Handling of product complaint
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This document outlines the National Pharmaceutical Regulatory Agency's process for handling product complaints in Malaysia. It discusses three key activities: 1) post-market quality surveillance through market sampling and laboratory analysis, 2) investigating complaints related to quality, regulation, or safety/efficacy, and 3) monitoring product safety profiles. The document defines critical, major, and minor quality defects and provides examples of each. It emphasizes that product complaints are an important tool for surveillance and companies are required to investigate the root causes of critical defects and propose corrective actions.
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This document provides guidance on preparing quality adverse drug reaction (ADR) reports. It outlines 14 items that should be included in a complete ADR report: (1) patient information, (2) ethnic group, (3) ADR description, (4) time to onset, (5) date of reaction, (6) dechallenge and rechallenge, (7) extent of reaction, (8) seriousness of reaction, (9) outcome, (10) drug-reaction relationship, (11) suspected drug, (12) relevant investigations/laboratory data, and (13) reporter details. Filling out all required information accurately can help detect safety signals and improve causality assessment. Quality ADR reporting
Introduction to budget impact analysis
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Causality Assessment
This document discusses approaches to assessing causality of adverse drug reactions (ADRs). It presents an example of a woman who experienced a pulmonary embolism after taking oral contraceptive pills while confined to bed after a pelvic fracture, making the cause difficult to determine. Various scales for assessing causality are described, including the Naranjo scale, WHO assessment scale, and criteria like timing of the reaction and response to dechallenge. The document recommends using the WHO assessment scale for standardized ADR reporting in Malaysia, as it does not require prior knowledge of a drug's associations, allowing causality assessments to contribute to ongoing reviews.
Errors happen
This document discusses a medication error incident where a 3-year-old boy was prescribed lamotrigine but was dispensed the wrong dosage. Specifically, he was prescribed 5mg tablets but was given 100mg tablets instead. When his mother administered 3 of the 100mg tablets, the boy became lethargic and vomited. An investigation found the error was due to similar packaging, multiple strengths of lamotrigine available, a confusing prescription, and non-compliance with pharmacy policies and procedures. Changes were made to improve storage, labeling, supervision, and adherence to checking policies to prevent future errors.
Time management
This document provides tips and advice for improving time management. It discusses setting goals, creating schedules and to-do lists, avoiding distractions and procrastination, and overcoming common time management problems. The key steps outlined are to set specific goals, create a calendar and weekly schedule, develop daily to-do lists, get organized, learn to say no and avoid taking on too many tasks, and stay focused on priorities. Common issues discussed include procrastination, distractions, feeling like you need to do everything, and letting outside events control your schedule. The document emphasizes tracking how time is spent and avoiding last-minute cramming.
RESEARCH PROTOCOL
This document outlines the essential components needed for writing a research protocol for NMRR registration. It discusses key sections like the title page, summary, background/significance, objectives, methodology, statistical analysis plan, ethics considerations, and references. The document provides examples and descriptions for each section to help researchers properly structure their protocol in a way that addresses all necessary aspects of their proposed study and satisfies ethical reviewers.
TAKLIMAT MERS RINGKAS
This document provides guidelines for reporting medication errors in Malaysia using the Medication Error Reporting System (MERS). The MERS allows healthcare professionals to register and submit error reports individually or centralized through facilities. Reporters can maintain and view their submitted reports, and generate data from the reports. The reporting and verification process involves the reporter submitting the report, a verifier approving or rejecting it, and the state and national Ministry of Health endorsing completed reports. User registration and report creation follow a multi-step online process through the MERS website.
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Handling of product complaint
- 2. INTRODUCTION
- 3. 3 NATIONAL PHARMACEUTICAL REGULATORY AGENCY CENTRE FOR POST REGISTRATION OF PRODUCTS & COSMETIC CONTROL PHARMACOVIGILANCE SECTION COMPLAINT MANAGEMENT SECTION SURVEILLANCE SECTION COSMETIC SECTION
- 6. 1. POST MARKET QUALITY SURVEILLACE ✘ Market sampling ✘ Laboratory analysis ✘ Label and packaging compliance 6 ACTIVITIES
- 7. 2. INVESTIGATION OF PRODUCT COMPLAINTS ✘ Quality defects ✘ Regulatory compliance related issues ✘ Safety & efficacy issues 7 ACTIVITIES
- 8. 3. SAFETY MONITORING OF PRODUCTS ✘ ADR monitoring ✘ Signal detection & risk assessment ✘ Risk communication ✘ Risk Management & research 8 ACTIVITIES
- 9. 9 Monitor safety profile REGULATORY ACTIONS GOALS Follow up on CAPAs to improve product quality Remove unsafe products from the market in timely manner Ensure products are of quality
- 11. 11
- 12. 12 Important! Can add in attachment State the quantity involved based on receiving (DO) Fill up ADR form
- 13. ✘ Effective tools of conducting surveillance ✘ Mainly related to quality defects ✘ When necessary, the Marketing Authorisation Holder required to initiate RCA and propose CAPA 13 HANDLING OF PRODUCT COMPLAINTS
- 15. ✘ An attribute of a product or component which may affect the QUALITY, SAFETY AND / OR EFFICACY of the product, and / or which is NOT IN LINE WITH THE APPROVED MARKETING AUTHORISATION for the product 15 DEFINITION
- 17. ✘ Wrong product (label & content are different) ✘ Correct product but wrong strength, with serious medical consequences ✘ Microbial, physical / chemical contamination, with serious medical consequences ✘ Mix up products within a pack ✘ Serious ADR which are batch / product related 17 CRITICAL QUALITY DEFECTS (life threatening / serious health risk)
- 18. 18 Label on the box was Ternolol 50 but label on the blister was Ternolol Tab 100mg After investigation..
- 19. ✘ Mislabelling (wrong , missing text / figures) ✘ Missing / incorrect information on package insert ✘ Microbial, physical / chemical contamination, with medical consequences ✘ Non-compliance with specification (assay, stability, fill / weight) ✘ Insecure closure with serious medical consequences (cytotoxics, child-resistant containers, potent product)19 MAJOR QUALITY DEFECTS (cause illness or mistreatment but not to a life threatening extent)
- 20. 20 It was discovered that one of the constituents of the drug referred to as an IMPURITY WAS OUT OF RANGE Instead of having a chemical presence of 0.1 per cent, it stood at 0.3 per cent, due to false packaging.
- 21. ✘ Faulty packaging (wrong, missing batch number / expiry date) ✘ Faulty closure ✘ Tablet defect/ empty blister ✘ Microbial, physical / chemical contamination which is unlikely to have medical consequences (a strand of hair embed in a tablet in an intact blister) 21 MINOR QUALITY DEFECTS (are not likely to pose a significant hazard to health)
- 22. 22 Tablet defects – empty blister / broken tablet
- 23. 23 What is the classification of this defect?
- 24. 24 Can we do a product complaint on similar packaging?
- 25. STATISTICS
- 26. 26
- 27. 27
- 28. 28
- 29. CONCLUSION - It is the responsibility of ALL -
- 30. 30 THANK YOU FOR YOUR ATTENTION! Any questions? Contact me at: nazmiliana@moh.gov.my 0179224977