Purpose: To provide guidelines for the safe administration, proper documentation and auditing of controlled substances by nursing personnel.

Transcription

1 University of Kentucky / UK HealthCare Policy and Procedure Policy # ND14-03 Title/Description: Administration, Documentation, and Auditing of Controlled Substances Purpose: To provide guidelines for the safe administration, proper documentation and auditing of controlled substances by nursing personnel. Policy Procedure Physician Orders and Documentation Nursing Documentation Patient Controlled Analgesics Non-Formulary Controlled Substances - Patient's Own Supply Auditing Controlled Substances in Lock Boxes and Key Control Auditing Controlled Substances in Pyxis MedStations and Password Security Discrepancies Involving Controlled Substances Controlled Substances in Solution (PCA or Continuous Infusions) Waste of Unused Solution and Documentation Persons and Sites Affected Policies Replaced Effective Date Review/Revision Dates Policy The Pharmacy shall dispense controlled substances from a central vault to controlled substances lockers or Pyxis MedStations in nursing and pharmacy areas. Access to locked cabinets and Pyxis MedStation shall be limited to authorized licensed nurses and pharmacy staff working in the specified area. Pharmacy shall maintain responsibility for all controlled substances in the Hospital. A perpetual inventory shall be maintained on all controlled substances covered under this policy. Procedure Physician Orders and Documentation 1. Only an authorized prescriber shall order controlled substances. 2. Telephone orders for controlled substances shall be co-signed by the physician as soon as possible. 3. Telephone orders shall be read back to ensure accuracy. Policy # ND14-03 Administration, Documentation, and Auditing of Controlled Substances 1

2 Nursing Documentation 1. When a single dose controlled substance has been administered, the nurse shall document that the patient has received the controlled substance on the Medication Administration Record (MAR). The time that the drug was given and the initials of the nurse who administered the drug shall be recorded on the MAR. 2. Unused portions of single dose narcotics shall be wasted individually in a timely manner by the nurse in the presence of another nurse. This waste and witness process shall be documented on the patient s profile in pyxis.. Patient Controlled Analgesics 1. At the time the controlled substance solution is started on the patient, the PCA Data Parameter shall be implemented. The nurse shall record the drug and concentration, the dose in ml, the hourly basal rates in ml, the lockout interval in min and the volume remaining in ml in the appropriate boxes. Bag and tubing change boxes shall also be checked at this time. Any subsequent bag or tubing changes shall be documented under the hour corresponding to the change. 2. Initiation of therapy shall be documented on the emar and co-signed by another RN or IV certified LPN. Any subsequent bag changes shall also be documented on the emar and co-signed at the time of initiation. 3. Any changes in drug or concentration shall be recorded on the PCA Data Parameter under the hour corresponding to the change at the time it occurs. Any changes in PCA dose, one hour limit, or lockout interval shall also be recorded under the hour corresponding to the change at the time it occurs. When the bag is changed, any wastage shall be documented in the pyxis, witnessed and co-signed by another nurse. 4. The nurse shall record hourly attempts and hourly injections on the PCA Data Parameter from the PCA devise stored memory every four hours. The nurse shall also record hourly basal rates from the PCA devise stored memory every four hours on the PCA Data Parameter. 5. When the PCA is discontinued, the nurse shall record the time including patient hourly usage and remaining volume on the PCA Data Parameter. If there is any remaining solution, this wastage is again documented in the pyxis, witnessed and co-signed by another nurse. Non-Formulary Controlled Substances - Patient's Own Supply A nurse may administer non-formulary controlled substances brought from home to the patient upon an order from the attending physician and identification of the medication by a pharmacist, in compliance with PH 04-03, Medications Brought into the Hospital by Patients. 1. Controlled Substances brought from home should be stored in the CII Safe utilizing the chain of custody sign off (see PH04-03). The chain of custody is simply a listing of the controlled substance, dosage form, strength, and quantity of medication present along with signatures of each professional handling the controlled substance. Policy # ND14-03 Administration, Documentation, and Auditing of Controlled Substances 2

3 (a) If the Patient s Own Supply (POS) is a controlled substance, the medication MUST BE NON-FORMULARY for approval. The first professional receiving the drug from the patient must perform a physical count in front of the patient if possible or have a witness. A pharmacist should complete the Chain of Custody and Alert Notification Forms. The Alert Notification Form must be attached to the FRONT of the patient s discharge form or noted in the medication history document. The designated pink tag should be given to the patient to attach to their personal belongings to serve as a reminder to pick up their medications before departure. (b) Pharmacy shall prepare a small supply of POS as unit dose to serve as an active source of administered medication. The Chain of Custody Form should be updated by the pharmacy personnel completing this process. Unit dose packaged medication should be loaded in a custom pocket in pyxis. Perpetual inventory of the unit dosed item is maintained via pyxis as doses are vended. The remainder of medication should be secured in a locked cabinet in the C2 safe within central pharmacy. (c) Upon discharge, the nurse will be alerted by the Alert Notification Form and will contact pharmacy services. Pharmacy services will obtain medications from the C2 safe and pyxis pocket. The signature of the patient must be obtained on the Chain of Custody Form prior to returning the medications. The Chain of Custody Form should be returned to central pharmacy to be filed. Chain of Custody Forms will be scanned and archived quarterly for record keeping. 2. For nursing areas using the controlled substance usage record (CSUR), the patient's supply shall be counted by two nurses and added to the unit inventory. The CSUR shall be updated during the daily sheet change following procedures for non-floor stock schedule-ii and III controlled substances. The medication shall be counted during routine audits. A nurse shall return medication remaining at time of discharge to the patient. This shall be documented on the Controlled Substance Usage Record and signed by two nurses. Auditing Controlled Substances in Lock Boxes and Key Control 1. For units with lock boxes for controlled substances, the nurses from the off-going and oncoming shifts shall count the controlled substances. The documentation shall be recorded on the controlled substances usage record. 2. Keys for the controlled substance cabinets shall be passed from the off-going to the oncoming shift nurse at the time of the inventory count. Keys shall be with a nurse at all times. 3. If the keys for the controlled substance cabinets are discovered to be off the floor, they shall be returned immediately. The staff member shall return the keys and remain to count the cabinet. 4. If the keys are off the unit for greater than four hours, the Patient Care Manager (PCM) or the Division Charge Nurse (DCN) for the area shall be contacted. If the keys remain off the unit for a time longer than the end of the shift on which the keys are missing, the Pharmacy Administrator and Hospital Operations Administrator (HOA) shall be Policy # ND14-03 Administration, Documentation, and Auditing of Controlled Substances 3

4 contacted. The Nurse Manager or Charge Nurse shall initiate having the locks changed with the hospital security key shop. Auditing Controlled Substances in Pyxis MedStations and Password Security 1. Controlled substances in Pyxis require that the nurse count the contents of each compartment or drawer accessed. This is a blind count. 2. If the quantity entered in Pyxis does not match the calculated quantity, the Pyxis system shall prompt the user to count again. 3. If the count does not match a second time, the Pyxis system shall record a discrepancy and a discrepancy icon shall appear in the lower right hand corner of the Pyxis screen. 4. The nurse finding a discrepancy shall be responsible for initiating a search to resolve the discrepancy (see discrepancy reporting below). The discrepancy reason shall be documented in the Pyxis. Discrepancies Involving Controlled Substances 1. In nursing areas that utilize a Pyxis MedStation, the nurse shall immediately take steps to resolve any discrepancy in the count of a controlled substance by checking with the last person to access that compartment. The nurse shall resolve the discrepancy before leaving the shift. 2. The nurse may also review the Pyxis printout which prints as soon as the discrepancy occurs. If the printout is not available, the same information appears on the Discrepancy Resolution screen. If necessary, the nurse shall call the previous user at home. 3. Before leaving his or her shift, the nurse shall review the sequence of events and perform an inventory of the medication in question to ensure that the count in the machine matches the count in the drawer or compartment. He or she shall ensure that the drawer location selected matches the drawer location on the discrepancy printout. 4. When the reason for the discrepancy has been determined, the nurse shall go to the Main Menu and select Document Discrepancy. This button is present only when an unresolved discrepancy is present at the station. (a) Several pre-entered reasons are present to choose from. If none of them fit the situation, choose Other and enter a brief description of the problem which caused the discrepancy to occur. Examples may include, Previous user miscounted. Drawer failed to open during remove took one when it recovered. (b) The discrepancy icon shall disappear from the screen and the count has been corrected. The process is now complete. 5. If the nurse is unable to determine the cause of the discrepancy, the Patient Care Manager or designee shall be notified. Follow up shall occur as soon as possible. 6. If the cause of the error is still undetermined, the nurse shall complete a Controlled Substance Discrepancy Note, and the nurse shall forward the note as indicated below. The inability to locate the previous person in the Pyxis (e.g. gone on vacation out of town) is the only acceptable reason for not being able to resolve the discrepancy. Policy # ND14-03 Administration, Documentation, and Auditing of Controlled Substances 4

5 7. The original discrepancy note shall be sent to the drug control pharmacist in the Central Pharmacy. One copy of the discrepancy note shall be routed to the appropriate Patient Care Manager. The other shall go to the Nursing Service Director. 8. Pharmacy shall monitor discrepancies and forward the Controlled Substances Discrepancy Report to the PCM. 9. The PCM or designee shall be responsible to use that report to assure all discrepancies are cleared at least every 24 hours. If a discrepancy remains unresolved for 48 hours, the Pharmacy shall suspend the Pyxis access of the person(s) causing the discrepancy until it is resolved. A notice of discrepancies not resolved shall also be sent to the Nursing Service Director, the Director of Pharmacy, and the CNO. 10. After three episodes where the staff person is responsible for triggering an unresolved discrepancy or disregarding an unresolved discrepancy, that is, not working to resolve a discrepancy noted on one s shift, shall result in counseling, training, and disciplinary action may be started by the PCM. Controlled Substances in Solution (PCA or Continuous Infusions) 1. There are currently two different procedures for storing patient controlled analgesia (PCA) bags or other controlled substances for infusion bags in the Pyxis machines. 2. Method 1: (a) Frequently used patient controlled analgesia (PCA) bags or other controlled substances for infusion products shall be loaded in Pyxis and available after pharmacy approves the physician s order in the pharmacy order system. 3. Method 2: (a) Other patient controlled analgesia (PCA) bags or other controlled substances for infusion products ordered less frequently shall be dispensed through the pharmacy IV module as a patient specific dose. (b) Because these specific solutions contain controlled substances, the pharmacy shall deliver these solutions directly to the nurse. The nurse shall receive the product from the pharmacy delivery person and sign the receiving documentation. The nurse shall immediately hang the new bag and waste the old bag with a witness. Waste of Unused Solution and Documentation 1. The nurse shall waste the solution remaining by wasting it in the presence of a second nurse who shall witness the destruction. 2. The nurse shall document the waste and witness process on the patient s profile in the pyxis system. (a) For controlled substance items/ivs/pca s obtained from a pyxis station, the pyxis waste function will list all controlled substances items vended and the item matching the medication to be wasted should be selected and the waste quantity/volume entered. (b) For controlled substance items/ivs/pca s obtained from pharmacy, the pyxis waste function should still be used to document waste. Policy # ND14-03 Administration, Documentation, and Auditing of Controlled Substances 5

6 i. Select Waste icon, select the ALL MEDS to obtain a list of the pyxis formulary items. ii. If the medication to be wasted is listed in the pyxis formulary, select that item and document waste quantity/volume. 3. If the medication to be wasted is not listed in the pyxis formulary, select the CUSTOM CSS/PCA item with the appropriate volume (e.g., 50ml, 100ml,etc.) and document waste volume.the nurse taking a transferred patient with an existing PCA/Epidural Bag shall accept responsibility for the documentation and waste of the bag that remained with the patient after transfer. Persons and Sites Affected Enterprise Chandler Good Samaritan Kentucky Children s Ambulatory Department Nursing Policies Replaced Chandler HP Good Samaritan Kentucky Children s CH Ambulatory KC Other ND08-05 Administration, Documentation, and Auditing of Controlled Substances Effective Date: 10/1988 Review/Revision Dates: 8/2012 Approval by and date: Joseph Dugan, Review Team Leader Darlene Spalding, Senior Nurse Administrator, Good Samaritan Hospital Kathleen Kopser, Senior Nurse Administrator, Chandler Hospital Colleen Swartz, Chief Nurse Executive Policy # ND14-03 Administration, Documentation, and Auditing of Controlled Substances 6