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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

A. Regulatory Basis

B. Risk and Risk Management

C. Draft FDA Circular

D. Discussion

Presentation 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

Regulation Outline




A. REGULATORY BASIS

Republic Act No. 9711


• Section 5, (k)


• Section 5, (l)


• 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




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

Other Risk Managements

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

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

Other Risk Managements

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

Managements




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


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

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


• 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


• 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

Sample only-DI

b) Risk Management Approach – overall risk management approach (processes, personnel involved, periodic reporting and monthly procedures to be performed)

1. Introduction

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


Sample only-DI

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

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


Sample only-DI

Objective Category

Objective name Particulars KRA KPI

Compliance to regulatory action

Compliance to product recalls

Full compliance; immediate removal from retailers

Up to date list of advisories; complete documentation on recalls

Compliance to GSP Compliance to Cold-chain

Products stored and maintained in correct temp

Consistent temperature on monitoring charts

compliance to ethical business practices

Ensure compliance to MCPs

Good performance of detailmen

Less than 2 complaints/ reports received

d) Data Lock point – timeframe to which the RMP is expected to be valid

1. Introduction

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.

Sample only-DI

Identification and assessment of risks that events that may adversely affect the set objectives


• 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


Risk Universe


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 managed records will hamper the process of recall


Power-outage Risk Power-outage will result into fluctuation in the temperature within the warehouse, and the shutting-down of cold rooms/walk-in freezers

Compliance to GSP

Detailmen Promotion Risk

Low technical skills of and/or unethical detailmen - poor training will result to low technical skills and/or unethical detailmen

compliance to ethical business practices

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

Sample only-DI

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


a) Routine risk minimization

Those planned activities conducted by the establishment regularly to minimize the risks


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


For identified risks with no risk minimization activities, appropriate justification must be provided


Risk Minimization

Business Ethics

Priority Risk Routine Risk Minimization

Additional Risk Minimization

Distribution Records Risk Ensure all relevant information is complete in the records

Special project to complete existing records/problematic records

Power-outage Risk Regularly view power interruption schedule

Additional back-up generator

Regular maintenance of generator

Detailmen Promotion Risk

Initial training and registration of new detailmen according to SOP 12345

Warning/sanction + re-training/orientation following SOP 1214515

Re-training after 1 year

Sample only-DI

• Communication system of drugstore to:

a) Internally

b) FDA

c) Consumers and HCP

d) Other relevant stakeholders


• Criteria when communication must be done

• Means for communicating

• Internal reporting procedure to management and appropriate regulatory agencies


Risk Communication

Distribution Records Risk

Criteria Communication Content Medium

Recall from FDA Inform records management team to review distribution records immediately

Phone

Voluntary Recall Inform records management team to review distribution records immediately

Phone

Sample only-DI

Risk Communication

Power Outage Risk


Continued power-outage Provide information to management/maintenance regarding the risks to quality and their preparation

Phone

Sample only-DI

Risk Communication

Detailmen Training Risk


Reporting of Physician of unethical/misleading promotional practices

Memo as warning the detailmen of the complaint received

Formal Letter

Monitoring of BOP-PRC Memo as warning the detailmen of the complaint received

Formal Letter

Monitoring of FDA Memo as warning the detailmen of the complaint received

Formal Letter

Sample only-DI

• Periodic monitoring of identified risks

• Criteria where evaluation is needed

• When RMP revision is required

5. Risk Monitoring and Management Evaluation

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.

Sample only-DI

C. Submission of RMP • When RMP is revised – submit to FDA

• Cover letter and summary of revisions made must be included


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


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


• 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


• 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


• 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


• 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


• 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 Management Objectives Objective Category

Objective name Particulars KRA KPI

Update to advisories and policies

Up to date review of issued advisories pertaining to safety of drug products

Full compliance Up to date list of advisories

Up to date review of laws affecting drugstores

Full compliance Up to date list of policies and SOPs


Compliance to product recalls

Full compliance; immediate removal from shelf

Up to date list of advisories; documentation on returns

Compliance to GSP Compliance to Cold-chain

Products stored and maintained in correct temp

Consistent temperature on monitoring charts Compliance to

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 meet and discuss

Lack of time to change SOPs


Malfunctioning computer

Difficulty in interpreting

Sample only-DS

Risk Universe


Recall Submission of CAPA Reporting to Inspector



Malfunctioning computer

Clients demanding for product to be dispensed

Disapproval of Owner

Sample only-DS

Risk Universe

GSP

Cold-chain Room-temperature products

Lock and Key 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 understanding of the Advisory to comply

Up to date advisories and policies

Time Management Risk Poor time management of staff resulting to neglect in checking the FDA website for recalls


Power-outage Risk Power-outage will result into fluctuation in the temperature within the store, and the shutting-down of refrigerator

Compliance to GSP

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

Minimization Additional Risk

Minimization

Interpretation Risk Conduct regular discussion with staff and owner

Consult with local chapter or national association

Consult with FDA

Time Management - Risk Allot specific time for checking FDA Website

No additional risk minimization required

Conduct regular discussion with staff and owner (presentation of new policies) and removal from shelf

Power-outage Risk Regularly view power interruption schedule

Continued power-outage: transfer products

Preparation of contingency (Cooler/generator)

Sample only-DS

Risk Communication

Time Management Risk


Supplier has not contacted the store on products recalled

Follow-up supplier Phone

Sample only-DS

Risk Communication

Power Outage Risk


Continued power-outage Provide information on owner regarding the possibility of poor quality meds

Phone

Contact supplier for any assistance

Phone

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.

Sample only-DS




D. DISCUSSION

ISO 31000

Annex 20, PIC/S-GMP

ICH Q9

US FDA: Quality Risk Management

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