Assignment 3 Drug protocol development Due date: (Name) APA reference style used 2 Drug therapy protocol for the administrating flucloxacillin for the treatment of suspected Staphylococcal skin infections Clinical Indication For Use: Staphylococcal skin infections and cellulitis including folliculitis, boils, carbuncles, bullous impetigo, mastitis and infected scabies (Australian Medicines Handbook [AMH], 2011). Limitations: This protocol is limited to the use of oral formulations of flucloxacillin. Justification For Use: To ensure the safe, appropriate and judicious administration of flucloxacillin for skin infections. Application of Protocol: This protocol is designed to be used for treatment of suspected staphylococcal skin infections in all age groups. Inclusion Criteria • Skin & skin structure infections caused by staphylococci & / or streptococci infections (Bullock, Manias, & Galbraith, 2007). • Adults and Children > 6 months of age. • Breastfeeding compatible (eTG, 2011). Exclusion Criteria • Methicillin-resistant Staphylococcus aureus (MRSA) (Neal, 2005). • Allergy to Penicillin / major allergy to Cephalosporins (AMH, 2011) • Hepatic Impairment. • Renal Impairment. • Pregnant (Consumer Medicine Information [CMI], 2010). Assessment • Taking a complete and accurate medical history and completing a physical examination are essential for choosing the safest antibiotic for a particular patient. • Take an accurate medication history that includes over the counter and naturopathic medications. • Collect swab of infection site for microscopy, culture and sensitivity (MIMs Online 2011) Pharmacodynamics Flucloxacillin is an isoxazolyl penicillin which is a potent inhibitor of the growth of most penicillinaseproducing staphylococci. The drug is stable in an acid medium. Flucloxacillin is considered bactericidal as it interferes with bacterial cell wall peptidoglycam synthesis by binding to penicillin-binding proteins, eventually leading to cell lysis and death. (Medicines and Healthcare products Regulatory Agency [MHRA], 2007) Pharmacokinetics Flucloxacillin provides good absorption after oral administration (30 - 80% absorbed from GI tract). Absorption of the drug is more efficient when taken on an empty stomach. Peak plasma levels are attained at 1 hour after administration and 1g dose provides peak plasma levels of 15mcg/ml. The drug 3 is rapidly excreted by the kidney, about 50% within 6 hours of administration. About 95% of flucloxacillin in circulation is bound to plasma proteins. (MHRA, 2007). Drug Interactions Probenecid - increases the bioavailability of flucloxacillin, if a patient is on a concurrent dose of probenecid then the course of flucloxacillin should be commenced at the lowest dose (refer to Medical Officer). (MiMS online, 2011) Form, Dose, Route & Duration Of Therapy Adult: Oral 250 – 500mg every 6 hours. Maximum 4g daily. Child: Oral 12.5 – 25mg/kg every 4-6 hours (AMH, 2011; Royal Children’s Hospital, 2007). Continue the course of antibiotics for seven days. Should be taken one hour prior or two hours after a meal. (MiMS online, 2011) Adverse Effects Common: Transient increases in liver enzymes and bilirubin, diarrhoea, nausea, and dyspepsia. Rare: Cholestatic hepatitis. Hepatic reactions, including severe cholestatic hepatitis (estimated incidence 1 in 15 000 exposures), can occur; may be delayed and take weeks to resolve; it is more frequent in people >55 years, females and with treatment >2 weeks (AMH, 2011). Hypersensitivity reactions Uncommon: Rash - most frequent symptom: usually maculopapular rash, erythema, urticaria Rare: Anaphylaxis. (AMH, 2011). Response To Adverse Event • Stop the medication immediately. • Assess severity of reaction. • Notify Medical Officer. • Adhere to hospital policy for ALS / APLS resuscitation management. Patient Advice & Education • Store below 25oC. Protect from light and moisture. Do not take if packaging is damaged or passes expiry date (Consumer Medicines Information [CMI], 2010). • Seek emergency medical care if experiencing any symptoms such as: skin rash, blistering or hives, facial (including lips, mouth or throat) swelling which may be accompanied by difficulty swallowing or breathing, shortness of breath, difficulty breathing, wheezing. (CMI, 2010). • Give patient Consumer Medication Handout on Flucloxacillin (MIMS online, 2011). • May cause diarrhoea in breastfeeding infants (eTG, 2011). 4 Justification and Critical Discussion as per Case Study Soft tissue and skin infections which include cellulitis, soft tissue abscesses, and impetigo are common infections in both adult and children populations. This discussion focuses on the justification of prescribing flucloxacillin for treatment of soft tissue and skin infections. It will also discuss how applicable this protocol is for …. as well as the implications of cultural and social aspects which impact on education and advising patient to ensure safety in its administration. Strategies on how the nurse addresses this issues will also be discussed. Staphylococcus aureus is a common bacterial pathogen identified and responsible for a majority of these infections (Casey, Lambert, & Elliott, 2007). According to the current Australian therapeutic guidelines, it recommends the use of the antimicrobial drug, flucloxacillin, in treatment of these infections (Therapeutic Guidelines Limited (TGA), 2011). Flucloxacillin is a semi-synthetic isoxazolyl penicillin and has known activity against the staphylococci organism (Leman & Mukherjee, 2005). Although S. aureus is known to cause these infections, resistant strains of this organism have been identified. In Australia, about 80% of all soft tissue and skin infections causative organism has been identified as a resistant strain of S. aureus called methicillinsensitive S. aureus (MSSA) (Nimmo et al., 2003). Most MSSA pathogens produce a penicillinase and the reason why most penicillins are now ineffective against this resistant organism. Flucloxacillin, although is a penicillin, remains an antimicrobial agent of choice because of the presence of a resistant side chain which prevents the inhibition of penicillinase produced by MSSA (Leman & Mukherjee, 2005). Staphylococcal aureus ability to develop resistance against commonly used antibiotics is well documented and there is a continued increase and concern in methicillinresistant staphylococcus aureus (MRSA) strain of this organism. A recent analysis of staphylococcus aureus in children was conducted by Wolf et al. (2010) to assess the susceptibility patterns of antibiotic resistance in this population group in Australia. The study found that most of the staphylococcal infections caused by MRSA were relatively low and supported the current Australian recommendations for the use of 5 flucloxacillin in treatment of simple infections unless there was documented evidence of geographical resistance or allergy (Wolf, et al., 2010, p. 409). Because of this increase in concern over MRSA, a retrospective study by Dabbas, Chand, Pallett, Royle, and Sainbury (2010) reviewed the causative organisms of breast abscesses to help guide appropriate antibiotic choice. Through this study, it was shown that that methicillin susceptible S. aureus still remained the commonest organism isolated and thus also recommended treatment of these infections with flucloxacillin (Dabbas, et al., 2010). Other studies in treatments of skin and soft tissue infections have also supported the use of flucloxacillin. A randomised, controlled study by Leman and Mukherjee (2005) showed that the use of flucloxacillin alone in treatment of cellulitis was no different than when used in conjunction with other antimicrobials and thus empirical treatment for this infection. Although this was a small study and may not be a true representation of population outcomes, another study by Tan, Newberry, Arts, and Onwuamaegbu (2007) may add some validity to these findings. This larger retrospective study assessed the mortality outcomes from treatments of cellulitis and found that adding other antimicrobials to flucloxacillin did not affect the survival of patients after one (1) year, and thus was a significant predictor of survival however, the authors did suggest that further research is required into the significance of their findings (Tan, et al., 2007). Given this current evidential information, and concerns of antibiotic resistance, flucloxacillin still remains the antimicrobial agent to use in treatment of soft tissue and skin infections. (Approx. 500 words) This protocol has been developed for general application in the unit however it needs to be utilised in conjunction with individual patient requirements. (Example only) The patient in the case study 1 has a …. cultural background which needs to be considered in applying this drug protocol. This is because….(Con’d for approx. 500 words). Total Word Count = 1000words. 6 References