ICHP Position Statement - Restricted Distribution Systems

Restricted Distribution Systems were originally put in place in order to limit distribution channels, thereby ensuring safe dispensing of a high-risk medication to the small patient population and allowing for a more effective drug allocation in shortages. However, in the recent years this strategy has been misused by the companies that have exclusivity on the market to prevent generic and biosimilars manufacturers from getting a hold of samples for equivalency studies.1 The Illinois Council of Health-System Pharmacists (ICHP) supports the drug distribution system that includes the traditional pharmacist prescriber-patient relationship.

ICHP acknowledges the possibility of instances to occur when the traditional drug distribution system may not be conducive to providing new and innovative care to the patient.  In cases when a restricted distribution system is required several criteria must be met:  1) continuity of care for the patient is not interrupted, 2) the pharmacist prescriber-patient relationship is maintained, 3) evidence based information is available, 4) consensus is reached by healthcare practitioners that this distribution system is needed for the safety of the patient, and 5) drug prices are not artificially inflated in the process.

ICHP strongly encourages pharmaceutical manufacturers and the FDA to consult with practicing pharmacists through their professional pharmacy organizations when contemplating a restricted distribution system for a drug product.

Reference:
Karas L, Shermock K, Proctor C, Socal M, Anderson G. American Journal of Managed Care. 2018;24(4):e122-e127

Reviewed 09/2014

Revised 01/2018

Reviewed 03/2021