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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
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
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
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
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
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
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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)
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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
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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.
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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
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Risk Management Objectives
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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
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.
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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
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
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Risk Universe
GSP
Cold-chain
Irregular checking
Lack of SOPs
Malfunctioning monitoring equipment
Power-outage
Malfunctioning refrigerator
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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
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Assessment of risks
• Delphi method was used to assess the risks identified in the risk universe and prioritize them.
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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
Compliance to regulatory action
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
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Unknown Risks
• The risk management team, as part of the periodic review, will also address risks not previously identified following SOP 2356
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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
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
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• 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
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
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Risk Communication
Power Outage Risk
Criteria Communication Content Medium
Continued power-outage Provide information to management/maintenance regarding the risks to quality and their preparation
Phone
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Risk Communication
Detailmen Training Risk
Criteria Communication Content Medium
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
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• 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.
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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
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
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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)
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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
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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.
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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
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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 regulatory action
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
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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
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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
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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
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Risk Universe
GSP
Cold-chain Room-temperature products
Lock and Key Products
Irregularly checking
Lack of SOPs
Malfunctioning monitoring equipment
Power-outage
Malfunctioning refrigerator
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Assessment of risks
• Delphi method was used to assess the risks identified in the risk universe and prioritize them.
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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
Compliance to regulatory action
Power-outage Risk Power-outage will result into fluctuation in the temperature within the store, and the shutting-down of refrigerator
Compliance to GSP
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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
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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)
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Risk Communication
Time Management Risk
Criteria Communication Content Medium
Supplier has not contacted the store on products recalled
Follow-up supplier Phone
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Risk Communication
Power Outage Risk
Criteria Communication Content Medium
Continued power-outage Provide information on owner regarding the possibility of poor quality meds
Phone
Contact supplier for any assistance
Phone
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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.
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