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Counterfeit medicines cause and control

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Counterfeit medicines cause and control Presentation Transcript

  • 1. Counterfeit medicines cause and control Siham Abdoun Mcs, PhD.
  • 2. Definition Counterfeit medicines are those medicines that are described as “deliberately and fraudulently mislabeled with respect to identity and / or source. Counterfeiting can apply to both branded and generic products. Counterfeit products may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient active ingredients, or with fake packaging” (WHO definition).
  • 3. Counterfeit medicines may be distributed through different channels such as government and private hospitals, pharmacies or other legal or illegal distributors.  Licensed distributors, pharmacists, health care providers or patients may be unable to detect or differentiate between counterfeit and genuine medicines.
  • 4. The World Health Organization (WHO) estimates that up to 1% of medicines available in the developed world are likely to be counterfeit. This figure rises to 10% globally, although in some developing countries they estimate one third of medicines are counterfeit
  • 5. What are the Causes of counterfeit?  Lack of appropriate drug legislation  Absence of or weak drug regulation  Weak enforcement and penal sanctions  Demand exceeding supply  High prices of medicines  Inefficient cooperation between stakeholders  Lack of regulation by exporting countries and within free trade zones  Trade through several intermediaries  Irrational use of medicines
  • 6. How to detect a counterfeit product? Visual inspection • It should be noted that in many cases, counterfeit products are rather similar in appearance to the original products; nevertheless, for some counterfeit medicines, pharmacists could detect them by a visual inspection Identification by chemical analysis.
  • 7. How can we combat counterfeit medicines? 1. National legislations: Legislations on the control of the manufacture, importation, exportation, distribution, supply and sale of medicines Provision for the control of counterfeit medicines in the legislation Definition of counterfeit medicines in the legislation
  • 8. 2. Capacity of National Medicines Regulatory Authorities (NMRA): training initiatives aimed for inspectors, enforcement officials, health professionals and supply chain stakeholders on the techniques for identification, detection, documentation, reporting and communication on counterfeit medicine
  • 9. 3. Market control: License or authorization of distribution channels Medicinal products authorized for marketing and control of informal market, The awareness and efforts of the government and other stakeholders in combating counterfeit medicines. Designated ports of entry for importation of pharmaceuticals
  • 10. Reduce trade intermediaries for imported medicines Strengthen GDP compliance inspections through harmonized provisions Gathering of Community Procedures for GDP Mandatory audit of suppliers by wholesalers
  • 11. 4. National Collaboration Collaboration with different stakeholders such as manufacturers, wholesalers, retailers etc. and collaboration with other authorities such as: • MRA-Customs • MRA-Police • MRA-Police-Customs
  • 12. 5. MRA and WHO initiatives In February 2006, WHO created the first global initiative, known as the International Medical Products Anti-Counterfeiting Taskforce (IMPACT). The IMPACT recommends the designation of a SPOC (Single Point of Contact) in each country to coordinate the fight against CM
  • 13. 6. International Collaboration 7. Free trade zones ;  Monitoring and enforcement for these free trade zones
  • 14. Thanks