EVALUATION OF SURGICAL ANTIBIOTIC PROPHYLAXIS IN ASEER AREA HOSPITALS IN KINGDOM OF SAUDI ARABIA

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1 EVALUATION OF SURGICAL ANTIBIOTIC PROPHYLAXIS IN ASEER AREA HOSPITALS IN KINGDOM OF SAUDI ARABIA Mohamed A. Hammad 1, Khaled M. AL-Akhali 2 & Abubakr T. Mohammed 3 1Lecturer of clinical pharmacy, Department of Clinical Pharmacy, Faculty of Pharmacy, King Khalid University, Abha, Kingdom of Saudi Arabia (E_mail: m_anwaaar@hotmail.com, mobile: , King Khalid University, Abha city Kingdom of Saudi Arabia P.O. 1882, Z.C Prof.of clinical pharmacy, head of Clinical Pharmacy Department, Faculty of Pharmacy, King Khalid University, Abha, Kingdom of Saudi Arabia(E_mail: khaled_akhali@yahoo.com,mobile: ). 3Lecturer of clinical pharmacy, Department of Clinical Pharmacy, Faculty of Pharmacy, King Khalid University, Abha, Kingdom of Saudi Arabia (mobile: ). ABSTRACT Objective: The aim of study to identify the antibiotics more used in surgical antibiotics prophylaxis and measures the adherence percent for surgical antibiotics prophylaxis guidelines in Aseer area Hospitals. Materials and method: Retrospective cross-sectional study was carried out. Sample size consisted of 164 patients selected randomly from Central Aseer Hospital and Khamis Moshate Hospital. Collection of the data from patient file in forms contain gender, age, diagnosis, pre antibiotic, post antibiotic, past medical history and surgical type. Results: In our study Cefazolin was the most used antibiotic in both preoperative and postoperative prophylaxis, 72 (43.9%) and 92 (56.1%) respectively. The adherence rate for pre and postoperative antibiotic prophylaxis guidelines in Aseer Hospital was 36/100 (36%) and 56/100 (56%) respectively by average 92/100 (46%) in adherence to guidelines. In Khamis Hospital the adherence for guidelines was 72/128 (56.25%) in both pre and postoperative antibiotic prophylaxis. The total average in both hospitals was 164/328 (50%). Conclusion: The findings of the present study show that, surgical antibiotic prophylaxis need more monitoring to guidelines adherence, also the need to clinical pharmacists intervention and continuous education to optimize the use of antibiotics which will decrease side effects and cost of treatment. Keywords: Antibiotic, Preoperative, postoperative, surgical, prophylaxis, procedure, Kingdom of Saudi Arabia. 1. INTRODUCTION Antibiotics are molecules that kill, or stop the growth of microorganisms, including both bacteria and fungi. Antibiotics that kill bacteria are called bactericidal and antibiotics that stop the growth of bacteria are called bacteriostatic. Surgical site infections (SSI s) account for approximately 15% of nosocomial infections and are associated with prolonged hospital stays and increased costs. Factors influencing the development of SSI s include bacterial inoculums and virulence, host defenses, perioperative care, and intraoperative management. Unfortunately, an increasing number of resistant pathogens, such as methicillin-resistant Staphylococcus aureus and Candida species, are commonly implicated in surgical wound infections. 1 Antimicrobial prophylaxis is used to reduce the incidence of postoperative wound infections. Patients undergoing procedures associated with high infection rates, those involving implantation of prosthetic material, and those in which the consequences of infection are serious should receive perioperative antibiotics. 2 Treatment, rather than prophylaxis, is indicated for procedures associated with obvious preexisting infection (i.e. abscess, pus, or necrotic tissue). Cephalosporins (such as cefazolin) are appropriate first line agents for most surgical procedures, targeting the most likely organisms while avoiding broad-spectrum antimicrobial therapy that may lead to the development of antimicrobial resistance. Duration of prophylaxis should not exceed 24 hours. 3 In many ways, the value of surgical antibiotic prophylaxis in terms of the incidence of SSI s after elective surgery is related to the severity of the consequences of SSI s. For example, in the presence of an anastomosis of the colon, prophylaxis reduces postoperative mortality. 4 In total hip replacement surgery prophylaxis reduces long term postoperative morbidity. 5 For most operations, however, prophylaxis only decreases short term morbidity. SSI s will increase the length of hospital stay. 6 The additional length of stay is dependent on the type of surgery. 7 Prophylaxis has the potential to shorten hospital stay. There is little direct evidence that it does so as few randomized trials have included hospital length of stay as an outcome measure. There is evidence to indicate that prevention of wound infection is associated with faster return to normal activity after discharge from hospital. 8 1

2 One of the aims of rationalising surgical antibiotic prophylaxis is to reduce the inappropriate use of antibiotics thus minimising the consequences of misuse. Penicillin and cephalosporin antibiotics are often the cornerstone of antibiotic prophylaxis. If a patient has been wrongly attributed with a penicillin allergy, optimal management may be compromised. Patient history is integral to evaluation of allergy. Cross-reactivity between penicillins and cephalosporins is generally quoted at 10%. 9 Rationalising surgical antibiotic prophylaxis will reduce the incidence possibility of the risk of anaphylactic shock, the incidence of antibiotic-associated diarrhea in patients receiving prophylactic antibiotics. Also increased antibiotic use leads to more resistance as demonstrated by a variety of large and small scale studies. 10, 11 The aim of study to identify the antibiotics more used in prophylaxis in Aseer area Hospitals and evaluate the use of antibiotics for pre and post operative. The study measures the adherence percent for surgical antibiotics prophylaxis guidelines. 2. METHODS A retrospective cross-sectional study was carried out in the Aseer and Khamis Moshate hospitals which work as a teaching hospital affiliated with the Kingdom of Saudi Arabia (KSA) Health System. The study was approved by the hospital s Institutional Review Board and Research Ethics Committee. The research was conducted in accordance with the ethical principles of the KSA Ministry of Health s legislation on human investigation, guaranteeing patient anonymity with regards to the information collected and data protection. Patients were selected randomly from Central Aseer Hospital and Khamis Moshate Hospital. Collection of the data from patient file in forms contain gender, age, diagnosis, pre antibiotic, post antibiotic, past medical history and surgical type. 3. STUDY SAMPLE The study sample consisted of 164 inpatients consecutively admitted (100 inpatients from Aseer and 64 inpatients from Khamis Moshate hospitals over period of 4 months. The patients were retrospectively identified from a schedule and, once included in the study, a detailed review of their complete medication list on day -1 was carried out. Information regarding demographics, diagnosis, allergy, and prescribed drugs were extracted from the patients clinical history records. 4. RESULTS Patient characteristics One hundred sixty four patients were included in the study; the majority was male 94/164 (57.3%) and female was 70/164 (42.7%). The median age was 36.5 years (range, 19 66). Administered drugs The 164 patients were prescribed and administered a median of 2.4 medications (range, 1 3) from a variety of antibiotics categories. Most of the antibiotics were administered using a central line. Table 1; Prophylactic surgical antibiotics used in Aseer area hospitals (total n. = 164) Variable 100 Aseer H. n (%) 100 Aseer H. n (%) 64 K. Moshat H. n (%) 64 K. Moshat H. n 328 Total Preoperative Postoperative Preoperative (%) Postoperative n (%) Cefazolin 32 (32) 52 (52) 40 (62.5) 40 (62.5) 164 (50) Metronidazole 48 (48) 36 (36) 12 (18.75) 20 (31.25) 116 (35.4) Gentamicin 24 (24) 40 (40) 20 (31.25) 8 (12.5) 92 (28.04) Ampicillin 0 4 (4) (1.2) Cefixime 4 (4) 4 (4) (2.43) Clarithromycin 4 (4) (1.2) Para-fungal 8 (8) (2.43) 2

3 Table 2; Type of surgeries performed during the study period in Aseer area Hospitals, (n = 164) Type of surgery No % Gastrointestinal % Genitourinary % Head & neck % Neurosurgical % Orthopedic % Cardiothoracic % Table 3; Adherence rate for pre and post operative antibiotic prophylaxis guidelines in Aseer area hospitals Variable Central Aseer Hosp. Khamis Hosp. Pre-antibiotic 36/100 (36%) 36/64 (56.25%) Post-antibiotic 56/100 (56%) 36/64 (56.25%) Average 92/200 (46%) 72/128 (56.25%) Total average for both hospitals is 164/328 (50%) 5. DISCUSSION The American Society of Health System Pharmacists Therapeutic Guidelines on Antimicrobial Prophylaxis in Surgery, 12 which have provided practitioners with standardized effective regimens for the rational use of prophylactic antimicrobials, have been revised as described on the basis of new clinical evidence and additional concerns. Prophylaxis refers to the prevention of an infection and can be characterized as primary prophylaxis, secondary prophylaxis (suppression), or eradication. Primary prophylaxis refers to the prevention of an initial infection. Secondary prophylaxis refers to the prevention of recurrence or reactivation of a preexisting infection. Eradication refers to the elimination of a colonized organism to prevent the development of an infection. These guidelines focus on primary prophylaxis. Secondary prophylaxis and eradication are not addressed. 13 The antibiotic chosen should have activity against the most common surgical wound pathogens. For cleancontaminated operations, the agent of choice should be effective against common pathogens found in the Gastrointestinal and Genitourinary tracts, in clean operations, the gram-positive Staphylococcus. aureus and Staphylococcus epidermidis predominate are predominant. So for most procedures, Cefazolin should be the agent of choice because of its relatively long duration of action, its effectiveness against the organisms most commonly encountered in surgery, and it s relatively low cost. Specific recommendations for the selection of prophylactic antimicrobials for various surgical procedures are provided in Table 4. However, these recommendations are based on data derived primarily from adult patients and from tertiary references. Neonatal and pediatric dosages are not provided. 14 3

4 Table 4 Procedure-Specific Recommendations for Surgical Antibiotic Prophylaxis 15 Procedure Likely organisms Recommended antibiotic* Adult dose Cutaneous Staphylococcus aureus, No uniform recommendation Staphylococcus epidermidis Head and neck S. aureus, streptococci Cefazolin (Ancef, Kefzol) Neurosurgery S. aureus, S. epidermidis Cefazolin Thoracic S. aureus, S. epidermidis Cefazolin Cardiac S. aureus, S. epidermidis Cefazolin Abdominal Gastroduodenal Gram-positive cocci, enteric gramnegative bacilli High risk: cefazolin Colorectal Enteric gram-negative bacilli, anaerobes Oral: neomycin (Neosporin) and erythromycin base 1 g orally (3 doses)# Parenteral: cefotetan (Cefotan) or cefoxitin (Mefoxin) Appendectomy Enteric gram-negative bacilli, anaerobes Cefotetan or cefoxitin Biliary Enteric gram-negative bacilli High risk: cefazolin Gynecologic and obstetric Enteric gram-negative bacilli, group B streptococcus, anaerobes Cefazolin Urologic S. aureus, enteric gram-negative bacilli Cefazolin Orthopedic S. aureus, S. epidermidis Cefazolin Noncardiac vascular S. aureus, S. epidermidis, enteric gram-negative bacilli Cefazolin Breast and hernia S. aureus, S. epidermidis High risk: cefazolin In our study Cefazolin was the most used antibiotic in both preoperative and postoperative prophylaxis, 72 (43.9%) in preoperative and 92 (56.1%) in postoperative. Second drug was Metronidazole, 60 (36.6%) in preoperative and 56 (34.1%). Gentamicin was used in 44 (26.8%) as preoperative prophylaxis, and it was used in 48 (29.3%) as postoperative prophylaxis. Ampicillin was used only in 4 (2.4%) as postoperative prophylaxis, Cefixime used in both pre and postoperative prophylaxis in 4 (2.4%), clarithromycin and Para-fungal were used only in preoperative prophylaxis by 4 (2.4%) and 8 (4.8%) respectively, as demonstrated in table 1 and table 2. The adherence rate for pre and postoperative antibiotic prophylaxis guidelines in Aseer Hospital was 36/100 (36%) in preoperative and 56/100 (56%) in postoperative antibiotic prophylaxis by average 92/100 (46%) in adherence to guidelines. In Khamis Hospital the adherence for guidelines was 72/128 (56.25%) in both pre and postoperative antibiotic prophylaxis as demonstrated in table 3. The total average in both hospitals was 164/328 (50%). Our adherence rate finding was near to other studies made in developed countries as shown in table 5 and better than the adherence rate finding in developing countries as demonstrated in table 6. 4

5 Table 5; adherence rate for surgical antibiotic prophylaxis guideline in developed countries Authors Countries & settings Procedures n Overall adherence (%) Gorecki USA 1 Hosp Elective & emergency Bailly France 18 Hosp Ortho, digestive, uro, vascular, others Lallemand France 18 Hosp Ortho, digestive, uro, vascular, others Van Kasteren Dutch 13 Hosp Elective procedures Quenon France 30 institution Total hip prosthesis Bedouch France Teaching H. THR Bull Austrialia 27 Hosp Cardiac, Ortho, Colon, Cholecys, Hysterec, Appen Tourmousoglou Greece 1 Hosp General surgery Table 6; adherence rate for surgical antibiotic prophylaxis guideline in developing countries Authors Countries & settings Procedures n Heineck Brazil Teaching H. Cholecystectomy, hysterectomy, herniorrhaphy Matti Philipine General H. Elective surgical cases van Disseldorp Nicaragua University H. Gen surgery, ortho, O&G, paed Askarian Iran 6 Teaching H. 9 surgery Overall adherence (%) Askarian India Neurosurgical CONCLUSION The findings of the present study show that, pre and postoperative antibiotic prophylaxis need more monitoring to adherence to the guidelines, also the need to clinical monitoring and intervention from clinical pharmacists to optimize the use of antibiotics which will decrease side effects and cost of treatment. Additionally, the present results reinforce the importance of continuous education development for medical team (physicians, pharmacists and nurses) which lead to optimize the therapy process and improve patient quality of life. Development of local guidelines should be in collaboration with surgeons to achieve optimal adherence. Ensure an effective dissemination of therapeutic guidelines to the targeted pharmacists and physicians. 5

6 7. ACKNOWLEDGEMENT We thank our colleagues in King Khalid University, Aseer hospital and Khamis Moshate hospital management and staff for their support, also thanksgiving for our families for arrange time and funds to do this study. 8. REFERENCES [1]. Antimicrobial prophylaxis for surgical procedures. In: Koda-20. Kimble MA et al., eds. Applied Therapeutics: The clinical use of drugs, 9th ed. Philadelphia, PA, Lippincott Williams & Wilkins, [2]. ASHP therapeutic guidelines on antimicrobial prophylaxis in surgery. AJHP 1999;56: [3]. Antibiotic prophylaxis for surgery. Treatment guidelines. The Medical Letter 2004;2(20): [4]. Baum ML, Anish DS, Chalmers TC, Sacks HS, Smith H, Jr., Fagerstrom RM. A survey of clinical trials of antibiotic prophylaxis in colon surgery: evidence against further use of no-treatment controls. N Engl J Med 1981;305(14): [5]. L idwell OM. Air, antibiotics and sepsis in replacement joints. J Hosp Infect 1988;11 Suppl C: [6]. Plowman R, Graves, N, Griffin, M, et al,. The socio-economic burden of hospital-acquired infection. London: Public Health Laboratory Service; [7]. Coello R, Glenister H, Fereres J, Bartlett C, Leigh D, Sedgwick J, et al. The cost of infection in surgical patients: a case-control study. J Hosp Infect 1993;25(4): [8]. Davey PG, Duncan ID, Edward D, Scott AC. Cost-benefit analysis of cephradine and mezlocillin prophylaxis for abdominal and vaginal hysterectomy. Br J Obstet Gynaecol 1988;95(11): [9]. Pichichero ME. A review of evidence supporting the American Academy of Pediatrics recommendation for prescribing cephalosporin antibiotics for penicillin-allergic patients. Pediatrics. 2005;115(4 Part 1): [10]. Goossens H, Ferech M, Vander Stichele R, Elseviers M. Outpatient antibiotic use in Europe and association with resistance: a crossnational database study. Lancet 2005;365(9459): [11]. Malhotra-Kumar S, Lammens C, Coenen S, Van Herck K, Goossens H. Effect of azithromycin and clarithromycin therapy on pharyngeal carriage of macrolide-resistant streptococci in healthy volunteers: a randomised, double-blind, placebo-controlled study. Lancet 2007;369(9560): [12]. ASHP Commission on Therapeutics. ASHP therapeutic guidelines on antimicrobial prophylaxis in surgery. Clin Pharm. 1992; 11: [13]. Fonseca SN et al. Implementing 1-dose antibiotic prophylaxis 2. for prevention of surgical site infection. Archives of Surgery (Chicago, Ill.), 2006, 141: [14]. Kernodle DS, Kaiser AB. Surgical and trauma-related infections. In: Mandell GL, Bennett JE, Dolin R, eds. Principles and practice of infectious diseases. 4th ed. New York: Churchill Livingstone; 1995: [15]. Ronald K. Woods, E. Patchen Dellinger, Current Guidelines for Antibiotic Prophylaxis of Surgical Wounds, Am Fam Physician Jun 1;57(11): [16]. Gorecki P, Schein M, Rucinski JC, et al. Antibiotic administration in patients undergoing common surgical procedures in a community teaching hospital: the chaos continues. World J Surg. 1999;23(5): [17]. Bailly P, Lallemand S, Thouverez M et al. Multicentre study on the appropriateness of surgical antibiotic prophylaxis. J Hosp Infect 2001;49:

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