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6.0.
BRIEF RESUME OF THE INTENDED WORK
6.1. NEED FOR THE STUDY :
An interaction is said to occur when the effects of one drug are changed by the
presence of another drug, herbal medicine, food, drink, or by some
environmental chemical agent.1
The incidence of adverse drug interactions has been estimated to be between 2.2
and 30% in hospitalized patients and between 9.2 and 70.3% in ambulatory
patients. Drug interactions are important in clinical practice and have been
estimated to account for 6-30% of all adverse drug reactions (ADR’s).
The Boston collaborative drug surveillance program examined 83,200 drug
exposures in almost 9,900 hospitalized patients and identified 3,600 ADR’s. A
total of 234 (6.5%) adverse drug reactions caused were attributed to drug
interactions.2
A U.S.A study found that drug-drug interactions accounted for 4.6% of adverse
events during hospitalization, and a recent literature review reported that 2.8% of
preventable adverse drug events in the hospitalized population were due to
drug-drug interactions. A retrospective review of adverse event reports, it was
noted that drug interactions accounted for 10.5% of all drug related events that
would likely result in patient death, if no intervention was made.
Drug interactions touch all facets of health care. Their effect on patients can vary
greatly, from no untoward effects to the most extreme result of severe morbidity
or death. Physician face medical-legal liability, if a poor patient out come is the
result of a known drug interaction. Health care facilities face increased
consumption of resources and increased costs for diagnosing and treating
patients with significant drug interactions. One study found that hospitalized
patients who received interacting drugs had a longer and more costly
hospitalization than patients who did not experience such interactions. The
common risk factors associated with drug-drug interactions are polypharmacy,
multiple prescribers, multiple pharmacies, genetic makeup, specific populations,
specific illnesses, drug dose, narrow therapeutic index drugs.3
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Clinical management of drug-drug interactions should include prospective and
concurrent patient-, disease-and drug-monitoring measures that are sensitive
enough to alert the pharmacist or healthcare provider to monitor specific patient, disease- or drug-therapy parameters and, whenever possible, correlate these
findings with clinical laboratory tests. Follow-up monitoring of a patient’s
therapy and making appropriate adjustments in the drug regimen can circumvent
potentially significant drug interactions. Patients at high risk for drug
interactions who also take drugs with narrow therapeutic index should be
monitored more closely for drug interactions, especially when a new drug is
added or discontinued. Many drug interactions can be avoided or managed
safely if adequate time and precautions are taken by a patient’s pharmacist.
Preventing and /or managing drug interactions will be more likely to occur when
the pharmacist takes time and utilizes an adequate patient data base that includes
the patient’s gender, age, vital signs, medical diagnosis (es), drug allergies,
relevant laboratory tests and a complete listing of medication being taken
routinely or taken on an as-needed basis. If two drugs have been identified as
having high potential to interact and cause harm, the pharmacist can contact the
patient’s physician to obtain an order for another medication that will not cause
the troublesome interaction. Pharmacist provide patient counseling on the use of
prescription and nonprescription medication, disease state(s), and the safety of
concurrent use of herbal products of all which plays a major role in avoiding
drug interactions.4
Information and studies on possible interactions due to large number of drugs
prescribed are lacking in India. Hence this study is very much needed for Indian
clinical setups. So it is important for the prescribers or physicians and their
patients to aware of drug induced hazards, preventive measures and management
approaches.
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6.2. REVIEW OF LITERATURE
A pharmacoepidemiologic study of drug interactions in a Brazilian teaching
hospital was conducted to assess the frequency of drug-drug interactions in
prescriptions and their potential clinical significance in patients of a Brazilian
teaching hospital. It was found that patients did suffer adverse drug reactions
from major drug-drug interactions and many physicians may be unaware of
drug-drug interactions. Education, computerized prescribing systems and drug
information, collaborative drug selection, and pharmaceutical care are strongly
encouraged for physicians and pharmacists.5
A study on prevalence of drug-drug interactions at hospital entry and during
hospital stay of patients in internal medicine was carried out to assess the
potential drug-drug interactions and to evaluate the number of potential drugdrug interactions created during hospitalization. It was concluded that the
number of major and moderate potential drug-drug interactions per patient did
not increase from hospital admission to discharge, it is important to realize that
47% of all major and moderate drug-drug interactions at hospital discharge were
created during hospitalization. Prescribing drugs with a low risk for potential
drug-drug interactions as well as careful monitoring for adverse drug reactions
are important measures to minimize harm associated with drug-drug
interactions.6
A study was carried out in the geriatric ward of Hospital Israelita Albert
Einstein, Brazil from January 2006-January 2007 to assess the prevalence of
drug interactions in elderly inpatients and to describe the most prevalent
interactions. The high drug interaction rate found in this study shows the
relevance of this issue among elderly inpatients and the need to assess and
monitor drug therapy in the elderly to prevent and reduce consequences of
potential drug interaction effects.7
A retrospective case-control study (1:1) was performed to estimate the rate and
factors associated with potential drug-drug interaction in prescriptions from
wards of a Brazilian teaching hospital. It revealed a positive pearson’s
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correlation between total drug-drug interaction and patient age, number of
prescribers, cardiology patients and hospitalization on weekends. Cardiology
women inpatients, age more then 55 years old, 7 or more drugs prescribed
(including digoxin) and hospitalized at weekends should be closely monitored
for adverse outcomes from drug-drug interaction. A collaborative approach
toward drug selection is strongly recommended, as well as electronic prescribing
and development of pharmaceutical care in Brazilian hospitals.8
A study on drug-drug interactions among elderly patients hospitalized for drug
toxicity was conducted to determine whether elderly patients admitted to
hospital with specific drug toxicities were likely to have been prescribed an
interacting drug in the week prior to admission. It was found that many hospital
admissions of elderly patients for drug toxicity occur after administration of a
drug known to cause drug-drug interactions. It identified many avoidable
hospital admissions for drug-related toxicity within a week following predictable
drug-drug interactions in elderly patients.9
A study on Emergency department drug-drug interactions: frequency and type,
potential and actual, triage and discharge was carried out to catalogue the most
common medications and allergies in a large unselected emergency department
population, and evaluate the frequency potential drug-drug interactions in this
cohort. It was found that the incidence of potential drug-drug interactions is high
in an unselected emergency population. It confirmed that the risk is higher
among current medications recorded at triage than it is for new medications
prescribed in the emergency department.10
A study on potential drug-drug and drug-disease interactions in prescriptions for
ambulatory patients over 50 years of age in Mexican institute of social security
(IMSS) family medicine clinics was carried out to determine the frequency of
potential drug-drug and drug-disease interactions and to identify the associated
factors for these interactions. It showed that the high frequency of prescription of
drugs with potential drug interactions; to lower the frequency of potential
interactions it could be necessary to make a careful selection of therapeutic
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alternatives, and in cases without other options, patients should be continuously
monitored to identify adverse events.11
A study was conducted to improve the clinical management of potential drugdrug interactions (pDDIs) by clinical pharmacist interventions during
hospitalization and at hospital discharge. It was concluded that the management
of clinically relevant potential drug-drug interactions can be improved by
physician’s advice of clinical pharmacists.12
A study on potential drug-drug interactions in the medication of medical patients
at hospital discharge was conducted to assess the frequency and potential clinical
significance of drug-drug interactions in the prescriptions of discharged medical
patients. It was found that the high proportion of patients was detected with at
least potential drug-drug interaction in the medication prescribed at discharge
and the proportion of drug-drug interactions associated with potentially relevant
clinical consequences appeared to be relatively low.13
A study was conducted to estimate the rate of potential drug-drug interactions in
the out patients of a typical Thai university hospital and to identify risk factors.
It was concluded that the potential drug interactions were common. The rate of
such interactions increased with the number of drugs prescribed and the patient’s
age.14
A study on determinants of potential drug-drug interaction associated dispensing
in community pharmacies in the Netherlands was carried out to identify
determinants of dispensing undesirable interacting drug combinations by
community pharmacies. The study showed medication surveillance in Dutch
community pharmacies seems to be effective. It was concluded that for most
drug-drug interactions, no determinants were found possibly indicating that the
quality of medication surveillance in the Netherlands is high.15
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6.3. OBJECTIVES OF THE STUDY :

To assess potential drug-drug interactions at hospital admission, during
hospitalization and at discharge.

To evaluate the number of potential drug-drug interactions created during
hospitalization due to changes in the medication order.

To manage the potential drug-drug interactions by clinical pharmacist
intervention during hospitalization and at discharge.

To evaluate the effect of intervention on potential drug-drug interactions
by clinical pharmacist.
7.0.
MATERIALS AND METHODS :-
7.1. Study design

Hospital based prospective study.
7.2. Source of Data :

Patient’s who admitted to general medicine department of KIMS hospital
and research centre.

Patient’s case sheet and medication order and laboratory reports.

Pre-structured patient proforma.

Patient’s discharge medication order.
7.3. Inclusion criteria

Patients of both gender, aged above 12 years, who have been admitted to
the Medicine department.

Patients with two or more drugs in their medication order.

Anti hypertensive drugs, Anti diabetic drugs, Antibiotics will be included
for the study.
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7.4. Exclusion criteria

Patients < 12 years of age.

Patients with less than 2 drugs in their medication order will be excluded.
7.5. Method and collection of Data

A prospective study will be conducted on inpatient medicine department
of KIMS Hospital and research centre.

Patient’s case sheet, medication order and laboratory data will be
reviewed.

Patient’s medication order during admission, hospitalization and at
discharge will be collected and evaluated.

Based on the profile of medication order, the potential drug-drug
interactions will be identified and classified according to the data base
available (Thomson micromedex drug reax system, AHFS, IDR, CIMS,
internet resources).

Clinical pharmacist’s intervention and clinical management of potential
drug-drug interactions will be documented.

Feed back form will be used to evaluate the clinical pharmacist’s
intervention to the medicine department.

All the collected data will be entered and analyzed statistically using
chi-square test.
7.6. Duration of the study

The study will be conducted for a period of 9 months.
7.7. Place of Study

Department of medicine, KIMS Hospital and Research centre, a tertiary
care teaching Hospital, Bangalore.
7.8. Does the study require any investigations or interventions to be
Conducted on Patients or other humans or animals?
No
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7.9. Has ethical clearance been obtained from your institution?
Yes, copy attached.
8.0
LIST OF REFERENCE
1. Karen B. Stockley’s drug interactions. 8th ed. London (UK):
Pharmaceutical Press; 2008. p. 1-11.
2. Bista D, Palaian S, Shankar PR, Prabhu MM, Paudel R, Mishra P.
Understanding the essentials of drug interactions: a potential need for
safe and effective use of drugs. Kathmandu University Medical Journal
2006;4(3 pt 15):421-430.
3. Richard AH, David JQ, Herfindal ET, Gourley DR, editors. Textbook of
therapeutics: drug and disease management. 8th ed. Philadelphia (USA):
Lippincott Williams & Wilkins; 2006. p. 47-72.
4. Charles HB, West L. Overview of drug interactions. A Jobson
Publication 2000;25:5.
5. Cruciol-Souza JM, Thomson JC. A pharmacoepidemiologic study of
drug
interactions
in
a
Brazilian
teaching
hospital.
Clinics
2006;61(6):515-20.
6. Priska V, Andre D, Stephan K, Jurg HB. Prevalence of drug-drug
interactions at hospital entry and during hospital stay of patients in
internal
medicine.
European
Journal
of
Internal
Medicine
2008;19(6):413-420.
7. Juliana Locatelli AAE. Drug interactions in hospitalized elderly patients.
Einstein 2007;5(4):543-346.
8.
Cruciol-Souza JM, Thomson JC. Prevalence of potential drug-drug
interactions and its associated factors in a Brazilian teaching hospital. J
Pharm Pharmaceut Sci [serial online] 2006 Dec [cited 2006 Dec 31];
9(3):427-433. Available from:URL: http://www.cspsCanada.org
9. David NJ, Muhammad M, Alexander K. Drug-drug interactions among
elderly patients hospitalized for drug toxicity. Journal of American
Medical Association 2003;289(13):1652-1658.
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10. Joshua NG, Issa EJ, Payal J, Thomson OS. Ed drug-drug interactions:
frequency & type, potential & actual, triage & discharge. The Internet
Journal of Emergency and Intensive Care Medicine 2005;8(2):10924051.
11. Svetlana VD, Hortensia RM, Laure del pilar torres A, Magdalena SO.
Potential drug-drug interactions for ambulatory patients over 50 years of
age in family medicine clinics in Mexico City. BMC Health Services
Research 2007;7:1.
12. Priska V, Andre D, Jurg HB, Stephan K. Drug-drug interactions in the
hospital: clinical pharmacist’s intervention to improve the management
of potential drug-drug interactions in a department of internal medicine.
Basel 2007 Mar 27:77-102.
13. Egger SS, Drewe J, Schlienger RG. Potential drug-drug interactions in
the medication of medical patients at hospital discharge. Eur J Clin
Pharmacol 2003;58(11):773-8.
14. Janchawee B, Wongpoowarak W, Owatranporn T, Chongsuvivatwong V,
Pharmacoepidemiologic
study of potential
drug interactions
in
outpatients of a typical Thai university hospital. Journal of Clinical
Pharmacy and Therapeutics 2005;30(pt 1):13-20.
15. Matthijis LB, Peter WJC, Marjon K, Riekert JB, Nico BK, Siem K et al.
Determinants of potential drug-drug interaction associated dispensing in
community pharmacies in the Netherlands. Pharm World Sci
2007;29:51-57.
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