HAZARDS RELATED TO PARENTERAL THERAPY

Presented by:Mrs. Arti R. Rajput, M.pharm(SUCOP,Pune)

CONTENT

Introduction to parenteral therapy.

Reason related to hazards.

Hazards associated parenteral therapy.

INTRODUCTION

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 easily occurred.

Injections are the preparation which are injected through skin or mucous membrane directly into a blood vessels ,tissue , or organ.

REASONS

Hazards may be because of following , 1) Inadequacy in the manufacturing of product.

2) Inadequacy during transport , storage , and handling.

3) Inadequacy during administration.

HAZARDS ASSOCIATED WITH PAR.

1) SEPSIS

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.

HAZARDS

2) TOXEMIA

It is due to biological toxin contaminating the product

Endotoxins of gram –ve bacteria cause ,

i)rise in body temp.,

ii)shivering ,

iii)vasoconstriction ,

iv) increase in B.P. ,

v)respiratory depression ,

vi) pain in joint. & back, headache, nausea etc.

HAZARDS

TOXEMIA

- Even refrigerated product may be contaminated with product that produces endotoxin ( Psechrophillic bacteria) .

- Injectable contaminated by S. aureus may results in toxic shock syndrome.

- Aspergillus flarus is a fungus produces a toxin , the infusion of within may cause sudden death.

HAZARDS

3) THROMBOSIS

It occurs with i.v. infusion and may cause following complications,

-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.

HAZARDS

4) PHLEBITIS

It occurs with i.v. infusion . It may or may not be associated with infection or may or may not result in thrombosis.

5) BLEEDING

It occurs if blood vessel is damaged by needle or if patient has platelet deficiency called haemophilia.

HAZARDS

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 inflammation.

HAZARDS

7) HAZARDS DUE TO PHYSICOCHEMICAL PROPERTIES OF FORMULATION

pH and osmotic pressure of formulation may have damaging effect on tissue.

8) HYPERSENSITIVITY

Hypersensitivity reaction because of drug itself, these may be immediate or delayed type.

HAZARDS

9) Overdose of drug and overload of fluid from i.v. administration.

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.

HAZARDS

11) FEVER

It may be due to abscess produced by i.m. injection or due to injection of pyrogenic material or due to hypersensitivity reaction.

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.

HAZARDS

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

additive.

HAZARDS

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.

PARENTRAL INCOMPATIBILITY

There are physical ,chemical ,or therapeutic problems that’s arise when parenteral drugs are combined and admin. by injection.

HAZARDS

PARENTRAL INCOMPATIBILITY

Problems of parenteral admixture incompatibility is of concern because ,

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 be important.

6)Delayed incompatibility may possible

HAZARDS

Parenteral admixture incompatibility may lead to following hazards.

1)The patient may not receive the full therapeutic effect of mixture.

2)Toxic decomposition product may result.

3)There may be irritation of vein or occlusion of vessels.

TYPES OF INCOMPATIBILITY

Types of incompatibility

1)Physical incompatibility

2)Chemical incompatibility

3)Therapeutic incompatibility

Two formulations combined together to show antagonistic or synergistic action.

e.g. – 1) warfarin + phytonadione = antagonistic action

2) Ca2+ + Digoxin = synergistic action

PHYSICAL INCOMPATIBILITY

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.

CHEMICAL INCOMPATIBILITY

This may be due to ,

1)Hydrolysis

2)Oxidation

3)Reduction or

4)Complexsation.

e.g. – 1)carbecilline inj + gentamycin inj =inactivation of

gentamycin.

2) ascorbic acid inj (low pH) +LVP containing penicillin=

penicillin deactivate due to low pH.

CHEMICAL INCOMPATIBILITY

3) Tetracycline inj + Ca2+ (ringer sol) = activity reduced by

Complexsation

INCOMPATIBILITY

Mixing of two injection may also lead the following

1)Adjuvant – adjuvant interaction

2)Antioxidant may get diluted and hence drug may undergo oxidation

3)N2 atom may be loss.

4)Light sensitive drugs may be affected.

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