Auditing and Improving Surgical Antibiotic Prophylaxis

Abstract

Background:

There is extensive evidence of the efficacy of anti-microbial drugs in preventing infections from surgical efforts. Our objective was to describe the results obtained in our annual surgical antibiotic prophylaxis (SAP) audit in the years 2013–2017.

Methods:

This was a retrospective observational study of SAP in surgical procedures carried out between 2013 and 2017 in a tertiary-level hospital. We examined the results from the services of general surgery, vascular surgery, neurosurgery, the breast unit, otolaryngology, maxillofacial surgery, traumatology, urology, pediatric surgery, gynecology, and plastic surgery.

Results:

Establishment of six process quality indicators and their evaluation in the annual audit were carried out by the pharmacy service for approximately 500 operations. The indicators that had a high percentage of compliance were indication for SAP, choice of anti-microbial agent, dose and route of administration, and administration of an intra-operative dose when this was appropriate. In contrast, time of administration of the first dose and duration of prophylaxis had a worse percentage of compliance.

Conclusions:

Compliance with the SAP protocols in our hospital is high. We consider that these better results are attributable to the establishment of quality indicators of SAP and to the annual audit that evaluates said indicators. Communication of the results obtained in the audit to the surgical services, which have as part of their objectives included in their management contracts compliance with said SAP protocols, encourages improvement. The use of prophylaxis kits is an improvement strategy that facilitates the correct choice of anti-microbial agent and prevents SAP from being prolonged inappropriately.

The introduction of anti-microbial drugs into clinical practice has been one of the greatest advances in medicine, both because of their direct effects (cure of infections) and because of their indirect effects (allowing the performance of procedures associated with a high probability of infection) [1,2]. The appropriate use of anti-microbial agents is necessary to ensure their therapeutic efficacy, prolong the useful life of antibiotics, and, thus, contribute to improving the prognosis of the patients. In addition, the optimization of antibiotic treatments should minimize the likelihood adverse events related to their use [3].

In Spain, the need for the proper use of anti-microbial drugs has led to the implementation of programs for optimizing the use of antibiotics (PROA) in hospitals, as well as to propose their implementation to health administrations and health professionals involved in the making of recommendations. These recommendations should be based on an operating model adapted to the different socio-healthcare measures of hospital care [4].

One of the main objectives of PROA is based on formalizing surgical antibiotic prophylaxis (SAP) through hospital protocols agreed to by the different specialists involved. This objective is based on the fact that a good proportion of the anti-microbial drugs used in hospitals are prescribed as prophylaxis and that monitoring of prophylaxis protocols associated with independent development of infections of the strategic pathways [5]. Surgical site infections (SSIs) are the third most common nosocomial infection (around 17% of the total number) [6], being associated with high morbidity and mortality rates [7].

Despite a large amount of evidence regarding the efficacy of anti-microbial drugs in preventing infections from surgical procedures and, thus, reducing deaths and the healthcare cost associated with treating them [8], the use of SAP in clinical practice frequently is inadequately highlighted with regard to the time of administration of the first dose, the choice of antibiotic, the lack of intra-operative dose administration, and prolonged use [9].

Surgical antibiotic prophylaxis contributes significantly to the consumption of antibiotics in hospitals and is already being associated with an increase in drug resistance, as well as to a large increase in healthcare spending [10]. Promoting improvement and efficacy of protocols in order to improve SAP and decrease SSIs is an unquestionable necessity for the management of a surgical service [11,12]. One of the main shortcomings of PROA is the lack of indicators with which to measure the quality of the use of anti-microbial drugs that allow evaluation of the impact of the improvement actions undertaken. In this context, the establishment of process quality indicators of SAP for adequate periodic and methodical evaluation through an annual audit, as well as dissemination to surgeons of the information obtained and the contribution of the necessary tools, is of great importance in facilitating SAP in the different surgical procedures carried out in the hospital. Our objective was to describe the results obtained in the annual SAP audit in the years 2013–2017 in our tertiary-level hospital with more than 30,000 annual surgical procedures.

Patients and Methods

This was a retrospective observational study of SAP in a sample of the surgical interventions carried out between 2013 and 2017 by general surgery, vascular surgery, neurosurgery, breast unit, otolaryngology, maxillofacial surgery, traumatology, urology, paediatric surgery, gynecology, and plastic surgery in a tertiary-level hospital, which is the only hospital of this level in our geographic area (2,754 km²). The study was approved by the hospital ethics committee.

The number of surgical interventions to be evaluated for each service and year was calculated to obtain 95% safety and accuracy close to 10%. To determine the sample size each year, we obtain a list of all the surgical interventions carried out in each service. Through a random selection, we collected sufficient surgical interventions of each service to achieve the desired statistical purposes. For each of the surgical interventions, electronic and paper records of each patient were reviewed; and data were collected, including surgical procedure, operating room entrance time, surgical incision time, surgical procedure end time, and antibiotic (agent, administration time of all doses, and route of administration). The following process quality indicators were evaluated: indication for SAP, choice of antibiotic, dose and route of administration, time of administration of the first dose, and duration of administration. All of them were considered correct or incorrect according to the protocols established in the hospital (Table 1). The different variables were collected and evaluated through a retrospective review of the clinical history of each patient by our specialty pharmacists. The results are sent every year to the hospital's medical department, which distributes them to each of the surgical services, which have compliance with the SAP protocols in the objectives of their management contracts, considering that this is one of the indicators of quality of care.

Table 1.

Quality Indicators of Surgical Antibiotic Prophylaxis

Indicator	Condition to evaluate
Indication for SAP	Prophylaxis indicated and administrated
Anti-microbial agent	Following established protocol
Dose and route of administration	Therapeutic dose and intravenous route
Time of administration of first dose	15 min–1 h before incision
Time of administration of first dose	2 h if antibiotic has a long half-life or for prolonged infusion
Intra-operative dose	Necessary if surgery lasts more than twice the half-life of the antibiotic
SAP duration	Not to exceed 24 h

Results

The periodic and methodical evaluation of the SAP of the different surgical services is carried out by an annual audit in which the pharmacy service evaluates the six process quality indicators of the SAP in around 500 surgical interventions of the more than 30,000 that are carried out annually. The overall hospital results obtained in this audit in the period 2013–2017 are shown in Table 2. It should be noted that the indicators that have a higher percentage of compliance are indication for SAP, choice of anti-microbial agent, dose and route of administration, and administration of an intra-operative dose when this is necessary. On the contrary, time of administration of the first dose and duration of prophylaxis are the indicators that had a worse percentage of compliance.

Table 2.

Annual Audit of the SAP 2013–2017 (%)

Year	2013 (n = 500)	2014 (n = 538)	2015 (n = 547)	2016 (n = 542)	2017 (n = 537)
Indication for SAP
Correct	99	96	95	97	98
Incorrect	1	4	5	3	2
Decreased	57	15	38	6	30
Exceeded	43	85	62	94	70
Choice of anti-microbial agent
Following protocol	94	91	93	95	95
Not following protocol	6	9	7	5	5
Enough coverage	55	77	67	76	52
Insufficient coverage	45	23	33	24	48
Dose and administration route
Correct	99	97	96	97	98
Time of administration of first dose
Correct	68	69	69	76	78
Incorrect	14	18	13	14	14
Non-assessable	18	13	18	10	8
Intraoperative dose
Correct	97	97	99	99	96
Duration of SAP
Correct	87	85	87	84	82
Incorrect	13	15	13	16	18
Shortened	6	5	14	1	4
Prolonged	94	95	86	99	96
Overall assessment	91	89	90	91	91

Decreased: SAP was indicated but was not administered; exceeded: SAP was not indicated but was administered; enough coverage: the anti-microbial agent was not the antibiotic in the protocol but was adequate for the micro-organisms involved in the surgery; insufficient coverage: anti-microbial agent was not the antibiotic in the protocol and was not adequate for the micro-organisms involved in the surgery.

The percentage of compliance with the indicator administration of the first dose ranged from 68% to 78% in different years. It should be noted that in between 8% and 18% of the cases, the indicator could not be evaluated because of the lack of hourly records of the administration of the first dose or of the surgical incision.

In relation to the duration of prophylaxis, the percentage of non-compliance ranged from 13% to 18%, which is mainly attributable to the prolongation of prophylaxis for more than 24 hours. On the other hand, the results obtained in the annual audit of 2017 are broken down by surgical service and are shown in Table 3. The sample selected for each service depended on the number of surgical procedures annually and ranged from 37 to 63. In the different surgical services, the same trend as in the global report is shown in terms of the degree of compliance with the different quality indicators.

Table 3.

Annual Audit of Surgical Antibiotic Prophylaxis 2017 According to Surgical Service

	Surgical service
Quality indicator	GS	MFS	PLS	VAS	GN	NSR	ORL	TRA	PS	BRU	UR
Sample	58	44	37	43	60	42	42	63	42	43	63
Population	2,729	655	1,788	895	1,714	734	1,498	1,839	820	541	1,632
Sensitivity (%)	95	95	95	95	95	95	95	95	95	95	95
Precision (%)	9	10	11	10	9	10	11	9	11	10	9
Indication for SAP (%)
Correct	100	100	100	98	100	98	88	97	100	98	100
Choice of anti-microbial agent (%)
Following protocol	98	98	100	98	92	98	86	97	95	98	89
Dose and route of administration (%)
Correct	100	100	100	98	100	98	88	97	100	100	100
Time of administration of the first dose (%)
Correct	81	75	75	84	80	81	69	76	74	93	75
Incorrect	16	20	14	14	8	12	29	8	19	5	14
Nonassessable	3	5	11	2	12	7	2	16	7	2	11
Administration of intra-operative dose (%)
Correct	88	93	100	98	97	100	95	95	100	98	97
Duration of SAP (%)
Correct	97	30	68	98	98	95	83	98	60	100	68
Incorrect	3	70	32	2	2	5	17	2	40	0	32
Decreased	0	0	0	100	0	0	0	0	0	0	0
Exceeded	100	100	100	0	100	100	100	100	100	0	100
Overall assessment	94	83	90	95	94	95	85	93	88	98	88

GS = general surgery; MFS = maxillofacial surgery; PLS = plastic surgery; VAS = vascular surgery; GN = gynecology; NSR = neurosurgery; ORL = otolaryngology; TRA = traumatology; PS = pediatric surgery; BRU = breast unit; UR = urology.

The global assessment, defined as the arithmetic mean of each indicator, reflects a variation between services from 83% to 98%.

Discussion

The process quality indicators contribute to evaluating SAP periodically and methodically and, thus, highlight the deficiencies that exist at the most critical points, encouraging implementation of improvement strategies. In our hospital, indicators of quality of SAP were defined more than 15 years ago after a systematic review of the literature. These indicators are in line with the key points of SAP established in 2013 by the European Centre for Disease Prevention and Control (ECDC) [6]. There are few published studies that assess the adequacy of SAP rigorously with respect to quality indicators. In our study, SAP was indicated in 97% of the surgical interventions in which it was administered. These data coincide with those published in another study carried out by Schmitt et al., who put the rate at 97.6% [13].

Regarding the time of administration of the first dose, it was adequate in 72% of the interventions. Other studies show lower figures for compliance with this indicator, such as the case of Schmitt et al. (who obtained 62.5% adequacy [13]) or Napolitano et al. (who obtained 53.4% adequacy [14]). In relation to this indicator, Ballestero et al. claim that administration of the first dose of SAP at an inappropriate time with respect to the start of the surgical intervention is the main cause of an incorrect prophylaxis regimen, which increases the likelihood of inadequate prophylaxis [15]. With regard to the duration of SAP, it was not correct in 15% of the interventions carried out in the study period. In this sense, a study performed in several European hospitals showed that in half of the patients operated on in 2006, the duration of SAP had been extended for more than 24 hours after surgery without justification [16]. Ballestero et al. obtained similar rates of inadequacy with respect to the duration of SAP, ranging from 12.82% in 2003 to 9.52% in 2005 [15].

In our hospital, regarding the overall assessment of SAP, compliance with the quality indicators in the study period was 90%, slightly higher than the 83.16% in another study conducted in Spain [15]. It is important to take into account that non-compliance with the recommended guidelines of SAP, as well as its application in an inadequate manner, entails an increase in costs and in bacterial resistance [17].

Our study has the limitation that it is a single-center retrospective and descriptive effort that did not analyze the infection rate or the micro-organisms isolated from surgical infections. Regarding the total sample size, it is enough to obtain 95% safety and accuracy close to 10%, but when we analyze the sample of each service, we achieve 95% safety with an accuracy ranging from 9%–12%. Nevertheless, the study has sufficient statistical power to reveal the quality of the process of SAP in our hospital.

The percentage of compliance with the SAP protocols in our hospital is high in relation to the data published in the literature. We consider that these better results are attributable to the establishment of quality indicators of the process of SAP, as well as to the performance of an annual audit that evaluates said indicators periodically and methodically.

To improve the performance of SAP in the hospital, prophylaxis kits were introduced, as some published studies have advocated [18,19]. Each of these kits contains necessary and sufficient antibiotic doses for the realization of adequate SAP for a particular procedures. If an intra-operative dose has to be administered, it can be taken from the prophylaxis kit even if the SAP is shortened because of this. The SAP finishes when the prophylaxis kit is empty and no additional doses have to be administered. The prophylaxis kit also contains a written form that will become part of the patient's medical records, where the health professional responsible for the administration of the antibiotic must enter the hour at which each dose was delivered.

The hospital's SAP protocol establishes four types of prophylaxis kits depending on the planned surgical intervention (Table 4). The use of each type of kit has been approved and agreed to by the hospital's Infection and Anti-microbial Policy Commission together with the different surgical services and the Pharmacy Service.

Table 4.

Composition of and Indication for Prophylaxis Kits

Kit number	Composition	Indication
1	Cefazolin 2 g pre-operatively +1 g/6 h × 3 doses	Clean surgery
2	Vancomycin 1 g pre-operatively +1 g 12 h later	Clean surgery; Penicillin allergy
3	Cefazolin 2 g pre-operatively	Minor surgery
4	Amoxicillin/clavulanic 2 g/200 mg (intravenous) pre-operatively +2 g/200 mg/8 h × 2 doses	Contaminated surgery

The use of prophylaxis kits is an improvement strategy that promotes the realization of adequate prophylaxis, especially because it ensures that the anti-microbial drug selection in each case will be the correct one (active principle, dose, and route) and helps to prevent the SAP from being prolonged unnecessarily. Likewise, we consider that communication of the results obtained in the audit to the different surgical services, which have in their objectives of the management contracts compliance with said SAP protocols, encourages improvement of care.

Footnotes

Acknowledgments

We are grateful for the assistance of Doctoral Programme in Pharmacy of the University of Granada.

Author Disclosure Statement

This study received no financial support. All authors report no conflicts of interest.

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