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Gaps #86968

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Gaps #86698: HUMS T.H.I.S GAP Analysis

Gaps #86765: GAPS > PHIS > THIS

GAPS > PHIS > ADR module needs to be provided ASAP

Added by Mohd Azmild Hamild over 1 year ago. Updated 6 months ago.

Status:
Assigned
Priority:
Critical
Assignee:
Daniyal Ansari
Category:
M Pharmacy
Target version:
-
Start date:
04/08/2025
Due date:
% Done:

0%

Estimated time:
Dev Due date:
30/04/2026
Release date to QA:
Issue released on:
Dev
Function:
HUMS

Description

Issues Description : ADR module needs to be provided ASAP

A dedicated Adverse Drug Reaction (ADR) module within the Pharmacy system to support the identification, documentation, and reporting of suspected drug-related adverse events is urgently required. This module is to ensure early detection and proper documentation of ADRs which are vital for patient safety, preventing recurrent events, and meeting institutional and regulatory reporting obligations, while strengthening pharmacovigilance practices.

Files

Download all files
MADRAC Form.pdf (495 KB) MADRAC Form.pdf CP Chan, 14/08/2025 11:59 AM
WORK PROCESS OF ADVERSE DRUG REACTION.docx (37.2 KB) WORK PROCESS OF ADVERSE DRUG REACTION.docx Dayang Yusreena A.M Yaakub, 06/02/2026 03:29 PM
ADR WIREFRAME.docx (590 KB) ADR WIREFRAME.docx Dayang Yusreena A.M Yaakub, 06/02/2026 03:29 PM
1. ADR Reporting Form.pdf (494 KB) 1. ADR Reporting Form.pdf Dayang Yusreena A.M Yaakub, 06/02/2026 03:29 PM
Screenshot 2026-02-06 203453.png (155 KB) Screenshot 2026-02-06 203453.png Dayang Yusreena A.M Yaakub, 06/02/2026 08:38 PM
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 #1

Updated by CP Chan about 1 year ago

  • Due date set to 30/11/2025
  • Assignee set to Sunil Shinde
  • Priority changed from Normal to High

Adverse Drug Reaction (ADR) Monitoring and Reporting
An ADR is “A response to a drug which is noxious and unintended, and which occurs at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease, or for the modifications of physiological function…WHO1972.

Examples of ADR are rashes, jaundice, anaemia, anaphylaxis (a severe, potentially life-threatening allergic reaction), leucopenia (a reduction in the number of white blood cells), nephrotoxicity (kidney damage) and nerve injury impairing vision or hearing.

*To provide a hyperlink to the ADR (Adverse Drug Reaction) module in CliniCare to facilitate access for the Clinical Pharmacist to do ADR Reporting *

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 #2

Updated by CP Chan about 1 year ago

To provide the MADRAC for in the system for ADR Reporting

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 #3

Updated by Mohd Azmild Hamild 11 months ago

  • Status changed from New to Assigned
  • Assignee changed from Sunil Shinde to Dayang Yusreena A.M Yaakub
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 #4

Updated by Mohd Azmild Hamild 10 months ago

  • Category set to M Pharmacy
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 #5

Updated by Dayang Yusreena A.M Yaakub 9 months ago

ADVERSE DRUG REACTION (ADR)

as discussed with pharmacist of ADR pharmacy module:

1. ADR form to be filled by SPECIALIST/MEDICAL OFFICER/NURSE/DENTIST/PHARMACIST
2. form received and screen by Drug Info Service (DIS) PHARMACIST
3. if incomplete information need to refer back to reporter
4. if complete , proceed send report to MADRAC/NPRA through email :
5. print and file documents

kindly refer to flow chart attached together with wireframe .

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 #6

Updated by Dayang Yusreena A.M Yaakub 9 months ago

Step to reproduce
1. Login System
2. Navigate to > Clinical Pharmacy > Select sub-mod Adverse Drug Reactions
3. Select patient > fill in details > save and print/ email

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 #7

Updated by Kamini Kumar 9 months ago

Upon discussion with @CP Chan , workaround : MADRAC form to be provided as template

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 #8

Updated by Daniyal Ansari 9 months ago

  • Dev Due date set to 30/04/2026
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 #9

Updated by Kierthini Nethi 8 months ago

  • Priority changed from High to Critical
  • Function HUMS added
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 #10

Updated by CP Chan 6 months ago

Use Case: Adverse Drug Reaction (ADR) Reporting Across CliniCare & MedCare
Patient Selection
A Doctor, Nurse, or Clinical Pharmacist identifies and selects the patient who has experienced a drug reaction within CliniCare.

ADR Tab Access
The healthcare professional clicks on the ADR Tab in CliniCare to initiate reporting by opening the MADRAC (Malaysian Adverse Drug Reactions Advisory Committee) reporting form.

Form Completion
The MADRAC form is completed with all required details.

Report Submission
The completed ADR Report (MADRAC Form) is submitted to the Pharmacy Module in MedCare

*Acknowledgement *
The Drug Information Service (DIS) Pharmacist in MedCare acknowledges receipt of the ADR Report.

Review Process
The DIS Pharmacist reviews the ADR report for completeness and accuracy.

Information Validation

If information is incomplete, the DIS Pharmacist initiates further investigation or refers the case back to the reporting Doctor/Nurse for clarification.

If information is complete, the DIS Pharmacist authenticates findings and updates the record in MedCare’s database.

External Reporting
The validated ADR report is forwarded to MADRAC / NPRA via email at .

Record Update
The DIS Pharmacist updates the record and ensures appropriate documentation within MedCare.

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