Tuesday, February 22, 2011

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Poisons, toxic and very toxic. CLP and labeling

Con questo post proverò a fare chiarezza su uno dei più grandi "problemi" che il farmacista preparatore si trova ad affrontare nel corso della sua attività: i VELENI.
Cominciamo con il dire che il termine " Veleno " è un termine impreciso in quanto era (è) utilizzato dalla Tabella 3 della Farmacopea per indicare tutte quelle sostanze che possono avere effetti molto gravi/letali anche a dosi molto basse. Il problema è che la Tabella 3 non è mai stata aggiornata, mentre sono aumentate le sostanze che, pur non essendo elencata in tale tabella, potevano rientrare in quella che era l'intenzione del legislatore di definire una sostanza come Veleno .

La soluzione a questo problema è arrivata con la Farmacopea XII ed il successivo supplemento: si è iniziato a dare una definizione precisa delle sostanze Tossiche e Molto tossiche , identificabili con il famoso simbolo del teschio.
Tossico       
Whereas before there was some discretion of the pharmacist, from the Pharmacopoeia XII, in fact, talk of poison (ie, a substance in a in Table 3), Toxic substance or Very toxic was exactly the same thing, namely the law for the dispatch of a recipe Galenic was exactly the same whether it contained a poison, toxic or very toxic .
Then he made a distinction between a substance Toxic and Very Toxic : Very toxic substance is a substance that should be considered Poison, Toxic substance , no.

Ultimately, no new changes and / or communications, this is the current situation:
  • considering a substance Toxic , the only performance is that the substance as such must be kept in locked cupboard (separate from drug). A recipe that Galenic containing this substance is not subject to the formalism of the "Toxic" and the recipe in this case, however, repeated 10 times for 6 months (unless it contains other particulate matter).
  • considering a substance " Very toxic "or" Poison "(ie contained in Table 3 Pharmacopoeia), the substance must be kept in a locked cabinet and the recipe calls for all the formalism of the case (see below). The recipe in this case and not repeat and that is excluding the 30 days of issuance.
Finally, here are the formalities required by law to send a recipe that contains a substance Galenic Very Toxic or Poison : Regarding the recipe
  • is desirable that shows the name of the patient
  • must indicate the dose of the substance ( Poison or Very toxic) in all letters
  • must indicate the dosage
  • must indicate the date of preparation
  • must be given the stamp and signature of the physician
The pharmacist, at ' act of the expedition:
  • affix the date of posting (if he can affix a stamp, but is not required by standard)
  • affix the price charged
  • record the name of the purchaser (which may not be the patient), which is more than 16 years
  • affix the label of the preparation for the word "POISON" or a suitable pictogram
  • preserves the original recipe for six months
From December 2010 has been replaced by a further innovation, which replaced the previous two pictograms with this:
'll discuss later in another post what happened and What changes.

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