A specialty pharmacy is licensed to provide medications for people with serious health conditions requiring complex treatments.1 These medications, called specialty products, typically have unique handling, preparation, dosing, or monitoring requirements.1 Specialty drugs are often used to treat chronic conditions such as cancer, liver disease (hepatitis C), rheumatoid arthritis, HIV/AIDS, multiple sclerosis, cystic fibrosis, and hemophilia.1,2
According to the National Association of Specialty Pharmacy, these medications have one or more of the following features2:
- Effective in treating complex, chronic, and/or rare conditions
- High cost: $10,000 to >$100,000 per year2,3
- Available through exclusive, restricted, or limited distribution, not retail pharmacies
- Require special storage, handling, and/or administration
- Require ongoing monitoring for safety and/or efficacy, possibly including Risk Evaluation and Mitigation Strategy.2
Some specialty medications are needed only by very small patient populations. In other cases, the drug must be shipped from the manufacturer to the pharmacy at lower temperatures—either frozen or refrigerated—because it is not stable at room temperature. Other drugs have specific types of side effects that must be watched closely. In these cases, drug manufacturers are required by the US Food and Drug Administration (FDA) to collect data about their usage, side effects, and patient experiences.3 By working with a smaller number of specialty pharmacies, drug manufacturers can ensure high-quality data collection and transfer to the FDA.1
Like all pharmacies, specialty pharmacies are licensed and regulated by the state in which they are located. Most specialty pharmacies are also recognized by independent third parties as providers of consistent and high-quality care, such as the Joint Commission.1 Pharmacists and other professionals who work for specialty pharmacies are responsible for ensuring that patients, including those who are severely ill, receive the medications that their healthcare provider has prescribed for their condition. Specialty pharmacy personnel also help patients and their families work with insurance companies to obtain reimbursement for these high-cost medications.1
The National Association of Specialty Pharmacy and the Association of Managed Care Pharmacy list several specialty pharmacy services that go beyond services offered to patients in a typical retail pharmacy1:
- 24-hour access to pharmacists
- Active patient outreach to ensure prescription refill and renewal
- Training and education to help patients self-administer and adhere to medications (ie, take the medication exactly as directed)
- Patient monitoring for drug safety, side effects, and efficacy, including talking with the patient and assessing whether physicians should be contacted
- Dispensing of specialty medications, including shipping coordination
- Investigation of insurance coverage to help determine patient out-of-pocket costs
- Enrollment in patient assistance programs to help with out-of-pocket costs
- Mandated reporting to insurance companies and/or drug manufacturers.
As an increasing number of expensive specialty drugs become available, specialty pharmacies are key to maximizing the value of these drugs for patients who need them. Appropriate use of such medications means better treatment outcomes for patients, and more efficient management of healthcare costs.3
- Byrne M. The ins and outs of specialty pharmacy. December 6, 2018. www.pharmacytimes.com/news/the-ins-and-outs-of-specialty-pharmacy. Accessed April 6, 2020.
- National Association of Specialty Pharmacy. NASP definitions of specialty pharmacy and specialty medications. February 24, 2016. http://naspnet.org/wp-content/uploads/2017/02/NASP-Defintions-final-2.16.pdf. Accessed April 6, 2020.
- Association of Managed Care Pharmacy. Specialty pharmaceuticals. July 18, 2019. www.amcp.org/about/managed-care-pharmacy-101/concepts-managed-care-pharmacy/specialty-pharmaceuticals. Accessed April 6, 2020.