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CTRI Number  CTRI/2013/01/003319 [Registered on: 23/01/2013] Trial Registered Retrospectively
Last Modified On: 23/01/2013
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Observational (Retrospective data) 
Study Design  Other 
Public Title of Study   Study to evaluate the drug utilization patterns in Government hospitals and medical colleges in Maharashtra and also to study the disease distribution pattern reported in those hospitals. 
Scientific Title of Study   Study of Drug Utilization in various hospitals across Maharashtra 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ritika Rajendra Kondra 
Designation  Ph.D. student 
Affiliation  B J Government Medical College Pune 
Address  B. J. Govt. Medical College, Near Pune Railway Station, Pune-1

Pune
MAHARASHTRA
411001
India 
Phone  09158888216  
Fax    
Email  ritika9d@yahoo.co.uk  
 
Details of Contact Person
Scientific Query
 
Name  Ritika Rajendra Kondra 
Designation  Ph.D. student 
Affiliation   
Address  B. J. Govt. Medical College, Near Pune Railway Station, Pune-1


MAHARASHTRA
411001
India 
Phone    
Fax    
Email  ritika9d@yahoo.co.uk  
 
Details of Contact Person
Public Query
 
Name  Ritika Rajendra Kondra 
Designation  Ph.D. student 
Affiliation   
Address  B. J. Govt. Medical College, Near Pune Railway Station, Pune-1


MAHARASHTRA
411001
India 
Phone    
Fax    
Email  ritika9d@yahoo.co.uk  
 
Source of Monetary or Material Support  
NA 
 
Primary Sponsor  
Name  NA 
Address  NA 
Type of Sponsor  Other [NA] 
 
Details of Secondary Sponsor  
Name  Address 
NA  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr B B Ghongane  B. J. Govt. Medical college and hospital  Dept. of Pharmacology B. J. Govt. Medical College Near Pune Railway Station Pune-1
Pune
MAHARASHTRA 
9922925590

ghongane.phdguide@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
B. J. Medical College and Sassoon General Hospital Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  All Health conditions and Diseases,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  95.00 Year(s)
Gender  Both 
Details  1.Data under the headings: Injectables, Orals and Miscellaneous
2.Data for 2009-10, 2010-11, 2011-12
3.Government hospitals under DMER receiving funding from the State Government.
 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Analysis of drug utilization patterns in Government hospitals in Maharashtra and their comparison.  2 years 
 
Secondary Outcome  
Outcome  TimePoints 
1.To discuss the National Drug Policies and irrational drug use.
2.To analyze the implementation of these policies in our country.
3.To study the utilization of drugs in various hospitals and medical colleges across Maharashtra.
4.To outline the disease pattern in patients and to correlate the use of these drugs to the disease pattern observed.
5.If possible, to compare the results with other states or countries. 
18 months 
 
Target Sample Size   Total Sample Size="0"
Sample Size from India="0" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/07/2011 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

WHO list of essential medicines is created by international experts, which is updated every few years (2-4 years). Medicines which are efficacious and cost- effective are recommended to be included in this list. Rationality is a concept that has different meanings in different settings. For example, rationality in medical setting could be different from the customer point of view, which is influenced by culture and economy. WHO aims to promote rational drug use, hence, the organization introduced the concept of essential drugs. This would help an efficient supply of a limited number of drugs in the market. Eventually it will lead to reduced cost of health care and flow of safe, legalized drugs in the market. The essential drug list comprises of 250 drugs based on the disease distribution in the world. However, there is still a shortage of these drugs in some countries. Shortages could be due to irrational prescriptions, improper storage facilities, improper selection of drugs etc.

The drug industry is business oriented; they produce drugs only to sell in the market irrespective of the needs of the people. Most of the drugs available in the Indian markets are the ones that have been banned in their country of origin. For example, the drug Nimesulide is commonly available in India as a painkiller; however it has been banned in many developed countries. These giant pharmaceutical companies are also known to flood our markets with more multivitamins than essential drugs, creating a shortage of the essential drugs used to treat diseases such as malaria and tuberculosis.

We would be requesting MIS data from all the medical colleges and hospitals that come under the Directorate of Medical Education and Research (DMER). This data will comprise of the following components:

 

  • Number of OPD registrations
  • Number of In- patients
  • Number of beds in the hospitals
  • Sanctioned grant for the purchase of drugs/ surgical items/ X- ray films etc.
  • Drugs not used for more than 6 months
  • Departments and categories of staff
  • Number of deaths etc.

 

The requested data would be analyzed to observe whether the drug utilization in these hospitals is appropriate, whether it follows the WHO guidelines, List of essential and non- essential drugs, whether the essential drugs is available to the people when they require them. These drugs should ideally be available to people all the time, as the Government purchases these drugs with the recommendation of the WHO.

 
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