View Full Version : NCPA President Steve Giroux's Testimony At FDA Behind The Counter Hearing

Medical Videos
12-25-2007, 11:10 PM
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.

"Hello, I am Steve Giroux, President of the National Community Pharmacists Association (NCPA) and a pharmacist from Middleport, New York.

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 drugs would be transitioning from Rx to BTC status; however, we do realize that on occasion this could be a two-way street such as the move of pseudoephedrine products from OTC to BTC. This is actually an extremely good example of why we need a uniform, standardized process in place for handling the BTC class of drugs.

There were many thoughts by our members with regard to benefits and costs to the healthcare system and for the most part we see great potential to relieve some of the growing burden on emergency rooms by providing access-with oversight from a healthcare professional-to medications in the BTC category.

Additionally, pharmacists are trained to be medication experts. They undergo a minimum of six intensive years of university training to learn about drugs and their effect on the body. By increasing the pharmacist's involvement with the patient in a formalized process, patients will benefit through an increased understanding and better use of their medications.

And our patients agree. A recent survey of 1,000 consumers, age 18 and older, conducted by the polling company™ found 68% of Americans strongly or somewhat strongly supported the development of a BTC category. By a greater than two-to-one margin, Americans endorsed a policy that would bring certain medications that are available off the shelf to behind the counter. Nearly two-thirds (62%) of Americans would also support allowing pharmacists to dispense specific drugs that currently require a doctor's prescription. These numbers hold especially true for parents. Americans with children under the age of 18 in their households were much more inclined than non-parents to support creating a BTC category (77% vs. 63%), giving pharmacists the ability to dispense certain medications that now require a doctor's prescription (66% vs. 59%) and moving some medicines from OTC to BTC status (69% vs. 65%).

Ultimately, we believe decisions in this area should put patient care first. The person who walks into a drug store is a customer, but once they reach the pharmacists' counter they are a patient…and in the words of one of our members, "We need to consider what is best for the patient rather than what is best for the healthcare system." That's why we are here today - it's all about our patients…and if we get this right it will benefit the healthcare system as well.

Now, about the logistics associated with BTC drugs. NCPA members were not fazed by the logistical questions asked by FDA. Workflow, inventory, record keeping, billing - all fundamental to keeping a community pharmacy open and successful and we will apply the same tactics to all logistical activities associated with BTC drugs when they become available.

As far as where to store BTC medications, our members' assumed that the first BTC drug (other than pseudoephedrine of course) would already be "behind the counter" as a prescription medication so they wouldn't need to make room for it on their shelves.

All agreed there must be a standardized protocol and electronic platform for dispensing these drugs for patient as well as practitioner safety and liability. With regard to reimbursement, pharmacists must be paid for services provided in conjunction with BTC medication. Health insurers should consider the addition of BTC medications to their formularies as a way to improve patient healthcare and lower costs. This topic deserves much further discussion than this forum able to provide.

One key point our members made was the need for all the BTC protocols to be available in central location such as a computer database, website. Although, most felt that a uniform electronic system could also enable tracking and monitoring of patients who go to multiple pharmacies and could potentially increase acceptance and participation by patients, pharmacists and physicians.

Our members were split 50:50 regarding who would oversee the BTC program. However, many thought that the FDA and the State Boards of Pharmacy should work together to define a process for the BTC class of drugs.

NCPA members feel strongly that a BTC class of drugs belongs solely in a pharmacy where well trained personnel can ensure appropriate patient care. We believe only a licensed pharmacist and potentially pharmacist intern under the supervision of a licensed pharmacist may provide the clinical intervention necessary for the dispensing of a BTC drug to a patient. This class of drugs should not be available in venues where pharmacists are not available such as gas stations, convenience stores, or vending machines as OTC drugs often are.

Training of pharmacists and staff is important and there were many suggestions encompassing web-based programs, live CE programming and other types recommended by our members that we would be glad to share in more detail with FDA in our written comments.

Overall NCPA members feel that the availability of BTC drugs will have a very positive impact on the practice of pharmacy as well as the practice of medicine. In general the availability of BTC products will build much better relationships between patients and their pharmacists.

NCPA would like to propose the first BTC product be available to patients in the United States as early as 2009 and pledge our support to work with the FDA to make that happen.

Thank you Deputy Commissioner Lutter and Deputy Director Throckmorton as well as the panel for allowing NCPA to comment on this incredibly important public healthcare issue."

Steve Giroux, RPh
President, NCPA (http://www.ncpanet.org/)

The National Community Pharmacists Association (NCPA) represents the nation's community pharmacists, including the owners of more than 23,000 pharmacies. The nation's independent pharmacies, independent pharmacy franchises, and independent chains represent an $84 billion marketplace, employ over 300,000 employees and dispense nearly half of the nation's retail prescription medicines.

http://www.ncpanet.org (http://www.ncpanet.org/)