HAZARDS RELATED TO
Mrs. Arti R. Rajput,
Introduction to parenteral therapy.
Reason related to hazards.
Hazards associated parenteral therapy.
Parenteral refers to injectable routes of administration.
Para means, “outside” and enteron means intestinal.
Injections should be sterile because they are placed in direct
contact with internal body fluid or tissue where infection can
Injections are the preparation which are injected through skin or
mucous membrane directly into a blood vessels ,tissue , or
Hazards may be because of following ,
1) Inadequacy in the manufacturing of product.
2) Inadequacy during transport , storage , and
3) Inadequacy during administration.
HAZARDS ASSOCIATED WITH
It results from microorganisms contamination the
product or delivery system prior to or during use or from
microorganism precipitation on patient skin.
e.g. – S. aureus.
-Sepsis may be localized (abscess) or systemic (septicaemia).
-In line bacterial filters remove the contamination. However , they
are costly affect flow rate and may sometimes get blocked.
- Common contamination are S.epidermidis , candida spp. , E.coli,
Enterobacteria , proteus klebsiella , Pseudomonas.
It is due to biological toxin contaminating the product
Endotoxins of gram –ve bacteria cause ,
i)rise in body temp.,
iv) increase in B.P. ,
v)respiratory depression ,
vi) pain in joint. & back, headache, nausea etc.
- Even refrigerated product may be contaminated with product
that produces endotoxin ( Psechrophillic bacteria) .
- Injectable contaminated by S. aureus may results in toxic shock
- Aspergillus flarus is a fungus produces a toxin , the infusion of
within may cause sudden death.
It occurs with i.v. infusion and may cause
-i) emboli formed may reach lungs causing pulmonary thrombosis
-ii) secondary infection may cause septicaemia.
- Thrombosis of artery is more serious than that of vein as it may
cause gangrene of concerned organ.
It occurs with i.v. infusion . It may or may not be
associated with infection or may or may not result in
It occurs if blood vessel is damaged by needle or if
patient has platelet deficiency called haemophilia.
6) PARTICULATE MATTER HAZARDS
Particles > 7 um are more
dangerous than smaller ones. Particulate matter may cause
occlusion of capillaries and blood vessels resulting in ischemia
and necrosis of tissue.
Thrombosis and embolism , phlebitis , thrombophlebitis ,
allergenic reaction , neoplastic response , pain and
7) HAZARDS DUE TO PHYSICOCHEMICAL PROPERTIES OF
pH and osmotic pressure of formulation may
have damaging effect on tissue.
Hypersensitivity reaction because of drug
itself, these may be immediate or delayed type.
9) Overdose of drug and overload of fluid from i.v.
10) AIR EMBOLI
Emboli occur with i.v. infusion without alarm system
is used. As little as 10 ml of air may be fatal .
-care should be taken to remove all air bubble from the syringe or
i.v. line prior to starting the infusion.
It may be due to abscess produced by i.m. injection or
due to injection of pyrogenic material or due to hypersensitivity
12)INFILTRATION AND EXTRAVASATION
Infiltration is unintentional infusion of sub.
Into a tissue. Extravas is leakage of a sub. From vessel into
surrounding tissue. Hypertonic Dextrose KCl solution and
extreme of pH may cause considerable pain if extravasatn occur
infection , phlebitis, thrombosis.
13)HAZARDS DUE TO INCOMPATIBILITY
Intravenous admixture incompatibility could be fatal
because of formation of toxic substance.
PARENTRAL ADMIXTURE INCOMPATIBILITY
- Admixture : when two or more parenteral combines, resulting
mixture is admixture.
-Additive : when SVP is added to LVP , the added SVP is called
PARENTRAL ADMIXTURE INCOMPATIBILITY
Parenteral admixture are used because,
1) Physician prescribes administration of several drug combining
the drug and administering them several time and resulting
in inconvenience .
2) The no. of pricking to the patient is reduced.
There are physical ,chemical ,or therapeutic problems that’s arise
when parenteral drugs are combined and admin. by injection.
Problems of parenteral admixture incompatibility is of concern
1)There is increase use of parenteral in therapeutics.
2)Several parenteral formulations are available in the market
3)There is increase use of LVP as vehicle of SVP.
4)Formulation are available in different drug.
5)Order of mixture of parenteral at the time of administration may
6)Delayed incompatibility may possible
Parenteral admixture incompatibility may lead to following
1)The patient may not receive the full therapeutic effect of
2)Toxic decomposition product may result.
3)There may be irritation of vein or occlusion of vessels.
TYPES OF INCOMPATIBILITY
Types of incompatibility
Two formulations combined together to show antagonistic or
e.g. – 1) warfarin + phytonadione = antagonistic action
2) Ca2+ + Digoxin
= synergistic action
This may result in to change in colour ,precipitation formation or
evolution of gas.
E.g. – 1) phenytoin sodium inj + LVP of acidic pH (dextrose)
In this reaction phenytoin get precipitate.
2) diazepam inj + LVP
In this precipitation of diazepam is observed.
3) sodium phenobarbitone + LVP of acidic pH (dextrose)
in this reaction phenobarbitone get precipitate.
This may be due to ,
e.g. – 1)carbecilline inj + gentamycin inj =inactivation of
2) ascorbic acid inj (low pH) +LVP containing penicillin=
penicillin deactivate due to low pH.
3) Tetracycline inj + Ca2+ (ringer sol) = activity reduced by
Mixing of two injection may also lead the following
1)Adjuvant – adjuvant interaction
2)Antioxidant may get diluted and hence drug may undergo
3)N2 atom may be loss.
4)Light sensitive drugs may be affected.