What is Specialty Pharmacy?

If you haven’t already heard the term specialty pharmacy or specialty pharmaceutical, you probably will soon.  With new “specialty drugs” entering the marketplace each year, your patients will eventually have the need for one of these therapies. So what exactly do those two terms mean? Although this seems like a simple question, a standard, industry-wide definition for either term remains elusive.
In defining a specialty pharmaceutical, there are two main factors: cost and complexity. A medication considered a specialty pharmaceutical may have some or all of the following key characteristics:
  • Treatment of complex, chronic, and/or rare conditions
  • High cost, often exceeding $10,000, with some costing more than $100,000 annually
  • Availability through exclusive, restricted, or limited distribution
  • Special storage, handling, and/or administration requirements
  • Ongoing monitoring for safety and/or efficacy
  • Risk Evaluation and Mitigation Strategy program required by the FDA

Although this category has historically focused on injectable and infused formulations, a significant number of specialty medications in oral dosage forms are also on the market. This trend is only expected to continue, especially among oral chemotherapy.
Common disease states treated by specialty drugs include oncology, multiple sclerosis, rheumatoid arthritis, Crohn disease, HIV/AIDS, hepatitis C, and growth hormone disorders.
Although cost is a major concern for specialty drugs, restricted distribution networks can also be problematic in long term care. Some manufacturers of specialty pharmaceuticals have restricted their products to specialty, mail order pharmacies – not allowing ICP or other long term care pharmacies access to these medications. Besides the delays this system introduces, limited distribution networks require facility staff, and sometimes the responsible party or patient, to provide medical and insurance information directly with the specialty, mail-order pharmacy. Prescribers may also be asked to provide documentation of medical necessity or to complete required training or paperwork before medication may be obtained.
Specialty pharmacy, which once occupied only a small niche in the marketplace, is a growing industry. Health care personnel, regardless of their area of practice, should understand the place of specialty pharmacy within the industry, even though the field may be difficult to define. Escalating costs, heightened needs for patient monitoring, special handling requirements, and limited distribution networks will require increased attention and management in the future.

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