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NCPA President Steve Giroux's Testimony at FDA Behind the Counter Hearing

Thursday, November 15, 2007 General News
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ALEXANDRIA, Va., Nov. 14 The following is the prepared testimony of NCPA president Steve Giroux before the public meeting of Food and Drug Administration (FDA) regarding behind the counter availability of certain drugs.
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"Hello, I am Steve Giroux, President of the National Community Pharmacists Association (NCPA) and a pharmacist from Middleport, New York.
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NCPA would like to thank the FDA for holding this public meeting to explore the public health benefit of certain drugs being available without a prescription, but only after intervention by a pharmacist in the Behind the Counter or "BTC" class of drugs.



NCPA strongly supports the creation of the BTC class of drugs. We believe it would reduce consumer healthcare costs, increase patient convenience, and provide a vehicle for postmarket safety supervision for consumer protection.



NCPA represents the pharmacist owners, managers, and employees of more than 23,000 independent community pharmacies across the United States.



They are community leaders actively involved in community-oriented public health, civic, and volunteer projects. Many hold local elected offices, others serve as state legislators.



The nation's independent pharmacists dispense 1.4 billion prescriptions annually, 41% of all the retail prescriptions in the United States. This is a huge responsibility, but as medication experts it is a responsibility that our members readily accept.



Not only are pharmacists the most accessible healthcare providers available to patients; pharmacists have the training and knowledge to provide clinical interventions and ensure, through specific clinical protocols, that patients meet the conditions for specific BTC use. They are also well qualified to educate patients on appropriate use of the drug product and follow up with the patients to ensure compliance with the medication regimen.



Today we are here for our patients and to support the BTC class of drugs which is similar to the "pharmacy only" concept in the UK. Our colleagues in the UK have told us that the "pharmacy only" concept has provided their patients greater access to more medications leading to improvement in patients' self-care and a decrease in unnecessary visits to the doctor.



Independent pharmacies already offer a wide range of patient services including nutritional counseling, compounding, diabetes education, immunizations and vaccinations, and smoking cessation clinics. Therefore additional services such as the counseling of patients on BTC medications should be easily integrated into the pharmacy workflow.



In a survey conducted by NCPA on November 2nd, 2007, our members were overwhelmingly positive (97.1%) about the prospect of helping patients by being able to offer a BTC drug after pharmacist consultation and clinical evaluation of a patient (no prescription from a physician necessary).



Regarding patient safety, our members regard pharmacist involvement in patient screening, lab testing, additional counseling, follow-up, and monitoring as a benefit to patient safety. They were very positive about the potential to enhance patient safety through their participation in these activities.



Many pharmacists responded that through increasing patient contact they can better ensure the patient gets the right medication at the right dose for the right condition and that they can refer patients to a physician for appropriate care when needed.



NCPA has long held a Statement of Position in support of a transitional class of drugs, called "Pharmacist Legend", so the idea that the BTC class could be transitional was well received by our members. We believe that the vast majority of the medications in the BTC class of d
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