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Università degli Studi di Napoli Federico II Dipartimento di Farmacia Dottorato di Ricerca in Scienza del Farmaco XXVII Ciclo Persistence to therapy and risk of fracture in patients treated with antiostoeporotic

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Università degli Studi di Napoli Federico II Dipartimento di Farmacia Dottorato di Ricerca in Scienza del Farmaco XXVII Ciclo Persistence to therapy and risk of fracture in patients treated with antiostoeporotic drugs: analysis of costs and consequences Coordinatore: Prof.ssa M. Valeria D Auria Tutor: Dott.ssa Enrica Menditto Candidato: Valentina Orlando Anno Accademico 2014/2015 Index General Introduction... 2 Chapter 1 Medication Adherence Medication Adherence Economic impact of non adherence to medication Identifying poor adherence Determinants of patient adherence Adherence to therapy: direct and indirect methods of measurement Direct methods Indirect methods Advantages and disadvantages emerging form literature review Chapter 2 Automated Databases: sources of data for Drug Utilization Research Automated Databases: definition and description Administrative databases Medical record databases Advantages Limitations Specific applications Drug utilization metrics: the ATC/DDD methodology Definition and measurement of exposure and outcome Pharmacy records as tool to measure medication compliance and persistence Medication Compliance Persistence Benefits Disadvantage Chapter 3 Economic evaluation in health care Why is important economic evaluation in health care? Methods of economic evaluation Cost-effectiveness plane Limitations From ICER to Net Benefit Chapter 4 Results Osteoporosis drugs in real world clinical practice : an analysis of Persistence Rates and reasons for lack of persistence with anti-osteoporotic drugs: analysis of the Campania region database Assessment and potential determinants of compliance and persistence to anti-osteoporosis therapy in Italy Gender differences in medication taking behaviour: a case of osteoporosis Persistence to therapy and the associated risk of fractures with antiosteoporotic drugs Cost analysis of osteoporosis in real word clinical practice General Discussion Appendix A: List of Antiosteoporotic drugs Appendix B: Hospitalizations for osteoporotic fracture Appendix C: Diagnostic tests Appendix D: Charlson Comorbidity Index (CCI) Appendix E: Statistical Methods General Introduction Medication non-adherence is an important public health concern, affecting health outcomes and overall health care costs. It is a widespread phenomenon and can be a barrier to safe and cost-effective use of medicines and services. The World Health Organization (WHO) define adherence as the extent to which a person s behavior taking medication, following a diet, and/or executing lifestyle changes - corresponds with the agreed recommendations from a provider. The failure to adherence to medication and physician prescriptions could lead to the individual not taking the prescribed drug, taking it at the wrong time or missing doses. Non-adherence can result in costly complications that are often more expensive than the medicines and worsen health outcomes. The first study on adherence was published in Later on, several papers have been published on this topic, with the aim to develop measures of adherence, to better understand factors related to poor adherence and to promote interventions to increase adherence. However, every effort to improve adherence was almost ineffective and non-adherence to medicines remains a challenge for health care professional and scientists. Non-adherence to treatment regimen is a prevalent problem of patients with chronic disorders. Adherence to long-term therapy for certain chronic illnesses in developed countries averages at only 50%. As the burden of chronic diseases continues to grow globally, so does the impact of non-adherence. The WHO estimates that the cost of non-adherence to drug therapy amounts to 125 million euros per year in Europe including costs from avoidable hospitalizations, nursing home admissions, and premature deaths. High economic costs of poor adherence to the treatment derive from an increased demand for health care, as the clinical benefits remain unfulfilled. This involves higher hospitalization costs and greater recourse to additional resources of the Health Service. The expenditures impact is particularly important from a public health perspective, since an optimal allocation of limited available health resources is a key factor to maximize the population health level. Performing cost-effectiveness analysis by using real world data may be widely useful to support decision makers. Moreover, it would also be useful, from a third party payer, to evaluate the cost-effectiveness of increasing adherence. Adherence is becoming a priority included in the political agenda of health care system and in the European Commission (EC), adherence has been highlighted as a priority. In 2012 was launched from EC the European Innovation Partnership on Active and Healthy Ageing (EIP-AHA) [http://ec.europa.eu/research/innovation-union/ index_en.cfm?section=active-healthy-ageing.]. The EIP-AHA A1 Action Group is focused on prescription and adherence. Part of the results of this thesis have been 2 made available to A1 Action Group as preliminary data that might be useful for the further focused interventions. Aim of this thesis This thesis aims to provide more evidence on relation between poor adherence and adverse outcomes and to define reason of poor adherence, by using drug-utilization approaches using different sources of health-related automated databases. The scope of the study is also to evaluate economic impact of enhancing adherence by using reallife approach. The case study is population exposure to anti-osteoporotic drugs: with ageing populations, the burden of osteoporotic fractures on society will increase in the coming years and the prevention of osteoporotic fractures is therefore a major public health issue. 3 Chapter 1 Medication Adherence 4 1.1 Medication Adherence During the last few decades, many different definitions of the process underlying the non-observance of physician s recommendations have been employed. Adherence is a relatively recent term which has replaced the notion of compliance. In the past few years, the concept of adherence has gained popularity as it implies a more reciprocal and dynamic interaction between health care providers and patients, and it recognizes the influence of medication-taking behavior [1,2]. Nowadays, the World Health Organization (WHO) definition of adherence has been universally accepted; the extent to which a person s behavior taking medication, following a diet, and/or executing lifestyle changes - corresponds with the agreed recommendations from a provider. This definition highlights the importance of an active involvement of the patient among with a good communication with the health professionals [3]. The first study on adherence was published in 1968 [4,5]. Later on, several papers have been published on this topic, with the aim to develop measures of adherence, to better understand factors related to poor adherence and to promote interventions to increase adherence. However, every effort to improve adherence was almost ineffective and non-adherence to medicines remains a challenge for health care professional and scientists. In developed countries non-adherence in the treatment of chronic diseases ranges from 30% to 50% and this rate is even higher in developing countries [6,7]. This degree of non-adherence results in a high number of patients that do not get the maximum benefits of medical treatment; as a consequence they experience a poor quality of life, poor health outcomes and health care costs increase [8,9]. Indeed, improvement of adherence may have a stronger effect on health outcomes than the development of new drugs [10]. Non-adherence to medical plans is a public health problem at every level of the population, but especially in older adults. Multiple chronic diseases and polypharmacy, the co-prescription of several drugs, are highly prevalent in older persons [11,12]. There is evidence that non-adherence increase with the number of chronic disease and the number of drugs. Chronic disease management requires a continuous psychological adaptation and behavioral reorganization that may lead to significant changes in respecting therapeutic indications [13]. 1.2 Economic impact of non adherence to medication Medication adherence is a growing concern to healthcare systems as nonadherence to pharmacotherapy has been associated with adverse outcomes and higher costs of care. Adherence to therapy represents a key factors necessary to gain a significant 5 reduction in morbidity and mortality and to optimize the use of financial resources, but this aspect is widely underestimated in clinical practice and by patients [14-18]. The World Health Organization (WHO) estimates that the cost of nonadherence to drug therapy amounts to 125 million euros per year in Europe including costs from avoidable hospitalizations, nursing home admissions, and premature deaths [3]. High economic costs of poor adherence to the treatment are caused from an increased demand for health care because the clinical benefits are unfulfilled. This involves higher hospitalization costs and greater recourse to additional resources of the Health Service. Several studies have suggested that patients with poor adherence to the treatment have higher costs for the health service than patients being more adherent to their treatment regimens. Furthermore, adherence to therapy is especially important for management of chronic diseases. In particular, a study by Sokol et al. related to four chronic conditions including diabetes, showed that a high level of adherence to therapy in diabetes is associated with lower costs related to illness and lower costs of hospitalization in patients more adherent to their treatment regimens [19]. Figure 1 Adherence improbe health and reduces costs Interesting results are reported in a recent analysis conducted by IMS Institute for Health Care Informatics, which estimated the economic impact of the use of inappropriate drugs in 186 countries, including Italy. The study considered six chronic diseases of high social impact such as diabetes, osteoporosis, heart failure, HIV, hyperlipidemia, hypertension, estimating at approximately $ 300 billion cost of using non-optimal drug therapies. It shows that two thirds of these costs are attributable to approximately ten million avoidable hospitalizations, equivalent to about 140 billion dollars. In particular, the issue causing highest cost was nonadherence to therapy, with a value of almost 50% of the total. This cost would amount to about 105 billion for the 69% and it is attributable to the hospitalizations [20]. 6 Adherence-based savings in medical costs appear to be driven primarily by reductions in hospitalization rates at higher levels of medication adherence. Hospitalization is the largest component of medical costs, so it is likely that the changes in hospitalization risk are the primary driver of the cost savings observed at higher levels of adherence. 1.3 Identifying poor adherence At present the most common model used to assess the causes of the low adherence is the Osterberg model. This model evaluates the negative effects on the patient s ability to follow a medication regimen as a consequence of interactions among the patient, health care provider, and health care system (Fig.2) [14]. In this model, the level of adherence to pharmacological therapies is related to the type of relationship between the health care provider and the patient. Figure 2: Barriers to adherence:the interactions among the patient, health care provider, and health care system Variables related to how health care providers interact and communicate with their patients are key determinants of adherence and patient health outcomes [21-25]. The health care providers prescribe the medical regimen, interpret it, monitor clinical outcomes and provide feedback to patients [26]. Patients who view themselves as partners in the treatment process and who are actively engaged in the care process 7 have better adherence behaviour and health outcomes [27]. Warmth and empathy of the clinician emerge time and again as being central factors [28]. Whereas Physicians contribute to patients poor adherence by prescribing complex regimens, failing to explain the benefits and side effects of a medication adequately, not giving consideration to the patient s lifestyle or the cost of the medications, and having poor therapeutic relationships with their patients [29-31]. Also, the health care delivery system has great potential to influence the adherence behaviour of patients. The policies and procedures of the health system itself control access to, and quality of care. System variables include the availability and accessibility of services, support for education of patients, data collection and information management, provision of feedback to patients and health care providers, community supports available to patients, and the training provided to health service providers. More broadly, health care systems create barriers to adherence by limiting access to health care, using a restricted formulary, switching to a different formulary, and having prohibitively high costs for drugs, copayments, or both [32-34]. To improve the patient s ability to follow a medication regimen, all potential barriers to adherence need to be considered. An expanded view that takes into account factors under the patient s control as well as interactions between the patient and the health care provider and between the patient and the health care system will have the greatest effect on improving medication adherence. 1.4 Determinants of patient adherence Adherence is not only affected by patient-provider relationship and/or systemic and organizational factors associated with health care system but also the nature of condition, complexity and duration of the treatment regimen, adverse drug reactions [35-37]. According to the WHO these determinants of non-adherence can be aggregated into five dimensions [3]: - social and economic, - health system related, - therapy-related, - condition-related - patient related In Table 1 lists all the factors relating to each dimensions [38]. 8 Table 1: Factors Reported to Affect Adherence 1.SOCIAL AND ECONOMIC DIMENSION Limited English language proficiency Low health literacy Lack of family or social support network Unstable living conditions; homelessness Burdensome schedule Limited access to health care facilities Lack of health care insurance Inability or difficult accessing pharmacy Medication cost Cultural and lay beliefs about illness and treatment Elder abuse 2. HEALTH CARE SYSTEM DIMENSION Provider-patient relationship Provider communication skills (contributing to lack of patient knowledge or understanding of the treatment regimen) Disparity between the health beliefs of the heath care provider and those of the patient Lack of positive reinforcement from the health care provider Weak capacity of the system to educate patients and provide follow-up Lack of knowledge on adherence and of effective interventions for improving it Patient information materials written at too high literacy level Restricted formularies; changing medications covered on formularies High drug costs, copayments, or both Poor access or missed appointments Long wait times Lack of continuity of care 3.CONDITION-RELATED DIMENSION Chronic conditions Lack of symptoms Severity of symptoms Depression Psychotic disorders Mental retardation/developmental disability 4.THERAPY-RELATED DIMENSION Complexity of medication regimen (number of daily doses; number of concurrent medications) Treatment requires mastery of certain techniques (injections, inhalers) Duration of therapy Frequent changes in medication regimen Lack of immediate benefit of therapy Medications with social stigma attached to use Actual or perceived unpleasant side effects Treatment interferes with lifestyle or requires significant behavioral changes 5. PATIENT-RELATED DIMENSION Physical Factors Visual impairment Hearing impairment Cognitive impairment Impaired mobility or dexterity Swallowing problems Psychological/Behavioral Factors Knowledge about disease Perceived risk/susceptibility to disease Understanding reason medication is needed Expectations or attitudes toward treatment Perceived benefit of treatment Confidence in ability to follow treatment regimen Motivation Fear of possible adverse effects Fear of dependence Feeling stigmatized by the disease Frustration with health care providers Psychosocial stress, anxiety, anger Alcohol or substance abuse 9 1.5 Adherence to therapy: direct and indirect methods of measurement The methods available for measuring adherence can be broken down into direct and indirect methods of measurement Direct methods Direct methods of measuring adherence include: - Measurement of concentrations of a drug or its metabolite in blood or urine and detection or measurement in blood of a biologic marker added to the drug formulation are examples of direct methods of measures of adherence. For instance, the serum concentration of antiepileptic drugs such as phenytoin or valproic acid will probably reflect adherence to regimens with these medications, and subtherapeutic levels will probably reflect poor adherence or suboptimal dose strengths. - Medication Event Monitoring System (MEMS) and electronic monitoring which consists of a monitoring system, applied to the packages delivered to the patient. Thus, each time the package is opened and the drug is extracted the system records the time and date. This method can be effective in identifying White Coat compliers or patients who lie in order to make a good impression to the doctor. This method is still considered the golden standard for the verification of the adherence to treatment in clinical trials Indirect methods Indirect methods of measuring adherence include: - Self-reports to assess the knowledge of patient about the medications prescribed and the dosing schedule. This provide information as to whether the patient is adherent with the actual dosing schedule. Subjective assessments by interviewers can bias adherence estimates. - Pill counts to be more precise counting the number of pills remaining in a patient's supply and calculating the number of pills that the patient has taken since filling the prescription is the easiest method for calculating patient medication adherence. - Pharmacy records based on pharmacy refills is one of the more frequently used methods in the literature and allows of obtaining refills and the frequency with which the refills are acquired reflect different aspects of a patient s adherence behavior. This tool allows you to check the number and type of treatments withdrawn from the patient and also any interruptions occurring after the first prescription. 10 1.5.3 Advantages and disadvantages emerging form literature review The collaborative group of European Innovation Partnership A1 Action Group on Active and Healthy Ageing has reviewed the international literature on all possible indicators for medication adherence assessment: self-report, therapeutic drug monitoring, pill count, electronic monitoring devices, data reviews, prescription refill records, automated refill reminders, medication event monitoring systems, pharmacy claims data and prescription claims databases, electronic pharmacy databases. In Table 2 are presented the most commonly used tools focusing on their advantages and disadvantages, with information stemming from the literature review [39]. Table 2 Adherence assessment measures in the elderly: advantages and disadvantages emerging form literature review. Measure Advantages Disadvantages Self-report Easily understood by patients Uncomplicated to score Cost effective Allows to measure medication and behavioural adherence (no other method allows this) May focus on adherence, persistence, and discontinuation Useful screening tool in order t
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