ImmunoVacs Ltd. Co.

3C # 6 Monzon St. Vista Verde 3 Cainta, Rizal

Prepared by: (Pharmacist) Signature over Printed Name (Me myself & I)

Reviewed and Approved by: Page S. Robles

Date of Effectivity: January 2020

Date of Review: December 2019 (3 to 6 months before the expiration of LTO)

Section A: Introduction
1. Internal Environment
Profile (Ipinapakilala mo ang botika mo) of the drugstore(include attached
establishments/institution)
Name of drugstore with location at with attached institution (declared suppliers & third
party service provider. (ex. Security Agency, pest control, agency (secretary/security
guard/ manpower)

Vision: To provide excellent care

Mission: to provide the quality products to the province of Batangas
(Mission and Vision is a direction of the company)

Organization chart
Owner
Pharmacy
Secretary
Cashier
(Identify accountability and responsibility)

RMP Team/Contact Person with Contact Details (owner or pharmacist) contact details
(landline, mobile and email address)

2. Risk Management Approach

Our pharmacy will use our SOP and FISHBONE Diagram

My RMP will be discussed 3 to 6 months before the expiration of LTO

Processes and RM Tools

Periodic Review

3. Risk Management Objectives

General Objectives
1. To ensure quality of medicine
a. To purchase only to legitimate sources

2. To store medicine properly

3. To ensure patient safety

A. To ensure rational use of drugs
B. To prevent dispensing errors
C. To ensure training of pharmacy personnel

3. To ensure proper Inventory Management

Specific Objectives
Key Result Areas

4. Data Lock Point (Validity of your RMP)

The validity of my RMP is 2 years)
Section B: Risk Identification

1. Risk Universe
Expire medicine
Out of Stock
Wrong Dispensing
Untrained staff
Product recall
Storage Condition
Labelling
Security
Natural Disaster and Calamity
Legal Risk
Financial Risk
Lost of Data
Counterfeat drugs
SSFFC - Substandard Spurious Falsely Labeled Falsified Counterfeat Medicine
Occupational Standard

2. Risk Assessment
FISHBONE DIAGRAM
ISHIKAWADIAGRAM
Paano ginagawa ang fishbone diagram

Quality
Quality

Patient
Safety
3. Risk Register Summary
The following are the priority based on my fishbone diagram
1. Inventory management
2. Staff
3. Storage

4. Unknown Risks
A. My pharmacy will determined the unknown risk by doing the following
* Review of product complain
* Review of Product recall from FDA website
* Review of FDA Inspection Report

Section C: Risk Minimization

1. Routine Risk Minimization

2. Addtional Risk Minimization
3. Justification for Identified Risks without Minimization Activities

Risk Routine Additional

Inventory management SOP on Procurement * Investment on Inventory
Management Software
* Monthly Manual
Inventory Management
Staff * Orientation and Exam for * Drafting of a
newly hired employees * training
Pre-qualification of calendar
employees * Additional
Revalidation exam of all
staff * Enrollment of PA-
II
Storage * SOP on Daily Monitoring * Procurement of
of Temperature Back-up Generator
* SOP on Good
Housekeeping * Procurement of
* SOP on Pest Control Additonal
* Calibration of Aircon or Additional
Thermometer Electric Fan/Air Cooler
* availability of Generator
* Installation of
Automatic
Alarm System of
Temperature
Risk Routine Additional
Staff
Wrong Dispensing
Prescription Order
Section D: Risk Communication
SOP on Dispensing
SOP on Dispensing
SOP on Dispensing
Additional Manpower
(Pharmacy
Assistant/Cashier)
Required Patient
counselling
Communication with the
Prescriber

1. Internal Communication

The Pharmacist or the Drugstore owner will communicate and discuss the RMP every
_______________ with the Staff.

2. Communication to FDA

The Pharmacist will notify the FDA regarding the RMP thru notification letter.

3. Communication to Consumers and Healthcare Professionals 4. Communication to

Other Stakeholders

Section E: Risk Monitoring and Management Evaluation

1. Routine Evaluation
The pharmacy will review on the date indicated in the cover.
The pharmacy will monitor the effectiveness or outcomes of the RMP every
________________(month/year).

2. Additional Evaluation
The Pharmacy will review the RMP even before the review date in cases of critical issues
or risk

3. Revision History
Date of Revision Reason for Change
July 20, 2017 Change of Section C
September 8, 2018 Change of Pharmacist
Courtesy of DSAP Batangas visit www.vaoservice.com