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Abida Syed M Haq National Pharmaceutical Control Bureau Ministry of Health Malaysia

CONTROL OF MEDICINES & HEALTH SUPPLEMENTS IN MALAYSIA: AN UPDATE ON SURVEILLANCE AND PHARMACOVIGILANCE ACTIVITIES. Abida Syed M Haq National Pharmaceutical Control Bureau Ministry of Health Malaysia. OVERVIEW OF PRESENTATION. Background information Current practice Statistics New issues.

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Abida Syed M Haq National Pharmaceutical Control Bureau Ministry of Health Malaysia

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  1. CONTROL OF MEDICINES & HEALTH SUPPLEMENTS IN MALAYSIA: AN UPDATE ON SURVEILLANCE AND PHARMACOVIGILANCE ACTIVITIES Abida Syed M Haq National Pharmaceutical Control Bureau Ministry of Health Malaysia

  2. OVERVIEW OF PRESENTATION • Background information • Current practice • Statistics • New issues TCM Updates Jan 2005

  3. Objectives of Surveillance & Pharmacovigilance • Ensure that drugs registered by the Drug Control Authority (DCA) for use in Malaysia comply in terms of quality, efficacy and safety to preregistration standards • Ensure that product inserts, labels, indications and claims of registered products are as approved by DCA • Continuously monitor the safety profile of marketed drugs in order to • Take necessary action to minimise risk to consumers • Reevaluate the benefit: risk ratio of registered products TCM Updates Jan 2005

  4. Surveillance Activities TCM Updates Jan 2005

  5. Strategies for Surveillance • Market sampling • Conduct lab testing to ensure quality/compliance of registered products in the market • Investigation of product complaints • Institution of punitive actions against non-compliant/ substandard products • Warning letters • Batch recalls of products • Adverse drug reaction reporting program TCM Updates Jan 2005

  6. MARKET SAMPLING • Registered products marketed in Malaysia are sampled and tested to ensure compliance to quality standards • No deviations in the formula in terms of ingredients, content • Records checked to ensure that products are manufactured by the approved manufacturer • Labels, product inserts are screened to ensure no false claims are made • Shelf life checked to ensure adherence to approved limit TCM Updates Jan 2005

  7. PRODUCT SURVEILLANCE SYSTEM • Planned surveillance • Traditional medicines • 10% of registered products taken for sampling per year • Sampling based on criteria such as: • Products not sampled in recent years • Manufacturer has GMP problems • Products which have failed lab testing before • Dormant products • Product registration holder advised to voluntarily remove dormant products from the register since products cannot be tested to ensure compliance TCM Updates Jan 2005

  8. PRODUCT SURVEILLANCE SYSTEM Product taken by NPCB for surveillance Pass Labtesting Subjected to routine monitoring Fail Directive for recall/warning Manufacturer identifies root cause for failure and institutes corrective and preventive measures New batch sampled by NPCB Pass Subjected to routine monitoring Lab testing Fail Tabled to DCA for cancellation of registration

  9. PRODUCT COMPLIANCE • Physical examination of products for • Compliance to labeling requirements • Claims, indications • Shelf life • Pack size • Packaging material TCM Updates Jan 2005

  10. PRODUCT COMPLAINTS • Health professionals and consumers can send in complaints related to registered products • All complaints are investigated • Product registration holders informed of all complaints forwarded to NPCB • Timeline for industry to respond with their findings: 2 weeks • Timeline for NPCB to resolve complaints: 6 weeks TCM Updates Jan 2005

  11. INVESTIGATION OF PRODUCT COMPLAINTS Receive complaint Registered product? NO Enforcement YES i.Product registration holder informed to checks retention sample, BMR ii.NPCB conducts investigation based on complaint sample • Appropriate action instituted based on the findings • No action • Recall • GMP inspection of premise • Intensified surveillance of manufacturer/other products

  12. FORMS OF PUNITIVE ACTION • If a product is found to be non-compliant in terms of • Exceeding limits for heavy metals, microbial contamination • Found to contain adulterants, scheduled poisons • Making unsubstantiated claims • the DCA can take punitive action such as • instruct a batch/product recall • deregistration • instituting court action with the help of pharmacy • enforcement TCM Updates Jan 2005

  13. PHARMACOVIGILANCE: SAFETY ISSUES • Source for potential harm could arise due to • Intrinsic effects of ingredients used • Active ingredients • Excipients • Poor formulation • Improper manufacturing procedures • Contamination • Deterioration • Adulteration TCM Updates Jan 2005

  14. SAFETY MONITORING • Conducted through adverse drug reactions (ADR) monitoring program • Local and international level • Literature reviews • DCA maintains good networking with WHO, USFDA, TGA Australia, EMEA to ensure information is up-to-date TCM Updates Jan 2005

  15. SAFETY MONITORING • Health professionals encouraged to report ALL ADRs encountered to the DCA • Mandatory under the law for product registration holders to report to the DCA cases of ADRs occurring as a result of the use their products • Under the ADR guidelines, product registration holders obliged to provide DCA with information pertaining to safety issues associated with their products even from literature TCM Updates Jan 2005

  16. SAFETYMONITORING • To facilitate drug safety monitoring, health professionals provided with POSTAGE PREPAID adverse drug reaction reporting forms FREE • ADR reporting also available on-line through NPCB’s website (www.bpfk.gov.my) TCM Updates Jan 2005

  17. SAFETY MONITORING • Consumer reports also accepted but usually advised to go through their health professionals • System for consumer reporting of ADRs for over-the counter and traditional medicines products in the pipeline TCM Updates Jan 2005

  18. SURVEILLANCE ACTIVITIES: 2004 • Number of traditional medicines sampled:1235 products • Number of recalls instituted: 118 • Number of Dietary Supplements sampled: 243 • Number of ADR reports received: • Traditional medicines – 20 • Dietary supplements - 4 • TO DATE NOT A SINGLE ADR REPORT SUBMITTED BY PRODUCT REGISTRATION HOLDER OF TM/DS FOR THEIR OWN PRODUCTS TCM Updates Jan 2005

  19. NEW ISSUES • Comfrey, Senecio: • Not allowed in registered products because contain pyrrolizidine alkaloids which have been associated with hepatic problems • Chelidonium majus • Products must carry a warning because of association with hepatic problems • Request for health professionals to report ADRs to products containing spirulina, lingzi • Skin reactions • Liver problems • Involvement in R&D project to study influence of TCM use in surgical patients TCM Updates Jan 2005

  20. THE WAY FORWARD • ►DCA has put in place systems to regulate products through • Pre-registration assessment • Licensing and inspections • Post-registration surveillance, pharmacovigilance • to ensure that consumers have access to safe, high quality, properly labeled products • ►Industry, researchers and health professionals must also play their role by reporting ADRs, submitting genuine product complaints, not making misleading claims/misinformation and ensuring rational drug use by consumers

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