The pharmacovigilance
program in Nepal is less than a decade old, and is hospital centered.
This study highlights the findings of a community based pharmacovigilance
program involving the community pharmacists.
Objectives: To collect the demographic details of the patients
experiencing adverse drug reactions (ADR) reported by the community
pharmacists; to identify the common drugs causing the ADRs, the
common types of ADRs; and to carry out the causality, severity
and preventability assessments of the reported ADRs.
Methods: The baseline Knowledge-Attitude-Practices (KAP) of 116
community pharmacists from Pokhara valley towards drug safety
was evaluated using a validated (Cronbach alpha=0.61). KAP questionnaire
having 20 questions [(knowledge 11, attitude 5 and practice 4)
maximum possible score 40]. Thirty community pharmacists with
high scores were selected for three training sessions, each session
lasting for one to two hours, covering the basic knowledge required
for the community pharmacists for ADR reporting. Pharmacist from
the regional pharmacovigilance center visited the trained community
pharmacists every alternate day and collected the filled ADR reporting
forms.
Results: Altogether 71 ADRs, from 71 patients (37 males) were
reported. Antibiotics/ antibacterials caused 42% (n=37) of the
total ADRs followed by non steroidal anti-inflammatory drugs [25%
(n=22)]. Ibuprofen/paracetamol combination accounted for ten ADRs.
The most common type of ADR was itching [17.2 % (n=20), followed
by generalized edema [8.6 % (n=10)]. In order to manage the ADRs,
the patients needed medical treatment in 69% (n=49) of the cases.
Over two third (69%) of the ADRs had a ‘possible’ association
with the suspected drugs and a high percentage (70.4%) were of
‘mild (level 2)’ type. Nearly two third [64.7 % (n=46)] of the
ADRs were ‘definitely preventable’.
Conclusion: The common class of drugs known to cause ADRs was
antibacterial/ antibiotics. Ibuprofen/ Paracetamol combination
use of the drug responsible for more number of ADRs and the most
common ADRs were related to dermatological system. Strengthening
this program might improve safe use of medicines in the community.
