TOTAL PARENTAL NUTRITION PRESENTATION BY ROOMA KHALID

1. PRESENTED BY
ROOMA KHALID
M.Phil pharmaceutics(2014-
2016)
Islamia University Bahawalpur

2.  Definition
 Objectives
 Indications
 Administration
 Formulation
 Compounding
 Documentation

3.  DEFINITION:
A method of feeding the patients by
infusing the mixture of all necessary
nutrients into the circulatory system, thus by
passing the GIT.
Also referred to as
Intravenous nutrition
Parental nutrition

4.  Parental nutrition is indicated generally
when there is severe gastro-intestinal
dysfunction (patients who cannot take
sufficient food or feeding formulas by enteral
route)

5. 1:Central or total parental nutrition (TPN)
2:Peripheral parental nutrition (PPN)

6. 1: CENTRAL OR TOTAL PARENTAL NUTRITION:
It is given via central
vein.central route is indicated when long
term feed is anticipated, high tonicity or
large volume formulations are required.
2: PERIPHERAL PARENTAL NUTRITION:
it is given via peripheral vein. It
is indicated for patients which require short
term feeding. Generally 900mOsmol/L is
maximum osmolarity tolerated by the
peripheral veins.

7.  For patients unable to tolerate any form of
enteral feeding, the administration of fluid
and nutrients via a parenteral route is
necessary.
 For long-term care a balanced diet
containing all the essential nutrients,
including vitamins and trace elements, must
be provided.

8.  To prevent unwanted weight loss and skin
break down, promoting positive nitrogen
balance and maintaining visceral and somatic
protein stores.
 Illness and injury promote catabolism and
hypermetabolism, so the patient is burning
calories faster to keep up with his body's
demands. If he doesn't get adequate
nutrition, his body will break down lean
muscle for glucose, which could slow healing
and prolong his recovery (Collins & Navarre,
2003).

9.  TPN reduces morbidity and mortality,
promotes tissue repair, and enhances the
immune response (Merck, n.d.)
 Johnston at al reported in 1978 that an
undernourished patient whose
gastrointestinal tract is temporarily or
permanently unusable can increase lean body
tissue and also lay down fat if fed a suitable
combination of nutrients intravenously.

10.  With an understanding of the clinical aspects
of TPN, pharmacists can recommend
regimens to fulfil the needs of the patient as
diagnosed by the physician.
 Possible interactions with concomintant
medication may be identified and advice
given on suitable administration systems.

11. TPN is considered necessary in following
conditions:
 Patients whose GIT tract is inaccessible, non
functional, perforated.
 Undernorished patients who cannot ingest
larger volumes of oral feedings and are being
prepared for surgery, radiation therapy, or
chemotherapy.
 Disorders requiring complete bowel rest e.g
ulcerative colitis

12.  Pediatric GI disorders e.g prolonged diarrhea

13. Powell-Tuck at al reported in 1978 a
technique for administration of the total
daily requirement for TPN via a single
container. This was a significant advance
over the multiple-bottle method of
administration. Three-litre bag therapy,
however, is not ideal for all patients.

14. In an intensive care unit, for example,
requirements for fluids and electrolytes may
change rapidly throughout the day and
require the careful titration that can only be
obtained with smaller volume fluids and
injections.

15. For short-term therapy rotation of peripheral
entry sites may provide a simple means of
administering TPN without the complications
of initiating central vein access. Silk at al
reported in 1983 that for longer-term
therapy a catheter placed into the superior
vena cava as being the safest method of
entry providing rapid dilution of the
hypertonic solution.

16. Adult TPN patients generally receive 2-3
litres of fluids per day. Rapid,uncontrolled
infusion of this amount of fluid would cause
renal overload and would be of no benefit to
the patient. It is thus vital that some form of
flow control device is employed. This may
range from simple clamps through to
electronic drip controllers.

17.  Once TPN has been initiated on a patient it is
essential that routine monitoring is carried
out. The clinical pharmacist should have an
understanding of the relevance of these
routine tests (particularly those such as 24-
hour urine analysis which is the main
determinant of nitrogen requirements) in
order to make adjustment to the TPN
formulation.

18. Parenteral nutrition solutions are complex
formulations that generally include energy
supplied as dextrose and fat, as well as
protein, electrolytes, trace
elements,vitamins, and water. These
components usually need to be individualized
for patients according to their primary
diagnosis, chronic diseases, fluid and
electrolyte balance,acid-base status, and
specific goals of parenteral nutrition.

19. 1. NITROGEN:
The main objective of parental
nutrition is to supply the undernourished
patient with sufficient utilizable nitrogen to
re-establish nitrogen balance, i.e. where the
amount of nitrogen administered is
approximately equal to that excreted (mainly
as urea).

20. 2.AMINO ACIDS:
The body’s relative requirements of the
individual amino acids is expected as follows:
 ESSENTIAL:
Which cannot be synthesized
by man. All the commercially available
solutions contain the eight essential amino
acids in varying proportions.

21.  NON ESSENTIAL AMINO ACIDS:
Those amino acids
which can normally be synthesized by the
body. These amino acids are used to increase
the amount of nitrogen available from the
solutions.
 SEMI ESSENTIAL AMINO ACIDS:
Those amino acids
which although they can in theory be
synthesized by the body, may occasionally
need to be provided in the TPN solution due
to the patient's age or disease state.

22. 3.ENERGY MACRO NUTIENTS
DEXTROSE:
 Dextrose is the primary source of parenteral
carbohydrate.
 Dextrose is needed by the central nervous
system, white blood cells, red blood cells,
and renal medulla.
 Each gram of hydrated dextrose used in
parenteral nutrition yields 3.4 kcal.

23.  Parenteral nutrition solutions suitable for
peripheral vein administration have dextrose
concentrations of 10% or less.
 Parenteral nutrition solutions with final
concentrations of 10% or greater must be
administered by a central vein because of
the high osmolarity.

24. 4. LIPIDS:
Administration of lipid emulsion on a
daily, twice or three times weekly basis
appears to provide a balanced mixture of
nutrients for the patient requiring long-term
feeding. Intravenous fat emulsions are used
in parenteral nutrition as an energy source
and to provide essential fatty acids.

25. Intravenous fat emulsions are particularly
beneficial as an energy source in patients
suffering from diabetes,stress, respiratory
acidosis, and hepatic steatosis.

26. 5.ELECTROLYTES:
 Electrolytes in maintenance or therapeutic
doses need to be added daily to the
parenteral nutrition solution to preserve
electrolyte homeostasis.
 Each patient’s requirements for individual
electrolytes depend on the primary disease
state, renal function, hepatic function,
pharmacotherapy, past intake, renal or
extrarenal losses, and nutritional status.

27.  Sodium is of critical importance in the fluid
balance of both of healthy and sick subjects.
 Sodium losses and gains are generally
accompanied by similar shifts in chloride ions
and a consequent movement in water.
 Severe losses may lead to hypovolaemia,
circulatory failure and shock. Generally a
serum concentration of 135-145 mEq/litre is
throught to be normal.

28.  Potassium is essential for the normal
operation of the cell and is an important
determinant of cell membrane resting
potential.
 Thus abnormally high or low levels can result
in poor nerve impulse conduction,
fluctuations in heart rhythm and even death
due to heart failure.
 It also plays a vital role in distribution of
body water

29.  Absence of calcium from TPN in the long
term may produce symptoms of
hypocalcaemia such as muscle spasm and
numbness.
 The effect of lack of calcium on the growing
child on TPN could understandably have a
dramatic effect of growth and development
of bones and teeth.

30. Magnesium has many physiological actions.
The most clinically significant effects of
magnesium imbalance are associated with
changes in neuromuscular or cardiovascular
function.

31.  By virtue of its buffering action phosphate
helps maintain body acid-base balance.
 If phosphate is not provided in the TPN
solution hypophosphataemia may develop
which can give rise to impaired red blood
cell function of many organs.
 Hypophosphataemia may also be induced as
a result of infusion of high glucose loads.

32.  Trace elements are essential micronutrients
that are metabolic cofactors essential for the
proper functioning of several enzyme
systems.
 Zinc, Copper, Selenium, Chromium, Iron,
Manganese, Cobalt, Molybdenum.
 Zinc requirements are increased in metabolic
stress and in gastrointestinal disease
secondary to diarrheal diseases.

33.  Manganese and copper are excreted through
the biliary tract, whereas Zinc, and
selenium are excreted renally.
 Therefore, copper and manganese should be
used with caution in patients with
cholestatic liver disease.

34.  Selenium stores have been shown to be
depleted in patients receiving long-term
parenteral nutrition or in those with thermal
injury, acquired immunodeficiency
syndrome, or liver failure.
 Therefore, selenium should be added initially
to the parenteral nutrition solution for
patients with these disease states or
conditions.

35. 7. VITAMINS
 Patients on long-term TPN therapy will
generally require some vitamin
supplementation.
 The commercial preparations of vitamins
available along with recommended daily
requirements which seem to vary according
to the current available recommendations.

36.  A Retinol
 B1 Thiamines
 B2 Riboflavine
 B6 Pyridoxine
 B12 Cyanocobalamin
 B Nicotinamide
 B Biotin

37.  B Pantothenic acid
 B Folic acid
 C Ascorbic acid
 D Calciferol
 E Tocopherol acetate
 K Phytomenadione

38.  Vitamins are an essential component of a
patient’s daily parenteral nutrition regimen
because they are necessary for normal
metabolism and cellular function of the
body.
 Individual parenteral vitamins are
recommended when the multivitamins
products are not available.

39.  Vitamins that are marketed as single-entity
parenteral formulations include
 vitamins A, D, E, K, B1 (thiamine), B2
(riboflavin), B3 (niacin), B6 (pyridoxine),
B9(folic acid), B12 (cyanocobalamin) , and C
(ascorbic acid).

40. 8. FLUIDS
 In the human body, water is the predominant
chemical entity, generally accounting for
more than half of the total body weight.
 An inverse relationship exists between the
amount of body fat and the amount of body
water present in an individual.

41.  Total water gains and losses in the healthy
adult fall within the range of 1500-3000ml
daily.
 Thus, where the patient requires TPN, the
volume administered will fall into this range
and may need to be supplemented by
additional fluids in the special cases of
burns, etc.
 Careful patient monitoring is required to
ensure that they do not become dehydrated.

42.  Nutrients are mixed just prior to infusions,
by breaking the plastic connectors between
the compartments, then vitamins and trace
elements are added extemporaneously to the
bag.
 Shelf –life of these bags is at least 12
months, but allow only for standardized
formulas.
 The use of three-compartment TPN bags is
less expensive in terms of application costs
than separate bottles or hospital-
compounded bag systems.

43.  Because of the complexity of parenteral
nutrition products, safe preparation is a
complicated task.
 The quality of the final product depends on
the facilities, resources,personnel training
and products used in preparation.

44.  Since the inception of parenteral nutrition,
pharmacists have developed policies and
procedures for parenteral nutrition
compounding based on their training and
interpretation of the literature.
 Parenteral nutrition is considered a high-risk
sterile product. Its compounding includes
complex and/or numerous aseptic
manipulations.

45.  Specific guidelines for aseptic processing
include media fill validations of both the
process and the personnel carrying out the
process.
 There are specific requirements for facilities,
space and environmental control similar to
those of a Class 100 clean-room
environment.

46.  Sterile product release checks require visual
inspection against a lighted white and black
background for evidence of visible
particulates or other foreign matter.
 In addition,compounding accuracy checks of
the addition of all drug products or
ingredients used to prepare the parenteral
nutrition product are ensured by validating
the volume and quantity used in admixture.

47.  Presterilized disposable membrane filtration
devices, which are sensitive in detecting low
levels of contamination and easy to use, are
commercially available.
 The compounding of parenteral nutrition
admixtures accelerates the rate of
physicochemical destabilization, resulting in
the recommendation to administer
parenteral nutrition as soon after its
preparation as possible certain amino acids,
lipids, and multivitamins are most
susceptible to instability.

48.  Pharmacist involved in TPN should have a
thorough understanding of the potential
stability issues in these mixtures and be able
to advise physicians accordingly.

49.  In general the following information will be
required on the label:
 Patient name/number
 Ward
 Product constituents
 Batch (dispensing number)
 Expiry date/time
 Storage conditions

50.  Other instructions such as guidance on
administration rate or technique, limitations
on further additions etc., may also be
required.

51.  Once the product has been filled and
labelled a pharmacist should perform a final
check against the prescription prior to
sending the product to the ward.
 This check should include the patient’s
name, ward, etc. and should once again
compare the constituents requested against
the final label.

52.  Details of further additions, storage,
conditions, expiry date, etc. should also be
confirmed and the batch number or other
reference allocated should be checked to
facilitate traceability in the event of any
difficulties arising subsequent to dispensing,
e.g. precipitation, discoloration, etc.

53.  The hospital pharmacist may be involved in
development of nursing care guidelines with
particular reference to further additions,
storage, etc.
 It may also be useful for the ward
pharmacist to check that TPN is being
correctly administered to the patient, i.e.
with correct flow control device, away from
direct sunlight, etc.

54.  Allwood at al recommends in 1984 that
compounded TPN solutions should be stored
at 2-8˚C in light of both microbiological and
chemical considerations.
 Should not be stored at room temperature
for periods in excess of the 12-24 hours
required for administration.

55.  Where supplies of compounded product are
to be made to hospitals or home patients
away from the site of manufacture, the
quality of the packaging system to maintain
product temperature during transit should be
validated to the satisfaction of local quality
control standards.
 Insulated polystyrene containers may be
useful for this purpose.

56.  Providing a TPN compounding service within
a hospital may be a costly venture for the
pharmacy department.
 All the factors must be considered when
developing true service costs and deciding
whether to produce in house or obtain
product from a regional hospital or
commercial source.

57.  Bags made of poly-ethylene and poly-
vinylchloride and of the copolymer
ethylenevinylacetate were used as containers
of perfusion solutions for total parenteral
nutrition.
 Injectable solutions for Total Parenteral
Nutrition containing L-
aminoacids,electrolytes and glucose, are
commonly sold as medicinal specialities in
glass containers.

58.  Bags made of plastic materials such as
copolymer ethylene-vinylacetate (EVA), poly-
ethylene (PE) and poly-vinylchloride (PVC)
are being used more and more often in the
manufacture of containers of perfusion
solutions.

59.  A work sheet should be generated for each
TPN-dispensing activity to be carried out for
recording materials, patient name, label
details, etc.
 The format for such a work sheet should be
agreed between the production and quality
control departments of the hospital in
accordance with local policy.

60.  Prescribe the nutrient formulation
 Recognize the needs of individual patients.
 Modification in quantities according to
clinical situation of patients.
 Monitor the interactions among various
electrolytes and drugs affect TPN mixture.
 Assist the health care team in developing a
cost effective formulary of nutrition
products.