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2010 | 61 | 3 |
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Sfałszowane inhibitory fosfodiesterazy typu 5 – narastające zagrożenie dla zdrowia publicznego

Treść / Zawartość
Warianty tytułu
EN
Counterfeit phosphodiesterase type 5 inhibitors – growing safety risks for public health
Języki publikacji
PL
Abstrakty
PL
Sfałszowane leki, wyroby medyczne i suplementy diety stanowią narastający i bardzo poważny problem dla zdrowia publicznego na świecie. W Europie w ostatniej dekadzie związany jest on przede wszystkim z rejestracją inhibitorów fosfodiesterazy typu 5 (PDE-5) stosowanych na dysfunkcję erekcji. Do grupy tej należą Viagra, Levitra i Cialis. Ocenia się, że ok. 2,5 min mężczyzn w Europie narażonych jest na sfałszowane produkty zawierające sildenafil, tyle samo co kupujących go w legalnej sieci dystrybucji. Zgodnie z deklaracjami Rady Europy fałszowanie produktów leczniczych i suplementów diety; na każdym etapie, od ich wytwarzania do podawania pacjentom, jest poważnym przestępstwem kryminalnym, które zagraża ludzkiemu życiu. Powoduje też zachwianie wiarygodności narodowych systemów ochrony zdrowia i nie może być traktowane jedynie jako naruszanie praw własności intelektualnej. W Polsce problem monitorowany jest przez Narodowy Instytut Leków, wykonujący badania skriningowe nielegalnych i sfałszowanych produktów metodami tandemowej spektrometrii mas i rentgenowskiej dyfrakcji proszkowej.
EN
Counterfeit drugs, medical devises and dietary supplements are inherently dangerous and a growing problem. In Europe the growth of the counterfeit medication market is attributable in part to registration of phosphodiesterase type 5 inhibitors (PDE-5) used for the erectile dysfunction. Viagra, Levitra and Cialis belong to this group. It has been estimated that up to 2.5 million men in Europe are exposed to an illicit sildenafil, suggesting that there may be as many illegal as legal users of sildenafil. In Europe a strong trend is observed towards increasingly professional counterfeits and imitations of Viagra, Cialis and Levitra, with regard to the appearance of tablets, capsules and packaging. The professional presentation will deceive potential consumers into assuming these products are legal, efficacious and safe. Globally, increased obstacles for counterfeiters are necessary to combat pharmaceutical counterfeiting, including fines and penalties. The worldwide nature of the counterfeit problem requires proper coordination between countries to ensure an adequate enforcement. We described the usefulness of the time-of-flight mass spectrometry with the electrospray ionization (LC-ESI-MS-TOF) and the X-ray powder diffraction method (XRPD) for PDE-5 counterfeit screening from the Polish illegal market.
Wydawca
-
Rocznik
Tom
61
Numer
3
Opis fizyczny
s.227-235,rys.,tab.,wykr.,bibliogr.
Twórcy
autor
  • Zakład Chemii Farmaceutycznej, Narodowy Instytut Leków, ul.Chełmska 30/34, 00-725 Warszawa
autor
autor
autor
Bibliografia
  • 1. World Health Organization. Counterfeit medical products. International Medical Products Anti-Counterfeiting Taskforce. Report by the Secretariat. WHO A62/14, 30 April 2009. http://www.coe.int/t/dghl/standardsetting/ medicrime/WHA%20A62_14-en.pdf (stan z marca 2010).
  • 2. World Health Organization. Counterfeit medical products. International Medical Products Anti-Counterfeiting Taskforce. Impact Final Brochure 2008.
  • 3. World Health Organization. New definition for Substandard Medicines. QAS/10.344, March 2010. http://www. who.int/impact/FinalBrochureWHA2008a.pdf (stan z marca 2010).
  • 4. European Commission Taxation and Customs Union. Summary of community customs activities on counterfeit and piracy: results at the European border – 2006. http:// ec.europa.eu/taxation_customs/resources/documents/ customs/customs_controls/drugs_precursors/seizures/ report_2006_en.pdf (stan z marca 2010).
  • 5. European Commission Taxation and Customs Union. Report on Community Customs Activities on Counterfeit and Piracy: Results at the European Border – 2007. http://ec.europa.eu/taxation_customs/resources/documents/ customs/customs_controls/counterfeit_piracy/ statistics2007.pdf (stan z kwietnia 2010).
  • 6. European Commission Taxation and Customs Union. 2008 Report on EU Customs enforcement of Intellectual Property Rights Results at the European Border. http://ec.europa.eu/taxation_customs/resources/documents/customs/customs_controls/counterfeit_piracy/statistics/2009_statistics_for_2008_full_report_en.pdf (stan z marca 2010).
  • 7. European Committee on Crime Problems (CDPC). Draft Council of Europe Convention on counterfeiting of medical products and similar crimes involving threats to public health. Strasbourg, 9 November 2009 CDPC (2009) 15 FIN, cdpc/docs 2009/cdpc (2009) 15 FIN–e.http://www. coe.int/t/dghl/standardsetting/medicrime /CDPC%20_ 2009_ 15Fin%20E%20Draft%20Convention%2009%2011%2009CM.pdf (stan z kwietnia 2010).
  • 8. Food and Drug Administration. Consumer Health Information. Hidden risks of erectile dysfunction „Treatments”sold online. February 21, 2009.http://www.fda.gov/downloads /ForConsumers/ConsumerUpdates/UCM143726.pdf (stan z kwietnia 2010).
  • 9. Food and Drug Administration. MasXtreme Capsules (Natural Wellness) - product contains undeclared drug ingredient. March 30, 2010. http://www.drugs.com/fda/masxtreme-capsules-natural-wellness-product-containsundeclared-ingredient-12713.html#ixzz0n3hB1Cpf(stan z maja 2010).
  • 10. Food and Drug Administration. Stud Capsule For Men: Product contains undeclared drug ingredient. April 6, 2010. http://www.drugs.com/fda/stud-capsule-menproduct- contains-undeclared-ingredient-12715.html#ixzz0n3hJ6lAp (stan z maja 2010).
  • 11. Venhuis B.J., Zomerb G., de Kaste D.: Structure elucidation of a novel synthetic thiono analogue of sildenafil detected in an alleged herbal aphrodisiac. J. Pharm. Biomed. Analysis 2008, 46, 814–817.
  • 12. Venhuis B.J., Blok-Tip L., de Kaste D.: Designer drugs in herbal aphrodisiacs. Forensic Sci. Int. 2008, 177, 25–27.
  • 13. Stecher V.J., Jackson G., Banks I., Arver S.: Analysis of Pharmaceuticals Seized by Authorities for Suspicion of Being Counterfeit Viagra (Sildenafil Citrate). 12th Congress of the European Society for Sexual Medicine, November 15–18, 2009, Lyon, France. http://2009.essmcongress.org/guest/AbstractView?MItabObj=co2binaries&MIcolObj =binary&MInamObj=id&MIvalObj=1447&MItypeObj=application%2Fpdf (stan z kwietnia 2010).
  • 14. Dorsey P.J., Hellstrom W.J.: The illicit sale of medications for the treatment of erectile dysfunction. Medscape Urology. http://www.medscape.com/viewarticle/566897 (stan z marca 2010).
  • 15. Jackson G., Arver S., Banks I., Stecher V.J.: Counterfeit phosphodiesterase type 5 inhibitors pose significant safety risks. Int. J. Clin. Pract. 2010, 64, 497–504.
  • 16. Blok-Tip L., Vogelpoel H., Vredenbregt M.J., Barends D.M., de Kaste D.: Counterfeits and imitations of Viagra and Cialis tablets: trends and risks to public. A survey of the analyses carried out at the Dutch National Institute for Public Health and the Environment in the time period 2000 – 2004. RIVM report 267041001/2005. http://www. rivm.nl/bibliotheek/rapporten/267041001.pdf (stan z kwietnia 2010).
  • 17. Venhuis B.J., Barends D.M., Zwaagstra M.E., de Kaste D.: Recent developments in counterfeits and imitations of Viagra, Cialis and Levitra. A 2005-2006 update. RIVM Report 370030001/2007. http://rivm.openrepository.com/rivm/bitstream/10029/16459/ 1/370030001. pdf (stan z kwietnia 2010).
  • 18. de Veij M., Deneckere A., Vandenabeele P., de Kaste D., Moensa L.: Detection of counterfeit Viagra with Raman spectroscopy. J. Pharm. Biomed. Analysis 2008, 46, 303–309.
  • 19. Venhuisa B.J., Zomerb G., Vredenbregta M.J., de Kaste D.: The identification of (−)-trans-tadalafil, tadalafil, and sildenafil in counterfeit Cialis and the optical purity of tadalafil stereoisomers. J. Pharm. Biomed. Analysis 2010, 51, 723–727.
  • 20. Singh S., Prasad B., Savaliya A.A., Shah R.P., Gohil V.M., Kaur A.: Strategies for characterizing sildenafil, vardenafil, tadalafil and their analogues in herbal dietary supplements, and detecting counterfeit products containing these drugs. Trends Anal. Chem. 2009, 28, No. 1, 13-28.
  • 21. Pucherta T., Lochmannb D., Menezesc J.C., Reicha G.: Near-infrared chemical imaging (NIR-CI) for counterfeit drug identification—A four-stage concept with a novel approach of data processing (Linear Image Signature). J. Pharm. Biomed. Analysis 2010, 51, 138–145.
  • 22. Venhuisa B.J., Zomerb G., Vredenbregta M.J., de Kaste D.: The identification of (−)-trans-tadalafil, tadalafil, and sildenafil in counterfeit Cialis and the optical purity of tadalafil stereoisomers. J. Pharm. Biomed. Analysis 2010, 51, 723–727.
  • 23. Trefi S., Routaboul C., Hamieha S., Gilard V., Malet-Martino M., Martino R.: Analysis of illegally manufactured formulations of tadalafil (Cialis) by 1H NMR, 2D DOSY 1H NMR and Raman spectroscopy. J. Pharm. Biomed. Analysis 2008, 47, 103–113.
  • 24. Pavlic M., Schubert B., Libiseller K., Oberacher H.: Comprehensive identification of active compounds in tablets by flow-injection data-dependent tandem mass spectrometry combined with library search. Forensic Sci. Int. 2010, 197, 40–47.
  • 25. Maurin J.K., Pluciński F., Mazurek A.P., Fijałek Z.: The usefulness of simple X-ray powder diffraction analysis for counterfeit control – the Viagra example. J. Pharm. Biomed. Analysis 2007, 43, 1514-1518.
Typ dokumentu
Bibliografia
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Identyfikator YADDA
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