Jul 01, 2018Pharmacies, both in retail and hospital locations, have to store for use many drugs and vaccines that must be maintained at a very specific temperature to ensure they retain effectiveness and regulatory compliance. These pharmaceuticals are often stored in small, self-contained refrigerators of varying quality, yet they maintain safe temperatures of important and valuable life-saving medications. The consequences to patient well-being, as well as the potential for regulatory fines, if they are not effectively operating can be severe.
Pharmacies are incredibly busy places and these refrigerators' doors are opened dozens of times per day by a range of personnel. Pharmacy personnel's focus on quickly and accurately filling a prescription can cause them to not notice whether the door is properly closed or if the inside temperature is at the right level.
The failure of proper storage could include degradation of prescription medication's effectiveness, which can impact patient health or possibly even cause fatalities. Not only is that contrary to their mission, but the organization might suffer financially by not receiving full insurance reimbursement for the patient's care, or the hospital may be sued or fined. Additionally, the Joint Commissions include provisions for hospitals incurring significant fines if their pharmacies are unable to provide proof that their medication storage has been in compliance with manufacturer specifications and regulatory requirements.
Aside from using small refrigerators with varying levels of quality, there are other actions that contribute to potential issues:
• Accidental mishandling, such as leaving the door ajar or unplugging from the power source
• Compressor failures due to overfilling beyond rated capacity or irregular power supply
• Maintenance falling behind the manufacturers' recommended schedule for filter replacements, cleaning or recharging refrigerant
• Inaccurate internal temperature readings
Failures of these critical pieces of pharmacy equipment often go undetected or unaddressed, exacerbating the problem. Why?
1. Many pharmacies assign team members to take manual readings of the temperature at preset intervals which do not account for issues that happen between two readings. It also distracts staff from performing their core duty: patient care. Moreover, urgent patient matters always take precedence over collecting temperature data, so staff may not be diligent about it causing further delays in attending to a failure.
2. Some hospitals rely on local alarms where the temperature-monitoring sensors may emit an audible sound when the temperature exceeds its limits. While this may work for a few alarms, it tends to fail in a larger institution. Hospital staff must react to several audible notifications in a given day and are already suffering from alarm fatigue. Adding another (perceived) low-priority alarm may result in it being neglected or, worse, turned off entirely.
3. Both of the above methods do not collect and store temperature data for proof of compliance. Without data, it is difficult to prove to the Joint Commission that a pharmaceutical or vaccine has always been stored within recommended temperature settings.
4. There are IoT software solutions in the marketplace that use Wi-Fi-based temperature-monitoring sensors that measure and transmit temperature data as often as at five-minute intervals. These solutions perform the basic functionality of storing and reporting on data values per appliance, and also alert a staff member via email or text message in case of a temperature issue. However, these systems do not follow through the entire lifecycle of the alarm, from occurrence to resolution. Simply alerting once may leave an email or text unattended for several hours. It is possible that the person being alerted may be on a break, off duty or on vacation. If the alarm is, in fact, closed, there is no way to record remediation steps taken to resolve the issue, which is a requirement from a compliance standpoint.
5. Hospitals and retail pharmacy chains must look for a solution with the capability to monitor, predict, and control the units.
• Monitor: Monitoring software can remotely capture and record temperature readings, as well as equipment performance, at predefined intervals. An operational range can be configured for each refrigerator, providing thresholds defining what temperature range the sensors should be experiencing. When the measured value goes above or below the defined range, the solution creates an alarm flag, which can then be evaluated and filtered.
Hospital personnel can receive an alert to evaluate, but if they fail to respond in a timely fashion and the temperature is still out of range, a timely work order can be routed to the appropriate responder. Look for software that can determine whether the alarm has been responded to or ignored by the first responder, so it can be escalated, if necessary, until the issue is resolved. The lifecycle of alarms and work orders can be recorded at every step until the issue is resolved. The team member who solves the issue has the ability to document how they fixed it, which supports compliance record keeping.
• Predict: In addition to monitoring exceptions, best-in-class IoT solutions can predict failures before they occur. Using historical data and artificial intelligence algorithms the system can warn team members of irregular temperature data patterns that historically lead to appliance failure. Getting early warnings is extremely helpful, as preventive maintenance is less expensive than reacting to a critical failure. Look for software that can integrate with sensors that measure the current drawn by the refrigerators. This enables the identification of voltage and current spikes that often cause damage to the equipment.
• Control: In some cases, if the refrigerator or control system allow bi-directional communication, software can predict failure and change the refrigerator's operational parameters to avoid the issue altogether. This could include changes to temperature set-points, varying of defrost cycles, and validation of standard across an enterprise. Systems with control measures are the most cost-effective because they require the least amount of human intervention.
Adoption of a best-in-class IoT platform can allow hospitals and pharmacies to keep their patients safe and avoid compliance fines, while empowering their staff to do what they do best: care for patients. Get automation to control this critical, but often overlooked piece of equipment.
Kapil Asher is the director of IoT solutions at Accruent, a leading provider of physical resource-management solutions. In this position, Asher works with hospitals in identifying challenges related to medical equipment availability, compliance on preventive maintenance and monitoring environmental conditions affecting patient care. Asher's specialties include sensor hardware, including passive and active RFID, software architecture, data analytics and workflow optimization.