ASEPTIC DISPENSING

Bilal Hassan
M.Phil Pharmaceutics
CONTENTS

 ASEPTIC DISPENSING OF:

 I/V Admixtures OR I/V additive solutions

 TPN OR Hyperailimentation (artificial supply of nutrients
typically IV )
 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 substances
 Examples
 Dextrose 5%, 10% Injection

 NaCl Injection (0.9%, 0.45%)

 Dextrose and NaCl Injection

 Preparation & dispensing of IV
additive solutions
Steps
1. 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 (laminar flow hood).
 Using sterile needles, syringes etc.

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

 Total parenteral nutrition (TPN) is a method of feeding that

bypasses the gastrointestinal tract. Fluids are given into a
vein to provide most of the nutrients the body needs. The
method is used when a person cannot or should not receive
feedings or fluids by mouth.
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.

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.

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
 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.