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Definition <ul><li>a process by which a practitioner obtains and documents a complete list of a patient‘s pre-admission me...
Ambulatory Inpatient Periodic Reconciliation Post-discharge Reconciliation Admission Reconciliation Discharge/Transfer Rec...
Background <ul><li>The problem of medical errors and adverse drug events </li></ul><ul><li>Medication reconciliation pract...
Background: Medical errors and ADEs <ul><li>98,000 Americans die each year as a result of medical errors, and 7,000 of the...
Background: Medication History Errors <ul><li>61% of admission notes had one drug and 33% more than one drug missing. </li...
Background: Medication Reconciliation  <ul><li>Prior to discharge pharmacist noted: </li></ul><ul><ul><li>37%  of discharg...
Background: National Mandate JCAHO Goal:  Medication Reconciliation of 100% Patients <ul><li>Accurately and completely rec...
Multidisciplinary Process <ul><li>Roles </li></ul><ul><li>History Taking </li></ul><ul><li>Verifier </li></ul><ul><li>“ Re...
Admission/Inpatient/Discharge Medication Reconciliation Process: Information Flow Inpatient Med List Inpatient Med List   ...
Outline <ul><li>Informatics interventions </li></ul><ul><ul><li>Pre Admission Med List  </li></ul></ul><ul><ul><ul><li>App...
Development of the PAML
 
 
 
 
Process of Medication Reconciliation <ul><li>1)    Obtain Emergency Department Pre-Admission Medication List (PAML) from p...
Process of Medication Reconciliation <ul><li>4)  Enter the PAML Builder and create the PAML.  Move medications from the so...
Process of Medication Reconciliation <ul><li>5)   Note uncertainties in meds, non-adherence, and meds held prior to admiss...
Process of Medication Reconciliation  <ul><li>7) Note the outpatient pharmacy or long-term care facility name, location, a...
Process of Medication Reconciliation  <ul><li>9)   Complete the PAML and mark it as ready for review within 24 hours of ad...
Process of Medication Reconciliation  <ul><li>11) Reconcile the PAML and discharge medications to create a coherent discha...
What are the benefits of the PAML? <ul><li>Improves patient safety by decreasing ADEs </li></ul><ul><li>Improves communica...
For the future <ul><li>Content </li></ul><ul><ul><li>Mapping of Medications </li></ul></ul><ul><li>Functions </li></ul><ul...
 
 
 
Architecture Med Mapping/Classification  EMR’s Hosp1 D/C Hosp2 D/C Med Reconciliation  Service API Application Common Med ...
Multi-Usage Drug Terminology:  Making Sense of the Tower of Medication Terminology Babble
<ul><li>The Need  </li></ul><ul><li>The History </li></ul><ul><li>Definitions and requirements </li></ul><ul><li>Important...
Where is Drug Terminology Needed? EHR Consumer CPOE Ambulatory EMR Retail Pharmacy Hospital Pharmacy System PBM Administer...
The Problem <ul><li>Limited ability to exchange drug information  </li></ul><ul><ul><li>Can  electronically exchange some ...
A bit of history of Drug Databases <ul><li>The big three </li></ul><ul><ul><li>FDB </li></ul></ul><ul><ul><li>Medispan </l...
A bit of history of Drug Databases <ul><li>Ninties to early 2000’s </li></ul><ul><ul><li>Consolidation  </li></ul></ul><ul...
Why National Drug Codes Stink <ul><li>Product Package Specific </li></ul><ul><li>No Central Authority </li></ul><ul><ul><l...
The Problem <ul><li>Terminologies exist, but: </li></ul><ul><li>Most are expensive to license </li></ul><ul><li>Many are s...
The Perfect Storm for interoperability <ul><li>Increased focus on healthcare quality and safety </li></ul><ul><ul><li>Auto...
Interoperability <ul><li>NAHIT Definition </li></ul><ul><li>In healthcare,  interoperability  is the ability of different ...
Systemic Interoperability Taxonomy* No PC/information technology Fax/Email  Structured messages,  non-standard content/dat...
10-Year Cumulative Net Return Level 4 in  billions $(200) $(100) $- 0 $100 $200 $300 $400 1 2 3 4 5 6 7 8 9 10 Years Level...
Some Core Concepts Clinical Drug Manufactured Drug Ingredients Packaged Product <ul><li>These concepts form the core of an...
Order = Dispense = Administer Orderable Item Dispensable Item Administrable Item ?? Sometimes, Always, or Maybe ?? Amox. 5...
Core Concept: (Active) Ingredients <ul><li>Active ingredients (chemicals) </li></ul><ul><ul><li>What is “in” the drug </li...
Core Concept: Routed Generic <ul><li>Active Ingredients </li></ul><ul><li>Route </li></ul><ul><li>Examples </li></ul><ul><...
Common entry point for CPOE Med:  Amoxicillin Oral Med:  Amoxicillin Oral
Core Concept: Clinical Drug (Generic) <ul><li>Active ingredients </li></ul><ul><li>Route </li></ul><ul><li>Strength (amoun...
Core Concept: Manufactured Drug <ul><li>Active  (and inactive) ingredients </li></ul><ul><li>Strength </li></ul><ul><li>Do...
Core Concept: Packaged Product <ul><li>All the previous, plus </li></ul><ul><li>Size </li></ul><ul><li>Units </li></ul><ul...
Putting it Together   Packaged Drug 0247-0372-00 Manufactured (Dispensable) Drug Fluoxetine HCl  oral 20 mg capsules  Dist...
Orderable Dispensable Administrable Monitorable
Orderable versus Dispensable  <ul><li>Orderable </li></ul><ul><ul><li>Amount -centric </li></ul></ul><ul><ul><li>Partially...
Dispensable versus Administrable  <ul><li>Dispensable </li></ul><ul><ul><li>Compounded and Strength/Form -centric </li></u...
Administrable versus Monitorable <ul><li>Administrable </li></ul><ul><ul><li>Strength/Form Concentration -centric </li></u...
The Scope <ul><li>We are overwhelmed as it is, with an infinite abundance of vaunted medicaments, and here they add a new ...
The Scope <ul><li>Chemical Entities </li></ul><ul><ul><li>~2,000 </li></ul></ul><ul><li>Clinical Drugs – Drug(s), Strength...
Terminology Challenges  <ul><li>Information model </li></ul><ul><ul><li>Conflicting views on key concepts </li></ul></ul><...
Operational Challenges <ul><li>Frequent updates </li></ul><ul><li>Data and database formats, customization  </li></ul><ul>...
Qualities of Good Terminologies <ul><li>Content coverage </li></ul><ul><li>Concept orientation </li></ul><ul><li>Concept p...
Other Requirements for  Drug Terminology <ul><li>Should be maintained by a primary code-assigning authority </li></ul><ul>...
The Solution? <ul><li>RxNorm </li></ul><ul><li>Formalize/merge  “clinical drugs” in UMLS  </li></ul><ul><li>“ Semantic nor...
Robust Data Model
RxNav
Qualities of Good Terminologies <ul><li>Content coverage </li></ul><ul><li>Concept orientation </li></ul><ul><li>Concept p...
Other Requirements for  Drug Terminology <ul><li>Should be maintained by a primary code-assigning authority </li></ul><ul>...
RxNorm Issues <ul><li>Currently Pulling data from sources in building </li></ul><ul><li>Future will be feed by FDA codes a...
In Summary <ul><li>Broad recognition of the need for  a national drug terminology </li></ul><ul><li>RxNorm development act...
Good Medication Nomenclature Practices  <ul><li>Routed Generic at the atomic level for orderables </li></ul><ul><li>Accoun...
“ I Don’t Want to Make the Wrong Mistake.” Yogi Berra John Poikonen, Pharm.D.
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Med Rec And Terminology To Mcp 2008

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lecture slides to pharmacy students at Mass College of Pharmacy 2007/8. The terminology part was a bit hard to grasp and would change for the future.

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  • Transcript of "Med Rec And Terminology To Mcp 2008"

    1. 1. Definition <ul><li>a process by which a practitioner obtains and documents a complete list of a patient‘s pre-admission medications and references this list when he or she writes admission, transfer, and discharge orders </li></ul>What is Medication Reconciliation?
    2. 2. Ambulatory Inpatient Periodic Reconciliation Post-discharge Reconciliation Admission Reconciliation Discharge/Transfer Reconciliation
    3. 3. Background <ul><li>The problem of medical errors and adverse drug events </li></ul><ul><li>Medication reconciliation practices in general </li></ul><ul><li>JCAHO mandate </li></ul>Why is Medication Reconciliation Important?
    4. 4. Background: Medical errors and ADEs <ul><li>98,000 Americans die each year as a result of medical errors, and 7,000 of these deaths are attributable to medication errors 1 </li></ul><ul><li>6-12% of ADEs result in ED visits and 5% in hospital admissions 2 </li></ul><ul><li>Estimated $177.4 billion spent in 2000 on drug-related morbidity and mortality 3 </li></ul><ul><li>Kohn LT. Corrigan JM. Donaldson MS, eds. To err is human: building a safer health system. Washington, DC: National Academy Press; 1999. </li></ul><ul><li>Johnson JA, Bootman JL. Drug-related morbidity and mortality. A cost of illness model. Arch Intern Med . 1995; 155:1949-1956. </li></ul><ul><li>Ernst FR, Grizzle AJ. Drug-related morbidity and mortality: Updating the cost-of-illness model. J Am Pharm Assoc (Wash). 2001 Mar-Apr;41(2): 156-7. </li></ul>
    5. 5. Background: Medication History Errors <ul><li>61% of admission notes had one drug and 33% more than one drug missing. </li></ul><ul><li>Classes most often missed included: CV drugs, benzodiazepines, H2 blockers, oral hypoglycemics, and NSAIDs. </li></ul>4. Lau et al (2000): The Completeness of medication histories in hospital medical records of patients admitted to the general medicine wards. British Journal of Clinical Pharmacology, 2000. 49 (6). p597-603. Lau et al 4 studied 304 general medicine patients, comparing the number and type of medications recorded on admission notes with those of an outpatient pharmacy record. Discrepancies were resolved by patient interview. Findings
    6. 6. Background: Medication Reconciliation <ul><li>Prior to discharge pharmacist noted: </li></ul><ul><ul><li>37% of discharge medication lists were missing a medication that the patient had been taking prior to admission, was not recorded on the admission medication list, did not receive in the hospital, and should have been prescribed at discharge (34/91) </li></ul></ul><ul><ul><li>49% of discharge medication orders had one or more unaccounted for discrepancies from the patient’s actual home medication regimen </li></ul></ul><ul><li>Phone follow-up 3-5 days later found: </li></ul><ul><ul><li>29% of patients NOT taking a medication on their discharge list, taking a different dose or frequency, or taking an additional medication </li></ul></ul><ul><ul><li>23% of patients not adhering to their discharge medications </li></ul></ul><ul><li>30 days after discharge, preventable adverse drug events were detected in 11% of control patients and 1% of intervention patients. </li></ul>5. Draft: Schnipper et al 2004. Medication Problems During and After Hospitalization: Findings from a Pilot Study of Pharmacist Interventions Discharge Medications and ADEs: An RCT performed 2002-2003 at BWH enrolled a total of 178 patients: 92 received active pharmacist intervention on discharge and 86 received usual care (medication list written by patient’s primary team with nurse education at the time of discharge).
    7. 7. Background: National Mandate JCAHO Goal: Medication Reconciliation of 100% Patients <ul><li>Accurately and completely reconcile medications across the continuum of care </li></ul><ul><li>Develop a process for obtaining and documenting a complete list of the patient's current medications upon the patient's admission to the organization, with the involvement of the patient, including a comparison of the medications the organization provides to those on the list </li></ul><ul><li>Communicate a complete list of the patient's medications to the next provider of service when the patient is referred or transferred to another setting, service, practitioner or level of care within or outside the organization. </li></ul>
    8. 8. Multidisciplinary Process <ul><li>Roles </li></ul><ul><li>History Taking </li></ul><ul><li>Verifier </li></ul><ul><li>“ Reconciliator” </li></ul><ul><li>Discipline </li></ul><ul><li>Physician </li></ul><ul><li>Nurse </li></ul><ul><li>Pharmacist </li></ul><ul><li>Settings </li></ul><ul><li>Inpatient </li></ul><ul><li>Clinic </li></ul><ul><li>Office </li></ul><ul><li>Pharmacy </li></ul>
    9. 9. Admission/Inpatient/Discharge Medication Reconciliation Process: Information Flow Inpatient Med List Inpatient Med List ’ DischargeOrders A highly heuristic and humanistic process performed during admission Minor modifications as more info become available Medication Reconciliation at Discharge Pt dx/condition Discharge Process Admission Process EMR Notes EMR Med Lists D/C Summary or Orders Pt & Family Outpt MDs Pharmacies Pre-Admission Med List Pre-Admission Med List ’ Pre-Admission Med List ’
    10. 10. Outline <ul><li>Informatics interventions </li></ul><ul><ul><li>Pre Admission Med List </li></ul></ul><ul><ul><ul><li>Application Development </li></ul></ul></ul><ul><ul><li>Unified Medication list </li></ul></ul><ul><ul><ul><li>Ultimate Goal </li></ul></ul></ul><ul><ul><li>Data challenges </li></ul></ul>
    11. 11. Development of the PAML
    12. 16. Process of Medication Reconciliation <ul><li>1)    Obtain Emergency Department Pre-Admission Medication List (PAML) from patient/floor. </li></ul><ul><li>2)    Print the medication source list from the PAML Builder. </li></ul><ul><li>3) Verify the pre-admission medications with the patient and/or family, marking up the printed medication source list and/or ED Pre-Admission Medication List. </li></ul><ul><li>-With assistance from pharmacists and nurses, access other sources of medication information. </li></ul>Patient begins constructing PAML while waiting in the ED…
    13. 17. Process of Medication Reconciliation <ul><li>4) Enter the PAML Builder and create the PAML. Move medications from the source list into the PAML or add new medications to the PAML. </li></ul>
    14. 18. Process of Medication Reconciliation <ul><li>5) Note uncertainties in meds, non-adherence, and meds held prior to admission. </li></ul><ul><li>6) Designate the planned action on admission for each med by selecting 1 of 4 instructions from a drop-down menu. </li></ul>
    15. 19. Process of Medication Reconciliation <ul><li>7) Note the outpatient pharmacy or long-term care facility name, location, and phone number in the “PAML Comments” section. </li></ul><ul><li>8) Note reasons for discontinuing or modifying medications in the “PAML Comments” section . </li></ul>
    16. 20. Process of Medication Reconciliation <ul><li>9) Complete the PAML and mark it as ready for review within 24 hours of admission. </li></ul><ul><li>10) During the course of the admission, update the PAML based on additional input from pharmacists, nurses, patients, and families. </li></ul>
    17. 21. Process of Medication Reconciliation <ul><li>11) Reconcile the PAML and discharge medications to create a coherent discharge medication regimen, noting reasons for changing or discontinuing pre-admission medications in “PAML Comments.” Then check a box verifying that the PAML and discharge medications have been reconciled. </li></ul><ul><li>12) Copy-and-paste the PAML into the discharge summary or note the exact changes from the PAML to the discharge regimen in the discharge summary. </li></ul><ul><li>13) If a medical student or nurse in the CPE builds a patient’s PAML, review it and mark it as ready for 2 nd review. If a medical student writes a patient’s discharge orders, verify that the PAML and discharge orders have been reconciled. </li></ul>Discharge
    18. 22. What are the benefits of the PAML? <ul><li>Improves patient safety by decreasing ADEs </li></ul><ul><li>Improves communication between providers </li></ul><ul><li>Eliminates redundancy in obtaining medication history </li></ul><ul><li>Increases compliance with JACHO requirements </li></ul><ul><li>Technology will eventually allow for more efficient order entry </li></ul>
    19. 23. For the future <ul><li>Content </li></ul><ul><ul><li>Mapping of Medications </li></ul></ul><ul><li>Functions </li></ul><ul><ul><li>Ordering from the Pre Admin Med List </li></ul></ul><ul><ul><li>Integration of CDS </li></ul></ul><ul><ul><li>Criteria for pharmacist in-depth review </li></ul></ul><ul><li>System Integration </li></ul><ul><ul><li>Retrieval of Medications from additional sources </li></ul></ul>
    20. 27. Architecture Med Mapping/Classification EMR’s Hosp1 D/C Hosp2 D/C Med Reconciliation Service API Application Common Med List Other Apps Decision Support Site Rules DDI DLI For- mulary Allergies FDB Medisp NDFF RxNorm Patient Gateway Claims (RxHub, etc) Retail Pharm LTC
    21. 28. Multi-Usage Drug Terminology: Making Sense of the Tower of Medication Terminology Babble
    22. 29. <ul><li>The Need </li></ul><ul><li>The History </li></ul><ul><li>Definitions and requirements </li></ul><ul><li>Important concepts </li></ul><ul><li>A few challenges </li></ul><ul><li>The Solution? </li></ul><ul><li>Good Medication Nomenclature Practice </li></ul>Today
    23. 30. Where is Drug Terminology Needed? EHR Consumer CPOE Ambulatory EMR Retail Pharmacy Hospital Pharmacy System PBM Administering Nurse Monitoring ADEs, FDA, CDC
    24. 31. The Problem <ul><li>Limited ability to exchange drug information </li></ul><ul><ul><li>Can electronically exchange some information about packaged drug products (NDC 0006-0114-68, Lipitor 10mg tablets in bottles of 100) </li></ul></ul><ul><ul><li>Cannot share other clinically useful concepts (atorvastatin [Lipitor] 50mg PO once daily)…due to lack of a standard (coded) terminology for exchange </li></ul></ul>
    25. 32. A bit of history of Drug Databases <ul><li>The big three </li></ul><ul><ul><li>FDB </li></ul></ul><ul><ul><li>Medispan </li></ul></ul><ul><ul><li>Multum </li></ul></ul><ul><li>Others </li></ul><ul><ul><li>Micromedex </li></ul></ul><ul><ul><li>Gold Standard Multimedia </li></ul></ul><ul><ul><li>Drug Information Technologies </li></ul></ul>
    26. 33. A bit of history of Drug Databases <ul><li>Ninties to early 2000’s </li></ul><ul><ul><li>Consolidation </li></ul></ul><ul><ul><li>FDB purchases Medicom and MediSpan </li></ul></ul><ul><li>The Enron/HealthSouth Episode of Drug DBs </li></ul><ul><ul><li>FDB achieved monopoly power in the sale of integratable drug data files in the United States. The effects of the acquisition were drastic price increases to customers, and reductions in product quality and customer service. </li></ul></ul><ul><li>FTC disgorgement </li></ul><ul><ul><li>Sale of Medispan to WK </li></ul></ul>
    27. 34. Why National Drug Codes Stink <ul><li>Product Package Specific </li></ul><ul><li>No Central Authority </li></ul><ul><ul><li>Assigned by Manufacture </li></ul></ul><ul><li>Multiple Formats </li></ul><ul><li>Codes reused </li></ul><ul><li>Assigned to non drug items </li></ul><ul><li>Some but not all OTCs </li></ul>
    28. 35. The Problem <ul><li>Terminologies exist, but: </li></ul><ul><li>Most are expensive to license </li></ul><ul><li>Many are specialized for specific uses or incomplete in some areas </li></ul><ul><li>They are incompatible </li></ul>
    29. 36. The Perfect Storm for interoperability <ul><li>Increased focus on healthcare quality and safety </li></ul><ul><ul><li>Automated decision support </li></ul></ul><ul><ul><li>Adverse event monitoring </li></ul></ul><ul><ul><li>Analysis of aggregate data </li></ul></ul><ul><li>Governmental </li></ul><ul><ul><li>HIPAA </li></ul></ul><ul><ul><li>FDA/VA/NLM </li></ul></ul><ul><ul><li>Biosurveillance </li></ul></ul><ul><li>Consumerism </li></ul><ul><ul><li>Ownership and use of online medical data </li></ul></ul>
    30. 37. Interoperability <ul><li>NAHIT Definition </li></ul><ul><li>In healthcare, interoperability is the ability of different information technology systems and software applications to communicate, to exchange data accurately, effectively, and consistently. </li></ul><ul><li>Level 4: Machine interpretable data (structured messages, standardized content). Examples include the automated transfer from an external lab of coded results into a provider’s EHR. Data can be transmitted (or accessed without transmission) by HIT systems without need for further semantic interpretation or translation. </li></ul>
    31. 38. Systemic Interoperability Taxonomy* No PC/information technology Fax/Email Structured messages, non-standard content/data Structured messages, standardized content/data *CITL Report on Healthcare Information Exchange and Interoperability Secure e-mail of free text and incompatible/proprietary structured messages, HL-7 msgs Machine-organizable data 3 PC-based and manual fax, e-mail, or scanned documents Machine-transportable data 2 Mail, phone Non-electronic data 1 EDI of structured messages with controlled terminology Machine-interpretable data 4 Examples Description Level
    32. 39. 10-Year Cumulative Net Return Level 4 in billions $(200) $(100) $- 0 $100 $200 $300 $400 1 2 3 4 5 6 7 8 9 10 Years Level 1 Level 2 Level 3
    33. 40. Some Core Concepts Clinical Drug Manufactured Drug Ingredients Packaged Product <ul><li>These concepts form the core of an information model for drugs </li></ul><ul><li>Additional key concepts for which vocabulary is required: </li></ul><ul><ul><li>Therapeutic Classification </li></ul></ul><ul><ul><li>Forms </li></ul></ul><ul><ul><li>Routes </li></ul></ul><ul><ul><li>Strength </li></ul></ul>Routed Generic
    34. 41. Order = Dispense = Administer Orderable Item Dispensable Item Administrable Item ?? Sometimes, Always, or Maybe ?? Amox. 500mg Q6H Amox. Susp. 250mg/5ml 80ml Bottle Amox. Susp. 500mg (10ml) PO Q6H
    35. 42. Core Concept: (Active) Ingredients <ul><li>Active ingredients (chemicals) </li></ul><ul><ul><li>What is “in” the drug </li></ul></ul><ul><li>Example: fluoxetine </li></ul><ul><li>Systems usually identify allergies at the level of ingredients </li></ul><ul><li>Ingredients may be further specified (salts) </li></ul><ul><li>Many systems represent the ingredients in a multi-ingredient drug as a specific entity in their data model (example: FDB “HICL”) </li></ul>Ingredients
    36. 43. Core Concept: Routed Generic <ul><li>Active Ingredients </li></ul><ul><li>Route </li></ul><ul><li>Examples </li></ul><ul><ul><li>Fluoxetine PO </li></ul></ul><ul><li>Many inpatient orders utilize concept of routed generic </li></ul><ul><li>Key concept for some decision support functions (Like Allergy and Drug - Drug Interactions) </li></ul>Ingredient Routed Generic 1 many
    37. 44. Common entry point for CPOE Med: Amoxicillin Oral Med: Amoxicillin Oral
    38. 45. Core Concept: Clinical Drug (Generic) <ul><li>Active ingredients </li></ul><ul><li>Route </li></ul><ul><li>Strength (amount, units, volume, volume units) </li></ul><ul><li>Dosage form </li></ul><ul><li>Examples: </li></ul><ul><ul><li>Fluoxetine 20mg Capsule </li></ul></ul><ul><ul><li>Rofecoxib 25 mg/5ml oral suspension </li></ul></ul><ul><li>Does not include route of administration </li></ul><ul><ul><li>“ Formulation” does) </li></ul></ul><ul><li>Key concept for systems used by physicians </li></ul><ul><ul><li>Prescriptions are usually specified at level of clinical drug </li></ul></ul>Clinical Drug Ingredients Routed Generic 1 many
    39. 46. Core Concept: Manufactured Drug <ul><li>Active (and inactive) ingredients </li></ul><ul><li>Strength </li></ul><ul><li>Dosage form </li></ul><ul><li>Trademark </li></ul><ul><li>Inactive ingredients </li></ul><ul><li>Manufacturer </li></ul><ul><li>Also called a “dispensable” drug </li></ul><ul><li>Example: </li></ul><ul><ul><li>Merck Vioxx 25 mg/5mL suspension </li></ul></ul><ul><ul><ul><li>Inactives: citric acid, strawberry flavor... </li></ul></ul></ul><ul><li>Key concept in nurse’s medication administration record </li></ul>Clinical Drug Manufactured Drug Ingredients Routed Generic 1 many
    40. 47. Core Concept: Packaged Product <ul><li>All the previous, plus </li></ul><ul><li>Size </li></ul><ul><li>Units </li></ul><ul><li>Package-specific devices (applicator, syringe, etc.) </li></ul><ul><li>One or more packaged components </li></ul><ul><li>Ex: Vioxx 50mg tab, bottles of 100 (NDC 0006-0074-68) </li></ul><ul><li>Packaged drugs are what the NDC code identifies </li></ul><ul><li>Pharmacy systems are built around the concept of packaged drugs </li></ul>Clinical Drug Manufactured Drug Ingredients Packaged Product Routed Generic 1 many
    41. 48. Putting it Together Packaged Drug 0247-0372-00 Manufactured (Dispensable) Drug Fluoxetine HCl oral 20 mg capsules Dista Labs Formulation Fluoxetine HCl oral 20 mg capsules Routed Generic Fluoxetine HCl oral Ingredient Fluoxetine HCl Brand Name PROZAC Label Name Fluoxetine HCl 20 mg cap Manufacturer Dista Labs Dose Form Capsule Strength 20 mg Route oral Clinical Drug Fluoxetine HCl 20 mg capsules
    42. 49. Orderable Dispensable Administrable Monitorable
    43. 50. Orderable versus Dispensable <ul><li>Orderable </li></ul><ul><ul><li>Amount -centric </li></ul></ul><ul><ul><li>Partially specified </li></ul></ul><ul><ul><li>Routed Generic is core KB element </li></ul></ul><ul><ul><li>Example: Dopamine IV at 3-5 mcg/kg/min </li></ul></ul><ul><li>Dispensable </li></ul><ul><ul><li>Compounded and Strength/Form -centric </li></ul></ul><ul><ul><li>Fully specified </li></ul></ul><ul><ul><li>Clinical drug core KB element </li></ul></ul><ul><ul><li>Multiple ingredient relationship </li></ul></ul><ul><ul><li>Example: Dopamine IV 400mg in Dextrose 5% in Water 500ml </li></ul></ul>
    44. 51. Dispensable versus Administrable <ul><li>Dispensable </li></ul><ul><ul><li>Compounded and Strength/Form -centric </li></ul></ul><ul><ul><li>Fully specified </li></ul></ul><ul><ul><li>Clinical drug core KB element </li></ul></ul><ul><ul><li>Multiple ingredient relationship </li></ul></ul><ul><ul><li>Example: Dopamine IV 400mg in Dextrose 5% in Water 500ml </li></ul></ul><ul><li>Administrable </li></ul><ul><ul><li>Strength/Form Concentration -centric </li></ul></ul><ul><ul><li>Fully specified </li></ul></ul><ul><ul><li>Clinical drug or compounded item or brand core KB element </li></ul></ul><ul><ul><li>Example: Dopamine IV 0.8mg per ml 500ml bag </li></ul></ul><ul><ul><li>BPOC may need brand for NDC matching </li></ul></ul>
    45. 52. Administrable versus Monitorable <ul><li>Administrable </li></ul><ul><ul><li>Strength/Form Concentration -centric </li></ul></ul><ul><ul><li>Fully specified </li></ul></ul><ul><ul><li>Clinical drug or compounded item or brand core KB element </li></ul></ul><ul><ul><li>Example: Dopamine IV 0.8mg per ml 500ml bag </li></ul></ul><ul><li>Monitorable </li></ul><ul><ul><li>Dose Temporal - centric </li></ul></ul><ul><ul><li>Fully specified </li></ul></ul><ul><ul><li>Clinical drug core and dose KB element </li></ul></ul><ul><ul><li>Example: Dopamine IV 3mcg per kg over 16 hours = clinical indicator </li></ul></ul>
    46. 53. The Scope <ul><li>We are overwhelmed as it is, with an infinite abundance of vaunted medicaments, and here they add a new one. </li></ul><ul><li>Thomas Sydenham, MD </li></ul><ul><li>1624 </li></ul>
    47. 54. The Scope <ul><li>Chemical Entities </li></ul><ul><ul><li>~2,000 </li></ul></ul><ul><li>Clinical Drugs – Drug(s), Strength, Route, Form </li></ul><ul><ul><li>~25,000 </li></ul></ul><ul><li>NDC </li></ul><ul><ul><li>~200,000 </li></ul></ul>
    48. 55. Terminology Challenges <ul><li>Information model </li></ul><ul><ul><li>Conflicting views on key concepts </li></ul></ul><ul><ul><li>Knowing where terminology stops and Info model starts, from orderable to monitorable </li></ul></ul><ul><li>Supporting vocabularies </li></ul><ul><ul><li>Routes </li></ul></ul><ul><ul><ul><li>Method versus site (injection versus epidural) </li></ul></ul></ul><ul><ul><ul><li>Granularity (iv versus cont. iv infusion) </li></ul></ul></ul><ul><ul><li>Dose forms </li></ul></ul><ul><ul><ul><li>Physical form or form plus site of admin? </li></ul></ul></ul><ul><ul><ul><ul><li>Tablet versus oral tablet </li></ul></ul></ul></ul><ul><ul><ul><li>Dispense form versus delivery form </li></ul></ul></ul><ul><ul><ul><ul><li>Inhaler versus spray </li></ul></ul></ul></ul><ul><ul><ul><li>Granularity </li></ul></ul></ul><ul><ul><ul><ul><li>Sustained release tab </li></ul></ul></ul></ul>
    49. 56. Operational Challenges <ul><li>Frequent updates </li></ul><ul><li>Data and database formats, customization </li></ul><ul><li>Legacy system support, backward compatibility </li></ul><ul><li>Multi-platform delivery </li></ul><ul><li>Customer support </li></ul>
    50. 57. Qualities of Good Terminologies <ul><li>Content coverage </li></ul><ul><li>Concept orientation </li></ul><ul><li>Concept permanence </li></ul><ul><li>Non-semantic (meaningless) concept identifiers </li></ul><ul><li>Polyhierarchy </li></ul><ul><li>Formal definitions </li></ul><ul><li>Multiple granularities </li></ul><ul><li>Multiple consistent views </li></ul><ul><li>Context representation </li></ul><ul><li>Graceful evolution </li></ul><ul><li>Recognized redundancy </li></ul><ul><li>These requirements are now broadly accepted, but not always present in existing terminologies </li></ul>Desiderata for Controlled Medical Vocabularies in the Twenty-first Century. Cimino JJ, Methods Inf Med 1998 Nov;37(4-5):394-403
    51. 58. Other Requirements for Drug Terminology <ul><li>Should be maintained by a primary code-assigning authority </li></ul><ul><li>Should be available for use at little or no cost </li></ul><ul><li>Content must be updated and made available quickly as drugs enter the market </li></ul><ul><li>Should be &quot;backwards compatible&quot; with the NDC system </li></ul><ul><li>Designed for compatibility with evolving international standards </li></ul><ul><li>Should adhere to an accepted, common information model </li></ul><ul><ul><li>Concepts and relationships organized in formal classes for query and presentation </li></ul></ul><ul><li>Must support abstraction at multiple levels of detail (granularity) </li></ul><ul><ul><li>Multiple user views and settings </li></ul></ul><ul><li>Will define how statements are composed and recorded </li></ul><ul><ul><li>Build from “atomic” concepts </li></ul></ul><ul><li>Should support synonyms and lexical variants </li></ul>
    52. 59. The Solution? <ul><li>RxNorm </li></ul><ul><li>Formalize/merge “clinical drugs” in UMLS </li></ul><ul><li>“ Semantic normal” form </li></ul><ul><li>Detail all semantic relationships </li></ul><ul><li>Utilizing HL7 vocabulary for dose forms, strength </li></ul><ul><li>Links to FDB, Micromedex, MediSpan, and Multum and VA National Drug File </li></ul>
    53. 60. Robust Data Model
    54. 61. RxNav
    55. 62. Qualities of Good Terminologies <ul><li>Content coverage </li></ul><ul><li>Concept orientation </li></ul><ul><li>Concept permanence </li></ul><ul><li>Non-semantic (meaningless) concept identifiers </li></ul><ul><li>Polyhierarchy </li></ul><ul><li>Formal definitions </li></ul><ul><li>Multiple granularities </li></ul><ul><li>Multiple consistent views </li></ul><ul><li>Context representation </li></ul><ul><li>Graceful evolution </li></ul><ul><li>Recognized redundancy </li></ul><ul><li>These requirements are now broadly accepted, but not always present in existing terminologies </li></ul>Desiderata for Controlled Medical Vocabularies in the Twenty-first Century. Cimino JJ, Methods Inf Med 1998 Nov;37(4-5):394-403
    56. 63. Other Requirements for Drug Terminology <ul><li>Should be maintained by a primary code-assigning authority </li></ul><ul><li>Should be available for use at little or no cost </li></ul><ul><li>Content must be updated and made available quickly as drugs enter the market </li></ul><ul><li>Should be &quot;backwards compatible&quot; with the NDC system </li></ul><ul><li>Designed for compatibility with evolving international standards </li></ul><ul><li>Should adhere to an accepted, common information model </li></ul><ul><ul><li>Concepts and relationships organized in formal classes for query and presentation </li></ul></ul><ul><li>Must support abstraction at multiple levels of detail (granularity) </li></ul><ul><ul><li>Multiple user views and settings </li></ul></ul><ul><li>Will define how statements are composed and recorded </li></ul><ul><ul><li>Build from “atomic” concepts </li></ul></ul><ul><li>Should support synonyms and lexical variants </li></ul>
    57. 64. RxNorm Issues <ul><li>Currently Pulling data from sources in building </li></ul><ul><li>Future will be feed by FDA codes and labeling information and will be pushing to industry </li></ul>
    58. 65. In Summary <ul><li>Broad recognition of the need for a national drug terminology </li></ul><ul><li>RxNorm development activity towards national drug terminology, particularly at the clinical drug level </li></ul><ul><li>Will require significant continued cooperation between government agencies </li></ul><ul><li>Still much unknown, and no clear timetables </li></ul>
    59. 66. Good Medication Nomenclature Practices <ul><li>Routed Generic at the atomic level for orderables </li></ul><ul><li>Account for Orderable transformation across the medication use process </li></ul><ul><li>Insist on RxNorm adoption </li></ul><ul><ul><li>the good must not get in the way of the perfect </li></ul></ul><ul><li>Generic data structures even in the face of a proprietary environment </li></ul><ul><ul><li>Plan for interoperability now! </li></ul></ul>
    60. 67. “ I Don’t Want to Make the Wrong Mistake.” Yogi Berra John Poikonen, Pharm.D.

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