PRINCE SATTAM BIN ABDUL AZIZ UNIVERSITY

COLLEGE OF PHARMACY

Sterile Dosage Form

(PHT 434)

Parenteral Admixture & Incompatibility

PRESENTED BY :

Dr shahid Jamil
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 Introduction

Pharmacist’s Roles in Admixture Preparations

Rationale behind starting admixture program

Responsibilities of pharmacist

Components of IV Admixture system

Incompatibilities

Types of Incompatibility
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 Intravenous Admixture System
• “Admixture system” refers to sterile IV
solutions that are prepared by using
one or more medications or
electrolytes and will be administered
via the parenteral route.
• It requires the measured addition of a
medication to a 50 ml or larger bag or
bottle of IV fluid.
• It can be provided to the patient in
his/her home.
• Many hospitals involved in
compounding IV solutions and
medications to outpatient settings.

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 Pharmacist’s Roles in Admixture Preparations

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 Rationale behind starting admixture
program
•Started with preparation of solutions not available
commercially.

•1971 FDA along with the USP established the National

Coordinating Committee on Large Volume Parenteral
(NCCLVP) to identify problems associated with large
Volume Parenteral in hospitals (LVPs).

•They developed procedures to be used by hospital

personnel for preparing and administering LVPs

It is no longer exist.

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 Rationale behind starting admixture
program
However, they had set some important standards of
practice which are still used today:
1. Recommended methods for compounding IV
admixtures in hospitals
2. Established a system for the surveillance and
reporting of problems with LVP’s in hospitals
3. Proposed test methods for particulate matter in
LVP’s
4. Set forth recommendations for labeling of LVP’s
and
5. Recommended procedure for in use testing of
LVP’s suspected of contamination or of
producing a reaction in a patient.
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 Responsibilities of Pharmacist
Contamination  The pharmacy must maintain a clean area
out of the direct flow of traffic with a
vertical or horizontal laminar air flow hood
to prepare IV admixtures.

compatibility  A pharmacist should be able to deal with

problems of physical, chemical, and
therapeutic incompatibilities ,
 to design suitable alternatives when these
problem arise.

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 Responsibilities of Pharmacist
Stability  Drug stability information must be readily
accessible to the pharmacist in order to
determine optimum conditions for drug
storage prior and after preparation,

 The stability of a drug at ideal storage

conditions will help to establish a
reasonable expiration date for the product,

 Product sterility, overall integrity also

inspected.

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 Components of IV Admixture system

Preparation
Area

Admixture Storage
system Area

SYSTEM
COMPONENT

Policies and
Personnel
Procedures

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 Preparation area

• Ideally a separate room in pharmacy.

• Size may vary.
• Requirements of room:
i. Washable floor covered with vinyl or epoxy coating,
ii. Hand-washing facility,
iii. Refrigerator
iv. Preparation Tools
v. Adequate Light
vi. Restricted Area
vii. Adequate Counter Space

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 Policies and Procedures
 Guidelines for preparing parenteral products should
be outlines in the pharmacy’s policy and procedure
manual.
 Detailed information regarding preparation,
labeling, storage and expiration dating of parenteral
products should be readily available in the
pharmacy.
 These policy help to provide quality control for the
parenteral products.

• Stability
stability is affected by place, environmental
condition, diluents used and other drugs.

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 Policies and Procedures
• Aseptic Technique
It refers to the ability of personnel who prepare
these IV solutions to handle these products in the
clean environment of a laminar or vertical air flow
hood without introducing viable microorganisms
into the product.
• Quality assurance
System to check aseptic environments and the
pharmacist’s access to both patient’s profile and
final product must be ensured; to provide more
stringent quality control over parenteral therapy.
Routine inspection of all laminar air flow hoods
must be performed.

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 Policies and Procedures
• IV profiling
Review preparation against patient’s current profile.
• Labeling
Labels should reflect the information provided in the
prescription.
Should include-
• patient’s name, ID no., room number,
• name and amount of drug added,
• name & volume of admixture solution,
• Approximate final total volume of the admixture,
• Prescribed flow rate,
• Date and time of preparation,
• Date and time of scheduled administration,
• Expiration date.

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 Policies and Procedures
• Auxiliary label
Required to avoid fatal errors.

These include-
• “Note dosage strength” (for conc. solutions).
• “Protect from light”,
• “Do not refrigerate”,
• “Caution: chemotherapeutic agent”
• “For epidural use only.”

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 Personnel
• Proper training in aseptic technique and sterile
product information is necessary.
• Training courses, self study programs can be
organized for this purpose.
• Training can be of varying levels (regular, intense or
module based).
• Job description for each of the personnel should be
well defined (who will do what?)
Storage area
• Will depend on the type of system one chooses to
use.
• There should be proper refrigeration facility
available.
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 IV room requirement
• Laminar air flow:
HEPA filtration (vertical or horizontal),
Checked in every 6 months.

• Refrigerator:
For slowing down microbial growth.

• Reference:
Handbook of injectable drugs
Compatibility and compounding charts.

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 Incompatibilities in parenteral admixtures
• A safe admixture is one that is free from micro-
organisms, free from particulate matter,
undecomposed and clinically compatible.

• Intravenous admixture incompatibilities are the

undesirable reactions that can occur when two or
more drugs are be administered through single IV
line or given in a single solution.

• It is reported that an average of 18 – 20% of

hospitalized patients suffer from adverse drug
reactions (in USA).

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 Factors causing incompatibility

Type Intervention
Difference in pH Refer to drug incompatibility
tables.
High Temperature Refrigerate the IV admixture if not
used within 1 hour after mixing.
Order of Mixing Alternate the order

Length of Time in Solution The IV drug should be mixed and

discarded if not used within 24
hours.

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 General Ways Of Prevention/ Minimization
Of Incompatibilities
1. Mix thoroughly when a drug is added to the preparation

2. Minimize the number of drugs mixed together in an IV

solution.

3. Solutions should be administered promptly after mixing so

that occurrence potential reactions can be minimized.

4. Always refer to compatibility references.

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 Types
1. Physical Incompatibilities

2. Chemical Incompatibilities

3. Therapeutic
Incompatibilities

4. Drug -IV Container

Incompatibilities

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 Physical Incompatibility
The incompatibility that is mainly on solubility changes and
container interactions.

Examples:
Insolubility, sorption, gas formation, change of pH of
solution.

Prevention:
i. Do not administer a precipitate forming drug.
ii. Avoid mixing drugs prepared in special diluents with
other drugs.
iii. In administration of multiple intravenous medications,
prepare each drug in a separate syringe
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 Chemical Incompatibility
Results from the molecular changes or rearrangement
and leads to chemical decomposition.
Reasons Prevention
HYDROLYSIS Store drugs in relatively water-
proof containers.
OXIDATION REACTION Minimize the exposure time of
the drug.
REDUCTION REACTION Keep away from suspected
reducing agents.
PHOTOLYSIS Storing drugs in lightproof
containers can usually prevent
photolysis.

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 Therapeutic Incompatibility
Result of antagonistic pharmacological effects of
several drugs in one patient.

Example:
Heparin with antibiotics

Intervention:
It is best to avoid mixing heparin with antibacterial
preparations because Heparin can affect the stability of
certain antibiotics.

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 Drug-IV Container Incompatibility
Incompatibility that arise from the chemical reaction of
the drug and the Intravenous container.

Type Definition
ADSORPTION The property of a solid/liquid to
attract and hold to its surface a
gas, liquid, solute or suspension.

ABSORPTION The act of taking up liquids or

other substances through a
surface of the body into body
fluids and tissues.

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 Reference
1. Chemical Incompatibility of Parenteral Drug
admixtures; T. J. McCARTHY; S.A. MEDICAL JOURNAL 2
(http://archive.samj.org.za/1974%20VOL%20XLVIII%20Jul%20-
%20Dec/Articles/03%20September/4.9%20CHEMICAL%20INCOMPATIBILITY%
20OF%20PARENTERAL%20DRUG%20ADMIXTURES.pdf)
2. “Prescriptions usually needed in Egyptian community
pharmacy”(http://pharm.shams.edu.eg/departments/ceutics/elearning/
4/Prescriptions%20usually%20needed%20in%20Egyptian%20community%20
pharmacy.pdf)
3. INTRAVENOUS (IV) ADMIXTURES
(http://www.sh.lsuhsc.edu/policies/policy_manuals_via_ms_word/Nursing/I-
45.pdf)

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