Health Care Groups Identify Potential Measures to Address Ongoing Drug Shortages

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Newswise As shortages of lifesaving medicines, including antibiotics, chemotherapy, and cardiovascular drugs continue to plague the United States, a group of health care organizations released a report exploring measures that should be considered to address this ongoing issue. The report summarizes manufacturing, regulatory, and economic issues related to drug shortages, as well as potential solutions that were considered at a 2014 Summit attended by 22 stakeholder groups, including health care professionals and other non-profit organizations, industry, public interest, and government agencies.

The 2014 Drug Shortages Summit was organized by the American Hospital Association (AHA), the American Society of Anesthesiologists (ASA), the American Society of Clinical Oncology (ASCO), the American Society of Health-System Pharmacists (ASHP), the Institute for Safe Medication Practices (ISMP), and The Pew Charitable Trusts. Previous summits were held in 2010 and 2013.

Presentations during the Summit validated a number of existing efforts to address drug shortages, including a provision in the Food and Drug Administration (FDA) Safety and Innovation Act that requires manufacturers to report supply disruptions for certain medications to the agency. Although new drug shortages are on the decline, existing shortages have persisted in significant numbers. According to the Government Accountability Office, the U.S. experienced more than 450 shortages in 2012 alone.

The Summit report explores the potential manufacturing, economic, and regulatory causes of drug shortages, and considers several possible solutions that merit further exploration, including:

- Improve quality systems to better prevent production problems that can lead to shortages by encouraging companies to foster a corporate quality culture, and use of an FDA-developed set of quality metrics to support early collaboration between manufacturers and the agency on quality issues.

- Identify regulatory efficiencies, such as synchronizing regulatory reviews by different global agencies to shorten the overall time for full approvals for facility upgrades.

- Allow for commercialization of trial batches of drugs that meet quality specifications to help mitigate losses during plant or line upgrade approvals.

- Incentivize manufacturer investments in capacity and reliability by increasing contractual penalties for failing to supply a product, and also allowing price increases.

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Health Care Groups Identify Potential Measures to Address Ongoing Drug Shortages

Affordable Care Act: More Florida Residents Enrolling in Health Care

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Published: Wednesday, February 4, 2015 at 12:01 a.m. Last Modified: Thursday, February 5, 2015 at 12:07 a.m.

LAKELAND | Florida has 1,339,791 residents newly enrolled or re-enrolled in health insurance through the Affordable Care Act since Nov.15, part of about 10 million nationwide.

About 38,000 of Florida's total came in the past two weeks.

Most of the newly enrolled nationwide, about 7.5 million, are people using federally facilitated exchanges, as Florida's is. At least 2.4 million more signed up on state-run exchanges, according to figures released Wednesday.

Interest continues as the Feb. 15 open enrollment deadline approaches.

At Winter Haven Hospital, a health-care navigator helping people sign up has at least three or four appointments, scheduled at two-hour intervals, set up daily.

Her clients are mostly women and white or answering "unknown" for their race, said Lisa Patterson, spokeswoman for BayCare Health System, which includes WHH.

Area residents also continue seeking help with enrollment at Central Florida Health Care clinics and other hospitals.

Through Jan. 15, 57 percent of Florida's total were re-enrollees and 43 percent were getting plans for the first time, said Benjamin Wakana, who is with the Department of Health and Human Services.

Ninety-three percent of Florida residents enrolling through the federal website are getting financial assistance through the Affordable Care Act, said Nick Duran, Florida state director for Enroll America.

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Affordable Care Act: More Florida Residents Enrolling in Health Care

Health care stocks lead an early advance on Wall Street

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FILE - This Aug. 9, 2011 file photo shows a Wall Street street sign near the New York Stock Exchange, in New York. Health care stocks were leading early gains in U.S. trading Thursday, Feb. 5, 2015, while the energy sector also rose as the price of oil recovered from a stumble. (AP Photo/Mark Lennihan, File)

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NEW YORK The stock market is notching its third big gain this week as the price of oil recovers and investors applaud a big acquisition in the pharmaceutical industry.

Energy stocks rose Thursday as crude oil gained 4 percent.

Hospira soared 35 percent after the drugmaker agreed to be acquired by Pfizer for $16 billion.

The Dow Jones industrial average rose 211 points, or 1.2 percent, to 17,884.

The Standard & Poors 500 rose 21 points, or 1 percent, to 2,062. The Nasdaq composite rose 48 points, or 1 percent, to 4,765.

The gains put the Dow and the S&P 500 back in the black for 2015.

Crude oil rose 4 percent to close at $50.48 a barrel.

Bond prices fell. The yield on the 10-year Treasury note rose to 1.81 percent.

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Health care stocks lead an early advance on Wall Street

Health Care Sector Update for 02/05/2015: PBH,IVC,IMMU

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Top Health Care Stocks

JNJ +0.89%

PZE +1.78%

MRK +1.08%

ABT -0.37%

AMGN -0.13%

Health care stocks were strongly higher, with the NYSE Health Care Sector Index posting a 1.1% jump and shares of health care companies in the S&P 500 rising 1.2% as a group.

In company news, Prestige Brands Holdings ( PBH ) climbed to a record high Thursday after the consumer health care and household cleaning products wholesaler beat analyst projections with its fiscal Q3 financial results and raised its FY15 guidance.

Net income during the three months ended Dec. 31 totaled $21.3 million, or $0.40 per share, improving on a $3.1 million profit during the same quarter last year. Excluding non-recurring items, the company earned $0.48 per share, up from $0.30 last year and exceeding the Capital IQ consensus by $0.08 per share.

Adjustments during the quarter included items related to PBH's recent acquisitions of Insight and Hydralyte.

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Health Care Sector Update for 02/05/2015: PBH,IVC,IMMU

Study finds genetic mutation behind most common breast cancer

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The study found that one variant increased the risk of oestrogen receptor positive disease by 14 per cent, while a second raised the chance by 11 per cent.

Researchers said the finding provided important clues about the way disease is caused, implicating a gene called KLF4, which is thought to help control the way cells grow and divide.

The research involved scientists from more than 130 institutions worldwide, including the London School of Hygiene and Tropical Medicine, and the University of Cambridge.

Researchers were looking for one-letter differences in DNA code that were more likely to be found in women with breast cancer than those without the disease, using a state-of-the-art genetic technique called fine mapping.

Study leader Dr Nick Orr said: "Our study zoomed in on an area of our genome that we knew was linked to breast cancer risk, and has identified two new genetic variants that add significantly to our knowledge about the genetic causes of the disease.

"The variants we identified are specifically associated with the most common, oestrogen receptor positive, form of breast cancer.

"The more genetic risk factors for breast cancer we discover, of which there are currently more than 80, the more accurately we will be able predict who is at risk of getting the disease. Ultimately this will be vital for designing preventative strategies against breast cancer."

Dr Emma Smith, senior science information officer at Cancer Research UK, praised the results.

She said: "Thanks to modern technology we're building an increasingly detailed picture of the small variations in DNA that can influence a woman's risk of breast cancer.

"The next challenges are understanding the biology underpinning their effects, so we can use this information to predict individual risk more accurately, improve screening and find better ways to treat and prevent breast cancer."

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Study finds genetic mutation behind most common breast cancer

Saudi Arabia Festival of Science and Creativity – MAWHIBA – keynote speaker – Video

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Saudi Arabia Festival of Science and Creativity - MAWHIBA - keynote speaker
MAWHIBA festival of Science and Creativity - report by Futurist keynote speaker Patrick Dixon. Future of education, high schools and university in Saudi Arabia. Research into science. Encouraging...

By: Patrick Dixon Futurist Keynote Speaker for Industry Conference

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Saudi Arabia Festival of Science and Creativity - MAWHIBA - keynote speaker - Video

Futurist predictions about technology that actually came true

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6. Handheld technology

Beyonce takes a selfie Photo: Beyonce.com

If you thought the art of taking a perfect selfie was only practiced by the Instagram generation, think again.

Here are a few examples of when art inadvertently predicted the future.

5. Big Brother

George Orwell's 1984 Photo: Penguin/AP

OK, so the selfie may not have been predicted in ancient times, but George Orwell knew exactly what was going on back in 1949.

Big Brother is watching you, wrote the India-born author in his dystopian classic Nineteen Eighty-Four.

His vision of a surveillance society in which governments monitor and keep tabs on what we are doing is a reality today.

Big Brother on the big screen

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Futurist predictions about technology that actually came true