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Understanding DUR Management
Workbook
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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
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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: ƒ
Identify the DUR Engine’s role in the process of managing DUR
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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.
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Pharmacy Basics: Workbook The following icons are used throughout the workbook:
This icon indicates a knowledge check.
This icon identifies an activity.
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.
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Initiate a Drug Utilization Review (DUR) After all necessary information is entered for a prescription, including the Credentials of the team member completing data entry, the RxConnect system assigns a number to the prescription. This prescription is then sent to the DUR Engine for a centralized DUR review.
Understand the DUR Engine The DUR Engine is a computer that performs centralized DUR on all prescriptions. It performs a comprehensive DUR against the patient’s profile. During the review, the DUR Engine performs checks for all completed and pending prescriptions at any CVS pharmacy. A prescription is considered pending as soon as data entry is complete and the prescription returns to the queue. In all, the DUR Engine checks for 11 different types of possible occurrences.
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Understand DUR Event Types When the DUR Engine discovers an exception, it reports a DUR event. Each DUR event can include one or more DUR occurrences. The two types of DUR events are: •
Critical DUR Events/Hard Stops – These events require DUR Intervention Codes and are displayed on the Verification screen for resolution by a Pharmacist. RxConnect requires one of three DUR Intervention Codes to be selected to resolve hard stop DUR: 1. Prescriber Consulted 2. Medication Review 3. Patient Consulted In those instances that Critical DUR Events are displayed over multiple pages, you must review each page of hard stops before you are given the option to enter an intervention code.
•
Informational DUR Events/Soft Stops – These events do not require DUR Intervention Codes and are displayed on the Verification screen by selecting “D” for review by a Pharmacist.
Knowledge Check Circle the correct answer for each question below. 1. DUR Checks are performed on those prescriptions in a patient’s 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
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Classify Prescription Checks The DUR Engine performs up to 11 checks on any prescription to assure safe usage by the patient. The 11 checks can be broken down into 3 module groups. The modules are classified as follows:
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. You’ll see that precaution modules are similar in the way they work, but the policy statements are different for each.
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Activity #1: Module Groups Now that you have learned about the different module groups that the 11 DUR checks can be grouped by, you will have a chance to apply your knowledge. Below are 3 definitions. Draw a line to match the definition with the appropriate Module name. Definition
Module Name
These three 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 of these modules deal with different groups of patients.
Drug Modules
These 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.
Warning Modules
These four modules check for precautions. You’ll see that these modules are similar in the way they work, but the policy statements are different for each.
Dosing Modules
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Identify DUR Checks The 11 checks that the DUR Engine performs to ensure the safety of the patients are: DUR Check 1. Drug-to-Drug
2. Drug Conditions
3. Drug-toAllergy
4. Duplicate Therapy
Description A drug-to-drug interaction is a pharmacological response that is different from the expected result when each drug is given separately. A Drug-to-Drug interaction check is based on the active ingredients of the drugs involved. The Drug Conditions contraindications refer to conditions that may be negatively affected by particular drug therapy or that may adversely affect specific drug actions. This check is based on the ICD-9-CM diagnosis codes in the patient’s profile. You need to ensure effective Drug Conditions checking by manually entering the ICD-9-CM codes because RxConnect does not infer the codes from the prescription information. You should ask the patient about conditions we should know about and update the patient’s profile to reflect this information. The Drug-to-Allergy check identifies and reports warnings associated with the use of certain drugs for patients with a history of hypersensitivity towards that particular drug or drug class. This check compares the National Drug Code (NDC) of the dispensed drug to the allergy codes in the patient’s profile. It is important to ask the patients about their drug allergies. You should enter this information in the patient’s profile to ensure that allergy check is performed. Recall that you also need to document if the patient has confirmed that they have No Known Allergies or not. Duplicate Therapy provides checking that is based on tailored therapeutic drug groupings. This includes detection of drugs that are frequently prescribed for multiple therapeutic uses, yet act by similar mechanisms or belong to the same or similar pharmacologic class(es). The Adult Daily Dose check provides quick check information regarding the minimum and maximum recommended daily doses for approved indications of the most frequently used drugs.
5. Adult Dosing This check is performed for all adults between the ages of 15 and 60. It assumes the patient weighs 70 kilograms (approx. 154 pounds). Note that dose is also based on NDC, Days Supply and total daily dosage. 9
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Identify DUR Checks, continued DUR Check 6. Pediatric Dosing
7. Geriatric Dosing
8. Pregnancy Precaution
Description The Pediatric Dosing check provides quick check information regarding the minimum and maximum recommended daily doses for patients 31 days to 14 years old. It does not handle checks for patients less than 31 days old. The Geriatric Daily Dosing check provides quick check information regarding the minimum and maximum recommended daily dose for geriatric patients. This check is performed for all patients 60 years and older. The Pregnancy Precaution information detects drugs that may not be appropriate for pregnant women. The information provides a comprehensive method for screening any drug for known precautions for pregnancy. This check is performed for all females aged between 15 and 45. The Lactation Precaution check provides warnings about the use of drugs in nursing mothers. This information answers the questions such as:
9. Lactation Precaution
10. Pediatric Precaution
11. Geriatric Precaution
• • •
Is the drug excreted in breast milk? What are the possible infant side effects? Is this a severe defect?
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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Identify DUR Checks, continued Manual DUR Messaging: There will be times when the DUR Engine is up and running, but you will see a “Perform Manual DUR” message. This will occur when: • • •
There is an active prescription on a patient’s file but the drug is no longer ed by FDB The drug dispensed is not an FDB ed drug (e.g., it was added by a pharmacy team member or by the central – also commonly referred to as a “Temporary” drug) Dosing information is either not available for the patient’s age or the dispensed item is not a medical device
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 state’s 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 FDB’s 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 patient’s 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 patient’s central profile. The Conflict Code for all Drug-to-Drug errors is “DD”.
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Modules: Drug-to-Drug, continued Warnings Defined – The Drug-to-Drug interaction check identifies potential drug problems without hindering data entry. Only clinically relevant information is maintained by FDB. Documentation level and clinical severity are some of the criteria considered when determining the suitability of including a drug interaction in DDIM. Frequency of occurrence is discussed in the monographs, but is not part of the criteria for addition to the module. •
•
•
Onset – The onset of a drug-to-drug interaction is extremely patient-specific. If a patient is on the verge of toxicity with a drug, adding another drug that impairs toxic elimination can produce toxicity very quickly. This kind of interaction may cause toxicity within a few hours. For another patient, the duration may extend to a week. Predisposing factors – Certain patients may be predisposed to the effects of an interaction due to their medical conditions. For example, the interaction between aminoglycosides and cephalosporins usually affects patients with pre-existing renal disease. Risk versus benefits – In some situations, the benefit of giving two interacting drugs together may outweigh the potential risk. Treating all patients in the same manner is inappropriate.
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Modules: Drug-to-Drug, continued Severity Level Definitions – Each drug interaction is linked to a severity level that indicates the interaction severity. The severity level is used to classify drug interactions and is considered clinically significant. The three severity levels are: 1. Severity Level 1 Definition – Contraindicated Drug Combinations. FDB’s research indicates that the drug combination is clearly contraindicated in all cases and should not be dispensed or istered to the same patient. A manufacturer’s label indicating the contraindication is sufficient to warrant including a drug combination in this category. CVS Policy – Severity Level 1 messages require Physician authorization and documentation* with the exception of DDIs which cause a decrease in the effectiveness of oral contraceptives. (These DDIs require documentation of patient counseling.) Suggested actions to address Level 1 interactions may include: 1. 2. 3. 4.
Discontinuation of one or both agents Dosage adjustments Altercation of a conflicting istration schedule Additional patient monitoring
*Documentation of the Prescriber authorization must be made in the DUR Comments field
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Modules: Drug-to-Drug, continued 2. Severity Level 2 Definition – Severe Interaction. FDB’s research indicates action is required to reduce risk of severe adverse interaction. Includes drug combinations that can produce serious consequences in most patients, but can be monitored and/or the agents titrated, significantly minimizing the risk of adverse effects. The combination may be absolutely contraindicated for some but not all patients. Those patients in whom the combination is contraindicated are identifiable. The information to identify such patients is contained in the corresponding DDIM detailed monograph. The action required can include discontinuing one or both agents, adjusting dosage, altering the istration schedule, and/or additional patient monitoring. CVS Policy – Severity level 2 messages require the Pharmacist to exercise professional judgment (has dose adjustment been made?), review the profile, consult with the patient (has doctor addressed known DDI in advance?), and the Prescriber if warranted (appears DDI has not been addressed). 3. Severity Level 3 Definition - Moderate interaction. FDB’s research indicates that action is necessary to assess the risk to the patient and take action as needed. The action required may include discontinuing one or both agents, adjusting dosage, altering istration schedules, and/or additional patient monitoring. CVS Policy – Severity level 3 messages require the Pharmacist to exercise professional judgment, review the profile, and assess the risk to the patient. 4. Severity Level 9 Definition unknown: Drug combination interaction potential is unknown. This involves alternative products, like herbals, so documentation is not as thorough as with prescription medications. Level 9 indicates that an interaction is possible, but does not indicate the potential severity of the interaction. CVS Policy - The Pharmacist should assess the risk and action should be taken as needed.
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Modules: Drug-to-Drug, continued Abbreviated Drug-to-Drug Monograph – The abbreviated Drug-to-Drug Monograph was designed to provide a quick/concise description of the drug interaction. This monograph includes: • • • • •
The monograph title Description of the two drugs that are causing the interaction Patient management recommendations Clinical effects of the interaction The mechanism of the action
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 Medicine’s 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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Modules: Drug-to-Drug, continued Following are the six reference classifiers: •
•
• • • •
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Manufacturer’s Information o Drug monographs contain manufacturer’s information that encomes product labeling, Dear Healthcare Professional letters, and correspondence between manufacturers and FDB. Human Clinical Trial o Human Clinical trials encom clinical trials of any size and type such as single-blind, double-blind, placebo, and non-placebo controlled, controlled, non-controlled. Case Report Meeting Abstract In Vitro/Animal Study Review Article o Review articles are infrequently utilized in DDIM, since they typically refer to the same references incorporated in the DDIM monograph. Use of review articles is limited to those articles that draw new conclusions from previous works.
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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Pharmacy Basics: Workbook Monograph Example: IA Code: 003055/31695 Interaction Description: GREPAFLOXACIN;SPARFLOXACIN/CLASS IA&III ANTIARRHYTHMICS
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 istered 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 istration 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 istration 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 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 istration 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) Manufacturer’s Prod Information: sparfloxacin (Rhon-Pouk-Rorer), Nov 1996. (1) 2) Manufacturer’s Prod Information: grepafloxacin (Glaxo Wellcome), Nov 11117. (1) Reference Classifier of (1) indicates reference is manufacturer’s information.
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Knowledge Check Circle the correct answer for each question below. 3. The FDB’s 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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Modules: Drug Conditions Policy Statement – Drug Conditions are not inferred. This check is dependent upon the entry of an ICD-9-CM diagnosis code in the patient’s record. Definition – The Drug Conditions Contraindications check detects potential conflicts between drugs (prescription; non-prescription; herbals; nutritional preparations) and disease states. How the Module Works – The fills and refills to be dispensed are checked against all ICD-9-CM conditions codes listed in the patient’s record. Conditions are identified using ICD-9-CM codes to indicate reported or actual conditions via the patient file. If the drug is a compound, then each ingredient will be checked against all ICD-9-CM conditions codes listed in the patient’s central file. Warnings Defined – Drug Conditions module contains alert statements for drugs that are absolutely contraindicated in certain conditions. This module also includes a second and third level for which the risk/benefit ratio should be assessed. Drugs contraindicated in pregnancy and lactation are included in Drug Conditions data as a first level contraindication or absolute contraindication as long as the patient’s profile contains an ICD-9 associated to pregnancy and/or lactation. Severity Level Definitions 1. Severity Level 1 Definition – Absolute Contraindication CVS Policy – It is CVS policy that severity level 1 messages require physician authorization and documentation. 2. Severity Level 2 Definition – Relative Contraindication 3. Severity Level 3 Definition – Warnings
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Modules: Conditions, continued CVS Policy for Level 2 and 3 – The Pharmacist must exercise professional judgment, review the profile, consult with the patient, and the Prescriber if warranted by the reviews. Example of differences in severity levels: Level 1 – (Labetalol) is contraindicated when (sinus bradycardia) exists. Level 2 - (Labetalol) should be evaluated carefully when (diabetes mellitus) exists. Level 3 - (Labetalol) should be evaluated when (renal failure) exists. The Conflict Code for all Drug-Conditions errors is “MC”.
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 patient’s 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 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 patient’s 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 patient’s profile to the active ingredients in the drug dispensed. Excipient Ingredient Allergies are not screened at this time.
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Note: A patient’s 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 product’s 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 patient’s profile. a. inactive b. active c. complete d. high risk
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Modules: Duplicate Therapy Policy Statement – Duplicate Therapy requires Pharmacists to exercise professional judgment, review the profile, discuss with the patient, and the Prescriber, if warranted. Definition – Duplications of therapy are defined as therapeutic or pharmacologic use repetitions of two or more drugs that create an increased potential for additive toxicity or adverse effects, or cause therapeutic redundancy without increased benefit. In many instances, this results from either Prescriber oversight or two different Prescribers prescribing similar drugs to treat unrelated conditions such as Naproxen and Piroxicam. Often a duplicate therapy event occurs due to a combination of products, where the individual ingredients are not easily recognized. Overlap is sometimes planned to achieve clinical effect. How the Module Works – The fill or refill to be dispensed is checked against every DUR eligible prescription on a patient profile. If the drug dispensed is a compound drug, each ingredient is checked with every DUR eligible prescription on the patient profile. Only systemic drugs are included in the check. Warnings Defined – The route of istration is important for the same drug therapy and therapeutic duplication. The route of istration, such as intravenous or oral, will only be checked against other drugs that are systemic. Drugs with non-systemic routes of istration are excluded from the check. For example, a Corisporin Otic ® preparation does not constitute Duplicate Therapy with oral Dexamethasone. Duplicate Therapy includes – Duplicate Therapy is based on the system date of the fill and the Days Supply plus 15 days. This ensures that all the patient’s prescriptions are included in the DUR checks until the discard date is printed on the vial. Duplicate therapy class checking uses specialized therapeutic drug classes developed specifically for duplicate therapy detection. The Conflict Code for all Duplicate Therapy errors is “ID”.
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Knowledge Check Circle the correct answer for each question below. 7. To ensure that all of a patient’s 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
Modules: Minimum/Maximum Daily Dosing Policy Statement – Dosing error messages require the Pharmacist to prescription information, review the profile, exercise professional judgment, consult with the patient to determine indication, and the Prescriber if warranted by reviews.
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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 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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Modules: Minimum/Maximum Daily Dosing, continued How the Module Works – Minimum/Maximum Dosing information is provided for the following age groups: • •
Pediatric patients 31 days to 14 years. Dosing check not available for infants younger than 31 days of age Adult patients from 15 to 110
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 ister other injectable drugs by nebulization. IPPB drugs, (drugs istered 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 istration (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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Modules: Minimum/Maximum Daily Dosing, continued Dosing for Pediatrics incorporates a growth chart age weight reference table, derived from the National Center for Health Statistics (NCHS) and is used as appropriate. The weight table utilizing age and sex, is used to estimate the patient’s weight. The pediatric dosing range is established utilizing the 5th and 95th percentile weight/age statistics for children in the United States. Pharmacist must the prescription information, review the profile, exercise professional judgment, and consult with the patient to determine the appropriateness of the medication. Conflict Codes are broken out as: • • • •
Low Dose – “LD” High Dose – “HD” Not recommended for age – “81” Not established for age – “82”
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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Modules: Pediatric Precautions Definition – Pediatric patients can be very sensitive to a drug therapy, especially within specific age ranges. With the Pediatric Precautions check, Pharmacists now have access to the valuable information for minimizing the adverse effects for patients in the age group of 31 days to 18 years. Examples include, but are not limited to, drugs that should not be used in pediatric patients because of their immature organ systems. How the Module Works – Only the fill or refill being dispensed is checked. Age range is 31 days to 18 years. If the drug is a compound, then each ingredient will be checked for Pediatric Precautions. Warnings Defined – The function of the Pediatric Precautions is to guide the Pharmacist in making appropriate decisions about drug therapy in pediatric patients. Contraindications and precaution evaluations, along with applicable age ranges, assist in making these decisions. In addition, brief summaries about the specifics of the precaution can be drawn. Evaluations regarding the severity of the possible side effects are called Severity Levels. Precautions information includes: • • •
Severity of the precaution Age range in days to which this precaution applies A brief summary of the precautions, if available
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Modules: Pediatric Precautions, continued There are three possible values in the Severity Level field: Severity Level 1 Definitions – Absolute Contraindication CVS Policy – Requires Pharmacists to obtain physician authorization and documentation. Documentation of the Prescriber authorization must be made in the DUR Comments field. Severity Level 2 Definitions – Relative Contraindication CVS Policy – Exercise professional judgment, and consult with patient. Severity Level 3 Definitions – For cases where no studies have been done but warnings exist. CVS Policy – Exercise professional judgment, and consult with patient. The Conflict Code for all Pediatric Precaution errors is “PA”.
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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Modules: Pregnancy Precautions
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 patient’s 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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Modules: Pregnancy Precautions, continued Severity Level C Definitions – Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies for humans. Potential benefits may warrant the use of the drug in pregnant women despite the potential risk. CVS Policy – Pharmacists must exercise professional judgment and discuss with the patient. Severity Level D Definitions – There is no positive evidence of human fetal risk based on the adverse reaction data from investigational or marketing experience or studies on humans. Potential benefits may warrant the use of the drug in pregnant women despite potential risks. CVS Policy – Pharmacists must obtain physician authorization and documentation. Severity Level X Definitions – Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience. The risk involved in the use of the drug by pregnant women clearly outweighs any potential benefits. CVS Policy – The drug SHOULD NOT BE DISPENSED. Pharmacists must notify the physician. When a FDA Pregnancy Category is not available, the FDB assigns a special Pregnancy Category along with a narrative description of any special precautions. Contraindications have FDB’s Pregnancy Category value of 1 while precautions have a value of 2.
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Modules: Pregnancy Precautions, continued Severity Level 1 Definitions – Severity level 1 indicates a contraindication. No FDA rating is assigned but is contraindicated or not recommended. CVS Policy – Pharmacists must obtain physician authorization and documentation*. Severity Level 2 Definitions – Severity level 2 indicates a precaution. No FDA rating is assigned but has precautions of warnings. CVS Policy – Pharmacists must exercise professional judgment and discuss with the patient. *Documentation of the Prescriber authorization must be made in the DUR Comments field. The Conflict Codes for Pregnancy Precautions are: Reported Pregnant – “PG” Unknown if Pregnant – “NP” Conflict Code of “NP” indicates the check was performed but the patient was considered not pregnant at the time because V22.0 was not on their file. You should always see this as a soft stop informational error.
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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Modules: Lactation Precautions
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 patient’s 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 encomes 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 patient’s 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 mother’s 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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Modules: Lactation Precautions, continued Severity Level 1 Definitions – Absolute contraindication. (Human data is usually available to recommendations.) This drug should not be given to breastfeeding mothers. CVS Policy – If the Excretion Effects and Lactation Effects codes are present with severity level 2, the Pharmacist must use professional judgment and may need to consult with the physician before dispensing.
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 mother’s 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 patient’s profile d. The Pharmacist enters a DUR comment to force the hard stop
Modules: Geriatric Precautions Definition – The Geriatric Precautions check provides warning messages for medications that should be used with caution by patients aged 60 years and above. It is important to note that physiologic age of the patient is not necessarily closely related to chronological age. Examples include, but are not limited to, drugs that should not be used in geriatric patients because of the risk for prolonged drug action due to impaired renal function. How the Module Works – Only the fill or refill being dispensed is checked. If a drug is a compound, then each ingredient will be checked for geriatric precautions. Warnings Defined – The Geriatric Precautions check encomes three basic features: • • •
It provides contraindications and precaution information for drug use in the geriatric population. It cites the organ system that suffers increased risk or the impaired organ system that suffers increased adverse effects if a specific drug therapy is pursued. It is a narrative describing the particulars of any precaution.
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Modules: Geriatric Precautions, continued Severity Level 1 Definitions – Severity level 1 indicates contraindication. CVS Policy – Pharmacists must obtain physician authorization and documentation. Documentation of the Prescriber authorization must be made in the DUR Comments field in RxConnect. Severity Level 2 Definition – Severity level 2 indicates precaution. CVS Policy – Pharmacists must exercise professional judgment, discuss with the patient, review the patient profile, and the Prescriber if warranted. The Conflict Code for all Geriatric Precautions is “GR”.
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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Third Party DUR Definition – Third Party Processors frequently provide patient specific information to help the DUR decision process. This information often pertains to CVS chain filled prescriptions as well as other chain prescriptions filled for that patient. RxConnect populates all TP DUR received from Third Party Processors and provides the following fields of information as long as it is populated by the Third Party: • • • • • • •
DUR Reason For Service Clinical Significance Level Pharmacy Message Quantity Filled On Prescriber
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 Engine’s 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, 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 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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Appendix #1: Knowledge Check Answer Key The following provide answers to the knowledge check questions from this course. Circle the correct answer for each question below. 1. DUR Checks are performed on those prescriptions in a patient’s 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 3. The FDB’s 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. a. True b. 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 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 patient’s record with an appropriate ICD-9-CM diagnosis code. a. True b. False
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6. The ______ ingredients in the fill or refill to be dispensed are checked against all allergy codes listed in the patient’s profile. a. inactive b. active c. complete d. high risk 7. To ensure that all of a patient’s 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 patient’s 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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Appendix #2: Module Groups Answer Key Definition
Module Name
These three 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 of these modules deal with different groups of patients.
Drug Modules
These 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.
Warning Modules
These four modules check for precautions. You’ll see that these modules are similar in the way they work, but the policy statements are different for each.
Dosing Modules
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Workbook
1
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
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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: ƒ
Identify the DUR Engine’s role in the process of managing DUR
ƒ
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.
3
Pharmacy Basics: Workbook The following icons are used throughout the workbook:
This icon indicates a knowledge check.
This icon identifies an activity.
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.
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Initiate a Drug Utilization Review (DUR) After all necessary information is entered for a prescription, including the Credentials of the team member completing data entry, the RxConnect system assigns a number to the prescription. This prescription is then sent to the DUR Engine for a centralized DUR review.
Understand the DUR Engine The DUR Engine is a computer that performs centralized DUR on all prescriptions. It performs a comprehensive DUR against the patient’s profile. During the review, the DUR Engine performs checks for all completed and pending prescriptions at any CVS pharmacy. A prescription is considered pending as soon as data entry is complete and the prescription returns to the queue. In all, the DUR Engine checks for 11 different types of possible occurrences.
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Understand DUR Event Types When the DUR Engine discovers an exception, it reports a DUR event. Each DUR event can include one or more DUR occurrences. The two types of DUR events are: •
Critical DUR Events/Hard Stops – These events require DUR Intervention Codes and are displayed on the Verification screen for resolution by a Pharmacist. RxConnect requires one of three DUR Intervention Codes to be selected to resolve hard stop DUR: 1. Prescriber Consulted 2. Medication Review 3. Patient Consulted In those instances that Critical DUR Events are displayed over multiple pages, you must review each page of hard stops before you are given the option to enter an intervention code.
•
Informational DUR Events/Soft Stops – These events do not require DUR Intervention Codes and are displayed on the Verification screen by selecting “D” for review by a Pharmacist.
Knowledge Check Circle the correct answer for each question below. 1. DUR Checks are performed on those prescriptions in a patient’s 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
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Classify Prescription Checks The DUR Engine performs up to 11 checks on any prescription to assure safe usage by the patient. The 11 checks can be broken down into 3 module groups. The modules are classified as follows:
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. You’ll see that precaution modules are similar in the way they work, but the policy statements are different for each.
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Activity #1: Module Groups Now that you have learned about the different module groups that the 11 DUR checks can be grouped by, you will have a chance to apply your knowledge. Below are 3 definitions. Draw a line to match the definition with the appropriate Module name. Definition
Module Name
These three 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 of these modules deal with different groups of patients.
Drug Modules
These 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.
Warning Modules
These four modules check for precautions. You’ll see that these modules are similar in the way they work, but the policy statements are different for each.
Dosing Modules
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Identify DUR Checks The 11 checks that the DUR Engine performs to ensure the safety of the patients are: DUR Check 1. Drug-to-Drug
2. Drug Conditions
3. Drug-toAllergy
4. Duplicate Therapy
Description A drug-to-drug interaction is a pharmacological response that is different from the expected result when each drug is given separately. A Drug-to-Drug interaction check is based on the active ingredients of the drugs involved. The Drug Conditions contraindications refer to conditions that may be negatively affected by particular drug therapy or that may adversely affect specific drug actions. This check is based on the ICD-9-CM diagnosis codes in the patient’s profile. You need to ensure effective Drug Conditions checking by manually entering the ICD-9-CM codes because RxConnect does not infer the codes from the prescription information. You should ask the patient about conditions we should know about and update the patient’s profile to reflect this information. The Drug-to-Allergy check identifies and reports warnings associated with the use of certain drugs for patients with a history of hypersensitivity towards that particular drug or drug class. This check compares the National Drug Code (NDC) of the dispensed drug to the allergy codes in the patient’s profile. It is important to ask the patients about their drug allergies. You should enter this information in the patient’s profile to ensure that allergy check is performed. Recall that you also need to document if the patient has confirmed that they have No Known Allergies or not. Duplicate Therapy provides checking that is based on tailored therapeutic drug groupings. This includes detection of drugs that are frequently prescribed for multiple therapeutic uses, yet act by similar mechanisms or belong to the same or similar pharmacologic class(es). The Adult Daily Dose check provides quick check information regarding the minimum and maximum recommended daily doses for approved indications of the most frequently used drugs.
5. Adult Dosing This check is performed for all adults between the ages of 15 and 60. It assumes the patient weighs 70 kilograms (approx. 154 pounds). Note that dose is also based on NDC, Days Supply and total daily dosage. 9
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Identify DUR Checks, continued DUR Check 6. Pediatric Dosing
7. Geriatric Dosing
8. Pregnancy Precaution
Description The Pediatric Dosing check provides quick check information regarding the minimum and maximum recommended daily doses for patients 31 days to 14 years old. It does not handle checks for patients less than 31 days old. The Geriatric Daily Dosing check provides quick check information regarding the minimum and maximum recommended daily dose for geriatric patients. This check is performed for all patients 60 years and older. The Pregnancy Precaution information detects drugs that may not be appropriate for pregnant women. The information provides a comprehensive method for screening any drug for known precautions for pregnancy. This check is performed for all females aged between 15 and 45. The Lactation Precaution check provides warnings about the use of drugs in nursing mothers. This information answers the questions such as:
9. Lactation Precaution
10. Pediatric Precaution
11. Geriatric Precaution
• • •
Is the drug excreted in breast milk? What are the possible infant side effects? Is this a severe defect?
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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Identify DUR Checks, continued Manual DUR Messaging: There will be times when the DUR Engine is up and running, but you will see a “Perform Manual DUR” message. This will occur when: • • •
There is an active prescription on a patient’s file but the drug is no longer ed by FDB The drug dispensed is not an FDB ed drug (e.g., it was added by a pharmacy team member or by the central – also commonly referred to as a “Temporary” drug) Dosing information is either not available for the patient’s age or the dispensed item is not a medical device
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 state’s 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 FDB’s 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 patient’s 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 patient’s central profile. The Conflict Code for all Drug-to-Drug errors is “DD”.
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Modules: Drug-to-Drug, continued Warnings Defined – The Drug-to-Drug interaction check identifies potential drug problems without hindering data entry. Only clinically relevant information is maintained by FDB. Documentation level and clinical severity are some of the criteria considered when determining the suitability of including a drug interaction in DDIM. Frequency of occurrence is discussed in the monographs, but is not part of the criteria for addition to the module. •
•
•
Onset – The onset of a drug-to-drug interaction is extremely patient-specific. If a patient is on the verge of toxicity with a drug, adding another drug that impairs toxic elimination can produce toxicity very quickly. This kind of interaction may cause toxicity within a few hours. For another patient, the duration may extend to a week. Predisposing factors – Certain patients may be predisposed to the effects of an interaction due to their medical conditions. For example, the interaction between aminoglycosides and cephalosporins usually affects patients with pre-existing renal disease. Risk versus benefits – In some situations, the benefit of giving two interacting drugs together may outweigh the potential risk. Treating all patients in the same manner is inappropriate.
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Modules: Drug-to-Drug, continued Severity Level Definitions – Each drug interaction is linked to a severity level that indicates the interaction severity. The severity level is used to classify drug interactions and is considered clinically significant. The three severity levels are: 1. Severity Level 1 Definition – Contraindicated Drug Combinations. FDB’s research indicates that the drug combination is clearly contraindicated in all cases and should not be dispensed or istered to the same patient. A manufacturer’s label indicating the contraindication is sufficient to warrant including a drug combination in this category. CVS Policy – Severity Level 1 messages require Physician authorization and documentation* with the exception of DDIs which cause a decrease in the effectiveness of oral contraceptives. (These DDIs require documentation of patient counseling.) Suggested actions to address Level 1 interactions may include: 1. 2. 3. 4.
Discontinuation of one or both agents Dosage adjustments Altercation of a conflicting istration schedule Additional patient monitoring
*Documentation of the Prescriber authorization must be made in the DUR Comments field
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Modules: Drug-to-Drug, continued 2. Severity Level 2 Definition – Severe Interaction. FDB’s research indicates action is required to reduce risk of severe adverse interaction. Includes drug combinations that can produce serious consequences in most patients, but can be monitored and/or the agents titrated, significantly minimizing the risk of adverse effects. The combination may be absolutely contraindicated for some but not all patients. Those patients in whom the combination is contraindicated are identifiable. The information to identify such patients is contained in the corresponding DDIM detailed monograph. The action required can include discontinuing one or both agents, adjusting dosage, altering the istration schedule, and/or additional patient monitoring. CVS Policy – Severity level 2 messages require the Pharmacist to exercise professional judgment (has dose adjustment been made?), review the profile, consult with the patient (has doctor addressed known DDI in advance?), and the Prescriber if warranted (appears DDI has not been addressed). 3. Severity Level 3 Definition - Moderate interaction. FDB’s research indicates that action is necessary to assess the risk to the patient and take action as needed. The action required may include discontinuing one or both agents, adjusting dosage, altering istration schedules, and/or additional patient monitoring. CVS Policy – Severity level 3 messages require the Pharmacist to exercise professional judgment, review the profile, and assess the risk to the patient. 4. Severity Level 9 Definition unknown: Drug combination interaction potential is unknown. This involves alternative products, like herbals, so documentation is not as thorough as with prescription medications. Level 9 indicates that an interaction is possible, but does not indicate the potential severity of the interaction. CVS Policy - The Pharmacist should assess the risk and action should be taken as needed.
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Modules: Drug-to-Drug, continued Abbreviated Drug-to-Drug Monograph – The abbreviated Drug-to-Drug Monograph was designed to provide a quick/concise description of the drug interaction. This monograph includes: • • • • •
The monograph title Description of the two drugs that are causing the interaction Patient management recommendations Clinical effects of the interaction The mechanism of the action
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 Medicine’s 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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Modules: Drug-to-Drug, continued Following are the six reference classifiers: •
•
• • • •
!
Manufacturer’s Information o Drug monographs contain manufacturer’s information that encomes product labeling, Dear Healthcare Professional letters, and correspondence between manufacturers and FDB. Human Clinical Trial o Human Clinical trials encom clinical trials of any size and type such as single-blind, double-blind, placebo, and non-placebo controlled, controlled, non-controlled. Case Report Meeting Abstract In Vitro/Animal Study Review Article o Review articles are infrequently utilized in DDIM, since they typically refer to the same references incorporated in the DDIM monograph. Use of review articles is limited to those articles that draw new conclusions from previous works.
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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Pharmacy Basics: Workbook Monograph Example: IA Code: 003055/31695 Interaction Description: GREPAFLOXACIN;SPARFLOXACIN/CLASS IA&III ANTIARRHYTHMICS
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 istered 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 istration 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 istration 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 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 istration 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) Manufacturer’s Prod Information: sparfloxacin (Rhon-Pouk-Rorer), Nov 1996. (1) 2) Manufacturer’s Prod Information: grepafloxacin (Glaxo Wellcome), Nov 11117. (1) Reference Classifier of (1) indicates reference is manufacturer’s information.
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Knowledge Check Circle the correct answer for each question below. 3. The FDB’s 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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Modules: Drug Conditions Policy Statement – Drug Conditions are not inferred. This check is dependent upon the entry of an ICD-9-CM diagnosis code in the patient’s record. Definition – The Drug Conditions Contraindications check detects potential conflicts between drugs (prescription; non-prescription; herbals; nutritional preparations) and disease states. How the Module Works – The fills and refills to be dispensed are checked against all ICD-9-CM conditions codes listed in the patient’s record. Conditions are identified using ICD-9-CM codes to indicate reported or actual conditions via the patient file. If the drug is a compound, then each ingredient will be checked against all ICD-9-CM conditions codes listed in the patient’s central file. Warnings Defined – Drug Conditions module contains alert statements for drugs that are absolutely contraindicated in certain conditions. This module also includes a second and third level for which the risk/benefit ratio should be assessed. Drugs contraindicated in pregnancy and lactation are included in Drug Conditions data as a first level contraindication or absolute contraindication as long as the patient’s profile contains an ICD-9 associated to pregnancy and/or lactation. Severity Level Definitions 1. Severity Level 1 Definition – Absolute Contraindication CVS Policy – It is CVS policy that severity level 1 messages require physician authorization and documentation. 2. Severity Level 2 Definition – Relative Contraindication 3. Severity Level 3 Definition – Warnings
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Pharmacy Basics: Workbook
Modules: Conditions, continued CVS Policy for Level 2 and 3 – The Pharmacist must exercise professional judgment, review the profile, consult with the patient, and the Prescriber if warranted by the reviews. Example of differences in severity levels: Level 1 – (Labetalol) is contraindicated when (sinus bradycardia) exists. Level 2 - (Labetalol) should be evaluated carefully when (diabetes mellitus) exists. Level 3 - (Labetalol) should be evaluated when (renal failure) exists. The Conflict Code for all Drug-Conditions errors is “MC”.
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 patient’s record with an appropriate ICD-9-CM diagnosis code. a. True b. False
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Pharmacy Basics: Workbook
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 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 patient’s 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 patient’s profile to the active ingredients in the drug dispensed. Excipient Ingredient Allergies are not screened at this time.
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Note: A patient’s 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 product’s 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 patient’s profile. a. inactive b. active c. complete d. high risk
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Pharmacy Basics: Workbook
Modules: Duplicate Therapy Policy Statement – Duplicate Therapy requires Pharmacists to exercise professional judgment, review the profile, discuss with the patient, and the Prescriber, if warranted. Definition – Duplications of therapy are defined as therapeutic or pharmacologic use repetitions of two or more drugs that create an increased potential for additive toxicity or adverse effects, or cause therapeutic redundancy without increased benefit. In many instances, this results from either Prescriber oversight or two different Prescribers prescribing similar drugs to treat unrelated conditions such as Naproxen and Piroxicam. Often a duplicate therapy event occurs due to a combination of products, where the individual ingredients are not easily recognized. Overlap is sometimes planned to achieve clinical effect. How the Module Works – The fill or refill to be dispensed is checked against every DUR eligible prescription on a patient profile. If the drug dispensed is a compound drug, each ingredient is checked with every DUR eligible prescription on the patient profile. Only systemic drugs are included in the check. Warnings Defined – The route of istration is important for the same drug therapy and therapeutic duplication. The route of istration, such as intravenous or oral, will only be checked against other drugs that are systemic. Drugs with non-systemic routes of istration are excluded from the check. For example, a Corisporin Otic ® preparation does not constitute Duplicate Therapy with oral Dexamethasone. Duplicate Therapy includes – Duplicate Therapy is based on the system date of the fill and the Days Supply plus 15 days. This ensures that all the patient’s prescriptions are included in the DUR checks until the discard date is printed on the vial. Duplicate therapy class checking uses specialized therapeutic drug classes developed specifically for duplicate therapy detection. The Conflict Code for all Duplicate Therapy errors is “ID”.
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Pharmacy Basics: Workbook
Knowledge Check Circle the correct answer for each question below. 7. To ensure that all of a patient’s 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
Modules: Minimum/Maximum Daily Dosing Policy Statement – Dosing error messages require the Pharmacist to prescription information, review the profile, exercise professional judgment, consult with the patient to determine indication, and the Prescriber if warranted by reviews.
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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 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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Pharmacy Basics: Workbook
Modules: Minimum/Maximum Daily Dosing, continued How the Module Works – Minimum/Maximum Dosing information is provided for the following age groups: • •
Pediatric patients 31 days to 14 years. Dosing check not available for infants younger than 31 days of age Adult patients from 15 to 110
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 ister other injectable drugs by nebulization. IPPB drugs, (drugs istered 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 istration (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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Pharmacy Basics: Workbook
Modules: Minimum/Maximum Daily Dosing, continued Dosing for Pediatrics incorporates a growth chart age weight reference table, derived from the National Center for Health Statistics (NCHS) and is used as appropriate. The weight table utilizing age and sex, is used to estimate the patient’s weight. The pediatric dosing range is established utilizing the 5th and 95th percentile weight/age statistics for children in the United States. Pharmacist must the prescription information, review the profile, exercise professional judgment, and consult with the patient to determine the appropriateness of the medication. Conflict Codes are broken out as: • • • •
Low Dose – “LD” High Dose – “HD” Not recommended for age – “81” Not established for age – “82”
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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Pharmacy Basics: Workbook
Modules: Pediatric Precautions Definition – Pediatric patients can be very sensitive to a drug therapy, especially within specific age ranges. With the Pediatric Precautions check, Pharmacists now have access to the valuable information for minimizing the adverse effects for patients in the age group of 31 days to 18 years. Examples include, but are not limited to, drugs that should not be used in pediatric patients because of their immature organ systems. How the Module Works – Only the fill or refill being dispensed is checked. Age range is 31 days to 18 years. If the drug is a compound, then each ingredient will be checked for Pediatric Precautions. Warnings Defined – The function of the Pediatric Precautions is to guide the Pharmacist in making appropriate decisions about drug therapy in pediatric patients. Contraindications and precaution evaluations, along with applicable age ranges, assist in making these decisions. In addition, brief summaries about the specifics of the precaution can be drawn. Evaluations regarding the severity of the possible side effects are called Severity Levels. Precautions information includes: • • •
Severity of the precaution Age range in days to which this precaution applies A brief summary of the precautions, if available
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Pharmacy Basics: Workbook
Modules: Pediatric Precautions, continued There are three possible values in the Severity Level field: Severity Level 1 Definitions – Absolute Contraindication CVS Policy – Requires Pharmacists to obtain physician authorization and documentation. Documentation of the Prescriber authorization must be made in the DUR Comments field. Severity Level 2 Definitions – Relative Contraindication CVS Policy – Exercise professional judgment, and consult with patient. Severity Level 3 Definitions – For cases where no studies have been done but warnings exist. CVS Policy – Exercise professional judgment, and consult with patient. The Conflict Code for all Pediatric Precaution errors is “PA”.
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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Pharmacy Basics: Workbook
Modules: Pregnancy Precautions
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 patient’s 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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Pharmacy Basics: Workbook
Modules: Pregnancy Precautions, continued Severity Level C Definitions – Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies for humans. Potential benefits may warrant the use of the drug in pregnant women despite the potential risk. CVS Policy – Pharmacists must exercise professional judgment and discuss with the patient. Severity Level D Definitions – There is no positive evidence of human fetal risk based on the adverse reaction data from investigational or marketing experience or studies on humans. Potential benefits may warrant the use of the drug in pregnant women despite potential risks. CVS Policy – Pharmacists must obtain physician authorization and documentation. Severity Level X Definitions – Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience. The risk involved in the use of the drug by pregnant women clearly outweighs any potential benefits. CVS Policy – The drug SHOULD NOT BE DISPENSED. Pharmacists must notify the physician. When a FDA Pregnancy Category is not available, the FDB assigns a special Pregnancy Category along with a narrative description of any special precautions. Contraindications have FDB’s Pregnancy Category value of 1 while precautions have a value of 2.
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Pharmacy Basics: Workbook
Modules: Pregnancy Precautions, continued Severity Level 1 Definitions – Severity level 1 indicates a contraindication. No FDA rating is assigned but is contraindicated or not recommended. CVS Policy – Pharmacists must obtain physician authorization and documentation*. Severity Level 2 Definitions – Severity level 2 indicates a precaution. No FDA rating is assigned but has precautions of warnings. CVS Policy – Pharmacists must exercise professional judgment and discuss with the patient. *Documentation of the Prescriber authorization must be made in the DUR Comments field. The Conflict Codes for Pregnancy Precautions are: Reported Pregnant – “PG” Unknown if Pregnant – “NP” Conflict Code of “NP” indicates the check was performed but the patient was considered not pregnant at the time because V22.0 was not on their file. You should always see this as a soft stop informational error.
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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Pharmacy Basics: Workbook
Modules: Lactation Precautions
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 patient’s 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 encomes 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 patient’s 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 mother’s 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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Pharmacy Basics: Workbook
Modules: Lactation Precautions, continued Severity Level 1 Definitions – Absolute contraindication. (Human data is usually available to recommendations.) This drug should not be given to breastfeeding mothers. CVS Policy – If the Excretion Effects and Lactation Effects codes are present with severity level 2, the Pharmacist must use professional judgment and may need to consult with the physician before dispensing.
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 mother’s 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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Pharmacy Basics: Workbook
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 patient’s profile d. The Pharmacist enters a DUR comment to force the hard stop
Modules: Geriatric Precautions Definition – The Geriatric Precautions check provides warning messages for medications that should be used with caution by patients aged 60 years and above. It is important to note that physiologic age of the patient is not necessarily closely related to chronological age. Examples include, but are not limited to, drugs that should not be used in geriatric patients because of the risk for prolonged drug action due to impaired renal function. How the Module Works – Only the fill or refill being dispensed is checked. If a drug is a compound, then each ingredient will be checked for geriatric precautions. Warnings Defined – The Geriatric Precautions check encomes three basic features: • • •
It provides contraindications and precaution information for drug use in the geriatric population. It cites the organ system that suffers increased risk or the impaired organ system that suffers increased adverse effects if a specific drug therapy is pursued. It is a narrative describing the particulars of any precaution.
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Modules: Geriatric Precautions, continued Severity Level 1 Definitions – Severity level 1 indicates contraindication. CVS Policy – Pharmacists must obtain physician authorization and documentation. Documentation of the Prescriber authorization must be made in the DUR Comments field in RxConnect. Severity Level 2 Definition – Severity level 2 indicates precaution. CVS Policy – Pharmacists must exercise professional judgment, discuss with the patient, review the patient profile, and the Prescriber if warranted. The Conflict Code for all Geriatric Precautions is “GR”.
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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Pharmacy Basics: Workbook
Third Party DUR Definition – Third Party Processors frequently provide patient specific information to help the DUR decision process. This information often pertains to CVS chain filled prescriptions as well as other chain prescriptions filled for that patient. RxConnect populates all TP DUR received from Third Party Processors and provides the following fields of information as long as it is populated by the Third Party: • • • • • • •
DUR Reason For Service Clinical Significance Level Pharmacy Message Quantity Filled On Prescriber
The Conflict Code for all Third Party errors is “TP” and all Third Party errors are considered informational.
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Pharmacy Basics: Workbook
Summary The RxConnect system automatically checks for eleven different types of possible DUR occurrences. In this topic, you learned to: • Identify the DUR Engine’s 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, 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 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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Appendix #1: Knowledge Check Answer Key The following provide answers to the knowledge check questions from this course. Circle the correct answer for each question below. 1. DUR Checks are performed on those prescriptions in a patient’s 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 3. The FDB’s 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. a. True b. 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 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 patient’s record with an appropriate ICD-9-CM diagnosis code. a. True b. False
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6. The ______ ingredients in the fill or refill to be dispensed are checked against all allergy codes listed in the patient’s profile. a. inactive b. active c. complete d. high risk 7. To ensure that all of a patient’s 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 patient’s 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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Pharmacy Basics: Workbook
Appendix #2: Module Groups Answer Key Definition
Module Name
These three 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 of these modules deal with different groups of patients.
Drug Modules
These 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.
Warning Modules
These four modules check for precautions. You’ll see that these modules are similar in the way they work, but the policy statements are different for each.
Dosing Modules
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