RESTRICTED DRUG DISTRIBUTION

To oppose restricted drug distribution systems that (1) limit patient access to medications; (2) undermine continuity of care; (3) impede population health management; (4) adversely impact patient outcomes; (5) erode patients' relationships with their healthcare providers, including pharmacists; (6) are not supported by publicly available evidence that they are the least restrictive means to improve patient safety; (7) interfere with the professional practice of healthcare providers; or (8) are created for any reason other than patient safety.

This policy supersedes ASHP policy 0714.

Rationale

Restricted drug distribution systems (RDDSes) that are not created solely for patient safety reasons significantly restrict patient access to medications. These systems were justified as a means to closely monitor patient use of medications that could potentially pose a safety risk. They were never intended to allow drug manufacturers to reduce pharmacists’ access to medications through limited distribution networks. Using restricted distribution as a tool to gain marketplace advantage rather than for patient safety undermines the justification for such limited systems. ASHP opposes the use of RDDSes for anything other than patient safety and encourages the FDA or other appropriate authorities to investigate whether RDDSes are being used in a manner inconsistent with the original intent. In addition, RDDSes may compromise continuity of care or interfere with pharmacists’ accountability for care to certain patient populations, such as when an RDDS prevents a patient’s pharmacist from obtaining it. Some investigational drugs approved for marketing under an RDDS are no longer available for qualifying patients on admission through the institution, despite the institution having a history of managing the drug while it was investigational. Such circumstances force the patient to seek care elsewhere or require them and their healthcare providers to unnecessarily utilize additional resources to provide care. In addition, healthcare organizations, responsible for the total care of the patient, including maintaining the patient’s medical records, may lose the established patient-care relationship when a patient must go to a specialty pharmacy for a drug the healthcare organization cannot access. RDDSes fragment the healthcare delivery system at a time when public and private payers are increasing incentives to integrate patient care.