Content about Clinical pharmacology

May 21, 2013

Report forecasts rapid rise in specialty drug spending through 2015

Spending on specialty drugs is likely to increase by 67% over the next couple of years, according to a new study by pharmacy benefit manager Express Scripts.

ST. LOUIS — Spending on specialty drugs is likely to increase by 67% over the next couple of years, according to a new study by pharmacy benefit manager Express Scripts.

May 20, 2013

Kerr Drug introduces Simplify My Meds synchronized-prescription program

Kerr Drug has introduced a new prescription-synchronization service, the retail pharmacy chain said Monday.

RALEIGH, N.C. — Kerr Drug has introduced a new prescription-synchronization service, the retail pharmacy chain said Monday.

Kerr, a regional chain based in Raleigh, N.C., announced the introduction of the new Simplify My Meds synchronized prescription refill service. The service uses the chain's new central-fill center in Kerr, and the company said it hoped the program would solidify customer loyalty by increasing convenience.

May 13, 2013

N.J. law designed to address prescription eye drop adherence

New Jersey Gov. Chris Christie signed legislation into law that will allow patients using prescription eye drops to get early refills in order to prevent interruptions in therapy.

TRENTON, N.J. — New Jersey Gov. Chris Christie signed legislation into law Monday that will allow patients using prescription eye drops to get early refills in order to prevent interruptions in therapy.

May 10, 2013

FDA must file Plan B appeal by noon on May 13 or remove age restrictions from all OTC EC products

Senior U.S. District Judge Edward Korman on Friday denied a Food and Drug Administration motion for a stay pending an appeal of Korman's earlier decision that all levonorgestrel-based emergency contraceptives be available without a prescription and without any age restrictions.

NEW YORK — Senior U.S. District Judge Edward Korman on Friday denied a Food and Drug Administration motion for a stay pending an appeal of Korman's earlier decision that all levonorgestrel-based emergency contraceptives be available without a prescription and without any age restrictions.

However, Korman did grant a stay "pending the hearing or submission of the defendants’ motion for a stay in the Court of Appeals on the condition that the motion for a stay be filed by noon on May 13, 2013."

May 6, 2013

FDA Law Blog: Recent Plan B One Step approval may reignite simultaneous Rx-OTC debate

The Food and Drug Administration may soon find itself in another Plan-B-generated quandary — the complications around granting a three-year marketing exclusivity for a medicine that is both prescription-only and over-the-counter, according to an FDA Law Blog posted Sunday by Hyman, Phelps & McNamara.

WASHINGTON — The Food and Drug Administration may soon find itself in another Plan-B-generated quandary — the complications around granting a three-year marketing exclusivity for a medicine that is both prescription-only and over-the-counter, according to an FDA Law Blog posted Sunday by Hyman, Phelps & McNamara.

May 1, 2013

FDA approves Plan B One-Step front-end placement for females 15 and older

The Food and Drug Administration announced that it has approved an amended application submitted by Teva Women’s Health to market Plan B One-Step (active ingredient levonorgestrel) for use without a prescription by women 15 years and older.

SILVER SPRING, Md. — The Food and Drug Administration on Tuesday announced that it has approved an amended application submitted by Teva Women’s Health to market Plan B One-Step (active ingredient levonorgestrel) for use without a prescription by women 15 years and older. The approval will move Plan B from behind the pharmacy counter into the family planning set of the pharmacy.

April 29, 2013

FDA appoints Mary Beth Clarke as director of Office of Executive Programs

A Food and Drug Administration staffer who has led implementation of the Generic Drug User Fee Act has been named to a new director position at the agency, the FDA said Monday.

SILVER SPRING, Md. — A Food and Drug Administration staffer who has led implementation of the Generic Drug User Fee Act has been named to a new director position at the agency, the FDA said Monday.

The FDA announced that it had appointed Mary Beth Clarke as permanent director of the Office of Executive Programs. Clarke had previously served as the OEP's executive director.

April 26, 2013

Obama administration hopes to tackle prescription drug abuse

More than 1.3 million emergency room visits in 2010 were related to abuse of prescription drugs, and the problem has become widespread enough that the Centers for Disease Control and Prevention classifies it as an epidemic. In response, curbing abuse of prescription drugs has become a cornerstone of the Obama administration's drug policy.

WASHINGTON — More than 1.3 million emergency room visits in 2010 were related to abuse of prescription drugs, and the problem has become widespread enough that the Centers for Disease Control and Prevention classifies it as an epidemic. In response, curbing abuse of prescription drugs has become a cornerstone of the Obama administration's drug policy.

April 23, 2013

Kmart store robbed, suspect steals information backed up electronically from store safe

An armed robber allegedly stole sensitive electronic information on pharmacy customers from a Kmart store in Little Rock, Ark., last month, the mass merchandise retailer said.

HOFFMAN ESTATES, Ill. — An armed robber allegedly stole sensitive electronic information on pharmacy customers from a Kmart store in Little Rock, Ark., last month, the mass merchandise retailer said.

April 17, 2013

Changes to REMS to allow dispensing of Vivus obesity drug in retail

The Food and Drug Administration has approved a modification to a program added to the labeling of an obesity drug to ensure patient safety.

MOUNTAIN VIEW, Calif. — The Food and Drug Administration has approved a modification to a program added to the labeling of an obesity drug to ensure patient safety.

Vivus announced that the FDA had approved changes to the risk evaluation and mitigatin strategy for Qsymia (phentermine and topiramate) extended-release capsules. The amendment to the REMS allows the drug to be dispensed through certified retail pharmacies in addition to the existing network of mail-order pharmacies.

April 12, 2013

FDA investigation finds widespread problems at compounding pharmacies

An inspection of more than two-dozen compounding pharmacies by Food and Drug Administration officials has found widespread problems with sanitation and sterilization practices, FDA commissioner Margaret Hamburg wrote in a blog post on the agency's website Thursday.

SILVER SPRING, Md. — An inspection of more than two-dozen compounding pharmacies by Food and Drug Administration officials has found widespread problems with sanitation and sterilization practices, FDA commissioner Margaret Hamburg wrote in a blog post on the agency's website Thursday.

April 11, 2013

Study finds wide disparities in antibiotic prescribing rates between South, Midwest

Research has indicated that about half of antibiotic prescriptions are unnecessary, raising concerns about the growth of bacteria resistant to them, but a new study by researchers at the Centers for Disease Control and Prevention also finds that prescriptions are highest in several states in the South and Midwest.

NEW YORK — Research has indicated that about half of antibiotic prescriptions are unnecessary, raising concerns about the growth of bacteria resistant to them, but a new study by researchers at the Centers for Disease Control and Prevention also finds that prescriptions are highest in several states in the South and Midwest.

The study, published Thursday in the New England Journal of Medicine, was based on a database maintained by IMS Health that includes a sample of more than 70% of U.S. prescriptions.

April 10, 2013

Cardinal Health Foundation helps combat Rx drug abuse with Generation Rx University

With the growing concern of the abuse of prescription stimulants like Adderall on college campuses, the Cardinal Health Foundation and the Ohio State University College of Pharmacy introduced Generation Rx University, the fourth in a series of interactive toolkits designed to help reduce the abuse of prescription drugs.

DUBLIN, Ohio — With the growing concern of the abuse of prescription stimulants like Adderall on college campuses, the Cardinal Health Foundation and the Ohio State University College of Pharmacy on Wednesday introduced Generation Rx University, the fourth in a series of interactive toolkits designed to help reduce the abuse of prescription drugs.

April 5, 2013

District Court orders FDA to lift prescription restriction of Plan B One-Step for underage women

The Food and Drug Administration has 30 days to approve over-the-counter availability of the emergency contraceptive Plan B One-Step to women of all ages, according to a decision issued by Judge Edward Korman of the U.S. District Court, Eastern District of New York.

NEW YORK — The Food and Drug Administration has 30 days to approve over-the-counter availability of the emergency contraceptive Plan B One-Step to women of all ages, according to a decision issued Friday by Judge Edward Korman of the United States District Court, Eastern District of New York. In a second decision, Korman declined to intervene on Teva Pharma's behalf in extending patent exclusivity for Plan B One-Step.

April 3, 2013

Study shows 75% of teens report increased knowledge from prescription drug prevention program

According to an independent research firm, a recent pilot program to address awareness of the dangers of prescription drug abuse in teens showed 75% of all respondents were more aware of the dangers of misusing and abusing prescription drugs after participating in the educational program.

ORLANDO, Fla. — According to an independent research firm, a recent pilot program to address awareness of the dangers of prescription drug abuse in teens showed 75% of all respondents were more aware of the dangers of misusing and abusing prescription drugs after participating in the educational program.

April 2, 2013

Smart devices and the empowered patient

These are the days of the empowered patient — the patient who asks questions, who wants to know about how to prevent the diseases that ailed their parents or how to live more successfully with the conditions they have, who seeks and finds health information from doctors, nurses, magazines and most especially from the teeming trove of online health sites.

These are the days of the empowered patient — the patient who asks questions; who wants to know about how to prevent the diseases that ailed their parents or how to live more successfully with the conditions they have; and who seeks and finds health information from doctors, nurses, magazines and most especially from the teeming trove of online health sites.

March 20, 2013

HRG launches ranking system for top prescriptions by ZIP code

Hamacher Resource Group is offering pharmacists a new service that it said would allow them to get the top prescriptions dispensed in their two-digit ZIP code to ensure they are accurately and competitively pricing drugs.

WAUKESHA, Wis. — Hamacher Resource Group is offering pharmacists a new service that it said would allow them to get the top prescriptions dispensed in their two-digit ZIP code to ensure they are accurately and competitively pricing drugs.

HRG said the service, Rx Top Sellers, would provide data on the top 200, 500, 750 or 1,000 prescriptions and include cash median prices that are charged by food-drug retailers and independent pharmacies, as well as mass merchandise retailers.

March 15, 2013

Medbox buys stake in drug-vending company, forms jointly controlled corporation

Pharmaceutical vending machine maker Medbox has bought a 50% stake in a Michigan-based company that has developed an automated medicine dispensing machine, Medbox said Friday.

NEW YORK — Pharmaceutical vending machine maker Medbox has bought a 50% stake in a Michigan-based company that has developed an automated medicine dispensing machine, Medbox said Friday.

The $5.15 million deal with MedVend includes a $300,000 capital infusion and additional loans if needed for operating expenses into a jointly controlled new corporation that will also be called MedVend.

March 14, 2013

Reports: FDA generic drug chief resigns

The director of the Food and Drug Administration's Office of Generic Drugs is stepping down, according to published reports.

NEW YORK — The director of the Food and Drug Administration's Office of Generic Drugs is stepping down, according to published reports.

Pharmalot, a blog run by journalist Ed Silverman, reported that Greg Geba is leaving the office over differences resulting from a recent reorganization, effective Friday.

March 12, 2013

State, territorial attorneys general call for anti-tampering measures in opioids

The attorneys general of 46 states and two territories are calling on the Food and Drug Administration to make prescription painkillers harder to abuse.

NEW YORK — The attorneys general of 46 states and two territories are calling on the Food and Drug Administration to make prescription painkillers harder to abuse.

March 12, 2013

Wellspan Health, Voiceport collaborate on improved medication adherence

VoicePort announced a finalized agreement to deploy their services with WellSpan Health, a new client located in York, Pennsylvania, offering a vast array of inpatient, outpatient, home health and physician services.

ROCHESTER, N.Y. — VoicePort today announced a finalized agreement to deploy their services with WellSpan Health, a new client located in York, Pa., offering a vast array of inpatient, outpatient, home health and physician services.

The company will install two of VoicePort's patient solutions: PharmaRemind patient notifications and Meducation prescription translation, education and written instruction service. Both innovative solutions will enter Wellspan Health's pharmacy work-flow in pursuit of delivering improved medication adherence for their pharmacy patients.

March 8, 2013

ESI report notes fall in spending on traditional drugs

While the country's spending on specialty drugs increased by 18.4% in 2012, spending on traditional drugs fell for the first time in 20 years, according to a report by Express Scripts.

ST. LOUIS — While the country's spending on specialty drugs increased by 18.4% in 2012, spending on traditional drugs fell for the first time in 20 years, according to a report by Express Scripts.

March 5, 2013

Rush to e-prescribing? Not so fast, say docs

You might want to make a note of this. On paper. Despite all the hoopla surrounding electronically generated prescriptions, e-communications and digitized patient recordkeeping over the past decade, most doctors still prefer to write prescriptions the old fashioned way, by hand, scrawled on a prescription pad and handed to the patient.

That was the finding of a recent study of physicians’ prescribing habits by point-of-prescription advertising company MediScripts. The company, which by its own description “puts brand messages at the center of the prescriber-patient engagement,” found that handwritten scripts still outpace e-prescribing by more than 60%. Drug Store News’ Alaric DeArment described the findings in a report on Feb. 28.

March 5, 2013

Senators encourage GAO to investigate ways to collaborate on prescription drug abuse

Several senators have requested that the Government Accountability Office look for ways to coordinate the efforts of law enforcement and public health agencies at various levels and nonprofit organizations to address prescription drug abuse.

WASHINGTON — Several senators have requested that the Government Accountability Office look for ways to coordinate the efforts of law enforcement and public health agencies at various levels and nonprofit organizations to address prescription drug abuse.

February 28, 2013

Generics stifling pioneer drug development?

Has the explosion in generic utilization curbed pioneer-drug research and development? That's one concern floated by some pharmaceutical industry watchers, who claim that the stunning market share gains made by generic drug makers could reduce incentives for branded drug companies to spend to develop new molecular entities, conduct lengthy clinical trials, gain FDA approval and bring those new drugs to market.