Download Exclusion criteria - Rajiv Gandhi University of Health Sciences

Rajiv Gandhi University of Health Sciences
Bangalore, Karnataka.
ANNEXURE-II
PROFORMA FOR REGISTRATION OF SUBJECTS FOR
DISSERTATION
01
Name of candidate and address
(in block letters)
OINAM JIMMY DEVI,
GHOUSIA WOMEN HOSTEL,
BANGALORE DAIRY CIRCLE,
BANGALORE-560 029
02
Name of institution
AL-AMEEN COLLEGE OF PHARMACY,
OPP. LAL BAGH MAIN GATE
HOSUR ROAD,
BANGALORE- 560 027
03
Course of study and subject
M. Pharm
Pharmacy Practice
04
Date of admission to course
26th JULY 2010
05
Title of the Topic:
“STUDY OF DRUG-DRUG INTERACTIONS IN THE MEDICATION CHARTS IN
MEDICINE WARDS AT ST. MARTHA’ S HOSPITAL, BANGALORE”.
6.0
6.1
BRIEF RESUME OF THE INTENDED WORK
Need for the study
Drug interactions are said to occur when pharmacologic activity of a drug is altered by the
concomitant use of another drug or by the presence of another drug or by the presence of food,
drinks or environmental chemicals. A large number of drugs are introduced every year, and
new interactions between medications are increasingly reported. The interaction may increase
(or) decrease the effectiveness of the drug, it also may result in a new side effect. Drug
interactions may lead to adverse drug reactions that can be severe enough to necessitate
hospitalization. Approximately 37-60% of patients admitted to the hospital may have one or
more potentially interacting drug combinations at admission. Drugs can be tools in the
prevention and treatment of diseases, but if not used properly, they may be harmful and cause
new symptoms (or) produce suboptimal effects. Most drugs have multiple pharmacologic
effects in patients, specially the newer, more complex drugs being marketed. Clinically
significant drug interactions can occur when two or more drugs are taken in combination.1
Drug-drug interactions (DDI) in patients receiving multi-drug therapy are of wide concern.
They may lead to risk of hospitalization and higher health care costs. At least 15% of the
patients admitted to hospitals have one DDI at admission. The risk of DDI can increase in the
hospital because new drugs are often added to an existing drug therapy. Drug-drug interactions
are often predictable and, therefore, avoidable or manageable, but the reactions caused by them
are mostly unknown.2
About 5% of all the adverse drug reactions in the hospitals are caused by DDI, the majority of
which are advoidable.3
Medicines are often used concomitantly with other drugs, and some degree of drug-drug
interactions occurs with concomitant use. Although only a small proportion of this interaction is
clinically significant. Therefore, in the evaluation and clinical application of drugs, appropriate
efforts should be made to predict the nature and degree of drug interactions so that patients will
not be adversely affected.4
The quality use of medicines is a key factor in achieving positive health outcomes. Evidence
indicates that there is significant scope for improvement in the use of drugs for hospitalized
patients as medication related problems have been identified as contributing to negative clinical
and economic outcomes including hospitalization and increased length of stay. The contribution
of various members of the healthcare team in improving the medication-related outcomes is less
well explored. In developed countries, pharmacists in hospitals frequently initiate changes to
patient’s therapy and management. For the purpose of the study an intervention is defined as
“any action by the pharmacist that directly results in a change to patient management or
therapy”.5
Drug therapy has become so difficult that no single professional is expected to optimize the
drug therapy and control drug related problems alone. However, optimization of drug therapy
may, by preventing drug related problems, influence health expenses, potentially save lives and
enhance patient’s quality of life.6
Hence, this project is proposed to identify drug-drug interactions in the drug therapy by
the clinical pharmacist and report the same to the physician so that adverse drug
reactions can be prevented and patient outcome can be improved.
6.2
Review of literature
A study has been carried out to the physicians expectations to prevent drug interactions in
clinical practice. A standard Questionnaire containing 12 Questions regarding prescription
writing, importance, experience, training program attended, training needs, source of
information, software need and software design for drug-drug interactions were prepared and
circulated to 100 doctors of various specialties. The filled Questionnaire were collected and
analyzed. 98% of doctors consider drug-drug interaction is an important aspect while writing
prescription. 61% of doctors had serious drug-drug interaction experience in their practice.1
A retrospective case-control study (1:1) was performed in 4 months using data of the
prescriptions held at the pharmacy of a 300 bed Brazilian teaching hospital. Approximately
11,250 adult inpatients received handwritten prescriptions with two or more drugs prescribed at
wards. In randomly selected 887 prescriptions, at least 653 (73.6%) prescriptions presented
more than one DDI with different adverse drug reactions, while 234 (26.4%) presented one.2
A study was conducted in the medical wards of the Ospedale Regionale di Lugano, sede Civico,
Switzerland. Prescribed drugs from 200 patients at discharge were analyzed for interactions
using commercially available software (Pharmavista). Clinical pharmacists and a physician
assessed the clinical relevant of detected interactions, eliminated those which were not
considered clinically relevant and formulated recommendations for those considered clinically
relevant. Among all patients, 62.5% (n=125) had at least one potential DDI, whereas 37.5%
(n=75) had no potential drug-drug interaction. In total, 373 potential drug-drug interactions
were identified: 223 (60%) of minor severity, 143 (38%) of moderate severity and 7 (2%) of
major severity.3
A pharmacoepidemiologic study of drug interactions in a Brazilian teaching hospital has been
reported. From 1785 prescriptions studied, at least 1 drug drug interaction was found in 887
prescriptions, which were classified as minor, moderate, major and undetermined. The median
number of drugs in each prescription was 7. Drug-drug interactions were identified by using
Micromedex, DrugReax System. From the 30 patients with major interactions, 17 presented
adverse drug reactions induced by exposure to a major drug-drug interaction. 7
In a study reported at Bou-Ali teaching hospital, Iran, a total number of 3130 prescriptions from
in-patients of ICU, CCU, internal and infectious wards were examined during the first 6 months
of 2000 and all the potential drug interactions present were extracted and classified in terms of
significance, onset, severity and documentation. Among the prescriptions examined 3960 cases
and 156 types of interaction were observed.8
A study was conducted with 3 separate population-based, nested case-control studies by
linking multiple health care databases over 7 years ( January 1, 1994, to December 31, 2000) in
Ontario, Canada 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. 179986 elderly patients treated with glyburide continuously for a total of 431662
patient-years of therapy were admitted to hospital with almost responsible diagnosis of
hypoglycemia.9
Pharmacist-initiated changes in drug therapy not only have the potential to save lives, enhance
patient’s quality of life and reduce length of stay, but can also be significantly cost-effective.
Reduced length of hospital stay and fewer drug-related (re)-admissions are two factors that can
be used as indicators of the justification of interventions.10
6.3
Objectives of the study :
To attend the ward rounds everyday in Medicine Intensive Care Unit (MICU) and
female medical ward of medicine unit I and to collect complete patient history,
diagnosis and note down all the medicines prescribed for the patients.

To classify all drugs prescribed according to the Anatomical-Therapeutical-Chemical
classification (ATC code, WHO 2004).

To analyze using various drug information resources for any anticipated or reported
drug interaction for the drugs prescribed.

In case, any patient is experiencing an adverse drug reaction, to check the prescription
for drug interaction and if that is the cause of ADRs.
7.0
Materials and methods
7.1
Source of data :
Data will be collected from prospective series of patients' medication charts, who are admitted
to the MICU and female general ward of medicine unit I in St.Martha’s hospital, Bangalore
during the nine month period of study.
Inclusion criteria

:
Patients who were prescribed with two or more drugs in emergency ward as well as
female general ward.

To include patients who are on both oral or parenteral medications.
Exclusion criteria:

All pediatric patients.
7.2
Method of collection of data:
The clinical pharmacist will participate in the ward rounds conducted in MICU and female
general ward of medicine unit I.
The pharmacist will make note of complete patient details, diagnosis, co-morbid conditions,
laboratory values and drugs prescribed with their doses and frequency of administration. Then
it will be analyzed for any reported drug interactions between the drugs prescribed.
If any patient is experiencing an adverse drug reaction, the clinical pharmacist will check
whether it is due to drug-drug interactions. The pharmacist will report to the physician incharge the findings of the data analysis.
7.3
Duration of study
The study will be conducted for a period of 9 months.
7.4
Does the study require any investigation or intervention to be conducted on patients or
other humans?
No.
7.5
Has ethical clearance been obtained from your institution in case of 7.3?
The project will be submitted to the Institutional Review Board of St. Martha’s hospital for
ethical clearance and the same will be submitted to the university.
8.0
References:
1. Satish A, Bhaskar H. Physician expectation to prevent the drug interactions in clinical
practice. Int Jour Pharm and Pharmaceut Sci; 2(3):172-73.
2. Joice MCS, Carlos JT. Prevalence of potential drug-drug interactions and its associated
factors in a Brazilian teaching hospital. J Pharm Pharmaceut Sci 2006; 9(3):427-33.
3. Bertoli R, Bissigb M, Caronzoloc D, Odoricod M, Pons M, Bernasconi E. Assessment
of potential drug-drug interactions at hospital discharge. Swiss Medical Weekly 2010
March. Available from URL: http://smw.ch/docs/PdfContent/smw-12979.pdf.
4. Flockhart DA. Methods of Drug Interaction Studies.2009 Jan. Available from URL:
http://nihs.go.jp/phar/material3/DiGIEngFinal011209.
5. Alagiriswami B, Ramesh M, Parthasarathi G, Basavanagowdappa H. A study of
clinical pharmacist initiated changes in drug therapy in a teaching hospital. ijopp 2009
Jan; 1(2):36-45.
6. Dooley MJ, Allen KM, Doecke CJ, Galbarth KJ, George TR, Jennifer B et.al. A
prospective multicentre study of pharmacist initiated changes to drug therapy and
patient management in acute care government funded hospitals. Br J Clin Pharmacol
2003 Oct; 57(4): 513-21.
7. Cruciol-Souza JM, Thomson JC. A pharmacoepidemiologic study of drug interactions
in a brazilian teaching hospital Clinics 2006; 61(6):515-20.
8. Giti H, Alireza SM. An Investigation of Drug Interaction in Hospital Pharmacy
Prescription. IJPR 2002 July; 1:15-19.
9. David NJ, Mamdani M, Alexander K, Andreas L, Donald AR. Drug-drug interactions
among elderly patients hospitalized for drug toxicity. JAMA 2003 Apr; 289(13):165258.
10. Struck P, Kristine PH, Moodley P, Rasmussen M. A pilot study of pharmacist-initiated
interventions in drug therapy in an Australian paediatric hospital. EJHP Science 2007;
13(4):105-12.
9.0
Signature of the candidate
10.0
Remarks of the Guide
Recommended for research and
submission of dissertation
11.0
Name & Guide
Dr. Shobha Rani R Hiremath
Professor and Head
Department of Pharmacy Practice
Al-Ameen College of Pharmacy
Bangalore-560 027
Signature
12.0
Co – Guide
Dr. Indira Ramaiah
Senior Consultant and Unit Head
(UNIT I)
Department of Medicine
St.Martha’s Hospital
No.5 , Nrupathunga Road
Bangalore-560 001
Signature
13.0
Head of the Department
Dr. Shobha Rani R Hiremath
Professor and Head
Department of Pharmacy Practice
Al-Ameen College of Pharmacy
Bangalore-560 027
Signature
14.0
Remarks of the Principal
Forwarded for approval
15.0
Principal
Prof. B.G. Shivananda
Principal
Al-Ameen College of Pharmacy
Bangalore-560 027
Signature