How Stricter State Regulations are Leading to Continuous Monitoring

Accurate temperature monitoring is necessary to ensure the safety and efficacy of all medications and vaccines. That should be a given in the pharmacy industry. But the truth is, for many pharmacy chains and independents, temperature monitoring is merely guesswork. Too frequently staff responsible for temperature monitoring don’t understand the “why” of recording temperatures. And when we don’t understand why, we often don’t realize the “how” either—that is, some methods are better than others.

In this blog post, we’ll demonstrate that manual clipboard monitoring, the status quo for most pharmacies, not only should be but will be replaced by continuous remote monitoring. We’ll start with a high-level overview of the issues, including:

• The current status of state regulations
• The probable future of state regulations
• The drawbacks of manual monitoring
• Why continuous monitoring is the way of the future

The Current Status of State Regulations

State regulations regarding temperature monitoring of medications and vaccines are typically vague, in a perpetual state of flux, and different from state to state. The nature of the regulations vary, as well as how they are interpreted and enforced. See the “heat map” below showing the wide range of regulatory requirements across the country. The darker the blue, the stricter the guidelines. This map has aggregated regulations from the perspective of community/retail pharmacies:

Many standards are vague or unclear in direction.  For example, consider this directive, typical of many states: “Must have sufficient temperature storage for medications.” What does this statement mean, exactly? What are the minimum requirements? Will they be enforced, and if so, how?

Perhaps the primary cause of this confusion is because four different governing bodies and health protection agencies set temperature guidelines: U.S. Pharmacopeial Convention (USP), State Boards of Pharmacy, The Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA). The relationships among these organizations are complex, and decisions made by one can have a ripple effect on the others.

Stricter State Regulations on the Horizon

As non-regulatory agencies such as USP set stricter guidelines, many state boards of pharmacy adopt their recommendations as law. In fact, as the map indicates, pharmacy temperature regulations are beginning to move in the direction of greater specificity. Some states are beginning to adopt more rigorous temperature monitoring requirements well beyond the current state of regulations, especially Oregon, Nevada, New Jersey and Massachusetts.

For instance, Oregon is leading the way by applying the standards for Vaccines for Children (VFC) to all medications and vaccines in the state. Why are these states going above and beyond? Because when it comes to medication and vaccine safety, it’s far more sensible to be proactive than reactive. These states have also experienced significant temperature excursion events, which led in Oregon to re-vaccinating thousands of citizens.

We expect even more major changes to occur in the near future.  With each passing year, the states on the map get darker and darker. It makes sense to implement higher standards now rather than have them forced upon you down the road when you aren’t prepared.

The Drawbacks of Manual Monitoring

Stricter temperature standards require greater accountability. And frankly, manual monitoring systems aren’t up to the task. Today, many pharmacies monitor temperatures twice a day using a clipboard system. In effect, a pharmacist or technician is expected to check the temperature of every storage unit (e.g. a refrigerator or freezer) and record the temperature manually, usually only at opening and closing time.

Although manual monitoring systems are “acceptable,” they are fallible due to human error. Manually logged data can be inaccurate, inconsistent, or in the worst cases, entirely overlooked. A clipboard system also lacks visibility. Checking twice a day does not guarantee medications and vaccines remained within the proper temperature range for an entire 24-hour period when temperature excursions could have taken place. In fact, these are quite common and often caused by everyday circumstances, such as:

• Compressor cycles 

• Air circulation patterns 

• Defrost cycles 

• Doors opening or closing 

• Inventory being put in or taken out
• Doors being left open by accident
• Power outages
  
  

A 2016 TempAlert study of 15,000 pharmacy refrigerators found that 1 in 4 are not operating as they should. This means temperature-sensitive medications and vaccines are frequently being exposed to temperatures which may likely reduce their effectiveness.

Additionally, the practice of clipboard/paper-based monitoring can devolve into a mindless habit. Employees responsible for manual temperature monitoring may see it simply as the WHAT—something to check off on a daily list of duties—without understanding WHY it’s important. And if they don’t know the WHY, they won’t understand HOW digital monitoring is superior for preventing temperature excursions and product loss.

Continuous Monitoring: The Way of the Future

Progressive pharmacies are already beginning to move away from paper logs/clipboard systems and toward continuous (24/7) temperature monitoring technology. A digital system provides a PROACTIVE approach to assuring medications are stored appropriately to stay safe and effective. It is impractical, in fact, impossible, to achieve the same results with a manual system.

A continuous monitoring solution should offer general temperature reporting, incident reporting, and real-time notification.

Above all, alerts are crucial to a timely intervention. Pharmacies not only need to know when temperature excursions happen but also must be able to respond immediately. That can only happen with digital alerts and real-time notifications.

Proactivity and knowledge are key. It’s vital to know when a temperature excursion has taken place before a vaccine or medication is delivered to a patient. Otherwise, it’s possible to dispense a vaccine or medication and only later find out it was ineffective or even dangerous.

Obviously, the negative consequences of uncorrected temperature excursions can be significant, including re-vaccination programs, patient lawsuits, the need to dispose of compromised inventory, serious reputational damage—and most importantly potential health consequences for patients. Just imagine...after convincing patients to get vaccinated for their own protection, they get notified their vaccine was degraded because of improper storage. They lose their sense of security, and you lose their trust.

A Tipping Point Fast Approaching

As states like Oregon move forward with increased regulation and the USP gears up to release new guidelines, it’s time to get on board with the future of temperature monitoring. Many national pharmacy chains are starting to realize they can’t manage regulatory changes on a state-by-state basis, and that it makes more sense to roll out best practices across the board.

Our advice is to be proactive. Strive to meet the highest requirements. If you aren’t able to roll out a digital system to every location at once, prioritize your activities state-by-state based on where regulations and enforcement are tightest today. But keep your eye on the horizon and remember the best offense is a good defense.

Get Access to Our Temperature Compliance Map! 

Get access to our interactive pharmacy temperature compliance map to view a state-by-state overview of temperature compliance rules and regulations for medications and vaccines.