Department of Pharmacy Policies & Procedures

Number: 5:14

Effective Date: Sept., 1984

Revisions: 2/97; 9/98; 5/00; 6/02; 10/08; 4/09

Reviewed:  9/09

Approval: 6/02

Subject: CONTROLLED DRUGS

 

A. POLICY

All drugs classified as Controlled Substances by the Drug Enforcement Agency will be dispensed through the pharmacy in a manner that provides complete accountability for the drug and its use.

B. GENERAL PROCEDURES

1. All narcotics are handled as floorstock rather than as individual patient stock. The drug is dispensed and charged to the patient in the same action when the nurse administers and records the drug usage.

2. Drugs are stocked in the Pyxis for most patient care areas. The Pyxis maintains records of all transactions on-line and generates a twice weekly report (Mon/Thurs) which serves as the controlled drug administration record.

3. The Controlled Drug Administration Record (CDAR) is used to maintain a record of drug received and administered to patients in areas not serviced by Pyxis.  It is printed and numbered by the CII Safe printer when the drug is dispensed.   A CDAR which is completely filled out serves as a request for more of the drug.

4. Scheduled drugs are replenished to the nursing station by the hospital pharmacy on a daily basis.

5. Controlled drugs may be sent to patient care areas via the pneumatic tube system, by pharmacist or technician delivery, by nurse (RN or LPN) or other authorized personnel pick-up or in the case of the VA 6E unit, in a sealed pouch by a designated escort.

6. All Nuclear Medicine Technologists may administer pharmaceuticals including adjunct oral and IV contrast under the direction of an authorized user. The scope of practice in nuclear medicine technologies includes, but is not limited to, the following area & responsibility: Diagnostic: Requires the utilization of appropriate techniques, and administration of non-radiopharmaceutical agents when part of standard procedures, to insure quality diagnostic images and/or laboratory results.

C. METHODS FOR DISPENSING CONTROLLED SUBSTANCES

1. For the areas where drugs are stocked in the Pyxis:

a. "Refill-Pick" and "Refill-Delivery" reports from Pyxis print daily. Drugs below the minimum are filled and delivered to the proper Pyxis station.

b. If a drug reaches "0" stock between refill reports a "Stock-out" report is printed. The proper drug is filled and loaded into the Pyxis.

c. Drugs not normally stocked in the Pyxis are loaded in the proper station upon receipt of an active order.

2. The pharmacy narcotic technician makes a regular morning run to patient care areas not using Pyxis. During this run the technician will:

a. Pick-up all charge tickets which have been generated during the past 24 hours.

b. Pick-up any completed CDAR forms and empty drug containers generated during the past 24 hours.

c. Check the Daily Drug Audit Sheet for fast moving drugs which may need an extra supply ordered.

d. Order any extra stock needed by the nursing unit for the next 24 hour period.

3. Departments around the UAMS campus who desire to obtain controlled substances from the pharmacy must do so using an Interdepartmental transfer.

a. The interdepartmental must be signed by a physician and his/her DEA number must be on the form.

b. If the drug is a Schedule II drug, a DEA form 222, correctly completed, must accompany the interdepartmental.

c. The brown and green copies of the DEA form 222 and/or a photocopy of the interdepartmental will be used as paper evidence of disbursement.

D. Dispensing narcotics to the Pyxis machine

1. Controlled drugs needed are pulled from stock.

2. Drugs are sorted by units for delivery

3. Drugs to be delivered are checked for accuracy of drug, dosage form and count by the pharmacist.

4. Proper paperwork is signed by the pharmacist

5. The narcotics are bagged and sealed for delivery to the units

6 The drug is delivered to the units by a technician/student and added to the Pyxis with a nurse witnessing the entry. If there is a discrepancy with the narcotics count prior to the delivery, it must be resolved before any addition(s) is made.

7. The Pyxis printout is signed by the witnessing nurse and returned to the narcotics technician/student.

E. Required paperwork with Pyxis

1. Each day a Pick list and Delivery list is printed. These lists show which drugs and quantity should be filled. The Delivery list is signed by the pharmacist when checking the drugs to be delivered. This sheet stays in the pharmacy while the drugs are delivered. The signed Pyxis printout is attached to the delivery list upon return to the pharmacy. At the end of two months these may be discarded.

a. A stockout sheet is printed in cases when the entire supply in a Pyxis is used. The pharmacist signs the stockout form and indicates the actual number of drugs dispensed to the unit. The stockout sheet remains in the pharmacy while the drug is delivered. After delivery, the Pyxis printout is matched with the stockout sheet by the narcotics technician. At the end of two months, these may be discarded.

b. The New Drug-Narcotic Load Sheet is used to record any narcotic which must be loaded new into the Pyxis. The drug, dose, and quantity is recorded and signed by the pharmacist. After delivery, the pharmacist must initial the form indicating that the total quantity was delivered to the Pyxis. If every thing checks out, the narcotics technician will discard this sheet each day.

c. The "Load/Unload" report is used to match all Pyxis printouts for medications loaded or unloaded. All Load/Unloads should have a printout. At the end of 6 months these may be discarded.

d. The "All Station Events" report prints on Monday and Thursday. This report is divided by schedule II and schedule III-V. These reports are filed and kept for two years as the controlled drug administration record.

F. Dispensing narcotics to units not using a Pyxis machine

1. The completed CDAR is checked for completeness of entries and the container is inspected to assure that it matches the sheet and is empty. In the event of a discrepancy, the unit must complete and/or correct the sheet before pharmacy can supply more.

2. If the CDAR is correctly completed the technician may refill from the CII Safe.  When the drug is obtained, a CDAR will print.

3. The number on the new CDAR and the nursing station name is written on the container of the new drug supply.

4. The drug, the new CDAR, and the completed CDAR are all stacked together for checking by a pharmacist.

5. When the pharmacist checks the process he/she places a signature on the delivery sheet.

6. The new form and drug supply are delivered to the nursing station.

a. The receiving nurse must sign the CII Safe delivery sheet after checking to see that the form and the drug match and are accurate.

b. The number of doses received is entered on the nursing unit daily audit sheet.

7. When the completed CDAR sheet is returned to the pharmacy it is "returned" using the bar code scanner. This eliminates the sheet from the list of outstanding drugs.  The completed CDAR is filed in the permanent record file for two years.

8. NucMed will have a double-locked narcotic box mounted in the PET area. They will do a daily narcotic count in the morning and in the evening. They will be in charge of the signing out and administration of the medication. Pharmacy can continue to refill the medication as it is signed out and used.

G. Sending narcotics by pneumatic tube

1. Controlled drugs will be sent via the pneumatic tube system using the SECURE TRANSACTION feature.

2. Pharmacy personnel will enter all relevant data on a Secure Transaction Log.

3. The nurse who received the authority code must retrieve the narcotic, sign the narcotic slip and return it to the pharmacy with the carrier.

H. ONE TIME DOSES

1. If a single emergency dose of a controlled drug is needed for a patient, one nursing station may sign out that dose from another nursing station as directed in Pharmacy policy 8:14.

2. When the patient requires a specialty product such as an I.V. prepared with a controlled substance or a drug which is not floorstocked on the nursing stations, pharmacy will dispense the drug on a "Single Dose Administration Record"

a. The sheet is filled in by hand with the name of the drug, the strength and/or amount of drug, the lot number and expiration date of the drug.

b. The pharmacist who prepares/dispenses the drug and the nurse who received the drug both sign at the bottom of the form.

c. The top (white) copy is given to the nurse with the drug and the bottom (yellow) copy is kept in the pharmacy.

d. When the drug is administered the nurse indicates the date and time of administration and stamps the patient's name on the form.

e. The white copy is placed with other narcotic shingles for pick up by the pharmacy technician.

f. If part of the drug must be wasted by the nurse, the waste may be documented and witnessed on the white copy if it is still available. If it is not, waste is documented and witnessed as a focus note on the patient flow sheet.

I. RETURNING UNNEEDED SUPPLIES OF CONTROLLED SUBSTANCES

1. On patient care areas not using Pyxis, after a drug has been kept for 30 days without being used, it may be returned to the pharmacy.

a. The nurse brings the partially completed CDAR, the remaining drug supply and the daily controlled drug audit sheet to the central hospital pharmacy.

b. The pharmacist verifies the quantity returned with the entries on the CDAR.

c. An entry is made on the bottom line of "Record of Waste and Spoilage and Returns" consisting of the date and the number of units returned which is signed and dated by the nurse.

d. The pharmacist then signs the form in the same area.
2. Controlled drugs may be unloaded from the Pyxis routinely due to lack of use or lack of space.

3. Returns are replaced to the CII Safe by the narcotics technician or the technician removing and returning the drug.

4.  The CII Safe / Pyxis Reconciliation Log is checked daily to verify any unloads and loads.

J. CONTROLLED SUBSTANCE INVENTORY

1. A perpetual inventory is maintained on all controlled substances by using the software capabilities of the C-II Safe.

2. Annually with the pharmacy inventory in June, a complete inventory is conducted on all controlled substances stored in the pharmacy.

a. All counts must agree with the electronic inventory. Supplies in the IV Preparation room are counted and documented separately.

b. Any discrepancies between the two inventories must be resolved.

c. A printout of the complete inventory with Schedule II drugs separated is prepared and signed by the individuals completing the inventory.

d. The copies are filed in the Quality Assurance files.

e. This inventory will meet the requirement for the biennial inventory required by the DEA.