To the best of our knowledge, this is a first study that describes and compares antibiotic prescribing in relation to the presence of infection and surgery conducted among the inpatients at OBGY departments of two private sector hospitals in India. In the present study, the patients were categorized by clinical presence and absence of infectious indications and were further divided into surgical, non-surgical and possible surgical groups. Although few studies conducted at hospital level or for the shorter period, are published (3, 16, 17), none of them has shown the prescribing patterns in OBGY department for the stated categories and groups. It is thus, clear that there is a limitation to compare the results of the present study with other studies.
Our results show an overall high prescribing rate of antibiotics to the inpatients, where more than 80% received antibiotics during their hospital stay. This percentage of the antibiotic prescribing rate in the OBGY department was comparable to a study conducted by Sharma et al., (86%) (17) but was lower compared than the study conducted by Alvarez et al. in a rural hospital in Andhra Pradesh, India (92%) (3). In both studies, the analysis was conducted for all admitted patients but did not correspond to the indications. In the present study, we analyzed data corresponding to recorded indications at both hospitals and observed extensive prescribing of antibiotics to the patients without any record of infectious indication. However, the antibiotics were prescribed to a higher extent to the patients who underwent surgery (>85%) than in the non-surgical group (>70%) in our study. Prescribing antibiotics to the patients who did not undergo surgery or had no signs of infection could not be explained at present and need further study.
Adherence to guidelines
Local prescribing guidelines were not present in either of the hospitals. The prescribing patterns were compared with the national and WHO list of essential medicines. The prescriptions in the TH showed significantly higher adherence to the NLEMI and prescribing by generic name than the NTH. Higher adherence to the national guidelines, not prescribing FDCs and more use of generic names in the infectious category was also observed in the TH than in the NTH. Studies show that the medical representatives lure consultants to prescribe antibiotics by trade name instead of generic name favouring the sale of the products of a particular pharmaceutical company (25). Consultants that work in the NTH are allowed to run private practices, where they were free to meet the medical representatives of pharmaceutical companies. These meetings are more likely to influence the contents of a doctor’s prescription. However, at the TH as per the hospital policy, generic medicines were purchased by the management and supplied to the pharmacy. Also, the consultants were not allowed to run a private practice, and contacts with medical representatives were also restricted in the TH. This could perhaps be, one of the explanations for the observed trade name prescribing patterns in the NTH.
Also, this might be a positive impact of continuing medical education seminars held at the TH as a part of the routine academic activity, might also have motivated towards being adherent to the recommendations. These hospital policies could be modified contextually and implemented at other similar settings to rationalise prescribing of antibiotics.
Hospitalisation and antibiotic treatment duration and treatment costs
Patients admitted to the TH had both; longer hospital stay and duration of antibiotic treatment significantly, compared to the patients in the NTH (Table 1). These long duration of stay and antibiotic prescribing days are a risk factor for HAIs. Suspicion or presence of HAIs results in prescribing antibiotics (26). Data was not available on the prevalence of HAIs from the study hospitals for entire study duration, due to reduced utilisation of diagnostic facilities. Therefore, it will be inappropriate to comment on the relationship between HAIs and antibiotic prescribing. However, the HAI prevalence could be expected to be similar to other comparable settings (27).
Stay days are directly related to receiving more prescriptions and increased treatment costs, but at the TH, all patient services, including stay, were free, so patients might not have enforced for early discharge. While in the NTH patients paid out-of-pocket for medical services and might have compelled the patients to choose for an early discharge.
Antibiotic prescribing in infectious and non-infectious categories
Choice of the drugs both at the category and group level varied significantly between the hospitals. The FDCs (J01RA*) and third-generation cephalosporins were frequently prescribed at the NTH, constituting more than half prescriptions. These FDCs are neither enlisted in the WHO list of essential medicines nor the NLEMI (17). Combining antibiotic substances to prepare an FDC is often irrational and costlier (1, 28) (17). Prescribing a broad spectrum and FDCs results in unnecessary exposure to antibiotics and increase the risk of bacterial resistance. This issue needs immediate attention of the policymakers and the prescribers (17, 29).
Presence of bacterial infection is an appropriate indication for antibiotic treatment in post-operative procedures, whereas a surgery per se is an indication to receive a single prophylactic dose of antibiotic before or during the surgery. In our study, contrary to the recommendations, antibiotics were prescribed even in the absence of any clinical decision or laboratory confirmation for the presence of infection. More than 70% of patients in the non-infectious, non-surgical group were also prescribed antibiotics at both hospitals (Table 2). These results are comparable with a study at another Indian hospital where nearly 70% of women with severe pre-eclampsia or eclampsia, which is not an indication for antibiotic use, were prescribed antibiotics (30). Most of these women had LSCS (54%). Prescribing prophylactic antibiotics for surgeries such as LSCS is recommended while in our study, only 23% of patients had LSCS (30). Prescribing antibiotic treatment for the non-infectious, non-surgical cases is unindicated and point towards the risk of development of antibiotic resistance.
Antibiotic prescribing in the groups
Our results from the surgical groups show that a large proportion of the inpatients, not having a confirmed infection, received antibiotic prescriptions. Despite evidence and recommendations for prescribing a single prophylactic dose of an antibiotic for the surgical indications. Moreover, the duration of prescribing antibiotics exceeded recommended prophylactic duration among almost all inpatients in the surgery groups of both categories (31, 32). Prescribing antibiotics as treatment is only indicated in cases of a postoperative or simultaneous infection for procedures such as cesarean section and hysterectomies (32). Comparable prescribing patterns have previously been presented in two Indian studies; by Sharma et al. and Kumar et al.; where patients were treated with antibiotic therapy for multiple days after cesarean section instead of single dose prophylaxis (30, 33). Prescribing extended duration of antibiotics to non-surgical patients not only risk to the development of antibiotic resistance but increase the treatment cost.
A survey conducted among 650 surgeons in India reflected that surgeons do prescribe antibiotics for extended periods than recommended in the standard surgeon's guidelines and recommendations (34). Lack of local prescribing guidelines could be one of the underlying reasons for the observed high antibiotic prescribing. Interventions such as development and successful implementation of relevant antibiotic prophylaxis guidelines and regular prescription audits would help to reduce antibiotic prescribing, as demonstrated for LSCS patients in a single centre study from Serbia (35). The Siberian research shows a significant post-intervention reduction in the use of 3rd generation cephalosporins and the total treatment cost by 47% (35). Reduced motivation to maintain personal hygiene is another common factor influencing antibiotic prescribing in LMICs. However, precise underlying reasons for prescribing antibiotics to the extended duration for unindicated conditions in the present study settings need further investigation using a qualitative approach.
In the non-surgical groups at both hospitals, FTND was the most common condition for admission and majority of the patients who gave birth to FTND also received antibiotic treatment. Antibiotic prescription to this group of patients cannot be justified as even the prophylactic use of antibiotics for FTND is not recommended (36). A previous study from Ujjain district in India has shown an antibiotic prescribing to 87% FTND patients (37). A high proportion of patients in this group received antibiotic treatment is another highlight. Although, an episiotomy is a possible indication for antibiotic prophylaxis in FTND, however, according to a Cochrane review, further studies are required to ascertain the need for antibiotic prophylaxis for an episiotomy (38). Thus, a focused study is suggested to investigate the rationality of prescribing antibiotics for FTND.
We also found that in both hospitals, at the time of admissions, a considerable proportion of the in-patients appeared with the indications that led to the abortions. Reasons for part of these admissions could be linked to the self-induced abortions. Some of these admissions might also be due to the spontaneous and clinically induced abortions due to abnormal growth of the fetus, such as intrauterine growth restriction of the fetus. However, further detail investigations are needed in the settings to confirm these assumptions.
Feedback to the prescribers on the current situation in OBGY departments
Qualitative studies to explain the underlying reason for antibiotic prescribing for non-indicated conditions and for a longer time than recommended
Emphasis on infection prevention through motivating hygiene in hospital and community
Continue prescription follow up and audits
Strengths and limitations
The major strength of this study is the relatively large population of 5558 patients included in the analysis. The data was collected over three years, that contributed to study the effect of seasonal variations on prescribing of the antibiotics.
Additionally, the data was collected comprehensively to overcome selection bias. All diagnoses were checked manually from records and patients were divided into diagnosis groups in consultation with two local obstetricians and gynaecologists for comprehensive categorisation of patients in the diagnoses groups and subgroups. The consultants were not identified at any stage of the study. This method of data collection might have given freedom of deciding the treatment plan for the patients.
Our study also had a few limitations. Firstly, since the data was collected manually, the possibility of missing data was foreseen. For the missing data, the records in the archive were checked before analysis. For a small proportion of patients, information on whether the patients were operated or not, could not be retrieved. For such patient records, a third diagnosis group, “possible surgical” was created to nullify the probable overestimation of antibiotic prescribing, otherwise. The diagnoses (indications) were not validated externally, as this was not the aim of the study. The use of DDD has been criticised because it has shown a weak correlation with prescribed daily doses in some settings. However, prescribed daily doses may vary among healthcare facilities, and DDD allows comparison among hospitals or clinics even when prescribed daily doses are different. The absence of computerised record systems in hospitals, and personal identification numbers, un-experienced staff for data collection and high staff turnover make a comprehensive study like this; time-consuming and tedious, that causes a delay in the analysis. We are aware that extensive manual checking and adding the ICD codes, and ATC codes for the new FDCs in the data have prolonged the analysis and delayed the presentation. However, the use of human resources is the only option to conduct such detailed studies at resource-constrained settings and at the same time, leads to a more accurate description of the prescribing patterns.