Bronchial asthma is a chronic airway disorder and it is considered to be one of the major health problems in the Western world. For about 20 years, until the 1990s, the prevalence of asthma was increasing steadily in many countries, and especially in children.16
The diagnosis of asthma is made after accurate history-taking from the patient and a clinic visit, along with lung function tests including spirometry, a bronchial obstruction reversibility test, and a nonspecific bronchial challenge test.11
The decision to start regular treatment depends on the severity of asthma at the time of diagnosis, and on the frequency and severity of exacerbations. A progressive, stepwise approach to drug therapy is recommended, with selection of the best options for the individual patient based on disease severity. A significant increase in the use of β2-agonists in combination with inhaled corticosteroids was observed during the last decade. These drugs are recommended as first-line treatment for moderate to severe asthma, because they control symptoms efficiently.16
Drugs used in the treatment of asthma are also used in the treatment of obstructive airway disease (R03), which makes up about 8% of total drug expenditure by the national health care system in Italy,22
and an amount in line with that spent by the Milano 2 ASL.
Due to the importance of this disease, expenditure on its treatment, and the current need to keep public health care expenditure in check, we deemed it necessary to investigate the prescription of these drugs in terms of appropriateness and sustainability of expenditure using the real population of a local health care unit. The public health care system has been using patient databases for years, mostly for administrative purposes and to keep expenditure under control.13
The information contained in administrative databases is a byproduct of economic and/or administrative operations, and so characterizes patients as “consumers” of health care services. The main information recorded relates to medical prescriptions and health care services provided.
Assessment of drug utilization as shown in the patient database of the Milano 2 ASL allowed us to identify prescribing patterns in an important sample of the asthmatic population, to define the total and per capita costs of this disease, and to suggest policies aimed at appropriateness and optimization of expenditure by defining benchmarks between districts, physicians, different time periods, prescriptions by age and gender, and territorial spread of the disease. As regards prescription trends, we observed that combinations of corticosteroids + β2-agonists are increasingly replacing the use of single active ingredients. Furthermore, medication use varied widely during the year, with peaks in prescription of drug combinations in the months of April–May and October–November, especially in the younger population aged 18–40 years, which is in line with international research on this topic.7
This may be further evidence of correct selection of only asthmatic patients and exclusion of patients potentially suffering from COPD.
In recent years, researchers have pointed to the persistence of problems connected with drug use, such as choosing the wrong medication, incorrect duration of treatment, inadequate dosage regimens, and undertreatment.23
For this reason, an analysis was also carried out on the appropriateness of prescribing for this category of patients by general practitioners. Our analysis showed that about 70% of patients were using their medications inappropriately. Total packs used inappropriately comprised about 45% of the total packs used by patients in our study. About 40% of the cost to the health care system of this inappropriateness related to antiasthma combination therapy, even though the situation slightly improved during the study period. For instance, 2% of patients using over 12 packs a year have a 7% impact on the total expenditure for this type of drug treatment. Our results showed that increasing the use of extrafine formulations in these patients would have resulted in reduced expenditure, without simultaneous worsening of the health status in the treated population, because of the lower cost of these drugs, the effectiveness of which is equivalent to that of the other formulations. Indeed, in 2009, in spite of the fact that prescriptions for the extrafine formulations increased until they overtook prescriptions for sprays, expenditure on extrafine formulations remained equal or even lower than the expenditure for spray drugs.
However, it is important to highlight that use of administrative databases also implies some limitations. The data collected come directly from pharmacy invoices, meaning that they provide a true estimate of medications dispensed, but not of the actual prescriptions written by physicians. The main limitation of administrative databases is indeed the lack of clinical data; because they are created for accounting purposes, they omit data on factors such as patient lifestyle, symptoms, diagnoses, and intermediate outcome indicators, including vital signs and results of biochemical investigations. Therefore, given that patient diagnoses are not available, we cannot be completely certain that our study patients were really suffering from asthma. Inclusion and exclusion criteria for the selection of the sample of asthmatic patients to be studied were based on the terms of prescription, ie, the kind of drugs used, treatment duration, need for oxygen therapy, and patient age.
In conclusion, based on the results obtained by observing medication use among asthmatic patients in the Milano 2 ASL, we can assert that there is a high level of inappropriate drug expenditure. However, it is improving, which has had a clear impact on both expenditure and patient health, given the potential for exacerbations over time. Being able to measure and understand the concept of appropriateness of therapy are not only critical to determining the effectiveness and safety of a certain drug, but they are also important for the creation of programs aimed at improving the quality of drug use. The appropriateness indicator chosen was the number of packs used, because the data sheets for these antiasthma products as well as the relevant guidelines15
recommend following a daily dosing regimen in order to achieve and maintain asthma control.17
The data reported here suggest that we need to define a maximum number of yearly drug combination prescriptions that can be written by general practitioners, with the recommendation that these therapies be used in a more continuous way, as is suggested in the scientific literature.16
In the light of the above results, we hope to be able to implement better health care planning and improve prescribing practices in the treatment of patients with asthma in Italy. The results of this study could be extended to other regional and/or national reference local health care units, in order to define and compare average standard costs per pathology, consolidated through the wide sample considered. Appropriate drug prescribing is of critical importance in order to achieve therapeutic objectives and to optimize use of resources by modern health care systems.