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Importance of the ACHC Distinction in Rare Diseases and Orphan Drugs for a Specialty Pharmacy Partner

When pharmaceutical manufacturers and providers are seeking a specialty pharmacy partner, it’s important to look into the distinctions and accreditations that the specialty pharmacy has achieved to see what sets them apart from others to best support patients. We are honored that Orsini Specialty Pharmacy was recently awarded the Distinction in Rare Diseases and Orphan Drugs by the Accreditation Commission for Health Care (ACHC). Orsini is one of only two specialty pharmacies that have received this distinction from ACHC.

About the Distinction
The ACHC Distinction in Rare Diseases and Orphan Drugs is available only to those pharmacies that already have ACHC Specialty Pharmacy Accreditation and recognize the specialized qualifications of pharmacies that provide orphan drugs to treat rare diseases. Orphan drugs are defined by the Food and Drug Administration (FDA) as those intended for the treatment, prevention or diagnosis of a rare disease or condition that affects fewer than 200,000 persons in the United States.

What Standards are Needed to Achieve this Distinction?
Standards that a specialty pharmacy must meet to achieve this distinction include the following:

  • Specialized disease-specific training of pharmacists and pharmacy staff, especially at drug launch
  • Development of disease management protocols for each rare disease serviced, including analysis of patient outcomes
  • Capabilities for recording and reporting complex data to meet manufacturer and payor requirements
  • Accommodation and validation of complex supply-chain logistics, including controlled cold and frozen storage, packaging and shipping with at-the-ready disaster recovery protocols to ensure continuity of drug delivery
  • Implementation and tracking of Risk, Evaluation, and Mitigation Strategies (REMS) programs and adverse-event reporting requirements
  • Designated program managers who collaborate with manufacturers to develop and implement drug-specific programs based on patient population, manufacturer and payor needs
  • Comprehensive patient management programs and specialized patient care teams with check-in at every refill
  • Accommodation of patients moving from clinical trials to commercial products, or to patient assistance organizations
  • Specialized patient liaisons to link patients with advocacy and financial assistance organizations

Orsini Specialty Pharmacy excels in these specialized areas and is able to meet unique drug needs and operationalize new drug launches quickly. Our pharmacists continuously train in rare diseases and orphan drugs in order to provide patient management programs and care plans to meet the needs of patients and manufacturer partners. We work as a team with prescribers, nurses, patients, and caregivers to monitor treatment and patient outcomes.

“We are honored to receive the Distinction in Rare Diseases and Orphan Drugs from ACHC,” said Mike Fieri, Orsini’s Chief Executive Officer. “This distinction further highlights our many years of experience and expertise in rare diseases, the strong collaboration we have with our manufacturing partners to ensure patients get access to the medications they need, and our unique high touch care model that enables us to provide individualized services to patients and caregivers.”

Orsini Specialty Pharmacy has a long-standing commitment to quality and patient safety. We are able to validate our ongoing diligence in the services we provide through the national accreditations that we hold. Learn more about this distinction and the accreditations that Orsini holds.