3. aseptic dispensing

ASEPTIC DISPENSINGChapter# 3

CONTENTS

ASEPTIC DISPENSING OF:

I/V Admixtures OR I/V additive solutions TPN OR Hyperailimentation Cytotoxic Dispensing Semi-sterile Dispensing (Eye drops, Ear

drops)

I/V admixture (I/V additive solutions) Sterile product produced when one or

more drugs are added to the IV solutions/fluids.

Additive – drug added to IV solution IV fluids

Large volume parenteral to be administered by intravenous infusion.

Group of sterile products referred to as large-volume parenteral

Prepared with Water for Injection, USP

Cont...Used in: Correction of disturbances in electrolyte

balance Correction of disturbances in body fluids

(fluid replacement) Vehicles for other drug substancesExamples

Dextrose 5%, 10% Injection NaCl Injection (0.9%, 0.45%) Dextrose and NaCl Injection

Preparation & dispensing of IV additive solutions

Steps1. Receipt of physician order.

Pharmacist work from physician’s order sheet.2. Prepare the label.

Label provide information:▪ Patient identification with location.▪ Physician’s name▪ Drugs with quantities▪ Date of compounding▪ Expiry date▪ Pharmacist name

Cont...

3. If necessary – prepare additional label. Positioned in upside down – to facilitate

when container is hung from pole on patient’s bed.

4. Preparation of IV solution – always in LFH. Using sterile needles, syringes etc.

Cont...5. Once drug is added – new seal

crimped on container. Seal colour should be different – warn

that drug has been added.

6. Before supplying – final inspection by pharmacist. Like label, clarity of solution and

calculations of preparation

TPN or Hyper-alimentation IV administration of sufficient nutrients

above usual basal requirements to achieve; Tissue synthesis Positive nitrogen balance & Anabolism

Used for specific patients – unable in enteral feeding.

Also known - TPN

Cont... TPN – part of total patient care. Simple procedures for its preparation. But require appropriate facilities & equipments.

Such as LFH – provide controlled environmental conditions.

Pharmacist – should know about: Preparation methods Stability & compatibility Facilities Equipments ▪ Required for this program.

Cont...Stability & compatibility TPN – consists of various ingredients.

i.e., complex pharmaceutical system Possibility of interactions &

incompatibility between entities present. So increase risk of its toxicity to patients.

Pharmacist – thorough understanding of stability & compatibility issues. Should consult available literature before

preparing TPN.

Cont...

Facility & environment TPN – require aseptic environment.

So LFH are used.

Personnel & training Trained personnel – should carry out

aseptic preparation of TPN. Should know about patient requirements

& product use.

Cont...Documentation Work sheet – should be designed for

TPN dispensing & maintained.

Work sheet contain information about: Materials, patient name, label details

etc.

Cont...

Manufacturing procedures Should be developed jointly by

production & quality control staff. On receiving request for TPN

Feasibility & stability is checked within normal clinical limits of requested combinations.

Information is then transferred to dispensing work sheet.

Cont...

Collection of materials & preparation In this case – first step is identification &

collection of all materials required.

Pharmacist – check these against the work sheet & then sign it.

When more than one TPNs are processed – care necessary to avoid intermixes of source materials, labels etc.

Cont... Materials – placed well within LFH. Organized in manner which will facilitate

systematic steps. And cause minimum disruption of air flow.

Inspection TPN bag – inspected for integrity of;

All ports Leaks Particulate materials

TPN – should meet criteria for limit test of particulate material.

Cont...

Labelling Label should contain:

Patient name/number Ward Product constituents Batch no. Expiry date Storage conditions etc.

Cont...

Storage TPN – stored at 2-6 °C.

to protect it from microbiological & chemical degradation.

Cont...Packaging Quality of packaging systems –

should comply QC standards &

To maintain product temp. during transfer.

Insulated polystyrene containers – most useful.

Cont...

Dispensing TPNs – dispensed according to above

mentioned procedure.

In addition – pharmacist in ward should check that TPN is administered correctly.

Cont...Charging of TPN TPN compounding service – costly for

pharmacy dept. Amino acids & lipids itself – costly items.

Pricing of TPN requires – identification of materials cost & labour costs etc.

All factors considered – before deciding in-house mfg; or obtain product from other hospital or manufacture supply.

Cytotoxic dispensing

Cytotoxic drugs – can kill cells. So used in treatment of cancer & to

destroy tumour & neoplastic cells.

Most cytotoxic injectables – available in powdered form. Require reconstitution.

Cont...

Pharmacist – can provide cytotoxic reconstitution service. Because of knowledge in pharmaceutics,

pharmacology, pharmaceutical chemistry & pharmacokinetics.

▪ Knowledge necessary for understanding:pharmacological action of cytotoxic drug & their stability in solution.

Cont...AREA OF SKILLS NEEDED FOR PHARMACIST

Safe handling Cytotoxic agents – non-selective so far & can

destroy some healthy tissue as well. So precautions necessary for personnel handling

them. Exposure to cytotoxic agents may cause:

Irritation of mucous membranes, eyes, skin Light-headedness, nausea, headache Allergic reactions Risk of malignancy, teratogenesis, leukaemia,

infertility

Cont...

So if proper precautions & procedures are followed then: possible direct exposure, inhalation of aerosolized drugs or ingestion – can be eliminated.

Cont...Preparation areas LAF cyctotoxic cabinet used for preparation.

Provides;▪ Product protection▪ Worker protection

Cytotoxic cabinet – reserved only for cytotoxic drugs.

Ventilation of area – should be adequate. But doors & windows – closed to prevent

draughts.

Cont... Working area – non-porous.

So can be easily cleaned.

Equipments & drugs – arranged in orderly manner. To avoid accidents.

Neutralizing solutions – close to hands. To neutralize effects of spills.

Horizontal LAF – never be used.

Cont...Techniques & precautions Prior to dispensing – product reconstituted.

But maintaining sterility of product & Ensuring maximum protection to operator.

Eating, smoking, drinking – prohibited in work area.

Suitable protective clothings & gloves – protect skin. Latex gloves used commonly.

Cont... Surgical face masks – to prevent inhalation.

Goggles – protect eyes. Should be washed after use.

Reconstitution – carried out on solid surface. Cleaned easily.

Broad edge tray – suitable when LFH surface is perforated.