November 14, 2012

(Washington, DC)— Neighborhood pharmacies, a primary outpatient source of compounded drugs in communities across America, must find new ways to demonstrate that they ascribe to the nation’s most rigorous safety protocols regarding compounding, the Pharmaceutical Care Management Association (PCMA) said today. PCMA has four questions that policymakers can ask to further explore these issues.

The U.S. House of Representatives House Energy and Commerce Subcommittee on Oversight and Investigations and the U.S. Senate Health, Education, Labor, and Pensions (HELP) Committee are holding hearings on pharmacy compounding over the next two days.

Nearly 90 percent of independent drugstores compound and more than 5,000 provide sterile medications. The National Community Pharmacists Association (NCPA), the national association representing independent drugstores, has said “compounding is one of the fastest growing areas for independent pharmacies.”

One challenge is that small organizations often find it more difficult than large ones to comply with best practices that require additional technology, costs, personnel, and training.

“When local communities need compounded medications, they turn to their neighborhood pharmacy. Local independent drugstores need to assure patients and policymakers they apply the highest patient safety standards when compounding medications,” said PCMA President and CEO Mark Merritt.

Four Key Questions for Policymakers

  • How can independent drugstores that compound demonstrate adherence to the nation’s most rigorous patient safety protocols?
  • Are independent drugstores compounding the same drugs as those implicated in the meningitis outbreak?
  • Should independent drugstores manufacture sterile drugs, such as injectable pain medication, or eye drops and hormone replacement therapy?
  • Are more independent drugstores compounding due to increased clinical demand or the higher fees that can be charged for compounding?