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

• 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

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

Objectives

• To describe changes in market share of selected medicines over time, following the 1999 Brazilian generics law

Generics

Original Brand ‘Similares’

Methods• Design: Time-series analysis• Source of 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

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

• In order to analyze IMS dataset it was necessary to deal with some characteristics of the dataset

• Two of these characteristics refer to:1.Pharmacological groups classification2.Identification of generics in the dataset

Some challenges

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 companiesTherefore, a direct comparison is sometimes difficult due

to the different nature and purpose of the two systems

Pharmacological groups classification

EphMRA/PBIRG vs. WHO/ATC Classification

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

Rules used to reclassify medicines, originally classified as Patent N/A or Unbranded by IMS Health, in Generics

Identification of generics in the dataset

• 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’

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 SourceIMS 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