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Linking Pharmacy and Data for Better Care. Part 2: Lab↔Med Candidates, Performance, Tools & Pearls. November 11, 2010 1:30pm – 2:30pm CST Voice conferencing: 513-241-1028 Conference ID: 40278 Participant, Please mute your phone by pushing *6 William Galanter MD/PhD

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slide1

Linking Pharmacy and Data for Better Care

Part 2: Lab↔Med Candidates, Performance, Tools & Pearls

November 11, 2010 1:30pm – 2:30pm CST

Voice conferencing: 513-241-1028

Conference ID: 40278

Participant, Please mute your phone by pushing *6

William Galanter MD/PhD

Medical Director, Clinical Information SystemsChair Pharmacy & Therapeutics Committee

Co-investigator UIC TOP-MED CERTDepartment of Medicine/Department of Pharmacy Practice

University of Illinois at Chicago (UIC)

This project was supported by grant number U18HS016973 from the Agency for Healthcare Research and Quality. The content is solely the responsibility of the authors and does not necessarily represent the official views of the Agency for Healthcare Research and Quality.

slide2

Outline

-Background of Lab↔Med Linkage decision support

-The problem

-The issue of timing

-The development of high priority Lab↔Med pairs

-Selection of pairs

-Design of alerts

-Results of the first phase of pairs

-Summary

-Examples

-Issues & Tips

slide3

Drug↔Drug Interaction (DDI)

Allergies, vitals, Weight

Rx

Lab

Lab↔Med*

Critical Labs

Dx

Rx↔Dx

Targets for Clinical Decision

Support (CDS) for medication use

Genotypes/Phenotypes

Rx↔Everything

*Arch Intern Med. 2003 Apr 28;163(8):893-900

slide4

Communication Issues

Registration

Clinical Data

Alert

Clinical Inbox

Alert

Alert

Alert

Alert

Alert

Pharmacy

Printer

Nurse

Physician

Orders

EMR

Rules

Engine

slide5

Synchronous Alerts

(synchronous to CPOE)

CPOE

Clinical Data

Alert

Registration

EMR

Rules

Engine

slide6

Asynchronous (to CPOE) Alerts

Clinical Data

Clinical Inbox

Alert

Alert

Alert

Alert

Alert

Pharmacy

Printer

Nurse

Physician

EMR

Rules

Engine or Reporting tool

slide7

Timed asynchronous Alerts

Clinical Inbox

Alert

Alert

Alert

Alert

Alert

Pharmacy

Printer

Nurse

Physician

EMR

Rules

Engine or Reporting tool

slide8

Asynchronous Alerts

Alert

Post-Alert

100%

80%

Lab results

60%

Proportion of patients

Provider

Pre-Alert

40%

20%

0

0

1

12

24

Hours

Compliance with alert recommendationsLow [Mg++] when on Digoxin

EMR

Galanter et al. J Am Med Inform Assoc. 2004 Jul-Aug;11(4):270-7.

slide9

Asynchronous Alerts

Alert

100

EMR

80

60

40

Lab results

20

Provider

P=0.05

0

5000

10000

15000

20000

25000

0

Exposure to Metformin after a new eGFR <60

% Patients receiving Metformin

Post Pre

Minutes after new lab

slide10

The timing of Lab↔Med CDS?

Synchronous

-Requires CPOE

-Compliance is a problem

-Immediate feedback

Real-time asynchronous

-Requires a 24o communication channel -Immediate feedback

Non real-time asynchronous reports

-Does not require CPOE (~<20% of US Hospitals in 2009*)

-Can use a dedicated team for a short period of time, thus adds reliability

-delayed feedback

*Health Affairs, 28, no. 2 (2009): 404-414 Clin Pediatr (Phila). 2009;48:389-396.

slide11

Development of an Asynchronous Daily Lab↔Med Report

Collaborators

University of Illinois at Chicago

Bruce L. Lambert, Ph.D., Rob Didomenico, PharmD, Mike Koronkowski, PharmD, Shengsheng Yu, MS, Fang-Ju Lin, BPharm, MS, Jessie Moja, MD

Brigham and Women’s Hospital

Gordon D. Schiff, MD

Stroger Hospital

Shane Borkowsky, MD, Mary Wisniewski RN, MSN

University of Washington

Beth Devine PharmD, MBA, PhD, Tom Payne, MD

Cerner Corporation

David McCallie MD, Margaret Kolm MD

selecting inpatient lab med pairs
Selecting Inpatient Lab↔Med Pairs

Modified Delphi Process

Started with 650 Lab↔Med pairs from;

-Review of the literature -Experience and CDS of Institutions -Experience of the EMR vendor

Panel of experts narrow the list to 24 pairs

Yu, Galanter, DiDomenico, Borkowsky, Schiff, Lambert. Consensus list of priority drug-lab linkages for an inpatient asynchronous alert program: Results of a Delphi survey. AJHP. In press.

selecting inpatient lab med pairs13
Selecting Inpatient Lab↔Med Pairs

Yu, Galanter, DiDomenico, Borkowsky, Schiff, Lambert. Consensus list of priority drug-lab linkages for an inpatient asynchronous alert program: Results of a Delphi survey. AJHP. In press.

slide16

Why did the experts pick these pairs?

Linear Regression Model Predicting Global Impression of Usefulness

Yu, Galanter, DiDomenico, Borkowsky, Schiff, Lambert. Consensus list of priority drug-lab linkages for an inpatient asynchronous alert program: Results of a Delphi survey. AJHP. In press.

slide17

First Phase of Lab↔Med pairs implemented at UIMCC

-All the potassium and pregnancy were done together

-Added another easy one

slide18

Issues to consider when producing the clinical logic

-Choosing cutoffs

-sensitivity vs. annoyance

-Choosing the time of day for the daily report-Potential to reduce risk -Volume of alerts

-Risk of Annoyance

-workflow

-Basic vs. advanced logic-maturity and depth of EMR

slide20

Potential report benefit vs. report time

*

*

risk

risk

risk

*

* Best Time

The best time to run the report depends on the alert, even when all alerts were triggering on K+

ACE/ARB

Supplemental K+

Hyperal with K+

Time of Day

slide21

Logic for ACE/ARB↔K+

Target meds: ACE, ARB, any ACE/ARB combination medication

Multum classes:Angiotensin Converting Enzyme Inhibitors (all members of this class) Angiotensin II inhibitors (all members of this class) Antihypertensive combinations (some members of this class)

Target labs: venous [K+], arterial [K+]

Logic: Presence of an active order for a target med with the most recent target lab is above the threshold at the time of report

Age: Any Gender: Either

Lab cutoff at University of Illinois Hospital (UIH):

≥90 days of age then >5.4 mEq/L <90 days of age then >5.8 mEq/L

Time chosen at UIH: 2:00 PM

Exclusion criteria: Hemodialysis order, peritoneal dialysis order

Optimal time to run the daily report: 11:00 AM

Data to retrieve: Name, MR#, Pair, Weight, CrCl, loc/svc, Med, Dose/Freq, Date/Time, Value

slide22

Logic for ACE/ARB↔K+

Rationale & Information:

The time chosen at UIH was based on pharmacists workflow, not the optimal time based on retrospective data.

At UIH, this pair is expected to produce roughly 1-2 alerts per day

Optimal time to run the daily report was determined based on the total time in danger for all patients with serum [K+] of greater than 5.4 mEq/L.

The specificity of the alert did not decrease much as the threshold rose above 5.4 mEq/L

The PPV of the alert is improved by 30% if the report is able to exclude ESRD patients on HD or PD. This distinction is not likely available in most hospitals.

In most patients with chronic kidney diseases, the ACE inhibitor or ARB can be continued if serum potassium is ≦5.5 mEq/L.1

For increased serum potassium concentrations of up to 5.5 mEq/L, the dose can be lowered. In patients receiving some combination of an ACE inhibitor, an ARB, and an aldosterone-receptor blocker, discontinuation of one drug may also be effective in lowering the serum potassium concentration. If the potassium concentration increases to a value >5.5 mEq/L despite the precautions noted above, then such drugs may need to be avoided.2,3

slide23

Logic for ACE/ARB↔K+

Rationale & Information: (continued)

For heart failure patients, although potassium elevations up to 5.5 mEq/L during treatment with RAAS antagonists are generally well tolerated and likely can be managed with reductions in dosage or dietary modification alone, levels greater than 5.5 mEq/L are of concern and should prompt discontinuation of one or more offending drugs, with short-term laboratory follow-up to confirm a return to normal.4 If potassium rises >5.5 mEq/L, halve dose of ACEI or ARB and monitor blood chemistry closely. If potassium rises > 6.0 mEq/L, stop ACEI or ARB immediately and monitor blood chemistry closely.5

When a patient starts receiving ACEI/ARB in heart failure or hypertension: Stable K+ increases to ≦6 mEq/L do not usually require change in treatment, although rises to 5.5–5.9 mEq/L should prompt more frequent monitoring. If it rises >6 mEq/L, all drugs that may increase potassium and concomitant nephrotoxic drugs should be stopped and specialist advice sought.6

The "normal" range for serum potassium is higher in neonates than adults7,8, therefore a different cutoff is used for patients under 90 days of age.

References:

1 K/DOQI clinical practice guidelines on hypertension and antihypertensive agents in chronic kidney disease. Am J Kidney Dis 2004;43:S1-290.

2 Palmer BF. Managing hyperkalemia caused by inhibitors of the renin-angiotensin-aldosterone system. N Engl J Med 2004;351:585-92.

3 Palmer BF. Angiotensin-converting enzyme inhibitors and angiotensin receptor blockers: what to do if the serum creatinine and/or serum potassium concentration rises? Nephrol Dial Transplant 2003;18:1973-5.

4 Desai AS. Hyperkalemia in patients with heart failure: incidence, prevalence, and management. Curr Heart Fail Rep 2009;6:272-80.

5 Dickstein K, Cohen-Solal A, Filippatos G, et al. ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure 2008: the Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2008 of the European Society of Cardiology. Developed in collaboration with the Heart Failure Association of the ESC (HFA) and endorsed by the European Society of Intensive Care Medicine (ESICM). Eur Heart J 2008;29:2388-442.

6 Smellie WS, Forth J, Coleman JJ, et al. Best practice in primary care pathology: review 6. J Clin Pathol 2007;60:225-34.

7 Arch Pediatr. 2007 Mar;14(3):249-53

8 Lexi-comp online; http://online.lexi.com/crlsql/servlet/crlonline

slide24

Logic for Clozapine↔WBC/ANC

Target meds: Clozapine

Multum classesMiscellaneous antiphsychotic agents (1 member of this class)

Target labs: WBC, ABS NEUT

Logic:Presence of an active order for the target medication with either of the most recent target labs below the threshold at the time of report.

Age: Either

Gender: Either

Lab cutoff at University of Illinois Hospital (UIH): ABS NEUT <2000 mm3 or WBC <3500 mm3

Time Chosen @ UIH: 2:00 PM

Optimal time to run the daily report: 10:00 AM

slide25

Logic for Clozapine↔WBC/ANC

Data to retrieve: Name, MR#, Pair, weight, loc/svc, Med, Dose/Freq, Date/time (WBC), WBC, Date/time (ANC), ANC

Rationale: The time chosen at UIH was based on pharmacists workflow, not the optimal time based on retrospective data.

At UIH, this pair is expected to produce roughly 0 alerts per day

Clozapine is rarely used at UIH. Only 43 patients were prescribed clozapine from January 2007 to December 2009. Among those patients, WBC was never below 3500 mm. Given the rare incidence of clozapine-WBC/ANC alert, FDA monitoring range for WBC and ANC is used as the cutoff for the lab tests. We recommend running the report at 10:00AM when most of the morning labs are posted.

Reference: CLOZARIL® (clozapine) Package Insert https://www.clozapineregistry.com/insert.pdf.ashx

slide26

Logic for Med↔Pregnancy

Target meds: Ergotamine, ergotamine/caffeine, dihyroergotamine, warfarin

Multum classes:Antimigraine agents (some members of this class) Anticoagulants/coumarins and indandiones (only member of this class)

Target labs: -Urine Pregnancy test -Point of Care Testing (POCT) pregnancy test -HCG-Serum

Target order at UIH: "patient is pregnant"

Logic: Presence of an active order for a target medication with any of the following;

-Active order for "patient is pregnant“

-Urine Pregnancy test (+) within 9-months

-Point of Care Testing (POCT) pregnancy test (+) within 9-months

-HCG-Serum > 25

Age: Any

Gender: Either (some errors are made in gender assignment in EMR's)

Time Chosen @ UIH: 2:00 PM

Best time per analysis: No preference

slide27

Logic for Med↔Pregnancy

Time Chosen @ UIH:2:00 PM

Best time per analysis:No preference

Data to retrieve: Name, MR#, Pair, loc/svc, Med, Date/time pregnancy order or lab, pregnancy order or lab.

Rationale:

At UIH, this pair is expected to produce roughly 0 alerts per day

The pregnancy test was infrequently ordered at UIH to verify pregnancy status. Therefore, active pregnancy orders, rather than pregnancy lab tests, will perform better as the indicator for pregnancy. A non lab pregnancy trigger is not likely available at most hospitals, but should be used if available. A trigger based on nursing documentation would work well

An hCG level above 25mIU/ml is used to be considered positive for pregnancy based on general pregnancy diagnosis guidelines.

slide28

Logic for K+-Sparing Diuretic↔K+

Target meds: amiloride, eplerenone, spironolactone, triamterene, amiloride/hydrochlorothiazide, spironolactone/hydrochlorothiazide, triamterene/hydrochlorothiazide

Multum classes: Potassium sparing diuretics (all members of this class)

Target labs: venous [K+], arterial [K+]

Logic: Active order for a target med with the most recent target lab above the threshold at the time of report

Age: Any Gender: Either

Lab cutoff at University of Illinois Hospital (UIH):

≥90 days of age then >5.0 mEq/L, <90 days of age then >6.0 mEq/L

Time chosen at UIH: 2:00 PM

Exclusion criteria: @UIH: Hemodialysis order, peritoneal dialysis order

Potential Additional logic:

-If cirrhosis patients can be identified, a [K+] cutoff of >5.4 meq/L would be more appropriate.

slide29

Logic for K+-Sparing Diuretic↔K+

Optimal time to run the daily report: 10:00 AM

Data to retrieve: Name, MR#, Pair, Weight, CrCl, loc/svc, Med, Dose/Freq, Date/Time, Value

Rationale & Information:

-At UIH, this pair is expected to produce roughly 1-2 alerts per day.

-Optimal time to run the daily report was determined based on the total time in danger for all patients with serum [K+] of greater than 5.0 mEq/L.

-Potassium sparing diuretics are mainly used for 3 indications for adults—heart failure, cirrhosis, and hypokalemia. ---At UIH the proportion of patients with CHF, cirrhosis and hypokalemia on spironolactone was 35%, 50% and 15%. -As UIH is a busy liver transplant center, the cirrhosis proportion might be higher than at some other hospitals. Because the diagnosis cannot be clearly defined, a single [K+] cutoff was used. For hypokalemia, the indication is cleared with high serum potassium concentrations, thus a relatively low [K+] cutoff would be reasonable . For patients with cirrhosis and ascites, the threshold of discontinuing spironolactone in terms of hyperkalemia is not well studied in cirrhosis. For heart failure, potassium sparing diuretics should not be administered to patients with baseline serum potassium > 5.0 mEq/L.1,2

-The development of potassium levels in excess of 5.5 mEq/L should generally trigger discontinuation or dose reduction of the aldosterone antagonist unless patients have been receiving potassium supplementation, which should then be stopped.1,3,4 Therefore as a [K+] cutoff of 5.0 was selected as this is appropriate in patients with an indication of hypokalemia, a good level to consider discontinuation in CHF. This is likely low in cirrhosis patients and if these patients can be identified by the report.

slide30

Logic for K+-Sparing Diuretic↔K+

Potential Additional logic: (Continued)

-Drug information on package inserts: If serum potassium is greater than 5 mEq/L or serum creatinine >4 mg/dl, interrupt or discontinue spironolactone therapy.5 Eplerenone is contraindicated with serum potassium >5.5 mEq/L at initiation for all patients. Patients who develop hyperkalemia (>5.5 mEq/L) may continue eplerenone therapy with proper dose adjustment. Dose reduction decreases potassium levels.6 Amiloride should not be used in the presence of elevated serum potassium level (>5.5 mEq/L).7

-The use of potassium sparing diuretics in neonates for bronchopulmonary dysplasia is controversial8,9, but does occur. In addition, the "normal" range for serum potassium is higher in neonates than adults10,11, therefore a different cutoff is used for patients under 90 days of age.

References:

1 Hunt SA. ACC/AHA 2005 guideline update for the diagnosis and management of chronic heart failure in the adult: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Update the 2001 Guidelines for the Evaluation and Management of Heart Failure). J Am Coll Cardiol 2005;46:e1-82.

2 Dickstein K, Cohen-Solal A, Filippatos G, et al. ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure 2008: the Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2008 of the European Society of Cardiology. Developed in collaboration with the Heart Failure Association of the ESC (HFA) and endorsed by the European Society of Intensive Care Medicine (ESICM). Eur Heart J 2008;29:2388-442.

3 Poggio R, Grancelli HO, Miriuka SG. Understanding the risk of hyperkalaemia in heart failure: role of aldosterone antagonism. Postgrad Med J 2010;86:136-42.

3 Brophy DF, Gehr TWB. Pharmacotherapy: a pathophysiologic approach. In: DiPiro JT, Talbert RL, Yee GC, Matzke GR, Wells BG, Posey LM, eds. Disorders of potassium and magnesium homeostasis. 7 ed: McGraw-Hill Companies, Inc; 2008.

4 Aldactone (spironolactone) [package insert]. New York, NY: G.D. Searle LLC; 2008.

5 http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/012151s062lbl.pdf

6 Inspar (eplerenone) [package insert]. New York, NY: G.D. Searle LLC; 2008. http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021437s006lbl.pdf 7 Midamor (amiloride) [package insert]. Whitehouse Station, NJ: Merck & Co. Inc; 2002.

8 Ann Pharmacother. 2005 May;39(5):823-8. Epub 2005 Apr 5.

9 Diuretics acting on the distal renal tubule for preterm infants with (or developing) chronic lung disease (Review). 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

10 Arch Pediatr. 2007 Mar;14(3):249-53

11 Lexi-comp online, http://online.lexi.com/crlsql/servlet/crlonline

slide31

Logic for K+supplement↔K+

Target meds: KCl, K-Phos, K-Phos/Na-Phos, Citric Acid/K-Citrate, K-HCO3, K-HCO3/KCl, KCl/NaCl, K-Gluconate, K-Acetate, Citric Acid/K-Citrate/Na-Citrate

Multum classes: Minerals and Electrolytes (some members of this class)

Target labs: venous [K+], arterial [K+]

Logic: -Active order for a target med with the most recent target lab above the threshold at the time of report.

Age: AnyGender: Either

Lab cutoff at University of Illinois Hospital (UIH):

≥90 days of age then >5.0 mEq/L <90 days of age then >5.8 mEq/L

Time Chosen @ UIH: 2:00 PM

Optimal time to run the daily report:

-Potassium containing hydration: 10:00 AM

-Potassium containing hyperalimentation: 8:00 AM

-Potassium Supplementation: 9:00 PM

slide32

Logic for K+ supplement↔K+

Data to retrieve: Name, MR#, Pair, weight, loc/svc, Med, Dose/Freq, Date/time, Value

Rationale & Information

-The time chosen at UIH was based on pharmacists workflow, not the optimal time based on retrospective data.

-At UIH, this pair is expected to produce roughly 3 alerts per day

-Serum [K+] of greater than 5.0 mEq/L is considered as having hyperkalemia in patients older than 90 days.1

-Optimal time to run the daily report was determined based on the total time in danger for all patients with serum [K+] of greater than 5.0 mEq/L.

-The "normal" range for serum potassium is higher in neonates than adults2,3, therefore a different cutoff is used for patients under 90 days of age.

References:

1 Strom JA, Harrington JT, Narayan G. Diagnosis of Disorders of Potassium Balance. In: Gennari FJ, ed. Medical Management of Kidney and Electrolyte Disorders. Basel, NY: Marcel Dekker, Inc.; 2001:217-236.

2 Arch Pediatr. 2007 Mar;14(3):249-533 Lexi-comp online; http://online.lexi.com/crlsql/servlet/crlonline

slide33

The Report

Abe Lincoln MR#0123456789

Richard Daley MR#0123456789

Ronald Reagan MR#0123456789

Baby Lude Beethoven MR#123456789

Mary Lincoln MR#123456789

Abe Lincoln MR#123456789

slide34

Frequency of alerts

First 100 days of Phase #1

UIH, ~450 bed hospital

slide35

A likely useful alert for a rare event

WBC & ANC vs. Time in a patient on clozapine

slide36

A likely useful alert for a non-rare event

Creatinine and K+ vs. Time

K+

Creatinine

slide38

Med ↔Pregnancy testing performance

Are pregnancy tests a good measure of pregnancy?

UIH 12/08-12/09, Females 12-52 @admission

Testing=POCT or lab, urine preg or HCG during or within 270 days prior to admission

Gold Standard is nursing documentation

slide39

The value of discrete knowledge for lowering false positives

[K+]↔ACE/ARB 1/2009

Raw

# of instances

Knowledge of Dx of ESRD on Dialysis

Chart Review for CHF & CRI

[K+]

slide41

Post-Alert Issues

at satellite pharmacies by patient location

Yes, but only through running the report again in 240

NO

Mode of communication

-Printing

-Placement on-line for on-demand use

-Sending to mobile devices

Documentation in the patient record

-Mandatory?

-Not mandatory?

-Only when changes made?

F/U for compliance?

Determining repeat offenders?

slide42

Pearls and Tips

-For the ACE/ARB/K+-sparing diuretic alerts based on serum K+, discrete knowledge of renal and cardiac status can improve the positive predictive value of the alerts. If this is impossible, train those managing the report to look for these issues first before contacting the patients clinical team

-Linking medication use to pregnancy testing is not likely to be an accurate intervention, but alerts are rare and errors can have severe consequences so it may still be worthwhile. Look first if patients are pregnant, not if they are women.

-Use your own data when possible to set thresholds, but it is easier and likely OK to use other’s or the FDA’s, especially for alerts which will rarely fire.

-It would always be best if your EMR knew who was pregnant and who was on dialysis.

slide43

Pearls and Tips

-Both the number of alerts and potential usefulness of the alerts depends on the time of day of the report. Running the report more frequently than once a day may improve performance if it can be managed in terms of workflow and staff needed for multiple runs.

-Thresholds can be changed rapidly, so early analysis of alert frequency and usefulness can decrease annoyance or increase value by fine tuning.

-Mode of communication and documentation needs to be tailored to each institutions planned workflow, but even if documentation in the patient record is not required, recording the response to the alerts is needed to help determine build errors or needed changes of clinical logic.

slide44

Conclusions

-Automating the use of clinical connections between discrete lab results and medication orders can be a useful way to reduce medication errors.

-A daily asynchronous lab↔med report can add a layer of safety, even with CPOE systems including real-time synchronous & asynchronous alerts and clinical pharmacists.

-This intervention does not require CPOE nor any advanced communication tools making it an option for almost any inpatient setting which has lab and pharmacy information systems.

slide45

Resources

Clinical logic for the first set of alerts can be found at;

http://www.uic.edu/com/dom/gim/TOPMED/Logic-Phase1.pdf

A list of all the pairs can be found at;

http://www.uic.edu/com/dom/gim/TOPMED/Pairs.pdf

An excellent source of references and an explanation of the Delphi process can be found in the reference below when available;

Yu et al. Consensus list of priority drug-lab linkages for an inpatient asynchronous alert program: Results of a Delphi survey. AJHP. 2010 In press.

slide46

Questions?

BillG@uic.edu