NCPA Offers Support for Nonprescription Class of Drugs at FDA Hearing

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Alexandria, Va. - March 22, 2012

Beverly Schaefer, RPh, owner of Katterman's Sand Point Pharmacy in Seattle, Washington, testified on behalf of the National Community Pharmacists Association (NCPA) at today's U.S. Food and Drug Administration (FDA) public hearing entitled, "Utilizing Innovative Technologies and Other Conditions to Expand Access to Nonprescription Drugs". She explained why pharmacists are well-equipped to handle another class of nonprescription drugs, what benefits the changes would have to the health care system, and what safety measures need to be incorporated.

"NCPA members fully support a nonprescription class of drugs with conditions of safe use and believe such a class will have a positive impact in enhancing public health, if used appropriately with pharmacist intervention," said Schaefer. "Benefits of the class include increased access to health care, improved utilization of health care resources, increased adherence to chronic use medications, decreased overall health care costs, and improved collaboration between members of the health care team. Standardized algorithms will be necessary to enable smooth and uniform integration of the proposed paradigm across all pharmacy settings. NCPA is committed to working closely with the FDA and other key stakeholders as this process evolves."

In her testimony, Schaefer described overburdened emergency rooms and doctor's offices with long waits and inconvenient hours as hampering patients' ability to address acute conditions. The proposed nonprescription class for "antivirals for a shingles or cold sore outbreak, rescue inhalers for asthma attacks, burn ointment for minor burns, steroid nasal sprays to reduce sinus inflammation, antihistamine eye drops for allergy relief, and epinephrine pens for allergic reactions" would be accessed through pharmacists, who are clinically-trained medication experts. As an added bonus, the utilization of pharmacists would help drive greater medication adherence, which is one of the most costly and persistent problems confronting America's health care system.

However, to ensure a new nonprescription class is implemented in a safe and collaborative fashion, Schaefer offered the following recommendations:

  • Products with conditions of safe use should be made available in pharmacy settings only, thus ensuring effective integration of the medications into the patient's regimen, with that pharmacist having proper documentation for each patient and open lines of communication with the patient's physician if necessary.
  • Standard algorithms for dispensing the nonprescription products should be put in place.
  • To prevent consumer confusion, patient access to the new drug class should not be dependent on a specific pharmacy. Patients should feel confident in knowing they can expect a continuum of safe and effective use of the nonprescription product, no matter which pharmacy a patient selects to obtain the drug.
  • Reimbursement for pharmacist services related to a new class must be addressed upfront.

The National Community Pharmacists Association (NCPA®) represents the interests of America's community pharmacists, including the owners of more than 23,000 independent community pharmacies. Together they represent a $93 billion health care marketplace, dispense nearly 40% of all retail prescriptions, and employ more than 315,000 people, including 62,400 pharmacists. Independent community pharmacists are readily accessible medication experts who can help lower health care spending. They are committed to maximizing the appropriate use of lower-cost generic drugs and reducing the estimated $290 billion that is wasted annually by improper medication use. To learn more go to or read NCPA's blog, The Dose, at

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