Department of Pharmacy Policies & Procedures

Department of Pharmacy Policies & Procedures

Number: 5:07

Effective Date: May, 1990

Revisions: 4/99; 10/01; 4/02; 3/05; 10/05; 9/09

Approval: 5/12/99

Subject: IV ADMIXTURES

A. POLICY

All intravenous fluids requiring mixing, compounding or other manipulation before administration to the patient will be prepared by the hospital pharmacy and sent to the nursing division in a ready-to-administer form except for some emergency or intensive care situations, or if pharmacy temporarily cannot provide this service. Preparation shall occur under conditions which meet the standards of USP Chapter <797>. Identification of compounded sterile preparations (CSPs) by risk category will be based on the following classifications from USP Chapter <797>:

1. Immediate-Use CSPs – compounded for use in emergency situations or when preparation of the CSP under low-risk level conditions would subject the patient to additional risk due to delays in therapy; no storage or batch compounding; applies only to products that would otherwise be considered low-risk CSPs; medium- and high-risk level CSPs are not eligible for immediate use. Administration must begin not later than 1 hour after preparation begins.

2. Low Risk Level with 12-Hour or Less Beyond-Use Date (BUD) – compounded without direct contact contamination in an ISO Class 5 laminar air flow hood not located in an ISO Class 7 buffer area; simple additives which administration must commence within 12 hours of preparing the CSP; preparations must be patient specific, based on a prescriber’s order. These products shall meet all of the following criteria:

a) Compounding area shall maintain ISO Class 5 and shall be in a segregated compounding area restricted to compounding activities that minimize the risk of product contamination.

b) The area shall not be in a location that has unsealed windows or doors that connect to the outdoors or high traffic flow, or that is adjacent to construction sites, warehouse, or food preparation.

c) Personnel shall follow proper cleansing and garbing procedures. Sinks should be separated from the immediate area.

d) The proper cleaning and disinfecting procedures are followed.

3. Low Risk Level CSPs – compounded with aseptic technique in an ISO Class 5 laminar airflow hood located within an ISO Class 7 buffer area using only sterile ingredients and devices. Compounding procedures involve only transferring, measuring, and mixing manipulations using not more than 3 sterile products and not more than 2 entries into each sterile container. Involves only a few closed-system basic, simple aseptic transfers and manipulations. Most products prepared by the pharmacy are low risk and involve the majority of the routine daily IV preparation.

4. Medium-Risk Level CSPs – products where multiple products are combined or pooled to make a product to be administered to multiple patients or to one patient on multiple occasions The compounding process includes complex aseptic manipulations other than the single-volume transfer and may involve preparation using a pump or compounder. The compounding process requires unusually long duration, such as that required to complete dissolution or homogenous mixing. This includes all products compounded on the automated compounder such as TPN solutions. This also includes preparing reservoir/infusion devices for administration over several days at ambient temperatures such as is done in the ACRC pharmacy.

5. High-Risk Level CSPs – products where non-sterile ingredients or a non-sterile device is involved in the preparation of a product which requires terminal sterilization before use. Sterility testing will occur for all high risk products prepared in batch for multiple patients and storage may be based on stability of the product. Products prepared extemporaneously for a specific patient may only be stored for 24 hours at room temperature or 3 days refrigerated.

6. Examples:

a) Immediate-Use – medications prepared during a Code Blue or for treatment in the Emergency Department

b) Low-Risk – reconstitution of single-dose vials of antibiotics or other small-volume parenterals, preparation of hydration solutions

c) Medium-Risk – pooled admixtures (CSPs made from bulk vials), parenteral nutrition solutions using automated compounders, batch compounded preparations that don’t contain bacteriostatic components

d) High-Risk – concentrated morphine, alum irrigation

7. Beyond-Use Dates – in the absence of passing additional sterility testing, the beyond use dates cannot exceed the following time periods before administration. Unless specified differently by the manufacturer or references, beyond-use dates are assigned according to the risk of contamination and storage conditions as outlined in the following table:

Risk Category	Room Temp (20-30°C)	Refrigerated (2-8°C)	Frozen (< -20°C)
Immediate-Use	1 hour	1 hour	N/A
Low-Risk	48 hours	14 days	45 days
Low-Risk with 12-hour BUD	12 hours	12 hours	N/A
Medium-Risk	30 hours	9 days	45 days
High-Risk	24 hours	72 hours	45 days

B. GENERAL PROCEDURES

1. All orders for IV medications are entered/verified in the hospital computer order entry system at the point of receipt of the order according to policy of processing and dispensing of drug orders.

2. IV drug concentrations listed in the hospital computer order entry system are recognized as the standard concentrations. All orders are reviewed by the pharmacist and may require clarification by the ordering or attending physician.

3. Unless the order specifies a particular start time or is to be initiated as a fluid change with the next bag, all IV orders will be entered to start "now" and should be filled and sent within one hour of receipt of the order.

4. Labels are generated at the time of order input for any fluids needed before the next regularly scheduled delivery.

5. IV deliveries are made three times daily according to the filling report times in the hospital computer order entry system (11AM, 7PM, 4AM).

6. The labels for each delivery are auto-generated at the set times within the hospital computer order entry system. These deliveries can also be called early within certain time periods established within the hospital computer order entry system.

C. PROCEDURE FOR IV ADMIXTURES

1. IV admixtures and piggybacks are prepared three times a day in conjunction with the delivery schedule.

2. The labels are printed for a delivery schedule. These labels are sorted by method of preparation. Those medications designated as “On Demand” or with a frequency of “PRN” are discarded. The commercially prepared (premixed) fluids and ADD-Vantage are assembled by the IV technician. An IV-certified technician may prepare a single additive IV with a pharmacist check. The fluids requiring judgment or extra manipulation are prepared by the pharmacist.

3. All IVs prepared and/or labeled by the pharmacy will have a tamper-tell seal placed over the injection port. If this seal is intact, the pharmacy can recycle the IV in the event the order is discontinued.

4. All IV admixtures are checked before delivery. This check includes physical inspection for particulate matter, accuracy of ingredients, quantities of each drug, and accuracy of base solution. The label is checked for proper expiration dating and then the pharmacist initials the label.

5. The IV admixtures are then sorted by nursing station and sent to the nursing station via the pneumatic tube system.

D. PROCEDURE FOR LARGE VOLUME PARENTERAL SOLUTIONS

1. Labels for all large volume parental (LVP) solutions supplied through the central IV additive service are auto-generated at 2000 (time period 0459-0458).

2. At 2000 a hardcopy of the LVP fill list is auto-generated when the LVP delivery labels print. The list may also be reprinted manually from the computer, if necessary. This list is used by a student or technician to check for excess supplies of LVPs left from the previous 24 hours. If the patient has extra LVPs available due to change in administration rate or procedures, this is noted on the fill list.

3. Information on the LVP fill list is used to predict the amount of fluids which will need to be made during the next 24 hours, assuming no changes.

4. Labels of fluids which are deemed unnecessary according to the LVP fill list will be pulled from the supply of labels run for the next 24 hours and discarded.

5. Remaining labels will be divided and stored by delivery with excess labels being removed first from the 4AM delivery.

6. During the next 24 hours, labels for fluids on new orders are printed for the remainder of the 24 hour period. These labels will be divided into the delivery times as needed according to the hang time on the label.

7. The LVP labels are pulled and prepared at the time that the IV piggyback and chemotherapy (IVPB) deliveries are prepared.

8. Large volume IV fluids are delivered with the IV piggybacks three times daily.

E. FLOORSTOCK OF PLAIN LARGE VOLUME IV FLUIDS

Each nursing unit has a standard supply of IV solutions to use on patients when hydration without additives is ordered. These are handled on a "par level" basis by Central Sterile Supply. Those fluids administered to the patient without medication added are supplied to the nursing unit by CSS within the parameters of policy 6:12 Distribution of Low Risk Medications/Solutions.

F. LABELING IV PREPARATIONS

All IV fluids sent from the pharmacy will be labeled under a standard format which is automatically produced by the computer. The label contains the following information:

1. Patient location

2. Patient name

3. Patient account number

4. Patient date of birth

5. Active ingredient(s) and quantity of each

6. IV solution (diluent)

7. Run rate or frequency

8. Scheduled hang time

9. Any special storage conditions

10. Date prepared

11. Expiration date and time

12. Initials of pharmacist

G. STORAGE AND DISTRIBUTION

1. When IV admixtures are delivered to the nursing unit, all IVs which have been prepared by the pharmacy are stored in the refrigerator on the unit unless the item has a "Do Not Refrigerate" auxillary label affixed to the product.

2. ADD-vantage drugs which are not reconstituted and other fluids commercially prepared are not placed in the refrigerator.

3. All IV fluids may be tubed to the nursing unit unless the product is on the "Do Not Tube" list. "Do Not Tube" auxillary labels should be attached to these products by the compounding pharmacist. Admixtures which require special padding will be tubed wrapped in bubble wrap or clean blue towels.

4. IV admixtures that require light protection will be stored and dispensed in brown light-resistant cover bags.

H. EXPIRATION DATING

1. All IV admixtures prepared in the IV room will be given a 48 hour expiration date if stored at room temperature. Products stored in the refrigerator will receive a 14 day expiration date unless classified as medium or high-risk products.

2. Commercial products which are ADD-Vantage or frozen premix solutions will be stamped with the date of assembly or thawing and the date of expiration in compliance with the manufacturer’s instructions. However, these products will receive a 48 hour expiration date on the IV label for purposes of inventory control.

I. PREPARATION OF IV SOLUTIONS FOR THE NURSERY

1. Any technician preparing nursery dilutions or drawing up syringes must be IV- certified. If IV-certified, student employees may handle any of these tasks listed for technicians.

2. IV Extempo labels for the 24 hour delivery are auto-generated at 2000 (time period 0400-0359).

3. All current dilutions will be discarded.

4. Preparation of new dilutions will be handled using either the posted Dilutions Instruction Chart or the directions for neonatal dilutions that are located on the prebuilt labels. Prepare all solutions on the standard preparation list and any other dilutions needed as indicated from the IV Extempo labels. Ampicillin will be diluted no earlier than 0100.

5. Label each dilution with the preparer's initials and the expiration date.

6. The pharmacist will check and initial all dilutions.

7. The IV area technician will pull up all the doses identified by the IV Extempo labels. The pharmacist will initial each dose, bag each patient's doses, verify proper storage labels are on the bag, and initial the bag.

8. All bulk dilutions are properly refrigerated after the batch is checked.

9. The IV technician will deliver the batches of syringes and IV bags. Delivery will begin in the Nursery areas using the bed location/medication room guide to place the patients' bagged syringes in the proper refrigerator. Any expired syringes remaining in the refrigerator will be removed. This delivery should be completed no later than 0400.

10. The night pharmacist will review expired doses returned to the pharmacy by the IV technician and obtain order clarification if needed.

11. The dispensing area technicians will be responsible for all other technician tasks during the preparation and delivery times for the Nursery.

J. PREPARATION OF FIRST DOSES FOR THE NURSERY

1. First dose labels for Nursery IV medications will print on the dispensing area label printer as soon upon order verification. These first doses should be regarded as "now" orders and filled immediately. Complete turn-around for a first dose should occur in 30 minutes.

2. The label will be removed from the printer and delivered to the designated area of the IV room. The IV area technician is responsible for frequently checking for such labels. The technician will then remove the proper dilution from the refrigerator, take it to the designated IV hood and prepare the dose.

3. Once checked and initialed by the pharmacist, the dose is tubed to the nursery. Items that cannot be tubed are dispensed from the pharmacy window.

4. The technician is responsible for seeing that the dose has been checked and tubed promptly, and that the dilution has been returned to its proper place in the refrigerator.

K. STANDARDIZED DRIPS FOR THE NURSERY

1. Certain IV drips for the Neonatal nursery will be prepared using standardized formulas:

a) Alprostadil 500 mcg/D5W 50ml

b) Amiodarone 100 mg/D5W 50ml

c) Bumetanide 1mg/D5W 25ml

d) Dobutamine 500 mg/D5W 250 ml (premix)

e) Dopamine 400 mg/D5W 250 ml (premix)

f) Doxapram 100 mg/D5W 100ml

g) Epinephrine 2 mg/D5W 100ml

h) Esmolol 2500 mg/NS 250 ml (premix)

i) Fentanyl 250 mcg/D5W 25ml

j) Fentanyl 250 mcg/NS 25ml

k) Insulin 50 units/0.225% NaCl 250ml

l) Midazolam 5 mg/D5W 25ml

m) Midazolam 5 mg/NS 25ml

n) Milrinone 20 mg/D5W 100 ml (premix)

o) Morphine 4 mg/D5W 50ml

p) Octreotide 500 mcg/D5W 50ml

q) Octreotide 500 mcg/NS 50ml

r) Vecuronium 25 mg/D5W 25ml

s) Vecuronium 25 mg/NS 25ml

2. Physicians must be able to clinically justify changing the concentration of the fluid.

3. The current weight of the infant will be verified in order to verify the dosing is correct.

4. Drips compounded by the pharmacy will receive a maximum of a 3 day expiration date on the label.

5. Fluids will be changed when the bag is complete or when the tubing is changed, whichever comes first.

L. CREDITING IV SOLUTIONS

1. When an IV is discontinued a label is generated in the central pharmacy on the IV printer. "Discontinue" labels for LVP solutions are placed with the large volume labels to be checked and pulled before the delivery is prepared.

2. IV solutions which have been prepared but not yet sent are pulled from the delivery.

3. If the IV solution was non-standard and made especially for the patient, the IV is stored in the refrigerator for the period of the expiration.

M. IV’S PREPARED BY NURSING UNITS

1. IV’s for all nursing units will be prepared by the pharmacy department unless the pharmacy has temporarily become unable to do so, there is a stability issue with the medication, or an emergency exists.

2. Pharmacy will contact all nursing units in the event that they will need to prepare their own IV’s. When pharmacy is again able to prepare IV’s, all nursing units will again be contacted and preparation on the nursing units will cease.

3. Nursing units will be allowed to prepare all necessary solutions except for chemotherapy and parenteral nutrition solutions.

4. IV base solutions will be obtained either from pharmacy or CSS. The drugs needed to make the necessary IV’s will be provided by the pharmacy according to standard drug dispensing procedures, unless such item(s) are floorstock on the unit. Pharmacy will provide the base solution and the drug in those cases where stability demands preparation on the unit.

5. Only licensed medical/nursing personnel will be allowed to prepare an IV solution on the unit.

6. Prepared IV solutions will have the red "Medication Added" label affixed to the IV bag with the appropriate information completed, including:

a) Patient name

b) Medication(s) and amount(s) added

c) Initials of licensed person who prepared IV

7. A label will be provided by pharmacy in those cases where stability concerns require nursing preparation of the IV.

N. CARDIOPLEGIC SOLUTIONS

1. Standard Solutions

a) Each evening, the pharmacy will make enough cardioplegic solution and pump primer solution to maintain a par level of 4 in the central pharmacy.

Cardioplegic Solution Formula:

Dextrose 70% 20 gm (28.6 ml)

Procaine 10% 3 ml (3 ml)

Magnesium Sulfate 50% 5 gm (10 ml)

Potassium Chloride 2 meq/ml 45 mEq (22.5 ml)

Sodium Bicarbonate 8.4% 75 mEq (75 ml)

Sodium Chloride 0.9% qs to 250 ml (110.9 ml)

Pump Primer Solution Formula:

Plasmalyte A 1000 ml

Heparin 10,000 units

Sodium Bicarbonate 8.4% 50 mEq

Mannitol 12.5 gm (50ml) will be added in the OR Satellite before use.

b) Label the bags using free-form solution labels in the Labels folder on the G drive (G:\Shared\Labels\Prebuilt Labels\IV Solution Labels) and use an expiration date of 7 days.

c) Store the bags in the refrigerator.

d) Discard any cardioplegia or pump primer solutions remaining from the previous week.

2. Solutions for Heart Transplant

a. When notified of a pending heart transplant, the pharmacy will immediately prepare two (2) bags of the following solution to use during and after harvest of the heart.

Dextrose 5% 1000 ml

Mannitol 25% 12.5 gm

Potassium Chloride 2 meq/ml 30 mEq

Sodium Bicarbonate 8.4% 25 mEq

b) Label the bags using free form solution labels in the Labels folder on the G drive (G:\Shared\Labels\Prebuilt Labels\IV Solution Labels) and give them a 72 hour expiration date.

c) Other products which must be sent with the two bags of cardioplegia solution are:

i) Liothyronine Sodium (T-3 - Triostat^®) Inj - 2 vials (stockroom)

ii) PhysioSol irrigation solution - 1 bottle (OR satellite)

d) These products may be sent from the pharmacy on request or may be taken from the OR satellite or the OR Night Cart.

e) Charges for heart transplant products will be handled by the OR Satellite pharmacist.