Disability
Adjusted Life Years (DALY) is a widely used measure to quantify
the burden of diseases or illness. DALYs for a disease is calculated
as the sum of the Years of Life Lost (YLL) due to premature mortality
in the population and the equivalent healthy Years Lost due to
Disability (YLD). The only difference from the YLD and Days Lost
due to Disability (DLD) calculation is that instead of considering
the duration of Adverse Drug Reaction (ADR) in years, it is calculated
in days.
Objective: DLD was measured for diclofenac tablets to prepare
the ADR profile. Methods: The study was done on the patients (18-65
years old) attending the community pharmacy at Kasaragod district,
South India, with prescription of diclofenac tablets. Patients
reported ADRs on their next visit to the pharmacy or they had
called to the provided phone number and reported it. Disability
Weight (DW) was calculated in an analogue scale from 0-1. Zero
represent complete health and 1 represent death or equivalent
condition. DW was multiplied with occurrence and duration of ADRs
in days. Results: About 943 patients received diclofenac
tablets in 1000 prescriptions were successfully followed up for
possible, probable and definite ADRs. A total of 561 reactions
reported in 2010 for diclofenac tablet in the study population.
There were 34 different types of ADRs under 12 physiological systems/organs.
Most common reactions were on gastrointestinal (GI) system (48%),
followed by skin (14%), Central Nervous System (10%), renal (7%),
and cardiovascular (7%). Abdominal pain, cramps or flatulence
was the highest occurring GI ADR (107), followed by 43 rashes,
42 nausea/vomiting, 37 indigestion, 34 peptic ulcers, 31 edema
etc. DLD for peptic ulcer was considerably high (0.078) per 1000
of the study population on diclofenac. The most damaging ADR were
peptic ulcer with or without perforation, followed by rash 0.036
DLD and edema 0.027 DLD. There was considerable DLD by acute renal
failure (0.012) Steven-Johnson syndrom (0.013) even though few
cases were reported. Conclusion: Diclofenac has a complex adverse
drug profile. Around 34 types of reactions were reported. Diclofenac
was widely prescribed because of the experiential belief of comparative
safety with other NSAIDs. The study shows the importance of pharmacovigilance
even on the most prescribed medicine. Most disabling ADR for the
study population was peptic ulcer with or without perforation.
YLD or DLD are useful measures of calculating disability caused
by ADRs. Future studies could focus on improving the usefulness
& precision of DLD.
