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Conserve supplies, prioritize needs, NHIA advises
Taming Ambulatory Infusion Pump Shortage
By Dave Doolittle
As a nationwide shortage of ambulatory infusion pump administration sets continues, pharmacists should take steps to conserve supplies while prioritizing patients with specific delivery needs, according to the National Home Infusion Association (NHIA).
The shortage “is specific to the administration sets commonly used by home infusion providers to administer continuous infusions to patients on therapies such as parenteral nutrition,” NHIA president and CEO Connie Sullivan, BSPharm, told Specialty Pharmacy Continuum. “NHIA was first made aware of the challenges by members in early December 2021.”
The NHIA issued a guidance (bit.ly/ 3G1bBa4) that recommends ways pharmacists can navigate the shortage, such as rationing supplies and considering nonpump options for administering medications. It also advises against stockpiling inventory “in the interest of fair allocation to all patients nationally.”
According to the guidance, pharmacists should consider: • assessing or reassessing each patient for the indication and requirement for an ambulatory infusion pump; • reserving pumps for situations in which flow accuracy is critical to patient response and safety; and • using non-pump options for administering antibiotics, hydration, monoclonal antibodies and more.
Several non-pump options are recommended in the guidelines, including using gravity administration and flow regulators for medications not at risk for free-flow complications; converting all nurse-administered therapies to gravity infusions; and prioritizing elastomeric infusion and syringes whenever possible.
“As a last resort, consider extending the time between bag and/or set changes,” the guidance says. Pharmacists also should work with patients and physicians to determine whether it is possible to prescribe equally effective medications that do not require ambulatory infusion pumps, the guidance notes.
The NHIA also recommends pharmacists take time to understand each patient’s learning needs and home situation to create an effective learning plan if changing medication administration, including assessing fall risk if using pole-mounted pumps.
Smiths Medical, the Minneapolisbased specialty medical device manufacturer that supplies the majority of sets, said it is once again producing at full capacity—“with normal levels of supply arriving at our distribution center in mid-January.” However, the shortage is still ongoing, caused by backorders and “unprecedented demand which is likely a market reaction to inventory concerns associated with global supply chain challenges,” the company said in a Dec. 21, 2021, letter (bit.ly/3H8k10R).
The continuing shortage has begun to negatively affect pharmacy businesses as well as patient care, Ms. Sullivan said. Some companies have had to spend extra capital to buy new pumps, while others are not accepting new patients whose therapies require such pump sets.
Steering Clear of Shortages
However, some companies have been able to navigate the shortage, such as New York–based Upstate HomeInfusion. CEO Greg LoPresti said the firm began taking steps early to avoid delivery interruptions, based on watching other supplychain issues throughout the COVID-19 pandemic. “The old standard is changing. Before it used to be ‘just in time,’ now it’s ‘expanding your inventory,’” Mr. LoPresti said. “Nobody wanted to have dead-head inventory on your shelves, but you have to now, or else it’s going to impact future revenue, because you will not be able to meet sales demand, and more importantly, serve your patients.”
In addition, Upstate HomeInfusion has taken several steps to conserve infusion pump sets for critical-access patients, including those needing pain control and total parenteral nutrition when precise flows are needed.
The company also has been using rate-flow sets to deliver antibiotics, hydration or monoclonal antibodies that require their own tubing set, he said.
“You have to have multiple different delivery channels—and this is mainly done by our pharmacy—for delivering medication just as the NHIA guidance states, and that’s exactly what we’ve done,” Mr. LoPresti said. “It’s a multipronged operational effort that requires your purchasing department, pharmacy and nurses all to be in lockstep. It’s not something you can do in hindsight.”
Battling Bad Infusors
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These IV therapy businesses advertise IV “treatments” for everything from hangovers to migraines to altitude sickness and COVID-19. “These businesses promote IV services to the general public without a medical assessment or prescriber order,” said the statement from the NHIA, ASHP, ASPEN and allied groups. “The situations being treated can usually be resolved with oral medications or through other means—making IV treatment unnecessary. The result is the diversion of scarce resources—many of which appear on the FDA’s drug shortage list—from patients who have legitimate medical needs.”
Direct access infusion companies have been growing rapidly within the last cou-
ple of years, said NHIA president and CEO Connie Sullivan, BSPharm. “Today, you can find one in almost every major metropolitan area. They are particularly common in California, and there are many in Colorado as well. They seem to be all over.”
A Google search for direct access infusion brought up multiple ads for such providers, including “Mobile IV Drips New Jersey” offering a 10% coupon; “The Cure IV,” which claims locations throughout California and says it is soon expanding to Dallas-Fort Worth, New York, Seattle and Washington, D.C.; and “LEAA Home IV Drips,” with locations in New York, New Jersey, Miami and Texas.
“These kinds of clinics have been operating a little under the radar, and that’s one of our questions. How are they doing that? Do they have a legitimate licensed clinician behind them that makes it possible for them to get the licenses that they need?” Ms. Sullivan asked. “It’s time for [federal and state officials] to start taking these clinics seriously and understand what they’re doing. If they are owned by physicians or nurses, we need to understand their scope of practice. Are they compounding? Do they have the expertise to compound safely? Do they adhere to USP <797> standards?”
In many cases, the NHIA and other organizations noted in their statement, these clinics may escape the licensure and accreditation requirements that traditional pharmacy and home health providers must abide by, since they often operate on a cash basis rather than through medical insurance plans.
Because these centers may not be registered with the FDA, the extent to which adverse events are associated with direct access infusion is likely underreported, the agency noted. But a number of cases of unsanitary compounding and/or complications associated with these services have been documented.
In February 2021, for instance, the FDA received a report about a California woman who was hospitalized and treated for suspected septic shock with multi-organ failure after reportedly receiving a home IV vitamin infusion compounded by Age Management Institute Santa Barbara, a
wellness clinic providing services including IV therapies and vitamin injectables, sexual health products, hormone replacement therapy, weight loss/management products and diagnostic laboratory assays.
“The patient’s blood cultures grew Pseudomonas fluorescens, a gram-negative bacterium,” the FDA said in a statement (bit.ly/3L284vX). A cooperative investigation involving the FDA and state regulators revealed unsanitary conditions at the clinic, including lack of a certified ISO 5 classified area for sterile compounding, visible contamination in the compounding area, difficult-to-clean equipment and surfaces such as carpeting in the IV storage and mixing room, standing water in a refrigerated storage area for sterile vials, and use of expired active pharmaceutical ingredients, the FDA reported (bit.ly/ 3AUIjcc-PPN).
The previous year, the clinic had received a warning letter in October 2020 from the Federal Trade Commission about advertising COVID-19 cures.
Advertising products, such as electrolyte infusions, containing ingredients that are in short supply, is of particular concern. “As licensed home infusion pharmacies and other providers are struggling to get the components we need, particularly for parenteral nutrition, with a severe shortage of even sterile water for injection to do the most basic pharmacy operations, how are they getting the supplies to make these vitamin infusions?” Ms. Sullivan asked.
The groups’ statement calls for federal and state regulators to take a fourpronged approach to boosting regulatory oversight of these infusion providers (box). The actions are a critical first step in protecting legitimate infusion providers and their patients, Ms. Sullivan noted. “As organizations invested in the safe and effective administration of infused medications to patients with acute and chronic medical conditions, we are highly devoted to ensuring the availability of these products and their safe administration to patients with legitimate medical needs,” she said. “Unlicensed and unregulated businesses administering medically unnecessary therapies with no adherence to industry and professional standards introduces unwarranted risks. We urge state regulatory agencies and the FDA to assess the impact of these operations and establish an appropriate licensing requirement.”
—Connie Sullivan, BSPharm
4 Steps to Better Federal And State Oversight
1. Investigate and assess the extent to which direct access infusion businesses are contributing to the ongoing national shortages of parenteral drugs, nutrition components and diluents/ solutions. 2. Require all businesses that sell direct access infusion therapies to the general public to comply with licensure and regulations applicable to the services offered. 3. Investigate claims of health benefit, treatment or cure, and require businesses that sell direct access infusion therapies to disclose the lack of evidence and unique risks of administering compounded IV products that are not medically necessary. 4. Establish a licensure category for businesses that sell direct access infusions.
Source: NHIA, ASHP, ASPEN and allied groups.
Ms. Sullivan reported no relevant fi nancial disclosures.
