title: A survey on illegal and counterfeit medicines for the treatment of erectile dysfunctions in Italy.
abstract: BACKGROUND
  In developed countries the phenomenon of pharmaceutical counterfeiting is steadily increasing through the illegal and the Internet market. Medicines for the treatment of erectile dysfunctions containing phosphodiesterase type 5 inhibitors (PDE5) are especially prone to falsification.
  
  
  OBJECTIVE
  To obtain evidence of the health risks for patients taking these products and to provide useful information to general practitioners and specialists in sexual medicine.
  
  
  METHODS
  First the samples were visually inspected and then analyzed to get information about their identity and quality.
  
  
  METHODS
  A survey on the PDE5 medicines analyzed by the Italian official medicines control laboratory between 2005 and 2011 was performed. All the analyzed medicines were gathered from the Italian illegal market (seizures by police forces) or were bought from illegal online pharmacies. Results.  The study revealed that 24% of the analyzed samples were counterfeit and 54% were illegal medicines. In 12% of the cases an intermediate classification (illegal/counterfeit) was assigned. Only 7% of the samples were original. Moreover, the examination of the packaging evidenced potential risks: outer and immediate packaging missing; inconsistency between the carton box and the blister as regards the expiry date and/or the batch number; expiry date or manufacturer's name or country missing.
  
  
  CONCLUSIONS
  In 19% of the samples a potential health risk for patients was identified due to either the presence in the sample of more than one undeclared PDE5(s) or an amount of the active ingredient higher than that declared (up to 190% of the maximum dose) or to the presence of potentially dangerous excipients of non-pharmaceutical origin or quality (e.g., gypsum or non-purified talc).
authors.affiliation: Dipartimento del Farmaco, Istituto Superiore di Sanità, Rome, Italy. mariacristina.gaudiano@iss.it
authors.forename: Maria Cristina
authors.initials: MC
authors.lastname: Gaudiano
authors.forename: Livia
authors.initials: L
authors.lastname: Manna
authors.forename: Andrea Luca
authors.initials: AL
authors.lastname: Rodomonte
authors.forename: Monica
authors.initials: M
authors.lastname: Bartolomei
authors.forename: Paola
authors.initials: P
authors.lastname: Bertocchi
authors.forename: Bruno
authors.initials: B
authors.lastname: Gallinella
authors.forename: Eleonora
authors.initials: E
authors.lastname: Antoniella
authors.forename: Nadia
authors.initials: N
authors.lastname: Muleri
authors.forename: Gabriele
authors.initials: G
authors.lastname: Civitelli
authors.forename: Stefano
authors.initials: S
authors.lastname: Alimonti
authors.forename: Laura
authors.initials: L
authors.lastname: Romanini
authors.forename: Leandro
authors.initials: L
authors.lastname: Rufini
authors.forename: Luisa
authors.initials: L
authors.lastname: Valvo
mesh_terms: D058110:Counterfeit Drugs / Q000008:administration & dosage* / Q000009:adverse effects*; D007172:Erectile Dysfunction / Q000188:drug therapy*; D005607:Fraud; D006801:Humans; D020407:Internet; D007558:Italy; D008297:Male; D008875:Middle Aged; D058986:Phosphodiesterase 5 Inhibitors
chemical_list: D058110:Counterfeit Drugs; D058986:Phosphodiesterase 5 Inhibitors