The European Journal of Public Health Advance Access originally published online on June 7, 2005
The European Journal of Public Health 2005 15(3):276-281; doi:10.1093/eurpub/cki080
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Health Services Research |
Antibiotic prescription in primary health care: clinical and economic perspectives (Catalonia, Spain)
Josefina Caminal1 and Joan Rovira2
1 Universitat Autònoma de Barcelona, Catalonia, Spain
2 Human Development Network, World Bank, Washington, DC, USA
Correspondence: Josefina Caminal, MD, PhD, Universitat Autònoma de Barcelona, Facultat de Medicina. Medicina Preventiva i Salut Pública, Edifici M, 08193 Bellaterra (Cerdanyola) Barcelona, Spain, tel. +34 93 581 3802, fax +34 93 581 2344, Email: josefina.caminal{at}uab.es
Received January 17, 2002, accepted January 19, 2004
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Abstract |
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Objective: To quantify clinical inappropriateness of antibiotic prescription and its costs in primary health care. Methods: 2470 cases of infectious disease during 1998 were analysed. Results: Of all cases, 69.9% did not require antibiotic treatment. Global clinical inappropriateness amounted to 43.7%, rising to 56.7% with the introduction of economic criteria. Treatment unnecessary but antibiotic provided (27.9%) represented the most important category. Costs of inappropriateness reached 68.4% of the estimated total cost. Conclusion: Appropriate antibiotic use should be focused on reducing antibiotic prescription when not indicated and restrainting the use of penicillins maintaining restrictive and adequate health policies, and also achieving co-responsibility from the general population.
Keywords: antibiotic prescription, clinical inappropriateness, costs of inappropriateness, primary health care
Appropriate antibiotic (AB) prescription in Primary Health Care (PHC) is the first step for optimum AB use and has the potential impact of reducing resistant micro-organisms generated by excessive use.1 Spain has one of the highest levels of AB consumption in the European Union: 32.4/DDD/1000 inhabitants/year, only surpassed by France, and three times higher than that in The Netherlands or Denmark.2 Since the AB introduction and their massive use, a significant increase in the prevalence of bacterial resistance has been verified on an international scale,3 for which Spain is well known, mainly for species causing community infections such as Pneumococcus, Meningococcus, Haemophilus influenzae, Campylobacter jejuni, Salmonella and Escherichia coli.4 The aim of this study is to quantify clinical inappropriateness of AB prescription in PHC and its concomitant costs.
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Methods |
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An observational cross-sectional design for infectious visits from adult patients in 40 PHC centres of Catalonia corresponding to 1,111,605 inhabitants during 1998. The required sample included 2470 cases with an estimated 50% of appropriate prescription, 0.05 as error and a 4% precision. To minimise dispersion a second sampling was performed by bi-stage pooling with probability proportional to unit size. Thus, the sample included 29 PHC centres and 251 general practitioners (GP).
Clinical information was registered in primary care clinical charts (PCCC) where the GP assigned diagnosis and treatment (this study was not intended to validate the information from the PCCC). Data were collected from clinical record archives by four independent observers using a purpose-designed questionnaire containing: patient data (age, sex, allergies or AB-adverse reactions, chronic baseline diseases or risk factors), infectious disease data, treatment data (name, dose, duration, AB route and guidelines, prescription origin) and resource use data (complementary tests and patient referral). Diagnoses were classified according to the WONCA system,5 and a Nominal Group, composed of experts on infectious diseases from hospitals and PHC, helped codify doubtful cases. Active ingredients were codified by the Anatomic Therapeutic Chemical classification.6 Quality control of the collected data included: a pre-test to validate the questionnaire; a training course to reduce inter-observer variability; and a standard control for recording information to reduce intra-codifier variability.
The standard clinical reference was based on the Recommendations on the use of antimicrobials in Primary Health Care,7 and it was adjusted in order to take into account the pattern of bacterial resistance of the geographic area analysed. Clinical categorization was based on the appropriateness criteria established for each infectious condition, which allowed for the prescription of a non-standard AB when justified because of patients having allergies or adverse reactions to AB, a baseline disease or risk factor. Global clinical appropriateness included two distinct concepts: the need for AB therapy and its correct selection (figure 1).
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The standard cost reference was defined as the minimum cost of an appropriate AB treatment for each specific prescription. Global economic appropriateness included two distinct criteria: clinical appropriateness of AB and cost-effective selection of brand (figure 1). To calculate drug cost we used the Pharmaceutical Specialities Catalogue.8 Inappropriate cost was defined as the difference between the real cost of AB prescription and the standard cost. A negative cost, resulting from clinical inappropriate prescriptions was classified as economically inapproptiate, as it is not an effective cost (figure 1).
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Results |
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Sample characteristics and prescription pattern
There were 2470 patients with infectious disease consultations of which 39.6% were males and 60.4% females. Mean age was 54 years (±19.4, range 15–99). Forty-six diagnostic codes from the WONCA classification were identified. In 214 cases, allergies or AB-adverse reactions were recorded; in 26 cases, treatment for chronic disease could interact with AB.
Antibiotic prescription was recorded in 1355 cases, for which six were non-valid values (four did not specify the AB and two recorded an unknown commercial brand). Information recorded in the PCCC regarding dose, schedule and duration of the prescribed AB treatment was frequently missing or incomplete. Dose was recorded in 75.8% of the cases, dose and schedule in 55.6%, and only in 20% of the cases were dose, schedule and duration all recorded. A high variability was observed in the range of commercial brands prescribed, especially for ciprofloxacin (12 different brands), amoxicillin (11 different brands) and amoxicillin–clavulanic acid (8 different brands).
Global clinical inappropriateness
Global clinical inappropriateness was calculated from the 2438 valid cases with full information available. Of the 32 non-valid values, 28 were non-classifiable by either WONCA criteria or Nominal Group, and four cases of AB treatment recorded in the PCCC had no AB specified. According to the reference guidelines, 30.1% required AB treatment and 69.9% did not. Global clinical inappropriateness was found in 43.7% of the cases: AB treatment not required but prescribed (27.9%) was the most frequent case, although the contrary case, and not prescribed when necessary, (3.8%) was also remarkably frequent (table 1).
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Global economic inappropriateness and cost of inappropriateness
Global economic inappropriateness was calculated from 2436 valid cases. Of the 34 non-valid cases, 32 had no full clinical information available and two had recorded commercial brands not listed in the Pharmaceutical Specialities Catalogue. Global inappropriateness reached 56.7% when introducing economic criteria; this figure includes all the clinically inappropriate categories (43.7%) as well as those cases in which, despite clinical appropriateness, the commercial brand prescribed did not correspond to the optimum (i.e. less costly) economic option available in the market (13.0% of cases) (table 1).
Antibiotic prescription resulted in an estimated global cost of 22,177.2 Euros (
), of which 15,169.2 (68.4%) were generated by inappropriate prescriptions (table 1).
The costs of 1065 clinically inappropriate prescriptions (43.7%) were 10.9/visit. Of these, 680 cases (27.9%) corresponded to diagnoses not requiring AB treatment, with an average cost of 12.0/visit (table 1).
Clinical inappropriateness for the most frequently prescribed antibiotic
More than 90% of prescriptions were concentrated in a few Anatomic Therapeutic Chemical classification groups: penicillin, macrolide, quinolone and cephalosporins. Penicillins were the most frequently prescribed AB (43.7%). Macrolide, cephalosporin and penicillin (J01CR and J01CA) prescriptions reached high inappropriateness levels: 89.6%, 89.5%, 83.2% and 77.9%, respectively; and the levels were particularly high for conditions not requiring AB treatment. It is also noticeable that the highest inappropriate level (100%) was found for prescription of tetracyclines, although this result is based on a small number of cases (n=6) (table 2).
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Clinical inappropriateness for the most prevalent diagnoses
Seven diagnoses—acute infection of upper respiratory tract, acute bronchitis, urinary tract infections, influenza syndrome, acute tonsillitis, gastroenteritis and exacerbation of chronic obstructive pulmonary disease—caused 86.8% of the visits and were the cause of 44.6% of the inappropriate prescriptions. Conditions related to respiratory infections were the most frequent diagnoses (68.0%).
By specific diagnoses, acute bronchitis showed the highest rate of global inappropriateness, 78.9% corresponding to diagnoses not requiring AB treatment (table 2).
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Discussion |
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The evidence that only half of the visits (56.3%) led to an appropriate clinical prescription, and that appropriateness decreased to 43.3% when adding economic criteria, are the most striking results. The most common cause of inappropriate use was unnecessary AB prescription, which always results in a welfare loss for patients and society, since, irrespective of who bears the costs, the prescribed drugs exert no additional benefit and put patients at risk of adverse effects, turning out to be a waste of resources.9
The results might be sensitive to the clinical appropriateness criteria adopted in the study. However, using alternative guidelines would hardly have produced significantly different results. Firstly because 69.9% of the infectious diseases attended gave rise to diagnoses not requiring AB treatment, despite a general consensus in the medical community on not to prescribe AB for those diagnoses.10 Secondly, because ABs such as ciprofloxacin or cefixime, the use of neither of which is justified in PHC under almost any guideline, rank among the 15 most frequently prescribed ABs, representing 7.9% of the AB prescriptions.
All PCCC reviewed were from adults. The sample requirements and criteria of AB treatment between children and adults differ so much that more funding would be required to carry out a study including children. Information was collected from PCCC, therefore there might be inaccuracies in the records, but under the assumption applied, the bias due to insufficient information systematically underestimates both clinical and economic inappropriateness.
Our results confirm the excessive use of ABs, but they also show their inappropriate usage, particularly for penicillins, which contributes to the increase in resistant strains, thus involving high social costs that go well beyond the cost of the AB themselves, the only cost category considered in the present study.11 Unnecessary prescriptions may be due to pressures upon practitioners, either in the form of insufficient time to devote to each patient or unconscious demands from the patients.12,13 However, recent studies have shown how different strategies could improve prescription in PHC oriented either to individuals, GPs or both.14–16
Regarding management of ABs as part of a global health policy strategy, there are two factors worth mentioning: the variability in the commercial brand prices for the same active ingredient, and the non-accordance of containers and number of dose units with the usual duration of the most frequent diagnoses. Notwithstanding the current tendency to deregulate certain therapeutic groups, the magnitude of the public health problem caused by inappropriate AB use in Spain would suggest that maintaining a restrictive policy is advisable.17,18 .
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Conclusion |
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Optimum clinical and economic AB use requires mainly reducing unnecessary AB prescribing and restraint in the use of penicillins for clinicians, maintaining restrictive and adequate health policies and also achieving co-responsibility from the population.
This research was partially funded by the Catalan Agency for Health Technology Assessment (Catalonia, Spain).
Key points
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Acknowledgments |
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The authors want to thank the contributors of all participants in the pilot study, nominal group, and research team. The complete list of participants is in the full report. The full report is available in Catalan, Spanish and English at: http://www.aatrm.net/cas/informes/fichas/br99003.html.
We would like to thank the Health Department of the Generalitat of Catalonia and the Autonomous University of Barcelona for their support.
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References |
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