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Course Notes

Course Notes. Purpose of Course Target Audience. Course Notes (cont.). Environment for Screen Captures Acronyms and Terms. AHLTA & CHCS Critical Fixes and Support (ACCFS) Pharmacy (PHR) Enhancements: Patient Safety Enhancements to Medication Orders.

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Course Notes

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  1. Course Notes • Purpose of Course • Target Audience

  2. Course Notes (cont.) • Environment for Screen Captures • Acronyms and Terms

  3. AHLTA & CHCS Critical Fixesand Support (ACCFS)Pharmacy (PHR) Enhancements: Patient Safety Enhancements to Medication Orders Pharmacy staff who order inpatient and outpatient medications. All patients and personal data used in this course are fictional and are not based on any real patients. This course does not contain protected personal health information (PHI) or personally identifiable information (PII). 3

  4. Agenda • Course Objectives • Training Overview • Lesson 1: New Data Elements • Lesson 2: Pregnancy Module • Lesson 3: Dosage Module • Course Summary • References • Questions

  5. Course Objectives By the end of this course, you will be able to: • Identify the new data elements added to the Pharmacy module to allow the dosage and pregnancy checks. • Interpret the pregnancy warning codes returned when drugs ordered for pregnant women have degrees of potential harm to the fetus. • Understand how the dosage module informs you that an issue prevented the dosage checks and how to resolve the problem. • Interpret the different types of dosage warnings.

  6. Training Overview • Need for Training • Target Audience • Methodology - PowerPoint Slides - CHCS Screen Captures - Questions

  7. Course Scenario You have been told that CHCS is now capable of performing dosage and pregnancy checks. As a pharmacy staff member who enters orders at site, you need to know how the dosage and pregnancy checks work, what changes in CHCS support these checks, and the implications of these changes to the current processes at site.

  8. Lesson 1: New Data Elements Topic 1: Overview of the New Data Elements Topic 2: Display/Edit Clinical Data Topic 3: Clinical Screening Parameters

  9. Lesson 1 Objectives By the end of this lesson, you will be able to identify and understand: • The new data elements that were added to enhance patient safety. • Where these new data elements are located within the functionality. • The clinical screening parameters that must be enabled for these checks to occur.

  10. Topic 1: Overview of the New Data Elements

  11. New Data Elements in CHCS • Pregnancy flag (appears only for female patients) • Height (inches) • Weight (pounds) • Body Surface Area (BSA) (calculated) • Serum Creatinine • Creatinine Clearance (CrCl) (calculated) • Gestational Age (appears only for patients less than 2 years old)

  12. Sources of Data Elements • AHLTA (v3.3.7) • Pregnancy • Height (cm) • Weight (kg) • Serum Creatinine (CDR) • CHCS • Serum Creatinine (Standardized Test) • Gestational Age • New Clinical Data Fields • Pregnancy • Height (cm) • Weight (kg) • Serum Creatinine • CrCl (age, weight, gender and Serum Creatinine) • BSA (height and weight) • Gestational Age

  13. Description of Data Elements

  14. Description of Data Elements (cont.)

  15. Question True or False: The Gestational Age and Pregnancy flag are conditional fields.

  16. Topic 2: Display/Edit Clinical Data

  17. Menu Path: PHROPMPMRX Select Prescriptions Menu Option: RX New Prescription Entry Select PATIENT: ACCFSXXX,ADOL 01/901-27-8860 12 Jul 1998 F New Prescription Entry ACCFSXXX,ADOL NO ALLERGIES DOCUMENTED YOU MAY SELECT: A FOR ACTIVE PRESCRIPTIONS ONLY B FOR BOTH ACTIVE AND INACTIVE PRESCRIPTIONS R FOR RANGE OF DATES <RET> TO BYPASS PROFILE SELECTION: A

  18. New Prescription Entry Screen ***** ACCFSXXX,ADOL ***** FMP/SSN: 01/8860 Age: 13y Sex: FEMALE Rank: DoD ID: Allergies: Pharmacy Comment: NONE Pregnancy:Unk (Apr 2012) Ht(in):60 (Apr 2012) Wt(lb):90 (Apr 2012) SrCr(mg/dl):3 (Apr 2012) CrCL(ml/min):20 BSA(m2):1.33 TYPE ----------------------------------A C T I V E----------------------------------- No. RX # DRUG STATUS QTY FILL DATE REF LEFT -------------------------------------------------------------------------------- 1) LE4054305 *BENADRYL/MOM--TOP SUSP 120ML/B A 30 Suspense NR 2) L1851172 ONDANSETRON--PO 4MG TAB W 7 Suspense 2 of 2 3) L1851173 *MICONAZOLE--TOP 2% CREA TU;30G A 15 Suspense NR 4) L1851176 CEFIXIME--PO 200MG/5ML SUSP ML W 10 Suspense 5 of 5 5) L2097905 COCAINE--TOP 4% SOLN W 14 Suspense NR 6) L1851178 DOXYCYCLINE (PERIOSTAT)--PO 20 W 30 Suspense NR

  19. New Prescription Entry Screen (cont.) New Prescription Entry ACCFSXXX,ADOL NO ALLERGIES DOCUMENTED YOU MAY SELECT: A FOR ACTIVE PRESCRIPTIONS ONLY B FOR BOTH ACTIVE AND INACTIVE PRESCRIPTIONS R FOR RANGE OF DATES <RET> TO BYPASS PROFILE SELECTION: (To edit clinical data, enter an asterisk ("*") at the drug prompt) Select DRUG: *

  20. Clinical Data Enter/edit Screen ***** ACCFSXXX,ADOL ***** FMP/SSN: 01/8860 Age: 13y Sex: FEMALE Rank: DoD ID: Allergies: Pharmacy Comment: NONE Patient clinical data: Pregnancy: UNK Date: 16 Apr 2012 Height (inches): 60 Date: 17 Apr 2012 Weight (lbs): 90 Date: 17 Apr 2012 BSA (m2): 1.33 Serum Creatinine (mg/dl): 3 Date: 05 Apr 2012 CrCL (mL/min): 20 --------------------------------------------------------------------------------------------------------------------------------------------- File/exit Abort Edit File changes and exit Select DRUG:

  21. Modify a Prescription Modify a Prescription ACCFSXXX,ADOL NO ALLERGIES DOCUMENTED YOU MAY SELECT: A FOR ACTIVE PRESCRIPTIONS ONLY B FOR BOTH ACTIVE AND INACTIVE PRESCRIPTIONS R FOR RANGE OF DATES <RET> TO BYPASS PROFILE SELECTION: Select PATIENT or RX #:

  22. Modify a Prescription - A Modify a Prescription ACCFSXXX,ADOL NO ALLERGIES DOCUMENTED YOU MAY SELECT: A FOR ACTIVE PRESCRIPTIONS ONLY B FOR BOTH ACTIVE AND INACTIVE PRESCRIPTIONS R FOR RANGE OF DATES <RET> TO BYPASS PROFILE SELECTION: A

  23. Select PRESCRIPTION(s) ***** ACCFSXXX,ADOL ***** FMP/SSN: 01/8860 Age: 13y Sex: FEMALE Rank: DoD ID: Allergies: Pharmacy Comment: NONE Pregnancy:Unk (Apr 2012) Ht(in):60 (May 2012) Wt(lb):90 (Apr 2012) SrCr(mg/dl):3 (Apr 2012) CrCL(ml/min):20 BSA(m2):1.33 TYPE ----------------------------------A C T I V E----------------------------------- No. RX # DRUG STATUS QTY FILL DATE REF LEFT -------------------------------------------------------------------------------- 1) LE4054305 *BENADRYL/MOM--TOP SUSP 120ML/B A 30 Suspense NR 2) L1851172 ONDANSETRON--PO 4MG TAB W 7 Suspense 2 of 2 3) L1851173 *MICONAZOLE--TOP 2% CREA TU;30G A 15 Suspense NR 4) L1851176 CEFIXIME--PO 200MG/5ML SUSP ML W 10 Suspense 5 of 5 5) L1851178 DOXYCYCLINE (PERIOSTAT)--PO 20 W 30 Suspense NR 6) L1851145 *ACETAZOLAMIDE--PO 500MG CPSR A 60 20 Apr 2012 NR (To edit clinical data, enter an asterisk (“*” ) at the Prescription prompt) Select PRESCRIPTION (s): *

  24. Clinical Data Enter/edit Screen ***** ACCFSXXX,ADOL ***** FMP/SSN: 01/8860 Age: 13y Sex: FEMALE Rank: DoD ID: Allergies: Pharmacy Comment: NONE Patient clinical data: Pregnancy: UNK Date: 16 Apr 2012 Height (inches): 60 Date: 17 Apr 2012 Weight (lbs): 90 Date: 17 Apr 2012 BSA (m2): 1.33 Serum Creatinine (mg/dl): 3 Date: 05 Apr 2012 CrCL (mL/min): 20

  25. Menu Path: PHRUDMIOEEMI ACCFSXXX,ADULINP Age:34 20/1111 DoD ID: L8D POL Known Allergies: NO ALLERGIES DOCUMENTED Pregnancy:Yes (Apr 2012) Ht(in):70 (Apr 2012) Wt(lb):143.3 (Apr 2012) SrCr(mg/dl):67 (Apr 2012) CrCL(ml/min):1 BSA(m2):1.81 (Enter an asterisk ("*") to edit clinical information) Select INPATIENT MEDICATION:

  26. Modify Inpatient Orders ACCFSXXX,ADULINP Age:34 20/1111 DoD ID: L8D MODIFIABLE ORD * 1 MED 120405-00006 RIFAMPIN-CAP (RIFADIN) <ORAL> 900MG QDAY {QD ( EVERY DAY )} for 99 days Starting 05 Apr 2012@1000 ~DRUG WARNING . . . . . . . . . . . . . . . ACCFST 5APR@0816 2 IVF 120403-00069 DEXTRAN 40/D5W--INJ SOLN 1000ML + ALTEPLASE (CATHFLO ACTIVASE) 2MG 50ML 2ML/HR for 99 days Starting 03 Apr 2012@1317 ~DRUG WARNING . . . . . . . . . . . . . . . ACCFST 3APR@1319 3 IVP 120423-00056 VINCRISTINE <PIGGY> 97.7MG Q8H for 99 days Starting 23 Apr 2012@1400 ~DRUG WARNING . . . . . . . . . . . . . . . ACCFST 23APR@1245 Reason for Modification: change duration and frequency Do you wish to edit the patient's clinical data? NO// Y

  27. Renew Unit Dose and IVP Orders ACCFSXXX,DIONE Age:26 98/2229 DoD ID: LICU RENEWABLE ORD * 1 MED 120514-00022 ADDERALL-TAB (ADDERALL) <ORAL > 10MG Q8H {QD ( EVERY DAY )} for 1 day Starting 14 May 2012@1400 ~Expires on 15 May 2012@1359~DRUG WARNING . ACCFSD 14MAY@1258 2 IVF 120514-00017 *STAT* SODIUM CHLORIDE--IV 0 .45% SOLN 1000ML + POTASSIUM CHLORIDE 20MEQ 100ML/HR for 1 day Starting 14 May 2012 @1252 ~Expires on 15 May 2012@1251 . . . . . . . ACCFSD 14MAY@1252 3 IVD 120514-00018 POTASSIUM CHLORIDE 20MEQ /1000ML DEXTROSE 5%/SALINE 0.45% 20ML/HR for 1 day Starting 14 May 2012@1253 + ~Expires on 15 May 2012@1252~DRUG WARNING . ACCFSD 14MAY@1254 Reason for Renewal: patient needs to continue on therapy Do you wish to edit the patient's clinical data? NO//

  28. Renew IVF,IVD or IVH Orders ACCFSXXX,DIONE Age:26 98/2229 DoD ID: LICU RENEWABLE ORD 1 MED 120514-00023 ADDERALL-TAB (ADDERALL) <ORAL > 10MG Q8H {QD ( EVERY DAY )} for 1 day Starting 14 May 2012@1400 ~Expires on 15 May 2012@1359~DRUG WARNING . ACCFSS 14MAY@1307 * 2 IVF 120514-00017 *STAT* SODIUM CHLORIDE--IV 0 .45% SOLN 1000ML + POTASSIUM CHLORIDE 20MEQ 100ML/HR for 1 day Starting 14 May 2012 @1252 ~Expires on 15 May 2012@1251 . . . . . . . ACCFSD 14MAY@1252 3 IVD 120514-00018 POTASSIUM CHLORIDE 20MEQ /1000ML DEXTROSE 5%/SALINE 0.45% 20ML/HR for 1 day Starting 14 May 2012@1253 + ~Expires on 15 May 2012@1252~DRUG WARNING . ACCFSD 14MAY@1254 Reason for Renewal: patient needs to continue with this order PATIENT: ACCFSXXX,DIONE ORDER: 120514-00017 ORDER TYPE: IV FLUID ORDERS *STAT* SODIUM CHLORIDE--IV 0.45% SOLN 1000ML + POTASSIUM CHLORIDE 20MEQ 100ML/HR for 1 day Starting 14 May 2012@1252 Latest Stop Date is 21 Aug 2012@1307 == 99 days (maximum) from now. Stop Date/time was 15 May 2012@1251 ... will renew for another 1 days: STOP/EXPIRATION DATE: 15 May 2012@1307//

  29. IVD and IVP Orders and Weight • Patient’s weight entered in pounds (lbs) will be converted to kilograms (kg). • The weight entered in these orders will update the patient’s clinical data. • If weight is not entered in these orders, dosage checking will use data, if available, in the patient’s clinical data fields for drugs that requires weight. • Dosage checking may not occur when IVD or IVP orders are renewed or modified if the patient’s weight is needed for the drug ordered.

  30. Patient Without Clinical Data Entered ***** ACCFSXXX,SAGE ***** FMP/SSN: 20/8989 Age: 34y Sex: FEMALE Rank: NE7 DoD ID: Allergies: Pharmacy Comment: NONE Patient has no clinical data TYPE ----------------------------------A C T I V E----------------------------------- No. RX # DRUG STATUS QTY FILL DATE REF LEFT -------------------------------------------------------------------------------- 1) LE4054305 *BENADRYL/MOM--TOP SUSP 120ML/B A 30 Suspense NR 2) L1851172 ONDANSETRON--PO 4MG TAB W 7 Suspense 2 of 2 3) L1851173 *MICONAZOLE--TOP 2% CREA TU;30G A 15 Suspense NR 4) L1851176 CEFIXIME--PO 200MG/5ML SUSP ML W 10 Suspense 5 of 5 5) L1851178 DOXYCYCLINE (PERIOSTAT)--PO 20 W 30 Suspense NR 6) L1851145 *ACETAZOLAMIDE--PO 500MG CPSR A 60 20 Apr 2012 NR (To edit clinical data, enter an asterisk (“*” ) at the Prescription prompt) Select PRESCRIPTION (s): *

  31. Patient with Gestational Age Field ***** ACCFSXXX,NEO ***** FMP/SSN: 04/6666 Age: 1m Sex: MALE Rank: DoD ID: 1999888777 Allergies: Pharmacy Comment: NONE Patient clinical data: Height (inches): 24 Date: 20 Apr 2012 Weight (lbs): 8 Date: 16 Apr 2012 BSA (m2): .24 Serum Creatinine (mg/dl): 62 Date: 20 Apr 2012 CrCL (mL/min): Gestational Age (wks): 36

  32. Question True or False: You are able to change the patient’s clinical data when modifying orders because new orders are created and drug checks are performed on these new orders.

  33. Topic 3: Clinical Screening Parameters

  34. Menu Path: PHRSFMCSP Clinical Screening Parameters -Set On: 09 Apr 2012@0920 -By: ACCFSXXX,SONIA Drug Check: ENABLE Interaction Check: ENABLE -Severity: MODERATE Overlap-DEA: SCHEDULE 5 Overlap-Family (Therapeutic Class):ENABLE Duplication Check: ENABLE Allergy Check: ENABLE Dosage Check: ENABLE Pregnancy Check: ENABLE -Severity: BCDX Redefined

  35. Menu Path: PHRSFMCSP (cont.) Clinical Screening Parameters -Set On: 09 Apr 2012@0920 -By: ACCFSXXX,SONIA Drug Check: ENABLE Interaction Check: ENABLE -Severity: MODERATE Overlap-DEA: SCHEDULE 5 Overlap-Family (Therapeutic Class):ENABLE Duplication Check: ENABLE Allergy Check: ENABLE Dosage Check: ENABLE Pregnancy Check: ENABLE -Severity: BCDX New fields

  36. Pregnancy Severity Level Clinical Screening Parameters -Set On: 09 Apr 2012@0920 -By: ACCFSXXX,SONIA Drug Check: ENABLE Interaction Check: ENABLE -Severity: MODERATE Overlap-DEA: SCHEDULE 5 Overlap-Family (Therapeutic Class):ENABLE -------------------------------------------------------------------------------- 1 BCDX 2 CDX 3 DX --------------------------------------------------------------------------------- -Severity: ??

  37. Question True or False: The ‘Dosage Check’ and ‘Pregnancy Check’ parameters must be set to ENABLE in the CSP menu in order for these checks to be performed on new orders.

  38. Lesson 2: Pregnancy Module Topic 1: Overview of Pregnancy Module Topic 2: Pregnancy Warning Report and Display

  39. Lesson 2 Objectives By the end of this lesson, you will be able to: • Interpret the pregnancy warnings returned from FDA or FDB. • Generate and print pregnancy checking reports for the patient’s inpatient and outpatient orders.

  40. Topic 1: Overview of Pregnancy Module

  41. Overview of the Pregnancy Module • Pregnancy Module provides precautionary information for the use of medications in female patients who are pregnant or in the childbearing age group. • Pregnancy checks will occur for New, Modified, Renewed, and Refilled prescriptions, and also when the medication of a prescription is changed within the EAP functionality. • Pregnancy checks will occur for all new IV orders (IVH, IVD, IVF and IVP) and Unit Dose Medications (MED).

  42. Overview of the Pregnancy Module (cont.) • Pregnancy checks will return warnings based on the ‘Severity’ parameter defined in the CSP option. • The ‘Severity’ setting is based on severity level codes (B,C,D,X) assigned by the FDA. • Pregnancy warnings may return an FDB precaution code (1 or 2) if FDA has not assigned a severity level code and FDB has determined that the drug warrants a pregnancy warning. • Currently, the transmission of the ‘Pregnancy’ flag will not generate a PDTS pregnancy warning.

  43. FDA Severity Categories

  44. FDA Severity Categories (cont.)

  45. FDB Pregnancy Warning Categories

  46. Question True or False: Pregnancy warnings may return an FDB precaution code (1 or 2) if FDA has not assigned a severity level code and FDB has determined that the drug warrants a pregnancy warning.

  47. Topic 2: Pregnancy Warning Report and Display

  48. Outpatient Screen Pregnancy Warning (C) >>> RX # LE4054285 <-- ACCFSXXX,ADULT F NEW DRUG: AMITRIPTYLINE--PO 50MG TAB ------------------------------------------------------------------------------- # WARNING DESCRIPTION SEVERITY =============================================================================== LOCAL WARNINGS 1. PREGNANCY WARNING C ENTER WARNING # FOR DETAILS:1 ENTER WARNING # FOR DETAILS: 1 =PRESCRIPTION LE4054285 Drug: AMITRIPTYLINE--PO 50MG TAB Qty: 180 HCP: ACCFSXXX,SONIA Refills left: 0 of 0 Last fill: (Never filled) Sig: T1 TAB BID Drug Ordered: AMITRIPTYLINE--PO 50MG TAB Pregnancy Precautions Description: AMITRIPTYLINE Pregnancy Precautions Severity Level: C Pregnancy Precautions Narrative: USE W/CAUTION;ACTIVE METABOLITE NORTRIPTYLINE MAY CAUSE INFANT URINARY RETENTION Pregnancy Precautions Severity Level Description ANIMAL STUDIES HAVE SHOWN ADVERSE EFFECT ON FETUS BUT NO WELL-CONTROLLED STUDIES IN HUMANS: POTENTIAL BENEFITS MAY WARRANT USE IN PREGNANT WOMEN DESPITE POTENTIAL RISKS; OR NO ANIMAL REPRODUCTION STUDIES AND NO ADEQUATE AND WELL-CONTROLLED STUDIES IN HUMANS.

  49. Inpatient Screen Pregnancy Warning (X) >>> ORDER# <NEW-MED> -- ACCFSXXX,ADULINP <<< NEW DRUG-1: WARFARIN--PO 2MG TAB * 3-WARNINGS: 2-INTERACT 0-DUPLICATE 0-ALLERGY 0-OVERLAP 0-DOSAGE 1-PREGNAN CY * -------------------------------------------------------------------------------- # WARNING DRUG / ALLERGY / DOSE REPORTS ================================================================================ 1 Pregnancy Warning WARFARIN--PO 2MG TAB 1 2 Interaction-Old Drug (IV) ALTEPLASE (CATHFLO ACTIVASE) 2MG--INJ VL 1 3 Interaction-Old Drug RIFAMPIN--PO 300MG CAP 1 ------------------------------------------------------------------------------ ENTER WARNING # FOR REPORT: 1 Drug Ordered: WARFARIN--PO 2MG TAB Pregnancy Precautions Description: WARFARIN SODIUM Pregnancy Precautions Severity Level: X Pregnancy Precautions Narrative: FDA D AND RECC IN PTS WITH PROSTHETIC HEART VAL VE; ALONE OR WITH LMWH OR UFH Pregnancy Precautions Severity Level Description STUDIES IN ANIMALS OR HUMANS HAVE SHOWN FETAL ABNORMALITIES AND/OR THERE IS POSITIVE EVIDENCE OF FETAL RISK BASED ON INVESTIGATIONAL OR MARKETING INFORMATION AND RISKS INVOLVED IN USE OF DRUG IN PREGNANT WOMEN CLEARLY OUTWEIGH POTENTIAL BENEFITS.

  50. Menu Paths: PHROPMDDIPHRUDMINMDDIPHRIVMVINDDI PEM Patient Education Monograph DRU Drug Information ARI Adverse Reaction Information DII Interaction Information TFW Test Drugs for Warnings PTW Patient Test for Drug Warnings FIN Formulary Inquiry PCR Pregnancy Checking Report Select Drug Data Inquiry Menu Option: PCR Pregnancy Checking Report

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