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. III. IV. Objective Scope 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
Other Risk From Risk Management Seminar (& Workshop) presentation by Juancho Robles Managements
Other Risk Managements From Risk Management Seminar (& Workshop) presentation by Juancho Robles
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 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
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 Power-outage Risk Detailmen Promotion Risk Incomplete/poorly managed records will hamper the process of recall Power-outage will result into fluctuation in the temperature within the warehouse, and the shutting-down of cold rooms/walk-in freezers Low technical skills of and/or unethical detailmen - poor training will result to low technical skills and/or unethical detailmen Compliance to regulatory action Compliance to GSP 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
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 Priority Risk Distribution Records Risk Power-outage Risk Detailmen Promotion Risk Business Ethics Routine Risk Minimization Ensure all relevant information is complete in the records Regularly view power interruption schedule Regular maintenance of generator Initial training and registration of new detailmen according to SOP 12345 Re-training after 1 year Additional Risk Minimization Special project to complete existing records/problematic records Additional back-up generator Warning/sanction + retraining/orientation following SOP 1214515
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 Recall from FDA Voluntary Recall Distribution Records Risk Criteria Communication Content Medium Inform records management team to review distribution records immediately Inform records management team to review distribution records immediately Phone Phone
Sample only-di Risk Communication Power Outage Risk Criteria Communication Content Medium Continued power-outage Provide information to management/maintenanc e regarding the risks to quality and their preparation Phone
Sample only-di Risk Communication Detailmen Training Risk Criteria Communication Content Medium Reporting of Physician of unethical/misleading promotional practices Monitoring of BOP-PRC Monitoring of FDA Memo as warning the detailmen of the complaint received Memo as warning the detailmen of the complaint received Memo as warning the detailmen of the complaint received Formal Letter Formal Letter Formal Letter
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 Management Objective Category Objectives 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 Compliance to room temperature monitoring Products stored and maintained in correct temp Consistent temperature on monitoring charts
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 FDA Advisories Up to Date Advisories and Policies 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 AO, FDA Circulars, Memos, Memorandum Circulars
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 Cold-chain GSP Room-temperature products Irregularly checking Lack of SOPs Malfunctioning monitoring equipment Power-outage Malfunctioning refrigerator Lock and Key Products
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 Time Management Risk Power-outage Risk Low technical skills/poor understanding of the Advisory to comply Poor time management of staff resulting to neglect in checking the FDA website for recalls Power-outage will result into fluctuation in the temperature within the store, and the shuttingdown of refrigerator Up to date advisories and policies Compliance to regulatory action 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 Interpretation Risk Time Management - Risk Power-outage Risk Routine Risk Minimization Conduct regular discussion with staff and owner Allot specific time for checking FDA Website Conduct regular discussion with staff and owner (presentation of new policies) and removal from shelf Regularly view power interruption schedule Preparation of contingency (Cooler/generator) Additional Risk Minimization Consult with local chapter or national association Consult with FDA No additional risk minimization required Continued power-outage: transfer products
Sample only-ds Risk Communication Time Management Risk Criteria Communication Content Medium Supplier has not contacted the store on products recalled Follow-up supplier Phone
Sample only-ds Risk Communication Power Outage Risk Criteria Communication Content Medium Continued power-outage Provide information on owner regarding the possibility of poor quality meds Contact supplier for any assistance Phone 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.
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