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
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:
1.
2.
Pharmacological groups classification
Identification of generics in the dataset
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
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
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’
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