The focus of this presentation will be medical non-adherence as a psychosocial issue in diabetes. The presentation will also focus elaborately on empowerment as an intervention amongst other interventions.

1. Evaluation of and Interventions for
Non Adherence to Oral Medications as a
Psychosocial Issue in
Type Two Diabetes Mellitus
DR. NIYOTI KHILARE

2. • The focus of this presentation will be medical non-adherence as a psychosocial
issue in diabetes.
• The presentation will also focus elaborately on empowerment as an intervention
amongst other interventions.

3. • Aim
To demonstrate a critical understanding of medical non-adherence in type two diabetes mellitus and
explore interventions for the same, so as to suggest recommendations for better clinical practice.
• Objectives
1. Discuss the concepts adherence and compliance, and the factors influencing non-adherence in
diabetes.
2. Explore and analyse concordance as a concept and empowerment as a strategic intervention to
improve patient outcomes in diabetes.
3. Explore and critically evaluate the other interventions for non-adherence.

4. BACKGROUND
• Prevalence of type 2 diabetes mellitus is at epidemic proportions -
According to the International Diabetes Federation (IDF), in 2017, 415 million adults have
diabetes (1 in 11 people).
However, by the year 2040, this number is expected to rise to 642 million i.e. One in Ten
people will be a victim to diabetes.
• Also, type 2 diabetes mellitus and its complications represent one of the largest budgets in
the healthcare system (Polonsky and Henry, 2016; IDF, 2017).

5. • Inadequate glycaemic control is seen in about 50% of patients (Ali et al., 2012; Polonsky
and Henry, 2016).
• A study by Wong et al. (2013) deduced that targets for adequate HbA1c control (HbA1c <7)
were achieved by only 55.5% patients with type 2 diabetes.
• Poor medication adherence is documented as a major contributing factor amongst 45%
patients with type 2 diabetes mellitus who failed to achieve adequate glycaemic control
(Polonsky and Henry, 2016).
• A strong correlation is seen between medical adherence, patient outcomes and treatment
costs (Rike et al., 2016).

6. SCOPE OF THE PROBLEM
• World wide adherence rate for medication in diabetes seems to range widely between 39%-
93% (Polonsky and Henry, 2016; Rike et al., 2016).
• Several studies have recognized medical non-adherence as a considerable problem in the
management of type 2 diabetes.
o A study on 2,38,000 patients with type two diabetes reviewed adherence rates between 36-47%
for a range of anti-diabetes drugs thus showing that the rate of non-adherence was >50% with
47% patients discontinuing in the first year (Farr et al., 2014).
o A recent meta-analysis of 27 studies of patients taking oral antidiabetics found that medical
adherence levels were suboptimal (Krass, Schieback and Dhippayom, 2015).

7. o Another meta-analysis inferred that discontinuation rates ranged between 10-61% over a year’s
follow up (Iglay et al., 2015).
o Whereas a retrospective analysis reported an overall discontinuation rate of 52.2% over 12
months (Curkendall et al., 2013).
o Primary non-adherence (failure to fill a first prescription) was seen in 31.4% patients in a study
that tracked >75,000 patients (Fischer et al., 2010).

8. • The main consequence of poor adherence is decreased glycaemic control and
increased hospitalization (García-Pérez et al., 2013).
o Ho et al. (2006) noted significant correlation (P<0.001) between non-adherence and mortality.
o A study of 15,984 patients in the UK identified medical non-compliance as an independent
risk factor for mortality in type two diabetes.
o The authors noted that even after controlling other factors like smoking etc, non-compliance
was found to be a major cause for mortality in patients with type two diabetes (Currie et al.,
2012).

9. • An inverse correlation between hospitalization costs & total health care and medical non-
adherence (García-Pérez et al., 2013; Polonsky and Henry, 2016).
• Jha et al. (2012) inferred that improved adherence to diabetes drugs could save $5 billion annually.
• Annual all cause health care costs were increased by $336 for non-adherent metformin users and
by $1509 for non-adherent sulfonyurea users as compared to adherent users in a retrospective
cohort study of >1,00,000 patients with type 2 diabetes, over a two year period (Hansen et al.,
2010).

10. CONCEPT
• The term compliance came to be described in 1950s and is the extent to which the patient
follows the health professional’s advice and takes treatment (Fraser, 2010; Poupoulas,
2015).
• Compliance literally means the act of following orders (Lloyd et al., 2006).
• This definition seems to imply an uninvolved patient within a paternalistic setting (Fraser,
2010; Poupoulas, 2015).
• Thus it was replaced by the term adherence which is defined as the extent to which a person’s
behavior – i.e. taking medications – corresponds with agreed recommendations from a
health care provider (Poupoulas, 2015; Blackburn, Swidrovich and Lemstra, 2013).

11. • Adherence is regarded as the proportion of patients taking at least 80% of prescribed
medications.
It is measured by either biological markers (serum drug levels) or by self –reporting,
questionnaires, pill counts, electronic pharmacy data (García-Pérez et al., 2013).
• Non persistence (stop taking medications altogether) and poor execution (failing to
take recommended quantity on a regular basis) are patterns of non-adherence
(Blackburn, Swidrovich and Lemstra, 2013).

12. FACTORS INFLUENCING NON-ADHERENCE
• Non-adherence is a result of external influences rather than baseline preferences
(Blackburn, Swidrovich and Lemstra, 2013).
The American College of
Preventive Medicine, 2011

13. • Social and Economic Factors: Low health literacy, lack of social support network, limited access to
health care facilities
• Health-care System Dimension: Provider-patient relationship, Lack of continuity of care
• Condition-related Dimension: Lack of symptoms, Depression
• Therapy-related Dimension: Complexity of dosage, Unpleasant side effects, Treatment interferes
with lifestyle
• Patient-related Dimension:
a) Physical factors: Visual impairment, Cognitive impairment, Swallowing problems
b) Psychosocial/Behavioral factors: Knowledge about the disease, Attitude towards treatment, Lack
of understanding the reason behind treatment, Perceived benefit of treatment, Motivation, Frustration
with health-care provider, Psychosocial stress.
(The American College of Preventive Medicine, 2011)
(Kindly refer to the chart on page 2 of the handout, for further details)

14. INTERVENTIONS
• World Health Organisation (2003):
Increasing the effectiveness of adherence interventions may have a far greater
impact on the health of the population than any improvement in specific medical
treatment.
• Interventions can be classified as:
1. Educational
2. Behavioural
3. Affective
(Schechter and Walker, 2002)

15. EMPOWERMENT & CONCORDANCE
• Compliance was used with the traditional model where the blame for poor control was placed on
the patient.
The terms “compliance” and “adherence” do not allow the patient a valid role in the decision
making process.
(Lloyd et al., 2006)
• However, diabetes is a disease with a fundamental physical basis deeply intertwined with
complex psychosocial issues – which directly, or indirectly, influence a patient’s medicine-
taking behavior (Snoek and Skinner, 2006).

16. • The empowerment approach recognizes that patients are in control of and responsible
for their daily self-management of diabetes and that, to succeed, a management plan had
to fit patient goals, priorities and lifestyle along with diabetes (Funnell and Anderson,
2004).
• The principle is to enable the patients to be the primary decision makers in managing their
health condition (Gadsby, 2014).
• Based on three fundamental aspects:
1. Choices
2. Control
3. Consequences
(Funnell and Anderson, 2004).

17. • Empowerment is a vision that guides each encounter with our patients and required both
professionals and patients to adopt new roles (Funnell and Anderson, 2004).
• The role of health professionals is to help patients make informed decisions to achieve their
goals and overcome barriers through education, appropriate care recommendations, expert
advice, and support.
Professionals need to give up feeling responsible “for” their patients and be responsible “to”
them.
• The role of the patient is to be involved and stay well-informed active partners or
collaborators in their own care.
• To effectively implement this approach, patients need education designed to promote
informed decision-making and providers need to practice in ways that support patient
efforts to become effective self-managers
(Funnell and Anderson, 2004).

18. • Diabetes self-management education (DSME) is the essential first step in patient
empowerment.
• Patients need to be able to care for themselves safely and effectively and to understand
the consequences of their decisions. Without DSME, patients cannot make or implement
informed self-management decision (Snoek and Skinner, 2006).
• Empowerment-based DSME can be provided in both individual and group sessions.
Strategies for implementing this approach include assessing needs, discussing roles and
responsibilities, incorporating the totality of diabetes care into the discussion and providing an
entire education programme.
Using the patient’s experiences and problems as a curriculum for the education
programme is another effective strategy (Snoek and Skinner, 2006).

19. • NICE (2016) highlight patient education as an important element in diabetes management. Well-
implemented structured education to people with T2DM is an integral part of diabetes care
(NICE, 2016).
• An example of this is Diabetes Education for Ongoing and Newly Diagnosed (DESMOND).
Studies have shown that DESMOND intervention improves diabetes related parameters and
encourages patients to set personal goals, thus empowering them to take better control of their
health. It helps patients to see their illness in a biomedical model, as well as the personal
functional and social model that most use as their initial conceptual framework for
understanding the impact of the illness. It enables patients to monitor their type 2 diabetes
effectively, to realise when their control is inadequate and to self-manage their lifestyle,
nutrition and medication in order to bring about improvement in diabetic control, or to know when
to seek professional help. Thus, it enables them to be an active partner in the management of their
type 2 diabetes, along with healthcare professionals (Tidy, 2016).

20. • Diabetes education has been shown to be effective for improving metabolic and psychosocial
outcomes and is an essential first step for self-management and empowerment.
• However, a one-time educational program is rarely effective to sustain the types of behavioral
change needed for a lifetime of diabetes self-care.
• Patients need ongoing support from their providers and the entire diabetes health care team
to maintain gains achieved through education (Funnell and Anderson, 2004).
• On-going diabetes self-management support (DSMS) helps in continuing to address the
educational, psychosocial and behavioral needs of the patient.

21. • Goal-setting is an effective strategy to provide DSMS.
• This includes defining a self-selected goal and the specific behavioural action the patient will take
towards the achievement of that goal.
• After patients carry out a self-management step, they are helped to determine what was learned
and to identify and take the next step.
• Patients are encouraged to think of these steps as self-management experiments rather than
successes or failures.
• The role of the professional is to actively listen and help the patient achieve clarity about
diabetes self-care problems, collaborate and provide information, and offer support and other
resources.
(Funnell and Anderson, 2004; Snoek and Skinner, 2006).
• Making educational programs an established element of diabetes care and vigorous participation
on the behalf of health care practitioners to ensure that maximum people with diabetes are
empowered is essential (Wallymahmed, 2015).

22. • As a health care provider, we need to implement certain strategies into practice, apart from
education, in order to promote patient empowerment.
• We can also show that we care about our patients as individuals first and about their diabetes
second.
• Rather than beginning the visit with a review of the patients' blood glucose record and laboratory
results, we can ask how they are feeling (psychologically as well as physically) and how they
believe they are doing in reaching their self-selected goals and caring for their diabetes.
This not only acknowledges their expertise, but also conveys that they are viewed as more than
just a blood glucose number (Funnell and Anderson, 2004).

23. The EMPOWERMENT model The TRADITIONAL model
Recognising Diabetes Bio-psychosocial illness. Physical illness
Patient-Provider
Relationship
Democratic;
Based on shared expertise.
Authoritarian;
Based on provider expertise.
Problems and Learning
needs
Usually identified by patient. Usually identified by the
professional.
View Patient is viewed as the problem
solver i.e. professional acts as a
resource and helps the patient set
goals and develop a self-
management plan.
Professional is viewed as the
problem-solver i.e. responsible
for the outcome.
Goal To enable patients to make
informed choices.
Behaviour changes that are not
adopted are used as learning tools
to provide new information that
can be used to develop future
plans and goals.
Behaviour change.
Behaviour strategies are used to
increase compliance with
recommended treatment.
Lack of compliance is viewed as
failure of the patient.
Behaviour changes Internally motivated. Externally motivated.
Power Patient and professional are both
powerful.
Patient is powerless;
Professional is powerful.

24. • Agreement between doctor and patients as to how to move forward, instead of a mere giving and
receiving of instructions, is perhaps the most positive approach.
• “Concordance”, describes a more equal relationship between physician and patient and builds on
the idea of a shared responsibility. The emphasis is more on setting out the goals of therapy and
not arbitrarily enforcing a treatment regime (Fraser, 2010).
• Concordance is not synonymous with compliance or adherence. It is synonymous with patient-
centred care. It does not refer to a patient's medicine-taking behaviour, but rather the nature of the
interaction between clinician and patient. The aim of concordance is the establishment of a
therapeutic alliance between the clinician and patient (Bell et al 2007).
• Concordance is defined as “agreement between the patient and healthcare professional, reached
after negotiation that respects the beliefs and wishes of the patient in determining whether, when
and how their medicine is taken, and (in which) the privacy of the patient’s decision (is recognised)”
(Poupoulas, 2015).

25. THE FOUR ELEMENTS OF CONCORDANCE
Patients have enough
knowledge to participate as
partners.
Prescribing consultations
involve patients as partners.
Patients are supported in
taking medicines.
ACCESS: Patients have access
to information about
diabetes, the treatment
options and their risks and
benefits.
Patients and health
professionals reach a joint
understanding of the
decision.
Medicines are reviewed
regularly, and opportunities
are used to discuss
medication.
EDUCATION: Empowers
patients to manage their own
health.
Professionals explain the
agreed treatment fully;
patients can be as involved as
they want in the treatment
decision.
Practical difficulties in taking
medicines are addressed.
CONFIDENCE: To ask
questions and engage in a
discussion about medicines.
Patient’s ability to follow
treatment is checked.
Information is effectively
shared within the care team
professionals, and with the
patient.
CONCORDANCE
A process of prescribing and taking medicine based on partnership.
Health professionals are prepared for partnership
Health professionals are equipped with the necessary skills to engage patients.
Health professionals regard it as important to invest time in reaching an informed
agreement.
Adapted from: Lloyd, C., Baker, N., Bryan,
J., Cox, J., Walker, R., Hill, J., Page, R.,
Cradock, S., Skinner, C. and Smith, J.
(2006). Living with diabetes. 2nd ed.
Milton Keynes: Open University, p.210.

26. OTHER INTERVENTIONS
• Patient-related reasons for non-adherence may include forgetfulness, the decision to
omit doses, lack of information and emotional factors (Bell et al., 2007)
• Behavioral approaches have their roots in cognitive-behavioral psychology and use
techniques such as reminders, memory aids, synchronizing therapeutic activities
with routine life events (e.g., taking pills before you shower) etc.
Reminders may be mailed, e-mailed, or telephoned.
The behavior in question must be negotiated with and accepted by individual patients so
that adoption of the behavior has a chance of succeeding in the long term (Schechter and
Walker, 2002).

27. • Clinician-related reasons may include
a) prescription of complex regimens,
b) failing to explain the benefits and side-effects of treatment,
c) not giving consideration to a patient's lifestyle or the cost of medicines,
d) and having a poor therapeutic relationship with the patient.
(Bell et al., 2007)

28. A. COMPLEXITY OF DOSING REGIMENS
• Fear of inconvenience of daily ingestion of too many drugs has been observed to
constitute hindrance to medication adherence among patients with chronic diseases in
general and diabetes patients in particular (García-Pérez et al., 2013).
• Modifications might involve decreasing the number of therapies and frequency of therapy.
• Minimising the number of daily doses has been found to be important in improving adherence
to the anti-diabetic treatment (Sharma et al., 2014).

29. B. SAFETY AND TOLERABILITY.
• Nonadherence could also be due to adverse events associated with medications.
• A cross-sectional study of patients with T2D treated with metformin and sulfonylureas found
that patients reporting moderate or worse symptoms of hypoglycemia had poorer medication
adherence vs those with no or mild hypoglycemia (Walz et al., 2014).
• It is probable that patients who achieve glycemic control with fewer adverse events, such as
weight gain and hypoglycemia, are more likely to remain adherent to medications. Hence,
medications should be prescribed keeping these factors in mind to improve adherence
(García-Pérez et al., 2013).

30. C. ECONOMY AND FINANCES
• Limiting the payments that patients are required to make may increase adherence and could
reduce the overall long-term costs (Giuffrida and Gravelle, 1998; García-Pérez et al., 2013;
Sharma et al., 2014).
• Reducing co-payments for statins in medicare beneficiary patients with diabetes was associated
with increased adherence and reduced medical costs, particularly in high-risk cases (Davidoff et
al., 2010).
D. THERAPEUTIC RELATIONSHIP
• Affective interventions seek to enhance adherence by providing emotional support and
encouragement. This includes rapport building through frequent telephone contact, home visits
when feasible, family-based approaches (Schechter and Walker, 2002).

31. • It is helpful to consider separately the aspects of adherence being improved and the type
of intervention being considered.
• It is important to bear in mind that no single intervention has been shown to maintain long-
term adherence; one must combine strategies from two or more of these categories to
achieve success.
(Schechter and walker, 2002)

32. (Blackburn, Swidrovich and Lemstra,
2013)

33. CRITICAL ANALYSIS
• Hernandez-Tejada et al. (2012) examined data of 378 subjects with type 2 diabetes recruited
from two primary care clinics. They inferred that diabetes empowerment was related to better
diabetes knowledge, medication adherence and improved self-care behaviors and
emphasized its relevance to improve outcomes in the management of diabetes.
• A study of 524 questionnaires from patients and their care-givers was analysed by Morello et al.
(2011). Participants in this study identified medication education as a key factor in
improving adherence.
• The 3 motivating factors most commonly identified as improving medication adherence were:
knowing that diabetes medications work effectively to lower blood glucose, knowing how to
manage medication adverse effects, and understanding medication benefits.

34. • However, there seem to be potential problems with the concordance model.
• Failure to take diabetic medication properly could lead to uncontrolled diabetes, long term
diabetic complications, coma, or even death.
• Where will the doctor stand ethically and legally if a patient makes an informed decision not to
take medication as directed?
• Additionally, concordance relies on the patient being the decision maker.
• However, certain patients may expect the doctor to tell them what to do.
(Chatterjee, 2006; Aronson, 2007)

35. • A qualitative study using home visits offered by the basic health care unit to patients with
diabetes mellitus, who did not attend the diabetes education program recognized home visit
as an important strategy for health care education to orient patients with type 2 diabetes on
self-care practices (Torres, Santos and Cordeiro, 2014).
• In a randomized trial where patients received up to 10 telephone calls from their health
educator at 4- to 6-week intervals over 1 year, there was a significant improvement in
medication adherence for the patients who were on oral medication (Walker et al., 2011).

36. • A review by Dezii, Kawabata and Tran (2002) noted that patients on once-daily regimens
had higher adherence (61%) than those on twice-daily regimens (52%).
• Similar results were see in a database analysis of 17 studies - adherence was 10–13% higher
for single-tablet formulations in patients with type 2 diabetes starting combination therapy
(Hutchins et al., 2011).
• A review of forty-nine studies consisting of different types and levels of interventions for
improving adherence found that multifaceted interventions, addressing several non-
adherence factors, were comparatively more effective in improving medication adherence
and glycaemic target in patients with T2DM than single strategies (Sapkota et al., 2015).

37. IMPROVING PERSONAL COMPETENCIES
• Understanding and acknowledging that diabetes has a psychosocial aspect to it, along with physical
illness, and addressing the psychosocial problems of a patient to provide holistic care
• Practice concordance rather than enforcing compliance
• Encouraging the patient to participate as a partner in the decision-making process and empowering
them to be able to do so
• Motivate rather than advice
• Recognise barriers to treatment-adherence, and address them individually, thus inculcating multiple
interventions for improved healthcare practice.

38. RECOMMENDATIONS
• Research to explore the feasibility of long-term interventions, development of more objective
adherence measures, and the inclusion of sufficient numbers of patients to detect improvements in
clinical outcomes (Polonsky and Henry 2016).
• More research needs to be done to estimate the true benefit to harm balance of empowerment.
All patients are not willing to take complete responsibility and some may prefer following the health
care professional’s advise.
• A strategy to identify patients who desire participation of this type and for whom it would be
beneficial and those for whom it would not be beneficial or might even be harmful should be
formulated (Aronson, 2007).
• Newer methods to increase communication and relationships between patients and healthcare
providers should be developed using resources such as electronic medical records and websites, as it
is anticipated that these will result in improved medication adherence (García-Pérez et al., 2013).

39. RECOMMENDATIONS FOR BEST PRACTICE
• Patient empowerment is a paradigm shift for healthcare professionals (Gadsby, 2014).
• Following recommendations are made in order to help health care professionals improve adherence amongst their patients:
o Acknowledge the patients' right and responsibility to make self-care choices and to be the primary decision-makers.
o Spend more time listening and less time offering advice.
o Review and revise diabetes care plans as needed based on patients' and providers' assessment of its effectiveness.
o Take advantage of teachable moments that occur during each visit.
o Supplement self-management support with information technology.
o Establish a partnership with patients and their families to develop collaborative goals.
o Assist patients in solving problems and overcoming barriers to self-management.
o Offer referrals to a diabetes education program and a registered dietitian.
o Create a team with other health care professionals in your system or area who have additional experience or training in the clinical,
educational, and behavioral or psychosocial aspects of diabetes care.
(Anderson and Funnell, 2004)

40. CONCLUSION
• Varying degrees of all categories of intervention need to be practiced to have a positive
impact on health or behavioral outcomes in diabetes; this possibly reflects the complex
psychological landscape of self-management in a chronic disease such as diabetes
(Schechter and Walker, 2002).
• Two major lessons regarding adherence interventions are reinforced.
1. Medication adherence has many possible determinants so eliminating a single
barrier will not solve the problem.
2. Small measures to improving medical adherence may have substantial reductions in
morbidity associated with diabetes.
(Blackburn, Swidrovich and Lemstra, 2013)

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48. DISCLAIMER
• This presentation is based on data and literature available until December 2017. This work was
submitted as a part of an assignment for the module Psychosocial Aspects in Diabetes for the course
M.Sc. Diabetes care to ARU, Cambridge, UK, under the guidance of Dr. Robert Priharjo. All sources and
aids used have been indicated as such. All texts either quoted directly or paraphrased have been
indicated by in-text citations. Full bibliographic details are given in the reference list which also contains
internet sources containing URL and access date, where possible.
• The author was a student of M.S. (by research) in Diabetes Care at ARU, Cambridge at the time when
this work was undertaken. The author has no other financial relationships with any organisations that
might have an interest in the submitted work; has no other relationships or activities that could appear
to have influenced the submitted work. All opinions presented in this manuscript belong to the author
alone, and not any institution to which they are or were affiliated. The author(s) declare(s) that there is
no conflict of interest.
• For any queries or suggestions, kindly contact the author at niyotikhilare@gmail.com.

49. THANK YOU VERY MUCH!