Federal government must find alternatives to rescheduling hydrocodone combination drugs
The Food and Drug Administration plans to officially recommend that products containing 15 mg or less of the opioid painkiller hydrocodone be rescheduled as Schedule II controlled substances, from the current Schedule III classification. While the idea is to combat abuse and misuse of the drugs, pharmacy groups say the rescheduling would make them harder to obtain for patients who legitimately need them.
The desire to combat abuse and misuse of prescription drugs — now a worse problem in the United States than cocaine or heroin — is laudable, but unlike those two drugs, hydrocodone has a legitimate use as a painkiller, and it’s the people who are using it properly and legally who will end up losing.
Most opioid painkillers are already Schedule II drugs, including Purdue Pharma’s OxyContin (oxycodone) extended-release tablets and Johnson & Johnson’s Duragesic (fentanyl) patch, as well as single-entity hydrocodone products like Zogenix’s recently approved drug Zohydro ER. But some drugs that combine a low-dose opioid with another analgesic, including AbbVie’s Vicodin (hydrocodone; acetaminophen) and J&J’s Tylenol with Codeine, are still Schedule III.
For the Drug Enforcement Administration’s purposes, the distinction between CII and CIII is that the former indicates a much higher potential for abuse and dependence than the latter. But for patients who need those drugs, it’s an even bigger difference. Under federal law, a prescription for a CIII drug is good for up to six months or five refills, whichever occurs first. But a CII drug cannot be refilled; instead, the physician must write multiple prescriptions to be filled sequentially over a period of up to 90 days.
For patients who suffer from chronic pain, it should be obvious why rescheduling such drugs as Vicodin could be a problem. It would also represent a change from the FDA’s previous resistance to rescheduling hydrocodone combination drugs, in contrast with the DEA’s push for it.
The DEA has a point. According to the National Institute on Drug Abuse, part of the National Institutes on Health, Vicodin was the most-abused drug among 12th graders after marijuana. But if the interest is in preventing abuse and misuse, there are alternatives to stricter laws. The National Community Pharmacists Association had a better idea when it suggested electronic prescription drug monitoring and tracking systems. Tamper-resistant features similar to the ones now on OxyContin and Opana ER would also help to discourage abuse.
New study confirms effectiveness of Guiding Stars nutrition program
PORTLAND, Maine — Guiding Stars really works. That’s the finding of an independent study that examined the Guiding Stars nutrition guidance program at more than 100 Hannaford grocery stores.
According to the study, which focused on ready-to-eat cereals, the program influences grocery shoppers’ selections and significantly increases demand for products that are rated more nutritious, at the expense of those that are not. The findings were published in the journal Food Policy.
The Guiding Stars system evaluates the nutritional value of every item in the store, including non-perishables, hot and cold prepared foods, produce, meat and dairy, salad bar, grab-and-go items and beverages. Each item is then rated according to its value: one Guiding Star is good, two Guiding Stars is better and three Guiding Stars is best. All items are scored using a patented algorithm based on the USDA Dietary Guidelines for Americans and other national evidence-based nutrition policies.
The Guiding Stars program is available in more than 1,800 supermarkets in North America and also operates in public school, college, hospital and corporate cafeterias.
According to the study, “Effects of the Guiding Stars Program on purchases of ready-to-eat cereals with different nutritional attributes,” shoppers were significantly more likely to choose ready-to-eat cereals with one, two or three Guiding Stars, indicating a higher nutritional value, versus those with zero stars, or a lower nutritional value. As a result, the market shares of cereals earning Guiding Stars increased, while those without stars declined in relative proportion. At the same time, the study results suggest that the Guiding Stars point-of-purchase information led customers to become increasingly loyal to products earning stars, even if the prices of those products fluctuate.
Scientists at the USDA, FDA and the University of Florida conducted the research. According to researchers, it validates previous studies that have already demonstrated that the Guiding Stars Program encourages consumers to choose more nutritious foods, especially when making quick purchase decisions. This research was undertaken in response to the Institute of Medicine’s 2012 report on front-of-pack nutrition labeling systems, and the study shows that the presence of point-of-sales guidance may help consumers select products that are more nutritious in terms of the Guiding Stars rating.
"This extremely well-designed and rigorous study makes an important contribution to the growing field of nutrition labeling or profiling systems and demonstrates that such systems can indeed positively influence consumer purchasing behavior," stated Leslie Fischer of the UNC-Department of Nutrition and member of the Guiding Stars Scientific Advisory Panel. "This work is very affirming and independently demonstrates that the Guiding Stars program has succeeded at helping shoppers to make more nutritious food choices, thus fulfilling the goal of the program."
In conducting the study, researchers examined purchase data of ready-to-eat cereals before and after implementation of the Guiding Stars Program at 134 Hannaford grocery stores, comparing it with data from an equal number of Hannaford-like control stores across the country without the Guiding Stars system in place. These control stores were included in order to separate program effects from such non-program effects as pricing and advertisements.
"This research is an exciting acknowledgment for the Guiding Stars program. These independent results once again demonstrate the positive impact our efforts have on helping consumers make better nutritional choices for themselves and their families," added Jim McBride, director of operations with Guiding Stars. "It’s incredibly rewarding to see our work validated by the leading food scientists in our nation at the USDA and FDA. And it is further evidence to our clients, as well as other retail and food service operators, that Guiding Stars is an effective, easy and convenient solution to encourage healthy choices."
"Poor diets are a significant cause of obesity, heart disease, stroke, cancer, diabetes, osteoarthritis and other health conditions that impose an economic burden on individuals and society overall," study authors wrote. "Our ﬁndings suggest that GSP has encouraged Hannaford customers to switch from cereals that the GSP considers less nutritious to cereals that the GSP considers more nutritious."
The study authors concluded "point-of-sale nutrition information programs may be effective in providing easy-to-ﬁnd nutrition information that is otherwise non-existent, difﬁcult to obtain, or difﬁcult to understand … the presence of this type of information may help consumers select products that are more nutritious in terms of GSP star rating."
Reports: P&G shareholder suggests sale of Iams pet food brand
NEW YORK — Procter & Gamble may be able to sell its Iams pet food unit to Del Monte Foods Co., according to published reports.
Bloomberg reported that P&G CEO A.G. Lafley was under pressure to improve the company’s business and that shareholder HighMark Capital Management said it could increase its share price by selling some assets, including Iams. Del Monte, HighMark said, would be a "logical" buyer for Iams, valued at around $2.5 billion, because it’s looking to grow its pet food business.
Del Monte announced earlier this month the sale of its consumer products business to Philippines-based Del Monte Pacific Ltd. so that it could focus on its pet products division. Del Monte currently owns such brands as Meow Mix, Kibbles ‘n Bits, Milk-Bone, 9Lives and others.