Everyday Iloveyou Drugstore Risk Management Plan

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The document outlines a risk management plan for a pharmacy, including its objectives, identified risks, and measures to minimize risks.

The general objectives are to ensure quality of medicine, patient safety, proper inventory management, and training of pharmacy personnel. The specific objectives and key result areas are not clearly defined.

The priority risks identified through a fishbone diagram are inventory management, staffing, storage, and unknown risks. Unknown risks will be determined by reviewing complaints, recalls, and inspection reports.

(Everyday Iloveyou Drugstore)Name of Drugstore

(Corner Stone, Busy City, Batangas)Address

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

Reviewed and Approved by: (Owner) Signature over Printed Name

Date of Effectivity: January 2017

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
Pharmacy Assistant

(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
ISHIKAWA DIAGRAM
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 training
newly hired employees calendar
* Pre-qualification of * Additional Revalidation
employees exam of all staff
* Enrollment of PA-II
Storage * SOP on Daily Monitoring * Procurement of Back-up
of Temperature Generator
* SOP on Good
Housekeeping * Procurement of Additonal
* SOP on Pest Control Aircon or Additional
* Calibration of Electric Fan/Air Cooler
Thermometer
* availability of Generator * Installation of Automatic
Alarm System of
Temperature
Risk Routine Additional
Staff SOP on Dispensing Additional Manpower
(Pharmacy
Assistant/Cashier)
Wrong Dispensing SOP on Dispensing Required Patient
counselling
Prescription Order SOP on Dispensing Communication with the
Prescriber

Section D: Risk Communication

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

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