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World Health Organization Access, Watch, Reserve Index: Use of fixed dose combinations being a challenge in India

1 Department of Pharmacy Practice, Nirmala College of Pharmacy, Muvattupuzha, Kerala, India
2 Department of Infectious Diseases, Aster Medcity, Ernakulam, Kerala, India

Date of Submission04-Jun-2021
Date of Decision23-Jul-2021
Date of Acceptance30-Jul-2021
Date of Web Publication11-Jan-2022

Correspondence Address:
Meby Susan Mathew,
Department of Pharmacy Practice, Nirmala College of Pharmacy, Muvattupuzha - 686 661, Kerala
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/picr.PICR_113_21

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 2023 Mar 23]. Available from: http://www.picronline.org/preprintarticle.asp?id=335578

   Introduction Top

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),[1] and in line with its guidelines, the Access, Watch, Reserve (AWaRe) tool was introduced in its Essential Medicines List in 2017.[2]

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).[3] 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.[3]

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.[4]

   Materials And Methods Top

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 Top


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 Top

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.[5] 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.[4]

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 Top

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 Top

Global Action Plan on Antimicrobial Resistance. World Health Organization. 2020. Available from: https://www.who.int/antimicrobialresistance/publications/global-action-plan/en/. [Last accessed on 2020 Jul 07].  Back to cited text no. 1
WHO Antibiotics Portal. Aware.essentialmeds.org. 2020. Available from: https://aware.essentialmeds.org/groups. [Lastaccessed on 2020 Jul 07].  Back to cited text no. 2
WHO Releases the 2019-AWaRe Classification Antibiotics. World Health Organization. 2020. Available from: https://www.who.int/medicines/news/2019/WHO_releases2019AWaRe_classification _antibiotics/en/. [Last acessed on 2020 Jul 07].  Back to cited text no. 3
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.  Back to cited text no. 4
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.  Back to cited text no. 5


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