Seroquel-Nurofen Plus mix up could involve parallel imports
This article was originally published in Scrip
The UK's medicines regulator, the MHRA, is investigating how rogue cut down blister packs of AstraZeneca's anti-pshycotic Seroquel XL (quetiapine) ended up in Packs of Reckitt Benckiser's Nurofen Plus (ibuprofen plus codeine), a non-prescription analgesic. The MHRA says that the Seroquel blisters were both parallel imports and originator products.
At this stage neither company, nor the MHRA, knows exactly what happened. According to Reckitt, the standard blister strips of Nurofen Plus were removed and replaced with foil-sealed strips of Seroquel. The medicines agency said it was investigating all avenues, including product consolidation, when wholesalers and parallel traders repackage cut blisters. Reckitt says it believes the parallel imports were of Seroquel, while AstraZeneca says it is investigating the reports.
AstraZeneca says the problem occurred outside the company's supply chain and pointed to the MHRA's statement that manufacturing errors on the part of either company were at this point thought not thought to be the cause of the problem.
Full-line wholesalers are taking any potential security breaches seriously, says BAPW, which represents British full-line wholesalers. "All member full-line wholesalers are currently conducting a rigorous warehouse check to confirm that they do not stock any of the affected batches. Until we have data available we cannot comment further," said the association.
Asked how it would manage negative fallout for the Nurofen brand, which has been highly successful in the UK, a Reckitt spokesperson said that the company would do everything to protect the health of the consumer. AstraZeneca said its priority was to support the investigation with the MHRA and Reckitt to identify the cause.
Both companies say they are taking the mix up very seriously and that they are working with the MHRA to get to the bottom of the issue. Neither company, nor the MHRA, were able to comment on how the situation could have been prevented without knowing the cause. The agency also declined to comment on possible penalties for the time being.
Boots, a pharmacy chain, brought the problem to the attention of Reckitt, which informed the MHRA, after three people in South London bought the defective Nurofen Plus packs. Two people took the Seroquel tablets but did not suffer any adverse event, says Reckitt.
Nurofen Plus is available without a prescription but is a "behind the counter" product, which means the patient must go through the pharmacist to buy it. The MHRA is asking pharmacists to check boxes before selling them and telling consumers to be "vigilant". The agency has issued a Class 4 alert, the least critical class of alert, to all pharmacies.
The MHRA was unable to comment on whether this type of situation had happened before.