Content about Safety

June 25, 2013

The healthcare industry continues to prepare for ACA implementation and the expected influx of newly eligible patients, said Emdeon's Kevin Mahoney. Many pharmacies are changing their staffing models in preparation for customers with expanded Medicaid benefits — especially as we approach the New Year. This is a good time for me to remind you to be thinking about your eligibility program.

In January, I offered Drug Store News readers a look at the pharmacy and technology trends facing our industry for the year. Here we are in June (can you believe it?), so I thought we should have a progress check and update for the back half of 2013.

July 25, 2013

The NPD Group, which tracks prestige beauty, has reported that sales of makeup and skin care with SPF reached $1.1 billion in U.S. prestige department stores from June 2012 to May 2013, a 24% increase from three years ago.

PORT WASHINGTON, N.Y. — The NPD Group, which tracks prestige beauty, has reported that sales of makeup and skin care with SPF reached $1.1 billion in U.S. prestige department stores from June 2012 to May 2013, a 24% increase from three years ago.

“Whether it is health concerns, or a more superficial fear of looking older, the intensified focus on sun protection from the beauty and healthcare industries is having a real impact on consumers and the market,” stated Karen Grant, VP and senior global industry analyst for the NPD Group.

January 28, 2013

Health care is evolving. As obvious of a statement as that is, it doesn’t change the fact that it is very real. Throughout last year, there was intense discussion on the Patient Protection and Affordable Care Act and what impact the outcome of the presidential election might have on its future. Now that the Supreme Court has ruled and elections are settled, healthcare companies and providers across the country are implementing strategies to meet ACA requirements.

Health care is evolving. As obvious of a statement as that is, it doesn’t change the fact that it is very real. Throughout last year, there was intense discussion on the Patient Protection and Affordable Care Act and what impact the outcome of the presidential election might have on its future. Now that the Supreme Court has ruled and elections are settled, healthcare companies and providers across the country are implementing strategies to meet ACA requirements.

December 11, 2012

E-prescribing offers many well-known benefits to physicians, pharmacists and patients alike. Beyond the well-known patient benefits, real-time transactions with automated requests and responses promise to create efficiencies by speeding the medication ordering process, reducing or eliminating the back-and-forth communications between pharmacists and clinicians commonly associated with handwritten prescriptions.

E-prescribing offers many well-known benefits to physicians, pharmacists and patients alike. Beyond the well-known patient benefits, real-time transactions with automated requests and responses promise to create efficiencies by speeding the medication ordering process, reducing or eliminating the back-and-forth communications between pharmacists and clinicians commonly associated with handwritten prescriptions.

October 16, 2012

Emerging multidisciplinary healthcare models, such as accountable care organizations and patient-centered medical homes, promise to elevate quality and lower costs by harnessing the power of provider, payer and patient collaboration. Often overlooked in the coordinated care equation, however, is the integral role pharmacists can play in delivering efficient and effective care.

Emerging multidisciplinary healthcare models, such as accountable care organizations and patient-centered medical homes, promise to elevate quality and lower costs by harnessing the power of provider, payer and patient collaboration. Often overlooked in the coordinated care equation, however, is the integral role pharmacists can play in delivering efficient and effective care.

October 1, 2012

The Council for Responsible Nutrition on Monday announced Jim Griffiths has been named as the association’s VP scientific and international affairs, effective Oct. 10.

WASHINGTON — The Council for Responsible Nutrition on Monday announced Jim Griffiths has been named as the association’s VP scientific and international affairs, effective Oct. 10.

July 23, 2012

Healthcare providers in today’s environment are committed to promoting patient safety while providing access to the most reliable and innovative treatments. Medication reconciliation, which is defined by The Joint Commission as “the process of comparing a patient’s medication orders to all of the medications that the patient has been taking,” is designed to prevent drug-related errors — including adverse interactions, overdoses or allergic reactions — and can assist healthcare providers, especially during care transitions when patients are most likely to receive new medications or alternative doses.

Healthcare providers in today’s environment are committed to promoting patient safety while providing access to the most reliable and innovative treatments.

June 22, 2012

A drug maker has resubmitted its new drug application to the Food and Drug Administration for an acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults.

MOUNTAIN VIEW, Calif. — A drug maker has resubmitted its new drug application to the Food and Drug Administration for an acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults.

Alexza Pharmaceuticals said it received a complete response letter for Adasuve last month from the regulatory agency. The CRL outlined the FDA's concerns about Alexza's manufacturing facility and the drug's draft product labeling. Alexza said it believes it has addressed these concerns in its resubmitted application.

June 11, 2012

Avanir Pharmaceuticals confirmed that the Food and Drug Administration has accepted the company's investigational new drug application for an Alzheimer's disease drug.

ALISO VIEJO, Calif. — Avanir Pharmaceuticals confirmed that the Food and Drug Administration has accepted the company's investigational new drug application for an Alzheimer's disease drug.

Avanir said the FDA's acceptance of AVP-923, an investigational treatment of agitation in patients with Alzheimer's disease, marks the fourth IND for the AVP-923 program. The drug will be evaluated in a phase-2 clinical trial during third quarter 2012.

May 14, 2012

Manufacturers of sunscreen now will have six additional months to meet the new labeling and testing requirements as imposed by the Food and Drug Administration, according to an announcement from the Federal Register.

WASHINGTON  — Manufacturers of sunscreen now will have six additional months to meet the new labeling and testing requirements as imposed by the Food and Drug Administration, according to an announcement from the Federal Register.

The FDA ordered the changes last summer but gave manufacturers one year — until this June — to get the revised bottles on the shelf.

April 19, 2012

The Personal Care Products Council and the Safe Cosmetics Alliance has announced support for legislation to strengthen and modernize regulatory oversight of the industry and to create a greater role for the Food and Drug Administration in assessing the safety of personal care products.

WASHINGTON — The Personal Care Products Council and the Safe Cosmetics Alliance has announced support for legislation to strengthen and modernize regulatory oversight of the industry and to create a greater role for the Food and Drug Administration in assessing the safety of personal care products.

March 22, 2012

Hawaiian Tropic Sun Care is taking its newest product — Hawaiian Tropic Silk Hydration lotion sunscreen — to the runway this summer as the official sun care sponsor of Mercedes-Benz Fashion Week Swim 2013 Collections in Miami.

SHELTON, Conn. — Hawaiian Tropic Sun Care is taking its newest product — Hawaiian Tropic Silk Hydration lotion sunscreen — to the runway this summer as the official sun care sponsor of Mercedes-Benz Fashion Week Swim 2013 Collections in Miami.

January 3, 2012

The Food and Drug Administration has accepted a regulatory approval application from Gilead Sciences for a drug to treat HIV, the company said.

FOSTER CITY, Calif. — The Food and Drug Administration has accepted a regulatory approval application from Gilead Sciences for a drug to treat HIV, the company said.

Gilead said the FDA planned to review the application for the Quad by Aug. 27.

The Quad combines four Gilead drugs — Truvada (emtricitabine and tenofovir disoproxil fumarate), cobicistat and elvitegravir — into one pill. The last drug was licensed from Japan Tobacco.

December 12, 2011

Medical Alarm Concepts Holding on Monday unveiled plans for the second phase of its MediPendant medical alert system marketing campaign: a bag stuffer/coupon offer placed alongside patient prescriptions in Albertsons.

KING OF PRUSSIA, Pa. — Medical Alarm Concepts Holding on Monday unveiled plans for the second phase of its MediPendant medical alert system marketing campaign: a bag stuffer/coupon offer placed alongside patient prescriptions in Albertsons that includes one free month of monitoring services and a lockbox device that allows for first responders to get into a home without having to break down the door.

December 7, 2011

Food and Drug Administration commissioner Margaret Hamburg on Wednesday issued a public statement that the agency was prepared to approve Plan B as a nonprescription medication, but reversed that decision following a directive from the Department of Health and Human Services Wednesday morning.

SILVER SPRING, Md. — Food and Drug Administration commissioner Margaret Hamburg on Wednesday issued a public statement that the agency was prepared to approve Plan B as a nonprescription medication, but reversed that decision following a directive from the Department of Health and Human Services Wednesday morning.

November 10, 2011

The Food and Drug Administration has accepted a new drug application for a skin cancer treatment developed by Roche.

BASEL, Switzerland — The Food and Drug Administration has accepted a new drug application for a skin cancer treatment developed by Roche.

Roche said that the FDA accepted its NDA for vismodegib, designed to treat advanced basal cell carcinoma in adults for whom surgery is considered inappropriate. The application was granted priorit review status and has a confirmed action date of March 8, 2012.

October 28, 2011

The Food and Drug Administration has approved a supplemental new drug application related to a drug made by Abbott, the company said.

ABBOTT PARK, Ill. — The Food and Drug Administration has approved a supplemental new drug application related to a drug made by Abbott, the company said.

October 11, 2011

The Food and Drug Administration has approved Mylan’s promethazine hydrochloride tablets, a generic drug for treating allergies, in the 12.5-mg, 25-mg and 50-mg strengths.

SUPPLIER NEWS — The Food and Drug Administration has approved Mylan’s promethazine hydrochloride tablets, a generic drug for treating allergies, in the 12.5-mg, 25-mg and 50-mg strengths. Promethazine hydrochloride tablets, which are manufactured by several companies, had sales of about $42 million during the 12-month period ended in June, according to IMS Health.


October 4, 2011

The Food and Drug Administration has launched an initiative that is designed to assure the safety of food sold at retail.

WASHINGTON — The Food and Drug Administration has launched an initiative that is designed to assure the safety of food sold at retail.

The Retail Food Safety Action Plan is designed to improve the way managers of food establishments (i.e., food stores, restaurants, schools and other foodservice opertaions) conduct food safety operations in their facilities and assure that personnel are trained on measures to keep food safe. Additionally, the initiative will expand the oversight of these establishments by federal, state and local public health agencies.

September 7, 2011

The Food and Drug Administration has accepted a regulatory approval application for a drug made by Vivus for treating erectile dysfunction.

MOUNTAIN VIEW, Calif. — The Food and Drug Administration has accepted a regulatory approval application for a drug made by Vivus for treating erectile dysfunction.

Vivus said it expected the Food and Drug Administration to complete its review of the application for avanafil by April 29, 2012.

"We are pleased with FDA's acceptance of our NDA," Vivus president Peter Tam said. "If approved, avanafil could be a valuable treatment alternative for the 18 million men in the United States that suffer from ED."

August 4, 2011

GlaxoSmithKline company Stiefel announced it is seeking approval for a facial acne treatment in patients ages 12 years and older.

RESEARCH TRIANGLE PARK, N.C. — GlaxoSmithKline company Stiefel announced it is seeking approval for a facial acne treatment in patients ages 12 years and older.

Stiefel said it has submitted a new drug application to the Food and Drug Administration for tazarotene foam. Tazarotene foam is subject to evaluation and approval by the regulatory authorities before it can be made available to physicians for prescribing to their appropriate patients, Stiefel said.

June 28, 2011

A new multimedia public service campaign that is designed to help families prevent food poisoning in the home has made its debut.

WASHINGTON — A new multimedia public service campaign that is designed to help families prevent food poisoning in the home has made its debut.

June 15, 2011

One month after the observance of Skin Cancer Awareness Month, the Food and Drug Administration announced Tuesday it is taking measures to assure all sunscreen products are safe and effective.

SILVER SPRING, Md. — One month after the observance of Skin Cancer Awareness Month, the Food and Drug Administration announced Tuesday it is taking measures to assure all sunscreen products are safe and effective.

June 6, 2011

The Food and Drug Administration on Friday addressed the current outbreak of E. coli O104 in Europe.

SILVER SPRING, Md. — The Food and Drug Administration on Friday addressed the current outbreak of E. coli O104 in Europe.

The U.S. regulatory agency said that it has been in "routine contact" with the Centers of Disease Control and Prevention and the European Union to monitor the current outbreak of E. coli O104 and to track any illnesses in the United States that may be related to the outbreak.

May 23, 2011

Generic drug maker Par has inked a definitive agreement to acquire an India-based developer and manufacturer of generic drugs.

WOODCLIFF LAKE, N.J. — Generic drug maker Par has inked a definitive agreement to acquire an India-based developer and manufacturer of generic drugs.

Par said it will acquire Edict Pharmaceuticals for up to $37.6 million in cash and Par's repayment of certain additional pre-close indebtedness. Par noted the acquisition is subject to customary conditions and approvals; the drug maker expects to complete the transaction by the end of the year.