Counterfeit Lipitor found in legitimate pharmaceutical supply chain
Counterfeit medicines — this time it is Lipitor, batch number 004405K1 — have been found in the legitimate supply chain for the third time in two years. Counterfeit Cialis and Reductil were discovered
last year (PJ, 28 August 2004, p277, and 11 September 2004, p335).
A Medicines and Healthcare products Regulatory Agency spokeswoman confirmed
that the MHRA had seized 73 packs of counterfeit Lipitor, which contained
lovastatin as an active ingredient instead of atorvastatin. She said
that lovastatin does not have a UK product licence, but the counterfeit
product poses no immediate safety risk to patients. The Dutch authorities
seized counterfeit Lipitor in May.
The MHRA has advised patients to return any suspect packs to pharmacies
for replacement with Lipitor that is known to be genuine.
Following the recall, Pfizer called for a clamp-down on parallel importing.
A spokeswoman for Pfizer said that the seized product had come from a
single UK full-line
wholesaler. The MHRA had been looking for it since mid-July, when it
had received information about the Dutch seizure, which had taken place
in Rotterdam.
She added that counterfeit packs could be identified by the absence of
a tamper-evident seal which was present on genuine packs of Lipitor.
Kate Lloyd, medical director of Pfizer UK, said: “Patient safety
is at risk if counterfeit products can easily be introduced into the
supply chain through cross-border trade, as patients will not gain the
benefits their doctor intended when selecting their medicines.”
Pfizer wants the repackaging of medicines by parallel importers to be
outlawed. It also wants a European standard barcode system for medicines,
so that they can be identified and recalled more easily. Other changes
the company wants to see include tamper-resistant packaging, stricter
penalties for people dealing in counterfeit medicines and new medicines
delivery mechanisms.
UniChem said that it had no stock of the counterfeit product.
David Pruce, director of practice and quality improvement at the Royal
Pharmaceutical Society, said: “Any pharmacist who has concerns
about the authenticity of any medicines that they hold in stock is advised
to contact either their local Society inspector or the MHRA for guidance
and advice.” |
The
Pharmaceutical Journal
Acrobat
Reader