International Standard Serial Number (ISSN): 2319-8141

International Journal of Universal Pharmacy and Bio Sciences 1(2): November-December2012

INTERNATIONAL JOURNAL OF UNIVERSAL

PHARMACY AND BIO SCIENCES
Pharmaceutical Sciences Review Article!!!

Received: 26-11-2012; Accepted: 30-11-2012

HOME PARENTERAL NUTRITION IN STERILE PRODUCTS

SenthilKumar Krishnan*, D. R.Nagesh

Department of Pharmaceutics, Sri Adhichunchanagiri College of Pharmacy, B.G. Nagara,

Mandya District, Karnataka, India. Pin 571448.

ABSTRACT
KEYWORDS: Professional personnel in the pharmaceutical industry may

Intravenous mixtures, have little awareness of the pharmacist responsibilities

Sterile compounding,
concerning sterile dosage forms in the hospital. It is also for
Home Parenteral
Nutrition. hospital pharmacists as an aid in the design of quality
For Correspondence:
SenthilKumar Krishnan* services and in the evaluation of program or operational

Address: Department of performance. With the practice of hospital pharmacy and

Pharmaceutics, Sri
Adhichunchanagiri have seen ways to apply their knowledge and experience to
College of Pharmacy,
the hospital setting. Institutional markets use virtually every
B.G. Nagara, Mandya
District, Karnataka, India. commercially available sterile dosage forms. The scope of the
Pin 571448.
inventory and usage rates varies among individual facilities,
Mb No. 08088911340
intensity of care and formulary policies.
Email:senthilsomesh2005
@gmail.com

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 International Standard Serial Number (ISSN): 2319-8141
1. INTRODUCTION :
About 40% o all the drugs administrated in the hospitals are given in the form of injections and
their use is increasing. Part of this increase in parenteral therapy is due to the wider use of
intravenous (IV) fluids. The IV fluids continues to remain as means of fluid replacement,
electrolyte balance restoration and supplementary nutrition and they also used as the vehicles for
vary finding greater use as the means of administering other drugs because of convenience, the
means to reducing the irritation potential of drugs and the desirability for continues and
intermittent drug therapy.
The use of IV fluids for this purpose requires the compounding of specific IV admixtures to meet
the clinical needs of the given patient. The combination of drug substances in an IV Fluid can
promote parenteral incompatibilities and give rise to conditions not favorable for drug stability. So
a new area of specialization has been created for the hospital pharmacist who can develop the
expertise to prepare this solutions- recognizing their compatibility and stability profiles and the
potential for contamination- and also participate n the administration of the solutions. When one or
more sterile products are added to IV fluids, the resulting combination for administration known as
IV admixture or IV additives. The U.S.P permits the addition of suitable substance to the official
preparations intended for injection for the purpose of increasing their stability or usefulness,
provide the substances are not interdicted in the individual monographs and harmless in the
amount administrated and do not interfere with the therapeutic efficacy of the preparation or with
specified assays and tests. Many of the added substances are antibacterial preservatives, buffers,
solubiliser, anti oxidants and other pharmaceutical adjuvant. Agents employed solely for coloring
effects are strictly prohibited in parenteral products.
The U.S.P also requires that one or more suitable substance be added to parenteral products that are
packaged in multiple dose containers, to prevent the growth of micro organisms regardless of the
method of sterilization employed, unless otherwise detected in the in the individual monograph or
unless the injections active ingredients themselves as bacteriostatic so such substances can be used
in concentrations that prevent the growth or kill of microorganisms in the preparation. Because
many of the usual preservatives agents are toxic when given in toxic amount or is irritating when
parenterally administered and special care must be taken in the selection of appropriate
preservative agents.

The maximum limits for some of the preservatives are;

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 International Standard Serial Number (ISSN): 2319-8141

For agents containing necessary and the cationic surface active compound 0.01%.
For agents like chlorobutanol, cresol, and phenol 0.5%
For sulphur dioxide as an anti oxidant 0.2%.
In addition to the stabling affects of additives the air with in an Injectable product is frequently
replaced with an inert gas such as nitrogen, to enhance the stability of the product by preventing
chemical reaction between the oxygen in the air and the drug.
Chelating agents:
It may be added, to bind in non ionisible form, trace amounts of heavy metals, which if free, would
catalyzes degrdative changes. The agent most commonly used is disodium or calcium disodium
salt of EDTA in a concentration of 0.05%. An example of this chelating agent is the stabilization of
thimersol in poliomyelitis vaccine. Thimersol is a present as a bacteriostatic agent but its unstable
in presence of cupric ions, the breakdown product of which destroy the antigenicity of the vaccine.
The chelating agent stabilizes the thimersol and thereby stabiles the vaccine. The heavy metals
extracted from rubber closures also may be bound by the presence of a chelating agent, reducing
the possibility of reactions with the ingredients in the formulation.
Sometimes complexion occurs between an added ingredient and a macromolecule in the
formulation. The methyl and propyl esters of p- hydroxybenzoic acid have been found to complex
with polysorbate so with a corresponding decrease in the antibacterial activity. Their effectiveness
can be regained by the non ionic surfactant. The additives are the injections packed in the
ampoules, vials, or sterile solutions and the latter is reconstituted with suitable diluents before
addition of to the IV fluid. All transferring and admixture preparations should be done aseptically.
Certain injections are light sensitive and are protected against photolysis by the container
packaging and in case of drug substances having poor stability in aqueous solutions, the drug is
packaged as a sterile solid either dry filled or lyophilized.
In order to increase the efficacy of i.v admixture programmes, a number of hospital pharmacist
have found it convenient to freeze the reconstituted drugs, particularly antibiotics. In cases where
published information is available, close adherence must be observed as to freezing temperature,
storage conditions and packaging.
When one or more additives are combined with an IV fluid, their presence together may modify
the inherent characteristics of the drug substance present: resulting in a parenteral incompatibility.

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 International Standard Serial Number (ISSN): 2319-8141
Risk Levels and Associated Risks in Sterile Compounding
Risk Level Risks
Low Risk product is compounded with commercially available components
compounding involves few aseptic manipulations
"closed system" transfers are used
High Risk, Category I prepared from commercially prepared compounds
closed system pooling of sterile drug products
complex, numerous manipulations over a long period of time
multiday infusion via a portable pump or reservoir
High Risk, Category II prepared from non sterile drug substance
"open systems"
Comparison of USP Section <1206> and ASHP Technical Assistance Bulletin Categories
USP Section <1206> ASHP Technical Assistance Bulletin
Low Risk Category Risk Level I
Sterile drug products transferred from vials or ampoules Single patient admixtures
into sterile final containers with syringe and needle.
Sterile drug products transferred into sterile elastomeric Single patient ophthalmic with
infusion containers with aid of mechanical pump and preservatives
appropriate sterile transfer device, with or without
Single patient syringes without
subsequent addition of sterile drug products with sterile
preservatives used in 28 hours
syringe and needle
Batch prefilled syringes with
Sterile nutritional solutions combining dextrose injection
and amino acid injection via gravity transfer into sterile preservatives
empty containers, with or without addition of sterile
drugs to final container with sterile syringe and needle.
High Risk Category I Risk Level 2
Sterile nutritional solutions compounded with automated TPNs for administration after 7 days
compounder, involving repeated attachment of fluid Injections for use in portable pump or
containers to proximal openings of compounder tubing reservoir
set and of empty final containers to distal opening.
Batch reconstituted antibiotics without
Additive transfers into filled final container from preservatives
individual drug products containers or from pooled Batch prefilled syringes without
additive solution preservatives
Ambulatory pump reservoirs prepared by adding more
than one drug product, with evacuation of air from
reservoir prior to dispensing
Ambulatory pump reservoirs prepared for multiday
(ambient temperature) administration
High Risk Category II Risk Level 3
Injectable morphine solutions prepared from non-sterile Alum bladder irrigations
morphine substance and suitable vehicles. Sterile
nutritional solutions prepared from non-sterile Morphine injections made from powder
ingredients, with initial mixing in non-sealed or non- or tablets
sterile reservoir TPNs made from dry amino acids

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 International Standard Serial Number (ISSN): 2319-8141

IV Additive Program:
It consist of polices and procedures for both the preparation and administration of intravenous
fluids to which drugs are to be added under specific conditions, on around the clock basis,
and controlled as to location and person preparing the product.
IV Additive Services:
It refers only to the preparation of the product by individuals who may not necessarily be the
same as those who will administer them and assume the responsibility for monitoring of its
clinical effect. The conclusion is arrived is that an additive service is a part of an IV additive
programmes.
Though the implementation of an IV additive service, the hospital pharmacist might be
expected to achieve the following objectives:

The preparation of final product is accomplished under aseptic conditions.

Drug interactions are avoided through judicious choice of additive and mixing
technique.
The final product is appropriately labeled, dispensed, stored.
The preparations IV solutions with their additives were a task performed by nurses or interns
or residents. The concept that these products requires the skills of the pharmacist has raised
many other questions not the least of which is availability of the product at odd hours
particularly if the site of preparation is moved to the main pharmacy. Thus has evolved the
satellite pharmacy, staffed by a clinical pharmacist and pharmacy technicians/. On final
analysis, it is relevant where the additives re added so long as definite polices are formulated
which spell out the responsibilities. In addition, it is imperative that the pharmacist become
involved in the preparation of these products in an environment conductive to the efficient
and safe preparation of them.
Preparation of IV additive solutions:
In the preparation of these solutions, the pharmacist should work from the physicians original
sheet or from a direct copy. Upon receipt order label must be prepared which involves the
following information:
Patient identification
Patient location
Physicians name
Name of the drug and quantities added
Date of compounding
Expiry date
Identification of pharmacist preparing the product

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 International Standard Serial Number (ISSN): 2319-8141

If necessary any auxiliary labeling should also be prepared at this time. When Appling label
to the container, it must be positioned in an upside down order to facilitate the reading when
container is hung from iv solution pole on the patient bed. Preparations of the solution always
take place under laminar flow hood using sterile needles and syringes. Once transfer is made,
the metal disc must be replaced and a new seal crimped on to the container. As a safety
device, a different colored seal should be used in view of the fact that it warns individuals
that drugs have been added.

Before permitting the admixture sent to ward pharmacist must carry out a final inspection of
the product. The inspection should include a review of label, clarity of solution, and
mathematics involved in the preparation.

ASHP guide lines for pharmacist participation in home Parenteral nutrition programmes:

Home Parenteral Nutrition (HPN) programs have been developed to meet the needs of the
patients who require prolonged or lifelong IV feeding. In many hospitals, pharmacist has
assisted in the solution preparation and supply; in patients training in solution preparation,
infusion technique, and catheter care and in monitoring the side effects of HPN. Certain
constitutional, personal and the patient resources needs are necessary to provide services to
patents safety.

The following guide lines will assist pharmacist in deciding whether they should develop an
HPN program.

INSTITUTIONAL QUALIFICATION

The hospitals should have an IV admixture program. Because in an around the clock, long
term form of the therapy, the institution must able to provide for a 24 hour service. The
institution must be able to respond to HPN related concerns, such as catheter and pump
repair, fluid and electrolyte imbalance, sepsis and support of the patients underlying disease.
Reimbursement arrangements for supplies and services should be established. The institution
must have criteria by which patients can be selected for HPN. Criteria should embrace
patients learning ability, physical capability, family support, medical condition and
prognosis.

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 International Standard Serial Number (ISSN): 2319-8141
PERSONAL QUALIFICATIONS
The pharmacist should have understanding of parenteral feeding therapy, including a
knowledge of acid base balance, fluid and electrolyte therapy, metabolic and mechanical
complications, total parenteral nutrition delivery systems, catheter care and management, and
drug nutrient and drug laboratory interactions.
PERSONAL QUALIFICATIONS
The pharmacist should have understanding of parenteral feeding therapy, including a
knowledge of acid base balance, fluid and electrolyte therapy, metabolic and mechanical
complications, total parenteral nutrition delivery systems, catheter care and management, and
drug nutrient and drug laboratory interactions. Good aseptic technique and experience in
preparing IV admixture is essential. A sufficient understanding of infectious disease is
needed to differentiate HPN related sepsis from underlying disease or drug reaction. The
pharmacist must also be aware of current standards recommendations on sterile admixtures
and quality assurance. The pharmacist should be knowledgeable in the unique aspects of
HPN, such as chronic infections, nutrient requirements, and effects of parenteral nutrition. A
caring, patient oriented attitude and good teaching skills are important in teaching HPN
techniques to patients. Other personnel such as physicians, nurses, dieticians and medical
social workers are important in assuring success with a patient on HPN.
RESOURCE REQUIREMENT
Substantial personal and equipment are needed for HPN programs. Tough the time will vary;
available information indicates that 7-44hrs are the time requires training the patient. Staff
must be available on 24 hr basis to answer questions for inpatients and out patients. Teaching
procedures may extend from early morning to late evening so as to involve both patient and
families. Therefore, involvement of more than one pharmacist may be required .the following
types of equipment are required for HPN programs.
Infusion devices
HPN base solutions.
Drug additives.
Needles, syringe, and alcohol wipes
Dressing change kits
IV sets, cassettes, and filters
IV pole, Catheter accessories.

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DISCUSSION:
Knowledge of alternative sources of HPN drugs and supplies is important. Procedures for

dealing with emergency shortage must be established. Pharmacist must take their own

decisions as to whether they elect to participate in HPN programs. They need to determine

the financial, social and professional impact of an HPN program upon their institution. They

need to consider the availability of these services from other hospitals or through private

providers of home health care. These guidelines are intended to help pharmacist make these

decisions.

REFERENCES:
1. Merchant S.H. and Quandrys J. S. (2003-04), Manufacture of pharmaceutical
preparations; the text book of hospital pharmacy, 6 edition, page no: 182-200.
2. William. E, Hassen. J.R.; Manufacturing of bulk and sterile; In Hospital pharmacy; 5
edition; 1986; page no: 455-463.
3. Remington: The science and practice of pharmacy. Page no: 837- 847.
4. Guidance for nurses and midwives in practice development units who are involved in
the education of staff in the preparation and administration of injections in near-
patient areas. August 2007 Review Date August 2008.

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