HEALTH

In testimony, NACDS hails federal effort to simplify patient medication information

BY Jim Frederick

ROCKVILLE, Md. Federal efforts to simplify and standardize the information that patients receive with their prescription medications are laudable and should continue, the chain pharmacy lobby told Obama administration health officials Monday.

That message to the Food and Drug Administration came from the National Association of Chain Drug Stores, which has pushed for simpler patient package inserts, and on a more basic level, a single standard for conveying patient medication information. In a presentation to an FDA public hearing, NACDS VP government affairs and pharmacy adviser Kevin Nicholson said his group is “very pleased” that the agency appears to be moving toward a single information document with standardized format and content. He urged federal health officials to “continue to move toward this laudable goal with all reasonable haste.”

Under current FDA rules, Nicholson testified, “Patients receive several different types of information, developed by different sources that may be duplicative, incomplete, or difficult to read or understand.” The agency should work with NACDS, other pharmacy groups, manufacturers and patients themselves, he asserted, to come up with a “one document solution” to the knotty issue of PMI.

“Patients want a useful document, designed and written for them, that recognizes their information needs, that focuses concisely on critical information and that provides them with clear instructions on where to go for further advice and instruction,” Nicholson told the FDA panel. What’s more, he said, “The provision of multiple documents, containing redundant or even conflicting information, creates logistical and financial burdens for pharmacies that compromise effective patient counseling. It would be far more convenient, efficient and ultimately more effective for pharmacists to counsel patients by providing a single document that could easily be understood and facilitate a discussion concerning proper use of medication.”

That said, the NACDS executive noted, “our first recommendation is for FDA approval of all PMI. However, considering that FDA approval may not be feasible, we urge the agency to develop pilot programs to test various modes of ensuring standard content and format, including using simplified and modified PPIs as PMI. Any pilot program should also test different modes of patient access and delivery to the patient at the pharmacy, at the point of prescribing and via the Internet and/or electronic health records,” Nicholson concluded. “The key to success for PMI will be for continued collaboration among the agency, manufacturers, pharmacies, prescribers and consumer groups.”

In mid-2008, NACDS and seven other pharmacy and consumer organizations submitted a citizen petition to urge the FDA to move to “a concise, plain-language document for patients that would consolidate and replace the multiple written communications pharmacies currently are required to distribute to patients.” Adopting a standard, easier-to-understand medication information format, Nicholson told the agency, would help boost patient adherence, improve health outcomes and cut needless healthcare expenditures.

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Dr. Siegal’s Cookie Diet introduces CalciOs

BY Allison Cerra

VIENNA, Va. Dr. Siegal’s Cookie Diet has expanded its offerings to include calcium-fortified cookies designed to treat occasional heartburn.

CalciOs cookies are vanilla-flavored cookies, each one providing 30% of the daily value of dietary calcium, Dr. Siegal’s Cookie Diet said. The cookies contain calcium carbonate, designed to treat heartburn relief. CalciOs also are free of artificial colors and preservatives.

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Pharmacies should get out of tobacco-selling, into smoking-cessation game

BY Antoinette Alexander

WHAT IT MEANS AND WHY IT’S IMPORTANT The news that San Francisco’s board of supervisors gave preliminary approval to ban tobacco sales at all retailers that operate pharmacies, including mass merchants and grocers, is a step in the right direction, because if drug stores are going to be banned from selling them, then all retail pharmacy outlets should be banned. However, there’s an even bigger picture to consider.

(THE NEWS: Report: San Francisco supervisors OK tobacco sales ban at pharmacies. For the full story, click here)

As many dollars as pharmacy retailers made selling cigarettes, there is much more to be gained in medication therapy management, and there is a significant opportunity for retail pharmacy to have a greater stake in the future of health care.

Cigarette smoking has been identified as the most important source of preventable disease, illness and death worldwide, according to the American Lung Association. Smoking-related diseases claim an estimated 443,000 American lives each year, including those affected indirectly by "secondhand" smoke.

Furthermore, smoking-related healthcare expenditures are a major drain on the U.S. healthcare system. According to the Centers for Disease Control and Prevention, smoking cost the United States more than $193 billion in 2004, including $97 billion in lost productivity and $96 billion in direct healthcare expenditures, or an average of $4,260 per adult smoker.

Clearly, there’s a positive role that pharmacists can play in smoking cessation. To further support this, a recently published study on the "effect of a pharmacist-managed smoking-cessation clinic on quit rates" found that pharmacists can play a vital role in smoking cessation, especially in a group setting, as they can reach more people within the same time frame.

The study found that at three months and six months, 47.6% and 52.4% of patients reported being smoke-free, respectively. The study was conducted on patients that had participated in the pharmacist-managed Smoking Cessation Group Clinic at the University of Iowa Hospitals and Clinics. Participants received structured group counseling on various topics associated with cessation.

It also should be noted that in August, the Centers for Medicare and Medicaid Services announced that Medicare coverage for seniors trying to quit smoking was expanded to include everyone on Medicare.

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