ASSESSMENT OF THE REGISTRATION STATUS, AVAILABILITY, UTILIZATION PATTERN AND RATIONALITY OF FIXED DOSE DRUG COMBINATIONS IN NEPAL
Loading...
Date
2010-04
Authors
ARJUN, POUDEL
Journal Title
Journal ISSN
Volume Title
Publisher
Abstract
Fixed dose drug combinations (FDCs), though offer certain advantage in terms of
patient compliance, their use is highly debatable. There is a widespread use of FDCs in
Nepal. However, there are no extensive studies on FDCs. The present study evaluated
the registration status, availability, utilization pattern and rationality of FDCs in Nepal.
Firstly, registration status of FDCs in the national drug list was assessed and their
availability in the Nepalese National Formulary (NNF) 1997, the WHO Model List of
Essential medicines (15th Edition) 2007 and the Essential Drug List (EDL) of Nepal
(third revision) 2002 were analyzed. Secondly, the availability of un-registered FDCs in
five major cities of Nepal was carried out using a snowball sampling method with a
visit of 20 retail pharmacies from each city. Thirdly, the toolkit developed by Health
Action International-Asia Pacific (HAI-AP) was used to justify the rationality of the
FDCs obtained from the five cities of Nepal. Fourthly, the utilization pattern of FDCs in
primary health care (PHC), secondary health care (SHC) and tertiary health care (THC)
centers from western Nepal was evaluated using systematic random sampling method
involving 100 prescriptions from each health care center. A total of 81 FDCs were
registered in Nepal. Higher percent (66.7%) of FDCs were·from India. Among the total
81 FDCs only, 7.0% were present in the NNF, 6.0% in the EDL of Nepal and 11.0% in
the WHO Model List. Only three combinations were present in all the formularies and
drug lists. Altogether, 41 un-registered FDCs were obtained from the five cities. None
of the FDCs fulfilled all the fundamental requirements as stated in the toolkit, thus
categorizing them to be 'irrational'. In the PHC center, 206 drugs were prescribed
among which 20.0% were FDCs. Antimicrobials were the highly prescribed FDCs
(57.1%). The unit price costs of all FDCs were below 100 NRs (USD1=NRs 80). In the
SHC center, 309 drugs were prescribed out of which 30% were FDCs. Vitamins,
minerals and dietary supplements were highly prescribed FDCs (25.8%). The costs of
63.5% of FDCs were below 100 NRs. In case of THC center, 33.5% were FDCs out of
total 270 drugs prescribed. As in SHC center, vitamins, minerals and dietary
supplements were highly prescribed FDCs (40.6%). The costs of 50.5% of FDCs were
below 100 NRs. In conclusion, considerable amount of FDCs are registered in Nepal
with extensive utilization in different levels of health care centers along with the
availability of unregistered and irrational FDCs in Nepalese pharmaceutical market
which needs to be weeded out.
Description
Keywords
FIXED DOSE DRUG