| CTRI Number |
CTRI/2024/12/078519 [Registered on: 24/12/2024] Trial Registered Prospectively |
| Last Modified On: |
23/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Dispensation error in a Tertiary care hospital |
|
Scientific Title of Study
|
An observational analysis of medicine dispensing errors in multi-specialty hospital. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Harshkamal Singh |
| Designation |
PharmD student |
| Affiliation |
Indus International Hospital |
| Address |
Clinical Trial department
Chandigarh Ambala Highway
Derabassi
SAS Nagar
Rupnagar
PUNJAB
140507
India |
| Phone |
9053104577 |
| Fax |
|
| Email |
harshkamalk@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Parminder Kaur |
| Designation |
Medical Superintendent |
| Affiliation |
Indus International Hospital |
| Address |
Admin Department
Chandigarh Ambala Highway
Derabassi
SAS Nagar
Rupnagar
PUNJAB
140507
India |
| Phone |
8872735888 |
| Fax |
|
| Email |
msiih@indushospitals.com |
|
Details of Contact Person
Public Query
|
| Name |
Dharmender Singh Lather |
| Designation |
Senior manager clinical trials department |
| Affiliation |
Indus International Hospital |
| Address |
Clinical trial department
Chandigarh Ambala Highway
Derabassi
SAS Nagar
Department of General Medicine
Chandigarh Ambala Highway
Derabassi
Rupnagar
PUNJAB
140507
India |
| Phone |
9215810327 |
| Fax |
|
| Email |
clinicalmanager@indushospitals.com |
|
|
Source of Monetary or Material Support
|
| Indus International Hospital
Derabassi, SAS Nagar, Punjab 140507 |
|
|
Primary Sponsor
|
| Name |
Clincal Trials department, Indus International Hospital |
| Address |
Indus International Hospital
Derabassi
SAS Nagar
Punjab 140507 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Harshkamal Singh |
Indus International Hospital |
IPD wards and daycare
Chandigarh Ambala Highway
Derabassi
Rupnagar
PUNJAB |
9053104577
harshkamalk@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Indus International Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z48||Encounter for other postproceduralaftercare, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
No treatment changes are subjected to the patients. |
| Comparator Agent |
NIL |
No treatment changes are subjected to the patients. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patient hospitalized at IIH for treatment under :-
Surgical ward
Onco ward
Executive ward
FICU
Private room ward
Medical ward |
|
| ExclusionCriteria |
| Details |
Patient below 18
HIV Patient & Leprosy
Death cases
Medico legal cases |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Occurrence of dispensation error/s at each phase of medication use cycle.
|
Two time points (Pre and Post discharge) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Designing policy for minimisation of errors at each phase. |
Post Discharge |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
Final Enrollment numbers achieved (Total)= "500"
Final Enrollment numbers achieved (India)="500" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
06/01/2025 |
| Date of Study Completion (India) |
20/05/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A dispensing error encompasses any mistake that happens during the process of preparing and providing medications in a hospital setting. These errors can be identified either while the medication is still within the pharmacy or after it has been distributed to other hospital departments. This definition applies to research that examines the nature of dispensing errors, how frequently they occur, and what circumstances or conditions may lead to such mistakes |