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ASSESSMENT OF INTRAVENOUS ADMIXTURES IN A
HOSPITALISED PATIENT OF A RURAL TERTIARY CARE
TEACHING HOSPITAL
SYNOPSIS FOR
M.PHARM DISSERTATION
SUBMITTED TO
RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES
BY
HYMAVATHI. R
B. Pharm
UNDER THE GUIDANCE OF
K.V. RAMANATH
M.Pharm, MBA (HRM &HSM), PhD
DEPARTMENT OF PHARMACY PRACTICE
SAC COLLEGE OF PHARMACY
BG NAGARA
RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,
BANGALORE, KARNATAKA
ANNEXURE-II
PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERATION
1
Name of the candidate &
Address
Ms. HYMAVATHI. R
DEPARTMENT OF PHARMACY PRACTICE,
SAC COLLEGE OF PHARMACY,
BG NAGARA, NAGAMANGALA-TALUK,
MANDYA-DIST, KARNATAKA-571448.
PERMANENT ADDRESS:
D/O R. CHANDRA MOHAN REDDY
D.NO-3/1149,NEAR DCC BANK,
Y.M.R COLONY,PRODDATUR,
DIST-KADAPA, ANDHRA PRADESH-516360.
2
Name of the institute
SAC COLLEGE OF PHARMACY
BG NAGARA,
NAGAMANGALA TALUK,
MANDYA DISTRICT,
KARNATAKA -571448
3
Course of the study
MASTER OF PHARMACY IN PHARMACY
PRACTICE
4
Date of admission
21/ 05/2010
5
Title of the topic
ASSESSMENT
OF
INTRAVENOUS
ADMIXTURES IN A HOSPITALISED PATIENT
OF A RURAL TERTIARY CARE TEACHING
HOSPITAL
6.
6. Need for the study:
Intravenous Admixtures are the preparations consisting of one or more sterile drug
products added to an intravenous fluid. Generally dextrose or sodium chloride solution
alone or in combination can be used as intravenous fluid. Intravenous admixtures are
used for drugs intended for continuous infusions. Drugs that may cause irritation or
toxicity when given as rapid direct intravenous injections are also prepared as
intravenous admixtures.
Intravenous Incompatibilities occur when two are more drugs are administered through
a single intravenous line or given in a single solution, resulting in an undesirable
reaction. A patient who receives a preparation in which an incompatibility has occurred
could experience toxicity or an incomplete therapeutic effect.1
There are three types of incompatibilities
1. Physical incompatibility.
2. Chemical incompatibility.
3. Therapeutic incompatibility.2
Intravenous therapy is a complex health care technology. In general, nurses prepare and
administer intravenous drugs prescribed by doctors. Nursing staff doesn’t have enough
knowledge regarding the compatibilities of intravenous drugs in infusions, leading to
physical or chemical or therapeutic incompatibility of drugs. Sometimes this will result
in severe adverse drug reactions in patients.3
Incompatibilities between infused drugs frequently occur in the hospitals. The Intensive
Care Units (ICU) are particularly concerned since patients in these units are often
subjected to treatment which includes numerous drugs.
The complexity of pharmacotherapy, the particular dilution of drugs for intensive care
as well as stress inherent units all will increase the probability of mistakes during
intravenous admixtures.
Availability of incompatibility charts on the wards and specific
training on drug
incompatibilities for nursing staff will certainly increase the security in the use of
intravenous drugs.4
Implementing a system with more active involvement of hospital pharmacists or clinical
pharmacists in this type of activities can lessen the errors during intravenous admixtures
and thus enhance the patient safety to a substantial degree.5
Adichunchanagiri Hospital and Research Center (AHRC) is a 750-bedded tertiary care
teaching hospital situated in a rural area of BG Nagara, Nagamangala taluk. There were
no studies conducted previously in this rural hospital regarding assessment of
intravenous admixtures in a hospitalised patient. Such a study could provide valuable
information to the physicians and nursing staff regarding the safe usage of intravenous
admixtures. With this aim the present study is taken to assess the intravenous
admixtures in a hospitalized patient of a rural tertiary care teaching hospital.
6.2 Review of Literature:
A study was conducted by Taxis K and Barber N on “Incidence and Severity of
Intravenous Drug Errors in a German hospital”. The main objective of the study
was to determine the incidence of errors in preparing and administering
intravenous drugs and to identify the stages in the process at which errors
occurred. This was a prospective ethnographic study carried out on two wards in
one German Non-University Hospital. They observed 122 intravenous drug
preparations and administrations. One or more errors occurred in the preparation
and administration of 58 of 122 intravenous drug doses. In total 65 errors were
identified. Four have potentially severe errors (3%), 38 (31%) potentially
moderate errors and 16 (13%) potentially minor errors.
Common errors included multiple step preparations and co-administration of
potentially incompatible drugs as intermittent infusions. The study concluded
that introduction of ward-based clinical pharmacy services, reduced the severity
of intravenous drug errors.3

Gikic M, Di Paolo ER, Pannatier A et al. conducted a study on “Evaluation of
Physicochemical Incompatibilities during Parenteral Drug Administration in a
Paediatric Intensive Care Unit (PICU)”, in the 8-bedded PICU at University
Hospital in Lausanne (Switzerland). The data was collected by a pharmacist over
a period of 30-days. The study was a prospective study. The objective of this
study was to identify the combinations of injectable drugs administered in the
PICU of the hospital and to analyse them according to the information found in
the literature. The methodology adopted was prospective method. In this study,
68.7% of drug combinations were observed and analysed. Among the 175 drugdrug/drug-solute combinations, 86.3% were compatible, 3.4% incompatible and
10.3% undocumented. In this study no clinical consequences resulting from drug
incompatibilities were found. Specific training on drug incompatibilities for
nurses increased the security in the use of injectable drugs in PICU.4

A study was conducted by Fahimi F, Sistanizad M, Abrishami R et al. on “An
Observational Study of Errors Related to the Preparation and Administration of
Medications given by Infusion Devices in a Teaching Hospital”. This study was
designed to evaluate the medication errors associated with infusion pumps in
intensive care unit (ICU). The study was a prospective, observational study.
Forty three doses were observed. Twenty (7.8%) errors were detected, of which
14 (20%) were incorrect doses, 4 (20%) were labeling errors, 2 (10%) were
unauthorized medication. This study concluded that usage of infusion pumps for
drug delivery resulted in a number of errors.5

Valia HD, Pierre V, Laurent G et al. conducted a study on “Evaluation of
Intravenous Drugs Compatibilities in an Adult ICU”. The main objective of the
study was to evaluate whether if patients intravenous medications were
administered according to known compatibility data. The study was a
prospective study. The study was conducted for 72 days in an adult ICU of a 34
bedded university hospital in Switzerland. They assessed drug-drug/drug-solute
combinations. Among the 6583 pairs recorded during the three months, 4242
pairs were analysed based on literature data and laboratory test. Among these
71.6% were considered compatible and 1.1% incompatible, 27.3% were
undocumented. Teaching was done to the nursing staff regarding intravenous
drug compatibilities, which reduced the incompatibility risks.6

A study was conducted by Serrurier C, Chenot ED, Vigneron J et al. on the
“Assessment of Injectable Drugs’ Administration in a two Intensive Care Units
and Determination of Potential Physicochemical Incompatibilities”. The study
was done by prospective method for two months with an objective of
determining potential physicochemical incompatibilities. They have observed 32
patients. Among 242 intravenous admixtures observed, 55 (23%) were
physically compatible, 12 (5%) physically incompatible, 5 (2%) with conflict
between two literature references and 170 (70%) without any data about stability
or compatibility. They also made nurses and physicians aware of compatibility
problems to minimize as low as possible.7

Bertsche T, Mayer Y, Stahl R et al. conducted a study on “Prevention of
Intravenous Drug Incompatibilities in an Intensive Care Unit (ICU), in
University of Heidelberg in 12 bedded ICU in a 1680 bed Teaching Hospital”.
The aim of the study was to reduce the frequency of incompatibility errors
during intravenous drug administration. They adopted both retrospective and
prospective method. In retrospective analysis of 100 patients, 3617 brands of
drug pairs were potentially given concurrently through one intravenous line and
7.2% of the drug pairs were incompatible. In the prospective study of 50
patients, the frequency of incompatible drug pairs was reduced by the time of
intervention from 5.8% to 2.4%. This study concluded that the administration of
incompatible intravenous drugs in critically ill patients was frequent but
significantly reduced by procedural intervention with standard operating
procedures.8

A study was conducted by Tissot E, Cornette C, Limat S et al. on
“Observational Study of Potential Risk Factors of Medication Administration
Errors”. The aim of the study was to assess the rate and the potential clinical
significance of medication administration errors and to determine the associated
risk factors. This was a prospective observational-based study carried out for
two months in two units of the 1243 bed University Hospital of Besancon
(France). The medication administration error rate was 14.9%, dose errors were
the most frequent (41%) errors, followed by wrong time errors (26%), wrong
rate errors (19%). According to these data, the quality of medication
administration process needs to be optimized in hospitals in order to minimize
medication administration errors.9
6.3 OBJECTIVES OF THE STUDY:
Primary objective:

To assess the intravenous admixtures in hospitalized patients.
Secondary objectives:
1. To understand the intravenous admixtures used in the hospitalized patients.
2.
To determine
combinations.
compatibility,
incompatibility
and
undocumented
drug
3. To determine the incidence and clinical consequences of intravenous
admixtures.
4. To provide guidelines for nursing staff and physicians regarding the
compatibilities of intravenous drug admixtures.
5. To assist the nursing staff in the preparation of intravenous admixtures.
7
MATERIALS AND METHODS:
7.1 Study design: The study is an observational based prospective study.
7.2 Source of data and Materials:
Compatibility Charts.
Drug Information Brochure.
Patient Data Collection Forms.
Patient’s Case Records.

Compatibility Charts:
These charts will be developed and used for assessing the most commonly
used intravenous drug admixtures and to outline the potential for
incompatibilities when these drugs are infused concurrently.

Drug Information Brochure :
This brochure will be used to write on specific drugs to provide information
regarding preparation, dilution, stability and administration of intravenous
drugs.

Patient Data Collection Form :
The following information will be collected like
1. Patient (name, age, reason for hospitalization)
2. Drugs and solutes (brand name, dose, dilution)
3. Drug administration (rate)
7.3 Inclusion Criteria:
Patients receiving one or more drugs simultaneously through the same
intravenous infusion line will be included in the study.
Exclusion Criteria:

When the drug delivery was interrupted and the infusion line was flushed with
0.9% sodium chloride, such patients will not be taken into the study.

Out Patients who will stay for a short time in the hospital will not be included in
the study.
7.4 Method of collection of data:
This is an observational based prospective study which will be conducted among
intravenous drug admixtures inpatients of the hospital. The intravenous drug
admixtures patient data will be collected in the Patient Data Collection Form.
When a single drug is delivered by infusion, the compatibility of the drug in the
infusion solution will be checked and when two or more drugs are used in the
same infusion line then drug-drug and drug-solute compatibilities will be
checked.
This obtained data will be compared with the information available in the
literature, i.e., from Incompatibility Charts and by referring standard text books
on Intravenous Admixtures. The identified incompatibilities will be documented
in a suitable documentation form.
Incompatibility charts on intravenous drug admixtures will be made available on
each ward as a reference for nursing staff to increase the security in the use of
intravenous drugs.
Assistance will be given to the nursing staff regarding intravenous admixtures
preparation by providing information if there is an incompatibility. This may
contribute to prevent unsafe medication practices.
7.5. Does the study require any investigation or interventions to be
on patients?
conducted
Yes
7.6. Has ethical clearance been obtained from your institution in case of
above?
Ethical committee clearance will be obtained by the Institutional Ethical Committee
of Adichunchanagiri Institute of Medical Science (AIMS) before the initiation of the
study.
7.7. Duration of the study:
The study duration will be approximately 12 months.
7.8. Study site:
The study will be conducted at Adichunchanagiri Hospital and Research Center
(AHRC), BG Nagara, Nagamangala Tq, Mandya Dist.
List of references:
8
1. John F. Sterile Products. In: Shargel L, Souney PK, Mutnick AH, Swanson LN.
Comprehensive Pharmacy Review. 7th ed. New Delhi: Wolters Kluwer Pvt Ltd;
2010. p. 566-85.
2. Scott SA. The Prescription. In: Alfonso RG. Remington The Science and Practice
of Pharmacy. 20th ed. New York: Lippincott Williams and Wilkins; 2000. p. 1687705.
3. Taxis K, Barber N. Incidence and severity of intravenous drug errors in a German
hospital. European Journal of Clinical Pharmacology 2004;59:815-7.
4. Gikic M, Di Paolo ER, Pannatier A, Cotting J. Evaluation of physicochemical
incompatibilities during parenteral drug administration in a pediatric intensive care
unit. Pharmacy World and Science 2000;22(3):88-91.
5. Fahimi F, Sistanizad M, Abrishami R, Baniasadi. An observational study of errors
related to the preparation and administration of medications given by infusion
devices in a teaching hospital. Iranian Journal of Pharmaceutical Research 2007;
6(4):295-9.
6. Valia HD, Pierre V, Laurent G, Rene C, Andre P. Evaluation of intravenous drugs
compatibilities in an adult ICU. 35th European symposium on Clinical Pharmacy
2006 Oct 21.
7. Serrurier C, Chenot ED, Vigneron J, May I, Demore B. Assessment of injectable
drugs administration in two intensive care units and determination of potential
physicochemical incompatibilities. The European Journal of Hospital Pharmacy
Science 2006;12(5):96-9.
8. Bertsche T, Mayer Y, Stahl R, Hoppe-Tichy T, Encke J, Haefeli WE. Prevention of
intravenous drug incompatibilities in an intensive care unit. American Journal of
Health System Pharmacy 2008;65(19):1834-40.
9. Tissot E, Cornette C, Limat S, Mourand JL, Becker M, Etievent JP et al.
Observational study of potential risk factors of medication administration errors.
Pharmacy World Science 2003;25(6):264-8.
9
Signature of the candidate
HYMAVATHI. R
Remarks of the guide
The proposed research work is original
and designed on rational basis. It would
be a good contribution.
11.1 Name and Designation of Guide
K.V. RAMANATH
10
11
ACA/CDC/PGT-M.Ph/SACP/36/2008-09
M. Pharm, MBA (HRM &HSM), PhD.
Associate Professor
Department of Pharmacy Practice
SAC College of Pharmacy
BG Nagara, Karnataka -571448
11.2 Signature
11.3 Co-Guide
NOT APPLICABLE
11.4 Signature
NOT APPLICABLE
11.5 Head of the Department
Dr. BJ MAHENDRA KUMAR
M. Pharm, PhD.
Prof. & H.O.D of Pharmacy Practice
SAC College of Pharmacy,
BG Nagara -571448.
11.6 Signature
12
12.1 Remarks of the Principal
12.2 Signature