Republic of the Philippines

Department of Health
FOOD AND DRUG ADMINISTRATION

Risk Management Plan

for Drug Establishments

Center for Drug Regulation and Research-Food and Drug Administration

26 August 2015
Presentation Outline
A. Regulatory Basis
B. Risk and Risk
Management
C. Draft FDA Circular
D. Discussion
 Regulation Outline
I. Background/Rationale
II. Objective
III. Scope
IV. Implementing Details
V. Roles and Responsibilities
of the MAH and Other
Drug Establishments
 Regulation Outline
VI. Penalties and Sanctions
VII. Repealing and
Separability Clause
VIII. Effectivity
 Republic of the Philippines
Department of Health
FOOD AND DRUG ADMINISTRATION

A. REGULATORY
BASIS
Republic Act
No. 9711
 Republic Act
No. 9711
• Section 5, (k)
 Republic Act
No. 9711
• Section 5, (l)
 Republic Act
No. 9711
• Article VII, Section 4 (h) of IRR of RA 9711

• Article II, A, Section 2 (l) of IRR of RA 9711

 FDA Circular
No. 2013-004
• Section V, (2)
Administrative Order
No. 2014-0034

• Section V, D
 Republic of the Philippines
Department of Health
FOOD AND DRUG ADMINISTRATION

B. RISK AND RISK

MANAGEMENT
• event that has a probability of occurring
• could have either a positive or negative impact to
the lifecycle of a medicinal product
• may have one or more causes
• one or more impacts (e.g., on cost, schedule, or
performance)
• all drug products assume some element of risk

Risk
a set of pharmacovigilance activities and
interventions designed to identify, characterise,
prevent or minimise risks relating to medicinal
products including the assessment of the
effectiveness of those activities and interventions

Risk Management
System
a detailed description of the risk management
system

Risk Management
Plan
 From Risk Management Seminar (& Workshop)
presentation by Juancho Robles

Other Risk
Managements
 Other Risk From Risk Management Seminar (&
Workshop) presentation by Juancho Robles

Managements
 Other Risk
From Risk Management Seminar (& Workshop)
presentation by Juancho Robles

Managements
 Republic of the Philippines
Department of Health
FOOD AND DRUG ADMINISTRATION

C. DRAFT FDA
CIRCULAR
 I. Background/
Rationale
• implementation of an RMP → coordinated and
economical applications of resources to
minimize, monitor, and control the probability
and/or impact of risks to drug products with
respect to safety, efficacy, and quality
 II. Objective
• to provide guidance on RMP as part of the
requirements for the issuance of LTO
1) Manufacturers
2) Distributors
3) Drugstores/Pharmacies/ Boticas including
hospital and institutional pharmacies
4) RONPDs
5) CROs
6) Sponsors

III. Scope
A. Risk Management Plan (RMP) for
Drug Establishments
• reqt for the licensing of drug establishments
– During initial for new establishments
– During renewal for existing establishments
• Must always be available for inspection

IV. Implementing
Details
B. Framework for RMP
1. Introduction
2. Risk Identification
3. Risk Minimization
4. Risk Communication
5. Risk Monitoring and Management
Evaluation

IV. Implementing
Details
a) Internal Environment – sets the basis on how
risks are viewed and addressed
 Description of the establishment (objectives,
mission and vision, activities)
 Responsibilities attached to the LTO
 Description of the organization (heads,
functions and responsibilities/duties)
 Risk management officer/team

1. Introduction
a) Internal Environment – sets the basis on how
risks are viewed and addressed
 Other attached establishments/institutions
critical to the functioning of the
establishment
 Contact information of responsible officers
during and beyond office hours

1. Introduction
 For illustration purposes only

Risk Management Plan is specific for

each establishment

Establishments are in a better

position to make their RMPs
 We highly recommend to conduct
internal risk management workshops
to make RMP
Sample only - DI

Internal Environment
• ABC Pharma Inc., is a licensed drug
distributor-importer with license number
LTO-123456 located at Alabang, Muntinlupa
city.
• ABC Pharma Inc. is owned by Juan dela Cruz
Sample only-DI

Internal Environment
• ABC Pharma Inc., is licensed to import raw
materials, active ingredients and/or finished
products for wholesale distribution to other
local FDA-licensed drug establishments.
• The following are my responsibilities as an
importer (petition form)
• As a Marketing Authorization Holder, the
following are my responsibilities with
regard to my products (petition form)
Sample only-DI

Internal Environment
• Attached is the organizational chart of the
establishment.
• In case of emergency, the following are the
contact information of the members of the
Risk Management Team
–A
–B
–C
b) Risk Management Approach – overall risk
management approach (processes, personnel
involved, periodic reporting and monthly
procedures to be performed)

1. Introduction
Sample only-DI

Risk Management Approach

• Attached is a flowchart of the overall risk
management approach/process of ABC
Pharma Inc.
• The team meets every 3rd week of the last
month of the quarter to conduct its periodic
review of risk management. Minutes and
attendance are taken. The SOP (SOP #1234)
for the risk management review is attached.
Sample only-DI

Risk Management Approach

c) Risk Management Objectives – ensure the safety,
efficacy, and quality of drug products they
engage with in order to protect public health;
comply with regulations of FDA
• GDP
• GSP
• Recalls
• Updates on Regulations
• Promotions and Advertisements

1. Introduction
Sample only-DI

Risk Management Objectives

• As a licensed drug importer, 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
Sample only-DI

Risk Management Objectives

Objective Category
Objective name Particulars KRA KPI
Compliance to Compliance to Full compliance; Up to date list of
regulatory action product recalls immediate advisories;
removal from complete
retailers documentation on
recalls
Compliance to GSP Compliance to Products stored Consistent
Cold-chain and maintained in temperature on
correct temp monitoring charts
compliance to Ensure compliance Good performance Less than 2
ethical business to MCPs of detailmen complaints/
practices reports received
d) Data Lock point – timeframe to which the RMP
is expected to be valid

1. Introduction
Sample only-DI

Data Lock Point

• With the recently promulgation of the MCPs,
our data lock point is six months.
• Within 2 months of the end of the data lock
point, we commit to submit the revised RMP
to FDA together with a summary of changes
made.
Identification and assessment of risks that events
that may adversely affect the set objectives

2. Risk
Identification
• Risk universe
• Assessment based on significance and likelihood
• Tabulated summary risk register:
– the priority risks
– the specific objectives under which the priority risks
belongs
– naming convention for each priority risks
• Risks not currently known and the planned
activities by the establishment to identify them

2. Risk
Identification
Sample only-DI

Risk Universe
Compliance to regulatory action
Recall Submission of CAPA Reporting to Inspector
Lack of time to check
Poor internet connection
Clients demanding for
product
Difficulty in coordinating
with retailers
Poor distribution records
Sample only-DI

Risk Universe
GSP
Cold-chain
Irregular checking
Lack of SOPs
Malfunctioning monitoring equipment
Power-outage
Malfunctioning refrigerator
Sample only-DI

Risk Universe
Business Ethics
Promotion Advertising Conventions
No time to review
promotional materials
Misleading promotional
designs
Low technical skills of
and/or unethical
detailmen
Pressure from physicians
Pressure from global
Sample only-DI

Assessment of risks
• Delphi method was used to assess the risks
identified in the risk universe and prioritize
them.
Sample only-DI

Summary Risk Registry

Business Ethics
Naming Convention Priority Risk Risk Management
Objective
Distribution Records Risk Incomplete/poorly Compliance to regulatory
managed records will action
hamper the process of
recall
Power-outage Risk Power-outage will result Compliance to GSP
into fluctuation in the
temperature within the
warehouse, and the
shutting-down of cold
rooms/walk-in freezers
Detailmen Promotion Low technical skills of compliance to ethical
Risk and/or unethical business practices
detailmen - poor training
will result to low
technical skills and/or
unethical detailmen
Sample only-DI

Unknown Risks
• The risk management team, as part of the
periodic review, will also address risks not
previously identified following SOP 2356
For each priority risks, indicate the corresponding
risk minimization plans. These plans may include
policies and procedures to ensure the identified
risks are prevented and/or minimized to an
acceptable level

3. Risk
Minimization
a) Routine risk minimization
 Those planned activities conducted by the
establishment regularly to minimize the
risks

3. Risk
Minimization
b) Additional risk minimization
 those planned activities conducted by the
drug establishment when routine risk
minimization activities are not sufficient to
manage a risk, or should a significant risk
occur

3. Risk
Minimization
For identified risks with no risk minimization
activities, appropriate justification must be
provided

3. Risk
Minimization
Sample only-DI

Risk Minimization
Business Ethics
Priority Risk Routine Risk Additional Risk
Minimization Minimization
Distribution Records Risk Ensure all relevant Special project to
information is complete complete existing
in the records records/problematic
records
Power-outage Risk Regularly view power Additional back-up
interruption schedule generator
Regular maintenance of
generator
Detailmen Promotion Initial training and Warning/sanction + re-
Risk registration of new training/orientation
detailmen according to following SOP 1214515
SOP 12345
Re-training after 1 year
• Communication system of drugstore to:
a) Internally
b) FDA
c) Consumers and HCP
d) Other relevant stakeholders

4. Risk
Communication
• Criteria when communication must be done
• Means for communicating
• Internal reporting procedure to management
and appropriate regulatory agencies

4. Risk
Communication
Sample only-DI

Risk Communication
Distribution Records Risk
Criteria Communication Content Medium
Recall from FDA Inform records Phone
management team to
review distribution
records immediately
Voluntary Recall Inform records Phone
management team to
review distribution
records immediately
Sample only-DI

Risk Communication
Power Outage Risk
Criteria Communication Content Medium
Continued power-outage Provide information to Phone
management/maintenanc
e regarding the risks to
quality and their
preparation
Sample only-DI

Risk Communication
Detailmen Training Risk
Criteria Communication Content Medium
Reporting of Physician of Memo as warning the Formal Letter
unethical/misleading detailmen of the
promotional practices complaint received
Monitoring of BOP-PRC Memo as warning the Formal Letter
detailmen of the
complaint received
Monitoring of FDA Memo as warning the Formal Letter
detailmen of the
complaint received
• Periodic monitoring of identified risks
• Criteria where evaluation is needed
• When RMP revision is required

5. Risk Monitoring and

Management Evaluation
Sample only-DI

Risk Monitoring and Management Evaluation

• The RMP will be reviewed and revised at the

end of the data lock point. Review shall
follow SOP 124345
• RMP shall be reviewed in instances the
identified risks occur which needed
additional risk management.
C. Submission of RMP
• When RMP is revised – submit to FDA
• Cover letter and summary of revisions made
must be included

IV. Implementing
Details
D. Monitoring of RMP
Implementation
• Trigger → FDA expects drug establishments are
implement their submitted RMP
• It is in this context – RMP is comprehensive to
cover significant risks, whether already
identified or yet to be identified

IV. Implementing
Details
 V. Roles and
Responsibilities of MAH
and other Establishments

• MAHs – expected to have a major role

• Other drug establishments – expected to
cooperate and coordinate with MAHs
• Drug establishment is capable of
maintaining/performing its post-marketing
commitments to ensure the safety, efficacy, and
quality of the drug product
• ensuring public health safety
VI. Penalties and
Sanctions
Failure to act on the part of the establishment as
stipulated in the submitted RMP, as well as
violation to any section in this FDA Circular shall
be a ground for the filing of appropriate regulatory
action, administrative sanctions, fines, and/or
penalties
• Provisions in previous circulars and memoranda
that are inconsistent with this Circular are
hereby withdrawn, repealed, and/or revoked
accordingly.
• If any provision in this FDA Circular, or
application of such provision to any
circumstances, is held invalid, the remainder of
the provisions in this FDA Circular shall not be
affected.

VII. Repealing/
Separability Clause
04 January 2016

VIII. Effectivity
Sample only-DS

Internal Environment
• DEF Drugs is a licensed drugstore with
license number LTO-123456 located at
Alabang, Muntinlupa city.
• DEF Drugs is owned by Juana dela Cruz
Sample only-DS

Internal Environment
• DEF Drugs is licensed to sell registered drug
products, including temperature sensitive
products, specifically vaccines to the general
public on a retail basis.
• The following are my responsibilities as an
drugstore (petition form)
Sample only-DS

Internal Environment
• Attached is the organizational chart of the
establishment.
• In case of emergency, the following are the
contact information of the Risk
Management Officer
–A
–B
–C
Sample only-DS

Risk Management Approach

• The risk management officer regularly
meets the team and facilitates the meeting
every 1st week of June to conduct its
periodic review of risk management.
Minutes and attendance are taken. The SOP
(SOP #1234) for the risk management
review is attached.
Sample only-DS

Risk Management Objectives

• As a licensed drugstore, our general risk
management objective is to ensure the
safety, efficacy, and quality of drug products,
and ensure compliance with regulatory
requirements Specifically,
– Regular updating to advisories and policies
– Ensure compliance to regulatory action
– Ensure compliance to GSP
Sample only-DS

Risk
Objective name
Management
Objective Category
Particulars
Objectives
KRA KPI
Update to Up to date review Full compliance Up to date list of
advisories and of issued advisories
policies advisories
pertaining to
safety of drug
products
Up to date review Full compliance Up to date list of
of laws affecting policies and SOPs
drugstores
Compliance to Compliance to Full compliance; Up to date list of
regulatory action product recalls immediate advisories;
removal from shelf documentation on
returns
Compliance to GSP Compliance to Products stored Consistent
Cold-chain and maintained in temperature on
Compliance to correct temp monitoring charts
room temperature
monitoring
Sample only-DS

Data Lock Point

• Since most objectives are done routinely, the
data lock point is set 2 months before the
expiration of the validity of the LTO
Sample only-DS

Risk Universe
Up to Date Advisories and Policies
FDA Advisories AO, FDA Circulars, Memos,
Memorandum Circulars
Lack of time to check
Lack of time to meet and discuss
Lack of time to change SOPs
Poor internet connection
Malfunctioning computer
Difficulty in interpreting
Sample only-DS

Risk Universe
Compliance to regulatory action
Recall Submission of CAPA Reporting to Inspector
Lack of time to check
Poor internet connection
Malfunctioning computer
Clients demanding for
product to be dispensed
Disapproval of Owner
Sample only-DS

Risk Universe
GSP
Cold-chain Room-temperature Lock and Key Products
products
Irregularly checking
Lack of SOPs
Malfunctioning monitoring equipment
Power-outage
Malfunctioning refrigerator
Sample only-DS

Assessment of risks
• Delphi method was used to assess the risks
identified in the risk universe and prioritize
them.
Sample only-DS

Summary Risk Registry

Naming Convention Description Risk Management
Objective
Interpretation Risk Low technical skills/poor Up to date advisories and
understanding of the policies
Advisory to comply
Time Management Risk Poor time management of Compliance to regulatory
staff resulting to neglect action
in checking the FDA
website for recalls
Power-outage Risk Power-outage will result Compliance to GSP
into fluctuation in the
temperature within the
store, and the shutting-
down of refrigerator
Sample only-DS

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 following SOP
2356
Sample only-DS

Risk Minimization
Naming Convention Routine Risk Additional Risk
Minimization Minimization
Interpretation Risk Conduct regular Consult with local chapter
discussion with staff and or national association
owner Consult with FDA
Time Management - Risk Allot specific time for No additional risk
checking FDA Website minimization required
Conduct regular
discussion with staff and
owner (presentation of
new policies) and
removal from shelf
Power-outage Risk Regularly view power Continued power-outage:
interruption schedule transfer products
Preparation of
contingency
(Cooler/generator)
Sample only-DS

Risk Communication
Time Management Risk
Criteria Communication Content Medium
Supplier has not Follow-up supplier Phone
contacted the store on
products recalled
Sample only-DS

Risk Communication
Power Outage Risk
Criteria Communication Content Medium
Continued power-outage Provide information on Phone
owner regarding the
possibility of poor quality
meds
Contact supplier for any Phone
assistance
Sample only-DS

Risk Monitoring and Management Evaluation

• The RMP will be reviewed and revised at the

end of the data lock point. Review shall
follow SOP 124345
• RMP shall be reviewed in instances the
identified risks occur which needed
additional risk management.
 Republic of the Philippines
Department of Health
FOOD AND DRUG ADMINISTRATION

D. DISCUSSION
ISO 31000
Annex 20, PIC/S-GMP
ICH Q9
US FDA: Quality Risk
Management