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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Re-evaluating Chinese currency remains a bad idea

BY Alaric DeArment

WHAT IT MEANS AND WHY IT’S IMPORTANT Herbert Hoover is alive and well — and picking up his prescriptions at the local drug store.

(THE NEWS: Retailers urge Congress to reject Chinese currency legislation. For the full story, click here.)

Of course, he isn’t. But if he were, he might have some advice to offer current members of Congress and occupants of the White House based on his experience with the Smoot-Hawley Tariff Act of 1930, which attempted to rescue the U.S. economy by imposing tariffs on imported goods, but instead ignited a trade war that many historians blame for deepening the Great Depression.

The legislation to impose tariffs on Chinese imports as a way to force it to revalue the yuan is based on the assumption that China manipulates its currency to make its manufactured goods more competitive in the U.S. market. Thus, the reasoning goes, if China were to revalue the yuan, it would help American manufacturers by making Chinese imports more expensive and American goods more competitive in China, thereby helping to ease the U.S.-China trade deficit, which totaled $226.9 billion last year and has so far reached more than $145 billion this year, according to U.S. Census data.

But it’s not that simple. In 1930, the United States manufactured most of its own consumer goods; but that’s no longer true, and the bulk of consumer goods, from toys to digital cameras, now come from China. Also frequently lost in the melee is the fact that most of the supposedly Chinese goods are not Chinese at all, but rather products with American, Japanese, Korean and European brands that are assembled in China. Unlike in the 1970s and 1980s, when such Japanese companies as Sony were eating the lunch of such American counterparts as General Electric, the “Made in China” label now graces the products of both.

For that reason, if legislators imposed big tariffs on Chinese goods or if China dramatically revalued the yuan, it would simply force retailers to pass the extra costs to consumers. So after picking up his prescriptions, Hoover would find the digital camera he had planned to buy from behind the counter noticeably more expensive. While this would not likely lead to another Great Depression, it would certainly diminish consumers’ purchasing power.

As for the manufacturing jobs, many experts have said they would simply migrate to cheaper countries rather than returning to the United States. This trend already is under way in textiles, as many clothing companies have started moving factories from China to such countries as Bangladesh in response to the increasing costs of manufacturing in China.

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j.hoston says:
Mar-20-2013 04:21 am

A brief introduction and definition on quality organization systems significance of quality, quality audits, audit objective, process of auditing & quality control tackle. Quality Audit Bangladesh

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Perrigo seeks approval for generic Zegerid OTC, Schering-Plough files suit

BY Alaric DeArment

ALLEGAN, Mich. Perrigo has filed for regulatory approval of a generic version of an over-the-counter medication for frequent heartburn, prompting a lawsuit from the branded version’s manufacturer.

The company announced Friday that it had filed for approval for omeprazole and sodium bicarbonate in the 20 mg/1,100 mg strength. The medication is a generic version of Zegerid OTC, made by Schering-Plough HealthCare, a subsidiary of Merck.

 

Schering-Plough filed a lawsuit Monday alleging patent infringement in the U.S. District Court for the District of New Jersey to prevent Perrigo’s commercialization of the product.

 

 

Zegerid had sales of around $60 million during the 12-month period ended in the “most recent month,” according to SymphonyIRI Group.

 

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