+--------------------------------+------------------+------------------+
| **BROOKHAVEN NATIONAL          | NUMBER: IC-02.0  | PAGE 1 OF 3      |
| LABORATORY**                   |                  |                  |
|                                |                  |                  |
| **GENERAL CLINICAL RESEARCH    |                  |                  |
| CENTER POLICY**                |                  |                  |
+--------------------------------+------------------+------------------+
|                                | PREPARED BY: B.  |                  |
|                                | Pyatt Infection  |                  |
|                                | Control M. Genua |                  |
|                                | Pharmacist       |                  |
+--------------------------------+------------------+------------------+
| SUBJECT: Pharmacy              | REVIEWED BY: W.  |                  |
|                                | Gunther GCRC     |                  |
|                                | Manager          |                  |
+--------------------------------+------------------+------------------+
|                                | APPROVED BY: G.  |                  |
|                                | J. Wang Medical  |                  |
|                                | Dept.Chair       |                  |
+--------------------------------+------------------+------------------+
|                                | EFFECTIVE DATE:  |                  |
|                                | 1-25-08          |                  |
+--------------------------------+------------------+------------------+
|                                | REVISION         |                  |
|                                | HISTORY: 4       |                  |
+--------------------------------+------------------+------------------+

[PURPOSE]{.underline}

The Pharmacy compounds and dispenses drugs for internal, external and
parenteral applications. This document sets forth requirements which
prevent contamination of drugs and solutions.

[POLICIES]{.underline}

1\. There shall be an effective infection prevention program in the
Pharmacy to ensure sterility of drugs and solutions.

2\. Only authorized personnel in the department shall be allowed to
prepare drugs or solutions for subject use.

3\. Specific pharmaceutical procedures shall be developed by the
Pharmacist relating to admixtures and drug reconstitution, and the
preparation of intravenous and irrigating fluids.

[RESPONSIBILITIES]{.underline}

1\. Authorized personnel are responsible for preventing contamination of
drugs and parenteral and irrigation solutions.

2\. In the event a recall of any item is declared, the Pharmacist, on a
working day or as soon as possible, will inform the authorized
personnel. The authorized personnel will then be responsible for
identification, collection and processing of the required item(s).

[PROCEDURES]{.underline}

1\. PERSONNEL: Only authorized personnel are permitted to prepare drugs
or solutions prescribed for subject use.

A. Wash hands before and after handling drugs and solutions.

B. Clean laboratory coat/gown is worn at all times in the Pharmacy.

C. Personnel with respiratory infections or dermatological diseases are
not permitted to handle open solution containers or come into contact
with medications in the Pharmacy.

D. No eating is allowed in the Pharmacy. Smoking is prohibited in the
entire building.

[PREPARATONS]{.underline}

1\. Preparation of oral products including tablets, capsules, liquid
medication and enteral feeding.

A. Use aseptic technique for preparation, including:

1\. Wash hands before mixing, packing, or dispensing drugs.

2\. Use no-touch procedures for counting tablets or capsules.

3\. Use clean equipment for mixing powders.

4\. Use prepackaged unit doses when available to facilitate clean
dispensing.

Bulk compounding and packaging of oral solutions:

1\. Use aseptic techniques for preparation (see #1) using sterile
diluent

2 Package in UNIT DOSE containers whenever possible

3\. Label unopened, refrigerated products for 6 month expiration

4\. Each unit, once opened, must be used within 24 hours and then
discarded

5\. Maintain compounding log indicating products used, manufacturer, and
expiration date, with signature and date of compounding

2\. Preparation of medications for ingestion or topical application such
as ointments, powders, and topical solutions

A. Are the same used for oral preparation with the following additions.

1\. Use sterile diluents.

2\. Use unit dose where possible.

3\. Date solutions and discard when expired.

3\. Preparation of products which may be administered by injection into
skin and tissues via intramuscular, subcutaneous, or intradermal routes,
intravenous route, or into body cavities or organs.

A. Use aseptic technique for preparation.

1\. Wash hands before preparing or drawing up into syringe.

2\. Use sterile supplies:

a\. Needles and syringes (dispose in puncture resistant containers).

b\. Water/saline for solution.

3\. Cleanse all injection ports with antimicrobial agent prior to entry.

4\. Use storage appropriate for product.

a\. Indicate expiration date clearly.

b\. Refrigerate (if appropriate).

c\. Define expiration time or date by which mixed products must be used.

4\. Preparation of parenteral solution such as large volumes for
intravenous fluid replacement, nutritional fluids (TPN) which contain
proteins, high glucose concentrations, vitamins, mineral elements, fats,
and small-volume solutions to provide medications (admixture/minibags).

1\. Examine all shipments for signs of rough handling and/or breakage
(e.g., water marks) and return to the manufacturer if defective.

2\. Avoid temperature extremes in storage area.

3\. Handle package carefully.

4\. Select a low-traffic area for medication preparation.

5\. Use laminar airflow hoods for preparation of parenteral products to
reduce airborne contamination.

a.  Hood should be inspected and certified by qualified personnel every
    6 months under an annual contract agreement. The following tests
    should include: Check of HEPA filter integrity and integrity of
    filter to cabinet seals, check and adjustment of airflow, cabinet
    leakage or air induction test as applicable, illumination test,
    noise level test, vibration test, electrical safety test, test of UV
    lamp

b.  The hood is then affixed with a dated certification sticker which
    includes the date of inspection, procedures performed, due dates for
    the next inspection, and the name of the inspector

b\. Keep objects inside the hood at a minimum because they can cause air
turbulence.

c\. Work at least 15 cm (=6\") inside the hood.

d.  Wipe hood surfaces (except filter surface) with sterile 70%-90%
    ethyl or isopropyl alcohol before each use and several times daily
    when the hood is in continuous use.

e.  Problems arising with the hood shall be reported to the building
    manager who then shall coordinate dates and work schedules for
    certification/repairs

f.  Records of service calls and repairs shall be kept by the building
    manager

6\. Provide convenient sinks for handwashing.

7\. Use an antimicrobial agent for handwashing prior to mixing
parenteral solutions.

8\. Check containers for cracks, leaks, turbidity and particulate matter
which may indicate contamination.

a\. Use a light-device to check IV solutions for dark particulate
matter.

b.  Use a dark background to check for fungal particles.

c.  Light sensitive solutions shall be protected from light

**[NOTE:]{.underline}** Many intravenous solutions will not be cloudy
even with bacterial concentrations of 10^5^ organisms/ml.

9\. Consider special clothing for personnel preparing parenteral
solutions.

NOTE: The CDC recommends gloves, gown and mask be worn when mixing large
batches of IV solutions.

10\. Avoid use of multidose vials.

a\. Use single-use vials whenever possible and discard after use.

b\. Affix label to the (vial) container, which contains the date the
multidose vial, was opened, the expiration date and the initials o f the
person who opened the vial. See attachment 1.

c\. Refrigerate multidose vials unless contraindicated by the
manufacturer (cold temperatures may inhibit activity of some
preservatives).

d\. Discard multidose vials according to manufacturer\'s instructions.
If there are no manufacturer\'s instructions discard the multidose vials
with preservative within 30 days, without preservative within 24 hours.

e.  Use contents of large-volume containers within 24 hours after
    opening.

f.  All open vials found which do not have the date and initials of
    person puncturing shall be immediately discarded.

11\. Label solutions to identify product for recall or to identify
suspected source of contamination. Label includes:

a\. The additive.

b\. Dosage of additive.

c\. Expiration date. (All expired solutions shall not be dispensed; they
shall be discarded)

d\. Date of preparation and identification of personnel performing
admixing.

12\. Monitor storage of solutions.

a\. Refrigerate all admixed fluids or use within 6 hours of admixture
(refrigeration will inhibit growth of microorganism).

b\. If required, store admixed solutions in the refrigerator.

**[NOTE:]{.underline}** Refrigeration must begin immediately after
admixture.

i\. Use storage temperatures which are product-specific.

ii\. Keep a log of daily temperature checks using a NIST thermometer

iii\. All solutions shall be stored with the earliest expiring items in
front, with the later expiring items in corresponding order behind.

13\. Maintain integrity of product prior to subject use.

a\. Keep cover on after opening irrigation solution container to reduce
risk of contamination.

b.  Continue refrigeration of admixture solutions prior to
    administration.

c.  Double check the label before administration

d\. Complete infusion within 24 hours of beginning administration to
subject, or discard solution.

5\. The custodial staff will follow IC-11.0

6.  The housekeeping staff will follow IC-12.0

7.  Engineering: Water used for compounding shall meet all potable water
    standards IC-10.0

> Air supply shall meet the standard subject care area requirements

# ATTACHMENTS

> 1\. Label to be affixed to multidose vial

The only official copy of this file is the one online at the Medical
Department website under "Clinical Research Center Policy Manual."
Before using a printed copy, verify that it is the most current version
by checking the document effective date on the website.