ADVERSE EVENT REPORTS ABOUT
OVER-THE-COUNTER DRUGS IN BRAZIL
1
MILENA OLIVEIRA BITTENCOURT , LAÍS FÁTIMA DE SOUZA FRANÇA, LEANDRO ALVES MACEDO
DA SILVA, MURILO FREITAS DIAS
BRAZILIAN HEALTH SURVEILLANCE AGENCY - ANVISA/ CENTER FOR SURVEILLANCE OF ADVERSE EVENTS AND QUALITY
DEVIATIONS - NUVIG/ PHARMACOVIGILANCE OFFICE - GFARM/ BRAZIL
1 [email protected]
Background:
Brazilian Pharmacovigilance has been developed, at Federal level, since
November 1999, through the Brazilian Health Surveillance Agency
(ANVISA). In the year 2001, Decree n. 696, of the Ministry of Health,
created the Brazilian Medicine Monitoring Centre (CNMM), placed in the
Pharmacovigilance Unit, which allowed the insertion of Brazil as the 62nd
country in the International Drug Monitoring Programme of the World
Health Organization (WHO), coordinated by the Uppsala Monitoring
Centre, in Sweden, a WHO Collaborative Centre.
In October 2005, Pharmacovigilance Unit was internally inserted into the
Center for Surveillance of Adverse Events and Quality Deviations, which
attributions include proposing, planning, coordinating and establishing
the national subsystem of health surveillance for post-marketing products
used in humans for diagnosis or therapy, including medicines.
Adverse event reports have been received mainly by electronic reporting
forms, available at http://www.anvisa.gov.br/servicos/
Form/farmaco/index.htm. The reports can also be sent by e-mail, fax,
telephone and mail.
According to adverse event type, the majority of reports were about
drug adverse reactions (49,8%), followed by quality deviations
(substandard products) (45,4%).
From 445 adverse reaction reports about OTC drugs received,
pharmacists contributed with 54,6% of reports. OTC drug quality
deviations reports were also sent mainly by pharmacists (69,6%).
From 35 OTC drug therapeutic ineffectiveness reports received by
CNMM, the majority were sent by consumers (45,7%). The other
adverse event types
medication error and drug intoxication
corresponded to 8 reports (0,9%). (Fig. 3)
Fig. 3. Percentage of adverse event reports about OTC drugs received by
CNMM, according to event type, from November 1999 to October 2006.
Quality deviantion (substandard product) reports
about OTC drugs according to professional
categories (N = 405)
Drug therapeutic ineffectiveness reports
about OTC drugs according to professional
categories (N = 35)
11,43%
(n=4)
5,93 %
(n=24)
8,15 %
(n=33)
5,71%
(n=2)
45,71%
(n=16)
69,63 %
(n=282)
Ove rall adverse event re ports about OTC drugs
according to event type (N = 893)
Pharmacists
Pharmacists
Physicians
In Brazil, over-the-counter (OTC) drug commercialization is regulated by
Decree n. 138 published in June, 2003. This Decree is now being reviewed
by Brazilian Health Surveillance Agency (Anvisa). A working group was
formed to evaluate safety and effectiveness of each active principle
belonging to OTC drug therapeutic classes. This evaluation must be
supported by drug complete information, toxicologic and adverse event
data, among other evidences.
3,92 %
(n=35)
Not informed
Not inf ormed
To describe adverse events about OTC drugs spontaneously reported to
Brazilian Medicine Monitoring Centre (CNMM) from November 1999 to
October 2006.
Methods:
Consumers
Physicians
Nurses
Others
0,90 %
(n=8)
49,83 %
(n=445)
45,35 %
(n=445)
ADR reports about OTC drugs according to
professional categories (N = 445)
Adverse drug reaction (ADR)
Quality deviation
Therapeutic inef fectiveness
Others (medication error, drug intoxication)
7,42 %
(n=33)
9,89 %
(n=44)
1,12 %
(n=5)
13,48 %
(n=60)
54,61 %
(n=243)
13,48 %
(n=60)
Pharmacists
Objectives:
0,25%
(n=1)
12,35 %
(n=50)
37,14%
(n=13)
Consumers
3,70 %
(n=15)
Physicians
Not informed
Consumers
Nurses
Dentists
Evaluating adverse event report rates between pharmacists and physicians:
- related to all adverse events about OTC drugs, pharmacists have contributed to
6 times more reports than physicians;
- related specifically to serious adverse events about OTC drugs, pharmacists
have contributed to 2 times more reports than physicians.
Only reports containing OTC drug as a suspected drug were evaluated.
They were evaluated according to reporting professional category, and
adverse event seriousness and event type (adverse drug reaction, quality
deviation, drug therapeutic ineffectiveness and others).
Evaluating adverse event report rates between pharmacists and consumers,
the results were:
- related to all adverse events about OTC drugs, pharmacists have contributed to
5,5 times more reports than consumers; and
- related specifically to drug therapeutic ineffectiveness about OTC drugs,
consumers have contributed to 1,2 times more reports than pharmacists.
Results:
Major limitations of this study:
From 9,279 total reports received, 893 (9,6%) were about OTC drugs.
Pharmacists were the most frequent reporting professionals (60,2%)
(Fig. 1).
 Related to CNMM database:
• Those described for spontaneous reporting system (like underreporting, OTC
drug exposure unknown).
• Most reports received by CNMM were from sentinel hospital network, which
includes 190 hospitals nationwide which use more hospitalar drugs.
• Database is still being consolidated.
Fig. 1. Percentage of adverse event reports about OTC drugs received by
CNMM from November 1999 to October 2006.
Overall adverse event reports (N = 9,279)
9,62 %
(n=893)
 Related to the research:
• Contradictory informations about drug market status in Anvisa´s database
(DATAVISA).
• Lack of an OTC drug active principle list.
Adverse event reports about OTC drugs according to
professional categories (N = 893)
5,38% 0,67%
(n=48) (n=6)
9,85%
(n=88)
10,86%
(n=97)
Conclusion:
60,25%
(n=538)
12,99%
(n=116)
90,38 %
(n=8386)
OTC drugs
POM drugs
Pharmacists
Not informed
Consumers
Nurses
Physicians
Dentists/Others (less than 1%)
Serious adverse events were present in 151 reports (16,9%); most of
these were reported by pharmacists (53,0%). (Fig. 2)
Fig. 2. Percentage of adverse event reports about OTC drugs received by
CNMM, according to seriousness, from November 1999 to October 2006.
Overall adverse event reports about OTC
drugs (N = 893)
16,91 %
(n=151)
83,09 %
(n=742)
Serious
Serious adverse event reports about OTC
drugs according to professional categories
(N = 151)
6,62 % 5,96 %
7,95 %(n=10) (n=9)
(n=12)
52,98 %
(n=80)
26,49 %
(n=40)
Non-serious
Pharmacists
Physicians
Not informed
Consumers
Nurses
Considering the results achieved, pharmacists are the most contributor
professionals for OTC drug pharmacovigilance in Brazil. They have not
only highly contributed to overall adverse event reports (60%) but also
contributed with most of serious adverse event reports (53%).
Pharmacists must be continually sensitized about reporting OTC
adverse events. In 2005 it was created a Reporting Pharmacy Program,
to enable pharmacists how to detect, identify and report adverse
events. This program is being nationally implemented, with
participation of 14 States until now in almost 3,000 pharmacies.
Other strategies are being planned by CNMM to sensitize physicians
and consumers about reporting OTC adverse events, such as
partnerships with medical associations and with consumer
organizations.