Prospective cohort study on adverse drug reactions on all admissions to
internal medicine: Incidence, risk factors and fatality
Abstract
Background Adverse drug reactions (ADRs) constitute major clinical
burden of public health concern. Intensive adverse drug reactions
monitoring in hospitals, though advocated are rare. Aims Intensive
monitoring of medical patients for ADRs to assess incidence, risk
factors and fatality of ADRs leading to hospital admission or occurring
in the hospital. Research design and methods Prospective cohort study on
1280 adult patients admitted to the six medical wards of a tertiary
institution over a 12-month period. Patients were assessed for ADRs
during and throughout admission. Causality assessment and preventability
of ADRs were assessed. Results Sixty-seven (5.2%) patients had ADRs,
which was the cause of admission in 46 (3.6%), and majority 61(91%) of
the ADRs were preventable. NSAIDs, 14 (20.3%), antidiabetics, 12
(17.4%) and antibacterial, 11 (15.8%) were the most suspected drugs.
Gastrointestinal tract (37%), CNS (30.2%), and skin (24.7%) were the
most affected organ/systems, while upper GI bleeding and hypoglycaemia
were the most observed ADRs. ADRs led to deaths in 7(10.4%) patients,
with overall case fatality rate of 0.5%. Stevens-Johnson Syndrome/Toxic
Epidermal Necrolysis 3/7(42.9%) had the highest fatality rate. Risk
factors, relative risk, 95% confidence interval for ADRs were alcohol
intake, 1.7 (1.04, 2.80) and duration of hospital stay, 2.0 (1.16,
3.26). Conclusions Preventable ADRs are common and important cause of
hospitalization and inpatients’ morbidity and mortality among medical
patients in Nigeria. Upper GI bleeding and hypoglycaemia, resulting from
NSAIDs and antidiabetic drugs were the most observed ADRs. Strategic
planning for intensive follow up of ADRs in Nigeria is advocated.