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Workbook
Table of Contents
Introduction ................................................................................................................ 3 Initiate a Drug Utilization Review (DUR)..................................................................... 5 Understand the DUR Engine ...................................................................................... 5 Understand DUR Event Types ................................................................................... 6 Classify Prescription Checks ...................................................................................... 7 Identify DUR Checks .................................................................................................. 9 Modules: Drug-to-Drug ............................................................................................. 12 Modules: Drug Conditions ........................................................................................ 20 Modules: Drug-to-Allergy.......................................................................................... 22 Modules: Duplicate Therapy ..................................................................................... 23 Modules: Minimum/Maximum Daily Dosing .............................................................. 24 Modules: Pediatric Precautions ................................................................................ 27 Modules: Pregnancy Precautions ............................................................................. 29 Modules: Lactation Precautions ............................................................................... 32 Modules: Geriatric Precautions ................................................................................ 34 Third Party DUR ....................................................................................................... 36 Summary .................................................................................................................. 37 Next Steps ................................................................................................................ 37 Payroll ...................................................................................................................... 37 Appendix #1: Knowledge Check Answer Key ......................................................... 38 Appendix #2: Module Groups Answer Key ............................................................... 41
Introduction
When a prescription is processed through the pharmacy system, the system automatically checks for eleven different types of possible Drug Utilization Review (DUR) occurrences. As a Pharmacist, you are responsible for addressing all DUR occurrences. Upon completion of this course, you should be able to: Identify the DUR Engines role in the process of managing DUR Identify each of the 11 occurrences for which the DUR Engine checks
You will learn the steps to complete final verification, including DUR verification in the Introduction to Quality Assurance Workstation web-based training. This training guide is provided in a self-paced format. Answers to each knowledge check are in the appendix at the end of this workbook. It will take you approximately 1/2 hour to complete this workbook.
It is important for you to read each section and complete all of the activities and knowledge checks. Successful completion of this training will provide you with knowledge that you need to understand your role during final verification.
Knowledge Check
Circle the correct answer for each question below. 1. DUR Checks are performed on those prescriptions in a patients profile that have been completed or are pending final verification. a. True b. False 2. Those prescriptions that result in a(n) ______ DUR Event require a DUR Intervention Code. a. Automatic DUR/Informational b. Critical DUR/Hard Stop c. Informational/Soft Stop d. Therapeutic DUR/Soft Stop
Drug modules: The drug modules check drug interactions with the patient based on their current prescriptions, known diseases, and known allergies. These modules also assure that there are no redundancies with current prescriptions.
Dosing modules: The three dosing modules check dosing levels for different age groups. The policy statement is identical for all three modules, and the modules themselves are similar. However, it is important to note that each dosing module deals with different groups of patients.
Warning modules: The four warning modules check for precautions. Youll see that precaution modules are similar in the way they work, but the policy statements are different for each.
Drug Modules
Warning Modules
Dosing Modules
2. Drug Conditions
3. Drug-toAllergy
4. Duplicate Therapy
5. Adult Dosing
7. Geriatric Dosing
8. Pregnancy Precaution
This check is performed for all females aged between 15 and 45. Pediatric patients can be very sensitive to drug therapy, especially within a specific age range. With the Pediatric Precaution, Pharmacists have access to valuable information for minimizing adverse effects of drugs on patients aged 18 years or younger. The Geriatric Precaution provides warning messages for medications that should be used with caution for patients aged 60 years and older.
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Conflict Codes of NE and NA are indicators that DUR was not performed or data is unavailable.
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Modules: Drug-to-Drug
Policy Statement Pharmacies have a professional responsibility to perform prospective DUR in accordance with the states Omnibus Budget Reconciliation Act (OBRA) regulations. Among other important clinical responsibilities, this action includes the patient profile review for a drug-to-drug interaction. If Pharmacists discover a drugto-drug interaction through their professional knowledge or RxConnect system, the situation must be reviewed and resolved. The check applies to all the interactions regardless of their severity level. Definition A drug-to-drug interaction is defined as a pharmacological response, which is different from the expected result obtained when each drug is given separately. This definition includes synergistic and antagonistic effects. However, it excludes additive effects, such as a side effect. The FDBs Drug-to-Drug Interaction Module (DDIM) is a clinically reviewed tool that assists in identifying and preventing most clinically significant drug-to-drug interactions for all prescriptions filled at any CVS store. The database covers every product that is approved for marketing in the United States. It also covers many commonly used herbal and nutritional products available at CVS. How the Module Works Every fill dispensed is checked against every DUR eligible prescription in a patients central profile. If the drug dispensed is a compound, the DUR Engine will check drug interaction codes for each ingredient to ensure that the drugs that make up the compound do not have a DUR interaction with each other. If there are no DUR interactions within the compound, then interaction codes for all ingredients that make up the compound will be checked to every other DUR eligible prescription on that patients central profile. The Conflict Code for all Drug-to-Drug errors is DD.
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*Documentation of the Prescriber authorization must be made in the DUR Comments field
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From the abbreviated drug-to-drug monograph, you can elect to view the full details of the Drug-to-Drug Monograph. Full Drug-to-Drug Monograph The Drug-to-Drug Monographs describe the drug interaction in detail and provide the following information: Description of the two drugs that are causing the interaction The monograph title The clinical severity of the interaction The mechanism of the action Clinical effects of the interaction Predisposing factors that may make the interaction more severe in certain patients Patient management recommendations A discussion section References to the primary literatures. Reference citations are formatted as in the National Library of Medicines MedLine
Reference Classifiers - (see Reference Section of DDI Monograph) The severity level is used to classify drug interactions and is considered clinically significant. To assist clinicians in evaluating the quantity and type of documentation for the interaction, FDB provides reference indicators at the monograph level identifying the types of references utilized in a monograph.
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Note: The first three represent the most reliable documentation sources.
Reference indicators are provided to assist the clinician with evaluating the available documentation for a Drug-to-Drug interaction.
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Severity Level: 1 Agents Linked Grepafloxacin, disopyramide, moricizine, procainamide, quinidine, amiodarone, bretylium, sotalol MONOGRAPH TITLE: Grepafloxacin; Sparfloxacin/Ia&III Antiarrhythmics SEVERITY LEVEL: 1 CONTRAINDICATED DRUG COMBINATION
This drug combination is clearly contraindicated in all cases and should not be dispensed or administered to the same patient.
MECHANISM OF ACTION: Unknown. Possible additive or synergistic effects of the QTc interval. CLINICAL EFFECTS: Increase QTc intervals, which may result in life threatening arrhythmias such as torsades
de pointes.
PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Concurrent administration of sparfloxacin with Class Ia (disopyramide, moricizine, progainamide, quinidine) or Class III (amiodarone, bretylium, sotlol) antiarrhythmic agents is contraindicated by the manufacturer of sparfloxacin. (1) Concurrent administration of these agents with grepafloxacin is also contraindicated by the manufacturer of grepafloxacin unless appropriate cardiac monitoring can be assured. (2) DISCUSSION: There is no published documentation to support this potential interaction. The product information
for grepafloxacin states that because prolongation of the QTc interval has been observed in healthy subjects receiving grepafloxacin, concurrent administration of grepafloxacin with medications known to prolong the QTc interval is contraindicated unless appropriate cardiac monitoring can be assured. (2) The product information for sparfloxacin states that torsades de pointes have been reported in patient receiving sparfloxacin and disopyramide and amiodarone. (1)
REFERENCES:
1) Manufacturers Prod Information: sparfloxacin (Rhon-Pouk-Rorer), Nov 1996. (1) 2) Manufacturers Prod Information: grepafloxacin (Glaxo Wellcome), Nov 11117. (1) Reference Classifier of (1) indicates reference is manufacturers information.
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Knowledge Check
Circle the correct answer for each question below. 3. The FDBs Drug-to-Drug Interaction Module (DDIM) database covers every product that is approved for marketing in the United States as well as many commonly used herbal and nutritional products available at CVS. c. True d. False 4. If a compound is being dispensed, the DUR Engine will check drug interaction codes for: a. The first ingredient entered as part of the compound b. The ingredient that makes up the majority of the compound c. Each ingredient that makes up the compound d. None of the drugs included in the compound as the system cannot check multiple drug ingredients
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Knowledge Check
Circle the correct answer for each question below. 5. The Drug Conditions Contraindications will only check for potential conflicts between drugs (prescription; non-prescription; herbals; nutritional preparations) and disease states that are present in the patients record with an appropriate ICD-9-CM diagnosis code. a. True b. False
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Modules: Drug-to-Allergy
Policy Statement Upon confirmation of patient allergy, Pharmacists must exercise professional judgment, review the patient profile, discuss with the patient, and contact the Prescriber, if warranted. Definition The Drug-to-Allergy check identifies and creates warnings associate with the use of certain drugs in patients with a history of hypersensitivity to a particular drug or drug class. How the Modules Works The active ingredients in the fill or refill to be dispensed are checked against all allergy codes listed in the patients profile. If the drug is a compound, then each ingredient will be checked against all allergy codes listed in the patient profile. Warnings Defined The module provides Drug to Allergy checks based on the allergies listed in the patients profile to the active ingredients in the drug dispensed. Excipient Ingredient Allergies are not screened at this time. Note: A patients profile may include excipient ingredient allergens (indicated by Do Not Use or Not Screened). These allergens will always cause a hard stop, prompting you to perform Manual DUR on these ingredients. You should check the products package insert before dispensing. The Conflict Code for Drug-Allergy errors is DA and Excipient Ingredient (manual DUR necessary) is EI.
Knowledge Check
Circle the correct answer for each question below. 6. The ______ ingredients in the fill or refill to be dispensed are checked against all allergy codes listed in the patients profile. a. inactive b. active c. complete d. high risk
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Knowledge Check
Circle the correct answer for each question below. 7. To ensure that all of a patients prescriptions are included in the DUR checks through the discard date printed on the vial, Duplicate Therapy checks will be based on the system date of the fill and the Days Supply plus __ days. a. 5 b. 15 c. 21 d. 30
Note: This module is intended as an aid to assist the Pharmacist in dosage review. Since not all products are included in dosage checking, it is imperative that the Pharmacist uses professional judgment in all cases.
Definition The Minimum/Maximum Daily Dose check provides age-appropriate quick check information regarding the minimum and maximum recommended daily doses for approved indications of the most frequently used drugs. The data is especially valuable in claims adjudication. The data presents dosage form level dosing (in terms of each, gram, milliliter, inhalations, etc.) for adult, geriatric, and pediatric age levels. Min/Max dosing information provides the range within which a drug is safely and effectively prescribed. Dosing is age-range and weight specific, when applicable.
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Based on the total daily dosage, only the fill or refill being dispensed is checked. In the event dosing is not available or not recommended for a specific age (e.g., pediatrics or geriatrics) or it has not been clinically established, a hard stop message will be provided to perform manual DUR. Warnings Defined The dosing check provides information on the most frequently prescribed drugs that have clinically significant dosing schedules. The selection criteria exclude otics, opthalmics, dentals and externals in which the dosing is variable. The vast majority of chemotherapy drugs are dosed in mg/kg or mg/ml type of units. Those units are not available in adult and geriatric Min/Max checking. Products intended for nebulization like albuterol are included in the data. However, it is not uncommon to administer other injectable drugs by nebulization. IPPB drugs, (drugs administered using a nebulizer that is in the IPPB line) would not have the range included in their data because the dosing ranges coded for the drug are dependent upon the route lined to the product. In this module, all data is clinically significant. The selection criteria eliminate those drugs with dose levels that are not easily defined. Drug metabolism Normal renal and hepatic functions are assumed. Approved indications All Food and Drug Administration (FDA)-approved indications are evaluated, but the data is not specific to the disease state. The minimum value represents the lowest accepted dose for the approved indications.
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Knowledge Check
Circle the correct answer for each question below. 8. Min/Max dosing information provides the range within which a drug is safely and effectively prescribed. Dosing is age-range and weight specific, when applicable but is not available for___________. a. Geriatric patients aged 75 and older b. Adult patients aged 15 to 110 c. Pediatric patients aged 31 days to 14 years d. Infant patients younger than 31 days of age
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Knowledge Check
Circle the correct answer for each question below. 9. In instances that a Pediatric Precaution exists, those that are assigned a Severity Level __ require a Pharmacist to obtain physician authorization and document the Prescriber response in the DUR Comments field of RxConnect. a. 1 b. 2 c. 3 d. any Severity Level
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Definition The Pregnancy Precautions check detects a drug therapy that may not be appropriate for pregnant women. This information provides a comprehensive method for screening any drug for known precautions for pregnancy. The Pregnancy Precautions check is performed for all females aged between 15 and 45 years. Examples include, but are not limited to, drugs that should not be used in pregnant patients because they can cross the placenta to affect the growing fetus. How the Module Works Only the fill or refill being dispensed is checked. All females aged 15 45 will be included in the check. Warnings are presented based on the use of the pregnancy condition code V22.0 in the patients profile. For example, if the patient is known to be pregnant and the drug in contraindicated, the fill process is stopped. However, if it is unknown if the patient is pregnant, the contraindication is presented as a soft stop and you must select D to view the DUR before completing the fill process. If the drug is a compound, then each ingredient is checked for pregnancy precautions. Warnings Defined The Pregnancy Precautions check provides information about contraindications, potential risks, and precautions. When the use of a specific drug in pregnancy shows documented problems in humans or animals, a severity level is assigned to the drug. In most cases, this information is expressed as an FDA-assigned Pregnancy Category. Severity Level A Definitions Adequate and well-controlled studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy and there is no evidence of risk in later trimesters. CVS Policy Pharmacists must exercise professional judgment. Severity Level B Definitions Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies for humans. CVS Policy Pharmacists must exercise professional judgment.
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Knowledge Check
Circle the correct answer for each question below. 10. The Pregnancy Precautions check is performed for all females aged between 15 and 45 years. a. True b. False
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Definition The Lactation Precautions provide warnings about the use of drugs in nursing mothers. These warnings allow you to make informed decisions about altering a patients drug therapy when potential problems exist and considers all female patients between the age of 15 and 45. This information answers the following questions. Is this a drug excreted in breast milk? What are the possible effects to the infant? Is this a severe effect? This information includes a narrative description of the particular precaution. In other words, it encompasses everything you need as a healthcare professional. How the Module Works Only the fill being dispensed (includes refills) is checked. All females ages 15 45 will be included in the check. Warnings are presented based on the use of the lactation condition code V24.1 in the patients profile. For example, if the patient is known to be lactating and the drug is contraindicated, the fill process is stopped. However, if it is unknown if the patient is lactating, the contraindication is presented as a soft stop and you must select D to view the DUR before completing the fill process. If the drug is a compound, each ingredient will be checked for Lactation Precautions. Warnings Defined The Lactation Precaution module supplies four basic pieces of information about drug use in a nursing mother. 1. Reports whether a contraindication, a precaution, or no risk has been documented in available studies 2. Establishes whether it is known if the drug is excreted in the mothers milk 3. Provides data on whether or not the excreted drug affects the infant 4. Provides the definitions of these precautions:
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Severity Level 3 Definitions No known risk. This drug has no known risks to nursing infants and does not adversely affect lactation. CVS Policy If the Excretions Effects and the Lactation Effects codes are present with severity level 3, the Pharmacist must use professional judgment and may need to consult with the physician before dispensing. Excretion Effects Language indicates the drug is excreted in the mothers milk. Lactation Effects Language indicates that there is a definite effect on the infant. Documentation of the Prescriber authorization must be made in the DUR Comments field. The Conflict Codes for Lactation Precautions are: Reported Pregnant NR Unknown if Pregnant NL
Tip: Conflict Code of NL indicates the check was performed but the patient was considered not lactating at the time because V24.1 was not on their file. You should always see this as a soft stop informational error.
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Knowledge Check
Circle the correct answer for each question below. 11. Lactation Warnings will only result in a soft stop or informational DUR unless___________. a. The patient is between the ages of 15 and 45 b. The drug being dispensed is a Compound c. The lactation condition code V24.1 is present in the patients profile d. The Pharmacist enters a DUR comment to force the hard stop
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Knowledge Check
Circle the correct answer for each question below. 12. Geriatric Precautions that result in either a Severity Level 1 or Level 2 require that a Pharmacist must obtain Prescriber authorization and document the authorization in the DUR Comments field. a. True b. False
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The Conflict Code for all Third Party errors is TP and all Third Party errors are considered informational.
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Summary
The RxConnect system automatically checks for eleven different types of possible DUR occurrences. In this topic, you learned to: Identify the DUR Engines role in the process of managing DUR Identify each of the 11 occurrences for which the DUR Engine checks
Course Completion
Congratulations! You have completed the Understanding DUR Management workbook. If you have any additional questions regarding what you have learned in this course, contact your Pharmacy Supervisor or Trainer to discuss.
Next Steps
In order to receive credit for the completion of this workbook, you need to complete an on-line assessment to test your understanding of what you have learned. This assessment is available from the Understanding DUR Management course description page on LEARNet. Please contact your Trainer with any questions/concerns.
Payroll
In order to be paid properly for completing this workbook and assessment, your time for completing this training should be submitted on your Weekly Pharmacist Payroll Sheet as part of regular operating hours. *Include time spent reading the workbook and completing the on-line assessment.
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6. The ______ ingredients in the fill or refill to be dispensed are checked against all allergy codes listed in the patients profile. a. inactive b. active c. complete d. high risk 7. To ensure that all of a patients prescriptions are included in the DUR checks through the discard date printed on the vial, Duplicate Therapy checks will be based on the system date of the fill and the Days Supply plus __ days. a. 5 b. 15 c. 21 d. 30 8. Min/Max dosing information provides the range within which a drug is safely and effectively prescribed. Dosing is age-range and weight specific, when applicable but is not available for___________. a. Geriatric patients aged 75 and older b. Adult patients aged 15 to 110 c. Pediatric patients aged 31 days to 14 years d. Infant patients younger than 31 days of age 9. In instances that a Pediatric Precaution exists, those that are assigned a Severity Level __ require a Pharmacist to obtain physician authorization and document the Prescriber response in the DUR Comments field of RxConnect. a. 1 b. 2 c. 3 d. any Severity Level 10. The Pregnancy Precautions check is performed for all females aged between 15 and 45 years. a. True b. False
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11. Lactation Warnings will only result in a soft stop or informational DUR unless___________. a. The patient is between the ages of 15 and 45 b. The drug being dispensed is a Compound c. The lactation condition code V24.1 is present in the patients profile d. The Pharmacist enters a DUR comment to force the hard stop 12. Geriatric Precautions that result in either a Severity Level 1 or Level 2 require that a Pharmacist must obtain Prescriber authorization and document the authorization in the DUR Comments field. a. True b. False
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Drug Modules
Warning Modules
Dosing Modules
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