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20.05.2010
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Greater Problems To Arise In The Drug Tracking System On June 1st From Pleas To Bring Deadline Forward And To Label Non-2d-Barcoded Drugs At Pharmacies
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Concerns have arisen in the pharmaceutical sector from the forward deadline shift from the yearend to June 01, 2010 to stop the sale of products without a 2D-barcode in connection with the Drug Tracking System (İTS) which came into force on Sunday, May 16th. Hundreds of millions of product boxes currently in the stock of pharmacies and wholesalers will have to be manually labeled to make these non-2D-barcoded products eligible for sale. However, the risk exists for potential mix-ups in labels which contain the entire product information, as pharmacies and wholesalers are not designed to perform this function. There is also the possibility of risk to patients’ health due to mislabeling of different doses of drugs, and of malicious parties to cause millions of liras in losses to the state from counterfeiting. Supporting implementation of the Drug Tracking System, the Association of Research-Based Pharmaceutical Companies said the problems could be overcome if the sale of non-2D-barcoded drugs which are currently in the stock of pharmacies were to be permitted, as originally conceived, until January 01, 2011.
Istanbul, May 18, 2010. The pharmaceutical industry is troubled by concerns surrounding the non-2D-barcoded products which are currently in pharmacy stocks, in the context of the Drug Tracking System (İTS) which was implemented by the Ministry of Health on Sunday, May 16, 2010. The manufacturers, who kept their end of the bargain and completed investing in the 2D-barcoding infrastructure, are no longer supplying non-2D-barcoded products to the market. However, the current pharmacy and wholesaler stocks of non-2D-barcoded products from 2009 are complicating operability of the Drug Tracking System.
In the “Regulation to Amend the Packaging and Labeling Regulation of Medicinal Products for Human Use,” issued on September 30, 2009 regarding the İTS, the sale of non-2D-barcoded products manufactured pre-January 01, 2010 had been allowed until January 01, 2011. However, two circular notices were subsequently issued, which not only shifted the deadline forward to June 01, 2010, but also ordered non-2D-barcoded products currently on the market to be affixed at pharmacies and wholesalers with 2D-barcode labels supplied by pharmaceutical companies.
According to circular notices currently in effect, the current stock levels will have to be determined and the quantity needed of labels will be reported to the manufacturers. After they are produced by manufacturers, the 2D-barcode labels will have to be manually affixed on every single product at pharmacies and wholesalers, after checking the expiry date of each.
This operation, which involves great physical hardship, will entail the risk of mislabeling products with the wrong dosage strength information. It will also leave room for malicious persons or groups to attempt at counterfeiting, putting 2D-barcodes on non-matching products, which will not only give rise to serious risks to patients, but also lead to a waste of national resources, as it will not be possible to label a large number of non-2D-barcoded products before expiry.
AİFD warns of risks
A statement released by the Association of Research-Based Pharmaceutical Companies (AİFD) highlighted the potential risks for imperiling patients’ health and counterfeiting, resulting from the procedure:
“The Drug Tracking System (İTS), an important system that will not only preclude counterfeiting but also largely eliminate off-record transactions, is the first of its kind worldwide. And that is why we have supported the Government on the İTS from the outset. We, as manufacturers, have invested over TL 200 million to make the switch to the 2D-barcode system. Currently, none of our members are supplying non-2D-barcoded products to wholesalers. However, the issue of labeling the current pharmacy and wholesaler stocks of pre-2010 non-2D-barcoded products by June 01, 2010 is a source of concern to us as it gives rise to serious risks to patients’ health. The AİFD is strictly against delaying the launch of the system. Our expectation is only that the current stocks of non-2D-barcoded products be permitted to be sold until yearend, and the disposition be completely dropped of having these products manually labeled at pharmacies. This way, the problems will be overcome. We are hoping that the Ministry will reconsider not the commencement date, but of the closure date of the system.”
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