Challenges for Controlled Supply of Ambient Pharmaceuticals



Pharma IQ
08/17/2011

Distributing ambient products has always presented a challenge, but no more so than in the current changing global landscape of the pharmaceutical industry.

The very emerging markets and fields which are offering opportunities for the industry, are presenting challenges for those involved with distributing the finished products. Distribution volumes are changing in line with clinical trial developments and regulations surrounding temperature controlled products are tightening.

The longer distances which products have to travel inevitably lead to a more complex network, increasing the chances of a failure in processes – be it technical or human.

Distribution volumes are changing in line with clinical trial developments and regulations surrounding temperature controlled products are tightening.

Indeed, regulatory pressures and compliance concerns have been named as the top general business concern for pharma supply chain managers in research by UPS and Harris International.

Some 58 percent said they were very or extremely concerned with increasing regulation, while a similar number said keeping up with regulations within the global market place is a challenge.

Although each market has slightly different requirements, the essentials remain the same: pharmaceutical companies must have methods in place to ensure the products meet the end user without having experienced a temperature breach.

According to separate research from Harris International conducted last year, more than 15 countries worldwide now use cumulative heat monitoring devices attached to each unit of medicine to ensure heat damage can be identified before the product is administered to the patient.
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New technologies are making the process of temperature monitoring – and the creation of temperature profiles – more sophisticated.

However, regulators are pushing for more stringent monitoring regulations than those currently laid out in guidance, including a requirement for continuous temperature monitoring, which will place more pressure on distribution channels.

Currently, the World Health Organization's Model Requirements For The Storage And Transport Of Time And Temperature Sensitive Pharmaceutical Products say that temperature should be measured at least six times per hour during distribution - just one of the criteria which monitoring systems must meet.

And for best practice end to end distribution to be achieved, these requirements must be instilled throughout the network.

A global distribution network holds many players and all must be educated in the regulations they must follow, with this then supported with strong communication and documentation provided with the product.

The fact is that ensuring temperature ranges are adhered to during distribution means little if the pharmacies are not provided with the correct information about how to store the pharmaceuticals, and the products are compromised by the time they reach the patient.

Also ranking highly on the list of concerns in the UPS study was security. The research found, of the 40 percent who described themselves as being highly concerned about product security, 60 percent said product theft is a top challenge, while 43 percent are worried about product diversion.

These are threats which are not likely to abate as the expansion into emerging markets continues – and presents and additional challenge to those already associated with the transportation of ambient pharmaceuticals.

With ambient pharmaceuticals, selecting the right equipment for the job has a great role to play.

Packaging which can ensure products remain within the correct temperature range throughout the journey will reduce the risks associated between transferring between modes of transport, while the use of track and trace technology will not only allow for temperature modelling, but also provide information on where the pharmaceutical products are and ensure the genuine article reaches the final destination.

As well as the operational challenges relating to the transport and supply of ambient pharmaceuticals, budgets remain a major concern, with nearly two-thirds saying they are concerned about managing supply chain costs.

And all this comes in the face of a changing pharma industry, meaning standard supply chains are likely to undergo an overhaul.

"The current pharmaceutical supply chain worked well when the 'blockbuster' paradigm prevailed, but pharma's focus in a post-health reform world is shifting from products to patients, and their supply chain processes need to adopt the speed and agility of other, more consumer-oriented industries such as consumer electronics and mass retailing," Wynn Bailey, head of supply chain strategies at PwC, said.
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In the future, supply chains to become more fragmented, with different streams established for different products, and for information to flow along the supply chain in two ways ,PwC noted in its Supplying the Future: Which Path Will You Take? report.

However, these challenges also present opportunities. The report concluded that companies which understand the value that can be unlocked from their supply chain will be the ones which succeed in the years to come.

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