|Ahead of print publication
World Health Organization Access, Watch, Reserve Index: Use of fixed dose combinations being a challenge in India
Femy Thomas1, Diya Shibuchan1, Lis Maria1, Maria Thomas1, Meby Susan Mathew1, Anup R Warrier2
1 Department of Pharmacy Practice, Nirmala College of Pharmacy, Muvattupuzha, Kerala, India
2 Department of Infectious Diseases, Aster Medcity, Ernakulam, Kerala, India
|Date of Submission||04-Jun-2021|
|Date of Decision||23-Jul-2021|
|Date of Acceptance||30-Jul-2021|
|Date of Web Publication||11-Jan-2022|
Meby Susan Mathew,
Department of Pharmacy Practice, Nirmala College of Pharmacy, Muvattupuzha - 686 661, Kerala
Source of Support: None, Conflict of Interest: None
|How to cite this URL:|
Thomas F, Shibuchan D, Maria L, Thomas M, Mathew MS, Warrier AR. World Health Organization Access, Watch, Reserve Index: Use of fixed dose combinations being a challenge in India. Perspect Clin Res [Epub ahead of print] [cited 2022 Aug 8]. Available from: https://www.picronline.org/preprintarticle.asp?id=335578
| Introduction|| |
The use of antibiotic fixed-dose combinations (FDCs) can have certain clinical benefits such as improving efficacy and adherence to the treatment regimen. However, inappropriate use of FDCs with agents having high resistance potential will lead to antimicrobial resistance (AMR). As an alert to the global issues of AMR, global action plan on AMR was adopted by the World Health Organization (WHO), and in line with its guidelines, the Access, Watch, Reserve (AWaRe) tool was introduced in its Essential Medicines List in 2017.
The tool classifies antibiotics into different AWaRe categories that include the Access group (first and second choice for empiric therapy), Watch group (the highest priority agents with high resistance potential), Reserve group (“last resort” agents). It also lists a group of antibiotics under “not-recommended” category, consisting mainly of FDCs of multiple broad-spectrum antibiotics that lack evidence-based indications and are not recommended in international guidelines.
In the context of AMR, the use of FDCs needs to be disheartened, since, they mostly include high resistance potential watch antibiotics with varying dosing regimen. Being a major drug producer and globally one of the highest antibiotic selling country, it is a huge challenge in an Indian setting to reduce the consumption of these antibiotics.
| Materials And Methods|| |
The study was carried out in a Quaternary Health Care Center in South India. Study subjects included all inpatients (IPs) who were prescribed with at least one antibiotic and visited the hospital during the time period of March 2019–August 2019, and the data were collected from the hospital medical records. Patient taking topical antibiotics were excluded. The collected data were analyzed descriptively using Excel-2010 and SPSS software version-20 (IBM Crop, Armonk, New York, USA) for compliance in accordance with “AWaRe-Classification-Database-2019.”
| Results|| |
A total of 12,202 antibiotic prescriptions were analyzed from 51 departments, out of which 819 prescriptions from 27 departments consisted of FDC.
Pattern of antibiotic utilization in accordance with the World Health Organization Access, Watch, Reserve tool
Overall usage of Access, Watch, Reserve antibiotics (n = 12,202)
There was a significant variation in the overall use of both Access (21.64%) and Watch (69.05%) antibiotics. The use of not-recommended antibiotics (FDCs) was found to be 6.71%.
Prescribing pattern of fixed-dose combinations among various age groups
The percentage use of not-recommended antibiotics was found to be highest in adult population (57.14%), followed by elderly (37.11%) and least in infants (0.24%).
Department-wise prescribing pattern of Access, Watch, Reserve antibiotics
From a total of 51 departments, only five departments had more than 60% of total prescriptions comprising of access antibiotics. The use of not-recommended antibiotics was found to be high in ophthalmology department (66%), followed by radiology (50%), with mostly prescribed agents being cefuroxime-clavulanic acid in the former and cefoperazone-sulbactam in the latter.
Pattern of not-recommended antibiotics prescribed: being Access, Watch, Reserve
Cefoperazone-sulbactam (84.12%) was the most prescribed antibiotic from the not-recommended group, while the least prescribed was meropenem-sulbactam (0.123%). A total of eight FDCs contributed to not-recommended antibiotic group, out of which only ampicillin + cloxacillin combination (0.36%) was from Access group, whereas all other FDCs had combinations with high resistance potential Watch group antibiotics (99.63%; cephalosporins and carbapenem).
| Discussion|| |
Considering the total antibiotic prescriptions, the use of not-recommended antibiotics was found to be high with a median percentage of 1.71% and an inter quartile range of 0–8.4. The reports from April to July-2017 edition of the Current Index of Medical Specialties, India, revealed that excess availability and overuse of Watch group antibiotics limit the use of low-resistance potential Access group antibiotics. Furthermore, the use of FDCs with Watch group antibiotics was found to be more in the IP setting, which was in line with the previous study conducted in India by Patricia. et. al.
Moreover, from the total FDCs prescribed, the use of high resistance potential Watch group containing FDCs was found to be significantly higher, which is classified as not-recommended by the WHO. The WHO aims to increase Access antibiotics prescribing to be > 60% of the total antibiotic usage, but with the current use of FDCs, it is a great challenge to reach this aim; nevertheless, the use of FDCs has to be discouraged.
| Conclusion|| |
AWaRe tool can be best used to analyse and prevent the inappropriate use of antibiotics, especially, fixed dose combination antibiotics. It is of greater importance to developing countries, where antibiotic stewardship programmes have not yet been well established.
We acknowledge Dr. T. R. John, Psychiatry consultant, Chief of Medical Services, Priya K, Pharm D, Adhin Antony Xavier, Pharm D and Staffs of Medical Records Department, Aster Medcity for their support.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
| References|| |
McGettigan P, Roderick P, Kadam A, Pollock AM. Access, Watch, and Reserve antibiotics in India: Challenges for WHO stewardship. Lancet Glob Health 2017;5:e1075-6.
Gandra S, Joshi J, Trett A, Lamkang AS, Laxminarayan R. Scoping Report on Antimicrobial Resistance in India. Washington, DC: Center for Disease Dynamics, Economics and Policy; 2017.