Managing Medicines: Mitigating the Risks of Inventory and Storage

THE NUMBER OF prescription drugs ordered and provided in the U.S. each year is staggering. Between 2011 and 2014, data provided by the Centers for Disease Control and Prevention (CDC) showed 48.9 percent of the U.S. population (more than 326 million¹) used at least one prescription drug in the past 30 days. The number of drugs ordered or provided was 3.7 billion in physician offices, with 76.2 percent of visits involving drug therapy. In hospital outpatient departments, the number of drugs ordered or provided was 329.2 million, with 72.5 percent of visits involving drug therapy. And, in hospital emergency departments, the number of drugs ordered or provided was 317.6 million, with 79.6 percent of visits involving drug therapy.²

For this magnitude of prescription drugs, there are strict guidelines for their storage and handling established by the U.S. Food and Drug Administration.³ In hospitals, those guidelines are governed by the Centers for Medicare and Medicaid Services and The Joint Commission (TJC) to ensure consistency and that the processes are followed for patient safety, ethical decision-making and quality care.⁴ In physician offices and clinics, storage guidelines are governed by states’ pharmacy and medical licensing board regulations. It is also recommended physician offices and clinics follow policies set forth by TJC and the Institute for Safe Medication Practices.⁵

Meeting medication management requirements can be a challenge. Adequate lighting, ventilation, temperature, sanitation, space and security are of paramount concern for proper storage. And, drug waste due to product expiration can be extremely costly. For example, according to sources at Newton-Wellesley Hospital in Massachusetts, the facility is able to return some expired drugs for credit, but in 2017, it had to destroy about $200,000 worth of outdated medication. And, a commentary in the Mayo Clinic Proceedings cited comparable losses at Tufts Medical Center in Boston. In fact, similar scenarios are replicated in hospitals across the country, and the cost is significant: About $800 million per year of drugs is lost due to expiry, and this does not include the costs of expired drugs at long-term-care and retail pharmacies.⁶

Adhering to safe protocols for storage and inventory of medicines can be extremely labor intensive, requiring strict policies are in place that are overseen by dedicated staff. Fortunately, over the past decade, many smart technology solutions have become available for healthcare facilities to expedite compliance.

The Complexities of the Cold Chain

Product safety is heavily reliant on cold-chain logistics to manage temperature-sensitive products as they move through the supply chain. Products requiring cold-chain handling are predominantly biologics (blood products and vaccines) derived from living cells, delivered in liquid form by injection or infusion and packaged in vials or syringes.⁷ Projected growth of cold-chain biopharma products is twice that of the industry overall,⁷ placing added emphasis and increased regulatory scrutiny on proper storage and dispensing.

Some drugs that require cold-chain management need to be stored at controlled room temperature. Vaccines need to be stored at between 2 degrees and 8 degrees Celsius,⁸ whereas other drugs need to be stored at between 20 degrees and 25 degrees Celsius, with allowable excursion between 15 degrees Celsius and 30 degrees Celsius, as long as the mean kinetic temperature remains in the defined range.⁹ Too much exposure to heat, cold or light at any step in the cold chain can damage drugs and result in loss of potency. In addition, exposure to freezing temperatures could destroy some drugs.⁸

CDC Storage and Inventory Guidelines

According to a 2011 survey by TJC, not storing medications per the manufacturer’s recommendations and failing to remove expired drugs are top reasons for noncompliance in medication storage.¹⁰ To help mitigate problems with cold storage of biologics, CDC has written step-by-step guidelines. An overview of these are:⁸

1) Medicine packages should be opened immediately to assess for damage and temperature. Damaged or incorrect temperature drugs should be segregated in a separate location, and the supplier should be contacted for advice on how to proceed.

2) Medicines should immediately be stored at the recommended storage temperature. To assist with this, it is recommended a sign be placed on the refrigerator that lists the appropriate storage temperatures.

3) Medicines should be stored in the middle of refrigerators and never in doors that are exposed to warm temperatures when units are opened. They should be stored in their original packaging inside designated storage trays positioned 2 inches to 3 inches from refrigerator walls. And, when new product arrives, the stock should be rotated by placing newer medicines behind older ones. To help stabilize and maintain proper temperatures, two or three containers of water should be placed in areas of the refrigerators where medicines cannot be stored such as in doors.

4) Temperature inside refrigerators should be monitored and recorded at least twice a day to ensure they are within the proper range. Since a drug’s appearance is not a reliable indicator that it has been stored in appropriate conditions, it is critical to monitor closely. And, gasket seals should be periodically checked to ensure doors close completely.

5) It is recommended to place temperature log sheets on refrigerators and document the twice-daily checks. Celsius and Fahrenheit log sheets are available at www.immunize.org/catg.d/p3037C.pdf and www.immunize.org/catg.d/p3037F.pdf, respectively.

6) If it is suspected medicines have been exposed to out-of-range temperatures or have been left out of refrigerators, they should be marked with “Do Not Use” and transferred to a functional refrigerator at the proper storage temperature while determining whether the medicine is still viable.

CDC also has step-by-step guidelines for inventorying medicines. Briefly described, these include:⁸

1) Expiration dates, printed on vials, manufacturer-filled syringes and packages, indicate when the product must be discarded if it has not been used. If an expiration date has only a month and year, the product may be used up to and including the last day of that month. If a day is included with the month and year, the product may only be used through the end of that day.

2) In some cases, products must be used before their expiration. In these cases, the product will have a beyond use date (BUD) that is calculated based on the date the vial is first entered and the storage information in the package insert. The BUD replaces the expiration date and should be noted on the label along with the initials of the person making the change.

3) A stock record should be used to keep track of inventory. The record can be in paper or electronic form, or it can be part of an immunization information system with the capacity to manage vaccine inventory. The stock record should be updated weekly, and it should account for and document every dose of the medicine, including:

• Date of delivery (and initials of the person who unpacked the delivery)
• Medication and diluent name and manufacturer • Number and expiration date for each lot (including expiration dates based on BUD guidance in the product information)
• Number of doses received
• Condition of each medication and diluent upon arrival (i.e., did it arrive in good condition at the proper temperature?)
• Center for Comparative Medicine reading if included in the shipping container (and actions taken if the monitor was triggered, signaling a possible temperature excursion)
• Number of doses used (i.e., administered, wasted, compromised, expired or transferred [and destination])
• Balance of remaining doses after subtracting the amount used Multiple doses of the same medication in the same presentation from the same lot with the same expiration date can be documented as one entry on the stock record. However, the total number of doses received should be indicated, regardless of how many vials or syringes the doses came in. Doses of diluents that come with lyophilized medications should be documented on a separate stock record.

4) At least once a month and before placing any order, all medications and diluent doses should be counted to ensure the number of doses in the storage unit matches the number of doses documented in the stock record. If the numbers don’t match, the correct number should be entered based on the count on a separate line below the old balance, and the corrected balance should be used for calculating stock quantities in the future.

At the end of each month, the total number of medications and diluent doses used during the month and the amount of stock still available should be determined. And, at the end of the year, the stock record should be used to determine the number of doses received and used during the year to help minimize future waste.

5) Expiration dates on medications and diluents should be checked at least once a week. And, expired medications should be immediately removed to avoid inadvertently administering them. Expired medications should be documented on the stock record.

Simplifying Storage and Inventory with Smart Technology

Without a doubt, safely storing and inventorying medicines can be time-intensive. While many facilities establish their own systems to follow recommended guidelines, there are a number of simplified options that automate most of the required tasks. Below are just two examples of such smart systems.

Verified Inventory Program-Consignment (VIPc). VIPc is a streamlined inventory management solution designed for high-value and critical-care products. Developed by FFF Enterprises, a major distributor of plasma products, vaccines and biopharmaceuticals, the system is a radio-frequency identification (RFID)-based consignment solution that tracks and monitors products and the conditions in which they are stored. The cabinets are monitored by FFF Enterprises’ VIPc team on a 24/7 basis for both temperature and inventory. In the event of a temperature excursion, the team responds immediately to ensure product integrity is not compromised. When product is loaded or removed from the cabinet, the RFID technology updates the inventory of the cabinet without any manual intervention on the part of the customer.

Throughout each day, the facility’s staff can dispense product from the cabinet as it is needed for patient dosing, and once a minimum par level (a minimum quantity of a given item that must be kept on hand) is reached, an alert will go to the VIPc team, and replenishment will arrive the next day. When it arrives, the facility’s staff can simply open the box, load the products into the cabinet and close the door. RFID scanning and updating of the inventory will happen automatically. And, since it is a consignment program, the facility is invoiced only for products dispensed from the cabinet, which occurs at the end of each week.

What’s more, the VIPc team proactively monitors product expiration to ensure these high-cost critical-care products don’t go to waste. In the event a customer is unable to use product and it becomes short-dated, the team will reach out to facilitate a return of the product well before it reaches its expiration date so it can be sent to a customer who can immediately use it. The team then replenishes that facility’s cabinet with longer-dated product.

VIPc has been placed primarily in acute facilities and hospital pharmacies. Products most frequently stored in the VIPc cabinets are coagulation factors, which are costly and have unpredictable usage, but are critical to have on hand to save patients’ lives when need arises. In addition, facilities store specialty products such as those used to treat snake bites, heart attacks and strokes. The cabinets are also in place in many ophthalmology surgery centers to store a product used in cataract surgeries. According to Karen Sasscer, senior director, product and contract management for VIPc, most customers have the system set up for refrigerated storage (between 2 degrees and 8 degrees Celsius), but the cabinets can also be configured for controlled room temperature storage (between 20 degrees and 25 degrees Celsius), which brings versatility to support products with varying storage requirements.

“One of the great things about the VIPc program is it is more than just a consignment program,” says Sasscer. “The RFID technology gives remote visibility into real-time inventory levels and VIPc cabinet activity. With this, our team is able to automatically replenish product based on par levels, which eliminates the need for the customer to manually count inventory and call in orders. For any product carried in VIPc, once the inventory level has reached the minimum par level, an alert is triggered to the VIPc team that ensures a replenishment order is placed to get the customer back up to its normal stocking level. These replenishment orders are always shipped for overnight delivery.”

MinibarRx (MBRx). MBRx is a smart refrigerator designed specifically for vaccine storage, handling and inventory management. Developed in 2013 as a stand-alone joint venture of affiliates of Minibar Systems (the world’s largest maker of refrigerated platforms to the hospitality industry) and InstantDx (a pioneer in electronic prescribing and healthcare-transaction services), the system is designed to improve the process of purchasing, storing, administering and billing for refrigerated vaccines in physician offices, retail pharmacies and non-acute, ambulatory surgery centers and urgent care facilities.

As an affiliate, FFF Enterprises provides the MBRx refrigerators with the vaccines it distributes and automates the MBRx process using its proprietary software that sets a reorder point for each refrigerated vaccine at each location based on average usage. Reports are received each day with all refrigerated vaccines that have reached a reorder point, and then orders are placed for those items up to the maximum capacity/par level for that medication. To avoid product expiry, electronic notifications are communicated to providers starting 45 days prior to the medication’s expiration date. An LCD screen on the unit also displays all vaccines close to expiring for proper management. If a product does expire before being used, the LED indicator light on the dispenser will turn red to indicate not to use the product. And, if the product is removed for use, an alarm will sound and an email notification will be sent. At this point, the product would then be returned for possible credit based on the manufacturer’s guidelines.

The MBRx system works as follows at the provider’s location: To remove a product, a staff member logs in with a unique four-digit code, an LED light illuminates green alerting the member to pull from a particular cartridge to manage expiry, and then the user removes what is needed and closes the door. When a vaccine is removed, it is automatically recorded and reordered when a minimum par level is reached. When orders are shipped to the practice, the medication information (product, lot number, expiration) are pushed to the machine to aid in the refill process. A staff member then enters a six-digit refill code, selects the product to refill, verifies the information matches, and the unit tells the member which dispenser the product goes in. Temperature readings are recorded automatically by the unit every 10 seconds, and they are uploaded to FFF’s portal every 10 minutes. If a temperature reading is out of the designated range, it triggers an alarm at the unit and sends an email notification to all MBRx internal support staff and any designated practice managers.

According to Tim Mikac, general manager and executive vice president of the MBRx division at FFF Enterprises, “Alerts of expiry are rare, as the reorder points are based on actual usage data and we only order when those thresholds are hit. However, when an expiration alert comes through, the office will work to schedule patients who could use that product, if possible. A wasted vaccine is unfortunate.”

MBRx greatly reduces the labor-intensive activity to comply with guidelines for storage and handling. “The MBRx unit reduces the amount of time spent ordering, rearranging and stocking product,” explains Mikac. “We provide 24/7 monitoring of temperature and power, and there are multiple temperature sensors integrated throughout the unit to provide a more accurate indication of the temperature at any point in the unit. Sensing built into the dispensers allows providers to know exactly when a product was taken out and who took it, and the current inventory can be accessed at any time via the screen or the physician portal. Reordering is done automatically via daily reorder reports, which eliminates the need to count inventory and place orders for anticipated usage. All of this offers reassurance that product is stored safely, offering optimal clinical outcomes.”

Easing the Burden

Considering the enormity of medicines — especially biologics requiring cold-chain-logistics — stored in healthcare practices, hospitals and pharmacies in the U.S., safe handling and dispensing is a serious concern. Rightly so, the many regulatory agencies overseeing healthcare facilities demand adherence to strict storage and inventorying guidelines to ensure patient safety. Since following those guidelines can be very time-consuming and costly, smart technology systems offer a valuable option to ease the burden and promote optimal outcomes for providers and patients.