University of Groningen
Medication use for acute coronary syndrome in Vietnam
Nguyen, Thang
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Chapter 1
Cardiovascular diseases and acute coronary syndrome
Cardiovascular diseases (CVDs) are a group of disorders of the heart and blood vessels. One of the common CVDs is ischemic heart diseases (IHDs) or coronary artery diseases including acute coronary syndrome and stable angina.1 There are two types of acute coronarysyndrome (ACS): (1) non‑ST‑elevation acute coronary syndrome (NSTEACS) comprising unstable angina and non‑ST‑elevation myocardial infarction, and (2) ST‑elevation acute coronary syndrome or myocardial infarction (STEACS/STEMI). Unstable angina is chest pain or discomfort that is accelerating in frequency or severity and may occur while at rest but does not result in myocardial necrosis. The discomfort may be more severe and prolonged than typical stable angina. Unstable angina, NSTEMI, and STEMI share common pathophysiological origins related to coronary plaque progression, instability, or rupture with or without luminal thrombosis and vasospasm.2
CVDs are a major contributor to the growing public health epidemic in chronic diseases or non‑communicable diseases (NCDs).3 CVDs are the number one cause of death globally:
more people die annually from CVDs than from any other cause.1,4 In 2015, CVD deaths were
17.9 million, rising by 12.5% since 2005.2 IHDs and stroke are the two main contributors to
CVD morbidity and mortality, accounting for 85.1% of all deaths due to CVDs and being the two leading causes of disability‑adjusted life years (DALYs) worldwide in 2015.1,4,5 IHDs are the
world’s biggest killer, accounting for 8.9 million deaths in 2015.5,6 The estimated socioeconomic
burden of IHDs is reflected in the loss of 164 million DALYs in 2015.5
A significant proportion of CVD deaths is among 85% of the population residing in low‑ and middle‑income countries (LMICs).7 According to the World Bank, LMICs comprise
of six geographic regions consisting of East Asia and the Pacific, Central and Eastern Europe and Central Asia, Latin America and the Caribbean, Middle East and North Africa, South Asia Region, and Sub‑Saharan Africa.8 The Global Burden of Disease study showed that over the
past three decades, high‑income countries, Latin America, Western Europe and Central Europe have shown declines in the number of CVD deaths whereas the rest of the world has shown an increase. East Asia (including Vietnam) registered a 47% increase over the same period.4
Survivors of ACS are at increased risk of recurrent infarctions and have an annual death rate of up to six times that in people of the same age who do not have IHDs.9 Evidence‑based
interventions for secondary prevention include the use of antiplatelet agents, beta‑blockers, angiotensin‑converting enzyme inhibitors, and statins, as well as modifying lifestyle‑related risk behaviors.1,9 The benefits of these medications are largely independent, but when used
together with smoking cessation, nearly 75% of recurrent vascular events may be prevented.1
Despite substantial benefits and generally low treatment costs, appropriate measures for secondary prevention after ACS are implemented in less than half of eligible patients, even in high‑income countries. Due to inequitable and inaccessible health care systems, inefficient use of limited resources and investing scarce resources in interventions that are not cost‑ effective, the secondary prevention coverage is far worse in LMICs.1,9
10
Chapter 1
Medicine use process
The purpose of pharmacotherapy management is to deliver the appropriate medicine to the patient who needs that medicine and to ensure the patient taking the medication as prescribed. To achieve the purpose, a physician should follow a standard process of medicine use (Figure 1).10 The process starts with a diagnosis to determine the problem
that requires treatment. The therapeutic goal should be defined. The physician must decide which treatment is required, based on up‑to‑date clinical practice guidelines, to achieve the desired goal for an individual patient. The Institute of Medicine defines clinical practice guidelines as “statements that include recommendations, intended to optimize patient care, that are informed by a systematic review of evidence and an assessment of the benefits and harms of alternative care options.”11 When the decision is made to treat the patient
with medications, the best medications for the patient are selected based on efficacy, safety, suitability, cost, and patient preferences. The dose, route of administration, and duration of treatment are determined, taking into account the condition of the patient. When receiving a medication, the patient should be provided proper information about both the medication and his or her condition. Next, the medication should be dispensed to the patient in a safe and hygienic manner, making sure that the patient understands the dosage and course of therapy. Then the patient decides whether or not to be adherent to taking the medication as prescribed. Finally, the physician should decide how to monitor the treatment, after consid‑ ering the probable therapeutic and adverse effects of the treatment during the follow‑up period.10 This process is supported by the World Health Organization (WHO) by depicting
six steps of rational treatment.12
General introduction
Physician adherence to prescribing guidelines
The first official guidelines for the diagnosis and management of ACS were published by the Agency for Health Care Policy and Research and the National Heart, Lung, and Blood Institute in 1994.13 Recently, organizations such as the American Heart Association (AHA),
the American College of Cardiology (ACC), the European Society of Cardiology (ESC), and the Vietnam National Heart Association (VNHA) have developed and disseminated guidelines to facilitate the management of patients with ACS. In addition to percutaneous or surgical revascularization and cardiac rehabilitation programs, these guidelines strongly recommend the use of secondary prevention medications including antiplatelet agents (aspirin, P2Y12 receptor antagonists, or both), beta‑blockers, angiotensin‑converting enzyme inhibitors or angiotensin II receptor blockers (ACEIs/ARBs), and statins.14–20
Prescribing of these guideline‑recommended medications has been shown to reduce both in‑hospital and postdischarge morbidity and mortality.21–25 Perhaps a convincing
example of the magnitude of the effect of guideline adherence is an observational study of 65,000 patients with NSTEMI showing that every 10 percent increase in adherence to prescribing guideline‑recommended therapies was associated with a 10 percent reduction in in‑hospital mortality [adjusted odds ratio (OR) 0.90, 95% confidence interval (CI) 0.84–0.97].26 In‑hospital mortality was significantly lower in the hospitals with the highest
compared to the lowest adherence quartile (4.2% vs. 6.3%).26
A number of large registries [including the Global Registry of Acute Coronary Events (GRACE),27 the Can Rapid Risk Stratification of Unstable Angina Patients Suppress
ADverse Outcomes with Early Implementation of the ACC/AHA Guidelines (CRUSADE),28
the Antiplatelet Therapy Observational Registry (ATPOR),29 and the Euro Heart Survey
(EHS)30] have shown variable adherence to guidelines for the management of patients
with ACS, though there have been improvements over the years.31 Adherence to guidelines
remains suboptimal in clinical practice,32–35 in particular, in LMICs.27,36 The ACCESS (Acute
Coronary Events – a Multinational Survey of Current Management Strategies) study,37
a prospective observational registry of patients hospitalized for ACS between 2007 and 2008 in 19 LMICs, found that aspirin and lipid‑lowering agents were each given to > 90% of patients, whereas uptake of beta‑blockers and ACEIs was at 78% and 68%, respectively.
Several large quality improvement programs have been implemented with the goal of increasing the use of guideline‑recommended medications for patients with ACS in the acute phase of the illness, at hospital discharge, and at long‑term follow‑up. The notable programs including the Guidelines Applied in Practice (GAP),38 the Get With
The Guidelines (GWTG),39 and the European Quality Improvement Program for Acute
Coronary Syndromes (EQUIPACS)40 have demonstrated that it is possible to improve
quality of care. A systematic review by Murphy et al. (2015)41 showed that organizational
interventions were associated with approximately 20% reduced mortality in patients with IHDs [risk ratio (RR) 0.79; 95% CI 0.66–0.93).
12
Chapter 1
Patient adherence to treatment
“Drugs don’t work in patients who don’t take them” (C. Everett Koop). Adherence is the key mediator between medical practice and patient outcomes.42 Adherence to medications or
medication adherence was defined as the process by which patients take their medications as prescribed, comprising initiation, implementation, and discontinuation.43 Patient compli‑
ance and medication adherence have been previously defined as synonymous.44 However,
in recent years, compliance has been viewed by many as having the negative connotation that patients are subservient to physicians.45 The term “medication adherence” is now the
preferred terminology.43,45
Numerous studies on how to properly measure and quantify medication adherence have been conducted but none of them can be counted as the gold standard.46 Different
tools have been designed and validated for different conditions, in different circumstances. Generally, measurements of medication adherence are categorized by the WHO as subjec‑ tive and objective measurements.46–48 Objective measures, including measurement of clinical
outcomes, dose counts, pharmacy records, electronic monitoring of medication administra‑ tion and drug concentrations, seemingly provide a good measure of a patient’s medication‑ taking behavior in many contexts,46–48 though most of these measures have drawbacks to
implement in resource‑limited settings.49 Subjective measures, including physician or
family reports, patient interviews and self‑report adherence scales, can be simple to use and are less expensive.46–48 The most common drawback is that patients tend to underreport
non‑adherence to avoid disapproval from their healthcare providers. However, recently a number of well‑validated adherence scales have been strongly correlated with objective measures of adherence in several different populations of patients.48
A substantial proportion of people do not adhere adequately to cardiovascular medications, and the prevalence of such suboptimal adherence is similar across all individual CVD medications.50 A systematic review by Chen et al. (2015)51 showed that the
proportion of medication adherence ranged from 54% to 86% in patients discharged from the hospital after an ACS. Notably, adherence to treatment is still suboptimal in LMICs.49,52
Poor medication adherence results in adverse health outcomes and increased healthcare costs. A large proportion of all CVD events may be attributed to poor adherence to cardio‑ vascular medications only, and the optimal adherence may confer a significant inverse association with subsequent adverse outcomes.50,53 A systematic review by Bitton et al.
(2013)54 showed that medication adherence significantly improves health outcomes, and
reduced total annual IHD costs (between $294 and $868 per patient, equating to 10.1%‑ 17.8% cost reductions between high‑ and low‑adherence groups).
A systematic review by Santo et al. (2016)55 showed that many types of inter‑
vention components were implemented to improve medication adherence in patients with IHDs including patient education, counselling, intensified patient care, medication aids, simplification of drug regimen reminders, financial incentives, collaborative care,
General introduction
lay health mentoring, and direct observation treatment. In terms of modes of delivery, the interventions were delivered by pharmacists, nurses, researchers, or other health professionals.55 Pharmacists, in addition to medication dispensing, can provide medica‑
tion education and disease management for patients, to improve medication adherence to achieve the goals of desired therapeutic outcomes, and to improve safe medication use.56 Previous systematic reviews conducted to measure the effect of pharmacists on the
care of patients with CVDs 57,58 and IHDs 56,59 have shown a positive impact on patient
outcomes. A recent study by Ho et al.60 evaluated a multifaceted intervention to improve
medication adherence involving pharmacist‑led medication reconciliation, education, and collaborative care between the pharmacists and physicians. Results of the study showed that patients randomized to the intervention were more likely to be adherent to cardio‑ vascular medications (clopidogrel, beta‑blockers, ACEIs, and statins) than those in the care as usual group (89.3% vs. 73.9%; p = 0.003).
Rationale and objectives of the thesis
Vietnam is a country located in Southeast Asia and borders Laos, Cambodia, and China.61
Economic reforms beginning in the late 1980s transformed Vietnam from one of the poorest countries to a lower middle‑income country by 2009.62,63 From 1990 to 2015, the
trend of lower death rate and birth rate was associated with an increase in total population (66 to 93 million), life expectancy at birth (71 to 76 years), elderly population (8% to 10%), and urban population (20% to 34%).64 The rapid economic growth, urbanization and aging
population in Vietnam have led to an increased burden of NCDs.66 NCDs are estimated to
account for 73% of total deaths.65 Cardiovascular diseases are a major contributor to the
NCD burden, accounting for 33% of total deaths.59 Notably, ACS is still one of the leading
causes of deaths in Vietnam.66 Vietnam has made some significant efforts to address NCDs
including the establishment of the NCD prevention and control program and advocating for its further prioritization, developing models for community‑based management of NCDs and initiating surveillance systems. Despite this progress, action to date has not been adequate to prevent the burden of NCDs from continuing to rise. Currently, health‑related challenges include a rising burden of CVDs, an ageing population, inequities in access to healthcare services, and insufficient capacity of the healthcare system.67 There are concerns
about quality of medical care and patient outcomes and therefore there is a growing demand for appropriate medicine use.68
The thesis has been inspired by the wish to gain more insight into the process of medicine use and contribute to the development of interventions to improve guideline and medication adherence in ACS in Vietnam. This thesis addresses two stages of the process of medicine use. The focus of the first part of the thesis is on physician adherence to prescribing guidelines. In Vietnam, prescribing guidelines for patients with ACS have
14
Chapter 1
been introduced in clinical practice, but little is known about the extent and patterns of physicians’ prescribing according to guidelines and the association between the guideline adherence and patient outcomes. The previous systematic review41 presented a significant
impact of organizational interventions on improved mortality of patients with IHDs, but the interventions involved both physician and patient adherence to recommendations on secondary prevention of IHDs (comprising lifestyle modification, prescribing medica‑ tions, or both). No work has been done focusing on types and the effect of interventions to enhance prescribing according to guidelines for patients with IHDs as far as we are aware. The second part of the thesis focuses on patient adherence to treatment. Although the importance of medication adherence in treatment for chronic diseases has been recognized, limited data indicate the extent of patient adherence to treatment for ACS and the role of pharmacists in improving the adherence in Vietnam. To measure medication adherence, standardized questionnaires have frequently been used because they are low in both cost and time expenditure. It is probably the most appropriate tool measuring medication adherence in LMICs like Vietnam where other inexpensive tools as pharmacy refill and pill counts cannot be used. Translation and cross‑cultural adaptation of these questionnaires are needed for studies on medication adherence in Vietnam. Therefore, the objectives of the thesis are:
1. To determine the extent of physician adherence to prescribing guideline‑recommended medications for patients with acute coronary in Vietnam.
2. To determine the association between in‑hospital guideline adherence and postdischarge major cardiovascular outcomes.
3. To determine types and the effect of interventions tested to improve prescribing and health outcomes in patients with ischemic heart diseases.
4. To translate and cross‑culturally adapt the Brief Illness Perception Questionnaire, the Beliefs about Medicines Questionnaire, and the Eight‑item Morisky Medication Adherence Scale into Vietnamese.
5. To determine the extent of patient adherence to treatment for acute coronary syndrome in Vietnam.
6. To assess whether a pharmacist‑led intervention enhances medication adherence in patients with acute coronary syndrome and reduces mortality and hospital readmission.
General introduction
Outline of the thesis
Chapter 1 introduces the importance of guideline and medication adherence in cardiovas‑
cular diseases and acute coronary syndrome worldwide and in Vietnam.
Chapter 2 determines the extent of physician adherence to prescribing guideline‑recom‑
mended medications and identifies potential factors associated with the guideline adherence in treatment for patients with acute coronary syndrome in Vietnam.
Chapter 3 determines the association between in‑hospital guideline adherence and
postdischarge major cardiovascular outcomes of patients with acute coronary syndrome in Vietnam.
Chapter 4 systematically reviews randomized controlled trials of interventions to enhance
prescribing guideline‑recommended medications for patients with ischemic heart diseases in order to determine types and the effect of interventions tested to improve prescribing and health outcomes in patients with ischemic heart diseases.
Chapter 5 translates and cross‑culturally adapts the Brief Illness Perception Questionnaire,
the Beliefs about Medicines Questionnaire, and the Eight‑item Morisky Medication Adherence Scale into Vietnamese.
Chapter 6 determines the extent of patient adherence to treatment for acute coronary
syndrome postdischarge and identifies factors associated with the patient adherence.
Chapter 7 determines the effect of pharmacist‑delivered multifaceted interventions on
medication adherence and clinical outcomes of patients with acute coronary syndrome postdischarge in Vietnam.
Chapter 8 summarizes and discusses the main findings of the thesis as well as proposes
implications for clinical practice and future research in Vietnam and in other low‑income and middle‑income countries.
16
Chapter 1
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