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PHARMACY POLICIES AND PROCEDURES

CLINICAL PCLIN 037: VANCOMYCIN I. II. III. PURPOSE: To lend direction and to insure continuity in the use of the glycopeptide antibiotics. POLICY: The glycopeptide antibiotics will be used as per procedure.

APPLICABLE DOCUMENTS/REFERENCES: Reference The Joint Commission Standard(s) MM.05.01.01, MM.05.01.07, MM.05.01.11, MM.06.01.01, PC.01.01.01; ACHC Standard(s) DRX5-2A, DRX5-2C; reference attachment "Pharmaceutical Protocol for Vancomycin" (page - 4.37A.2 -), "Additional Drug Information: the Glycopeptide Antibiotics Vancomycin and Teicoplanin" (page - 4.37B.5 -); reference attachments "Vancomycin Sample Case Study" (page - 4.37C.8 -), "Therapeutic Review/Pharmaceutical Care Plan-Vancomycin" (page - 4.37D.10 -) and "Sample" Therapeutic Review/ Pharmaceutical Care Plan - Vancomycin (page 4.37E.12 -); reference attachment "Assurance Kinetics" located in the front of the manual PROCEDURE:

IV.

The clinician will review the therapeutic protocol prior to treating the patient (see attached).

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Policies and Procedures Manual for Home Infusion Pharmacy ©1992 MED-PASS, Inc. (Revised May 2012)

PHARMACEUTICAL PROTOCOL FOR VANCOMYCIN Indication Vancomycin (parenteral) is indicated for the treatment of severe Staphylococcal infections (including methicillin-resistant Staphylococci) including: Pneumonia Osteomyelitis Skin and skin structure Septicemia Endocarditis Vancomycin has also been effective alone or in combination with an aminoglycoside to treat other Gram positive forms of endocarditis. Contraindications Patients with a known hypersensitivity or allergy to vancomycin. Precautions Avoid in patients with previous hearing loss.

A. B. C. D. E. F.

Prolonged use may result in bacterial or fungal overgrowth leading to a secondary infection.

Dosage reduction may be required in patients with reduced renal function, due to risk of nephrotoxicity. Patients over 60 years of age and/or patients with renal impairment should be given serial tests of auditory function. Rapid IV administration may cause hypotension accompanied by flushing and/or rash (known as redman syndrome). Vancomycin dosing should be guided by serum vancomycin concentrations.

Adverse Reactions Adverse reactions most frequently include: Pain/induration/tenderness at Thrombophlebitis Macular rashes/chills/urticaria/ injection site pruritus Nephrotoxicity Blood dyscrasias Hypotension (see Precautions) Wheezing Muscular pain of back and neck Nausea Vertigo/dizziness/tinnitus Ototoxicity

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Policies and Procedures Manual for Home Infusion Pharmacy ©1992 MED-PASS, Inc. (Revised 2011)

Drug Interactions Current or sequential use of other ototoxic or nephrotoxic drugs (i.e., aminoglycosides, amphotericin, bacitracin, cisplatin, IV furosemide and IV erythromycin) Dosage Usual dose is 2 gms per day, divided as 500 mg q6h, or 1 gm q12h. Dosage reduction is indicated in patients with renal dysfunction. Serum vancomycin levels guide dosage adjustment. Administration * Vancomycin is administered by slow intravenous infusion. To reduce the frequency and severity of developing thrombophlebitis, IV solution should be diluted (2.5 - 5 g/L), change site of infusion often, and infuse IV solution over AT LEAST 60 MINUTES. Vancomycin is not administered intramuscularly as it causes tissue irritation and necrosis.

A.

B.

To prepare solutions for IV infusion, reconstitute either vial with diluent (10 ml sterile water to the 500 mg vial, 20 ml sterile water to the 1 g vial). Further dilute 500 mg or less in 100 ml solution; more than 500 mg in 250 ml solution. Commonly used solutions include 0.9% NSS and 5% dextrose. Serum Levels * Vancomycin therapy may be monitored and dosage adjusted based on serum levels.

A. B.

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Trough level is drawn just before next dose. Infuse vancomycin over AT LEAST 60 minutes. Draw peak serum vancomycin level ONE HOUR after end of infusion. Therapeutic range: Peak level: 20 - 40 mcg/ml Trough level: 6 - 15 mcg/ml

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Stability/Storage * When reconstituted and diluted according to instruction, vancomycin is stable for 24 hours at room temperature or for seven days if refrigerated.

* Please refer to manufacturer's guidelines for more complete information.

Policies and Procedures Manual for Home Infusion Pharmacy ©1992 MED-PASS, Inc. (Revised 2011)

Suggested Monitoring Parameters

Frequency Every visit

Monitor Temperature, respiratory rate, orthostatic vital signs Assess pain, induration, tenderness at injection site Assess presence of thrombophlebitis Assess presence of urticaria, rash, chills, pruritus Assess presence of wheezing Assess presence of nausea Assess presence of sore throat or mouth, or thrush Assess presence of muscular pain of back or neck Assess presence of loss of hearing, tinnitus, vertigo, dizziness CBC with diff Serum creatinine BUN Trough and peak vancomycin serum levels Serial audiometry in the following circumstances: · therapy more than 2 weeks · concurrent or consecutive oto- or nephrotoxic drugs · over 60 years of age · renal dysfunction

At least weekly

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Policies and Procedures Manual for Home Infusion Pharmacy ©1992 MED-PASS, Inc. (Revised 2011)

ADDITIONAL DRUG INFORMATION: THE GLYCOPEPTIDE ANTIBIOTICS VANCOMYCIN AND TEICOPLANIN CHARACTERISTICS: Vancomycin was isolated in the Lilly Research Laboratories from Streptomyces orientalis, an organism which was found in Borneo. Based on its carbohydrate and peptide content, vancomycin is classified as a glycopeptide antibiotic and it was the first member of this class. Presently, vancomycin and teicoplanin are the only ones used clinically. Glycopeptide antibiotics have higher molecular weights than penicillins, cephalosporins, tetracyclines, aminoglycosides and macrolides. When vancomycin was introduced for clinical use in 1958, it was employed for the treatment of staphylococcal infections resistant to available antibiotics, but within two years, it was replaced by methicillin and cephalothin which had less side effects. However, with the spread of methicillin-resistant Staph aureus strains, vancomycin was resurrected. (Kucers, A.; Bennett, N.Mck. -The Use of Antibiotics. Philadelphia, PA: Lippincott; 1987) With the increased incidence of methicillin-resistant isolates of Staphylococcus aureus and Staphylococcus epidermidis the need for development of alternative antimicrobials from the glycopeptide class resulted in the development of teicoplanin. In the mid 1970's two potential antimicrobials were isolated, via fermentation, from Actinoplanes teicomyceticus. The two were named TA1 and TA2. TA1 was shown to be considerably less active than TA2 and was abandoned. TA2, now known as teicoplanin is a glycopeptide antibiotic complex. Both vancomycin and teicoplanin inhibit cell-wall synthesis. (Pyrka, R.; Rodvold, K.A.; Rotschafer, J.C., Teicoplanin: An Investigational Gylcopeptide Antibiotic". CP 7:647 - 658; 1988)

INDICATIONS: IV vancomycin is used in the treatment of potentially life-threatening infections caused by susceptible organisms which cannot be treated with other effective, less toxic antiinfective agents or if the patient is allergic to a penicillin or cephalosporin. Vancomycin has been successfully used alone in the treatment of endocarditis, osteomyelitis, pneumonia, septicemia and soft-tissue infections caused by Staphylococcus aureus or S. epidermidis. Vancomycin is effective alone or in combination with an aminoglycoside for the treatment of endocarditis caused by Streptococcus viridans or S. bovis. For endocarditis caused by Enterococci (S. faecalis), vancomycin should be used in combination with an aminoglycoside. IV vancomycin is also used for prophylaxis of bacterial endocarditis in penicillin-allergic adults and children. Although vancomycin is not effective via the oral route for the treatment of systemic infections, the drug may be given orally for the treatment of Staphylococcus enterocolitis or for antibiotic-associated pseudomembranous colitis secondary to Clostridium difficile (considered the drug of choice). (ASHP. AHFS Drug Information 1989)

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Policies and Procedures Manual for Home Infusion Pharmacy ©1992 MED-PASS, Inc. (Revised 2011)

Teicoplanin's antimicrobial activity is similar to vancomycin's and is restricted to Gram positive organisms (see page 3.33A.2). Resistance to glycopeptides is common in Leuconostoc spp. and Pediococcus spp. and has been reported in Lactobacilli A stepwise acquisition of vancomycin resistance in a strain of Staphylococcus haemolyticus has recently been described. Certain strains of S. haemolyticus appear to be resistant to teicoplanin and susceptible to vancomycin. Recent reports suggest that Enterococcus faecium and E. faecalis are resistant to vancoymcin (Leclercq, R.; Derlot, E.; Weber, M.; Duval, J.; Courvalin, P. "Transferable Vancomycin and Teicoplanin Resistance in Enterococcus faecium"; Antimicrobial Agents and Chemotherapy. 1:10 15; 1989). ROUTE: Vancomycin is administered by slow IV infusion. The drug is very irritating to tissue and must not be given IM. For intermittent IV infusion, the reconstituted vials, 500 mg or 1 gm, should be further diluted to 100 or 200 ml respectively and infused over at least one hour. Teicoplanin can be administered safely by both IM or IV routes. Teicoplanin has been infused IV over five minutes without adverse reactions; however, most trials used 30 minute infusions. No infusion-related reactions resembling the vancomycin "redneck" or "redman" syndrome have been reported. DOSAGE: For the treatment of potentially life-threatening infections in adults with normal renal function, the usual IV dose of vancomycin is 500 mg every six hours or 1 gm every 12 hours. For neonates and young infants with normal renal function, an initial IV dose of vancomycin of 15 mg/kg, followed by 10 mg/kg every 12 hours in neonates younger than eight days, and 10 mg/kg every 8 hours for infants 8 days to one month. For older children with normal renal function, an IV dose of 40 mg/kg daily given in divided doses. For prophylaxis of bacterial endocarditis, adults and children weighing 27 kg or more receive 1 gm and that children weighing less than 27 kg receive 20 mg/kg. The dose should be infused over one hour beginning one hour before the procedure. In patients with impaired renal function, an initial IV dose of 15 mg/kg should be given. Subsequent dosage must be based on renal function and serum concentrations of the drug. Some clinicians have recommended that 1 gm of vancomycin be administered at 12 hour intervals in patients with serum creatinine concentrations less than 1.5 mg/dl; at three to six day intervals in patients with serum creatinine of 1.5 to 5 mg/dl; at 10 to 14 day intervals in patients with serum creatinine greater than 5 mg/dl.

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If serum levels of vancomycin are going to be used to determine and adjust dosage, a pharmacokinetic evaluation should be performed. Unlike aminoglycosides which can be adequately dosed utilizing a one-compartment model, vancomycin is best individualized utilizing a two-compartment model which takes into consideration a significant alpha distribution phase. One-compartment models underpredict the half- life of the drug and overpredicts the volume of distribution. This could lead to overdosing and toxicity.

Policies and Procedures Manual for Home Infusion Pharmacy ©1992 MED-PASS, Inc. (Revised 2011)

The dosage regimen currently used for teiocoplanin in patients with normal renal function is 6 mg/kg every 12 hours for three doses, then 6 mg/kg every 24 hours. For patients with endocarditis, the dose has been increased to 15 mg/kg two times a day. In patients with renal impairment, one investigator recommended the usual loading dose, then 6 mg/kg every 48 hours for moderate renal impairment; and 6 mg/kg every 72 hours for severe renal impairment (Pyrka, R. et al. "Teicoplanin: An Investigational Glycopeptide Antibiotic". CP 7:647 - 658; 1988).

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Policies and Procedures Manual for Home Infusion Pharmacy ©1992 MED-PASS, Inc. (Revised 2011)

Vancomycin Sample Case Study

"MJ" is a 58 year old black female with MRSA osteomyelitis of right distal tibia secondary to a compound fracture sustained in an MVA which required surgical intervention for open reduction of the fracture. Her course was stable following surgery; however, two (2) weeks post-operatively she developed pain, swelling, and erythema in the right calf. She was afebrile. Bone biopsy revealed MRSA, and vancomycin 1.0g IV q 12h was begun on 9/1. She is responding clinically, with reduced swelling and tenderness at the infection site, and would like to complete the last four (4) weeks of her six (6) week infusion therapy at home. Medications: Enalapril 10mg po QD, Glipizide 10mg po BID, Furosemide 20 mg po QD prn swelling

Lab Values

Day 1 (9/11) admission to home care WBC Normal = 5-10 x 10³ ESR Normal = 0-10 mm/hr Serum Creat Normal = 0.5-1.2mg/dL BUN Normal = 10-20mg/dL Vancomycin Levels Peak: Normal = 20-40mcg/ml Level: Normal = 5-10mcg/ml 13,000/mm³ Day 6 Day 8

Day 15

7500/mm³

7200/mm³

30mm/hr

5mm/hr

3mm/hr

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1 hr after 1hr infusion: 32mcg/ml

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0.9mg/dL 1.5mg/dL 12.5mg/dL 25mg/dL 1 hr after 1.5 hr infusion: 45mcg/ml just before next dose: 18mcg/ml

1.3mg/dL

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3mm/hr

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Day 22 8000/mm³ 3mm/hr 1.5mg/dL 25mg/dL 1 hr after 1.5 hr infusion: 32mcg/ml just before next dose: 8mcg/ml

1.3mg/dL

20mg/dL

25mg/dL

1 hr after 1.5 hr infusion: 32mcg/ml just before next dose: 7mcg/ml

1 hr after 1.5 hr infusion: 30mcg/ml just before next dose: 5mcg/ml

just before next dose: 8mcg.ml

Home Infusion Therapy Course: Day 1: With first dose of vancomycin given at home, "MJ" experiences chills, rash on upper torso and dizziness. Redman syndrome is suspected. The pump is checked to be sure that the infusion time was 60 minutes. The infusion time is increased to 90 minutes. "MJ" is given diphenhydramine (50mg po) 20-30 minutes before beginning vancomycin infusion. "MJ's" symptoms do not recur.

4.37C.8

Policies and Procedures Manual for Home Infusion Pharmacy ©1992 MED-PASS, Inc. (Revised 2011)

Day 6: Vancomycin peak and trough levels are elevated, as are serum creat and BUN, indicating possible nephrotoxicity. Using kinetics, a longer dosing interval (lengthened to 24 hours) is calculated and administered. Day 8: Vancomycin peak and trough levels are within recommended blood levels. Day 28: Patient's vancomycin home infusion therapy discontinued. "MJ" was afebrile and asymptomatic. References: Locksley RM. Staphylococcal Infections. In: Braunwald E, Isselbacher KJ, Petersdorf RG, Wilson JD, Martin JB, Fauci AS, eds. Harrison's Principles of Internal Medicine. 11th ed. New York: McGraw-Hill, 1987:537-43.

Armstrong EP. Bone and Joint Infections. In: DiPiro JT, Talbert RL, Hayes PE, Yee GC, Matzke GR, Posey LM, eds. Pharmacotherapy: a pathophysiologic approach. 2nd ed. New York: Elsevier, 1992:1739-50. Aweeka FT. Bone and Joint Infections. In: Koda-Kimble MA, Young LY, eds. Applied Therapeutics: the clinical use of drugs. Applied Therapeutics, 1992:45-1-8.

Berkow R, ed. The Merck Manual. 16th ed. Rahway NJ: Merck and Co., 1992:1343-6.

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Policies and Procedures Manual for Home Infusion Pharmacy ©1992 MED-PASS, Inc. (Revised 2011)

Patient Name: THERAPEUTIC REVIEW/PHARMACEUTICAL CARE PLAN - VANCOMYCIN MEDICAL/DRUG RELATED PROBLEM

1. The patient presents with a ____________________________ infection secondary to ___________ _____________________________ (microorganism) as per a temp of ___ºF, WBC of _____/mm³, bands of ____%, and a clinical observation of__________________________ 2. Vancomycin has the potential to cause nephrotoxicity especially if dosed inappropriately and/or the patient presents with kidney dysfunction.

DESIRED THERAPEUTIC OUTCOME/GOALS

1. The infection has cleared as per the patient's temp <100ºF, sed rate of < 20 mm/hr, WBC of 12,000/mm³, bands < 3%, and clinical observation ____________________________ _____________________________ _____________________________

CLINICIAN INTERVENTION

1. The patient will receive vancomycin _____grams every ____hours via ______________________________ (where and how) for ______days to infuse over ___minutes.

MONITORING

1. The status of the patient's infectious disease and its response (or lack of) to vancomycin will be monitored via specific hematological tests including a CBC (with diff) and sed rate every _____days, as well as vital signs (body temp) and a routine ____ (freq) physical assessment.

RESOLUT. DATE

INITIALS

2. To minimize the potential for nephrotoxicity by insuring that trough levels of vancomycin fall between ______mcg/ml and peak levels fall between _______mcg/ml. That the patient's kidney function is normal as per a BUN of ____mg/dl and serum creatinine of ______mg/dl. 3. To minimize the potential for causing ototoxicity and/or worsening existing auditory problems and recognizing the fact that ototoxicity may be irreversible, vancomycin peaks and troughs should be normalized as should the BUN and serum creatinine.

2. To insure that the vancomycin is initially being dosed properly by crosschecking recommended dose with___________________________ (literature recommendations, nomogram, kinetics consult) and the dose is adjusted as per patient's ongoing clinical needs.

3. Vancomycin has the potential to cause ototoxicity.

4. The rapid infusion of vancomycin has been associated with redman syndrome (aches and pains, hypotension, erythematous rash).

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4. To minimize the potential for the occurrence of redman syndrome.

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3. As in #2 above and to recommend an audiology consult if existing ototoxicity is suspected, patient has renal dysfunction, patient is >___years of age, or therapy to exceed __weeks.

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2. In order to minimize the potential for vancomycin-induced nephrotoxicity the following will be monitored: *A baseline BUN and q___days thereafter. *A baseline SCr and q___days thereafter. *A vancomycin peak and trough after _____days, and q___days thereafter. 3. In order to minimize the potential for vancomycin-induced ototoxicity the following will be monitored: *A baseline BUN and q___days thereafter. *A baseline SCr and q___days thereafter. *A vancomycin peak and trough after _____days, and q___days thereafter. *A baseline audiology consult, the routine _______testing. *A routine ________(freq) physical exam which addresses the patient's hearing status (tinnitus, etc.)

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4. To recommend that the vancomycin be infused over a minimum of ______ minutes, and/or the patient be premedicated with _______________ ______________________________ ______________________________ to counter the histamine release.

4. In order the minimize the potential for the occurrence or reoccurrence of redman syndrome, the following will be monitored: *The patient's response to the initial and subsequent infusions and any dermatological abnormalities. *That the vancomycin is, in fact, being infused over a minimum of 60 minutes.

Policies and Procedures Manual for Home Infusion Pharmacy ©1992 MED-PASS, Inc. (Revised 2011)

THERAPEUTIC REVIEW/PHARMACEUTICAL CARE PLAN ­ VANCOMYCIN MEDICAL/DRUG RELATED PROBLEM

5. When vancomycin is given in conunction with______________________ _______________________________ (another drug) an interaction may occur which could enhance the toxicity of _______________________________ 6.

DESIRED THERAPEUTIC OUTCOME/GOALS

5. To minimize or eliminate the potential for drug interaction-induced toxicity.

CLINICIAN INTERVENTION

5. To insure that there are no adverse drug interactions prior to the start IV vancomycin. If there is/are potential adverse drug interaction to recommend changing drug ___________________ to drug ___________________________, or ______________________________

MONITORING

5. If the drugs are to be given together, to monitor for potential toxicity via ____________________ _____________________________ _____________________________ every __________day(s).

RESOLUT. DATE

INITIALS

7.

RN Signature

Date

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Pharmacist Signature

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Policies and Procedures Manual for Home Infusion Pharmacy ©1992 MED-PASS, Inc. (Revised 2011)

Patient Name: "MJ" "SAMPLE" THERAPEUTIC REVIEW/PHARMACEUTICAL CARE PLAN ­ VANCOMYCIN MEDICAL/DRUG RELATED PROBLEM

1. The patient present with a osteomyelitis infection of rt, tibia secondary to: MRSA as per a temperature of 100°F, WBC of 13,000/mm³, ESR of 30mm/hr, and clinical observation of pain, swelling and erythema at site 2. Vancomycin has the potential to cause nephrotoxicity especially if dosed inappropriately and/or if the patient presents with kidney dysfunction. BUN & Creatinine WNL.

DESIRED THERAPEUTIC OUTCOME/GOALS

1. The infection has cleared as per the patients temperature <100 F, sedimentation rate <20 mm/hr, WBC <12,000/mm³, bands <3%, and clinical observation of no pain, swelling or erythema at site. 2. To minimize the potential for nephrotoxicity by insuring that trough levels of vancomycin fall between 510mcg/ml and peak levels fall between 20-40mcg/ml; that the patient's kidney function is normal per a BUN of _mg/dL & a serum creat of _1.3mg/dL. 3. To minimize the potential for causing ototoxicity and/or worsening existing auditory problems and recognizing the fact that ototoxicity may be irreversible, vancomycin peaks and troughs should be normalized as should the BUN & serum

CLINICIAN INTERVENTION

1. The patient will receive vancomycin 1.0g/IV every 12 hours via SIGMA pump thru picc line infused over 60 minutes.

MONITORING

1. The statue of the patient's infectious disease and its response to vancomycin will be monitored via specific hematological tests including a CBC (w/diff) & ESR every seven (7) days, as well as vital signs & a routine daily physical assessment. 2. In order to min. the potential for vancomycin- induced nephrotoxicity, the following will be monitored: *BUN baseline & q7days thereafter. *Serum Creat baseline & q7days thereafter. *Vancomycin peak & trough levels after 2 days, & q7 days thereafter.

RESOLUT. DATE

Day 28

INITIALS

2. To insure that the vancomycin is initially being dosed properly by cross-checking recommended dose with a kinetics consult.

3. Vancomycin has the potential to cause ototoxicity.

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3. As in #2 above and to recommend an audiology consult if existing ototoxicity is suspected, patient has renal dysfunction, patient is greater than 60 years of age, or therapy to exceed two weeks.

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3a. In order to minimize the potential for vancomycin-induced ototoxicity the following will be monitored: *BUN baseline & q7 days thereafter. *Serum Creat baseline & q7 days thereafter. *Vancomycin peak & trough levels after 2 days, then q7 days thereafter.

Day 13

3b. *Baseline audiology consult, then routine monthly testing. *Routine weekly physical exam which addresses the patient's hearing status (tinnitus, etc.)

Policies and Procedures Manual for Home Infusion Pharmacy ©1992 MED-PASS, Inc. (Revised 2011)

"SAMPLE" THERAPEUTIC REVIEW/PHARMACEUTICAL CARE PLAN - VANCOMYCIN MEDICAL/DRUG RELATED PROBLEM

4. On Day 1 patient experienced chills, rash on upper torso & dizziness suggestive of Redman syndrome.

DESIRED THERAPEUTIC OUTCOME/GOALS

4. To minimize the potential for the reoccurrence of Redman syndrome.

CLINICIAN INTERVENTION

4. To recommend that the vancomycin be infused over 90 min., and the patient be premedicated with Diphenhydramine 50mg to counter the histamine release.

MONITORING

4a. In order to minimize the potential for the occurrence or recurrence of Redman syndrome the following will be monitored: *The patient's response to the initial & subsequent infusions and any dermatological abnormalcies. 4b. *That the vancomycin is, in fact, being infused over a minimum of 60 minutes.

RESOLUT. DATE

Day 2

INITIALS

5. When vancomycin is given in conjunction with Furosemide, an interaction may occur which could enhance the toxicity of both drugs and increase the possibility of oto- and/or nephro-toxicity.

5. To minimize or eliminate the potential for drug interaction-induced toxicity.

5. To insure that there are no adverse drug interactions prior to the start of IV vancomycin. If there is/are potential adverse drug interactions to recommend changing drug furosemide to drug HCTZ, or monitor appropriately. 6. Increase vancomycin dosing interval to 1.0g IV q 24 hours.

6. On Day 6 vancomycin peak levels of 45mcg/ml & trough levels of 18mcg/ml are above normal recommended blood levels. RN Signature

6. Return to vancomycin peak levels between 20-40mcg/ml & trough levels between 5-10 mcg/ml

Date

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5. If the drugs are given together, to monitor for potential toxicity via vancomycin peak and trough BUN levels, Scr, audiometry (q40d) every 7 days.

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Day 8 Date

6. Vancomycin peak & trough levels after 2 days and q7 days thereafter.

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Policies and Procedures Manual for Home Infusion Pharmacy ©1992 MED-PASS, Inc. (Revised 2011)

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