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From the Département dadministration de la santé et Groupe de recherche interdisciplinaire en santé (Dr. Blais), Université de Montréal, Montréal; Faculté de pharmacie et Groupe de recherche en Épidémiologie (Dr. Grégoire), Université Laval, Québec city; Centre universitaire de santé de lEstrie (Ms. Rouleau), Sherbrooke; Service de pneumologie (Dr. Cartier), Hôpital du Sacré-Coeur de Montréal, Montréal; Centre hospitalier St-Joseph de La Malbaie (Dr. Bouchard), La Malbaie; and Centre de pneumologie de lHôpital Laval (Dr. Boulet), Institut de cardiologie et de pneumologie de lUniversité Laval, Québec City, Québec, Canada.
A complete list of participants is given in the Appendix.
Correspondence to: Régis Blais, PhD, Groupe de recherche interdisciplinaie en santé, Université de Montréal, PO Box 6128, Station Centre-ville, Montréal, Québec, Canada H3C 3J7; e-mail: Regis.Blais{at}umontreal.ca
| Abstract |
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Design: Population-based retrospective drug utilization review using pharmacists billing data of the Prescription Drug Insurance Plan administered by the Quebec health insurance board. However, the database used did not contain complete patient clinical information to accurately assess severity of asthma.
Setting: Province of Quebec, Canada.
Patients: Persons who received at least one outpatient prescription of ISAB (age range, 5 to 45 years) or ILAB (age range, 12 to 45 years) for the treatment of asthma between August 1997 and April 1998.
Measurements: Percentages of patients whose use was appropriate according to three criteria regarding the average daily dose of ISAB (criterion 1), the renewal interval of ILAB (criterion 2), and the concomitant daily use of corticosteroids for the expected length of utilization of ILAB (criterion 3).
Results: Overall proportions of appropriate use according to criterion 1 were as follows: 75% (without inhaled corticosteroids [ICS]) and 84% and 43% (with one or more than one prescription of ICS, respectively). Appropriateness was slightly higher for female patients, younger patients (5 to 18 years old), and those treated by pediatricians. However, appropriateness was only 9% among patients who received at least two prescriptions of ISAB during the study period. The proportion of appropriate use was 19% according to criterion 2 and 15% according to criterion 3; there were few differences by gender or by age, but the appropriateness according to criterion 2 was somewhat higher for patients of respirologists.
Conclusion: Compared to the 1996 Canadian asthma consensus conference recommendations, ISAB are overused, ICS are underused, and ILAB are often used improperly. Close collaboration between health professionals and patients is essential to improve the pharmacotherapy of asthma.
Key Words: asthma Canadian consensus corticosteroids drug utilization review inhaled ß2-agonists
| Introduction |
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The understanding and treatment of asthma have improved in recent years, especially with the advent of new and more effective drugs. In 1992, the US National Institutes of Health published guidelines for the diagnosis and management of asthma based on scientific evidence.2 In 1996, a Canadian Asthma Consensus Conference developed similar guidelines.3 In particular, recommendations were formulated about the use of inhaled ß2-agonists, coupled with inhaled corticosteroids (ICS) when needed. The Canadian consensus statement has been publicized among physicians and pharmacists, through several local continuing medical education programs across Canada and by publications of these guidelines in local journals.4 5 Yet, previous experiences have shown that guideline dissemination alone does not guarantee change in clinical practice.6 We suspected that this could also be the case for the drugs recommended for asthma. Identifying instances where drug treatment is less than optimal would help design interventions to improve the effectiveness of therapy.
The objective of this study was to assess the appropriateness of use of inhaled short-acting ß2-agonists (ISAB) and inhaled long-acting ß2-agonists (ILAB) for the treatment of asthma, according to specific criteria based on the recommendations of the 1996 Canadian asthma consensus conference. Using a large population-based approach, this study quantifies the problem of appropriateness of pharmacotherapy for asthma and identifies potential predictors, which has rarely been done before.
| Materials and Methods |
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65 years old), welfare recipients, and those who do not
have access to a private group plan.
The study population included the persons who received at least one
outpatient prescription of ISAB or ILAB for the treatment of asthma,
between August 1, 1997 and April 30, 1998. To simplify the analysis and
because they were few, users of ß2-agonists
administered with a nebulizer were not selected. To compensate for the
absence of valid diagnostic information in the RAMQ database and retain
actual asthma subjects, a number of exclusions were made. Patients
> 45 years old were excluded because of a higher prevalence of COPD
in this age group. For the analysis of ISAB, children < 5 years old
were excluded because of the difficulty of diagnosing asthma and to
avoid including cases of bronchiolitis, which is common at that age.
For the analysis of ILAB, children < 12 years old were excluded
because the medication is not officially indicated for this age group.
Subjects who took certain drugs (acetylcysteine, racemic epinephrine,
ipratropium alone or in combination with salbutamol, morphine,
pancreatin, pancrelipase, and tobramycin) were excluded because they
could have received inhaled ß2-agonists for
medical conditions other than asthma. Among those who used ISAB, we
also excluded subjects who took oral corticosteroids during the study
period, in order to exclude those with severe asthma who may
temporarily require higher doses of ISAB during acute asthma episodes.
As the appropriate consumption of ISAB is difficult to assess in
patients with more severe asthma, we excluded subjects who received
estimated daily doses of inhaled beclomethasone or its equivalent:
> 800 µg for those aged between 5 years and 11 years, or 1,000 µg
for those
12 years old. Finally, among subjects who had only one
prescription of ISAB during the study period, we excluded those for
whom the interval between the date the prescription was filled and the
end of the observation period was < 100 days for salbutamol
consumption (other periods apply for other drug denominations according
to number of inhalations per device) because the time frame was then
too short to assess the appropriateness of use.
Two databases from the RAMQ were used and linked at the patient level using unique encrypted health insurance numbers. The pharmacist billing database provided information on the drugs dispensed (type of drug, duration of treatment, and date where prescription was filled) and the identification of the prescriber (including specialty) and the patient. The beneficiary database contained the patient age, gender, and region of residence. The validity of the Quebec prescription claims databases for pharmacoepidemiologic research has been established.8
Study subjects were classified into four mutually exclusive groups: users of ISAB without ICS (n = 20,633), with one (n = 6,716) or more than one (n = 6,067) prescription of ICS during the study period, and users who received ILAB with or without ISAB (n = 775). The generic names of the study drugs for ISAB are fenoterol, pirbuterol, salbutamol, and terbutaline; those for ILAB are formoterol and salmeterol; and those for ICS are beclomethasone, budesonide, flunisolide, fluticasone and triamcinolone. Based on the dates when the prescriptions were filled and the use of appropriate equivalence factors related to beclomethasone for different ICS, average daily consumption of ISAB and ICS (of beclomethasone dipropionate equivalent) was calculated. Table 1 presents the approximate equivalence of different ICS used in this study and estimated from various expert sources.9 10 11 12 However, there are yet no definite equivalence factors because the mode of administration and absorption varies by drug.
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Criterion 1:
Use of ISAB was considered appropriate if two
inhalations per day or less of equivalent salbutamol were taken, either
with or without ICS. The Canadian consensus guidelines recommend a
maximum of two inhalations of ß2-agonists three times a
week, excluding use to prevent symptoms due to exercise. Since the
available data contained no information on use of
ß2-agonists for exercise-induced symptoms, a less
stringent criterion was employed to allow for such use. The
appropriateness of the daily dosage was assessed both according to the
quantity dispensed and by measuring the time interval between two
dispensings of ß2-agonists. In the event that only one
prescription of ISAB was present in the database during the study
period, use was automatically found appropriate because the interval
between the date the prescription was filled and the end of the
observation period was at least equivalent to 100 days of salbutamol
consumption (ie, two inhalations per day).
Criterion 2:
Use of ILAB was considered appropriate if they
were refilled between 25 days and 35 days after filling of the initial
prescription. According to the experts, if the prescription was
refilled before 25 days, consumption was considered too high; if it was
after 35 days, consumption was deemed insufficient to control asthma
properly.
Criterion 3:
If an inhaled or oral corticosteroid was
concurrently taken (the exact dose varies with each patient condition
although it is generally accepted that the dose of ICS should be at
least 400 µg/d) during the full period of the prescription for ILAB,
utilization was considered appropriate. According to the Canadian
asthma consensus guidelines, ICS should not be interrupted during
treatment with ILAB.
For each of the four study groups, we calculated the proportion
(percentage) of patients whose use of
ß2-agonists was appropriate according to the
specified criteria, broken down by patient characteristics (age,
gender, and region of residence) and physician specialty. The numerator
was the number of patients whose use was appropriate and the
denominator was the total number of patients in each category. The
analysis of associations between appropriateness of use and physician
and patient characteristics was done using Pearson
2 test.
| Results |
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In the group using both ISAB and ICS, the overall proportion of appropriate use was 84% among subjects who had only one prescription of ICS and 43% among those who had more than one. Considering only the subjects who had at least two prescriptions of ISAB during the study period, appropriateness drops to 11% (126 of 1,173 subjects) and 8% (282 of 3,758 subjects), respectively. Overall, appropriateness was quite similar for male and female subjects, but was higher for younger ones, especially among those who had more than one prescription of ICS during the study period (57% among subjects 5 to 11 years old, 35% among subjects 19 to 45 years old). Subjects treated by pediatricians had a higher proportion of appropriate use. The proportion varied somewhat less across regions in the group with one prescription of ICS (81 to 89%) than with two or more prescriptions (36 to 48%).
The Canadian consensus guidelines suggested that for people
12
years old who are not optimally controlled with low doses of ICS (400
µg/d), this dose should be increased up to 1,000 µg of
beclomethasone or equivalent. This study shows that 63% of subjects in
this age group whose use of ISAB was considered questionable took on
average < 400 µg/d of inhaled beclomethasone or its equivalent,
ie, probably not enough to be adequately controlled. For
younger children, the recommended dosage is more variable, so a similar
assessment is more difficult to make. Yet, 57% of children aged
between 5 years and 11 years used daily doses < 200 µg of inhaled
beclomethasone or its equivalent.
Only 775 users of ILAB were identified. There were more female than male subjects and many more adults than adolescents in this group (Table 3 ). Unlike subjects taking ISAB, nearly half of the subjects received the prescription of their long-acting preparations from respirologists and about one third from general practitioners. The interval for refilling a prescription of ILAB (criterion 2) was considered appropriate for 19% of users. Few (5%) refilled their initial prescription of ILAB too early, ie, before 25 days, while 76% did so > 35 days after. Appropriateness was even lower for criterion 3 (15%) regarding the necessity to use corticosteroids concurrently. For both criteria, appropriateness did not vary by gender or by age, but for criterion 2, it was somewhat higher for subjects treated by respirologists than other physicians. Analysis by region was not conducted because many regions had too few cases.
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Finally, the 1996 Canadian consensus guidelines stated that when a patient is treated with ILAB, ISAB could also be used if needed, but at the lowest possible dosage.2 The concurrent use of ISAB among users of ILAB was thus examined. Results showed that 47% of the latter group also took on average more than the two maximum recommended inhalations of salbutamol or its equivalent daily.
| Discussion |
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Explanations for suboptimal drug use could be related to the characteristics of patients, health-care providers, policies, and the drugs themselves. First, higher proportion of appropriate use of ISAB among 5- to 18-year-old patients may be due to the fact that parents take charge of the treatment of children, especially younger ones, and monitor it closely. Second, erroneous negative perceptions about the potential side effects of ICS among asthmatic patients may be a barrier to adherence to optimal treatment.21 Finally, the inappropriate use of ILAB may be explained by the lack of knowledge among users as to the specific role of the various medications employed in the treatment of asthma, ie, ISAB, ILAB, and ICS.
For health-care professionals, several factors may contribute to the nonadherence to clinical recommendations (eg, unawareness of recent knowledge, practice setting, mode of remuneration).22 In this study, the fact that pediatricians (for ISAB) and respirologists (for ILAB) prescribe more appropriately than general practitioners may be due to differences in training and practice volume.23 24 Alternatively, inappropriate or insufficient patient education by providers may also lead to inadequate use of medication.
Policies such as cost-sharing arrangements could also influence the appropriateness of drug use. The cost of corticosteroids is much higher than the cost of ß2-agonists. Despite the public drug plan coverage in Quebec, co-payment by users may reduce compliance to optimal treatment of asthma. Under the RAMQ drug plan, prescribed medications are free of charge for children up to 18 years old. Gratuity for this category of subjects may then explain why the proportion of appropriate use (especially with ICS) is higher since economical accessibility is a facilitator.
The characteristics of the drugs themselves may also condition their optimal use. The overuse of ISAB and underuse of ICS by patients may be due to the fact that the former provide immediate relief of acute symptoms compared to the latter, a long-term controller whose effect can take more than a week to show. Patients may prefer the medication they actually feel is beneficial, while failing to properly treat the underlying inflammatory cause of their symptoms. The difficulty in taking this type of medication could also cause problem. For example, wrong techniques of administration of inhalers may reduce their effect and contribute to their overuse, especially in the case when a drug, such as ß2-agonists, is taken for immediate relief.
Since the use of drugs is the outcome of a process involving mainly the physician, the pharmacist, and the patient, behavioral change should be sought in all three to improve the pharmacotherapy of asthma. For ISAB, since general practitioners are the main prescribers, they should be the principal target of interventions aimed at changing physician behavior. Adult male patients should receive special attention because of their lower appropriate use of ISAB. In the case of ILAB, everyone needs to be reminded that ICS should not be interrupted during a treatment with ILAB (criterion 3).
Various types of interventions could be implemented to improve the quality of drug prescribing and utilization, and many of them have been reviewed elsewhere.19 22 25 26 27 In any case, close collaboration between health professionals and patients is essential. Here are some proposals that apply especially to the subject of this study. For example, an algorithm for the treatment of asthma should be distributed to physicians and pharmacists to ensure that a consistent message is delivered to asthmatic patients. Physicians and pharmacists should have inhaler placebo demonstrators in their work settings to teach patients how to use this type of device. Public authorities should support the implementation of centers where physicians and pharmacists can refer asthmatic patients for education and informative material about environmental risk factors and treatments for asthma.28 Professionals themselves should participate in continuing education activities to improve their knowledge and skills regarding this disease.
This study has a number of limitations, especially related to the use of administrative databases. The main limitation is the absence of valid information about the clinical indication for treatment. The large number of subjects who had only one prescription for ISAB during the study period makes us think that, despite our efforts, the selection of asthmatic patients was not perfect. The absence of diagnostic information in the database also precludes adjustment of appropriateness for case severity, which would be useful when comparing regions or physicians by specialty. Another limitation comes from the fact that the study is based on claims that pharmacists send to the RAMQ when they fill a prescription. Information on actual consumption of medication delivered is not known for sure but only assumed. Yet the RAMQ drug prescriptions database has been shown to be both reliable and valid.8 Finally, the data source employed did not include samples that were given to subjects by physicians nor medications received by patients who were admitted to hospitals. As a consequence, given that criterion 1 is based on the refill patterns of ISAB, the proportion of appropriate use may have been overestimated. Conversely, daily dosages of ICS that were calculated may have been underestimated.
In summary, this study suggests that the recommendations of the 1996 Canadian Asthma Consensus Conference were far from being followed by physicians and/or their patients. A new Canadian asthma consensus report has now been published.29 In the light of our results, it seems that special actions need to be taken to make sure that the new guidelines are not only disseminated but implemented by all involved parties.
| Appendix 1 |
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| Acknowledgements |
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| Footnotes |
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This study was funded by the Comité de revue de lutilisation des médicaments of the province of Quebec.
Received for publication February 1, 2000. Accepted for publication November 16, 2000.
| References |
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