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
|
|
Primary Sponsor
|
Name |
NA |
Address |
NA |
Type of Sponsor |
Other [NA] |
|
Details of Secondary Sponsor
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
All Health conditions and Diseases, |
|
Intervention / Comparator Agent
|
|
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 |
|
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. |