Pharmacy Purchasing & Products: What policies and procedures have you instituted to help with managing IVIG?
Kavish Choudhary: Our approach was to first establish comprehensive guidelines for IVIG use, as well as a thorough approval process for each dose. Currently, every unit dose of IVIG needs to be approved by the medical director. Our institution has 21 approved indications, eight of which are also FDA approved. We rarely go outside of the approved indications; generally, we only do so for increased dosing amounts or frequency.
For the first time in a number of years it has become a buyers’ market for IVIG. The abatement of the long-term shortage presents an opportunity to streamline purchasing, thus increasing safety and controlling costs. At the University of Utah Hospitals and Clinics we decided to designate a single primary product for all of our IVIG usage; we still carry secondary products on our shelves, but in much lower quantities than before. The intent of this program is to increase patient safety by minimizing confusion during the ordering and administration processes. With consistent product use across the entire health system, the opportunity for error is minimized. In addition, by consolidating IVIG products to a single manufacturer, we have an opportunity to reduce inventory and save about 10% to 15% on our annual IVIG spend. From inception to implementation, this program took seven months to establish and required dozens of meetings with the various manufacturers, as well as P&T and staff meetings to get everyone on the same page.
PP&P: What was your process for determining the primary IVIG product?
KC: We started by establishing the criteria we wanted the manufacturers to meet. First, could the manufacturer guarantee that they would meet our volume needs? We anticipate using 40,000-60,000 IVIG grams a year. We also needed our GPO to support this approach. We then established the following product-specific criteria to meet our practice needs:
These criteria were determined based on our desire to reduce preparation time while meeting the clinical needs of our patients.
Once these criteria were met, we asked whether the manufacturers could offer sufficient supplies of IVIG to satisfy the needs of our 340B program. We were then able to narrow our choices, and the manufacturer best suited to meet our needs became evident.
PP&P: Was the medical staff supportive of this change?
KC: Once the pharmacy staff from each area that provided IVIG therapy was on board with the consolidation plan, we began discussions with the physicians who most commonly prescribe IVIG. They were convinced of the value of a consistent product that eliminated the need for test doses to ensure tolerance with every product switch, as long as they could continue to access specialty products for those patients with specific needs. For example, some patients require low IgA content, others receive their product via a manufacturer’s registry, and there are some patients who require a certain product due to previous adverse reactions or tolerance issues.
PP&P: How do you manage the process of switching patients to your main product?
KC: This is where educating the infusion and nursing staff comes into play; they need to ensure there is a slower infusion the first time a patient receives this product and tolerance must be monitored. From the patient’s perspective, because we have had to use so many products over the past few years, many of our long-standing patients have become accustomed to numerous product switches; so, one more change is not an issue for them.
PP&P: What are some of the challenges to managing IVIG distribution?
KC: With strong clinical guidelines in place—creating a defined process for what gets approved—many potential problems are minimized. Of course, figuring out how much IVIG to carry at all times continues to be challenging even when shortages are not a factor.
Generally, we plan our ordering in conjunction with our chronic patients’ schedules. Our goal is to avoid storing significant amounts of IVIG on the shelves at any given time; rather, we aim to order on an as-needed basis. Because 80% of our dispenses are in the outpatient sector and most of these patients are treated monthly or every six weeks, there is sufficient flexibility to plan supply levels based on scheduled treatments. Inventory needs for the inpatient side are less predictable, therefore I recommend always keeping some extra product on reserve for inpatients.
While we have transitioned to a primary product, we maintain all of the IVIG products on formulary; this way, we are prepared should another shortage occur. Another benefit to the streamlined inventory is that trading product between the different areas that dispense IVIG is much easier now.
PP&P: How do you manage the storage of IVIG at your health system?
KC: Because some products require refrigeration and others can be stored at room temperature, you need to plan for both options. Given the size of some vials, I recommend dedicating a refrigerator solely to IVIG storage. Choose a unit with sufficient storage to manage those deliveries of larger allotments, not just your standard delivery. Considering the cost of IVIG products, a temperature monitoring system for the refrigerator is imperative. In addition, establish a back-up storage plan in the event of a refrigeration malfunction; this is particularly important during a shortage.
Given the myriad controls that need to be in place for a refrigerated product and the fact that we have significantly more shelf space available than refrigerator space in our facility, we included room temperature storage as a criterion in determining the best product for our health system.
PP&P: What steps go into planning the IVIG budget?
KC: To plan for the coming year’s purchasing needs, start by analyzing usage over the past few years. Not only will this give you a framework to plan your purchasing, but it will also show developing trends. For example, when examining usage among a sampling of patients, I noticed that many of our long-term patients are increasing their dosages slightly but regularly over time, probably due to weight gain and tolerance issues.
A review of overall utilization should indicate the number of new patients usually added on an annual basis. We assess our inpatient and ambulatory data separately. Typically, inpatient dispensing remains consistent over the course of the year despite occasional monthly spikes. It is among our ambulatory patients that we tend to find incremental growth.
We also stay abreast of the literature to determine if any new indications are on the horizon. While we do not expect any new indications for 2010, there may be additional neurological disorders that IVIG will be indicated for by early 2011. After taking all of these factors into consideration, we planned our purchasing to reflect the expected increase in number of patients along with an increase in dose sizes. As most manufacturers publish their pricing in advance, we are able to predict the number of grams and projected expense with pretty fair accuracy.
PP&P: Can you share tips for working with your GPO on purchasing?
KC: It is important to keep your GPO in the loop as you move to a primary supplier. Be aware of their contracting timelines so that the transition is smooth. With the exception of 340B pricing, our goal is to support our contract and always purchase through the GPO. Good communication is a key component to this.
PP&P: How did the switch to a primary supplier affect your 340B
KC: The inventory is physically separated, but we also use 340B split billing software, which allows us to have a virtual inventory as a double check. In the past, the biggest problem with 340B was obtaining sufficient grams of IVIG. We have resolved this by streamlining the formulary and including 340B product availability as part of our criteria for choosing a manufacturer.
PP&P: What is your protocol for brand substitutions?
KC: We have written our protocol so that when the prescriber orders IVIG, they are not ordering a product by name, rather they are simply selecting “IVIG.” Pharmacy then supplies the product that is available, thus eliminating the need to request permission for a substitution. The prescriber’s order indicates the amount of grams and the desired percentage (5% or 10%); following our protocol, pharmacy rounds to the nearest vial size.
PP&P: Do you have any parting words for us?
KC: Even though IVIG is no longer on shortage, treat it as if it is and you can curtail any unapproved uses and ensure a well-managed program. Strong guidelines and a strict approval process are key to successfully managing supplies of this expensive product. Continually update your guidelines and streamline your approval process for IVIG.
If you use CPOE, allow for flexibility in the ordering process so that product substitution can occur in the event of a shortage. Your protocols should allow for therapy substitution even if you have established a primary product. Now that the shortages have abated, this is an excellent time to streamline your purchasing; however, keep in mind that because this a novel approach for this marketplace, you will have to be proactive and persistent to realize the best savings.
Kavish Choudhary, PharmD, MS, is the pharmacy manager at the University of Utah Hospitals and Clinics. Kavish received a PharmD from Ohio Northern University, and a MS in health system pharmacy administration from the University of Wisconsin, Madison.
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