Considerations for Starting a Specialty Pharmacy

The health care industry continues to evolve, and over the past decade specialty pharmacy has fought to make a name for itself. However, ironing out the misconceptions and misunderstandings of what specialty pharmacy actually is and the value it brings remains a challenge.

In the session, I’m Starting a Specialty Pharmacy—–Now What? Introduction to Specialty Pharmacy at the 2017 National Association of Specialty Pharmacy (NASP) Annual Meeting and Educational Conference, speaker Chandra Wahrgren, MBA, of Ardon Health, reminded the audience of the importance to recognize and respect the variation that the industry continues to experience when defining what constitutes a specialty medication.

Some payers define specialty pharmacy based on therapeutic class, cost, administration, site of care, benefit design, and even formulary placement. “But we understand it goes well beyond just fulfilling the medication,” Wahrgren said during the session.

NASP defines specialty drugs as being “more complex than most prescription medications and are used to treat patients with serious and often life threatening conditions including cancer, hepatitis C, rheumatoid arthritis, HIV/AIDS, multiple sclerosis, cystic fibrosis, organ transplantation, human growth hormone deficiencies, hemophilia, and other bleeding disorders. These medications may be taken orally but often must be injected or infused and may have special administration, storage, and delivery requirements.”

The role of a specialty pharmacy is further directed by the structure and the organizational focus in which the business originates, according to Wahrgren. How specialty pharmacy has evolved in the different structures, including wholesale distribution, retail, independent, managed care, etc.

“Specialty pharmacy plays a unique role in the space and it’s really up to us to start expanding the reach in terms of how it’s understood in the overall health care paradigm,” Wahrgren said in the session.

It must balance the individualized needs that help patients through their health journey, and work with advocacy and outreach to support and improve outcomes.

“As the health care delivery system is transforming, we should anticipate not only what our role as specialty pharmacy [is] and where we fit but, ultimately, recognize the premise in which our industry and service model has been built naturally compliments and balances the ladder of the coordinating care—–which is particularly important––and the community-based population health,” Wahrgren said.

“Specialty pharmacy is no longer a short list of medications used to treat acute and/or serious conditions, but rather with a rich pipeline of expanding medications we are helping more and more patients live longer and better lives.”

Specialty medications differ from traditional prescriptions in numerous ways. For instance, they may have special administration, storage, and delivery requirements.

How these products are stored and shipped is crucial to overall patient care. In the session, Mark Maurice, MIE, from Sensitech, touched on temperature management and regulations.

The United States Pharmacopeia (USP) plays a direct role in temperature management. It is an organization that creates reference standards/guidance documents for the FDA aimed at improving global health. The documents are referenced by the State Boards of Pharmacy.

Regulatory requirements are continuously changing, which means keeping a close eye on them is crucial.

Over the past 6 months, Maurice noted several interesting trends in state regulations. In terms of distribution, 18 states now require temperature management and 10 states require all distribution into their state to meet USP standards. From a storage standpoint, 29 states now require temperature management and 14 are referencing USP requirements.

“This is an increasing trend that states are realizing they have to put specific requirements in the way of distribution temperature management,” Maurice said in the session. “Referencing federal requirements…that’s a benefit, because then you get a uniformed approach.”

According to the CDC, there are approximately 45,000 clinics in the United States that are required to meet these requirements. Product storage in refrigerators and freezers requires continuous temperature monitoring, 0.5°C accuracy, alarm capability, download and archive data. Furthermore, sensor locations must be defined from thermal mapping and thermometers with paper records are no longer allowed.

Temperature mapping is used to document and control the temperature distribution within a storage area. For example, to store products in a refrigerator, individuals must place sensors throughout the space and conduct a study for several days that monitors the sensors.

“In a standard refrigerator, they’re usually looking for somewhere between 15 and 20 sensors,” Maurice said. “Then you download all that data to see if you have uniform temperature throughout. Most refrigerators have a supply [that] will monitor temperatures well below the 2-degree requirement and potentially freeze products. So, in doing that, you can see where you can and cannot store products in refrigerators.”

USP 1079 is a document that provides guidance on good storage and distribution practices. It applies to all organizations and individuals involved in any aspect of the storage and distribution of drug products.

In the session, Maurice said that monitoring the product is needed because cold to the touch does not define hot and cold excursions during storage and shipping. Furthermore, “pharmaceuticals cannot withstand a freeze thaw cycle. It de-thaws the molecules and renders that product 0% effective.”

Thermal shock can occur when a product is placed directly on the thermal pack. Instead, some type of barrier must be put in place to separate the 2. Thermal shock can be as detrimental to the product as the exterior temperature.

Once a product is placed in a pack-out, it is not meant to go inside of a refrigerator for storage until the courier picks it up, since it is designed to withstand exterior temperature, according to Maurice. Other concerns include insufficient insulation and the length of time deliveries sit at someone’s front door. Maurice said that exterior temperature will eventually begin to impact the interior temperature depending on how long it has sat out.

In addition to temperature management, data are also important to the specialty pharmacy space.

“Contrary to what many people believe, we really don’t control drug prices we are sort of price takers,” Daniel Duffy, MBA, said in the session. “What we do control is the cost and efficiencies of our operations…really focusing on quality.”

The shift towards value-based care falls on the quality of the cost. To achieve this model and show the value of a specialty pharmacy, data needs to be used.

“To prove value-based care and quality you need great data,” Duffy said. “Prove you’re generating value.”

Duffy continued, “The unsung heroes of a specialty pharmacy and the absolute critical resource of a specialty pharmacy is the patient access specialist.”

Gaining specialty pharmacy accreditation is important because it demonstrates value and helps collect key data points needed in the future.

“Getting those metrics are important so you can help manage the operations,” said Quintin Jessee, RPh, DPh in the session.

Accreditations provide an unbiased evaluation of specialty pharmacies. Furthermore, it can serve as a consultative support and advice on best practices in the industry, such as cold chain management standards.

The standards also help organizations build solid foundations for specialty pharmacy practice, such as policy and procedure development and disaster management recovery programs.

Jessee stressed, however, that “accreditations do not guarantee you will be successful in getting access to limited distribution drugs or payer contracts.” In fact, one accreditation may not be enough anymore.

As the industry changes and evolves, payers are starting to look for “some standards built around outcomes, patient management, and collecting data,” Jessee said.

“As those get more robust, that’s going to help build that solid platform for you to grow on, but just know that it’s going to be something that will continually grow and get more advanced.”

Jessee concluded that specialty pharmacies need to become active about what the metrics should be rather than being told what the metrics are.