Trends in ensuring safety for home infusion: The case for tamper-evident products
19 May 2021
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 IV infusion providers are taking to ensure safety, Becker's Hospital Review recently spoke with Neil Colby, RPh, an infusion pharmacist for CDRx Infusion in Boca Raton, Fla.
CDRx is a compounding pharmacy focused on specialty medications for oncology. The company provides IV medications for use in the home care setting. CDRx serves South Florida, particularly Dade, Broward and Palm Beach counties, but its products are distributed to 18 states across the country. Mr. Colby oversees the pharmacy for the home infusion operations.
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 as possible. This is leading to growth in home care and home infusion services. Mr. Colby observed, "If, for example, a hospital is just giving a patient an IV antibiotic three times a day, that patient doesn't need to be in the hospital because we could send the drug to the patient's home."
This trend is driving significant growth in the home care and the home infusion markets. It is also leading companies such as CDRx to provide a variety of different types of medications for administration in patients' homes, using different types of packaging and different administration methods. Packaging includes IV bags, IV push syringes, prefilled syringes and more.
For home IV infusion providers, patient safety is a paramount concern
In Mr. Colby's experience, the complexity and risks associated with medications administered intravenously are greater than with oral medications. The reason is because IV medications can become contaminated. As Mr. Colby explained, "With an oral medication, you're not going to get sepsis, you're not going to have bacterial contamination because it's oral and you don't have an IV contamination." But with medications delivered via an IV, "If it's contaminated with bacteria . . . and someone accessed it, it could lead to sepsis and that could lead to death." Further explaining the risks of a contaminated IV, Mr. Colby stated, "The reaction can happen much quicker because there can be bacterial contamination and you're getting it right into the bloodstream. It can be much quicker."
While Mr. Colby recognized that the greatest risks from contaminated compounds are to health patients, he acknowledged that contamination also poses significant risks to a pharmacy. "If something happens to a patient," said Mr. Colby, "it could circle back to the pharmacy, because it's your patient. They're going to want to know, 'Why did this happen?'"
Any issues with patient safety pose reputational risk and financial risk for a pharmacy and can threaten a pharmacy's long-term viability. Mr. Colby discussed these risks. "You don't want an investigation into your pharmacy," he said. "When the FDA goes into places, even if you're not guilty, you don't want your name in black and white . . . even the accusation can do tremendous damage. You don't even want an accusation." Additionally, if there is an accusation, you want really solid supporting evidence that you have made the best effort to ensure safety, Mr. Colby said.
The bottom line, said Mr. Colby, is that when an IV pharmacy has a safety-related event, "A 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 the consistent standards that are part of USP <797>, in his view, these standards were mainly focused on product manufacturing and handling within the pharmacy. USP <797> doesn't 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, you're not responsible." But he doesn't buy that. The reputational risks apply to a compounding pharmacy and a home infusion provider throughout the entire supply chain.
It is the desire to ensure safety for the last mile, until safely administered to the patient, that has motivated Mr. Colby to use tamper-evident products at CDRx. "I don't need a law to know that this is the right thing to do," he said.
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 the benefit, that when you really start to say that this makes sense." He added, "It's risk mitigation at a very, very low cost to the pharmacy."
As part of its workflow, CDRx now applies tamper-evident packaging to syringes in its sterile buffer room.
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 is 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 a 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.
In particular, Mr. Colby prefers and CDRx uses solid tamper-evident products provided by International Medical Industries. IMI's solid, tamper-evident syringe caps solve the last mile problem by ensuring safety until a product is used by a patient. 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 really 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 syringe safety and that the syringe caps are easy for patients to deal with. "These 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; they aren't so difficult that they can't be used by patients themselves.
As more medications are delivered in patients' homes by home infusion providers, these providers will be under greater pressure to ensure safety in the compounding manufacturing processes, in distribution and until drugs are provided to patients.
While there are many options for tamper-evident products, those products provided by IMI are cost effective, easy to use and provide the highest level of security. IMI's tamper-evident products ensure that the sterile products produced in a compounding pharmacy are not contaminated. This ensures patient safety and mitigates the risks that pharmacies and home infusion providers face, while making sure that a provider doesn't read its name in the newspaper and isn't subject to an investigation for compromising patient safety.
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