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April 2016, Vol 4, No 4 - The First Word
Donald J. Dietz, RPh, MS

Patients often select their pharmacy based on its close proximity to their home or place of work, whether their insurance is accepted (eg, costs), its appearance, and whether their customer service is satisfactory.

Community pharmacists focus on dispensing prescriptions accurately, following applicable laws, and providing excellent customer service. These axioms were taught to me in pharmacy school by Professor Amadio nearly 40 years ago, and largely remain true today. In a recent announcement, the National Association of Specialty Pharmacy (NASP) defines specialty pharmacy and specialty medications in a way that could impact these axioms in the future.1

Although these terms have been around for decades, they have never had official definitions. Capitol Hill members and staff at general federal regulatory agencies have continuously requested clarity around the meaning of these terms through regulatory definitions.

Table

Defining Specialty Pharmacy and Specialty Medications

NASP comprises 1500 individual and 84 corporate members, including specialty pharmacies, retail chain specialty pharmacies, and health-system−based specialty pharmacies. NASP is committed to specialty pharmacist education and certification.

Specialty Pharmacy

Specialty pharmacy is defined by NASP as “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, [human immunodeficiency virus/acquired immune deficiency syndrome (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 Drugs

According to NASP, “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.”

Accreditation and Licensing

All community and specialty pharmacies are licensed by the state in which they are located, and must follow all applicable federal laws.

Pharmacies can dispense brand, generic, compound, and specialty medications, in addition to other products. If—and until—states establish additional levels of certification, any licensed pharmacy should be able to dispense a specialty medication if they meet the requirements (eg, Risk Evaluation and Mitigation Strategy [REMS]), and if the drug being dispensed is not a limited distribution drug.

What This Means for Community Pharmacy

Yes, pharmacists at specialty pharmacies may be subject matter experts on particular disease states or drug products. However, if that knowledge and skill is a differentiating factor, they need to promote their services to patients and prescribers. There may well be community pharmacists with similar skill sets who can offer the same services to patients. This exemplifies competition and free choice, which are imperative to patients choosing a pharmacy. For very complex therapies and rare diseases, I suspect that the patient and their physician will, and would, elect to use the specialty pharmacy. For other specialty prescriptions, community pharmacy remains a viable option for patients.

More specialty pharmaceuticals are now available in oral formulations, reducing the need for training on product administration. A number of other medications have clear instructions, and are self-administered in penlike devices (eg, autoinjectors). My elderly father was able to self-administer enoxaparin obtained at a community pharmacy after one demonstration. As the migration to oral products continues, community pharmacies are an option for patients.

As science has evolved, most research and development focuses on large, complex drug molecules or specialty medications. According to the NASP definition, approximately 21 of the 45 novel drugs approved in 2015 would likely be considered specialty drugs. NASP reports that, by 2019, specialty drugs are projected to signify 50% of US drug spending.1 New definitions should take care not to limit new brand products dispensable by community pharmacies.

New drugs in the pipeline for diabetes, arthritis, cholesterol management, and psoriasis could all be considered specialty drugs. One could argue that soon-to-be-approved products containing insulin as part of their combination therapy would be classified as specialty drugs.

Generic specialty drugs and biosimilars are also becoming available. Approximately 85% of prescriptions dispensed today are generics. These definitions could impact the ability of community pharmacies to dispense injectable generics for popular rheumatoid arthritis and multiple sclerosis products.

Conclusion

Specialty pharmacies originated from community pharmacies that were clinically focused, and saw a marketplace necessity to provide additional services to meet patient needs. Assuming costs to the payer are similar, patients and their physicians should be free to evaluate clinical services available at specialty and community pharmacies and decide what option is best for their particular need.




Reference

  1. NASP Releases Final Guidance on Defining the Specialty Pharmacy Space [news release]. Washington, DC; National Association of Specialty Pharmacy; February 25, 2016. www.prweb.com/releases/2016/02/prweb13234685.htm. Accessed March 22, 2016.
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