Supply Chain Management

Restricted Distribution of Pharmaceuticals

Policy 0119

11/01/2001 Introduced
02/01/2006 Revised
12/01/2010 Revised

04/07/2015 Revised

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)

Drug Shortages

Policy 1102

10/01/2011 Introduced

02/21/2021 Reapproved