"It has finally happened," a cold-chain colleague called to tell me.
"What has?" I asked.
"It was only a matter of time before some government in their infinite wisdom authorized that the basis for the quality of medicine shall be determined by the temperature to which it has been exposed during its lifetime and that the consumer- the most unqualified individual in the entire supply chain - should make that call," he bemoaned.
He then forwarded to me The Official Bulletin of The Republic of Argentina Law for Regulating The Cold Chain of Medicine.
"This is such a bad idea on so many levels," he said of the one-and-a-half page document, "that I hardly know where to begin. And it's Argentina. ARGENTINA! Like they have the infrastructure and processes in place to pull this off!"
In fairness to you, gentle reader, here are the specific articles of the Argentine law causing so much consternation:
ARTICLE 1: Within a period of two (2) years from the time the present law takes effect [enacted March 26, 2009], all medicine for human or animal use containing thermolabile active principles must have a temperature indicator incorporated in the individual container that is indelible, unalterable and irreversible, and that will provide confirmation that said product has not lost the cold chain by the time it reaches the consumer.
ARTICLE 2: The indicator will be installed by the factory and must remain on the medicine, even on the individual consumer unit.
ARTICLE 3: For multi-dose packaging, the indicator must remain on the container, so that the consumer can check to see that the cold chain was not interrupted on the product in his or her possession, thus denaturing or rendering the medicine's original properties inactive.
"While seemingly well-intentioned, it is obvious to anyone with any knowledge of the distribution of cold-chain drugs, that this is not only impractical, but it is completely opposed to all current best practices acknowledged and accepted by regulators globally," my friend cried. "The last thing we need is for other countries to jump on this band wagon. We've come so far - this could mean a giant step backwards for the safe distribution of drugs! This is the worst proposal to come along since e-pedigree!" he shouted.
...I couldn't agree more.
