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The pharmaceutical supply chain requires special attention and care in today’s regulatory and consumer environment. By developing a solid plan of action for their logistics, shippers can effectively meet and exceed these requirements while keeping the end patient as their focal point.
The pharmaceutical supply chain requires special care and attention, not the least of which should be focused on the ultimate patient who relies on the medicines for healing, recovery, and to maintain his or her overall wellbeing and quality of life.
This places some pretty heavy responsibility onto the pharma supply chain, where products must be transported safely and kept at a specific temperature all while meeting regulatory, providers’ and patients’ demands.
“The main objective of any pharma transportation plan should be the patients’ wellbeing,” says Benjamin Zervas, a Schenker, Inc., Global Account Director. “Medicines must get to the patient in good order, be kept at necessary temperatures during transport, and meet strict monitoring and traceability requirements.”
Wanted: End-to-End Visibility and Traceability
The growth of temperature-controlled products is continuing at more than double the rate of non-temperature-controlled products, indicating that the cold chain business in biopharma will continue to grow at a healthy pace. According to the Biopharma Cold Chain Sourcebook, the pharma cold-chain logistics will be worth $16.6 billion by 2021 (up from $13.4 billion in 2017). The industry is growing at a rate of 5-6% annually, with the value of shipped temperature-controlled pharmaceuticals growing at a rate of 10.7% annually.
This growth puts added pressure on the temperature-controlled supply chain and makes a well-thought-out logistics approach that much more important. “The key is to develop a good temperature-controlled transport strategy that incorporates traceability and end-to-end supply chain visibility,” Zervas says, “in order to counteract any composite product on the market, which can be very dangerous for a patient.”
Zervas, whose young son relies on myriad different medicines to maintain his wellbeing and quality of life, says pharma shippers run in to the biggest supply chain challenges on the carrier front, where figuring out which ones can and cannot perform up to standards can be a major challenge. Add the driver shorter and capacity crunch to the equation and the issue exacerbates even further.
“These are just the realities of transportation right now, and they require a good, hard look at which carriers are actually capable of performing,” says Zervas. Through an auditing process, for example, DB Schenker ensures that the transportation providers have the right processes in place and that they can perform the transport within the shipper’s parameters.
“If the airline or the carrier cannot perform that, then we have to think outside of the box to ensure that we transport the product at the right temperature,” says Zervas, “while also handling any additional requirements or protections during transport.” Those requirements can include any or all of the following, each of which must be incorporated into any company’s temperature-controlled logistics plan:
Carrier performance and infrastructure. Carefully audit the carrier’s performance capabilities and that of its transportation network (e.g., the coolers and controlled room temperature zones at various airports or ports). Consider whether ports have sufficient outlets and/or research containers, for example, and ensure that they align with your company’s needs.
Local regulatory requirements.Trace the requirements from origin to destination to make sure you’re not missing anything. “We see a lot of shipments held up at customs due to missing paperwork and product identifications (on the label),” says Zervas, who tells pharma companies to pay close attention to all local, federal, and/or country regulatory requirements (or, work with a logistics provider that will handle this for you).
Batch traceability. The World Health Organization (WHO) estimates that around 50% of product recalls are still attributed to artwork errors and mislabeling.The Falsified Medicines Directive (FMD) 2011/62/EU, which is due for adoption in February 2019, will require pharmaceutical companies to apply serialization codes to every applicable pack (OTC and some minor exemptions). “As WHO becomes even more stringent on traceability of batches right down to the patient or end user,” says Zervas, “traceability is becoming more and more important to factor into the pharma supply chain plan.”
Contingency planning. Devised for an outcome other than the usual or expected plan, contingency planning is a commonly-used risk management tool that helps shippers better control their supply chain activities. A pharma manufacturer that regularly uses a carrier that’s been ground by aviation authorities, for example, would turn to its contingency plan to quickly reallocate those shipments to Carrier B.
Disaster recovery planning. Contingency planning also relates to disaster recovery planning. “The hurricane in Puerto Rico in 2017 is a prime example, and mainly because so many pharmaceutical companies produce medicines there,” Zervas explains. “When the hurricane hit, some were definitely better prepared than others.”
Put the patient first. Making sure the patient isn’t impacted by supply chain performance should be the focal point. “When we manage the pharma supply chain, I always think about family members and friends who are receiving the pharmaceuticals that we’re handling,” Zervas says. “We want to make sure that the product gets to the end patient in perfect condition and that it can actually do its job in helping that patient feel better.”
In return for taking these steps, temperature-controlled shippers get a secure supply chain, few (if any) shipment losses, fewer delayed shipments, and the privilege of arming their patients with the medications that they need. “Real people rely on these goods, and we take that responsibility very seriously,” says Zervas. “Ensuring supply chain security—without creating a risk for the patients—should always be top priority.”
