A Study of Antibiotics Prescription Pattern in Pre, Intra &amp; Post Operative Period to Patients Who Later Developed Surgical Site Infections in a Tertiary Care Centre.

doi:10.21203/rs.3.rs-4340562/v1

Introduction: Antimicrobial resistance(AMR) has emerged as major public health problem all over the world which can be controlled in paying great attention to judicious use of them. In 2012, Indian Council of Medical Research(ICMR) started Antibiotic Stewardship Program(ASP) to reduce Surgical site infections(SSIs) by doing right antimicrobial prophylaxis and emphasised to prevent drug resistance. Thus, we aimed to see the pattern of antibiotics prescribed in pre, intra and post-operative period to patients, who later developed SSIs.

Methodology: After local IEC-DHR approval, Data is collected using Retrospective Descriptive Type Study Design in tertiary care centre of government of Maharashtra. All patients’ medical records who undergone Surgeries performed in General Surgery, Obstetrics-Gynaecology, Orthopaedics Departments and later developed surgical site infections in post-operative period are included. Duration of Study is 6 Months (Jan’23 to Jun’23). Only antimicrobials used are recorded & Data from Prescriptions are analysed using latest versions of M.S.Excel.

Results: Total 71 case records are studied and Females found more. 19-30years of age patients are more. Antimicrobials of Third generation cephalosporins are used most frequently in Pre, Intra and post-op period. Among it, Inj. Ceftriaxone was prescribed more commonly as ‘Monocef’. Half of Antimicrobials are prescribed with Generic names and match Daily Defined Dose(DDD) recommended by WHO. Average duration of post-operative treatment was 12-13days. Antibiotics were prescribed till discharge to all.

Conclusion: In our study, case records of patients who later developed surgical site infections are studied to know Demographic profile. Type, Dose, Interval of Pre, Intra and Post-operative prophylaxis were according to ASP of India by ICMR. Prescription pattern is Most commonly Polypharmacy and Fixed Drug Combinations were preferred. I.V. was used more than P.O. Treatment modifications are done in 1/4^th cases after microbiological reports of swabs of infected sites and this need to be increased.

Clinical Pharmacology

Antibiotics

Surgical Site Infections

Antibiotic Prescriptions

Post-operative Antibiotics

Antibiotic stewardship programme

1.1 Background Information

Antimicrobial resistance (AMR) has emerged as a major public health problem all over the world. In 2006, Centres for Disease Control and Prevention (CDC) guideline for “Management of multi-drug resistant organism in health care setting” stated that emergence of multi-drug resistance can be controlled in paying great attention to judicious antimicrobial use. Similarly, in 2009, CDC launched “Get Smart for Healthcare Campaign” to promote improved use of antibiotic in In-patient settings. In 2015, the White House published the National Action Plan for Combating Antibiotic-Resistant Bacteria with five main goals to:

i. curb antibiotic resistance,

ii. strengthen antimicrobial resistance surveillance,

iii. advance development of rapid diagnostics,

iv. accelerate research targeting novel therapeutics, and

v. collaborate with other countries to strengthen prevention, development, and surveillance efforts. (1)

Surgical site infections (SSIs) are the second most common cause of nosocomial infections. Administration of prophylactic antibiotics in certain surgical procedures can decrease post-operative infections, decrease the length of hospital stay and reduce the overall cost of care. In 2012, Indian Council of Medical Research (ICMR) started Antibiotic Stewardship Program (ASP) to preserve the effectiveness of the drugs and to maximize hospital infection control practices to limit this spread of resistance to antibiotics. Nowadays, the situation in the development and approval of newer antimicrobial agent is not encouraging. Centre of Health Protection of the Department of Health rolled out “the Antibiotic Stewardship Programme in Primary Care,” aiming to optimize the use of antibiotics by providing evidence-based antibiotic prescription guidance for common infections in community for doctors and healthcare professionals, as reference. (1)

Recent work by the World Health Organization (WHO) “Clean Care is Safer Care programme” shows that surgical site infection (SSI) is the most surveyed and frequent type of Healthcare Associated Infections (HAI). (2)

Appropriate prescription of antibiotics is seen as one of the most effective ways to reduce SSIs. Previous studies and organizations have suggested that antibiotics should ideally be administered 60 min before the first incision, with a second dose potentially administered for longer procedures, i.e., longer than 4 h. (3) More recently, the WHO AWaRe guidance book (2022) has suggested that antibiotic prophylaxis should be administered 120 min or less before starting surgery as a single dose, and not continued after surgery if proper hygienic care is taken.

Antimicrobials are used in surgical wards most commonly in post-operative period & prophylactically in pre & intra operative period. (4,5) Antibiotic prophylaxis in pre & intra-operative period is mandatory to prevent and minimize post-operative SSIs. (3,5) But, despite the surgical prophylaxis, Inappropriate and excessive use of antibiotics for this purpose leads to increase in nosocomial infections, hospital costs, ineffectiveness and/or decline in susceptibility of bacteria, thus resistance to antibiotics and, eventually burden on health care resources and ultimately this can be great threat to modern medicine. (1,3,4,6) Inappropriate antibiotics prescribed for unnecessary indications, in the form of wrong doses, variable durations, not reviewing microbiological reports, choosing wrong type of class of antibiotic suitable for surgeries. Appropriate use of antibiotics also enhances rate of wound healing by providing sterile environment around the surgical sites. (5) Obese people are more likely to have SSIs than non-obese, hence choice of antimicrobials according to patients’ condition is also important. (7)

Goal of Antimicrobials is not only to sterilize tissues, but also to reduce intra-operative contamination in operating settings. Prophylactic antibiotics are still used subjectively by physicians as no single drug of choice is yet found. (8) locally published studies show antibiotics are second most prescribed agents after analgesics. (9) Prescriptions are an indirect measure of antibiotics consumption & not a measure of rate of resistance emergence which is multifactorial. (10)

1.2 Lacunae and Rationale of study

However, there is currently limited available research study done regarding the prescription of antibiotics for surgical prophylaxis among various hospitals in India. Prescription audit and guidelines for judicious use of antibiotics can show better impact not only on SSIs and other infectious diseases, but also on appropriate use of antibiotics. Also, in future, References and evidences can be provided to support such studies related to antimicrobial resistance and focusing on its usage in pre, intra and post-operative periods. It is always beneficial to be aware of current situation of antibiotic prescription pattern especially reducing SSIs.

1.3 Aim and Objectives

Keeping this scenario in mind, we aimed to study pattern of Antibiotics prescribed in pre, intra, post-operative period to patients who later developed surgical site infections in tertiary care centre, With following objectives:

i. To study the prescription pattern of antibiotics used for patients before, during and after surgery and who later found with surgical site infections in tertiary care centre.

ii. To calculate the defined daily dose (DDD) of drugs according to WHO’s ATC (Anatomical therapeutic chemical classification) and DDD system.

iii. To measure compliance of antibiotic drugs use according to Antibiotic Stewardship programme to prevent surgical site infections.

2.1 Study Setting and Design

Retrospective Descriptive Type of Study Design is used and we conducted study in a tertiary care centre of government of Maharashtra for duration of 6 months from January 2023 to June 2023. This hospital is Asia’s 1^st rural tertiary care centre and chosen as it is very well-known teaching institute especially for high quality, most advanced surgical treatments and for convenience.

Medical Records of All patients who undergone Surgeries performed in Departments of General Surgery, Obstetrics and Gynaecology, Orthopaedics and later developed surgical site infections in post-operative period are included.

2.2 Definitions

Definition of antibiotic stewardship is “Coordinated intervention is designed to improve and measure the appropriate use of antimicrobial agents, by promoting the selection of optimal antimicrobial drug regimen including dosing, duration of therapy and route of administration” (SHEA, IDSA, PIDS – April 2012). (1)

Defined Daily Dose (DDD) is defined by WHO “an assumed average maintenance dose in grams per day for a drug used for its main indication in adults”. It is antibiotic use in hospitals by aggregating the total number of grams of each antibiotic purchased, dispensed, or administered during a period of interest divided by WHO assigned DDD. The World Health Organization publishes defined daily dose values for nearly all antimicrobials with the ATC Code drug classification system. DDD estimates are not appropriate for children and those with reduced drug excretion such as renal impairment. (11)

SSIs are defined as “Infections occurring up to 90 days after surgery and affecting either the incision or deep tissue at the operation site”.

2.3 Data Collection Process and Statistical Analysis

Data is collected using prescription sheets as data collecting tool, and only antimicrobials used during hospitalization are recorded. The Handwritten prescriptions sheets of surgeons are evaluated in details for Socio-demographic profile viz. Age, Gender, and Dose, Formulation, Duration and Frequency of antibiotics use.

WHO core indicators for drug utilization study (11) are assessed which are:

a. Percentage of drugs prescribed by generic name out of total drugs prescribed.

b. Percentage of Oral antibiotics prescribed out of total antibiotics prescribed.

c. Percentage of Injections prescribed out of total antibiotics prescribed.

The compliance of antibiotics prescribed is checked using Antibiotic Stewardship Program (ASP) measures like Monitoring of Antibiotic use and restriction, no unnecessary prescription by better diagnosis, no inappropriate prescription by observing Dose, Route of administration, Duration. (1)

Data collected is entered and analyzed in latest version Microsoft Excel software using appropriate statistical methods. Descriptive statistics is used to summarize the patient socio-demographic and clinical data.

2.4 Ethical Considerations and Approval

The study was reviewed by the Institutional Ethics Committee of DHR (Department of Health Research of India) of Swami Ramanand Teerth Rural Government Medical College and Hospital, Ambajogai, Dist. Beed, Maharashtra, India. The Study is commenced after obtaining approval of the above Institutional ethics committee of DHR vide letter no. S.R.T.R.G.M.C./Pharma/IEC-DHR/64/2023 Dated: 08/08/2023.

3.1 Socio-demographic Characteristics

Total 71 medical case records of patients are found as per inclusion criteria i.e., patients who have undergone Surgeries performed in Departments of General Surgery, Obstetrics and Gynaecology, Orthopaedics and later developed surgical site infections in post-operative period. Out of them, Females were 39 and remaining 32 were male. Patients’ case records are tabulated in an age wise classification of 6 groups and department wise as per below Tables 1 & 2 respectively.

Table No.1: Socio-demographic data showing Age group wise classification and Gender wise no. of patients with total summarization.

Sr. No.	Age Groups	Female	Male	Total
1	<12 Years	0	2	2
2	13-18 Years	1	0	1
3	19- 30 Years	22	8	30
4	31-45 Years	6	12	18
5	46-60 Years	5	4	9
6	>60 Years	5	6	11
Total		39	32	71

Table No.2: Socio-demographic data showing gender wise no. of patients from different wards with total summarization.

Dept.	Female	Male	Total
Surgery	10	31	41
OBGY	28	N.A.	28
Ortho	1	1	2
Total	39	32	71

3.2 Prescription Indicators (Table No.3)

Total 234 Antibiotics were prescribed to 71 patients during their hospital stay. Out of these 118 Antibiotics were prescribed with Generic names and remaining 116 with brand names. 186 antibiotics were given in injectable dosage form, while 45 antibiotics in tablets and one drug each in as capsule, ointment, and syrup form. Thus, 186 antibiotics were given through parenteral route while 47 no. of drugs through oral and that 1 ointment was locally applied. 181 antibiotics were prescribed twice in a day, while 49 for thrice daily and remaining 4 for once a day. 118 of total prescribed antibiotics match with Daily Defined Dose (DDD) recommended by WHO remaining 116 does not match. It is observed that Average duration of hospital stay was 12-13 days with minimum 3 days to maximum 60 days of stay of some patients and all patients are prescribed antibiotics till their last day of hospital stay.

In the below table no. 3, Various prescription parameters/indicators are assessed and the antibiotic drugs used out of total antibiotics are shown with percentages.

Table No.3: Prescription Indicators

Prescription Indicators Assessed	Out of Total 234 No. of Antibiotics	Percentage
*i. Format of Prescribed Antibiotics*
Generic Names	118	50.43%
Brand Names	116	49.57%
*ii. Dosage Form of Antibiotics*
Injectables	186	79.48%
Tablets	45	19.23%
Capsules	1	0.43%
Syrup	1	0.43%
Ointments	1	0.43%
*iii. Route of Antibiotic Drugs Administration*
Parenteral	186	79.48%
Oral	47	20.09%
Local	1	0.43%
*iv. Frequency of Antibiotics taken per day*
Twice Daily	181	77.35%
Thrice Daily	49	20.94%
Once Daily	4	1.71%
*v. Compliance with Defined Daily Doses by WHO*
Match	118	50.43%
Do Not Match	116	49.57%

3.3 Antibiotic Usage (Table No.4)

In overall pre, intra and post-operative period and all wards, Antibiotics of 3^rd generation cephalosporins are prescribed for 61 no. of times followed by Penicillin with B-lactamase inhibitors which were used for 52 times, and as for other groups, Nitroimidazoles (Metronidazole) are prescribed for 49 times, Oxazolidinone (Linezolid) for 22 times, Aminoglycosides for 17 times, Fluoroquinolones (Ciprofloxacin) for 15 times, Carbapenems (Meropenem) for 9 times, Macrolides (Azithromycin) thrice, Tetracyclines twice (Doxycycline once and Tetracycline once) and Penicillin only (Amoxicillin) and polymyxin (Colistin) are used once. Among 3^rd generation cephalosporins, Ceftriaxone was prescribed 39 no. of times followed by Cefotaxime for 22 times. Among Penicillin with B-lactamase inhibitors, Amoxicillin with Clavulanic acid (Clavam) was prescribed 36 no. of times followed by Piperacillin with Tazobactam (Piptaz) for 16 times. Among Aminoglycosides, Gentamycin was prescribed 10 no. of times followed by Amikacin for 7 times.

In the below table no. 4, Antibiotics prescribed in overall pre, intra and post-operative period and all wards, are shown according to classes of antibiotics with frequency of usage of each class with percentages, followed by each drug according to WHO ATC classification code and recommended DDD with observed DDD (in Grams) followed by their individual Frequency of usage with percentages.

Table No.4: Antibiotic Usage

Sr. No	Class	Used No. of Times	Use (%)	Drug	ATC Code	WHO DDD	Observed DDD	Used No. of Times	Use (%)
1	Tetracyclines	2	0.86	Doxycycline	J01AA02	0.1	0.2	1	0.43
1	Tetracyclines	2	0.86	Tetracycline	J01AA07	1	1	1	0.43
2	Penicillin	1	0.43	Amoxicillin	J01CA04	1.5	1	1	0.43
3	Penicillin + B lactamase Inhibitors	52	22.41	Clavam I.V.	J01CR02	3	2.4	19	8.19
				Clavam Tab		1.5	1.25	17	7.33
				Piptaz	J01CR05	14	9	16	6.90
4	Cephalosporin	61	26.29	Cefotaxime	J01DD01	4	2	22	9.48
4	Cephalosporin	61	26.29	Ceftriaxone	J01DD04	2	2	39	16.81
5	Carbapenem	9	3.87	Meropenem	J01DH02	3	2	9	3.88
6	Macrolides	3	1.29	Azithromycin	J01FA10	0.3	0.5	3	1.29
7	Aminoglycosides	17	7.33	Gentamycin	J01GB03	0.24	0.16	10	4.31
7	Aminoglycosides	17	7.33	Amikacin	J01GB06	1	1	7	3.01
8	Fluoroquinolone	15	6.47	Cipro I.V.	J01MA02	0.8	1	11	4.74
8	Fluoroquinolone	15	6.47	Cipro Tab		1	1	4	1.72
9	Polymyxin	1	0.43	Colistin	J01XB01	9	6	1	0.43
10	Nitroimidazole	49	21.12	Metro I.V.	J01XD01	1.5	1.5	47	20.26
10	Nitroimidazole	49	21.12	Metro Tab	P01AB01	2	1	2	0.86
11	Oxazolidinone	22	9.49	Linezolid	J01XX08	1.2	1.2	22	9.48

In this study period, Total 71 Medical records of patients who undergone Surgeries and later developed surgical site infections in post-operative period are studied. From the data collected, it is found that Female patients were more than male. On analyzing data age group wise, patients of 19–30 years of age were more than other age groups as depicted in below Figure No. 1.

Authors point of view about this analysis is solely accounting socio-demographic profile of patients related to this study and does not depict any exact relation of Surgical site infections to their age.

While analyzing prescriptions of these patients, it is found that almost half of antibiotics were prescribed in generic format and remaining in brand name format. Also, Majority of Injectable dosage forms is preferred considering its advantage over other types of dosage forms. Thus, it is very clear to say that parenteral route of administration was most chosen by surgeons. As per considering the frequency of antibiotics administered to patients, more than three forth of antibiotics are given twice a day (Bis in Die). One of the measures of Antibiotic Stewardship Programme, Compliance of Doses of antibiotics with reference to WHO Daily Defined Dose system, more than half of them match with recommended dose and 6.5% are overdosed while 41% are underdosed. (Table No. 4). All this observation can be best demonstrated pictorially in below Figure No. 2.

Among all antibiotics analyzed from prescriptions of all these records shows that third generation cephalosporins are used most frequently in Pre, Intra and post-op period, within them, Ceftriaxone was prescribed more commonly as ‘Monocef’ in injectable forms. As 3rd generation cephalosporins comes in ‘Watch’ group of antibiotics according to WHO AWaRe classification (1), Hence, we suggest avoiding of unnecessary prescriptions of ‘Watch’ group of antibiotics should be implemented to reduce Antimicrobial Resistance. Average duration of post-operative treatment was 12–13 days and All of them were prescribed antibiotics till discharge. Hence, this extensive duration of antibiotics prescription post-operatively till day of discharge should be reduced.

An Ideal antibiotic should be selected based on its pharmacokinetic profile, considering its toxicity, cost-benefit and effectiveness, route of administration needed for various types of surgeries, drug sensitivity pattern of the hospital i.e., Hospital Antibiogram. Every Health care institution should regularly assess or review antimicrobial prescriptions & conduct meeting regarding standardizing t/t and strict adherence to Antibiotic stewardship programme (ASP). It is highly recommended to take ASP rounds led by Infectious disease Specialist, Clinical Pharmacologist, Clinical Microbiologist, Chief Pharmacist frequently. As globally, there is no standard measure to quantify antibiotic consumptions across all clinical settings. Hence, WHO recommended use of Daily Defined Dose (DDD) System to enable comparison between various hospitals and institutes.

Although Efforts have been put like improvement of OT rooms and its ventilation or fumigation & sterilization, and implementing advance surgical techniques along with antibiotic surgical prophylaxis in pre, intra and post operative period, Surgical Site Infection (SSI) remains the most common nosocomial infection. Not only health care professionals but patients are also responsible for inappropriate use of antibiotics. Also, Health care professionals should be in touch with recent updates regarding antimicrobial resistance to prophylactic antibiotics and administer antibiotics with correct indications, selection, duration, and dosage. Some suggestions that need to addressed to improve future outcome of antibiotic usage in pre & intra operative period are:

a. Selection of Appropriate agent based on type of surgery and expected flora,

b. Timing before operation to achieve effective concentration at time of incision,

c. Duration of maintenance of adequate concentration at end of operation according to pharmacokinetic of antibiotics.

d. Consultation with Infectious disease Specialist, Clinical Pharmacologist, Clinical Microbiologist before administrating antibiotics for surgical procedures.

In our study, case records of patients who later developed surgical site infections are studied to know their Socio-demographic profile viz, age, gender, hospitalized wards. Type, Duration, Dose, Interval of Pre, Intra and Post-operative prophylaxis in some extent was not complied with ASP of India by ICMR. Prescription pattern is most commonly Polypharmacy and Fixed Drug Combinations were preferred. I.V. route of administration of Drugs was used more than per oral route. Treatment modifications are done in only one fourth cases after microbiological reports of swabs of infected sites and this percentage need to be increased. All the patients received antibiotics till discharge. Also, Initiation of Intra-Operative prophylaxis of Antibiotics is at the time of anesthesia induction. It is observed in some cases that there was too long antibiotic coverage in post-operative period. In future, we will continue to monitor the situation further and will take more patients in consideration.

6.1 Funding/Sponsorship/Support

The authors received No funding/sponsorship/financial support for the research, authorship, and/or publication of this article.

6.2 Conflict of Interests

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper and no conflict of interests in any terms or by any means during the study.

6.3 Declaration of generative AI in scientific writing

The authors declare no support is taken of any Artificial Intelligence tool or technology in any terms or by any means during the study and have no relationships that may have inappropriately influenced them in writing this article.

6.4 Informed Consent Statement

No informed consent was needed and taken, as this was a retrospective study of patients’ medical records found in institute and no direct contact with any patients was encountered. In addition, all patients’ details, data, and records is kept confidential by authors.

6.5 Acknowledgement

The authors acknowledge the invaluable contributions of all teaching and non-teaching staff of Department of Pharmacology of the Swami Ramanand Teerth Rural Government Medical College and Hospital, Ambajogai, Dist. Beed, Maharashtra, India. The authors also, take it as a privilege to acknowledge Dean Dr. B. S. Khaire, Medical Superintendent Dr. Rakesh R. Jadhav for allowing to study medical records, and All principals, physicians, nursing staffs and other healthcare professionals of the institute for their academic and administrative support during our research work. The authors are thankful to all staffs of Medical Record Section Department of the institute for the very convenient and easily accessible management of patients’ medical records.

6.6 Study Limitations

Time of Administration of 1^st antibiotic dose before surgical incision was not assessed. Only 3 Surgical wards (General Surgery, Obstetrics & Gynecology and Orthopedics) of the tertiary care centre are taken under consideration, hence study results do not replicate the whole tertiary care centre and other government teaching & non-teaching hospitals. Also, 6 months duration Retrospective type of study designs by its nature has its own limitations as compared to other type of study designs and may involve missing key information.

6.7 Authors’ Contributions

Dr. Vaibhav B. Chavhan is a M.D. Pharmacology student and was involved in every step of the study from Conceptualization, study design, data collection, analysis, validation, and interpretations, also writing of 1^st draft, abstract and manuscript. Dr. J.B. Jaju sir is the student’s P.G. Guide who supervised and guided him throughout his M.D. programme and from study design to manuscript writing. Dr. Asha D. Jadhav is P.G. Students’ In-Charge and assisted in background, methodology, data validation and drafting. All authors contributed to discussion, successive reviews and corrections before submission and have read & approved to publishing version of the final corrected manuscript.

6.8 Data Availability

Additional data that support this study and its findings are available to lead author Dr. Vaibhav B. Chavhan upon reasonable request to Dean of Concerned institute of tertiary care centre in soft copies only, for five years after publication of this article.

6.9 Disclaimer

The Views expressed in this research study are solely of lead author Dr. Vaibhav B. Chavhan under the guidance of other authors and none other than.

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The authors declare no competing interests.

A Study of Antibiotics Prescription Pattern in Pre, Intra & Post Operative Period to Patients Who Later Developed Surgical Site Infections in a Tertiary Care Centre.

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Abstract

Figures

1. INTRODUCTION

2. METHODS AND MATERIALS

3. RESULTS

4. DISCUSSION

5. CONCLUSION

Declarations

References

Additional Declarations

Status:

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