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E speranza I . C abral, MD S ecretary of H ealth Keynote Address at

“. . . now is the time to stop butting heads and start linking arms. It is not impossible to work out a united plan that will be acceptable for all, and in the end will benefit those who need it most.”. E speranza I . C abral, MD S ecretary of H ealth Keynote Address at

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E speranza I . C abral, MD S ecretary of H ealth Keynote Address at

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  1. “. . . now is the time to stop butting heads and start linking arms. It is not impossible to work out a united plan that will be acceptable for all, and in the end will benefit those who need it most.” Esperanza I. Cabral, MD Secretary of Health Keynote Address at The 3rd MeTA Philippines Forum

  2. “. . . now is the time to stop butting heads and start linking arms. It is not impossible to work out a united plan that will be acceptable for all, and in the end will benefit those who need it most.” Esperanza I. Cabral, MD Secretary of Health Keynote Address at The 3rd MeTA Philippines Forum

  3. COUNTERFEIT DRUGS NEMIA T. GETES, RPh, MM Chief, Regulation Division I FDA

  4. Bureau of Food and Drugs was renamed to FOOD and DRUG ADMINISTRATION under R. A. No. 9711

  5. R.A. No. 8203 - SPECIAL LAW ON COUNTERFEIT DRUGS • Enacted on 06 September 1996 • Effective on 27 October 1996

  6. COUNTERFEIT DRUG refers to medicinal products with the correct ingredients, but not in the amounts as provided hereunder, wrong ingredients, without active ingredients,with insufficient quantity of active ingredient, which results in the reduction of the drug’s safety, efficacy, quality,strength or purity

  7. COUNTERFEIT DRUG is a drug which is deliberately and fraudulently mislabeled with respect to identity and/or source or with fake packaging, and can apply to both branded and generic products

  8. COUNTERFEIT DRUG a drug product refilled in containers by unauthorized persons if the legitimate labels or marks are used

  9. an unregistered imported drug product, except drugs brought in the country for personal use as confirmed and justified by accompanying medical records COUNTERFEIT DRUG

  10. COUNTERFEIT DRUG a drug which contains no amount of or a different active ingredient or less than80% of the active ingredient it purports to possess as distinguished from an adulterated drug including reduction or loss of efficacy due to expiration

  11. NUMBER OF REGISTERED PRODUCTS As of December 2009 DRUGS - 31,603 FOODS - 30,689 COSMETICS - 11,269 HHS - 2,583

  12. DRUG MANUFACTURERS - 285 DRUG TRADERS - 438 DRUG DISTRIBUTORS - 4,719 DRUG RETAIL OUTLETS - 32, 538

  13. QUALITY ASSURANCE LOOP PRODUCT REGISTRATION LICENSING OF ESTABLISHMENT LABORATORY ANALYSIS Physico- chemical Microbial Toxicological GMP GDP GSP POST MARKETING QUALITY MONITORING Product Quality Label Information Advertisements Safety, Efficacy, Quality

  14. CLASSIFICATION OF DRUGS COMMONLY COUNTERFEITED • Antibiotics • Multivitamins and Minerals • Analgesics and Antipyretics • Antidiabetics • Antihypertensives • Cough and Cold Remedies • Corticosteroid hormones • Uterine Stimulant 14

  15. COMPARISON OF SOME COUNTERFEIT WITH THE AUTHENTIC DRUGS

  16. Dexamethasone (Decilone forte) Tablet Font size is smaller, thinner & uniform Font color is fuchsia pink Print is permanent Authentic Diamond mark in fuchsia pink Blister is glossy & flexible Font size is bigger & bolder Font color is red Counterfeit Print is easily erased Rectangular mark in dark red Blister is hard & coarse 16

  17. Ibuprofen+Paracetamol (Alaxan) Tablet Has therapharma logo Dosage form is “Tablet” Authentic With diamond mark Correct spelling of “RESISTANT” Has no therapharma logo Dosage form is “Tablets” Has no diamond mark Counterfeit Wrong spelling - “RESISTAANT” 17

  18. Ibuprofen+Paracetamol (Alaxan) Tablet No big diamond mark With big diamond mark Blister is fine & flexible Authentic Blister is hard LN & ED were properly printed LN & ED were not properly printed Counterfeit The word Alaxan is more prominent The word Alaxan is not readable 18

  19. Paracetamol (Biogesic)500 mg Tablet With company logo Don’t bear the words TABLETS B.P. Authentic Foil is shiny & fine Counterfeit Has no company logo With the words TABLETS B.P. Foil is dull & coarse 19

  20. Paracetamol (Biogesic)500 mg Tablet Color of tablet is dark peach Authentic The words B.No. & EXP. were not printed; font is finer Counterfeit Color of tablet is lighter The words B.No. & EXP. were printed; font is bolder 20

  21. Gliclazide (Diamicron)80 mg Tablet With barcode Has no barcode Label code no. is 021531131 Label code no. is 021521131 Company logo & name are smaller & finer Authentic Counterfeit Company logo & name are bigger & bolder Font size are bigger & bolder Font size are smaller & finer Rx symbol is bigger & darker Rx symbol is smaller & lighter 21

  22. Gliclazide (Diamicron)80 mg Tablet Blister is fine & flexible with diamond shape markings Blister is hard with dotted markings Counterfeit Authentic Shelf-life is 3 years based from the date of mfr & expiry date Shelf-life is 5 years based from the date of mfr & expiry date 22

  23. Loperamide (Diatabs)2 mg Capsule Foil is glossy & the size is almost square Authentic Company logo is B Counterfeit Foil is glossy & the size is rectangular Company logo is S With ® symbol Without ® symbol 23

  24. Ascorbic Acid (Fern-C)500 mg Capsule Font size is smaller but clearer Authentic Blister is shiny, fine & dotted Counterfeit Font size is bigger Blister is dull, hard & with diamond-shape markings 24

  25. Ascorbic Acid (Fern-C)500 mg Capsule Blister is plain; no markings Authentic Counterfeit Blister has dotted markings 25

  26. Ofloxacin (Inoflox)200 mg Tablet Authentic Company logo is biggerwith distinct colors Rx symbol is in between the cut off line Counterfeit Company logo is smaller with overlapped colors Label is perfectly laminated Rx symbol is above the cut off line Plastic label is loosely detached from the foil 26

  27. Trimetazidine (Vastarel)20 mg Tablet Font color is dark red Font color is red Counterfeit Authentic Rx symbol is lighter & is closer to the generic name Rx symbol is clear & has wider gap with the generic name Company name & logo are bigger & bolder Company name & logo are smaller & lighter Foil is dull & coarse Foil is glossy & fine 27

  28. Ampicillin+Sulbactam (Unasyn) 500:250 mg Powder for injection Authentic Counterfeit Fill color is dark blue Fill color is blue

  29. Ampicillin+Sulbactam (Unasyn) 500:250 mg Powder for injection Rubberplug has 2 puncture marks indicating previous use

  30. Inactivated Influenza Vaccine (Vaxigrip) Vial Counterfeit Authentic

  31. Inactivated Influenza Vaccine (Vaxigrip) Vial Counterfeit Authentic

  32. Inactivated Influenza Vaccine (Vaxigrip) Vial Authentic Counterfeit

  33. HARMFUL EFFECTS OF COUNTERFEIT DRUGS Can kill May worsen the present illness May cause another illness May not be effective May cause adverse drug reaction with other medications

  34. Reported Effects of Some Counterfeit Drugs Cefuroxime (Zinacef) Powder for Injection • Caused vomiting, severe pain, weakness, dizziness after administration • Laboratory analysis showed absence of the active ingredient • Establishment where the product was bought did not have a license with FDA

  35. Reported Effects of Some Counterfeit Drugs Ampicillin+Sulbactam (Unasyn) Powder for Injection • Caused difficulty in breathing • Laboratory analysis showed none conformance with specification

  36. STRATEGIES IN CURBING THE PROLIFERATION OF COUNTERFEIT DRUGS Generate public awareness Inspection of establishments Post marketing surveillance Partnership with other government agencies: LGUs, Law Enforcers, Bureau of Customs Capability enhancement Intensified surveillance Issuance of directives Medicines surveillance

  37. GENERATE PUBLIC AWARENESS Publication of health advisories Distribution of IEC materials Media interviews Conduct of seminars for pharmacists & owners of drug retail outlets & distributors

  38. INSPECTION OF ESTABLISHMENTS Implementation of licensing requirements Monitoring of compliance to: Good Manufacturing Practice Good Distribution Practice Good Storage Practice

  39. POST MARKETING SURVEILLANCE Monitoring of products & collection of samples in the market Test buy operations in unlicensed establishments

  40. PARTNERSHIP with other GOVERNMENT AGENCIES Execution of search warrants & other legal orders Close collaboration with the Bureau of Customs for incoming shipments at the ports of entry Coordination with the LGUs in the monitoring of unlicensed establishments

  41. CAPABILITY ENHANCEMENT Trainings & seminars (abroad & local) Regional hands-on trainings nationwide National FDRO seminar/workshop

  42. INTENSIFIED SURVEILLANCE Regional audit inspection Saturation drive

  43. ISSUANCE OF DIRECTIVES ‘One of the practices which enables counterfeiting is the re-usage of vials obtained from hospitals with counterfeiters refilling the same for sale to the public’ • MEMORANDUM CIRCULAR NO. 22 s. 1994 Inventory, proper disposal and / or destruction of used vials / bottles. • BUREAU CIRCULAR NO. 16 s. 1999 Amending Memorandum Circular # 22 dated September 8, 1994 re: BFAD to witness destruction

  44. STATISTICAL REPORTSREFERRALS: 2008 2009PSD 464 603LSD 324 351 LICD 315 310

  45. ROVs issued re: RA 8203 2008 – 393 2009 – 726Legal Orders Delivered / Executed re: RA 8203 2008 – 2009 – 315 624

  46. How can we help in the fight against counterfeit drugs? To always purchase stocks only from BFAD-licensed drug distributors. To familiarize yourselves on the packaging of drugs; take note of the registration number (DR No., DRP No., DRHR No., or BR No.), Lot or Batch No., Expiry Date, and the company logo and/or name of the manufacturer or trader. To be vigilant & report any suspected counterfeit drug at the Food and Drug Administration

  47. There is no such thing as a “good counterfeit”… Counterfeiting takes away the right of every patient to be cured; it denies life in every life saving situation; and it removes chances to alleviate sufferings from a disease in order for the patient to live a normal life with their loved ones. Thus, counterfeiting is a criminal offense and like terrorism, it ruins innocent lives.

  48. Notify us in case you suspect Counterfeit Drugs... Food and Drug Administration Civic Drive, Filinvest Corporate City Alabang, Muntinlupa City 1781 Tel. No.: (02) 8094390 Telefax No: (02) 8078275 Cell. Nos.: 09054171771 09092080500 Email address: ireport@bfad.gov.ph Website: www.bfad.gov.ph

  49. BEWARE!!! COUNTERFEIT DRUGS BE AWARE!!!

  50. THANK YOU

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