Restricting The Use Of The FDC Of Ampicillin/Amoxicillin And Cloxacillin In A Nepalese Teaching Hospital
Dear Editor,
We read with interest the article by Alam K et al., on ‘Fixed dose combination antimicrobial practices in Nepal – Review of literature’. The authors have provided a comprehensive background on the use of fixed dose combination (FDC) antimicrobials in Nepal. They have also mentioned the problems which are associated with FDC antimicrobials and the possible solutions. In this letter, we want to share our experience about creating a hospital antibiotic use policy and about not including an ‘irrational’ FDC in the hospital medicines list.
KIST Medical College (KISTMC) is a new medical school in the Lalitpur district of the Kathmandu valley. The hospital started functioning in January 2008 and a Medicine and Therapeutics Committee (MTC) was established in February 2008. The MTC has been active in promoting the rational use of medicines (RUM) in the hospital (1). The MTC has created a hospital medicines list by selecting medicines on the basis of their efficacy, safety, cost and convenience and by not including the preparations and the medicines of doubtful efficacy in the medicines list, developing a process for including new medicines in the list, regulating pharmaceutical promotion, running medicine (pharmaceutical) care services, monitoring drug use and improving pharmacy services.
A maximum of four brands (two Nepalese and two international) of a particular generic medicine were selected for inclusion in the hospital medicine list (2). The criteria for the selection were the registration of the brand with the national drug regulatory authority (Department of Drug Administration (DDA)), the possession of the Good Manufacturing Practice (GMP) certification by the company and cost. For efficacy, we went by the descriptions which were available in the literature. A limitation was that we did not have the means to directly compare the efficacy and the quality of various brands.
Among the medicines which were not selected for inclusion in the hospital medicine list, were the FDCs of ampicillin and cloxacillin and those of amoxicillin and cloxacillin. These FDCs were extensively debated on in the MTC. We put forward the reasons why we felt that these FDCs should not be included in the hospital list. The data was put forward, which explained as to why these FDCs could be considered as irrational. After convincing the MTC members, it was decided to have a presentation on the FDCs during the academic detailing sessions. Detailed discussions and deliberations followed. Among the objections which were raised by the practitioners the point was discussed, that if the combinations were irrational and were not to be used, then why they were licensed for marketing by the drug regulatory authorities in Nepal and India. Another objection was that the preparations were widely used and strongly promoted. Some also stated that they had a favourable experience with the combinations in other settings. After long deliberations, we decided not to include these FDCs in the hospital medicine list. We assured the practitioners that the medicines would be available separately and that if needed, they could use both in the same patient.
The MTC also decided to frame an antibiotic use policy for both the medical and the surgical departments. The medical departments were able to formulate an antibiotic use policy, but the surgical departments are still in the process of doing so. A possible problem in Nepal and South Asia was that many clinicians viewed prescribing as their individual right and prerogative and were uncomfortable with the attempts to regulate this right. Also, many hospitals in Nepal and South Asia have a number of private pharmacies outside. The patients and prescribers may have a free access to all the medicines in the private pharmacies.
In Nepal, in many hospitals, the practitioners are engaged in private practices and medical representatives (MRs) and industry personnel have free access to the doctors during their practice. In Nepal, Patan hospital and KIST Medical College are among the institutions regulating pharmaceutical promotion and the access of MRs to prescribers. However, free access to medicines outside the hospital could influence the prescribers. At present, few of the doctors are prescribing the FDC of ampicillin and cloxacillin in the hospital but none of them are using the FDC of amoxicillin and Cloxacillin. We plan to conduct drug utilization studies and to monitor medicine use in the hospital in the near future.
Our experience shows that there are a number of factors which influence antibiotic use by the clinicians. Their experience, the opinion of leaders and the promotional activities of companies, all can play a part. These issues have to be taken into consideration in order to successfully modify the prescribing behaviour.
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