Specialty Pharmacy/Biosimilars

AMCP supports the leadership role of pharmacists within specialty pharmacy, including ensuring the proper use, storage, control, safe handling, preparation, distribution, administration, and care management processes for these medications. Specialty pharmaceuticals are generally high-cost medications, usually prescribed for people with complex or chronic medical conditions, or they may be medications that typically exhibit one or both of the following characteristics:

• drugs that have unique monitoring, storage, or shipment requirements; and 

• drugs that require additional patient education and support from a health care team which includes a pharmacist with specialty medication experience.

AMCP generally opposes any restrictions on the distribution of pharmaceutical products either by the pharmaceutical industry or as a condition for FDA-approval. AMCP acknowledges that circumstances may occur with the use of specific medications that require special distribution, monitoring and management processes.  As long as,

  
1. The requirements do not interfere with the continuity of care for the patient;
2. The requirements preserve the pharmacist-patient relationship;
3. The requirements are based on scientific evidence fully disclosed and evaluated by physicians, pharmacists, and others;

4. There is scientific consensus that the requirements are necessary and represent the least restrictive means to achieve safe and effective patient care;
5. The cost of the product and any associated product or services are identified for purposes of reimbursement, mechanisms are provided to compensate providers for special services, and duplicative costs are avoided;

6. All requirements are stated in functional, objective terms so that any provider who meets the criteria may participate in the care of patients;

7. The requirements do not interfere with the professional practice of pharmacists, physicians, or other appropriately qualified healthcare professionals.
 
(The enumerated principles are drawn from ASHP Principles for Restricted Distribution Systems. June 2007)