Erano diretti in Sicilia, ma sul Tir c’erano 27 gradi, anche per i salvavita
di Antonio Mariozzi
ANAGNI- Migliaia di farmaci sequestrati sull’autostrada Roma-Napoli, nel Frusinate. Ben 716 scatole stipate su trentadue pedane e trasportate da un Tir diretto in Sicilia. Il mezzo era fermo in una piazzola di sosta vicino al casello di Anagni, dove gli agenti della polizia stradale hanno proceduto a un controllo che ha portato al maxisequestro per decine di migliaia di euro. Negli scatoloni c’erano anche farmaci « salvavita».
Farmaci a rischio alterazione
Il grosso quantitativo di medicinali era stato caricato in una casa farmaceutica a Lodi,in Lombardia, per rifornire ospedali e farmacie nella zona di Catania, in Sicilia. I sigilli sono scattati perché i poliziotti, in collaborazione con il personale dell’Asl di Frosinone, hanno riscontrato una temperatura nel vano del semirimorchio in media di 27° centigradi, mentre i medicinali dovevano viaggiare tra i 2 e gli otto gradi centigradi. Una violazione che avrebbe dunque potuto causare, secondo la polizia stradale, un’alterazione nell’efficacia terapeutica dei farmaci, con conseguente pericolo per la salute pubblica.
Sigilli e sanzioni
Gli agenti del dirigente Giovanni Consoli, che in questi giorni di fine agosto stanno eseguendo importanti sequestri lungo la tratta dell’Autosole in Ciociaria, hanno messo i sigilli al vano di carico della merce e hanno imposto ai conducenti – A. S di 54 anni e A.M di 50, entrambi originari di Catania – l’obbligo di trasportare il quantitativo di farmaci nel luogo di destinazione, dove l’azienda sanitaria di competenza dovrà procedere a nuove verifiche. Per i due autisti, al momento, non ci sono provvedimenti. La Polstrada di Frosinone ha solo contestato infrazioni al codice della strada per seicento euro e inflitto una multa da tremila a diciottomila euro per le violazioni sulla normativa sanitaria.
22 agosto 2014 | CORRIERE DELLA SERA ROMA/CRONACHE
Related news: Farmaci, una maxi multa per il trasporto a rischio
Si veda: Ministerial Decree July 6, 1999
Circular 13 January 2000, n. 2 in the GU 18 February 2000, n. 40
Guidelines of 7 March 2013 on good distribution practices for medicines for human use OJEU
The Informatori Scientifici, oltre alle norme riportate, devono rispettare anche l’art. 125, comma 10, del D.Lgs. 219/06:
Article 125. Legislative Decree 219/06
Free samples
1. Free samples of a medicine for human use can only be given to doctors authorized to prescribe it and must be delivered only through scientific representatives. Physicians must ensure storage according to the instructions indicated on the package or on the package leaflet.
2. Samples cannot be delivered without a written request bearing the date, stamp and signature of the recipient.
3. Scientific reps may deliver two samples per visit to each healthcare professional for each dosage or pharmaceutical form of a medicinal product exclusively in the eighteen months following the date of first marketing of the product and within the maximum limit of eight samples per year for each dosage or form.
4. Without prejudice to the provisions of paragraph 2, scientific representatives may also deliver to the doctor no more than four samples per visit, within the maximum limit of ten samples per year, chosen from the company list of medicinal products on the market for more than eighteen months.
5. The quantitative limits of paragraphs 3 and 4 also apply to medicines that can be sold to the public in pharmacies and are not dispensed with costs borne by the National Health Service.
6. Each sample must be graphically identical to the smallest package on the market. Its content may be lower, in number of dosage units or in volume, than that of the package on the market, provided it is therapeutically suitable; the non-correspondence of the content and, possibly, of the primary packaging to the authorized package must be expressly referred to on the label.
7. The summary of the product characteristics must always be delivered together with the samples, except in the case provided for by paragraph 5 of article 122.
8. Except in the case of obvious technical difficulties, on the outer packaging, on the primary packaging and, where appropriate, on the self-adhesive stamp used for dispensing the medicinal product at the expense of the National Health Service, the indication "free sample - not to be sold" or other similar expression.
9. No sample of the medicines governed by the consolidated text referred to in the decree of the President of the Republic of 9 October 1990, n. 309.
10. Pharmaceutical companies are required to ensure that any storage conditions indicated on the external packaging or on the primary packaging of the medicinal product are respected until the sample is delivered to the doctor. In particular, companies will have to provide their scientific representatives with all the necessary information relating to the methods of correct conservation and distribution of medicines envisaged by current legislation, equipping them with the appropriate stowage tools for free samples for their transport. Scientific reps must be given free samples in quantities proportional to the number of visits scheduled for a given period, generally every fifteen days.
11. The delivery of samples to the hospital doctor is subject to the provisions of this article.
12. Pharmaceutical companies are required to withdraw from the scientific representatives any medical request referred to in paragraph 2 and to keep, for eighteen months, suitable documentation to prove that the delivery of samples took place in compliance with the provisions of this decree.
13. The Minister of Health, on the proposal of AIFA, taking into account the trend in the consumption of medicines, may, by decree, reduce the number of samples that can be delivered by scientific representatives pursuant to this article or provide for specific further limitations for certain categories of medicines.
