POLICIES AND PROCEDURES. Pharmacy Services for Nursing Facilities

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1 POLICIES AND PROCEDURES Pharmacy Services for Nursing Facilities

2 Contents I. GENERAL POLICIES AND PROCEDURES A. Organizational Aspects 1. Provider Pharmacy Requirements Consultant Pharmacist Services Provider Requirements Arrangements with Noncontract Pharmacy... 6 B. Medication Orders 1. Non-Controlled Medication Order Documentation Controlled Substance Prescriptions Stop Orders Standing Orders Therapeutic Interchange C. Medication Ordering and Receiving from Pharmacy 1. Pharmacy Hours and Delivery Schedule Pharmacy Delivery Ordering and Receiving Non-Controlled Medications from the Dispensing Pharmacy Receiving Controlled Substances Emergency Pharmacy Service and Emergency Kits Multiple Source Drug Products House-Supplied (Floor Stock) Medications Medication Labels Medication Packaging Medications Brought to the Facility by a Resident or Responsible Party Personnel Authorized to Handle Medications in the Facility D. Medication Storage in the Facility 1. Storage of Medications Controlled Substance Storage Bedside Medication Storage E. Disposal of Medications and Medication-Related Supplies 1. Controlled Substance Disposal Discharge With Medications POLICIES AND PROCEDURES Pharmacy Services for Nursing Facilities i

3 Contents 3. Discontinued Medications Returning Medications to Pharmacy Medication Destruction F. Miscellaneous Special Situations 1. Out-on-Pass Medications/Leave of Absence Use of Investigational Medications Medications Not Covered by Third-Party Payers Medications Brought into the Facility by Physicians or Residents/Family Members Drug Product Defect Reporting Drug Product Recalls Box Warning Medications Unavailable Medications II. MEDICATION ADMINISTRATION A. Preparation and General Guidelines 1. Equipment and Supplies for Administering Medications Medication Administration General Guidelines Vials and Ampules of Injectable Medications Infusion Therapy Products General Information Reconstitution of Medication for Parenteral Administration Preparation of Emergency or Short-Stability Infusion Therapy Products Controlled Substances Irrigation Solutions General Guidelines for Administering Medication via Enteral Tube Self-Administration of Medications Multi-Dose Medication Delivery System B. Specific Medication Administration 1. Administration For All Medications Oral Medication Administration Sublingual, Buccal, and Transmucosal Medication Administration Nasal Administration Eye Drop Administration Policies and : Pharmacy Services for Nursing Facilities ii

4 Contents 6. Eye Ointment and Gel Administration Ear Drop Administration Oral Inhalation Administration Rectal Suppository Administration Rectal Enema Administration Vaginal Medication Administration Enteral Tube Medication Administration Transdermal Drug Delivery System (Patch) Application Injectable Medication Administration Topical Medication Administration III. MEDICATION MONITORING A. Consultant Pharmacist Reports 1. Medication Regimen Review (Monthly Report) Documentation and Communication of Consultant Pharmacist Recommendations B. Medication Monitoring and Management 1. Monitoring of Medication Administration Medication Management Preventing and Detecting Adverse Consequences and Medication Errors Continuous Quality Improvement (CQI) of the Medication Use Process Standing Orders for Routine Medication Therapy Monitoring (Optional) POLICIES AND PROCEDURES Pharmacy Services for Nursing Facilities iii

5 ORGANIZATIONAL ASPECTS IA1: PROVIDER PHARMACY REQUIREMENTS Policy Regular and reliable pharmaceutical service is available to provide residents with prescription and nonprescription medications, services, and related equipment and supplies. A written agreement with a provider pharmacy stipulates financial arrangements and the terms of the services provided. If the provider pharmacy also provides consultant pharmacist services and/or infusion therapy products, separate contracts/agreements/addendums are maintained for each service. A. The facility maintains a written agreement with the provider pharmacy, signed by the administrator and an authorized representative of the provider pharmacy. B. The provider pharmacy maintains a current pharmacy permit/license as required by state regulation as well as any other mandated business or professional credentials as well as adequate professional liability insurance and provides proof of it to the facility upon each renewal. C. The provider pharmacy is responsible for rendering the required service in accordance with local, state, and federal laws and regulations; facility policies and procedures; community standards of practice; and professional standards of practice. D. The provider pharmacy agrees to perform the following pharmaceutical services, including but not limited to: 1) Assisting the facility, as necessary, in determining the appropriate equipment and packaging to meet the medication needs of the residents and the facility. 2) Accurately dispensing prescriptions based on authorized prescriber orders. 3) Providing medications packaged in accordance with the facility s needs and equipment requirements. 4) Supplying only approved medications, biologicals, and supplies, other than extemporaneously compounded medications or investigational drugs. 5) Labeling all medications dispensed in accordance with the medication labeling policy and with state and federal requirements. 6) Providing routine, timely, and emergency pharmacy service 24 hours per day, seven days per week. a. Emergency or stat medications are available for administration as soon as possible after the order is received by the pharmacy. b. All other new medication orders are received and available for administration as soon as possible on the next routine delivery, unless indicated otherwise by facility staff. Medications will be delivered by the primary pharmacy or back-up pharmacy, or are available from the emergency medication kit. 7) Performing an initial medication use assessment for each new resident. 8) Maintaining a medication profile on each resident that includes all medications dispensed and facility-provided information such as resident s age, diagnoses, weight, condition, medication allergies, diet, and any other pertinent information. 9) Reviewing the resident s profile prior to dispensing any medication. Page 1 of 121

6 10) Screening each new medication order for an appropriate indication or diagnosis; for medication interactions; for duplication of therapy with other drugs in the same therapeutic class ordered for the resident; and for appropriate drug dose, dosing interval, and route of administration, based on resident specific information and other pertinent variables. If diagnosis or indication is not available, notifying the nursing staff of the need to obtain the information from the prescriber prior to administering the drug. 11) Providing medication information and consultation to the facility s nursing staff. 12) Providing, maintaining, and replenishing an emergency medication supply in a sealed and properly labeled container in a timely manner. 13) Assisting the prescriber in documenting the medical necessity for a non-covered or non-formulary medication ordered for a resident otherwise eligible for medication benefits through Medicare, Medicaid or other third-party programs, or providing therapeutic alternatives to the prescriber that are covered. Page 2 of 121

7 ORGANIZATIONAL ASPECTS IA2: CONSULTANT PHARMACIST SERVICES PROVIDER REQUIREMENTS Policy Regular and reliable consultant pharmacist services are provided to residents. A written agreement with a consultant pharmacist stipulates financial arrangements and the terms of the services provided. A. The facility maintains a written agreement with the consultant pharmacist or with the provider pharmacy if providing consultant pharmacist services, signed by the administrator and the consultant pharmacist or appropriate pharmacy representative. B. The consultant pharmacist maintains current licensure and any other mandated professional or business requirements and adequate professional liability insurance. C. The consultant pharmacist agrees to render the required service in accordance with local, state, and federal laws, regulations, and guidelines; facility policies and procedures; community standards of practice; and professional standards of practice. D. The facility agrees to notify the consultant pharmacist of each new resident admitted to the facility, for example, by providing a current census at each consultant pharmacist visit and upon request by the consultant pharmacist. E. The consultant pharmacist provides consultation on all aspects of the provision of pharmacy services in the facility. In collaboration with facility staff, the consultant pharmacist helps to identify, communicate, address, and resolve concerns and issues related to the provision of pharmaceutical services. This includes, but is not limited to: 1) Working with facility staff on the development, implementation, evaluation, and revision of pharmaceutical services procedures, helping assure that the procedures address the needs of the residents and reflect current standards of practice. 2) Evaluating the process of receiving and interpreting prescribers orders; acquiring, receiving, storing, controlling, reconciling, compounding, dispensing, packaging, labeling, distributing, administering, monitoring responses to, and using and/or disposing of all medications, biologicals, and chemicals. 3) Assisting in the destruction of medications on location under state and federal guidelines, when appropriate. 4) Assisting in the identification and evaluation of medication-related issues, including the prevention and reporting of medication errors and the provision and monitoring the use of medication-related devices. 5) Advising on the coordination of pharmaceutical services if multiple pharmaceutical service providers are utilized, (e.g., provider pharmacy, infusion services, prescription drug plans). 6) Providing consultation on medication delivery systems and packaging. 7) Identifying one or more current medication references to facilitate the identification of medications and information on contraindications, side effects and/or adverse effects, dosage levels and other pertinent information. 8) Assisting facility in defining schedules for administering medications to maximize the effectiveness, maintain appropriate serum concentrations (e.g., antibiotics, pain medications), to avoid potential medication interactions, and, when possible, considering residents choice. Page 3 of 121

8 9) When appropriate, reviewing the Resident Assessment Instrument (RAI) or care plan and the Minimum Data Set (MDS), and participating in interdisciplinary care planning sessions. 10) Assisting in the assessment and improvement in nursing staff medication administration, including infusion therapy and use of medication delivery and testing devices, through medication pass observation and through medication record reviews. 11) Collaborating with facility leadership in setting standards and developing, implementing, and monitoring policies and procedures for the safe and effective distribution, control, and use of medications and related equipment and services in the facility. 12) Helping develop medication-related documentation procedures, (e.g., identification of abbreviations approved for use in the facility). 13) Assisting in establishing quality assurance and continuous quality improvement (CQI) activities regarding the medication use process: prescribing; dispensing; storing; administering; and monitoring of medications in the facility. 14) Developing mechanisms for communicating, addressing, and resolving issues related to pharmaceutical services. 15) Serving on facility committees as required or requested. 16) Identifying educational and informational needs about medications and medication use. 17) Providing medication and other clinical information from sources, such as nationally recognized organizations, to the facility staff, practitioners, residents, and families as needed. 18) Participating on the interdisciplinary team to address and resolve medication-related needs or problems. F. Specific activities that the consultant pharmacist or designated pharmacy personnel performs includes, but is not limited to: 1) Reviewing the medication regimen (medication regimen review) of each resident as required by regulations, or more frequently under certain conditions (e.g., upon admission or with a significant change in condition), incorporating federally mandated standards of care in addition to other applicable professional standards as outlined in the procedure for medication regimen review, and documenting the review and findings in the resident s medical record or in a readily retrievable format if utilizing electronic documentation. 2) Communicating to the responsible prescriber and the facility leadership potential or actual problems detected and other findings relating to medication therapy orders as well as recommendations for changes in medication therapy and monitoring of medication therapy. 3) Checking the emergency medication supply to ascertain that it is properly sealed and stored and that the contents are not outdated. 4) Checking the medication storage areas, and the medication carts, for proper storage and labeling of medications, cleanliness, and removal of expired medications. 5) Checking for availability of one or more current medication references to facilitate the identification of medications and information on contraindications, side effects and/or adverse effects, dosage levels and other pertinent information. If needed, the consultant pharmacist will provide the facility with a list of appropriate references. 6) Submitting a written report and recommendations for each review of medication storage. 7) Reviewing medication administration records (MARs), treatment administration records (TARs) and physician orders to ensure proper documentation of medication orders and administration of medications to residents. 8) Participating in other facility activities as requested by administrator or director of nursing and as agreeable to both parties. Page 4 of 121

9 G. The consultant pharmacist documents activities performed and services provided on behalf of the residents and the facility. 1) A written or electronic report of findings, recommendations and irregularities resulting from the activities as described above is given to the administrator, director of nursing and medical director. a. Additional findings of irregularities shall be given to the attending provider, nursing department or other department as appropriate. 2) Resident-specific recommendations are documented in the resident s active medical record. 3) Attending providers are required to document in the resident s medical record that the identified irregularity has been reviewed and what, if any, action has been taken to address it. If there is to be no change in the medication, the attending provider should document the rationale in the resident s medical record. 4) The facility will develop and maintain specific policies and procedures for the monthly drug regimen review that will guide time frames for the different steps in the process and steps the pharmacist must take when a irregularity is identified that requires urgent action to protect the resident. Page 5 of 121

10 ORGANIZATIONAL ASPECTS IA3: ARRANGEMENTS WITH NONCONTRACT PHARMACY Policy A resident or responsible party may request that medications be obtained from a pharmacy other than the facility s contract provider pharmacy. Such noncontract pharmacies will adhere to facility medication policies and procedures and assure delivery on a timely basis. This and other relevant policy and procedures are provided to the noncontract pharmacy provider. A. The facility informs the resident and/or responsible party about relevant policies and procedures related to purchasing medications from a noncontract pharmacy. The facility informs the noncontract pharmacy of the facility s policies and procedures regarding medication services. 1) The person distributing these copies documents this activity and signs and dates the entry. 2) Notification of agreement by the noncontract pharmacy to strictly adhere to the facility policy and procedure (including labeling and packaging requirements) for pharmacy services is documented in the resident s business office record. B. The contract provider pharmacy is informed about the arrangement with the noncontract pharmacy. C. The business office representative notifies the charge nurse of the resident s choice of a noncontract pharmacy after the noncontract pharmacy has agreed to the terms of this policy. D. The charge nurse prominently marks the resident s current medication administration record (MAR) and/or medical record with the name of the selected noncontract pharmacy. E. The facility orders and receives medications from the noncontract pharmacy in accordance with the procedures for ordering and receiving medications from the dispensing pharmacy. F. The noncontract pharmacy provides medications, herbals, biologicals, supplies and services in accordance with all applicable requirements of federal, state, and local laws, rules and regulations, and standards of practice and utilizes similar dispensing, labeling, and packaging systems as the contract provider pharmacy in order to provide safe and accurate medication administration by the facility nursing staff. 1) If the noncontract pharmacy does not comply with the facility s policies and procedures, the administrator may inform the resident and/or responsible party that pharmacy services will be provided by the contracted pharmacy. G. The noncontract pharmacy provides routine and timely pharmacy service; emergency or stat medications are available for administration as soon as possible after the order is prescribed. 1) All other new medication orders are received and available for administration as soon as possible on the next routine delivery, unless indicated otherwise by facility staff. If a delay is anticipated or actualized, medications will be ordered/delivered by the primary pharmacy or back-up pharmacy, or will be taken from the emergency medication kit. 2) If the noncontract pharmacy declines to promptly supply an emergency medication for any reason, the facility shall be notified as to the reason. a. The contract provider pharmacy for the facility may then be requested to fill an emergency order that complies with facility policy and procedure. b. If the request is for a Schedule II medication, the following applies: Page 6 of 121

11 1. The contract provider pharmacy will obtain verbal authorization from the prescriber and an emergency supply quantity will be dispensed. 2. A follow-up written prescription is sent to the contract provider pharmacy by the prescriber within 7 days. A facsimile order may be sent to the provider pharmacy if the prescriber writes it and includes all required documentation on the order. c. The facility will assist the contract provider pharmacy by furnishing the necessary information for performing this service by: 1. Providing billing information for the resident and/or noncontract pharmacy. 2. Providing information on resident s current medications to enable the provider pharmacy to perform a drug use evaluation and clinical screening before filling the prescription. H. Medications and related supplies are delivered to the appropriate authorized facility personnel by the noncontract pharmacy in accordance with the pharmacy delivery policy. I. Residents, family members or friends of residents may desire to bring in some medications (either prescription or nonprescription) that have been purchased from a noncontract pharmacy. In such cases, medications may only be brought into the facility if the following conditions are met: 1) State law and regulations allow such use. 2) No medications may be administered to a resident or left in a resident s room by family or friends. Medications must be brought to the nurse s station and be presented to the nurse. 3) These medications must be ordered by the attending physician, or authorized mid-level prescriber, and entered on the physician order sheet and medication administration record. 4) The contents of each container must be labeled in accordance with established policies. If the medication is an over-the-counter product, it must be in its original container with original labeling. 5) The contents of each container are positively identified using an appropriate reference or personnel. 6) The quantity does not exceed quantities specified in the facility s policies and procedures. 7) Drugs not identified by the physician or pharmacist must be returned to the family. If drugs are not picked up by the family within 30 days, the facility will destroy such drugs in accordance with established policies. 8) Nursing will discuss and determine a reorder plan with the family or friend for future supplies. 9) In the event, said medication order is discontinued or the resident expires, the remaining supply of these medications are not returned to the family or friend, but are disposed of using the medication disposal procedure used by the facility. J. All medications are dispensed by the noncontract pharmacy in containers that meet legal requirements for stability and that are compatible with the medication packaging system in use in the facility. K. Each medication provided by the noncontract pharmacy is labeled in accordance with the policy on medication labeling, facility requirements, and state and federal requirements. Any medication improperly labeled is rejected and returned to the pharmacy that issued it. L. Medications are dispensed by the noncontract pharmacy in quantities that do not exceed quantities specified in the facility s policies and procedures. M. Controlled medications listed in all Schedules (II-V) are provided by the noncontract pharmacy in easily accountable quantities and in containers designed for easy counting of contents to facilitate inventory control. Page 7 of 121

12 N. All controlled substances (CII-V) are reordered when a limited supply remains. The noncontract pharmacy then has the responsibility to obtain a valid prescription from the physician; however, the facility assists in the acquisition of the prescription if possible. If unable to obtain the prescription and provide the medication prior to the depletion of the current supply, the noncontract pharmacy will notify the facility immediately. The provider pharmacy for the facility may then be asked to obtain and fill the prescription. O. All medications are ordered and received by the facility in accordance with the policy on ordering and receiving medications from the dispensing pharmacy. P. All medications are delivered to the facility in accordance with the policy on pharmacy delivery. Q. The noncontract pharmacy bills the third-party payor if applicable, or resident or responsible party directly for all medications and supplies provided. Methods of payment are ascertained at the time of admission to the facility. R. The noncontract pharmacy provides the facility with a delivery and on-call schedule and notifies the facility immediately of any changes in the schedule or their contact information. Page 8 of 121

13 MEDICATION ORDERS IB1: NON-CONTROLLED MEDICATION ORDER DOCUMENTATION Policy Medications are administered only upon the clear, complete, and signed order of a person lawfully authorized to prescribe. Verbal orders for non-controlled medications are received only by licensed nurses or pharmacists and confirmed in writing by the prescriber. Verbal orders received by pharmacists must also be communicated to the facility by the prescriber or via telephone order procedure. Medication orders from physician assistants, nurse practitioners, clinical nurse specialists and pharmacists are accepted if they comply with the requirements listed below, are in accordance with state law, and comply with applicable formularies or prescribing protocols that have been provided to the facility by the responsible physician. To facilitate effective communication, documentation, and aid in prevention of medication errors, medication orders should be clear and concise and free of potentially dangerous abbreviations. A. Elements of the Medication Order 1) Medication orders specify the following: a. Name of medication. b. Strength of medication, where indicated. c. Dose and dosage form. d. Time or frequency of administration. e. Route of administration. f. Quantity or duration (length) of therapy. If not specified by prescriber on a new order, the duration is limited by automatic stop order policy, when applicable. g. Diagnosis or indication for use. 2) PRN (as needed) orders clearly delineate the condition for which they are being administered, for example, as needed for pain, or as needed for sleep. B. Any dose or order that appears inappropriate considering the resident s age, condition, allergies, or diagnosis is verified by nursing with the attending physician C. The prescriber is contacted by nursing to verify or clarify an order (e.g., when the resident has allergies to the medication, there are contraindications to the medication, significant drug interactions are present, and the directions are confusing). D. The prescriber is contacted by nursing for direction when delivery of a medication will be delayed or the medication is not or will not be available. E. Documentation of the Medication Order 1) Each medication order is documented in the resident s medical record with the date, time, and signature of the person receiving the order. The order is recorded on the physician order sheet or the telephone order sheet if it is a verbal order, and on the Medication Administration Record (MAR) or Treatment Administration Record (TAR). a. New Handwritten Orders 1. By the prescriber while present in the facility. a) The nurse on duty at the time the order is received enters it on the physician order sheet/telephone order sheet if not written there by the Page 9 of 121

14 prescriber, and notes the order as follows: Noted 3:00 p.m., 5/17/2011, M. Jones, R.N.. b) If necessary, the order and the indication for its use are clarified and the prescriber s signature is obtained before the prescriber leaves the nursing station. 2. Sent with the resident from an office visit. b. New Verbal Orders a) The nurse on duty at the time the order is received enters it on the physician order sheet/telephone order sheet and notes the order as follows: Noted 3:00 p.m., 5/17/2011 M. Jones, R.N.. b) If the order is from a prescriber other than the attending physician, the order is verified with the current attending physician. 1. The nurse documents the verbal order and the reason for its use on the telephone order sheet/physician s order sheet as follows: Noted 3:00 p.m. 5/17/2011, M. Jones, R.N. and completes the following steps. a) Mail or deliver the appropriate copy of the telephone order form to the attending physician for signing. b) Transmit the appropriate copy to the pharmacy for dispensing. c) Obtain prescriber signature within 7 days. 2. Place the signed copy on the designated page in the resident s medical record. c. Written Transfer Orders (sent with a resident by a hospital or other health care facility) 1. Implement a transfer order without further validation if it is signed and dated by the resident s current attending physician, unless the order is unclear or incomplete or the date signed is different from the date of admission. 2. If the order is unsigned or signed by another prescriber or the date is other than the date of admission, the receiving nurse verifies the order with the current attending physician before medications are administered. The nurse documents verification on the admission order record by entering the time, date, and signature. Example: Order verified by phone with Dr. Smith/M. Jones, R.N. 3. Obtain the indication for each medication ordered. 4. The nurse who transcribes the orders to the physician order sheet and MAR documents on the admission form the date, the time and by whom the orders were noted, as follows: Noted 3:00 p.m., 5/17/2011, M. Jones, R.N.. d. Renewed or Recapitulated (Recapped) Orders (to continue a medication therapy beyond a previous order with limited duration) 1. The prescriber renews the order either by repeating the entire order process or with a statement such as continue XXX for ten days. The prescriber writes a new order for continued therapies that require a change in directions, dosage form, or strength. 2. Medication orders are recapped on a monthly basis when the prescriber signs the physician order summary. A designated nurse reviews the order summary before giving it to the prescriber to sign. e. Orders Faxed From the Physician s Office 1. The nurse on duty at the time the order is received notes the order and enters it on the physician order sheet. 2) The following steps are initiated to complete documentation and receive the medications: a. Clarify the order. b. Call, fax, or electronically transfer the medication order to the provider pharmacy. Page 10 of 121

15 c. Transcribe newly prescribed medications on the MAR or TAR. When a new order changes the dosage of a previously prescribed medication, discontinue the previous entry by writing DC d and the date and highlighting the entry in yellow. Enter the new order on the MAR/TAR. d. After completion, document each medication order entered on the appropriate form with date, time, and signature. Example: Noted 1:15 p.m., 5/17/2011. M. Jones, R.N. 3) Standing orders are accepted for prescription medications, treatments, and nonprescription medications. The nurse implementing the standing order(s) adds the order to the MAR. F. Scheduling New Medication Orders on the Medication Administration Record (MAR) 1) Non-Emergency Medication Order a. The first dose of medication is scheduled to be given after the next regularly scheduled pharmacy delivery to the facility. 2) Emergency/STAT Medication Order (Medication Contained in Emergency Supply) a. Schedule the appropriate number of doses to be administered prior to the regularly scheduled pharmacy delivery. Thereafter, doses are scheduled according to facility policy. 3) Emergency/STAT Medication Order (Medication NOT Contained in Emergency Medication Supply) a. An emergency/stat order is placed with the provider pharmacy, and the medication is scheduled to be given as soon as possible. Subsequent doses are scheduled according to facility policy. G. Receipt of Orders from Nurse Practitioners, Physician Assistants, Clinical Nurse Specialists, and Pharmacists 1) Orders may be accepted from non-physician personnel licensed to work with the resident s physician, if state law permits. 2) The orders must comply with all the legal requirements for a physician s medication order. 3) The responsible physician countersigns the orders as mandated by regulations and the Kansas Board of Healing Arts. 4) Applicable formularies, protocols, or prescribing guidelines are kept on file in the facility and are followed closely. Page 11 of 121

16 MEDICATION ORDERS IB2: CONTROLLED SUBSTANCE PRESCRIPTIONS Policy Before a controlled drug can be dispensed, the pharmacy must be in receipt of a clear, complete, and signed written prescription from a person lawfully authorized to prescribe. A chart order is not equivalent to a prescription for controlled drugs. Therefore the prescriber issuing the chart order must also provide the pharmacist with a valid prescription. The written prescription may be faxed to the pharmacy for long-term care facility residents. Verbal orders for controlled medications are permitted for CII controlled drugs only in emergency situations. Verbal orders for controlled medications received by facility nursing staff should be noted in the resident s medical record and nursing facility staff must confirm that the prescriber or the prescriber s employee has communicated the order to the pharmacy. Verbal orders received by pharmacists from prescribers must also be communicated to the facility before authorized nursing facility staff may access any controlled substances from the emergency supply located in the facility. This may be done either by the prescriber directly or via telephone order from the pharmacist to the facility. Incomplete prescriptions and verbal orders for controlled substances may not be edited or changed by facility nursing staff. Controlled substance prescriptions from physician assistants and nurse practitioners who are authorized to prescribe controlled drugs are valid if they comply with the requirements listed below, are in accordance with state law, and comply with applicable formularies or prescribing protocols that have been provided to the facility by the responsible physician. To facilitate effective communication, documentation, and aid in prevention of medication errors, medication orders should be clear and concise and free of potentially dangerous abbreviations. A. Elements of a controlled substance prescription: 1) Date the prescription is issued.* 2) Full name and address of the resident, including street address of the facility. 3) Name of medication.* 4) Strength of medication. 5) Dosage form.* 6) Quantity prescribed. 7) Route of administration. 8) Dose and frequency (or time) of administration. 9) Duration (length) of therapy or number of refills (for CIII-Vs). If not specified by prescriber on a new order, the duration is limited by automatic stop order, when applicable. 10) Diagnosis or indication for use. 11) Name, address, and DEA registration number of prescriber. 12) Manual signature of prescriber.* 13) PRN (as needed) orders clearly delineate the condition for which they are being administered, for example, as needed for severe pain (pain scale 7-10), or as needed for sleep. * These are components of a CII prescription deemed essential elements according to the Drug Enforcement Administration (DEA) that may not be modified by a pharmacist upon oral directions from a prescriber. 1 B. The prescriber is contacted to verify or clarify a prescription when needed (e.g., when the resident has allergies to the medication, there are contraindications to the medication, significant drug interactions are present, the administration directions are confusing, and the prescription is incomplete). If changes to a controlled substance prescription are necessary, the prescriber (or prescriber s employee) must communicate the new order to the facility nursing staff for documentation in the chart and communicate or transmit the new prescription to the pharmacy prior to dispensing. C. The prescriber is contacted for direction when delivery of a medication will be delayed or the medication is Page 12 of 121

17 not or will not be available. D. Documentation of the Controlled Substance Prescription 1) Each controlled substance prescription is documented in the resident s medical record with the date, time, and signature of the person receiving the prescription. The prescription is recorded on (the physician order sheet or the telephone order sheet or posted elsewhere in the record), and recorded on the Medication Administration Record (MAR). E. New Prescriptions 1) If prescriptions are written by the prescriber while present in the facility or sent with the resident from an office visit, emergency room visit, or upon hospital discharge, the prescriber is encouraged to document on separate paperwork the fact that a prescription has been provided to ensure accountability on the receiving end. For written prescriptions received by the facility: a. If the prescription is from a prescriber other than the attending physician, the order is verified with the current attending physician. The nurse communicates that verification to the pharmacy prior to dispensing. b. The prescription is faxed to the pharmacy by the prescriber or prescriber s agent. 1. If this is not possible, the facility nurse on duty faxes the prescription to the pharmacy with a notation of his/her name and the facility name on the cover sheet or order as the sender. After faxing to the pharmacy, the nurse on duty should place the written prescription in a container for the provider pharmacy to receive upon delivery of medication. 2. The pharmacy prepares the medications based on the faxed copy of the prescription and the pharmacy representative will pick up the original, written prescription prior to handing off the dispensed controlled substance. c. Written transfer orders can only be accepted if they contain all components of a legal, complete prescription as outlined above (including prescriber signature) and if the transfer orders are transmitted to the pharmacy by the prescriber or authorized prescriber s agent. 2) New orders for controlled substances communicated to the nurse on duty verbally or orally by the prescriber, including emergency medications: a. If the prescriber is present in the facility, all new orders for controlled substances must be written, contain all required elements and be signed by the prescriber before leaving the facility. b. New orders for controlled substances communicated to the nurse verbally or orally by the prescriber via telephone are entered onto the physician order sheet and/or telephone order sheet and noted as follows: T.O., noted 3:00 p.m. 5/17/2011, M. Jones, R.N.. To ensure the pharmacy has a complete, valid prescription from which to dispense the medication, the facility requests that: 1. The prescriber or prescriber s employee prepares a written prescription and faxes the complete prescription (containing all required elements) to the pharmacist directly, OR 2. In instances of an emergency situation, the prescriber orally/verbally communicates the order directly to the pharmacist for a quantity sufficient for the emergency situation. 3) In order to communicate CII orders orally/verbally between the prescriber and pharmacist, the prescription must meet DEA s criteria of an emergency situation. Conformance with such criteria must be discussed between the prescriber and pharmacist and documented on the prescription: a. Immediate administration of the controlled substance is necessary for proper treatment of the intended ultimate user; b. No appropriate alternative treatment is available, including administration of a drug Page 13 of 121

18 which is not a controlled substance under Schedule II; AND c. It is not reasonably possible for the prescribing practitioner to provide a written prescription to be presented to the person dispensing the substance prior to dispensing. 4) Only after verifying that the above communication has occurred and the pharmacy and facility receive a complete prescription, the nurse breaks the container seal and removes the required medication if it is available in the emergency kit. If the medication is not available in the emergency kit, the nurse contacts the pharmacy using the after-hours emergency number(s) if necessary. 5) Within seven days of dispensing an orally/verbally communicated emergency prescription for a CII medication, the prescriber must prepare and send a written confirmation of the verbal prescription to the pharmacy. The written authorization must include the words, Authorization for Emergency dispensing and the date of the written authorization. It is the pharmacy s responsibility to follow-up with the prescriber to ensure a written authorization is received. However, the pharmacy may seek the facility s help to obtain the prescription from the prescriber in a timely manner. If a written authorization is not received within seven (7) days, the pharmacy must report the practitioner to the regional DEA office. If the pharmacist has not received written authorization and has not reported the practitioner to the DEA, the pharmacy no longer is authorized to fill emergency CII oral/verbal orders. F. Refill Requests for CIII-CV, and Partial Fill Requests for CII 1) If one or more refills (CIII-Vs) or a partial fill quantity (CIIs) remains and medications are not automatically refilled by the pharmacy, refills are: a. Written on a medication order form or ordered by peeling the top label from the label and placing it in the appropriate area on the order form provided by the pharmacy for that purpose, and requested from the pharmacy 5 days in advance of need to assure an adequate supply is on hand. 2) If only one refill remains (CIII-Vs) or only a partial fill quantity remains (CII), the pharmacy will simultaneously dispense the remaining refill, and, if necessary proactively seek out a new, complete prescription from the prescriber for future use. If a new prescription is not obtained by the pharmacy before the medication is requested again, the facility is notified. In this situation, the facility may be asked to contact the prescriber for a new prescription prior to the medication running out. G. When accessing medications from the facility s emergency kit, refer to IC5: EMERGENCY PHARMACY SERVICE AND EMERGENCY KITS. H. Scheduling Orders for New Controlled Substance Prescriptions on the Medication Administration Record (MAR). 1) Non-Emergency Medication Order a. The first dose of the medication is scheduled to be given after the next regularly scheduled pharmacy delivery to the facility. 2) Emergency/STAT Medication Order (Medication contained in Emergency Supply) a. Schedule the appropriate number of doses to be administered after notification is received from the pharmacy that the prescription has been received and prior to the regularly scheduled pharmacy delivery. Thereafter, doses are scheduled according to facility policy. 3) Emergency/STAT Medication Order (Medication not contained in Emergency Medication Supply) A. An emergency/stat order is placed with the provider pharmacy, and the medication is scheduled to be given as soon as possible. Subsequent doses are scheduled according to facility policy. I. Receipt of Orders from Nurse Practitioners, Physician Assistants, Clinical Nurse Specialists, and Pharmacists. Page 14 of 121

19 1) Orders may be accepted from non-physician personnel licensed to work with the resident s physician, if state law permits and the practitioner has a DEA number. 2) The orders must comply with all the legal requirements for a controlled substance prescription. 3) The responsible physician countersigns the orders as mandated by regulations and the Kansas Board of Healing Arts. 4) Applicable formularies, protocols, or prescribing guidelines are kept on file in the facility and are followed closely. References: 1 Issuance of Multiple Prescriptions for Schedule II Controlled Substances, 72 Fed. Reg , Preamble to Final Rule, available at 2 DEA General Questions and Answers, Page 3, available at Page 15 of 121

20 MEDICATION ORDERS IB3: STOP ORDERS Policy New medication orders are subject to automatic stop orders unless the medication orders specify the number of doses or duration of medication. A time limit is included in recapped orders. A. The following classes of medications, whether the order is for routine or as needed (PRN) use, are stopped automatically after the indicated number of days, unless the prescriber specifies a different number of doses or duration of therapy to be given. 1) Anti-infectives (oral and parenteral) for acute conditions. 2) Ophthalmic and Otic antibiotic and steroid preparations for acute problems. 3) Cough and cold preparations. 4) Decongestants and antihistamines for acute conditions. 5) Controlled substance analgesics for acute conditions. B. Certain medications should not be discontinued before consulting with the prescriber and determining a taper schedule. Page 16 of 121

21 IB4: STANDING ORDERS Policy MEDICATION ORDERS Certain, common, self-limited conditions are often amenable to treatment with nonprescription medications, using good nursing judgment. To facilitate prompt treatment of such conditions, and to avoid unnecessary telephone calls to those prescribers who approve, standing orders are used. Standing orders cannot be utilized for controlled substances. A. Only licensed nurses implement standing orders. Professional judgment is used in the initiation and administration of standing orders. B. The order is written following the procedure for verbal prescriber orders in accordance with the policy on prescriber medication orders. In indicating the source of the order, the abbreviation s.o. is used to indicate a standing order. C. An alternative to the above policy is practiced in some states. The facility identifies a short list of over-thecounter medications for commonly occurring conditions (i.e. constipation, cough, pain or temperature) in addition to pneumococcal and influenza vaccinations. This list of medications and vaccinations is added to all patients physician s orders, unless contraindicated, upon admission to the facility. D. Documentation of the situation requiring the use of the standing order is placed in the Nursing Notes section of the resident s medical record prior to initiation of the order. E. A copy of facility Standing Orders Policy is sent to all physicians with an explanatory cover letter. The facility Standing Orders Policy are posted at each nursing station or placed in the Medication Administration Record [MAR]. F. A signed physician authorization to use standing orders is maintained on file by the facility for each responsible physician who authorizes it (note: some states require that standing orders must also be patient specific). Page 17 of 121

22 IB5: THERAPEUTIC INTERCHANGE Policy MEDICATION ORDERS For all residents, medications may be substituted with equivalent products if pre-approved by the attending physician as outlined in a therapeutic interchange statement. A. The facility will maintain all applicable therapeutic interchange (TI) statements on file. B. Anytime a therapeutic interchange is utilized, a copy of the therapeutic interchange statement will be maintained in the patient s chart. C. The interchange is unique to the physician, not the facility, and therefore only applicable to the participating physician s patient population. D. The interchange will always be applied unless stated otherwise by the physician or clinically contraindicated. Page 18 of 121

23 MEDICATION ORDERING & RECEIVING FROM PHARMACY IC1: PHARMACY HOURS AND DELIVERY SCHEDULE Policy A schedule of pharmacy hours and delivery times is established and posted in a visible area in the facility (i.e., Medication rooms, by the telephone/fax machine). A. The administrator, director of nursing, and dispensing pharmacy establish a daily delivery and pick-up schedule for medication orders. B. The schedule lists the pharmacy s regular and after business hours, applicable telephone numbers, routine medication order delivery times, and other pertinent information. Page 19 of 121

24 MEDICATION ORDERING & RECEIVING FROM PHARMACY IC2: PHARMACY DELIVERY Policy The dispensing pharmacy will transport medication to the facility in a manner that prevents contamination, degradation, and diversion of medications. A. Drivers will wear identifiable uniforms or nametags so they are easily recognized when in the facility. B. A pharmacy provides a method of confirmation of receipt of medications by the driver for each delivery that leaves the dispensing pharmacy. C. After the contents are verified, the tote is secured by the pharmacy staff and given to the driver. D. The medications are transported in accordance with manufacturer s specifications and according to state and federal laws. 1) The delivery is not exposed to extreme temperatures. 2) The delivery is not left unsecured. 3) The delivery is not exposed to contamination and is separated from medications being returned to the pharmacy. E. Upon arrival at the facility, the driver delivers the medication directly to a licensed nurse. F. The pharmacy provides a method, such as a manifest, for both parties to confirm delivery and receipt of all items. G. The nurse receiving the delivery provides a written or electronic signature to the driver as proof of delivery. Page 20 of 121

25 MEDICATION ORDERING & RECEIVING FROM PHARMACY IC3: ORDERING AND RECEIVING NON-CONTROLLED MEDICATIONS FROM THE DISPENSING PHARMACY Policy Medications and related products are received from the dispensing pharmacy on a timely basis. The facility maintains accurate records of medication order and receipt. A. Ordering Medications from the Dispensing Pharmacy 1) Medication orders are written on a medication order form (i.e., telephone order sheet, reorder form, etc.), written in the chart by the physician, written on a transfer order form, or requested electronically and transmitted to the pharmacy. The written entry includes: a. Date ordered. b. Whether the order is new or a repeat order (refill). If the order is a repeat order (refill), include the prescription number. c. Resident s name and other identifying information, when necessary. d. Medication name and strength, when indicated. e. Directions for use, if a new order, or direction changes to a previous order with indication as to whether a new supply is needed from the pharmacy. f. Name of pharmacy supplier if other than provider pharmacy. 2) If not automatically refilled by the pharmacy, repeat medications (refills) are written on a medication order form or ordered by peeling the top label from the physician order sheet and placing it in the appropriate area on the order form provided by the pharmacy for that purpose and ordered as follows: a. Reordering of medications is done in accordance with the order and delivery schedule developed by the pharmacy provider(s). Quantities of medications sent from the pharmacy may vary in accordance with payer status, insurance plan, or law. Reorder medication 3 to 4 days in advance of need, as directed by the pharmacy order and delivery schedule, to assure an adequate supply is on hand. When reordering medication that requires special processing, such as a specially compounded medication, order at least 5 days in advance of need. b. The nurse who reorders the medication is responsible for notifying the pharmacy of changes in directions for use or previous labeling errors. c. The refill order is called in, faxed, or otherwise transmitted to the pharmacy. When available and legible, the pharmacy label (including bar-code, if used) is pulled and transmitted to the pharmacy. 3) Stat and emergency medications are ordered as follows: a. During regular pharmacy hours, the pharmacy is notified of the emergency or stat order; the order is then phoned or faxed to the pharmacy, to be provided (and subsequently administered) as soon as possible. If available, the initial dose is obtained from the emergency kit, when necessary. b. If after hours, medications should be ordered as outlined in the Emergency Pharmacy Service and Kits Policy. c. For emergency controlled medications, see IB2: CONTROLLED SUBSTANCE PRESCRIPTIONS. 4) When phoning or faxing a medication order to the pharmacy, the following information is given: Page 21 of 121

26 a. Resident s name and other identifying information when necessary. b. Prescription number if a refill. c. Complete order if a new medication order or direction changes to a previous order. d. Name of prescriber for a new order, if different than the attending physician. e. Indication for use. f. Name of person calling in order. 5) New Admission/Re-admission Orders: a. When calling/faxing medication orders for a newly admitted resident, the pharmacy is also given any pertinent ancillary orders, allergies, and diagnoses to facilitate generation of a patient profile and, if applicable, medical records (i.e., Medication Administration Record, Physician s Order Sheet). These admission orders must include a physiciansigned order to transfer facilities or order to admit to facility on current medications. b. Facility indicates name of pharmacy supplier, if other than contract pharmacy provider, and indicates whether a new supply of medication is needed from the pharmacy. B. Receiving Medications from the Pharmacy 1) A licensed nurse: a. Receives medications delivered to the facility and documents that the delivery was received and was secure. b. Verifies medications received and directions for use with the medication order form. c. Promptly reports discrepancies and omissions to the issuing pharmacy and the charge nurse/supervisor. Discrepancies/omissions must be reported to pharmacy within 24 hours. d. Immediately delivers the medications to the appropriate secure storage area or a designee under the direct supervision of the licensed nurse. e. Assures medications are incorporated into the resident s specific allocation prior to the next medication pass. 2) Delivery records are retained as required per rules and regulations. Page 22 of 121

27 MEDICATION ORDERING & RECEIVING FROM PHARMACY IC4: RECEIVING CONTROLLED SUBSTANCES Policy Medications included in the Drug Enforcement Administration (DEA) classification as controlled substances and medications classified as controlled substances by state law are subject to special ordering, receipt, and recordkeeping requirements by the facility in accordance with federal and state laws and regulations. A. The director of nursing, in collaboration with the consultant pharmacist, maintains the facility s compliance with federal and state laws and regulations in the handling of controlled substances. Only authorized, licensed nursing and pharmacy personnel have access to controlled substances. B. Controlled substances prescribed for a specific resident are delivered to the facility only if a valid prescription has been received by the pharmacy prior to dispensing. C. New and refill orders for controlled substances are ordered as detailed in the procedure for Documenting and Ordering Controlled Substance Prescriptions from Pharmacy. D. An individual resident s controlled substance record is prepared by the pharmacy or the facility for each controlled substance prescribed for a resident. The following information is completed upon dispensing or upon receipt of the controlled substance: 1) Name of resident. 2) Prescription number. 3) Drug name, strength (if designated), and dosage form of medication. 4) Date received. 5) Quantity received. 6) Name of person receiving the medication supply. E. Medications listed in Schedules II, III, IV, and V are stored under double lock. Alternatively, in a unit dose system, Schedule III, IV, and V medications may be distributed with other medications throughout the cart, while the Schedule II medications are kept under double lock. The access key/code to controlled substances is not the same key/code that allows access to other medications. The medication nurse or medication aid on duty maintains possession of a key/code to controlled substances. The director of nursing and pharmacy keeps back-up keys/codes to all medication storage areas, including those for controlled substances. F. The count of each medication and quantity of cards is verified with each shift change and when change of possession of keys/codes occurs. G. Controlled substances are reordered when a five day supply remains to allow for transmittal of the required written prescription to the pharmacist. H. The facility may designate a particular drug, which is not mandated as a controlled substance by state or federal laws and subject to abuse or diversion, to be handled under these procedures for controlled substances. I. The facility obtains any permits required by state agencies and keeps current copies on file. J. Only licensed personnel may receive controlled substances from the pharmacy driver/courier. for receiving controlled substances include: Page 23 of 121

28 1) A nurse signs for the medications, including the controlled substances, on the pharmacy delivery ticket and inspects the medications. 2) A nurse reconciles controlled substance orders and refill requests against what has been received from the pharmacy. 3) A nurse notifies the pharmacist if controlled substance orders or doses are missing or incorrect. 4) The receiving nurse transfers medications and accompanying inventory sheets to an authorized nurse on the unit (if different than the nurse who received the medication). 5) Two nurses witness placement of the controlled substances in the secured compartment of the medication cart. 6) Controlled substance inventory sheets are completed, if necessary, and filed appropriately. See also policies and procedures relating to controlled substances in emergency medication kit. Page 24 of 121

29 MEDICATION ORDERING & RECEIVING FROM PHARMACY IC5: EMERGENCY PHARMACY SERVICE AND EMERGENCY KITS Policy Emergency pharmacy service is available on a 24-hour basis. Emergency needs for medication are met by using the facility s approved emergency medication supply or by special order from the provider pharmacy. The provider pharmacy supplies emergency medications including emergency drugs, antibiotics, controlled substances and products for intravenous use in limited quantities in portable, sealable containers in compliance with applicable state regulations. A. Telephone/fax numbers for emergency pharmacy service are available. B. There is a physician on call 24/7 and contact information (e.g. telephone number) is available. C. The dispensing pharmacy is called if an emergency arises requiring immediate pharmacist consultation concerning appropriateness of therapy, drug information, etc. If the required information is unavailable from the dispensing pharmacy, the pharmacy will determine the appropriate method for obtaining it, including speaking with the facility s consultant pharmacist. D. The dispensing pharmacy supplies emergency or stat medications according to the contract agreement. E. Medications are not borrowed from other residents. The ordered medication is obtained either from the emergency box, from the provider pharmacy or a back-up pharmacy that is determined by the provider pharmacy. F. The emergency supply is maintained in a secure, designated area, along with a list of supply contents and expiration dates as follows: 1) Emergency non-parenteral medications are kept in the portable, sealable emergency kit. These include antibiotics and controlled substances. 2) Emergency infusion therapy kits are kept in a separate portable, sealable emergency IV kit. G. When an emergency or stat order is received, the nurse follows the procedure for order documentation in accordance with the policy on Prescriber Medication Orders. H. To access medication from the emergency kit secondary to a new order or when medication for which there is a current prescription is not readily available, the nurse should not take a medication from the e-box without checking allergies on the medical record and possible drug-drug interactions. 1) The nurse confers with the prescriber to determine whether the order is a true emergency, i.e., order cannot be delayed until the scheduled pharmacy delivery. 2) Only after verifying that the above communication has occurred, the pharmacy has received a transmission of the order, and drug allergies, interactions, and other contraindications have been checked, the nurse breaks the seal on the e-kit and removes the required medication (if it is available in the emergency kit). If the medication is not available in the emergency kit, the nurse contacts the pharmacy, using the after-hours emergency number(s) if necessary. 3) The nurse records the medication use from the emergency kit on the emergency kit use form and faxes a record of this to the pharmacy as soon as possible after the medication has been administered. 4) Use of the emergency medication is noted on the resident s medication administration record (MAR). Page 25 of 121

30 5) Before going off duty, the charge nurse indicates the opened status of the emergency kit at the shift change report, and transfers the new medication orders to oncoming staff. I. If exchanging kits, when the replacement kit arrives, the receiving nurse gives the used kit to the pharmacy personnel for return to the pharmacy. J. Kits opened during the weekend or on holidays are reported to the pharmacy the first working day after the kit was opened. K. The kits are monitored/inventoried by the provider pharmacy at least every 30 days for completeness and expiration dating of the contents. The expiration date and list of contents is located on the outside of the kit. L. Attending physicians are informed regarding the availability of emergency medications in the facility. Page 26 of 121

31 MEDICATION ORDERING & RECEIVING FROM PHARMACY IC6: MULTIPLE SOURCE DRUG PRODUCTS Policy The cost of medications is controlled, in part, by the use of multiple-source drug products, when appropriate. All provisions of state law, Food and Drug Administration (FDA) bioequivalence guidelines, and the physician s therapeutic objectives are followed in choosing multiple-source drug products. Definitions Pharmaceutically Equivalent Drug Products: Drug products that contain the same active ingredient(s), in identical amounts, in identical dosage forms, administered by the same route of administration and that meet existing standards in the United States Pharmacopeia (USP). The products may differ in characteristics such as color, flavor, shape, packaging, inert ingredients, and the method of manufacture. Multiple-Source Drug Products: Pharmaceutically equivalent drug products that are marketed by different pharmaceutical companies. Innovator Brand Products: A drug product manufactured and marketed by the pharmaceutical company that introduces it to the market. In most cases, this is the same company that conducted the research and obtained the patent for the drug product. Often referred to as brand name product. Non-Innovator Multiple Source ( Generic ) Drug Product: A multiple source drug product that is marketed by a company other than the one that introduced it to the market, generally after the patent for the product has expired. Often referred to as generic product. Certification: The process by which a prescriber communicates the medical necessity for an innovator brand product for a particular resident. This usually involves writing the phrase Brand necessary or Brand medically necessary on the prescription/order in the prescriber s own handwriting. A. The provider pharmacy dispenses non-innovator multiple-source ( generic ) drug products whenever feasible and when required according to Medicaid, Medicare, or other third-party payer programs that dictate multiple-source drug product use in place of innovator products, unless the prescriber complies with item B. below. B. Physicians may indicate refusal of innovator product substitutes when ordering medications. In the case of a Medicaid resident, the physician complies with the required paperwork to document the necessity of an innovator product, as required by OBRA 90 revisions to Title XIX of the Social Security Act and other state-specific rules/regulations, as follows: 1) On prescriptions: a. The prescriber must certify in his or her own handwriting that a specific brand is medically necessary for a particular recipient. The handwritten phrase brand necessary or brand medically necessary must appear on the face of the prescription. b. The prescriber must also document in the resident record the reason why the drug is medically necessary. 2) On facility orders: a. The provider pharmacy uses sound professional judgment and prudent buying concepts when selecting non-innovator multiple-source ( generic ) drug product substitutes for innovator products, including bioequivalence data, FDA comparative data, etc. Page 27 of 121

32 b. The provider pharmacy labels non-innovator multiple source ( generic ) drug products as detailed in the medication labels policy and in keeping with applicable state laws. Page 28 of 121

33 MEDICATION ORDERING & RECEIVING FROM PHARMACY IC7: HOUSE-SUPPLIED (FLOOR STOCK) MEDICATIONS Policy The facility maintains a supply of commonly used over-the-counter medications considered as floor stock or house medications (not resident-specific), as permitted by state regulation, to be administered only upon receipt of an order from an authorized prescriber. A. The Quality Assessment and Assurance Committee establishes a list of non-prescription (overthe-counter) medications to be utilized as floor stock. B. The floor stock medication list is posted in medication rooms and provided to the dispensing pharmacy. C. Floor stock medications are ordered from the provider/dispensing pharmacy, or other store/supplier. D. Floor stock medications are appropriately labeled denoting stock supply. The manufacturer s or pharmacy s label should include the following: 1) Medication name. 2) Medication strength. 3) Quantity. 4) Lot number. 5) Expiration date. 6) Manufacturer and/or distributor. Page 29 of 121

34 MEDICATION ORDERING & RECEIVING FROM PHARMACY IC8: MEDICATION LABELS Policy Medications are labeled in accordance with facility requirements and state and federal laws. Only the dispensing pharmacy/registered pharmacist can modify, change, or attach prescription labels. A. Labels are permanently affixed to the outside of the prescription container. No medication is accepted with the label inserted into a vial. If a label does not fit directly onto the product, e.g., eye drops, the label may be affixed to an outside container or carton, but the resident s name, at least, must be maintained directly on the actual product container. 1) Except when contraindicated by manufacturer packaging. B. Each prescription medication label includes: 1) Resident s name. 2) Specific directions for use, including route of administration. a. Due to the complexity and length/amount of instructions, some medications may be labeled use as directed and refer the person administering the medication to the medication administration record for instruction details. 3) Medication name. a. Non-innovator multiple-source drug products dispensed in place of innovator brand products are labeled with the non-innovator multiple source drug product (generic) name and the manufacturer s name or an acceptable abbreviation. 4) Strength of medication. a. Injectables and Liquids: strength per ml and the amount to be given in milliliter (ml) equivalents on the label. b. Example: When furosemide 40 mg is ordered and the pharmacy supplies it in an ampule containing 40 mg/ml, the directions read Inject 40 mg (1 ml). 5) Prescriber s name. 6) Date dispensed. 7) Quantity of medication. 8) Beyond use (or expiration) date of medication. 9) Name, address, and telephone number of dispensing pharmacy. 10) DEA number of dispensing pharmacy, if required. 11) Prescription number. 12) Accessory labels indicating storage requirements and special procedures. Example: Shake well Take on empty stomach, one hour before or 2 hours after meals. 13) Container number and total number of containers (e.g., 1 of 3, 2 of 3, 3 of 3) when multiple containers are dispensed for one prescription/order. 14) Initials of dispensing pharmacist. 15) Lot number of medication dispensed (check State regulation - may not be required). C. Labels on controlled substances should indicate that the medication is a controlled substance, usually noted as a large red C. Page 30 of 121

35 D. Improperly or inaccurately labeled medications are rejected and returned to the dispensing pharmacy within 24 hours. E. Resident-specific nonprescription medications (not floor stock) that are not labeled by the pharmacy are kept in the manufacturer s original container and identified with the resident s name. Facility personnel may write the resident s name on the container or label as long as the required information listed above (see B.) is not covered. F. Medication labels are not altered, modified, or marked in any way by nursing personnel. Contents are not transferred from one container to another. Under no circumstances are unattached labels requested or accepted from the pharmacy. Only the pharmacy/registered pharmacist may place a label on the medication container. 1) If the physician s directions for use change or the label is inaccurate, the nurse may place a change of order check chart label on the container indicating there is a change in directions for use, taking care not to cover important label information. 2) When such a label appears on the container, the medication nurse checks the resident s medication administration record (MAR) or the physician s order for current information. 3) The dispensing pharmacy is informed prior to the next refill of the prescription so the new container will contain an accurate label. G. Medication containers having soiled, damaged, incomplete, illegible, confusing, or makeshift labels are returned to the dispensing pharmacy for relabeling or destroyed in accordance with the medication destruction policy. H. Medications dispensed by physicians must conform to the above labeling requirements. I. If the pharmacy or a dispensing physician labels a medication incorrectly, a medication discrepancy report should be completed, and the pharmacy must be notified within 24 hours in accordance with IC8D. J. Floor stock medications may be labeled as floor stock or house supply and kept in the original manufacturer s container. The manufacturer s or pharmacy s label should include the following: 1) Medication name 2) Medication strength 3) Quantity 4) Lot number 5) Expiration date 6) Manufacturer and/or distributor K. When medication is ordered for use at the bedside, the medication label contains, in addition to the instructions for use, a notation that it may be self-administered and stored at the bedside. Page 31 of 121

36 MEDICATION ORDERING & RECEIVING FROM PHARMACY IC9: MEDICATION PACKAGING Policy Medications are provided in packaging to facilitate accurate administration and accountability of the medication. All packaging meets USP (United States Pharmacopeia) standards. A. Solid oral medication forms (tablets and capsules) are supplied by the provider pharmacy using an agreed upon distribution system. 1) Medication packages are labeled by the provider pharmacy and placed in the medication cart for each resident. 2) The days supply of medication will be determined by the facility s contractual arrangement or insurance payer. B. Unit-dose packages have an expiration date on them that is checked before administering the medication to the resident. C. Product specific packing, other factors related to a dosage form, regulations or policies and procedures may preclude non-oral solids from being stored in close proximity to the oral solids. It is suggested that nurses review the medication administration records (MARs) prior to passing medications in order to prevent errors of omission related to the location of specific products. These medications may include: 1) Medications requiring refrigeration 2) Schedule II controlled substances 3) Liquid medications 4) Injectable medications 5) Externally applied medications, e.g., ointments, sprays, and other treatment medications 6) Oversize or irregularly shaped medication containers D. Any problems noted with packaging of a medication are reported immediately to the dispensing pharmacy. Page 32 of 121

37 MEDICATION ORDERING & RECEIVING FROM PHARMACY IC10: MEDICATIONS BROUGHT TO THE FACILITY BY A RESIDENT OR RESPONSIBLE PARTY Policy Medications brought into the facility by a resident or responsible party are used only upon written order by the resident s attending physician, after the contents are verified, and if the packaging meets the facility s guidelines. Unauthorized medications are not accepted by the facility. A. Use of medications brought to the facility by a resident or responsible party is allowed only when the following conditions are met: 1) The medication name, dosage form, and strength have been verified by: consulting a tablet identification reference (e.g., Physician s Desk Reference), or calling the dispensing pharmacy for a physical description of the medication. 2) The medication was ordered by the resident s physician and entered in the resident s medical record for bedside storage and self-administration by the resident 3) The medication container is clearly labeled in accordance with facility procedures for medication labeling and packaged in a manner consistent with facility guidelines for medications. 4) The medications are received directly from another health care facility, e.g., discharge medications arriving with the resident from an acute hospital in the interim until medications for the resident are received from the provider pharmacy. B. A licensed nurse: 1) Receives medications delivered to the facility and documents delivery of the medication appropriately. 2) Verifies medications received and directions for use with the original medication order. 3) Assures medications are incorporated into the resident s specific allocation/storage area. 4) These delivery/receipt records are retained for 6 years. C. Medications not ordered by the resident s physician, or unacceptable for other reasons, are returned to the responsible party or designated agent. If unclaimed within thirty days, the medications are disposed of in accordance with facility medication destruction/disposal procedures. Page 33 of 121

38 MEDICATION ORDERING & RECEIVING FROM PHARMACY IC11: PERSONNEL AUTHORIZED TO HANDLE MEDICATIONS IN THE FACILITY Policy Only authorized personnel have access to medications in the facility. A. Licensed/certified nursing personnel who administer medications have authorized access to medication storage areas in the facility. Consistent with their scope of practice, licensed nurses may transcribe and transmit orders to the pharmacy(ies), receive and store medications, and have possession of the keys to all drug storage areas in the facility. Keys to medication storage areas are under the control of licensed personnel only. B. Medication aides, under supervision of a licensed nurse, may have access to medication storage areas and may administer medications with the exception of controlled drugs, injectable drugs, and topical drugs to open wounds, as allowed under state law or other regulation. C. Unauthorized personnel may not have access to medication storage areas. D. Pharmacists and pharmacy personnel may have access to medication storage areas. Page 34 of 121

39 MEDICATION STORAGE IN THE FACILITY ID1: STORAGE OF MEDICATIONS Policy Medications and biologicals are stored safely, securely, and properly, following manufacturer s recommendations or those of the supplier. The medication supply is accessible only to licensed nursing personnel, pharmacy personnel, or staff members lawfully authorized to administer medications. A. The provider pharmacy dispenses medications in containers that meet regulatory requirements, including standards set forth by the United States Pharmacopeia (USP). Medications are kept in these containers. Nurses may not transfer medications from one container to another or return partially used medication to the original container.. B. Only licensed nurses, pharmacy personnel, and those lawfully authorized to administer medications (such as medication aides) permitted to access medications. Medication rooms, carts, and medication supplies are locked when not attended by persons with authorized access. C. Orally administered medications are kept separate from externally used medications and treatments. D. Eye medications are kept separate from ear medications. E. Except for those requiring refrigeration or freezing, medications intended for internal use are stored in a medication cart or other designated area. F. Medications labeled for individual residents are stored separately from floor stock medications when not in the medication cart. G. Potentially harmful substances [such as urine test reagent tablets, household poisons, cleaning supplies, disinfectants] are clearly identified and stored in a locked area separately from medications. H. Outdated, contaminated, or deteriorated medications and those in containers that are cracked, soiled, or without secure closures are immediately removed from inventory, disposed of according to procedures for medication disposal, and reordered from the pharmacy, if a current order exists. I. Medication storage areas are kept clean, well-lit, and free of clutter and extreme temperatures and humidity. J. Medication storage conditions are monitored on a regular basis by staff and corrective action taken if problems are identified. K. Refrigerated medications are kept in closed and labeled containers, with internal and external medications separated and separate from fruit juices, applesauce, and other foods used in administering medications. [Other foods such as employee lunches and activity department refreshments are not stored in this refrigerator.] Temperature A. Medications and biologicals are stored at their appropriate temperatures and humidity according to the United States Pharmacopeia guidelines for temperature ranges. B. Medications requiring storage at room temperature are kept at temperatures ranging from 15ºC (59ºF) to 25ºC (77 ºF) Page 35 of 121

40 C. Medications requiring refrigeration are kept in a refrigerator at temperatures between 2ºC (36ºF) and 8ºC (46ºF) with a thermometer to allow temperature monitoring. Medications requiring storage in a cool place are refrigerated unless otherwise directed on the label. Controlled-substances that require refrigeration are stored within a locked box within the refrigerator. This box must be attached to the inside of the refrigerator. D. Medications that should be frozen should be stored in the freezer at 14 F (-4 ) to -20 F (-10 C) E. The Facility should maintain a temperature log in the storage area to record temperatures at least once a day. F. The Facility should check the refrigerator or freezer in which vaccines are stored, at least two times a day, per CDC Guidelines. Infusion Therapy Storage and Labeling A. Intravenously administered medications are kept separate from orally administered medication. B. The Facility should assure infusion products are stored at the appropriate temperature in a medication-only refrigerator or freezer or in a designated area of a medication or biological-only refrigerator or freezer. C. Facility should assure that the infusion therapy product storage area is kept clean and free of clutter. For storage of controlled substances, see ID2: CONTROLLED SUBSTANCE STORAGE Expiration Dating A. Expiration dates of dispensed medications shall be determined by the pharmacist at the time of dispensing. B. Drugs re-packaged by the pharmacy staff will generally carry an expiration date as follows: (Note: the pharmacist determines the exact date based upon a number of factors as well as applicable law or regulation) 1) Blister-pack cards and medication vials 12 months from the date of dispensing (where the manufacturer s expiration date is longer than twelve months). If the manufacturer s expiration date is less than 12 months, the expiration date on the label will be the manufacturer s date. 2) Drugs dispensed in the manufacturer s original container will carry the manufacturer s expiration date. Once opened, these will be good to use until the manufacturer s expiration date is reached unless the medication is: a. In a multi-dose injectable vial b. An ophthalmic medication c. An item for which the manufacturer has specified a usable life after opening C. When the original seal of a manufacturer s container or vial is initially broken, the container or vial will be dated. 1) The nurse shall place a date opened sticker on the medication and enter the date opened and the new date of expiration (NOTE: the best stickers to affix contain both a date opened and expiration notation line). The expiration date of the vial or container will be [28] days unless the manufacturer recommends another date or regulations/guidelines require different dating. D. The nurse will check the expiration date of each medication before administering it. E. No expired medication will be administered to a resident. F. All expired medications will be removed from the active supply and destroyed in the facility, regardless of amount remaining. The medication will be destroyed in the usual manner. G. Disposal of any medications prior to the expiration dating will be required if contamination or decomposition is apparent. Page 36 of 121

41 H. Nursing staff should consult with the dispensing pharmacy for any questions related to medication expiration dates. Page 37 of 121

42 MEDICATION STORAGE IN THE FACILITY ID2: CONTROLLED SUBSTANCE STORAGE Policy Medications included in the Drug Enforcement Administration (DEA) classification as controlled substances are subject to special handling, storage, disposal and recordkeeping in the facility in accordance with federal, state and other applicable laws and regulations. A. The director of nursing, in collaboration with the consultant pharmacist, maintains the facility s compliance with federal and state laws and regulations in the handling of controlled substances. Only authorized licensed nursing and pharmacy personnel have access to controlled substances. B. Schedule [II-V] medications and other medications subject to abuse or diversion are stored in a permanently affixed, [double-locked] compartment separate from all other medications. The access system to controlled medications is not the same as the system giving access to other medications (the key that opens the compartment is different from the key that opens the medication cart). If a key system is used, the lawfully authorized staff member on duty maintains possession of the key to controlled substance storage areas. Back-up keys to all medication storage areas, including those for controlled substances, are kept by the director of nursing or designee. C. Controlled-substances that require refrigeration are stored within a locked box within the refrigerator. This box must be attached to the inside of the refrigerator. D. A controlled substance accountability record is prepared by the pharmacy/facility for all Schedule II, III, IV, and V medications including those in the emergency supply. The following information is completed on the accountability form upon dispensing or receipt of a controlled substance or use of a controlled substance from the emergency supply: 1) Name of resident, if applicable. 2) Prescription number, if applicable. 3) Name, strength, and dosage form of medication. 4) Date received. 5) Quantity received. 6) Name of person receiving medication supply. E. At each shift change, or when keys are transferred, a physical inventory of all controlled substances, including refrigerated items is conducted by two lawfully authorized staff members and is documented. The emergency supply may be verified by assuring that the seal on the supply has not been broken. If the seal has been broken to the emergency narcotic supply, then a physical count of the contents must be conducted and paperwork must be present to account for any medications removed from the supply. (Contents of the emergency narcotic supply is limited by individual state and federal laws.) F. Any discrepancy in controlled substance counts is reported to the director of nursing immediately. The director or designee investigates and makes every reasonable effort to reconcile all reported discrepancies. The director of nursing documents irreconcilable discrepancies in a report to the administrator. 1) If a major discrepancy or a pattern of discrepancies occurs, or if there is apparent criminal activity, the director of nursing notifies the administrator and consultant pharmacist immediately. Page 38 of 121

43 2) The administrator, consultant pharmacist, and/or director of nursing determine whether other action(s) are needed, e.g., notification of police or other enforcement personnel. 3) The medication regimen of residents using medications that have such discrepancies are reviewed to assure the resident has received all medications ordered and the goal of therapy is met. G. Current controlled substance accountability records are kept in the MAR, or designated book. H. Controlled substances are not surrendered to anyone, including the resident s physician, other than releasing controlled medications for a resident on pass or therapeutic leave to a resident or responsible party upon discharge from the facility, or to the DEA or other law enforcement officials functioning in a professional capacity in exchange for a receipt documenting the transaction. I. Controlled substances remaining in the facility after the order has been discontinued or the resident has been discharged are retained in the facility in a securely locked area with restricted access until destroyed. Page 39 of 121

44 MEDICATION STORAGE IN THE FACILITY ID3: BEDSIDE MEDICATION STORAGE Policy Bedside medication storage is permitted for residents who wish to self-administer medications, upon the written order of the prescriber and once self-administration skills have been assessed and deemed appropriate in the judgment of the facility s interdisciplinary resident assessment team. A. A written order for the bedside storage of medication is present in the resident s medical record. B. Bedside storage of medications is indicated on the resident medication administration record (MAR) and in the care plan for the appropriate medications. C. For residents who self-administer medications the following conditions are met for bedside storage to occur: 1) The manner of storage prevents access by other residents. Lockable drawers or cabinets are required only if unlocked storage is deemed inappropriate. Facility management should have a copy of the key in addition to the resident. 2) The medications provided to the resident for bedside storage are kept in the containers dispensed by the provider pharmacy [or in the original container if a nonprescription medication]. D. All nurses and aides are required to report to the charge nurse on duty any medications found at the bedside not authorized for bedside storage and to give unauthorized medications to the charge nurse for return to the family or responsible party. Families or responsible parties are reminded of this procedure and related policy when necessary. E. Bedside medication storage is routinely monitored by the medication nurse or lawfully authorized staff during medication storage review. F. When the interdisciplinary team determines that bedside or in-room storage of medications would be a safety risk to other residents, the medications of residents permitted to selfadminister are stored in the central medication cart or medication room. Page 40 of 121

45 DISPOSAL OF MEDICATIONS & RELATED SUPPLIES IE1: CONTROLLED SUBSTANCE DISPOSAL Policy Medications included in the Drug Enforcement Administration (DEA) classification as controlled substances are subject to special handling, storage, disposal, and recordkeeping in the facility in accordance with federal and state laws and regulations. A. The director of nursing, in collaboration with the consultant pharmacist, is responsible for the facility s compliance with federal and state laws and regulations in the handling of controlled medications. Only authorized licensed nursing and pharmacy personnel have access to controlled medications. B. When a dose of a controlled medication is removed from the container for administration but refused by the resident or not given for any reason, it is not placed back in the container. It is destroyed in the presence of [two licensed nurses], and the disposal is documented on the accountability record/book on the line representing that dose. The same process applies to the disposal of unused partial tablets and unused portions of single dose ampules and doses of controlled substances wasted for any reason. C. All controlled substances remaining in the facility after a resident has been discharged, or the order is discontinued, are disposed of: 1) In the facility by a licensed nurse and a consultant pharmacist (or others as allowed by state law). D. Disposition is documented on the individual controlled substance accountability record. E. The nurse(s) and/or pharmacist witnessing the destruction ensures that the following information is entered on the individual controlled substance accountability record: 1) Date of destruction. 2) Resident s name. 3) Name and strength of medication. 4) Prescription number. 5) Amount of medication destroyed. 6) Signatures of witnesses. F. Accountability records for controlled substances that are disposed of or destroyed are maintained in the residents medical records for 6 years. G. A controlled substance may be returned to the provider pharmacy if it is refused at the time of delivery. Page 41 of 121

46 DISPOSAL OF MEDICATIONS & RELATED SUPPLIES IE2: DISCHARGE WITH MEDICATIONS Policy Medications are sent with the resident upon discharge from the facility only under conditions that protect the resident and assure compliance with applicable state laws. A. Medications may be sent with the resident on discharge if ordered by the prescriber. B. The labels on discharge medications are verified for completeness and accuracy by reconciling them against the most recent physician s orders. C. Directions for use are reviewed with the resident and/or responsible party. D. If the discharging nurse is unable to answer a question about these medications, the provider pharmacy or consultant pharmacist is called for the information before releasing the medications. E. The telephone number of the provider pharmacy is given to the resident or responsible party to use in the event that additional information is needed regarding drug therapy. F. The resident or responsible party should sign the Medication Release Form as proof of chain of custody. G. The nurse should document the number of doses of each medication discharged to the patient or responsible party on the Medication Release form. H. If medications were brought into the facility by a resident or responsible party and not returned or destroyed, the nurse returns these medications to the resident and documents return of the medications to the resident or responsible party along with other property or valuables upon discharge. I. In the event there is concern about controlled substances being discharged with the resident and/or the resident s representative, the attending physician may choose not to discharge the resident with those medications. J. If the resident is being discharged with controlled substances, facility staff should complete the controlled substance inventory record. Page 42 of 121

47 DISPOSAL OF MEDICATIONS & RELATED SUPPLIES IE3: DISCONTINUED MEDICATIONS Policy When medications are discontinued by the prescriber or the resident is discharged and medications are not sent with the resident, the medications are marked as discontinued and stored in a secure and separate area from the active medications. Residents whose medications are sent home on discharge are provided medications in accordance with state laws and regulations, and according to discharge medication policies. A. If a prescriber discontinues a medication and, in the nurse s judgment, it is unlikely to be reordered within [seven] days, the medication container is marked with a stop drug or discontinued sticker, and the date of discontinuation is indicated along with the name of the nurse. (See sample Stop Drug sticker below.) STOP DRUG or DISCONTINUED Date: Nurse Name: Qty: B. The nurse documents the order to discontinue the medication in the resident s record. The Physician s Order sheet and the Medication Administration Record (MAR) are updated and notate accordingly. C. Discontinued medications are removed from the medication cart or active supply immediately upon receipt of an order to discontinue (to avoid inadvertent administration). Medications awaiting disposal or return are stored in a locked secure area designated for that purpose until destroyed or picked up by pharmacy. D. Non-controlled discontinued medications that are unopened (such as unit-dose packages or sealed containers) may be returned to the pharmacy in accordance with the Medication Return policy. Discontinued medications not returned to the pharmacy are destroyed in accordance with the Medication Destruction policy. Page 43 of 121

48 DISPOSAL OF MEDICATIONS & RELATED SUPPLIES IE4: RETURNING MEDICATIONS TO PHARMACY Policy With the exception of controlled substances or where prohibited by state law, discontinued or unused medications are returned to the provider pharmacy for credit whenever possible. A. Medications [other than controlled medications or where prohibited by state law] may be returned to the provider pharmacy if the medication is in a sealed package or container (such as a unit-dose package or sealed bottle). B. For each medication returned, an entry is made on the medication return form. The entry includes the return date, patient name, prescription number, medication name and strength, and return quantity. C. Medications to be returned to the pharmacy should be secured until the time of pick up. D. The medication disposition form is kept with the medications for return until picked up by pharmacy. The receiving pharmacy representative signs the form to indicate receipt and leaves the original with the facility representative. E. Completed medication return forms are kept by the facility per federal or state regulations, whichever is more stringent. Page 44 of 121

49 DISPOSAL OF MEDICATIONS & RELATED SUPPLIES IE5: MEDICATION DESTRUCTION Policy Discontinued medications and medications left in the facility after a resident s discharge, which do not qualify for return to the pharmacy for credit, are destroyed.* Destruction methods comply with federal and state laws and regulations, including the Office of National Drug Control Policy (ONDCP) guidelines for medication destruction. ( A. Unused, unwanted and non-returnable medications should be removed from their storage area and secured until destroyed. B. Medications should not be flushed down the toilet or drain unless the package insert specifically instructs you to do so (i.e., fentanyl patches) [refer to state laws and regulations]. C. Ointments, creams, and similar substances, tablets, capsules and liquids are placed in a container and picked up by the provider pharmacy for the destruction of medications. The provider pharmacy is contacted if the facility is unsure of proper disposal methods for a medication. D. Controlled substances are retained in a securely locked area with restricted access until destroyed by the facility director of nursing and consultant pharmacist. E. Medication destruction occurs only in the presence of two licensed nurses or one licensed nurse and a pharmacist. F. The nurse(s) and/or pharmacist witnessing the destruction ensures that the following information is entered on the destruction form or individual controlled substance accountability record. 1) Date of destruction 2) Resident s name 3) Name and strength of medication 4) Prescription number 5) Amount of medication destroyed 6) Signatures of witnesses G. The medication destroy form with controlled substances disposal information is kept on file in the facility for 6 years. Page 45 of 121

50 MICELLANEOUS SPECIAL SITUATIONS IF1: OUT-ON-PASS MEDICATIONS/LEAVE OF ABSENCE Policy The charge nurse on duty assures that residents have their necessary medications before leaving the facility on pass or therapeutic leave of absence. A. When receiving a physician s order for a resident to go out on pass, the charge nurse on duty reviews the resident s medication orders and directions for use with the physician and determines if pass medications are needed. It may be possible to alter administration times to eliminate the need for out-on-pass medications if the resident s physician concurs and gives an order to do so. The physician s order should list the medications to be dispensed for the leave of absence, including controlled substances. B. The nurse should determine the total number of doses of each medication that will be needed based on the length of the leave of absence before notifying the pharmacy. C. If the resident will be gone for an extended length of time, it is recommended that nursing staff speak with the pharmacy and determine whether the resident s insurance will cover the dispensing of pass/leave medications. D. All medications provided to the resident and/or responsible party for administration while on pass are properly labeled with full directions for use. All medications, including any controlled substance, should be signed for by the resident and/or responsible party on the Medication Release/Receipt Form. E. Current medication orders and directions for use are reviewed with the resident or responsible party before the resident leaves the facility. If there is a question about the medication that the charge nurse is unable to answer, the provider pharmacy is called for the information before releasing the medication. F. The out-on-pass medication(s) taken by the resident are recorded on the reverse side of the resident s current medication administration record (MAR) or by the system process utilized by the emar. Doses are not documented on the front of the MAR unless the nurse administers the medication. However, the licensed nurse on duty at the time the resident returns to the facility may enter, in the nurse s notes, a summary of the resident s or responsible party s report of compliance with the dosage instructions. (Example: 5/17/2011, 7:00 p.m., Sally Johnson, daughter of Mrs. Johnson states that resident took digoxin, as directed, each morning. (signed) M. Jones, R.N. ) G. A circled initial is placed on the MAR for each dose of regularly scheduled medications that would normally have been administered by the facility while a resident is out on pass. The reason for the circled initial (for example, out on pass with meds ) is explained in the nursing comments section on the back of the MAR for each medication dose due. Page 46 of 121

51 MICELLANEOUS SPECIAL SITUATIONS IF2: USE OF INVESTIGATIONAL MEDICATIONS Policy A resident may be participating in a clinical drug trial and be receiving a medication designated as an investigational new drug (IND) by the Food and Drug Administration (FDA). The medication may not currently be on the market, or may be a medication currently on the market but is being investigated for a new indication. In either case, the investigational product is under the control of the principal investigator of the study. The principal investigator may be a physician who practices at the nursing home or may be an outside physician. The medication supply may be issued to the facility by either the pharmacy or the principal investigator/study coordinator. At the initiation of a clinical drug trial, it is important to determine that all facility policies related to drug administration, storage, labeling, administration, and monitoring are followed and that said policies are aligned with the protocols to be followed by the research team. A. If an investigational drug is used in a research study, the study must have approval from an FDA-licensed Institutional Review Board (IRB). Some states may require a research license be obtained for the facility. B. A copy of an executed informed consent form, indicating Institutional Review Board (IRB) approval, must be kept in the resident s medical record. This consent form must include the name and the address of the facility. C. The informed consent document may not waive or appear to waive the resident s legal rights or relieve the investigator of liability. The IRB will make this determination. An informed consent procedure includes documentation of the provision of the following information to the resident/legal authorized representative: 1) A description of discomforts and risks attendant with use of the investigational new drug and alternatives to it. 2) Information about any medications required to be used in conjunction with the investigational new drug. 3) Expected benefits from the use of the investigational new drug. 4) The potential benefits, risks, and alternatives to medications used with the investigational new drug. 5) The likelihood of success. 6) The possible results of non-treatment. 7) An offer by the investigator to answer the resident s questions about the study or the investigational treatment. 8) A statement affirming the resident s right to withdraw from participation without jeopardizing future services or treatment. 9) A statement assuring confidentiality of any information that might identify the resident. 10) The identity and professional status of individuals responsible for authorizing and performing treatments. 11) Any professional relationship of the investigator to another health care provider or institution that might suggest a conflict of interest. 12) The relationship of the investigator to educational institutions involved in the resident s care and services. 13) Any business relationship among individuals providing the investigational new drug. 14) Disclosure of any patient stipend payments. Page 47 of 121

52 D. The consent form must be in the primary language of the individual(s) who sign(s) it. If a consent form is needed in another language than what is available, said document must be approved by the Institutional Review Board. E. All drug-related studies use a scientifically sound methodology that is appropriate to the study design and hypothesis. Such studies are conducted with full consideration of each subject s best interests. F. The principal investigator or study coordinator must provide information about the study and its procedures (protocol) with facility staff prior to the initiation of the study. Emphasis should be placed on potential medication side effects, special monitoring, including possible adverse reactions and laboratory studies, medication storage and administration documentation. Printed materials must be provided with this information also. A copy of the protocol, or a synopsis, must be kept in the resident s medical record. G. An order must be written by the attending physician indicating the resident may participate in the clinical trial and receive all interventions (including study drug) outlined in the protocol. H. Facility should ensure that all Investigation New Drugs are signed out in order to account for each dose administered. I. The resident may not have participated in another clinical trial within the last thirty days. J. All packaging from the study medication must be kept and returned to the study coordinator. K. The facility s consultant pharmacist should be made aware of the study and which residents are participating. L. If the resident is discharged from the facility, the investigator is informed to assure appropriate hand-off to the next heath care professional. M. If an individual receiving an investigational new drug applies for admission to the facility, the facility (IRB/Quality Assessment and Assurance Committee) determines prior to admission whether the above conditions can be satisfied, including but not limited to: 1) Obtaining a copy of the informed consent signed by the resident or responsible party. This consent must list the name of the receiving facility. 2) Obtaining a copy of the Investigational New Drug (IND) protocol and determining the ability of the receiving facility to participate in the study. 3) Ensuring that the study drug is provided to the resident without interruption. 4) Attending physician s approval. 5) Willingness/ability of research team to conduct research at the receiving facility. 6) Facility staff should be made aware of medication side effects, possible adverse reactions, and associated lab work. N. If the stated conditions cannot be met, the resident and/or responsible party is informed. If participation in the study is terminated by the resident and/or responsible party due to failure to satisfy the above conditions, this is documented in the individual s admission record. O. The investigator and the resident s attending physician are informed if the resident or responsible party withdraws consent to continue participation in the investigational new drug research. P. Investigational medications are labeled, stored, documented and accounted for in accordance with facility policies and procedures for approved medications. Q. The facility/research team establishes a mechanism for ensuring that there is always a sufficient supply of the medication available for the duration of the study. Page 48 of 121

53 R. The facility ensures that additional costs which are not part of the resident s standard care, such as medications, laboratory tests, or procedures incurred by the resident or facility as a result of study participation, are not borne by the resident or the facility. S. Records of the receipt and disposition of the medication are retained in the facility as required by state or federal regulation. T. The facility must provide the consultant pharmacist with a copy of the IND protocol to be used during medication regimen review. Review should include: a. Reviews of use of the investigational new drug in the facility; b. The resident s response; and c. Reported findings to the Quality Assessment and Assurance Committee. Page 49 of 121

54 MICELLANEOUS SPECIAL SITUATIONS IF3: MEDICATIONS NOT COVERED BY THIRD-PARTY PAYERS Policy When a non-covered (non-formulary) medication is ordered for a resident eligible for medicationrelated benefits under Medicaid, Medicare, or other third-party payer programs, the provider pharmacy notifies physician and facility of formulary options and/or prior authorization process A. When non-covered medications are ordered, the provider pharmacy or licensed nurse consults with the resident s physician to seek a change to a covered item. B. When an order is obtained to start a new medication, it will be upon approval of payer, as a prior authorization does not allow for timeliness of initiating a new medication, and new medication may actually be denied coverage by payer. C. If the physician elects not to change the order, and if appropriate, the physician is asked to document medical necessity according to the process set forth by the third-party payer. The pharmacist then attempts to obtain coverage following third-party payer procedures. D. If coverage is not available and third-party rules permit, the pharmacy bills the resident or responsible party, or the facility, as allowed by state law and per the facility s pharmacy provider agreement. Page 50 of 121

55 MICELLANEOUS SPECIAL SITUATIONS IF4: MEDICATIONS BROUGHT TO THE FACILITY BY PHYSICIANS OR RESIDENTS/FAMILY MEMBERS Policy All medication supplies dispensed by a physician or brought in by the resident or family member are labeled, packaged and stored in accordance with product requirements, state and/or federal regulations and facility policies. These medications will only be accepted if there is a current order and if medications are permitted by state and federal law. Medications brought into the facility by physicians or resident family members are reported to the provider pharmacy and added to the resident profile to maintain a complete and accurate drug profile. A. Medication Samples The FDA provides direction for the lawful use of medication samples. The following guidelines should be followed: 1) A physician may dispense medication samples to a patient for the purpose of providing an immediate medication supply when it is not feasible or practical to have a prescription filled. a. The issued supply must not exceed the quantity necessary until such time a prescription can be filled. b. The issuing physician maintains written records of accountability for all samples issued. 2) Due to the above guidelines, the use of samples in the nursing facility is discouraged. Some states do not allow the use of sample medications in nursing facilities. B. Physician Dispensed Medications 1) When medications are provided in physician-dispensed medication containers, containers should be labeled appropriately according to state and federal requirements. 2) Physician-dispensed medications are stored, documented, and accounted for in accordance with facility policies and procedures for medications. 3) The issuing physician maintains written records of accountability for all medications received and dispensed. C. Dispensed Medications from a Physician Outside of the Facility 1) It is not uncommon when a resident has surgery or another procedure outside of the facility for the resident to return with medications issued by a physician at the hospital or clinic. These medications can be administered only if labeled appropriately according to state and federal requirements. 2) The attending physician must approve the use of the medication supply and write an order for the medication. 3) If approved and ordered, the nurse may write the name of the resident on the medication label and list the order on the medication administration record. D. The Facility does not accept imported medications brought into the facility by a resident or family member. E. A licensed nurse must identify medications brought into the facility by a resident or responsible party before administration. Page 51 of 121

56 MICELLANEOUS SPECIAL SITUATIONS IF5: DRUG PRODUCT DEFECT REPORTING Policy Problems with medication product formulation, packaging, and/or therapeutic effect are reported to the Food and Drug Administration (FDA), in consultation with the dispensing pharmacy. A. Medications are inspected prior to administration to a resident. B. If problems are detected with the medication [crumbled tablets, melted or broken capsules, congealed liquid, particulates in injectable or infusion products, or other possible indicators of poor quality], the medication is not administered, and the dispensing pharmacy is contacted. C. In consultation with the dispensing pharmacy, a determination is made of the likely source of the problem (such as a manufacturing problem versus incorrect handling of the medication during shipment, repackaging, or storage at the pharmacy or the facility). D. If a determination is made that a manufacturing defect is the most likely problem, an FDA MedWatch Voluntary Report Form is completed and sent to the FDA. A copy of the form is retained by the facility so that the information is available in the event of a follow-up request by FDA. Page 52 of 121

57 MICELLANEOUS SPECIAL SITUATIONS IF6: DRUG PRODUCT RECALLS Policy The dispensing pharmacy maintains a record of all medications dispensed to the facility. In the event of a consumer-level recall by the manufacturer or the Food and Drug Administration (FDA), the facility is notified by the dispensing pharmacy to return the affected product to the dispensing pharmacy for disposition. The consultant pharmacist should also be notified of the recall. A. The dispensing pharmacy maintains a record of all medications dispensed to the residents of the facility in sufficient detail to enable a recall, if necessary (e.g. documentation of lot numbers dispensed). B. Upon receipt of a recall notice from the manufacturer or FDA, the dispensing pharmacy sends a written notification to the facility with instructions for the return to the dispensing pharmacy of the affected drug product with name, strength, lot number(s) and expiration date. The Pharmacy should provide a list of residents who may have received the affected drug products. C. Facility staff should check all medication storage areas for the affected drug product including carts, cabinets, emergency drug supplies, stock medications. D. Facility staff should segregate all recalled medication until their return to the pharmacy. E. The facility is responsible for locating and returning the affected product to the dispensing pharmacy. The dispensing pharmacy is responsible for the disposition of the affected product as directed by the manufacturer or FDA. F. The dispensing pharmacy replaces the recalled drug product with a new supply, if available. In the event a replacement supply is not available, the dispensing pharmacy contacts the prescriber(s) and the facility to discuss alternative medication therapy. G. If alternative drug therapy is ordered, the charge nurse obtains instructions from the prescriber, including a new order for alternative medication therapy, if appropriate and discontinues the previous order. H. If the recall information indicates that prior use of the recalled drug product may result in adverse consequences, the resident and/or responsible party is provided this information by the prescriber or the facility. The charge nurse documents this in the resident s medical record, including to whom the information was given. I. Facility staff will monitor and report to the physician any adverse reactions that may have been caused by the recalled medication as specified in the recall notification. Page 53 of 121

58 MICELLANEOUS SPECIAL SITUATIONS IF7: BOX WARNING MEDICATIONS Policy Many medications used by residents in the nursing home may carry an FDA-issued box warning. The box warning is a serious type of warning the FDA can require on medication labeling and is important to the health and safety of prescription drug consumers. Nursing facility staff, prescribers and pharmacists should be familiar with box warnings for any medication used in a nursing home resident and assure that these medications are used and monitored appropriately. A. All licensed nurses, attending physicians, mid-level prescribers and pharmacists should be familiar with the medications used by the residents they serve that carry a box warning. B. Facility staff is informed of symptoms, side effects, and special monitoring (i.e. labs) to monitor and report associated with medications with box warnings via the care plan. C. Medications which carry a box warning are identified by information on MAR, EMAR, online sources, and other forms of communication among healthcare providers. Page 54 of 121

59 MICELLANEOUS SPECIAL SITUATIONS IF8: UNAVAILABLE MEDICATIONS Policy Medications used by residents in the nursing facility may be unavailable for dispensing from the pharmacy on occasion. This situation may be due to the pharmacy being temporarily out of stock of a particular product, a drug recall, manufacturer s shortage of an ingredient, lack of physician authorization to refill, third party coverage limitations, or the situation may be permanent because the drug is no longer being made. The facility must make every effort to ensure that medications are available to meet the needs of each resident. A. The pharmacy staff shall: 1) Call or notify nursing staff that the ordered product(s) is/are unavailable. 2) Notify nursing when it is anticipated that the drug(s) will become available. 3) Suggest alternative, comparable drug(s) and dosage of drug(s) that is/are available, which is covered by the resident s insurance. B. Nursing staff shall: 1) Notify the attending physician of the situation and explain the circumstances, expected availability and optional therapy(ies) that are available. a. If the facility nurse is unable to obtain a response from the attending physician, the nurse should notify the nursing supervisor and contact the Facility Medical Director for orders and/or direction. 2) Obtain a new order and cancel/discontinue the order for the non-available medication. 3) Notify the pharmacy of the replacement order. Page 55 of 121

60 PREPARATION & GENERAL GUIDELINES IIA1: EQUIPMENT AND SUPPLIES FOR ADMINISTERING MEDICATIONS Policy The facility maintains equipment and supplies necessary for the preparation and administration of medications to residents. A. The following equipment and supplies are acquired and maintained by the facility for the proper storage, preparation, and administration of medications: 1) Lockable medication carts, cabinets, drawers, and/or rooms with well-lit and ventilated medication preparation areas. 2) A refrigerator and freezer with a thermometer for each section with a temperature log. 3) Thermometers for reading room temperatures. A temperature log with acceptable temperature ranges for each area should be maintained at all times. 4) Space for medication preparation with access to a convenient water source. 5) Oral syringes, parenteral syringes, needles, droppers, soufflé cups, water pitchers, drinking cups, applesauce/pudding, calibrated plastic medication cups, clean tissue, cotton balls, alcohol wipes, lubricant (for rectal and vaginal administration), labels for date opened/date expires, discontinued and other applicable procedures. 6) Devices for crushing and splitting tablets. 7) Examination gloves. 8) Facility-approved hand sanitizer (securely stored so that residents cannot accidentally ingest large quantities). 9) Small-volume nebulizer for administration of inhaled medications. 10) Disposal containers for medications, sharps, and bio-hazardous waste generated during medication administration. B. The charge nurse on duty ensures that equipment and supplies relating to medication administration are clean and orderly. C. If carts are furnished by the provider pharmacy, the pharmacy promptly repairs or replaces nonfunctional carts. If carts belong to the facility, the cart manufacturer or distributor is notified for prompt repair or replacement if a problem with a medication cart occurs. Page 56 of 121

61 PREPARATION & GENERAL GUIDELINES IIA2: MEDICATION ADMINISTRATION GENERAL GUIDELINES Policy Medications are administered as prescribed in accordance with good nursing principles and practices and only by persons legally authorized to do so. Personnel authorized to administer medications do so only after they have been properly oriented to the medication management system in the facility. The facility has sufficient staff and a medication distribution system to ensure safe administration of medications without unnecessary interruptions. A. Preparation 1) Medications are prepared only by licensed nursing, medical, pharmacy or other personnel authorized by state laws and regulations to prepare medications. 2) Hand washing and Hand Sanitization: The person administering medications adheres to good hand hygiene, which includes washing hands thoroughly before beginning a medication pass, prior to handling any medication, after coming into direct contact with a resident, and before and after administration of ophthalmic, topical, vaginal, rectal, and parenteral preparations and medications given via enteral tubes. Examination gloves are worn when necessary (refer to specific administration procedures for each route in Sections IIA and IIB of this manual). Hand sanitization is done with an approved sanitizer between hand washings, when returning to the medication cart or preparation area (assuming hands have not touched a resident or potentially contaminated surface). Sanitization can be done at regular intervals during the medication pass such as after each room, again assuming hand washing is not indicated. Sanitization is not a substitute for proper hand washing, and washing should be done if there is any question. 3) An adequate supply of disposable containers and equipment is maintained on the medication cart for the administration of medications. Disposable containers are never reused. 4) FIVE RIGHTS Right resident, right drug, right dose, right route and right time, are applied for each medication being administered. A triple check of these 5 Rights is recommended at three steps in the process of preparation of a medication for administration: (1) when the medication is selected, (2) when the dose is removed from the container, and finally (3) just after the dose is prepared and the medication put away. a. Check #1: Select the Medication label, container and contents are checked for integrity, and compared against the medication administration record (MAR) by reviewing the 5 Rights. b. Check #2: Prepare the dose the dose is removed from the container and verified against the label and the MAR by reviewing the 5 Rights. c. Check #3: Complete the preparation of the dose and re-verify the label against the MAR by reviewing the 5 Rights. 5) Prior to administration, the medication and dosage schedule on the resident s medication administration record (MAR) are compared with the medication label. If the label and MAR are different and the container is not flagged indicating a change in directions or if there is any other reason to question the dosage or directions, the physician s orders are checked for the correct dosage schedule. 6) Tablet Splitting: If breaking tablets is necessary to administer the proper dose, hands are washed with soap and water or alcohol gel [and examination gloves worn] prior to handling tablets. Examination gloves must be worn if the tablet requires special handling. The following guidelines are followed: Page 57 of 121

62 a. A tablet-splitter is used to ensure accuracy and to minimize contact with the tablet. The splitter blade and surface contacting tablet are cleaned before and after each use. b. If the tablet is scored, every attempt is made to break along score lines. c. If using only one-half of the tablet from a unit-dose package, the remainder is disposed of according to facility procedure. If in a vial, the 1/2 tablet is returned to the original vial, if allowed by applicable law. d. Since unscored tablets may not be accurately broken, their use is discouraged if a suitable alternative is available (such as liquid or half-strength tablet). e. Where possible, the provider pharmacy is requested to package half tablets or the prescriber is contacted for an alternative dosage form (e.g., liquid) or therapeutic equivalent that does not require splitting. 7) Tablet Crushing/Capsule Opening: Crushing tablets may require a physician s order, per facility policy. If it is safe to do so, medication tablets may be crushed or capsules emptied out when a resident has difficulty swallowing or is tube-fed, using the following guidelines. a. Long-acting or enteric-coated dosage forms should not be crushed; an alternative should be sought. Some long-acting capsules can be opened and administered (without crushing contents). Gloving is recommended to protect the nurse form exposure to contents of the capsule. Check with pharmacist before opening any capsules. b. Each medication preparation area includes a device that is specifically used for crushing medications. c. Medications are crushed between two soufflé cups [or using a comparable device] to prevent contact between the medication and the crushing device. If contact occurs, the crushing device is to be properly cleaned prior to further use. d. Medication should be crushed and administered individually if administered via tube. If administered in applesauce or other vehicle, they may be combined. e. For residents unable to swallow or who have difficulty swallowing, tablets which can be appropriately crushed may be ground coarsely and mixed with the appropriate vehicle [such as applesauce] so that the resident receives the entire dose ordered. Please consult with the product literature or Do Not Crush lists which the facility may have or with the pharmacist if there is a question about medications to be crushed. f. Water should be offered to help remove any bitter taste that may not be masked by the applesauce or other vehicle. g. If the resident is tube-fed, medications are crushed finely to prevent clogging the tube. h. The need for crushing medications is indicated on the resident s orders and the MAR so that all personnel administering medications are aware of this need and the consultant pharmacist can advise on safety issues and alternatives, if appropriate, during medication regimen reviews. 8) Liquid dosage forms may be a practical alternative in place of solid tablets, especially if tablets have a coating and will not crush finely. The nurse checks with the provider pharmacy to determine if a liquid form is available and covered by the applicable payment program. The physician is contacted for a new order before changing the dosage form. 9) When administering high-risk medications in liquid form or those requiring precise measurement, such as digoxin or morphine, devices provided by the manufacturer or obtained from the provider pharmacy, (e.g., oral syringes) are used to allow accurate measurement of doses. Additionally, the facility may elect to have 2 nurses check the dose of high risk medications. 10) When administering as needed (PRN) medications at times other than the medication pass, the dose may be prepared in the medication cart storage area and taken to the resident s bedside, leaving the cart locked and secured. 11) If a medication with a current, active order cannot be located in the medication cart/drawer, other areas of the medication cart, medication room, and facility (e.g., other units) are searched, if Page 58 of 121

63 possible. If the medication cannot be located after further investigation, the pharmacy is contacted or medication removed from the night box/emergency kit. 12) When possible, the medication administration record (MAR) should contain supplemental information to help assure accurate dosing. Examples of supplemental information include numbers of tablets or capsules required for the dose (1/2 tablet, 2 capsules, 4 tablets, etc), location of medication (ex: in refrigerator), sequencing (such as for inhalers), or monitoring (ex: Box Warning Drug, or see PT/INR). Some of this information may be found on the pharmacy label. B. Administration 1) Medications are administered only by licensed nursing, medical, pharmacy or other personnel authorized by state laws and regulations to administer medications. 2) If medication requires monitoring of BP, pulse, FBS before administration, the person administering the med will perform the required monitoring before administration. If there are hold parameters, the monitoring information will be compared to parameters and medication will be administered or held. If med is held, nurse will be notified and document. 3) Medications are administered in accordance with written orders of the prescriber. 4) If a dose seems excessive considering the resident s age and condition, or a medication order seems to be unrelated to the resident s current diagnoses or conditions, the nurse calls the provider pharmacy for clarification prior to the administration of the medication or if necessary contacts the prescriber for clarification. This interaction with the pharmacy and/or prescriber and the resulting order clarification are documented in the nursing notes and elsewhere in the medical record as appropriate. 5) When medications are administered by mobile cart taken to the resident s location (room, dining area, etc.) medications are administered at the time they are prepared. Medications are not pre-poured. 6) When medications are administered from a central location, such as the medication room, medications for the immediate administration time may be prepared not more than 60 minutes in advance for all residents, or per applicable state law or regulation. In no case shall more than one dose time be prepared in advance. 7) Medications are administered without unnecessary interruptions. 8) The person who prepares the dose for administration is the person who administers the dose. 9) Residents are identified before medication is administered using [two] methods of identification. Methods of identification include: a. Checking photograph attached to medical record. b. Calling resident by name (except in residents with cognitive impairment). c. Having the resident verify his/her last name. d. If necessary, verifying resident identification with other facility personnel. 10) Hands are washed before putting on examination gloves and upon removal for administration of topical, ophthalmic, injectable, enteral, rectal, and vaginal medications. 1,2 11) An adequate amount of water or other acceptable liquid are given with oral medications. More liquids may be necessary when administering certain medications (e.g., bisphosphonates for osteoporosis). Check with the manufacturer s recommendations or pharmacist if unsure. 12) A schedule of routine dose administration times is established by the facility and utilized on the administration records. 13) Medications are administered within [60 minutes] of scheduled time, except before, with or after meal orders, which are administered [based on mealtimes]. Unless otherwise specified by the prescriber, routine medications are administered according to the established medication Page 59 of 121

64 administration schedule for the facility. Note that patient preference will be taken into consideration and medication times may be adjusted accordingly. 14) Residents are allowed to self-administer medications when specifically authorized by the attending physician and in accordance with procedures for self-administration of medications. 15) Medications supplied for one resident are never administered to another resident. 16) During administration of medications, the medication cart is kept closed and locked when out of sight of the medication nurse or aide. No medications are kept on top of the cart. The cart must be clearly visible to the personnel administering medications, and all outward sides must be inaccessible to residents or others passing by. In addition, privacy is maintained at all times for all resident information (e.g., MAR) [by closing the MAR book/covering the MAR sheet or computer screen] when not in use. 17) For residents not in their rooms or otherwise unavailable to receive medication on the pass, the MAR is flagged with [tags, colored plastic strips, drinking straws, or paper clips]. After completing the medication pass, the nurse returns to the missed resident to administer the medication. 18) The resident is always observed after administration to ensure that the dose was completely ingested. If only a partial dose is ingested, this is noted on the MAR, and action is taken as appropriate. 19) Monitoring of side effects or medication-related problems occurs continually, but particularly after medication administration and especially after the first few doses of a new medication. C. Refusals of Medication 1) Residents may actively refuse medications. Refusals may also be through cheeking or pocketing of pills in the mouth. To detect this, the nurse should observe the resident take and swallow the medication. To check, the nurse can offer additional water. Additionally, the nurse can inspect the mouth. This inspection should include an assessment for possible dry mouth which can result from the effects of other medications that the resident may be taking. Dry mouth can cause the medication to stick to the inside of the mouth. 2) Residents may cheek and discard medications for a number of reasons including having to take too many medications at one time, the administration time is inconvenient, feelings that the medications are not vital or ineffective, or side effects are unpleasant. Nursing should investigate these and other potential reasons for refusal or cheeking. 3) A swallowing assessment may be appropriate if the nurse suspects the resident is having difficulty swallowing and cheeking medications as a result. 4) In no case is it acceptable to crush and otherwise hide medications in food in an attempt to manage refusals. 5) Medication refusal must be reported to the prescriber after repeated doses are refused and there must be documentation of prescriber notification of such. D. Documentation (including electronic) 1) The individual who administers the medication dose records the administration on the resident s MAR directly after the medication is given. At the end of each medication pass, the person administering the medications reviews the MAR to ensure necessary doses were administered and documented. In no case should the individual who administered the medications report off-duty without first recording the administration of any medications. 2) Current medications, except topicals used for treatments, are listed on the medication administration record (MAR). 3) Topical medications used in treatments are listed on the treatment administration record (TAR). Page 60 of 121

65 4) The resident s MAR is initialed and timed by the person administering the medication, in the space provided under the date, and on the line for that specific medication dose administration. Initials on each MAR are cross referenced to a full signature in the space provided. If utilizing EMAR, same information to be readily retrievable. 5) When PRN medications are administered, the following documentation is provided: a. Date and time of administration, dose, route of administration (if other than oral), and, if applicable, the injection site. b. Complaints or symptoms for which the medication was given with specific location if appropriate. c. Results achieved from giving the dose and the time results were noted. d. Signature or initials of person recording administration and signature or initials of person recording effects, if different from the person administering the medication. e. If PRN medication is the same as a timed routine medication, appropriate interval is allowed between the PRN and routine doses. f. If a medication aid is administering medications, a licensed nurse assesses the need for the PRN, communicates this approval to the medication aid approval to administer, then documents appropriately. 6) If a dose of regularly scheduled medication is withheld, refused, not available, or given at a time other than the scheduled time (e.g. the resident is not in the facility at scheduled dose time, or a starter dose of antibiotic is needed), the space provided on the front of the MAR for that dosage administration is [initialed and circled]. An explanatory note is entered on the reverse side of the record and the nurse is notified per facility protocol. If [consecutive doses] of a vital medication are withheld, refused, or not available the physician is notified. Nursing documents the notification and physician response. 7) If an electronic MAR system is used, specific procedures required for resident identification, identifying medications due at specific times, and documentation of administration, refusal, holding of doses, and dosing parameters such as vital signs and lab values are described in the system s user manual. These procedures should be followed, and may differ slightly from the procedures for using paper MARs. Electronic systems also describe procedures for secure access, maintaining privacy of resident information, and for electronic signatures. Maintenance and support procedures for these systems are described in the system user manuals. will vary between the various electronic systems available. References 1 Section , F-441, of the Centers for Medicare & Medicaid (CMS) Guidance to Surveyors for LTC Facilities states, Hand hygiene should occur before and after putting on sterile gloves and after taking off all gloves during all resident care that requires the use of gloves. This includes Medication administration (e.g., eye drops, sublinguals, and injections) 2 Centers for Disease Control and Prevention (CDC). (2002). Guideline for hand hygiene in health-care settings: recommendations of the Healthcare Infection Control Practices Advisory Committee and the HICPAC/SHEA/APIC/IDSA Hand Hygiene Task Force. MMWR 2002; 51 (No.RR-16). Page 61 of 121

66 PREPARATION & GENERAL GUIDELINES IIA3: VIALS AND AMPULES OF INJECTABLE MEDICATIONS Policy Vials and ampules of injectable medications are used in accordance with the manufacturer s recommendations or the provider pharmacy s directions for storage, use, and disposal. A. Vials and ampules dispensed by the pharmacy are maintained in the box or container, with the pharmacy label, in which they are dispensed. B. A multi-dose vial dispensed for a single patient will have the patient name affixed on the vial. C. The date opened and the initials of the first person to use the vial are recorded on multi-dose vials [on the vial label or an accessory label affixed for that purpose]. These labels are not required on single-use vials or ampules. D. Ampules and single-use vials (containing no preservative) are discarded immediately after use. E. The solution in multi-dose vials (MDV) is inspected prior to each use for unusual cloudiness, precipitation, or foreign bodies. The rubber stopper is inspected for deterioration. If a MDV is opened and does not indicate the date opened, the date opened reverts to the date of dispensing on the container, and the use period determined from that date. If the dispensing date cannot be determined, the product should not be used and should be discarded according to the facility s policy. F. If an unused/unopened multi-dose vial shows visible evidence of precipitation or contamination or the rubber stopper is deteriorating, it is not used, and it is returned to the provider pharmacy. A replacement vial is ordered from the provider pharmacy. The provider pharmacy determines the need for reporting a defective solution to the manufacturer and/or filing a Drug Product Problem Report with the Food and Drug Administration MedWatch program. G. Medication in multi-dose vials may be used, per manufacturer recommendation based on storage and date opened, if inspection reveals no problems during that time. USP <797> guidelines recommend discarding multi-dose vials (other than some insulins) at 28 days after opened. Page 62 of 121

67 PREPARATION & GENERAL GUIDELINES IIA4: INFUSION THERAPY PRODUCTS GENERAL INFORMATION Policy Infusion therapy products are safely and accurately administered by an authorized nurse using a method approved by the Quality Assessment and Assurance Committee or other designated committee. A. Please reference Policies and for Infusion Nursing. Book available for purchase through appropriate vendors. (i.e. Amazon.com, Barnesandnoble.com, ins1.org) Page 63 of 121

68 PREPARATION & GENERAL GUIDELINES IIA5: RECONSTITUTION OF MEDICATION FOR PARENTERAL ADMINISTRATION Policy To provide for the safe and accurate reconstitution of parenteral medications prior to administration, manufacturer information is reviewed and aseptic technique is observed. A. Read medication package literature, medication label, or other appropriate reference to determine the correct diluent and quantity of diluent to be used. 1) Note any special steps required (such as shaking). B. Wash hands thoroughly. C. Break and remove seal from vial of medication. D. Break and remove seal from both diluent and medication vials and wipe rubber stoppers with alcohol swab. E. Inject into diluent bottle with syringe an amount of air equal to the amount of fluid to be withdrawn for reconstitution of medication. 1) Do not allow needle to touch any surface other than stopper. F. Withdraw the appropriate amount of diluent into syringe. G. Inject diluent into medication vial slowly and observe resulting solution or suspension for clarity, unusual color, or large particles, such as precipitation. Follow manufacturer s instructions for completing the dissolution (shaking sharply or gently, waiting period for dissolving powder, color changes to note, etc.) If there appears to be a problem, do not administer medication without consulting pharmacist for further information. H. Administer medication or add to intravenous (IV) solution as directed and complete documentation. I. Discard unused medication and diluent according to facility disposal policy. Page 64 of 121

69 PREPARATION & GENERAL GUIDELINES IIA6: PREPARATION OF EMERGENCY OR SHORT-STABILITY INFUSION THERAPY PRODUCTS Policy Infusion therapy products are prepared and delivered by the infusion therapy product provider except in emergencies or when product stability precludes preparation in the pharmacy. Infusion therapy products are prepared in the facility only by a registered nurse who has been trained on infusion therapy preparation and who follows infection control measures. A. The infusion therapy product provider notifies the charge nurse about any infusion therapy product that will not be admixed in the pharmacy, but will require admixing by nursing at the time of administration. B. Such notification is documented and the need for a nurse to prepare the admixture is indicated on the infusion therapy record and on the care plan. C. The infusion therapy product provider supplies complete preparation and handling instructions along with the products to be mixed, and a label to be completed and affixed to the infusion therapy product container. Label should also include the time of infusion therapy product preparation. D. Date and time of preparation of the infusion therapy product is documented in the resident s medical record as well as the time that the infusion was started. E. Infusion therapy products are prepared in accordance with infection control standards and manufacturer s recommendations. F. The area in which infusion therapy supplies and products are stored and prepared for use is kept clean and free of clutter. Refer to facility injectable therapy policies for additional information. Page 65 of 121

70 PREPARATION & GENERAL GUIDELINES IIA7: CONTROLLED SUBSTANCES Policy Medications included in the Drug Enforcement Administration (DEA) classification as controlled substances are subject to special handling, storage, disposal, and recordkeeping in the facility, in accordance with federal and state laws and regulations. A. The Director of Nursing and the consultant pharmacist in collaboration maintain the facility s compliance with federal and state laws and regulations in the handling of controlled medications. Only authorized licensed nursing and pharmacy personnel have access to controlled medications. B. [All controlled substances, CII-V] are stored and maintained in a locked cabinet or compartment. CII are double locked. C. Preparation of the dosage form occurs according to the medication administration policy. D. Accurate accountability of the inventory of all controlled drugs is maintained at all times. When a controlled substance is administered, the licensed nurse or medication aide administering the medication immediately enters the following information on the accountability record and the medication administration record (MAR): 1) Date and time of administration. (MAR, Accountability Record). 2) Amount administered. (Accountability Record). 3) Remaining quantity. (Accountability Record). 4) Initials of the nurse administering the dose, completed after the medication is actually administered. (MAR, Accountability Record). E. When a dose of a controlled medication is removed from the container for administration but refused by the resident or not given for any reason, it is not placed back in the container. It must be destroyed according to facility policy and the disposal documented on the accountability record on the line representing that dose. The same process applies to the disposal of unused partial tablets and unused portions of single dose ampules. This does not apply to controlled drugs packaged in unit-dose containers that are unopened (vials, ampules, patches). F. All controlled medications are reordered when a minimum [five-day] supply remains to allow time for acquisition and transmittal of the required original written prescription to the provider pharmacy, if necessary. G. All controlled medications are verified at shift change and upon changing of personnel responsible for the controlled substances (i.e. has keys to lock box) by actual quantity of each medication and total number of packages (number of cards, bottles, boxes). H. Fentanyl patches are handled per manufacturer guidelines after removal of used patch. Page 66 of 121

71 PREPARATION & GENERAL GUIDELINES IIA8: IRRIGATION SOLUTIONS Policy Irrigation solutions are used in accordance with label directions for storage, use, and disposal. Aseptic technique is used in the handling and application of irrigation solutions. A. Irrigation solutions are labeled with the date and time immediately upon opening. B. Solutions prepared by the provider pharmacy, if unopened, are disposed of by the expiration date indicated. Solutions without an expiration date are not accepted. Solutions prepared by the provider pharmacy are discarded within [seventy two (72)] hours after opening. C. Solutions prepared in the facility (such as Neosporin G.U., hydrogen peroxide solutions) are disposed of within [twenty four (24)] hours. D. Solutions without preservatives, in the original manufacturer s container (such as water, acetic acid and sodium chloride for irrigation), are disposed of within [twenty four (24)] hours after opening. E. Aseptic/sterile technique is used in the handling and application of irrigation solutions. F. When expired, unused solutions are [poured down the drain]. It is not necessary to record disposal of partial containers. Page 67 of 121

72 PREPARATION & GENERAL GUIDELINES IIA9: GENERAL GUIDELINES FOR ADMINISTERING MEDICATION VIA ENTERAL TUBE Policy The facility assures the safe and effective administration of enteral formulas and medications via enteral tubes. Selection of enteral formulas, routes and methods of administration, and the decision to administer medications via enteral tubes are based on nursing assessment of the resident s condition, in consultation with the physician, dietitian, and consultant pharmacist. A. Enteral formulas, equipment, route of administration, and flow rate are selected based on an assessment of the resident s condition and need. B. Interactions between medications and feeding formulas (e.g., phenytoin), and interactions of multiple medications, are considered before administering medications through the enteral tube. If necessary, information is obtained from the provider pharmacy or consultant pharmacist. C. In-service training on bacteriological safety, administration, and monitoring of enteral solutions and medications via the enteral tube is provided by the facility to nursing personnel. D. The manufacturer s written recommendations regarding suggested time period for hanging of the product are consulted when determining the schedule for enteral feeding administration. E. When new medication orders are received from the prescriber, the intended route of administration, via enteral tube, is also obtained. The provider pharmacy is informed that the resident is receiving medications through the enteral tube, and orders for medications are transmitted with the route of administration being an enteral tube. Medications for enteral administration are obtained in easily pulverized or liquid form. The provider pharmacy is consulted to determine the best method for preparing dosage forms for enteral tube administration when liquid formulations are not available. If alternative medications or dosage forms are deemed necessary, the prescriber is contacted for a new order. F. Enteral tubes are flushed with at least [30 ml] 1 of water before administering medications and after all medications have been administered. Drinking water can be used. G. Prior to crushing tablets for administration through the enteral tube, the nurse must consult the medication crushing guidelines to determine if the tablet can be crushed. 1) Crushed medications are not mixed together. The powder from each medication is mixed with water before administration. The soufflé cup is rinsed with water to get all of the medication. 2) Each medication is administered separately to avoid interaction and clumping. The enteral tubing is flushed with at least [five (5) ml] of water between each medication to avoid physical interaction of the medications. [Alternatively, crushed medications may be mixed together, diluted with sufficient water, and administered together so long as no incompatibilities exist. The enteral tube is still flushed with at least 30ml of water before and after administering the group of medications. 1 ] H. The provider pharmacy or consultant pharmacist is consulted when changing to a different formulation or when initiating enteral therapy for necessary dose scheduling adjustments of the medications or feeding schedule adjustments. Page 68 of 121

73 1) If on continuous feeding, it may be necessary to change to intermittent feeding or pause the feeding prior to medication administration to avoid an interaction between enteral solutions and some medications. 2) If on intermittent feeding, it may be necessary to delay feeding up to two hours to avoid a medication interaction with enteral solutions. I. Medications that are GI irritants (such as potassium chloride solution) are diluted as recommended for oral administration, since there is a high potential for gastric irritation when medications are administered directly into the stomach through enteral tubes. The consultant pharmacist and/or dispensing pharmacy is contacted with questions and the physician is contacted if new orders are necessary. J. Avoiding drug & formula interactions: a limited number of medications, such as Dilantin (phenytoin) suspension should be administered with the tube feeding stopped. For continuous feeding schedules, this means that windows for medication administration need to be calculated into the 24-hour feeding schedule. Feeding should be stopped one hour prior to the dose, and not re-started until one hour after the dose. For a twice daily dose such as required for Dilantin Suspension, this means the feeding will be scheduled over 20 hours instead of 24 hours. A feeding rate of 1800 cal/24 hour would then be 1800 cal/20 hours, or 90cal/hr. This rate may then be converted to an ml/hr rate depending on the formula and pump capabilities. See also detailed procedures for administering medication through enteral feeding tubes. Consult facility s nursing policy and procedure manual regarding enteral tube feedings for additional information. References: 1 Section (m), F-332/333, of the Centers for Medicare & Medicaid (CMS) Guidance to Surveyors for LTC Facilities states, Flush the enteral feeding tube with at least 30 ml of preferably warm water before and after medications are administered. While it is noted that some facility policies ideally adopt flushing the tube after each individual medication is given, as opposed to after the group of multiple medications is given, unless there are known compatibility problems between medicines being mixed together, a minimum of one flushing before and after giving the medications is all the surveyor need review. There may be cases where flushing with 30 ml after each single medication is given may overload an individual with fluid, raising the risk of discomfort or stress on body functions. 2 CREST (Clinical Resource Efficiency Support Team) Home Enteral Tube Feeding Working Groups. Guidelines for the Management of Enteral Tube Feeding in Adults Boullata, J. "Practice Issues in Enteral Nutrition: Water" - accessed on 12/3/09 at: BoullataHandout.pdf Page 69 of 121

74 PREPARATION & GENERAL GUIDELINES IIA10: SELF-ADMINISTRATION OF MEDICATIONS Policy In order to maintain the residents high level of independence, residents who desire to self-administer medications are permitted to do so if the facility s interdisciplinary team has determined that the practice would be safe for the resident and other residents of the facility and there is a prescriber s order to self-administer. A. If the resident desires to self-administer medications, an assessment is conducted by the nurse of the resident s cognitive (including orientation to time), physical, and visual ability to carry out this responsibility during the care planning process. An order from the physician is then obtained to self-administer if appropriate. B. If the resident indicates no desire to self-administer medications, this is documented in the appropriate place in the resident s medical record, and the resident is deemed to have deferred this right to the facility. C. For those residents who self-administer, the nurse verifies the resident s ability to selfadminister medications by means of a skill assessment conducted on a [yearly] basis or when there is a significant change in condition. 1) The resident is instructed in the use of the package, purpose of the medication, reading of the label, and scheduling of medication doses. 2) The resident is then requested to read the label on each package and indicate at what time the medication should be taken and any other special instructions for use. 3) The resident is asked to demonstrate the removal of the medication from the package and, in the case of nonsolid dosage forms such as an inhaler, to verbalize the steps involved in administration. 4) The resident is asked to complete a bedside record indicating the administration of the medication (if bedside storage is to be used). D. The results of the nurses assessment of resident skills and of the determination regarding bedside storage are recorded in the resident s medical record, on the care plan. E. If the resident demonstrates the ability to safely self-administer medications, a further assessment of the safety of bedside medication storage is conducted. F. If some medications are administered by the facility and some are approved for selfadministration, the MAR will clearly identify which medication the resident may self-administer. G. Bedside medication storage is permitted only when it does not present a risk to confused residents who wander into the rooms of, or room with, residents who self-administer. Conditions outlined in ID3: BEDSIDE MEDICATION STORAGE are met for bedside storage to occur. See also policy and procedure ID3: BEDSIDE MEDICATION STORAGE Page 70 of 121

75 PREPARATION & GENERAL GUIDELINES IIA11: MULTI-DOSE MEDICATION DELIVERY SYSTEM Policy Oral solid medications may be dispensed in multi-dose packets, per regulation and applicable law. A. Oral solid medications may be dispensed in multi-dose packets with all medications for a single pass time included in one packet. 1) Some residents using many doses at the same pass time may have medications in two medication packets. B. Each resident s dispensed medication packets are attached in chronological sequence. 1) The medication to be administered will begin with the medications to be administered in the morning, followed by the medications to be administered on sequential pass times, as established by the facility. C. Multi-dose medications will be replaced on a schedule agreed upon by the facility and the provider pharmacy. The facility should provide the pharmacy with accurate facility census before the scheduled replacement. D. The resident s name, the date and time of administration, and the name, strength, and description of each medication, and RX number and any additional information as required by regulation or applicable state law, will appear on one side of the packet. The opposite side of the packet is transparent which enables the care giver to see all medications contained in the packet. E. ALL PRN medications will be dispensed in unit of use packaging and must be reordered by facility staff. F. Schedule II-V controlled substances and PRN controlled substances will not be included in the multidose package, but will be filled using unit of use packaging to allow for accountability of inventory. G. All other forms of medication, i.e. liquids, injectables, ophthalmics, otics, inhalers, suppositories, topicals, etc. will be provided with medication labels and will not be automatically replaced by the pharmacy. H. As required by FDA approved manufacturer s labeling, some medications will be dispensed in the original manufacturer s container with medication labels and must be reordered by facility staff. I. Medications that are subject to change frequently or have a narrow therapeutic window (ex. warfarin) and cytotoxic drugs will not be packaged in the multi-dose package. These will be packaged in individual unit of use packaging and must be reordered when needed by facility staff. J. All oral solid medications considered to be hazardous will be packaged in unit of use packaging and must be reordered when needed by facility staff. K. All stop order medications, such as antibiotics, will be supplied in unit of use packaging with the exact number of doses ordered. In the event that the prescriber decides to extend the order for an additional number of days, Facility staff must obtain a new physician s order and fax it to the pharmacy. NEW ORDERS: A. When a new medication is added to the resident s medication regimen, the pharmacy will send the new medication(s) in a separate single dose strip pack that contains the exact number of doses to be Page 71 of 121

76 administered until the next fill cycle. This strip pack can be stapled by staff to the appropriate dose packets until the exchange. B. Whenever medications are ordered at times other than the normal pass times, but no more than four times a day, they will be filled in separate packets. 1) For example, if a medication is ordered every 6 hours at 6am, noon, 6pm, and midnight, the doses will be contained in separate packets labeled with those times. All other routinely ordered medications to be administered at standard pass times will be packaged together in multi-dose packets. REORDERING MEDICATIONS: A. It is not necessary to reorder routinely-ordered medications that are included in the multi-dose strip packets. These packets will automatically be refilled by the pharmacy on a cycle determined by the facility and pharmacy. B. No multi-dose packets or discontinued doses may be returned to the pharmacy and dispose of the doses per facility policy. DIRECTION CHANGES: A. The pharmacy must be notified of all new orders and direction changes. 1) When a medication is changed, the facility will send the pharmacy the order to discontinue the previous medication dosage and provide a new order. 2) Facility Staff should follow the facility policy and procedures in this instance. B. Strength increases: Facility staff may leave the original strength in the existing packets (if possible). The pharmacy will send the correct number of additional tablets/capsules in a single dose strip pack to be attached to the multi-dose packets to be used until the next cycle fill. C. Direction changes involving an increase in frequency: The correct number of doses will be sent in a single dose packaging strip to be attached to the appropriate multi-dose strip until the next cycle. D. In all cases, the multi-dose packets will be revised to reflect all direction changes at the time of the next medication exchange. It is the care giver s responsibility to make sure the packets in the facility are corrected when changes occur. DISCONTINUED MEDICATIONS: A. Whenever a medication order is discontinued, staff should notify the pharmacy. The medication should be removed or isolated from each packet on the current medication pass only and discarded per facility protocol. B. Facility staff should call the pharmacy to confirm identification of the medication to be removed. 1) To remove medication, the medication nurse will: a. Pull strip of existing medication. b. Isolate the pill by reading description of medication on the package. c. Push the pill to the upper corner of the packet. d. Make a small slit into the top of the package. e. Remove the pill from the package. C. If a medication is missing from a regular shipment, a stat or emergency dose may be called to the pharmacy. Page 72 of 121

77 SPECIFIC MEDICATION ADMINISTRATION IIB1: ADMINISTRATION PROCEDURES FOR ALL MEDICATIONS Policy To administer medications in a safe and effective manner. A. Security: All medication storage areas (carts, medication rooms, central supply) are locked at all times unless in use and under the direct observation of the medication nurse/aide. B. Privacy: 1) Provide privacy for resident during administration of medications, 2) Secure (cover) records containing protected health information, (e.g., Medication Administration Records (MARs) and Treatment Administration Records (TARs)). C. Review The 5 Rights three times: 1) FIVE RIGHTS Right resident, right drug, right dose, right route and right time, are applied for each medication being administered. A triple check of these 5 Rights is recommended at three steps in the process of preparation of a medication for administration: (1) when the medication is selected, (2) when the dose is removed from the container, and finally (3) just after the dose is prepared and the medication put away. 2) Prior to removing the medication package/container from the cart/drawer; a. Check MAR/TAR for order. b. Note any allergies or contraindications the resident may have prior to drug administration. c. If unfamiliar with the medication, consult a drug reference, manufacturer package insert, or pharmacist for more information. d. Check for vital signs, other tests to be done during/prior to medication administration. e. Prepare resident for medication administration. 3) Prior to removing the medication from the container a. Check the label against the order on the MAR. b. Note any supplemental labeling that applies (fractional tablet, multiple tablets, volume of liquid, shake well, give with another medication, etc). c. Due to the complexity and length/amount of instructions, some medications may be labeled use as directed. Refer to the MAR for instruction details. 4) After the dose has been prepared and before returning the medication to storage. D. Check expiration date on package/container before administering any medication. When opening a multi-dose container, place the date on the container. E. Identify resident using appropriate identification methods before administering medication (e.g., photo plus verbal confirmation of last name, photo and confirmation by family member, etc.). F. Cleanse hands using antimicrobial soap and water or facility-approved hand sanitizer before beginning a med pass, before handling medication, and before contact with resident. Page 73 of 121

78 G. Use a barrier (e.g., clean disposable tray or plastic cup) to carry medication containers into the resident s room, if the resident has a known contagious condition or infection. This will serve as a barrier between the supplies and the over-the-bed table or other surface on which the supplies are placed while the medication is administered. H. When applicable, explain to resident the type of medication being administered. I. Obtain and record any vital signs or other monitoring parameters ordered or deemed necessary prior to medication administration. J. After administration, return to cart, replace medication container (if multi-dose and doses remain), and document administration in the MAR or TAR, and controlled substance sign out record, if indicated. K. Monitor for side effects or adverse drug reactions immediately after administration and throughout each shift. L. If resident refuses medication, document refusal on MAR or TAR. Research refusals for possibility of dry mouth, resident reluctance, development of swallowing difficulty. M. When administering an as needed (PRN) medication, document reason for giving, observe for medication actions/reactions and record on the PRN effectiveness sheet/nurse s notes. N. Once removed from the package or container, unused or partial doses should be disposed of in accordance with the medication destruction policy. If the medication is a controlled substance, the procedure for destruction of controlled substances should be followed. O. Wash hands with antimicrobial soap and water or use facility-approved hand sanitizer at appropriate intervals. P. Notification of Physician/Prescriber 1) Persistent refusals 2) Held medications for pulse, blood pressure, low or high blood sugar, or other abnormal test results, vital signs, resulting in medications being held 3) Suspected adverse drug reactions These guidelines refer to all medications, in addition to specific procedures for each route of administration. Page 74 of 121

79 SPECIFIC MEDICATION ADMINISTRATION IIB2: ORAL MEDICATION ADMINISTRATION Purpose To administer oral medications in a safe, accurate, and effective manner. Equipment Required A. Medication cart (if medications are stored in a central location) with medications. B. Refrigerated medications (if applicable). C. Medication book or computer containing Medication Administration Record (MAR, emar). D. Calibrated medication cups or syringe (if applicable) for liquid medications E. Soufflé cups for solid medications F. Drinking cups; straws. G. Mortar and pestle/tablet crusher/tablet splitter. H. Pitcher of water. I. Spoons and other devices required for the administration of medications. J. Applesauce, pudding, food, etc. (if needed for medications opened/crushed and administered in food). K. Supplements on ice. L. Controlled substances records (if appropriate). M. Facility-approved hand sanitizer. N. Waste receptacle for trash and a separate container for contaminated pills. O. Drug reference (available in facility). P. Sharps container (alternatively, may be located in resident s room). Special Considerations A. Refer to crushing guidelines prior to crushing any medication for assurance that it can be pulverized. B. Refer to medication reference text for administration of any medication when added to any substance such as applesauce, juice, milk, etc. or confirm with pharmacist. C. Mortar and pestle/tablet crusher/tablet splitter should be cleaned after each use if a double soufflé cup or other protective cover is not used between the tablet and all surfaces of the device. General guidelines on medication administration: A. Wash hands when beginning a med pass, or when contact with resident is expected or has occurred. B. Review and confirm medication orders for each individual resident on the Medication Administration Record PRIOR to administering medications to each resident. Review medication administration record for any tests or vital signs that need to be determined prior to preparing the medications. Discuss with resident and determine if there is a need for any as needed medication such as for pain. C. For solid medications: 1) Pour or push the correct number of tablets or capsules into the soufflé cup, taking care to avoid touching the tablet or capsule, unless wearing gloves. Page 75 of 121

80 2) Crush medications, if indicated by prescriber s order for this resident, only after checking the Medication Crushing Guidelines. Crush in tablet crusher or mortar and pestle or with other appropriate device and clean immediately after use if a double soufflé cup or other protective cover is not used between the tablet and the device. Mix crushed medications in small amount of appropriate substance (e.g. applesauce, juice, etc). D. For liquid medications: 1) Shake well liquids labeled as a suspension (i.e., SUSP). 2) Pour correct amount directly into a graduated/calibrated medication cup or measuring device or pull up correct amount into an oral syringe. Measure volume at eye level, on a flat surface, and read volume from the bottom of the meniscus (curve). 3) Wipe rim and sides of bottle with tissue or paper towel and replace cap after pouring. 4) Any dropper supplied with a medication should be used to measure dose. If none is supplied, oral dosing syringes with appropriate calibrations are used. 5) Dilute liquid medication in fluid if indicated by prescriber s order. Liquid potassium supplements must be diluted. Bulk laxatives, and liquid stool softener may be diluted in juice or water at the nurse s discretion in the volume recommended by the manufacturer. E. If resident is in bed, head of bed should be elevated to greater than 45 degrees prior to administration of medication and for at least 2 minutes after or ask resident to sit upright for a time specified by the medication manufacturer (e.g., bisphosphonates). F. Administer medication and remain with resident while medication is swallowed. Caution with residents who have difficulty with swallowing. Do not leave medications at bedside, unless specifically ordered by prescriber. G. Follow all medication with an adequate amount of water. Be especially aware of certain medications that require water or other liquid for safety reasons. Examples: liquid potassium products should be diluted in juice; osteoporosis medications must be administered with a full glass of water (and with the resident in an upright position), and non-steroidal anti-inflammatory agents must be administered with a full glass of water. All of these medications can erode the esophagus or stomach if not administered with adequate fluids. H. Wash hands with antimicrobial soap and water or use facility-approved hand sanitizer at appropriate intervals. I. Chart medication administration on Medication Administration Record immediately following each resident s medication administration. Page 76 of 121

81 SPECIFIC MEDICATION ADMINISTRATION IIB3: SUBLINGUAL, BUCCAL, AND TRANSMUCOSAL MEDICATION ADMINISTRATION Purpose To administer sublingual medications under the resident s tongue in a safe, accurate, and effective manner. To administer buccal medications in the resident s cheek in a safe, accurate, and effective manner. To administer transmucosal medication in the mouth, without swallowing it whole, in a safe, accurate, and effective manner. Equipment Required A. Medication cart (if medications are stored in a central location) with medications. B. Refrigerated medications if applicable. C. Soufflé cup. D. Medication administration record (MAR). E. Facility-approved hand sanitizer. F. Examination gloves. G. Drinking cups, straws. H. Pitcher of water. I. Controlled substances records (if appropriate). J. Waste receptacle. K. Drug reference (available in facility). General guidelines on medication administration: Sublingual / Buccal Tablets A. Wash hands when beginning a med pass, or when contact with resident is expected or has occurred. B. Put on examination gloves. C. Pour proper number of sublingual/buccal tablets/capsules into soufflé cup. D. Have resident take a sip of water to moisten his or her mouth, and instruct resident to swallow water. E. Place medication in the resident s mouth or help resident to do so if capable, following the directions shown below. 1) Place buccal tablet in the pouch between cheek and upper or lower gum. Page 77 of 121

82 2) Place sublingual tablet under the tongue. F. Instruct resident to close his/her mouth and to not swallow or chew until the tablet has completely dissolved. Eating, drinking, and smoking should be avoided while the tablet is dissolving. G. Instruct the resident to avoid rinsing the mouth for several minutes after the tablet has dissolved. H. Remove and dispose of examination gloves. Wash hands thoroughly with antimicrobial soap and water. Buccal Film (e.g., Onsolis ) A. Put on examination gloves. B. Instruct resident to wet the inside of the cheek using the tongue or rinse the mouth with water to wet the area for placement of film. C. Open the medication package immediately prior to product use. Place the entire film near the tip of a gloved finger with the designated side facing up. Place the designated side of the film against the inside of the cheek. D. Press and hold the film in place for 5 seconds. The film should stay in place on its own after this period. Liquids may be consumed after 5 minutes. E. The film should not be cut or torn prior to use. F. The film will dissolve within 15 to 30 minutes after application. The film should not be manipulated with the tongue or finger(s) and eating food and smoking should be avoided until the film has dissolved. G. Remove and dispose of examination gloves. Wash hands thoroughly with antimicrobial soap and water or facility-approved hand sanitizer. Transmucosal Tablet/Lozenge (e.g. ACTIQ ) A. If resident contact is expected, wear examination gloves. B. Place unit in mouth (or instruct resident to place in mouth) and allow it to dissolve. Tablet/lozenge may be moved from one side of the mouth to the other. Instruct resident to suck (do not chew) on the tablet/lozenge over time recommended in manufacturer recommendations (e.g., 15 minutes). Applicator/handle should be removed after tablet/lozenge is consumed or if resident has achieved an adequate response from medication or if excessive sedation or other effects occur. C. Remove and dispose of examination gloves. Wash hands thoroughly with antimicrobial soap and water or facility-approved hand sanitizer. Page 78 of 121

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