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5th International Conference and Exhibition on Pharmaceutical
Regulatory Affairs, August 03-05, 2015 Florida, USA
The effectiveness of the spontaneous reporting system
at detecting suspected adverse drug reactions in a
resource limited setting
Avong YK1, Jatau B1, Ekong E1, Ndembi N1, Okuma J1, Osakwe A2, Akang G3,
Agbaje A1, Mensah C1, Dakum P1
1.Institute of Human Virology, Nigeria, Maina Court, Herbert Macaulay Way, Abuja, Nigeria
2. National Agency for Food and Drug Administration and Control (NAFDAC), Abuja
3. National Tuberculosis and Leprosy Control Program, Abuja, Nigeria
Introduction
• Adverse events (AEs) of second line anti-tuberculosis drugs
(SLDs) are relatively well documented. However, the actual
burden has rarely been described in detail in programmatic
settings
• The spontaneous reporting system (SRS) was utilized to
investigate the occurrence of these events in the national cohort
of multidrug-resistant tuberculosis (MDR-TB) patients in Nigeria
Aims and objectives
The aim was to investigate the burden of ADRs as well as assess
some of the risk factors during the intensive phase of MDR-TB
treatment. The objectives were to measure:
•
The incidence of ADRs
•
The types and severity of ADRs
•
Time to onset of ADRs
•
Duration of ADRs
Study Sites
Methods
Design:
• A retrospective, multicenter observational cohort study, using
pharmacovigilance data systematically collected at all MDRTB treatment centers in Nigeria
• Characteristics of AEs during the intensive phase treatment
were documented, and risk factors for development of AEs
were assessed
Statistics
• Summary statistics applied to describe socio-demographic and
treatment characteristics
• Associations between the occurrence of AE and demographic
and clinical characteristics were explored through multivariate
logistic regression using a stepwise backward elimination
approach
• P-values based on Wald’s test are indicated
Measurement tool
• The NAFDAC “Yellow form” was used as the primary tool for
data collection
• The Yellow form has 4 main sections:
1. Patient details
2. Adverse drug reaction
3. Suspected drug and
4. Source of report
NAFDAC Yellow Form
Adverse
Drug
Reaction
Section
Suspected
Drug
Section
Source of
Report
Section
Patient
Details
Section
Result: ADR reporting rate
VARIABLE
NUMBER (%)
TOTAL
460
Mainland Hospital, Yaba, Lagos
97 (21)
Government Chest Hospital, Jericho
82 (18)
University College Hospital, Ibadan
69 (15)
National Tuberculosis and Leprosy
Training Center, Zaria
41 (9)
Infectious Disease Hospital, Kano
40 (9)
University of Port Harcourt Teaching
Hospital, Port Harcourt
38 (8)
Jos University Teaching Hospital, Jos
29 (6)
University of Uyo Teaching Hospital, Uyo
13 (3)
Result: Characteristics
Burden and Severity of ADRs
Time to Onset of ADR
Duration of ADRs
ADRs and risk factors
• Body weight increased the risk of ADRs
• HIV did not expose the patients to greater risk of ADRs
• Age was not associated with ADRs
Discussion
• We reported a wide range of ADRs, thereby confirming
existing knowledge on the toxicity of SLDS and the
effectiveness of the SRS. ADRs should be managed
concurrently with MDRTB
• The most frequently occurring ADRs: Gastro-intestinal
condition, especially bleeding; Neurological conditions,
Ototoxicity and psychiatric disorders. Health workers should
be alert to these ADRs
• Fatality was associated with GIT bleeding, electrolyte
imbalance and heart failure. Prompt treatment needed
• Disability was associated with ototoxicity and psychiatric
disorders. Hearing aids needed
Discussion
• Allergic reactions (mainly allergy) were the first to occur,
while electrolyte imbalance took longer time to occur. Patient
monitoring should commence early and should continue until
therapy is completed with full cure
• Most ADRs resolved after a relatively short period. Do not
rush to discontinue therapy at the appearance of ADRs but
adherence should be enforced at this time
• Increased in body weight increased the risk of ADRs.
This is unusual; overdosing is however suspected.
• Age had no association with ADRs. This might be cohort
specific as mean age was only 33 years.
Discussion
• Significant variation in the reporting of ADRs by treatment
centers. Standardization of training of all health workers is
needed
• Co-infection with HIV did not significantly increased the risk
of ADRs. Treatment of MDRTB should not be delayed
because of HIV
Conclusion
• The SRS unmasked a wide range of AEs among the
participants, some of which were disabling and fatal
• Early identification and prompt management as well as
standardized reporting of AEs at all levels of healthcare,
including the community is urgently needed.
• Safer regimens for drug-resistant TB with the shortest duration
are advocated
• The SRS was reliable and could be used in public health
programs like the anti-retroviral therapy, MDRTB and malaria
Limitations
• Misclassification of ADRs
• Chronic ADRs may not have been captured
Acknowledgements
• Institute of Human Virology, Nigeria
• National Tuberculosis and Leprosy Control Program, Nigeria
• National Agency for Food and Drug Administration and
Control
• Global Fund to Fight AIDS, Tuberculosis and Malaria
• Research and Training in Tropical Diseases at the World
Health Organization (WHO/TDR)
• WHO Regional Office for Europe, Operational Research Unit
(LUXOR)
• Médecins Sans Frontières, and Brussels Operational Center,
Luxembourg;
• The Centre for Operational Research, International Union
Against Tuberculosis and Lung Disease, France
• Study participants and staff of study sites