Specialty drugs are distinguished by two main characteristics: cost and complexity. Specialty drugs are expensive because of their delicate nature such as limited shelf life, need for climate-controlled shipping and meticulous storage. Specialty drugs are complex because they require special handling and services, inventory management and intense administration. They also need a high level of patient monitoring, risk evaluation and mitigation strategies, patient education on disease, and drug regimen.
The Centers for Medicare and Medicaid Services (CMS) define a specialty drug1 as one that costs more than $600 per month. Other sources consider a “specialty” drug one that have five of the following eight characteristics:
- Treats specific, mainly chronic, and often rare conditions
- Usage initiates with a specialist
- Typically, not administered orally
- Requires special handling
- Involves unique distribution and administration channels, such as special distribution management and specialized paperwork
- Is costly, ranging from $6,000 to $750,000 per year
- Requires a high degree of patient management, like increased supervision of counseling
- Results in patients requiring reimbursement assistance
A specialty pharmacy consists of a high-touch comprehensive care system of pharmacological care wherein patients receive expert therapy management and support tailored to their individual needs.2
Table 13 below provides definitions of Specialty Pharmacy and Specialty pharmaceutical as per ASHP Specialty Pharmacy Resource Guide.
Figure 1 ASHP SPECIALTY PHARMACY RESOURCE GUIDE
Mesa Labs provides packaging, wireless temperature monitoring and compliance services for specialty pharmacies and their partner organizations. Solutions for these organizations include single dose, up to pallet sized temperature controlled packaging. Mesa’s temperature monitoring systems monitor environmental conditions related to storage and shipment using refrigeration equipment, vehicles and warehouses. Services cover the gamut from compliance gap analysis to development of storage and handling operating procedures, sustainability programs, training plans and Risk Evaluation and Mitigation Strategies (REMS).