Produced by

Becker’s Hospital Review

June 2021

Faculty

Neil Colby, RPh

Director of Infusion Pharmacy Services

CDRx Infustion

Introduction

To ensure safety throughout the supply chain and in the patient’s home, providers are adopting tamper-evident products for intravenous home infusion.

To better understand the steps home infusion providers are taking to ensure safety, Becker’s Hospital Review recently spoke with Neil Colby, RPh, an infusion pharmacist and Director of Infusion Pharmacy Services for CDRx Infusion in Boca Raton, Fl.

CDRx Infusion is a Home Infusion and specialty pharmacy provider.  The company provides IV medications for use in the home and physician office setting. CDRx serves all of Florida, including Dade, Broward, and Palm Beach counties; CDRx also serves 19 other states across the US.

The trend of caring for patients at home is driving growth in the home infusion market 

One of the major trends in healthcare — driven by payers and hospitals focused on managing costs — is discharging patients as quickly and as safely possible. This is leading to growth in home care and home infusion services. Patients that require infusion therapy no longer need to be hospitalized, as infusion pharmacies and home health companies such as CDRx Infusion can provide these services in the home care setting.  Patients prefer to heal in the comfort of their homes.  Patients can receive, as an example, IV antibiotics in the home just the same as they can receive them in the hospital; not only is this a more convenient option for the patient, but it is also more cost effective for our health care system.

This trend is driving significant growth in the home care and the home infusion markets. It is also leading companies such as CDRx Infusion to provide a variety of medications for administration in patients’ homes, using different types of packaging and a broad selection of administration methods. Packaging includes IV bags, IV push syringes, and ambulatory infusion pumps, to name a few.

For home IV infusion providers, patient safety is a paramount concern

In Mr. Colby’s experience, the complexity and risks associated with intravenous medication administration are greater than with oral medications. Since IV medications are infused directly into the bloodstream via an IV line,

it is critical that the medication infused is a sterile, pyrogen free product and all procedures during the infusion process promote sterility to avoid things such as a line-associated bloodstream infection.   As Mr. Colby explained, “With oral medications, it is not required that a pill or capsule, for example, be sterile; the food we eat is not sterile, and our GI system protects us from getting bacteria from the things we ingest before it can enter our bloodstream. But when it comes to IV therapy, sterility and proper infusion technique are paramount.  With IV medication, if someone were to access the medication outside the pharmacy and contaminate the product . . . it could likely lead to sepsis, line infections, and/or other complications that could put the patient’s health at risk.”

Prep-Lock Tamper Evident Products from IMI

Figure. Prep-Lock Tamper Evidnet Product by IMI

While Mr. Colby recognizes that the greatest risks from pharmaceuticals that are tampered with and/or contaminated are to the health of the patient, he acknowledged that it also poses significant liability risks to the pharmacy. According to Mr. Colby, “If something happens to a patient, it could circle back to the pharmacy, because it is the pharmacy’s responsibility to ensure product safety and to do everything possible to protect the integrity of the product until the time of administration, which includes protecting the dispensed medication from possible malicious and/or accidental tampering.” If something untoward happens, the unthinkable, questions will be asked of the pharmacy “what was done to secure the integrity of the product”? It is unfortunate, but history tells us the unthinkable is possible and the adulteration of pharmaceutical products is something we need to protect against.
One of the major trends in healthcare — driven by payers and hospitals focused on managing costs — is discharging patients as quickly and as safely possible. This is leading to growth in home care and home infusion services.

Any issues with patient safety pose reputational and financial risks for the pharmacy and can threaten a pharmacy’s long-term viability. Mr. Colby discussed these risks. “You don’t want to experience a bad outcome that puts a patient’s health at risk and may damage the reputation of the pharmacy leading to accusations regarding the pharmacy’s procedures and processes.  You don’t want the pharmacy name in black and white in connection with tampered pharmaceutical product.” Additionally, if there is an accusation, you want solid supporting evidence that you have made the best effort to ensure product safety and security, Mr. Colby said.

The bottom line, said Mr. Colby, is that when an IV pharmacy has a safety-related event, “the pharmacy may never recover from a situation like that.”

Tamper-evident products help ensure safety throughout the supply chain

USP <797> provides standards for the sterile preparation of pharmaceutical compounding. Per the USP website, “USP develops standards for preparing compounded sterile medications to help ensure patient benefit and reduce risks such as contamination, infection or incorrect dosing.” In Mr. Colby’s view, prior to USP <797> there was tremendous variation in the processes used by different compounding pharmacies, but with USP <797>, “Everybody has the same playbook.”

However, while Mr. Colby embraces the idea of consistent standards that are part of USP <797>, in his view, these standards were mainly focused on product compounding and handling within the pharmacy setting. USP <797> does not necessarily provide standards to ensure safety all the way to the patient.

From Mr. Colby’s perspective, this is where tamper-evident caps come in. He explained, “You can think of tamper-evident caps as the last mile from the pharmacy to the patient, wherever the product goes.” Mr. Colby has heard people say, “When it leaves your control or is dispensed to the patient, you’re no longer responsible.” But he does not subscribe to this theory. The reputational risks apply to a compounding pharmacy and a home infusion provider throughout the entire supply chain and as healthcare providers we want to ensure patient safety.

It is the desire to ensure safety for that last mile, until safely administered to the patient, that has motivated Mr. Colby to use tamper-evident products at CDRx Infusion. “I don’t need a law to know that this is the right thing to do,” he said.  Patient safety and product security is of paramount importance.

IMI’s solid, tamper-evident syringe caps ensure the integrity of the compounded medication for that last mile from pharmacy to patient administration.
“I find their product to be the best on the market in terms of the device itself, the functionality and the securement.” 

 

Mr. Colby views tamper-evident products as having a strong cost/benefit and risk mitigation proposition. He described his perspective: “The cost of securing [tamper-evident products] is very low relative to the percent of the overall product costs . . . and when you sit down and really look at your cost versus benefit, that’s when you really start to say this makes sense.” He added, “It’s risk mitigation at a very low cost to the pharmacy.”

As part of its workflow, CDRx Infusion applies tamper-evident packaging in its sterile buffer room prior to dispensing any IV push syringes or IV piggyback bags.

The distinct advantages of solid tamper-evident products

“There’s a lot of products out there; we prefer a solid product,” Mr. Colby emphasized. He mentioned that many people use products marketed as tamper-evident, which are essentially tape or a sticker. In Mr. Colby’s opinion, “That’s not really a security device.” He believes these products still provide the ability for someone to tamper with a product, without the nurse noticing. “Those soft devices, in my opinion, do not provide the same level of security that a solid device provides. It simply doesn’t do the job,” Mr. Colby said. 

CDRx Infusion uses solid tamper-evident products provided by International Medical Industries. Again, in Mr. Colby’s experience, tamper-evident caps act as the last mile from the pharmacy to the patient. IMI’s solid, tamper-evident syringe caps ensure the integrity of the compounded medication for that last mile from pharmacy to patient administration.

 

The most important benefit, in Mr. Colby’s view, is, “You feel confident that your IV bags are not going to be tampered with.” He continued, “I find their product to be the best on the market in terms of the device itself, the functionality and the securement.” 

What makes IMI’s products the best are the level of safety and security they provide with the ease of use for both the pharmacy to apply as well as in the example of the syringe security for the patient and nurse to use.  Mr. Colby likes IMI’s product because “[t]hese things, the syringe caps, are so easy for the patients to use.”  This is particularly important because many of the patients are older and can experience challenges opening packages. But IMI’s syringe caps work with just the right amount of pressure and do not present a dexterity concern even for elderly patients.

As more medications are delivered in patients’ homes by home infusion pharmacies, providers will be under greater pressure to ensure safety throughout the entire supply chain.  While there are many options for tamper-evident products, the products provided by IMI are cost effective, easy to use, and provide the highest level of security. IMI’s tamper-evident products ensure sterile products compounded in the pharmacy are not adulterated and they provide product security throughout the entire supply chain including the last mile up to patient administration.  IMI’s tamper-evident products also mitigate the risks that home infusion providers face should a bad actor with nefarious intentions attempt to do unthinkable things.

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