The definition of a specialty drug continues to evolve as the specialty drug pipeline advances and expands. Specialty pharmaceuticals (specialty drugs) are best defined by the full range of each product’s attributes, rather than solely by cost and route of administration. Specialty drugs sometimes require special handling and administration (injection or infusion), and patients using a specialty drug may need careful oversight from a health care provider, in tandem with a specialty pharmacist, who can watch for side effects and ensure that the medication is working as intended.
While there is no agreed-upon definition for specialty pharmaceuticals, there are common characteristics of a specialty drug including:
Involves complex treatment regimens that require ongoing clinical monitoring and patient education
Has special handling, storage, or delivery requirements
Is generally biologically derived and available in injectable, infusion, or oral form
Has increased potential for limited or exclusive product availability and distribution
Is dispensed to treat individuals with less common and rare diseases
Treats diseases or conditions marked by long-term or severe symptoms, side effects, or increased fatality
Has higher costs than traditional small molecule drugs
Given these parameters, pharmaceutical manufacturers must ensure that the specialty pharmacy can meet or even exceed the standards of their product’s specific special handling requirements such as overnight shipping or same-day delivery, ultra-cold chain storage (-80°C) requirements, and the ability to deliver to multiple sites of care. This standard should apply whether it be a rare disease, cell, or gene therapy.
Orsini is a leading independent national specialty pharmacy accredited by ACHC, JCAHO, URAC, and VIPPS. The services we provide allow patients, physicians, payers, and manufacturers to improve care, simplify processes, and achieve better outcomes.