RISK

MANAGEMENT
PLAN
FATIMA HILL PHARMACY
APRIL 2019
I. INTRODUCTION

Fatima Hill Pharmacy was established in 1994 as a retail pharmacy in

Pob. Sur, Carmen, Bohol (in front of Carmen Public Market) . It was
originally established by Mrs. Elisa A. Torrefranca and her husband, Luis
Torrefranca. To date, it is now owned by their son, Mr. Marlon A.
Torrefranca. They noticed that there were only few pharmacy in the
area and the demand for medicines were high. So the couple decided to
open a pharmacy near the public market so it would be accessible for
the patients.

VISION STATEMENT

To be the leading pharmacy in the town of Carmen.

MISSION STATEMENT

Our mission is to provide quality, safety and low-cost medicines to the

community so the less fortunate patients can still acquire the optimum
medication they need.

MANAGEMENT TEAM

• Manager: Marlon A. Torrefranca

• Finance Head: Marlon A. Torrefranca
• Purchaser: Merelina R. Torrefranca
• Pharmacist: Sushmita T. Cajes
• Staff:
Azenith Tutor
Jinky Decinan
Nerilyn Bernados
RISK MANAGEMENT TEAM

• Chairman: Marlon Torrefranca

• Members:
Merelina Torrefranca
Sushmita T. Cajes
Azenith Tutor
Jinky Decinan
Nerilyn Bernados

*For any report on our establishment, staff or the quality of the

products we sell, please contact 0977-614-8588.

RISK MANAGEMENT COMMITMENT

Fatima Hill Pharmacy is committed to the assurance of patient safety

and the protection of public health through the implementation of its
Risk Management Plan.

RISK MANAGEMENT OBJECTIVE

As a licensed retail pharmacy, our general risk management objective is

to ensure the safety, efficacy and quality of drug products and ensure
compliance with regulatory requirements including good storage
practices, good dispensing practices, good distribution practices and to
comply with legal and ethical business practices.
 DATA LOCK POINT

This Risk Management Plan is valid until _______ (maybe 2 to 3 years) or

until 2-3 months before the expiration of our LTO.

This Risk Management Plan shall be reviewed, evaluated and updated

annually or if the need arises.

II. RISK IDENTIFICATION

A. Quality Risk Management on People

Lack of training for pharmacists
Lack of training for pharmacy assistants
Long work hours
Absenteeism and tardiness

B. Quality Risk Management on Facilities & Equipment

Poor ventilation in the pharmacy area
Presence of pests (cockroaches, rodents, termites)
Risk of flooding
Insufficient water supply
Poor maintenance of refrigerator

C. Quality Risk Management on Processes

• Procurement and Receiving of Deliveries

*Assurance of Quality of Products purchased and received

-SOP on purchasing not followed
-SOP on receiving of deliveries not followed
*Assurance of Availability
-Poor inventory control
-Limited financial resources
-Pilferage/shrinkage
• Storage
-quality assurance of cold chain products and biological
during power outage
-products displayed in the wrong shelf
-storage of expired and damaged medicines

• Good Dispensing Practices

*Risk of dispensing error
-Lack of dispensing SOP resulting to dispensing errors
-Multitasking of personnel
-Lack of training for Antimicrobial Stewardship
-Lack of training of frontline personnel
*ADR Reporting
-Lack of SOP on ADR reporting
-Poor understanding of ADR and reportable ADEs
-Lack of communication
between pharmacy and agency for ADR reporting
*Medication Counselling
-Lack of dedicated area for counselling
-No SOP for medication counselling
-No patient medication profile
• Compliance to Regulation
 expired licenses
 non-compliance to SOPs
  lack of communication with regulatory agencies
 managing drug recalls

Analyzation of Probable Risk

• High Probability

• Low Probability

 Severe impact

 Low impact
III. RISK MINIMIZATION “What Should Be Done To Prevent Risk To Happen”
 IV. RISK COMMUNICATION

RISK IDENTIFIED WORK AREA RISK SCHEDULE PERSON RISK KEY RESULT
CLASSIFICATION RISK MINIMIZATION RESPONSIBLE COMMUNICATION INDICATOR

Process: Wrong Dispensing Arrange stocks Daily PA assigned Dialogue with Systematic
dispensing counter on display in a to shelf supervisor display of
Dispensing systematic stocks
matter

SALAD Weekly Senior PA Dialogue with Warning

medications supervisor stickers in
must not be proper place
placed
together
and/or proper
special warning
stickers are in
place

Follow SOP for Daily All staff Monthly meeting SOP minutes
proper of meetings
dispensing of
medications

Potential Dispensing Where there Always All frontline Submit incident Incident report
drug counter are 2 or more staff report in case of
interaction meds in the error
not checked prescription,
before
dispensing Check for drug
intxn.

Ask the patient Always All frontline Face-to-face with Entry in

if he is on any staff patient prescription
other book
medication

Provide As needed All frontline Face-to-face with Entry in

information to staff patient patient profile
the patient to
prevent Inform prescriber
possible drug by telephone
intxn.

People Lack of Pharmacy Update As Pharmacist Emails, Memo, Updated

training for knowledge needed & PA Texts knowledge;
RPH and through
 PA seminars Earn CPD
units

Long work Pharmacy Encourage Daily All staff Dialogue with Less work
hours time supervisor hour &
management minimize OT

Compliance to Expired Pharmacy Make a list or Monthly Pharmacist Coordinate with Compliance
regulation licenses take note of partner or to FDA
the expiry of owner requirements
the licenses

Dispensing No patient Counselling Print patient Daily Pharmacist Face-to-face Provide

medication area information with customer Patient
profile sheet or information
counselling sheet or
guide forms counselling
and file on a guide form
folder.
V. RISK MONITORING AND EVALUATION

Fatima Hill Pharmacy shall review and revise the RMP at the data lock
point set at April 2020.

Risk Monitoring shall be done on a monthly basis as a part of the report

by the Operations Manager / Store Owner. Any additional risk
management shall be included in the annex and shall be appropriately
communicated to stakeholders.
This Risk Management Plan was prepared by Sushmita T. Cajes for Fatima Hill
Pharmacy and was communicated and implemented on April 2019. Due
acknowledgement is given to Fatima Hill Pharmacy and the Cebu Pharmacists
Association for the assistance in the making of this document.

Reference:
International Conference on Harmonization (ICH) Q9 Guideline for
Quality Risk Management