Zachariah Gerger, PharmD, DO

The pharmacy benefi ts community has made amazing progress in improving both access to and implementation of medication utilization and adherence programs. It is no longer enough for a prescription to be written and filled. We now ask whether the patient really took the medicine and even more importantly, whether it worked. These programs have helped both to improve patients’ quality of life and to control costs.

The medication utilization and adherence programs were developed by individuals willing to think outside the box. They created literally from nothing a system that both saves money and makes us feel better. We need more of this kind of change.

There is another giant side to medications in a pharmacy, what I like to call the “back of the house.” Unseen and behind locked doors is an area known only to pharmacy specialists. It is here that parenteral products are bought, managed, manipulated, and sold from and through pharmacies everywhere. We know that the future pipeline of products in line for the marketplace is filled with amazing agents that come in small liquid quantities in little bottles that are usually sold without being viewed by consumers. This is the domain of specialty pharmacies that work to ensure access to and often control the sterility of products for safe delivery to consumers. Historically, this domain has gone unnoticed.

Now, with the exploding development of products created as monoclonal antibodies, we have seen an increasing need for specialty pharmacy services to provide drug delivery. Usually these drug products are expensive, parenteral, and sold in “single use” nonpreserved vials. Current mandates from the United States Pharmacopeia specify that nonpreserved or single-use drugs must be discarded 1 hour after opening outside International Organization for Standardization (ISO) 5 air conditions or after 6 hours when ISO 5 air conditions are maintained for the entire time.

 Throughout the United States, that has meant that pharmacies end up wasting unused product at often-extraordinary expense. If we could fi nd a way to store these products safely for more than the 6 hours currently allowed, cost savings could be realized in the current system.

The American Journal of Pharmacy Benefits,

 we saw how Derek M. McMichael, PharmD, and his team evaluated a system for controlling contamination in single-use vials for up to 168 hours.

 They demonstrated that a single-use vial may not in fact have to be discarded quickly and ultimately may be used for multiple patients. The cost savings that would result are obvious.

What is not discussed is the pink elephant in the room, which is liability. Single-use vials ensure that once the sterile field is broken (and assuming the product is sterile in the container), the last operator is the one who ensures that sterility is maintained until the medication is delivered to and essentially into the patient. However, any pharmacist or institution that manipulates a single-dose vial for a specific patient is already assuming this liability. McMichael and colleagues are simply proposing a safe

method to increase the duration of product sterility to possibly allow use for multiple patients.

Another barrier to the change in practice proposed by McMichael et al might be pharmaceutical manufacturers. Some may embrace the PhaSeal system as a way to enhance utilization of product by more patients. Others may believe that PhaSeal poses a risk to them if in fact the product is not delivered in a sterile manner and a patient is harmed. Or companies might believe that the PhaSeal system would harm sales of their products, as institutions could buy larger quantities of expensive drugs for a theoretically lower price. My take is that the Pharmaceutical Research and Manufacturers of America would embrace the PhaSeal system as a way to show that they do want to see more use of their products to help consumers, because they have an obligation both to aid patients and to maintain a bottom line. This technology helps both.

At the Pharmacy & Therapeutics Society we work to advance the safe use of all pharmaceuticals and to promote utilization of products for the maximum benefit to the greatest number of people. It is not lost on us that specialty pharmaceuticals are increasing the bottom line everywhere. As president, I salute the team from Indiana University Hospital led by Dr McMichael and the affiliated institutions who are thinking “inside the vial” for ways to both control costs and to provide safe use of these medications.

Articles

Systems exist that enable storage of parenteral drugs in single-use vials for more than the 6 hours currently permitted, decreasing waste and increasing savings.

New Thinking Inside the Vial...

How important is personal health compared with other decisions we make every day? It is probably number one. Yet when it comes to other people, we generally make decisions about how healthcare is delivered based on a world outside of healthcare. Decisions are not made based on the needs we see right in front of us but on exogenous factors. In the world of scientific discovery and drug development, do researchers inside companies decide what products to pursue based on who wins an election? Do they ask a health plan or employer what new drug they are willing to fund for the future? No. The pipeline is filled with incentives driven by the healthcare needs of our society and of course an opportunity for profit.

Advances in healthcare come from years or even decades of scientifi c development. Historically some of our most valuable and novel agents have been unanticipated discoveries. Others have come from natural products such as plant and animal molecules. Now we are seeing the focus shift profoundly to targeted therapies and even an ability to change how we defi ne a disease such as cancer or HIV.

The newest biologic agents in the pipeline offer tremendous opportunities in our search for ways to fight illness. Scientific researchers have found new ways to target products that improve effectiveness and lessen side effects. Sometimes even specific treatment paradigms are developed based on genetic markers, allowing for maximum effectiveness. Our challenge is getting these products to the right patient population at the proper time. We are even seeing the development of formularies that ultimately will be unique to each individual.

Now the bad news—all this innovation has a price (and the price often is quite large).

One need look back only a short time and remember the “epidemic” of AIDS and HIV infections. This was a taboo subject and frightening at best. Today HIV is readily described as an illness that needs to be managed. Who among us watching the course of HIV in the 1980s and 1990s would ever consider that this disease would or could be “managed”? This is nothing less than amazing. Just ask Magic Johnson, who since his retirement from professional basketball has headed a foundation to promote HIV/AIDS education and prevention.

How nice it would be if the development of products were timed to what we could afford. But that is not how it works. Advances in healthcare do have an expense direction. That direction is nearly always up. We know the cost and we know new advances are coming to market fast, yet it seems we often delay our response to these changes, no matter how profound they may be. Our current systems for defining these products, labeling them, delivering them to patients, billing for them, and even using them are antiquated. The evolution of new and expensive pharmaceutical and biologic agents is creating a near-revolution in healthcare. Our systems for this entire area of “specialty” need reformulation.

Specialty medications and all they encompass will force a sea change in the pharmacy benefit landscape. We are unable to really figure out whether these agents are part of a pharmacy benefit or a medical benefit. Sometimes we do one or the other based on some intricate back-office formula that does not really fit either. We do know that if we allow the copayment or other charges to increase too much, patients will not take or use the medicine. This failure serves no one. Finding the delicate balance with tools we use today has been a struggle. We just do not have it right yet.

Even worse, we sometimes cannot even describe what we have. The billing and labeling codes for specialty products are composed in strange ways because they do not fit our current coding models. Sometimes we need to link our pharmacy billing services with a medical office visit and/or treatment. This situation obligates us to create a complicated crosswalk that may be unique to our own billing organization. The problems escalate from there. A system is needed to allow these services to be described in a consistent way.

We have waited too long to get on with it. Some have pinned hopes on federal programs such as Medicare to define and organize specialty pharmaceutical agents. We look to our elected officials to answer our demands for a unified system, but they are driven by politics rather than the needs of patients. We seem to be waiting for someone else to tell us what is paid for and by whom. Our needs are now and we cannot wait for answers based on outside influences. Those of us who understand the changes best need to take the steps forward and create a new specialty paradigm. If we do not seize this opportunity to control who gets what when, then others with far less knowledge will make those decisions for us. The ambiguity will never leave us, but we can make choices based on what we know now.

Specialty healthcare products bring profound opportunities for us all. As we define how this benefit is to be administered, we need to use endogenous resources to create our future. We need to act together and act now.

The systems for developing, delivering, and billing for specialty pharmaceuticals are ripe for innovation of our own making. 

Our World Is Endogenous

There is no universal agreement on what specialty pharmacy actually means and what products fall under its ever-expanding purview. We talk about it with our boss, we

 complain about it to our chief financial

officer, and we try to figure out how to get it off our

expense record. Ask any of us and it is obvious—specialty

pharmacy is the elephant in the room. It is big,

Specialty pharmacy is part of specialty healthcare. However, when we ask our spouse or our children to define “specialty pharmacy” or even worse, “specialty healthcare,” their expressions go blank. My young adult children look at me bewildered and say something like, “Oh, it is something those specialists use, sort of, right?” We have kept it a secret from our own families! To an ordinary citizen, specialty healthcare or specialty pharmacy is from outer space. Yet from all indications, specialty pharmacy will allow the best care we can provide in the most remarkable ways. By the way, it will bankrupt us, too.

Who will get these remarkable new therapies? Everyone? Only those patients with good insurance? Or, will a panel of experts decide which treatment goes to which person? These questions are just the beginning.

It seems as if specialty pharmacy has more in common with advances such as implantable pacemakers, devices for pain control, blood sugar monitors, and the like than with traditional pharmaceuticals or antibiotics. The marketplace does not fully understand specialty pharmacy products and how they will fit into our current treatment paradigms. To educate a payer on the importance of one of these products for a patient, substitute the name of that product for the name of an implantable device. The language is the same.

While we are sorting out issues related to what specialty pharmacy means and how it can help people, we need to address another issue—coding. There needs to be a way to code for these products so our computers can speak with one another intelligently. We have it backwards so far. We are using DNA testing to determine who may have these medications before we even have defined where these medications fit in our treatment and financial paradigms. Yes, we have some work to do.

When I got sick as a child, my mother took me to the doctor. At checkout, she paid the doctor and that was it. We went to the drugstore, where she paid cash for my medicine, and that was it, too. It was very simple. In college, I bought major medical insurance. I still had to pay for outpatient doctor visits, but if I needed surgery or hospitalization, it would be covered by insurance. As my family grew, I got full-coverage medical insurance and only paid a co-payment to see the doctor. Things got even better when my medicine was covered for the most part by insurance. Enter the new pharmacy benefit.

Ultimately, we all share the risk for specialty healthcare products and it may be our next insurance need. To quote Perry Cohen, PharmD, president of The Pharmacy Group, “There is a new tent out there just like the medical care tent or the pharmacy care tent, and it is called the specialty healthcare tent. It is here now and you can come inside and work out how it should look or not. Either way, it is here now and getting bigger every day” (Personal communication). The metaphor he provides will help us get something done. Either we decide our fate on this one or it will be decided for us.

The Pharmacy & Therapeutics Society is at the forefront of these changes. We are inside the specialty healthcare tent, and we want to see these products used in a rational and sustainable manner. It is time we step up collaboration with other like-minded individuals, companies, and organizations to determine how specialty healthcare can and should look in the future. We ask you to join us in this endeavor.

There is no universal agreement on what specialty pharmacy actually means and what products fall under its ever-expanding purview.