Assessment of Extent and Quality of Pharmacoeconomic Studies in India Using Quality of Health Economic Studies Score: A Targeted Literature Review.

OBJECTIVES: We assessed the quality of pharmacoeconomic studies conducted in India to report key areas of focus on the findings from the reviewed studies. METHODS: A targeted literature review was conducted using well-defined search strategy in PubMed to identify economic studies conducted in India from May 2017 to April 2022. Only economic evaluation studies were included, whereas trial-based cost analyses were excluded. The quality of included studies was assessed using the Quality of Health Economic Studies tool, which comprised 16 evaluation criteria related to objectives, source, funding, perspective, subgroup analysis, scales, and economic modeling related parameters. Based on scores (100 points), studies were rated as good (≥75), fair (50-74), and poor (≤49) quality. RESULTS: Search strategy provided 888 studies; 95 of these were economic studies, and 74 were included in the analysis. These 74 studies included budget impact analysis (n = 4), burden of illness (n = 8), cost-benefit analysis (n = 5), cost-consequences analysis (n = 1), cost-effectiveness analysis (n = 55), and cost-utility analysis (n = 1). The average quality score of studies was 64.08. Of the studies, 15 studies were rated as "good," 51 "fair," and 8 "poor." It was observed that primary outcome measures, stating negative outcomes, reporting bias, and implementing statistical and sensitivity analysis significantly affected the quality score. CONCLUSIONS: Most of the health economic studies conducted in India are of fair quality, and there is a need for standardization of guidelines and increase in number of Indian peer-reviewed health economics journals. A collaborative effort from pharma companies, policy makers, education experts, curriculum planners, and medical faculty is needed to promote quality economic studies.

An overview of the characteristics and quality assessment criteria in systematic review of pharmacoeconomics.

BACKGROUND: The systematic review of economic evaluations plays a critical role in making well-informed decisions about competing healthcare interventions. The quality of these systematic reviews varies due to the lack of internationally recognized methodological evaluation standards. METHODS: Nine English and Chinese databases including the Cochrane Library, PubMed, EMbase (Ovid), NHS economic evaluation database (NHSEED) (Ovid), Health Technology Assessment (HTA) database, Chinese National Knowledge Infrastructure (CNKI), WangFang, VIP Chinese Science & Technology Periodicals (VIP) and Chinese Biomedical Literature Database (CBM) were searched. Two reviewers independently screened studies and extracted data. The methodological quality of the literature was measured with modified AMSTAR. Data were narrative synthesized. RESULTS: 165 systematic reviews were included. The overall methodological quality of the literature was moderate according to the AMSTAR scale. In these articles, thirteen quality assessment tools and 32 author self-defined criteria were used. The three most widely used tools were the Drummond checklist (19.4%), the BMJ checklist (15.8%), the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement (12.7%). Others included the Quality of Health Economic Studies (QHES), the Consensus on Health Economic Criteria (CHEC), the checklist of Center for Reviews and Dissemination (CRD), the Philips checklist, the World Health Organization (WHO) checklist, the checklist of Critical Appraisal Skills Program (CASP), the Pediatric Quality Appraisal Questionnaire (PQAQ), the Joanna Briggs Institute (JBI) checklist, Spanish and Chinese guidelines. The quantitative scales used in these literature were the QHES and PQAQ. CONCLUSIONS: Evidence showed that pharmacoeconomic systematic reviews' methodology remained to be improved, and the quality assessment criteria were gradually unified. Multiple scales can be used in combination to evaluate the quality of economic research in different settings and types.

Evaluation of quality of pharmacoeconomic studies involved in traditional Chinese medicine in China.

OBJECTIVES: The pharmacoeconomic studies of traditional Chinese medicine (TCM) are still in its infancy. Assessing the quality of pharmacoeconomic studies of TCM to improve the efficiency of health resource allocation and guide the rational use of medicine. METHODS: Four databases were searched from inception to January 2018. The Consolidated Health Economic Evaluation Reporting Standards statement (CHEERS) and the Quality of Health Economic Studies (QHES) were used to assess the reporting quality and methodological quality. STATA 12.0 and Meta analyst 3.13 were used to analyze the related data. RESULTS: A total of 178 studies were included. The methodological evaluation of the study found that the total score of QHES was 47.85 ± 8.09. The report quality evaluation results found that many studies did not report comprehensive information, such as lack of detailed reports on abstracts, study perspectives, time frames, discount rates, model selection, but the titles, study background and location, and health results, resource and cost estimates, analysis methods, and heterogeneity analysis are reported in more detail. Six of the ten stratification factors have statistically significant differences. CONCLUSION: The overall quality of pharmacoeconomic studies of TCM is low, and further standardization and improvement are needed to obtain reliable study results.

Interventional Pharmacoeconomics.

The increasing cost of health care is a major challenge around the world, but particularly in the United States. One reason for increased costs is the rapidly rising cost of oncology drugs. Potential solutions to this problem involve broad changes to health policy. However, an alternative solution is the development of lower-cost off-label treatment regimens, based on pharmacologic rationale, with significant potential economic impact. The pharmacologic and clinical properties of many drugs allow for a variety of different strategies. We describe this approach of interventional pharmacoeconomics and provide multiple individual examples.

Pharmacoeconomic Evaluations: Guidelines for Drug Purchasers.

OBJECTIVE: To propose a set of guidelines for use by health care organizations in the United States that seek useful, comparative clinical information and economic analysis on pharmaceutical products to make sound drug purchasing decisions. PRACTICE INNOVATION: Based on a therapy intervention approach, the guidelines provide a structured framework to help managed care purchasers become more consistent in how they evaluate drug products for inclusion in the formulary. The guidelines factor in the need to examine the impact of new drug products on overall costs within the entire health system. PRACTICE SETTING: Intended for use by managed care organizations in the U.S. that purchase prescription drugs. INTERVENTION: Not applicable. MAIN OUTCOME MEASURE: Not applicable. RESULTS: The guidelines provide MCOs with a new systematic approach for identifying the overall cost and clinical outcomes impact of drug therapies. The guidelines are designed to take into account the characteristics of the patient population being treated and the fact that patients generally are redistributed among different treatment categories once a new drug product is introduced, thus offering MCOs an analysis model that extends beyond the traditional partial cost-outcomes approach. Emphasis is placed on looking at the cost-outomes impact of a new drug or therapy within a systems or disease area framework in which the redistribution of patients between therapy options is explicitly modelled. The guidelines specify that the following information elements be used in pharmacoeonomic analysis: product description, place in therapy, comparator products, therapy intervention framework, supporting clinical data, supporting pharmacoeconomic data, system impact assessments-costs-outcomes, overall assessment, and bibliography and supporting materials.

Ipragliflozin as an add-on therapy in type 2 diabetes mellitus patients: An evidence-based pharmacoeconomics evaluation.

AIM: To evaluate the efficacy, safety and cost-effectiveness of ipragliflozin as an add-on therapy in patients with type 2 diabetes mellitus (T2DM). METHODS: PubMed, EMBASE, the Cochrane Library, Web of Science and four Chinese databases, as well as the ClinicalTrials.gov website were searched from their inception through Jan 2019. Methodological quality was assessed using the Cochrane risk of bias, and meta-analysis was performed using RevMan5.3. RESULTS: A total of 11 randomized controlled trials with 1766 patients were included. Ipragliflozin administered (50 mg) once daily as an add-on therapy to other glucose-lowering medications (metformin, pioglitazone, sulfonylurea, α-glucosidase inhibitor, sitagliptin, insulin) was associated with reductions in hemoglobin A1c (HbA1c) of -0.74% (95% confidence interval (CI) -1.00 to -0.48), fasting plasma glucose (WMD -25.03 mg/dL; 95% CI -32.89 to -17.16), weight, waist circumference, blood pressure, and triglycerides levels. Neither the incidence of treatment-emergent adverse events (TEAEs) (RR 1.08; 95% CI 1.00 to 1.16) nor drug-related TEAEs (RR 1.19; 95% CI 0.93 to 1.54) was significantly increased. However, it was associated with an increased risk of hypoglycemia when added to insulin (RR 1.71; 95% CI 1.13 to 2.61). Compared with the pioglitazone group and the sitagliptin + metformin group, the incremental cost-effectiveness ratio of ipragliflozin add-on therapy group was $4976.89, $2089.76 per percentage of qualified HbA1c, respectively. CONCLUSION: Ipragliflozin as an add-on therapy is well tolerated and effective. Ipragliflozin as an add-on therapy do not appear cost-effective compared with metformin alone, but may be competitive against pioglitazone group and the sitagliptin + metformin group.

Assessing Data Sources for Medicine Price Studies.

OBJECTIVES: There is no established methodology to assess the feasibility of medicine price data sources. Against this backdrop, a framework to guide the selection of most appropriate price data sources for pharmacoeconomic research has been developed. METHODS: A targeted literature review was carried out. Dimensions discussed in literature as relevant for medicine price comparisons and practical experience of the authors in medicine price studies informed the conceptional work of the framework development. A draft version of the framework was reviewed by peer pricing experts. The feasibility of the framework was tested in case studies. RESULTS: According to the developed framework (called Re-ADAPT), a medicine price data source should meet the following criteria: reliability and sustainability; accessibility at a cost that users can afford; provision of medicine price information at the date(s) required; information for the defined geographic area, or at least in a representative way; coverage of the pharmaceuticals and at the price type(s) required. Easy handling and provision of additional information were defined as supportive assets of candidate data sources (secondary criteria). The case studies confirmed the feasibility of the Re-ADAPT framework. In some cases, however, it can be difficult to disentangle assessment criteria (particularly geographic area, scope of pharmaceuticals and price types) for separate consideration, given their interlinkage. CONCLUSIONS: While selection of the most appropriate data sources will remain a challenge, the Re-ADAPT framework aims to provide practical guidance and thus contribute to a more careful, balanced, and evidence-based selection of data sources for medicine price studies.

Evaluation of Quality of Pharmacoeconomic Studies in Asia-Pacific Region and Identification of Influencing Variables.

OBJECTIVES: To assess the quality of pharmacoeconomic studies and identify different variables influencing the quality of these studies conducted in the Asia-Pacific (APAC) region. METHODS: A systematic literature search was performed with PubMed and Cochrane using different combinations of terms for cost-effectiveness, cost-utility, and cost-minimization analyses. The Quality of Health Economic Studies (QHES) instrument was used for quality assessment of included studies. Logistic regression was performed to determine the association of factors with high-quality studies (QHES score ≥75). RESULTS: Of 262 retrieved studies, 128 met the inclusion criteria. The mean QHES score was 67.4 ± 1.35. The distribution of studies in each quality quartile was as follows: high (n = 59 [46.09%]), fair (n = 50 [39.06%]), and poor (n = 19 [14.83%]). Most of the high-quality studies (n = 80 [62.5%]) were conducted in Japan and Australia. Only 11 high-quality studies (18.64%) were published in specialty journals and 4 (6.78%) in Asian journals. Primary authors who had advanced training in health economics were associated with a higher number of high-quality studies (n = 51 [86.44%]). Training of primary authors was significantly associated with high-quality studies (odds ratio 7.1; 95% confidence interval 2.9-19.23). Impact factor of journal, per-capita expenditure on health care, and out-of-pocket expense on health did not have a significant association with high-quality scores. CONCLUSIONS: High-quality pharmacoeconomic research is confined to a few countries of the APAC; it can be improved by advance training of authors in public health or health economics. Also, a greater interest of various stakeholders in funding the research and the introduction of specialty journals in the APAC are warranted.

A systematic review of pharmacoeconomic guidelines.

OBJECTIVE: To review, summarize, and analyze both similarities and differences of pharmacoeconomic (PE) guidelines, to enable researchers to access their characteristics and the current state of PE guidelines; furthermore, to learn which methodological issues still remain contested and to promote the methodological development of PE guidelines. MATERIALS AND METHODS: The authors performed a search for PE guidelines using PubMed, the Cochrane library database, and the websites of the International Society for Pharmacoeconomics and Outcomes Research. Information of each guideline was extracted using a pre-designed extraction template, which included 22 aspects; the guidelines were summarized in the forms of charts, and their characteristics have been described. RESULTS: A total of 40 PE guidelines were studied. The most common methodological issues include the types of analysis, sources for effectiveness, use of quality-adjusted life-years (QALYs) to measure outcomes, and use of incremental cost effectiveness ratios to present results. The majority of the guidelines preferred a cost utility analysis with outcomes expressed in terms of QALYs. Most of the guidelines preferred meta-analysis or meta-analysis of the randomized controlled trials, and required a systematic review of all evidence. Issues that varied most in the guidelines were the choice of the comparator, recommended costs to be included, methods related to indirect cost calculations, methods of sensitivity analysis, and discounting rate. CONCLUSION: A comparison of these guidelines revealed that a number of differences exist among them in several key aspects, and some critical methodological issues still exist, for which no best solution is available. Furthermore, efforts need to be made to develop harmonious methods for the PE, and to improve the transferability of the outcomes of PE evaluations.

Good practices for real-world data studies of treatment and/or comparative effectiveness: Recommendations from the joint ISPOR-ISPE Special Task Force on real-world evidence in health care decision making.

PURPOSE: Real-world evidence (RWE) includes data from retrospective or prospective observational studies and observational registries and provides insights beyond those addressed by randomized controlled trials. RWE studies aim to improve health care decision making. METHODS: The International Society for Pharmacoeconomics and Outcomes Research (ISPOR) and the International Society for Pharmacoepidemiology (ISPE) created a task force to make recommendations regarding good procedural practices that would enhance decision makers' confidence in evidence derived from RWD studies. Peer review by ISPOR/ISPE members and task force participants provided a consensus-building iterative process for the topics and framing of recommendations. RESULTS: The ISPOR/ISPE Task Force recommendations cover seven topics such as study registration, replicability, and stakeholder involvement in RWE studies. These recommendations, in concert with earlier recommendations about study methodology, provide a trustworthy foundation for the expanded use of RWE in health care decision making. CONCLUSION: The focus of these recommendations is good procedural practices for studies that test a specific hypothesis in a specific population. We recognize that some of the recommendations in this report may not be widely adopted without appropriate incentives from decision makers, journal editors, and other key stakeholders.

Assessment of the quality of pharmacoeconomic evaluation literature in China.

OBJECTIVE: To evaluate the quality of Chinese pharmacoeconomic-evaluation literature published between 2012-2014 retrieved from the Chinese National Knowledge Infrastructure (CNKI) in order to assess their adherence to recommendations of the Chinese Pharmacoeconomic Guidelines. METHODS: Identified literature was screened according to pre-specified criteria to access legibility for inclusion. Each included piece of literature was systematically compared against the recommendations proposed by the relevant Chinese guidelines. RESULTS: After culling, 259 studies were included in the comparative analysis. When compared to a previous study evaluating the quality of similar literature published between 1997-2007, the results showed improvements in certain technical aspects over the years. Particularly, an improvement was observed in more diverse evaluation methods being used, increased use of cost-utility analysis (2.43% in 2012-2014 vs 0.26% in 1997-2007) and use of discounting (45% in 2012-2014 vs 4.35% in 1997- 2007). In addition, a small number of studies were starting to apply modeling. CONCLUSION: The quality of economic evaluation literature has improved in recent years, with more researchers realizing the importance and necessity of using discounting, sensitivity analysis, and modeling when conducting economic evaluation. This study also highlights certain important areas needing further attention when conducting economic evaluations in China. These include the ICER threshold of economic analysis, more detailed guidance in performing sensitivity analysis and modeling, as well as transferability of cost data across different regions. Overall, the results would support the positive contribution of the Chinese Economic Guideline in promoting economic evaluations in China.

Cost-consequence analysis of Pharmaceutical Care program for systemic arterial hypertension in the public health system in Brazil

ABSTRACT In Brazil, 80% of hypertensive patients have no blood pressure controlled, this fact has caused severe financial consequences for the public health system (PHS) and the Pharmaceutical Care (PC) has emerged as an effective alternative. The aim of this study was to analyze the costs and outcomes of systemic arterial hypertension (SAH) for conventional assistance compared to assistance with PC in the PHS. This is a pharmacoeconomic study with cost-consequence analysis nested to clinical trial. Hypertensives patients were followed-up from 2006 to 2012. During 2009 they were assisted by the PC program in Ribeirão Preto-SP, Brazil. Clinical indicators, systolic and diastolic blood pressure (SBP and DBP), triglycerides, total cholesterol (TC) and its fractions and healthcare indicators, consumption of antihypertensive medication and consultations were analyzed. Costs were listed as direct medical and direct non-medical. The average cost of conventional care for 104 patients followed-up was US$ 198.97, in the PC period and after discharge was US$ 407.91 and US$ 214.96 patient/year. After discharge of patients from PC there was reduction of SBP, DBP, TC and cardiovascular risk, 9.4 mmHg, 4.6 mmHg, 12.0 mg/dL, and 23% [p<0.005], respectively. The PC program optimized clinical and healthcare indicators and impacted in the SAH costs for the PHS.

Quality of pharmacoeconomic research in China: A systematic review.

BACKGROUND: The number of pharmacoeconomic publications in the literature from China has risen rapidly, but the quality of pharmacoeconomic publications from China has not been analyzed. OBJECTIVES: This study aims to identify all recent pharmacoeconomic publications from China, to critically appraise the reporting quality, and to summarize the results. METHODS: Four databases (PubMed, Web of Science, Medline, and EmBase) were searched for original articles published up to December 31, 2014. The Consolidated Health Economic Evaluation Reporting Standards statement including 24 items was used to assess the quality of reporting of these articles. RESULTS: Of 1046 articles identified, 32 studies fulfilled the inclusion criteria. They were published in 23 different journals. Quality of reporting varied between studies, with an average score of 18.7 (SD = 4.33) out of 24 (range 9-23.5). There was an increasing trend of pharmacoeconomic publications and reporting quality over years from 2003 to 2014. According to the Consolidated Health Economic Evaluation Reporting Standards, the reporting quality for the items including "title," "comparators of method," and "measurement of effectiveness" are quite low, with less than 50% of studies fully satisfying these reporting standards. In contrast, reporting was good for the items including "introduction," "study perspective," "choice of health outcomes," "study parameters," "characterizing heterogeneity," and "discussion," with more than 75% of the articles satisfying these reporting criteria. The remaining items fell in between these 2 extremes, with 50% to 75% of studies satisfying these criteria. CONCLUSION: Our study suggests the need for improvement in a number of reporting criteria. But the criteria for which reporting quality was low seem to be limitations that would be straightforward to correct in future studies.

Adherence With Therapeutic Regimens: Behavioral and Pharmacoeconomic Perspectives.

There is an extensive literature regarding nonadherence with both therapeutic regimens and medication. This literature includes reviews of empirical research regarding the factors associated with nonadherence. Health care system, provider, and patient factors as well as the nature of the illness and therapeutic regimen all effect adherence rates. Different behavioral models for adherence counseling such as the Health Belief Model, the Theory of Reasoned Action, the Medication Interest Model, and Motivational Interviewing have also been reported in the research literature. This article will discuss the development of a brief model for patient counseling with specific techniques illustrated for pharmacists based on empirical findings that have demonstrated effectiveness in the adherence research literature. In addition, the article will address the measurement of the economic impact of medication nonadherence and propose a framework for assessing the cost-effectiveness of pharmacist counseling to increase adherence. The problem of nonadherence has significant effects upon health care expenditures through increase in physician's visits, emergency department incidents, rehospitalizations, and nursing home readmissions. Thus, the overall goal is to assist the pharmacist in developing a brief adherence counseling program in community pharmacy and evaluating the economic feasibility of the intervention demonstrating the value-added proposition of pharmacist intervention.

Predictive validation of modeled health technology assessment claims: lessons from NICE.

The use of cost-effectiveness modeling to prioritize healthcare spending has become a key foundation of UK government policy. Although the preferred method of evaluation-cost-utility analysis-is not without its critics, it represents a standard approach that can arguably be used to assess relative value for money across a range of disease types and interventions. A key limitation of economic modeling, however, is that its conclusions hinge on the input assumptions, many of which are derived from randomized controlled trials or meta-analyses that cannot be reliably linked to real-world performance of treatments in a broader clinical context. This means that spending decisions are frequently based on artificial constructs that may project costs and benefits that are significantly at odds with those that are achievable in reality. There is a clear agenda to carry out some form of predictive validation for the model claims, in order to assess not only whether the spending decisions made can be justified post hoc, but also to ensure that budgetary expenditure continues to be allocated in the most rational way. To date, however, no timely, effective system to carry out this testing has been implemented, with the consequence that there is little objective evidence as to whether the prioritization decisions made are actually living up to expectations. This article reviews two unfulfilled initiatives that have been carried out in the UK over the past 20 years, each of which had the potential to address this objective, and considers why they failed to deliver the expected outcomes.

Validation of modeled pharmacoeconomic claims in formulary submissions.

Modeled or simulated claims for costs and outcomes are a key element in formulary submissions and comparative assessments of drug products and devices; however, all too often these claims are presented in a form that is either unverifiable or potentially verifiable but in a time frame that is of no practical use to formulary committees and others who may be committed to ongoing disease-area and therapeutic-class reviews. On the assumption that formulary committees are interested in testable predictions for product performance in target populations and ongoing disease area and therapeutic reviews, the methodological standards that should be applied are those that are accepted in the natural sciences. Claims should be presented in a form that is amenable to falsification. If not, they have no scientific standing. Certainly one can follow ISPOR-SMDM standards for validating the assumptions underpinning a model or simulation. There is clearly an important role for simulations as an input to policy initiatives and developing claims for healthcare interventions and testable hypotheses; however, one would not evaluate such claims on the realism or otherwise of the model. The only standard is one of the model's ability to predict outcomes successfully in a time frame that is practical and useful. No other standard is acceptable. This sets the stage for an active research agenda.

Pharmacoeconomics education in US colleges and schools of pharmacy.

OBJECTIVE: To determine the extent of pharmacoeconomics education in US colleges and schools of pharmacy provided to doctor of pharmacy (PharmD) students in 2011. METHODS: E-mails requesting syllabi and information about courses covering pharmacoeconomic topics were sent to all US colleges and schools of pharmacy from which PharmD students had graduated in 2011 (n=103). RESULTS: Of 87 responding pharmacy colleges and schools, 85 provided pharmacoeconomics education in 2011. The number of hours dedicated to pharmacoeconomic-related topics varied from 2 to 60 per year (mean=20). CONCLUSIONS. Pharmacoeconomics education is provided at almost all US colleges and schools of pharmacy; however, variation in the number of teaching hours and topics covered demonstrates a lack of standardization in the PharmD curriculum. Pharmacy administrators and educators should invest more resources and tools to standardize training in this area.

How should we deal with patient heterogeneity in economic evaluation: a systematic review of national pharmacoeconomic guidelines.

OBJECTIVE: To review and analyze recommendations from national pharmacoeconomic guidelines with regard to acknowledging patient heterogeneity in economic evaluations. METHODS: National pharmacoeconomic guidelines were obtained through the ISPOR Web site. Guidance was extracted by using a developed data extraction sheet. Extracted data were divided into subcategories on the basis of consensus meetings. RESULTS: Of the 26 included guidelines, 20 (77%) advised to identify patient heterogeneity. Most guidelines (77%) provided general methodological advice to acknowledge patient heterogeneity, including justifications for distinguishing subgroups (65%), prespecification of subgroups (42%), or methodology to acknowledge patient heterogeneity (77%). Stratified analysis of cost-effectiveness was most commonly advised (20 guidelines; 77%); however, guidance on the specific application of methods was scarce (9 guidelines; 34%) and generally limited if provided. Guidance to present patient heterogeneity was provided by 15 guidelines (58%), most prominently to describe the definition (31%) and justification (31%) of subgroups. CONCLUSIONS: The majority of national pharmacoeconomic guidelines provide guidance on acknowledging patient heterogeneity in economic evaluations. However, because guidance is mostly not specific, its usefulness is limited. This may reflect that the importance of acknowledging patient heterogeneity is usually recognized while there is a lack of consensus on specific methods to acknowledge patient heterogeneity. We advise the further development of national pharmacoeconomic guidelines to provide specific guidance on the identification of patient heterogeneity, methods to acknowledge it, and presenting the results. We present a checklist that can assist in formulating these recommendations. This could facilitate the systematic and transparent handling of patient heterogeneity in economic evaluations worldwide.

[A standardized amount indicator by equivalent patient to control outpatient pharmaceutical expenditure, Spain]. / Desarrollo del indicador Población Estandarizada Equivalente para el control del gasto farmacéutico ambulatorio.

BACKGROUND: The outpatient pharmaceutical expenditure in developed countries represents a huge percentage of the total health budget, because of that, it is necessary to use tools aimed to control and guarantee an efficient use of these resources. Improving the current construction of the indicator of pharmaceutical expenditure in order to have a more adjusted tool of pharmaceutical expenditure control. METHODS: We introduce the concept of "equivalent patient" in the standardization of outpatient pharmaceutical expenditure, considering in its design several socio demographic variables in order to supersede the previous model which just considered the "Co-payment status" for adjusting the outpatient pharmaceutical expenditure. We considered variables as age, sex, co-payment status and nationality to elaborate the concept of equivalent patient. RESULTS: By applying the standardization method we obtained 160 groups of consumption with weights from 0,10 to 4,39 equivalent patients. CONCLUSIONS: We obtained a tool capable of improving the construction of Pharmaceutical Expenditure Indicators, which are essential for the design of measures aimed to stimulate the rational use of drugs. In a micro level of analysis, the new indicator is useful to establish economic incentives aimed to encourage good performance from physicians in the prescription field.