NASP Releases Final Guidance on Defining the Specialty Pharmacy Space

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NASP is at the forefront of defining the evolving industry in the current regulatory environment

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“NASP developed these definitions in response to many requests from capital hill members and staff at federal regulatory agencies. NASP will remain at the forefront of defining our evolving industry.” -- Burt Zweigenhaft, President of NASP

The National Association of Specialty Pharmacy (NASP), the premier trade association representing all stakeholders in the specialty pharmacy industry, is pleased to announce definitions of specialty pharmacy and specialty medications. This announcement comes on the heels of a full day of congressional office visits to discuss specialty pharmacy with relevant parties on Capitol Hill. “NASP developed these definitions in response to many requests from Capitol Hill members, and staff at federal regulatory agencies. NASP will remain at the forefront of defining our evolving industry,” said Burt Zweigenhaft, President of NASP.

The following definitions of specialty pharmacy and specialty medications were developed by NASP. NASP was founded in 2012 to represent the rapidly growing specialty pharmacy industry in the United States. It is projected that specialty drugs will represent 50% of the US drug spending by 2019. Currently, NASP consists of 84 corporate members and 1,500 individual members, including the nation’s leading independent specialty pharmacies, retail chain specialty pharmacies, and health system–based specialty pharmacies. NASP is committed to specialty pharmacist education and certification, and strongly invested in the continuing improvement of specialty pharmacy practice as advances in medicine and treatment regimens emerge.

What Is a Specialty Pharmacy?

A specialty pharmacy is a state-licensed pharmacy that solely or largely provides only medications for people with serious health conditions requiring complex therapies. These include conditions such as cancer, hepatitis C, rheumatoid arthritis, HIV/AIDS, multiple sclerosis, cystic fibrosis, organ transplantation, human growth hormone deficiencies, and hemophilia and other bleeding disorders. In addition to being state-licensed and state-regulated, specialty pharmacies should be accredited by independent third parties such as URAC®, the Accreditation Commission for Health Care (ACHC), the Center for Pharmacy Practice Accreditation (CPPA), or The Joint Commission, to ensure consistent quality of care.

Specialty pharmacies connect patients who are severely ill with the medications that are prescribed for their conditions, provide the patient care services required for these medications, and support patients who are facing reimbursement challenges for these highly needed but also frequently costly medications.

Specialty medications have a complex profile that requires intensive patient management. Some specialty medications also require special handling. Although some are taken orally, many of these medications need to be injected or infused, some in a physician's office or hospital. Specialty pharmacies provide services that include training on how to use these medications, comprehensive treatment assessment, patient monitoring, and frequent communication with caregivers and the patient’s physician or other healthcare providers.

The expert services that specialty pharmacies provide drive adherence, persistence, and proper management of medication dosing and side effects, and ensure appropriate medication use. The specialty pharmacy’s patient-centric model is designed to provide a comprehensive and coordinated model of care for patients with chronic illnesses and complex medical conditions, achieve superior clinical and economic outcomes, and expedite patient access to care.

What Is a Specialty Medication?

Specialty drugs are 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, and hemophilia and other bleeding disorders. These medications may be taken orally, but must often be injected or infused, and may have special administration, storage, and delivery requirements. Many of these injectable medications are self-administered in the patient’s home. Infused specialty medications are administered in various treatment settings, such as a patient’s home with the support of a home healthcare professional, sometimes in a doctor’s office, or even in a hospital.

The complexity of these medications may be due to the drug itself, the way it is administered, the management of its side effect profile, the disease or condition it is used to treat, special access conditions required by the manufacturer, payer authorization or benefit requirements, patient financial hardship, or any combination of these factors. As a result, patients being treated with specialty medications require comprehensive patient care, clinical management, and product support services.

Specialty prescription medications cannot routinely be dispensed at a typical retail community pharmacy because the therapy typically requires special handling, as well as significant patient education regarding appropriate utilization. Typical retail pharmacies are not designed to provide the patient care or other services that specialty medications require.

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About the National Association of Specialty Pharmacy

The National Association of Specialty Pharmacy (NASP), based in Washington, DC, is a 501(c)(6) trade association representing all stakeholders in the specialty pharmacy industry. Its members include the nation’s leading specialty pharmacies, pharmaceutical and biotechnology manufacturers, group purchasing organizations, distributors, and more. With 84 corporate members and 1,500 individuals, NASP is the unified voice of specialty pharmacy in the United States.

NASP is dedicated to patient access, national policy advocacy, specialty pharmacist education and certification, and the engagement of all stakeholders in the specialty pharmacy industry. For additional information, visit NASPnet.org, or the NASP YouTube channel.

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Bob Fulcher, COO
National Association of Specialty Pharmacy
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