NCPA reaches Fight4Rx goal

(Drug Topics) The member pharmacies of the National Community Pharmacists Association (NCPA) have reached their goal of recruiting more than 12,000 patients for Fight4Rx.org, an online effort aimed at turning pharmacy patients into activists for community pharmacies. Read more

Judge: Morning-after pill should be available to 17 year olds

(Drug Topics) A federal judge has ruled that 17 year olds should be able to get the morning-after pill without a prescription, and ordered the Food and Drug Administration to consider expanding access all women.

Before Monday's decision, the FDA had agreed to make the emergency contraceptive known as Plan B available without a prescription only to women 18 and older and only from a pharmacy counter. The Center for Reproductive Rights sued the government in Brooklyn Federal Court, charging the FDA put politics before science in drafting the rules.

In his written decision, Judge Edward Korman noted there appeared to be “political considerations, delays and implausible justifications” in the decision-making process. “The record shows that FDA officials and staff both agreed that 17-year-olds can use Plan B safely without a prescription,” Korman wrote.

Korman said the FDA's justification for this age restriction, that pharmacists would be unable to enforce the prescription requirement if the cutoff were age 17 rather than 18, lacks credibility.

“While the FDA is free, on remand, to exercise its expertise and discretion regarding the proper disposition of the citizen’s petition, no useful purpose would be served by continuing to deprive 17 year olds access to Plan B without a prescription,” Korman said.

A spokesman for the Brooklyn U.S. attorney's office, which represented the FDA, told various media outlets the ruling is being reviewed.

CPI releases new concerns about Pfizer’s Celebrex study

(Drug Topics)The Center for Public Integrity (CPI) has called into question the ethics and necessity of the Prospective Randomized Evaluation of Celecoxib Integrated Safety versus Ibuprofen or Naproxen study (PRECISION), sponsored by Pfizer and run by Steven Nissen, MD, with the Cleveland Clinic. Read more

Proposed Pharmacy Bill by Idaho House Committee Targets Moral Issues

(KPVI, Idaho. By: Tammy Scardino) The state of Idaho is now one step closer to passing legislation that would put into writing an unspoken understanding that pharmacists have the right to refuse filling a prescription. What makes this a hot topic is the specific type of medication that gets denied. Read more

Wyeth liability case advances in California

(Drug Topics) California may be moving toward a new form of liability. The state Supreme Court declined to hear an appeal from Wyeth in a case the held the drug maker liable for injuries caused by generic versions of Reglan (metoclopramide) made by another manufacturer. Read more

Study: ‘Smart drug’ Provigil may be habit-forming

AP - A so-called "smart drug" popular with young people may carry more of an addiction risk than thought, a small government study suggests. Scans of 10 healthy men showed that the prescription drug Provigil caused changes in the brain's pleasure center, very much like potentially habit-forming classic stimulants. Modafinil, the drug's generic name, is sometimes used as an illegal study aid by college students.

"It would be wonderful if one could take a drug and be smarter, faster or have more energy," said Dr. Nora Volkow, director of the National Institute on Drug Abuse, who led the study with a Brookhaven National Laboratory scientist. "But that is like fairy tales. We currently have nothing that has those benefits without side effects."

The study, appearing in Wednesday's Journal of the American Medical Association, may bust the myth that the drug is safe for healthy people, experts said.

Provigil is approved to treat excessive daytime sleepiness caused by narcolepsy. On the market since 1999, it's the flagship product of Cephalon Inc. of Frazer, Pa., and its sales approached $1 billion last year. The company is developing a spin-off called Nuvigil.

Modafinil's reputation as a brain enhancer stems from an Air Force study that found it improved the performance of sleep-deprived fighter pilots. College students buy and sell it illegally, as they do Ritalin and Adderall, to stay alert while studying.

Several scientists recently wrote in the journal Nature that healthy people should have the right to boost their brains with pills like Provigil. One author of that commentary, brain scientist Martha Farah of the University of Pennsylvania, said the new study "goes to show that we need a little caution and a little humility when we're messing around with our brain chemistry."

"But even now, after all the years that it has been on the market, we are still learning things about it that are relevant to its safety," Farah said.

The men in the study were 23 to 46 years old. They received either a dummy pill or modafinil. Effects were measured by PET scans, which showed that the drug increased dopamine, the brain's "feel-good" neurotransmitters.

Modafinil once was thought to be safer than conventional stimulants because it was believed that it did not engage the brain's dopamine system, which is linked with addiction. Studies in mice and monkeys suggested otherwise.

The new study is the first human evidence that a typical dose of modafinil affects dopamine in the brain as much as a dose of Ritalin, a controlled substance with clear potential for dependence.

Volkow said modafinil acts slowly when swallowed and is difficult to inject, making it less likely to be abused. Its high price, about $10 per pill compared to Ritalin at $2 per pill, also makes it less attractive to people seeking a high. That may change when generics become available in 2012, Volkow said.

Jeffry Vaught, chief science officer for Cephalon, said the company has seen no evidence the drug is highly abused.

"If abuse is a problem with modafinil, it's minimal at best," Vaught said. "We're not seeing it used at rave scenes."

Prescribing information for the drug warns of severe rashes and other side effects such as headache, nausea and anxiety. Cephalon doesn't support the drug's use as a cognitive enhancer.

"There's no substitute for sleep," Vaught said.

New Treatments Improve Control for Severe Asthma

(HealthDay) Over just one decade, new asthma medications and tools have significantly improved the management of this serious airway disease. When compared to children treated in the mid-'90s, children with severe asthma during 2004 to 2007 were less likely to need oral steroids and rescue inhalers, and their lung function scores were improved, according to a study from National Jewish Health in Denver. Read more

Another Example of TelePharmacy in Action

(By Jo Dee Black – Great Falls Tribune. Chester, Montana) — Keri and Justin VanCampen grew up in small Montana communities and wanted to raise their family in the same type of environment.

Thanks to programs designed to promote business in rural communities, the couple are doing just that in the Hi-Line community of Chester, population 871 according to the last Census. They’ve not only created jobs for themselves, but for five other small town Montana residents. Read more

Failure To Track Pharmacy Mistakes May Be ‘Prescription For Trouble’

(MSNBC) CLEVELAND/News Channel 5 – Prescription medication can save your life. But the wrong pills can kill you.

“There was an egregious error and the family believes it occurred on numerous occasions,” Owen Dunn said.

Dunn’s grandfather, Joe Hayduk, had a bladder disorder but pharmacy records show he was given a drug for diabetes instead. Hayduk died within months. Read more

Biotech generics bill introduced in Congress

(Drug Topics) A bipartisan bill that would allow the U.S. Food and Drug Administration (FDA) to approve affordable copies of biotech drugs has been introduced in Congress. Reps. Henry A. Waxman (D-CA), Frank Pallone (D-NJ), Nathan Deal (R-GA), and Jo Ann Emerson (R-MO) introduced H.R. 1427, the Promoting Innovation and Access to Life-Saving Medicine Act.

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