Pharmacy Basics Workbook January 2020 Last Updated 01/16/2020 Course Code: 204010 Pharmacy Basics: Workbook Table of Contents Introduction ................................................................................................................................3 Pharmacy Settings......................................................................................................................5 Delivering Patient Care ..............................................................................................................8 The Pharmacy Workflow ...........................................................................................................8 Eight Service Standards .............................................................................................................9 Knowledge Check ....................................................................................................................11 Regulations and Regulatory Agencies .....................................................................................12 Medication Identification .........................................................................................................16 Types of Medication ................................................................................................................20 Schedule III-V Dispensing.......................................................................................................28 Prescription Labels...................................................................................................................31 Third Party Billing ...................................................................................................................35 The Customer Receipt..............................................................................................................36 Course Completion ..................................................................................................................49 Next Steps ................................................................................................................................49 Appendix #1: Knowledge Check Answer Key .......................................................................50 Appendix #2: Reporting Thefts or Losses of Controlled Substances ......................................53 Page 2 of 58 Pharmacy Basics: Workbook Introduction In this training course, you will build upon what you have learned in the Pharmacy Introduction web-based course. You will have an opportunity to explore the Pharmacy and the tools that we use at the different workstations. Upon completion of this course, you will be able to: List various pharmacy settings and identify CVS Health pharmacy settings Describe key information included on the stock bottle Identify the various types of medication dosage forms Recognize the elements of prescription labels Recognize medication schedules Identify Action and Patient Care Notes and recognize the importance of communicating information to patients effectively Identify the different communication vehicles used in the pharmacy This training guide is provided in a self-paced format. You will need to complete this workbook in a pharmacy where you will have an opportunity to explore and ask questions. If you need help completing any of the activities or locating any of the required materials, ask a Pharmacy Team Member for assistance. Answers to each knowledge check are in the appendix at the end of this workbook. It will take you approximately 1 hour to complete this workbook. This course is a prerequisite to the Foundations of Pharmacy class. Please bring your completed workbook to class, as your Trainer may review your work at the start of the class. Page 3 of 58 Pharmacy Basics: Workbook Introduction Continued The following icons are used throughout the workbook: This icon indicates a knowledge check. This icon identifies an activity. This icon indicates which materials from the pharmacy are needed to complete the 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 the work that occurs in the pharmacy. Materials You will need the following materials to complete the activities (To comply with HIPAA regulations, ensure all patient information is removed from sample materials.): A complete printed prescription label Page 4 of 58 Pharmacy Basics: Workbook Pharmacy Settings Welcome to Pharmacy Basics training where you will discover the basic information needed to be successful in the practice of pharmacy. Let’s start with understanding all of the various settings where the practice of pharmacy occurs. As a technician, you practice pharmacy in at least one of the 9 types of pharmacy settings. You should know which of these you work in within the larger context of the practice of pharmacy. In addition to know which type of pharmacy setting you work in, it is helpful to know which other pharmacy settings exist at CVS Health. You may have patients that are served through a few different types of pharmacy settings where CVS Health operates, and being aware of these other settings will help you better serve patients on their path to better health. Pharmacy Settings Knowledge Check The reference guide on the next page lists the different pharmacy settings with brief key points for each one. Read through the next two pages and then answer the questions below. Write your answer in the column on the right. Question Your Answer 1. Which type of pharmacy setting do you work in if you work at a pharmacy CVS retail store? 2. Which other types of pharmacy settings do you think there are at CVS Health? As you answer this question, think about our services such as Omnicare and other ways that our patients receive their filled prescriptions from CVS Health. Page 5 of 58 Pharmacy Settings QRG Pharmacy Basics: Workbook This Quick Reference Guide (QRG) gives an overview of Pharmacy Settings: Community Retail Pharmacy 1 Processes prescription services to the public 2 Includes chain, independent, mass merchandiser, and food store pharmacies 3 Designated units are the pharmacy counter, drop-off window, storage area, equipment area, and waiting bin area Ambulatory Care Pharmacy 1 Is affiliated with a healthcare facility to reduce readmissions 2 Assists discharged patients with their medication regimen Compounding Community Pharmacy 1 Are community pharmacies that specialize in compounding services 2 Fills prescriptions for commercially available prescription products Home Health Care/Home Infusion Pharmacy 1 Provides medication and consulting services in patients’ homes 2 Provides home infusion of IV pumps as primary service Hospice Pharmacy 1 Assesses the appropriateness of medication orders to comfort a patient who is terminally ill 2 Ensures patients and caregivers understand and follow the directions with use of medication Page 6 of 58 Pharmacy Basics: Workbook Quick Reference Guide (QRG) Continued Hospital Pharmacy 1 Assists licensed pharmacists with the preparation and distribution of prescription medications in hospitals 2 Helps fill orders for patients and ensures delivery of medication to correct units 3 Ensures the right amount of stock to meet patients’ needs Long-term Care Pharmacy 1 Offers services to meet needs of people with chronic illness or disability 2 Distributes medications that have been ordered 3 Maintains an individualized pharmaceutical plan for residents in long-term care facilities Mail-Order Pharmacy 1 Sends medications to patients through mail or other delivery services 2 Used in situations where the need for medication is known in advance 3 Provides customer service where pharmacists can consult with patients Nuclear Pharmacy 1 Are specially licensed and regulated pharmacies that prepare radioactive materials called radiopharmaceuticals 2 Promotes health by effectively using these radioactive drugs for diagnosis and therapy 3 Dispenses doses to a hospital or clinic nuclear medicine department where the dose is administered to the patient Page 7 of 58 Pharmacy Basics: Workbook Delivering Patient Care In the Pharmacy Introduction web-based training, you learned that as a member of the Pharmacy team, you play an integral role in ensuring that each customer receives the specialized care and exceptional service that he or she deserves. At CVS/pharmacy, we refer to this specialized care as Patient Care, a proactive, patient-centered approach to caring for customers. All that we do is with the patient in mind. As a result of having the right conversation, with the right patient, at the right time, Pharmacy Team Members have the ability to help patients improve their medication adherence and overall health. One way Pharmacy Teams can demonstrate patient care is by providing friendly and efficient customer service. However, at CVS we truly differentiate ourselves by the services and programs that we deliver to our patients. Throughout this course and your additional training, you will learn more about the various ways we provide exceptional service to our customers. The Pharmacy Workflow In the Pharmacy Introduction web-based training, you learned how the workflow (or prescription filling process) helps to support CVS’ ability to provide exceptional customer service and ensure the safety of our patients. The following graphic illustrates the flow of a prescription once it is received in the pharmacy: Customer service and quality checks are embedded throughout the prescription filling process. All of the tasks that you perform have a direct impact on the experience of your customers and on the safety of your patients. The work that you do and interactions you have are critical to our continued success as an organization. Page 8 of 58 Pharmacy Basics: Workbook Pharmacy Workflow Continued By understanding and adhering to the roles and responsibilities at each workstation, you will be able to work efficiently, so you can care more for customers. CVS is committed to ensuring you have the knowledge, skills, and tools you need to succeed in your new role. Eight Service Standards Pharmacy workflow consists of Eight Service Standards that must be followed to ensure we provide the best possible service to our customers. To maximize their effectiveness, all of these elements must be incorporated into the regular practices of your store. An Eight Service Standards job aid should be displayed in your store as a reminder of the essential elements of workflow that must be followed. Page 9 of 58 Pharmacy Basics: Workbook Eight Service Standards Continued Let’s take a closer look at the Eight Service Standards: Work Efficiently There are four critical behaviors that will enable Team Members to be more efficient: 1. Schedule to the model and follow the myWorkstation Assignment tool. This ensures that the right person is in the right place at the right time to best serve customers. 2. Follow the Priority Cards at each workstation. This ensures that customers receive top priority and all work is completed. 3. Work the Action Queues top down. This ensures customer expectations are met. 4. Use the process and systems. This ensures Pharmacy Teams are following workflow, which reinforces our commitment to patient safety and service excellence. Care More By working efficiently, Team Members care more by: 1. Promptly acknowledge all customers. This ensures customers are served in a friendly and courteous manner. 2. Provide undivided attention to a customer. This ensures customers feel welcomed and card for. 3. Immediately follow up on issues and use Electronic Action Notes. This ensures we are demonstrating respect for customers and building trusted relationships. 4. Help at Pick-up if there are 3 or more customers in line. This ensures customers know they are a top priority. Page 10 of 58 Pharmacy Basics: Workbook Knowledge Check Recall what you learned in the Pharmacy Introduction web-based training. Identify the workstation that corresponds to the roles and responsibilities outlined below. Workstation Roles and Responsibilities This workstation, which is staffed by a Pharmacist, is where final accuracy checks are completed prior to dispensing a prescription to the patient. The Team Member assigned to this workstation fills prescriptions to keep the process flowing and to ensure medication(s) are filled when promised. At this workstation the Team Member is responsible for both Drop-off and Pick-up tasks. This is a critical piece of the prescription fulfillment process. When a customer brings a prescription to the pharmacy, the interaction at this workstation is the customer’s first indication of the service level that will be provided by the pharmacy team. Team Members serve customers picking up their prescription(s) in the store. Page 11 of 58 Pharmacy Basics: Workbook Regulations and Regulatory Agencies CVS is committed to quality assurance; the safety of our patients is our top priority. In addition to caring about the safety of our patients, we use quality assurance activities to meet several federal and state regulations. We will take a closer look at 6 laws and regulatory agencies that impact the way we work. You will read about what the law or agency does, why it is necessary, and how it impacts you at work. HOW WHY WHAT 1. Food and Drug Administration (FDA) Agency that regulates the development, testing, purity, safety, and effectiveness of prescription and over-the-counter (OTC) medications o Approves medications for sale in the United States o Regulates advertising and labeling of prescription and OTC medications Ensures patient health and safety Ensures that patients can easily obtain the medications they are prescribed When new medications are approved by the FDA and introduced into the marketplace, you will begin to receive and fill prescriptions for those medications When the FDA recalls medications, the Pharmacist on duty is responsible for ensuring our patients are safe 2. Comprehensive Drug Abuse Prevention and Control Act of 1970 (Controlled Substance Act (CSA)) and state controlled substance laws WHAT HOW WHY Law that regulates the manufacturing, distribution, prescribing, and dispensing of controlled substances The federal CSA is enforced by the Drug Enforcement Administration (DEA) States also have laws and regulations relating to controlled substances Because controlled substances pose a high risk of addiction, extra precautions are taken to monitor these medications and protect patients from the negative side effects When filling prescriptions for controlled substances, additional steps must be taken, such as ensuring that each prescription has the Prescriber DEA number included on it Page 12 of 58 Pharmacy Basics: Workbook Regulations and Regulatory Agencies Continued WHAT 3. Consumer Product Safety Commission (CPSC) Agency that oversees the Poison Prevention Packaging Act. Requires that most prescriptions for oral use are dispensed in childresistant containers (i.e., safety caps) To protect young children from opening and consuming potentially harmful medications All prescriptions filled at CVS will have a child-resistant safety cap A patient or prescriber may request a non-safety cap, and the patient will have to sign to acknowledge this request via the Electronic Signature Log HOW WHY Law that requires record-keeping (e.g., patient profiles) for all medications used by a patient Requires Pharmacists (or Pharmacy Support Staff Members, as allowed by law) to make an Offer to Counsel for all new prescriptions Ensures that patients have an opportunity to obtain information about their medications At the Pick-up and Drive-thru workstations, you will make the Offer to Counsel (in accordance to state law) to each patient for each prescription as prompted by the pharmacy register o However, only Pharmacists (or Interns under the supervision of a Pharmacist) are allowed to counsel patients The patient will have to sign via the Electronic Signature Log to accept or decline consultation HOW WHY WHAT 4. Omnibus Budget Reconciliation Act of 1990 (OBRA ’90) Page 13 of 58 Pharmacy Basics: Workbook Regulations and Regulatory Agencies Continued 5. State Boards of Pharmacy WHY Agencies that license and/or register Pharmacists and Pharmacy Support Staff and they have the power to revoke, suspend, or place on probation the licenses and/or registrations of those who are found guilty of violating laws or regulations Regulate technical functions of pharmacy departments Also employ inspectors to examine pharmacies for compliance State Boards of Pharmacy license and regulate pharmacies and Pharmacy staff in order to protect patients’ health HOW WHAT Regulations and required actions vary across states. Your Trainer will address your state’s requirements in your classroom training WHY WHAT 6. Health Insurance Portability and Accountability Act (HIPAA) of 1996 and Privacy Rule of April 14, 2003 Both HIPAA and the Privacy Rule are laws that were enacted to protect the privacy of patients Compliance with this regulation helps maintain the privacy and security of patients’ protected healthcare information You and all new employees must complete HIPAA (Handling PHI and Other Confidential Info) training You will provide a written Notice of Privacy Practices (NoPP) to all new pharmacy patients o Patients will sign the Electronic Signature Log to acknowledge that they received the NoPP HOW You and all Pharmacy Team Members must be careful and considerate when conversing with each other or with other customers, providers, insurance plans At all times you must adhere to the confidential trash procedures that were covered in the New Employee Compliance training Incidental Use and Disclosure: CVS employees must make reasonable efforts to avoid being overheard discussing patient medications and health-related topics and reasonably limit the information disclosed when discussing Protected Health Information (PHI) Page 14 of 58 Pharmacy Basics: Workbook Activity #1: Regulation Scenarios Now that you have learned about the different regulatory agencies and legislation that affect pharmacies, you will have a chance to apply your knowledge. Below are 6 scenarios that happen every day in a pharmacy. Read each scenario and identify the agency or law that applies to the scenario. Write your answer in the column on the right. Scenario Regulation or Agency 1. A patient gives you her medication vial. She explains that she would like to exchange the safety cap for a non-safety cap because she is unable to open the vial. 2. A license and/or registration for each Pharmacist and Pharmacy Support Staff Member that works in the store are displayed on the wall. 3. You make the Offer to Counsel (per state regulations) to ensure the patient is fully informed about his/her prescriptions. 4. You read about a new medication that has recently been approved and ask your Pharmacist when your store might get the medication. Your Pharmacist tells you it will be available in a few weeks. 5. You place Blue Trash Bags at all pharmacy workstations to ensure all Confidential Pharmacy trash (excluding food & beverage), Pharmacy records, Front Store confidential materials, and MinuteClinic trash (where applicable) are disposed of properly. Page 15 of 58 Pharmacy Basics: Workbook Medication Identification Now that you have reviewed the different workstations, let’s take a closer look at some of the items we use at those workstations. The first item we’ll look at is a medication stock bottle. Prescription medications arrive from the CVS Warehouse or Outside Vendor in the manufacturer’s packaging. These are called stock bottles. When filling a prescription at Production, it is very important that you match the information on the stock bottle to the information on the prescription label to ensure that you are filling the order with the correct medication. Because of this need for accuracy, you must know what information can be found on a stock bottle and what that information means. Refer to the graphic below to see what information is available on the stock bottle. Page 16 of 58 Pharmacy Basics: Workbook Activity #2 Below you will find a graphic of the front and back of another stock bottle. The table on the following page describes the information that the Food and Drug Administration (FDA) requires on all medication stock bottles. Read the description of each item contained on a stock bottle, and then locate that item on the sample graphic. Page 17 of 58 Pharmacy Basics: Workbook Activity #2 Continued Item Product name Medication Strength Storage Requirement Package Quantity Medication Dosage Form Manufacturer’s Name Controlled Substance Mark Lot Number Expiration Date Description Example from Previous Page All medications have a name. Most medications are available as brand or generic. Brand medications are often designated by a registered trademark ® after their names. This indicates the amount (often milligrams or grams) of the active ingredient. Most medications come in a variety of strengths, which is always clearly visible on the stock bottle label. Medications may have different storage requirements: Most medications are stored at room temperature Some medications must be refrigerated (e.g., Insulin) Different package sizes are available for many different medications. Medications are available in many different dosage forms (e.g., tablets, liquids, ointments, etc.). This name must be listed on the medication stock package. Controlled Substance medication must have the letter “C” and the Roman numeral schedule number (II-V) assigned by the Drug Enforcement Administration (DEA) on the stock bottle. This number indicates the particular batch produced by the manufacturer. Every prescription medication is given an expiration date when manufactured. N/A Page 18 of 58 Pharmacy Basics: Workbook Activity #2 Continued Item National Drug Code (NDC) Number Description Example from Previous Page This 11 digit number is assigned by the manufacturer and placed on all prescription stock packages: National Drug Code 12345 - 6789 - 12 The first five digits of the NDC number identify the manufacturer The middle four digits identify: o Medication name o Strength o Dosage form The last two digits identify the package size NOTE: If the stock bottle only shows 10 digits, you need to add the leading zero to the appropriate section. For example, 7321 - 9234 - 01 should be converted to 07321 - 9234 – 01. Page 19 of 58 Pharmacy Basics: Workbook Types of Medication Understanding the information on the stock bottle will help you find the correct medication, but it is also important that you understand the different kinds of medications in the pharmacy. The medication type can affect how prescriptions are dispensed and what processes you must follow when completing the order. Dosage Forms Active ingredients, along with inactive ingredients, make up a particular dosage form. The various dosage forms are designed to improve taste, appearance, stability, and absorption. Some medications are available in more than one dosage form. When assigned to Drop-off or Production, it is critical you validate you are dispensing the correct dosage form. There are four categories of dosage forms, which are detailed in the tables below. 1. Oral Solids: These medications are taken by mouth. Tablets Tablets are solid dosage forms which can vary in shape and size. Unless otherwise noted, tablets should be swallowed whole, with water. Capsules Capsules are generally small and oblong with a gelatin coating and are filled with medication. Page 20 of 58 Pharmacy Basics: Workbook Dosage Forms Continued 2. Oral Liquids: These medications are taken by mouth. Solutions These liquids are made up of solid medicinal ingredients that are typically dissolved in water. Solutions are usually clear, but may have some color. Suspensions These liquids have medication particles that are suspended in liquid; the medication is not dissolved as it is with solutions. Suspensions must be shaken before being poured into smaller containers. Reconstitutables These medications come as a powder and require a specific amount of distilled water be added. After reconstituting, these medications typically need to be refrigerated and should be discarded after 10-14 days. According to CVS policy only the Pharmacist or Intern, under the direct supervision of a Pharmacist, is allowed to reconstitute. Reconstitution should take place only after the customer has arrived to pick up the prescription. 3. Topicals: These medications are applied directly to the skin. Creams Creams are made of water, oil, and other substances. Creams are less greasy than ointments and are usually absorbed by the skin. Ointments This topical product is typically a greasy preparation, usually with a petroleum jelly base. Lotions Lotions are similar to creams, but contain more liquid. Like creams, they are less greasy than ointments and are absorbed by the skin. Lotions are typically prescribed when needed to cover a larger part of the body. Patches Patches deliver medication through the skin. They typically contain enough medication to leave on anywhere from 12 hours to several days. Gels Gels are suspensions that are set to form a jelly. Gels tend to have a drying effect on the skin. Page 21 of 58 Pharmacy Basics: Workbook Dosage Forms Continued 4. Other: The following medications are administered in various ways. Aerosols Aerosols are sprayable products used to deliver medications. This dosage form is most commonly used for delivering medications to the top of the skin, or for inhaling into the lungs or nasal passages. Suppositories Suppositories are typically manufactured in cylindrical, egg, or pear shapes and are made for insertion into the rectum or the vagina. Otic preparations Otic (ear) medications are typically dispensed from bottle droppers. Ophthalmic preparations Ophthalmic (eye) medications are dispensed in bottle droppers or in an ointment form; these medications must be sterile (i.e., free of bacterial contamination). Injectibles Injectibles are sterile preparations injected with syringes. The most common type stocked in our pharmacies is Insulin. Generic Medications Most medications are available as brand or generic. According to the U.S. Food and Drug Administration (FDA), a generic drug is a copy that is identical to a brand-name drug in dosage, safety, strength, how it is taken, quality, performance and intended use. FDA-approved generic drugs are bioequivalent and therapeutically equivalent to their brand-name counterparts. Dispensing generic medications has become the most effective way we can help our customers manage prescription costs while ensuring their health outcomes. New lower-cost, therapeutically equivalent generics are becoming available at a faster rate than ever and our customers, both those who pay full price for their medications as well as those with insurance coverage, are relying on those generics to control their prescription expenses. Page 22 of 58 Pharmacy Basics: Workbook Activity #3 Scavenger Hunt. Search your Pharmacy for examples of each of the following types of medications. Record the medication name and NDC number in the space allocated below. Always ensure the medication is placed back in the proper area when you are finished. Name NDC Number Tablet Capsule Liquid Ointment Ophthalmic preparation Otic preparation Aerosol Reconstitutable Lotion Insulin Page 23 of 58 Pharmacy Basics: Workbook Controlled Substances As a member of the Pharmacy Team, it is important you are able to recognize prescriptions for controlled substances. Controlled substances are drugs that have a high potential for addiction and abuse. As a result, the manufacture, possession and/or use of controlled substances is strictly regulated by the federal and state governments. Controlled substances are classified into five schedules by federal law. They are: Schedule Schedule I (CI) Schedule II (CII) Schedule III (CIII) Schedule IV (CIV) Schedule V (CV) Description These substances have a high potential for abuse. Currently, no medicinal use is indicated for them. They are not found in retail pharmacies, and it is illegal to possess them in the United States. These medications have a high potential for abuse and also for severe physical and psychological dependence. Prescriptions for CII substances are subject to the most stringent regulations. These medications have potential for abuse, but less potential than those Schedule I or II medications. Abuse of these substances may lead to moderate to low physical dependence or severe psychological dependence. These medications have a lower potential for abuse than Schedules I, II, and III and are less likely to cause physical or psychological dependence. These medications have limited potential for abuse. These medications are generally used as cough suppressants or as anti-diarrheals. There are very specific and stringent regulations pertaining to the handling and dispensing of controlled medications. Some of the requirements and limitations vary depending on the Schedule. Ordering and Receiving Schedule II substances Schedule II controlled substances (CII) are ordered with an official DEA order form (DEA 222 form). Only Pharmacists that have been granted a valid Power of Attorney (POA) can execute a DEA 222. Under no circumstances should a Pharmacist who does not have a valid POA execute or submit a DEA 222. All executed POA forms must be kept on file at the Pharmacy in which the POA is executing 222 forms in sequential order in the appropriate folder in the Regulatory Records Box. It is imperative that once you receive these forms, you ensure that they contain your store’s address and DEA information. Once verified that Page 24 of 58 Pharmacy Basics: Workbook Controlled Substances Continued the forms are for your location, it is required that these forms are stored, submitted and filed properly. At CVS/pharmacy and according to policy, only Pharmacists are allowed to handle CII medications, and they must remain locked in the safe at all times. Dispensing Controlled Substances CVS Pharmacists must dispense controlled substances only pursuant to valid prescriptions that comply with federal and state laws. A prescription is considered valid as long as both of the following requirements have been met. 1. The prescription must have been issued for a legitimate medical purpose by a prescriber, acting in the usual course of his or her professional practice. o If you have a question regarding the validity of a prescription, ask your Pharmacist. o The Pharmacist should document these inquiries on the back of the prescription as allowed by state law (including the name of the person who was spoken to and the time of the conversation). o Even if the prescriber indicates that the prescription should be filled as written, the Pharmacist must use his or her professional judgment to determine whether the prescription was issued for a legitimate medical purpose and in the normal course of professional practice. o Even if a prescription contains all of the required information and otherwise meets the federal and state prescription requirements, it must not be dispensed unless it was written for a legitimate medical purpose. Only the Pharmacist can determine whether a prescription is valid and can be dispensed. The authority of mid-level practitioners to prescribe controlled substances varies by state; you must comply with state law regarding prescribing authority. 2. A controlled substance prescription must contain all required information and meet all federal and state requirements. It is the responsibility of the Pharmacist to ensure all prescriptions are valid, prior to dispensing medication. Page 25 of 58 Pharmacy Basics: Workbook Controlled Substances Continued As a Technician, you must verify that the information has been filled out completely on the prescription. If the prescription was written for a legitimate medical purpose, it must contain all required information including: • • • • • • • • Patient’s full name and address Prescriber’s full name, address and DEA registration number Date the prescription is issued Drug name, strength, dosage form and quantity Directions for use Number of authorized refills, if any Manual signature of the prescriber You must also verify the prescription is written on a tamper proof Rx blank, where required NOTE: The full list of required data elements can be found in the CVS/pharmacy Accepting Prescription policy on RxNet. Pharmacy Support Staff should also be alert for any sign that the prescription is forged or has been altered. Look for “red flags” when working in the Pharmacy and receiving and filling prescriptions for controlled substance(s). All Pharmacy colleagues identifying a potential red flag must bring it to the attention of the Pharmacist. NOTE: When entering prescription information into RxConnect, all Pharmacy colleagues must ensure that correct prescriber information is entered, including the correct prescriber office address. There can be multiple prescribers with similar names and you must make sure that the correct prescriber is identified and selected. Page 26 of 58 Pharmacy Basics: Workbook Controlled Substances Continued Schedule II Dispensing: A Pharmacist may dispense a controlled substance listed under Schedule II only pursuant to an original hard-copy prescription that is manually signed by a practitioner; the original prescription can be an e-prescription in states where electronic prescribing is approved. • Unless they are emergency prescriptions or it is a prescription from a long term care facility or hospice, CII prescriptions may not be dispensed until the Pharmacy receives the original prescription (even if a faxed copy was received in advance). • Must be in writing and manually signed by the prescriber; the original prescription can be an e-prescription in states where electronic prescribing is approved. A partial fill for a CII is allowed if a Pharmacist cannot supply the full quantity written, provided that the Pharmacist notes the quantity supplied on the prescription and the remaining portion is dispensed within seventytwo (72) hours. If the remaining portion cannot be filled within the seventy-two (72) -hour period the Pharmacist must notify the prescriber and get a new prescription. o Partial fills may also be allowed for patients in long term care facilities or with terminal diagnoses. This usually requires proper documentation on the prescription and may not be permitted by your state’s law. Federal law permits an emergency CII prescription to be phoned into the pharmacy, with the amount dispensed limited to that necessary to treat the patient during the emergency period. Please note that company policy further restricts the maximum supply that may be dispensed in this situation to a seventy-two (72) hour supply. • • If the Pharmacy does not receive the written prescription, the Pharmacy team must notify the DEA. • Schedule II prescriptions may not be refilled. However, in some cases, DEA regulations allow practitioners to write multiple prescriptions for Schedule II drugs (e.g., methylphenidate) to be dispensed over a number of months. To be valid, such multiple prescriptions must meet the following requirements, among others: • The total amount prescribed and dispensed pursuant to all of the prescriptions must be limited to a 90-day supply with the original date written on it. Page 27 of 58 Pharmacy Basics: Workbook Controlled Substances Continued • Each prescription must be issued on a separate prescription blank. • Each separate prescription must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his or her professional practice • The practitioner must provide written instructions on each prescription indicating the earliest date the Pharmacy may fill the prescription (in the form of “do not fill until __________”) o Date listed on the Rx must not be predated • The issuance of multiple prescriptions must be permissible under applicable state law. Many states limit the prescribing of Schedule II drugs to a 30-day supply. • In an emergency, a CII prescription may be phoned into the Pharmacy, but the amount dispensed must be limited to the amount necessary, or as required by your state law, to treat the patient during the emergency period and the prescriber must follow up with a written prescription within seven (7) days, or less if required by your state’s law. The Pharmacist must notify the local DEA field office if the prescriber fails to provide a written prescription within the required amount of time required by law. o NOTE: If your state law is more stringent than the federal regulation, the state law must be followed. Schedule III-V Dispensing • Schedule III and V (C III-V) controlled substances may be dispensed pursuant to the following: o A written prescription signed by the prescriber o A faxed prescription as long as the original fax is manually signed by the prescriber • For faxed prescriptions, an electronic, stamped or typed signature is not a valid signature o An oral prescription provided that the prescription is promptly reduced to writing by the Pharmacist and contains all information on a written prescription except for the signature of the prescriber • These verbal prescriptions are maintained with other CIII-V prescriptions Page 28 of 58 Pharmacy Basics: Workbook Controlled Substances Continued Note: If your state law is more stringent than the federal regulation, the state law must be followed. • Schedule III and IV prescriptions may be refilled if authorized on the prescription. However, under federal law, the prescription may only be refilled five times within six months after the original date of issue. After five refills or six months, whichever comes first, a new prescription is required. • Remember that state law may be more stringent. Note: Partial refills are permitted in some states as long as they do not exceed the amount prescribed in 6 months. • Under federal law, Schedule V prescriptions may only be refilled if authorized on the prescription by the prescriber. Note: Some states impose additional limits on controlled substance refills. Partial refills are permitted in some states as long as they do not exceed the amount prescribed in 6 months. Page 29 of 58 Pharmacy Basics: Workbook Knowledge Check Circle the correct answer for each question below. 1. Controlled substances are medications that: a. Cannot be refilled b. Are not available at CVS/pharmacy c. Have potential for abuse d. Are usually over-the-counter medications 2. If the prescription was written for a legitimate medical purpose, it must contain: a. Patient’s full name and address b. Prescriber’s full name, address and DEA Registration number c. Drug name, strength, dosage form, quantity and directions d. Number of authorized refills, if any e. Signature of the prescriber and the date issued Activity #4 Some states have additional requirements related to the handling/dispensing of controlled substances. It is important that you recognize the different schedules and understand the regulations pertaining to each. Ask the Pharmacist to: 1. Review any state specific requirements pertaining to controlled medications in your state. a. One example includes state agencies with specific requirements for the reporting of thefts or losses of controlled substances. Refer to Appendix #2 for the detailed information to review with your Pharmacist. 2. Show you samples of each schedule type and how they are identified on the bottle. Record your notes below: Page 30 of 58 Pharmacy Basics: Workbook Prescription Labels Now that you understand medication types and medication stock bottle labels, let’s take a look at the information provided on prescription labels. Materials In this section, you will review the information found on the prescription label. Ask a Pharmacy Team Member to help you print a label that you can use for the activities in this section. Once this activity is complete, discard the label in the appropriate blue trash bag to ensure confidentiality. The prescription label is produced from the laser printer after prescription information is entered into the Pharmacy Computer System. The label has four sections, and each section is used in a different way (refer to the label you obtained from a Pharmacy Team Member): Section 1: The top section of the label contains the medication label, auxiliary stickers, and ReadyFill Sticker (if applicable). Section 2: The middle section of the label is the customer receipt. This section contains promised date and time, order total, CareCheck Plus offerings, Page 31 of 58 Pharmacy Basics: Workbook Materials Continued Electronic Action Note (if applicable), Patient Care Note (if applicable) and HIPAA Acknowledgement (if applicable). Section 3: The bottom section of the label contains the medication monograph which provides a brief description including uses and side effects. Section 4: The back of the label contains the CVS Notice of Privacy. The purpose of the CVS Notice of Privacy Practices (NoPP) is to comply with HIPAA by informing our patients of the ways we may use their health information and the reasons we may disclose this information to others. The NoPP prints each time we fill a prescription for a new customer and in available in several languages. NoPP procedures vary depending on the state you are working in. Your Trainer will discuss the CVS NoPP procedures with you in your classroom training. Medication Guides Medication Guides are also attached to prescription labels to address issues that are specific to particular drugs and drug classes. They contain FDA-approved information that can help patients avoid serious adverse events. FDA requires that Medication Guides be issued with certain prescribed drugs and biological products when the Agency determines that: • Certain information is necessary to prevent serious adverse effects • Patient decision-making should be informed by information about a known serious side effect with a product, or • Patient adherence to directions for the use of a product is essential to its effectiveness. Page 32 of 58 Pharmacy Basics: Workbook Activity #5 Review Section 1 of your sample label. This section of the label includes: Medication label Auxiliary stickers ReadyFill stickers (if applicable) Does your sample include a ReadyFill sticker? Discuss what the ReadyFill program is with the Pharmacist or a Trainer. Record your notes below. Page 33 of 58 Pharmacy Basics: Workbook The Medication Label The medication label is removed from the prescription label and affixed to the customer’s medication bottle, vial, or package. It contains the following information: Patient name and address CVS store number, address, and telephone number Prescription number Refill information Pharmacist who verified the prescription Date the prescription was filled Date the prescription was written Quantity of medication dispensed Date medication should be discarded Name, strength, dosage form, and manufacturer of medication Directions for taking medication Barcode Prescriber Medication description Cautionary statements Auxiliary stickers Page 34 of 58 Pharmacy Basics: Workbook Activity #6 Use the medication label section of your label to answer the questions below. 1. What is the name of the medication? 2. When was the prescription filled? 3. How many refills are available on the prescription? 4. When should the medication be discarded? Third Party Billing At CVS/pharmacy, over 92% of all prescriptions filled are processed using a third party insurance plan. The term “third party” refers to any plan, group, or person other than the customer that pays for all or part of the cost of a prescription. In the pharmacy, third party typically refers to a plan or group rather than an individual. Common types of third parties include insurance plans funded privately, funded through a customer’s employer, or funded through state or federally-funded programs. Third parties can also include non-insurance based discounts, such as our own Health Savings Pass or medication coupons given to a patient at the doctor’s office or a prescription discount card. CVS bills prescriptions on-line through the computer system for most third party insurances. By doing so, the patient only has to pay for the co-pay portion of the prescription for which he/she is responsible. Page 35 of 58 Pharmacy Basics: Workbook The Customer Receipt The middle portion of the prescription label is called the customer receipt. This receipt is placed on the outside of the prescription bag and is used to file prescriptions numerically in the Waiting Bins. The receipt typically includes the: 1. First two letters of the patient’s last name and date filled 2. Waiting Bin Numeric Assignment 3. Pharmacy address 4. Patient information 5. Prescription information 6. Third Party Plan code and name 7. Safety cap indicator 8. Prescription number, including two-digit refill number 9. Promised date and time 10. Order total 11. Barcode used to scan prescription into the register 12. Quantity of medication being dispensed 13. Refills remaining on the prescription 14. Dispense as Written (DAW) code 15. ReadyFill Indicator Page 36 of 58 Pharmacy Basics: Workbook The Customer Receipt Continued The information indicated on the previous page may vary depending on the type of receipt. There are three types of customer receipts which can often be identified by the Third Party (TP) code located under the Prescriber name: 1. Cash: For these types of receipts, customers pay the full retail price of the prescription. A Third Party Code of 1 or TP: 1 indicates a prescription was not billed to a Third Party. 2. Discounts: In some states, CVS offers a 10% Senior Citizen discount to individuals 60 years of age or older on all prescriptions that are not billed to an insurance plan. The discount will automatically be applied to the patient’s prescription (if applicable). Also, CVS Health employees receive a discount on eligible cash prescriptions. TP: 1 designation will also appear on these receipts, as the medication was not billed to a Third Party. 3. Third Party: Many CVS customers have third party coverage that helps pay for their medication. Usually, these customers are responsible for a co-pay. The copay may be a fixed amount or a percentage of the full price. The amount they must pay will be listed on the receipt. The Third Party Code for these prescriptions will display the name of the customer’s prescription insurance that was used. The receipt portion of the prescription label is placed on the outside of the bag. Page 37 of 58 Pharmacy Basics: Workbook The Customer Receipt Continued The lower portion of the customer receipt may also contain information about different programs, offers, or privacy practices. Examples of what you might see are: CareCheck Plus offering: A program that targets certain prescriptions as they are processed through the Pharmacy Computer System. This program educates the patient about his or her health condition and/or the medication that they have been prescribed. It may provide coupons for over-thecounter products that are directly related to the product being dispensed or specific information concerning the patient’s medication or medical condition. Other messages printed by CareCheck Plus may relate to corporate initiatives such as FLU messaging, requesting donations for ALS at the register, or Minute Clinic messages. HIPAA Acknowledgement: The first time a patient receives a prescription at CVS we must provide our Notice of Privacy Practices (NoPP) and obtain the patient’s electronic signature to acknowledge receipt of it. If the patient is not picking up his/her own prescription an acknowledgement is included on the label so that it can be provided at another time. Electronic Action Note: An Action Note is used by the Pharmacy Staff to document any issues, resolutions, and steps taken contact the patient and resolve the issue. This information must be communicated to the customer. Patient Care Note: Patient Care Notes allow pharmacy teams to interact with patients effectively to help improve health outcomes through adherence to prescribed therapy. You will learn more about Patient Care Notes and the specific programs they support. As an example, these notes may indicate that the Pharmacist must counsel the patient, or the Team Member at Pick-up may need to communicate program specific information to the patient. In some instances Patient Care Notes will print on the prescription label and in others, they will need to be stapled to the outside of the prescription bag. Page 38 of 58 Pharmacy Basics: Workbook The Customer Receipt Continued Always review the customer receipt thoroughly prior to ringing the sale to ensure the patient name on the pharmacy register matched the customer receipt. You will be prompted by the pharmacy register when Counseling is required. Inform the patient that the Pharmacist has important information about one of their prescriptions, direct them to the counseling area and notify the Pharmacist that counseling is required. Activity #7 In order to help you recognize and understand the parts of a prescription label receipt, use your sample label to answer the questions below. 1. What is the type of the receipt? 2. What is the price the patient will pay for the prescription? 3. What is the prescription number? 4. What quantity of medication was dispensed? 5. What type of cap (safety or non-safety) will the patient receive? 6. How many prescriptions are in the order? 7. Is the prescription enrolled in ReadyFill? Page 39 of 58 Pharmacy Basics: Workbook Electronic Action Notes An Action Note is used to document information that needs to be communicated to the customer. Electronic Action Notes document any issue with a prescription, attempts to resolve the issue, and attempts to contact the customer regarding the issue. Team Members at Drop-off or Production may be prompted by the pharmacy computer system to contact the patient with an issue and complete an Electronic Action Note. The Action Note will print on the label receipt. Page 40 of 58 Pharmacy Basics: Workbook Action Note Responsibilities The proper use of an Action Note benefits our customers as well as everyone in the pharmacy. It is important to know the Action Note at each workstation. Workstation Action Note Responsibility Drop-off The Team Member at Drop-off is most often the originator of the Action Note. When an issue arises, the Team Member at Drop-off is prompted by the pharmacy computer system to: Production Quality Assurance Contact the patient to reset expectations Enter the result of your attempt to contact the patient into the pharmacy computer system The Team Member at Production may be the first person to identify a partial fill or out-of-stock situation. When this occurs, the Team Member must edit the prescription to reflect the partial or out-ofstock and: Contact the patient to reset expectations Enter the result of your attempt to contact the patient into the pharmacy computer system If an issue arises, the QA Pharmacist is prompted by the pharmacy computer system to: Contact the patient to reset expectations Pick-up Drive-thru Enter the result of the attempt to contact the patient into the pharmacy computer system The Team Member at Pick-up is responsible for communicating information on an Action Note, as prompted by the pharmacy register. The Team Member at Drive-thru has the same responsibility as Pick-up. Page 41 of 58 Pharmacy Basics: Workbook Viewing an Action Note for a Prescription You can access and review Action Note information in: • • The Pharmacy computer system: If a patient calls to inquire about a recent call to their home, it may be due to an issue with their medication. You can access their Patient Profile to view the Action Note. • When the Action Note indicator is orange, it indicates that the issue regarding the prescription has not yet been communicated to the customer. • When the indicator is gray, it means that the Action Note and the issue has been communicated to the customer. At the Pharmacy register at time of pick-up: At Pick-up and Drive-thru, Team Members will have visibility to Action Notes and the information needed to communicate the issue to the customer. Page 42 of 58 Pharmacy Basics: Workbook Communication Vehicles Pharmacy Team Members have various ways of communicating with each other, other stores, Field Management, and the Customer Support Center. In this section, you will learn about a few examples of how information is exchanged. Spark Spark is the CVS Enterprise Portal used to access web-based tools designed to improve communication, provide access to key business information, and support our commitment to flawless execution. Spark provides stores with a single point of access to tools such as: E-mail: Stores receive emails from the Contact Support Center as well as Field Management. It is important for emails to be read and printed on a daily basis for other Team Members to review. Hub: A central location that allows Store Teams to review workload, assign accountability and completion dates, create store-specific tasks, print to-do lists, and mark tasks completed once they are performed. RxNet: An intranet site available that contains various reference and resource materials for the Pharmacy Team. Bulletin Board: Contains Announcements and Reference Materials. Links: Access to key websites and applications. Reports: Access to Store Level reporting for various programs and processes. Once logged in to the CVS Enterprise Portal, you can easily access all of the applications available on the Spark home page without having to log into each application separately with different passwords. Page 43 of 58 Pharmacy Basics: Workbook Activity #8 Ask a Pharmacy Team Member to help you access Spark from the Pharmacy Computer System. 1. View any tasks in the Hub for you to complete and record those tasks in the space below. 2. Access the store e-mail and send a message to your Pharmacy Trainer. Enter the following in the Subject line: “ (Your name) Completing Pharmacy Basics Workbook”. Page 44 of 58 Pharmacy Basics: Workbook RxNet RxNet is a CVS Intranet site available from Spark. The following items are a few examples of the information available on RxNet: Patient Care Initiative (PCI) Programs Page: Provides access to CVS Health program information aimed at improving patient outcomes RxConnect Support Page: Support site for the pharmacy computer system Quality Assurance: Site dedicated to patient safety including best practices, procedures and incident reporting Clinical Services Page: Professional support such as the Drug Information Center, Immunization Program, and Compounding Corner Inventory Management Tab: Provides access to the Inventory Management Guide, ordering information, and Drug Recalls Payer Relations: A resource for key third party information Pharmacy Operations Manual: A reference tool that provides the Pharmacy Team with the direction necessary to run the department Pharmacy Workload Calendar: A monthly calendar that identifies the key activities that must be completed by the Pharmacy Team Language Line Services: Provides information about our Telephonic translation service of approximately 150 languages which is offered to patients that do not speak or understand English Page 45 of 58 Pharmacy Basics: Workbook Activity #9 Ask a Team Member to help you access RxNet from the Pharmacy Computer System. Explore the following: 1. Inventory Management Reference Guide 2. Pharmacy Operations Manual 3. Your state-specific reference page Record your notes in the space below. Page 46 of 58 Pharmacy Basics: Workbook V-NET (Voice Networking) and Contact Information Calls can be made between stores or to the Support Center by using the CVS calling plan system, better known as V-Net. Calls are dialed as follows: Contact Calling other stores Calling individual extensions at the Contact Support Center Helpdesk for all technical support, human resource support or program support. (For example, RxConnect problems, printer repairs, Third Party issues, Human Resource issues) Telephone Number 1-700-600-XXXX (XXXX = store #) 1-700-602-XXXX (770-XXXX = extension #) Calling the FIXX line for repairs 1-866-349-9287 1-866-528-7272 NOTE: In most stores, you will first need to dial ‘9’ to obtain an outside line. Red Bag Red Bags are an interoffice mail system. Hard copy communications and other items that need to be delivered to the stores are delivered via Red Bag. For example, Connections is a CVS newsletter that keeps all CVS colleagues informed about changes, initiatives, and important news within the company. CVS.com CVS.com is an extension of our CVS/pharmacy stores with 24/7 convenience. It contains industry leading online tools and services that complement the CVS Health Vision, Mission, and Values. The site provides health and drug information to empower the CVS customer to take charge of their health, improving the quality of their lives. The key prescription management services available on CVS.com include: • View your CVS prescription profile online • View/print your CVS prescription history • Submit prescription refills online for pick-up at any CVS/pharmacy location • Check the status of prescriptions online • Set up email refill reminders • Request prescriptions to be transferred from competitor pharmacies and filled at any CVS/pharmacy location Page 47 of 58 Pharmacy Basics: Workbook Activity #10 To take advantage of the advanced prescription management features offered online, visit CVS.com, create an account (if not already a registered user), and become familiar with the site and the features available. 1. Create a CVS.com account by providing an email address and password 2. Sign-up for prescription management by providing the store and prescription number from a CVS prescription and answering a few questions to ensure the prescription history is accessible only to you Explore the site and list the benefits that you think the Pharmacy Team will see by patients using the site. Record your notes in the space below and discuss the Pharmacy Teams benefits with a Team Member. Page 48 of 58 Pharmacy Basics: Workbook Course Completion Congratulations! You have completed the Pharmacy Basics workbook. You should now be able to: Describe key information included on the stock bottle Identify the various types of medication dosage forms Recognize the elements of prescription labels Recognize medication schedules Identify and communicate Action and Patient Care Notes correctly Identify the different communication vehicles used in the pharmacy 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 Pharmacy Basics Workbook course description page on LEARNet. Please contact your Trainer with any questions/concerns. Once you have completed the assessment, you will attend the Foundations of Pharmacy class. Remember to bring your completed workbook to the Foundations of Pharmacy class. Your Trainer will review the activities during class. Page 49 of 58 Pharmacy Basics: Workbook Appendix #1: Knowledge Check Answer Key The following provide answers to the knowledge check questions from this course. The Activities will be reviewed during the Foundations of Pharmacy class. Pharmacy Settings Question Your Answer 1. Which type of pharmacy setting do you work in if you work at a pharmacy CVS retail store? Community Retail Pharmacy 2. Which other types of pharmacy settings do you think there are there at CVS Health? As you answer this question, think about our services such as Omnicare and other ways that our patients receive their filled prescriptions from CVS Health. Compounding Community Pharmacy (Specialty Services), Long-term Care Pharmacy (Omnicare), and Mail-Order Pharmacy The Pharmacy Workflow Workstation Roles and Responsibilities Quality This workstation, which is staffed by a Pharmacist, is where final Assurance accuracy checks are completed prior to dispensing a prescription to the patient. Production The Team Member assigned to this workstation fills prescriptions to keep the process flowing and to ensure that the patient receives the correct medication(s) when promised. Drive-thru At this station the Team Member is responsible for both Drop-off and Pick-up tasks. Drop-off This is a critical piece of the prescription fulfillment process. When a customer brings a prescription to the pharmacy, the interaction at this workstation is the customer’s first indication of the service level that will be provided by the pharmacy team. Pick-up Team Members serve customers picking up their prescription(s) in the store. Page 50 of 58 Pharmacy Basics: Workbook Appendix #1: Knowledge Check Answer Key Continued Regulation Scenarios Regulation or Agency Scenario 1. A patient gives you her medication vial. She explains that she would like to exchange the safety cap for a non-safety cap because she is unable to open the vial. CPSC 2. A license for each Pharmacist that works in the store is displayed on the wall. State Board 3. You make the Offer to Counsel (per state regulations) to ensure the patient is fully informed about his/her prescriptions. OBRA ‘90 4. You read about a new medication that has recently been approved and ask your Pharmacist when your store might get the medication. Your Pharmacist tells you it will be available in a few weeks. FDA 5. You place Blue Trash Bags at all pharmacy workstations to ensure all HIPAA Confidential Pharmacy trash (excluding food & beverage), Pharmacy records, Front Store confidential materials, and MinuteClinic trash (where applicable) are disposed of properly. Medication Identification Item Answer Product name Plavix Medication Strength Storage Requirement Package Quantity Medication Dosage Form Manufacturer’s Name Controlled Substance Mark Lot Number Expiration Date National Drug Code (NDC) Number 75 mg 25o C (77o F) 90 Tablets Bristol-Myers Squibb N/A F6843 08 - 2009 63653-1171-1 Controlled Substances 1. Controlled substances are medications that: a. Cannot be refilled b. Are not available at CVS/pharmacy c. Have potential for abuse d. Are usually over-the-counter medications Page 51 of 58 Pharmacy Basics: Workbook Appendix #1: Knowledge Check Answer Key Continued 2. If the prescription was written for a legitimate medical purpose, it must contain: a. Patient’s full name and address b. Prescriber’s full name, address and DEA Registration number c. Drug name, strength, dosage form, quantity and directions d. Number of authorized refills, if any e. Signature of the prescriber and the date issued Page 52 of 58 Appendix #2: Reporting Thefts or Losses of Controlled Substances Colleague Responsibility Federal regulations require that thefts and significant losses of controlled substances be reported to the DEA. The DEA must receive initial notification of the theft or loss of controlled substances within 24 hours of discovery of the theft or loss. Therefore, it is important that all CVS/pharmacy colleagues immediately report any suspected theft or loss of a controlled substance to the Pharmacist on duty, who is responsible for executing their due diligence to confirm the loss within 72 hours and filing the Initial Notification with 24 hours of confirmed loss. CVS/pharmacy wants to ensure the security of controlled substances and prevent the possible diversion of prescription drugs to addicts or criminals. We also must prevent diversion of drugs by CVS/pharmacy colleagues. Pharmacy colleagues must immediately report an incident to the Pharmacist on duty so that the appropriate investigation and notifications can take place. The incident should also be reported to the Ethics Line by calling 877-CVS-2040 or online at www.cvscaremarkethicsline.ethicspoint.com. If a colleague is not comfortable reporting an incident to the Pharmacist on duty, then the incident must immediately be reported to the Ethics Line by calling 877-CVS-2040 or online at www.cvscaremark-ethicsline.ethicspoint.com. Incidents to be reported: • • • You suspect that there may have been a theft of controlled substances You suspect unauthorized access to or any breach of security regarding controlled substances You believe that there has been an unexplained loss of controlled substances, which might include: o a loss of a significant amount of a controlled substance o a pattern of losses o any other suspicious circumstances regarding the loss of controlled substances Page 53 of 58 Appendix #2: Reporting Thefts or Losses of Controlled Substances, continued The Reporting Process The Pharmacist on duty must report the loss or theft of controlled substances immediately upon discovery. The Initial Notification of Suspected Controlled Substance Theft or Potential Significant Loss Form must be filled by using the electronic Initial Notification of Suspected Controlled Substance Theft or Potential Significant Loss Form (available in Spark under the “Applications” tab) and notify his/her District Leader or Target Pharmacy Supervisor of the situation within 24 hours of discovery of theft or loss. The Pharmacist on Duty must complete the electronic Initial Notification form located within Spark in full, listing the correct fax numbers for the nearest DEA Field Office, State Board of Pharmacy (where applicable) and/or State Controlled Substance Authority (where applicable.) The Spark application will automatically send a copy of the form to CVS Drug Loss Program team at Drug_Loss_Program@CVSHealth.com. The information from the Initial Notification Form and the Mandatory Internal Coversheet will be entered into the Archer Drug Loss Program Database (“Archer DLP”) by a member of the Drug Loss Program team. Upon completion, the Drug Loss Program team will distribute a copy of the Initial Notification form identifying theft or significant loss to the store via fax, which needs to be stored in the correct folder in the Regulatory Records Box. The Pharmacist must also notify his or her District Leader or Target Pharmacy Supervisor within 24 hours of any theft or potential loss involving controlled substances. At the conclusion of a case involving a loss, a Drug Loss Program team member will submit the closing documentation (DEA 106 form or Letter of Conclusion) to the applicable regulatory agencies. Once the DEA 106 form or Letter of Conclusion has been completed, the Pharmacy will receive and must retain a copy of all paperwork including the Initial Notification form (if received from the Drug Loss Program team), completed DEA 106 form or letter of conclusion in the Regulatory Records Box. Before filing submitted 106 forms in your Regulatory Records box, please ensure that your store is following the security measures that are documented on section 17 of the form. • All thefts, regardless of the quantity involved, must be reported. This includes if the Pharmacy is the victim of colleague theft, armed robbery, burglary, “snatch and grab” or other similar incidents where controlled substances or listed chemicals are taken. All “significant losses” of controlled substances must be reported. The DEA has not defined “significant,” so the Drug Loss Program will make the determination, with the assistance of Legal, as to whether a loss qualifies as “significant.” NOTE: For controlled substance liquids, particularly Schedule II liquids, accurate dispensing is important as even small amounts of overdispensing or small quantities remaining in dispensing vessles can add up to a signficant loss over time. Page 54 of 58 If you have any legal questions regarding theft/loss reporting, you may send your question to Drug_Loss_Program@CVSHealth.com. Appendix #2: Reporting Thefts or Losses of Controlled Substances, continued In some cases, the state agency may have different time requirements for the filing of theft/loss notifications or reports, may require that events other than theft or “significant loss” be reported and may require the use of a specific state reporting form. Some states have their own theft/loss reporting requirements, and it is the responsibility of any Pharmacist working in those states to be aware of the specific state requirements. All colleagues handling controlled substances should be thoroughly familiar with CVS/pharmacy policies and procedures on reporting of thefts/losses of controlled substances. The critical role of each CVS/pharmacy colleague is as follows: Colleague Responsibility All CVS Colleagues • Pharmacist on duty • • • • • District Leader or Target Pharmacy Supervisor • • The colleague discovering the theft or loss of a controlled substance should report the matter to the Pharmacist on duty. If the colleague is not comfortable reporting to the Pharmacist on duty, he/she may notify the Ethics Line by calling 1-877CVS-2040. The Pharmacist on duty must report the suspected loss or theft of controlled substances within immediately upon discovery by electronically submitting an Initial Notification of Suspected Controlled Substance Theft or Significant Loss Form. The Pharmacist on duty must complete the electronic Initial Notification of Suspected Controlled Substance Theft or Significant Loss Form which is available in RADAR, under the “Applications” tab and be sure to o Complete it in full o List the correct fax numbers for the nearest DEA Field Office and State Board of Pharmacy (where applicable) The Spark application will automatically send a copy of the form to the CVS Drug Loss Program team at Drug_Loss_Program@CVSHealth.com. Police must also be notified of all thefts. The Pharmacist must also notify his or her District Leader or Target Pharmacy Supervisor within 24 hours of any theft or loss involving controlled substances. The District Leader or Target Pharmacy Supervisor will coordinate the investigation with Loss Prevention and is responsible for filling in the 106 fields in the Archer DLP. Note: If you are not familiar with the Archer DLP please refer to course # 820001. Page 55 of 58 Appendix #2: Reporting Thefts or Losses of Controlled Substances, continued Once reported to the District Leader or Target Pharmacy Supervisor, the District Leader or Target Pharmacy Supervisor must: • Confirm that the Initial Notification form was submitted to the appropriate regulatory agencies • Coordinate with Loss Prevention to initiate an investigation of the incident • If the incident is a theft, it must also be reported to local law enforcement • Upon completion of the investigation, complete the 106 fields in the Archer DLP so that Rx Regulatory can submit the DEA 106 Form • If the investigation remains ongoing for more than 30 days, update DEA (and state authorities, if applicable) with a letter of continuation every 30 days until the investigation is complete What must be reported? If questionable or suspicious activity is observed you must report these activities. Furthermore, all violations of company policy or procedure must be addressed individually and the appropriate field management notified. To report this activity, you may provide the information to: District Leader or Target Pharmacy Supervisor RLPM Regional Director or HR Business Partner The Ethics Line at 1-877-CVS-2040 Failure to timely report a potential violation of the law or company policy related to controlled substances can lead to action up to and including termination. The information on suspicious activity you are expected to provide does not have to be a result of witnessing diversion. You are expected to report on suspicions or indications that diversion may be occurring. The Loss Prevention department’s role is to validate concerns and report findings to the appropriate parties. All information is handled discreetly and confidentially. Similarly, there are times that you as a Pharmacist may be asked for information or participate in an investigation. All LP investigations are confidential. Please do not discuss actions or details with anyone other than the LP department. This will jeopardize the investigation and prolong a loss. Additionally, questions or concerns about diversion or potential diversion can be directed to Drug Loss Program team at Drug_Loss_Program@CVSHealth.com. Page 56 of 58 Appendix #2: Reporting Thefts or Losses of Controlled Substances, continued In-Transit Losses “In-transit” losses are those losses that occur while controlled substances or listed chemicals are en route from one facility to another (e.g., from a wholesaler to a distribution center, or from a distribution center to a retail store). All in-transit losses must be reported to the DEA, regardless of the quantity of controlled substances involved. Pharmacists and Pharmacy colleagues must notify the Pharmacy Team Leader or the Pharmacist on duty immediately of any shortages in shipments of controlled substances received in the Pharmacy. The Pharmacy Manager or Pharmacist must refuse any shipment from an outside vendor if any shortage or discrepancy is identified. The Pharmacy Manager or Pharmacist on duty must immediately notify their District Leader or Target Pharmacy Supervisor, Loss Prevention and Distribution Services (if the order is being received from a distribution center) upon discovery of an in-transit loss. • Penalties for Violations • Consequences: • Failure to report thefts or losses in a timely manner can result in serious consequences for the company, including monetary penalties and other sanctions. • Failure by a colleague to immediately report a potential theft or loss of a controlled substance or a security breach regarding controlled substances can result in disciplinary action, up to and including termination. • We will promptly investigate any incident involving the theft or loss of controlled substances or listed chemicals. • Any colleague involved in stealing or diverting controlled substances, listed chemicals or other drugs will be terminated. Information about the incident also will be turned over to law enforcement and state authorities, including state Boards of Pharmacy. Page 57 of 58 Payroll Slip for Pharmacy Basics Self-paced Workbook In order to be paid properly for completing this workbook and assessment, you must then complete this form and give it to your Home Store Manager who will record the appropriate number of hours under the payroll code indicated. Employee Name: ___________________________ Day: __________________________________ Start Time*: _______________ End Time*: ________________ EMP ID: _______________ Date: ______ / ______ / ______ Total Hours to be charged to TR7 Payroll*: __________ *Include time spent reading the workbook and completing the on-line assessment. Employee Signature: ________________________________________________ Home Store Manager – Retain this form with your payroll records for the appropriate time period. Page 58 of 58