COFA reassures pharmacies on Argentina's traceability proposals

The Pharmaceutical Confederation of Argentina (COFA) has issued a statement in support of the country's proposed medicine traceability rules, seeking to reassure pharmacy operators that a manageable solution can be implemented.

COFA represents largely independent pharmacy operators in Argentina, some of which have expressed concerns about the ramifications of Resolution 435/2011, which was introduced in April this year in order to defend the medicines supply chain from counterfeit, stolen, unlicensed and otherwise illegal medicines.

435/2011 was fleshed out in May by a resolution from the country's medicines regulatory ANMAT (3683/2011), which put a one-year deadline (from June 15 2011) for implementing a traceability system based on the use of GS1-compliant serial numbers on secondary drug packaging of critical medicines such as cancer and HIV medications.

The latter document stipulated that codes would be carried by 2D datamatrix and human-readable codes and would also include a Global Trade Item Number (GTIN) and optionally lot number and expiration dates.

In its statement (available in Spanish here), COFA emphasises the benefits to pharmacists of the system, such as tracking breakages and loss of cold-chain integrity, whilst noting that pharmacists will be required to record sensitive data, for example information linking a medicine pack with the receiving patient's name and address.

COFA reassures its members that it is working with the National Federation of Chambers of Pharmacy (FACAF) and the Association of Medical Mutual and Union of Argentina (AFMYSRA) to make sure that the traceability system takes into account issues of patient confidentiality.