HEALTH

CHPA president addresses OTC efficacy, drug abuse

BY Michael Johnsen

WASHINGTON During her opening address to Consumer Healthcare Products Association members here, Linda Suydam, president of the CHPA, noted that two Food and Drug Administration meetings held last year have forever changed the over-the-counter regulatory landscape.

The two meetings Syudam referenced—an FDA advisory panel on the efficacy of children’s cough-cold medicine and a separate panel on the efficacy of phenylephrine—called into question the long-standing efficacy of monographed products. “What was learned from both of these meetings is that the regulatory landscape is changing,” she said. “We must move forward on the science supporting our product.”

To this end, CHPA is already committed to conducting pharmacokinetic and efficacy studies in pediatric populations for monographed OTC medicines.

Another point of concern identified by Suydam was the issue of dextromethorphan abuse. She commended the industry for pulling together on this issue, and through CHPA effectively raised awareness and education behind DXM abuse. “The level of cooperation among members this past year has been exceptional.”

Looking forward, the industry prognosis is positive, however not without its challenges. For example, “FDA’s chronic underfunding will take a long time to rectify,” Suydam said, regardless of whether a Democrat or a Republican wins the presidential election next year.

keyboard_arrow_downCOMMENTS

Leave a Reply

No comments found

TRENDING STORIES

Polls

Which area of the industry do you think Amazon's entry would shake up the most?
HEALTH

NACDS submits statement on its members’ efforts to curb drug abuse

BY Adam Kraemer

ALEXANDRIA, Va. In preparation of Wednesday’s by the U.S. Senate Judiciary Subcommittee on Crime and Drugs and the Senate Caucus on International Narcotics Control entitled “Generation Rx: The Abuse of Prescription and Over-the-Counter Drugs,” the National Association of Chain Drug Stores submitted a statement for the record.

Among the contents of the statement, the Association commended Senator Joe Biden, D-Del. “We thank Chairman Biden, and members of the Subcommittee and Caucus on International Narcotics Control, for the opportunity to provide this statement on the abuse of prescription and over-the-counter drugs. As healthcare providers of these critical and highly beneficial products, we are deeply concerned about the problem of consumers’ using these products in potentially harmful ways. We will continue to work with Congress and the administration to find solutions to curb drug abuse.”

In the statement, NACDS shared that its members have taken to restricting access to methamphetamine precursors, implementing age restrictions on dextromethorphan and dihydroepiandrosterone products, and working with states to implement prescription monitoring programs.

NACDS also stressed their commitment to working with Congress to craft legislation that will shut down rogue Internet operators while still allowing legitimate pharmacies to function. In addition, the association urged Congress to work with the Department of Justice and the Drug Enforcement Administration to issue regulations allowing the electronic prescribing of controlled substances.

E-prescribing, NACDS stated, offers numerous benefits that can help reduce the abuse of controlled substances. “A paperless prescribing system is preferable to today’s paper world because it adds new dimensions of safety and efficiency to current practice. Moreover, electronic prescribing offers enhanced controlled substance reporting and monitoring capabilities that allow the DEA, as well as state and local law enforcement agencies, the ability to identify potential abuse immediately.”

The full text of the statement can be found here.

keyboard_arrow_downCOMMENTS

Leave a Reply

No comments found

TRENDING STORIES

Polls

Which area of the industry do you think Amazon's entry would shake up the most?
HEALTH

Iowa bill to track meds purchases passes House

BY Michael Johnsen

DES MOINES, Iowa House File 2265, which would create an electronic system to track the purchase of products containing pseudoephedrine, passed the Iowa House on Monday and has been forwarded to that state’s Senate.

If the bill passes, retailers would be obligated to use the electronic system to instantly check the photo identification of people buying PSE-containing cough and cold products. The system would prevent the practice of “smurfing,” by which drug abusers in search of PSE products acquire the maximum amount of product they can buy at one store, only to buy more at another store down the road.

According to a report in the Des Moines Register, House File 2265 would set up a pseudoephedrine advisory council to help the Iowa Board of Pharmacy implement an electronic monitoring system.

The local daily also noted that the proposal does not allocate money to help the state set up the system, a cost estimated at around $230,000. In addition, depending upon what type of system is ultimately adopted, retailers could be charged a fee of as much as 10 cents per transaction and also be obligated to purchase a $900 device per store to scan identification cards, the paper added.

keyboard_arrow_downCOMMENTS

Leave a Reply

No comments found

TRENDING STORIES

Polls

Which area of the industry do you think Amazon's entry would shake up the most?