We chat together, sire; he gives me prescriptions;
I never follow them, so I get well.
Molière quoted in Taschereau (1822)
Medicines are central to most people with diabetes’ care plan. The purpose of this chapter is to explore people with diabetes’ medicine-related beliefs and behaviours, not to discuss the pharmacodynamics and pharmacokinetics of medicines or how to choose a medicine regimen. Such information can be found in most medicine formularies and diabetes textbooks. Health professionals (HPs) can have a significant effect on people’s medicine self-management practices, which can be positive and affirming or negative and disempowering. The latter is more likely to lead to medicine non-compliance and less than optimal outcomes. HPs also have their own medicine-related beliefs and behaviours, which are shaped by their experiences just as people with diabetes’ experiences shape their beliefs and behaviours.
Although a healthy diet and regular activity are essential, most people with diabetes need medicines to manage or prevent hyperglycaemia, hypertension and lipid abnormalities as well as to treat other concomitant conditions. The cost of uncontrolled diabetes is high for both the individual and society, thus metabolic targets have become more stringent since the release of the findings of the Diabetes Control and Complications Trial (DCCT) (1993) and the United Kingdom Prospective Study (UKPDS) (1998). It is now common for people with T2DM to take three to four antihypertensive agents, oral glucose lowering medicines (GLM) and/or insulin: usually more than one GLM and more than one insulin type, lipid-lowering agents as well as other medicines.
Dunning and Manias (2005) found people with diabetes took an average of 7.4 medicines per day, range from 1 to 12 in multiple doses at various times during the day, which is polypharmacy. There are several definitions of polypharmacy, and the term may have different meanings and be understood differently in different populations. For the purpose of this book polypharmacy was defined as:
The use of a number of different drugs [medicines] possibly prescribed by different doctors and often filled in different pharmacies, by a patient who may have one or several health problems.
Mosby’s Medical Dictionary (2009)
Some researchers refer to ‘thoughtful’ and ‘unthoughtful’ polypharmacy to distinguish between careful considered medicine combinations and an ad hoc process of adding medicines to the existing medicine regimen, which often occurs when multiple prescribers are involved. Polypharmacy in diabetes could be thoughtful polypharmacy to comply with recommendations in medicine titration algorithms and guidelines because it addresses the multifactorial metabolic and other abnormalities associated with diabetes. However, to be truly thoughtful, the effects on the individual, including the ‘pill burden’, must be part of the decision-making framework. In addition, polypharmacy can only be truly thoughtful if the person with diabetes is actively involved in medicine-management decisions.
Medicines are associated with a high rate of errors, adverse events (AEs) and hospital admissions (Green et al. 2007; Jenkins and Vaida 2007). Medicine errors and AEs also occur in hospitals and aged-care facilities and result inconsiderable morbidity and mortality (Roughead and Lexchin 2006). Importantly, many errors and AEs are avoidable (Jenkins and Vaida 2007). Box 11.1 outlines some of the factors associated with medicine-related errors and AEs.
Significantly, some medicines commonly used to manage diabetes, such as insulin, are regarded as high-risk medicines (HRM) because they have a high risk of causing harm, even when they are used as prescribed (Institute of Safe Medicine Practice 2008). Children, pregnant women and older people are particularly vulnerable groups and are at greater risk of AEs. A number of strategies have been implemented to reduce medicine-related errors and AEs (see Box 11.2).
Inappropriate medicine use affects health outcomes such as blood glucose, lipids and blood pressure. Medicine self-management is complex and requires the individual to master complex medicine-specific self-care behaviours. Medicine self-management is far more complex than ‘taking the medicine as directed’, yet people are often labelled non-compliant if they do not follow HP advice.
I got a new medicine script from my doctor three months ago but I don’t know what to do with it. He told me to take it three times a day but by the time I got to the chemist I forgot what he said and I could not understand the chemist lady because she had an accent—Chinese, I think. Anyway I didn’t want to stay there asking questions because she started talking louder when I asked her about taking it [medicine] so I left. I’m not deaf, you know. Then I tried to read the label on the box but the print is so small and it just said take one tablet three times a day as directed, but I do not know what that means so I decided not to take them, anyway they are pretty big and look hard to swallow. It’s all too much bother so I don’t take it.
- Older people; for example, 30% of unplanned hospital admissions of older people are associated with medicine errors or AEs. A number of factors are involved: changed medicine pharmacokinetics and pharmacodynamics due to the ageing process and renal and liver disease, which can alter medicine metabolism and excretion and can lead to accumulated doses. In addition, medicine self-management can be compromised by mental, visual, fine motor skills and problem-solving deficits. This means older people are at risk of Type A AEs, which are largely predictable, thus, many could be prevented. Some older people rely on family and other carers to help them manage their medicines, which adds another layer of complexity to the medicine error potential
- People with serious health conditions who use multiple medicines, for example using 5 or more regular per day and more than 12 doses per day
- People using medicines with a narrow therapeutic index, which are usually high-risk medicines (HRMs) such as insulin, heparin, cancer medicines and opioids
- Recent transitions between care facilities, for example between hospital, rehabilitation or age care facilities and home
- Discharge from hospital within the preceding 4 weeks
- When changes to the medication regimen are not recorded on discharge summaries or communicated among relevant healthcare providers
- When people consult a number of HPs, some of whom might be CAM practitioners
- Changes in the treatment regimen within the preceding 3 months
- People using complementary medicines (CAM) and other CAM therapies, especially if they do not disclose their use and when CAM use is not documented
- People with literacy and numeracy deficits
- Administering medicines via the wrong route
- When HPs transcribe medicine prescriptions, e.g. telephone medicine orders
- Distractions during medicine administration rounds
- Proactively identifying people at risk of non-compliance and being aware of the factors associated with non-compliance
- Using quality use of medicines, which encompasses using non-medicine options where possible and stopping unnecessary medicines, i.e. reducing polypharmacy
- A range of medicine safety standards and guidelines, e.g. Australian National Commission on Safety and Quality in Health Care, UK Department of Health and the US Institute of Safe Medicine Practice standards
- Computerised Physician Order Entry programme
- A range of clinical decision support tools
- Automated alert systems that alert HPs to the need to ask the individual about medicine allergies. Another form of alerts, HRM medicine alerts, alert HPs to the problems associate with HRM and suggest strategies for reducing the risk. The latter may not reach all key stakeholders
- Educating HPs and people with diabetes and carers about medicine-related errors and how to reduce them. Medicine alerts can trigger education for HPs but were not designed for the public. However, education needs to be interactive, use a range of strategies and link the information to relevant local and individual issues
- Ward-based pharmacists and other strategies where pharmacists, doctors and nurses work closely together, e.g. on medication safety committees and medicine review programmes
- Regular comprehensive medicine reviews and medicine reconciliation programmes for people most at risk, e.g. those described in Box 11.3. Six monthly medicine reviews might be indicated for older people prescribed more than four medicines
- Using a structured validation processes in hospitals and aged-care homes when prescribing and administering high doses of insulin, e.g. > 50 units of intermediating acting and mixed insulin and > 25 units of short or rapid acting insulin. Only having 50 unit syringes available for general use on the wards also reduces high dose insulin errors
- Improving communication among HPs and with people with diabetes and carers, and discharge planning
This lady’s decision could be construed as non-compliance—but is it? Was it common sense? Perhaps her non-compliance actually prevented a medicine-related error, AE or admission to hospital. It is impossible to tell without understanding her general, cultural, health and medicine-related beliefs. Certainly it appears she did not have the information she needed to make an informed decision about her new medicine. Her story also shows some of the people involved in the ‘medication pathway’ who need to give clear, specific, consistent information, clearly did not—so who was non-compliant within their respective roles? What role did the doctor and the pharmacist play in the lady’s decision to not take the medicine?
Many people do not understand directions such as ‘take one tablet three times a day’ for various reasons, including inadequate literacy and numeracy skills and the fact that such information is ambivalent and unclear (Davis et al. 2009). People need clear, explicit directions about how to manage their medicines. The lady’s experience highlights the fact that people do not receive the medicine information they need to manage medicines safely, even when HPs explain medicines to them (Dunning and Manias 2005).
Complementary and alternative medicines and therapies
Complementary and alternative medicines and therapies (CAM) use is very common: more than 50% of the population in most countries use CAM. Many people with diabetes use CAM medicines and other CAM (Egede et al. 2002; Dunning 2003; Manya et al. 2012). People, especially older people, also use over-the-counter medicines such as analgesics (Roumie and Griffin 2004). CAM use can be self-initiated or an HP might refer the individual to a CAM practitioner. People with diabetes use CAM for a number of reasons including to improve well-being and quality of life, manage pain, stress and intercurrent illness such as colds and ‘flu’, to treat unpleasant symptoms including medicine side effects, and because they encompass spirituality ‘they treat the whole person’.
Purposeful (thoughtful) CAM use, whether CAM is used alone or in combination with other medicines and treatments, has risks and benefits. At the very least, HPs must ask about CAM use in a non-judgemental way and document it. In addition, people need education about safe CAM use, just as they need information about other medicines. A knowledgeable HP must supply CAM information, and this might not be a conventional HP. In addition, conventional practitioners need to rethink the contention that CAM GLM ‘do not work’. Some do, as the following story shows.
A 26-year-old Chinese lady who recently returned from visiting her mother in China was being investigated for an insulinoma because she was having frequent episodes of profound hypoglycaemia. Her mother had T2DM and had just been diagnosed with cancer. Tests demonstrated very high plasma insulin levels that correlated with very low plasma glucose and hypoglycaemia symptoms but radiological investigation did not identify the site of the insulinoma. The lady was scheduled for exploratory surgery to locate the insulinoma.
I asked the doctors
have you asked Miss XX whether she has been using any CAM medicines.
Yes—she said no.
What words did you use when you discussed it with her?
I asked if she was using any unproven or alternative treatments.
Do you mind if I talk with her about CAM and her visit to her mother in China?
There were three important clues that Miss XX’s hypoglycaemia could be due to herbal GLM: being Chinese, her recent visit to China and her mother’s T2DM. When I asked her about her visit to China and how her mother was getting on she said:
Mum was more worried about me making the long trip home when my work is so busy. She thought I looked tired and had no energy so she gave me some of her diabetes medicines to increase my energy levels. That’s when I started having these turns, but I kept taking the medicine to increase my yang. She got them from the Chinese medicine doctor.
The story shows the importance of using appropriate language when asking questions, being non-judgemental, considering cultural issues and having an open mind.
‘Compliance’: to use or not to use, that is the question
Although I rarely, if ever, ask people with diabetes about ‘compliance’, I choose to use ‘compliance’ rather than adherence or concordance or other euphemisms in this chapter, even though the recently released Language Position Statement (Diabetes Australia 2011) stated compliance can have negative connotations for people with diabetes. One reason I choose to use compliance is that it is difficult to find one agreed definition of compliance and the word is used interchangeably with other words such as adherence and concordance. The three words, compliance, adherence and concordance, do not actually mean the same thing and all three have both positive and negative connotations. Some authors use compliance to refer to shared decisions between the individual and the HP prescriber: a positive connotation (Segal 2007; Bissonnette 2008).
The main reason I choose compliance is that it is actually a composite term that includes three interrelated concepts:
In order to reach an agreement, or make a shared decision, both parties need access to and be able to understand relevant information about the various management options. The HP needs to understand the individual’s medicine beliefs and attitudes and behaviours. If such an agreement cannot be reached, and maintained, the desired outcome is unlikely to be achieved (Cramer et al. 2007). Often the HP’s perspectives and those of the person with diabetes are different, and they have different ways of determining benefit and risk (see Chapters 3 and 4) (Britten 2003). Another consideration is whether 100% compliance (optimal compliance) is required or whether an individually determined ‘appropriate’ compliance rate is acceptable. The latter often happens, for example stopping antibiotics when feeling better.
However, optimal compliance is important with some medicines such as those with a narrow therapeutic index such as digoxin, warfarin and insulin in T1DM to main therapeutic blood levels. Thus, desired outcomes and compliance must be examined from at least two perspectives: the person with diabetes and the HP, and sometimes other people involved in medicine management such as family caring for children and older people. In some cases, dispensers (pharmacist) and funder perspectives might need to be considered.
People with diabetes’ perspective
Understanding the person with diabetes’ perspective is essential to enable the HP help them decide on a medicine self-care regimen that suits their lifestyle and achieves the desired mental and physical outcomes. People with diabetes consider several factors when deciding to take/not take a medicine and considering the benefits and risks of medicines. Some factors include the following:
- Cost: some people reduce doses or change dose intervals to reduce costs even though many medicines are subsidised in Australia, e.g. ‘We’re good mates. We’ve all got the diabetes and we do lots of things together and we all pretty much take the same medicines. So we decided to pool our medicines when we get ’em from the chemist and share ’em out. Sometimes we run out before we can get more, but we do pretty well’ (Dunning and Manias 2005). Underuse of medicines because of cost is a problem in many countries (Kemp et al. 2011).
- Likelihood and type of side effects: e.g. ‘I will not take any more of those satin medicines [statins] they make me ache. The doctor said I was imaging things, but it is me that’s aching and I know when I’m aching and I don’t want to ache.’ Likewise, some people with diabetes reduce insulin doses to avoid hypoglycaemia, a common and significant side effect of insulin and sulphonylureas. HPs do not always recognise or understand the effects of hypoglycaemia on well-being, the fear it engenders and the associated sense of loss of control and sense of vulnerability. (Tay et al. 2001).
- Remembering to take the medicines in their usual daily routines. People with diabetes in the Dunning and Manias (2005) study gave a range of reasons for forgetting to take their medicines for a range of reasons. Most did not worry about the missed doses and took the next due dose; others took all or part of the dose when they remembered. For example:
- ‘I’m getting old and my memory—well she ain’t what she used to be you know.’
- ‘I always forget my insulin at work because I get busy and distracted. I’m just too busy sometimes, well often actually.’ This man’s story illustrates competing priorities the individual needs to accommodate.
- ‘I never forget my metformin but I often forget my insulin.’
- ‘I am not sure I really forget to take them—I just take a rest from them when I am on holidays and when I eat out. That’s not the problem for me; I have trouble remembering to take them when the holiday is over.’
- Perception that taking medicines means ‘you are sick’. ‘I won’t take insulin it means you have come to the end of the road—it is the last resort and I have no options left. No I won’t take it’ (Dunning 1998).
- Stigma associated with injecting insulin in public because ‘they might think I am a drug addict’.
- Whether they can ‘stop the medicine for a while sometimes, you know have a little holiday from medicines’.
- Medicine burden (polypharmacy) ‘I am on so many medicines and each time I see another specialist for all my problems they give me another one. It is hard to remember to take this one before meals and this one after meals and the little green one, I call it rat sack, must be swallowed whole. But I have a system now for taking it in turns to stop some of them for a while. I don’t feel any different when I do so I think it is a good system.’
- Cultural customs and beliefs: for example, Chinese people avoid situations and times likely to bring bad luck and often avoid visiting a doctor or going to hospital on certain days, especially Chinese New Year, and many do not take medicines at this time (Yen Yang et al. 2011). Interestingly, Yen Yang is a Taiwan national interviewing Chinese people with diabetes who immigrated to Australia about their diabetes self-care practices; she did not find this practice unusual because it is ‘just part of my culture’. However, it was important interesting information for Rasmussen and I (co-researchers) because we are from a different culture.
Strictly speaking, many of these quotes illustrate non-compliance: they also provide a great deal of insight into how and why people make decisions about using/not using medicines. In addition, considering the positive aspects, they also reflect proactive decision-making, albeit the decisions may not be ideal from an HP’s perspective. They make a great deal of sense if we consider the individual experiences embodied in the quotes and reflect on how common they are—if HPs only ask!
It is also important to point out that the individuals disclosed the information during routine diabetes outpatient clinic consultations and interviews conducted as part of medicine-related research. In both settings, non-judgemental questions, active listening and acceptance were employed to establish a trusting relationship with the individual. These techniques helped the individuals feel safe to disclose information about their behaviours most knew HPs usually regard as non-compliance.
The accuracy of self-reported behaviour is problematic. However, research suggests people who say they do not follow treatments usually report accurately, but those who report they follow treatment recommendations usually report inaccurately (Spector 1986).
HPs, especially prescribers and educators perspectives
HPs generally base their decision to recommend a medicine and decide doses and the dose regimens on the following:
- An assessment that encompasses physical, and hopefully, emotional aspects but does not always include exploring the individual’s medicine perspectives or capability in any detail, often because of time constraints.
- Prescriber’s previous experience managing diabetes and its treatment. For example, registrars often adopt similar practices to the consultants with whom they trained. However, there is evidence that physician compliance with care standards decrease as physicians become more experienced and that older physicians are less likely to adopt newly ‘proven’ therapies (Choudhry and Fletcher 2005). It is not clear whether the same is true for other HPs groups. Likewise, a number of reasons could account for the finding.
- Decision-making aides such as online medicine handbooks and diabetes guidelines. These guidelines include the recommendation to achieve normoglycaemia and control lipids and hypertension to prevent diabetes complications.
- Information gained from pharmaceutical representatives, continuing medical education programmes and conferences.
- Their understanding of the individual’s beliefs and ability to afford medicines.
- Concerns about multiple prescribers being involved and the risks associated with inadequate communication among prescribers and dispensers.
Carers, particularly family members
Carers often assume a care role when the individual is too young, has mental and/or physical disabilities or is no longer able to self-care because of age-related disabilities. Parents usually receive information, but it is not always the case with older people. For example, we found that husbands and wives caring for their relatives with diabetes receiving palliative care were very distressed and unsure about their knowledge and ability to help their relative with diabetes perform self-care activities such as injecting insulin and blood glucose monitoring (Dunning et al. 2012).
Developing a trusting partnership with carers is essential and might include providing accurate, timely and easy to understand medicine education. In fact, Carer’s Australia would like general practitioners to include a ‘carer identification field’ on their professional electronic software packages such as prescribing and e-Health programmes (Hughes 2010).
HPs need to appreciate that carers provide support and care for older relatives with complex needs. The carers are often also old and have health problems and may require medicines themselves. The stress of caring for an older relative may mean they neglect their own health and may not ‘take their medicines as directed’. Thus, carers might need education about their relative’s medicines as well as their own medicine regimen and advice about how to accommodate medicines management into their other personal and care-giving responsibilities.
Carers are also an important source of information and can provide valuable information about their relative’s medicine history, beliefs and behaviours that might not otherwise be available.
Extent of non-compliance
Many researchers have explored medicine compliance, but although they often use different definitions of compliance, there is clear evidence that non-compliance is common. People are reluctant to take medicines, even modern medicines with fewer side effects, and try to reduce the number of medicines they take (Pound et al. 2005). Common ways of measuring compliance include:
- Pill counts.
- Frequency of completing the full course of a medicine.
- Prescription refill rates.
- MEMs containers, which have a microprocessor in the lid that records the data and time the container is opened. MEMs do not measure actual use. They are expensive, even for research purposes. The theory is that if a person opens the medicine container, they are likely to take the medicine.
- Self-reported medicine behaviours using self-completed questionnaires, interviews or informal discussing during clinical consultations (Matsuyama et al. 1993; Kriev et al. 1999; Dunning and Manias 2005; Cramer et al. 2007).
These studies indicate dose omissions, stopping medications without consulting an HP and inappropriately changing medicine doses are common. Haynes et al. (1996) found half the medicines prescribed for chronic diseases are not taken. Other research suggests one fifth of people do not begin to take prescribed medicines (e.g. the lady on page 181), a further fifth stop taking medicines before they complete the full course and a further 40% do not take their medicines ‘as directed’. Many of these examples of ‘non-compliance’ are evident in the quotes on page 185.
Adjusting medicine doses is interesting. HPs expect insulin-treated people with diabetes to eventually learn how to and to adjust their insulin doses according to their blood glucose patterns, activity, diet and illness. Thus, an individual who practises insulin dose adjustment is actually undertaking appropriate medicine self-management and most likely preventing AEs. Not adjusting insulin doses could be non-compliance in some circumstances such as during illness because it can result in ketoacidosis, a serious life-threatening condition.
Is there a relationship between medicine compliance and optimal health outcomes?
If people do not take their medicines, they will not ‘work’. However, there is a complex relationship between people’s compliance rates (optimal, appropriate or not appropriate) and the effects on health outcomes, but understanding about the relationship is limited. One reason for lack of information is the different ways outcomes are measured and the fact that most measurement tools are subjective (individual self-reports such as the quotes in this chapter) or objective, valid scales (Di Matteo et al. 2002). Likewise, many randomised controlled trials that examine medicine efficacy do not consider compliance in the study design.
Despite these limitations, compliance has a positive effect on treatment outcomes (Di Matteo et al. 2002; Simpson et al. 2006). Di Matteo et al. (2002) undertook a meta-analysis of 63 studies and found compliance reduced the risk of no or poor outcomes by 26% compared with non-compliance. The DCCT (1993) and UKPDS (1998) demonstrated improvements in HbA1c and other parameters, which were partly due to medicines although it is possible some of the effects could be attributed to regular monitoring, support and encouragement from the research team.
A number of other factors affect the outcomes. These include the pharmacodynamics of the particular prescribed medicines, which is affected by a number of individual factors such as age, gender and pharmacogenetics. Factors that induce the enzymes involved in medicine metabolism result in shorter duration and intensity of the medicine effect. Factors that inhibit the enzymes have the opposite effect. Enterohepatic circulation, intestinal flora and nutrition status play a role.
Likewise, altering medicine dose forms can affect the duration of action and medicine bioavailability, for example, crushing long-acting dose forms of metformin and inappropriately cutting medicines in half because of cost.