Mistakes happen. In the pharma industry, these mistakes can lead to product recalls. Perhaps the medication is not the correct strength or maybe it became contaminated with metal fragments…
…and sometimes, entirely the wrong drug is found in the packet. In a case that has had UK media reports aflame, a prescription only antipsychotic drug was found in certain packets of a common pain medication that was manufactured by a completely different company. Is it a repackaging mistake? Or are more sinister intentions at work? Either way, it’s clear there are could be a few security holes in pharma’s distribution chains.
Late yesterday afternoon, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) issued a statement warning the public to be cautious when using Neruofen Plus (made by Reckitt Benckiser) because AstraZeneca’s Seroquel XL 50 mg, had been found in certain packets. Seroquel XL is indicated for the treatment of schizophrenia and bipolar disorder.
It’s a pretty big mistake. In fact, it’s so major that some media reports led themselves to the conclusion that it could be sabotage. In its own statement, the MHRA also believes that a manufacturing error is unlikely. “Seroquel XL tablets are made by a different company (AstraZeneca) at a different site. Manufacturing errors by Reckitt Benckiser and AstraZeneca are not considered to be part of the cause at this stage.”
Three packets have been identified so far—all in south London. The MHRA believes that three different batches may be affected, which equates to anywhere between 4000–7500 packs, according to a report from the UK’s BBC. The MHRA statement says that the packs contained “rogue” cut-down blisters of Seroquel that included both parallel-imported tablets (from different companies) and originator product.
Several media reports have claimed that the swap may have happened in a wholesale warehouse. Whatever the cause, the situation raises issues about the integrity of pharmaceutical packaging. For instance, in the UK, many non-prescription medicines are not wrapped in cellophane and do not have protective seals, which means that anyone can open them and, if their intentions are malicious, tamper with the contents. Should these packages be more secure? And, in the event that medicines are swapped, should blister packs be more clearly labelled?
According to the MHRA, there is a clear difference in the design of the blister packaging of Nurofen (silver and black) and Seroquel (gold and black). But the question is, how many people out there actually double-check that they’re taking the right medicine after they’ve opened the carton? In addition, text on blister packaging can often be small, which doesn’t encourage people to take notice.
The case also raises issues about the distribution and wholesale chain. In particular, if parallel importing was involved, it will reinforce long-cited concerns about this “grey market”. Parallel trade and the repackaging of drugs—to the frustration of many stakeholders—is legal in the EU. If you’re unfamiliar with parallel trade then the article “Who’s afraid of parallel trade?” is a good introduction, or you can take a look at the EUROPA website.
At the moment, there’s no solid information as to the exact cause, and the MHRA has warned that we may never know the full story, saying: “We have some information to suggest possible links between these cases. It is possible that these problems are linked to product consolidation and/or erroneous examination of returns. Work is ongoing to obtain more information but the full facts may never be fully established.”
However, the situation has also highlighted something that pharma companies are reluctant to use in this kind of situation: communication.
Writing for The Drum, Jonathan Hemus said: “Crucial to effective reputation protection is filling the information vacuum and reassuring your stakeholders… But Reckitt Benckiser – parent company of Nurofen Plus – has appeared slow to activate these communication channels. Hours after the Medicines and Healthcare products Regulatory Agency (MHRA) had issued its announcement about the issue, there was:
no information on the Nurofen website
no information on the Reckitt Benckiser website
no information on the Nurofen Facebook page
no one manning the consumer helpline.”
At the time of writing this blog, there was still very little information available outside of the MHRA and third-party news sites, but this may change.
Unfortunately, mistakes do happen and product recalls will continue. And in the EU, at least for the foreseeable future, there will be continued concerns over parallel trade and repackaging. But in comparison to the complexity of these issues, you’d think that disseminating information to the public was relatively easy.