1. Therapeutic Drug Monitoring (TDM) Sticker Project A New Method for Documenting Times of Medication Doses and Drug Levels

2. Goals and Objectives Primary objective  To implement a system to encourage complete and accurate documentation of dose / level information at the bedside to allow for an accurate assessment of antibiotic levels for optimization of antibiotic treatment Secondary objective  To reduce the need for repeating antibiotic levels, to minimize…  Delayed attainment of therapeutic levels of drug  Delayed attainment of safe levels of drug  Discomfort to patient  Increased cost associated with levels

3. TDM Stickers Therapeutic Drug Monitoring (TDM) Record Med: Vancomycin Gentamicin Tobramycin Amikacin Other: ____ Dose: ____ Frequency: q6h q8h q12h q24h Other: ____ Date / precise time of preceding dose; Date: ____ Time: ____ Date / precise time of serum concentration; Date: ____ Time: ____

4. Why are we doing this??? Real life case #1 –A 13 year old boy with CF is being treated with tobramycin. A tobramycin peak and trough are ordered with the 4 th dose due at 1600. The antibiotic is timed at 0000, 0800, 1600. The 1600 dose is not charted. The tobramycin trough = 2.8 mcg/ml (goal < 2 mcg/ml) and peak = 14.2 mcg/ml (goal 10-14). The timing documented in the computer for the trough and peak are both reported as 1600. Of note, it is now 1100, and today’s 0800 dose has not yet been given. –Assessment: Cannot accurately assess the levels… Was the 2 nd dose given??? If yes, at what time??? Were the trough and peak drawn at the right times, at the end of the interval and 1 hour post-dose, respectively??? –Plan: Recommend repeating tobramycin peak and trough levels –Implications Potential delayed optimization of treatment… safety and effectiveness Potential increase discomfort to patient… peripheral venipuncture Increase cost… repeat levels

5. The Health-Care Team and The TDM Sticker Project Physicians NursesPharmacists The success of this program is dependent upon the active involvement of all professionals involved in the process of monitoring drug levels

6. TDM Sticker Project – Procedures Physician orders antibiotic requiring monitoring of drug levels Physician orders drug levels Nurse processes order for drug level and clips sticker(s) to nurses notes Nurse administers dose preceding TROUGH level and documents precise time of dose on sticker, then adheres sticker in nurses notes section of patient bedside chart Nurse draws trough level and documents precise time level drawn on sticker Nurse draws peak level and documents precise time level drawn on sticker Nurse administers dose preceding PEAK level and documents precise time of dose on sticker, then adheres sticker in nurses notes section of patient bedside chart Pharmacist assesses level(s) and makes recommendation regarding dose modification

7. TDM Sticker: Commonly Asked Questions What antibiotics do I need to use the sticker for??? The sticker should be used whenever levels are ordered for vancomycin, gentamicin, tobramycin, and amikacin

8. Where do I place the sticker in the patient’s chart??? TDM Sticker: Commonly Asked Questions To keep things easy, the sticker should be placed where you normally document your notes, in the nursing notes section of the patient bedside.

9. What if there is no room in the nurse’s notes section??? TDM Sticker: Commonly Asked Questions In that case, you can add a new progress notes sheet to your nurses notes and place it there.

10. How do I fill out the sticker??? TDM Sticker: Commonly Asked Questions It’s easy. Just circle the medication, fill in the dose, circle the frequency, and write in the precise time you gave the dose before the level was drawn, and then the precise time you drew the level. We’ll do an example in just a few minutes.

11. What does “precise time” mean for dose and serum concentration??? TDM Sticker: Commonly Asked Questions Good question. This is important. The precise times should be exactly when the dose was started or the level was taken. If the dose was given on a previous shift, this information may need to be obtained during sign-out.

12. Do I need to fill out two stickers if I am checking a peak and a trough??? TDM Sticker: Commonly Asked Questions Yes. When only a trough is ordered, such as for vancomycin, only one sticker is needed. But, when both a peak and trough are ordered, such as for the aminoglycosides; gentamicin, tobramycin, & amikacin, two stickers must be used.

13. TDM Sticker Examples Therapeutic Drug Monitoring (TDM) Record Med: Vancomycin Gentamicin Tobramycin Amikacin Other: ____ Dose: ____ Frequency: q6h q8h q12h q24h Other: ____ Date / precise time of preceding dose; Date: ______ Time: ____ Date / precise time of serum concentration; Date: ______ Time: ____ 100 10-1-070755 1330 10-1-07 So my patient is being treated with vancomycin 100mg IV q6h and has a trough ordered with the 4 th dose. The 3 rd dose was scheduled to be given at 0800, but I gave it at 0755. I drew the level at 1330. This is how I am going to fill out the sticker…

14. Therapeutic Drug Monitoring (TDM) Record Med (Circle): Vancomycin Gentamicin Tobramycin Amikacin Dose: _25__ mg Frequency (Circle): q6h q8h q12h q24h Date / precise time of preceding dose; Date: 10-1-07 Time: 0810 Date / precise time of serum concentration; Date: 10-1-07 Time: 1605 Therapeutic Drug Monitoring (TDM) Record Med: Vancomycin Gentamicin Tobramycin Amikacin Other: ____ Dose: ____ Frequency: q6h q8h q12h q24h Other: ____ Date / precise time of preceding dose; Date: ______ Time: ____ Date / precise time of serum concentration; Date: ______ Time: ____ 25 10-1-070810 1605 10-1-07 Therapeutic Drug Monitoring (TDM) Record Med (Circle): Vancomycin Gentamicin Tobramycin Amikacin Dose: _25__ mg Frequency (Circle): q6h q8h q12h q24h Date / precise time of preceding dose; Date: 10-1-07 Time: 0810 Date / precise time of serum concentration; Date: 10-1-07 Time: 1605 Therapeutic Drug Monitoring (TDM) Record Med: Vancomycin Gentamicin Tobramycin Amikacin Other: ____ Dose: ____ Frequency: q6h q8h q12h q24h Other: ____ Date / precise time of preceding dose; Date: ______ Time: ____ Date / precise time of serum concentration; Date: ______ Time: ____ 25 10-1-071610 1740 10-1-07 So my patient is being treated with gentamicin 25mg IV q8h and has a peak and trough ordered with the 3 rd dose. The 2 rd dose was scheduled to be given at 0800, but I gave it at 0810. I drew the trough level at 1605. The 3 rd dose was scheduled to be given at 1600, but I gave it at 1610. The peak level was due at 1710, but I actually drew it at 1740. This is how I am going to fill out the sticker…

15. Efficacy of a TDM Sticker Protocol on V7 Pilot study –Site: Variety 7 –Design: Open, case-control study –Inclusion: All patients requiring vancomycin, gentamicin, tobramycin, or amikacin levels, who were admitted to V7 during 1/1/2006 – 12/31/2006 Patients were identified by a clinical pharmacist rounding on V7 –Patient demographics Aminoglycoside: n = 11 patients (18 sets of levels) Vancomycin: n = 5 patients (6 sets of levels)

16. Results Use of the sticker appeared to increase the % of drug levels that could be accurately assessed Improvement = 67% for the monitoring of aminoglycoside levels Assessable Levels (n) 100% 33% 100% 36% 100% 50% 0% 100% Note: Time of dose and level documented via sticker indicated the trough level was drawn a mean 0.26 hours (range 0.04-0.62 hours) later than standard documentation indicated

17. Results Use of the sticker allowed for better assessment of the drug level The calculated mean peak appeared to be lower in the sticker protocol group, while the calculated mean trough appeared to be similar between the two groups Calculated drug level (mg/L)

18.  Implementation of the therapeutic drug monitoring sticker project on a general pediatric floor appeared to result in…  Improved data collection verses traditional methods  A more accurate assessment of antibiotic levels for optimization of antibiotic treatment  A hypothesized decreased need for repeating levels Conclusions