Research design, length, and location:
A prospective study was conducted in the orthopedic department inpatient, of tertiary care hospital of Hyderabad, Telangana for the period of October 2020 to March 2021. The data collected is regarding the sensitivity of cultures and bacterial resistance patterns of the hospital.
Sampling techniques:
A random sampling method was employed to get relevant samples.
Sample size:
The size of the sample was determined by the data mentioned in Karthikeyan et al analysis. Which follows the below formula [16].
N = Z 2 P (1-P)/ D2
N = required size of the sample: P = antibiotic prevalence rate: Z = standard normal confidence interval of 95% where the value is equal to 1.96 : D = margin of sampling error tolerated.
Criteria of the study:
Criteria for inclusion:
This study includes inpatients of both male and female genders over 18 years of age irrespective of their illness.
Criteria for exclusion:
Pregnant women, paediatrics, psychiatric patients and outpatients were excluded from being selected for this study.
Pre intervention phase:
The collection of data was initiated to monitor the patterns of prevalent antibiotics using a predesigned proforma. A follow-up of the patient’s records was carried out using the case files of the MRD department after permission from hospital management.
Assessment of appropriateness of antimicrobial use.
Compliance with the ASP guidelines can be accessed using the antimicrobial policy of the department. The primary investigator after receiving instructions, accessed each prescription for the adherence to guidelines, which is followed by the inspection by the expert technical committee. In order to test the rationality of the antibiotics being used, a validated approach based upon a set of parameters as described by Gyssens et al. [23] and updated by Willemsen et al. [24] having the following conditions were utilized: 1. Inappropriate choice, 2, inappropriate indication, 3 inappropriate implementation; 4 appropriate decisions which are to be followed by all antibiotics; 5 missing or inadequate data to assess the appropriateness of antimicrobial used; 6 other antimicrobial regulation deviations from the department policy. An initial data analysis was performed to assess guideline noncompliance.
Intervention phase:
This phase was conducted from November 2020 to February 2021, a duration of four months after the availability of pre-intervention phase data. This phase consists as below
A. Restriction of antibacterial usage:
Implementation of justification form towards the usage of restricted antibiotic groups such as Carbapenems, Linezolid and Polymyxins was done effectively.
B. Awareness and Education:
This aspect provides awareness regarding ASP guidelines. This section aims at influencing the prescribing behavior along with increasing the stewardship strategy acceptance. The nurses are educated and made aware of the importance of monitoring medications for length, dosage and path along with discussing with the physician.
C. Antimicrobial policy compliance:
Every hospital has their own Antibiogram that is based upon the culture sensitivity of the hospital. The challenge in this policy is that the guidelines are to be followed, reviewed, and updating the antimicrobial patterns in a timely manner.
D. De-escalation of therapy:
This step is crucial as the anti-microbiotic prescribed must be deescalated depending upon the drug susceptibility, change in the antibiotic spectrum to treat the infections and reduce the antibiotic resistance.
E. Optimization of Dosage:
Characteristics of each patient, pattern of injury, causative organism, site of infection, and pharmacokinetic as well as pharmacodynamic characteristics are taken into account for the dosage of the drug to optimize antibiotic usage.
F. Combination therapy control:
According to previous studies, the overuse of combinational therapy has emerged as a major factor which contributed to antimicrobial resistance.
G. Administration and adjustment of drug route:
This is based upon the clinical condition of the patient- adjustment of the administration route can be considered until it is in accordance with the guidelines but has better bioavailability.
Resolving issues with the ASP:
Principle investigator and the orthopedic department meetings were organized as communication is critical in implementing the stewardship program. Few issues arose during the implementation which were addressed and resolved aiming for perfect implementation of stewardship programs.
Data collection:
Collection of data was mainly focused upon the SSI monitoring program of W.H.O., visits to the medical ward daily, and sheets of regular prescription. The stewardship programme has observed that prescriptions are not in compliance. Indications for prophylaxis, better antibiotic options as well as other aspects were evaluated. The first prophylactic dose, dose recommended, intraoperative doses if necessary, and the total number of postoperative doses, Daily fixed dosed (DDD)/100 bed per days was used to calculate the amount of prophylactic antibiotics prescribed during the study.
Variables:
In the present study, two variables which are considered are rationality of the antibiotic surgical prophylaxis as a dependent and other factors which are patients age, gender, surgery type, geographical area, antibiotics used, and duration of hospital stay.
Statistical analysis:
The mean, median, standard deviation of the variables and the P value of the data collected were calculated by two-way Anova. The prescribing practices of anti-microbiotics were analyzed using time series data. Linear regression was employed to know the changes in prescription trends.
Ethical committee approval:
The institutional Ethical Committee has granted ethical approval with eh certificate number. Before collection of the data, the informed consent of patients or their relatives or attendants was obtained.