US biosecurity experts are calling on industry and the Government to “get a handle” on the supply chain for drugs used in times of pandemic or bio attack.
In a new paper, leaders from industry and academia said although the Government has a strategic national stock pile (SNS) of medicines for such incidences and recently invested $400m into medical countermeasures , measures are insufficient to deal with the latent issues.
“The SNS provides a short-term buffer in acute incidents, but it is impractical to create and sustain an SNS that could supply antimicrobials for all contingencies, especially during long-term shortages and supply shocks,” they said, adding that production problems can drag down countermeasures.
The biggest threat for the current system, they noted, is ignorance of the foreign supply chain amongst the organisations who handle medications used in times of national crisis – which falls largely under the remit of the US Centers for Disease Control and Prevention (CDC), rather than the US Food and Drug Administration (FDA).
And with 40 per cent of the finished pharmaceuticals and 80 per cent of the active pharmaceutical ingredients (API) and bulk chemicals used in medications taken by US patients manufactured abroad, the team say that a lack of knowledge means a crisis is inevitable unless the system changes.
Speaking to in-PharmaTechnologist.com, the paper’s lead author Amesh Adalja, an associate at the Univeristy of Pittsburgh’s (UPMC) Center for Biosecurity, said authorities must work with industry to learn more about supply sources for drugs in the stock pile.
“Medicines that are needed in times of pandemics such as flu, or for biosecurity attacks such as anthrax, are generic drugs produced in foreign countries which are vulnerable to supply shocks,” he said. “The problem is that there is not a lot of information here in terms of the national security stand point.”
Of “supply shocks” he said that often the Government is not aware of the fact that a large proportion of ingredients used, or finished products marketed, come from single sources. He said that if a problem occurs for those sole suppliers – such as natural disaster – biosecurity becomes threatened.
“Tamiflu influenza treatment, for instance, is made from a very rare plant and if there is a bad harvest of that at the same time as a pandemic it’s a big problem,” he said.
The authors – which included former GSK exec and industry vet George Poste – said in order to put more security measures in place authorities must first address weaknesses in the system.
“Industry will definitely play a part in this,” he said. “The manufacturers should have all that information somewhere. They will need to work with the government to help this process.”
Problems arising from new media
However the paper, titled ‘The Globalization of US Medical Countermeasure Production and Its Implications for National Security’, does not lay all blame on industry and the authorities’ door step.
The team said that in some cases of shortage, substitutes could be a solution – for instance with antimicrobials such as ampicillin and penicillin – but that the replacement may not be adopted because it is not the “treatment of choice” in the public eye.
“Although drugs might be pharmacologically equivalent the public may be conditioned to demand the treatment of choice described in media and social networks,” they wrote.
“If ciprofloxacin were scarce during an anthrax incident, the public might be recalcitrant to substitutions. During Amerithrax, there were reports of such behaviour when doxycycline was used for post exposure prophylaxis instead of ciprofloxacin.”