Newswise — On November 14, the Food and Drug Administration (FDA) will hold an informational meeting to hear opinions on the behind-the-counter (BTC) method of drug distribution. BTC implies the medications are distributed to patients upon a pharmacist's discretion, eliminating the need for a physician's prescription and improving the public health benefit. The issue is the center of controversy in the healthcare field.
"The involvement of the pharmacist in counseling patients will be of great value in assuring the effective and safe use of these medications," said Dr. Daniel A. Hussar, Remington professor of pharmacy at USP's Philadelphia College of Pharmacy. "Also, this role will enhance the recognition of pharmacists as sources of useful information regarding other medications and healthcare issues."
Quite a few prescription drugs potentially qualify for BTC availability. Dr. Hussar has developed a preliminary list of medications for which he believes the public interest would be well served if they were made available BTC. This list includes: varenicline (Chantixâ„¢); epinephrine, used to treat serious allergic reactions; oseltamivir (Tamifluâ„¢), for influenza infections; and statins, for high cholesterol.
According to Dr. Hussar, fears about increased availability of potentially dangerous medications should not be a concern. "The products and their dosages that would be approved for inclusion in this category are not going to be drugs that have serious risks, such as seizures, associated with them."
As an example, Dr. Hussar points to the highly-effective prescription smoking cessation product Chantixâ„¢. "There are going to be some patients who want to stop smoking and try the nonprescription products without success, but won't go to see a physician. I feel availability from pharmacists could open the door to some people having access to the drug with the result that they stop smoking."
Many pharmacists support the BTC availability of medications, but the FDA has long been apprehensive about making a decision on instating a third method of drug distribution. However, the FDA's decision to approve nonprescription BTC availability of the drug levonorgestrel (Plan B®), in late 2006, proved they have the capacity to make such a call. The choice to give pharmacists the authority to distribute this "emergency contraception" medication to women 18 years of age and older was made without any new jurisdiction being granted to the FDA.
"The current leadership of the FDA has indicated receptiveness to expanding the concept of BTC availability of drugs on a nonprescription basis," said Dr. Hussar. "They have a series of questions for which they want input from interested parties." On November 14, representatives from professional pharmacy organizations, such as the American Pharmacists Association, as well as individual pharmacists, will attend the FDA's public meeting to present opinions about the expansion of BTC practices.
Opponents of BTC drug availability may include pharmaceutical companies because, as Dr. Hussar explains, "the goal of nonprescription medication manufacturers is to make as much profit as they possibly can. They look at BTC availability as restricting the distribution. Therefore, the drugs will not have the same sales potential as they would if people could just take them off the shelf."
Furthermore, prescription medications are often patented, which allows the pharmaceutical companies to charge top dollar. Dr. Hussar believes, however, that any loss in revenue would be offset by increased sales. "I would contend that even though the price of the BTC product would be lower, the number of units sold would be much higher than if it were on prescription," he said.
The role of health insurance companies that cover much of the cost of many prescription medications also raises valid concerns. While some insurance companies do not cover OTC medications in their prescription plans, others are willing to reimburse patients for the cost of certain OTC medicines, such as Prilosec OTC©, which offer a less-expensive alternative to similar prescription medications. Patients could end up paying for their BTC medicines, but Dr. Hussar believes there will be pressure on insurance companies to continue covering BTC medications that were once obtainable by prescription only.
"There will be expanded responsibility for the pharmacist that I think we should welcome," said Dr. Hussar. "I don't think we should be fearful of allowing pharmacists to take a higher level of responsibility."
University of the Sciences in Philadelphia is a private, coeducational institution dedicated to education, research, and service. Comprising five colleges, including its new Mayes College of Healthcare Business and Policy, USP specializes in educating its 2,800 students for rewarding careers through its undergraduate, graduate, and doctoral degree programs in pharmacy, health and related sciences, and healthcare business and health policy. Founded in 1821 as the nation's first college of pharmacy, it is where the founders of six of the top pharmaceutical companies in the world launched their futures.
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