Nearly three-quarters of the respondents to a MedPage Today poll supported action by the FDA to formalize a behind-the-counter drug dispensing category.
Nearly three-quarters of the respondents to a MedPage Today poll supported action by the FDA to formalize a behind-the-counter drug dispensing category.
The agency will hold a public hearing next month to consider the category, which would make drugs available without a prescription but only after consultation with a pharmacist. (See: FDA to Consider Drug Category Between Rx and OTC)
The new category -- something midway between Rx and OTC and involving pharmacists more directly in the drug-decision process -- is already in use for the emergency contraceptive Plan B and cold remedies that contain pseudoephedrine. The FDA requires that those medications be kept behind the pharmacy counter and sales are limited to customers who show photo identification.
To gauge receptiveness to the new category before the hearing, MedPage Today asked visitors whether the FDA should formalize the new category?
Nearly three out of four (73%) of the 783 respondents said Yes, pharmacists are qualified to provide the type of counseling many drugs require.
Although physician respondents were about equally split on the question, one came down strongly on the No side. "I am not competent to run their pharmacies, and they need a bit more time to study medicine and physical diagnosis before this movement goes any further," he said. "It is a bad idea growing in the night-soil of big pharmacy chains."
Those who were against the behind-the-counter move were the most vocal in response to the poll. Among them was a nurse practitioner. Although he said he has great respect for pharmacists, he believes that a behind-the-counter category would be tantamount to allowing pharmacists to diagnose and prescribe. "Pharmacists do not perform the complete and comprehensive exams needed to diagnose properly and so may miss serious or potentially serious diseases."
Recognizing that problem, a pharmacist noted that "unless we can order follow-up labs, we will be shooting in the dark." He said he'd also "like to see greater cooperation between physicians and pharmacists."
A patient came down on both sides of the question, noting that a behind-the-counter category might "provide a use for the knowledge" most pharmacists don't use any more. But he finds it aggravating that he has "to pay a physician for access to certain medications that I know from past use are safe and effective for me."
One physician, like a number of other respondents, took exception to the phrasing of the possible responses. "Pharmacists are not simply pill counters who dispense preprinted information. I do not, however, feel that they are fully qualified to give counsel in terms of prescribing."
But she believed the move for behind-the-counter dispensing is being promoted by pharmaceutical companies. "They don't want to always have to go through an M.D. to sell their medications, but they don't want the liability of having many of these potentially dangerous medications dispensed over the counter. So, they've decided to place some of the liability on pharmacists."
So, ultimately, she came down in the negative column. "I do not think their current level of training warrants this change."
One physician respondent raised a number of questions that were beyond the scope of the poll to examine, but will undoubtedly be raised in the FDA hearings next month: Will pharmacists know a patient's history? Will pharmacists communicate with the patient's physician and who will follow-up? Will there be a consultation charge? And, ultimately, who will be medically and legally responsible for untoward events?