Improvement of restricted drug distribution systems (RDDS) should be a key element of the reauthorization of the Prescription Drug User Fee Act (PDUFA).
ASHP also wants the FDA to direct its drug safety and risk management advisory committee to craft recommendations to improve RDDS programs. In addition, ASHP wants pharmacists to be consulted as the FDA develops guidance documents to improve methods for naming and labeling medications.
Brian Meyer, director of the government affairs division for ASHP, said that pharmacists are able to provide the practice perspective to the naming, labeling, and packaging issues and challenges that confront them everyday. "Without their [R.Ph.s'] input, policymakers and other stakeholders would make decisions that do not reflect the impact on everyday practice."
According to a recent ASHP survey of its members who have experience with RDDS, timely access to drugs for patients and continuity of care are frequently or occasionally a problem in the vast majority of hospitals and healthcare systems. Survey results reveal that most health-system pharmacists believe that some aspects of RDDS programs can be standardized.
ASHP's Meyer said that RDDS needs to be standardized and have consistent and routine registration procedures (for patients, prescribers, and pharmacists) that can be easily implemented by pharmacies. "Currently, these systems are developed independently by each manufacturer, which creates unnecessary complexity and introduces the opportunity for error." Meyer asserted that RDDS programs should be evaluated from a practical standpoint also and take into consideration continuity of care issues. For instance, if a patient is discharged at 3:00 PM on a Saturday, that patient might not have access to a pharmacy that could provide necessary medication. "It should be noted," said Meyer, "that the rationale for this standardization is ensuring patient safety, maintaining patient continuity of care, and appropriate use of pharmacist time and resources."
ASHP officials believe that the reauthorization of PDUFA provides an opportunity to improve elements of FDA oversight of these programs, improving patient care and reducing unnecessary burdens on the healthcare system. ASHP thinks this PDUFA reauthorization should provide for research on how well existing and new restricted drug distribution systems are achieving their goals. Also, new PDUFA reauthorization legislation should mandate that drug manufacturers and FDA partner with professional organizations in conducting this research.
ASHP also believes that the drug safety and risk management advisory committee should analyze FDA standards and recommend new policy in several key areas related to RDDS, including: