Protecting Temperature Sensitive Therapies in the New Climate Normal

July 2023 went down in the history books as the world’s hottest month on record, possibly back over 100,000 years according to scientists. Parts of Europe, China, and the US experienced prolonged periods of record-breaking heat last month. In Arizona, temperatures rose to above 110 degrees for 27 consecutive days, creating many hazardous health situations. In Phoenix, hospitals reported treating patients with third-degree burns after coming into brief contact with scorching pavement.

NASA climate experts suggest that August and September are looking just as hot. The extreme heat can damage medications such as insulin and other temperature-sensitive injectable therapies that may face exposure while in a hot cargo area during transit, left on a front porch after mail order delivery, or inadvertently left in a car.

Clinical breakthroughs require safeguarding

The majority of injectable therapies have labels that require storage between 2° and 8°C (36°F to 46°F) until opened. Many of today’s best-selling and most commonly prescribed medicines – Ozempic, Humira, Dupixent, Keytruda – have this requirement. When these medicines are packaged for distribution, which increasingly happens in a direct-to-patient manner, qualified shipping containers built with advanced insulation and coolants are used to maintain the required temperature range for the expected shipping duration.  Therapies leave distribution centers well-protected for the elements, but risk is introduced by real world factors like human error and weather events.

With the increase in direct-to-patient (mail order) shipping over recent years given better convenience and potential cost savings, onus has seemingly shifted to patients for helping ensure their own medication safety. When temperature-sensitive medicine is exposed to heat, its efficacy is compromised. Sometimes medicine can become discolored or experience a change in consistency when it experiences a temperature excursion. However, sometimes it looks the same – and many times, a patient doesn’t even think to check. When a vial of insulin is left in the sun, it breaks down only after an hour of exposure. This means any injections drawn from the affected vial will not manage blood glucose levels effectively, putting the patient in harm’s way.

The best defense is a good offense

For patients receiving medicines at their home, there are many approaches to employ in order to limit possible exposure. Signing up for delivery alerts, installing a doorbell camera, and asking a loved one or neighbor to retrieve deliveries in a timely manner can all help lessen the likelihood of a medicine being left out in the heat for too long. While all of these strategies are good for mitigating risk after the time of delivery, none take in to account what happened during transit. The only way to be certain a medicine stayed within range during the entire distribution journey is to outfit the product packaging with temperature sensors that record what the medicine experienced in an end-to-end manner. With advances in IoT technologies, these loggers have become smaller, smarter, and more cost efficient to deploy as ‘connected packaging.’

Imagine being a patient and opening a package of medicine and immediately seeing a visual stoplight indicator letting you know if the therapy is safe to take (green light) or experienced a temperature excursion (red light). Taking this scenario, a step further, the presence of a red light sends a signal alerting the distributor to the issue including the medicine name, temperature data, serial number; in addition, a replacement is ordered and expedited for delivery. These capabilities are available today and very timely given a troubling global warming outlook that is coinciding with ongoing new development of injectable therapies.

With climate change anticipated to continue its impact on planet Earth, short of any significant and widespread change, there will be more severe and catastrophic events – heat and otherwise. And while there is heightened concern for handling of medicines in need of cold chain protection in the face of prolonged heat, ‘standard’ therapies may be at risk, too. When talking about outdoor temperature readings in the 100s, the notion of ‘room temperature,’ commonly defined as 15 to 25 °C (59 to 77 °F), becomes harder to achieve. This may introduce the need to rethink how to maintain a stable temperature range for formations such as tablets and capsules (stay tuned to our blog for more on this emerging topic).