Content about Clinical pharmacology

February 3, 2014

The Generic Pharmaceutical Association on Monday identified its key priorities for 2014 — guarding against confusion a proposed labeling change would cause; gaining access to biosimilar generics; and heralding the cost savings generated by generic utilization.

WASHINGTON — The Generic Pharmaceutical Association on Monday identified its key priorities for 2014 — guarding against confusion a proposed labeling change would cause; gaining access to biosimilar generics; and heralding the cost savings generated by generic utilization. 

February 3, 2014

HIT policy needs to focus on specific goals for improving patient medication adherence in order to realize the goals of improving patient health and achieving cost savings in the U.S. healthcare system.

WASHINGTON — HIT policy needs to focus on specific goals for improving patient medication adherence in order to realize the goals of improving patient health and achieving cost savings in the U.S. healthcare system, according to an expert panel convened today by the Network for Excellence in Health Innovation and Prescriptions for a Healthy America.

In particular, the panel said the two highest priorities for HIT should be providing electronic access to accurate mediation lists and complete drug formulary information for prescribing physicians.

January 31, 2014

The Biotechnology Industry Organization and the Indiana Health Industry Forum commended the Indiana Senate for passing legislation designed to create a pathway for the substitution of interchangeable biologic medicines.

WASHINGTON — The Biotechnology Industry Organization and the Indiana Health Industry Forum on Thursday commended the Indiana Senate for passing legislation designed to create a pathway for the substitution of interchangeable biologic medicines.

The policies outlined in the identical SB 262 align with BIO’s principles on biologic substitution, therefore BIO and IHIF support passage of this bill as it moves along for consideration by the Indiana House of Representatives.

January 22, 2014

The Food and Drug Administration launched the advisory committee membership nomination portal, an online, interactive system that allows interested individuals to submit nominations for membership to any of the agency’s 33 advisory committees.

SILVER SPRING, Md. — The Food and Drug Administration on Wednesday launched the advisory committee membership nomination portal, an online, interactive system that allows interested individuals to submit nominations for membership to any of the agency’s 33 advisory committees.  

January 17, 2014

The Medicare Part D program and taxpayers often pay more when prescription drugs are obtained through "preferred" pharmacies and mail order than they would if the same prescriptions were filled through other, "non-preferred" pharmacies, according to a cost comparison made by the National Community Pharmacists Association released Thursday using the Medicare Plan Finder website.

ALEXANDRIA, Va. — The Medicare Part D program and taxpayers often pay more when prescription drugs are obtained through "preferred" pharmacies and mail order than they would if the same prescriptions were filled through other, "non-preferred" pharmacies, according to a cost comparison made by the National Community Pharmacists Association released Thursday using the Medicare Plan Finder website. The findings come shortly after recently proposed requirements that officials with the U.S.

January 15, 2014

Perrigo on Tuesday announced that it has received final approval for its abbreviated new drug application for fluocinonide cream 0.1%, the generic equivalent to prescription-only Vanos Cream 0.1%.

DUBLIN — Perrigo on Tuesday announced that it has received final approval for its abbreviated new drug application for fluocinonide cream 0.1%, the generic equivalent to prescription-only Vanos Cream 0.1%. 

Perrigo was awarded 180-days of generic drug exclusivity as it was the first company to submit an ANDA containing a paragraph IV certification. Perrigo had previously resolved litigation with the brand and has commenced shipment of the product.

January 13, 2014

Users of a medication-management app can now refill their prescriptions using an enhancement to it.

HAIFA, Israel — Users of a medication-management app can now refill their prescriptions using an enhancement to it.

MediSafe announced Monday an updated version of its Medication Refill Reminder app allowing users to enter contact information for their preferred pharmacies and, once alerted that a medication refill is needed, to click on the pharmacy logo that directs them to the mobile refill page of the specified pharmacy. The app currently supports refills for Walgreens, CVS, Rite Aid and Health Mart.

January 13, 2014

VoicePort announced that they have launched their Prescription Adherence Solution at Klingensmith's Drug Stores, an eight-store independent drug chain headquartered in Ford City, Pa.

ROCHESTER, N.Y. — VoicePort on Monday announced that they have launched their Prescription Adherence Solution at Klingensmith's Drug Stores, an eight-store independent drug chain headquartered in Ford City, Pa. 

"Our integration to their pharmacy system allows for intelligent and timely patient communications via voice, text or e-mail to keep them current to their prescriptions," noted Alphonse Sasso, VoicePort VP business development. 

January 7, 2014

Big Y pharmacies and En-Vision America have recently partnered on a pair of novel programs designed to improve compliance among seniors with impaired vision.

SPRINGFIELD, Mass. — Big Y pharmacies and En-Vision America have recently partnered on a pair of novel programs designed to improve compliance among seniors with impaired vision. 

"The pharmacists are engaging with all patients and making them aware of this new service," Jan Winn, Big Y director of pharmacy, HABC and GM, shared with DSN. "The larger print labels are a big hit with the 'babyboom' generation."

January 3, 2014

According to reports, as many as 2.1 million Americans signed up for new insurance coverage that went into effect Jan. 1. However, even though these newly insured people had coverage, what they perhaps didn't have was the identification card to process claims, such as prescriptions, for example. But don't worry, retail pharmacy was fast to the rescue, offering those 2.1 million patients who had obtained insurance through a health exchange the benefit of the doubt and a 30-day supply of their prescriptions at no upfront cost once their coverage was verified.

According to reports, as many as 2.1 million Americans signed up for new insurance coverage that went into effect Jan. 1. However, even though these newly insured people had coverage, what they perhaps didn't have was the identification card to process claims, such as prescriptions, for example. But don't worry, retail pharmacy was fast to the rescue, offering those 2.1 million patients who had obtained insurance through a health exchange the benefit of the doubt and a 30-day supply of their prescriptions at no upfront cost once their coverage was verified. 

January 3, 2014

Rite Aid is providing prescriptions at no upfront cost to customers who have enrolled in the health insurance marketplaces, but have not received an ID number, the retail pharmacy chain said.

CAMP HILL, Pa. — Rite Aid is providing prescriptions at no upfront cost to customers who have enrolled in the health insurance marketplaces, but have not received an ID number, the retail pharmacy chain said.

The company said that during the month of January, it would dispense a 15- to 30-day supply of many medications to customers who bring in confirmation of their enrollment until their prescription coverage details are available. The Patient Protection and Affordable Care Act, popularly known as Obamacare, took full effect Wednesday.

January 2, 2014

The Kroger Co. has joined the list of retailers offering supplies of prescription drugs at no upfront cost to customers who have enrolled in the health insurance marketplaces, but have yet to receive an identification number.

CINCINNATI — The Kroger Co. has joined the list of retailers offering supplies of prescription drugs at no upfront cost to customers who have enrolled in the health insurance marketplaces, but have yet to receive an identification number.

The company announced Thursday that it would offer up to a 30-day supply of certain prescription drugs to customers who provide confirmation of their enrollment at one of the retailer's pharmacies.

January 2, 2014

The number of new drugs approved by the Food and Drug Administration fell by more than 30% in 2013 compared with 2012, according to agency records.

NEW YORK — The number of new drugs approved by the Food and Drug Administration fell by more than 30% in 2013 compared with 2012, according to agency records.

December 5, 2013

Compounding pharmacies that produce sterile drugs can register as outsourcing facilities and may be exempt from certain Food and Drug Administration approval requirements, according to a document published on the FDA's website.

NEW YORK — Compounding pharmacies that produce sterile drugs can register as outsourcing facilities and may be exempt from certain Food and Drug Administration approval requirements, according to a document published on the FDA's website.

November 20, 2013

Following actions by the Food and Drug Administration, USPLabs has agreed to recall and destroy the dietary supplement OxyElite Pro, as it has been linked to dozens of cases of acute liver failure and hepatitis, including one death and illnesses so severe that several patients required liver transplants, the agency noted Wednesday.

SILVER SPRING, Md. — Following actions by the Food and Drug Administration, USPLabs has agreed to recall and destroy the dietary supplement OxyElite Pro, as it has been linked to dozens of cases of acute liver failure and hepatitis, including one death and illnesses so severe that several patients required liver transplants, the agency noted Wednesday. 

November 15, 2013

A Food and Drug Administration expert panel has voted to recommend approval for a drug to treat a circadian rhythm disorder that affects most people with total blindness.

WASHINGTON — A Food and Drug Administration expert panel has voted to recommend approval for a drug to treat a circadian rhythm disorder that affects most people with total blindness.

November 8, 2013

When the maker of a branded drug updates the safety information on its product labeling, makers of generic versions of that drug must wait until the Food and Drug Administration approves the new labeling before they can update theirs, but that could soon change under a rule proposed by the FDA.

SILVER SPRING, Md. — When the maker of a branded drug updates the safety information on its product labeling, makers of generic versions of that drug must wait until the Food and Drug Administration approves the new labeling before they can update theirs, but that could soon change under a rule proposed by the FDA.

November 7, 2013

Aisle7 on Thursday announced the launch of Healthnotes Interactions Checker, a next-generation solution simplifying the task of deciding which nutrients positively or negatively interact with the medicines they take.

PORTLAND, Ore. — Aisle7 on Thursday announced the launch of Healthnotes Interactions Checker, a next-generation solution simplifying the task of deciding which nutrients positively or negatively interact with the medicines they take. More than half of all Americans take some form of dietary supplement, and an estimated 40% of U.S. adults take both drugs and nutrients as part of their health regimen. Of these, 60% aren’t discussing possible interactions with their physician or pharmacist, Aisle7 noted. 

November 4, 2013

The Food and Drug Administration has asked Ariad Pharmaceuticals to suspend marketing and sales of a chemotherapy drug for leukemia due to the risk of life-threatening side effects, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration has asked Ariad Pharmaceuticals to suspend marketing and sales of a chemotherapy drug for leukemia due to the risk of life-threatening side effects, the agency said.

November 1, 2013

The Food and Drug Administration has released a new video that warns consumers against buying drugs from rogue-internet pharmacies, part of the ongoing effort by the agency to keep fake and contaminated drugs out of the U.S. supply chain.

NEW YORK — The Food and Drug Administration has released a new video that warns consumers against buying drugs from rogue-internet pharmacies, part of the ongoing effort by the agency to keep fake and contaminated drugs out of the U.S. supply chain.

October 28, 2013

The Food and Drug Administration has launched an online learning course aimed at healthcare professionals to educate them about potentially untruthful or misleading drug ads and promotional materials.

SILVER SPRING, Md. — The Food and Drug Administration has launched an online learning course aimed at healthcare professionals to educate them about potentially untruthful or misleading drug ads and promotional materials.

October 25, 2013

A Food and Drug Administration expert panel has recommended approval for a drug made by Johnson & Johnson for treating hepatitis C, the company said.

NEW YORK — A Food and Drug Administration expert panel has recommended approval for a drug made by Johnson & Johnson for treating hepatitis C, the company said.

J&J subsidiary Janssen Research & Development said the 19-member FDA Antiviral Drugs Advisory Committee voted unanimously to recommend approval for TMC435 (simeprevir), a 150-mg drug meant for administration once per day with the generic antiviral ribavirin and a biotech drug known as an interferon, for treating genotype 1 chronic hepatitis C.

October 22, 2013

The Food and Drug Administration has approved drugs for depression and smoking cessation made by Jubilant Life Sciences, the company said.

NOIDA, India — The Food and Drug Administration has approved drugs for depression and smoking cessation made by Jubilant Life Sciences, the company said.

Jubilant, based in India, announced the approval of generic bupropion hydrochloride extended-release tablets in the 100-mg, 150-mg and 200-mg strengths, and another bupropion hydrochloride extended-release tablet product in the 150-mg strength.

The first product is a generic version of GlaxoSmithKline's antidepressant Wellbutrin SR, while the second is a version of GSK's anti-smoking drug Zyban.

October 22, 2013

The state Senate of Pennsylvania will vote on a bill to curb misuse of prescription drugs, according to published reports.

NEW YORK — The state Senate of Pennsylvania will vote on a bill to curb misuse of prescription drugs, according to published reports.

The Beaver County, Pa., Times reported that Pennsylvania House Bill 1694 cleared the lower house of the state legislature in a 191-7 vote. The bill is designed to stop doctor-shopping and pill mills by creating an electronic prescription drug database to track drugs dispensed by doctors and veterinarians. Doctors and pharmacists can then use it to verify patients' medication histories.

October 14, 2013

The governor of California has vetoed a bill that critics said would have limited patients' access to knock-off versions of biotech drugs.

NEW YORK — The governor of California has vetoed a bill that critics said would have limited patients' access to knock-off versions of biotech drugs.