To minimize risk and help you remain compliant, choose temperature-controlled packaging and services to help monitor your sensitive healthcare shipments.
Somewhere in Michigan, a woman with Parkinson’s disease waits at the pharmacy and nervously checks her watch. Taking her medication even a little bit late can intensify her symptoms. The pharmacist regretfully informs her that the shipment of medication hasn’t arrived yet.
“The guidelines are there to help maintain product quality, safety and efficacy by helping prevent product spoilage.”
– UPS’s Susan Li
At a clinic in Micronesia, a severely ill man insists that he can’t have measles – he’s been vaccinated. What he doesn’t know is that his vaccine was rendered ineffective after overheating in transit.
Shipping pharmaceuticals and other medical materials is a responsibility that goes beyond simple customer service. Problems with a shipment may impact your reputation and raise questions about your reliability. Shipping Category A and Category B Biological Substances is heavily regulated and must comply with governmental requirements as outlined in step 2 below and summarized here.
When shipping pharmaceuticals, to help avoid spoilage, control shipping costs, maintain security and assist with cold chain compliance, you’ll have to navigate a series of logistical challenges. Follow the steps below to help enable your time- and temperature-sensitive medical shipments to arrive on time and in good condition.
1. Pick a logistics provider that has extensive healthcare experience.
Choosing a logistics partner with experience in the healthcare field is the first and most important step when dealing with sensitive pharmaceutical and medical shipments.
A carrier with healthcare expertise can help minimize a number of risks and help you avoid costly re-shipments and write-offs. Perhaps just as important, they can provide expert assistance with complex cold chain challenges, which can help ensure your products are available for your customers.
Select a logistics partner with highly trained personnel, proper transport and storage equipment, and efficient procedures in place. UPS healthcare logistics experts can help you with everything from finding the best temperature-sensitive packaging to providing services that offer proactive, high-tech monitoring through final delivery.
2. Understand the rules and regulations.
Regulations regarding medical shipments vary widely from country to country.
Certain products may be subject to standards set by both the FDA and DEA (depending on the nature of the product) and medical equipment such as MRI parts are typically expensive, high-tech machinery that necessitate that the shipper follow standard best packaging practices for fragile goods. Biologicals and clinical samples may also be subject to Hazardous Materials or Dangerous Goods Regulations, depending on the mode of transport.
Guidelines for storage and distribution practices of drug products can be found at USP 1079
(United States Pharmacopeia). EU’s Good Distribution Practices
also include guidelines for best practices. “The guidelines are there to help maintain product quality, safety and efficacy by helping prevent risks such as product spoilage or theft,” says Susan Li, a senior cold chain packaging strategist for UPS.
The guidance in the EU’s guidelines can be supplemented by two technical reports (numbers 39 and 46) published by The Parenteral Drug Association (PDA). According to Li, "They help to translate the guidance into practices that your company can adopt."
3. Help maintain the required temperature range from pickup through delivery.
Temperature control isn’t just a matter of keeping your pharmaceuticals cool. Excessively low temperatures may be just as harmful as heat, while some items must remain at controlled room temperatures. A seemingly minor fluctuation of 2 degrees Celsius for a long period of time may spoil some pharmaceuticals.
Cold-chain shipments often require constant refrigeration between 2 and 8 degrees Celsius. The manufacturer’s recommendations detailing how the product should be shipped and stored, along with the FDA’s requirements for pharmaceutical storage conditions (CFR211), are good sources of information. International shipments may be subject to additional requirements as well.
An experienced logistics provider with the appropriate service offerings can help your healthcare shipments maintain the appropriate temperature throughout transit, storage and delivery. Look for a logistics provider that offers global access to compliant, healthcare-dedicated facilities and distribution spaces.
4. Pack healthcare products in temperature-controlled packaging.
From tarmacs to trailers, temperature fluctuations may negatively impact many healthcare shipments. Select the appropriate level of pre-qualified temperature-controlled packaging (TCP), which has been tested and validated to maintain a specific temperature range for a particular period of time.
Choose passive, active or hybrid TCP depending upon your needs and budget. Passive temperature-controlled packaging is typically comprised of a cooler within a corrugated box packed with refrigerant (dry ice or gel pack), cushioning (foam or packing peanuts), a leak-proof bag and absorbent material.
More complex active TCP includes thermostat-controlled refrigerated containers that are operated by an onboard power source like lithium batteries. Hybrid systems combine elements of both passive and active systems. UPS Cold Chain Solutions include Temperature True® Packaging, featuring custom packaging that offers multiple levels of protection.
5. Track and monitor your medical shipments.
Better tracking and monitoring could have provided the pharmacist in Michigan with better visibility into when the customer’s Parkinson’s medication would arrive.
When unexpected transit interruptions occur due to weather, customs delays or security inspections, it’s crucial to know that your product remains within the acceptable temperature range.
To identify incidences of temperature fluctuation and, potentially spoilage, it’s a good idea to place a temperature-monitoring device within your package. Devices range from thermometers that record minimum and maximum temperatures to a variety of battery-powered recording devices.
Competent logistics providers with the appropriate portfolio of services are capable of proactively monitoring where your temperature-sensitive goods are 24/7, predict likely delays – and importantly, take action to intervene and protect your product (for example, by replenishing coolant or providing refrigeration, if required).
According to MaryBeth Clapper, a UPS healthcare marketing manager for UPS Proactive Response® service, “More healthcare shippers are looking for protective services that help identify and intervene to minimize the probability that high-value, temperature-sensitive products could be spoiled in transit.”
When it comes to time- and temperature-sensitive medical shipments, higher levels of preparation may help lower spoilage rates, fewer re-ships and higher customer satisfaction, from Michigan to Micronesia.
Items you’ll need:
- Temperature-controlled packaging
- Cushioning material
- Temperature-monitoring device
Offer flexible delivery options
Allow recipients to schedule their delivery with UPS My Choice® service to ensure that your customers get their medication when they need it.
Packing tips for liquids
Enclose liquid clinical samples and biologicals in a watertight receptacle, surround it with absorbent material and seal it in a plastic bag or container before inserting it in appropriate outer packaging.
Shipping drug samples?
Simplify order processing with UPS SampleSure® technology.
UPS: Creating a Better Healthcare Cold Chain
UPS: Supply Chain Cost Management
UPS Temperature Control Solutions
FDA Code of Federal Regulations Title 21
EU Good Distribution Practices