Surveillance and pharmacoeconomics of antimicrobial use among inpatients in a tertiary care, teaching hospital in New Delhi, India: Assessing need for policy formulation :Pinky Dharmshaktu, Vandana Roy, Monika Agarwal, Mradul K Daga, Niladhar S Hadke, MAMC Journal of Medical Sciences

ORIGINAL ARTICLE
Year : 2016 | Volume : 2 | Issue : 3 | Page : 134--140

Surveillance and pharmacoeconomics of antimicrobial use among inpatients in a tertiary care, teaching hospital in New Delhi, India: Assessing need for policy formulation

Pinky Dharmshaktu¹, Vandana Roy¹, Monika Agarwal¹, Mradul K Daga², Niladhar S Hadke³,
¹ Department of Pharmacology, Maulana Azad Medical College and Associated Hospitals, University of Delhi, Delhi, India
² Department of Medicine, Maulana Azad Medical College and Associated Hospitals, University of Delhi, Delhi, India
³ Department of Surgery, Maulana Azad Medical College and Associated Hospitals, University of Delhi, Delhi, India

Correspondence Address:
Dr. Vandana Roy
Department of Pharmacology, Maulana Azad Medical College, New Delhi - 110 02
India

Abstract

Objective: Although extensive use of antimicrobial medicines (AMMs) has been reported in India, there are limited data on AMM use and expenditure incurred on the same among inpatients. This study was conducted to determine (i) the pattern of AMM prescribed, (ii) adherence of AMM used with the hospital essential medicine list (EML), and (iii) expenditure incurred on AMM. Materials and Methods: An observational, prospective study was conducted among inpatients in Medicine and Surgery Departments of a tertiary care teaching hospital in New Delhi, India, who were receiving AMM. AMM use characteristics (name, dose, dosage form, frequency, duration, route) and expenditure incurred and ABC analysis was done. Results: AMMs were prescribed to 60.1% of patients. Of these, the indication for prescribing AMM was therapeutic in 76.1% patients. On an average, 2.52 antimicrobials were prescribed per patient. The most common route of antimicrobial administration was parenteral (71.9%). Biological samples were sent for bacterial culture sensitivity testing only in 21.1% cases, of which 23.6% were positive. A total of 46 different antimicrobials were prescribed. The most commonly prescribed AMMs were ceftriaxone, metronidazole, ciprofloxacin, amoxicillin-clavulanic acid, and levofloxacin. The number of AMMs prescribed from EML was 1125 (74.4%). Expenditure on antimicrobials accounted for 52% of the total expenditure on medicines. ABC analysis revealed that the maximum expenditure (72%) was on medicines used in a small (9.82%) percentage of patients. The parenteral use of newer, more expensive antimicrobials, not included in the hospital EML, accounted for a large proportion of expenditure on antimicrobials. Conclusion: There is an urgent need to develop a hospital antimicrobial policy, guidelines for use, and generate awareness among physicians to improve and rationalize the economy of antimicrobial use in the hospital.

How to cite this article:
Dharmshaktu P, Roy V, Agarwal M, Daga MK, Hadke NS. Surveillance and pharmacoeconomics of antimicrobial use among inpatients in a tertiary care, teaching hospital in New Delhi, India: Assessing need for policy formulation.MAMC J Med Sci 2016;2:134-140

How to cite this URL:
Dharmshaktu P, Roy V, Agarwal M, Daga MK, Hadke NS. Surveillance and pharmacoeconomics of antimicrobial use among inpatients in a tertiary care, teaching hospital in New Delhi, India: Assessing need for policy formulation. MAMC J Med Sci [serial online] 2016 [cited 2023 Mar 21 ];2:134-140
Available from: https://www.mamcjms.in/text.asp?2016/2/3/134/191675

Full Text

Introduction

Extensive use of antimicrobial medicines (AMM) has been reported from India. However, there are limited data on AMM use among inpatients. It has been reported that antimicrobial use may be inappropriate in up to 50% of patients.[1] Inappropriate use of AMM has contributed to the development of drug resistance and a waste of economic resources, more relevant in a middle-income country like India.

Antimicrobial sensitivity data, guidelines for use of AMM, and essential medicine lists (EML) help in rationalizing the use of AMMs. However, this information is frequently unavailable, and access to essential medicines is poor in developing countries including India.[2] Availability of antimicrobial drug utilization data allows for internal benchmarking against the institute's own past performance as regards the use of AMM as well as external benchmarking against national performance. It will also help in assessing the impact of antimicrobial management programs.[3]

The Government of (NCT) Delhi has formulated a list of essential medicines which is updated every 2 years.[4] The list is recommended for prescribing medicines as far as possible, especially in the public sector. All such medicines are to be dispensed free of costs to patients. The list acts as a means to restrict misuse of medicines.

Lok Nayak Hospital is a 1750-bedded, public sector, tertiary care, teaching hospital in Northern India. Although AMMs may account for a large percentage of prescribed medicines and proportion of hospital budget, there are no data available on the utilization pattern and economic assessment of antimicrobials used in the hospital. Hence, the present study was conducted to assess the (i) pattern and consumption, (ii) rationality and cost of antimicrobials used, and (iii) compliance of prescribed antimicrobials with the hospital EML in patients admitted to Medicine and Surgery Departments of Lok Nayak Hospital.

Materials and Methods

An observational, prospective study was conducted in the Departments of Medicine and Surgery, Lok Nayak Hospital, New Delhi, India, from January to December 2010. The study was approved by the Institutional Scientific and Ethics Committee. Written informed consent was provided by all patients enrolled in the study.

Records of the patients admitted to Medicine and Surgery wards were observed for AMM use (alternate month in each ward over a period of 1 year). Of the total records with antimicrobials prescribed, 300 records each in medicine and surgery were randomly (every sixth) included in the study. The patients of either sex, irrespective of age and diagnosis, receiving antimicrobial therapy during their hospital stay were included in the study. A predesigned case record form was used to collect patients' demographic details, history of illness, treatment history, and antimicrobial use characteristics which included: (i) Evidence of infection where clinical evidence included signs and symptoms suggestive of infection and laboratory evidence included relevant hematological, microbiological, biochemical, and radiological investigations; (ii) indication for use of AMM, whether therapeutic or prophylactic; (iii) availability of antibiotic sensitivity data; (iv) AMM prescribed: Generic name, dose, dosage form, frequency, duration, route, quantity, and cost; (v) change of antimicrobial therapy, if any, and reasons thereof; (vi) inclusion of the prescribed AMM in the hospital EML.[4]

The WHO International Classification of Diseases-10 was used to classify diseases.[5] The AMM was ranked based on patients encounter. A patient encounter means number of patient to whom one or more AMM was prescribed.

The rationality of antimicrobial prescribed was assessed as per Kunin's criteria.[6] The criteria were as follows:

Agree with the use of antimicrobial therapy/prophylaxis, the program is appropriate.Agree with the use of antimicrobial therapy/prophylaxis, but a potentially fatal bacterial infection cannot be ruled out or prophylaxis is probably appropriate, advantages derived remain controversial.Agree with the use of antimicrobial therapy/prophylaxis, but a different (usually less expensive or toxic) antimicrobial is preferred.Agree with the use of antimicrobial therapy/prophylaxis, but a modified dose is recommended.Disagree with the use of antimicrobial therapy/prophylaxis, administration is unjustified.

The cost of drugs in Indian Rupees (1 US$ = Rs. 46.57, June 2010) was determined using the drug price list supplied by the hospital pharmacy, and ABC analysis of expenditure incurred on antimicrobials was performed.[7] The expenditure on antimicrobials according to the route of drug administration, Kunin's criteria, and inclusion of antimicrobial in the hospital EML was determined. Comparison of AMM use in the Departments of Medicine and Surgery was performed.

Statistical analysis

Statistical analysis was done using SPSS Inc. Released 2007. SPSS for Windows, Version 15.0. (SPSS Inc., Chicago, IL). The results are expressed as mean ± standard deviation. The association between the AMM used and age, sex, indication, days, and cost of therapy is assessed and expressed in percentage. For continuous variables with a normal distribution, Student's t-test was used. Categorical variables were compared using Chi-square test. Correlation between microbial evidence of infection and antimicrobial agent used was assessed using contingency coefficient. The results were considered statistically significant if P < 0.05.

Results

During the 1-year study period, there were 2495 total admissions in medicine and surgery departments. Of these, 1499 (60.1%) were receiving AMM (1073 out of 1527 [70.3%] in medicine and 426 out of 968 [44%] in surgery). The demographic characteristics of the patients are shown in [Table 1]. The ten most common conditions for which AMA were prescribed in medicine and surgery are shown in [Table 2].{Table 1}{Table 2}

Utilization pattern of antimicrobial medicines

A total of 4596 drugs were prescribed to 600 patients, of which 1512 (32.9%) were antimicrobials. The majority of the patients (75.2%) were prescribed more than one AMM (range 1-9). The average number of antimicrobials used per patient per treatment episode was 2.5. Overall, the mean duration of antimicrobial therapy was 5.6 ± 4.5 days (range 1-37). It was more in medicine (P < 0.05). Parenteral intravenous route of administration (70.8%) was most commonly used overall. Most of the antimicrobials (74.4%) prescribed were from the hospital EML [Table 3].{Table 3}

The use of antimicrobials was based on history and clinical findings in all the cases. A total of 127 patient samples (21%) were sent for laboratory confirmation of infection, of which 30 reports (23%) were positive. There was a positive association between the microbial evidence of infection and the AMM used (contingency coefficient = 0.688, P < 0.05). Overall, antimicrobials were used for a therapeutic indication in 76.1% and for prophylaxis in 23.7% [Table 4]. Overall, AMMs were not changed for most (92.3%) patients. However, antimicrobials were changed more frequently in medicine. The most common reason for the change of AMM was patient not responding to the treatment [Table 4]. The adverse drug reactions observed were nephrotoxicity with amikacin and hepatotoxicity with antitubercular treatment.{Table 4}

A total of 46 AMMs were used, 41 in medicine and 21 in surgery. Ceftriaxone and metronidazole were the most commonly prescribed AMMs in medicine and surgery, respectively. Overall, the most commonly prescribed AMMs were ceftriaxone, metronidazole, ciprofloxacin, amoxicillin-clavulanic acid, and levofloxacin [Figure 1].{Figure 1}

Rationality of antimicrobial medicines used

Overall, the treatment given was appropriate as per Kunin's criteria 1 in 548 (91.33%), criteria 2 in 16 (2.67%), and criteria 3 in 36 (6%) patients.

Expenditure on antimicrobial medicines

Of the total expenditure on medicines overall, 52.12% was on antimicrobials, 53.63% in medicine, and 42.59% in surgery. The average cost of antimicrobial per patient was Rs. 1834 [Table 5]. The maximum expenditure was on parenteral AMMs.{Table 5}

The ABC analysis of total expenditure incurred on AMA overall showed that 72% expenditure was on 6.52% AMMs and 10.9% of expenditure was on 86.95% of the antimicrobials used [Table 6]. Roughly, 10% AMM consuming about 70% of total expenditure constituted Group A, AMM consuming nearly 20% value made up Group B, and the remaining 87% AMM consuming about 10% of total expenditure formed Group C. The cutoffs were not exactly 10/20/70% and differed marginally which is permissible.{Table 6}

Many medicines in A and B categories were AMMs, not from hospital EML. A total of 16 antimicrobials prescribed were not included in hospital EML. These were levofloxacin, azithromycin, amoxicillin-clavulanic acid, tazobactam-piperacillin, clindamycin, nitrofurantoin, oseltamivir, cefaclor, Pantop HP, artesunate, itraconazole, cefixime, cefoperazone, ciprofloxacin-tinidazole, ivermectin, tinidazole. These accounted for 29.4% of total antimicrobial expenditure.

In the Medicine Department, maximum antimicrobial expenditure was incurred on meropenem [Figure 2], while in Surgery Department, maximum expenditure was incurred on amoxicillin + clavulanic acid [Figure 3].{Figure 2}{Figure 3}

Discussion

The use of antimicrobials while benefitting many has also been marked by both overuse and misuse resulting in rising drug costs, adverse reactions, and problems of drug resistance. In view of the increasing number of multidrug-resistant organisms and escalating antimicrobial expenditure, many hospitals worldwide have initiated measures to quantify the extent of problem by doing drug utilization studies (DUS). Infections are among the most common causes of morbidity and mortality in India. Yet, there is a relative lack of DUS for AMMs in India. This study was an attempt to quantify the use of AMM and expenditure incurred on them in Medicine and Surgery departments of a large public sector tertiary care teaching hospital in India. The patients in two departments were comparable in terms of the basic demographic parameters such as age, sex, and duration of stay in the hospital.

Antimicrobials were prescribed to the majority of the admitted patients, similar to the previous reports from India.[8],[9] Studies from other countries have reported AMM use varying from 30% in countries such as Sweden and Scotland to 50%-65% in Nepal and Libya.[10],[11],[12],[13] Lesser use of AMM in developed countries could be because of differences in the incidence of infectious diseases or due to adherence to antibiotic policies.

The patterns of antimicrobial use observed were similar to that in other studies performed in India and outside.[9],[11],[14],[15],[16],[17] Thus, we observe that the pharmacological classes of AMM used in most health facilities are similar though the individual medicines may be different.

The majority of the patients in our study were prescribed more than one AMM, in congruence with findings from another study in India.[9] A possible reason could be the empirical use of AMMs without bacteriological evidence for infection. The average duration of antimicrobial therapy in this study was 5.6 ± 4.5 days. In a study in Greece, the mean duration of antibiotic prophylaxis was found to be 2.6 ± 1.4 days.[14] A surgical ward study performed in China noted that the mean duration of antimicrobial therapy was 1.7 days with the range of 1-19 days.[15] Overall, maximum numbers of antimicrobials were administered parenterally. Similar figures were seen in data from other developing countries.[16] It is probable that serious infections and comorbid conditions in inpatients justified the intravenous use of AMMs. However, the parenteral route should only be used in an emergency for severely ill patients, for medicines with poor bioavailability, or in patients with gastrointestinal dysfunction. Intravenous therapy besides being expensive increases the indirect costs of treatment.

Antimicrobial use was started as empirical therapy in almost all cases with few samples sent for bacteriological case confirmation. In all the cases, in which culture report was positive, antimicrobials administered were as per the culture sensitivity report or changed accordingly. A study performed in pediatric inpatients in South India reported bacterial culture in only 5% cases.[17] Other studies from Nepal and Israel have reported laboratory confirmation in 10%-25% cases.[10],[16],[18] These studies indicate a high prevalence of empirical antimicrobial use which could be due to the lack of adequate microbiological testing in the hospitals. The reasons for this need evaluation.

Although overall antimicrobials were used for therapeutic indications in most patients, prophylactic use was more common in surgery. As expected, high rates of antimicrobial prophylaxis have been observed in surgery wards in other studies.[15] In a study performed in the US in Surgery Departments, it was seen that 99.3% of patients received antimicrobial prophylaxis.[19] Another study in China found a high rate of antibiotic prophylaxis of 98% for clean-contaminated surgery and 78% for clean surgery.[15]

Practically, it is difficult to define appropriateness of a patient's treatment as the prescribing physician is often subjected to different kinds of pressures which may influence prescribing. The criterion we used for rational prescribing was Kunin's criteria, wherein the use of antimicrobials for different conditions is assessed.[6] This is based on the patient's detailed history and physical examination findings, diagnosis, treatment prescribed and evidence of infection and also on an exhaustive review of medical literature and guidelines of national and international professional bodies. In the absence of local Standard Treatment Guidelines (STG) for the treatment of common infections for assessing the appropriateness of the prescribed antimicrobial, the criterion was useful. Categories 1 and 2 essentially indicate "appropriate" therapy; categories 3 and 4 indicate that there was some deficiency in the choice or use of antibiotics by the physician managing the problem.

In this study, majority of patients (91.3%) received antimicrobial treatment as per Kunin's criteria 1. The main reasons for antimicrobial therapy falling in Kunin's criteria 2 and 3 were the usage of antimicrobials with overlapping spectrum, when transitioning from intravenous to oral route, the same antimicrobial should have been used instead of giving a different antimicrobial, and costly and newer antimicrobials were used where an older antimicrobial could have sufficed. These findings are similar to other studies where the use of antimicrobial was appropriate in 73%-92% cases.[13],[17],[20] Thus, it appears that the use of antimicrobials in inpatients in medicine and surgery departments although extensive and not supported with laboratory bacteriological antimicrobial sensitivity data is mostly based on rational reasoning.

In this study, it was observed that 52% of the total cost of medicine treatment received by the patients was spent on antimicrobials. It was reported in another study from India that antimicrobials contributed to nearly 72.5% expense of the total expenditure incurred on entire medications.[21] The cost of medicines prescribed is an important consideration, especially in a developing country like India where health budgets are limited. In the UK, antibiotics accounted for 19% of the total expenditure on medicines, which was the highest spend of all categories of medicinal products.[22]

The average cost of antimicrobial per patient was Rs. 1834. A study in Nepal showed that the average cost of antibiotic treatment was 818 Nepalese rupees (1 NPR = 0.626 INR).[16] This is much lesser than in our study. The antimicrobials incurring maximum expenditure were mostly newer AMM and were also not listed in the hospital EML.

Medicines included in the EML have been selected keeping in mind the efficacy, safety, cost of medicine, and suitability for patients attending the hospital. The essential medicine concept is based on the premise of medicines that fulfill the health-care needs of majority of the population. The majority of the prescribed antimicrobials (74.4%) were from the EML of the hospital in the study. The ABC analysis showed that a few expensive antimicrobials prescribed to few patients were not listed in the hospital EML but accounted for majority of the expenditure.

This also indicates that prescribing expensive antimicrobials without microbiological confirmation should be avoided wherever possible, especially if other alternative drugs are available, as it makes a large impact on the medicines budget of the hospital. The possible reasons for this could be a lack of STGs and nonavailability of antibiotic sensitivity data. Thus, the doctor may be prescribing broad-spectrum AMM to cover all possible pathogens.

Maximum antimicrobial expenditure was on medicines administered parenterally. This is also in conformity with the fact that parenteral antimicrobials cost more than their oral counterparts.

The antibiotic policy is a key issue for better care of patients, rational use of AMM, and combating antimicrobial resistance.[23] However, at the time of the study, the hospital did not have an antibiotic policy. STG is also not available for use within the hospital. Thus, doctors are prescribing AMM based on their clinical acumen and experience. This, approach may not be the best possible way of treating infections. The limitation of this study is the sample size used. Analysis of data of all patients would have greatly added to the situation analysis. This was not possible since records of patients are not computerized, and all data collection and analysis had to be done manually. Hence, approximately 20% of all patients prescribed AMM were selected.

Conclusion

The study highlights a high prevalence of AMM prescription associated with the lack of laboratory confirmation, nonavailability of STGs, and antibiotic sensitivity data. A few newer AMMs account most of the medicine budget, which is used for a small proportion of patients. There is an urgent need for a hospital antibiotic policy to be formulated to improve and rationalize the economics of AMM use in the hospital.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

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