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Strengths and challenges of data for medicines use research: Pharmaceutical sales data in Brazil

Strengths and challenges of data for medicines use research: Pharmaceutical sales data in Brazil. Andréa H. Dâmaso Universidade Federal de Pelotas, Brazil andreadamaso.epi@gmail.com. Problem Statement.

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Strengths and challenges of data for medicines use research: Pharmaceutical sales data in Brazil

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  1. Strengths and challenges of data for medicines use research: Pharmaceutical sales data in Brazil Andréa H. Dâmaso UniversidadeFederal de Pelotas, Brazil andreadamaso.epi@gmail.com

  2. Problem Statement • Finding reliable sources of data on medicines sales or consumption in a large country is challenging; Brazil is no exception • Because health insurance companies do not reimburse patients for their out-of-pocket expenses with medicines, private pharmacies do not rely on standardized datasets about medicine sales that could be used for research purposes

  3. Problem Statement • In order to evaluate the impact of policies such as the implementation of generic medicines in the Brazilian market (dated from 1999) it would be important to have longitudinal data on medicine sales in the country before and after the introduction of generics in the market

  4. Objectives • To describe changes in market share of selected medicines over time, following the 1999 Brazilian generics law Generics Original Brand ‘Similares’

  5. Methods • Design: Time-series analysis • Sourceof data: IMS Health - a leading provider of information services for the healthcare industry around the world • Setting: Longitudinal data on sales by wholesalers to retail pharmacies in Brazil using data collected between 1998 and 2010 • Data collected by IMS Health in Brazil comprises a monthly audit of more than 58,000 pharmacies • Stratified cluster sample of 11 regions • Sampling units are 130 pharmacies (direct sales) and more than 400 wholesalers (indirect sales) • The reporting time covers all days of the month and the projection is regional for pharmacies and wholesalers

  6. Results • We analyzed 8,559 products marketed in Brazil between 1998 and 2010 • 448 medicines used in diabetes • 2,113 medicines used to treat hypertension • 2,825 systemic antibiotics

  7. Some challenges • In order to analyze IMS dataset it was necessary to deal with some characteristics of the dataset • Two of these characteristics refer to: • Pharmacological groups classification • Identificationofgenerics in thedataset

  8. Pharmacological groups classification • IMS classifies Pharmacological groups using EphMRA/PBIRG Anatomical Classification that is similar to the WHO/ATC Classification • ATC • Mainly classifies substances according to the therapeutic or pharmaceutical aspects • The main purpose of the ATC classification is for international drug utilization research • EphMRA • Classifies products, mainly according to their indications and use • Classification has a primary objective to satisfy the marketing needs of the pharmaceutical companies Therefore, a direct comparison is sometimes difficult due to the different nature and purpose of the two systems

  9. Pharmacological groups classification EphMRA/PBIRG vs. WHO/ATC Classification

  10. Identification of generics in the dataset • IMS Health classification of products includes the following types • licensed brands • original brands • other brands • patent N/A • unbranded • In order to identify the groups of medicines available in Brazil, according to the IMS Health classification, we conducted a reclassification in the dataset • we kept the same classification for licensed brands, original brands and other brands medicines • we evaluated, case by case, all medicines originally classified as patent N/A and unbranded • Our main objective was to identify which medicines from these two groups were generics, considering that all generics in Brazil are unbranded

  11. Identification of generics in the dataset Rules used to reclassify medicines, originally classified as Patent N/A or Unbranded by IMS Health, in Generics • ANVISA (National Agency of Sanitary Surveillance) date: list that includes the date generics were approved to be commercialized in Brazil • IMS launch date: pack launch date provided by IMS dataset • Brazilian Website ‘Consulta remédios’: includes all Brazilian medicines available in the market and classifies products as: generics, original brand and ‘similares’

  12. Conclusions • In spite of the challenges of adapting data initially targeted to the industry to a source of information to medicine use research, data from IMS Health made it possible to evaluate the impact of the generic medicines policy in the Brazilian market share Funding Source IMS Health provided data in kind. Drs. Wagner and Ross-Degnan were supported by a grant from the World Health Organization for the development of the ICIUM2011 scientific program

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