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Packaging and Temperature Indicator Selection for Pharmacy Pack-Outs

There are several forces pushing healthcare professionals to provide patients with personalized medicine, in which treatments are tailored to suit the needs of individual patients. The development of disease-specific biomarkers, advanced technologies in high-throughput chemical screening and genomic sequencing, and healthcare reform policies that require more efficient patient care are all leading to the formulation of medications that target specific people instead of the general population.

Still, the last mile of shipment between a specialty pharmacy and the patient’s mailbox is the most hazardous leg of a medication’s journey along the whole cold chain.

Ultimately, it may be easier to find these new drugs in specialty pharmacies rather than retail businesses, and all signs are pointing to a significant expansion in the business of specialty pharmacies across the U.S. For example, Express Scripts noted that spending on specialty prescription drugs in the country will grow by 67 percent by the end of 2015. This is driven in part by the onslaught of new biologics, as well as clinical trends that see doctors delaying treatments for patients in anticipation of new medications hitting the market. Specifically, spending will increase for products that treat diabetes, cancer, multiple sclerosis, inflammatory conditions and hepatitis C.

Specialty pharmacies may even play a more active and engaging role in patient care. Experts from many PBM’s have demonstrated that support from a specialty pharmacist can improve adherence rates for immunosuppressive medication among organ transplant recipients.

Furthermore, the patient population itself is also dynamic. Chief among the most significant changes is the ongoing growth in the number of senior citizens, who tend to have more complex and chronic medical conditions compared to the general population. The U.S. Census Bureau estimated that between 2010 and 2015, the number of individuals age 65 or older will increase by 16 percent.
Between 2010 and 2020, that percentage increase will be 36 percent.

All of the above underscores the growing prominence of specialty pharmacies, as well as the importance of maintaining optimal potency for these products as they make their way from the pharmacy to the patient’s mailbox. Still, even after a drug completes the journey – starting from the manufacturer, to the wholesaler, to the specialty pharmacy to the patient’s home – the entire trip is all for naught if the specialty pharmacy is having issues with maintaining proper temperature control.

This can happen on the front and back end of handling a medication. Once your business receives a shipment of drugs from a manufacturer or wholesaler, you need to pay attention to how you handle it and where you store it. Refrigerators and freezers must be compliant with industry regulations, and even within these storage devices, temperature distribution is not likely to be perfectly uniform.

Following the best practices regarding the reception and storage of medications is something that comes under the control of specialty pharmacies. What is more unpredictable is the patient experience. If the customer is not confident in the product because the temperature of the delivered package does not feel right, he or she may request a new shipment. At an additional cost of $20 to $50 per product replacement – an expense that is independent of the drug itself – this spending will accumulate rapidly if a specialty pharmacy cannot keep reshipment requests under control.

The repercussions are numerous regardless of whether there truly was a temperature excursion. At the level of the patient, requests for reshipment cause a delay of care, and a possible deterioration of the disease state. If there was temperature abuse, and the patient is not aware of it, he or she may use medications that are not as potent as they should be, which is another potential cause of worsening symptoms.

Meanwhile, there are brand and image issues that reach far and wide. Consumers may lose confidence not only in the medication and its manufacturer, but also in the specialty pharmacy that shipped it. In short, temperature excursions – or the mere perception of them – are expensive.

Fortunately, they are also preventable.

Drug manufacturers have been dealing with issues surrounding the prevention of temperature excursions for the last 25 to 30 years, and during the last decade, the accumulating knowledge has been flowing downstream to other segments of the pharmaceutical industry.

“[Regulators] focused on the manufacturer level: How are they maintaining their product temperature? What documents do they have to prove it?” said James Chasteen, product development manager of Cold Chain Technologies. “Once that segment of the supply chain firmed up everything they were doing, you saw the regulation move down the chain to the wholesalers, and then you saw the wholesalers start to get in line.”

Now, manufacturers and pharmacy benefit managers want more of a say of what happens during the last mile between the specialty pharmacy and the patient’s mailbox. The former is interested in protecting its brand and consumer confidence, while the latter wants to control the growing costs of drug reshipment.

It starts with the packaging

With the availability of a wide range of packaging products designed to protect drugs from temperature abuse – insulated boxes, gel packs and so on – it can be very tempting for specialty pharmacies to think that they can take care of what is widely known as “the last mile” of a medication shipment themselves.

However, what you do not know can hurt you and your customers. Sure, you can use frozen gel packs to keep their medications cool, but if you do not know where to place the frozen gel packs in the package in relation to the product load and other shipment components, you may subject the medication to damage from temperatures that are too low.

Ultimately, you need to look at the journey of your products, and you need to explore the individual components of the package.

  • What kind of medications do you ship to patients? Cancer therapies? Biologics? Drugs for autoimmune disorders?
  • What hazards does the package have to withstand in order to protect the product load? Heat? Cold?
  • What is the geographical reach of your customer base?
  • Are they within the same region as your specialty pharmacy, or are they distributed throughout various locations with different climates?
  • How quickly will your package be received?
  • Are your patients able to take it indoors and open it right away, or do they work and need to leave it outdoors for an indeterminate amount of time?

Once you answer these questions, you can have a better idea of what products you need for packaging purposes in order to provide adequate protection, ensure smooth relationships with manufacturers and wholesalers, and inspire patients’ confidence in your specialty pharmacy.

Excluding the medication itself, your list of basic packaging components may look something like this: a time-temperature indicator, insulation or packing materials, gel packs and the box. Even without the wide variety of individual shipping products, there is no one-size-fits-all approach to drug shipment. Your specialty pharmacies’ needs will dictate which products you should choose.

The reputation of time-temperature indicators is growing

Vaccine programs around the world bring millions of doses of potentially life-saving inoculations to countries that have few resources. The problem here is that transportation and storage can become issues, particularly in hotter climates. However, the use of time-temperature indicators in the field can give public health workers assurances about whether temperature abuse occurred.
While this is an obvious asset in international public health efforts, there are still stakeholders among the specialty pharmacies in the U.S. who are skeptical about the value of time temperature indicators in their businesses. Specifically, they are concerned about whether patients will be able to interpret the devices that can be enclosed in a shipment, and how much extra costs will be added onto a shipment to cover the expense of a time-temperature indicator.

Still, the last mile of shipment between a specialty pharmacy and the patient’s mailbox is the most hazardous leg of a medication’s journey along the whole cold chain.

“The packaging materials to distribute one dose of product from a pharmacy to a patient is much less robust than the processes and the packaging that is used to ship multiples doses of product from a central warehouse or a manufacturer to the pharmacy,” said Michael Montana, Business Development Manager at Temptime.

“Explore the possibility of incorporating reliable temperature monitoring devices into cold chain logistics, a strategy employed by some pharmaceutical manufacturers, although not yet adopted by many of the specialty pharmacies who ship directly to patients,” Ron Krawczyk, managing partner at Blue Fin Group, wrote in Specialty Pharma Journal.

“Some indicators can be affixed directly to individual units to show the end user (patient or caregiver) whether the product was, or was not, exposed to excessive heat or cold outside the proper shipping range. By employing this tactic, the distributor or specialty pharmacy can address the concern of the manufacturer by stating that they are engaging in processes that will monitor the shipment, ensuring careful handling of the product, and for the patient, confidence that their medicines have been maintained within the proper temperature range.”

You need to weigh the concerns you have about time-temperature indicators against your customers’ desires and needs, your relationships with your suppliers and your business’s bottom line.

One survey of patients, conducted by experts at Citizens Rx, revealed that 96 percent of respondents wanted their pharmacies to enclose time-temperature indicators in their shipments. The same percentage of participants said that such an action demonstrated that the pharmacies made their safety a top priority. Ultimately, more than half of all patients in the survey said they had concerns about their delivered drugs being too warm or too cold.

As to the cost concerns surrounding time-temperature indicators, it is important to remember that there are several types of devices, according to experts from CoolPack:

  • Digital time-temperature indicators provide very accurate, full time histories in the form of X-Y axis graphs. Different devices are available for single or multiple use. However, they rely on battery power.
  • Chemical time-temperature indicators undergo physical changes, which are manifested into some sort of visual on the devices themselves, upon exposure to temperature excursions. Although they are not quite as accurate as digital devices, they can be easier to pack because of their sizes. Most of these devices are for single use.

Additionally, there are different indicators that can monitor cumulative temperature excursions or single instances of abuse. Whichever one you choose for an individual shipment will depend on whether the medication can be exposed to single events without any adverse effects.

Ultimately, when it comes to the patient, chemical time-temperature indicators are much cheaper than digital options. The additional cost may be unavoidable, but it is definitely worth the investment. You can earn the trust of your customers by showing them that you care about their safety, and they can feel more confident about the potency of the drugs you ship to them. This can significantly reduce the number of unnecessary reshipment requests, eliminating treatment delays and additional expenses for manufacturers and payers.

Pick your packs

Gel packs are a valuable component of the packaging system because they help maintain a near- constant temperature during the shipping process. These items are typically available in two forms.

  • Rigid or brick gel packs look like bricks or bottles. You should use this variety of temperature control if you are particularly concerned about providing a reliable shape in your insulation. Additionally, rigid gel packs are reusable.
  • Flexible gel packs are readily available in custom sizes. Although flexible gel packs are less expensive than rigid gel packs, they are also more likely to leak and are often restricted to single uses.

Knowing how to pack these temperature maintenance products can be just as pivotal as the products themselves, according to Anthony Rizzo of Cold Chain Technologies.

“There are two common practices in the specialty pharma market that have long been avoided in the first mile – those shipments made from the manufacturer,” he said. “These include placing frozen refrigerants directly on the product and placing packed out shippers into a refrigerator prior to carrier pickup. Either of these practices, on their own, has the potential to damage product. Combined they almost guarantee that product temperatures will go too low.”

Consider the construction and material of your boxes

Ultimately, the thermal system of your package – medication, time-temperature indicator, gel packs – are encased within a box that not only has to withstand climate forces, but also impacts and vibrations. When deciding on what box to use, there are two characteristics to bear in mind: construction and material.

Construction

  • The bodies of molded boxes come with matching lids that help maintain the integrity of the thermal system. They are not collapsible.
  • Paneled boxes have six matching faces and are collapsible.
  • Compared to molded boxes, paneled boxes are more likely to lose thermal control, particularly at the corners of the boxes.

Material

  • Expanded polystyrene, or white foam, is the most broadly used type of insulating material, according to Cool Pack. It is also used to absorb impacts and vibrations.
  • Polyurethane, also known as yellow foam, is another common material.
  • Vacuum panels, which are paneled boxes, is a relatively new type of boxing material.

While expanded polystyrene is inexpensive, flexible and low-weight, it is not a robust insulator, and it is not recyclable. Polyurethane is not recyclable, either, but compared to expanded polystyrene, it is more durable and has better insulation capabilities. Unfortunately, polyurethane is also heavier than expanded polystyrene. Meanwhile, vacuum panels are both collapsible and high-performing, but they are also the most expensive form of insulation technology available for the shipment of drugs.

Make sure your process works

Reviewing the individual needs of the products that you ship to your customers will determine the most appropriate packaging. Once you decide which packaging components you need to buy, you will be
forming partnerships with each vendor you encounter. As part of this relationship, be sure to ask the vendors for documentation on the specifications of the packaging components they are selling to you.

Still, being able to select the most appropriate elements of your packaging does not necessarily mean that your shipment process will protect the drugs that you send to patients. Even when you pack a shipment according to manufacturers’ recommendations, temperature excursions are still possible. One study, conducted by experts from Modality Solutions, compared the performances of five common specialty pharmacy packaging containers: insulated bubble bags, insulated envelopes, insulated box liners, expanded polystyrene panel sheet coolers and expanded polystyrene molded coolers. Laboratory conditions simulated seasonal extremes in weather over the course of a delivery. Results showed that none of the packages were able to protect their contents from temperature excursions during the first 24 hours of shipment. Additionally, most of them failed to live up to their published claims.
Being able to validate this process is likely to go above and beyond what your specialty pharmacy is capable of, which is why you should consult a firm that specializes in thermal packaging solutions. Such businesses should be up to date on the best practices of maintaining temperature control throughout the lifetime of a medication, from the manufacturer to the patient.

Thermal packaging solution firms often have laboratories that are capable of recreating the conditions that drug shipments will undergo in the real world. Depending on the geographical reach of your customer base, the firm you choose to work with can simulate various climate environments during different points in time throughout the year. These experiments produce detailed laboratory reports that either validate your shipping process or pinpoint areas that need improvement.
The reports also provide an opportunity for specialty pharmacies to receive education on the best practices in medication shipment, such as how to arrange the components of a thermal system. This procedure may have considerations for where to place frozen gel packs, how to fill void spaces and how to seal containers.

Do not think that validation of your current shipment process is the final step. As with the partnership you form with the vendors of the individual packaging components, the relationship you establish with a thermal packaging solution firm is an ongoing one.
“It is important to note that as these specialty pharmacy businesses grow and expand, they will be taking on new therapies to distribute,” Chasteen said. “Those new therapies may have different thermal properties and may have different temperature criteria. [Specialty pharmacies] may be shipping to different locations if their businesses grow. They may open new distribution centers and specialty pharmacies to help serve the public. As all of those changes take place, it is important to go back and
go through that same process. This is an ongoing continuous improvement process to always make sure that as these changes occur, your packaging you selected is still doing what it needs to do even though that environment has changed.”

Chasteen also noted that specialty pharmacies can learn more about thermal packaging solution firms through educational seminars, industry events or scientific publications.

Always remember the patient through business squeeze

Being able to demonstrate that you are able to protect the integrity of your drug shipments from temperature abuse can make you stand out for accrediting bodies in the industry, such as URAC and the Accreditation Commission for Health Care. In turn, these stamps of approval can boost your reputation among customers.
Still, reputation or not, it is the patient who should be at the center of all your self-improvement efforts. “The direction of temperature-controlled shipping should always be patient- and product-safety
driven,” Geoffrey Glauser, vaccine and therapeutic supply chain contractor and subject-matter expert with Conceptual Mindworks, told Packaging World. “The more data that is gathered that supports such activities will further ensure safe administration of the pharmaceutical or biological. The more one focuses on the safety and effectiveness of a medication, the more positive impact it will have on the medical malady.”

SOURCES

Specialty Drug Spend Expected to Significantly Increase Throughout 2015

Study-Shows-Higher-Adherence–Lower-Costs-for-Patients- Acquiring-Drugs-from-a-Specialty-Pharmacy

New-Bill-Would-Allow-Cancer-Patients-to-Choose-Preferred- Outpatient-Setting

http://www.coolpack.com/lesson_info.php?id=31

http://www.coolpack.com/lesson_info.php?id=33

http://www.coolpack.com/lesson_info.php?id=32

http://www.coolpack.com/lesson_info.php?id=41

Protecting-Medicines-Through-Cold-Chain- Distribution

http://aoa.gov/AoARoot/Aging_Statistics/future_growth/future_growth.aspx

http://www.specialtypharmajournal.com/index.php?option=com_content&view=article&id=3731

Cold Chain Interview with Mike Montana, Temptime