Sfałszowane inhibitory fosfodiesterazy typu 5 – narastające zagrożenie dla zdrowia publicznego

• Autorzy: Fijalek Z. , Sarna K. , Blazewicz A. , Marin J.

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.

Słowa kluczowe

PL

leki; wyroby medyczne; zafalszowania; inhibitory fosfodiesterazy; zdrowie publiczne; zagrozenia zdrowia; suplementy diety; przestepczosc

EN

drug; medical product; adulteration; phosphodiesterase inhibitor; public health; health hazard; diet supplement; crime

• Wydawca: -
• Czasopismo: Roczniki Państwowego Zakładu Higieny
• Rocznik: 2010
• Tom: 61
• Numer: 3
• Opis fizyczny: s.227-235,rys.,tab.,wykr.,bibliogr.

Twórcy

autor

Fijalek Z.

• Zakład Chemii Farmaceutycznej, Narodowy Instytut Leków, ul.Chełmska 30/34, 00-725 Warszawa

autor

Sarna K.

autor

Blazewicz A.

autor

Marin J.

Bibliografia

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