becker, 1995) NONCOMPLIANCE: TYPES & DIMENSIONS

38. Perri (1998) refers to “dimensions” of noncompliance that include: initial noncompliance or defaulting refill compliance or persistence (Product Persistence Curves) improper medication use NONCOMPLIANCE: TYPES & DIMENSIONS

39. Data depicted in Figure 1 Persistence Curve

40. Perri (1998) (cont’d) IMPROPER MEDICATION USE Over or under use of medication, including the wrong time Taking the wrong medicine Not completing the course of therapy Administration errors Using another person’s medication Using old, possibly expired medication NONCOMPLIANCE: TYPES & DIMENSIONS

41. UNIVERSITY OF MISSOURI The Unwitting Nonadherer - misunderstands the prescribed regimen or does not receive adequate information about the regimen The Unwilling Nonadherer - is unable to adhere to the treatment process because of economic, physical, environmental or personal barriers The Intelligent Nonadherer - makes an intentional choice to alter his or her therapy NONCOMPLIANCE: TYPES & DIMENSIONS

42. MEDICATION NON-ADHERENCE No matter the type or dimension that non-adherence may take there is no non-adherer who is in a better position than another Non-adherers usually end up not only hurting themselves but their families and become a burden on a nation’s health care delivery system

43. NON-ADHERENCE PREVALENCE CONTRIBUTING FACTORS CONSEQUENCES/ COSTS

44. NON-ADHERENCE: PREVALENCE Determination of accurate prevalence rates for noncompliance is limited by: available measurement methods difficulty in distinguishing between patients not responding to treatment and patients not complying with treatment Inconsistent predictors - cuts across drugs, diseases, prognosis, and symptoms

45. Current measurement methods patient self reports clinical outcomes pill counts refill records biological and chemical markers microelectronic medication event monitors ALL HAVE LIMITATIONS Most unreliable method is patient self reports Pill counts, although subjective, found to be just as reliable as medication event monitoring (MEM) NON-ADHERENCE: PREVALENCE (cont’d)

46. NON-ADHERENCE PREVALENCE (cont’d) COMPLIANCE RATES BY DISEASE TYPE Disease Epilepsy Arthritis Hypertension Diabetes Oral contraceptives HRT Asthma Rates of noncompliance 30% to 50% 50% to 71% 40% (average) 40% to 50% 8% 57% 20% ( Perri , 1998)

47. > 2/3 of patients admitted to the medical wards at the Kingston Public Hospital in Jamaica were found to be due to non-adherence (Kerr & Reid, 2000) 44% of hypertensive patients & 30% of diabetics non-adherent at the time of their visit to HOPE Worldwide, Jamaica ( Swaby et al., 2000); (perceived to be due to poor socioeconomic conditions, lack of education, and cultural beliefs) PREVALENCE RESEARCH: JAMAICA

48. Specialist Hypertension Clinic at the University Hospital of the West Indies in Jamaica – on average only four days of medications missed per month, that is, an average noncompliance of 13% (Simpson et al., 2000) Drug Serv Pharmacy Adherence Study (Kerr et al., 2007) – 99 hypertensive patients; 20% were non-adherent PREVALENCE RESEARCH: JAMAICA

49. PREVALENCE RESEARCH: JAMAICA Medication Adherence and Health Insurance/Health Benefit in Adult Diabetics in Kingston, Jamaica, West Indian Med J 2016; 65 (2): 320. ( Bridgelal-Nagassar et al., 2016). Found overall prevalence of medication non-adherence among 260 diabetic patients was 33% Predictive Relationship between Treatment Adherence Glycated Hemoglobin and Diabetic Complications Among Jamaicans, Dissertation, Walden University, ( Nwaukwa , 2018). Of 119 diabetic patients, 66% had low adherence.

50. NON-ADHERENCE: PREVALENCE The overwhelming consensus about the prevalence rate HIGH USUALLY UNDERSTATED ONGOING RESEARCH NEEDED

51. NONCOMPLIANCE PREVALENCE CONTRIBUTING FACTORS CONSEQUENCES/ COSTS

52. NATURE OF ADHERENCE The common belief that patients are solely responsible for taking their treatment is misleading. There are other factors that affect people’s behaviour and capacity to adhere to their treatment. Adherence is a multidimensional phenomenon determined by the interplay of multiple sets of factors

53. CONTRIBUTING FACTORS No non-adherent personality type identified Age, gender, race, income, educational level, patient intelligence, actual seriousness of the disease, the actual efficacy of the treatment are not predictors of non-adherence Patient perception is what seems to be material in adherence Traditionally thought to be due to side-effects of medications but goes beyond side-effects Patients may have more than one reason for their non-adherence Relatively few specific and consistent predictors of patient non-adherence identified

54. (WHO, 2003)

55. Predictors fall into the following categories disease related factors medication related factors patient-related factors patient-provider interaction ( Berkow et al., 1992; Curtin et al., 1999; DiMatteo & DiNicola , 1982; Kerr & Reid, 2000; Lash & Harding, 1995; Perri , 1998; Stafford, 2002; Tierney, et al., 1999; University of Missouri, n.d ). CONTRIBUTING FACTORS

56. STUDENT ACTIVITY Read The Patient & Medicine Use Pt 1, slides 58 – 64 and Influence of Jamaican Cultural and Religious Beliefs (Brown et al., 2022) article then answer the following question: What role does culture play in medicine use in Jamaica ?

57. Culture Shared system of values, beliefs, and learned patterns of behaviour Specifies acceptable and nonacceptable behaviours Offers individuals guidance on dealing with aspects of life Dynamic Influenced by an individual’s: Proximity to culture of origin Education Gender Age Sexual preference

58. Culture and Health Care Culture and cultural values are related to beliefs about health and illness. Culture is learned and shared by group members. What you believe, your values, and much of your behaviour are culturally determined. Subcultures Groups that share many of the elements of mainstream culture, but maintain their own distinctive customs, values, norms, and lifestyles. Disease and illness occur within a cultural context.

59. Aspects of Culture That Impact Health Care Language Beliefs about health and illness Time orientation Beliefs about aging Family practices Death practices Childbirth practices Pain response Child-rearing practices Grief response Food habits Touch and privacy Sexuality

60. Impact of Culture on Health Health beliefs regarding illness Causative factors of illness Personal views regarding specific illnesses Health practices Prayer Rituals Folk remedies Herbs Alternative health practitioners

61. Impact of Culture on Health (cont’d) Communication Patterns Verbal Use of slang Use of interpreter Nonverbal Eye contact Personal space Facial expressions Preferred Decision-Making Involvement of the family Group versus individual emphasis

62. Culture and Health Care Ethnocentric Evaluating others ' customs according to values of his or her own cultural group; this can lead to misperceptions and conflict. Cultural competence The ability of health organizations and practitioners to recognize the cultural beliefs, values, attitudes, traditions, language preferences, and health practices of specific cultural groups and to apply that knowledge to produce positive health outcomes continued on next slide

63. Culture and Health Care Why Is Cultural Competence Important? Health care services that are respectful of and responsive to the health beliefs, practices, and cultural needs of diverse patients can help bring about positive health outcomes. Culture may influence: Health, healing, and wellness belief systems How illness, disease, and their causes are perceived, both by the patient/consumer and the health care provider The behaviours of patients/consumers who are seeking health care and their attitudes toward health care providers

64. NON-ADHERENCE PREVALENCE CONTRIBUTING FACTORS CONSEQUENCES/ COSTS

65. Consequences/Costs of Non-Adherence WORSENING CONDITION INCREASED COMORBID DISEASES INCREASED HEALTH CARE COSTS DEATH

66. interventions

67. INTERVENTION Evidence shows that: single interventions , such as simply supplying information leaflets or giving routine instructions when a medicine is dispensed, appear to be of little value strategies which combine educational inputs with practical advice and emotional and peer group support are moderately effective successful strategies to change health-related behaviours must focus on enabling people to act on information which is already available to them thus patient confidence building and empowerment to manage their own care is essential holistic, patient-centred approaches like concordance are required to address poor adherence

68. INTERVENTION ISSUES Adherence is the most important modifiable factor that compromises treatment outcome Problem has been the tendency to focus on unidimensional factors (patient related) All five dimensions of adherence should be considered in a systematic exploration of the factors affecting adherence and the interventions aimed at improving it Multi-level approach – targeting more than one factor with more than one intervention is most effective

69. INTERVENTIONS Roter et al. (1998) from a meta-analysis of 153 studies published between 1988 and 1994 evaluating a range of interventions suggested that ideal interventions should address patient: Satisfaction Empowerment Understanding of illness Quality of life Functional status Psychological well-being

70. MTM ROLE OF THE PHARMACIST IN IMPROVING MEDICATION ADHERENCE DETECTION & ASSESSMENT EDUCATOR COUNSELOR RESEARCHER FACILITATOR PARTNER CLINICIAN

71. INTERVENTION STRATEGIES DIRECT METHODS OF DETECTION PILL COUNTS ELECTRONIC PILLBOXES COMPARING DATES ON PRESCRIPTION LABELS WITH THE NUMBER OF PILLS REMAINING MONITORING SERUM, URINE OR SALIVA LEVELS OF DRUGS OR METABOLITES ASSESSING PREDICTABLE DRUG SIDE EFFECTS SUCH AS BRADYCARDIA FROM BETA-BLOCKERS

72. INTERVENTION STRATEGIES INDIRECT METHODS OF DETECTION MONITOR APPOINTMENT KEEPING EVALUATING THERAPEUTIC RESPONSES EXAMINING PHARMACY RECORDS BEST METHODS: ACCURATE OBJECTIVE UNOBTRUSIVE

73. INTERVENTION STRATEGIES DETECTION & ASSESSMENT OF MEDICATION NON-ADHERENCE “RIM” TECHNIQUE ( Perri , 1998) – recognize, identify & manage Use both objective & subjective evidence to recognize the existence of an adherence problem Supportive probing questions, empathic responses and other universal statements can be used to further identify the causes of non-adherence Pharmacist must develop partnership with patient to be able to manage the non-adherent patient once identified

74. Motivational Interviewing Developed by Miller and Rollnick (2002) Encourages a partnership between patient and health professional Used to facilitate patient behaviour change Explores patient’s ambivalence to change Principles: Expressing empathy Developing discrepancy Rolling with resistance Avoiding argumentation Supporting self-efficacy

75. Motivational Interviewing (cont’d) Selected factors found from the health behaviour models that encourage behaviour change and can be used in the MI process: Want to change Face few barriers in performing the behaviour change Believe they have the skills necessary to change Believe in positive outcomes as a result of the change Believe important “others” support the change

76. INTERVENTION STRATEGIES Mandatory counseling of patients on hospital wards, family members, other members of the health care team Motivate the patient to be involved in managing his health needs Keep patients current on the status of their health problem Praise patients for improvements (no matter how small) Having patients repeat back instructions for care in their own words Listen for confusion or misconceptions

77. STUDENT ACTIVITY Watch the “Ask Me 3” video

78. INTERVENTION STRATEGIES Determine if patients understand and agree with the physician’s assessment of their health status Give written information to take home regarding their treatment plan and instructions on taking their medications Multimedia educational campaigns, particularly those that graphically illustrate the negative consequences of noncompliance Design special labels

79. INTERVENTION STRATEGIES Teach patients methods for self monitoring Develop devices, memory cueing techniques and special packaging that can act as reminders Implement a formal follow-up system with patients

80. CLINICAL INTERVENTIONS Recommend adjustments to patient’s drug regimen affordability Simplification Memory-enhancing routines or memory cueing strategies as proxies for regimen simplification if already prescribed a single unit dose, one time per day Tailor treatment to the circumstances of the individual patient Reinforce a well-established doctor-pharmacist-patient relationship Involve patients in self-care activities

81. RESEARCH INTERVENTIONS Pharmacists in an ideal position to collect data on environment, process, and outcomes of care Use data to intervene effectively in patients’ therapies

82. PHARMACIST INTERVENTION BENEFITS Enhanced quality of life for patients Improved profit potential for the pharmacy Improved economic, clinical and humanistic outcomes

83. PHARMACIST INTERVENTION (cont’d) Canadian example of savings Pharmacist interventions - $79.6 to $103.1 million Identification of noncompliance - $19.8 million Pharmacist counseling - $168.8 to $256.6 million Estimated savings to the health care system - $268.2 to $388.5 million, amounting to $44,000 to $64,000 per pharmacy.

84. PHARMACIST INTERVENTION (cont’d) Have challenges to overcome: No reimbursement for these services Incomplete product-linked view of pharmacy services Technological deficiencies Training needs A lack of commitment to the pharmaceutical care concept

85. PHARMACIST INTERVENTION (cont’d) Resistance to development of needed partnerships Limited time and finances to integrate, coordinate and manage drug use Need for experienced personnel Infrastructural changes LOCAL LEVEL - Costs may seem to outweigh benefits NATIONAL LEVEL- Benefits outweigh costs

86. THE WAY FORWARD Further research to provide evidence of benefits of pharmacist intervention Pharmacists and their representative organizations to publicize worth of pharmacist-directed professional activities, roles, and responsibilities National rather than a local impetus Lobby government using cost savings empirical evidence Introduction of a formal monitoring system within hospitals for non-adherence reporting Access computer programmes that will evaluate interventions in terms of outcomes

87. THE WAY FORWARD Broaden the availability of clinical skills training and extend pharmaceutical care Increase understanding of the concept of pharmaceutical care Design suitable models of pharmaceutical care The changing role of the pharmacist to become an accepted fact Use public health information to help set local goals for pharmaceutical care Generate information about medication usage to inform public health policy

88. CONCLUSION HEALTH ECONOMIC IMPACT OF NON-ADHERENCE PHARMACIST INTERVENTION IMPROVED NATIONAL HEALTH STATUS

89. Required Reading Chapter 33, Managing Access to Medicines & Health Technologies “Encouraging appropriate medicine use by consumers” (General Recommended Texts folder) Adherence Report WHO – Chapter V (Resource Folder)

90. Study Questions How do the following factors contribute to appropriate medicine use? Provider-patient communication Inadequate counseling Lack of resources for medicines Complexity and duration of treatment Availability of information What strategies can be used by health care facilities to monitor adherence? What are the determinants of adherence and how can these be addressed to improve adherence? What factors are important to consider when developing public campaigns to educate consumers on appropriate medicine use?