How To Mitigate Pharma Supply Chain Risks

By Gail Dutton, contributing editor

Collaboration is the single best way to mitigate supply chain risks, as well as to enable significant improvements in terms of speed, on-time pickup and delivery, damage reduction, and other parameters, according to speakers at the September IQPC Cold Chain & Temperature Management Global Forum in Chicago. What organizations must accept is that communications and information-sharing goes both ways. By monitoring shipments and by accumulating, mining, analyzing, and sharing resultant data, logistics organizations throughout the supply chain can improve their operations and prevent future problems.

Johnson & Johnson understands that. Although its 50-person team knows its temperature control requirements and is alerted to excursions, “We need a more proactive approach,” says Alan Davis, supply chain temperature control leader, Johnson & Johnson. Therefore, the company is validating a solution to identify and understand the trends. “We need to use the data to recognize not just whether there were excursions, but how close shipments came to experiencing excursions.” With that information, the company can work with service and packaging material providers to strengthen the supply chain to prevent future excursions.

Global Monitoring
AstraZeneca has monitored shipments on its 400 international lanes for the past decade. Now it is analyzing that data to uncover patterns it can use to craft a global temperature management program. Actual numbers are confidential, but excursions have declined dramatically, says Christine Foster, senior quality assurance supplier manager, AstraZeneca.

Initial findings revealed a high number of temperature excursions in controlled room temperature shipments. Deeper analysis pointed to a limited understanding of route performance related to mode, seasonality, forwarder, and service and also showed global inconsistencies. In response, Foster says, “We updated the temperature monitoring system, harmonized route performance criteria, and [based upon excursion severity] prioritized our focus around air transportation.”

AstraZeneca also performed a route risk assessment, which identified additional risks and led to the development of a global standard. For temperature monitoring, the company held a kaizen event and deployed multitemperature sensors and alarms, which dramatically reduced excursions. “We looked at passive and active protection,” Foster explains, “and engaged our forwarders to ensure they understood our business. With access to our raw data, they now can proactively see trends and mitigate risks.”

Working with TSS AB, AstraZeneca deployed the Cargo 2000 information system to provide data on routes to help identify risk mitigation strategies specific to each route. Because the information is managed through a central application, data quality and consistency have improved, and automatic ad hoc analyses of all routes are quickly available.

Likewise, Cubist Pharmaceuticals worked with its freight forwarder to monitor APIs being shipped from Italy to the U.S. Surprisingly, “We found the cargo made multiple stops before entering the U.S.,” notes Michele Johnson, supply chain consultant. “Some of the unexpected stops were caused by scheduling changes, but more related to re-icing and other materials- handling issues.” Subsequently, Cubist streamlined its supply chain to reduce handoffs, thereby reducing risks and costs.

Innovations in packaging and changes in transportation make it worthwhile to consider alternative modes of transportation. As railroads improve delivery times and truckers work in teams to minimize stops, intermodal and ground transportation are becoming options. These options come with tradeoffs, though. “Be cognizant of inventory carrying cost, stock on hand, and the urgent needs of customers,” Davis cautioned. “If you move from air to ground, for example, you may need more inventory on hand, or customers may need to order earlier. Manufacturers also must account for the risk of longer temperature excursions and have solutions available to remediate midshipment incidents. Solutions include placing temperature monitors and GPS trackers on the cargo so incidents are reported and can be addressed in near real time.”

Understand Handoffs
In addition to being aware of stops and handoffs, pharma companies also should understand the environmental aspects of each lane. That includes passive thermal protection options for each lane, their complexity and repeatability, the feasibility of recharging batteries or passive heating or cooling materials at each handoff location, solutions’ potential for refurbishment and reuse, and any seasonal variations.

Logistics considerations for controlled room temperature (CRT) also should be identified. Johnson & Johnson is reevaluating its legacy products to develop the same level of stability and temperature information that it has for new products, thus minimizing excursions. And carriers are beginning to temperature-map their facilities to better accommodate temperature-sensitive cargo.

Understanding airline SOPs also helps minimize incidents. For example, if an airline color-codes sensitive shipments, shippers should ensure their coding system doesn’t conflict. Davis also advises affixing special-handling labeling in multiple languages, recognizing that for many handlers English is a second language. Additionally, “Movements at airports should be well-defined in SOPs. Interim airports may be challenging, and shippers may not be aware of all the transitions their products experience,” Davis says.

Ground handlers, whether for the last-mile delivery or for handoffs in transit, also need access to the SOPs for their pharma clients, Davis insists. The information should include emergency contacts, temperature- controlled safe havens, monitoring systems in use, and real-time temperature and GPS visibility. “Handlers also need recurrent training, a strong understanding of pharma needs, and access to temperaturecontrolled warehousing options with surge capacity,” he adds.

Customs facilities pose additional challenges. “They aren’t always safe havens for temperature control,” Davis points out. To lessen the risks, ship a test package through customs so the documents are on file before commercial-sized shipments are transported. “There are no guarantees, but customs approval of an earlier shipment helps mitigate challenges. The contacts on the ground at destination countries are very important, so establish them up front.”

Provider Selection
Particularly as temperature control shipping becomes more important, differences among logistics providers are emerging. In evaluating potential logistics partners, “Bayer HealthCare looks for three things: operational visibility, flexibility to manage risks, and reliability,” says Carlos Castro, transportation/cold chain project manager.

When Bayer HealthCare looked at its logistics chain, it established a baseline with key performance indicators to facilitate objective analyses. “The goal is to balance costs and risks,” Castro explains. For example, “A particular transportation mode may save money, but may increase risk by making multiple stops. Therefore, it may be better to pay more to ensure there are no stops.” Cubist Pharmaceuticals relies heavily on its 3PL (third party logistics provider). Johnson says a full-service, end-to-end logistics provider is vital to ensure that packages are never held hostage to handoffs. It also insists upon a quality assurance approach to managing services.

Johnson & Johnson goes deeper, looking not only at its freight forwarders, but at the core strengths of those forwarders’ partners. “Understand them. They make the difference between good and great providers,” Davis says.

FedEx takes a similar approach, working with approximately five other freight forwarders. “We know the SOPs we need. We travel to their facilities and review their SOPs with an eye to maximum visibility, complete transparency, contingency preparedness, and responses to challenges. If they have no records of those challenges, they’re either inexperienced, or they document poorly,” says Ken May, Temp-Assure Solutions analyst, FedEx. “I look for partners who know their own weaknesses.”

Speakers at the IQPC event advise pharmaceutical companies to supplement their primary logistics provider with secondary and even tertiary providers to ensure their goals are met. Logistics providers have different financial objectives, cultures, and regulatory concerns than their pharmaceutical partners, they point out. Those differences aside, a multitiered approach helps ensure the shippers maintain the flexibility to respond to new and evolving global challenges.

Packaging And The Sustainability Mindset
Companies at the IQPC conference support the notion of sustainable packaging, but haven’t agreed whether single-use or reusable packaging best advances their goals. Single-use advocates still must deal with degradation and disposal, while reusable proponents struggle to ensure containers are returned and that packaging retains its properties throughout multiple uses.

When LifeCell recently piloted its reusable shipping system, it educated customers beforehand to expect a new, returnable shipper. “Make it very obvious,” says Chris Masick, senior packaging engineer. “We added a label that said, ‘Do not discard. I’m a reusable shipper,’ as well as prepaid return labels to make it easy for customers to return shippers to the proper location. Some still get it wrong.” For the recalcitrant, LifeCell relies upon tracking software to aid recovery. “The sooner you act, the better the chance of recovery.”

Return rates depend largely upon the sustainability mindset at receivers’ locations and regulatory compulsion. For example, “Canada had 100% compliance, and California was more receptive than our other American pilot locations,” Masick says.

When it comes to packaging and logistics, Masick also advocates collaboration within a pharmaceutical division. “Stop working in a silo,” he says. Instead, involve the logistics and quality assurance departments early in packaging decisions. “They may need to work with leasing agreements or review documentation to justify use of a certain product or may have other concerns that, when addressed early, help advance projects more quickly and amicably.”

Dana Dallas, vaccine/cold chain program manager, Defense Logistics Agency Troop Support, encourages box and device manufacturers to collaborate, too. “Ideally, packing material would be designed for the box and delivered as a one-concept solution.” Likewise, temperature monitors should be tested with passive solutions and the research made available so shippers know how specific solutions behave and understand where best to position monitors.

The mounting need for temperature-controlled shipping is complicating an already complex supply chain. The solution, speakers agreed, is close, consistent collaboration with trusted logistics providers. By sharing data, partners have the opportunity not only to address individual shipping issues, but to enact improvements that actually reduce excursions and improve service.