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American Journal of Health-System Pharmacy - Abstract

Purpose The frequency of and risk factors for medication errors by pharmacists during order verification in a tertiary care medical center were reviewed.

Conclusion An increase in the number of orders verified per shift was associated with an increased rate of pharmacist errors during order verification in a tertiary care medical center.

FDA is ready to restore some informal communications for generic drugs, but only for applications not covered by the newly implemented user fee action dates…applicants with pending ANDAs (abbreviated new drug application) that are not covered by user-fee goals will have the right to a status report under a new policy …governing communications with ANDA applicants in response to widespread criticism from the generic industry about the loss of interaction that followed enactment of the Generic Drug User Fee law..

…federal judge has ruled Takeda's patent on Velcade (bortezomib) invalid…Velcade's patent was challenged by Actavis, Sandoz, and Accord Healthcare…Takeda expected to have patent protection until 2022, but based on the latest court decision, generics could hit the market by 2017…Velcade,..is a big seller for Takeda, bringing in almost $2.9 billion in revenues in 2014.

J.D. Power’s 2015 U.S. Pharmacy Study was released Monday, and it highlights that patients remain satisfied with their pharmacies despite myriad changes to the healthcare landscape in recent years…"Pharmacies serve as a benchmark for other entities in the healthcare ecosystem, as they continue to have the highest levels of customer satisfaction in the healthcare industry, demonstrating that focusing on customer satisfaction is good for both patients and businesses."

Female libido drug Addyi from Sprout stirred up its fair share of controversy last week with its FDA green light, which came despite serious potential side effects such as severe drowsiness, nausea and dizziness. But if it can succeed despite those side effect worries, it certainly wouldn't be the first drug to do so......Advair, Fosamax, Epogen, Gilenya, Tecfidera

Illinois man (Ram Kamath) pleaded not guilty..to conspiring with an online Canadian pharmacy to smuggle mislabeled, unapproved...counterfeit prescription drugs into the U.S...Federal prosecutors accuse Canadadrugs.com,..and its affiliated companies..selling $78 million in prescription drugs,..mislabeled by having text in a foreign language or missing the required "Rx only" symbol.

..federal appeals court…affirmed the Federal Trade Commission's power to regulate cybersecurity—a decision that follows a number of massive healthcare data breaches over the past year… FTC alleges that Wyndham engaged in unfair cybersecurity practices that exposed consumers' personal data to unauthorized access and theft…FTC doesn't now get involved in many healthcare breach cases,..But it could.

..Food and Drug Administration, which once approved as few as 40% of new drugs submitted by industry, has been on a green-light-almost-everything jag, approving 89% of drug applications. What’s more, a closer look showed an even higher approval rate. This year so far, 96% of new molecular entities.. – that have been submitted to the FDA have reached the market. For anyone who was watching the FDA a decade ago, that’s just shocking. Good or bad, it’s a radical change...there are a lot of factors that explain why the FDA approval rate is suddenly so high,..

1. The approval rate is much lower, because only 12% of drugs that enter clinical trials reach the market.
2. Drug companies are better at research, and they are simply producing better drugs.
3. Drug companies are picking areas where the chances of approval are higher.
4. The FDA is doing a better job communicating with companies.
5. The FDA has more power to restrict the use of an approved drug than it used to.
6. The FDA is taking a risk by taking strong stands against drug approvals right now.
7. The FDA is without a permanent commissioner.
8. It’s just random chance.
9. In the current political environment, the agency is approving drugs it shouldn’t.

...new federal tool aimed at helping patients determine the best hospital for their care is raising questions over whether it provides an accurate assessment of quality.. CMS is developing a hospital quality star-rating system for the Hospital Compare website… We are not confident that the measures currently available…to create a single, methodologically sound rating of all aspects of hospital quality,".. should incorporate risk adjustment for socio-economic factors so results reflect differences in treatment across hospitals.

Kyle Bass struck out. A U.S. review board (Patent and Trademark Office) nixed the hedge funder's challenge to two Acorda Therapeutics patents,.. showing Bass that his short-selling crusade against "low quality" pharma patents won't be an easy home run…Bass' very public challenges could work against him--particularly given the fact that he's made no secret of his plans to make money off the IPR process (inter partes review), by shorting the shares of companies with so-called "weak" patents.