Fatima Doctors’ Hospital No. Adm.

2022-03-
001
Title: Effective Date ( After
approval by FDA)
PHARMACY RISK Retires Policy Dated: None
MANAGEMENT PLAN Previous Versions Date None
Approval Date:

RISK MANAGEMENT PLAN

(HOSPITAL PHARMACY)

INTRODUCTION

Risk is defined as an event that has a probability of occurring, and could have either a
positive or negative impact to the lifecycle of a medicinal product. A risk may have one or
more causes and, if it occurs, one or more impacts either in cost, schedule or performance, for
example.
Risk management means managing a wide spectrum of risks that could affect the practice
of pharmacy. It involves protection of the patient, protection of the pharmacists and
technicians, and protection of the pharmacy itself. It goes beyond merely putting the right
tablets in the bottle with the correct directions on the label. It is even broader than protecting
the patient from harm, although that must remain the primary focus of all.

SCOPE

This Plan applies to FDH Pharmacy, and ALL Drug products available.

OBJECTIVE

This guidance is intended to propose to FDA a standard concept for FDH Pharmacy Risk
Management Plan ( RMP) in order to deal with “Important identified risks” both
Pharmacovigilance and Risk Minimization Plan. The whole plan is called “Risk Management
Plan (RMP).” - This guidance should be used as a guideline when the FDH Pharmacy
considers further surveillances and studies regarding the safety of the drug products available
at the Pharmacy and additional actions to mitigate risks at anytime when the need is
identified. This guidance is intended to aid and improve safety measures based on the MDH
Pharmacy protocols.
 Fatima Doctors’ Hospital No. Adm. 2022-03-
001
Title: Effective Date ( After
approval by FDA)
PHARMACY RISK Retires Policy Dated: None
MANAGEMENT PLAN Previous Versions Date None
Approval Date:

Definition of Terms:

Risk - a set of pharmacovigilance activities and interventions designed to identify,

characterize, prevent or minimize risks relating to medicinal products including the
assessment of the effectiveness of those activities and interventions.
Risk Identification / Assessment - is a term used to describe the overall process or
method where you:

 Identify hazards and risk factors that have the potential to cause harm (hazard
identification).
 Analyze and evaluate the risk associated with that hazard (risk analysis, and risk
evaluation).
 Determine appropriate ways to eliminate the hazard, or control the risk when the
hazard cannot be eliminated (risk control).

Risk Minimization - is the process of doing everything possible to reduce the probability
and/or impact of a risk towards zero.

Risk Communication – Exchange of information and opinions, and establishments of an

effective dialogue, among those responsible for assessing, minimizing, and regulating risks,
and those who maybe affected by the outcome of those risk.

SAFETY SPECIFICATION

The Fatima Doctors’ Hospital Pharmacy, is a licensed hospital Pharmacy located at

Lagro, Quezon City owned by Mr. Juan Dela Cruz, and as owner, the responsibilities are
below;
1. As a licensed hospital Pharmacy, our general risk management objective is to ensure
the safety, efficacy, and quality of drug products, and ensure compliance with
regulatory requirements specifically,
– Ensure compliance to regulatory action
– Ensure compliance to GSP
– Ensure compliance to ethical business practices
2. To ensure that the data lock point is observed,
3. Ensure that all healthcare professionals such as Physicians, Nurses and Pharmacists are
medically qualified and competent,
 Fatima Doctors’ Hospital No. Adm. 2022-03-
001
Title: Effective Date ( After
approval by FDA)
PHARMACY RISK Retires Policy Dated: None
MANAGEMENT PLAN Previous Versions Date None
Approval Date:

4. That all Adverse Drug Reactions (ADR) and Adverse Event (AE) will be reported to
the Pharmacovigilance Center using the FDH Adverse Drug Reaction ( ADR) Report
Form,
5. To recall all Drug products that has an Adverse Drug Reactions from the Pharmacy
and general store room. Make report and return the product to the distributor,
6. To update this FDH Pharmacy RMP when the need is identified and based on the FDA
guidelines and Circulars.

The FDH Risk Management Officer

To address the need of a Risk Management Plan in the FDH Pharmacy, the Hospital
Administrator appoint the Medical Director, Dr. Christine Garcia as the FDH Risk
Management Officer. Under her, are the Chief Nurse and the Chief Pharmacist. The term of
reference of the FDH Risk Management Officer as follows;

1. Review and approve the risk policies and any material changes made to these;
2. To review and recommend to the Leadership and Management Committee
standards for the RMP which require their approval; and
3. Monitor compliance with the GSP ( cold-chain protocol ) and other policy in FDH
Pharmacy RMP

Risk Identification
1. COMPLIANCE TO REGULATORY ACTION
Objectives:
To be fully compliant with the FDA regulations and to have a complete list of advisories
and documentation of recall products.
 Fatima Doctors’ Hospital No. Adm. 2022-03-
001
Title: Effective Date ( After
approval by FDA)
PHARMACY RISK Retires Policy Dated: None
MANAGEMENT PLAN Previous Versions Date None
Approval Date:

Mitigation Plan Process:

Risk Description Level of Action to be Time / Responsible

Severity Taken Schedule Person
1. Compliance to
regulatory Action

1.1. Lack of Time Medium 1. Update at Every Morning Pharmacist on

to Check at the Low FDA website Monday – duty
FDA website Friday
1.2. Poor Internet 1. Contact the
Connection Low IT Pharmacist on
maintenance Every time duty
Technician problem exist

1. To update Risk
1.3. Other Risk
the RMP and Management
unidentified Upon
make report Officer
but may occur Identification
to FDA ( data
lack point)

2. COMPLIANCE TO GOOD STORAGE PRACTICE ( GSP)

Objectives:
To be compliant with the protocol on Cold Chain, “that all products are stored and
maintained in correct temperature and to have a consistent temperature on the monitoring
charts.”

Mitigation Plan Process:

Risk Description Level of Action to be Time Responsible
Severity Taken /Schedule Person
2. Compliance to Good
Storage Practice
2.1. Cold Chain
Irregular Medium 1.To Check Every Pharmacist on
Checking the Morning Duty
Refrigerator if Mondays to
power is on Sundays
2.To Check
the
temperature of
refrigerator and
record to chart
 Fatima Doctors’ Hospital No. Adm. 2022-03-
001
Title: Effective Date ( After
approval by FDA)
PHARMACY RISK Retires Policy Dated: None
MANAGEMENT PLAN Previous Versions Date None
Approval Date:

2.2. Power Outage Low 1. Start up the Within 20 Maintenance

Generator Set minutes from Technician
the time of On duty
power
interruption

2.3. Malfunctioning Medium 1. To Replace the Upon Pharmacist on

Monitoring Equipment monitoring detection of Duty
equipment malfunctionin
g
1.
Prepare
Purchase
2.4. Malfunctioning 1. Request Request Pharmacist on
Refrigerator Low repair of the Duty
Refrigerator
2. Transfer the 1. Upon
Note: Refer to drugs to detection of
1.Contingency Plan for another malfunctioni
Both Mechanical and refrigerator ng
Power failure
2. Maintenance and
care of the Bio Ref.
3. Monitoring and
Adjusting of Temp. of
Bio Ref.

3. CONDUCT OF PRODUCT RECALL

Objectives:
To be fully compliant with the FDA regulations and proper conduct of product recall in the
hospital pharmacy
 Fatima Doctors’ Hospital No. Adm. 2022-03-
001
Title: Effective Date ( After
approval by FDA)
PHARMACY RISK Retires Policy Dated: None
MANAGEMENT PLAN Previous Versions Date None
Approval Date:

Mitigation Plan Process:

Risk Description Level of Action to be Time / Responsible
Severity Taken Schedule Person
3. Conduct of Product Recall

3.1 Complaint or High 1. Suspend Chief

notification received distribution of Upon Pharmacist
from FDA of product affected product receiving of
recall in the hospital notification

3.2 Patient Medium 1. Verification of Upon verification Risk Management

claiming illness source by of source Officer
product recall
team
2. Collect
minimum data
set on drug
incident
3. Risk
management
decision on level
of product recall
3.3 Risk Low 1. Chief Upon absence of Chief
Management Pharmacist or risk management Pharmacist/Chief
Officer not Chief Nurse to officer Nurse
available assume
responsibilities of
Risk
Management
Officer

Risk Minimization:

Standards:

In order to minimize the risks, the above step by step mitigation planned activities shall be
followed. The Risk Management Officer shall review and monitor compliance to the above
standards. If upon review, the Risk Management Officer found that the above planned
activities were routinely performed by the responsible persons and still not sufficient to
manage the risks, then a supplemental policy shall be formulated to address the current and
the newly identified risks.
 Fatima Doctors’ Hospital No. Adm. 2022-03-
001
Title: Effective Date ( After
approval by FDA)
PHARMACY RISK Retires Policy Dated: None
MANAGEMENT PLAN Previous Versions Date None
Approval Date:

Risk Monitoring and Management Evaluation

Standards:

1. The FDH Pharmacy RMP will be reviewed and revised at the end of the data lock point
or after six (6) months after FDA approval,
2. Review shall follow SOP of the Pharmacovigilance, and
3. RMP shall be reviewed in instances the identified risks occur which needed additional
risk management.

Annex: The Standard Operating Procedures of Pharmacovigilance

EFFECTIVITY:

This FDH Pharmacy Risk Management Plan (RMP) will take effect after approval by the
Food and Drug Administrations ( FDA ).

MR. JUAN DELA CRUZ

Hospital Administrator