POLYTECHNIC UNIVERSITY OF THE PHILIPPINES 1

Chapter 6

RISK MANAGEMENT PLAN

This chapter discusses the risk management plan of a mobile pharmacy

business. This chapter consists of the business’s internal environment, risk

management approach, risk management objectives, data lock point, risk

identification, risk minimization, risk communication, and risk monitoring and

management evaluation.

Introduction

A. Internal Environment

RXpress is a mobile pharmacy which will be roaming around

Manila, Taguig, Parañaque, Makati and Caloocan to sell medicines and

health and wellness products, and provide healthcare services such as

blood sugar monitoring and blood pressure tests. RXpress will also

accept online pre-orders from their Facebook page.

RXpress is a partnership between:

 Arbol, Charlene A.  Duban, Diana A.

 Cabornay, Aaron James S.  Estrada, Denzel John Dredd S.

 Cano, Daniella Dhanice S.  Francisco, Mariah Ann P.

 De Lara, Khyla Gaile O.  Gregorio, Radha E.

 Docor, Meryl A.
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The following are the responsibilities of RXpress as a mobile

pharmacy:

● RXpress will roam around the neighborhoods of Manila,

Taguig, Parañaque, Makati and Caloocan to sell medicines

under the supervision of the company’s PRC registered

pharmacist

● The approved and valid License to Operate will be

displayed in a conspicuous place of the plant and office,

and the roaming vehicle

● Comply with the regulatory standards of FDA, in particular

good distribution and storage practices

● Ensure that RXpress conduct business with legal

entities/legal establishments

● Ensure that the products RXpress will distribute and/or sell

are registered or to be registered to FDA prior to sale

In case of emergency, the following are the contact information

of the members of the Risk Management Officer:

● Ms. Charlene Arbol

▪ Email address: charlenearbol10@[Link]

▪ Mobile number: +63 918 287 8797

● Ms. Daniella Dhanice Cano

▪ Email address: canodanielladhanice@[Link]

▪ Mobile number: +63 977 790 7271

The risk management officer regularly meets the team and

facilitates the meeting every 1st week of the month to conduct its

periodic review of risk management. Minutes and attendance are taken.

C. Risk Management Objectives

As a licensed mobile pharmacy, RXpress’ general risk

management objective is to ensure the quality of drug products and

patient safety. Specifically:

 Ensure the quality of medicine

 Ensure patient safety

 Ensure compliance to GSP

Table 1
Objective Category
Objecti Particul
KRA KPI
ve ars
Ensure Purchas Keep Up to
quality e only update date
of on d on list of
medicin legitimat FDA adviso
e e adviso ries
sources ries
Ensure Prevent Pharm Pharm
patient dispensi acy acy
safety ng person person
errors nel nel
trainin trainin
g g
certific
ates
Complia Complia Produ Consis
nce to nce to cts tent
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GSP room stored temper
tempera and ature
ture mainta on
monitori ined in monito
ng correct ring
temper charts
ature

D. Data Lock Point

The data lock point is set for 6 months. The Data Lock Point is

valid until 2 months before the expiration of the validity of the LTO of

this establishment.

Risk Identification

A. Risk Universe

● Ensure the quality of medicine

▪ Lack of time to check advisories

▪ Poor internet connection to check advisories

▪ Malfunctioning computer to check advisories

▪ Counterfeit drugs

▪ Product recall

▪ Substandard Spurious Falsely Labeled Falsified Counterfeit

Medicine (SSFFC)

● Ensure patient safety

▪ Wrong drug dosage or drug product given to the patient

doctor

▪ Issuance of erroneous/violated prescriptions

▪ Untrained staff

● Ensure compliance to GSP

▪ Storage condition

▪ Natural disaster and calamity

▪ Irregular checking of temperature

▪ Malfunctioning monitoring equipment

▪ Power-outage

▪ Malfunctioning refrigerator

B. Risk Assessment

The Ishikawa Diagram was used to assess the risks identified in

the risk universe and prioritize them.

C. Summary Risk Register

Table 2
Summary Risk Register
Naming Risk
Conventi Priority Risk Management
on Objective
IT risks Internet and/or To ensure
computer quality of
failure could medicine
hinder the
company to be
updated on
FDA
advisories and
recalls
Staff risk Untrained staff To ensure
will result to patient safety
errors which
could be fatal
to patient
safety such as
dispense of
wrong dosage,
erroneous
drug, etc.
Power- Power-outage Compliance to
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outage will result into GSP
risk fluctuation in
the
temperature
within the
storage and
the shutting
down of the
refrigerator.

D. Unknown Risks

The risk management officer, in coordination with the store staff,

as part of the periodic review, will also address risks not previously

identified through:

● Review of customer complaints

● Review of product recall from FDA

● Review of FDA Inspection Report

Risk Minimization

Table 3
Quality Risk Minimization
Routine Risk Additional Risk
Risk
Minimization Minimization
Supplier ⮚ Standard Operating ⮚ Perform with
s Procedures for Supply regulatory agencies,
Chain Management. industry organizations,
⮚ Assignment of a group international agencies
to strictly monitor and such as the WHO,
tighten the security of and law enforcement
RXpress’ supply to identify and combat
chain. fakes.
⮚ Use verification
methods at different
points in the supply
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chain to ensure the
integrity of the
products.
⮚ Take advantage of
new technologies to
ensure that there will
be no spurious,
substandard, falsified,
falsely-labeled, and
counterfeited medical
products as much as
possible.
Staff ⮚ Standard Operating ⮚ Planned training
Procedures for seminars for all the
Human Resources staffs to nourish their
Department. skills.
⮚ Standard Operating ⮚ Scheduled refresher
Procedures for examinations.
Training Department. ⮚ Surprise evaluation of
⮚ Standard Operating staffs all year round.
Procedures for
Learning and
Development.
Informat ⮚ Standard Operating ⮚ Hiring of external IT
ion Procedures for experts to help in
Technol Information operations in case of
ogy Technology unforeseen events.
Department. ⮚ Backing up files and
equipment in different
areas aside from the
ones in the main
facility.
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Inventor ⮚ Standard Operating ⮚ Manual monthly
y Procedures for inventory
Manage Procurement management.
ment Department. ⮚ Investment on
⮚ Standard Operating inventory
Procedures for Daily management
Monitoring of software.
Temperature. ⮚ Procurement of back-
⮚ Standard Operating up generator.
Procedures for Good ⮚ Procurement of
Housekeeping. additional cooling
⮚ Standard Operating appliances.
Procedures for Pest ⮚ Installation of
Control. automatic alarm
⮚ Calibration of system of
thermometer. temperature.
⮚ Availability of
generator.

Table 4
PATIENT SAFETY
Routine Risk Additional Risk
Risk
Minimization Minimization
Staff ⮚ Standard Operating ⮚ Planned training
Procedures for seminars for all the
Human Resources staff to nourish their
Department. skills.
⮚ Standard Operating ⮚ Scheduled refresher
Procedures for examinations.
Training Department. ⮚ Surprise evaluation of
⮚ Standard Operating staff all year round.
Procedures for
Learning and
Development.
Wrong ⮚ Standard Operating ⮚ Required patient
Dispensi Procedures on counselling.
ng Dispensing.
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Prescrip ⮚ Standard Operating ⮚ Communication with
tion Procedures on the prescriber.
Order Dispensing.

Risk Communication

A. Internal Communication

The head pharmacist will communicate to all the staff of RXpress

about the Risk Management Plan on a monthly basis. In case of

unanticipated events, the pharmacist in charge could call for an

emergency meeting with all the staff to converse about the RMP.

B. Communication to DFA

The head pharmacist will notify the FDA regarding the Risk

Management Plan of RXpress via notification letter.

C. Communication to Consumers and Healthcare Professionals

The staff in charge of communication to consumers and

healthcare professionals could relay the necessary information about

the RMP through the social media pages or by their given personal

contact information.

D. Communication to Other Stakeholders

The staff in charge of communication to other stakeholders could

transmit the necessary information about the RMP through the social

media pages or by their given personal contact information.

Risk Monitoring and Management Evaluation

A. Routine Evaluation
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RXpress will review on the date indicated in the cover. In

addition, it will monitor the effectiveness of the Risk Management Plan

on a monthly basis.

B. Additional Evaluation

RXpress will review the Risk Management Plan even before the

review date in cases of critical issues or risk.